chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: I had 3 immunizations of Shingrix; also experienced sore arm; Drug dose administration interval too long; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th November 2018).   On 5th August 2019, the patient received the 2nd dose of Shingrix. On 18th February 2020, the patient received the 3rd dose of Shingrix. On 5th August 2019, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On 18th February 2020, the patient experienced extra dose administered. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, drug dose administration interval too long and extra dose administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. This question was about the Shingrix shot. The patient just noticed he had 3 immunizations of Shingrix. On 5th August 2019, the patient received the 2nd dose of Shingrix late, which led to lengthening of the vaccination schedule. The patient received the 3rd dose of Shingrix, extra dose administered. The patient asked would this cause any issues. Reporter noted during call that he also experienced sore arm that resolved after getting Shingrix doses. Reporter asked that his physician not be contacted in follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Laboratory test, Nausea, Pain in extremity
Clinical narrative: I had nausea; I had arm pain; headaches; extreme fatigued; develop a red rash on my hands and arms / Two weeks later the rash covered both my arms /Two weeks later the rash covered both my arms / the rash was now on my back, my neck and starting on my legs; This case was reported by a consumer via call center representative and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced nausea, pain in arm, headache, fatigue and red rash. The patient was treated with prednisone and steroid cream. On an unknown date, the outcome of the nausea, pain in arm, headache and fatigue were recovered/resolved and the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the nausea, pain in arm, headache, fatigue and red rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had nausea, arm pain, headaches, and extreme fatigue after vaccination. The patient started to develop a red rash on hands and arms and later the rash covered both arms and within another week the rash was now on back, neck and starting on legs. The patient question was how long would this rash last and Would I always have this rash.      Lab Comments: done on an unknown date
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: I had nausea; I had arm pain; headaches; extreme fatigued; develop a red rash on my hands and arms / Two weeks later the rash covered both my arms /Two weeks later the rash covered both my arms / the rash was now on my back, my neck and starting on my legs; This case was reported by a consumer via call center representative and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced nausea, pain in arm, headache, fatigue and red rash. The patient was treated with prednisone and steroid cream. On an unknown date, the outcome of the nausea, pain in arm, headache and fatigue were recovered/resolved and the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the nausea, pain in arm, headache, fatigue and red rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had nausea, arm pain, headaches, and extreme fatigue after vaccination. The patient started to develop a red rash on hands and arms and later the rash covered both arms and within another week the rash was now on back, neck and starting on legs. The patient question was how long would this rash last and Would I always have this rash.      Lab Comments: done on an unknown date
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: large upper body rash and rash on her neck; rash at the injection site; This case was reported by a pharmacist via sales rep and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received Shingrix. On 14th March 2020, 2 days after receiving Shingrix, the patient experienced itchy rash. In March 2020, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash and itchy rash were unknown.   It was unknown if the reporter considered the injection site rash and itchy rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient who got the shingrix vaccine 3 days ago. 2 days in she presented with a rash at the injection site. On the day of reporting, she presented with a large upper body rash and rash on her neck that itches. The reporter referred the patient to the physician and asked if this was a normal reaction.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Vaccine positive rechallenge
Clinical narrative: developed a large red spot not at the injection site; This case was reported by a other health professional via sales rep and described the occurrence of localized erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (refer case US2020AMR014835) and NSAIDS (received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced localized erythema. The patient was treated with ace inhibitor nos (Ace Inhibitor). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the localized erythema was recovered/resolved.   The reporter considered the localized erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experianced large red spot after every shigrix vaccination. The large red spot not at the site of administration but red spot at few inches from site of administration. The patient was fine but think about red spot which are not at site of administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: had symptoms for 3-4 days; body ache; tiredness; fever; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix 50 mcg/mg. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, tiredness and fever. On an unknown date, the outcome of the influenza-like symptoms, general body pain, tiredness and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine and had flu-like symptoms for 3-4 days afterward - body ache, tiredness, and fever.  The patient was very reluctant to get their second dose because of initial reaction. Those side effects were like COVID-19.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: fever; fatigue; muscle ache; This case was reported by a physician via call center representative and described the occurrence of fever in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, fatigue and muscle pain. On an unknown date, the outcome of the fever, fatigue and muscle pain were unknown.   It was unknown if the reporter considered the fever, fatigue and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The physician reported that many patients were hesitant to receive their second dose during the pandemic due to symptoms of fever, fatigue, and muscle ache which might be confused with symptoms of COVID-19. Did not consent to follow-up. This case has been linked with US2020059976, reported by same reporter.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Headache, Heart rate increased, Joint swelling, Musculoskeletal pain
