chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Shingrix (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. Previously experienced adverse reactions included fever (The patient had fever with past unspecified vaccinations). On 15th February 2018, the patient received the 1st dose of Shingrix .5 ml. On 16th February 2018, 1 days after receiving Shingrix, the patient experienced fever, injection site itching, injection site induration, sleep disturbance, injection site erythema and injection site warmth. The patient was treated with paracetamol (Tylenol). In February 2018, the outcome of the fever and sleep disturbance were recovered/resolved. On an unknown date, the outcome of the injection site itching, injection site induration, injection site erythema and injection site warmth were not recovered/not resolved. The reporter considered the fever, injection site itching, injection site induration, sleep disturbance, injection site erythema and injection site warmth to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient herself. At 13:00, the patient received Shingrix vaccine on the left arm. The day after the vaccine was administered, she noticed her upper arm was bright red from her shoulder to her elbow. It was hot to the touch and itchy. It remained bright red for about 3 days and at the reporting time was less red and looked as if it might bruise. The patient developed a light fever for which she took Tylenol. The patient also said for a couple of nights, her sleep was disturbed which she compared to hallucination. The patient's arm was still a lighter shade of red, hot to touch and itchy at the reporting time. The patient did not take any other medications and no other vaccines had been administered within the last 4 weeks. The patient did report the adverse events to the Centers for Disease Control (CDC) but pharmacist encouraged her to report to GlaxoSmithKline as well. Follow up information was received from pharmacy manager on 30th May 2018: The Shingrix was accidentally administered by subcutenous route, which led to inappropriate route of vaccination. The registered pharmacist mistook it for Zostavax. On an unknown date, less than a year after receving Shingrix the patient had soreness. The contributing factors for the medication error were reported as they did not have enough staff so registered pharmacist had to fill, did phone calls, run register verified, type plus administed vaccines. The VAERS details were updated. Sender's Comments: US2018028288: Previous VAERS submission in paper format.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site cellulitis in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX.  In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On 30th April 2018, the patient experienced injection site cellulitis. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site cellulitis was recovered/resolved and the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site cellulitis, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: On 30th April 2018, the patient presented to the office with redness and increased warmth at the injection site and diagnosed as cellulitis. The patient was treated with bactrim for 7 days and it got resolved.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site cellulitis in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX.  In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On 30th April 2018, the patient experienced injection site cellulitis. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site cellulitis was recovered/resolved and the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site cellulitis, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: On 30th April 2018, the patient presented to the office with redness and increased warmth at the injection site and diagnosed as cellulitis. The patient was treated with bactrim for 7 days and it got resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Immediate post-injection reaction, Injection site rash, Injection site vesicles
Clinical narrative: Revieved SHINGRIX Vaccine on May 9, 2018. Shortly afterwards (3 - 4 days) a light, flat red rash appeared. The rash became raised from surface of skin, and appeared as a blistering red rash that ringed my upper chest and face, from the clavicle to my shoulder to the back of my neck. Experienced extreme pain and itchy, burning sensation. The doctor confirmed that I received the new SHINGRIX Vaccine (GSK). Because lab results taken shortly afterwards, at hospital confirmed Shingles Doctor prescribed anti-viral(Valaciclovir). Currently taking Gabapentin for intermittent nerve pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash, Viral test
Clinical narrative: Revieved SHINGRIX Vaccine on May 9, 2018. Shortly afterwards (3 - 4 days) a light, flat red rash appeared. The rash became raised from surface of skin, and appeared as a blistering red rash that ringed my upper chest and face, from the clavicle to my shoulder to the back of my neck. Experienced extreme pain and itchy, burning sensation. The doctor confirmed that I received the new SHINGRIX Vaccine (GSK). Because lab results taken shortly afterwards, at hospital confirmed Shingles Doctor prescribed anti-viral(Valaciclovir). Currently taking Gabapentin for intermittent nerve pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash, Injection site vesicles, Rash, Tenderness
Clinical narrative: Revieved SHINGRIX Vaccine on May 9, 2018. Shortly afterwards (3 - 4 days) a light, flat red rash appeared. The rash became raised from surface of skin, and appeared as a blistering red rash that ringed my upper chest and face, from the clavicle to my shoulder to the back of my neck. Experienced extreme pain and itchy, burning sensation. The doctor confirmed that I received the new SHINGRIX Vaccine (GSK). Because lab results taken shortly afterwards, at hospital confirmed Shingles Doctor prescribed anti-viral(Valaciclovir). Currently taking Gabapentin for intermittent nerve pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Bone pain, Burning sensation, Herpes zoster, Musculoskeletal pain
