chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain/arms; pain/shoulders; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The Health care professional reported that the patient experienced aches in both arms and shoulders after receiving the Shingrix.  The Health care professional was unaware when the pain started and if it had subsided.  The reporter would like to know if there were patients with similar reactions.  No further information provided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Feeling cold, Pain, Pyrexia
Clinical narrative: armpit pain; Pain; fever; chills; elbow pain; This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 30th April 2020) for prophylaxis.   On 24th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th April 2019, immediately after receiving Shingrix, the patient experienced axillary pain, pain, fever, chills and pain in elbow. On an unknown date, the outcome of the axillary pain, pain, fever, chills and pain in elbow were recovered/resolved.   It was unknown if the reporter considered the axillary pain, pain, fever, chills and pain in elbow to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid. The patient stated shortly after getting the 1st dose of Shingrix within the same day, she developed a pain in her armpit that then shot down to her elbow and has remained. The pain started as soon as she moves. The patient also had fever, chills and pain that lasted a few days but was now resolved. The patient contacted her doctor who instructed her to take a pain reliever but also recommended she not get the 2nd dose of Shingrix. The reporter did not give consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: chills; fever; feeling sick; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 13th May 2019, the patient received the 2nd dose of Shingrix .5 ml. On 13th May 2019, less than a day after receiving Shingrix, the patient experienced chills, fever and feeling unwell. On an unknown date, the outcome of the chills, fever and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was also reported that the patient felt like he was getting sick. The reporter did not provide any additional details.
Age: 74.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at the injection site; Pain at the injection site; Redness at the injection site; Swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   Concurrent medical conditions included fibromyalgia. Concomitant products included Herpes zoster (Shingrix).   On 13th May 2019 16:00, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received Influenza vaccine at an unknown dose. On 13th May 2019, immediately after receiving Shingrix and not applicable after receiving Influenza vaccine, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine.  Additional case details were reported as follows: On 1st March 2019, the patient received the 1st dose of Shingrix.  The patient had more pain at the injection site because of fibromyalgia when she got the flu vaccine every year, compared to most people.  The patient did not have a specific brand of flu vaccine that she had received in mind.  Till the reporting time, the patient had all those redness, swelling and pain injection site symptoms.  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: injection site pain/pain/ residual pain at the injection site; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were unknown.   It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received the 1st dose of Shingrix vaccine in the Fall of 2018 in left arm. He thought that he received it in the afternoon. He experienced a lot of pain at the injection site after receiving the vaccination.  This pain occurred for months after receiving the product and he describes that the pain was cyclic- he would had pain, it would stop and then start again.  He said that now, when he gets tired, he feels residual pain at the injection site.  The reporter did not consent to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Pain, Pruritus generalised, Pyrexia
Clinical narrative: Fever; Itching all over body; Bruising at injection site; Body aches; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced fever, generalized pruritus, injection site bruising and general body pain. On an unknown date, the outcome of the fever, generalized pruritus, injection site bruising and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, generalized pruritus, injection site bruising and general body pain to be related to Shingrix.  Additional details were reported as follows: Adverse reaction to Shingrix vaccine fever, itch all over for 17 days post vaccinatioin, also a large bruise at injection site for 17 days post vaccination and body aches.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Pain, Painful respiration
Clinical narrative: feel yucky; heavy chest; hard to breathe; breath would hurt; body aches; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 5G7A7, expiry date 18th May 2021) and (batch number 9CC72, expiry date 18th May 2021) for prophylaxis.   On 9th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced general body pain. On 10th May 2019, the patient experienced feeling bad, chest heaviness, difficulty breathing and painful respiration. On an unknown date, the outcome of the general body pain, feeling bad, chest heaviness, difficulty breathing and painful respiration were recovered/resolved.   It was unknown if the reporter considered the general body pain, feeling bad, chest heaviness, difficulty breathing and painful respiration to be related to Shingrix.  Additional details were provided as follows:  After receiving the Shingrix, the patient experienced body aches.  The next day, he started to feel yucky and he had a heavy chest and it was hard to breathe.He reported that when he would breath it would hurt to take in a deep breath.  His symptoms resolved but the registered pharmacist. was unaware of the timeframe.  The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased activity, Feeding disorder, Influenza like illness, Nausea
Clinical narrative: nauseous; extreme flu-like symptoms; couldn't eat; ruined her life; This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On 5th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced nausea, influenza-like symptoms, unable to eat and decreased activity. On an unknown date, the outcome of the nausea, influenza-like symptoms, unable to eat and decreased activity were recovered/resolved.   The reporter considered the nausea, influenza-like symptoms, unable to eat and decreased activity to be possibly related to Shingrix.  Additional details were provided as follows: The patient experienced extreme flu like symptoms within 8 hours of receiving their 1st dose of Shingrix.  Symptoms were described as nauseous and could not eat, and that it ruined her life. Symptoms were lasted 10 days and have since resolved.  The reporter thought it was 95 parsent likely to have been caused by the Shingrix.  The reporter did not consent to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Malaise, Myalgia
Clinical narrative: Influenza-like symptoms; injection site soreness; Generalized tiredness; generalized muscle soreness; body aches; malaise; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received at the age of 48 years) and Hepatitis B vaccine with an associated reaction of therapy non-responder (received 6 doses over past 20 years, refer case US2019GSK093765).   On 15th May 2019, the patient received Shingrix. On 16th May 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, injection site pain, tiredness, generalized muscle aches, general body pain and malaise. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, tiredness, generalized muscle aches, general body pain and malaise were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain, tiredness, generalized muscle aches, general body pain and malaise to be related to Shingrix.  Additional details were provided as follows: The reporter was the concerned patient. In the morning of reporting day, the patient experienced flu-like symptoms which lets him know a response was being stimulated.  The patient reported generalized tiredness, generalized muscle soreness, body aches, malaise, and injection site soreness. Injection site soreness was no worse than a Tetanus shot (unspecified vaccine).
