chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMR, VARCEL
Symptoms: Pruritus, Rash, Rash maculo-papular
Clinical narrative: On June 5th, at 7:30 AM was noted to have maculopapular rash on trunk and slightly on back. No other rash noted on arms, face, neck or legs. Complained of slight itching.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Cough, Headache, Nausea
Clinical narrative: Patient was experiencing the following symptoms at 10:45pm- vomiting, extreme nausa, severe headache and backache, very high temperature, awful chills-whole body vibrating and coughing. Went to ER at 11:15pm and discharged at 4am. ER doctor did find a low grade pneumonia and UTI but felt all the symptoms started with the vaccine in his opinion and caused a domino effect. He also said not to get the second shot and to review this with her PCP.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia, Pyrexia, Tremor, Urinary tract infection, Vomiting
Clinical narrative: Patient was experiencing the following symptoms at 10:45pm- vomiting, extreme nausa, severe headache and backache, very high temperature, awful chills-whole body vibrating and coughing. Went to ER at 11:15pm and discharged at 4am. ER doctor did find a low grade pneumonia and UTI but felt all the symptoms started with the vaccine in his opinion and caused a domino effect. He also said not to get the second shot and to review this with her PCP.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Palpitations, Tremor
Clinical narrative: About 7 hours after vaccination, he stated that his arm started hurting and throbbing like he had been stung by a bee. He said his whole body was shaking and continued to all night. He checked and he did not have a fever. His heart rate was racing and about 110 BPM when he checked. The next morning he said he is feeling okay. His arm does not hurt as bad, but there is soreness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Migraine, Neuralgia, Pain
Clinical narrative: Patient reports nerve pain and arm tingling within 24 hours of the vaccine and then it progressed to a rash on her body that she reports was from head to toe that lasted for 4 days. She then got a migraine that lasted another 4 days. The rash subsided and then flared up again and she reported the rash reappeared worse than before. She states her injection site had severe swelling and she experienced severe fatigue with aches and pains.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash generalised
Clinical narrative: Patient reports nerve pain and arm tingling within 24 hours of the vaccine and then it progressed to a rash on her body that she reports was from head to toe that lasted for 4 days. She then got a migraine that lasted another 4 days. The rash subsided and then flared up again and she reported the rash reappeared worse than before. She states her injection site had severe swelling and she experienced severe fatigue with aches and pains.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Lip swelling, Swelling face
Clinical narrative: Patient stated two main adverse events. The first one is swelling in the lip and left check and the second is bone and joint aches in whole body. Patient did not report any hives or itching. Patient stated that symptoms lasted from the night after the vaccine was administered until today. The lip swelling has been slowing disappearing.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: Pt was fine immediately after injection and stated that the vaccine didn't hurt as badly as she expected it to. However, the next day she states that she had a fever, chills, body aches, nausea (almost had to vomit) and diarrhea. She stated that she spoke with her doctor about the vaccine and the events that happened afterwards and she was informed that half of the people who received the SHINGRIX vaccine have reported similar outcomes postvaccination. I was informed and immediately wanted to report the event. No other patients have come forward with issues postvaccination.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash started on trunk on 6/3/18, spread to face, neck and arms. Afebrile. Rash is itchy.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal tenderness, Adverse drug reaction, Cellulitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 50-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included rash. On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced abdominal pain, nausea, abdominal discomfort and abdominal tenderness. On an unknown date, the patient experienced cellulitis (serious criteria GSK medically significant) and pain in arm. The patient was treated with antibiotics nos (Brand Names Not Known). On an unknown date, the outcome of the cellulitis was unknown and the outcome of the abdominal pain and abdominal discomfort were recovering/resolving and the outcome of the pain in arm and nausea were recovered/resolved and the outcome of the abdominal tenderness was not recovered/not resolved. It was unknown if the reporter considered the cellulitis, abdominal pain, nausea, abdominal discomfort and abdominal tenderness to be related to SHINGRIX. