chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Pyrexia, Swelling
Clinical narrative: I started to feel nausea and arm pain at about 6:30pm. The arm pain progressed over the course of the night until it became untenable the next morning. I had no shoulder mobility and there was a oval red mark (about 2 inches in diameter) that was swollen. My fevers ranged from 98-101.8 degrees F. I had pounding headaches despite taking 800mg Ibuprofen and 1000mg TYLENOL every 6-8 hours. I iced it and heated it alternatively for several days and I experienced nausea and a  loss of appetite. Two days later, my tongue hurt in my throat for a few minutes.  For treatment, the doctor gave me Prednisone (four 10mg tablets per day), ZOFRAN to help with nausea, and ZYRTEC. I started to feel better that night.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Acute myeloid leukaemia, Laboratory test abnormal, Second primary malignancy
Clinical narrative: Subject is enrolled on a clinical trial that is evaluating the nonavalent HPV vaccine in cancer survivors and received HPV Vaccine Dose 1-3 on 5/24/17, 7/21/17 and 11/29/17. On 5/24/18 subject was diagnosed with a secondary malignancy, cancer therapy-related acute myeloid leukemia. The event has been deemed by the responsible site physician (MD) and by the overall responsible physician for the study (MD) as unrelated to HPV vaccine and definitely related to prior cancer therapy (chemotherapy) that the patient received for treatment of his primary cancer.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Oral pain, Rash vesicular, Tongue blistering
Clinical narrative: Patient's mouth has blisters and pain; tongue also had blisters. Patient described skin condition like chicken pox.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes along left side of jaw, cheek, and underneath the ear. Pain along left side as result of swollen lymph nodes. Headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Swelling, redness, bruising.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Patient with right arm pain without swelling, redness, tenderness. Pain started day vaccine was given.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-MAY-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. 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.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Loss of personal independence in daily activities, Nausea
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of shivering in a 61-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. On 22nd March 2018, the patient received SHINGRIX. On 22nd March 2018, 12 hrs after receiving SHINGRIX, the patient experienced shivering, sweating, muscle pain, headache and nausea. On an unknown date, the outcome of the shivering, sweating, muscle pain, headache and nausea were recovering/resolving. It was unknown if the reporter considered the shivering, sweating, muscle pain, headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient reported that approximately 12 hours after her 1st dose of SHINGRIX, she experienced shivering, headache, sweating, nausea, muscle ache, she reports she missed 3 days of work. The patient began to feel better at day 3 after injection. The patient noted she works at Pfizer, and she did a VAERS report on herself.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of shivering in a 61-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. On 22nd March 2018, the patient received SHINGRIX. On 22nd March 2018, 12 hrs after receiving SHINGRIX, the patient experienced shivering, sweating, muscle pain, headache and nausea. On an unknown date, the outcome of the shivering, sweating, muscle pain, headache and nausea were recovering/resolving. It was unknown if the reporter considered the shivering, sweating, muscle pain, headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient reported that approximately 12 hours after her 1st dose of SHINGRIX, she experienced shivering, headache, sweating, nausea, muscle ache, she reports she missed 3 days of work. The patient began to feel better at day 3 after injection. The patient noted she works at Pfizer, and she did a VAERS report on herself.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Impaired work ability, Myalgia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of shivering in a 61-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. On 22nd March 2018, the patient received SHINGRIX. On 22nd March 2018, 12 hrs after receiving SHINGRIX, the patient experienced shivering, sweating, muscle pain, headache and nausea. On an unknown date, the outcome of the shivering, sweating, muscle pain, headache and nausea were recovering/resolving. It was unknown if the reporter considered the shivering, sweating, muscle pain, headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient reported that approximately 12 hours after her 1st dose of SHINGRIX, she experienced shivering, headache, sweating, nausea, muscle ache, she reports she missed 3 days of work. The patient began to feel better at day 3 after injection. The patient noted she works at Pfizer, and she did a VAERS report on herself.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of shivering in a 61-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. On 22nd March 2018, the patient received SHINGRIX. On 22nd March 2018, 12 hrs after receiving SHINGRIX, the patient experienced shivering, sweating, muscle pain, headache and nausea. On an unknown date, the outcome of the shivering, sweating, muscle pain, headache and nausea were recovering/resolving. It was unknown if the reporter considered the shivering, sweating, muscle pain, headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient reported that approximately 12 hours after her 1st dose of SHINGRIX, she experienced shivering, headache, sweating, nausea, muscle ache, she reports she missed 3 days of work. The patient began to feel better at day 3 after injection. The patient noted she works at Pfizer, and she did a VAERS report on herself.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: The patient developed hives on her abdomen area the day after the vaccination. They lasted a few weeks before subsiding. The patient did not seek any medical attention, but treated herself with diphenhydramine.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash pruritic, Rash vesicular, Varicella