Clinical narrative: Revieved SHINGRIX Vaccine on May 9, 2018. Shortly afterwards (3 - 4 days) a light, flat red rash appeared. The rash became raised from surface of skin, and appeared as a blistering red rash that ringed my upper chest and face, from the clavicle to my shoulder to the back of my neck. Experienced extreme pain and itchy, burning sensation. The doctor confirmed that I received the new SHINGRIX Vaccine (GSK). Because lab results taken shortly afterwards, at hospital confirmed Shingles Doctor prescribed anti-viral(Valaciclovir). Currently taking Gabapentin for intermittent nerve pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neck pain, Neuralgia, Pruritus, Rash erythematous
Clinical narrative: Revieved SHINGRIX Vaccine on May 9, 2018. Shortly afterwards (3 - 4 days) a light, flat red rash appeared. The rash became raised from surface of skin, and appeared as a blistering red rash that ringed my upper chest and face, from the clavicle to my shoulder to the back of my neck. Experienced extreme pain and itchy, burning sensation. The doctor confirmed that I received the new SHINGRIX Vaccine (GSK). Because lab results taken shortly afterwards, at hospital confirmed Shingles Doctor prescribed anti-viral(Valaciclovir). Currently taking Gabapentin for intermittent nerve pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Vaccination failure, Varicella virus test positive
Clinical narrative: Revieved SHINGRIX Vaccine on May 9, 2018. Shortly afterwards (3 - 4 days) a light, flat red rash appeared. The rash became raised from surface of skin, and appeared as a blistering red rash that ringed my upper chest and face, from the clavicle to my shoulder to the back of my neck. Experienced extreme pain and itchy, burning sensation. The doctor confirmed that I received the new SHINGRIX Vaccine (GSK). Because lab results taken shortly afterwards, at hospital confirmed Shingles Doctor prescribed anti-viral(Valaciclovir). Currently taking Gabapentin for intermittent nerve pain.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Antibody test negative, Ataxia, Cerebellar ataxia, Immunology test normal, Laboratory test normal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cerebellar ataxia in a male patient who received SHINGRIX for prophylaxis.  Co-suspect products included BOOSTRIX for prophylaxis and PREVNAR 13 for prophylaxis.  Concomitant products included tamsulosin hydrochloride (Flomax), evolocumab (Repatha) and rivaroxaban (Xarelto). In March 2018, the patient received the 1st dose of SHINGRIX, BOOSTRIX and PREVNAR 13. In April 2018, less than a month after receiving SHINGRIX and BOOSTRIX, the patient experienced cerebellar ataxia and staggering. On an unknown date, the patient experienced neuromuscular pain and back pain. On an unknown date, the outcome of the cerebellar ataxia, neuromuscular pain, back pain and staggering were unknown. It was unknown if the reporter considered the cerebellar ataxia, neuromuscular pain, back pain and staggering to be related to SHINGRIX and BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the medical assistant. The patient administered SHINGRIX, Tdap, and PREVENAR 13 on the same day sometimes during the last week of March. On Sunday 1ST April 2018 he called his physician's office to report symptoms of severe back pain, along with acute muscular with nerve component as per the verbatim of the reporter. On 30th April, 2018 he called physician's office to report that he was staggering around like he was drunk. The diagnosis of acute cerebellar mid line ataxia was confirmed by magnetic resonance imaging. Magnetic resonance imaging results of brain for C Spine, T Spine, and L Spine were all negative. As per the reporter patient did not go to an emergency room, but he did visit the physician's office. The reporter gave permission to contact physician. All questions were asked. Medical assistant provided very limited information in regards to the events, she rather had the physician speak to representative for further information. She did mention that physician wanted to speak to an another physician who could speak to him about this. Reference number was provided to the medical assistant if there was any additional data to be provided, and direct phone number to medication information department was also provided for the physician to contact.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Viral test negative
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cerebellar ataxia in a male patient who received SHINGRIX for prophylaxis.  Co-suspect products included BOOSTRIX for prophylaxis and PREVNAR 13 for prophylaxis.  