chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Brachial plexopathy, Burning sensation, Bursitis, Complex regional pain syndrome, Electromyogram
Clinical narrative: Immediately upon injection I felt an instant burn/pain like fire being injected in to arm. My arm started to continue to burn, ache, throb and arm also started drooping. My arm has continued to go numb, tingle, burn, ache, throb and have disabled of my whole left side now. I was diagnosed with brachial plexopathy now it's CRPS type 2 with bursitis in hip and knee.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Nerve block, Nuclear magnetic resonance imaging
Clinical narrative: Immediately upon injection I felt an instant burn/pain like fire being injected in to arm. My arm started to continue to burn, ache, throb and arm also started drooping. My arm has continued to go numb, tingle, burn, ache, throb and have disabled of my whole left side now. I was diagnosed with brachial plexopathy now it's CRPS type 2 with bursitis in hip and knee.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Immediately upon injection I felt an instant burn/pain like fire being injected in to arm. My arm started to continue to burn, ache, throb and arm also started drooping. My arm has continued to go numb, tingle, burn, ache, throb and have disabled of my whole left side now. I was diagnosed with brachial plexopathy now it's CRPS type 2 with bursitis in hip and knee.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain, Herpes zoster, Pruritus, Rash
Clinical narrative: After vaccine, pt had actual shingles.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain, Herpes zoster, Rash
Clinical narrative: After vaccine, pt had actual shingles.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: After vaccine, pt had actual shingles.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX (batch number NX952, expiry date unknown). Concomitant products included Atorvastatin, TRAVATAN, buspirone and Metoprolol succinate. On 20th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 2 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced injection site swelling and myalgia. On an unknown date, the outcome of the injection site swelling and myalgia were not recovered/not resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site swelling, myalgia and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included Multivitamin. After receiving SHINGRIX, the patient's arm ached a little on the days 2 and 3, but it started getting worse on the 4th or 5th day. The patient contacted her pharmacist. At the time of reporting, the patient still had swelling at the injection site and myalgia up her arm into her neck and this made it painful for her to move her arm. The patient was concerned because she would have to cancel a trip which has coming up at the beginning of June.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX (batch number NX952, expiry date unknown). Concomitant products included Atorvastatin, TRAVATAN, buspirone and Metoprolol succinate. On 20th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 2 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced injection site swelling and myalgia. On an unknown date, the outcome of the injection site swelling and myalgia were not recovered/not resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site swelling, myalgia and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included Multivitamin. After receiving SHINGRIX, the patient's arm ached a little on the days 2 and 3, but it started getting worse on the 4th or 5th day. The patient contacted her pharmacist. At the time of reporting, the patient still had swelling at the injection site and myalgia up her arm into her neck and this made it painful for her to move her arm. The patient was concerned because she would have to cancel a trip which has coming up at the beginning of June.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase, C-reactive protein, Differential white blood cell count, Full blood count, Impaired work ability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX (batch number NX952, expiry date unknown). Concomitant products included Atorvastatin, TRAVATAN, buspirone and Metoprolol succinate. On 20th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 2 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced injection site swelling and myalgia. On an unknown date, the outcome of the injection site swelling and myalgia were not recovered/not resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site swelling, myalgia and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included Multivitamin. After receiving SHINGRIX, the patient's arm ached a little on the days 2 and 3, but it started getting worse on the 4th or 5th day. The patient contacted her pharmacist. At the time of reporting, the patient still had swelling at the injection site and myalgia up her arm into her neck and this made it painful for her to move her arm. The patient was concerned because she would have to cancel a trip which has coming up at the beginning of June.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX (batch number NX952, expiry date unknown). Concomitant products included Atorvastatin, TRAVATAN, buspirone and Metoprolol succinate. On 20th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 2 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced injection site swelling and myalgia. On an unknown date, the outcome of the injection site swelling and myalgia were not recovered/not resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site swelling, myalgia and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included Multivitamin. After receiving SHINGRIX, the patient's arm ached a little on the days 2 and 3, but it started getting worse on the 4th or 5th day. The patient contacted her pharmacist. At the time of reporting, the patient still had swelling at the injection site and myalgia up her arm into her neck and this made it painful for her to move her arm. The patient was concerned because she would have to cancel a trip which has coming up at the beginning of June.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate, X-ray limb