Clinical narrative: The patient developed hives on her abdomen area the day after the vaccination. They lasted a few weeks before subsiding. The patient did not seek any medical attention, but treated herself with diphenhydramine.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Hypersensitivity, Urticaria
Clinical narrative: The patient developed hives on her abdomen area the day after the vaccination. They lasted a few weeks before subsiding. The patient did not seek any medical attention, but treated herself with diphenhydramine.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: The patient developed hives on her abdomen area the day after the vaccination. They lasted a few weeks before subsiding. The patient did not seek any medical attention, but treated herself with diphenhydramine.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a elderly female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced generalized urticaria and pruritus. On an unknown date, the outcome of the generalized urticaria and pruritus were not recovered/not resolved. It was unknown if the reporter considered the generalized urticaria and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient started developing itchy hives the same day she received SHINGRIX in June 2018, the hives continued to get worse over the next several days and spread all over her body. It was now been about a month later and she still had the hives at the time of reporting. The patient had not seen her health care professional but was planning to get an appointment. The patient spoke with the pharmacist where she received the vaccine and was instructed to take Benadryl.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a elderly female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced generalized urticaria and pruritus. On an unknown date, the outcome of the generalized urticaria and pruritus were not recovered/not resolved. It was unknown if the reporter considered the generalized urticaria and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient started developing itchy hives the same day she received SHINGRIX in June 2018, the hives continued to get worse over the next several days and spread all over her body. It was now been about a month later and she still had the hives at the time of reporting. The patient had not seen her health care professional but was planning to get an appointment. The patient spoke with the pharmacist where she received the vaccine and was instructed to take Benadryl.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Erythema, Oropharyngeal pain, Peripheral swelling, Pruritus, Sensory disturbance
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of localized erythema in a female patient who received TWINRIX for prophylaxis. On an unknown date, the patient received TWINRIX 1 ml. On an unknown date, less than a day after receiving TWINRIX, the patient experienced localized erythema, ear pruritus, headache, pharyngeal lesion, neck pain, shoulder pain and sore throat. On an unknown date, the outcome of the localized erythema, ear pruritus, headache, pharyngeal lesion, neck pain, shoulder pain and sore throat were unknown. It was unknown if the reporter considered the localized erythema, ear pruritus, headache, pharyngeal lesion, neck pain, shoulder pain and sore throat to be related to TWINRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that, after vaccination with TWINRIX, the patients upper shoulder turned red and could feel something in the left side of her neck and the left side of her head. One day after the vaccination, the patient experienced ear pruritus and oral disorder. The next day, after the vaccination, the shoulder pain was gone but her ear was itchy and throat was sore felt like little bumps of her throat like a rash. On the next day of the vaccination, the patient also went to urgent care.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Ear pruritus, Erythema, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of localized erythema in a female patient who received TWINRIX for prophylaxis. On an unknown date, the patient received TWINRIX 1 ml. On an unknown date, less than a day after receiving TWINRIX, the patient experienced localized erythema, ear pruritus, headache, pharyngeal lesion, neck pain, shoulder pain and sore throat. On an unknown date, the outcome of the localized erythema, ear pruritus, headache, pharyngeal lesion, neck pain, shoulder pain and sore throat were unknown. It was unknown if the reporter considered the localized erythema, ear pruritus, headache, pharyngeal lesion, neck pain, shoulder pain and sore throat to be related to TWINRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that, after vaccination with TWINRIX, the patients upper shoulder turned red and could feel something in the left side of her neck and the left side of her head. One day after the vaccination, the patient experienced ear pruritus and oral disorder. The next day, after the vaccination, the shoulder pain was gone but her ear was itchy and throat was sore felt like little bumps of her throat like a rash. On the next day of the vaccination, the patient also went to urgent care.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Oral disorder, Oropharyngeal pain, Pharyngeal lesion