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: One week after receiving SHINGRIX, the patient experienced abdominal discomfort, pain, cramping, and nausea. An abdomen was tender till the time of reporting. The patient also had soreness in arm. Less than a year after receiving SHINGRIX, the patient developed cellulitis which was thought to be unrelated to the vaccine and was given antibiotics. The patient was then developed a rash from the antibiotics. The healthcare professional stated that the patient went to the emergency room because of the abdominal pain and did not provide the name of the antibiotics the patient was on. The healthcare professional did not have any information on the 2nd patient in which the abdominal pain occurred. This case has been linked with case US2018GSK099775, reported by same reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 50-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included rash. On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced abdominal pain, nausea, abdominal discomfort and abdominal tenderness. On an unknown date, the patient experienced cellulitis (serious criteria GSK medically significant) and pain in arm. The patient was treated with antibiotics nos (Brand Names Not Known). On an unknown date, the outcome of the cellulitis was unknown and the outcome of the abdominal pain and abdominal discomfort were recovering/resolving and the outcome of the pain in arm and nausea were recovered/resolved and the outcome of the abdominal tenderness was not recovered/not resolved. It was unknown if the reporter considered the cellulitis, abdominal pain, nausea, abdominal discomfort and abdominal tenderness to be related to SHINGRIX. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: One week after receiving SHINGRIX, the patient experienced abdominal discomfort, pain, cramping, and nausea. An abdomen was tender till the time of reporting. The patient also had soreness in arm. Less than a year after receiving SHINGRIX, the patient developed cellulitis which was thought to be unrelated to the vaccine and was given antibiotics. The patient was then developed a rash from the antibiotics. The healthcare professional stated that the patient went to the emergency room because of the abdominal pain and did not provide the name of the antibiotics the patient was on. The healthcare professional did not have any information on the 2nd patient in which the abdominal pain occurred. This case has been linked with case US2018GSK099775, reported by same reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 50-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concurrent medical conditions included rash. On 21st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced abdominal pain, nausea, abdominal discomfort and abdominal tenderness. On an unknown date, the patient experienced cellulitis (serious criteria GSK medically significant) and pain in arm. The patient was treated with antibiotics nos (Brand Names Not Known). On an unknown date, the outcome of the cellulitis was unknown and the outcome of the abdominal pain and abdominal discomfort were recovering/resolving and the outcome of the pain in arm and nausea were recovered/resolved and the outcome of the abdominal tenderness was not recovered/not resolved. It was unknown if the reporter considered the cellulitis, abdominal pain, nausea, abdominal discomfort and abdominal tenderness to be related to SHINGRIX. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: One week after receiving SHINGRIX, the patient experienced abdominal discomfort, pain, cramping, and nausea. An abdomen was tender till the time of reporting. The patient also had soreness in arm. Less than a year after receiving SHINGRIX, the patient developed cellulitis which was thought to be unrelated to the vaccine and was given antibiotics. The patient was then developed a rash from the antibiotics. The healthcare professional stated that the patient went to the emergency room because of the abdominal pain and did not provide the name of the antibiotics the patient was on. The healthcare professional did not have any information on the 2nd patient in which the abdominal pain occurred. This case has been linked with case US2018GSK099775, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of injection site swelling in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that, on an unspecified date, an unspecified patient experienced severe reactions to SHINGRIX. The physician reported that swelling at the injection site, "was the size of a pear". No additional information was provided.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Approximately 2 hours after receiving vaccine, patient felt fatigue. Fatigue has been ongoing as of this writing (day7). On day 3, patient developed chills. On day 4, patient developed fever measured to 103. Fever has continued (low grade). Patient also developed a headache on day 3 which has continued. She saw her primary care physician who ordered labs. Those results are not available at this time. Yesterday (day 6), patient developed a sore throat, non bloody diarrhea, and a left side anterior cervical lymph node which is nontender and the size of a dime.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Approximately 2 hours after receiving vaccine, patient felt fatigue. Fatigue has been ongoing as of this writing (day7). On day 3, patient developed chills. On day 4, patient developed fever measured to 103. Fever has continued (low grade). Patient also developed a headache on day 3 which has continued. She saw her primary care physician who ordered labs. Those results are not available at this time. Yesterday (day 6), patient developed a sore throat, non bloody diarrhea, and a left side anterior cervical lymph node which is nontender and the size of a dime.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Crying, Emotional disorder, Feeling hot, Pain
Clinical narrative: Patient had fever of 101 including alternating heat and chills, intense body aches, intense feelings of restlessless and emotional disturbance, including crying. Patient had very sore arm, all symptoms lasted roughly 3 days. Patient describes it as a horrible experience.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Restlessness
Clinical narrative: Patient had fever of 101 including alternating heat and chills, intense body aches, intense feelings of restlessless and emotional disturbance, including crying. Patient had very sore arm, all symptoms lasted roughly 3 days. Patient describes it as a horrible experience.