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX (batch number NX952, expiry date unknown). Concomitant products included Atorvastatin, TRAVATAN, buspirone and Metoprolol succinate. On 20th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 2 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced injection site swelling and myalgia. On an unknown date, the outcome of the injection site swelling and myalgia were not recovered/not resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site swelling, myalgia and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included Multivitamin. After receiving SHINGRIX, the patient's arm ached a little on the days 2 and 3, but it started getting worse on the 4th or 5th day. The patient contacted her pharmacist. At the time of reporting, the patient still had swelling at the injection site and myalgia up her arm into her neck and this made it painful for her to move her arm. The patient was concerned because she would have to cancel a trip which has coming up at the beginning of June.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 62-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). Concomitant products included MACROBID, AMBIEN, meloxicam and tramadol. On 26th April 2018 09:15, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives were recovering/resolving. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the left arm. The pharmacy was notified about the hives on 2nd May 2018 and at that point the patient had already visited her doctor's office. The pharmacy last spoke with the patient on 4th May 2018 and at that point the hives were getting better. The patient still wanted to get the 2nd dose and the patient's physician had apparently indicated that it was okay for her to get the 2nd dose.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Inflammation, Joint range of motion decreased, Pain
Clinical narrative: Pt reports after injection was administered in the R deltoid muscle signficant myalgia reported with persistent symptoms lasting to date of reporting.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Pt reports after injection was administered in the R deltoid muscle signficant myalgia reported with persistent symptoms lasting to date of reporting.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). On 27th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 21 days after receiving SHINGRIX, the patient experienced pain in arm and movement disorder. On an unknown date, the outcome of the pain in arm and movement disorder were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and movement disorder to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient did not have pain with injection initially. But, 3 weeks after receiving SHINGRIX, the patient experienced arm pain and difficulty to lift her arm. The pharmacist was not sure if the events occurred on the same arm where the vaccine was administered. The call was transferred to medical information system (MIS) for discussion.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). On 27th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 21 days after receiving SHINGRIX, the patient experienced pain in arm and movement disorder. On an unknown date, the outcome of the pain in arm and movement disorder were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and movement disorder to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient did not have pain with injection initially. But, 3 weeks after receiving SHINGRIX, the patient experienced arm pain and difficulty to lift her arm. The pharmacist was not sure if the events occurred on the same arm where the vaccine was administered. The call was transferred to medical information system (MIS) for discussion.
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 87-year-old male patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020). Concomitant products included Metoprolol. On 9th May 2018, the patient received SHINGRIX. On 9th May 2018, 7 hrs after receiving SHINGRIX, the patient experienced fever, myalgia and chills. On 10th May 2018, the outcome of the fever, myalgia and chills were recovered/resolved. The reporter considered the fever, myalgia and chills to be almost certainly related to SHINGRIX. Additional details were provided as follows: At 18:00 hrs, the patient developed fever, chills, and myalgia. The events were lasted approximately 12 to 15 hours.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: One hour after injection, I had a hammering headache which continued in spite of taking Ibuprofen. During night had sweats and body ached something terrible - could not sleep. The following morning (5/16), I was terribly weak, tired, muscle pain and continued headache. Around 9 a.m. got the chills and shivering. Remainder of 5/16 I felt terrible - continued with symptoms mentioned above. Laid on sofa most of day because I was to weak to move. Had no appetite.  Called pharmacist at about 3:30 and he said that only thing I could do was take Tylenol. He mentioned that he'd had a male client that had reported similar side effects. Took 2 Tylenol around 9 p.m. and went to bed. Feel better this morning, 5/17, but still somewhat weak. I doubt that I will take the second injection as recommended. Have yet to discuss this with my doctor.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Myalgia, Night sweats, Pain
