chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Tactile fever; fatigue; Arm pain moderate; Arm swelling mild; This case was reported by a physician via sales rep and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix. On 14th August 2020, less than a day after receiving Shingrix, the patient experienced fever, fatigue, pain in arm and swelling arm. On 15th August 2020, the outcome of the fever was recovered/resolved. On 16th August 2020, the outcome of the fatigue, pain in arm and swelling arm were recovered/resolved.   The reporter considered the fever, fatigue, pain in arm and swelling arm to be probably related to Shingrix.  Additional details were provided as follows: The patient received the vaccine in left deltoid. Patient was not admitted to the hospital overnight or prolong an existing hospitalization. Health care professional did not consider the event(s) to be life threatening. Health care professional did not consider the event(s) to result in persistent or significant disability/incapacity. No surgical or medical intervention to prevent one of the outcomes described in preceding questions. The patient did not result in a congenital anomaly or birth defect. This case has been linked with case US2020AMR174130reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR174130:Same reporter (husband)
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Erythema, Pruritus
Clinical narrative: she developed a red; she developed a red, itchy; her right upper arm had an "outbreak of tiny blisters."/outbreak of tiny blisters" on her left abdomen/the same symptoms developed on her left upper thigh; diagnosed with dry skin; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included stress.   On 31st May 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced erythema of extremities, itchy upper limbs, blister and dry skin. On an unknown date, the outcome of the erythema of extremities, itchy upper limbs and blister were recovered/resolved and the outcome of the dry skin was unknown.   The reporter considered the erythema of extremities, itchy upper limbs, blister and dry skin to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and 2-3 weeks later she developed a red, itchy right upper arm.  She stated that next her right upper arm had an outbreak of tiny blisters and lasted for one day and resolved.  The patient stated that 1-2 weeks after that she developed another outbreak of tiny blisters on left abdomen resolved after a day then the same symptoms developed on her left upper thigh, lasting one day, and then back to her right upper arm, resolving after one day as well.  The patient stated that sought medical treatment and was diagnosed with dry skin and provided a cream to treat it.  The HCP told her that they felt this was not related to the Shingrix vaccine. The reporter did not consent to follow up. The reporter declined demographics and declined to provide further details for this AE.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: chills; joint soreness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 24th August 2020 08:00, the patient received the 2nd dose of Shingrix. On 24th August 2020, less than a day after receiving Shingrix, the patient experienced chills, soreness of joint and tiredness. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, soreness of joint and tiredness were recovering/resolving.   The reporter considered the chills, soreness of joint and tiredness to be related to Shingrix.  Additional details were reported as follows: The patient received his 2nd dose of Shingrix at 8 AM on 24th August 2020 in left deltoid. On same night, he developed chills, joint soreness and tiredness. On morning of 25th august 2020, he felt same so he took Tylenol. He was feeling better at time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Brain injury, Condition aggravated
Clinical narrative: worsens brain injury symptoms /previous brain injury felt a worsening of their brain injury condition after receiving the vaccine.; worsens brain injury symptoms; This case was reported by a consumer via call center representative and described the occurrence of brain injury in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included brain injury (had a previous brain injury).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced brain injury (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the brain injury and condition aggravated were unknown.   It was unknown if the reporter considered the brain injury and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but it was selected as adult as per the vaccine indication. The patient who had a previous brain injury felt a worsening of their brain injury condition after receiving the vaccine. The reporter did not consent to follow up. There are no additional details for this report.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Erythema multiforme
Clinical narrative: developed Erythem Multiform after receiving the 1st dose of Shingrix, a Gsk flu vaccine; This case was reported by a other health professional via call center representative and described the occurrence of erythema multiform-like eruption in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included multiple myeloma.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema multiform-like eruption (serious criteria GSK medically significant). On an unknown date, the outcome of the erythema multiform-like eruption was unknown.   It was unknown if the reporter considered the erythema multiform-like eruption to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix and Influenza vaccine, the patient experienced erythema multiform-like eruption. The patient had tested due to her medical history of Multiple myeloma not related to a vaccine. The reporter consented to follow up. This case was linked with case US2020AMR174273, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR174273:same patient
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Rash
Clinical narrative: received a group of vaccines and developed a full body rash; Redness; This is a spontaneous report from a contactable nurse and physician through a Pfizer sales representative.  A 4-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot. CW5294, Expiration date: Jun2022) at single dose; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine Inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) and rotavirus vaccine live reassort oral 5v (ROTATEQ); all on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced rash/redness described as "baby received a group of vaccines and developed a full body rash". Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives all over the body; Initial information was received on 26-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA232560, 2020SA230493 and 2020SA231710 (same reporter).  This case involves a male patient(age between 20-30 years) who experienced hives all over the body (urticaria), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given.   On an unknown date, the patient received 0.5 mL (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Pre-filled syringe) (lot UJ432AB and expiry date 30-Jun-2021) via unknown route in the deltoid(not otherwise specified) for prophylactic vaccination.  On an unknown date, the patient developed non-serious hives all over the body (urticaria) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was reported as unknown.
