chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Gastrointestinal disorder, Gastrooesophageal reflux disease, Headache, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in an adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shoulder pain, gastroesophageal reflux, poor sleep, gastrointestinal disorder, headache and feeling bad. On an unknown date, the outcome of the shoulder pain, gastroesophageal reflux, poor sleep, gastrointestinal disorder, headache and feeling bad were unknown. It was unknown if the reporter considered the shoulder pain, gastroesophageal reflux, poor sleep, gastrointestinal disorder, headache and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced unspecified common, minor reactions explained as shoulder hurts, headache, felt crummy, did not sleep well, unspecified GI (gastrointestinal issue) issues, and reflux. The patient did not state the day of SHINGRIX injection nor timing of events.  The patient was feeling better at the time of reporting. The patient was hang up when the patient was told that could not provide medical advice on how to manage events and was referred to her healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in an adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shoulder pain, gastroesophageal reflux, poor sleep, gastrointestinal disorder, headache and feeling bad. On an unknown date, the outcome of the shoulder pain, gastroesophageal reflux, poor sleep, gastrointestinal disorder, headache and feeling bad were unknown. It was unknown if the reporter considered the shoulder pain, gastroesophageal reflux, poor sleep, gastrointestinal disorder, headache and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced unspecified common, minor reactions explained as shoulder hurts, headache, felt crummy, did not sleep well, unspecified GI (gastrointestinal issue) issues, and reflux. The patient did not state the day of SHINGRIX injection nor timing of events.  The patient was feeling better at the time of reporting. The patient was hang up when the patient was told that could not provide medical advice on how to manage events and was referred to her healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the right arm. The caller was a pharmacist reporting that a patient received a dose SHINGRIX and experienced injection site reactions of swelling, redness and pain that extended down to her elbow and resolved after 4 to 5 days.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in an adult female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine at unknown arm. The patient experienced swelling at the injection site of the arm, which persisted at the time of reporting. The pharmacist did wish to divulge her demographics.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 6th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th July 2018, 12 hrs after receiving SHINGRIX, the patient experienced headache, chills and fatigue. In July 2018, the outcome of the headache and chills were recovered/resolved. On an unknown date, the outcome of the fatigue was recovering/resolving. It was unknown if the reporter considered the headache, chills and fatigue to be related to SHINGRIX. Additional information was received as follows: At 11:00, the patient received SHINGRIX on the left arm. The patient experienced headache, fatigue and chills which started approximately 12 hours after the second dose of SHINGRIX. The patient gave permission to contact her physician.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a 61-year-old male patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020) for prophylaxis. Concurrent medical conditions included diabetes. On 21st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, 7 days after receiving SHINGRIX, the patient experienced Guillain Barre Syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity, numbness in feet and chest pain. On an unknown date, the outcome of the Guillain Barre Syndrome, tingling of extremity, numbness in feet and chest pain were unknown. It was unknown if the reporter considered the Guillain Barre Syndrome, tingling of extremity, numbness in feet and chest pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a registered pharmacist. The patient received SHINGRIX vaccine on the right arm. The patient experienced tingling of feet and numbness, then developed chest pain and was seen by cardiologist. The patient was referred to neurologist who performed spinal tap and was diagnosed with Guillain-Barre Syndrome. The patient was hospitalized for a period of time for treatment as well. The reporter was unsure of exact dates or length of hospitalization. The contact details of the physician was provided.
Sex: F
Vaccine: MEN
Symptoms: Fatigue, Mobility decreased, Sluggishness
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a female patient who received Meningococcal B vaccine for prophylaxis. On 29th June 2018, the patient received the 1st dose of Meningococcal B vaccine. In June 2018, less than a week after receiving Meningococcal B vaccine, the patient experienced mobility decreased, tiredness and sluggishness. On an unknown date, the outcome of the mobility decreased, tiredness and sluggishness were unknown. It was unknown if the reporter considered the mobility decreased, tiredness and sluggishness to be related to Meningococcal B vaccine. Additional details were received as follows: The case was reported by the patient's mother. The age at vaccination was not reported. The reporter asked did anyone have any reaction to the vaccination. A day before reporting, the reporter's daughter received vaccine and could barely lift her arm. The patient was also very tired and sluggish. The patient was not herself.