Clinical narrative: One hour after injection, I had a hammering headache which continued in spite of taking Ibuprofen. During night had sweats and body ached something terrible - could not sleep. The following morning (5/16), I was terribly weak, tired, muscle pain and continued headache. Around 9 a.m. got the chills and shivering. Remainder of 5/16 I felt terrible - continued with symptoms mentioned above. Laid on sofa most of day because I was to weak to move. Had no appetite.  Called pharmacist at about 3:30 and he said that only thing I could do was take Tylenol. He mentioned that he'd had a male client that had reported similar side effects. Took 2 Tylenol around 9 p.m. and went to bed. Feel better this morning, 5/17, but still somewhat weak. I doubt that I will take the second injection as recommended. Have yet to discuss this with my doctor.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a Registered Nurse and refers to 8 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 06-SEP-2017, 18-SEP-2017 and 20-SEP-2017; three patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number M031574, expiration date: 11-NOV-2018), for prophylaxis. Additionally, on 01-SEP-2017, 17-SEP-2017, 26-SEP-2017 and 29-SEP-2017, five patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number N000326, expiration date 14-OCT-2019) for prophylaxis (doses, routes, routes of administration and anatomical locations were not reported for any vaccine). Both vaccines were exposed to a temperature excursion of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion was at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. Follow-up information was received from the Registered Nurse on 11-MAY-2018. A request was made for patient identifiers and dates of vaccination. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information, it was determined that this case is now valid because patient identifiers were received. Follow-up information has been received from an unspecified reporter from the office of the physician on 14-MAY-2018. On 29-SEP-2017, the 17-year old patient received the improperly stored dose of GARDASIL 9. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1805USA006935; US-009507513-1805USA006936; US-009507513-1805USA006937; US-009507513-1805USA006938; US-009507513-1805USA006939; US-009507513-1805USA006940; US-009507513-1805USA006941.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site nodule, Local reaction
Clinical narrative: This spontaneous report has been received from a Pediatrician referring to a 4 year old male patient. The patient had no medical history, concurrent conditions, drug, allergy history to be reported. On 02-MAY-2018, the patient was vaccinated with PROQUAD lot # N028445, expiration date 09-APR-2019), intradermally into the thigh for prophylaxis (strength, dose and frequency were not reported). Concomitant therapies included sterile diluent (MRK STERILE DILUENT). It was reported that on 02-MAY-2018, the injection created a bubble on the skin (injection site nodule) and a local reaction which was 3cm by 3cm across and was a "deep pink red" color (injection site erythema), which became more red on 03-MAY-2018. The physician reported she did not see any vesicles. Treatment included an unspecified dose of ibuprofen and cool compress. There was no laboratory diagnostics or studies performed. It was reported that the patient sought medical attention for the events. The outcome of local reaction, injection site erythema and injection site nodule was reported as not recovered. At the time of the reporting, the causality between the aforementioned events and PROQUAD was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 08-MAY-2018, the patient was vaccinated with an expired dose of VAQTA 50/1.0 U/mL injection, one dose, for expiration date, lot #N005605 and expiration date reported as 08-APR-2018 (dose, frequency and route of administration were not reported). No adverse effects were reported.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 61 year old female patient, reporting on herself. The patient's current condition included sulfa drug allergy, arthritis, on and off acid reflux and osteoporosis. The patient did not have any concomitant medications ongoing. On 28-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 1 dose for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified date in 2018 (reported as "no long after receiving the PNEUMOVAX 23), the patient developed swelling, redness and muscle pain at the injection site. Approximately on 07-MAR-2018 (reported as about a week after receiving the vaccine) the patient recovered from swelling and redness. Approximately on 24-APR-2018 (reported as about two weeks ago),  the patient recovered from muscle pain.  Further, the patient informed that starting on 06-MAY-2018, she developed a red spot around the injection site, that was red, warm to the touch and painful and was starting to expand in size. The patient received an unspecified treatment. At the time of reporting, the patient had not recovered from red spot around the injection site, that was red, warm to the touch and painful and was starting to expand in size. The causal relationship between the vaccination with PNEUMOVAX 23 and the events was not provided by the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been  eceived from a physician assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 08-MAY-2018, the patient was vaccinated with an expired dose of VAQTA (dose and route unknown, lot # N002921 with expiration date 08-APR-2018) for prophylaxis. No adverse effects reported. No product quality complaint (PQC) was involved. Therapy was also reported as not discontinued.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a health professional via a company representative and refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was inadvertently vaccinated with a dose of VARIVAX and PROQUAD (exact dose, lot numbers and expiry dates were not reported) for prophylaxis. It was unknown if the patient received both VARIVAX and PROQUAD on the same date. Both vaccines were reconstituted with sterile diluent (lot number and expiration unknown). No adverse effects were reported.
