chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Severe reaction around injection site, 8.5 cm in diameter. Bright red, severe swelling, hot to touch and very tender to touch. 3 days later symptoms slowly decreasing, now 7 cm in diameter with treatment. Cause may have been inappropriate administration by pharmacist into subcutaneous tissue instead of muscle. Prior to injection, pharmacist pinched arm to elevate fat layer, did not inject needle completely into muscle layer and when removing needle the vaccine dripped out of injection site. It was also injected too low on the arm to be in the meat of the deltoid muscle.
Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Crying, Diet refusal
Clinical narrative: Baby cried unconsolably for 45 minutes. Would not nurse, swallow medication administered, or calm.  By 6:42 pm she nursed and swallowed the dose of infant Tylenol.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Altered state of consciousness, Feeling abnormal, Hyperhidrosis, Tinnitus
Clinical narrative: Within 5 minutes of administering vaccine, patient reports feeling not good, sweaty, ringing and feels like going to pass out. 911 call activated, checked the BP-80/60, hr-70, O2 sat-100% and RR-18. Denies any SOB, wheezing or chest tightness. EpiPen was ready to administer but patient BP back to 90/60 s and stayed the HR and Sats as above. No syncope. Chest sound clear and patient reports never had vaccine before and have some phobia towards injections. EMS came to the clinic, by the time patient is already start feeling better so patient doesn't want see the EMS. Watched the patient in the clinic for 30 minutes.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Headache, Impaired work ability, Malaise
Clinical narrative: Approximately 6-12 hours post vaccination, patient developed fevers, chills, myalgias. On the day after vaccination, her fevers were as high as 105F. She was acutely ill and was not able to go to work. She was seen in clinic 2 days after the vaccination, she was still febrile to 101.7F, with associated chills, myalgias, dizziness, headache. Improves with tylenol/advil.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Approximately 6-12 hours post vaccination, patient developed fevers, chills, myalgias. On the day after vaccination, her fevers were as high as 105F. She was acutely ill and was not able to go to work. She was seen in clinic 2 days after the vaccination, she was still febrile to 101.7F, with associated chills, myalgias, dizziness, headache. Improves with tylenol/advil.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient said that she developed shingles, 2 spots, on her body after the vaccine, approximately 1 week after immunization.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Rash
Clinical narrative: Patient developed "burning pain in left breast" the day after vaccination was given. This persisted and developed into a painful rash around the trunk but no blisters. The patient visited an urgent care facility where a provider advised that it was a possible shingles outbreak, and was given triamcinolone, bacitracin, valacylovir, and hydrocodone/acetaminophen to treat the symptoms.
Age: 43.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Asthenia, Bone pain, Discomfort, Fatigue, Headache
Clinical narrative: A few hours after vaccination there we symptoms of: extreme fatigue, headache no energy whatsoever. Muscle aching, bone aching in the entire body; sleepiness; an overall feeling of heaviness; shallow breathing; an overall feeling of being sick; The symptoms continue even a WEEK later (today). NyQuil alleviates some of the symptoms for a few hours, only for the symptoms to return.
