chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 17-NOV-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-NOV-2011, the patient was treated at a medical care facility for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient has been prescribed VALTREX to manage her painful symptoms. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated for a persistent and severe vesicular rash, 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 is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In January 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a physician office as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-FEB-2016, the patient was treated at physician office for a persistent and severe vesicular rash, 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 is unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood test, Pruritus generalised
Clinical narrative: Patient experienced a blister on left foot three (3) days after getting vaccine. Patient felt itchy throughout body and reports eating tomatoes, eggs, acidic food causes the blister to flare up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Pain, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 05-MAR-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-SEP-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as shingles and neuropathy. The patient was prescribed gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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. Upon internal review, neuropathy was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) referring to an identified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N035176 expiring on 09-JUN-2019, for prophylaxis (dosage schedule and route of administration were not reported). Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) properly stored. The administered dose of the vaccine experienced a temperature excursion of 6°F to 14°F for 3 hours and of 15°F to 46°F (21°F) for another 2 hours , as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same source.; Sender's Comments: US-009507513-1805USA015000: Original Case : 1805USA015000.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) referring to an identified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N025929 expiring on 18-MAR-2019, for prophylaxis (dosage schedule and route of administration were not reported). Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) properly stored. The administered dose of the vaccine experienced a temperature excursion of 6°F to 14°F for 3 hours and of 15°F to 46°F (21°F) for another 2 hours , as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same source.; Sender's Comments: US-009507513-1805USA015000:Original Case : 1805USA015000.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Guillain-Barre syndrome, Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of Guillain-Barre syndrome in a 64-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. Concomitant products included Albuterol, Flonase, Levothyroxine, ranitidine hydrochloride and Singulair. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st May 2018, 8 days after receiving SHINGRIX, the patient experienced Guillain-Barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization) and upper back pain (serious criteria hospitalization). On an unknown date, the outcome of the Guillain-Barre syndrome, tingling of extremity and upper back pain were not recovered/not resolved. It was unknown if the reporter considered the Guillain-Barre syndrome, tingling of extremity and upper back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine at 10:00 in the left deltoid. The physician stated that the patient presented with symptoms of upper back pain and arm tingling on 31st May 2018. On 1st June 2018, the patient went to the emergency room due to worsening of symptoms and was then discharged the same day. Due to continued worsening of symptoms the patient re-visited emergency room on 4th June 2018, and later that day was transferred to tertiary care hospital. The patient was currently hospitalized and was being treated for Guillain-Barre syndrome at the time of reporting. The healthcare professional gave permission to contact them for any further information required.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Borrelia test negative, CSF test normal, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of Guillain-Barre syndrome in a 64-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. Concomitant products included Albuterol, Flonase, Levothyroxine, ranitidine hydrochloride and Singulair. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st May 2018, 8 days after receiving SHINGRIX, the patient experienced Guillain-Barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization) and upper back pain (serious criteria hospitalization). On an unknown date, the outcome of the Guillain-Barre syndrome, tingling of extremity and upper back pain were not recovered/not resolved. It was unknown if the reporter considered the Guillain-Barre syndrome, tingling of extremity and upper back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine at 10:00 in the left deltoid. The physician stated that the patient presented with symptoms of upper back pain and arm tingling on 31st May 2018. On 1st June 2018, the patient went to the emergency room due to worsening of symptoms and was then discharged the same day. Due to continued worsening of symptoms the patient re-visited emergency room on 4th June 2018, and later that day was transferred to tertiary care hospital. The patient was currently hospitalized and was being treated for Guillain-Barre syndrome at the time of reporting. The healthcare professional gave permission to contact them for any further information required.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle spasms, Muscular weakness, Nausea, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of Guillain-Barre syndrome in a 64-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. Concomitant products included Albuterol, Flonase, Levothyroxine, ranitidine hydrochloride and Singulair. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st May 2018, 8 days after receiving SHINGRIX, the patient experienced Guillain-Barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization) and upper back pain (serious criteria hospitalization). On an unknown date, the outcome of the Guillain-Barre syndrome, tingling of extremity and upper back pain were not recovered/not resolved. It was unknown if the reporter considered the Guillain-Barre syndrome, tingling of extremity and upper back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine at 10:00 in the left deltoid. The physician stated that the patient presented with symptoms of upper back pain and arm tingling on 31st May 2018. On 1st June 2018, the patient went to the emergency room due to worsening of symptoms and was then discharged the same day. Due to continued worsening of symptoms the patient re-visited emergency room on 4th June 2018, and later that day was transferred to tertiary care hospital. The patient was currently hospitalized and was being treated for Guillain-Barre syndrome at the time of reporting. The healthcare professional gave permission to contact them for any further information required.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Schwannoma
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of Guillain-Barre syndrome in a 64-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. Concomitant products included Albuterol, Flonase, Levothyroxine, ranitidine hydrochloride and Singulair. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st May 2018, 8 days after receiving SHINGRIX, the patient experienced Guillain-Barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization) and upper back pain (serious criteria hospitalization). On an unknown date, the outcome of the Guillain-Barre syndrome, tingling of extremity and upper back pain were not recovered/not resolved. It was unknown if the reporter considered the Guillain-Barre syndrome, tingling of extremity and upper back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine at 10:00 in the left deltoid. The physician stated that the patient presented with symptoms of upper back pain and arm tingling on 31st May 2018. On 1st June 2018, the patient went to the emergency room due to worsening of symptoms and was then discharged the same day. Due to continued worsening of symptoms the patient re-visited emergency room on 4th June 2018, and later that day was transferred to tertiary care hospital. The patient was currently hospitalized and was being treated for Guillain-Barre syndrome at the time of reporting. The healthcare professional gave permission to contact them for any further information required.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Erythema, Pruritus, Skin warm
Clinical narrative: Pt received PREVNAR 13 vaccine in office 5-29-18. On 6-5-18 she contacted office and came in to visit nurse due to 10.5cm x 9cm red area on her left upper lateral arm. The area was warm to touch and had several raised vesicles noted. Dr. also examined patient. Patient was unable to recall exactly when her symptoms began after the injection, but said it was several days after the vaccine. She was prescribed BENADRYL PO PRN for the itching and redness.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Large red injection site reaction on Left arm.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Herpes zoster, Injection site reaction, Injection site vesicles, Rash
Clinical narrative: Patient developed a painful rash to left deltoid area 2 days after receiving vaccination. Seen in urgent care on 5/28 and seen by PCP on 5/29. Patient diagnosed with herpes zoster at site of injection with active blisters covering Lt deltoid and scattered clusters down to dorsum on Lt hand. Pt treated with Valacyclovir, Lidocaine patch, Tramadol and now referred to pain management. Rash is subsiding however pain continues.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Rash generalised
Clinical narrative: Rash all over the body and redness on the left thigh (injection site).