Clinical narrative: I had a minor headache; I had some back muscle aches; feel a little sluggish; I have a slight temperature; my shoulder has some soreness; shoulder has some swelling; my pulse is running in the upper 80s. I normally run in the 60-70 range; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix, the patient experienced headache, muscular back pain, sluggishness, fever, shoulder pain, swollen joints and pulse increased. On an unknown date, the outcome of the headache, muscular back pain, sluggishness, fever, shoulder pain, swollen joints and pulse increased were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscular back pain, sluggishness, fever, shoulder pain, swollen joints and pulse increased to be related to Shingrix.  Additional details were provided as follows: The patient took Shingrix shot yesterday (the day before yesterday).  The patient believed have a slight temperature.  The patient had a minor headache last night, some back muscle aches, (nothing serious), and feel a little sluggish. The patient shoulder had some soreness and swelling. The patient's oxygen level was 95 and pulse was running in the upper 80's. The patient normally run in the 60-70 range.  Breathing was fine and do not have any coughing issues. The reporter wanted to know when it would be back to normal.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Sluggishness
Clinical narrative: I had a minor headache; I had some back muscle aches; feel a little sluggish; I have a slight temperature; my shoulder has some soreness; shoulder has some swelling; my pulse is running in the upper 80s. I normally run in the 60-70 range; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a day after receiving Shingrix, the patient experienced headache, muscular back pain, sluggishness, fever, shoulder pain, swollen joints and pulse increased. On an unknown date, the outcome of the headache, muscular back pain, sluggishness, fever, shoulder pain, swollen joints and pulse increased were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscular back pain, sluggishness, fever, shoulder pain, swollen joints and pulse increased to be related to Shingrix.  Additional details were provided as follows: The patient took Shingrix shot yesterday (the day before yesterday).  The patient believed have a slight temperature.  The patient had a minor headache last night, some back muscle aches, (nothing serious), and feel a little sluggish. The patient shoulder had some soreness and swelling. The patient's oxygen level was 95 and pulse was running in the upper 80's. The patient normally run in the 60-70 range.  Breathing was fine and do not have any coughing issues. The reporter wanted to know when it would be back to normal.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Hyperhidrosis, Pyrexia
Clinical narrative: I also feel joint soreness most of the time; experienced a low-grade fever of 99.2 to 100.4; I wake up with sweet-drenched clothing each morning; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th March 2020, the patient received the 1st dose of Shingrix. On 31st March 2020, 1 days after receiving Shingrix, the patient experienced sweating. On 1st April 2020, the patient experienced fever. On an unknown date, the patient experienced joint pain. On an unknown date, the outcome of the fever, joint pain and sweating were not recovered/not resolved.   It was unknown if the reporter considered the fever, joint pain and sweating to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix shots on Monday (the day before reporting). The patient had experienced a low-grade fever of 99.2 to 100.4 now for the last five days. The patient also felt joint soreness most of the time.  The soreness and fever subsides during the day but returns nightly. The patient wake up with sweet-drenched clothing each morning as well. The patient wanted to know was this normal after the shot and when could he/she expect these symptoms to go away.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspepsia, Fatigue, Headache, Pyrexia
Clinical narrative: terrible headache; tired; my temp is 100.1; feel like I have bad heartburn; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th April 2020, the patient received the 2nd dose of Shingles vaccine. On 7th April 2020, 1 days after receiving Shingles vaccine, the patient experienced headache, tiredness, fever and heartburn. On an unknown date, the outcome of the headache, tiredness, fever and heartburn were not recovered/not resolved.   It was unknown if the reporter considered the headache, tiredness, fever and heartburn to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had terrible headache, was tired, their temp was 100.1 degree F, and they feel like they had bad heartburn.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a other health professional via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: injection site is tender; injection site is red; injection site is red tender and warm; This case was reported by a consumer and described the occurrence of injection site tenderness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site tenderness, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site tenderness, injection site erythema and injection site warmth to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: My arm still hurts; My arm still hurts & bothers me at night disturbing my sleep; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and sleep disturbance. On an unknown date, the outcome of the pain in arm and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient's arm still hurts and bothers them at night disturbing sleep.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: 18 year old patient who received an adult dose of Engerix-B; 18 year old patient who received an adult dose of Engerix; pain at the injection site/ Soreness at the injection site/ tenderness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received HBV (Engerix B adult) (batch number 239TF, expiry date 4th June 2022) for prophylaxis.  