chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a female patient 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 patient experienced injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site erythema and injection site blisters were unknown. It was unknown if the reporter considered the injection site erythema and injection site blisters to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The physician told sales representative that another physician received the dose of the SHINGRIX vaccine recently. The patient experienced horrendous side effects. The patient said that it almost looked like she had shingles on her arm. The patient got redness at the injection site and blisters at the injection site. The patient reported for assistance. At the time of reporting, the reporter felt like he was giving too much information and did not to continue providing further details. Physician did not want to report this to GlaxoSmithKline. The reporter did not want follow up on this report. Sales representative would attempt to collect further details during next visit.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: 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 60-year-old female patient who received BOOSTRIX (batch number 7ZZ3Z, expiry date 30th November 2019). Previously administered products included dTPa vaccine (The patient had received an unknown brand of dTPa 18 years earlier.). On 10th March 2018 14:38, the patient received BOOSTRIX (intramuscular) .5 ml. In March 2018, less than a month after receiving BOOSTRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. The reporter considered the pain in arm to be related to BOOSTRIX. Additional details were provided as follows: The patient experienced no significant adverse events at the time of 1st dose. BOOSTRIX (and Tdap in general) was indicated as 1 dose per lifetime. In March 2018, less than a month after vaccination with BOOSTRIX, the patient experienced pain in the left arm that radiates down the arm since receiving the BOOSTRIX vaccine. The reporter was unable to provide additional details. MI spoke with health care professional after transfer.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Feeling abnormal, Feeling cold, Immediate post-injection reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a 57-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). Concomitant products included dTpa vaccine (Reduced antigen). On 20th March 2018, the patient received SHINGRIX. On 20th March 2018, the patient received SHINGRIX. On 20th March 2018, immediately after receiving SHINGRIX, the patient experienced feeling bad and feeling cold. On an unknown date, the outcome of the feeling bad and feeling cold were recovering/resolving. The reporter considered the feeling bad and feeling cold to be related to SHINGRIX. Additional details were reported as follows: The reporter was not aware of any medical history, current medications and other medical intervention and he reported no allergies. The patient received a dose of SHINGRIX in her right deltoid. The patient felt of a vice around her arm when the fluid went in and a cold feeling down to her hand. The reporter stated that the patient denied nerve pain. The pharmacist stated that it took 10 to 15 minutes of massaging the site and the patient moving her arm for it to improve. The reporting pharmacist stated she was 100 percent sure that the patient's reaction was related to SHINGRIX.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Patient experienced syncope episode after receiving 11 yr. vaccinations in our office. Patient waited in our office for 15 minutes. Upon leaving, patient felt nauseated and vomited x 3. Patient slept well and was fine rest of evening.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional information was received as follows: The health care professional reported that the patient experienced chills or shivering after receiving SHINGRIX. This case has been linked with case US2018047707, reported by the same reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain, Injection site warmth, Product preparation error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that he vaccinated the patient only with the liquid AS01B adjuvant that was not mixed with the antigen powder for SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was asking for, how to proceed with revaccination. No further information was provided. Follow-up information was received from HCP on 21st March 2018: ---add narrative portion of source doc in narrative. On an unknown date, less than a year after vaccination with SHINGRIX, the patient experienced injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site warmth, injection site pain and injection site erythema were unknown. No further information was provided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: Patient reported fever, arm pain and chills, and also a red spot at injection site. She took ibuprofen (400 mg) to relieve symptoms. On 3/30/2018 when given a follow up call she reported pain better but injection site red, warm and itching. She had taken CLARITIN and ibuprofen earlier in the day and was advised to continue to take ibuprofen and possibly a cold compress topically and diphenhydramine 25 mg by mouth at bedtime.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported fever, arm pain and chills, and also a red spot at injection site. She took ibuprofen (400 mg) to relieve symptoms. On 3/30/2018 when given a follow up call she reported pain better but injection site red, warm and itching. She had taken CLARITIN and ibuprofen earlier in the day and was advised to continue to take ibuprofen and possibly a cold compress topically and diphenhydramine 25 mg by mouth at bedtime.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 77-year-old female patient who received BOOSTRIX (batch number TB2R2, expiry date 2nd December 2019). The patient's past medical history included cat bite. On 15th February 2018, the patient received BOOSTRIX. In February 2018, less than a month after receiving BOOSTRIX, the patient experienced itchy rash and erythropapular rash. The patient was treated with DEXILANT, trazodone and XANAX. On an unknown date, the outcome of the itchy rash and erythropapular rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash and erythropapular rash to be related to BOOSTRIX. Additional information was reported as follows: The case was previously reported to the doctor. The patient was homebound. After vaccination with BOOSTRIX, the patient broke out with rash. Initially the rash appeared near the injection site, further it moved down to her left arm and past her elbow. The reporter described the rash as itchy red bumps. The physician of the patient treated her with two kinds of creams and pills.
