chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: the vaccine had excursion earlier today and was opened, vial was not stable. a child was given a dose from this; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a health care professional.   This case involves a 4 years old male patient who received 0.5 ml dose of IPV (VERO) lot P1E701M (Expiry date 09-Nov-2020) via intramuscular route in the right thigh on an unknown date.   The patient's medical history, past vaccinations and family history was not provided.  concomitant vaccinations included 5th dose of DTap, 2nd dose of Varivax and 2nd dose of MMR.  It was a actual medication error case due to incorrect product storage.  It was reported that excursion earlier today and was told Ipol open vial was not stable. She said she found out that a child was given a dose from this vial today.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Menactra was inadvertently administered/no AE; Initial information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 11 years old male patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that expired dose of Menactra was inadvertently administered/no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL).  On 13-Aug-2019, the patient received 1st dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5916AA and expiry date: 27-Jun-2019 via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired doses of IPOL; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA231643.  This case involves a 6 years old male patient who received an expired doses of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient received any concomitant vaccines during the same visit   On 09-Aug-2019, the patient received a single dose of suspect IPV (VERO) lot N16511M, exp date 02-Aug-2019  It was of actual medication error due to expired vaccine used..  It was unknown whether  adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired doses of IPOL; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA231643 and 2019SA233553 (same reporter).  This case involves a patient who received an expired doses of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient received any concomitant vaccines during the same visit   On 09-Aug-2019, the patient received a single dose of suspect IPV (VERO) lot N16511M, exp date 02-Aug-2019  It was of actual medication error due to expired vaccine used..  It was unknown whether  adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This is a spontaneous case from the, initially reported by a nurse to Merck National Service Center (reference number SEQ19-01885) on 07-Aug-2019, concerning a female patient of unknown age.  The patient's medical history included: Sjogren's disease. On an unspecified date in 2018 (reported as last year), the patient was administered unspecified Influenza vaccine [dose, route of administration, anatomical location, batch number, and expiry date: not reported] for an unknown indication. On an unspecified date, within 4 hours after vaccination, the patient experienced an anaphylactic reaction requiring hospitalization for an unspecified time in an unspecified hospital. On unspecified date (reported as four months ago) patient had partial hysterectomy due to unknown reasons, which required five units of blood or plasma. It was reported that Afluria could not be ruled out. Therefore, the product name was filed under miscellaneous (unspecified Influenza vaccine). The outcome of the event of anaphylactic reaction was not reported. The reporter assessed the case as serious (hospitalization and life threatening).  Company comment: The patient developed anaphylactic reaction, within 4 hours after vaccination with unspecified Influenza vaccine. Chronology is plausible. Information regarding concomitant drugs was not provided. Based on provided information, causal role of the suspect product is assessed as related.; Reporter's Comments: The patient developed anaphylactic reaction, within 4 hours after vaccination with unspecified Influenza vaccine. Chronology is plausible. Information regarding concomitant drugs was not provided. Based on provided information, causal role of the suspect product is assessed as related.
Age: 10.0
Sex: M
Vaccine: MNQ, TYP, YF, TYP, YF
Symptoms: Borrelia test negative, CSF culture negative, CSF glucose normal, CSF protein normal, CSF red blood cell count positive
Clinical narrative: 6 days of fever, vomiting, headache with CSF analysis with flucose 61, ptn 56, WBC 80 (44 segs, 9 lymphs, 47 monos), RBC 29, culture negative. meningitis/encephalitis PCR panel, arbovirus including West Nile negative, Lyme negative. Had CT scan at outside institution.  We requested Yellow fever serology and PCR from CSF specimen be sent to DH and CDC on 6/21  Of note: Re: types of vaccines above in #13 he received the following vaccines: yellow fever (unknown which type), meningococcal B and ACWY(unknown which one), and typhoid at a travel clinic.