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 patients arm was extremely sore, by 8pm that night her arm was red, swollen, itchy and warm.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy test positive, Rash generalised
Clinical narrative: Since taking the TDAP shot back in Dec 14, 2017, I have experienced severe rash all over my body. Been prescribed medications from the Clinic/Pharmacy and the Hospital/Pharmacy starting in mid-Jan 2018 through 5 June 2018. Oral Meds include: Cetirizine, Prednisone, Hydroxyzine, Loratadine and a (corticosteroid) Clobetasol Propionate Cream. Only the Prednisone was effective which I started taking in April 2018 and completed in May 2018. However, after completing the Prednisone medication, the rash came back 3 weeks later and is now worse than before. Continuing to see doctor for more treatment as of June 5, 2018.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Nausea
Clinical narrative: By night at 10pm, patient had upset stomach, bad nausea and a bit of diarrhea. The problems lasted for about 1 month. During this month took Coca Cola and cranberry juice to help settle stomach. Eventually patient was able to tolerate eggs. Patient called doctor after 3 weeks of symptoms--by then it was getting better. Patient was weak and mostly in bed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pruritus, Lethargy
Clinical narrative: Approximately 17 hours after receiving the vaccine 05/08/2018 at 11:30 am, developed flu-like symptoms: Chills, over-all body aches, fever (101.1), lethargy. Began taking TYLENOL 500 mg every 4-6 hours until symptoms resolved the next morning, approx. 6:00 am. On 05/09/2018, at 6:00 am, approximately 36 hours after the injection, a localized reaction at the injection site was noted(redness and itching that began as approximately 1 inch in diameter and spread to about 3-4 inches in diameter). Began BENADRYL 25 - 50 mg every 6 hours until redness and itching resolved on 05/12/2018.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Pain, Pyrexia
Clinical narrative: Approximately 17 hours after receiving the vaccine 05/08/2018 at 11:30 am, developed flu-like symptoms: Chills, over-all body aches, fever (101.1), lethargy. Began taking TYLENOL 500 mg every 4-6 hours until symptoms resolved the next morning, approx. 6:00 am. On 05/09/2018, at 6:00 am, approximately 36 hours after the injection, a localized reaction at the injection site was noted(redness and itching that began as approximately 1 inch in diameter and spread to about 3-4 inches in diameter). Began BENADRYL 25 - 50 mg every 6 hours until redness and itching resolved on 05/12/2018.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Laparotomy, Occult blood positive
Clinical narrative: Infant developed intussusception on 06/01/2018. Vaccines administered 05/24/2018. Baby required open laparotomy to correct.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Ear swelling, Erythema, Urticaria
Clinical narrative: This spontaneous report was received from an office manager and refers to a 18-month-old male patient. The patient had no pertinent medical history, concomitant medications, drug reactions or allergies. On 01-JUN-2018, the patient was vaccinated with VAQTA injection, dose reported as 25/0.5, intramuscularly, lot # N026997 and expiration date: 10-NOV-2018, as a "part of routine vaccinations" (frequency was not reported). The office manager reported, that the patient returned to the doctor's office "1 hour later" on 01-JUN-2018, with "puffy ears, red cheeks and hives". The patient received an unspecified dose of BENADRYL. The outcome of events was reported as recovering/resolving at the time of this report. No causality assessment was provided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 1st May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, injection site erythema and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. This case was initially reported via voice message. The pharmacy was called back for additional details. The patient experienced injection site reaction consisting of a swollen arm, round red circle at the injection site, and flu like symptoms, which were not delineated. The patient stated that, it was not cellulitis, but as erythema.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Injection site pain, Insomnia, Middle insomnia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sleep loss in a 64-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (On an unknown date, the patient received ZOSTAVAX). On 23rd May 2018 13:30, patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, several hours after receiving SHINGRIX, the patient experienced sleep loss, chills, muscle pain, feeling hot and injection site pain. On an unknown date, the patient experienced incorrect product storage. On an unknown date, the outcome of the sleep loss, injection site pain and incorrect product storage were unknown and the outcome of the chills and feeling hot were not recovered/not resolved and the outcome of the muscle pain was recovering/resolving. The reporter considered the sleep loss, chills, muscle pain, feeling hot and injection site pain to be related to SHINGRIX. Additional information was reported as follows: The pharmacist herself was the patient who reported the case. The patient received the vaccine on the left arm. The nurse indicated at the time of injection, that the vaccine had been frozen. This led to incorrect storage of drug. The lot number and expiry date for SHINGRIX were unknown. The patient started to feel achy all over the last night, before the date of reporting. It worsened over time but was a little better on the date of reporting. She also felt feverish even though she did not take her temperature. The pain in her arm woke her up several times during the night and she experienced chills so she didn't sleep well. The site of the injection was very sore and tender. It hurted to lifted her arm up. The patient's call was transferred to Medical Investigation to see if she needed to be revaccinated.