Concomitant products included tamsulosin hydrochloride (Flomax), evolocumab (Repatha) and rivaroxaban (Xarelto). In March 2018, the patient received the 1st dose of SHINGRIX, BOOSTRIX and PREVNAR 13. In April 2018, less than a month after receiving SHINGRIX and BOOSTRIX, the patient experienced cerebellar ataxia and staggering. On an unknown date, the patient experienced neuromuscular pain and back pain. On an unknown date, the outcome of the cerebellar ataxia, neuromuscular pain, back pain and staggering were unknown. It was unknown if the reporter considered the cerebellar ataxia, neuromuscular pain, back pain and staggering to be related to SHINGRIX and BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the medical assistant. The patient administered SHINGRIX, Tdap, and PREVENAR 13 on the same day sometimes during the last week of March. On Sunday 1ST April 2018 he called his physician's office to report symptoms of severe back pain, along with acute muscular with nerve component as per the verbatim of the reporter. On 30th April, 2018 he called physician's office to report that he was staggering around like he was drunk. The diagnosis of acute cerebellar mid line ataxia was confirmed by magnetic resonance imaging. Magnetic resonance imaging results of brain for C Spine, T Spine, and L Spine were all negative. As per the reporter patient did not go to an emergency room, but he did visit the physician's office. The reporter gave permission to contact physician. All questions were asked. Medical assistant provided very limited information in regards to the events, she rather had the physician speak to representative for further information. She did mention that physician wanted to speak to an another physician who could speak to him about this. Reference number was provided to the medical assistant if there was any additional data to be provided, and direct phone number to medication information department was also provided for the physician to contact.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Nervous system disorder, Neurological symptom, Vertigo CNS origin
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cerebellar ataxia in a male patient who received SHINGRIX for prophylaxis.  Co-suspect products included BOOSTRIX for prophylaxis and PREVNAR 13 for prophylaxis.  Concomitant products included tamsulosin hydrochloride (Flomax), evolocumab (Repatha) and rivaroxaban (Xarelto). In March 2018, the patient received the 1st dose of SHINGRIX, BOOSTRIX and PREVNAR 13. In April 2018, less than a month after receiving SHINGRIX and BOOSTRIX, the patient experienced cerebellar ataxia and staggering. On an unknown date, the patient experienced neuromuscular pain and back pain. On an unknown date, the outcome of the cerebellar ataxia, neuromuscular pain, back pain and staggering were unknown. It was unknown if the reporter considered the cerebellar ataxia, neuromuscular pain, back pain and staggering to be related to SHINGRIX and BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the medical assistant. The patient administered SHINGRIX, Tdap, and PREVENAR 13 on the same day sometimes during the last week of March. On Sunday 1ST April 2018 he called his physician's office to report symptoms of severe back pain, along with acute muscular with nerve component as per the verbatim of the reporter. On 30th April, 2018 he called physician's office to report that he was staggering around like he was drunk. The diagnosis of acute cerebellar mid line ataxia was confirmed by magnetic resonance imaging. Magnetic resonance imaging results of brain for C Spine, T Spine, and L Spine were all negative. As per the reporter patient did not go to an emergency room, but he did visit the physician's office. The reporter gave permission to contact physician. All questions were asked. Medical assistant provided very limited information in regards to the events, she rather had the physician speak to representative for further information. She did mention that physician wanted to speak to an another physician who could speak to him about this. Reference number was provided to the medical assistant if there was any additional data to be provided, and direct phone number to medication information department was also provided for the physician to contact.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Back pain, Cerebellar ataxia, Gait disturbance, Neuromuscular pain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cerebellar ataxia in a male patient who received SHINGRIX for prophylaxis.  Co-suspect products included BOOSTRIX for prophylaxis and PREVNAR 13 for prophylaxis.  Concomitant products included tamsulosin hydrochloride (Flomax), evolocumab (Repatha) and rivaroxaban (Xarelto). In March 2018, the patient received the 1st dose of SHINGRIX, BOOSTRIX and PREVNAR 13. In April 2018, less than a month after receiving SHINGRIX and BOOSTRIX, the patient experienced cerebellar ataxia and staggering. On an unknown date, the patient experienced neuromuscular pain and back pain. On an unknown date, the outcome of the cerebellar ataxia, neuromuscular pain, back pain and staggering were unknown. It was unknown if the reporter considered the cerebellar ataxia, neuromuscular pain, back pain and staggering to be related to SHINGRIX and BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the medical assistant. The patient administered SHINGRIX, Tdap, and PREVENAR 13 on the same day sometimes during the last week of March. On Sunday 1ST April 2018 he called his physician's office to report symptoms of severe back pain, along with acute muscular with nerve component as per the verbatim of the reporter. On 30th April, 2018 he called physician's office to report that he was staggering around like he was drunk. The diagnosis of acute cerebellar mid line ataxia was confirmed by magnetic resonance imaging. Magnetic resonance imaging results of brain for C Spine, T Spine, and L Spine were all negative. As per the reporter patient did not go to an emergency room, but he did visit the physician's office. The reporter gave permission to contact physician. All questions were asked. Medical assistant provided very limited information in regards to the events, she rather had the physician speak to representative for further information. She did mention that physician wanted to speak to an another physician who could speak to him about this. Reference number was provided to the medical assistant if there was any additional data to be provided, and direct phone number to medication information department was also provided for the physician to contact.