Age: 43.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Hypopnoea, Malaise, Myalgia, Somnolence
Clinical narrative: A few hours after vaccination there we symptoms of: extreme fatigue, headache no energy whatsoever. Muscle aching, bone aching in the entire body; sleepiness; an overall feeling of heaviness; shallow breathing; an overall feeling of being sick; The symptoms continue even a WEEK later (today). NyQuil alleviates some of the symptoms for a few hours, only for the symptoms to return.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Diarrhoea, Influenza like illness, Nausea
Clinical narrative: Severe sphincter of odi flare with excruciating pain for 3/4 hours the morning after the injection and 4 days of flu like symptoms including chills, nausea and diarrhea. First shot in the series was less severe and did not cause sphincter of odi flare.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sphincter of Oddi dysfunction
Clinical narrative: Severe sphincter of odi flare with excruciating pain for 3/4 hours the morning after the injection and 4 days of flu like symptoms including chills, nausea and diarrhea. First shot in the series was less severe and did not cause sphincter of odi flare.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster
Clinical narrative: PATIENT PRESENTED WITH WHAT APPEARED TO BE CELLULITIS OR SHINGLES ON HER FACE ON 3/6/2019.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear congestion, Ear discomfort, Pain in jaw, Stomatitis, Tinnitus
Clinical narrative: Patient came into the Pharmacy on 3-6-19 to mention that after the vaccine he started to develop pressure and congestion in his ears with a persistent ringing in the ears. On 3-7-19 he came back to pick up an electronic Rx for Valacyclovir as he went to a clinic because it was not getting better, and he was starting to have discomfort down his jaw and what felt like a sore in his mouth towards the back of the tongue.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Headache, Injection site erythema, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiffness in arm of vaccine, headache, stiff neck, fevers x 2 days. Area of erythema on right shoulder surrounding vaccine 12 x 8 cm.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Myalgia, Nausea, Urticaria
Clinical narrative: Intense muscle aches, nausea, site swelling 4 inches x 2 inches, hives neck/chest.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: 13x13cm area of erythema, mild low grade fever. Pt presented to ED 2/1/19 9:29pm with above Sx's. Ibuprofen 176mg given to pt in ED. Pt F/U in clinic 2/2/9, continued large (L) thigh erythema, "remains within outline made in ER yesterday." At 2/2/19 appointment, mother of child did confirm that two immunizations were given in the (L) thigh and two immunizations were given in the (R) thigh. While rooming the patient I did visualize two injection sights on (L) thigh and two on (R) thigh. During the rooming process, pt's mother stated she had a similar vaccine reaction around pt's current age.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Left posterior arm: Red, warm to touch, feels hard, mild pain 3/10 w/ pressure. No fevers. After Vaccine was administered patient stated she went outdoor horse riding, felt fatigue, and very tired after.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at the site of injection in the left arm where PREVNAR was given for more than 5 days.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 85-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 10th July 2018, the patient received SHINGRIX. On 10th July 2018, less than a day after receiving SHINGRIX, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was recovering/resolving. It was unknown if the reporter considered the muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced muscle soreness every since she received SHINGRIX. She had reported to her physician and had been seen by the doctor numerous times. Emergency room visit required.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Dizziness, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 85-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 10th July 2018, the patient received SHINGRIX. On 10th July 2018, less than a day after receiving SHINGRIX, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was recovering/resolving. It was unknown if the reporter considered the muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced muscle soreness every since she received SHINGRIX. She had reported to her physician and had been seen by the doctor numerous times. Emergency room visit required.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of chronic fatigue syndrome in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic fatigue syndrome. On 29th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chronic fatigue syndrome, influenza-like symptoms and unwell. On an unknown date, the outcome of the chronic fatigue syndrome and unwell were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the chronic fatigue syndrome, influenza-like symptoms and unwell to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient receives SHINGRIX and became very ill with flu-like symptoms for about 4 days. The patient did go to a convenient care during that time. The patient had to cancel plans, she had during those days because she was so ill. Since then the patient had a severe flare-up of chronic fatigue syndrome. There are days the patient cannot get off the sofa or shower and it was one month later she think there needs to be a warning. The patient was not anti-vaccine and get a flu shot every year.