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Poor quality sleep, Product storage error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sleep loss in a 64-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (On an unknown date, the patient received ZOSTAVAX). On 23rd May 2018 13:30, patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, several hours after receiving SHINGRIX, the patient experienced sleep loss, chills, muscle pain, feeling hot and injection site pain. On an unknown date, the patient experienced incorrect product storage. On an unknown date, the outcome of the sleep loss, injection site pain and incorrect product storage were unknown and the outcome of the chills and feeling hot were not recovered/not resolved and the outcome of the muscle pain was recovering/resolving. The reporter considered the sleep loss, chills, muscle pain, feeling hot and injection site pain to be related to SHINGRIX. Additional information was reported as follows: The pharmacist herself was the patient who reported the case. The patient received the vaccine on the left arm. The nurse indicated at the time of injection, that the vaccine had been frozen. This led to incorrect storage of drug. The lot number and expiry date for SHINGRIX were unknown. The patient started to feel achy all over the last night, before the date of reporting. It worsened over time but was a little better on the date of reporting. She also felt feverish even though she did not take her temperature. The pain in her arm woke her up several times during the night and she experienced chills so she didn't sleep well. The site of the injection was very sore and tender. It hurted to lifted her arm up. The patient's call was transferred to Medical Investigation to see if she needed to be revaccinated.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sleep loss in a 64-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (On an unknown date, the patient received ZOSTAVAX). On 23rd May 2018 13:30, patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd May 2018, several hours after receiving SHINGRIX, the patient experienced sleep loss, chills, muscle pain, feeling hot and injection site pain. On an unknown date, the patient experienced incorrect product storage. On an unknown date, the outcome of the sleep loss, injection site pain and incorrect product storage were unknown and the outcome of the chills and feeling hot were not recovered/not resolved and the outcome of the muscle pain was recovering/resolving. The reporter considered the sleep loss, chills, muscle pain, feeling hot and injection site pain to be related to SHINGRIX. Additional information was reported as follows: The pharmacist herself was the patient who reported the case. The patient received the vaccine on the left arm. The nurse indicated at the time of injection, that the vaccine had been frozen. This led to incorrect storage of drug. The lot number and expiry date for SHINGRIX were unknown. The patient started to feel achy all over the last night, before the date of reporting. It worsened over time but was a little better on the date of reporting. She also felt feverish even though she did not take her temperature. The pain in her arm woke her up several times during the night and she experienced chills so she didn't sleep well. The site of the injection was very sore and tender. It hurted to lifted her arm up. The patient's call was transferred to Medical Investigation to see if she needed to be revaccinated.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). Concomitant products included CRESTOR and MEDROL. On 23rd May 2018, the patient received the 2nd dose of SHINGRIX. On 25th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site bruising. On an unknown date, the outcome of the injection site erythema and injection site bruising were unknown. It was unknown if the reporter considered the injection site erythema and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the left arm, slightly below the deltoid. The patient experienced redness and a bruise around the injection site, for which no medical intervention was required.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in extremity in unspecified adult patients who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was unknown. It was unknown if the reporter considered the pain in extremity to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that, his office had probably vaccinated around 60 patients with SHINGRIX vaccine and half of them experienced a sore arm. No additional information was available. This case has been linked with case US2018094043, reported by the same reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 76-year-old male patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). On 24th May 2018 13:15, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th May 2018, less than an hour after receiving SHINGRIX, the patient experienced chills and vomiting. On an unknown date, the outcome of the chills and vomiting were not recovered/not resolved. The reporter considered the chills and vomiting to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional stated that the patient received SHINGRIX in the afternoon and with in 15 minutes he had chills and vomiting. The health care professional stated that the patient called the retail pharmacy to report this reaction. No medical intervention or other interventions were required. The patient was reported to be at home resting and "sleeping it off." The reported batch number of the SHINGRIX (LT5333) did not exist and, was updated to LT533 as per sales database.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Furuncle, Herpes zoster, Pain, Pruritus, Skin tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old male patient who received SHINGRIX (batch number LT533, expiry date 10th November 2020). The patient's past medical history included shingles. On 10th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 10 days after receiving SHINGRIX, the patient experienced shingles, skin tightness, pruritus, boil and pain. On an unknown date, the outcome of the shingles, skin tightness, pruritus, boil and pain were unknown. It was unknown if the reporter considered the shingles, skin tightness, pruritus, boil and pain to be related to SHINGRIX. Additional details were provided as follows: About ten days later, the patient developed a case of shingles on my left forehead and scalp. The first symptom was an unusually feeling of tight skin and some itching in that area followed by an outbreak of boils. The patient received a prescription of VALTREX from the physician and the boils and scalps disappeared at the end of ten days. At no point was the condition particularly painful although the area was somewhat tender if I pressed it or slept with that side of my side on the pillow. The pharmacist told me that the 1st shot offered no protection and that the 2nd shot on schedule.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Malaise