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy, Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 41-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2020). The patient's past medical history included shingles. On 9th February 2018 10:45, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th February 2018, 8 hrs after receiving SHINGRIX, the patient experienced fever, muscle pain, fatigue and lethargy. The patient was treated with TYLENOL. On 12th February 2018, the outcome of the fever, muscle pain, fatigue and lethargy were recovered/resolved. The reporter considered the fever, muscle pain and fatigue to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the lethargy to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. Approximately 8 hours of administration of the SHINGRIX, the patient experienced a fever, muscle aches, lethargy and fatigue. On 9th February 2018, the patient's body temperature was recorded at 100.4 degrees Fahrenheit. The patient contacted the office by phone and TYLENOL was recommended. The symptoms were resolved by the third day after vaccine administration. The baby number of SHINGRIX (CZ4KL) did not exist and was updated to 3Z4KL, as per sales database.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Extensive swelling of vaccinated limb, Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 14th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th March 2018, less than a day after receiving SHINGRIX, the patient experienced chills, headache and erythema of extremities. In March 2018, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown and the outcome of the chills, headache and erythema of extremities were recovering/resolving. The reporter considered the extensive swelling of vaccinated limb, chills, headache and erythema of extremities to be related to SHINGRIX. Additional information was received as follows: The patient received the vaccine between 2:15 and 4:00pm in left arm. On the same day, at evening, the patient was started to experienced chills and headache. The patient's arm started to swell and it became red. The patient reported to the pharmacist that the swelling started to spread on down to the arm on 20th March 2018. The pharmacist reported that when he saw the patient on the day of reporting, the patient's left arm was completely swollen when it was compared to right arm. The pharmacist instructed the patient to go to her physician and that the patient's should have gone to the emergency room.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain 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 pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the 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 patient was an employee. This case had been linked to the case US2018GSK048935 and US2018GSK053449 reported by the same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased activity, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 74-year-old male patient who received SHINGRIX. Concurrent medical conditions included carcinoid tumor (Carcinoid and cancer). Concomitant products included Baby Aspirin and SANDOSTATIN. On 9th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and pain in arm. In March 2018, the patient experienced upset stomach, shaky feelings, feeling cold, decreased activity, fatigue, loose stools and low blood pressure. In March 2018, the outcome of the upset stomach, shaky feelings, feeling cold, injection site erythema, pain in arm and loose stools were recovered/resolved. On an unknown date, the outcome of the decreased activity, fatigue and low blood pressure was unchanged. The reporter considered the upset stomach, shaky feelings, feeling cold, decreased activity, injection site erythema, pain in arm, fatigue, loose stools and low blood pressure to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. At 16:00, the patient received SHINGRIX in the right arm. The day after receiving the vaccination the patient developed soreness in his arm and red streaking from the injection site down to his elbow. These symptoms were resolved within five days. Less than a month after vaccination, the patient experienced an upset stomach, loose stools, fatigue, alternating low blood pressure with normal blood pressure, feeling a little shaky, feeling cooler than normal, and feeling less active. All symptoms resolved within a week except, the patient was still continuing to have alternating blood pressure, fatigue and unable to be as active at the time of reporting. The reporter gave permission for his physician to be contacted and provided the following information.