chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Influenza, Pemphigus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Pemphigus flare; Condition aggravated; Influenza; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 79-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Previously administered products included Pneumococcal vaccine and Tdap vaccine. Concurrent medical conditions included pemphigus (chronic in nature).   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), pemphigus (serious criteria GSK medically significant), condition aggravated and influenza. On an unknown date, the outcome of the vaccination failure, pemphigus, condition aggravated and influenza were unknown.   It was unknown if the reporter considered the vaccination failure, pemphigus, condition aggravated and influenza to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had safely taken pneumococcal and Tdap vaccines. The reporter stated that, the patient was not able to take the next dose of influenza vaccines secondary to a flare in his pemphigus. In addition, he always got the flu after influenza vaccination.   The call center representative noted that, the reporter was not sure about the reaction experienced by the patient but it did not sound like influenza.  The reporter also denied providing the details of the manufacturer of the influenza vaccine used.   Further details including phone number was not provided to contact the reporter. The reporter did not allowed for follow up. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for Influenza, time to onset for event and laboratory confirmation for influenza were not provided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: fever of 101 degrees; nausea; vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Enbrel).   On 24th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 25th August 2019, 1 days after receiving Shingrix, the patient experienced fever, nausea and vomiting. On 26th August 2019, the outcome of the fever, nausea and vomiting were recovered/resolved.   It was unknown if the reporter considered the fever, nausea and vomiting to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient experienced fever of 101 degrees and nausea and vomiting all day the day following their second dose of Shingrix. As of in morning of day of reporting, all symptoms were resolved. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Injection site bruising, Injection site swelling, Musculoskeletal pain
Clinical narrative: Brusing at injection site; Swelling at Injection Site; Joint pain; Shoulder Pain; This case was reported by a other health professional via call center representative and described the occurrence of injection site bruising in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date 31st August 2020) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Bexsero. On an unknown date, less than 2 months after receiving Bexsero, the patient experienced injection site bruising, injection site swelling, joint pain and shoulder pain. On an unknown date, the outcome of the injection site bruising, injection site swelling, joint pain and shoulder pain were unknown.   It was unknown if the reporter considered the injection site bruising, injection site swelling, joint pain and shoulder pain to be related to Bexsero.  Additional details were provided as follows: The patient experienced bruising at the injection site, swelling, joint and shoulder pain after dose 1 of Bexsero. The reporter did not consent to follow up. The reporter would not give any additional information about the patient.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Blood glucose normal, Dizziness, Loss of consciousness, Pallor
Clinical narrative: passed out; faint; Felt weak; Looked pale; dizzy; Looked to have a seizure like shaking; This case was reported by a other health professional via call center representative and described the occurrence of passed out in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA113A, expiry date 31st March 2020) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Menveo (intramuscular) .5 ml. On 27th August 2019, 5 min after receiving Menveo, the patient experienced passed out (serious criteria GSK medically significant), faint (serious criteria GSK medically significant), feelings of weakness, pallor, dizziness and tremor. On 27th August 2019, the outcome of the passed out, faint, dizziness and tremor were recovered/resolved. On an unknown date, the outcome of the feelings of weakness and pallor were not recovered/not resolved.   It was unknown if the reporter considered the passed out, faint, feelings of weakness, pallor, dizziness and tremor to be related to Menveo.  Additional details were provided as follows: The healthcare professional (HCP) stated that the patient received Menveo in the office this morning and 5 minutes later felt weak, dizzy, faint, and looked pale. The reporter stated the patient passed out and looked to have a seizure like shaking. The reporter stated that the patient recovered quickly of all symptoms except she was still pale and weak. The reporter stated that they took the patient's blood pressure and it was normal, blood sugar was 93, and oxygen level was normal. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Seizure like phenomena, Syncope, Tremor