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of chronic fatigue syndrome in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic fatigue syndrome. On 29th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chronic fatigue syndrome, influenza-like symptoms and unwell. On an unknown date, the outcome of the chronic fatigue syndrome and unwell were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the chronic fatigue syndrome, influenza-like symptoms and unwell to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient receives SHINGRIX and became very ill with flu-like symptoms for about 4 days. The patient did go to a convenient care during that time. The patient had to cancel plans, she had during those days because she was so ill. Since then the patient had a severe flare-up of chronic fatigue syndrome. There are days the patient cannot get off the sofa or shower and it was one month later she think there needs to be a warning. The patient was not anti-vaccine and get a flu shot every year.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Middle insomnia, Musculoskeletal stiffness, Oropharyngeal pain, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of chronic fatigue syndrome in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic fatigue syndrome. On 29th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chronic fatigue syndrome, influenza-like symptoms and unwell. On an unknown date, the outcome of the chronic fatigue syndrome and unwell were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the chronic fatigue syndrome, influenza-like symptoms and unwell to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient receives SHINGRIX and became very ill with flu-like symptoms for about 4 days. The patient did go to a convenient care during that time. The patient had to cancel plans, she had during those days because she was so ill. Since then the patient had a severe flare-up of chronic fatigue syndrome. There are days the patient cannot get off the sofa or shower and it was one month later she think there needs to be a warning. The patient was not anti-vaccine and get a flu shot every year.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chronic fatigue syndrome, Condition aggravated, Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of chronic fatigue syndrome in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic fatigue syndrome. On 29th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chronic fatigue syndrome, influenza-like symptoms and unwell. On an unknown date, the outcome of the chronic fatigue syndrome and unwell were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the chronic fatigue syndrome, influenza-like symptoms and unwell to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient receives SHINGRIX and became very ill with flu-like symptoms for about 4 days. The patient did go to a convenient care during that time. The patient had to cancel plans, she had during those days because she was so ill. Since then the patient had a severe flare-up of chronic fatigue syndrome. There are days the patient cannot get off the sofa or shower and it was one month later she think there needs to be a warning. The patient was not anti-vaccine and get a flu shot every year.
Age: 21.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt reports bilateral hand neuralgia beginning 2 weeks following immunizations. States difficulty with grasp, unable to open bottles, jars, difficulty with lifting. Unable to perform some basic ADLs. No self tx. Reports symptoms are gradually improving but still c/o of pain and numbness. Also reported right sided eye pain with difficulty focusing. Began approximately the same time and has since resolved.
Age: 21.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Eye pain, Grip strength decreased, Hypoaesthesia, Loss of personal independence in daily activities, Neuralgia
Clinical narrative: Pt reports bilateral hand neuralgia beginning 2 weeks following immunizations. States difficulty with grasp, unable to open bottles, jars, difficulty with lifting. Unable to perform some basic ADLs. No self tx. Reports symptoms are gradually improving but still c/o of pain and numbness. Also reported right sided eye pain with difficulty focusing. Began approximately the same time and has since resolved.
Age: 21.0
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Pain, Vision blurred, Visual impairment
Clinical narrative: Pt reports bilateral hand neuralgia beginning 2 weeks following immunizations. States difficulty with grasp, unable to open bottles, jars, difficulty with lifting. Unable to perform some basic ADLs. No self tx. Reports symptoms are gradually improving but still c/o of pain and numbness. Also reported right sided eye pain with difficulty focusing. Began approximately the same time and has since resolved.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Varicella
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 57-year-old female patient who received SHINGRIX (batch number MX2LT, expiry date 21st May 2021) for prophylaxis. On 23rd February 2019, the patient received SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced papular rash and chickenpox. On an unknown date, the outcome of the papular rash and chickenpox were not recovered/not resolved. It was unknown if the reporter considered the papular rash and chickenpox to be related to SHINGRIX. Additional details reported as follows: On 27th February 2019, the patient came to the pharmacy with a papular rash. The patient went to the emergency room and was diagnosed with chicken pox. The emergency room physician noted that, the patient had picked up an antibiotic the same day the patient received SHINGRIX, but it was at a different pharmacy than the reporter. The patient indicated that she did not feel sick the day of vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash papular, Varicella
