chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination, Product dose omission
Clinical narrative: started Rabies vaccine in 2016. She did not continue it; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient (age not reported) who started RABIES (HDC) VACCINE [IMOVAX RABIES] (number not reported via unknown route in unknown administration site) on an unknown date of 2016 and the patient did not continue it later with the other doses.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It is an actual medication error case due to missed dose.  It was unknown whether the patient had any adverse event or not.  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: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: Two patients had been vaccinated with vaccines which were shipped on May 22 and received May 28, vaccines were too long in transit packed for 2 day shipping/No AE; Initial and additional information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157728 (sibling).  This case involves a 14 years old male who was vaccinated with a 0.5ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] which were shipped on may 22 and received may 28, vaccines were too long in transit packed for 2 day shipping lot P2A89, Expiration Date: 14-Sep-2020 via unknown route in unknown administration site on 30-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  Patients have no reported adverse events at this time.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: two ActHIB vaccines were inadvertently administered from a shipment package that experienced a delayed transit time/ no AE; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via phone.  This case is linked to case 2019SA157837 (same reporter).  This case involves a 6 months old male patient who was vaccinated with 0.5 ml third dose of HIB (PRP/T) VACCINE [ACT-HIB] (Batch number: UJ128AAB and expiry date: 08-Nov-2020) via intramuscular route in the left thigh on 31-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE); DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) on an unknown date.  It was a case of actual medication error due to deteriorated drug administered.  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 holders 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.   Documents held by the sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Adacel immunization from shipment that was too long in transit / no adverse event; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 5 patient (with an unknown demographic) who was vaccinated with dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and Expiry date unknown) via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error due to incorrect product storage. It was reported that 5 patients who received Adacel immunization from shipment that was received last week that was too long in transit.  It was not reported that if any adverse reaction was experienced or not.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: inflammation and swelling at the injection site; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA157325, 2019SA157349 and 2019SA157350.  This case involves a 51 years old female patient who experienced inflammation and swelling at the injection site, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-May-2019, the patient received a first  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5609AA (Expiry date 04-Apr-2021) via intramuscular route in the right deltoid.  On an unknown date, the patient developed a non-serious inflammation and swelling at the injection site (vaccination site inflammation) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was inflammation and swelling at the injection site.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for inflammation and swelling at the injection site.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: swelling at the injection site; inflammation at the injection site; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case is linked to cases 2019SA157325, 2019SA157348 and 2019SA157350 (same reporter).  This case involves a male patient of unknown age who experienced swelling and inflammation at the injection site, while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered by patient on that day.  On 23-May-2019, the patient received a second dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5609AA and Exp. Date 04-Apr-2021) via intramuscular route in the right deltoid.  On an unknown date, the patient developed swelling at the injection site (vaccination site swelling) and inflammation at the injection site (vaccination site inflammation) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of lab data not reported.  Final diagnosis was inflammation and swelling at the injection site.   It was not reported if the patient received any corrective treatment.  The outcome of events not reported.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: inflammation and swelling at the injection site; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2019SA157325.  This case involves a female patient of unknown age who experienced inflammation and swelling at the injection site, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-May-2019, the patient received 1st dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5609AA and expiry date: 04-Apr-2021 via intramuscular route in the right deltoid.   On an unknown date, following the vaccination the patient experienced injection site inflammation.  (Other relevant tests included no lab data.)  Final diagnosis was Injection site inflammation.  It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as unknown at the time of reporting.  List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: a 10 years old patient had been vaccinated with vaccine which was shipped on May 22 and received May 28, too long in transit/No AE; Initial and additional information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA156956 (sibling).  This case involves a 10 years old male who was vaccinated with a 0.5ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] which was shipped on 22-May-2019 and received on 28-May-2019, vaccine was too long in transit (lot P2A89, Expiration Date: 14-Sep-2020) via unknown route in unknown administration site on 30-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage. It was reported that vaccine was only packed for 2 day shipping and it was 5 days.  Patient did not have any adverse events at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Swelling, fever redness.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Rash
