chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site discolouration, Malaise, Oral mucosal erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination for the patients was not specified. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter reported that one of her friend stated that they had friends who expereinced unknown adverse reaction after vaccination with shingle shot. The reporter was not sure if only one person or multiple patients experienced the adverse reaction. The reporter did not specify the adverse reactions experienced by the patients. The reporter had advised the patients to call the company to report the adverse reactions experienced after shingles vaccination. The reporter stated that she was about to tell her friend about it. This case was linked to case US2018117586, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Oral pain, Pain, Pain in extremity, Pyrexia, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination for the patients was not specified. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter reported that one of her friend stated that they had friends who expereinced unknown adverse reaction after vaccination with shingle shot. The reporter was not sure if only one person or multiple patients experienced the adverse reaction. The reporter did not specify the adverse reactions experienced by the patients. The reporter had advised the patients to call the company to report the adverse reactions experienced after shingles vaccination. The reporter stated that she was about to tell her friend about it. This case was linked to case US2018117586, reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX (batch number 4492P, expiry date 30th April 2020) for prophylaxis. On 27th June 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that patient was administered SHINGRIX on Wednesday and returned to the pharmacy on the day of reporting and was still having redness and swelling at the injection site. The health care professional was asking if this was normal for these reactions to last 5 days. The patient also said that her arm where she was administered SHINGRIX bothered her when she was laying down on that arm and was painful. No further information was provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 29th June 2018, the patient received the 1st dose of SHINGRIX. On 29th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The healthcare professional (HCP) stated that, on the day of vaccination, his mother experienced arm pain and flu like symptoms which lasted all weekend. The patient spent the weekend in bed. The patient was recommended to take TYLENOL. The reporting HCP did not administer the vaccine, and did not have vaccine information, or any other information for this adverse event.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 22nd March 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX on the left arm. The patient experienced pain in his left arm after vaccination with SHINGRIX. The patient reported that in March 2018, the pain lasted for approximately 2 days. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 29th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th June 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site erythema, injection site swelling, injection site warmth and injection site induration. The patient was treated with ibuprofen. On 30th June 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site induration were recovering/resolving. The reporter considered the fever, injection site erythema, injection site swelling, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient's date of birth was not obtained. The age at vaccination was not reported. The patient received SHINGRIX vaccine on an unknown arm. The reporter was the patient who experienced fever that resolved the next day and also had injection site reaction that included redness, swollen area approximately 3 inches across the arm that was hard and warm to the touch. The patient reported that her doctor advised to take Ibuprofen to help with that. The patient had denied permission to contact their physician.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 85-year-old male patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 10th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The physician did not had lot number and expiration. The physician reported that he experienced injection site soreness almost immediately after receiving SHINGRIX. The physician reported that he received TYLENOL which had slightly improved symptom. The physician reported that he was almost certain that it was caused by vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Herpes zoster, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 58-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 29th June 2018, the patient received SHINGRIX (intramuscular). On 1st July 2018, 2 days after receiving SHINGRIX, the patient experienced shingles, chills and fever. On 2nd July 2018, the patient experienced back pain. On an unknown date, the outcome of the shingles and back pain were unknown and the outcome of the chills and fever were recovered/resolved. It was unknown if the reporter considered the shingles, chills, back pain and fever to be related to SHINGRIX. Additional details were provided as follows: On Friday, the patient received