Age: 10.0
Sex: M
Vaccine: MNQ, TYP, YF, TYP, YF
Symptoms: CSF test abnormal, CSF white blood cell count increased, CSF white blood cell differential, Computerised tomogram, Differential white blood cell count
Clinical narrative: 6 days of fever, vomiting, headache with CSF analysis with flucose 61, ptn 56, WBC 80 (44 segs, 9 lymphs, 47 monos), RBC 29, culture negative. meningitis/encephalitis PCR panel, arbovirus including West Nile negative, Lyme negative. Had CT scan at outside institution.  We requested Yellow fever serology and PCR from CSF specimen be sent to DH and CDC on 6/21  Of note: Re: types of vaccines above in #13 he received the following vaccines: yellow fever (unknown which type), meningococcal B and ACWY(unknown which one), and typhoid at a travel clinic.
Age: 10.0
Sex: M
Vaccine: MNQ, TYP, YF, TYP, YF
Symptoms: Full blood count, Headache, Lumbar puncture abnormal, Metabolic function test, Polymerase chain reaction
Clinical narrative: 6 days of fever, vomiting, headache with CSF analysis with flucose 61, ptn 56, WBC 80 (44 segs, 9 lymphs, 47 monos), RBC 29, culture negative. meningitis/encephalitis PCR panel, arbovirus including West Nile negative, Lyme negative. Had CT scan at outside institution.  We requested Yellow fever serology and PCR from CSF specimen be sent to DH and CDC on 6/21  Of note: Re: types of vaccines above in #13 he received the following vaccines: yellow fever (unknown which type), meningococcal B and ACWY(unknown which one), and typhoid at a travel clinic.
Age: 10.0
Sex: M
Vaccine: MNQ, TYP, YF, TYP, YF
Symptoms: Pyrexia, Viral test, Vomiting, West Nile virus test negative
Clinical narrative: 6 days of fever, vomiting, headache with CSF analysis with flucose 61, ptn 56, WBC 80 (44 segs, 9 lymphs, 47 monos), RBC 29, culture negative. meningitis/encephalitis PCR panel, arbovirus including West Nile negative, Lyme negative. Had CT scan at outside institution.  We requested Yellow fever serology and PCR from CSF specimen be sent to DH and CDC on 6/21  Of note: Re: types of vaccines above in #13 he received the following vaccines: yellow fever (unknown which type), meningococcal B and ACWY(unknown which one), and typhoid at a travel clinic.
Age: 10.0
Sex: M
Vaccine: MNQ, TYP, YF, TYP, YF
Symptoms: Flavivirus test positive
Clinical narrative: 6 days of fever, vomiting, headache with CSF analysis with flucose 61, ptn 56, WBC 80 (44 segs, 9 lymphs, 47 monos), RBC 29, culture negative. meningitis/encephalitis PCR panel, arbovirus including West Nile negative, Lyme negative. Had CT scan at outside institution.  We requested Yellow fever serology and PCR from CSF specimen be sent to DH and CDC on 6/21  Of note: Re: types of vaccines above in #13 he received the following vaccines: yellow fever (unknown which type), meningococcal B and ACWY(unknown which one), and typhoid at a travel clinic.
Age: 39.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second adult dose of Hepatitis A vaccine was given 16 days too soon. No adverse events reported.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Breath holding, Intensive care, Seizure
Clinical narrative: 16 mos male came in for wcc. Pt has history of breath holding spells. Has been followed by neurology and cardio for breath holding spells. Dtap, hib hep A vaccines ordered and given. Following vaccines pt had breath holding spell then seizure activity. O2 applied while waiting for EMS. Fire dept called pt transported to hospital and transferd to second hospital PICU where he is admitted.