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypotension, Injection site erythema, Nervousness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 74-year-old male patient who received SHINGRIX. Concurrent medical conditions included carcinoid tumor (Carcinoid and cancer). Concomitant products included Baby Aspirin and SANDOSTATIN. On 9th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and pain in arm. In March 2018, the patient experienced upset stomach, shaky feelings, feeling cold, decreased activity, fatigue, loose stools and low blood pressure. In March 2018, the outcome of the upset stomach, shaky feelings, feeling cold, injection site erythema, pain in arm and loose stools were recovered/resolved. On an unknown date, the outcome of the decreased activity, fatigue and low blood pressure was unchanged. The reporter considered the upset stomach, shaky feelings, feeling cold, decreased activity, injection site erythema, pain in arm, fatigue, loose stools and low blood pressure to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. At 16:00, the patient received SHINGRIX in the right arm. The day after receiving the vaccination the patient developed soreness in his arm and red streaking from the injection site down to his elbow. These symptoms were resolved within five days. Less than a month after vaccination, the patient experienced an upset stomach, loose stools, fatigue, alternating low blood pressure with normal blood pressure, feeling a little shaky, feeling cooler than normal, and feeling less active. All symptoms resolved within a week except, the patient was still continuing to have alternating blood pressure, fatigue and unable to be as active at the time of reporting. The reporter gave permission for his physician to be contacted and provided the following information.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in a female 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 pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist was the concerned patient. The sales representative reported the information to medical information. The age at vaccination was not reported. The healthcare professional did not want to speak further to medical information at the time regarding the adverse event. No further information was reported regarding the event.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain 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 pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the 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 patient was an employee. This case has been linked to the case US2018GSK048935 and US2018GSK053450 reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Myalgia, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a 59-year-old female patient who received SHINGRIX. Co-suspect products included SHINGRIX. The patient's past medical history included shingles (in early 50's around the time that the patient was going through menopause). On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain, muscle pain, cramp and activities of daily living impaired. On an unknown date, the outcome of the pain, muscle pain, cramp and activities of daily living impaired were unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. It was unknown if the reporter considered the muscle pain, cramp and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that the reporter's mother shared with her that her sister had received SHINGRIX. On an unknown date, less than a year after receiving 1st dose of SHINGRIX, the patient experienced mild pain. On an unknown date, less than a year after receiving 2nd dose of SHINGRIX, the patient experienced lots of muscle aches and cramps which caused her to stay in bed and interrupted her activities of daily living. The reporter did not know if there had been resolution and stated that her mother informed her of her sister's experience approximately 1.5 weeks ago.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a nurse via sale rep and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received SHINGRIX. On 7th February 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, erythema of extremities and activities of daily living impaired. On an unknown date, the outcome of the influenza-like symptoms, erythema of extremities and activities of daily living impaired were unknown. It was unknown if the reporter considered the influenza-like symptoms, erythema of extremities and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported, but it could be 50 or 51 years old. The patient received SHINGRIX at his work. The patient experienced Grade 3 flu like symptoms, he could not brush his hair, and his arm was red all the way around (like a band around his arm). He missed work for 3 to 4 days due to these symptoms and they lasted for 1 weeks. He told his wife that he believed he would have rather had shingles then experience these side effects. This case has been linked to the case US2018GSK053449 and US2018GSK053450 reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Gastrointestinal disorder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a unspecified number of 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 patient experienced chills and gastrointestinal disorder. On an unknown date, the outcome of the chills and gastrointestinal disorder were unknown. It was unknown if the reporter considered the chills and gastrointestinal disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The health care professional reported that a number of patients had reported reactions after the first dose of SHINGRIX, from chills to GI stuff (gastrointestinal disorder) all the stuff that was in the label. The health care professional did not have any details about specific lots, patient identifiers, or the number of patients involved.