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL, PNC, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: L thigh with 3 cm of erythema with induration, minimally warm to touch. Prescribed antibiotic for cellulitis.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL, PNC, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: L thigh with 3 cm of erythema with induration, minimally warm to touch. Prescribed antibiotic for cellulitis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Diarrhoea, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Patient called complaining  of low grade fever, aching muscles and stomach soreness on 6/6 and felt poorly for several days. She had an episode of diarrhea on 6/9 and felt back to her normal baseline after this. Patient was advised to treat with OTC meds for muscle aches.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: Arm/injection site started itching 4 days after, became red and warm to touch. Red area around injection site 4" x 3.5" No respiratory symptoms, hive resolving.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Rash, Rash pruritic
Clinical narrative: Pt stated 2 days after the immunization, he started having muscle pain in both legs and itchy rash on left forearm. He's been using TYLENOL and "After Bite" to relieve symptoms. Symptoms improving, pt has appt with MD in 1 month.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC13, RV5, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None; reporting the administration gave varicella along with MMR.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt dizzy and then fainted.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL, PNC13, VARCEL, HEPA, PNC13
Symptoms: Injection site erythema
Clinical narrative: Had vaccines 5/23, at site of Varicella vaccine pt started with redness at injection site, worse today area marked, call if erythema spreads outside of marked area. Cephalexin BID for 10 days.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL, PNC13, VARCEL, HEPA, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Had vaccines 5/23, at site of Varicella vaccine pt started with redness at injection site, worse today area marked, call if erythema spreads outside of marked area. Cephalexin BID for 10 days.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Abdominal pain, Colectomy, Explorative laparotomy, Flatulence, Food refusal
Clinical narrative: Three days after receiving ROTARIX vaccine patient began having gassiness, fussiness and abdominal pain. A day later, he also began having bloody stool. He was thought to have milk protein allergy and was sent home. Later that night, 4 days after vaccination, patient also began refusing food. Seven days after vaccine he developed fever and bilious emesis in addition to persistence of preceding symptoms. He was found at that time to have intussusception. Reduction of intussusception failed twice. During attempt to reduce with air, the bowel was perforated. Ex-lap was performed and patient underwent subtotal colectomy, partial ilial resection and end ileostomy on 5/24. He required parenteral nutrition for approximately two weeks, was transitioned to NG tube feeds and ultimately oral feeds. He required blood transfusion of 1 unit pRBCs on 5/29.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Gastrointestinal tube insertion, Haematochezia, Haemoglobin decreased, Ileectomy, Ileostomy
Clinical narrative: Three days after receiving ROTARIX vaccine patient began having gassiness, fussiness and abdominal pain. A day later, he also began having bloody stool. He was thought to have milk protein allergy and was sent home. Later that night, 4 days after vaccination, patient also began refusing food. Seven days after vaccine he developed fever and bilious emesis in addition to persistence of preceding symptoms. He was found at that time to have intussusception. Reduction of intussusception failed twice. During attempt to reduce with air, the bowel was perforated. Ex-lap was performed and patient underwent subtotal colectomy, partial ilial resection and end ileostomy on 5/24. He required parenteral nutrition for approximately two weeks, was transitioned to NG tube feeds and ultimately oral feeds. He required blood transfusion of 1 unit pRBCs on 5/29.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Intestinal perforation, Intussusception, Irritability, Milk allergy, Packed red blood cell transfusion
Clinical narrative: Three days after receiving ROTARIX vaccine patient began having gassiness, fussiness and abdominal pain. A day later, he also began having bloody stool. He was thought to have milk protein allergy and was sent home. Later that night, 4 days after vaccination, patient also began refusing food. Seven days after vaccine he developed fever and bilious emesis in addition to persistence of preceding symptoms. He was found at that time to have intussusception. Reduction of intussusception failed twice. During attempt to reduce with air, the bowel was perforated. Ex-lap was performed and patient underwent subtotal colectomy, partial ilial resection and end ileostomy on 5/24. He required parenteral nutrition for approximately two weeks, was transitioned to NG tube feeds and ultimately oral feeds. He required blood transfusion of 1 unit pRBCs on 5/29.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Parenteral nutrition, Pyrexia, Vomiting
