chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Skin irritation
Clinical narrative: Redness on arm; Left arm irritation; Chills; Fatigue; This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix. On 20th August 2019, less than a day after receiving Shingrix, the patient experienced fatigue and chills. On 21st August 2019, the patient experienced erythema of extremities and skin irritation. The patient was treated with methotrexate. On an unknown date, the outcome of the erythema of extremities and skin irritation were not recovered/not resolved and the outcome of the fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, skin irritation, fatigue and chills to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The patient experienced redness fatigue, chills, and arm irritation following dose of Shingrix. The reporter consented to follow up. The health care professional describes redness as redness covering the upper arm and stopping at the elbow. The redness began the day after receiving the vaccine and has not improved since it began.  The health care professional describes fatigue as the patient taking a three hour nap. The chills and fatigue began after the vaccine, on the same day, but has since resolved.  The health care professional could not provide complete address of the pharmacy that administered the dose. The health care professional notes the patient takes methotrexate.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Progressive bilateral pruritic rash; Severe flu-like symptoms; Severe nausea; headache; myalgia; fatigue; chills; This case was reported by a nurse via call center representative and described the occurrence of nausea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ovarian cancer. Concurrent medical conditions included non-hodgkin's lymphoma.   On 1st August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd August 2019, 1 days after receiving Shingrix, the patient experienced nausea, headache, myalgia, fatigue, chills and influenza-like symptoms. In August 2019, the patient experienced itchy rash. On an unknown date, the outcome of the nausea, headache, myalgia, fatigue and chills were recovered/resolved and the outcome of the itchy rash was not recovered/not resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the nausea, headache, myalgia, fatigue, chills, itchy rash and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The patient experienced severe flu-like symptoms for 3 days following the vaccine including severe nausea, headache, myalgia, fatigue and chills. The reporter never took her temperature to see if she had a fever. The symptoms resolved after 3 days. The week before the reporting date, the patient experienced progressive bilateral pruritic rash. The reporter was not sure if it was related to Shingrix.  This was related to patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rash pruritic
Clinical narrative: Progressive bilateral pruritic rash; Severe flu-like symptoms; Severe nausea; headache; myalgia; fatigue; chills; This case was reported by a nurse via call center representative and described the occurrence of nausea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ovarian cancer. Concurrent medical conditions included non-hodgkin's lymphoma.   On 1st August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd August 2019, 1 days after receiving Shingrix, the patient experienced nausea, headache, myalgia, fatigue, chills and influenza-like symptoms. In August 2019, the patient experienced itchy rash. On an unknown date, the outcome of the nausea, headache, myalgia, fatigue and chills were recovered/resolved and the outcome of the itchy rash was not recovered/not resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the nausea, headache, myalgia, fatigue, chills, itchy rash and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The patient experienced severe flu-like symptoms for 3 days following the vaccine including severe nausea, headache, myalgia, fatigue and chills. The reporter never took her temperature to see if she had a fever. The symptoms resolved after 3 days. The week before the reporting date, the patient experienced progressive bilateral pruritic rash. The reporter was not sure if it was related to Shingrix.  This was related to patient.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Immediate post-injection reaction, Injection site pain, Pain, Post herpetic neuralgia
Clinical narrative: pain at injection site; pain in rib cage/pain shocks; Pain behind the ears and occipitals; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (10 years ago). Previously administered products included Zostavax. Concurrent medical conditions included post herpetic neuralgia.   On 22nd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd August 2019, immediately after receiving Shingrix, the patient experienced injection site pain, thoracic pain and pain localized. On an unknown date, the outcome of the injection site pain, thoracic pain and pain localized were recovering/resolving.   It was unknown if the reporter considered the injection site pain, thoracic pain and pain localized to be related to Shingrix.  Additional details were provided as follows: The patient still has some post-herpatic pain from time to time. The patient states that later the same evening (less than a day after vaccination), she developed pain in her rib cage, pain behind the ears and the occipitals. The patient stated that it hurts to touch the area around her ribcage and she experiences painful shocks from time to time.  The pain that she was currently feeling, feels the same as the pain she felt when she had Shingles 10 years ago. The patient did not provide any additional details and did not have HCP's full address at the time of the call.