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of localized erythema in a female patient who received TWINRIX for prophylaxis. On an unknown date, the patient received TWINRIX 1 ml. On an unknown date, less than a day after receiving TWINRIX, the patient experienced localized erythema, ear pruritus, headache, pharyngeal lesion, neck pain, shoulder pain and sore throat. On an unknown date, the outcome of the localized erythema, ear pruritus, headache, pharyngeal lesion, neck pain, shoulder pain and sore throat were unknown. It was unknown if the reporter considered the localized erythema, ear pruritus, headache, pharyngeal lesion, neck pain, shoulder pain and sore throat to be related to TWINRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that, after vaccination with TWINRIX, the patients upper shoulder turned red and could feel something in the left side of her neck and the left side of her head. One day after the vaccination, the patient experienced ear pruritus and oral disorder. The next day, after the vaccination, the shoulder pain was gone but her ear was itchy and throat was sore felt like little bumps of her throat like a rash. On the next day of the vaccination, the patient also went to urgent care.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Pain, Skin warm, Tenderness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown) for prophylaxis. On 5th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th July 2018, 1 days after receiving SHINGRIX and an unknown time after starting Zantac, the patient experienced injection site erythema, injection site warmth and injection site induration. The patient was treated with ranitidine hydrochloride (Zantac). In July 2018, the outcome of the injection site warmth was recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site induration was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site induration to be related to SHINGRIX. Additional information was received as follows: The reporting nurse was reporting an adverse event for herself. The patient received SHINGRIX on the left arm. Approximately 24 hours after receiving SHINGRIX, the patient experienced redness outside of the Band-Aid that was placed at the injection site. Within 3 hours after the redness, the patient experienced induration at the injection site that was increasing in size and continued to grow until it reached 2.75 inches by 4 inches. The patient stated that this area was also warm. The patient stated that she went to urgent care and was prescribed Zantac. On the reporting day, the patient spoken with her primary care office and had submitted a report to VAERS. The patient stated that the heat at the site had gone away, the erythema had decreased some, however, the induration had not decreased. The patient was able to provide the lot number but did not have the expiration date.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown) for prophylaxis. On 5th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th July 2018, 1 days after receiving SHINGRIX and an unknown time after starting Zantac, the patient experienced injection site erythema, injection site warmth and injection site induration. The patient was treated with ranitidine hydrochloride (Zantac). In July 2018, the outcome of the injection site warmth was recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site induration was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site induration to be related to SHINGRIX. Additional information was received as follows: The reporting nurse was reporting an adverse event for herself. The patient received SHINGRIX on the left arm. Approximately 24 hours after receiving SHINGRIX, the patient experienced redness outside of the Band-Aid that was placed at the injection site. Within 3 hours after the redness, the patient experienced induration at the injection site that was increasing in size and continued to grow until it reached 2.75 inches by 4 inches. The patient stated that this area was also warm. The patient stated that she went to urgent care and was prescribed Zantac. On the reporting day, the patient spoken with her primary care office and had submitted a report to VAERS. The patient stated that the heat at the site had gone away, the erythema had decreased some, however, the induration had not decreased. The patient was able to provide the lot number but did not have the expiration date.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Herpes zoster, Pain, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced multiple side effects from immunization and never had this experience with anything like that before.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced multiple side effects from immunization and never had this experience with anything like that before.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced multiple side effects from immunization and never had this experience with anything like that before.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Feeling abnormal, Headache, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced multiple side effects from immunization and never had this experience with anything like that before.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Paraesthesia, Pyrexia, Scratch, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced multiple side effects from immunization and never had this experience with anything like that before.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pruritus