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: body aches; dizziness; fever; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA229965, 2020SA230493 and 2020SA231710 (same reporter).  This case involves an unknown demographic patient (age reported as between 20-30 year) who experienced dizziness, fever (pyrexia) and body aches (pain), while received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (dosage form: pre-filled syringes) (lot UJ432AB and expiry date: 30-Jun-2021) via an intramuscular route in the deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious dizziness, fever (pyrexia) and body aches (pain) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of this report, event outcome was not reported (unknown).
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pyrexia, Vertigo
Clinical narrative: significant vertigo; fever of 100.8 F; Headache; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient (age not reported) who experienced fever of 100.8 F (Fahrenheit) (pyrexia), significant vertigo (vertigo) and headache, while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  On 24-Aug-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (dosage form: prefilled syringe) (lot UJ432AB and expiry date was not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever of 100.8 F (pyrexia), significant vertigo (vertigo) and headache (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included: Body temperature - On an unknown date: 100.8 F  Details of laboratory data was not reported.  The patient was treated with PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL [IBUPROFEN]).  At the time of this report, outcome of the event was not reported (unknown).
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain during injection, increased pain 3 days after injection and muscle/joint pain 2 weeks after.  My left arm continues to hurt, especially if I try to raise or lift anything.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pollakiuria, Pyrexia
Clinical narrative: Fever, chills, nausea, headache.  plus frequent urination.  thought I had UTI -didn't.  Because of Covid I had a covid test which came back negative
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: Fever, chills, nausea, headache.  plus frequent urination.  thought I had UTI -didn't.  Because of Covid I had a covid test which came back negative
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Induration
Clinical narrative: 2 CM X 2CM ERYTHEMA WITH INDURATION
Sex: F
Vaccine: PPV
Symptoms: Injection site discharge
Clinical narrative: oozing from the injection site; This spontaneous report was received from a medical assistant and refers to a 67-year-old, non-pregnant female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly (exact dose, injection site, lot # and expiration date were not provided) for routine vaccination.  On 24-AUG-2020, she experienced oozing from the injection site. No treatment was given for the event. On the same date, the patient recovered (reported as no issue).  The relatedness between the event and the suspect vaccine was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: the patient received an expired dose of Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.   On 28-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) 0.5 ml, lot number S002496 was verified to be valid, expiration date reported and validated as 23-JUL-2020 (route of administration was not provided) for prophylaxis.   It was not reported if the patient experienced any additional adverse effects.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Abdominal pain upper, Dizziness, Headache, Pyrexia
Clinical narrative: patient received flu vaccine at approximately 2pm.  She "jumped" off the table and left with her dad. Dad called the office at around 240pm to report that after they left the office and got on the elevator, pt reported "feeling light-headed and having stomach pains like she had period cramps".  During this call, dad reported the patient was feeling better. It was advised that dad monitor the patient and injection site. dad was agreeable to the plan.  Later that night, around 8pm, dad called out after hours service and got the on-call doctor, Dr. dad reported a fever of 103 and pain to back of head. Denied neck pain and had full ROM without pain to neck. no photophobia and some mild abnominal pain and dizziness. She has not had any known contact with anyone who was sick.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Muscle spasms, Pyrexia, Seizure like phenomena, Tremor, Vaccine positive rechallenge
Clinical narrative: Fever and seizure like activity (body spasms, eye closing, shaking) that persisted only for 24-48 hours after the vaccines. Also, seen at a lesser degree after the 4 month vaccines prior to this although unknown if they were related to the vaccines until the second occurrence. These symptoms ONLY occur on the dayof and day following the vaccine administration
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Peripheral swelling, Skin warm