Clinical narrative: Three days after receiving ROTARIX vaccine patient began having gassiness, fussiness and abdominal pain. A day later, he also began having bloody stool. He was thought to have milk protein allergy and was sent home. Later that night, 4 days after vaccination, patient also began refusing food. Seven days after vaccine he developed fever and bilious emesis in addition to persistence of preceding symptoms. He was found at that time to have intussusception. Reduction of intussusception failed twice. During attempt to reduce with air, the bowel was perforated. Ex-lap was performed and patient underwent subtotal colectomy, partial ilial resection and end ileostomy on 5/24. He required parenteral nutrition for approximately two weeks, was transitioned to NG tube feeds and ultimately oral feeds. He required blood transfusion of 1 unit pRBCs on 5/29.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site pain, Nausea
Clinical narrative: Erythema, pain at injection site, headache, nausea ongoing for 3 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypersomnia, Injection site warmth, Somnolence
Clinical narrative: Dizziness, drowsiness resulting in sleeping for approximately 12-18 hours, "hot" feeling at injection site.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Band neutrophil count increased, Bandaemia, Blood culture negative, Blood electrolytes normal, Body temperature increased
Clinical narrative: Fussy/irritable, decreased PO. Tm 105 at home. No rhinorrhea, cough, diarrhea, emesis, or focality on symptoms. 2 complex febrile seizures on 6/9, another 2 complex febrile seizures on 6/10; (full body convulsing "like seizures" involving all 4 extremities, eye deviation and with froth coming from the corner of her mouth, unresponsive and shaking) with postictal period. Maculopapular, erythematous and blanching rash developed on 6/11, trunk to face and arms.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Chest X-ray normal, Electroencephalogram normal, Eye movement disorder, Febrile convulsion, Foaming at mouth
Clinical narrative: Fussy/irritable, decreased PO. Tm 105 at home. No rhinorrhea, cough, diarrhea, emesis, or focality on symptoms. 2 complex febrile seizures on 6/9, another 2 complex febrile seizures on 6/10; (full body convulsing "like seizures" involving all 4 extremities, eye deviation and with froth coming from the corner of her mouth, unresponsive and shaking) with postictal period. Maculopapular, erythematous and blanching rash developed on 6/11, trunk to face and arms.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Haemoglobin decreased, Hypophagia, Irritability, Pallor, Platelet count decreased
Clinical narrative: Fussy/irritable, decreased PO. Tm 105 at home. No rhinorrhea, cough, diarrhea, emesis, or focality on symptoms. 2 complex febrile seizures on 6/9, another 2 complex febrile seizures on 6/10; (full body convulsing "like seizures" involving all 4 extremities, eye deviation and with froth coming from the corner of her mouth, unresponsive and shaking) with postictal period. Maculopapular, erythematous and blanching rash developed on 6/11, trunk to face and arms.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Postictal state, Rash, Rash erythematous, Rash maculo-papular, Tremor
Clinical narrative: Fussy/irritable, decreased PO. Tm 105 at home. No rhinorrhea, cough, diarrhea, emesis, or focality on symptoms. 2 complex febrile seizures on 6/9, another 2 complex febrile seizures on 6/10; (full body convulsing "like seizures" involving all 4 extremities, eye deviation and with froth coming from the corner of her mouth, unresponsive and shaking) with postictal period. Maculopapular, erythematous and blanching rash developed on 6/11, trunk to face and arms.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Unresponsive to stimuli, Urine analysis normal, White blood cell count decreased
Clinical narrative: Fussy/irritable, decreased PO. Tm 105 at home. No rhinorrhea, cough, diarrhea, emesis, or focality on symptoms. 2 complex febrile seizures on 6/9, another 2 complex febrile seizures on 6/10; (full body convulsing "like seizures" involving all 4 extremities, eye deviation and with froth coming from the corner of her mouth, unresponsive and shaking) with postictal period. Maculopapular, erythematous and blanching rash developed on 6/11, trunk to face and arms.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site infection, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: 5 yo female presents to the clinic accompanied by her mother for an infection on her left leg, the MOP states that the pt has gotten shots done and got one on her left leg, the Mop states that there has been a warm spot that has arose on her leg and she states that it has gotten worse since then, the mop states that it had arise over the weekend, the pt reported there has been tenderness in there area with low grade fever which lasted 2-3 days.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) referring to an identified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # N035173 expiring on 09-JUN-2019, for prophylaxis) (dosage schedule and route of administration were not reported). Concomitant therapies included Merck sterile diluent properly stored. The administered dose of the vaccine experienced a temperature excursion of 6 degrees to 14 degrees F for 3 hours and of 15 degrees F to 46 degrees F (21 degrees F) for another 2 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1806USA004922; US-009507513-1806USA004923.