Clinical narrative: passed out; faint; Felt weak; Looked pale; dizzy; Looked to have a seizure like shaking; This case was reported by a other health professional via call center representative and described the occurrence of passed out in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA113A, expiry date 31st March 2020) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Menveo (intramuscular) .5 ml. On 27th August 2019, 5 min after receiving Menveo, the patient experienced passed out (serious criteria GSK medically significant), faint (serious criteria GSK medically significant), feelings of weakness, pallor, dizziness and tremor. On 27th August 2019, the outcome of the passed out, faint, dizziness and tremor were recovered/resolved. On an unknown date, the outcome of the feelings of weakness and pallor were not recovered/not resolved.   It was unknown if the reporter considered the passed out, faint, feelings of weakness, pallor, dizziness and tremor to be related to Menveo.  Additional details were provided as follows: The healthcare professional (HCP) stated that the patient received Menveo in the office this morning and 5 minutes later felt weak, dizzy, faint, and looked pale. The reporter stated the patient passed out and looked to have a seizure like shaking. The reporter stated that the patient recovered quickly of all symptoms except she was still pale and weak. The reporter stated that they took the patient's blood pressure and it was normal, blood sugar was 93, and oxygen level was normal. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site pain, Injection site reaction, Peripheral swelling, Rash erythematous
Clinical narrative: erythematous rash; numbness in right arm radiating down to hand; Mild pain at injection site; Also had swelling of right hand; This is a spontaneous report from a contactable physician via Pfizer Sales Representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced numbness in right arm radiating down to hand. Patient also had an erythematous rash above the site of injection, mild pain at injection site and also had swelling of right hand on an unknown date after use of the product. The outcome of the events was unknown.  Information on the batch number has been requested.
Sex: M
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site discharge, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: warm and hot like cellulitis with a lot of fluid under the skin; lot of fluid under the skin; localized redness; swelling of the entire upper left arm; Initial information received on 22-Aug-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 10 years old male patient who experienced localized redness, swelling of the entire upper left arm and warm and hot like cellulitis with a lot of fluid under the skin, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Two other vaccines were given at the same visit. One was a vaccine containing tetanus. The mom was unable to remember the other vaccine.  In 2011, the patient received a first 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a serious localized redness (erythema), swelling of the entire upper left arm (extensive swelling of vaccinated limb) and warm and hot like cellulitis with a lot of fluid under the skin (cellulitis and discharge) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. All the events were assessed as Medically significant.  Other relevant tests not reported.  Final diagnosis was erythema, discharge, extensive swelling of vaccinated limb and cellulitis.   There was no treatment for the reaction. No antibiotics were given.  The reactions resolved on its own after two or three days.  Information on the batch number was requested.  Documents held by the sender: none.; Sender's Comments: Patient developed cellulitis after vaccination. Time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: TDAP
Symptoms: Cough, Ear infection, Facial paralysis, Parosmia, Pyrexia
Clinical narrative: bells palsy; has trouble with her vision; trouble with her vision, sense of smell and speech on the affected side; trouble with her vision, sense of smell and speech on the affected side; seriousness criteria : medically significant.   Initial information received on 26-Aug-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves female patient of an unknown age who experienced bell's palsy, fever, bad cough and ear infection, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history included bad cough, and possibly a fever and ear infection. The patient's past, medical treatment(s), vaccination(s) and family history were not provided.  On 29-MAY-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5081AA via unknown route in unknown administration site.  On an unknown date, the patient developed a serious bell's palsy (facial paralysis), has trouble with her vision (visual impairment), trouble with her vision, sense of smell and speech on the affected side (parosmia) and trouble with her vision, sense of smell and speech on the affected side (speech disorder) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  No lab data was reported.  Final diagnosis was bell's palsy.  The patient was treated with ACYCLOVIR [ACICLOVIR] (ACYCLOVIR [ACICLOVIR]) and antibiotics, she has multiple specialists/ HCP guiding her care.  The patient was Not Recovered from bell's palsy, has for trouble with her vision, sense of smell and speech on the affected side.  Documents held by sender: none.; Sender's Comments: This case concerns female patient of an unknown age who experienced facial paralysis, cough, pyrexia and ear infection after vaccination with ADACEL. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab /radiological investigation excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: TDAP