Clinical narrative: Got extreme flu like symptoms in a couple hours after shot given. Now 5 days later extremely ill.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Cough, Paraesthesia oral, Throat tightness
Clinical narrative: Per mom, after leaving the office and walking down to the car, she put child in her car seat. This is when child started coughing, c/o "burning feeling" in chest, face, mouth, throat felt tight and tongue felt like it was tingling. Mom said she monitored her closely but did not give her any medications. She monitored her for 20 minutes, which was when symptoms started to subside.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site papule, Injection site reaction, Injection site swelling, Pallor
Clinical narrative: Comments: R anterior thigh with raised somewhat papular area. Blanches to palpation. Palpation does not seem to cause pain. 5 cm at the largest diameter. Treated w/ mupirocin 2% topical ointment and recommended BENADRYL cream.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Skin lesion
Clinical narrative: PATIENT RECEIVED VACCINE AT Pharmacy. CAME TO CLINIC WITH RASH UNDER ARMS. LESIONS UNILATERAL TO AFFECTED AREA, CAUSING PAIN ALONG THE NERVE ROOT. VALTREX 1 GRAM TABS THREE TIMES A DAY FOR SEVEN DAYS. IBUPROFEN 800 MG THREE TIMES A DAY FOR FIFTEEN DAYS. FOLLOW UP IN ONE WEEK. PHARMACIST GAVE LOT AS B334Y EXPIRATION 10/17/20. DILUTENT LOT D3L5G EX 11/29/20
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Onset approx. 24 hours after immunization: Chills & sweats, body aches, injection site pain/redness/swelling, denied anyphylaxis.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Onset approx. 24 hours after immunization: Chills & sweats, body aches, injection site pain/redness/swelling, denied anyphylaxis.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient developed left shoulder pain a few hours after receiving the SHINGRIX vaccine. She was evaluated the next day at an urgent care center. She was prescribed hydrocodone and ibuprofen 800 mgs there and was provided with an arm sling. On 6/1/2018 she had intact sensation FROM fingers, wrist, elbow, strong pinch/grip of her left hand. Left arm and elevation forward and laterally to 35 degrees, posterior arm movement with hand to L5.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Herpes zoster, Hyperaesthesia, Hypoaesthesia
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 31-MAY-2016, 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. Shortly after receiving the ZOSTAVAX vaccine the patient developed skin sensitivity, a burning sensation throughout her torso, and feelings of numbness and tingling in her feet. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles. Thereafter, the patient's feelings of numbness, weakness, and tingling in her extremities worsened in intensity and duration, and on 07-JAN-2017, the patient presented to another physician and was diagnosed as suffering from acute transverse myelitis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review acute transverse myelitis was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis transverse, Paraesthesia
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 31-MAY-2016, 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. Shortly after receiving the ZOSTAVAX vaccine the patient developed skin sensitivity, a burning sensation throughout her torso, and feelings of numbness and tingling in her feet. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles. Thereafter, the patient's feelings of numbness, weakness, and tingling in her extremities worsened in intensity and duration, and on 07-JAN-2017, the patient presented to another physician and was diagnosed as suffering from acute transverse myelitis. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review acute transverse myelitis was considered medically significant. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Insomnia, Pain
Clinical narrative: Patient reported that he had such extreme pain that it triggered an anxiety attack that more than one day in which he could not sleep.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Acute kidney injury, Blood creatine phosphokinase increased, Inflammatory marker increased, Injection site pain, Musculoskeletal pain
Clinical narrative: Pain/soreness in L bicep then bilateral buttock pain overnight that got worse. Was found to be rhabdomyolysis. CK peaked at 9303. Patient treated with IVF and pain control with rapid improvement in CK and improvement in pain symptoms, as well as resolution of AKI and elevated trop. Patients CK was down to 2200 at time of discharge and inflammatory markers had improved significantly.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Rhabdomyolysis, Troponin increased
Clinical narrative: Pain/soreness in L bicep then bilateral buttock pain overnight that got worse. Was found to be rhabdomyolysis. CK peaked at 9303. Patient treated with IVF and pain control with rapid improvement in CK and improvement in pain symptoms, as well as resolution of AKI and elevated trop. Patients CK was down to 2200 at time of discharge and inflammatory markers had improved significantly.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Pain, Swelling
Clinical narrative: Pt was given SHINGRIX SUB Q instead of IM. Pt experienced exact same side effects as IM. Pain, redness and swelling. GlaxoSmithKline was called about incident and they explained that they did test vaccine sub q and it is a valid dose just more painful then IM.