Age: 58.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second adult dose of Hepatitis A vaccine was given 16 days too soon.  Rehab facility is in rural area, was unable to connect to internet or use cell phone to call my staff at County Health and Human Services, Immunizations clinic to verify date of last dose. No adverse events reported.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: I developed a severe head ache about 8 hours after the injections. After about 12 hours (the next day) I developed a rash that started around the top of my left bicep and expanded to cover my entire bicep region over the course of the day.  The rash is not in the region of the injection which was given in the deltoid muscle. The rash is warmer than surrounding skin and is tender to the touch and the bicep area aches.  Also, I was extremely fatigued the day following the injections, so much so that I could not stay awake and had to take a nap.  The injection was on Monday afternoon. It is now Thursday morning and I still have the rash. The headache and fatigue are now gone.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Somnolence
Clinical narrative: I developed a severe head ache about 8 hours after the injections. After about 12 hours (the next day) I developed a rash that started around the top of my left bicep and expanded to cover my entire bicep region over the course of the day.  The rash is not in the region of the injection which was given in the deltoid muscle. The rash is warmer than surrounding skin and is tender to the touch and the bicep area aches.  Also, I was extremely fatigued the day following the injections, so much so that I could not stay awake and had to take a nap.  The injection was on Monday afternoon. It is now Thursday morning and I still have the rash. The headache and fatigue are now gone.
Age: 42.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second adult dose of Hepatitis A vaccine was given 16 days too soon.  Rehab facility is in rural area, was unable to connect to internet or use cell phone to call my staff County Health and Human Services, Immunizations clinic to verify date of last dose. No adverse events reported.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever 102, chills and shivering, headache, body aches, nausea and vomiting, fatigue. (Two days lost work)
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 102, chills and shivering, headache, body aches, nausea and vomiting, fatigue. (Two days lost work)
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second adult dose of Hepatitis A vaccine was given 16 days too soon.  Rehab facility is in rural area, was unable to connect to internet or use cell phone to call my staff at Immunizations clinic to verify date of last dose. No adverse events reported.
Age: 41.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second adult dose of Hepatitis A vaccine was given 16 days too soon.  Rehab facility is in rural area, was unable to connect to internet or use cell phone to call my staff at Immunizations clinic to verify date of last dose. No adverse events reported.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Fatigue, Influenza like illness, Injected limb mobility decreased
Clinical narrative: rash on injection arm, swelling & heat at injection site, intense pain in injection arm rendering arm immobile, fever, chills, nausea, fatigue, loss of appetite, body aches. flu like symptoms. all symptoms lasted approximately 4 days. swelling and arm pain lasted up to a week. a bump is still felt at injection site on arm 2 weeks later. Treated with ibuprofen q4hrs.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain, Pain in extremity
Clinical narrative: rash on injection arm, swelling & heat at injection site, intense pain in injection arm rendering arm immobile, fever, chills, nausea, fatigue, loss of appetite, body aches. flu like symptoms. all symptoms lasted approximately 4 days. swelling and arm pain lasted up to a week. a bump is still felt at injection site on arm 2 weeks later. Treated with ibuprofen q4hrs.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash
Clinical narrative: rash on injection arm, swelling & heat at injection site, intense pain in injection arm rendering arm immobile, fever, chills, nausea, fatigue, loss of appetite, body aches. flu like symptoms. all symptoms lasted approximately 4 days. swelling and arm pain lasted up to a week. a bump is still felt at injection site on arm 2 weeks later. Treated with ibuprofen q4hrs.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received regarding a case in litigation, referring to a currently 74 year old female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 13-FEB-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pte was treated by a physician due to herpes zoster. The pte claimed that the damages ad a result of vaccination with zoster vaccine live (ZOSTAVAX) were injury to themselves and economic losses. At the time of the report, the outcome of herpes zoster was unknown. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable. The age group was captured as adult as per Shingrix indication.  An undisclosed amount of people have mentioned having flu-like symptoms following Shingrix vaccine. The reporter consented to follow up. This case has been linked with US2019146715, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Product supply issue
Clinical narrative: Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable. The age group was captured as adult as per Shingrix indication.  An undisclosed amount of people have mentioned having flu-like symptoms following Shingrix vaccine. The reporter consented to follow up. This case has been linked with US2019146715, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Erythema, Feeling of body temperature change