Age: 63.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS, PPV, TDAP, VARZOS, PNC13, TDAP, VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal normal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cerebellar ataxia in a male patient who received SHINGRIX for prophylaxis.  Co-suspect products included BOOSTRIX for prophylaxis and PREVNAR 13 for prophylaxis.  Concomitant products included tamsulosin hydrochloride (Flomax), evolocumab (Repatha) and rivaroxaban (Xarelto). In March 2018, the patient received the 1st dose of SHINGRIX, BOOSTRIX and PREVNAR 13. In April 2018, less than a month after receiving SHINGRIX and BOOSTRIX, the patient experienced cerebellar ataxia and staggering. On an unknown date, the patient experienced neuromuscular pain and back pain. On an unknown date, the outcome of the cerebellar ataxia, neuromuscular pain, back pain and staggering were unknown. It was unknown if the reporter considered the cerebellar ataxia, neuromuscular pain, back pain and staggering to be related to SHINGRIX and BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the medical assistant. The patient administered SHINGRIX, Tdap, and PREVENAR 13 on the same day sometimes during the last week of March. On Sunday 1ST April 2018 he called his physician's office to report symptoms of severe back pain, along with acute muscular with nerve component as per the verbatim of the reporter. On 30th April, 2018 he called physician's office to report that he was staggering around like he was drunk. The diagnosis of acute cerebellar mid line ataxia was confirmed by magnetic resonance imaging. Magnetic resonance imaging results of brain for C Spine, T Spine, and L Spine were all negative. As per the reporter patient did not go to an emergency room, but he did visit the physician's office. The reporter gave permission to contact physician. All questions were asked. Medical assistant provided very limited information in regards to the events, she rather had the physician speak to representative for further information. She did mention that physician wanted to speak to an another physician who could speak to him about this. Reference number was provided to the medical assistant if there was any additional data to be provided, and direct phone number to medication information department was also provided for the physician to contact.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Within hours of receiving vaccine patient's arm was extremely sore, by 8 pm that night her arm was red, swollen, itchy and warm, pt went to ER and followed up w/ PCP.
Age: 20.0
Sex: F
Vaccine: ANTH, JEV1
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Injection site erythema, Injection site haemorrhage
Clinical narrative: Pt is a 20 yo Female who presented to clinic for lightheaded/dizziness that started 15 minutes after receiving her JEV-1 (R deltoid IM) and Anthrax (L deltoid IM) vaccines. She also developed R forearm pain/swelling around the same time. Medic came to pt's shop to administer vaccines and pt was brought to clinic when she started experiencing symptoms. Pt had golf ball sized swelling at R forearm, just inferior to antecubital space, with extreme tenderness to palpation and pain with any movement distal to swelling. Injection site had drop of dried blood with mild erythema where bandage adhesive was attached. No evidence of streaking, broken skin any where in right upper extremity. Pt also reported mild numbness/tingling at palmar aspect of R hand. Pt had mild decreased range of motion and weakness due to pain. Pt was observe in office from 1100 to 1500 with no evidence of shortness of breath, chest pain, dyspnea, swelling elsewhere. Pt was given Benadryl 50 mg and Naproxen 500 mg.  With no improvement. Heat was applied to area 20 minutes on/20 minutes off for an hour and then ice was applied for the same time frame with no improvement. Pt was advised on return precautions for anaphylaxis, compartment syndrome, cellulitis. Pt advised to have buddy at all times for next 12-24 hours. Pt advised to follow up in clinic on Monday, 11JUN18, but did not.
