chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Haematochezia, Headache, Influenza like illness, Injection site pain, Insomnia
Clinical narrative: Within a few hours of vaccine he was experiencing headache, earache, chills and flu like symptoms. He then had a fever and diarrhea. He missed school and also left early a couple days because of the diarrhea, chills, headache and pain at injection site. Put him on a BRAT diet until we noticed blood in his stool and salmon colored mucus along with a sleepless night on june 20th so we made an appointment for a doctor to make a house visit and discovered he has a ear infection along with the stomach problems. They gave him a 10 day antibiotic which only exacerbated the inflammation in his gut which caused an increase in the red stool and salmon colored mucus. He had 2 more visits and they are asking for a stool sample to see what is happening with his gut and may refer to a GI doctor if problem does not clear up. He still complains of on and off ear pain but the last visit on August 6th shows no infection but the pain still comes and goes.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Loss of personal independence in daily activities, Mucous stools, Pyrexia, Stool analysis
Clinical narrative: Within a few hours of vaccine he was experiencing headache, earache, chills and flu like symptoms. He then had a fever and diarrhea. He missed school and also left early a couple days because of the diarrhea, chills, headache and pain at injection site. Put him on a BRAT diet until we noticed blood in his stool and salmon colored mucus along with a sleepless night on june 20th so we made an appointment for a doctor to make a house visit and discovered he has a ear infection along with the stomach problems. They gave him a 10 day antibiotic which only exacerbated the inflammation in his gut which caused an increase in the red stool and salmon colored mucus. He had 2 more visits and they are asking for a stool sample to see what is happening with his gut and may refer to a GI doctor if problem does not clear up. He still complains of on and off ear pain but the last visit on August 6th shows no infection but the pain still comes and goes.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: swollen lip  (NO breathing problems or additional swelling of mouth, tongue, or throat)
Age: 25.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Influenza like illness, Injection site pain, Malaise
Clinical narrative: The patient reports soreness and in the injection  at the site as well as becoming progressively more ill with flu like symptoms.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Pruritus
Clinical narrative: Patient had pimple like reaction on opposite side of body. 1 pimple like dot on middle arm, midriff, calf and toe and they itched really bad and appeared about a week after the injection. They are now going away but are not completely gone.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: Woke up at night with severe nausea and vomiting (one episode).  Woke up again later in the night attempting to vomit but dry heaving. Felt feverish, chills, decreased appetite for following 2 days.  Missed work due to feeling unwell, but was able to eat and drink without emesis.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Retching, Vomiting
Clinical narrative: Woke up at night with severe nausea and vomiting (one episode).  Woke up again later in the night attempting to vomit but dry heaving. Felt feverish, chills, decreased appetite for following 2 days.  Missed work due to feeling unwell, but was able to eat and drink without emesis.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient reported 3 inch red patch at injection site the next day following administration
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: WARM TO THE TOUCH, RED, ITCHING
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Swelling
Clinical narrative: Swelling and redness of right arm and neck
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Body temperature increased, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: She was in her room all afternoon, lying in bed under thick blankets.  She came out saying "I feel really bad". She has hot and cold flashes, ache all over the body in the muscles and joints, serious headache, severe tiredness, debilitating pain and tiredness in the body, loss of apetite (ate only a little fruits since lunch), sensitivity to light and noise, heart rate was 92 at 8:30 PM, her temperature is 101 at 10 PM. I would like to take her to ER but she does not want to move.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Feeling cold, Headache, Hot flush, Hyperacusis, Myalgia
Clinical narrative: She was in her room all afternoon, lying in bed under thick blankets.  She came out saying "I feel really bad". She has hot and cold flashes, ache all over the body in the muscles and joints, serious headache, severe tiredness, debilitating pain and tiredness in the body, loss of apetite (ate only a little fruits since lunch), sensitivity to light and noise, heart rate was 92 at 8:30 PM, her temperature is 101 at 10 PM. I would like to take her to ER but she does not want to move.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Photophobia