SHINGRIX. On Sunday, the patient experienced fever and chills. On Monday, 3 days after vaccination, the patient woke up with pain on the right side of her lower back. The patient went to the health care professional office and was diagnosed with shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were recovered/resolved. It was unknown if the reporter considered the pain and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) stated that almost all of her patients complained of severe erythema and pain that last about 2 to 3 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 62-year-old male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced itchy rash, hives and erythematous rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved and the outcome of the hives and erythematous rash were unknown. The reporter considered the itchy rash to be related to SHINGRIX. It was unknown if the reporter considered the hives and erythematous rash to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in the left arm. The patient experienced the rash on arms and legs. The patient described the rash as little red bumps that are itchy and could possibly be hives. The patient stated that the rash went away and came back and on morning of the reporting day, the rash was on both arms.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 84-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included autoimmune disorder. Concomitant products included PREVENAR. On 18th June 2018, the patient received the 1st dose of SHINGRIX. On 19th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site rash. The patient was treated with prednisone and BENADRYL. On an unknown date, the outcome of the injection site rash was recovering/resolving. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information was received as follows: This case was reported by Physician Assistant, Certified (PA-C). The age at vaccination was not reported. On 16th June 2018, the patient received PREVENAR 13. The patient received PREVENAR and SHINGRIX on different arms. The patient broke out with a bad rash on both arms at the site of injection extending down to her hands. The patient received the 5 day prescription for Prednisone. The patient was seen by the provider on 21st June 2018, the patient was not better at that time. On 28th June 2018, the patient was improving but still had the rash, a prescription for BENADRYL was called in. The provider stated that the patient would not be completing the SHINGRIX series as she did not know which vaccine caused the reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Neck pain, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain, fever, general body pain, chills and neck pain. On an unknown date, the outcome of the injection site pain, fever, general body pain, chills and neck pain were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, general body pain, chills and neck pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in unknown arm. The patient experienced fever, pain at injection site, body aches, chills and neck pain for 24 hours roughly beginning 4 hours after receiving SHINGRIX. The reporter did not give consent for follow up. This case has been linked with case US2018GSK122228 reported by the same reporter for the same patient.
Sex: F
Vaccine: MENB
Symptoms: Chills, Erythema, Headache, Injection site pain, Malaise
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, viral infection, chills, headache, fever, erythema, swelling, pain in arm and unwell. On an unknown date, the outcome of the injection site pain, viral infection, chills, headache, fever, erythema, swelling, pain in arm and unwell were unknown. It was unknown if the reporter considered the injection site pain, viral infection, chills, headache, fever, erythema, swelling, pain in arm and unwell to be related to BEXSERO. Additional details were provided as follows: The reporter was the father of the patient. The age at vaccination was not reported. The patient reported that the BEXSERO was very painful at injection site, viral like symptoms, chills, headache , fever, redness, swelling, sore arm were experienced and did not feel well at all. The doctor was hesitant to give 2nd dose.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia, Swelling, Viral infection
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain, viral infection, chills, headache, fever, erythema, swelling, pain in arm and unwell. On an unknown date, the outcome of the injection site pain, viral infection, chills, headache, fever, erythema, swelling, pain in arm and unwell were unknown. It was unknown if the reporter considered the injection site pain, viral infection, chills, headache, fever, erythema, swelling, pain in arm and unwell to be related to BEXSERO. Additional details were provided as follows: The reporter was the father of the patient. The age at vaccination was not reported. The patient reported that the BEXSERO was very painful at injection site, viral like symptoms, chills, headache , fever, redness, swelling, sore arm were experienced and did not feel well at all. The doctor was hesitant to give 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (Refer case US2018GSK119885). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain and pain in arm. On an unknown date, the outcome of the pain and pain in arm were unknown. It was unknown if the reporter considered the pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced very mild pain noting nothing like symptoms after 1st dose SHINGRIX, except sore arm. The reporter did not give consent for follow up. This case has been linked with case US2018GSK119885 reported by the same reporter for the same patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Cellulitis, Gait inability, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: Several hours after injection his R thigh and knee began to swell. He reported pain in the area. The pain and swelling worsened throughout the night and he was unable to walk on the leg the following day. He was seen in our office in follow-up the next day and diagnosed with limb swelling secondary to vaccine and instructed to provide supportive care. Due to worsening swelling he was seen in an ER later that night and diagnosed with cellulitis and prescribed KEFLEX of which he only had 1 dose. He was seen in our office again (by myself) on 7/11 (2 days after injection) and noted to have swelling of entire R leg however no erythema or warmth was noted in the leg or around the injection site. His reaction was again determined to be unilateral limb swelling secondary to vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Peripheral swelling, Vaccination complication, Weight bearing difficulty
Clinical narrative: Several hours after injection his R thigh and knee began to swell. He reported pain in the area. The pain and swelling worsened throughout the night and he was unable to walk on the leg the following day. He was seen in our office in follow-up the next day and diagnosed with limb swelling secondary to vaccine and instructed to provide supportive care. Due to worsening swelling he was seen in an ER later that night and diagnosed with cellulitis and prescribed KEFLEX of which he only had 1 dose. He was seen in our office again (by myself) on 7/11 (2 days after injection) and noted to have swelling of entire R leg however no erythema or warmth was noted in the leg or around the injection site. His reaction was again determined to be unilateral limb swelling secondary to vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reported redness, pain, swelling at left deltoid injection site less than 12 hours after receiving immunization. Pt performed self care at home with TYLENOL, rest, ice and BENADRYL. No visit to ER or Urgent Care. Reported Sxs to us 2 mos after receiving.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Approximately 12 hours after vaccine I started running a low grade fever that lasted for 3 days. Left arm was very sore. I took Tylenol to help with fever and muscle aches. On July 9th I had second dose of SHINGRIX and again 12 hours later I started running a fever that lasted 24 hours. Once again left arm was very sore. Pharmacist suggested I contact  you with information.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chills, Fatigue, Immediate post-injection reaction, Injection site rash
Clinical narrative: Immediate sensation of thickening of tongue, tingling on face. Later chills, fever, extreme exhaustion, swollen injection site with rash and peeling skin. Was ill for five days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Malaise, Paraesthesia, Pyrexia
Clinical narrative: Immediate sensation of thickening of tongue, tingling on face. Later chills, fever, extreme exhaustion, swollen injection site with rash and peeling skin. Was ill for five days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Tongue disorder
Clinical narrative: Immediate sensation of thickening of tongue, tingling on face. Later chills, fever, extreme exhaustion, swollen injection site with rash and peeling skin. Was ill for five days.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: FEVER, CHILLS, HEADACHE, MUSCLE ACHE DIDN'T TAKE ANYTHING. MY ARM STILL HURTS.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema
Clinical narrative: PARENT REPORTED 1 X 2 INCH AREA OF REDNESS AT VACCINE SITE. NO STREAKING, NOT WARM TO TOUCH, AFEBRILE. DISCUSSED COMFORT MEASURES AND PLAN IF FOLLOW-UP BECOMES NECESSARY.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy - Complete Paralysis of Left Side of Face occuring four days after injection.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom brought Pt. in on 07-10-18 with his R deltoid swollen, red and warm. Dr. looked at it and informed the mom that he was having an allergic reaction to the immunization that he received yesterday. Dr. gave instruction to the mom to give him BENADRYL and IBU and if he started running a fever or if she noticed it getting worse to bring him back to the clinic or to the ER. I called the morning of 07-11-18 and the mom stated that the swelling had gone down and it looked much better.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Headache, Pyrexia, Tremor, Vomiting
Clinical narrative: Approximately 12 hours after vaccination, Pt had vomiting, shaking, headache, fever, severe abdominal pain. This lasted approximately 4 hours. EMS was called due to Pt "shaking because of abdominal pain". Pt's mother also uses the term, "writhing in pain" to describe Pt. Pt was not transported via ambulance because his BP, O2 and Pulse were WNL. No breathing difficulty or hives were present when symptoms began at 3 AM.
