chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: MENB
Symptoms: Sensory loss
Clinical narrative: Sore arm shortly after vaccine administered.  The next day could not lift arm and had felt like I had the flu.  Could not feel my legs and when getting up legs buckled as no sensation. Lasted a couple of hours and then went away and thought might be getting Guillain-Barre syndrome.  Felt horrible for about 5 days and could use my arm after 2 days.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Within 5-10 minutes of receiving the vaccines the client began feeling "lightheaded" and became very pale. She and Mom had gone to the waiting room. Taken to a clinic room with and exam table to lie down on.  BP 98/60, P74. Given some apple juice and cold compresses were put on her neck and forehead.  After about 10 -15 minutes the pink color came back into her face.  BP, 98/62, P 72, BS 85.  She said that she had not eaten since earlier in the morning.  Mom said she thought that she had a seizure but that was not observed, a very short amount of syncope may have occured.  She has no history of a previous seizure.  Called and talked to Mom 8/6/19 she reports calling the clients MD but had to leave a message. No reports of any other events after leaving the office.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: a former worker reported today 7/16/19 that he feels that the flu shot he received in June  has caused numbness in his arm.  The former employee has not cooperated with any follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Tinnitus
Clinical narrative: headache, tinnitus, fatigue, injection site pain ---all occurred less than 24 hours after injection was administered
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pt complains of swelling  and pain at injection site and left arm
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Concussion, Fall, Fatigue, Head injury, Influenza like illness
Clinical narrative: Patient felt flu like symptoms evening after the vaccine, was extremely fatigued the next day, at 3pm the next afternoon had sudden onset nausea, fainted and hit her head leading to a concussion, when she resumed consciousness she called 911 and was medivacked to the hospital with signs of stroke (no stroke was confirmed)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Loss of consciousness, Nausea, Syncope
Clinical narrative: Patient felt flu like symptoms evening after the vaccine, was extremely fatigued the next day, at 3pm the next afternoon had sudden onset nausea, fainted and hit her head leading to a concussion, when she resumed consciousness she called 911 and was medivacked to the hospital with signs of stroke (no stroke was confirmed)
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Feeling hot, Hyperhidrosis, Posture abnormal, Syncope
Clinical narrative: Gave Menactra first in right arm, then HPV in left arm.  While giving HPV, Patient fainted.  She was sitting in armed,high back chair. Her head dropped to the side for a few seconds, then she came to.  Was very hot, sweaty, and weak.  Gave her cold water and a granola bar.  She then stated to her mom that she had only eaten an orange for lunch and it was now 6:30pm.  She stayed sitting in the pharmacy for over 30 minutes until she felt stronger.  I spoke with the mom 08/06/2019 and she said Patient experienced no other side effects and felt better after eating and getting a good night's sleep.
Age: 11.0
Sex: U
Vaccine: HPVX, MNQ
Symptoms: Product storage error
Clinical narrative: Menactra that reached 33.5 degree Celsius was administered [Incorrect product storage]  Case Description: Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an-other health professional by phone.   This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660. (Same reporter).   This case involves a 11 years old patient (gender not reported) who was vaccinated with 0.5 ml first dose of vaccine MENINGOCOCCAL VACCINE [MENACTRA] (lot number U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site on 09-Jul-2019. These vaccines reached at 33.5 degree Celsius that day.  Medical history: not reported.   Concomitant medications included patient was vaccinated with a dose of HPV VACCINE.   It was an actual medication error case due to incorrect product storage.   It was unknown whether the patient experienced any adverse event post vaccination.   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.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Antinuclear antibody, Blood thyroid stimulating hormone, Full blood count, Metabolic function test
Clinical narrative: Diffuse alopecia on head / increased hair loss started. Shortly after HPV #1 then seemed a little better. Now has increased hair loss and significantly thinned hair starting 4-6 weeks after HPV # 2
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Serum ferritin, Thyroxine