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 57-year-old female patient who received SHINGRIX (batch number MX2LT, expiry date 21st May 2021) for prophylaxis. On 23rd February 2019, the patient received SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced papular rash and chickenpox. On an unknown date, the outcome of the papular rash and chickenpox were not recovered/not resolved. It was unknown if the reporter considered the papular rash and chickenpox to be related to SHINGRIX. Additional details reported as follows: On 27th February 2019, the patient came to the pharmacy with a papular rash. The patient went to the emergency room and was diagnosed with chicken pox. The emergency room physician noted that, the patient had picked up an antibiotic the same day the patient received SHINGRIX, but it was at a different pharmacy than the reporter. The patient indicated that she did not feel sick the day of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 84-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (at the age of 48 years old). In December 2018, the patient received the 1st dose of SHINGRIX. On 26th February 2019, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Two months before the date of report, the patient had the 1st injection of SHINGRIX. On the date of report the patient was diagnosed with shingles for the second time. She was asking if she could receive the 2nd injection when it becomes available.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 84-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (at the age of 48 years old). In December 2018, the patient received the 1st dose of SHINGRIX. On 26th February 2019, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Two months before the date of report, the patient had the 1st injection of SHINGRIX. On the date of report the patient was diagnosed with shingles for the second time. She was asking if she could receive the 2nd injection when it becomes available.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: 2/27/2019 pain started on left side of neck continued to migrate to left side of head behind left ear. Over the next two days large bumps began to appear on left quarter of head down neck and upper back. Saw doctor a few days later. Symptoms have continued at a significant pain level on left head, neck, under arm. Bumps are crusting over.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Headache, Neck pain, Rash, Scab
Clinical narrative: 2/27/2019 pain started on left side of neck continued to migrate to left side of head behind left ear. Over the next two days large bumps began to appear on left quarter of head down neck and upper back. Saw doctor a few days later. Symptoms have continued at a significant pain level on left head, neck, under arm. Bumps are crusting over.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, warmth and redness at injection site started within an hour after shot. Abdominal pain and severe diarrhea started after two days .
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Pain, swelling, warmth and redness at injection site started within an hour after shot. Abdominal pain and severe diarrhea started after two days .
Age: 1.08
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Relevant medical history, drug reactions/allergies and concomitant medication for the patients involved were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (thimerosal free) lot number: M037248 (expiration date: 21-FEB-2019) for prophylaxis (strength, route, dose or units were not provided); ROTATEQ lot number: N030150 (expiration date: 29-AUG-2019), lot number: R002521 (expiration date: 18-SEP-2019), orally, for prophylaxis (strength, route, dose or units were not provided) and LIQUID PEDVAXHIB lot number: N031492 (expiration date: 02-MAY-2020), lot number: R005118 (expiration date: 28-NOV-2020) for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: 0°C to 1°C (0.9°C) for 30 minutes - Previous temperature excursion: 0°C to 1°C (1.4°C) for 7 minutes. No adverse effects were reported. Follow up information has been received from the reporting medical assistant and stated that this case refers to a 13 month old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 10-OCT-2018, the patient vaccinated just with a dose of improperly stored LIQUID PEDVAXHIB lot # N031492, expiration date: 02-MAY-2020, for prophylaxis (strength, dosage, frequency and route were not provided). This case was previously considered as non-valid, but upon receipt of follow-up it was determined that the case is now valid (patient identifiers were provided). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA003267.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Information has been received from a pharmacist referring to a 66 year old female patient with no drug reactions/allergies. Information about medical history, other concurrent condition and concomitant medication was unknown. On 05-FEB-2019 the patient was vaccinated with PNEUMOVAX 23 (lot # R022232 with expiration date of 16-APR-2020, intramuscularly; dose and frequency were not reported) for prophylaxis. On an unknown date in February 2019 the patient complained of swelling in an unspecified upper arm, which moved down to around her elbow. She explained that it was like having fluid around the elbow. She sought medical attention via speaking with pharmacist. Unspecified treatment for the events was given. On 07-FEB-2019, she went to her physician's office due to swelling. The physician said she was fine. The outcome of the events was also reported as not recovered. The causality was unknown.