Age: 0.92
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received PENTACEL and Hib on the same day. No adverse events, just vaccine error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Pallor, Syncope, Walking aid user
Clinical narrative: Patient fainted a few mins after the shot was given. It took over 20mins for him to be able to walk with assistance after eating a candy bar and drinking orange juice. He was still light-headed, nauseous and pale a few hours after the shot. However, he woke up the next morning feeling well enough to go to school.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Needle issue
Clinical narrative: MA prepared vaccine and cleared the air through the needle by pushing the vaccine through the needle. When she went to inject the vaccine, the vaccine would no longer push through the needle and the plunger was pushing back as though the needle was blocked. Injection was discontinued. Vaccine was not given.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient complained that her arm hurt after. Her doctor that prescribed the shot advised her to apply ice.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Face injury, Fall, Loss of consciousness, Neurological examination normal, Swelling face
Clinical narrative: Patient was sitting in chair in exam room after vaccine and fainted, fell forwards and hit face on the floor. She had a few seconds of full-body shaking per parental report. Regained consciousness after less than one minute and was able to answer questions normally. She laid flat on her back and feet were elevated for a few minutes. Allowed sips of water as mental status was normal. An ice pack was applied to the left side of her forehead just above the eye, as this was where she hit her face on the floor and was developing slight swelling. Continued having her lie down for about 15 minutes after the event, then sit for 5 minutes before attempting to walk. Blood pressure was monitored and was normal. Neuro exam normal. Facial swelling resolved after icing. Signs and symptoms of concussion were discussed and patient was discharged home from the clinic.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Tremor
Clinical narrative: Patient was sitting in chair in exam room after vaccine and fainted, fell forwards and hit face on the floor. She had a few seconds of full-body shaking per parental report. Regained consciousness after less than one minute and was able to answer questions normally. She laid flat on her back and feet were elevated for a few minutes. Allowed sips of water as mental status was normal. An ice pack was applied to the left side of her forehead just above the eye, as this was where she hit her face on the floor and was developing slight swelling. Continued having her lie down for about 15 minutes after the event, then sit for 5 minutes before attempting to walk. Blood pressure was monitored and was normal. Neuro exam normal. Facial swelling resolved after icing. Signs and symptoms of concussion were discussed and patient was discharged home from the clinic.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Chills, Loss of consciousness, Pain
Clinical narrative: Patient says she doesn't remember having any adverse symptoms after receiving immunization on 4/25/18. However, 12 days ago, she says she passed out and woke up in the hospital. Hospital told her she had a reaction to something but they don't know what it is. She states she started shivering around 12 days ago, and having pain as well. She says is still shivering now, even after hospitalization.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: An area of diffuse erythema and local increased temp was noted when her clothing was removed that evening, but we are not sure as to when it began. It was located approximately 2 fingerbreadths inferior to the injection sight. No systemic fever, but we empirically gave TYLENOL upon return home (around 6 pm) that day. The next morning (today) the area of erythema had increased and swelling was evident and the area was tender to touch. Dimensions today are 2 1/2 inches x 1 3/4 inches. She still does not feel febrile to touch x still with local increased temp over the area in question. O/w, appears to be at baseline. Although she is diabetic and elderly, we doubt cellulitis, since the skin abnormality developed away from the area of trauma from the injection. She had blood drawn from that arm before the immunization near the antecubital area, but no erythema is there or at the site of tourniquet application.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Immediate post-injection reaction, Injection site pain, X-ray
Clinical narrative: R posterior shoulder pain, starting immediately after the immunization and persisting for the past 3.5 months. No loss of function in arm, no numbness or tingling; normal strength in arm. Pain is worse when she leans on or rotates her arm. No fevers, no swelling or any visible deformities.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site rash, Pain