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abnormal dreams, Drug ineffective, Herpes zoster, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 6th October 2019). Co-suspect products included VALTREX tablet for shingles and post herpetic neuralgia. The patient's past medical history included post herpetic neuralgia (had 8 episodes of shingles and post herpetic neuralgia since June 2016), shingles and gastroesophageal reflux disease. Previously administered products included ZOSTAVAX (received prior to SHINGRIX). Concurrent medical conditions included multiple allergies (general allergies). Concomitant products included ACIPHEX, ALLEGRA, Aspirin (Baby) and glucosamine. On 29th December 2017, the patient received SHINGRIX (intramuscular). In June 2016, the patient started VALTREX (oral) 1 g 3 times daily (3 g daily). In June 2016, less than a month after starting VALTREX, the patient experienced abnormal dreams and upset stomach. On 29th December 2017, the patient experienced pain in arm. On 29th January 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and lack of drug effect. VALTREX was continued with no change. On an unknown date, the outcome of the vaccination failure and lack of drug effect. VALTREX was continued with no change. On an unknown date, the outcome of the vaccination failure and lack of drug effect were unknown and the outcome of the shingles, post herpetic neuralgia, abnormal dreams and upset stomach were recovering/resolving and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the shingles, post herpetic neuralgia, abnormal dreams, upset stomach and lack of drug effect to be related to VALTREX. Additional details were provided as follows: The patient reported that during his shingles and post herpetic neuralgia in June 2016, the patient received VALTREX, 1 gram three times daily. After receiving VALTREX, the patient experienced stomach upsets and screwy dreams. On 29th December 2017, the patient received SHINGRIX on right arm. Less than a day after receiving vaccination, the patient experienced arm soreness. After receiving SHINGRIX, the patient experienced another episode of shingles and worsening of post herpetic neuralgia with latency of 31 days. On 17th February 2018, the patient experienced another episodes of shingles. The patient reported that his post herpetic neuralgia was worse than before with these last 2 episodes. The reported batch number of SHINGRIX 324KL did not exist and was updated to 3Z4KL, as per sales database. Upon internal review following corrections were performed on 30th March 2018: The event vaccination failure was deleted since the patient had only dose of SHINGRIX and the case was downgraded to nonserious.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 6th October 2019). Co-suspect products included VALTREX tablet for shingles and post herpetic neuralgia. The patient's past medical history included post herpetic neuralgia (had 8 episodes of shingles and post herpetic neuralgia since June 2016), shingles and gastroesophageal reflux disease. Previously administered products included ZOSTAVAX (received prior to SHINGRIX). Concurrent medical conditions included multiple allergies (general allergies). Concomitant products included ACIPHEX, ALLEGRA, Aspirin (Baby) and glucosamine. On 29th December 2017, the patient received SHINGRIX (intramuscular). In June 2016, the patient started VALTREX (oral) 1 g 3 times daily (3 g daily). In June 2016, less than a month after starting VALTREX, the patient experienced abnormal dreams and upset stomach. On 29th December 2017, the patient experienced pain in arm. On 29th January 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and lack of drug effect. VALTREX was continued with no change. On an unknown date, the outcome of the vaccination failure and lack of drug effect. VALTREX was continued with no change. On an unknown date, the outcome of the vaccination failure and lack of drug effect were unknown and the outcome of the shingles, post herpetic neuralgia, abnormal dreams and upset stomach were recovering/resolving and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the shingles, post herpetic neuralgia, abnormal dreams, upset stomach and lack of drug effect to be related to VALTREX. Additional details were provided as follows: The patient reported that during his shingles and post herpetic neuralgia in June 2016, the patient received VALTREX, 1 gram three times daily. After receiving VALTREX, the patient experienced stomach upsets and screwy dreams. On 29th December 2017, the patient received SHINGRIX on right arm. Less than a day after receiving vaccination, the patient experienced arm soreness. After receiving SHINGRIX, the patient experienced another episode of shingles and worsening of post herpetic neuralgia with latency of 31 days. On 17th February 2018, the patient experienced another episodes of shingles. The patient reported that his post herpetic neuralgia was worse than before with these last 2 episodes. The reported batch number of SHINGRIX 324KL did not exist and was updated to 3Z4KL, as per sales database. Upon internal review following corrections were performed on 30th March 2018: The event vaccination failure was deleted since the patient had only dose of SHINGRIX and the case was downgraded to nonserious.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shivering in a 73-year-old female patient who received SHINGRIX. Concomitant products included SHINGRIX. On 19th March 2018 15:00, the patient received the 2nd dose of SHINGRIX. In March 2018, 12 hrs after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was recovering/resolving. The reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired nurse practitioner. For further tolerance to 1st dose, refer linked cases US2018047675. At approximately 15:00, the patient received 2nd dose of SHINGRIX in the left arm. On 20th March 2018, the patient experienced shivering and needed to put on warmer clothes and turn on her heater. The patient was concerned about why her reactions would be different. The patient had PI.