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. On an unspecified date in 2016, 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. ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or herpes zoster. Later in 2016, the patient was treated by a physician for the onset of a severe vesicular rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX and/or as a result of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events is unknown. 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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 10-JUN-2016, the patient was treated by a physician for the onset of a painful vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-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 04-MAY-2015, the patient was inoculated with ZOSTAVAX vaccine (lot number and expiration unknown) unknown route, at a pharmacy. The inoculation was recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 09-MAY-2015, the patient contracted a persistent strain of shingles, or herpes zoster. The patient was treated at a family care center, for the onset of a blistering rash, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the defective ZOSTAVAX, and or as a result of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, 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 with ZOSTAVAX vaccine. The outcome of the events was unknown. Additional information has been requested.
Sex: U
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 patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. During 2016, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a physician for the onset of a 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, she 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: 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 07-JAN-2010, 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 04-JUN-2016, the patient was treated by a physician at a community hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live (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: Blister, 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. Medical history, concurrent conditions, and concomitant medications were not provided. During 2012, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a military medical facility/clinic as recommended for routine adult health maintenance and 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-JUN-2016, the patient was treated at a medical facility/clinic (by an unspecified healthcare professional) for a blistering 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, he 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: 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 16-OCT-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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 13-AUG-2016, she was treated at a clinic for a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX and tramadol for management of her painful symptoms. 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: 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 2015, 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, and the patient subsequently contracted a persistent strain of herpes zoster. During 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. 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-JAN-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, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical facility for a severe 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, 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 26-OCT-2009, 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, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUL-2013, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir (VALTREX) 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. 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2006, 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, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at an emergency medicine facility for a severe 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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. Medical history, concurrent conditions, and concomitant medications were not provided. During 2015, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical group office (by an unspecified health care professional) 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. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, 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, she 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: 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-JUL-2011, the patient was inoculated with ZOSTAVAX (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical group office (by an unspecified health care professional) 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 26-JUL-2012, the patient was treated by a physician at an office facility for a blistering vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed acyclovir and oxycodone to help manage her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The 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: 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. 16-OCT-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, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a hospital for a blistering 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. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka-Merck) PROQUAD lot # N022973 with expiration date of 19-FEB-2019, by subcutaneous route (strength, dose, and anatomical location) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature range between -14°C to -10°C (-13.7°C) during a time frame of 30 minutes which was called by a data logger. No previous temperature excursions were reported. Sender's Comments: US-009507513-1805USA006861.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M038857 with expiration date of 19-FEB-2019, by subcutaneous route (strength, dose, and anatomical location) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature range between -14°C to -10°C (-13.7°C) during a time frame of 30 minutes which was called by a data logger. No previous temperature excursions were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1805USA006064.
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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 02-NOV-2016, the patient was inoculated with ZOSTAVAX (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy (by an unspecified health care professional) 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 08-JUN-2017, the patient was treated by an advanced practice registered nurse (APRN) at an immediate health care facility for a blistering vesicular outbreak, which was diagnosed as a herpes zoster. On or about 23-JUN-2017, the patient sought subsequent treatment from a physician for ongoing and worsening symptoms of shingles, which was diagnosed as a herpes zoster dermatitis. The patient has been prescribed valacyclovir and FAMVIR to manage 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, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reported 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: Blister, 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 13-MAY-2014, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at the department of health 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 10-JUN-2016, the patient was treated by a physician (site not specified) for a blistering 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, he 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: U
Vaccine: HEPA, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were inadvertently administered with improperly stored doses of PNEUMOVAX 23 (lot#R002354, expiration date: 17-DEC-2019) and VAQTA (lot# N031940, expiration date: 23-NOV-2018) for prophylaxis which had a temperature excursion of 32°F to 35°F for 57 minutes. The previous temperature excursions were 47°F to 77°F for 33 hours, 52 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. This is a non-valid case due to lack of patient identifiers.