Age: 37.0
Sex: M
Vaccine: FLUC4, HEP
Symptoms: Urticaria
Clinical narrative: Generalized urticarial rash w/o anaphylaxis.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cough, Crying, Decreased eye contact, Developmental regression, Dysarthria
Clinical narrative: Noticeable speech regression, normally very vocal and was able to copy sounds perfectly, saying "hi at two months. Was silent except for crying for over three months after this vaccine. Significant  fine motor skills regression. She could not easily pick up objects, she struggled to coordinate her right and left hand, started to grab small objects with entire hand clumsily instead of with her fingers like she did before the vaccine. She hit all her milestones very early before this. Born able to hold her head up, rolling at 5 weeks old, when you stood her up she would try to walk. After this vaccine she didn't start crawling until she was 9 months old and didn't walk until she was 15 months old. She doesn't make direct eye contact and her speech is very slurred when she tries to talk. Her hearing was perfect when she was born and now it is like she doesn't hear how to fully pronounce a word. Had a chronic cough for over a month.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Fine motor skill dysfunction, Hypoacusis, Speech disorder developmental
Clinical narrative: Noticeable speech regression, normally very vocal and was able to copy sounds perfectly, saying "hi at two months. Was silent except for crying for over three months after this vaccine. Significant  fine motor skills regression. She could not easily pick up objects, she struggled to coordinate her right and left hand, started to grab small objects with entire hand clumsily instead of with her fingers like she did before the vaccine. She hit all her milestones very early before this. Born able to hold her head up, rolling at 5 weeks old, when you stood her up she would try to walk. After this vaccine she didn't start crawling until she was 9 months old and didn't walk until she was 15 months old. She doesn't make direct eye contact and her speech is very slurred when she tries to talk. Her hearing was perfect when she was born and now it is like she doesn't hear how to fully pronounce a word. Had a chronic cough for over a month.
Age: 1.17
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via company representative regarding a 14 months pediatric patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date, the patient was vaccinated with VAQTA for prophylaxis (dose number, frequency, route, anatomical location, lot # and expiration date were not provided). On an unspecified date, the patient received a dose regiment of VAQTA too soon at 14 months instead of the 16 month and the patient experienced an adverse reaction. At the reporting time, the outcome of adverse reaction was unknown. The reporter did not assess the relatedness between VAQTA and the reaction.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site swelling, Pain, Skin lesion
Clinical narrative: Pt with (RT) upper arm swelling developed 3 days ago, pain for 1-2 days now resolved, however swelling remains (localized reaction). 9 cm diameter circular lesion, non-tender, mild erythema.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-SEP-2017, 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 and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-SEP-2017, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2011, the patient was inoculated at a clinic with ZOSTAVAX 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 25-MAY-2016, the patient was treated by a physician at a clinic for the onset of a severe vesicular rash which was diagnosed as acute zoster. The patient was prescribed FAMVIR and lidocaine patches for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the 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 or about 30-JUL-2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as shingles. The outcome of the events is unknown. 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: Adverse event
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 an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided). On an unknown date, the patient suffered an unspecified adverse event. The outcome of the event is unknown. Causality was not assessed. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-MAR-2012, 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 or about 25-AUG-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. 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: PPV
Symptoms: Pain in extremity, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient's husband). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at a single dose for pneumonia vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient had a pneumonia vaccination that hurt the patient's arm a lot. It was also reported that the patient has been hospitalized twice in the last few years with serious pneumonia. The outcome of the events was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Patient only received the MenCYW-135 Liquid Conjugate Component of the vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Severe body aches, fever.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Feeding disorder, Haemorrhagic disorder, Headache, Incomplete course of vaccination
Clinical narrative: With the first dose (out of 3) I got extremely sick. 102 fever. Headache. Stomach pain and started having irregular bleeding. Became very ill, couldn't eat, my stomach constantly hurt me.  Flu like symptoms!! 2nd shot, everything was amplified so badly I never got my third!
