chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin abrasion, Vaccine positive rechallenge
Clinical narrative: fever; rash at the injection site; red at the injection site; scratchy at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 21st March 2019, refer case US2019149405).   On 7th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced fever, injection site rash, injection site erythema and injection site abrasion. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was unknown and the outcome of the injection site rash, injection site erythema and injection site abrasion were recovered/resolved.   It was unknown if the reporter considered the fever, injection site rash, injection site erythema and injection site abrasion to be related to Shingrix.  Additional details were provided as follows: The husband reported that his wife had Shingrix and experienced a fever of 101 to 101.5, but the symptoms were worse. The reporter Consented to follow up. No additional details were available as the reporter's cell phone died in a remote location. The reporter also added that his wife had a decent rash at the injection site. It was red at the injection site and scratchy at the injection site. The events were gone by time of reporting. This case has been linked with US2019149405, reported by same reporter.      Lab Comments: Lab test performed on an unknown date
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Fatigue; it felt that someone had taken a cheese grater  to her skin; Joint pain; Nausea; Injection site swelling; Injection site Pain; Massive headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 17th May 2019, refer linked case US2019149376).   On 13th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, several hours after receiving Shingrix, the patient experienced joint pain, nausea, injection site swelling, injection site pain, headache, fever and paresthesia. On 15th August 2019, the patient experienced fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the joint pain, nausea, injection site swelling, injection site pain, headache, paresthesia and fatigue were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the joint pain, nausea, injection site swelling, injection site pain, headache, fever, paresthesia and fatigue to be related to Shingrix.  Additional information received were as follows: The patient experienced joint pain, swelling and pain at the injection site. The patient experienced nausea, massive headache and felt that someone had taken a cheese grater to her skin. On the 12th hours after receiving Shingrix, the patient experienced fever (the patient's body temperature was recorded as 102.7 degree F.) that lasted for one day. On the reporting date, 2 days after receiving Shingrix, the patient had a low grade fever (the patient's body temperature was recorded as 99 degree F.) and was experiencing fatigue, joint pain and soreness at the injection site, but was less swollen.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain of skin, Paraesthesia, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Fatigue; it felt that someone had taken a cheese grater  to her skin; Joint pain; Nausea; Injection site swelling; Injection site Pain; Massive headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 17th May 2019, refer linked case US2019149376).   On 13th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, several hours after receiving Shingrix, the patient experienced joint pain, nausea, injection site swelling, injection site pain, headache, fever and paresthesia. On 15th August 2019, the patient experienced fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the joint pain, nausea, injection site swelling, injection site pain, headache, paresthesia and fatigue were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the joint pain, nausea, injection site swelling, injection site pain, headache, fever, paresthesia and fatigue to be related to Shingrix.  Additional information received were as follows: The patient experienced joint pain, swelling and pain at the injection site. The patient experienced nausea, massive headache and felt that someone had taken a cheese grater to her skin. On the 12th hours after receiving Shingrix, the patient experienced fever (the patient's body temperature was recorded as 102.7 degree F.) that lasted for one day. On the reporting date, 2 days after receiving Shingrix, the patient had a low grade fever (the patient's body temperature was recorded as 99 degree F.) and was experiencing fatigue, joint pain and soreness at the injection site, but was less swollen.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2019, the patient received Shingrix. On 11th August 2019, 1 days after receiving Shingrix, the patient experienced headache. The patient was treated with sumatriptan succinate (Imitrex). On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache 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 did not have a migraine for a long time but had the shingles shot last Saturday and had suffered from headache since Sunday. The patient finally took imitrex last night but still had remnants of a headache.  The patient enquired could this all be connected to the shot or just coincidental. The reporter did not give permission to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sore on lips; This case was reported by a consumer and described the occurrence of cold sores lip in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores (the patient had cold sore 30 years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown.   It was unknown if the reporter considered the cold sores lip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got first shot of Shingrix and experienced cold sore on lips next day after the shot.  The patient had cold sore 30 years ago, and patient, thought it was connected.  The patient was surprised to see that cold sore was not included into side effects list.  The patient asked if these two viruses were similar? And it would be worse after second dose?