Clinical narrative: She was in her room all afternoon, lying in bed under thick blankets.  She came out saying "I feel really bad". She has hot and cold flashes, ache all over the body in the muscles and joints, serious headache, severe tiredness, debilitating pain and tiredness in the body, loss of apetite (ate only a little fruits since lunch), sensitivity to light and noise, heart rate was 92 at 8:30 PM, her temperature is 101 at 10 PM. I would like to take her to ER but she does not want to move.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Malaise, Rash
Clinical narrative: Patient felt sick the next day. She described it as she was hit by a truck. She was extremely tired and felt very sick. Her injection arm also developed two big round spots of rash one around site and another below it.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Dry throat, Throat irritation
Clinical narrative: dry itchy throat and dry cough extreme
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash & RASH TRIAMCINOLONE small amount BID
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Throat irritation, Wheezing
Clinical narrative: On car ride home after receiving HPV9 vaccine,  patient reportedly started to wheeze "his-throat"  felt "funny"  Father is physician - when got home he  evaluated him, gave albuterol nebs, Benadryl & oral steroids
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Muscle twitching, Muscular weakness, Pain in extremity
Clinical narrative: Went to hospital with cut on foot not knowing what cause but as needed tetnus shot they gave shot and after said it was also whooping cough dose arm hurt after shot also other arm then went on arms got weak and burning feeling. twitchy in arms and lip. this happen after (shot) and still bad.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Warm to Touch, Pain, Redness, swelling spread down to MidaRm  Use cold compress Hydrocortison
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received immunization 7/30/19. She was seen for F/U on 8/1/19 due to redness at injection site. First dose of Hep A. Afebrile. Pruritic are with mild swelling (blanching of patch).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Pt reported she experienced a reaction from vaccine. A welt the size of her hand formed at the injection site. Pt was vacationing with a physician and area was assessed. Pt took ibuprofen and applied ice packs. Welt has resolved.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dyskinesia, Immediate post-injection reaction, Musculoskeletal stiffness, Opisthotonus, Pallor
Clinical narrative: Patient in for office visit. Did not appear nervous at all prior to vaccines. Calm, talkative, and smiling. While patient was sitting on exam table, gave Tdap vaccine in left arm & patient tolerated well. Gave Menactra vaccine in right arm and immediately after withdrawing needle, patient arched her back, fell back on exam table, became unresponsive and pale, very stiff, and arms began jerking. This lasted for less than 30 seconds. When awakened, patient did not remember what happened. Applied cold wet compresses to forehead and neck. Reported she had not anything to eat. Gave a sucker and sips of 7-up and monitored in clinic for 1 hour. Remained alert and oriented, denied any other symptoms.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient in for office visit. Did not appear nervous at all prior to vaccines. Calm, talkative, and smiling. While patient was sitting on exam table, gave Tdap vaccine in left arm & patient tolerated well. Gave Menactra vaccine in right arm and immediately after withdrawing needle, patient arched her back, fell back on exam table, became unresponsive and pale, very stiff, and arms began jerking. This lasted for less than 30 seconds. When awakened, patient did not remember what happened. Applied cold wet compresses to forehead and neck. Reported she had not anything to eat. Gave a sucker and sips of 7-up and monitored in clinic for 1 hour. Remained alert and oriented, denied any other symptoms.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Back pain, Fatigue, Loss of personal independence in daily activities, Lymph node pain
Clinical narrative: Moderate to severe low back pain starting a few hours after vaccine was administered and continuing for one week. She is also having fatigue and tender axillary lymph nodes. She has missed school + has had no relief with ibuprofen.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Metabolic function test, Urine analysis
Clinical narrative: Swelling, pain, redness in (L) deltoid. Pt has been taking Benadryl every 4 hours and it seemed to be working (per PA chart note). Pt also applying ice.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Head injury, Headache, Syncope