Age: 40.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 40 year old male patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 20-JUL-2017, the patient was inadvertently vaccinated with a pediatric dose of VAQTA intramuscularly in to right deltoid (lot # M039202, expiration date: 11-MAR-2018, dose was not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 3 different adolescent patients of unknown gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown dates, the patients were vaccinated with GARDASIL 9 for prophylaxis (doses, route of administration, lot# and expiration date were not reported). On an unknown date in approximately 2017, also reported as "after receiving a shot of GARDASIL 9" and "in the last 6 to 9 months", the patients had bumps in their arms that persisted and did not stick out. The nurse also reported, that the patients had the bumps in their arms in a close proximity of time. It was unknown, if the patients received the treatment for reported event. On an unknown date, one of the patients was seen by a dermatologist (details were not provided). The outcome the event was unknown. The relatedness between the events and GARDASIL 9 was not provided.
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. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2016, the patient was treated at a health facility, for the onset of a severe vesicular rash, which 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: 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. On or about 29-DEC-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-JUN-2016, the patient was treated at a health center for the onset of a severe vesicular rash accompanied, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. In October 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-FEB-2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX for management of his 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-JUN-2016, the patient was treated at a healthcare facility/office (by an unspecified healthcare professional) for the onset of a severe vesicular rash, which was diagnosed as shingles. On or about 26-JUL-2016, the patient sought subsequent treatment at the healthcare facility/office, for continued and worsening vesicular outbreaks, which were diagnosed as herpes zoster and post-herpetic neuralgia. The patient was prescribed "Idomethacin", oxycodone, gabapentin and hydrocodone for management of her painful symptoms and 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUN-2016, the patient was treated at a healthcare facility/office, by a physician,  for the onset of a vesicular rash, which 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: 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 male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-JUL-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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. On or about 31-AUG-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. He was prescribed acyclovir and tramadol to manage his painful symptoms and chronic pain. As a direct and proximate result of 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 October 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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. In January 2015, the patient was treated at a medical center for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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. On or about 01-JUL-2008, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and 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. On or about 01-OCT-2010, the patient was treated at the same clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 05-MAR-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain  of herpes zoster. On or about 01-AUG-2013, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age (reported as college aged) and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with PROQUAD, subcutaneous for prophylaxis; dose, strength, lot# and expiration date were unknown. PROQUAD, was administered to a patient of inappropriate age. No adverse event was reported. The outcome of drug administered to patient of inappropriate age and no adverse event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-DEC-2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as zoster. The patient was prescribed valacyclovir (VALTREX) for management of her painful symptoms. On or about 21-MAR-2016, the patient sought subsequent treatment from a physician for a persistent and severe vesicular rash, which was diagnosed 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 is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2015, the patient was treated for a persistent and severe vesicular rash, 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 is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a persistent and severe vesicular rash, 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 is unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report was received 65-year-old female patient, who was reporting on herself. The patient's concurrent conditions included paroxysmal arterial fib ration (paroxysmal afib), primordial ulcer, fibromyalgia. She was allergic to AUGMENTIN and VIACIN which made her sick and caused vomiting (date was not provided). On 23-NOV-2009, the patient was vaccinated with ZOSTAVAX, one injection for prophylaxis (lot# and expiration date were not reported). It was uncertain, if ZOSTAVAX injection was administered subcutaneously or intramuscularly. Other suspect therapies included STERILE DILUENT (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included SOTALOL. On an unknown date, after taking ZOSTAVAX, the patient experienced diarrhea. No laboratory test was performed. The patient did not receive any treatment for the reported event. The outcome of the event was unknown. The relatedness between the events and ZOSTAVAX was not provided.