Clinical narrative: Within hours of getting vaccine, patient developed cellulitis in right arm,, which included moderate, swelling, and hot to touch.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Soreness at injection site moderate. Low grade fever (99.5) starting around 9pm on the evening of vaccination. Chills. Fever resolved during the night. Also received a seasonal flu shot at the same time in the opposite arm. Not sure of the exact vaccine which is why I did not select one for your drop down menu.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Dizziness, Erythema
Clinical narrative: Aproximately 22 hrs after the Recombinant zoster (shingles) vaccine  I had adverse reactions. Fever, headache , chills,  upset stomach with diarrhea .  Felt extremely light headed and nauseaous. Almost passed out when standing up. Stayed in bed all day and rested.  Vaccine was administered to left arm, , 48 hours later , it is still, swollen, sore to touch and red.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Aproximately 22 hrs after the Recombinant zoster (shingles) vaccine  I had adverse reactions. Fever, headache , chills,  upset stomach with diarrhea .  Felt extremely light headed and nauseaous. Almost passed out when standing up. Stayed in bed all day and rested.  Vaccine was administered to left arm, , 48 hours later , it is still, swollen, sore to touch and red.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Dizziness, Eye movement disorder, Hypotonia, Loss of consciousness
Clinical narrative: 0905 - While giving dismissal instructions to grandmother and client (about 30 seconds after vaccine administration), RN noticed client's eyes roll back in head and loss of consciousness. Client's body went rigid to the point of standing up out of chair. RN supported client as client's upper body involuntarily spasmed 4 times before body going limp. As RN eased client into a comfortable sitting position, client regained consciousness. Client appeared confused but alert x 4. Client stated being dizzy. Offered water and graham crackers, client refused. Circulated air with floor stand fan. Client stated had a waffle for breakfast. Client stated had not passed out with vaccinations before but had a syncopal episode once after physical exertion from running from her house to grandparents' house and back on a hot summer day. Offered water again, client declined. Had client wait in clinic 15 minutes. Client stated feeling better, less dizzy. Client escorted from clinic by grandparents, walked with a steady even gait.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Muscle rigidity, Muscle spasms
Clinical narrative: 0905 - While giving dismissal instructions to grandmother and client (about 30 seconds after vaccine administration), RN noticed client's eyes roll back in head and loss of consciousness. Client's body went rigid to the point of standing up out of chair. RN supported client as client's upper body involuntarily spasmed 4 times before body going limp. As RN eased client into a comfortable sitting position, client regained consciousness. Client appeared confused but alert x 4. Client stated being dizzy. Offered water and graham crackers, client refused. Circulated air with floor stand fan. Client stated had a waffle for breakfast. Client stated had not passed out with vaccinations before but had a syncopal episode once after physical exertion from running from her house to grandparents' house and back on a hot summer day. Offered water again, client declined. Had client wait in clinic 15 minutes. Client stated feeling better, less dizzy. Client escorted from clinic by grandparents, walked with a steady even gait.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Blood culture negative, Body temperature increased, Chest X-ray normal, Decreased appetite, Full blood count normal
Clinical narrative: 105.3 rectal temperature. He was vomiting and not eating well. This was the evening that vaccines were given. The next day our office called for an update in the morning and afternoon. 8/27/2020 11:30 am- "Mom took him to ED last night at 8 pm as she thought he appeared lethargic and T was 105.3. Mom notes that they gave him Tylenol in ED, monitored him for a short while and was discharged to home.  Today T is 98.7. He is eating well. Interactive when mom talks with him and seems to be doing well." 8/27/2020  3:00 pm- "Mom said fever went to 102.8 today, and she gave tylenol. It has come down to 100.7. Patient is doing some better today. Instructed mother we will fill out a form for Vaccine reaction. Please let us know if fever goes above 103 again. Please continue to treat fever though. Also let us know if the fever goes longer than 72 hr."  Notes in chart on 8/28/2020 9:00 am - "101.2 rectal temp. Patient is alert and happy and eating without vomiting. Having adequate wet diapers. No rashes noted. T will go down to 99 with Tylenol. Mom denies any respiratory or other symptoms at this time, solely intermittent fever. "