Clinical narrative: Patient stated that she has a rash on her chest and that the arm in which she received the vaccine is numb and has not improved since the beginning of symptoms.  I spoke with the patient last on 06/10/2019 and was informed of the incident.  I informed that patient that she should contact her PCP and see if they would like her to come in to their office for further investigation.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Periarthritis
Clinical narrative: client came in the clinic today to receive his 3rd twinrix.   He stated he was diagnosed with frozen shoulder  from the previous time he was at the clinic.  He is unsure if it was from this visit or the prior visit 12/07/1018.   He also went bowling.  Client has been in therapy for his arm to strengthen and to regain range of motion.   At the previous visit 12/07/2018 he received the influenza vaccine in the left deltoid.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Autism spectrum disorder, Decreased eye contact, Developmental regression
Clinical narrative: My son suffered a seizure following MMR/Varicella vaccination approx. 7-10 days after injections. He used to repeat words/phrases and exhibit typical infant behavior. Following these vaccinations he severely regressed, lost all words/sounds he had previously gained and lost eye contact. He developed quirky behaviors ie head butting, grimacing and wincing and also OCD behaviors. Shortly following my son's 2nd Birthday, he was seen by a developmental pediatrician and diagnosed with ASD.  He is currently receiving through early intervention, including Speech and Occupational Therapy 4x/week.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Grimacing, Head banging, Obsessive-compulsive disorder, Seizure
Clinical narrative: My son suffered a seizure following MMR/Varicella vaccination approx. 7-10 days after injections. He used to repeat words/phrases and exhibit typical infant behavior. Following these vaccinations he severely regressed, lost all words/sounds he had previously gained and lost eye contact. He developed quirky behaviors ie head butting, grimacing and wincing and also OCD behaviors. Shortly following my son's 2nd Birthday, he was seen by a developmental pediatrician and diagnosed with ASD.  He is currently receiving through early intervention, including Speech and Occupational Therapy 4x/week.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient was out of town and stopped into a local pharmacy. She was advised to go to urgent care. Her arm had grown increasingly red, swollen, painful. Per information from patient, MD at urgent care wasn't sure if she had developed cellulitis or was experiencing a reaction.  She was prescribed Doxycycline and Prednisone.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Diarrhoea, Irritability, Rash generalised
Clinical narrative: Temp on 6/6/2019 101 then rash from head to toe, loose stools, cranky
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abscess, Crying, Injection site bruising, Injection site erythema, Injection site mass
Clinical narrative: Mom states that patient developed a lump and a bruise in his left thigh at the MMRV injection site shortly after vaccination.  The lump and bruise were present for 1 month before the bruise resolved, but the lump remained. Last week, the area turned red and a scab appeared. Patient was seen in our office today by DR, diagnosed with an abscess and is being treated with a topical OTC antibiotic.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site scab, Pain, Pain in extremity
Clinical narrative: Mom states that patient developed a lump and a bruise in his left thigh at the MMRV injection site shortly after vaccination.  The lump and bruise were present for 1 month before the bruise resolved, but the lump remained. Last week, the area turned red and a scab appeared. Patient was seen in our office today by DR, diagnosed with an abscess and is being treated with a topical OTC antibiotic.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: I saw this 4-year-old child for infection in her lateral left thigh which developed at the site of 4 year vaccine injection.  The painful swelling persisted for over 2 months so she was instructed to bring her in for evaluation.  It is my impression that this is in injection site infection.  I have started therapy and I will be following her up closely.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: excessive vomiting
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Coordination abnormal, Dyskinesia, Dystonia, Erythema