Clinical narrative: Diffuse alopecia on head / increased hair loss started. Shortly after HPV #1 then seemed a little better. Now has increased hair loss and significantly thinned hair starting 4-6 weeks after HPV # 2
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: pt presented to Health Department 5 days after vaccine was given with a red swollen area on her right arm below the deltoid muscle. Area measured 5x2in. Area was warm to touch. patient when to her PCP and was diagnosed with cellulitis and was placed on antibiotics.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pyrexia, Rash generalised
Clinical narrative: approximately 1.5 hours after vaccine pt's mom called stating she had a fever and headache, and this morning she called to inform us headache was gone but that she had a rash from head to toe.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: pain w/limitations to range of motion
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Injection site discolouration, Injection site erythema, Injection site nodule, Injection site reaction
Clinical narrative: injection site reaction (swelling, hot, red/purple, knotting up), migraine, fever, throwing up, throat swelling, blood glucose of 800. pt was treated in the ER over a course of approximately 12 hours, then discharged
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Migraine, Pharyngeal swelling, Pyrexia
Clinical narrative: injection site reaction (swelling, hot, red/purple, knotting up), migraine, fever, throwing up, throat swelling, blood glucose of 800. pt was treated in the ER over a course of approximately 12 hours, then discharged
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: injection site reaction (swelling, hot, red/purple, knotting up), migraine, fever, throwing up, throat swelling, blood glucose of 800. pt was treated in the ER over a course of approximately 12 hours, then discharged
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Lethargy, Myalgia
Clinical narrative: Redness  and soreness at site of vaccination  muscle pain fever/headache shivering  nauseous lethargic
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Redness  and soreness at site of vaccination  muscle pain fever/headache shivering  nauseous lethargic
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: According to wife, approximately 36 hours of fever of 102.8 degrees farenheit, extreme headache, chills, and body aches.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia oral, Nausea
Clinical narrative: Patient received Harvix on 8/5/19 at  7:05 PM. They waited in Pharmacy for 15 minutes and went home.  Patient's husband called at 7:45 pm and stated she is experiencing Nausea and numbness on her lips. Pharmacist advised to take Benadryl and go to hospital immediately. We called her in morning at 10:25 am on 8/6/19 to check on her condition. Patient stated she  did not go to hospital but took Benadryl and feeling lot better. No numbness on lips anymore and Nausea getting better too. I also called MD t 10:30 Am 8/619 and had to leave message to follow up on Adverse reactions.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope Episode
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Contusion, Epistaxis, Full blood count, Gingival bleeding, Immune thrombocytopenic purpura
Clinical narrative: Two weeks post-vaccination, on April 3, 2019, patient started rapidly developing petitchae and excessive bruising all over his body, followed by bloody noses and bleeding in the mouth and gums. On April 4, 2019, our Pediatrician sent him to the ER where he was  visually diagnosed  and then confirmed via a complete blood count (CBC) with Idiopathic thrombocytopenic purpura "ITP", requiring immediate hospitalization and treatment. The hematology group at Hospital took a complete blood count and struggled to find even 1  platelet in his CBC. Patient platelet counts were dangerously low and required an IV treatment of IVIG.  He responded to treatment with his platelet count rising to 19 within 24 hours (still well below the normal 150-450 range).
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Immunoglobulin therapy, Mouth haemorrhage, Petechiae, Platelet count decreased
Clinical narrative: Two weeks post-vaccination, on April 3, 2019, patient started rapidly developing petitchae and excessive bruising all over his body, followed by bloody noses and bleeding in the mouth and gums. On April 4, 2019, our Pediatrician sent him to the ER where he was  visually diagnosed  and then confirmed via a complete blood count (CBC) with Idiopathic thrombocytopenic purpura "ITP", requiring immediate hospitalization and treatment. The hematology group at Hospital took a complete blood count and struggled to find even 1  platelet in his CBC. Patient platelet counts were dangerously low and required an IV treatment of IVIG.  He responded to treatment with his platelet count rising to 19 within 24 hours (still well below the normal 150-450 range).