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 73-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 16th March 2018, the patient received SHINGRIX .5 ml. On 21st March 2018, 5 days after receiving SHINGRIX, the patient experienced injection site rash and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were not recovered/not resolved. The reporter considered the injection site rash and injection site itching to be possibly related to SHINGRIX. Additional information was received as follows: The pharmacist reported that a patient received SHINGRIX on a Friday and started having symptoms on Wednesday. No other vaccines given on the same day.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash erythematous
Clinical narrative: Red rash in left arm had two vaccine shots in that arm.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area of redness, swelling, warmth and induration continuing to spread for 4 days extending to medial thigh.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Within 12 hours I developed a headache, chills/shivers, and a 99.8 degree fever.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eyelid oedema, Influenza virus test negative, Pyrexia, Streptococcus test negative, Swelling face
Clinical narrative: The next morning at around 8 AM I noticed his left eyelid starting to swell. He also had a low-grade fever of about 100. By 12:30 PM, his eye lid was so super swollen and his temperature was at 103.9. We took him to the pediatrician and she tested for strep throat and flu which both came back negative. We were told to monitor him and were sent home. When we got back home the swelling on his left I started to subside, and all the swelling shifted to the right side of his face. His Right cheek and down to his lip started to severely swell. His temperature was also at 103.We called my pediatrician back and they recommended going to the ER which we did. At the ER they gave him an epinephrine shot and another dose of BENADRYL. It is now two days after the dose of vaccines, and my sons eye is still swollen.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Eczema, Purpura, Pyrexia
Clinical narrative: High fever after vaccines for 2 days-given TYLENOL , bleeding rash/eczema 1.5 week after shots-warm baths with baking soda.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQHIB
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm, Tenderness
Clinical narrative: My daughter's arm is warm, itchy, red, and I took a picture. It has progressively gotten worse. It remains sore & untouchable. 9 days later.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased appetite, Diarrhoea, Pyrexia
Clinical narrative: Tactile fever begininng around 11pm on 3/22/18 and copious loose stools at 2 AM on 3/23/18. Decreased appetite. Resolved fully in 72 hours.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site warmth
Clinical narrative: Patient presented 03/30/18 with site reaction: approximately 3 inches in diameter, irregular, sensitive, with redness, and warm to the touch; patient reported pain post administration in right side of back and described pain as feeling like she was hit by a 2 x 4 or punched; pain resolved within 24 hours after taking naproxen.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red, bumpy rash on bilateral antecubital areas.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Chills and body aches.
Age: 64.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: I did not know anything about the common side effects this drug had. None of the staff, at Doctor's office, told me anything about possible side effects. I started having pain in my left arm and arm would hurt reaching for something. Later, commercials for PREVNAR mentioned common side effects
Age: 64.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: I did not know anything about the common side effects this drug had. None of the staff, at Doctor's office, told me anything about possible side effects. I started having pain in my left arm and arm would hurt reaching for something. Later, commercials for PREVNAR mentioned common side effects
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Diagnosed with Guillain-Barre Syndrome at the local hospital.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Immediate post-injection reaction, Injection site pain, Insomnia, Pain, Pain in extremity
Clinical narrative: On March 22,2018 pt states she received both vaccines in left upper deltoid, during the injection she states she felt pain and as if the needle was going in a downward direction instead of going in straight. Pain was immediate and increased throughout the day. By night time patient states pain left deltoid was 10/10 and unable to sleep. Patient states she took TYLENOL alternating with Ibuprofen and ice first couple days without full pain relief. States pain is deep and achy constant worse with movement radiates to left hand. Denies numbness and tingling. Patient states she is still taking the alternating ibuprofen and TYLENOL sporadic thorough the day without relief.