Age: 20.0
Sex: F
Vaccine: ANTH, JEV1
Symptoms: Joint range of motion decreased, Pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Pt is a 20 yo Female who presented to clinic for lightheaded/dizziness that started 15 minutes after receiving her JEV-1 (R deltoid IM) and Anthrax (L deltoid IM) vaccines. She also developed R forearm pain/swelling around the same time. Medic came to pt's shop to administer vaccines and pt was brought to clinic when she started experiencing symptoms. Pt had golf ball sized swelling at R forearm, just inferior to antecubital space, with extreme tenderness to palpation and pain with any movement distal to swelling. Injection site had drop of dried blood with mild erythema where bandage adhesive was attached. No evidence of streaking, broken skin any where in right upper extremity. Pt also reported mild numbness/tingling at palmar aspect of R hand. Pt had mild decreased range of motion and weakness due to pain. Pt was observe in office from 1100 to 1500 with no evidence of shortness of breath, chest pain, dyspnea, swelling elsewhere. Pt was given Benadryl 50 mg and Naproxen 500 mg.  With no improvement. Heat was applied to area 20 minutes on/20 minutes off for an hour and then ice was applied for the same time frame with no improvement. Pt was advised on return precautions for anaphylaxis, compartment syndrome, cellulitis. Pt advised to have buddy at all times for next 12-24 hours. Pt advised to follow up in clinic on Monday, 11JUN18, but did not.
Age: 20.0
Sex: F
Vaccine: ANTH, JEV1
Symptoms: Tenderness
Clinical narrative: Pt is a 20 yo Female who presented to clinic for lightheaded/dizziness that started 15 minutes after receiving her JEV-1 (R deltoid IM) and Anthrax (L deltoid IM) vaccines. She also developed R forearm pain/swelling around the same time. Medic came to pt's shop to administer vaccines and pt was brought to clinic when she started experiencing symptoms. Pt had golf ball sized swelling at R forearm, just inferior to antecubital space, with extreme tenderness to palpation and pain with any movement distal to swelling. Injection site had drop of dried blood with mild erythema where bandage adhesive was attached. No evidence of streaking, broken skin any where in right upper extremity. Pt also reported mild numbness/tingling at palmar aspect of R hand. Pt had mild decreased range of motion and weakness due to pain. Pt was observe in office from 1100 to 1500 with no evidence of shortness of breath, chest pain, dyspnea, swelling elsewhere. Pt was given Benadryl 50 mg and Naproxen 500 mg.  With no improvement. Heat was applied to area 20 minutes on/20 minutes off for an hour and then ice was applied for the same time frame with no improvement. Pt was advised on return precautions for anaphylaxis, compartment syndrome, cellulitis. Pt advised to have buddy at all times for next 12-24 hours. Pt advised to follow up in clinic on Monday, 11JUN18, but did not.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness, hot around area of injection. Headache. Nausea.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Pain, swelling, redness, hot around area of injection. Headache. Nausea.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Feeling cold, Feeling jittery, Heart rate decreased
Clinical narrative: Roughly 5 minutes after receiving the vaccine that patient felt extremely faint, light headed, jittery and cold. A trained EMT on-site was monitoring heart rate and noted it was low but did not give specific BPM. EMS services were called and the patient was taken to a near by ER of their choice. They were seen in the ER and returned to work the following day.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: DONOR CONTACTED THE CENTER TODAY 06/10/2018 TO DISCLOSE THAT ABOUT FIVE HOURS AFTER RECEIVING THE VACCINE (ON 061018)THE DONOR STATED SHE BEGAN TO ITCH ALL OVER AND HAD HIVES ALL OVER HER ARMS, TRUNK (FRONT AND BACK) AND LEGS. DONOR STATED SHE WENT TO WORK AND A CO WORKER "WHO IS A NURSE" GAVE HER SOME BENADRYL. DONOR STATED THE HIVES AND ITCHING KEEPS RETURNING AND SHE IS HEADED TO THE URGENT CARE AND WILL NOTIFY THE CENTER AFTER SHE HAS BEEN SEEN. DONOR STATED SHE HAD A TETENUS INJ  AND HAD THE SAME REACTION ABOUT 3 OR 4 MONTHS AGO. DONOR HAS NOT CONTACTED THE CENTER AFTER GOING TO URGENT CARE.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness of L deltoid that lasted >10days.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's concomitant therapies included sterile diluent. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # N014634 with expiration date 07-NOV-2018) and/or improperly stored doses of M-M-R II (lot # M045394 with expiration date 14-NOV-2018), both for prophylaxis (dose and route were not reported for the suspect therapies). No adverse effects were reported. It was stated that the temperature was -14 to -10 degrees Celsius with a duration of 33 hours and 46 minutes. A previous temperature excursion was reported with a temperature of -14 to -10 degrees Celsius for 16 hours and 53 minutes. A digital data logger was involved. Follow-up information has been received from Medical Assistant on 06-JUN-2018. A call was placed to the reporter. A request was made for patient identifiers and vaccination dates for the two lots involved. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information on 08-JUN-2018, it was determined that this case is now valid because patient identifier was received. On 27-SEP-2017, the patient was vaccinated with improperly stored PROQUAD reconstituted with properly stored sterile diluent. This is one of the reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to two unspecified patients of unknown age and gender. No information about the patients' medical history and concurrent conditions was provided. On 27-DEC-2017, the patient were vaccinated with improperly stored doses of VARIVAX (lot # N020686 with an expiration date in 13-JUL-2018), for prophylaxis that underwent a temperature excursion from -9 degrees Celsius to 8 degrees Celsius during 1 hour and 30 minutes. The doses underwent a previous temperature excursion from  -9 degrees Celsius to 8 degrees Celsius during 2 hours and 13 minutes, the vaccines were reconstituted with properly stored sterile diluent (manufacturer unknown). Digital data logger was involved. No adverse events reported and no product quality complaint (PQC) was involved. As of 07-JUN-2018, all telephone attempts to obtain follow-up information have been unsuccessful.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6 months old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, at 6 months of age, the patient was vaccinated with VAQTA 25/0.5 (units not provided) injection, lot # N005796 with expiration date on 26-MAY-2018 (dose and route of administration were not reported) (product use in unapproved population, drug administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 30-MAY-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX injection, (lot # M025864, expiry date: 24-MAY-2018), subcutaneously for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided). It was reported that Merck sterile diluent used for reconstitution was properly stored. No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In October 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In July 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-JUL-2016, 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 20-JUL-2016, the patient was treated by a family physician 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 ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received 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 30-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-JUN-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 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: Decreased immune responsiveness, 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 2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster with complications. During 2015, the patient was treated by a physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, 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. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster with complications. On or about 16-JUN- 2014, 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: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In January 2009, the patient was inoculated with ZOSTAVAX by a physician at the physician's office 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 03-JUL-2016, the patient was treated by the same physician at the office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a physician regarding a female patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 06-JUN-2018, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). In approximately June 2018, the reporter stated that the patient was prescribed a corticosteroid injection for an unspecified reason. At the reporting time the outcome of the event was unknown. The causal relationship between ZOSTAVAX and the event was not reported. No product quality complain was present.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, 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 02-DEC-2012, the patient was inoculated 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-JUN-2016, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as shingles. On or about 22-JUN-2016, the patient sought subsequent treatment from a physician assistant for the onset of a severe vesicular rash, which was diagnosed as ongoing herpes zoster. On or about 13-JUL-2016, the patient sought additional treatment at medical center for ongoing and worsening symptoms of zoster outbreaks and pain, which was diagnosed as complicated herpes zoster and facial nerve palsy involving the partial paralysis of facial muscles. The patient has been prescribed hydrocodone/acetaminophen (NORCO), valacyclovir (VALTREX) and prednisone for management of her pain and chronic symptoms.  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. Upon internal review facial nerve palsy involving the partial paralysis of facial muscles was considered medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-AUG-2013, 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. On or about 02-JAN-2014, the patient was treated by a physician (at an unspecified facility/office) for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The 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: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a clinic as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 11-JUL-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed prednisone and valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is 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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In January 2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a physician office as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-JUL-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, 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 or about 05-DEC-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at Health Department as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-JUN-2016, the patient was treated at a clinic 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. The outcome is unknown. Additional information has been requested.