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Influenza-like symptoms; injection site soreness; Generalized tiredness; generalized muscle soreness; body aches; malaise; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received at the age of 48 years) and Hepatitis B vaccine with an associated reaction of therapy non-responder (received 6 doses over past 20 years, refer case US2019GSK093765).   On 15th May 2019, the patient received Shingrix. On 16th May 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, injection site pain, tiredness, generalized muscle aches, general body pain and malaise. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, tiredness, generalized muscle aches, general body pain and malaise were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain, tiredness, generalized muscle aches, general body pain and malaise to be related to Shingrix.  Additional details were provided as follows: The reporter was the concerned patient. In the morning of reporting day, the patient experienced flu-like symptoms which lets him know a response was being stimulated.  The patient reported generalized tiredness, generalized muscle soreness, body aches, malaise, and injection site soreness. Injection site soreness was no worse than a Tetanus shot (unspecified vaccine).
Sex: M
Vaccine: MENB
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: dizziness; high fever; chills; body aches; This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 19-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 13th May 2019, the patient received the 1st dose of Bexsero (intramuscular). On 13th May 2019, less than a day after receiving Bexsero, the patient experienced dizziness, fever, chills and general body pain. On 15th May 2019, the outcome of the dizziness, fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the dizziness, fever, chills and general body pain to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported but it could be 18 years or 19 years. Within hours after receiving Bexsero, the patient experienced dizziness, fever, chills and body aches, which resolved within 2 days. The reporter consented for follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Rash, Scratch, Skin irritation
Clinical narrative: Skin eruption/ Shows spotup on skin; Skin Scratching; Skin irritation; Spot that show on the skin; This case was reported by a consumer via call center representative and described the occurrence of skin eruption in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced skin eruption, scratch, skin irritation and dry skin. The patient was treated with steroids nos (Steroid Shot (Nos)) and topical steroid nos (Steroid Ointment Nos). On an unknown date, the outcome of the skin eruption, scratch, skin irritation and dry skin were not recovered/not resolved.   It was unknown if the reporter considered the skin eruption, scratch, skin irritation and dry skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine on left hand, intramuscularly, since then he was experiencing skin eruptions, scratching, irritation and spots that show up on the skin that keeps moving to different parts of the body and it occurs on his arms, chest, legs and forehead.  He was also experiencing dry skin. He went to his local dermatologist and received a steroid shot and had been prescribed steroid ointments, and nothing was working. No further details were provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In February 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix last year and developed shingles 11 weeks ago, at the time of reporting. The reporter did not state dose 1 was related to shingles The patient did not receive 2nd dose of Shingrix and was asking for information on timing of dose 2 due to active shingles. The reporter did not provide any other details and did not consent to follow-up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Vomiting
Clinical narrative: pain; vomiting; felt bad; This case was reported by a consumer via call center representative and described the occurrence of pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (In 2012, the patient had heart transplant).   On 7th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a month after receiving Shingrix, the patient experienced pain, vomiting and feeling bad. On an unknown date, the outcome of the pain, vomiting and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, vomiting and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient was the report's wife. After vaccination with 2nd doase of Shingrix, the patient was in bed for 3 days, after which the symptoms were resolved related to the patient.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction; At the injection site there is a slight bruise about 1 inch in diameter and it is raised; there is an area about 3 inches by 2.25 inches that is erythematous and has a noticeable border around it and is warm to the touch; there is an area about 3 inches by 2.25 inches that is erythematous and has a noticeable border around it and is warm to the touch; felt a little pruritus, but it's not really itching; This is a spontaneous report from a contactable pharmacist. A 65-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number X49142 , expiry date May2020) via an unspecified route of administration, on 14May2019 06:00, at 0.5ml single at right deltoid, for immunisation. Relevant medical history included type II diabetes mellitus diagnosed in 2008 and respiratory type illness or virus with his sinuses. Concomitant medications not reported. The patient previously received flu vaccine in 2016 (three years ago) for immunization and experienced injection site pain and weakness in the arm that lasted about 9 months. In May2019, the patient experienced injection site reaction described as at the injection site there is a slight bruise about 1 inch in diameter and it is raised. The patient also felt a little pruritus, but it's not really itching. Then there is an area about 3 inches by 2.25 inches that is erythematous and has a noticeable border around it and is warm to the touch. It is warmer than the other tissue around it, but it does not look infected. It was not sure if the reaction was worsening yet or not. It seems to be going through its phases. Outcome of the events was unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio, Anion gap normal, Aspartate aminotransferase normal, Basophil count decreased