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Patient states reaction started 8pm on 8/2/2019. Symptoms included pain, redness, itching at injection site (right arm). Patient calls Health Department  8/6/2019 11:30a to inquire about "what to do?", Is this normal" etc. At that time she listed her symptoms as pain, redness, itching, swelling (half dollar size) at injection site- also hot to touch. Advised her this may be a reaction to vaccine as it contains a partial live virus. To place cool compress on site. If it gets worse as always go to PCP and/Urgent Care. Called patient at 130pm on 8/6/2019 to check on patient, patient states the swelling became worse-spread in both ways, meaning to elbow and very near shoulder. She was very concerned and went to the Urgent Care. Patient states the Urgent care was concerned about the swelling, and a small blister rash developed on back of arm patient was unable to see. Patient states she was given a shot of steroids, a prescription of steroids to begin tomorrow and wrapped her arm in an ace bandage. She was instructed by them to keep covered.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site warmth, Rash vesicular
Clinical narrative: Patient states reaction started 8pm on 8/2/2019. Symptoms included pain, redness, itching at injection site (right arm). Patient calls Health Department  8/6/2019 11:30a to inquire about "what to do?", Is this normal" etc. At that time she listed her symptoms as pain, redness, itching, swelling (half dollar size) at injection site- also hot to touch. Advised her this may be a reaction to vaccine as it contains a partial live virus. To place cool compress on site. If it gets worse as always go to PCP and/Urgent Care. Called patient at 130pm on 8/6/2019 to check on patient, patient states the swelling became worse-spread in both ways, meaning to elbow and very near shoulder. She was very concerned and went to the Urgent Care. Patient states the Urgent care was concerned about the swelling, and a small blister rash developed on back of arm patient was unable to see. Patient states she was given a shot of steroids, a prescription of steroids to begin tomorrow and wrapped her arm in an ace bandage. She was instructed by them to keep covered.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Headache, Heart rate increased, Pyrexia
Clinical narrative: Child had fever, headache and rapid heart rate 3-4 hours after immunization was given. S/S lasted 12-24 hrs.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Syncope, Vomiting
Clinical narrative: Patient received Menveo & hepatitis a. Patient had syncopal episode. BP 101/63 HR 76. While supine. BP was 106/70 HR 86 while sitting up. Patient had x1 emesis Patient was give juice & was able to walk without complaint. BP 107/69 HR 67 when leaving
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: The patient reported that she has missed her 3rd dose of GARDASIL 9 in which she received her last dose in March 2018; No adverse reactions; This spontaneous report was received from a female patient of unknown age referring to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in March 2018, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly, (dose, site of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had missed her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse reactions were reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; The patient received VAQTA on 07-DEC-2010/the patient received a booster dose of VAQTA on 23-MAY-2011; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 12-JUL-2010, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #, expiration date, route, dose and frequency were not reported) for prophylaxis.   It was also reported that, on 23-MAY-2011 (reported as "14 days early"), the patient received a booster dose of hepatitis a vaccine, inactivated (VAQTA) (lot # 0124AA has been verified to be a valid lot number, reported expiration date was 12-DEC-2013, but upon internal validation established as 12-FEB-2013; route, dose and frequency were not reported) for prophylaxis.   No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: PNC, PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; PREVNAR 13 on 10/2018, (exact date was not specified), PNEUMOV AX 23 on 02/2019 (exact date was not specified), and PREVNAR 13 on 7/26/2019.; This spontaneous report was received from a male patient of unknown age who was also a dentist. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  The patient reported that he received pneumococcal vaccines on the following dates: on an unknown date in October 2018, pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR); on an unknown date in February 2019, pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and on 26-JUL-2019, again pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) (lot number, expiration data, route of administration, anatomical location, dose and frequency were not provided). No adverse effects were reported. The outcome of inappropriate schedule of product administration was unknown.