Clinical narrative: After administering vaccines. Patient was fine. As patient was leaving to go home he fainted hit the back of his head on the floor. patient was responsive and wasn't pale. Patient complained of dizziness and pain of head. Patient was asking to lay down in a room until patient felt OK to walk. Vitals were taken. Patient was seen by the Doctor before leaving guardian had a wheelchair in the car just in case. Patient was feeling better before going home.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient got fainted for 2 seconds after receiving last shot (Gardasil 9) She was quickly recovering right after it.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Lethargy, Pallor, Vomiting
Clinical narrative: vomiting x 3-4 episodes turned pale, lethargic
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pain, Pruritus, Rash macular
Clinical narrative: -Painful, Red sizable Splotches, Itch/Hot feeling To Touch.  -2 red areas - one around injection site and one below it.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: -Painful, Red sizable Splotches, Itch/Hot feeling To Touch.  -2 red areas - one around injection site and one below it.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Warm to touch red, swollen hematoma in spot of injection
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: slept most of the day; achiness; tired; felt bad/felt terrible; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling bad. On 21st April 2019, the outcome of the pain, tiredness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient felt badly after receiving 1st dose of Shingrix. The patient felt achy and tired on the day after Shingrix vaccination.  These effects resolved by the 2nd day after the vaccination. This case has been linked with case US2019116903 reported by the same reporter.  Follow up information was received from consumer on 30th July 2019: On 20th April 2019, 1 day after receiving Shingrix, the patient felt terrible. The patient also experienced sore arm and ran down after receiving Shingrix. The patient slept most of the day after receiving Shingrix. It was unknown if the reporter considered the pain in arm and sleepiness to be related to Shingrix. For the tolerance of 2nd dose of Shingrix refer case US2019AMR139443.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Pain, Pain in extremity
Clinical narrative: slept most of the day; achiness; tired; felt bad/felt terrible; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling bad. On 21st April 2019, the outcome of the pain, tiredness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient felt badly after receiving 1st dose of Shingrix. The patient felt achy and tired on the day after Shingrix vaccination.  These effects resolved by the 2nd day after the vaccination. This case has been linked with case US2019116903 reported by the same reporter.  Follow up information was received from consumer on 30th July 2019: On 20th April 2019, 1 day after receiving Shingrix, the patient felt terrible. The patient also experienced sore arm and ran down after receiving Shingrix. The patient slept most of the day after receiving Shingrix. It was unknown if the reporter considered the pain in arm and sleepiness to be related to Shingrix. For the tolerance of 2nd dose of Shingrix refer case US2019AMR139443.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: slept most of the day; achiness; tired; felt bad/felt terrible; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling bad. On 21st April 2019, the outcome of the pain, tiredness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient felt badly after receiving 1st dose of Shingrix. The patient felt achy and tired on the day after Shingrix vaccination.  These effects resolved by the 2nd day after the vaccination. This case has been linked with case US2019116903 reported by the same reporter.  Follow up information was received from consumer on 30th July 2019: On 20th April 2019, 1 day after receiving Shingrix, the patient felt terrible. The patient also experienced sore arm and ran down after receiving Shingrix. The patient slept most of the day after receiving Shingrix. It was unknown if the reporter considered the pain in arm and sleepiness to be related to Shingrix. For the tolerance of 2nd dose of Shingrix refer case US2019AMR139443.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: slept most of the day; achiness; tired; felt bad/felt terrible; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling bad. On 21st April 2019, the outcome of the pain, tiredness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient felt badly after receiving 1st dose of Shingrix. The patient felt achy and tired on the day after Shingrix vaccination.  These effects resolved by the 2nd day after the vaccination. This case has been linked with case US2019116903 reported by the same reporter.  Follow up information was received from consumer on 30th July 2019: On 20th April 2019, 1 day after receiving Shingrix, the patient felt terrible. The patient also experienced sore arm and ran down after receiving Shingrix. The patient slept most of the day after receiving Shingrix. It was unknown if the reporter considered the pain in arm and sleepiness to be related to Shingrix. For the tolerance of 2nd dose of Shingrix refer case US2019AMR139443.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Pain, Peripheral swelling