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: pain at injection site; pain in rib cage/pain shocks; Pain behind the ears and occipitals; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (10 years ago). Previously administered products included Zostavax. Concurrent medical conditions included post herpetic neuralgia.   On 22nd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd August 2019, immediately after receiving Shingrix, the patient experienced injection site pain, thoracic pain and pain localized. On an unknown date, the outcome of the injection site pain, thoracic pain and pain localized were recovering/resolving.   It was unknown if the reporter considered the injection site pain, thoracic pain and pain localized to be related to Shingrix.  Additional details were provided as follows: The patient still has some post-herpatic pain from time to time. The patient states that later the same evening (less than a day after vaccination), she developed pain in her rib cage, pain behind the ears and the occipitals. The patient stated that it hurts to touch the area around her ribcage and she experiences painful shocks from time to time.  The pain that she was currently feeling, feels the same as the pain she felt when she had Shingles 10 years ago. The patient did not provide any additional details and did not have HCP's full address at the time of the call.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Horrific Headache; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On 12th August 2019, less than a day after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that, the patient had horrific headache for 10 days after vaccination with Shingrix.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Neuralgia, Tinnitus
Clinical narrative: Neuropathy pain; tinnitus; nausea; swelling at injeciton site; This case was reported by a pharmacist via call center representative and described the occurrence of neuropathic pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number N4C23, expiry date 15th November 2021) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced neuropathic pain (serious criteria GSK medically significant), tinnitus, nausea and injection site swelling. On an unknown date, the outcome of the neuropathic pain, tinnitus, nausea and injection site swelling were unknown.   It was unknown if the reporter considered the neuropathic pain, tinnitus, nausea and injection site swelling to be related to Shingrix.  Additional details were received as follows: The patient was experiencing tinnitus, neuropathy pain, swelling at injection site and nausea.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Mass
Clinical narrative: lump under the skin; redness of entire upper arm; This case was reported by a nurse via call center representative and described the occurrence of mass in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced mass and erythema of extremities. On an unknown date, the outcome of the mass was unknown and the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the mass and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as an adult as per Shingrix indication.  The patient received vaccine in unknown arm. The patient received the initial dose of Shingrix on unknown date, developed a lump under the skin and redness of entire upper arm. 10 days later the redness resolved. The healthcare professional was not at the office so she did not have any patient information. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain at injection site; redness at injection site; swelling at injection site; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling and tiredness. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and tiredness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix in left arm. The patient experienced pain at injection site, redness at injection site and swelling at injection site. The patient planned to continue follow-up with her physician on an unknown date.  The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site erythema, Injection site rash
Clinical narrative: allergic reaction; Rash; Injection site erythema; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced allergic reaction, injection site rash and injection site erythema. On an unknown date, the outcome of the allergic reaction, injection site rash and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, injection site rash and injection site erythema to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient developed an allergic reaction to the flu vaccine, a red rash at the injection site that appeared to be getting bigger every year (every time the patient received the vaccine). The reporter specified, it had been more than 5 years since the patient had flu vaccine. The patient's physician recommended they no longer get the flu vaccine. The reporter consented to follow up. The reporter had no further information to provide.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: fever; headache; redness at injection site; swelling at injection site; warmth at injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16th August 2019, the patient received Boostrix .5 ml. In August 2019, less than a week after receiving Boostrix, the patient experienced fever, headache, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the fever and headache were recovered/resolved and the outcome of the injection site erythema, injection site swelling and injection site warmth were recovering/resolving.   It was unknown if the reporter considered the fever, headache, injection site erythema, injection site swelling and injection site warmth to be related to Boostrix.  Additional details were provided as follows: The case was reported by patient's husband.  The patient experienced fever of 101.5 degrees F, headache, swelling at the injection site, redness at the injection site, and warmth at the injection site. The reporter consented to follow up. The reporter did not provide any additional details and did not have the address of the health care professional(HCP).