Age: 1.08
Sex: M
Vaccine: HEP, IPV, MMR, UNK, UNK
Symptoms: Abnormal faeces, Aphasia, Autism spectrum disorder, Body temperature increased, Cognitive disorder
Clinical narrative: Autism; his back arched in agony; Severe constipation; fever; diarrhea; Rashes; he receive four vaccines: MMR, Hepatitis B, IPV and DtaP; His diarrhea looked like tar; losing his words; cognitive function plunged; Dark circles; gastrointestinal issues; screamed cotinuously for 12 hours; he became quiet; his back arched in agony; This spontaneous report was received from an other reporter who posted on social media and refers to a 13-month-old male patient. His concurrent condition included body temperature of 101 degrees and the doctor recommended acetaminophen (TYLENOL). No information regarding the patient's medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2005 (reported as in the fall of 2005), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (exact dose, site of injection and route of administration, lot # and expiration date were not reported) for prophylaxis reconstituted with sterile diluent (exact dose, lot # and expiration date were not reported). On the same date, the patient received hepatitis b vaccine (manufacturer unknown)(exact dose, site of injection and route of administration, lot # and expiration date were not reported) for prophylaxis, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP) and unspecified poliovirus vaccine inactivated (IPV) (doses, sites and routes of administration, indications, lots # and expiration dates were not reported). On the same day, the patient's body temperature spiked at 104 degrees and he screamed continuously for 12 hours, his back arched in agony and his diarrhea looked like tar. On an unknown date in 2005, the patient started losing his words (reported as almost immediately), became quiet and his cognitive function plunged. It was reported that dark circles appeared below his eyes, rashes and agonizing gastrointestinal issues plaqued him. Severe constipation made his stools like pebbles. The patient had two more visits with his pediatrician, who told there was nothing to worry about, because boys are usually delayed developmentally. On an unknown date (reported as on 22 December), the patient was diagnosed with autism. The outcome of the events and the relatedness between the events and the suspect therapies were not reported.  Upon internal review, the events of autism and tarry stool were considered to be medically significant.
Age: 1.08
Sex: M
Vaccine: HEP, IPV, MMR, UNK, UNK
Symptoms: Constipation, Dark circles under eyes, Diarrhoea, Gastrointestinal disorder, Melaena
Clinical narrative: Autism; his back arched in agony; Severe constipation; fever; diarrhea; Rashes; he receive four vaccines: MMR, Hepatitis B, IPV and DtaP; His diarrhea looked like tar; losing his words; cognitive function plunged; Dark circles; gastrointestinal issues; screamed cotinuously for 12 hours; he became quiet; his back arched in agony; This spontaneous report was received from an other reporter who posted on social media and refers to a 13-month-old male patient. His concurrent condition included body temperature of 101 degrees and the doctor recommended acetaminophen (TYLENOL). No information regarding the patient's medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2005 (reported as in the fall of 2005), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (exact dose, site of injection and route of administration, lot # and expiration date were not reported) for prophylaxis reconstituted with sterile diluent (exact dose, lot # and expiration date were not reported). On the same date, the patient received hepatitis b vaccine (manufacturer unknown)(exact dose, site of injection and route of administration, lot # and expiration date were not reported) for prophylaxis, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP) and unspecified poliovirus vaccine inactivated (IPV) (doses, sites and routes of administration, indications, lots # and expiration dates were not reported). On the same day, the patient's body temperature spiked at 104 degrees and he screamed continuously for 12 hours, his back arched in agony and his diarrhea looked like tar. On an unknown date in 2005, the patient started losing his words (reported as almost immediately), became quiet and his cognitive function plunged. It was reported that dark circles appeared below his eyes, rashes and agonizing gastrointestinal issues plaqued him. Severe constipation made his stools like pebbles. The patient had two more visits with his pediatrician, who told there was nothing to worry about, because boys are usually delayed developmentally. On an unknown date (reported as on 22 December), the patient was diagnosed with autism. The outcome of the events and the relatedness between the events and the suspect therapies were not reported.  Upon internal review, the events of autism and tarry stool were considered to be medically significant.