Symptoms: Speech disorder, Visual impairment
Clinical narrative: bells palsy; has trouble with her vision; trouble with her vision, sense of smell and speech on the affected side; trouble with her vision, sense of smell and speech on the affected side; seriousness criteria : medically significant.   Initial information received on 26-Aug-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves female patient of an unknown age who experienced bell's palsy, fever, bad cough and ear infection, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history included bad cough, and possibly a fever and ear infection. The patient's past, medical treatment(s), vaccination(s) and family history were not provided.  On 29-MAY-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5081AA via unknown route in unknown administration site.  On an unknown date, the patient developed a serious bell's palsy (facial paralysis), has trouble with her vision (visual impairment), trouble with her vision, sense of smell and speech on the affected side (parosmia) and trouble with her vision, sense of smell and speech on the affected side (speech disorder) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  No lab data was reported.  Final diagnosis was bell's palsy.  The patient was treated with ACYCLOVIR [ACICLOVIR] (ACYCLOVIR [ACICLOVIR]) and antibiotics, she has multiple specialists/ HCP guiding her care.  The patient was Not Recovered from bell's palsy, has for trouble with her vision, sense of smell and speech on the affected side.  Documents held by sender: none.; Sender's Comments: This case concerns female patient of an unknown age who experienced facial paralysis, cough, pyrexia and ear infection after vaccination with ADACEL. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab /radiological investigation excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site reaction, Pain
Clinical narrative: Severe pain at the time of injection followed a day later by a red rash around the site of injection that lasted for a few days. The pain at the injection site has been continuous, is still present 5 months later and shows no signs of abating.  I am currently receiving physical therapy to help restore range of motion to my left arm and shoulder. The center of the problem is in the deltoid muscle where I received the shot.  My shoulder joint is moving more easily thanks to physical therapy, but even trying to move my arm to the side or behind me is nearly impossible and causes me to experience arm pain in the muscle where I got the shot.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Severe pain at the time of injection followed a day later by a red rash around the site of injection that lasted for a few days. The pain at the injection site has been continuous, is still present 5 months later and shows no signs of abating.  I am currently receiving physical therapy to help restore range of motion to my left arm and shoulder. The center of the problem is in the deltoid muscle where I received the shot.  My shoulder joint is moving more easily thanks to physical therapy, but even trying to move my arm to the side or behind me is nearly impossible and causes me to experience arm pain in the muscle where I got the shot.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Computerised tomogram, Condition aggravated, Laboratory test, Mast cell activation syndrome
Clinical narrative: My son was given this WITHOUT MY PERMISSION. I found this record in 2019 in transferring records. This incident caused my son two emergency room visits, seizures, anaphylactic episode with profuse vomiting, face swelling, throat closing, and triggered PANS disorder and mast cell activation syndrome to worsen in my son causing many, many doctors appointments to calm.  I do have documentation in correspondence with his integrative doc and ER records.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Neuropsychiatric syndrome, Seizure, Swelling face, Throat tightness, Vomiting
Clinical narrative: My son was given this WITHOUT MY PERMISSION. I found this record in 2019 in transferring records. This incident caused my son two emergency room visits, seizures, anaphylactic episode with profuse vomiting, face swelling, throat closing, and triggered PANS disorder and mast cell activation syndrome to worsen in my son causing many, many doctors appointments to calm.  I do have documentation in correspondence with his integrative doc and ER records.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Hyperhidrosis, Hypopnoea
Clinical narrative: Per patient report below:  "? achy wrist and elbow in my left arm  ? chills and fever, profuse perspiration  ? ringing in the ears  ? lightheadedness to the point that I shouldn't drive to work today  ? random charlie horse-like spasms in my right thigh (weird)  ? my wife told me that I was making shallow rapid breaths while sleeping last night "
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired driving ability, Muscle spasms, Pyrexia, Respiratory rate increased, Tinnitus