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site hyperaesthesia, Injection site rash, Injection site swelling
Clinical narrative: bumpy, raised, red rash at injection site; bumpy, raised, red rash at injection site; Injection site redness; Injection site warm; Injection site sensitive to the touch; Discomfort; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2019, 1 days after receiving Shingrix, the patient experienced injection site rash, injection site swelling, injection site erythema, injection site warmth, injection site hyperesthesia and injection site discomfort. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site rash was recovering/resolving and the outcome of the injection site swelling, injection site erythema, injection site warmth, injection site hyperesthesia and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site rash, injection site swelling, injection site erythema, injection site warmth, injection site hyperesthesia and injection site discomfort to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on right arm. The caller reported that an evening before the reporting date, she experienced a bumpy, raised, red rash around the injection site area that was warm and sensitive to the touch. The caller reported that she used cold compress on it and that helped with discomfort. The caller reported that rash had improved some on the reporting date but was still present. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: bumpy, raised, red rash at injection site; bumpy, raised, red rash at injection site; Injection site redness; Injection site warm; Injection site sensitive to the touch; Discomfort; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2019, 1 days after receiving Shingrix, the patient experienced injection site rash, injection site swelling, injection site erythema, injection site warmth, injection site hyperesthesia and injection site discomfort. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site rash was recovering/resolving and the outcome of the injection site swelling, injection site erythema, injection site warmth, injection site hyperesthesia and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site rash, injection site swelling, injection site erythema, injection site warmth, injection site hyperesthesia and injection site discomfort to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on right arm. The caller reported that an evening before the reporting date, she experienced a bumpy, raised, red rash around the injection site area that was warm and sensitive to the touch. The caller reported that she used cold compress on it and that helped with discomfort. The caller reported that rash had improved some on the reporting date but was still present. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Dry mouth, Dysphonia, Erythema, Glossodynia, Oral candidiasis
Clinical narrative: Hoarseness / Deeper Voice; Oral Thrush; Dry Mouth; white tongue; Rosy Cheeks; Warm Body; Sensitive Tongue; The white in mouth extended to the back of tongue and down throat; The white in mouth extended to the back of tongue and down throat; This case was reported by a consumer via call center representative and described the occurrence of dry mouth in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cortisone (non-proprietary) (Cortisone) for inflammation.   Concomitant products included cortisone (non-proprietary) (Cortisone Shot).   On 8th August 2019, the patient received the 1st dose of Shingrix (intramuscular) and Cortisone at an unknown dose and frequency. On 9th August 2019, 1 days after receiving Shingrix, the patient experienced dry mouth and oral thrush. On 13th August 2019, the patient experienced hoarseness. In August 2019, the patient experienced tongue white, localized erythema, skin warm, sensitive tongue, pharyngeal disorder and oral mucosal discoloration. On an unknown date, the outcome of the dry mouth, localized erythema and skin warm were resolved with sequelae and the outcome of the tongue white, pharyngeal disorder and oral mucosal discoloration were unknown and the outcome of the oral thrush, sensitive tongue and hoarseness were recovering/resolving.   It was unknown if the reporter considered the dry mouth, tongue white, localized erythema, skin warm, oral thrush, sensitive tongue, hoarseness, pharyngeal disorder and oral mucosal discoloration to be related to Shingrix.  Additional information received were as follows: The patient reported that the following day after vaccination her mouth was drier than usual. Then a few days later reported her tongue was white and became progressively worse or whiter. The white in mouth extended to the back of tongue and down throat. The patient stated that after receiving cortisone shot her mouth may get a little dry, cheeks may become rosy, and her body may feel warm, but those three things occurred with a greater effect. The patient stated that thrush was almost gone, but her tongue was still sensitive, her throat feels hoarse and her voice was deeper than usual. The patient consented to follow up.