Clinical narrative: Patient is a 66 year old female who presents for evaluation of Allergy. reaction to Shingrix, her arm is red, it's better today than it was originally. Allergies in chart. Patient had received Varivax 4-5 years ago. Had no problem with the shot. Received Shingrix #1 5:30pm 8/7/19. Started having symptoms 24hrs later. Had chills, dizziness, weakness and felt hungry. Then felt cold and hot. Does not remember anything for 2 hours. After the 2 hrs realized that she had a very bad headache that she says was "10/10. Worse headache she ever had in her life" She took 2 Tylenol and went to sleep. Headache was gone when she awoke at 4am Saturday morning. All the flu like symptoms were gone. She had pain in her upper L arm.  Arm was bright fire red, swollen, hot to touch, painful to touch, but no pain to move arm. The redness covered all  outer aspect of left upper arm from base of deltoid down past elbow. Some of the redness has dissipated.  Redness extends now from base of deltoid to about 3 inches above elbow.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hunger, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Patient is a 66 year old female who presents for evaluation of Allergy. reaction to Shingrix, her arm is red, it's better today than it was originally. Allergies in chart. Patient had received Varivax 4-5 years ago. Had no problem with the shot. Received Shingrix #1 5:30pm 8/7/19. Started having symptoms 24hrs later. Had chills, dizziness, weakness and felt hungry. Then felt cold and hot. Does not remember anything for 2 hours. After the 2 hrs realized that she had a very bad headache that she says was "10/10. Worse headache she ever had in her life" She took 2 Tylenol and went to sleep. Headache was gone when she awoke at 4am Saturday morning. All the flu like symptoms were gone. She had pain in her upper L arm.  Arm was bright fire red, swollen, hot to touch, painful to touch, but no pain to move arm. The redness covered all  outer aspect of left upper arm from base of deltoid down past elbow. Some of the redness has dissipated.  Redness extends now from base of deltoid to about 3 inches above elbow.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient is a 66 year old female who presents for evaluation of Allergy. reaction to Shingrix, her arm is red, it's better today than it was originally. Allergies in chart. Patient had received Varivax 4-5 years ago. Had no problem with the shot. Received Shingrix #1 5:30pm 8/7/19. Started having symptoms 24hrs later. Had chills, dizziness, weakness and felt hungry. Then felt cold and hot. Does not remember anything for 2 hours. After the 2 hrs realized that she had a very bad headache that she says was "10/10. Worse headache she ever had in her life" She took 2 Tylenol and went to sleep. Headache was gone when she awoke at 4am Saturday morning. All the flu like symptoms were gone. She had pain in her upper L arm.  Arm was bright fire red, swollen, hot to touch, painful to touch, but no pain to move arm. The redness covered all  outer aspect of left upper arm from base of deltoid down past elbow. Some of the redness has dissipated.  Redness extends now from base of deltoid to about 3 inches above elbow.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased activity, Erythema, Injection site pain, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Sharp pain at time of injection high on left shoulder top of deltoid muscle.  Then just ache until 1 1/2 hours later and I could barely lift left arm without exclaiming in abrupt pain and deep ache in bicep and deltoid  increased over evening. Weakness in arm. Redness in an oval about 5" x 6" developed on upper arm developed late in evening and lasted overnight. Trouble putting arm into clothing sleeve or lifting items.  Soreness continued, disrupting sleep Aug. 8-10 and gradually dissipated.  Took Ibuprofen. Ache in injection area of left arm came back unexpectedly on August 15 night and lasted to afternoon of August 18. Then same arm pain-weakness lifting arm returned on overnight of August 20-21 and still occurring at this date August 22. Can barely use arm - much sleep disruption and activity diminished.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Sharp pain at time of injection high on left shoulder top of deltoid muscle.  Then just ache until 1 1/2 hours later and I could barely lift left arm without exclaiming in abrupt pain and deep ache in bicep and deltoid  increased over evening. Weakness in arm. Redness in an oval about 5" x 6" developed on upper arm developed late in evening and lasted overnight. Trouble putting arm into clothing sleeve or lifting items.  Soreness continued, disrupting sleep Aug. 8-10 and gradually dissipated.  Took Ibuprofen. Ache in injection area of left arm came back unexpectedly on August 15 night and lasted to afternoon of August 18. Then same arm pain-weakness lifting arm returned on overnight of August 20-21 and still occurring at this date August 22. Can barely use arm - much sleep disruption and activity diminished.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Tenderness
Clinical narrative: Redness, tenderness, and inflammation on the right arm (8" x 4") following Shingrix vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Onset of minor symptoms about 6 hrs after injection: soreness at site of injection and tiredness. About 10 hrs post injection: headache, nausea. About 12 hrs post injection and through the night: chills, fever, severe headache, stomach pain, severe muscle pain. 24 hours post injection: tiredness, headache, slight nausea.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Onset of minor symptoms about 6 hrs after injection: soreness at site of injection and tiredness. About 10 hrs post injection: headache, nausea. About 12 hrs post injection and through the night: chills, fever, severe headache, stomach pain, severe muscle pain. 24 hours post injection: tiredness, headache, slight nausea.