Clinical narrative: Pt called this evening reporting arm pain in her armpit area that started this morning. Pt also has some red spots at the site of the Band Aid and higher up on the arm from where the vaccine was given. Pt has full range of motion, but arm hurts with movement. Pt has taken some ibuprofen and will monitor and use ibuprofen or APAP as needed for pain. Pt will call again or follow-up with MD if loses range of motion or reaction worsens where she is concerned.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza, Nausea, Pyrexia
Clinical narrative: Flu symptoms - fever, chills, nausea.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Pt noted left arm swelling on 6/1/18 and was prescribed MEDROL Dose Pack by outside urgent care provider. Pt did not start steroid therapy but has now reported symptom improvement (by 6/5/18). Pt continues to have slight swelling and pruritis in left arm. Pt denies any shortness of breath or swelling in right arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Rash erythematous, Skin warm
Clinical narrative: Patient experienced flu like symptoms for 2-3 days. Patient also had a red elevated, hot, sore rash that started the day of and grew larger over 1 week. After 1 week, the rash then dissapaited on its own.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Musculoskeletal stiffness, Pain
Clinical narrative: The day after the vaccines, the patient experienced fever and severe body aches (including stiffness in the neck) and headache for 4 days. Patient called her PCP, who said he thought it was due to the vaccines. After 4 days symptoms began to resolve. The only lingering symptoms were slight redness and itchiness at vaccination sites (both arms), but she was feeling much better.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: The day after the vaccines, the patient experienced fever and severe body aches (including stiffness in the neck) and headache for 4 days. Patient called her PCP, who said he thought it was due to the vaccines. After 4 days symptoms began to resolve. The only lingering symptoms were slight redness and itchiness at vaccination sites (both arms), but she was feeling much better.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Evening after dose given had low-grade fever, myalgias, headache. Took Ibuprofen that helped with symptoms the following AM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Noticed SOB within 2 hours after vaccine. SOB lasted about 24 hours. Also injection site is hot, red, swollen about 2 inches in diameter within 12 hours after injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient says she had fever, chills, dizziness for 2-3 days and had swelling, redness and pain in the arm of injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient says she had fever, chills, dizziness for 2-3 days and had swelling, redness and pain in the arm of injection.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Headache, Malaise
Clinical narrative: Patient complained about getting sick with fever, fatigue, no energy to move, severe headache, redness, swelling and painful arm (injection arm) and she had the symptoms for about 5-7 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient complained about getting sick with fever, fatigue, no energy to move, severe headache, redness, swelling and painful arm (injection arm) and she had the symptoms for about 5-7 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Contusion, Erythema, Influenza like illness, Pain
Clinical narrative: Started experiencing severe pain, flu-like symptoms later that evening and into the next day, relieved only with TYLENOL. Also experienced bruising/redness and burning that are still persisting 4 days post-injection.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt vaccinated pm of 6/4/18; underside of pt's right arm developed a swollen circular area the morning after vaccination; area is a little itchy and outer ring is red; pt states no other discomfort. Pt states he has never had any type of reaction to a vaccine before. Recommended benadryl and continued observation for treatment; recommended pt follow up with pcp if symptoms worsen or do not resolve quickly.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: Patient stated she felt light headed, hot and nauseous just minutes after the vaccine. This only lasted a few minutes and the patient relaxed and drank water and felt better.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Injection pain was immediate with shoulder and bicep pain by that evening. The pain continued to increase resulting in taking over the counter pain medication in order to sleep. I was unable to lift my arm over my head for many weeks and am just now able to rotate my shoulder without major pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Nausea, Pain
Clinical narrative: Aching flu like systems, chills, weakness, nausea, low grade fever, which lasted 4 days & injection arm was extremely sore for 7 days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Aching flu like systems, chills, weakness, nausea, low grade fever, which lasted 4 days & injection arm was extremely sore for 7 days.