Age: 68.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Oral mucosal discolouration, Pharyngeal disorder, Skin warm, Tongue discolouration
Clinical narrative: Hoarseness / Deeper Voice; Oral Thrush; Dry Mouth; white tongue; Rosy Cheeks; Warm Body; Sensitive Tongue; The white in mouth extended to the back of tongue and down throat; The white in mouth extended to the back of tongue and down throat; This case was reported by a consumer via call center representative and described the occurrence of dry mouth in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cortisone (non-proprietary) (Cortisone) for inflammation.   Concomitant products included cortisone (non-proprietary) (Cortisone Shot).   On 8th August 2019, the patient received the 1st dose of Shingrix (intramuscular) and Cortisone at an unknown dose and frequency. On 9th August 2019, 1 days after receiving Shingrix, the patient experienced dry mouth and oral thrush. On 13th August 2019, the patient experienced hoarseness. In August 2019, the patient experienced tongue white, localized erythema, skin warm, sensitive tongue, pharyngeal disorder and oral mucosal discoloration. On an unknown date, the outcome of the dry mouth, localized erythema and skin warm were resolved with sequelae and the outcome of the tongue white, pharyngeal disorder and oral mucosal discoloration were unknown and the outcome of the oral thrush, sensitive tongue and hoarseness were recovering/resolving.   It was unknown if the reporter considered the dry mouth, tongue white, localized erythema, skin warm, oral thrush, sensitive tongue, hoarseness, pharyngeal disorder and oral mucosal discoloration to be related to Shingrix.  Additional information received were as follows: The patient reported that the following day after vaccination her mouth was drier than usual. Then a few days later reported her tongue was white and became progressively worse or whiter. The white in mouth extended to the back of tongue and down throat. The patient stated that after receiving cortisone shot her mouth may get a little dry, cheeks may become rosy, and her body may feel warm, but those three things occurred with a greater effect. The patient stated that thrush was almost gone, but her tongue was still sensitive, her throat feels hoarse and her voice was deeper than usual. The patient consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Inflammation, Muscle spasms, Musculoskeletal pain, Pain
Clinical narrative: Inflammation; radiating pain; Arm pain; Shoulder pain; Joint Pain; Muscle Spasm / Muscle spasm of the left shoulder, upper arm and neck; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 273BZ, expiry date 31st May 2021) for prophylaxis.   On 6th February 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, between 4 and 5 months after receiving Shingrix, the patient experienced joint pain, muscle spasm, radiating pain, pain in arm and shoulder pain. On an unknown date, the patient experienced inflammation. On an unknown date, the outcome of the joint pain, muscle spasm, inflammation, radiating pain, pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the joint pain, muscle spasm, inflammation, radiating pain, pain in arm and shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. Since receiving the vaccine patient experienced joint pain in the arm she received the Shingrix vaccine in.  The pharmacist stated he received a letter from patient's physician dated 23rd July 2019. The letter stated that since past 3 weeks patient experienced sharp and electric like pain that radiates down from back of shoulder and left upper arm.  The patient was also experienced increased muscle spasm of the left shoulder, upper arm and neck.  The patient had tried physical therapy and it did not improve symptoms.  In the letter physician noted that the way injection was given might have caused patient to developed inflammation. No further details were provided. The reporter gave permission to follow up. As per sales data sheet reported batch number was changed from 273B2 to 273BZ.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Inflammation; radiating pain; Arm pain; Shoulder pain; Joint Pain; Muscle Spasm / Muscle spasm of the left shoulder, upper arm and neck; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 273BZ, expiry date 31st May 2021) for prophylaxis.   