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of itchy skin in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included surgery (unspecified). Previously administered products included Percocet with an associated reaction of pruritus (after surgery). On 1st July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was recovering/resolving. It was unknown if the reporter considered the itchy skin to be related to SHINGRIX. Additional details were reported as follows: This case was reported via email. The patient's concomitant medications included oral steroids for 8 weeks which ended in April (unspecified). The patient developed severe itchy skin which lasted over a week and slowly improved by the time of reporting. The patient had similar reactions to Percocet after surgery. The reporter agreed to be followed up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of itchy skin in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included surgery (unspecified). Previously administered products included Percocet with an associated reaction of pruritus (after surgery). On 1st July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was recovering/resolving. It was unknown if the reporter considered the itchy skin to be related to SHINGRIX. Additional details were reported as follows: This case was reported via email. The patient's concomitant medications included oral steroids for 8 weeks which ended in April (unspecified). The patient developed severe itchy skin which lasted over a week and slowly improved by the time of reporting. The patient had similar reactions to Percocet after surgery. The reporter agreed to be followed up.
Sex: U
Vaccine: HEP, RV5, HEP, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 03-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot number R003149 and expiration date of 19-FEB-2019 for prophylaxis (dose was not reported) and RECOMBIVAX HB lot number N011851 and expiration date of 19-DEC-2019 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 9.3°C with a time frame of 8 hours 46 minutes. There was no previous temperature excursion. A "data logger" was involved.
Sex: U
Vaccine: HEP, RV5, HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 03-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot number R003149 and expiration date of 19-FEB-2019 for prophylaxis (dose was not reported) and RECOMBIVAX HB lot number N011851 and expiration date of 19-DEC-2019 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 9.3°C with a time frame of 8 hours 46 minutes. There was no previous temperature excursion. A "data logger" was involved.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Erythema, Headache, Influenza like illness
Clinical narrative: On 6/27 following vaccination, tolerable pain at site of injection. At 2 am, 6/28 awoke with generally sick, shivering, and overwhelming weakness. Hours later, the left arm (site of injection), very swollen, red, very hot extending to 2 inches above elbow, also purple  Currently site of injection is with scar.  Started on prednisone 6/29- 10 mg x 3 per day with decrease over eight days. Took anti inflammatory over the counter for pain and temp; benedryl for reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Skin discolouration
Clinical narrative: On 6/27 following vaccination, tolerable pain at site of injection. At 2 am, 6/28 awoke with generally sick, shivering, and overwhelming weakness. Hours later, the left arm (site of injection), very swollen, red, very hot extending to 2 inches above elbow, also purple  Currently site of injection is with scar.  Started on prednisone 6/29- 10 mg x 3 per day with decrease over eight days. Took anti inflammatory over the counter for pain and temp; benedryl for reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Body temperature, Chills, Injection site erythema, Injection site pain
Clinical narrative: On 6/27 following vaccination, tolerable pain at site of injection. At 2 am, 6/28 awoke with generally sick, shivering, and overwhelming weakness. Hours later, the left arm (site of injection), very swollen, red, very hot extending to 2 inches above elbow, also purple  Currently site of injection is with scar.  Started on prednisone 6/29- 10 mg x 3 per day with decrease over eight days. Took anti inflammatory over the counter for pain and temp; benedryl for reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site scar, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: On 6/27 following vaccination, tolerable pain at site of injection. At 2 am, 6/28 awoke with generally sick, shivering, and overwhelming weakness. Hours later, the left arm (site of injection), very swollen, red, very hot extending to 2 inches above elbow, also purple  Currently site of injection is with scar.  Started on prednisone 6/29- 10 mg x 3 per day with decrease over eight days. Took anti inflammatory over the counter for pain and temp; benedryl for reaction.