Clinical narrative: Within 12 hours patient had redness and swelling in her left ankle was red and hot and swollen despite no injury and no unusual activity.  It was very hard to walk on it and quite painful.  She ended up seeing our office and podiatry and physical therapy and had an MRI.   Within a couple of weeks of that the redness and swelling settled down, but she developed dystonia and lost coordination of her gait--her leg would not move as expected as she was trying to walk and would unpredictably flex/spasm or relax and buckle at inappropriate intervals while walking.  Physical Therapy felt she had a neurologic rather than musculoskeletal etiology. By the end of April after therapy her dystonia begin to remit at times though again unpredictably.  Patient really has not been able to walk effectively and without pain since the day of the injection 4 months ago.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Joint swelling, Nuclear magnetic resonance imaging, Skin warm
Clinical narrative: Within 12 hours patient had redness and swelling in her left ankle was red and hot and swollen despite no injury and no unusual activity.  It was very hard to walk on it and quite painful.  She ended up seeing our office and podiatry and physical therapy and had an MRI.   Within a couple of weeks of that the redness and swelling settled down, but she developed dystonia and lost coordination of her gait--her leg would not move as expected as she was trying to walk and would unpredictably flex/spasm or relax and buckle at inappropriate intervals while walking.  Physical Therapy felt she had a neurologic rather than musculoskeletal etiology. By the end of April after therapy her dystonia begin to remit at times though again unpredictably.  Patient really has not been able to walk effectively and without pain since the day of the injection 4 months ago.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: About three hours after the injection, the back side of the left arm became very painful, from the elbow to the shoulder.  It felt like the arm was in a vise--twisted and very sore.  I could not lift the arm, and could barely move it without a great deal of pain.  I also felt slight nausea and felt chilled, with my teeth chattering.  There was also moderate swelling  at the back of the left arm, between the left elbow and the shoulder.  By the next morning, the swelling was somewhat reduced and the pain was moderate, not severe.  It was still hard to fully raise the arm, and it felt like there was a knotted muscle at the back of the arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Nausea, Pain
Clinical narrative: About three hours after the injection, the back side of the left arm became very painful, from the elbow to the shoulder.  It felt like the arm was in a vise--twisted and very sore.  I could not lift the arm, and could barely move it without a great deal of pain.  I also felt slight nausea and felt chilled, with my teeth chattering.  There was also moderate swelling  at the back of the left arm, between the left elbow and the shoulder.  By the next morning, the swelling was somewhat reduced and the pain was moderate, not severe.  It was still hard to fully raise the arm, and it felt like there was a knotted muscle at the back of the arm.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: Asthenia, Blood pressure increased, Dysstasia, Excessive eye blinking, Eye movement disorder
Clinical narrative: Immediately following the injection of vaccines and post the Depo injection the client had a syncopal episode - patient was unable to communicate, eyes rolled back and fluttered per RN. The RN observed some tremors/twitching in hands. Client was seated at the time. The entire episode lasted less than 30 seconds.  Her vital signs were within normal limits.  She was monitored for 20 minutes before leaving the clinic with her Mom. Mom called the clinic on 6/11/19 to report that pt continued to have difficulties with muscle twitching, weakness and not being able to stand on her own. She described it as "seizure-like" activity. She called an Urgent Care that referred her to the Emergency Room. The ER stated a 6-8 hour wait so mom contacted pt's PCP. The PCP stated that pt should tak Ibuprofen, check her blood pressure and temperature. Mom reported that pt was afebrile, her BP was elevated with a systolic of 142. Her neuro/muscular symptoms resolved over night and mom reports that pt is feeling better this morning. She has a follow up visit with her PCP on Friday.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: Immediate post-injection reaction, Muscle twitching, Seizure like phenomena, Syncope, Tremor
Clinical narrative: Immediately following the injection of vaccines and post the Depo injection the client had a syncopal episode - patient was unable to communicate, eyes rolled back and fluttered per RN. The RN observed some tremors/twitching in hands. Client was seated at the time. The entire episode lasted less than 30 seconds.  Her vital signs were within normal limits.  She was monitored for 20 minutes before leaving the clinic with her Mom. Mom called the clinic on 6/11/19 to report that pt continued to have difficulties with muscle twitching, weakness and not being able to stand on her own. She described it as "seizure-like" activity. She called an Urgent Care that referred her to the Emergency Room. The ER stated a 6-8 hour wait so mom contacted pt's PCP. The PCP stated that pt should tak Ibuprofen, check her blood pressure and temperature. Mom reported that pt was afebrile, her BP was elevated with a systolic of 142. Her neuro/muscular symptoms resolved over night and mom reports that pt is feeling better this morning. She has a follow up visit with her PCP on Friday.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Vertigo
Clinical narrative: Headache, fatigue, vertigo, malaise.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: High Fever of 102 from day 2 to day 4 post immunization, on day 4-9 after immunization, Measels like rash on back
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: Patient had localized raised red rash to right thigh where vaccines were given.  Per Father he noticed this reaction after he took the band aid off.