On 6th February 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, between 4 and 5 months after receiving Shingrix, the patient experienced joint pain, muscle spasm, radiating pain, pain in arm and shoulder pain. On an unknown date, the patient experienced inflammation. On an unknown date, the outcome of the joint pain, muscle spasm, inflammation, radiating pain, pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the joint pain, muscle spasm, inflammation, radiating pain, pain in arm and shoulder pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. Since receiving the vaccine patient experienced joint pain in the arm she received the Shingrix vaccine in.  The pharmacist stated he received a letter from patient's physician dated 23rd July 2019. The letter stated that since past 3 weeks patient experienced sharp and electric like pain that radiates down from back of shoulder and left upper arm.  The patient was also experienced increased muscle spasm of the left shoulder, upper arm and neck.  The patient had tried physical therapy and it did not improve symptoms.  In the letter physician noted that the way injection was given might have caused patient to developed inflammation. No further details were provided. The reporter gave permission to follow up. As per sales data sheet reported batch number was changed from 273B2 to 273BZ.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Exposure via skin contact, Immediate post-injection reaction, Occupational exposure to product, Product complaint, Wound
Clinical narrative: Product quality issue; Pharmaceutical product complaint; Finger knick; inadvertent exposure to vaccine; exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of cut wound in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) and (batch number T2472, expiry date 23rd January 2022) for prophylaxis. This case was associated with a product complaint.   On 9th August 2019, the patient received Shingrix. On 9th August 2019, the dose was an unknown dose. On 9th August 2019, immediately after receiving Shingrix, the patient experienced cut wound, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the patient experienced product quality issue and pharmaceutical product complaint. On an unknown date, the outcome of the cut wound, inadvertent exposure to vaccine, exposure via skin contact, product quality issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the cut wound to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist was an experienced user. The pharmacist stated that she did not observe any defect but while she was drawing out the Shingrix adjuvant, with the syringe in her right hand and the adjuvant vial in her left hand, and inverting the adjuvant upside down to draw the content out, she got a knick on her left forefinger which was gloved and did bleed. The pharmacist had to discard the adjuvant because she felt it had contaminated the vaccine surface.  The pharmacist stated that she thought that she knicked her finger on the red ring of the adjuvant vial. The vaccine was not administered.  The pharmacist had taken a picture and would be emailing. The pharmacist had discarded the adjuvant vial and thus the defective product will be not be sent to Glaxosmithkline. The Glaxosmithkline tp process credit for one dose of the Shingrix vaccine. The pharmacist has not provided the Glaxosmithkline direct account no. The reporter reported that stated there appeared to be a small raised or sharp area on the metal ring, just enough to cause her finger to bleed. The reporter said that she sent a photo to our group mailbox, but had not received it by the time the reporter spoke to her and confirmed she had the correct email address and she said she would resend the photo. At the time the reporter was typing this email, and still had not received the photo. The reporter said it was hard to see the raised area in the photo and confirmed the sample was thrown away. The metallic skirt of the vial of adjuvant was broken during the preparation of the vaccine and hurt the pharmacist. The metallic skirt already damaged in the box or when taking the flip off away from the skirt The pharmacist would call back to provide this information. The reporter did not consent to follow-up.