Age: 38.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: X-ray limb
Clinical narrative: On March 22,2018 pt states she received both vaccines in left upper deltoid, during the injection she states she felt pain and as if the needle was going in a downward direction instead of going in straight. Pain was immediate and increased throughout the day. By night time patient states pain left deltoid was 10/10 and unable to sleep. Patient states she took TYLENOL alternating with Ibuprofen and ice first couple days without full pain relief. States pain is deep and achy constant worse with movement radiates to left hand. Denies numbness and tingling. Patient states she is still taking the alternating ibuprofen and TYLENOL sporadic thorough the day without relief.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus, Rash morbilliform
Clinical narrative: Patient within a couple hours complained to his wife of itching and to look at his back. He had "measles-like" bumps all over his back, chest, and surrounding injection site. I advised wife to take him to ER where he received IM BENADRYL and famotidine. He left the ER with an Rx for prednisone that the wife, although advised otherwise, wanted to hold off on filling. She picked up a box of BENADRYL and maximum strength OTC famotidine from pharmacy.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Eye pain, Headache, Heart rate increased
Clinical narrative: 10 hours after shot felt head and shoulder ache and aching behind eyes. No appetite, could only sleep. Arm painful hips sore. Elevated heartbeat. Lasted until Sunday. Ok by Monday. I recommend patients be told to have nothing to do the next day.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: 10 hours after shot felt head and shoulder ache and aching behind eyes. No appetite, could only sleep. Arm painful hips sore. Elevated heartbeat. Lasted until Sunday. Ok by Monday. I recommend patients be told to have nothing to do the next day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient states that she has hives going down her arm to her wrists. She states the hives itch, but do not burn or cause pain. Patient states this is not from the adhesive allergy.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Her brother, called us today for the first time to report the reaction and said that he took the bandaid off a couple of hours after the injection and it bled from the site of the injection. Then he said that it started to swell and itch at the injection site. Today (2 days later) he said that the swelling had spread down her arm to her wrist and the entire area was itching.  I asked him what they had tried or taken and he said, nothing. I told him to call the doctor on call for her primary care physician (since it is Saturday) and see what they want her to do. He called back and said the PCP's nurse told him to give her BENADRYL according to the package directions.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth BELOW injection site on arm. Injection given in deltoid and symptoms manifested in elbow area of same arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Got shot on Mar 29. Mar 30 felt very tired and entire body ached. Mar 31 had hives all over right thigh with one blister, hives above left knee, injection site sore, red and warm to touch.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: Got shot on Mar 29. Mar 30 felt very tired and entire body ached. Mar 31 had hives all over right thigh with one blister, hives above left knee, injection site sore, red and warm to touch.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Vomiting
Clinical narrative: Nausea and vomiting on 03-31-2018 at 1:00 AM the evening of the vaccination. Still unable to eat due to nausea on 03-31-2018 and flu-like symptoms as of 4:30PM on 03-31-2018.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Aggression, Breath odour, Decreased appetite, Delusion
Clinical narrative: Onset of fever and malaise within a couple of hours....102 temp. Anorexia abdominal pain. On 3/30/2018 I arrived home to find him paranoid delusional combative and making NO SENSE. I looked at his phone in which he had texted nonsense in 5 texts. I asked him to read them and he was unable. His gait was unsteady and he fell. He had difficulty with month and date knew year and president vice president. He did have a slight odor of alcohol BUT has never been like this after drinking 3 beers. I am aware that his 2 children were vaccine exempt due to severe reactions. He went to bed where he constantly flipped and flopped and writhed for several hours when I got out of the bed due to being repetitively kicked. He woke up and remembered NOTHING of what happened. Was shocked when I showed him the texts from his phone.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Fall, Gait disturbance, Malaise, Pyrexia