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Formication, Paraesthesia, Pyrexia
Clinical narrative: fever; tingling sensation on skin; felt like pin prickling or like bugs crawling across her skin; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced fever, tingling skin, sensation of foreign body and discomfort. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the tingling skin, sensation of foreign body and discomfort were unknown.   It was unknown if the reporter considered the fever, tingling skin, sensation of foreign body and discomfort to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported but it could be 71 years or 72 years. The patient stated, she experienced fever which was resolved. About 3 or 4 months before the reporting date, she experienced tingling sensation on skin that moved around all over her body and felt like pin prickling or like bugs crawling across her skin and was very uncomfortable.   The patient had not seen a physician about this issue till the time of reporting. The patient did not consent to follow-up and she declined follow up with her physician until she had a chance to be seen by him.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Warm and redf; Itchy; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of feeling of warmth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd August 2019, 2 days after receiving Shingrix, the patient experienced feeling of warmth, pruritus and erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the feeling of warmth, pruritus and erythema were recovering/resolving.   It was unknown if the reporter considered the feeling of warmth, pruritus and erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient received vaccine in unknown arm. The patient called on Thursday, that they were having reaction below the injection site. It was warm, red and itching.  The healthcare professional advised the patient to take a Benadryl. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Warm and redf; Itchy; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of feeling of warmth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd August 2019, 2 days after receiving Shingrix, the patient experienced feeling of warmth, pruritus and erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the feeling of warmth, pruritus and erythema were recovering/resolving.   It was unknown if the reporter considered the feeling of warmth, pruritus and erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient received vaccine in unknown arm. The patient called on Thursday, that they were having reaction below the injection site. It was warm, red and itching.  The healthcare professional advised the patient to take a Benadryl. The reporter consented to follow up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Paraesthesia, Swelling
Clinical narrative: RED BUMP on torso; tingling all over his body/Tingling of extremity; Erythema; This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 43S97, expiry date 26th November 2021) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix .5 ml. In August 2019, couple of days after receiving Shingrix, the patient experienced erythema. On an unknown date, the patient experienced local swelling and tingling. On an unknown date, the outcome of the local swelling, tingling and erythema were unknown.   It was unknown if the reporter considered the local swelling, tingling and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced a tingling all over his body a couple of days following the vaccine. The tingling was primarily on his extremities and a red bump presented on his torso.  The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Continuous positive airway pressure, Decreased appetite, Fatigue, Headache, Peripheral swelling
Clinical narrative: red rash on his arms, face, back and legs.; fever of 101F; fatigue; excruciating headache; swollen hands; loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced fever, fatigue, headache, hand swelling and appetite lost. On 18th August 2019, the patient experienced red rash. The patient was treated with paracetamol (Tylenol), benadryl (nos) (Benadryl) and steroids nos (Steroids). On an unknown date, the outcome of the red rash was unknown and the outcome of the fever, fatigue, headache, hand swelling and appetite lost were recovered/resolved.   It was unknown if the reporter considered the red rash, fever, fatigue, headache, hand swelling and appetite lost to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient himself. At the time of reporting, the patient used continuous positive airway pressure (CPAP) machine. In the evening after receiving Shingrix, the patient experienced a red rash on his arms, face, back and legs.  The patient also developed fever of 101degrees F, excruciating headache, fatigue, and loss of appetite.  The patient's states hands were swollen, but he was not sure if they were actually swollen. The patient received treatment with Tylenol for the fever and headache. The patient also received Benadryl for rash. On the day of reporting, the patient started treatment with steroids. The patient's doctor advised him not to receive the 2nd dose of Shingrix. The reporter consented to follow up. The reporter did not provide any additional details.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: red rash on his arms, face, back and legs.; fever of 101F; fatigue; excruciating headache; swollen hands; loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced fever, fatigue, headache, hand swelling and appetite lost. On 18th August 2019, the patient experienced red rash. The patient was treated with paracetamol (Tylenol), benadryl (nos) (Benadryl) and steroids nos (Steroids). On an unknown date, the outcome of the red rash was unknown and the outcome of the fever, fatigue, headache, hand swelling and appetite lost were recovered/resolved.   It was unknown if the reporter considered the red rash, fever, fatigue, headache, hand swelling and appetite lost to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient himself. At the time of reporting, the patient used continuous positive airway pressure (CPAP) machine. In the evening after receiving Shingrix, the patient experienced a red rash on his arms, face, back and legs.  The patient also developed fever of 101degrees F, excruciating headache, fatigue, and loss of appetite.  The patient's states hands were swollen, but he was not sure if they were actually swollen. The patient received treatment with Tylenol for the fever and headache. The patient also received Benadryl for rash. On the day of reporting, the patient started treatment with steroids. The patient's doctor advised him not to receive the 2nd dose of Shingrix. The reporter consented to follow up. The reporter did not provide any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise, Nausea, Vomiting