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: One vaccine was given in the left thigh and the other was given in the right thigh. The vaccine that was given in my daughter's right thigh is the one that caused a reaction. The pediatric's office will not give me the lot number, dosage amount, or let me know which vaccine was given in the right thigh. Within six hours of receiving the vaccine, my daughter's thigh became swollen, red, and hot to the touch. The following day a severe rash covered the area of the injection site. It has been five days and there is still redness, warmth, and a rash. I gave my daughter BENADRYL on day three, but it did not alter the reaction.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 month old female patient. On 22-JUN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ lot # R003534, expiration date 31-AUG-2019 oral for prophylaxis. The vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 20 minutes. No previous temperature excursions were reported. Digital data logger was involved. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA006807: US-009507513-1807USA006808: US-009507513-1807USA006809: US-009507513-1807USA006810.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history was not reported. In June 2015, the patient was vaccinated for prophylaxis with the first dose of GARDASIL lot # 010215, expiration date 17-JAN-2016. In August 2017, the patient was vaccinated with second dose of GARDASIL lot # N019923, expiration date 28-APR-2019. On 28-JUN-2018, the patient was vaccinated with a dose of GARDASIL 9 lot # N025429, expiration date 21-JUL-2020. No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 16-FEB-2018, the patient inadvertently received an expired dose of (Wistar RA 27-3) M-M-R II for prophylaxis, lot # M004305 and expiration date on 25-JAN-2018 (strength, dose number, anatomical location and route of administration were not reported), without adverse effect reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA003048.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a 6 month old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date, the patient was vaccinated with VAQTA (dose, route, lot# and expiration date were not provided) for prophylaxis. No adverse symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's relevant medical conditions, concomitant medications and concurrent conditions were unknown. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX for prophylaxis, lot# N031938 and expiration date 13-NOV-2019 or lot# N028715 and expiration date 13-OCT-2019 (dose, strength and frequency were unknown). It was reported that the vaccines had a temperature excursion of 15°F to 46°F (28.23°F) during 1 hour and 30 minutes. No previous temperature excursions were reported. Data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 16-FEB-2018, the patient inadvertently received an expired dose of M-M-R II for prophylaxis, lot # M004305 and expiration date on 25-JAN-2018 (strength, dose number, anatomical location and route of administration were not reported), without adverse effect reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1807USA000991:
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse regarding a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2018 the patient was vaccinated with GARDASIL 9 (lot#, expiration date, strength, dosing details and route of administration were not reported) for prophylaxis. On 08-MAY-2018 (last menstrual period), the patient had menses and after that patient found out she was pregnant. The estimated date of conception was 22-MAY-2018 and expected due date (EDD) was 12-FEB-2019 (also reported as February 2019). No treatment was given for adverse event. No intervention was given to prevent serious criteria. The pregnancy outcome was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Guillain-Barre syndrome, Respiratory tract infection
Clinical narrative: This spontaneous case was received from a nurse regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with first and second doses of GARDASIL 9 (dose, unit, lot#, expiration date and route were not reported). On unknown dates, the patient experienced Guillain-Barre Syndrome and respiratory infection and was admitted to hospital. The duration of hospitalization was unspecified. The outcome of the events was reported as recovered. The causality assessment of the events to the suspect therapy was not reported. No product quality complaint (PQC) was involved. Upon internal review, the events Guillain-Barre Syndrome and respiratory infection were determined to be medically significant.
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 of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-JUN-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 25-OCT-2011, the patient was treated at a hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-JAN-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated at a clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2014, the patient was treated at a clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-DEC-2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date 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. The outcome of the events is unknown. 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. 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, 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 long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. 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. 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 provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, 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 long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a 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.