Clinical narrative: Onset of fever and malaise within a couple of hours....102 temp. Anorexia abdominal pain. On 3/30/2018 I arrived home to find him paranoid delusional combative and making NO SENSE. I looked at his phone in which he had texted nonsense in 5 texts. I asked him to read them and he was unable. His gait was unsteady and he fell. He had difficulty with month and date knew year and president vice president. He did have a slight odor of alcohol BUT has never been like this after drinking 3 beers. I am aware that his 2 children were vaccine exempt due to severe reactions. He went to bed where he constantly flipped and flopped and writhed for several hours when I got out of the bed due to being repetitively kicked. He woke up and remembered NOTHING of what happened. Was shocked when I showed him the texts from his phone.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: Onset of fever and malaise within a couple of hours....102 temp. Anorexia abdominal pain. On 3/30/2018 I arrived home to find him paranoid delusional combative and making NO SENSE. I looked at his phone in which he had texted nonsense in 5 texts. I asked him to read them and he was unable. His gait was unsteady and he fell. He had difficulty with month and date knew year and president vice president. He did have a slight odor of alcohol BUT has never been like this after drinking 3 beers. I am aware that his 2 children were vaccine exempt due to severe reactions. He went to bed where he constantly flipped and flopped and writhed for several hours when I got out of the bed due to being repetitively kicked. He woke up and remembered NOTHING of what happened. Was shocked when I showed him the texts from his phone.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site rash, Injection site swelling, Pain
Clinical narrative: Patient experienced some redness and swelling around injection site (minor after vaccination). 2 days after vaccination patient experienced additional redness, and a rash on left arm, below injection site but above elbow. Patient stated the rash was itchy. Patient also described minor pain to the touch "if you press really hard" upon examination on 3/31/18 by RPh. RPh (myself) was told patient that I was not overly concerned, as the rash is a possible side effect of the live vaccination. Advised patient to keep the rash covered and away from any persons who may be immunocompromised. Advised patient that if rash does not show any improvement for another week she should follow-up with a physician for further evaluation. However, patient did state that rash has been improving.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient experienced some redness and swelling around injection site (minor after vaccination). 2 days after vaccination patient experienced additional redness, and a rash on left arm, below injection site but above elbow. Patient stated the rash was itchy. Patient also described minor pain to the touch "if you press really hard" upon examination on 3/31/18 by RPh. RPh (myself) was told patient that I was not overly concerned, as the rash is a possible side effect of the live vaccination. Advised patient to keep the rash covered and away from any persons who may be immunocompromised. Advised patient that if rash does not show any improvement for another week she should follow-up with a physician for further evaluation. However, patient did state that rash has been improving.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Feeling abnormal, Injection site pain, Mental impairment, Musculoskeletal pain
Clinical narrative: Patient complained of severe pain at injection site, all down her left side especially around left back blade and around to front left breast. Patient felt fuzzy, she felt she could not think, Patient is starting to feel better today 3/31/18.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient complained to have sore arm for more than 4 months now. Normally, the soreness only last a few days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Awoke in the middle of the night about 16 hours after injection with hard shaking chills. Got up and took acetaminophen 100mg by mouth. Went back to bed, rested until the shaking eased and fell back to sleep. I did not take my temperature because it was too difficult while shaking so hard. I was completely fine four hours later when I woke up.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Alopecia, Anogenital warts, Anxiety, Eye pruritus, Eye swelling
Clinical narrative: Experienced bad headaches, swollen itchy watering eyes, nasal congestion for the first two weeks following HPV vaccine. In August 2016, patient came home from school every day and slept and expressed significant fatigue. Patient has never done this before. He has always been very active (sports, hunting, etc.), so this was a new behavior for him. Patient experienced upper respiratory infections in October, November, then had the flu in December. Frequent complaints of headaches, rashes on abdomen and chest, complaints of eye sensitivity to light, swollen eyes. Developed genital warts in November (patient is not sexually active). Hair loss, receding hairline. Increased anxiety, anger, mood swings. Patient stated, "my body feels like an old man, I can't keep up with my buddies, I don't have any energy". Upper respiratory infections in May and June.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza, Laboratory test
Clinical narrative: Experienced bad headaches, swollen itchy watering eyes, nasal congestion for the first two weeks following HPV vaccine. In August 2016, patient came home from school every day and slept and expressed significant fatigue. Patient has never done this before. He has always been very active (sports, hunting, etc.), so this was a new behavior for him. Patient experienced upper respiratory infections in October, November, then had the flu in December. Frequent complaints of headaches, rashes on abdomen and chest, complaints of eye sensitivity to light, swollen eyes. Developed genital warts in November (patient is not sexually active). Hair loss, receding hairline. Increased anxiety, anger, mood swings. Patient stated, "my body feels like an old man, I can't keep up with my buddies, I don't have any energy". Upper respiratory infections in May and June.