Sex: M
Vaccine: VARZOS
Symptoms: Meningoencephalitis herpetic, Muscular weakness, Myopathy, Neuralgia, Pneumonia
Clinical narrative: herpes viral encephalitis; Rhabdomyolysis; Community Acquired Pneumonia; Streptococcus Pneumonia; myopathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 12-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). One day after receiving zoster vaccine live (ZOSTAVAX) (on approximately 13-JUN-2017), patient developed weakness in his arm and nerve pain in both legs. He was treated for herpes viral encephalitis and was ultimately diagnosed with rhabdomyolysis and community acquired pneumonia due to Streptococcus pneumonia and myopathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Meningoencephalitis herpetic, myopathy, pneumonia streptococcal, pneumonia and rhabdomyolysis were considered to be disabling.      Upon internal review, meningoencephalitis herpetic, pneumonia streptococcal, pneumonia and rhabdomyolysis were considered to be medically significant.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia streptococcal, Rhabdomyolysis
Clinical narrative: herpes viral encephalitis; Rhabdomyolysis; Community Acquired Pneumonia; Streptococcus Pneumonia; myopathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 12-JUN-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). One day after receiving zoster vaccine live (ZOSTAVAX) (on approximately 13-JUN-2017), patient developed weakness in his arm and nerve pain in both legs. He was treated for herpes viral encephalitis and was ultimately diagnosed with rhabdomyolysis and community acquired pneumonia due to Streptococcus pneumonia and myopathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Meningoencephalitis herpetic, myopathy, pneumonia streptococcal, pneumonia and rhabdomyolysis were considered to be disabling.      Upon internal review, meningoencephalitis herpetic, pneumonia streptococcal, pneumonia and rhabdomyolysis were considered to be medically significant.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoacusis, Rash, Vestibular neuronitis
Clinical narrative: vestibular neuritis; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 07-JUN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the prevention of shingles. Shortly thereafter, the patient suffered a severe rash. On an unspecified date in or around June 2017, the patient presented to her doctor because of the rash and she was diagnosed with shingles. Subsequently, she began having troubles hearing and was diagnosed with vestibular neuritis. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of Zoster Vaccine Live (ZOSTAVAX.) At the reporting time, the patient had not recovered from the events of shingles and vestibular neuritis. The reporter considered the event of shingles and vestibular neuritis to be related to zoster vaccine live (ZOSTAVAX).   The reporter considered shingles and vestibular neuritis to be disability events.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: injection site redness; Injection site tenderness; Injection site swelling; developed an unspecified "rash" after receiving a dose of PNEUMOVAX 23; This spontaneous report was received from a medical assistant and refers to 94 years old female patient of unknown race. The patient's pertinent medical history, concurrent conditions, historical and concomitant drugs were not reported. The patient's drug allergies included erythromycin.  On 06-JUN-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscular for immunization lot number S004547 with expiration date on 12-AUG-2020 (dose, strength, frequency and route of administration were not reported).  On 07-JUN-2019, the patient experienced injection site redness, tenderness and swelling and developed an unspecified rash after receiving a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The patient sought medical attention and treatment was given for the adverse event. No laboratories or studies were performed for the adverse events. At the moment of this report the patient had not recovered from injection site redness, tenderness, swelling and rash.  The relatedness between the events occurrence and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) administration was not reported.