On 5th February 2020, the patient received Engerix B adult. On 5th February 2020, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional information was provided as follows: The patient received an adult dose of Engerix B vaccine, which led to overdose and adult product administered to child. The reporter consented to follow up.   Follow-up information received from pharmacist on 10th February 2020: The reporter spoke to the patient , the patient did not experienced any additional adverse events besides topical soreness, tenderness and pain at injection site. The reporter stated that overdose and adult product administered to child were due to erroneous administration. It was unknown if the reporter considered the injection site pain to be related to Engerix B adult. The VAERS details were updated.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Headache, Immune system disorder, Nausea, Pain in extremity
Clinical narrative: Sore arm; slight headache; slight fever; slight nausia; wild upward spikes in blood glucose levels; appears that the Shingrix is affecting the immune response such that the infusion set is rendered; insulin pump not working / insulin infusion difficulties; This case was reported by a consumer via call center representative and described the occurrence of infusion related reaction in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 19th February 2020, the patient received Shingrix. In February 2020, unknown after receiving Shingrix, the patient experienced infusion related reaction, blood glucose increased and immune disorder (nos). On 20th February 2020, the patient experienced pain in arm, headache, fever and nausea. On an unknown date, the outcome of the infusion related reaction, pain in arm, headache, fever, nausea, blood glucose increased and immune disorder (nos) were unknown.   It was unknown if the reporter considered the infusion related reaction, pain in arm, headache, fever, nausea, blood glucose increased and immune disorder (nos) to be related to Shingrix.  Additional details were provided as follows: The patient had type I diabetes mellitus over 35 years. The patient received Shingrix vaccine in the afternoon of 19th February 2020. In the beginning morning of 20th February 2020, the patient experienced pain in arm, headache, fever, nausea. Less than a day after vaccination, the patient experienced  infusion related reaction, blood glucose increased and immune disorder (nos). The reporter stated that, changing the infusion set followed by additional insulin slowly reduced blood sugar level after several hours, but then the blood sugar level would shoot up again. No sugar or carb intake, so diet should not be a factor. These symptoms have continued into 22nd February 2020. The reported batch number G7224 for Shingrix did not exist and was updated to G72Z4 as per the sales database. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm; slight headache; slight fever; slight nausia; wild upward spikes in blood glucose levels; appears that the Shingrix is affecting the immune response such that the infusion set is rendered; insulin pump not working / insulin infusion difficulties; This case was reported by a consumer via call center representative and described the occurrence of infusion related reaction in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 19th February 2020, the patient received Shingrix. In February 2020, unknown after receiving Shingrix, the patient experienced infusion related reaction, blood glucose increased and immune disorder (nos). On 20th February 2020, the patient experienced pain in arm, headache, fever and nausea. On an unknown date, the outcome of the infusion related reaction, pain in arm, headache, fever, nausea, blood glucose increased and immune disorder (nos) were unknown.   It was unknown if the reporter considered the infusion related reaction, pain in arm, headache, fever, nausea, blood glucose increased and immune disorder (nos) to be related to Shingrix.  Additional details were provided as follows: The patient had type I diabetes mellitus over 35 years. The patient received Shingrix vaccine in the afternoon of 19th February 2020. In the beginning morning of 20th February 2020, the patient experienced pain in arm, headache, fever, nausea. Less than a day after vaccination, the patient experienced  infusion related reaction, blood glucose increased and immune disorder (nos). The reporter stated that, changing the infusion set followed by additional insulin slowly reduced blood sugar level after several hours, but then the blood sugar level would shoot up again. No sugar or carb intake, so diet should not be a factor. These symptoms have continued into 22nd February 2020. The reported batch number G7224 for Shingrix did not exist and was updated to G72Z4 as per the sales database. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Product complaint
Clinical narrative: experienced swelling to the size of a 50 cent piece at the site of injection; tenderness and the site being hot; tenderness and the site being hot; Product Complaint; nausea; This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA64AZ, expiry date 31st October 2021) for prophylaxis. This case was associated with a product complaint.   On 3rd March 2020, the patient received the 2nd dose of Bexsero (intramuscular) .5 ml. On 3rd March 2020, immediately after receiving Bexsero, the patient experienced nausea. On 4th March 2020, the patient experienced injection site swelling, injection site tenderness, injection site warmth and pharmaceutical product complaint. On an unknown date, the outcome of the nausea, injection site swelling, injection site tenderness, injection site warmth and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the nausea, injection site swelling, injection site tenderness and injection site warmth to be related to Bexsero.  Additional details were provided as follows: The patient experienced swelling to the size of a 50 cent piece at the site of injection that started The patient noted tenderness and the site being hot, also noted nausea right after the vaccination on the same day but no vomiting. The patient called into the office, but hasn't been seen.  The health care professional reviewed prescribing information of the events reported and the post marketing information. No product to return and no replacement at the time of reporting. The reporter consented to follow up. This case has been linked with case US2020040984, reported by the same reporter.   Follow up information was received from QA department on 11th March 2020: Conclusions of the QA statement were received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   On 1st September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient experienced pain in arm after vaccination. The patient received a second dose of Shingrix in December 2019. The reporter consented to follow up.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Chest X-ray abnormal, Chills, Immediate post-injection reaction, Injection site haemorrhage, Lung disorder