Clinical narrative: Injection Site Pain; Nausea; Vomiting; Headache; been sick; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced sickness. On 23rd August 2019, the patient experienced injection site pain, nausea, vomiting and headache. On an unknown date, the outcome of the injection site pain, nausea, vomiting, headache and sickness were unknown.   It was unknown if the reporter considered the injection site pain, nausea, vomiting, headache and sickness to be related to Shingrix.  Additional details were provided as follows: This case was reported by an office manager at a physician's office who herself was a patient. The age at vaccination was not reported. The patient received Shingrix and she did not feel the same with the 2nd dose as she did with the 1st dose.  The patient indicated that has been so sick since receiving the vaccination. On 23rd August 2019, she called in sick and experienced nausea, vomiting, headache, and injection site pain the entire weekend. On 26th August 2019, the field representative received an email from the patient. On 27th August 2019, the GlaxoSmithKline representative called back stating that he followed up and patient and did not wish to be recontacted by GlaxoSmithKline regarding these events. The sales representative stated that he received an email requesting the name of the health care professional where the reported consumer received their Shingrix injection. The sales representative stated that he did not had that information as the person who reported the information was a manager at a facility he visits and just happened to be talking to her when she provided the information.  The reporter did not have additional information about the incident.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Scab, Vaccination failure
Clinical narrative: Suspected vaccination Failure; Shingles on the base of the spine to the right side; Scabbing; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2019, the patient received Shingrix (intramuscular). In August 2019, less than 2 months after receiving Shingrix, the patient experienced scab. On 17th August 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and scab were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and scab to be related to Shingrix.  It was unknown if the reporter considered the vaccination failure, shingles and scab to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix on left arm. The patient broke out with shingles on the base of spine to the right side.  At the time of reporting, the patient was recovering with formation of scab. The reporter did not consent to follow-up.  No further details were provided. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirmation were unknown.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Scab, Secretion discharge, Skin lesion
Clinical narrative: shingles; rash; open lesions; wheeping lesions; scabs; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date unknown) for prophylaxis.   On 9th August 2019, the patient received the 1st dose of Shingrix. On 11th August 2019, 2 days after receiving Shingrix, the patient experienced shingles, rash, skin lesion and secretion discharge. In August 2019, the patient experienced scab. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, rash, skin lesion, secretion discharge and scab were recovering/resolving.   It was unknown if the reporter considered the shingles, rash, skin lesion, secretion discharge and scab to be related to Shingrix.  Additional case details were provided as follows: The reporter noted that, the patient was in another country prior to his 1st dose. She was not aware of any previous shingles cases or if he had received the other zoster vaccine on the market in the past. The patient returned to the pharmacy with report of rash and shingles, 2 days after receiving vaccine. The patient had went on vacation in the state but developed a open, weeping lesions between his eye brows. The patient was seen at an urgent care and physician diagnosed him with shingles and prescribed valacyclovir. The area was now dry, scabs appeared and the patient was getting better. The reporter noted that, the area was not indicative of a shingles area but the appearance did mimic shingles. It was unknown if he would receive the 2nd dose. The prescribing information with post marketing data was shared and offered to the reporter. She also wanted to know 1st dose efficacy, if 2nd dose should be received by this patient and use with valacyclovir.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Hypoaesthesia, Nausea, Nervousness, Pain in extremity
Clinical narrative: Pain in her arms and legs; Numbness in her extremeties; feels shaky; Dizziness; Nausea; This is a spontaneous report from a contactable Nurse. A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), lot AM6864, intramuscular in right deltoid on 16Aug2019 at 12:30 PM at 0.5 ml, single for immunisation. Medical history included ongoing anxiety and ongoing depression, both diagnosed by a historical provider. Concomitant medications included aripiprazole (ABILIFY), venlafaxine (VENLAFAXINE). Prior vaccinations within 4 weeks was none. The patient previously had received meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) on unspecified date for immunization, however it was unknown if she had a reaction to that vaccine administration. The patient previously took SINGULAIR for unknown indication and experienced drug hypersensitivity.  On 16Aug2019 at 15:12 the patient experienced pain in her arms and legs, numbness in her extremities, feels shaky, dizziness and nausea. The patient was admitted to the Emergency Department and was treated with IV fluids. The events were considered serious as medically significant. The patient recovered from the events on 16Aug2019 and was discharged from the emergency department at 19:28. The events were assessed related to TRUMENBA.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: PNC13
Symptoms: Bone pain
Clinical narrative: Bone pain; Pain is a 6 on scale of 1-10; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A male patient of an unspecified age (reported as 65, unit unknown) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported bone pain with of 6 on scale of 1-10. The outcome of the event was unknown.  Information on the batch number has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Swelling, Urticaria
Clinical narrative: Allergies: Pneumococcal Vaccine - Hives,Swelling; Swelling; Hives; This is a spontaneous report from a contactable physician.  A 56-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies: pneumococcal vaccine - hives, swelling on an unspecified date with outcome of unknown.   Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.