Sex: U
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: inflammation and swelling on injection site; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional via phone.  This case is linked to cases 2019SA157349, 2019SA157348, 2019SA157350 and 2019SA157349 (same reporter).  This case involves adult patient of unknown demographics who experienced inflammation and swelling on injection site, while received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On 10-Apr-2019, the patient received a first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5602AA and expiration date: 19-Mar-2021) via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious inflammation and swelling on injection site (vaccination site inflammation) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No Lab data was reported.  Final diagnosis was inflammation and swelling on injection site.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for inflammation and swelling on injection site.  Documents held by the sender: none.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: ActHIB vaccine was inadvertently administered to a 2 months old patient from a shipment package that experienced a delayed transit time the placed on 28May2019, however package was not received until 31May2019/no AE; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff).  This case is linked to case 2019SA157296 (same reporter).  This case involves a 2 months old female patient who was inadvertently vaccinated with a 0.5ml first dose of HIB (PRP/T) VACCINE [ACT-HIB] from a shipment package that experienced a delayed transit time (lot UJ128AAB, Expiration Date: 08-Nov-2020) via intramuscular route in the right thigh on 31-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PCV13 (PNEUMOCOCCAL CONJUGATE VACCINE).  It was an actual medication error due to incorrect product storage. The product was placed on 28-May-2019, however package was not received until 31-May-2019.  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 holders 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.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Neck pain
Clinical narrative: Stomach upset, shivering, neck ache
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient noticed redness and swelling and aching the day after the shot.  He administered ice pack and took advil.  Redness and warmth spread over 48 hours, the swelling went down day 3, but the redness and warmth continued to spread.  The swelling was about 5 inches in diameter.  He went to the walk in clinic on day 4 (today)  and was diagnosed with cellulitis.  The dr. prescribed an antibiotic which he will take tonight.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ, UNK
Symptoms: Abnormal behaviour, Memory impairment, Speech disorder
Clinical narrative: Mom called the day after the vaccines were given. She stated she was acting like she was 'high'. She doesn't take other drugs. She was saying weird things. She stated she didn't remember the last two days. Mom and patient came into the office to have her ppd test read, and talked with Dr. She was feeling somewhat better.
Age: 12.0
Sex: M
Vaccine: HEPA, IPV, VARCEL
Symptoms: Polymerase chain reaction positive, Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Vaccine induced varicella - ~20 lesions, PCR positive from 1 lesion.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Eye pruritus, Eye swelling, Headache, Migraine, Nausea
Clinical narrative: I received 3 vaccines. Hep A first dose, Yellow Fever, and typhoid. Within the hour of receiving the vaccinations I had waves of nausea and head aches as well as tenderness in my left ear. These symptoms lasted from Thursday - Sunday. On Sunday I had a migraine from the moment I woke up at 7:30am - 9:30pm when I dozed off to sleep. I slept for less than 30 minutes only to be awaken by pain and a severe itching in my eyes only to realize that both eyes were swelling and red. My eyes continued to swell and deepen In Color  over the course of an hour almost to the point of shutting. I took two Benadryl although there was no immediate relief. I thought it best to be driven to the Emergency room, I was checked in but by then the Benadryl had slowly started working and alleviating some of the swelling and welts around my eye.   The swelling and red color in my eye stayed for 20 hours even after more Benadryl and Zyrtec has been taken by me.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Ocular hyperaemia, Pain, Swelling of eyelid, Tenderness
Clinical narrative: I received 3 vaccines. Hep A first dose, Yellow Fever, and typhoid. Within the hour of receiving the vaccinations I had waves of nausea and head aches as well as tenderness in my left ear. These symptoms lasted from Thursday - Sunday. On Sunday I had a migraine from the moment I woke up at 7:30am - 9:30pm when I dozed off to sleep. I slept for less than 30 minutes only to be awaken by pain and a severe itching in my eyes only to realize that both eyes were swelling and red. My eyes continued to swell and deepen In Color  over the course of an hour almost to the point of shutting. I took two Benadryl although there was no immediate relief. I thought it best to be driven to the Emergency room, I was checked in but by then the Benadryl had slowly started working and alleviating some of the swelling and welts around my eye.   The swelling and red color in my eye stayed for 20 hours even after more Benadryl and Zyrtec has been taken by me.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Migraine, Myalgia, Pain
Clinical narrative: Severe migraine - unresponsive to over the counter medications; lasted nearly 12 hours.  Muscle pain and aches - the injection site was the most painful (to the touch).