Age: 35.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Shaking; This case was reported by a other health professional via call center representative and described the occurrence of tremor in a 35-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 12th August 2019, the patient received Boostrix and Menveo. On 12th August 2019, 5 min after receiving Boostrix and Menveo, the patient experienced tremor. On 12th August 2019, the outcome of the tremor was recovered/resolved.   It was unknown if the reporter considered the tremor to be related to Boostrix and Menveo.  Additional case details were reported as follows: The healthcare professional stated that a patient was vaccinated with both Menveo and Boostrix vaccine and within 5 minutes of vaccination, they had a shaking reaction which had been resolved. The reporter consented to follow up.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash; Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 85-year-old male patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 12th July 2019, the patient received the 1st dose of Shingrix. On 11th August 2019, 30 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional case details were reported as follows: The patient developed shingles rash approximately two days ago from day of reporting. The reporter gave permission to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Influenza like illness, Myalgia, Pain
Clinical narrative: Stomach Issues; Runny Nose; Aches; Muscle pain; Feeling tired; Flu-like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix. On 9th August 2019, 2 days after receiving Shingrix, the patient experienced influenza-like symptoms, pain, muscle pain and tiredness. On an unknown date, the patient experienced stomach discomfort and runny nose. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the stomach discomfort and runny nose were not recovered/not resolved and the outcome of the pain, muscle pain and tiredness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, stomach discomfort, runny nose, pain, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller reported Shingrix received and on the 2nd day, the caller had flu like symptoms from the neck down including aches, muscle pain, and feeling tired. The caller reported flu like symptoms passed in less than 24 hours. One week later after vaccination caller reported having stomach issues and a runny nose that has not resolved. The reporter did not give consent to follow up. The caller declined to provide address and only wanted to provide limited information. The caller did not want to receive mail for follow up and did not consent for medicine doctor follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Stomach Issues; Runny Nose; Aches; Muscle pain; Feeling tired; Flu-like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix. On 9th August 2019, 2 days after receiving Shingrix, the patient experienced influenza-like symptoms, pain, muscle pain and tiredness. On an unknown date, the patient experienced stomach discomfort and runny nose. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the stomach discomfort and runny nose were not recovered/not resolved and the outcome of the pain, muscle pain and tiredness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, stomach discomfort, runny nose, pain, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller reported Shingrix received and on the 2nd day, the caller had flu like symptoms from the neck down including aches, muscle pain, and feeling tired. The caller reported flu like symptoms passed in less than 24 hours. One week later after vaccination caller reported having stomach issues and a runny nose that has not resolved. The reporter did not give consent to follow up. The caller declined to provide address and only wanted to provide limited information. The caller did not want to receive mail for follow up and did not consent for medicine doctor follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 74A7L, expiry date 22nd July 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The healthcare professional consented to follow up regarding this case.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: pain in the upper left arm; Shoulder pain; burning pain; This case was reported by a physician via call center representative and described the occurrence of pain in fingers in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 2 hrs after receiving Shingrix, the patient experienced pain in fingers, pain burning and shoulder pain. On an unknown date, the outcome of the pain in fingers, pain burning and shoulder pain were recovered/resolved.   It was unknown if the reporter considered the pain in fingers, pain burning and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on left deltoid. The patient received Shingrix approximately 3 weeks ago before reporting. Approximately 2.5 hours after receiving the vaccine, the patient developed pain in the upper left arm. The pain moved to the left shoulder and then down to the tips of the fingers in the left hand. The patient described this pain as a fiery, burning pain. The severe pain eventually resolved starting with the finger tips and going up the left arm. The patient was experiencing pain in the upper left arm, but it was not as severe. The severe pain lasted for approximately 3 days. The reporter saw the patient in the office on the day of reporting. Emergency room visit required. The reporter did not provide any additional details.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness