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Rash pruritic
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of itchy rash in a female patient who received SHINGRIX for prophylaxis. On 21st May 2018, the patient received SHINGRIX. On 3rd July 2018, 43 days after receiving SHINGRIX, the patient experienced itchy rash and erythromacular rash. On an unknown date, the outcome of the itchy rash and erythromacular rash were unknown. It was unknown if the reporter considered the itchy rash and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vial shot at pharmacy. Suddenly before the day before reporting, she developed several red, itchy spots on various parts of body (outside of left leg, near groin, and midsection). The patient asked if this could be related to that shot.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were unknown. It was unknown if the reporter considered the fever and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's husband developed a fever and severe vomiting after the dose of SHINGRIX. The reporter stated that although this did not appear to be a true allergic response, his physician advised against receiving a booster. The reporter asked what were GlaxoSmithKline's recommendations.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site swelling, Skin discolouration
Clinical narrative: This case was reported by an other health professional via sales rep and described the occurrence of injection site swelling in an adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Down's syndrome. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, influenza-like symptoms and skin discoloration. On an unknown date, the outcome of the injection site swelling, influenza-like symptoms and skin discoloration were unknown. It was unknown if the reporter considered the injection site swelling, influenza-like symptoms and skin discoloration to be related to SHINGRIX. Additional details were provided as follows: The reporter was a phlebotomist. The age at vaccination was not reported. The sales representative stated that during in-service with reporter's practice, the reporter mentioned that her aunt had severe swelling at the injection site, large round spot on her upper arm, and also had flu like symptoms. The reporter did not agree to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain in extremity, Paraesthesia, Rash pruritic
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a 59-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 16th June 2018, the patient received the 2nd dose of SHINGRIX. On 2nd July 2018, 16 days after receiving SHINGRIX, the patient experienced shingles and itchy rash. In July 2018, the patient experienced tingling and headache. On an unknown date, the patient experienced pain in arm. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles, pain in arm, itchy rash, tingling and headache were unknown. It was unknown if the reporter considered the shingles, pain in arm, itchy rash, tingling and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 58 or 59 years. The patient's mother had a mild case of shingles that developed into postherpetic neuralgia (PHN), due to which the patient was proactive about getting the vaccine. The patient never had shingles. Aside from a sore arm for a couple days, there were no side effects. On 2nd July, the patient noticed an itchy rash on the left side of stomach. On 3rd July, the patient was diagnosed with shingles and started on Valacyclovir. On 5th July, the patient had additional shingles symptoms of headache (left side only) and tingling on the entire left side of body. The reporter knew the vaccine was not live and did not cause outbreak. However, it did not completely prevent outbreak either, though the patient was hoping the vaccine would lessen the duration and severity. The patient was a former medical reporter and was curious if they had received other reports like this and if she could be concerned about postherpetic neuralgia.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a other health professional via other manufacturer and described the occurrence of diarrhea in a elderly female patient who received Influenza vaccine unspecified for prophylaxis. Co-suspect products included JUXTAPID capsule for homozygous familial hypercholesterolemia. The patient's past medical history included homozygous familial hypercholesterolemia. On an unknown date, the patient received Influenza vaccine unspecified 2014-2015 season at an unknown dose. In December 2014, the patient started JUXTAPID (oral) 10 mg at an unknown frequency. On an unknown date, unknown after receiving Influenza vaccine unspecified 2014-2015 season, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown. It was unknown if the reporter considered the diarrhea to be related to Influenza vaccine unspecified 2014-2015 season. Additional details were provided as follows: The case was received from a specialty pharmacy reported by a dietician. The age at vaccination was not reported. On an unspecified date in December 2014, the patient commenced treatment with lomitapide 5 mg daily orally. The dose was increased to 10 mg daily orally on an unspecified date. On an unspecified date, during the winter season, the patient experienced diarrhea after having the flu shot. The patient experienced an additional episode of diarrhea between April 2018 and May 2018. No additional information was provided. No change was made to the administration of lomitapide as a result of this event.
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dry skin face in a 81-year-old male patient who received SHINGRIX for prophylaxis. On 1st July 2018, the patient received SHINGRIX In July 2018, less than a month after receiving SHINGRIX, the patient experienced dry skin face. On an unknown date, the outcome of the dry skin face was unknown. It was unknown if the reporter considered the dry skin face to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 80 or 81 years. The patient developed dry skin on face under the eyes all the way to chin. The patient asked if this was regular side effect. The patient had no pain and no impact on site spot either on shoulder (left side).