Clinical narrative: Per patient report below:  "? achy wrist and elbow in my left arm  ? chills and fever, profuse perspiration  ? ringing in the ears  ? lightheadedness to the point that I shouldn't drive to work today  ? random charlie horse-like spasms in my right thigh (weird)  ? my wife told me that I was making shallow rapid breaths while sleeping last night "
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Lip swelling, Nausea, Urticaria
Clinical narrative: Per ER reports patient started with hives 1 day after receiving the vaccine located on the left and right hips. Hives then spread to the left antecubital region, and posterior portion of left ear. Three days after being vaccinated parents report that patients left lower lip began to swell and they gave the patient Benadryl.  The following morning (day 4 after vaccine) symptoms had not decreased with the treatment of Benadryl and the right side of lower lip had begun to swell. Patients also reports having an episode of being lightheaded and nausea lasting approximately 3 minutes on day 4. Pt was transported to the ED by EMS on day 4, and was given 0.3 Epinephrine IM and 50mg Benadryl in route to the ED. Upon arrival to the ED patient was found to be hemodynamically stable and in no acute distress. Patient was given Predisone, and Zantac. Patient was discharged with a 5 day course of Predisone to be taken once daily, and a prescription of EpiPen injectables.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Feeding disorder, Headache, Nausea, Pain in extremity
Clinical narrative: day 1, sore arm.  day 2 - 9 am - vomiting, nausea, major pain in lower back, headache,  unable to eat or drink, started feeling better about 4pm, stayed in bed until 8 pm.,sore arm.  contacted medical office, nurse said if I could go to Urgent Care if needed. day 3 - sore arm, all symptoms are gone.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: day 1, sore arm.  day 2 - 9 am - vomiting, nausea, major pain in lower back, headache,  unable to eat or drink, started feeling better about 4pm, stayed in bed until 8 pm.,sore arm.  contacted medical office, nurse said if I could go to Urgent Care if needed. day 3 - sore arm, all symptoms are gone.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: patient states left arm is still sore over 3 months after receiving vaccine @ injection site. patient also had red, hot injection site rash that lasted 2 weeks
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Mobility decreased, Musculoskeletal pain, X-ray limb normal
Clinical narrative: I had flu like symtoms for 2 Days. Left shoulder pain began. Unable to crank car window. Dr XRay and said Rotator Cuff ok - pain persists unable to life arm normaly
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; the patient received improperly stored VARIVAX; This non-valid spontaneous report was received from a Certified Medical Assistance referring to multiple unspecified number of patients of unknown demographics. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R012413, expiration date 28-OCT-2019, strength, dose and route were unknown), both vaccines reconstituted with properly stored diluent and administered for prophylaxis. It was reported that the temperature excursion was noticed by the digital data logger and that the temperature excursion was for 3 hours from -9 to 8 degrees Celsius. There was no previous temperature excursion. No adverse effects were reported.  Follow-up information has been received on 28-AUG-2019. A phone call was placed to the medical assistant. The phone call was answered by the receptionist. The C.M.A was unavailable. A message was left requesting a return phone call. Additionally, a request was made for patient identifiers, lot and vaccine received and on what date.  Follow up information had been received on 29-AUG-2019. A returned phone call was received from the medical assistant, and the following information was provided. The patient was a one year old female. On 27-NOV-2018, she was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N014371, expiration date 09-MAY-2019, strength, dose and route were unknown) for prophylaxis.  Upon receipt of follow-up information it was determined that this case now is valid, because the patient identifier was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA012348: US-009507513-1908USA012358: US-009507513-1908USA012365: US-009507513-1908USA012374: US-009507513-1908USA012377:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; vaccinated with one dose of improperly stored PROQUAD; This spontaneous report as received from a registered nurse refers to a 10-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 30-JUL-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) one dose (lot # R030803, expiration date: 22-APR-2020, exact dose and route of administration were not reported) that was reconstituted with properly stored sterile diluent (lot number and expiration date not reported) for prophylaxis. From an unspecified date, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in temperature range of 6 Fahrenheit degrees to 14 Fahrenheit degrees for 24 hours. There was no previous temperature excursion. No adverse effects were reported. Call was because of digital data logger.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; one expired dose of VAQTA was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not reported.  On 12-AUG-2019, the patient was vaccinated with one expired dose of Hepatitis A vaccine, inactivated (VAQTA) (lot # R022983, expiration date: 09-AUG-2019) (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Age: 0.58