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: With the first dose (out of 3) I got extremely sick. 102 fever. Headache. Stomach pain and started having irregular bleeding. Became very ill, couldn't eat, my stomach constantly hurt me.  Flu like symptoms!! 2nd shot, everything was amplified so badly I never got my third!
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: After routine exam, I was administering MENACTRA and Tdap, I gave MENACTRA in Left Deltoid, and placed a band aid, and as I walked to patient's right side, the patient fainted as I laid her on the exam table. I had not even attempted to administer the Tdap. Patient attempted to sit up too soon and became faint again. After 15 minutes, the PA examined patient and the Tdap was administered in the right deltoid while patient lying down. Second injection tolerated well and no fainting, or ill effect. Patient waited 15 minutes after the 2nd injection (Tdap) and had no fainting, was feeling fine, color good and patient left in excellent condition.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Lethargy, Nausea, Pain
Clinical narrative: The afternoon of the injection my arm became a little red and puffy and was very sore to touch. By evening it hurt to move my arm. The following day I woke with a headache and a little nausea...as the day went on, I had aches and pains and was very lethargic. I took Tylenol and a 3 hour nap but still wasn't much better. I had a little soup for dinner and another Tylenol before bed. I woke feeling better but the arm is still very sore to touch. I had the same symptoms after the first injection so I almost didn't get the 2nd one.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: The afternoon of the injection my arm became a little red and puffy and was very sore to touch. By evening it hurt to move my arm. The following day I woke with a headache and a little nausea...as the day went on, I had aches and pains and was very lethargic. I took Tylenol and a 3 hour nap but still wasn't much better. I had a little soup for dinner and another Tylenol before bed. I woke feeling better but the arm is still very sore to touch. I had the same symptoms after the first injection so I almost didn't get the 2nd one.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs was not provided. Concomitant therapies included properly stored sterile diluent. On an unknown date, the patient was vaccinated with a improperly stored M-M-R II (rHA) lot # N023146, expiration date 24-AUG-2019 (route and dose were not provided) for prophylaxis. The vaccines were exposed to a temperature of 47°F to 77°F during 33 minutes. No adverse effects were reported. It was reported that data logger was involved.
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 medical student refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On unknown dates (reported as over a year ago), the patient was vaccinated with two doses of GARDASIL for prophylaxis (doses, lot numbers and expiration dates were not reported). On 29-JUN-2018 (reported as "today"), the patient completed the vaccination series with GARDASIL 9 (dose, lot number and expiration date were not reported). No adverse event was reported.
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 25-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot# N034006, expiration date 01-FEB-2020 (strength, dose, frequency and route of administration were not provided). Furthermore on 29-JUN-2018, an unspecified patient received an improperly stored dose of M-M-R II (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis which was reconstituted with properly stored sterile diluent (MRK). The doses of PEDVAXHIB and M-M-R II were exposed to a temperature excursion of 9 degrees Celsius (C) to 25 degrees C during a time frame of 1 hour and 30 minutes, which was detected by the data logger. There was a previous temperature excursion of 9 degrees C to 25 degrees C for 45 minutes. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic 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 29-DEC-2009, the patient was inoculated with ZOSTAVAX at a facility as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles, and other complications. In 2016, the patient was treated by a Dermatologist for a blistering vesicular outbreak that was diagnosed as severe herpes zoster with ophthalmic complications. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, ophthalmic herpes zoster was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes ophthalmic, 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 an unknown date in 2006, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, 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 or about 08-MAY-2014, the patient was treated by an optometrist for the onset of a vesicular rash, which was diagnosed as herpes zoster with ocular manifestations. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. 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, herpes zoster with ocular manifestations was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, 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 or about 18-AUG-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed capsaicin and VALTREX for management of her painful symptoms and chronic pain. The outcome of the events is unknown. 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 significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-NOV-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 or about 27-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed tramadol and VALTREX for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-JAN-2016, 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 later in 2016, the patient was treated by a physician 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 the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-JUL-2008, 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 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 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.