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 59 years old female patient. The patient had no illness at the time of vaccination. There has no pre-existing physician-diagnosed allergies, birth defects or medical conditions. Information about concomitant medication was not provided. The reporter reported that on 08-FEB-2019, the patient received a dose of PNEUMOVAX 23 (lot # N014946, expiration date was 01-FEB-2019, intramuscular in right (R) Deltoid; strength and dose were not reported) for prophylaxis in a private doctor's office/hospital after its labeled expiration date. No adverse effects or reaction were reported in the patient. No prescription drug treatment was required for the experience. Vaccine was purchased with private funds. No temperature excursion occurred as a result of a reading from a digital data logger. No other vaccination within 4 weeks prior to the date of vaccination.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injection site discomfort, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report has been received from a physician regarding to a female patient of unknown age with no concomitant therapies, medical history and drug allergies. On 29-JAN-2019, the patient was vaccinated with the first dose of GARDASIL 9 (lot # R024264 and expiration date 29-OCT-2019) (dose and anatomical location of vaccination was not reported) for human papillomavirus (HPV) prophylaxis. On an unspecified date in 2019, reported as "starting on an unspecified date following injection", the patient had been experiencing discomfort at the injection site as well pain in her wrist. On approximately 12-FEB-2019 (reported as two weeks after vaccination), the physician reported that the injection site was indurated 3 cm. On 21-FEB-2019, the patient called to the physician office and reported that she was still experienced pain at the injection site and wrist and there was a small lump under the skin at the injection site. No laboratories were performed, no intervention to prevent serious criteria was need, no significant disability or incapacity was present, no hospitalization was needed and no life threatening occurred. At the reporting time the patient was not "fully recovered" also reported as "not recovered". The causality assessment between of GARDASIL 9 and all the events was not provided.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse via a company representative referring to a 7 years old male patient. The patient's medical history, concurrent condition and concomitant medication were not reported. On 29-JAN-2019 the patient was vaccinated with the first dose of VARIVAX and on 25-FEB-2019 was received the second dose (dose, route, lot # and expiration date were unknown) for prophylaxis, which was too close together. No adverse effect was reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received on 26-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 15-MAY-2015, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. On 27-FEB-2017, the patient presented to a physician with complaints of pain and a rash on her back and abdomen. The physician diagnosed the patient with shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitation not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Shingles was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Back pain, Erythema, Herpes zoster, Hip arthroplasty
Clinical narrative: Information has been received on 26-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 15-MAY-2015, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. On 27-FEB-2017, the patient presented to a physician with complaints of pain and a rash on her back and abdomen. The physician diagnosed the patient with shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitation not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Shingles was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Infection, Muscle spasms, Myalgia, Pain, Paraesthesia
Clinical narrative: Information has been received on 26-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 15-MAY-2015, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. On 27-FEB-2017, the patient presented to a physician with complaints of pain and a rash on her back and abdomen. The physician diagnosed the patient with shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitation not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Shingles was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Post herpetic neuralgia, Rash, Scab, Soft tissue atrophy, Spinal decompression
Clinical narrative: Information has been received on 26-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 15-MAY-2015, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. On 27-FEB-2017, the patient presented to a physician with complaints of pain and a rash on her back and abdomen. The physician diagnosed the patient with shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitation not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Shingles was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Spinal fusion surgery