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Oropharyngeal pain, Upper-airway cough syndrome
Clinical narrative: sore throat caused by post-nasal drip has lasted 21 hours so far
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Urticaria
Clinical narrative: Pt describes redness and swelling at injection site with an onset of <24 hours. The area was also severely sore. The redness/swelling/pain spread over the next 3 days until becoming hives/welts within 3 days diffuse over her entire left arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Bladder dysfunction, Dizziness, Dyspnoea
Clinical narrative: Treatment of the adverse event is ongoing and the physicians are not sure it is related to shingrix but they think it is a possibility. Symtpoms have been weakness , shortness of breath, joint pain, could not walk, dizziness, rash, bladder stopped functioning, numbness on feet and legs.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Hypoaesthesia, Rash
Clinical narrative: Treatment of the adverse event is ongoing and the physicians are not sure it is related to shingrix but they think it is a possibility. Symtpoms have been weakness , shortness of breath, joint pain, could not walk, dizziness, rash, bladder stopped functioning, numbness on feet and legs.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Dizziness, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Approximately 2 hours after receiving the immunizations patient began feeling  feverish (hot, sweaty, chills), he also had onset of headache and dizziness with reported near syncope in shower.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Presyncope, Pyrexia
Clinical narrative: Approximately 2 hours after receiving the immunizations patient began feeling  feverish (hot, sweaty, chills), he also had onset of headache and dizziness with reported near syncope in shower.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Lethargy, Myalgia, Pyrexia
Clinical narrative: lethargy, fever, apatite loss, muscle ache/joint pain
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: Pt had abdominal cramping, diarrhea, and vomiting following vaccination. Responded appropriately to questions throughout episode, no difficulty breathing reported , and pulse regular, Pt refused ambulance, called pt mother to take to ER. ER MD prescribed Bentyl & Ondansetron with rest and hydration.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Ear infection
Clinical narrative: Ear infection
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Lethargy, Myalgia, Pyrexia
Clinical narrative: starting abput 6 hour post injection, extreme lethargy, fever, fitful sleep morning brought muscle pain and aches (similar to flu sx) started to recover around 36 hours after immunization.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in jaw, Toothache
Clinical narrative: Cyclical tooth pain/jaw joint  came and went on a regular basis for about a day then completly ceased
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pain in jaw, Toothache
Clinical narrative: Cyclical tooth pain/jaw joint  came and went on a regular basis for about a day then completly ceased
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Large Local Reaction. The size of patients palm.
Age: 68.0
Sex: M
Vaccine: TYP
Symptoms: Computerised tomogram abdomen abnormal, Diarrhoea, Enteritis, Nausea, Vomiting
Clinical narrative: Patient seen in the ER for GI symptoms Nausea, vomiting and diarrhea.  began right before second dose of oral typhoid.
Age: 68.0
Sex: M
Vaccine: TYP
Symptoms: White blood cell count increased
Clinical narrative: Patient seen in the ER for GI symptoms Nausea, vomiting and diarrhea.  began right before second dose of oral typhoid.
Age: 27.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient fell faint and passed out for 2 minutes after administration of all 3 vaccines. EMS came and took patient's vitals and cleared patient as okay.
Age: 1.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Encephalitis, Hyporesponsive to stimuli, Lethargy, Meningism, Pyrexia
Clinical narrative: My son had his 1st round of several vaccines at once, so I do not know which one caused him some encephalitis like, and maybe a little of meningitis like, symptoms, and fever and lethargy.  Maybe the MMR as it is grown on chicken embryo, maybe the Tdap, maybe the Hib flu set off strep/pneumococcal pneumonia.  I really do not know what the problem was/is.  Please just get the list of vaccines from the doctor's office, for the record.  He became either unresponsive or hyper-responsive, and was just not himself.  So, we gave him megadoses of Vitamin C and got him out in the sun for UVB-Vit D3 via skin, kind of like they recommend when an infant not processing bilirubin and has jaundice, as either sun or the bili-lights had to be done for several of my children right after they were born.  So something to do with the liver, I guess.  I was told acetaminophen ok if vaccine reaction, but no this actually was hard on his liver and made his vaccine reaction worse.  He eventually got better.