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; a 7 month old infant was administered VARIVAX; This spontaneous report was received from a nurse referring to a 7-month-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies and drug reactions/allergies were not provided.  On 16-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034398, expiration date: 27-NOV-2020), 1 dose, subcutaneously for prophylaxis (Inappropriate age at vaccine administration). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2015, the patient (pt) was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles and was treated by a healthcare provider at medical office; and was hospitalized due to the event (date unspecified). As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt 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 was reported as not resolved.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 58.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; a patient received a expired VAQTA; Information has been received from a registered nurse referring to a 58-year-old patient. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.        On 27-AUG-2019, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) (strength: 50 U/1.0 mL, lot # R027987, expiration date: 09-AUG-2019) for prophylaxis. No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 14-MAY-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported) by a doctor for the long-term prevention of shingles and zoster-related conditions. On the same day, His healthcare providers including but not limited to the doctor (inoculated vaccine to him) relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to his zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by the doctor for shingles (onset date unknown). As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has 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 the event was considered not recovered.  The event was considered related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: HEP, HEPA
Symptoms: Abdominal pain, Amylase normal, Arthralgia, Biopsy skin abnormal, Blood urine absent
Clinical narrative: Henoch-Schonlein purpura nephritis; Henoch-Schonlein purpura nephritis;   This literature marketed information has been received from the authors in a published literature article and refers to a 59-year-old man.  On an unknown date, the patient was intramuscularly vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown); and hepatitis b vaccine (recombinant)(manufacturer unknown) (dosage schedule not reported) for prophylaxis.   After 3 days of vaccination, the symptoms began. He presented with 3-weeks of a mildly itchy rash on the lower extremities and buttocks associated with abdominal pain, nausea and diarrhea, low grade fever and joint aches. An abdominal pain evaluation was performed by his primary care physician that included the following normal tests: comprehensive metabolic panel, amylase, lipase and CT scan of the abdomen. Complete Blood Count (CBC) revealed a slightly elevated white blood cell (WBC) of 11.4 (units not provided) with 81.2% neutrophils. He was started on doxycycline due to concern for Rocky Mountain Spotted Fever. On our examination, the patient had widespread palpable purpura involving the lower extremities, buttocks, groin, lower abdomen, lower back and upper extremities. Biopsies for routine processing and direct immunofluorescence (DIF) were taken. A urinalysis was performed and was negative for blood and protein. Hepatitis panel was negative. Biopsy revealed perivascular and interstitial neutrophil-predominant dermatitis with focal fibrin deposition in small vessels consistent with leukocytoclastic vasculitis. DIF revealed 2-3+ granular IgA deposition in several superficial dermal blood vessels consistent with IgA vasculitis. He improved with prednisone (recovering) but flared upon its discontinuation (not recovered). He was restarted on prednisone with plan to initiate dapsone as a steroid-sparing agent. His urinalysis will be followed for abnormalities.  Upon internal review, the event of henoch-schonlein purpura nephritis was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Computerised tomogram abdomen normal, Diarrhoea, Full blood count, Henoch-Schonlein purpura, Henoch-Schonlein purpura nephritis
Clinical narrative: Henoch-Schonlein purpura nephritis; Henoch-Schonlein purpura nephritis;   This literature marketed information has been received from the authors in a published literature article and refers to a 59-year-old man.  On an unknown date, the patient was intramuscularly vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown); and hepatitis b vaccine (recombinant)(manufacturer unknown) (dosage schedule not reported) for prophylaxis.   