Clinical narrative: Information has been received on 26-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 15-MAY-2015, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. On 27-FEB-2017, the patient presented to a physician with complaints of pain and a rash on her back and abdomen. The physician diagnosed the patient with shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitation not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of ZOSTAVAX. Shingles was considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of an unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or drug reactions/allergies. On 04-FEB-2019 (reported as "starting on or after"), the unspecified patients were administered improperly stored doses of VARIVAX with lot number R022116 and expiration date on 02-AUG-2020, (strength, dose, dose number, anatomical injection site and route of administration were not reported) for prophylaxis. The sterile diluent used for reconstitution of the vaccines was properly stored. It was reported that on an unknown date, the vaccines were exposed to a temperature excursion on -14 C (Celsius) degrees to -10 C degrees (-12.1 C degrees) for 4 hours. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This report was received from a 52 years old female consumer via Pfizer referring to herself. The patient's current conditions included lupus and rheumatoid arthritis (RA). The patient was vaccinated with PREVNAR 13 about 5 years ago and also received a different pneumonia vaccine before the PREVNAR 13. On an unknown date in 2014 (reported as one year after the PREVNAR 13), the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot# and expiration date were unknown) for prophylaxis. On unknown dates, the patient developed pneumonia several times since receiving all of these vaccines. The outcome of pneumonia was unknown. The causality assessment was not provided. Upon internal review, pneumonia was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Retinal oedema, Visual impairment, Vitreous detachment
Clinical narrative: Information has been received on 26-FEB-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 26-OCT-2016, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving ZOSTAVAX, the patient suffered from deteriorated visual impairment, retinal edema, and posterior vitreous detachment. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitation not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. Deteriorated visual impairment, retinal edema and posterior vitreous detachment were considered to be disabling. Upon internal review, retinal edema and posterior vitreous detachment were considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 28-FEB-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On or about 15-AUG-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) by a physician at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated by a physician at a physician's office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is not recovered/not resolved. The causality of the events is related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported. On unknown date, the patient was vaccinated with PROQUAD, albumin status of rHA (recombinant human albumin), (lot # R015739, expiration date: 02-DEC-2019), dose, route of administration and injection site were not provided), for prophylaxis. It was unknown if the sterile diluent (lot# and expiration date were not provided) used to reconstitute the vaccine was stored properly. On unknown date, the vaccine was stored in temperature -9 Celsius degrees to +8 Celsius degrees, for 36 hours and 27 minutes. There was previous temperature excursion: from -14 Celsius degrees to 10 Celsius degrees, for 3 hours and 6 minutes. The digital data logger was involved. There were no adverse effects.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 15-JAN-2019, the patient received an improperly stored dose of PROQUAD (Lot # R012416 and expiration date 28-OCT-2019), subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of PROQUAD was exposed to a temperature excursion of 11.9 Fahrenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1903USA002598: US-009507513-1903USA002599: US-009507513-1903USA002597: US-009507513-1903USA002596: US-009507513-1903USA002595: US-009507513-1903USA002600.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at approximately 61 years of age, the patient was administered the ZOSTAVAX vaccine at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a physician's office for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 04-DEC-2018, the patient received an improperly stored dose of PROQUAD (Lot # R012416 and expiration date 28-OCT-2019), subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of PROQUAD was exposed to a temperature excursion of 11.9 Fahrenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1903USA002600: US-009507513-1903USA002596: US-009507513-1903USA002597: US-009507513-1903USA002599: US-009507513-1903USA002598: US-009507513-1903USA001826.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 06-DEC-2018, the patient received an improperly stored dose of PROQUAD (Lot # R012416 and expiration date 28-OCT-2019), subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of PROQUAD was exposed to a temperature excursion of 11.9 Fahrenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1903USA001826: US-009507513-1903USA002595: US-009507513-1903USA002597: US-009507513-1903USA002598: US-009507513-1903USA002599: US-009507513-1903USA002600.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 29-JAN-2018, the patient received improperly stored dose of VARIVAX (lot # N017394, expiration date 07-JUN-2019) subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of VARIVAX was exposed to a temperature excursion of 11.9 Fahrenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1903USA001826; US-009507513-1903USA002595; US-009507513-1903USA002596; US-009507513-1903USA002597; US-009507513-1903USA002599; US-009507513-1903USA002600.