Age: 1.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Unresponsive to stimuli
Clinical narrative: My son had his 1st round of several vaccines at once, so I do not know which one caused him some encephalitis like, and maybe a little of meningitis like, symptoms, and fever and lethargy.  Maybe the MMR as it is grown on chicken embryo, maybe the Tdap, maybe the Hib flu set off strep/pneumococcal pneumonia.  I really do not know what the problem was/is.  Please just get the list of vaccines from the doctor's office, for the record.  He became either unresponsive or hyper-responsive, and was just not himself.  So, we gave him megadoses of Vitamin C and got him out in the sun for UVB-Vit D3 via skin, kind of like they recommend when an infant not processing bilirubin and has jaundice, as either sun or the bili-lights had to be done for several of my children right after they were born.  So something to do with the liver, I guess.  I was told acetaminophen ok if vaccine reaction, but no this actually was hard on his liver and made his vaccine reaction worse.  He eventually got better.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Jaw disorder, Pain in jaw, Pruritus, Rash erythematous
Clinical narrative: On Monday, May 6, I went in to the office of Dr. with absolutely nothing wrong with me.  I was feeling good and just went in for the first yearly check-up since I came to this state.  I assumed that they would have requested my records from former doctor's office; but apparently not, I have since found out.    Dr. suggested a tetanus shot.  I assumed she had records to indicate that I needed one.  I waffled and then said, OK--because I was not sure how long it had been and my personal records were at home.  Also, just this moment I discovered she gave me Tetanus, Diphtheria and Pertussis.  She only mentioned I needed a Tetanus shot.  A day later I started itching around my torso.  I just figured it might be a small reaction to the shot and didn?t think too much about it so I waited for it to get better--for about two weeks!!!  but by Friday, May 24, I was itching terribly and I had an itchy, spotty red rash from my neck to my ankles.  I wrote a note to your office requesting some help.  By Tuesday, May 28, I had received no call so I wrote another note requesting some help.  The rash was now raised in places and there were tiny pin-prick sores in random places.  No one called me back.  So I called--thinking I would get a nurse.  Instead, I got a very sympathetic lady who made all kinds of suggestions that I had already tried and when I asked my last question, she asked, ?Oh.  Did you want to speak to a nurse??  I said yes and she indicated that she was not a nurse.  So that was that.  Instead of getting me a real appointment, she scheduled me a video appointment for Friday, May 31.  After understanding that the appointment would require me to take pictures of my rashy naked body from head to foot and then send them to the doctor, I cancelled because that is not something that I am comfortable doing and doesn?t seem very professional way to treat something that?s been going on for 3 weeks.  Sometime in all of this I woke up with a jaw that would not open very well.  That lasted for about three days so that I could only eat very soft things.  Every day I would wake up and hope that today would be better, but no, not really.  I think a nurse called me once but never offered to get me an appointment so someone could look at what was going on.  My jaw has since returned to almost normal.  Occasionally it will hurt when I first open my mouth.  But my rash continues unabated.  It is just getting less itchy.  My husband is acquainted with a medical doctor and he asked how I was and my husband explained my predicament and my concern that it was a reaction to a tetanus shot.  His reply: ?Oh, yeah.  It happens.  Takes sometimes 6-7 weeks to get over it.?  The dermatologist with whom I have an appointment in two days agreed as well.  So I keep waiting.  It?s now been 5 weeks.
Age: 19.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Syncope
Clinical narrative: fainting
Age: 19.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Blindness, Blood pressure decreased, Brain contusion, Computerised tomogram head abnormal, Concussion
Clinical narrative: fainting
Age: 19.0
Sex: M
Vaccine: TDAP, DTAP
Symptoms: Loss of consciousness, Memory impairment, Skin laceration, Suture insertion, Syncope
Clinical narrative: fainting
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Inflammation, Lethargy, Malaise
Clinical narrative: Besides the tenderness, redness, and inflammation, I have experienced general malaise, lethargy, just feeling punky, on days 3, 4, and 5 after vaccination.  I?m am otherwise healthy and well rested.  My husband received his second shot of Shingrex at the same time, and also experienced the same general sense of malaise.