Age: 77.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: "CANNOT USE LEFT ARM, 5% OF NORMAL USE; VERY SORE"
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Menveo 0.5 ml on the Left Arm By MA on 8/20/2019 at 11:58 AM.  Patient was only given liquid component of the vaccine. Medical assistant did not reconstitute the liquid component with the powdered vaccine.  Menveo Lot# AMVA152A NDC-58160-955-09 Exp-07/31/2020 Manufacturer- GlaxoSmithKline
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever  after vaccination
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Posture abnormal, Vomiting
Clinical narrative: About 5 minutes after receiving vaccine, patient became light headed and had brief loss of consciousness- a few seconds. Was sitting in chair in waiting room and slumped over. After she regained consciousness and was given water, she vomited 1 time. BP was 98/60 and HR was 70 immediately after. Patient stated she felt fine shortly after vomiting. She stayed another 15 minutes in the clinic with no further events. Stated she felt normal before leaving.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Injection site erythema, Vomiting
Clinical narrative: -Redness at the site - vomiting/diarrhea RX; supportive care
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Vision blurred
Clinical narrative: Vision blurry  Onset approx 7-12-19 to present
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Localised infection
Clinical narrative: Patient's left arm was infected per doctor.  It looked red and inflammed. Patient is currently taking antibiotic( Keflex 500, Take one capsule by mouth 4 times a day)
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient reported back to the pharmacy on 8.22.19 to complain she has been experience muscle soreness and stiffness in the neck, shoulder, and arm areas for the past 3 weeks. Patient is not able to completely lift up left arm. She also was initiated on Metoprolol around the same time and was unsure if the pain could be attributed to the shot, medication, or combination of both.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Gait disturbance, Injection site pain, Pain
Clinical narrative: My reaction to the Shingrix vaccination was full body debilitating pain primarily in joints.  Became noticeable about 2 hours after injection and kicked in full force by about 8 PM that evening.  Lasted for about 20 hours before subsiding.  Initial sign was the expected muscle pain at injection site, which occurred within the first hour.   I don't recall how the pain progressed, as I was preoccupied.  I was up the entire night in severe burning, searing  head-to-toe pain.  Difficulty walking or sitting due to pain.  Remained flat in bed, in and out of sleep,  the remainder of the day on 08/18 until the pain subsided to a tolerable level in the early evening.  Called my physician.  No treatment.  She suggested that I do not get the 2nd shot, but I am leaning toward getting the shot as other family members have had shingles within the past 3 years.  Outcome:  No residual effects.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain in extremity, Tenderness
Clinical narrative: arm red and sore. slightly tender and inflammed
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Rash macular, Skin discolouration
Clinical narrative: PATIENT ARM IS BLACK AND BLUE WITH SPLOTCHY RASH
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 8/19/19 - Tingling down back of R leg into small toe -Off and On since 8/19/19 but has eased up 8/21/19 - Tingling/numbness in R thumb and index finger
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Staff LVN administering MMR-V and VZV incorrectly verified vaccines resulting in child receiving two administration doses on VZV. Child's parent(mother) was contacted by provider in clinic and informed of the vaccine error and informed of signs and symptoms of vaccines reactions and contact information. Follow to patient and parents was also provided 24 hours after vaccine administration and additionally will continue for 48 hours for follow nurse calls .