Clinical narrative: shivering/ Teeth chattering; he still felt very bad, and that general feeling of not feeling well; weight loss; something in lung; bleeding at injection site; sore arm; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site hemorrhage in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix and Influenza vaccine. In October 2019, immediately after receiving Shingrix and Influenza vaccine, the patient experienced injection site hemorrhage, pain in arm, fever, shivering, feeling unwell, weight loss and lung disorder. The patient was treated with guaifenesin (Mucinex). On an unknown date, the outcome of the injection site hemorrhage, pain in arm, fever, shivering and feeling unwell were recovered/resolved and the outcome of the weight loss and lung disorder were unknown.   It was unknown if the reporter considered the injection site hemorrhage, pain in arm, fever, shivering, feeling unwell, weight loss and lung disorder to be related to Shingrix and Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reports that he got Shingrix and a flu vaccination on the same day in late October 2019, around October 20. He had bleeding at the injection site for Shingrix immediately after vaccination. His arm was very sore for several days after getting the vaccine. About 12 hours after he got the vaccines he woke up with a fever, 3 degrees F above normal, and such intense shivering that his teeth were chattering. It took about 1.5 hours for the shivering to lessen so he could go back to sleep. The fever lasted about 6-12 hours after it started. Once the fever and shivering resolved he still felt very bad, and that general feeling of not feeling well continued. Five days after getting the vaccine he saw his HCP because he still felt terrible. He had a chest x-ray and the HCP saw something in his lung and was recommended that he take Mucinex. He continued to not feel well and was losing weight, so 3 weeks later he saw his HCP again. After the 2nd HCP visit, he continued to not feel well, but the symptoms gradually resolved. Consented to follow up. Emergency room Visit Required.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia, Weight decreased
Clinical narrative: shivering/ Teeth chattering; he still felt very bad, and that general feeling of not feeling well; weight loss; something in lung; bleeding at injection site; sore arm; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site hemorrhage in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix and Influenza vaccine. In October 2019, immediately after receiving Shingrix and Influenza vaccine, the patient experienced injection site hemorrhage, pain in arm, fever, shivering, feeling unwell, weight loss and lung disorder. The patient was treated with guaifenesin (Mucinex). On an unknown date, the outcome of the injection site hemorrhage, pain in arm, fever, shivering and feeling unwell were recovered/resolved and the outcome of the weight loss and lung disorder were unknown.   It was unknown if the reporter considered the injection site hemorrhage, pain in arm, fever, shivering, feeling unwell, weight loss and lung disorder to be related to Shingrix and Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reports that he got Shingrix and a flu vaccination on the same day in late October 2019, around October 20. He had bleeding at the injection site for Shingrix immediately after vaccination. His arm was very sore for several days after getting the vaccine. About 12 hours after he got the vaccines he woke up with a fever, 3 degrees F above normal, and such intense shivering that his teeth were chattering. It took about 1.5 hours for the shivering to lessen so he could go back to sleep. The fever lasted about 6-12 hours after it started. Once the fever and shivering resolved he still felt very bad, and that general feeling of not feeling well continued. Five days after getting the vaccine he saw his HCP because he still felt terrible. He had a chest x-ray and the HCP saw something in his lung and was recommended that he take Mucinex. He continued to not feel well and was losing weight, so 3 weeks later he saw his HCP again. After the 2nd HCP visit, he continued to not feel well, but the symptoms gradually resolved. Consented to follow up. Emergency room Visit Required.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Soreness at the application arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, diabetes and asthma.   On 25th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient's age could be 64 or 65 years of age. The patient was due to the second dose of Shingrix in May 2020 but this would likely be delayed due to the COVID-19 outbreak.  The pharmacist also mentioned that this patient experienced soreness at the application arm after dose one. Consented to follow up. This case is linked to the case US2020060868 and US2020060864 reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain
Clinical narrative: Headache; Feeling unwell; Ache; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache, feeling unwell and general body pain. On an unknown date, the outcome of the headache, feeling unwell and general body pain were recovered/resolved.   It was unknown if the reporter considered the headache, feeling unwell and general body pain to be related to Shingrix.  Additional details were provided as follows: Pharmacist who was also a patient reported that after receiving the dose of Shingrix experienced headache, feeling unwell and ache which lasted for 24 hours. Consented to follow up. This case is linked to the case US2020060863 and US2020060868, reported by the same reporter.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: A patient experienced soreness in the arm. Consented to follow up. This case has been linked with US2020060863 and US2020060864, reported by same reporter.