After 3 days of vaccination, the symptoms began. He presented with 3-weeks of a mildly itchy rash on the lower extremities and buttocks associated with abdominal pain, nausea and diarrhea, low grade fever and joint aches. An abdominal pain evaluation was performed by his primary care physician that included the following normal tests: comprehensive metabolic panel, amylase, lipase and CT scan of the abdomen. Complete Blood Count (CBC) revealed a slightly elevated white blood cell (WBC) of 11.4 (units not provided) with 81.2% neutrophils. He was started on doxycycline due to concern for Rocky Mountain Spotted Fever. On our examination, the patient had widespread palpable purpura involving the lower extremities, buttocks, groin, lower abdomen, lower back and upper extremities. Biopsies for routine processing and direct immunofluorescence (DIF) were taken. A urinalysis was performed and was negative for blood and protein. Hepatitis panel was negative. Biopsy revealed perivascular and interstitial neutrophil-predominant dermatitis with focal fibrin deposition in small vessels consistent with leukocytoclastic vasculitis. DIF revealed 2-3+ granular IgA deposition in several superficial dermal blood vessels consistent with IgA vasculitis. He improved with prednisone (recovering) but flared upon its discontinuation (not recovered). He was restarted on prednisone with plan to initiate dapsone as a steroid-sparing agent. His urinalysis will be followed for abnormalities.  Upon internal review, the event of henoch-schonlein purpura nephritis was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hepatitis viral test negative, Hypersensitivity vasculitis, Immunology test, Lipase normal, Metabolic function test normal
Clinical narrative: Henoch-Schonlein purpura nephritis; Henoch-Schonlein purpura nephritis;   This literature marketed information has been received from the authors in a published literature article and refers to a 59-year-old man.  On an unknown date, the patient was intramuscularly vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown); and hepatitis b vaccine (recombinant)(manufacturer unknown) (dosage schedule not reported) for prophylaxis.   After 3 days of vaccination, the symptoms began. He presented with 3-weeks of a mildly itchy rash on the lower extremities and buttocks associated with abdominal pain, nausea and diarrhea, low grade fever and joint aches. An abdominal pain evaluation was performed by his primary care physician that included the following normal tests: comprehensive metabolic panel, amylase, lipase and CT scan of the abdomen. Complete Blood Count (CBC) revealed a slightly elevated white blood cell (WBC) of 11.4 (units not provided) with 81.2% neutrophils. He was started on doxycycline due to concern for Rocky Mountain Spotted Fever. On our examination, the patient had widespread palpable purpura involving the lower extremities, buttocks, groin, lower abdomen, lower back and upper extremities. Biopsies for routine processing and direct immunofluorescence (DIF) were taken. A urinalysis was performed and was negative for blood and protein. Hepatitis panel was negative. Biopsy revealed perivascular and interstitial neutrophil-predominant dermatitis with focal fibrin deposition in small vessels consistent with leukocytoclastic vasculitis. DIF revealed 2-3+ granular IgA deposition in several superficial dermal blood vessels consistent with IgA vasculitis. He improved with prednisone (recovering) but flared upon its discontinuation (not recovered). He was restarted on prednisone with plan to initiate dapsone as a steroid-sparing agent. His urinalysis will be followed for abnormalities.  Upon internal review, the event of henoch-schonlein purpura nephritis was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Nausea, Neutrophil percentage increased, Palpable purpura, Perivascular dermatitis, Protein urine absent
Clinical narrative: Henoch-Schonlein purpura nephritis; Henoch-Schonlein purpura nephritis;   This literature marketed information has been received from the authors in a published literature article and refers to a 59-year-old man.  On an unknown date, the patient was intramuscularly vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown); and hepatitis b vaccine (recombinant)(manufacturer unknown) (dosage schedule not reported) for prophylaxis.   After 3 days of vaccination, the symptoms began. He presented with 3-weeks of a mildly itchy rash on the lower extremities and buttocks associated with abdominal pain, nausea and diarrhea, low grade fever and joint aches. An abdominal pain evaluation was performed by his primary care physician that included the following normal tests: comprehensive metabolic panel, amylase, lipase and CT scan of the abdomen. Complete Blood Count (CBC) revealed a slightly elevated white blood cell (WBC) of 11.4 (units not provided) with 81.2% neutrophils. He was started on doxycycline due to concern for Rocky Mountain Spotted Fever. On our examination, the patient had widespread palpable purpura involving the lower extremities, buttocks, groin, lower abdomen, lower back and upper extremities. Biopsies for routine processing and direct immunofluorescence (DIF) were taken. A urinalysis was performed and was negative for blood and protein. Hepatitis panel was negative. Biopsy revealed perivascular and interstitial neutrophil-predominant dermatitis with focal fibrin deposition in small vessels consistent with leukocytoclastic vasculitis. DIF revealed 2-3+ granular IgA deposition in several superficial dermal blood vessels consistent with IgA vasculitis. He improved with prednisone (recovering) but flared upon its discontinuation (not recovered). He was restarted on prednisone with plan to initiate dapsone as a steroid-sparing agent. His urinalysis will be followed for abnormalities.  Upon internal review, the event of henoch-schonlein purpura nephritis was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pyrexia, Rash, Rash pruritic, Urine analysis normal, White blood cell count increased