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Altered state of consciousness, Dizziness, Dry mouth, Fatigue, Headache
Clinical narrative: Sore right arm, headache, extremely tired, dry mouth, thirsty, nausea, retching, vomiting, severe right thigh cramping, incontinence, lightheadedness, feeling as if I were going to pass out.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Incontinence, Muscle spasms, Nausea, Pain in extremity, Retching
Clinical narrative: Sore right arm, headache, extremely tired, dry mouth, thirsty, nausea, retching, vomiting, severe right thigh cramping, incontinence, lightheadedness, feeling as if I were going to pass out.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Thirst, Vomiting
Clinical narrative: Sore right arm, headache, extremely tired, dry mouth, thirsty, nausea, retching, vomiting, severe right thigh cramping, incontinence, lightheadedness, feeling as if I were going to pass out.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; Received first dose at age 11 years old, received second dose at age 15 years old; This spontaneous report was received from a nurse prescriber and refers to a 15-year-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the 11-year-old patient, received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in June 2019, the 15-year-old patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effect was reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; second dose was administered 2/13/2019 and third dose was administered 8/5/2019 after first dose was administered 7 /2018 (unspecified date); This spontaneous report was received from a nurse and 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 in July 2018, the patient was vaccinated with first dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, lot# and expiration date were not reported) for prophylaxis. On 13-FEB-2019, the patient was vaccinated with second dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, lot# and expiration date were not reported) for prophylaxis. On 05-AUG-2019, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; the patient was inadvertently administered a dose of MMR II that was expired; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 16-AUG-2019, the patient was inadvertently vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N020922, expiration date: 01-AUG-2019 for prophylaxis (dose and route of administration were not reported). No adverse effect was reported.
Age: 14.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Loss of consciousness, Syncope
Clinical narrative: after 30 minutes, the patient had not regained consciousness; patient received her first dose of GARDASIL 9 and subsequently fainted; This spontaneous report was received from a medical assistant referring to a 14 year old female patient with asthma. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown by reporter.    On 15-AUG-2019, the patient was vaccinated with her first dose of the series with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R032768 (verified to be a valid lot number), expiration date reported and established as 31-AUG-2021, in her arm, as age-based recommendation. During this same visit, the patient also received meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO). Subsequent to vaccines administration, the patient fainted (syncope) and after 30 minutes, she had not regained consciousness (loss of consciousness); thus, she was taken to the emergency room. The patient was not admitted and was discharged this same day. The patient returned to the nurse's office on 16-AUG-2019 and reported there were no problems. It was unknown if any treatment was given for the adverse experiences or if any laboratory study was performed.  The causality assessment was not provided.  Upon internal review, syncope and loss of consciousness were considered medically significant event.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pruritus, Rash erythematous, Rash vesicular, Scab
Clinical narrative: Red Blisters / blisters all over the body; Red Blisters / blisters all over the body; Itching; Scabbing; Flu Like Symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 49Y35, expiry date 31st January 2020) for prophylaxis.   On 3rd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a week after receiving Shingrix, the patient experienced blistery rash, red rash, pruritus, scab and influenza-like symptoms. In August 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the blistery rash, red rash, pruritus and scab were unknown.   It was unknown if the reporter considered the blistery rash, red rash, pruritus, scab and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. Less than 2 weeks after receiving the vaccine, the patient experienced flu like symptoms that lasted for 2 days. The patient also experienced itching along with red blisters all over the body which started scabbing about a week later. No further details were provided. This case had been linked to the case US2019146724, reported by same reporter. In the document in narrative dose number was reported as 1st, but in structural field and database it was mentioned as 2nd, therefore kept as reported in database.