Clinical narrative: felt like  they had the flu; not felt good; Really Bad Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2019, the patient received the 2nd dose of Shingrix. On 9th August 2019, less than a day after receiving Shingrix, the patient experienced headache. In August 2019, the patient experienced influenza like illness and feeling bad. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the influenza like illness and feeling bad were unknown.   It was unknown if the reporter considered the headache, influenza like illness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. On the last Friday (from the reporting date), the patient received 2nd dose of Shingrix and was not felt good since.  For the first 48 hours after the vaccine,  the patient had a really bad headache and felt like  having flu. The patient did not consent to follow-up. All information was collected via chat and no contact information provided when requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: PAIN AT TE INJECTION SITE; REDNESS AT INJECTION SITE; SWELLING; TIRED; MUSCLE ACHES; UPSET STOMACH; headache; This case was reported by a other health professional via call center representative and described the occurrence of injection site burning in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced injection site burning, injection site erythema, swelling, tiredness, muscle pain, upset stomach and headache. On an unknown date, the outcome of the injection site burning, injection site erythema, swelling, tiredness, muscle pain, upset stomach and headache were recovering/resolving.   It was unknown if the reporter considered the injection site burning, injection site erythema, swelling, tiredness, muscle pain, upset stomach and headache to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine the day before reporting and experienced all the side effects listed on the same day. She described the redness as presented at the injection site 1 to 1 inches that traveled down her arm a few inches. It looks like a burn.The pain at the injection site was measured as an 8/10 and then a 6/10. The pain was still present and it was difficult to use her seat belt because it goes over the site. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Swelling
Clinical narrative: PAIN AT TE INJECTION SITE; REDNESS AT INJECTION SITE; SWELLING; TIRED; MUSCLE ACHES; UPSET STOMACH; headache; This case was reported by a other health professional via call center representative and described the occurrence of injection site burning in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced injection site burning, injection site erythema, swelling, tiredness, muscle pain, upset stomach and headache. On an unknown date, the outcome of the injection site burning, injection site erythema, swelling, tiredness, muscle pain, upset stomach and headache were recovering/resolving.   It was unknown if the reporter considered the injection site burning, injection site erythema, swelling, tiredness, muscle pain, upset stomach and headache to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine the day before reporting and experienced all the side effects listed on the same day. She described the redness as presented at the injection site 1 to 1 inches that traveled down her arm a few inches. It looks like a burn.The pain at the injection site was measured as an 8/10 and then a 6/10. The pain was still present and it was difficult to use her seat belt because it goes over the site. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Injection site erythema, Injection site pruritus
Clinical narrative: redness at injection site; itching at injection site; stomach pains; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site itching, stomach pain and upset stomach. The patient was treated with clobetasol propionate. Shingrix was discontinued. On an unknown date, the outcome of the injection site erythema and injection site itching were not recovered/not resolved and the outcome of the stomach pain and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, stomach pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and developed redness and itching at the injection site.  The redness at the injection site is approximately 6 inches in diameter. The patient already had a standing appointment with her physician and so she showed the physician the area on her arm during the appointment and the physician  advised the patient to use Clobetasol propionate on the site and advised patient to not get the 2nd dose.  The patient also experienced stomach pains and upset stomach following the administration of the vaccine. The patient did not consent to follow-up. Emergency room visit required. The patient did not provide any additional details. This case was linked with the case US2019149373, reported for patient's husband.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis contact, Fatigue, Insomnia, Pain in extremity, Pruritus
Clinical narrative: Vesicular rash; Itching; Sore arm; Fatigue; Poison ivy rash; Cannot sleep; This case was reported by a nurse via call center representative and described the occurrence of vesicular rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th August 2019, 2 days after receiving Shingrix, the patient experienced vesicular rash. In August 2019, the patient experienced pruritus, pain in arm, fatigue, poison ivy rash and sleeplessness. On an unknown date, the outcome of the vesicular rash, pruritus, pain in arm, fatigue and poison ivy rash were not recovered/not resolved and the outcome of the sleeplessness was unknown.   It was unknown if the reporter considered the vesicular rash, pruritus, pain in arm, fatigue, poison ivy rash and sleeplessness to be related to Shingrix.  