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Influenza virus test negative, Lethargy, Metabolic function test, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: 105.3 rectal temperature. He was vomiting and not eating well. This was the evening that vaccines were given. The next day our office called for an update in the morning and afternoon. 8/27/2020 11:30 am- "Mom took him to ED last night at 8 pm as she thought he appeared lethargic and T was 105.3. Mom notes that they gave him Tylenol in ED, monitored him for a short while and was discharged to home.  Today T is 98.7. He is eating well. Interactive when mom talks with him and seems to be doing well." 8/27/2020  3:00 pm- "Mom said fever went to 102.8 today, and she gave tylenol. It has come down to 100.7. Patient is doing some better today. Instructed mother we will fill out a form for Vaccine reaction. Please let us know if fever goes above 103 again. Please continue to treat fever though. Also let us know if the fever goes longer than 72 hr."  Notes in chart on 8/28/2020 9:00 am - "101.2 rectal temp. Patient is alert and happy and eating without vomiting. Having adequate wet diapers. No rashes noted. T will go down to 99 with Tylenol. Mom denies any respiratory or other symptoms at this time, solely intermittent fever. "
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Vaccination complication, Vomiting
Clinical narrative: 105.3 rectal temperature. He was vomiting and not eating well. This was the evening that vaccines were given. The next day our office called for an update in the morning and afternoon. 8/27/2020 11:30 am- "Mom took him to ED last night at 8 pm as she thought he appeared lethargic and T was 105.3. Mom notes that they gave him Tylenol in ED, monitored him for a short while and was discharged to home.  Today T is 98.7. He is eating well. Interactive when mom talks with him and seems to be doing well." 8/27/2020  3:00 pm- "Mom said fever went to 102.8 today, and she gave tylenol. It has come down to 100.7. Patient is doing some better today. Instructed mother we will fill out a form for Vaccine reaction. Please let us know if fever goes above 103 again. Please continue to treat fever though. Also let us know if the fever goes longer than 72 hr."  Notes in chart on 8/28/2020 9:00 am - "101.2 rectal temp. Patient is alert and happy and eating without vomiting. Having adequate wet diapers. No rashes noted. T will go down to 99 with Tylenol. Mom denies any respiratory or other symptoms at this time, solely intermittent fever. "
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Poor quality sleep
Clinical narrative: Pain and soreness in area of shot, overnight mild fever (restless sleep), muscle aches, mild headache, fatigue (especially the following day)
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain and soreness in area of shot, overnight mild fever (restless sleep), muscle aches, mild headache, fatigue (especially the following day)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy, bumpy rash on my stomach -- started Friday morning by Saturday became about 3" by .5" -- called doctor's office talked with an on-call RN who recommended ice and 1% hydrocortisone cream  Still resolving -- it is shrinking and the itchiness has subsided
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception, Irritability, Lethargy, Ultrasound abdomen, Vomiting
Clinical narrative: On 8/25/2020 - Over 24 hours, Patient had vomiting, fussiness, lethargy that progressed to bilious vomiting.  He was found to have intussusception.  This has been previously linked to the Rotavirus Vaccine.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Rash
Clinical narrative: Patient called 9/2/20 to report that he had shortness of breath on 9/1/20, but that it was resolved today.  He also reported that a rash started on his arms on 9/1/20 and continues today.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received Shingrix vaccine on 8/11/20. The vaccine was given approximately 2 inches down from the shoulder according to the pharmacist. The patient stated that she had pain at the time of injection, and the pharmacist recommended that the patient use an ice pack to help with swelling or pain at the site of the injection. The next day the patient reported to the pharmacist on duty that she was experiencing shoulder pain and immobility. The patient believed that the vaccine was injected too high in her arm. The pharmacist counseled the patient to take ibuprofen for pain and utilize ice packs. The patient stated she was seen in Employee Health, but there is no recorded encounter in the medical record to investigate further. She contacted her physicians office and stated she was unable to lift her right arm to shoulder height nor was she able to carry anything with it.  She was taking 800 mg Ibuprofen TID along with 1000 mg Tylenol BID and applying ice 4 times daily. They physician advised on Thursday  8/13 the patient should follow up if not resolved by Monday. No follow up shown in chart.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip erythema, Lip pain