Clinical narrative: cellulitis; she also experienced chills, fever and pain at the injection site down to the elbow; she also experienced chills, fever and pain at the injection site down to the elbow; she also experienced chills, fever and pain at the injection site down to the elbow; This spontaneous report refers to a 67-year-old female patient reporting on herself. The patient's concurrent condition included allergy to penicillin. There was no information about the patient's concomitant therapies or medical history provided.  On 31-OCT-2018 at 16:01, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot # R018735, expiration date was reported as 08-APR-2020, but upon internal validation established as 06-APR-2020) one dose intramuscularly in the left arm for prophylaxis (recommendation from immunologist).  On 31-OCT-2018 after receiving the vaccine, the patient developed cellulitis in the left arm. She also experienced chills, fever and pain at the injection site down to the elbow. The patient sought medical attention and unspecified lab diagnostics were performed. As treatment antiobiotics by urgent care were prescribed. The outcome of the events was reported as not recovered/not resolved. The causality assessment between the events and suspect therapy was not provided.   Upon internal review, the event of cellulitis was considered to be medically significant.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Injection site pain, Laboratory test, Pyrexia
Clinical narrative: cellulitis; she also experienced chills, fever and pain at the injection site down to the elbow; she also experienced chills, fever and pain at the injection site down to the elbow; she also experienced chills, fever and pain at the injection site down to the elbow; This spontaneous report refers to a 67-year-old female patient reporting on herself. The patient's concurrent condition included allergy to penicillin. There was no information about the patient's concomitant therapies or medical history provided.  On 31-OCT-2018 at 16:01, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot # R018735, expiration date was reported as 08-APR-2020, but upon internal validation established as 06-APR-2020) one dose intramuscularly in the left arm for prophylaxis (recommendation from immunologist).  On 31-OCT-2018 after receiving the vaccine, the patient developed cellulitis in the left arm. She also experienced chills, fever and pain at the injection site down to the elbow. The patient sought medical attention and unspecified lab diagnostics were performed. As treatment antiobiotics by urgent care were prescribed. The outcome of the events was reported as not recovered/not resolved. The causality assessment between the events and suspect therapy was not provided.   Upon internal review, the event of cellulitis was considered to be medically significant.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered
Clinical narrative: Upon injection, most of the vaccine squirted out of the syringe and did not enter the subcutaneous tissue. It was difficult to determine if this was due to leaking at the cutaneous tissue or if there was a defect in the syringe. The dose was repeated. The pt reported no unusal SE.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Diarrhoea, Dry skin, Erythema, Fatigue
Clinical narrative: From March 27, 2019 through April 25, 2019 I experienced six burning/rash outbreaks and diarrhea. Midafternoon on march 27th I began to feel fatigued. That night the diarrhea began which lasted for six days. The next morning I experienced my first outbreak. Each outbreak was three days of intense 'burning' with bright red skin and then it would begin to temper with the color gradually fading through shades of pink to white along with an itchy rash. Each outbreak lasted 7-8 days. The outbreaks overlapped and so I experienced all these effects continually  for four weeks. the day following the three days of bright red burning, the skin was still hot but calmer (day 4) , and then the next day (day 5) another system would experience an outbreak. As the itching subsided the skin became very dry and flakey. The outbreaks in order: legs, arms, groin, midriff & lower back, left side and buttock, nner and upper thigh of both legs.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Skin exfoliation, Skin warm
Clinical narrative: From March 27, 2019 through April 25, 2019 I experienced six burning/rash outbreaks and diarrhea. Midafternoon on march 27th I began to feel fatigued. That night the diarrhea began which lasted for six days. The next morning I experienced my first outbreak. Each outbreak was three days of intense 'burning' with bright red skin and then it would begin to temper with the color gradually fading through shades of pink to white along with an itchy rash. Each outbreak lasted 7-8 days. The outbreaks overlapped and so I experienced all these effects continually  for four weeks. the day following the three days of bright red burning, the skin was still hot but calmer (day 4) , and then the next day (day 5) another system would experience an outbreak. As the itching subsided the skin became very dry and flakey. The outbreaks in order: legs, arms, groin, midriff & lower back, left side and buttock, nner and upper thigh of both legs.