Additional case details were reported as follows: The vaccine lot number and expiry date was unknown. The patient recived vaccine in right arm. All information was provided through an interpreter. The patient experienced a vesicular rash which does not resemble shingles. It was bilateral, scattered, and not in a linear fashion. It looked almost like poison ivy and was itching. The patient denied pulling weeds, but did drive on his tractor and cut grass.  The patient could not sleep due to the itching. The patient also reported a sore arm and fatigue.  There was no local reaction at the injection site. It was unknown when the sore arm and fatigue started. The start date for itching not provided. The reporter consented to follow up. In the document outcome of other events was reported as recovering, but its mentioned as not recovered, so kept as reported.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash; Itching; Sore arm; Fatigue; Poison ivy rash; Cannot sleep; This case was reported by a nurse via call center representative and described the occurrence of vesicular rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th August 2019, 2 days after receiving Shingrix, the patient experienced vesicular rash. In August 2019, the patient experienced pruritus, pain in arm, fatigue, poison ivy rash and sleeplessness. On an unknown date, the outcome of the vesicular rash, pruritus, pain in arm, fatigue and poison ivy rash were not recovered/not resolved and the outcome of the sleeplessness was unknown.   It was unknown if the reporter considered the vesicular rash, pruritus, pain in arm, fatigue, poison ivy rash and sleeplessness to be related to Shingrix.  Additional case details were reported as follows: The vaccine lot number and expiry date was unknown. The patient recived vaccine in right arm. All information was provided through an interpreter. The patient experienced a vesicular rash which does not resemble shingles. It was bilateral, scattered, and not in a linear fashion. It looked almost like poison ivy and was itching. The patient denied pulling weeds, but did drive on his tractor and cut grass.  The patient could not sleep due to the itching. The patient also reported a sore arm and fatigue.  There was no local reaction at the injection site. It was unknown when the sore arm and fatigue started. The start date for itching not provided. The reporter consented to follow up. In the document outcome of other events was reported as recovering, but its mentioned as not recovered, so kept as reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number T4952, expiry date 18th June 2021) for prophylaxis.   On 21st March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The husband reported that his wife had the Shingrix and experienced a fever of 101 to 101.5.  The reporter consented to follow up. No additional details were available as the reporter's cell phone died in a remote location. This case has been linked with US2019AMR149970, reported by same reporter.      Lab Comments: Lab test performed on an unknown date
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: cellulitis; redness; swelling; rash; pain; This is a spontaneous report from a contactable nurse via a Pfizer sales representative.  An 18-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. Patient had MS (multiple sclerosis). The patient had no concomitant medications. No other vaccines were administered at time of meningococcal group b rlp2086 vaccination. After first dose the patient experienced redness, swelling, rash and pain, possible cellulitis after vaccination. Patient received vaccine on Friday. The patient took diphenhydramine hydrochloride (BENADRYL) over weekend and patient was better by the following Monday. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of TRUMENBA and the onset of possible cellulitis cannot be excluded assuming a plausible temporal association.  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 and Investigators, as appropriate.
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administering Adacel instead of Daptacel; Adacel administered at 15 month old female patient; Initial information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 months old female patient who received 0.5 ml  vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5602AA via intramuscular route in the right thigh instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 13-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  It was reported that inadvertently administering Adacel instead of Daptacel to 15month old. Caller stated patient has had 3 doses prior of Daptacel, this was intended to be the fourth dose of Daptacel.  No adverse event reported at the time of report.  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: 54.0
Sex: M
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age, Product preparation error, Product preparation issue
Clinical narrative: administering the patient to use a prefilled 0.9% saline syringe instead of 0.4% saline; 54 year old patient recive ActHIB; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 54 year old male patient who received Booster dose of HIB (PRP/T) VACCINE Box lot Lot # Box Act HIB UI914AAA exp 11/14/2019 (Vial- Lot # UI914AA exp 11/28/2019) 0.9% prefilled syringe via intramuscular route in the left deltoid on 16-Aug-2019.  The patient's medical history included allergic to latex,   Medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was a case of actual medication error due to inappropriate reconstitution technique and Inappropriate age at vaccine administration. (It was reported that nurse administering the patient to use a prefilled 0.9% saline syringe instead of the diluent provided. After the patient got the dose she realized that it should have been 0.4% saline)  It was unknown whether any adverse event occurred.  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.  Documents held by sender: none.