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The pharmacist was the patient. The age at vaccination was not reported. The patient stated that the first vaccination was more painful than the second. For the tolerance of 2nd dose of SHINGRIX refer case US2018118644, reported by same reporter for same patient.
Sex: F
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable registered nurse for her daughter via a Pfizer sales representative. A 17-year-old female patient received the first dose of TRUMENBA via an unspecified route of administration on an unspecified date, reported as about a year and two months before, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced minor swelling. Outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received PREVNAR 13, (batch/lot number and expiration date were not reported), 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 swelling and soreness that was persistent about a week after. The outcome of the events was recovered two weeks after. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018282314 same reporter, suspect product, event, and different patient.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received PREVNAR 13, (batch/lot number and expiration date were not reported), 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 swelling and soreness that was persistent about a week after. The outcome of the events was recovered two weeks after. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018282298 same reporter, suspect product, event, and different patient.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 82 years old female patient who experienced injection site reaction including mostly redness and swelling of the upper arm., while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medication was not reported. On an unknown date in 2017, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number: UI824AB, via intramuscular route in the upper arm. On an unknown date, the patient developed a non-serious injection site reaction which included mostly redness and swelling of the upper arm (inflammation localized, vaccination site reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient's past vaccination(s) included Fluzone HD in Jun-2015 and Fluzone HD in Jun-2016, both on an unknown dates. Final diagnosis was injection site reaction including mostly redness and swelling of the upper arm.. Lab tests was not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for injection site reaction including mostly redness and swelling of the upper arm.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Swelling face, Swollen tongue, Urticaria
Clinical narrative: Initial information received on 03-Jul-2018 regarding an unsolicited valid serious case received from nurse. This case involves a 16 years old female patient who experienced hives, swelling of tongue and swelling of face and extra dose administered while she received vaccine MENACTRA. The patients past medical history, medical treatment(s) and family history were not provided. Concomitant medication was not reported. On 21-Jun-2018, the patient received a 0.5 ml second single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848AA (Exp: 31-Mar-2019) via unknown route in the left arm. On 03 Jul 2018, The patient developed a serious tounge and facial swelling without respiratory distress (swelling face) 12 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant. On 03 Jul 2018, The patient developed a serious tounge and facial swelling without respiratory distress (swollen tongue) 12 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant. On 03 Jul 2018, The patient developed a serious adverse event which started with generalized hives from "head to toe" (urticaria) 12 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant. It was reported that patient had Menactra with first dose on an unknown date and she did not report any problem with first dose. It was also a case of extra dose administered. Final diagnosis was hives, Swelling of tongue, Swelling of face and extra dose administered. As corrective treatment her mother gave Claritin and she went to the Urgent care who sent her to the Emergency room (ER). The ER doctor gave her Benadryl and steroids and it resolved. The patient outcome is reported as Recovered / Resolved on an unknown date for hives, as Recovered / Resolved on an unknown date for tounge swelling and as Recovered / Resolved on an unknown date for facial swelling. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error; Sender's Comments: Patient experienced hives, Swelling of tongue and Swelling of face 12 days after vaccination. Time to onset is compatible with the role of vaccine. 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.
Age: 31.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Erythema, Injection site irritation, Injection site papule, Rash, Skin exfoliation
Clinical narrative: Rash 17 days post SPV. Developed papules distant from site near elbow. Lesions red, raised and scaly. C/o itch. No drainage. Site irritation from dressing. Treated with steroids for 5 days with improvement. Also with one lesion on opposite arm, near anthrax vaccination site. Pt otherwise well. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 31.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Skin lesion
Clinical narrative: Rash 17 days post SPV. Developed papules distant from site near elbow. Lesions red, raised and scaly. C/o itch. No drainage. Site irritation from dressing. Treated with steroids for 5 days with improvement. Also with one lesion on opposite arm, near anthrax vaccination site. Pt otherwise well. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient complained of pain, redness, swelling, and that the area was warm to the touch.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Day after vaccine, vaccinate arm was sore in the morning, consistent soreness continued for 4-6 weeks, in recent past, pain has mitigated (less severe) and in past few days no pain. Pain comes and goes, not aggrevated by moving arm. No swelling at injection site, not arthritis pain, felt like I was punched in the arm.