Age: 49.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: The individual donated plasma and then proceeded to receive the Twinrix vaccine after which he felt "lightheaded" and lost consciousness for < 10 seconds.  The individual recovered quickly and was released to home.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth and redness in site area
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients may have been administered vaccines improperly stored; This spontaneous report was received from a nurse and an office manager and refers to an unknown number of patients of unknown age and gender. There was no information provided about the patients' concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history.  On multiple unspecified dates, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) (exact dose, frequency, route and site of administration were not reported); with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot# R000550, expiration date 08-JAN-2020) (exact dose, frequency, route and site of administration were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB) (lot# R000877, expiration date 24-SEP-2020) (exact dose, frequency, route and site of administration were not reported) all administered for prophylaxis. The administered doses were exposed to a temperature below 36 Fahrenheit degrees (F): 31.6 F for 2 hours and 13 minutes and 25.7 F for 1 hour and 35 minutes, and temperature above 47 F: 50.5 F for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  Follow-up information was received from a physician's receptionist on 01-AUG-2019. The patient was a 16-year-old female. On 11-JUL-2019, she was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) 0.5 mg in left deltoid (frequency and route of administration were not reported). It was clarified that no patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB). The reported temperature excursion occurred from 30-MAY-2019 to 22-JUL-2019. The reporter stated that the temperature probe was misplaced, which resulted in an incorrect reading. No adverse effects were reported.  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA003824: US-009507513-1908USA003825:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a dose ofV ARN AX following a temperature excursion.; No adverse effects were reported.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information reported regarding the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 30-JUL-2019, the patient received a dose of (VARIVAX) (dose and route were not provided; lot number R017636 and expiration date 20-JUN-2020 have been verified to be valid (expiration date was also reported as: 23-OCT-2020) for prophylaxis, following a temperature excursion. The temperature excursion was from 6 Fahrenheit degrees to 14 Fahrenheit degrees (-14 Celsius degrees to -10 Celsius degrees) (-12.48 Celsius degrees), within a time frame 120 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient was treated for shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 22-APR-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were unknown) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions (prophylaxis).   On an unspecified date, the patient experienced shingles, which led to hospitalization. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), 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.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Subsequent to Plaintiff's ZOSTAVAX inoculation, Plaintiff was treated by a healthcare provider, at Medical Center, for Bells Palsy.; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions (prophylaxis).         On an unknown date, the patient was treated by a healthcare provider for bells palsy.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, 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 would continue to suffer such losses, and damages in the future.  At the time of this report, the outcome of the event was unknown. The relationship between zoster vaccine live (ZOSTAVAX) and the event was considered as related by the reporter.  Upon internal review, bells palsy was determined to be medically significant.    Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Plaintiff was treated by a healthcare provider for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to male patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not provided.   On or about 16-AUG-2017 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, batch/lot number and expiration date were not provided) for long-term prevention of shingles and/or zoster-related conditions.  On an unknown date (reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation), the patient experienced shingles. The patient was treated by a healthcare provider.  As a direct and proximate result of patient's use of 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 would continue to suffer such losses, and damages in the future.     The outcome of shingles was considered as not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 27-MAR-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for 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 healthcare provider for shingles. As a direct and proximate result of 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 would 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent condition, or concomitant medication.  In 2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was hospitalized. On an unspecified date, the patient was treated by a healthcare provider for shingles. 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 would continue to suffer such losses, and damages in the future.  The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose # and route of administration were 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 healthcare provider and hospitalized for shingles. The patient had and would continue to 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. At the time of the report, the outcome of shingles was considered as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event shingles was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequent to patients inoculation, patient was treated by a healthcare provide for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and will 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 shingles was not recovered.  The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age was not reported). No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2016, 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 healthcare provider for shingles. 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
Clinical narrative: patient was treated for shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 10-DEC-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were unknown) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions (prophylaxis).   On an unspecified date, the patient experienced shingles, which led to hospitalization. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), 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.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's inoculation, patient was treated by a healthcare provide for shingles.  As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and will 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 shingles was reported as not recovered.   The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2007, 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 physician. 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).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unspecified date in 2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, frequency, route, lot # and expiration date were not reported).         On an unknown date, the patient was treated by physician for shingles. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, plaintiff 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 included 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 suffered such losses, and damaged in the future. The outcome of event was considered as not recovered. The reporter considered event to be related to Zoster Vaccine Live(ZOSTAVAX).