Age: 46.0
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: received the YF-VAX via intramuscular route; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2019SA233343, 2019SA233344 and 2019SA233345 (same reporter).  This case involves a 46 years old patient (gender not reported) who was vaccinated with a 0.5 ml  dose of vaccine YELLOW FEVER VACCINE - US [YF-VAX] lot U6288AB (Exp. Date not reported) via intramuscular route in the left deltoid on 13-Aug-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate route of vaccination. The vaccine must be vaccinated with subcutaneous route and not with intramuscular and intravenous route.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 49.0
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received a dose of YF-VAX via intramuscular route/no AE; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA233337, 2019SA233344 and 2019SA233345 (same reporter).  This case involves an 49 years old patient (gender not reported) who received a dose of YELLOW FEVER VACCINE - US [YF-VAX] (LOT U6288AB, and expiry date not reported) via intramuscular route in the left deltoid on 13-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate route of vaccination as patient received a dose of YF-VAX via intramuscular route.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 18.0
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received a dose of YF-VAX via intramuscular route/no AE; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA233343, 2019SA233337 and 2019SA233345 (same reporter).  This case involves an 18 years old patient (gender not reported) who a received a 0.5 mL dose of YELLOW FEVER VACCINE - US [YF-VAX] (LOT UI933AA, and expiry date not reported) via intramuscular route in the left deltoid on 13-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate route of vaccination as patient received a dose of YF-VAX via intramuscular route.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 16.0
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received a dose of YF-VAX via intramuscular route/no AE; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA233343, 2019SA233344 and 2019SA233337 (same reporter).  This case involves an 16 years old patient (gender not reported) who a received a 0.5 mL dose of YELLOW FEVER VACCINE - US [YF-VAX] (LOT UI933AA, and expiry date not reported) via intramuscular route in the left deltoid on 13-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate route of vaccination as patient received a dose of YF-VAX via intramuscular route.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ActHib portion of Pentacel was reconstituted with Quadracel / no adverse event; Initial and follow information received on 19-Aug-2019 and 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 4 months old female patient who received dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number and Expiry date unknown) via unknown route in unknown administration site, that was reconstituted with only ActHib portion of Pentacel by mistakenly.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate reconstitution technique.  At a time of reporting, no adverse reactions occur.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Daptacel instead of Adacel to a 10 years old patient; administered Daptacel instead of Adacel to a 10 years old patient; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 10 years old patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that administered Daptacel instead of Adacel to a 10 years old patient.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP, DTAPIPV, IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a nurse administered Quadracel to a 6 month-old child instead of the intended 3rd dose of DTaP and IPV; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six months old female patient who was vaccinated with a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (frequency once) lot C5635AA (expiry date: 18-Jun-2021) via intramuscular route in the left thigh (reported as left VL) on 19-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation; PNEUMOCOCCAL VACCINE POLYSACCH (PNEUMOVAX 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It is an actual medication error case due to wrong vaccine administered. It was reported that the Quadracel was vaccinated to a six month-old child instead of the intended 3rd dose of DTaP and IPV.  It was reported that the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: Pentacel was given without the Acthib portion, no AE; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a nine months old male patient who received third 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UG015AA and Exp. Date 26-Oct-2020 (Acthib Lot: UG015AA Exp. 26-Oct-2020 and Dtap Ipv Lot: U6218AA Exp. 26-Oct-2020) via intramuscular route in the right thigh, on 14-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique.  It was reported that Pentacel was given without the Acthib portion. Dtap-Ivp was administered on august 14 2019 to patient,however the Acthib portion was never mixed or administered to the patient.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.