Sex: U
Vaccine: FLU4
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: drug allergy; This case was reported by a nurse via other manufacturer and described the occurrence of drug allergy in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included amoxicillin for an unknown indication and levofloxacin (Levaquin) for an unknown indication.   Concomitant products included pregabalin (Lyrica).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose, amoxicillin at an unknown dose and frequency and Levaquin at an unknown dose and frequency. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, amoxicillin and Levaquin, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown.   It was unknown if the reporter considered the drug allergy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient's Height was reported as 5'-06" and Weight: 130 lb. It was reported that the patient had drug allergies to Amoxicillin, Flu vaccine and Levaquin. It was unknown whether the reporter had consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: pain in arm; Chills; Aches; This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, chills and pain. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm, chills and pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, chills and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 61 years or 62 years. The patient received 1st dose of Shingrix 11 months before the date of reporting. The patient had been putting off 2nd dose of Shingrix because after 1st dose, the pain in arm, chills and aches made the patient miserable for 3 days. The patient informed the doctor and the doctor advised to receive 2nd dose. The patient also had the other vaccine about 8 years ago and asked about total effective resistance to shingles now without 2nd dose of Shingrix.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pain; Chills/Shivering; warm to touch at injection site area; Injection site rash; Redness at injection site; Swollen at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date 2nd October 2021) and (batch number 9235B, expiry date 29th November 2021) for prophylaxis.   On 9th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 9th August 2019, less than a day after receiving Shingrix, the patient experienced chills. On 12th August 2019, the patient experienced pain. In August 2019, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site rash. On an unknown date, the outcome of the injection site erythema, injection site swelling, pain, injection site warmth and injection site rash were unknown and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, chills, pain, injection site warmth and injection site rash to be related to Shingrix.  Additional information received were as follows: The pharmacist was called in to question to how to proceed and asked any information on how to get rid of this reaction. The healthcare professional stated that the patient experienced chills and shivering 1st night. Less than a week after receiving Shingrix, the patient experienced redness, swollen, rash warm to touch at injection site area. The healthcare professional stated that 3 days after receiving Shingrix, the patient appeared on the reporting date as rash was spreading rapidly and pain.  The adverse event was collected. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Pain; Chills/Shivering; warm to touch at injection site area; Injection site rash; Redness at injection site; Swollen at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date 2nd October 2021) and (batch number 9235B, expiry date 29th November 2021) for prophylaxis.   On 9th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 9th August 2019, less than a day after receiving Shingrix, the patient experienced chills. On 12th August 2019, the patient experienced pain. In August 2019, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site rash. On an unknown date, the outcome of the injection site erythema, injection site swelling, pain, injection site warmth and injection site rash were unknown and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, chills, pain, injection site warmth and injection site rash to be related to Shingrix.  Additional information received were as follows: The pharmacist was called in to question to how to proceed and asked any information on how to get rid of this reaction. The healthcare professional stated that the patient experienced chills and shivering 1st night. Less than a week after receiving Shingrix, the patient experienced redness, swollen, rash warm to touch at injection site area. The healthcare professional stated that 3 days after receiving Shingrix, the patient appeared on the reporting date as rash was spreading rapidly and pain.  The adverse event was collected. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pruritus, Rash erythematous, Rash vesicular, Scab
Clinical narrative: Red Blisters all over the body; Red Blisters all over the body; Itching; Scabbing; Flu Like Symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 49Y35, expiry date 31st January 2020) for prophylaxis.   On 3rd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced blistery rash, red rash, pruritus, scab and influenza-like symptoms. On an unknown date, the outcome of the blistery rash, red rash, pruritus and scab were unknown and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the blistery rash, red rash, pruritus, scab and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. Less than 2 weeks after receiving Shingrix, the patient experienced flu like symptoms that lasted for 2 days. The patient also experienced itching along with red blisters all over the body which started scabbing about a week later. No further details were provided. This case had been linked to the case US2019146721, reported by same reporter. In the XML document in narrative dose number was reported as 1st, but in structural field and system it was mentioned as 2nd, therefore kept as reported in system.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Product administered at inappropriate site
Clinical narrative: Malaise; Redness; Soreness; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   Concomitant products included DENOSUMAB (PROLIA).   On 9th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a week after receiving Shingrix, the patient experienced malaise, injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the malaise, injection site erythema, injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the malaise, injection site erythema, injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid. The pharmacist reported the patient contacted her at on the day of reporting with complaints of redness, soreness and swelling around the site of injection and that patient was not feeling well (malaise). Most of the redness was below the injection site. The patient told pharmacist that her oncologist said pharmacist injected arm too low. The reporter gave consent to follow up. The registered pharmacist consented to receive follow up from Safety, if desired.