Clinical narrative: Soreness, pain and redness of upper lip.  Patient reported very sore and painful for 2 weeks after vaccination and then soreness/pain lessened.  Still has some redness and soreness 70 days later.  Patient applied vaseline to area.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored temperature excursion; This spontaneous report as received from a physician 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 06-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status rHA, lot # S020160, expiration date 30-JUN-2021 (dose and route of administration were not reported) for prophylaxis and wit improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # S038175, expiration date 26-NOV-2021 (dose and route of administration were not reported) for prophylaxis. The administered doses of vaccines experienced temperature excursion of 50 degrees Fahrenheit (F), 6 F to 14 F (10 F) for 1 hour and 15 min, 15 F to 46 F (44.8 F) for 1 hour and 30 min, 47 F to 77 F (50 F) for 2 hours and 30 min. There was no previous temperature excursion reported. Digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion on PROQUAD reported lhat a dose was administered to a patient; 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 an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 ml, lot # S017256, expiration date 01-DEC-2020 (dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine experienced temperature excursion of - 13.7 degrees Celsius for 24 min. There was no previous temperature excursion reported. Digital data logger was involved.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: expired vaccine was administered; This spontaneous report was received from a physician and refers to a patient of unknown age (reported as 26 (unit not provided)) and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 28-AUG-2020, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S021729, expiration date 20-AUG-2020 (strength, dose, site and route of administration were not provided) for prophylaxis (expired product administered). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021729; expirationdate: 20-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: there have been doses administered/temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On an unspecified date in August 2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) 0.5 ml, lot number S031882 was verified to be valid, expiration date reported and validated as 07-APR-2021 (route of administration was not provided) for prophylaxis.  On 17-AUG-2020, the administered dose of vaccine experienced a temperature excursion of -14 to -10 Celsius degrees (maximum -9.5 Celsius degrees) intermittently for 38 hours and 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved.  It was not reported, if the patient experienced any additional adverse reactions.
Sex: M
Vaccine: TDAP
Symptoms: Foetal exposure during pregnancy, Jaundice neonatal, Poor feeding infant
Clinical narrative: jaundice; Drug exposure in utero; issues with latching; This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of jaundice in a male patient exposed to DTPa (Reduced antigen) (Boostrix) in utero. The mother received the product for prophylaxis.   On 30th December 2019, the 31-year-old mother received Boostrix. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed to Boostrix at an unknown time during the pregnancy. At 37 weeks gestation, the patient was born via vaginal delivery and weighed 3260 grams (7lbs 3oz) at birth. The patient was diagnosed with jaundice (serious criteria hospitalization) and breast feeding problem (infant). On an unknown date, the patient experienced drug exposure in utero. On an unknown date, the outcome of the jaundice was recovered/resolved and the outcome of the breast feeding problem (infant) and drug exposure in utero were unknown.   It was unknown if the reporter considered the jaundice and breast feeding problem (infant) to be related to Boostrix.     See case US2020172562 for details regarding the mother case.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that the patient's mother received Boostrix vaccine on 30th December 2019 at 33 weeks gestational age, two weeks after receiving the vaccine the patient's mother developed gestational high blood pressure.  The mother first high blood pressure reading was 130/81 and had the other blood pressure readings. At 37 weeks the patient's mother was sent to the hospital for an induction due to continued high blood pressure.  The mother had a normal delivery of a baby boy with a birth weight of 7lbs 3 oz. The patient and mother were in the hospital for three days due to baby being jaundice and having issues with latching. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020172562:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Migraine
Clinical narrative: migraine headaches/jr. migraine headaches; This case was reported by a consumer via interactive digital media and described the occurrence of migraine headache in a child patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced migraine headache. On an unknown date, the outcome of the migraine headache was recovered/resolved.   It was unknown if the reporter considered the migraine headache to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had DTP as a child, the patient was diagnosed with jr. migraine headaches at age 7.  The patient reported that the event didn't resolve until about age 25 when the patient used an elimination diet of food additives food colorings, vitamins, herbs, yoga, and chiropractic treatments. The patient asked if the vaccine could cause migraine in children.