Clinical narrative: Henoch-Schonlein purpura nephritis; Henoch-Schonlein purpura nephritis;   This literature marketed information has been received from the authors in a published literature article and refers to a 59-year-old man.  On an unknown date, the patient was intramuscularly vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown); and hepatitis b vaccine (recombinant)(manufacturer unknown) (dosage schedule not reported) for prophylaxis.   After 3 days of vaccination, the symptoms began. He presented with 3-weeks of a mildly itchy rash on the lower extremities and buttocks associated with abdominal pain, nausea and diarrhea, low grade fever and joint aches. An abdominal pain evaluation was performed by his primary care physician that included the following normal tests: comprehensive metabolic panel, amylase, lipase and CT scan of the abdomen. Complete Blood Count (CBC) revealed a slightly elevated white blood cell (WBC) of 11.4 (units not provided) with 81.2% neutrophils. He was started on doxycycline due to concern for Rocky Mountain Spotted Fever. On our examination, the patient had widespread palpable purpura involving the lower extremities, buttocks, groin, lower abdomen, lower back and upper extremities. Biopsies for routine processing and direct immunofluorescence (DIF) were taken. A urinalysis was performed and was negative for blood and protein. Hepatitis panel was negative. Biopsy revealed perivascular and interstitial neutrophil-predominant dermatitis with focal fibrin deposition in small vessels consistent with leukocytoclastic vasculitis. DIF revealed 2-3+ granular IgA deposition in several superficial dermal blood vessels consistent with IgA vasculitis. He improved with prednisone (recovering) but flared upon its discontinuation (not recovered). He was restarted on prednisone with plan to initiate dapsone as a steroid-sparing agent. His urinalysis will be followed for abnormalities.  Upon internal review, the event of henoch-schonlein purpura nephritis was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; Second dose was inadvertently administered as PROQUAD / patient's age: 27 years-old; This spontaneous report was received from a nurse concerning to a 27 year old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. The patient's pertinent past drugs included measles virus vaccine live (EndersEdmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (M-M-R II) and varicella virus vaccine live (Oka/Merck)) (VARIVAX).  On 29-AUG-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, frequency, route of administration, lot # and expiration date were not provided) (product administered to patient of inappropriate age). It was reported that a sterile diluent was used.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient was administered adose of improperly stored varivax; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. Information on patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 19-AUG-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX) (lot # S004554, expiry date: 14-FEB-2021), dose details, route, strength of all the vaccines were unknown) for prophylaxis. The vaccine was stored at a temperature range of (-14 degree Celsius to -10 degree Celsius (-14.4 degree Celsius)) for time frame of 18 minutes. No previous temperature excursion involved. The digital data logger was involved. No adverse effects reported.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: Has negative titers for MMR II; This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug allergy/reactions were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route, lot/ batch #, expiration date were not reported) for prophylaxis. It was also reported that no additional doses were administered.  On 30-AUG-2019, the patient had negative titers for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (hepatitis b surface antibody negative). No product quality complaint was involved. The outcome of hepatitis b surface antibody negative was unknown. The reporter's causality assessment was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Comparison of intensity of adverse events per dose; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The age group was captured as adult as per Shingrix indication.  The registered pharmacist reported that most patients who do get the second dose of Shingrix, the adverse events were not as bad as with dose 1 but sometimes just as bad and sometimes worse. No further details were provided by registered pharmacist. The reporter gave permission to follow up. For tolerance for 2nd dose, refer linked case US2019146733.
Sex: M
Vaccine: DTAP, PPV
Symptoms: Injury
Clinical narrative: Injured; This case was reported by a consumer via interactive digital media and described the occurrence of injury in a male patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On an unknown date, the patient received DTaP vaccine at an unknown dose and PNEUMOCOCCAL VACCINE at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced injury. On an unknown date, the outcome of the injury was unknown.   It was unknown if the reporter considered the injury to be related to DTaP vaccine.  Additional details were provided as follows: The patient was injured from DTaP and pneumococcal vaccine.  The reporter trying to recover the patient for a decade. It was unknown if the reporter considered the injury to be related to Pneumococcal vaccine.