Age: 60.0
Sex: F
Vaccine: MENB, MNQ, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Fever, swelling and redness from shoulder to elbow with a hard mass in bicep accompanied by pain and limited range of motion, the swelling and redness extended on day 3 to below the elbow. On day 3 was told to apply ice every hour for 20 minutes and to keep arm elevated, and to take Benadryl. As of today 7/16/18 the swelling, redness and pain are still present but to a much smaller degree. Range of motion is restored and hard mass is decreasing.
Age: 60.0
Sex: F
Vaccine: MENB, MNQ, PPV
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever, swelling and redness from shoulder to elbow with a hard mass in bicep accompanied by pain and limited range of motion, the swelling and redness extended on day 3 to below the elbow. On day 3 was told to apply ice every hour for 20 minutes and to keep arm elevated, and to take Benadryl. As of today 7/16/18 the swelling, redness and pain are still present but to a much smaller degree. Range of motion is restored and hard mass is decreasing.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Pt stated that she had severe flu like symptoms for 3 to 4 days after injection. Was very fatigued.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Ophthalmological examination, Rash
Clinical narrative: Headaches started 7-1-2018 and still continue bumps to face started 7-8-2018 while out of town, went to doctor 7-12-2018, went to eye doctor 7-16/2018
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Fatigue, Influenza like illness, Palpitations
Clinical narrative: Severe flulike symptoms including shaking, chills, fever (100.8 oF), palpitations, exhaustion for 36 hours. 36-48 hours symptoms abated except for extreme exhaustion. Necessitated bedrest for 2 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Severe flulike symptoms including shaking, chills, fever (100.8 oF), palpitations, exhaustion for 36 hours. 36-48 hours symptoms abated except for extreme exhaustion. Necessitated bedrest for 2 days.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site edema in an unspecified number of adult patient's who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site edema, injection site erythema, injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site edema, injection site erythema and injection site pain were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site edema, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient experienced local adverse events described as edema, redness and pain which resolved in 2 days. The physician suspected that the patient received the SHINGRIX via subcutaneous route and not intramuscular route which led to inappropriate route of vaccination. The physician declined to be followed up.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, No adverse event, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a college age patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in approximately May 2018 (reported as "month ago"), the patient was vaccinated with first dose of M-M-R II, subcutaneously (lot number and expiration date not provided) for prophylaxis. On 13-JUN-2018, the patient was vaccinated with second dose of M-M-R II, subcutaneously (lot number and expiration date not provided) for prophylaxis. On an unspecified date in 2018, the patient had negative test results for Measles, Mumps and Rubella antibodies. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a pharmacist referring to a 25 year old female patient. The patient's concurrent condition, pertinent medical history and drug reactions were not reported. On an unknown date, the patient received an expired dose of GARDASIL 9 (intramuscular, lot # M017983 with expiration date 30-MAY-2018) for prophylaxis. This dose was the second dose of a three dose series. No adverse effects reported. No product quality complaint was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a nurse, referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-JUN-2018, the patient inadvertently received a pediatric/adolescent dose of VAQTA lot # N026997, expiration date on 10-NOV-2018, 0.5 ml, once, intramuscularly (anatomical location was not reported) for prophylaxis. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same source.; Sender's Comments:  US-009507513-1807USA006062:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer 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 2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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, the very virus that ZOSTAVAX was intended to prevent. In 2011, the patient was treated at a medical center for a vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a family health center (considered a physician's office) for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 12-MAR-2016, the patient was treated at a hospital (not specified if admitted, therefore considered Emergency Room visit until follow-up received) by for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX by a physician for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2013, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. Well along in 2013, the patient sought subsequent treatment from another physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer 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 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. Later on or about 31-OCT-2011, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer 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. On or about 29-DEC-2008 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. Later on or about 12-SEP-2009, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer 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 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. Later in 2014, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer 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 February 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. Later in July 2018, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer 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 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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. In 2016, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. 01-DEC-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 or about 15-FEB-2016, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer 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. On or about 31-AUG-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 or about 18-JUN-2016, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. On or about 30-JUN-2016 the patient sought subsequent treatment from a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-MAR-2015, the patient was inoculated with ZOSTAVAX at a medical office for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). 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 or about 22-AUG-2016, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as severe shingles. She was prescribed valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 was unknown.  Causality assessment was related. Additional information has been requested.