Age: 1.75
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered a dose of Quadracel to a 21 month old; Initial information received on 24-Mar-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 21 months old patient who was administered a dose of  DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Inappropriate age at vaccine administration).  Medical history, medical treatment and family history were not provided. Patient previously recieved 3 doses of TDAP vaccine.   Concomitant medication included Hepatitis A vaccine.  On 20-Mar-2020, the patient visited the doctor and patient received a fourth dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5497AA) (expiry date: 17-Jul-2020) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration.  At the time of report, 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 and Module VI of the 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
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired Menactra dose was administered inadvertently to a consumer, no AE; Initial information received on 24-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old female patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (first dose 0.5 mL, lot U6152AA, expiry date: 19-Mar-2020) inadvertently via intramuscular route in the left deltoid on 24-Mar-2020 for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  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.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 62 year old female patient was administered expired Tenivac vaccine, no AE; Initial information received on 24-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 62 years old female patient who received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (booster dose 0.5 mL, lot U5882AA, expiry date: 08-Mar-2020) inadvertently via intramuscular route in the left deltoid on 10-Mar-2020 for prophylactic vaccination  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 expired vaccine used.  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.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: reconstituted ActHIB with " a plain diluent", not the ActHIB provided diluent, no AE; Initial information received on 27-Mar-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 2 months old patient (gender not reported) who received a 0.5 ml first dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UJ138AAA, expiry date: 31-Jan-2021) on 27-Mar-2020 via an intramuscular route in the left thigh for prophylactic vaccination.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  It was an actual medication error due to wrong solution used in drug reconstitution.  At the time of reporting, the patient did not experienced any 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.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: reconstituted the vaccine ACT-HIB with sterile water instead of the provided saline/ no AE; Initial information received on 30-Mar-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a two month old female patient who was vaccinated with a 0.5 mL first dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ161AAA and expiry date 26-Nov-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 26-Mar-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  It is an actual medication error due to wrong solution used in drug reconstitution. it was reported that a dose of ACT-HIB was reconstituted with sterile water instead of the provided saline.  At the time of this report, 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.
Age: 0.5
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was given to a six month old patient/No AE; Initial information was received on 30-Mar-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a six months old female patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age)  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.   It was also a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse reaction was reported.  There will be no information available on the batch number for this case.  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 and Module VI of the 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.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: reporting an expired dose of Daptacel was inadvertently administered, no AE; Initial information received on 30-Mar-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 18 months old female patient who inadvertently received an expired dose of 0.5 ml (first dose) of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5254AA, expiry date: 18-Sep-2019, via intramuscular route in the left thigh on 27-Sep-2019 as prophylactic vaccination (expired product administered).  The patient's past vaccination(s) included 3 previous doses of Pentacel.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant vaccination included Hepatitis A vaccine.   It was a case of actual medication error due to expired vaccine used.  At the time of report, 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.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel inadvertently given to patient, no AE; Initial information received on 31-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 17 months old female patient who inadvertently received a 0.5 ml dose of an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (cycle series 4, lot C5367AA, expiry date: 30-Mar-2020) on 31-Mar-2020, via an intramuscular route in the left thigh  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient did not experienced any 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.