Age: 54.0
Sex: M
Vaccine: PNC, VARZOS
Symptoms: Fatigue, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: fatigue; Tactile fever; Arm pain MODERATE; Arm swelling mild; This case was reported by a physician via sales rep and described the occurrence of fatigue in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received PREVNAR. On 14th August 2020, less than a day after receiving Shingrix, the patient experienced fatigue, fever, pain in arm and swelling arm. On 15th August 2020, the outcome of the fever was recovered/resolved. On 16th August 2020, the outcome of the fatigue, pain in arm and swelling arm were recovered/resolved.   The reporter considered the fatigue, fever, pain in arm and swelling arm to be probably related to Shingrix.  Additional details were provided as follows: The case was reported by the physician for himself. The patient received the vaccine to prevent herpes zoster. The patient was not admitted to the hospital overnight or prolong an existing hospitalization. The Health care professional did not consider the events to be life threatening. The health care professional did not consider the events to result in persistent or significant disability and incapacity. No surgical or medical intervention to prevent one of the outcomes described in preceding questions. The patient did not result in a congenital anomaly or birth defect. This case has been linked with case US2020AMR174300 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR174300:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: Lethargic; Vomiting; Nausea; Chills; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of lethargy in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced lethargy, vomiting, nausea, chills and fever. On an unknown date, the outcome of the lethargy, vomiting, nausea, chills and fever were unknown.   It was unknown if the reporter considered the lethargy, vomiting, nausea, chills and fever to be related to Shingrix.  Additional details were provided as follows: The expiry date was updated from 26th March 2020 to 26th March 2022, as per sales data sheet. The age at vaccination was not reported. The Caller was the pharmacist reporting the AE for a patient.  The patient received Shingrix and had lethargic, had fever and chills, and nausea and vomiting. Limited information was known about the resolution of the symptoms. The HCP information not provided. This case linked with US2020173751, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020173751:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: Vomiting; Nausea; Lethargy; Chills; Fevers; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced vomiting, nausea, lethargy, chills and fever. On an unknown date, the outcome of the vomiting, nausea, lethargy, chills and fever were unknown.   It was unknown if the reporter considered the vomiting, nausea, lethargy, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Pharmacist calling to report and mentioned a 2nd male that was with the first reported adverse event. The patient received Shingrix and had lethargic, had fever and chills, and nausea and vomiting. Limited information was known about the resolution of the symptoms. The HCP information not provided. Only initials and gender were provided for this patient as he did not receive the injection in the Pharmacist, that called pharmacy. This case linked with US2020173785, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020173785:same reporter
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itchiness at the injection site; swelling at the injection site; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA232560, 2020SA229965 and 2020SA231710 (same reporter).  This case involves a female patient (aged 20-30 years) who experienced itchiness at the injection site (vaccination site pruritus) and swelling at the injection site (vaccination site swelling), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given.   On an unknown date, the patient received 0.5 mL dose (once) of suspect INFLUENZA QUADRIVAL A-B VACCINE (Pre-filled syringes) (lot UJ432AB and expiry date 30-Jun-2021) via unknown route in the deltoid(not otherwise specified) for prophylactic vaccination.  On an unknown date, the patient developed non-serious itchiness at the injection site (vaccination site pruritus) and swelling at the injection site (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was reported as unknown.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry mouth, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Achy, Sore at the shot site, dry mouth, unable to function
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Palpitations, Papule, Paraesthesia, Urticaria
Clinical narrative: Hives starting about seven hours after injection.  Started on sides of chest and abdomen as red bumps that itched.  Went to bed and about six or seven hours later awoke to find my whole chest and abdomen covered in hives.  Heart was racing and felt tingly all over.  Took pictures of hives for doctor. Took an antihistamine and went back to sleep.  Upon awakening the hives were gone.  Called doctors office to report.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient's entire upper arm was dark red and noticeably swollen.  He stated that he hadn't experienced any changes in his already troubled breathing and that it was just local to the site of injection