Age: 1.08
Sex: M
Vaccine: HEP, IPV, MMR, UNK, UNK
Symptoms: Opisthotonus, Rash, Screaming
Clinical narrative: Autism; his back arched in agony; Severe constipation; fever; diarrhea; Rashes; he receive four vaccines: MMR, Hepatitis B, IPV and DtaP; His diarrhea looked like tar; losing his words; cognitive function plunged; Dark circles; gastrointestinal issues; screamed cotinuously for 12 hours; he became quiet; his back arched in agony; This spontaneous report was received from an other reporter who posted on social media and refers to a 13-month-old male patient. His concurrent condition included body temperature of 101 degrees and the doctor recommended acetaminophen (TYLENOL). No information regarding the patient's medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2005 (reported as in the fall of 2005), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (exact dose, site of injection and route of administration, lot # and expiration date were not reported) for prophylaxis reconstituted with sterile diluent (exact dose, lot # and expiration date were not reported). On the same date, the patient received hepatitis b vaccine (manufacturer unknown)(exact dose, site of injection and route of administration, lot # and expiration date were not reported) for prophylaxis, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTaP) and unspecified poliovirus vaccine inactivated (IPV) (doses, sites and routes of administration, indications, lots # and expiration dates were not reported). On the same day, the patient's body temperature spiked at 104 degrees and he screamed continuously for 12 hours, his back arched in agony and his diarrhea looked like tar. On an unknown date in 2005, the patient started losing his words (reported as almost immediately), became quiet and his cognitive function plunged. It was reported that dark circles appeared below his eyes, rashes and agonizing gastrointestinal issues plaqued him. Severe constipation made his stools like pebbles. The patient had two more visits with his pediatrician, who told there was nothing to worry about, because boys are usually delayed developmentally. On an unknown date (reported as on 22 December), the patient was diagnosed with autism. The outcome of the events and the relatedness between the events and the suspect therapies were not reported.  Upon internal review, the events of autism and tarry stool were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. On 09-DEC-2014, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a pharmacy as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician at a healthcare center. It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the adverse event was not reported.   The reporter considered the adverse event to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Herpes zoster; Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a male patient (pt) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a pharmacy as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions.  Subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician at a healthcare center (vaccination failure). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and vaccination failure was not reported.   The reporter considered the herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles; Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center for shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2012, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a hospital as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a physician at a healthcare center (vaccination failure). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and vaccination failure was not reported.   The reporter considered the herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.     On 27-AUG-2013, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a healthcare provided at a medical office for for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).        Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a physician for Bell's Palsy for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   The outcome of Bell's Palsy was reported as not recovered.    The reporter considered Bell's Palsy to be related to Zoster Vaccine Live(ZOSTAVAX). Upon internal review Bell's Palsy was determined to be a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.      On 18-MAR-2013, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a healthcare provided at a medical office for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).         Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a healthcare provider for shingles for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was reported as not recovered.     The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.      On an unspecified date in 2015, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a pharmacist for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).         Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a healthcare provider for shingles for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.    The outcome of herpes zoster was reported as not recovered.     The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a patient (gender and age were not reported) regarding a case in litigation and refers to himself/herself. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 13-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a Nurse Practitioner for shingles and was treated by a Nurse Practitioner. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles; Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center for shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a male patient (pt) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2007, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a hospital as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a physician at a healthcare centerdue to herpes zoster (vaccination failure). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and vaccination failure was not reported.   The reporter considered the herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.      On an unspecified date in 2012, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a healthcare provider at a medical office for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).         Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a healthcare provider for shingles for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.    The outcome of herpes zoster was reported as not recovered.     The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles; Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center for shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a male patient (pt) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2013, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a pharmacy as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a physician at a healthcare center due to herpes zoster (vaccination failure). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and vaccination failure was not reported.   The reporter considered the herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.      On 02-APR-2015, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a healthcare provider at a medical office  for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).         Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a healthcare provider for shingles for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.    The outcome of herpes zoster was reported as not recovered.     The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles; Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center for shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a male patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2018, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a hospital as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a physician at a healthcare center due to herpes zoster (vaccination failure). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and vaccination failure was not reported.   The reporter considered the herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles; Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center for shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a male patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. On or about 15-MAR-2013, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a pharmacy as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a physician at a healthcare center due to herpes zoster (vaccination failure). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and vaccination failure was not reported.   The reporter considered the herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).