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Rash, Rash macular
Clinical narrative: about 1/2 h after receiving his IZ while still at the office patient showed called me to the room due to red dots on his palms.   I examined his skin from head to soles of his feet. Only skin finding was blanching fine erythematous macule on both palms. No raised lesions. No tenderness or swelling. He did not c/o itchiness or pain and had no tenderness to area.   I asked him to stay in office for observation. Rechecked 7 minutes later and rash was less red. Checked again at 15 minutes and rash had almost completely resolved. He developed no other symptoms. He was allowed to leave with staff member from the facility who I informed of rash and resolution. Advised to seek care if rash returned. Emergent care in unlikely event of SOB,lethargy, hives.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Dry mouth, Fatigue, Headache, Malaise
Clinical narrative: severe headache, fatigue, dry mouth, generalized malaise began the evening of the administration. Teen took Tylenol and oral fluids. When mother called, she was advised to seek medical attention if symptoms persist.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: patient's husband cal;led on 9/2/20 at 12pm to report that his wife experienced a high fever (no number was divulged) and shivering in the middle of the night that was resolved with 2 ibuprofen otc
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Cardiovascular examination, Injection site reaction, Neuralgia
Clinical narrative: Patient said "nerve pain started in arm and extended to shoulder and collar bone area on the same side as shot received"
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient reported back to the pharmacy at 9:25am with his wife indicating he fainted twice. He sat in our lobby and was given water and orange juice. He was evaluated every 10 minutes for symptoms. at 9:51 he was asked to stay for 10 more minutes, but he elected to leave with his wife going to his house.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Nausea
Clinical narrative: Nausea, chills, dizzy for about 24 hours
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Wrong product administered
Clinical narrative: Administration error: RN administered Adult dose Havrix Hep A to patient who was 16y11mo of age. Pt tolerated vaccine well. Error recognized next day by clinic staff. RN reached pt by phone to let her know about error and assess for any adverse effects. Pt reported that her arm was sore after injection but soreness was tapering off. Pt verbalized understanding of error and denied further questions/concerns.
Age: 56.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of Hep A and Hep B. Patient needs an adult dose will have to have one more dose of each vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Intense pain at injection site, low grade fever, chills, headache, achiness all over, fatigue,
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Intense pain at injection site, low grade fever, chills, headache, achiness all over, fatigue,
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Feeling hot, Pain
Clinical narrative: Soon after receiving the vaccine and on the car ride home, the patient began to feel hot. Later at home in the evening, she experienced chills, aches, and weakness. This morning she reports the symptoms fading and asked if she could take Tylenol. I advised her it was a good option for her symptoms. No reported fever. I advised her to monitor herself for a fever, and to contact the doctor if her symptoms persist for more than 2-3 days or if they worsen. I will follow up with a phone call in one week.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Pyrexia
Clinical narrative: As per patient stated to MD fever and sore arm at the site of Bexero.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Chronic low grade fever for 3 weeks
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion on V ARIV AX reported that a dose was administered to a patient; 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 an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, lot # S028921, expiration date reported as 15-SEP-2021, but upon internal validation established as 16-SEP-2021(dose and route of administration were not reported) for prophylaxis. The administered dose of vaccine experienced temperature excursion of -13.7 degrees Celsius for 24 min. There was no previous temperature excursion reported. Digital data logger was involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No other AE/PQC reported; HCP reports a 65 year old patient was given PNEUMOVAX 23 instead of PREVNAR 13; This spontaneous information has been received from a medical assistant, concerning a 65-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On 23-AUG-2020, the patient was vaccinated pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter intramuscularly as prophylaxis, lot number P007790 with expiration date 03-DEC-2021 (strength and anatomical location were not provided) instead of pneumococcal 13v conj vaccine (CRM197) (PRENAR 13) (wrong vaccine administered).  No adverse events were reported.