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Basophil percentage decreased, Bilirubin urine, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Blood calcium decreased, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine increased, Blood glucose normal
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Blood potassium normal, Blood pressure increased, Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Carbon dioxide normal, Dyspnoea, Eosinophil count decreased, Eosinophil percentage decreased, Globulin
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Glucose urine absent, Haematocrit normal, Haematuria, Haemoglobin increased, Headache
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Lymphocyte count decreased, Lymphocyte percentage decreased, Malaise, Mean cell haemoglobin concentration normal, Mean cell volume normal
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Monocyte count normal, Monocyte percentage, Neutrophil count normal, Neutrophil percentage increased, Nitrite urine absent
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Platelet count normal, Protein total normal, Protein urine absent, Pyrexia, Red blood cell count normal
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Red blood cells urine negative, Red cell distribution width normal, Specific gravity urine normal, Urine ketone body absent, Urobilinogen urine
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Vomiting, White blood cell count normal, White blood cells urine negative, pH urine normal
Clinical narrative: Fever to 103, headache, vomiting, malaise, shortness of breath that started six hours after the vaccine. Was evaluated in the emergency room on 5/22/19 due to not feeling well, cleared but noted to have elevated creatinine and BP. Followed up in office on 5/24/19 and noted to have microscropic hematuria but other symptoms had resolved
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Nausea, Pyrexia, Somnolence
Clinical narrative: extreme fatigue on the day following the injection; slept entire day; fatigue accompanied by fever from 99 - 100, slight nausea, and lack of appetite; on third day after injection slight fatigue, but no other symptoms none of these symptoms occurred after first injection -- then only very sore arm and some swelling at injection site
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Crying, Gaze palsy, Hypotonia, Immediate post-injection reaction, Respiratory arrest
Clinical narrative: Immediately after being injected with the vaccine, baby starts to cry and the nurse tells mom (me) to pick him up. I pick him up and try to comfort him and notice his eyes roll back, his whole body go limp, and he?s not breathing. At this point it had only been 20 seconds since being injected. I yell ?he?s not breathing? and the nurse leaves the room to get help. I laid him on the table and blew on his face and pushed his chest, he starts to cry again and is able to move again just as a team of nurses and doctors rush in. Doctor states that sometimes children pass out from holding their breath from crying too much or getting too upset.  They send us home.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Resuscitation
Clinical narrative: Immediately after being injected with the vaccine, baby starts to cry and the nurse tells mom (me) to pick him up. I pick him up and try to comfort him and notice his eyes roll back, his whole body go limp, and he?s not breathing. At this point it had only been 20 seconds since being injected. I yell ?he?s not breathing? and the nurse leaves the room to get help. I laid him on the table and blew on his face and pushed his chest, he starts to cry again and is able to move again just as a team of nurses and doctors rush in. Doctor states that sometimes children pass out from holding their breath from crying too much or getting too upset.  They send us home.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine administered via intramuscular and not subcutaneous.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash generalised
Clinical narrative: Got MMR-Varicella & Hep A, for first time,. Woke up Wed. AM with the rash all over. Mom gave him Benadryl 3 ml, it helped a little. No facial swelling or prob. breathing
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenitis, Pain
Clinical narrative: After the administration of the vaccine (Gardasil 9), patient gradually experienced left side pain near lymph nodes around subclavian over the next 5 days. Patient gradually progressed to lymphadenitis where patient sought to seek treatment.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Whole body ache on the following day
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Crying, Hyperventilation, Panic attack, Syncope
Clinical narrative: Patient was in office for well child exam.  Administered Menactra & Adacel to Patient and as recommended patient was being monitored for 15 minutes after vacciens. Prior to getting vaccines patient was very nervous about receiving vaccines . Mom was given VIS and both provider and MA discussed vaccines and potential for reaction as well as the recommendation to stay for 15 minutes after vaccines given.  Mom agreed with plan for patient to be monitored for 15 minutes after vaccines given.  Patient was alert but crying after vaccines.  Mom was left in the room with patient for monitoring. Ten minutes in to the 15 minute monitoring time mom began to yell for help.  Provider and other clinical staff entered exam room.   Mom stated that  patient fainted for a few seconds. No injury.    Patient was alert in room but was breathing heavy and crying. She then started to have a panic attack.   After reassurance  and some time lying down the patient began to calm. Mom stated patient had not eaten for sometime and so patient was given apple juice. Patient rechecked/monitored for 20 minutes and symptoms completely resolved.  Vitals rechecked  and stable just before leaving office .  Patient left office with mom on her own and mom made aware to call office with any concerns.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient had large (whole area of upper arm), red rash at injection site. Patient states slightly tender to the touch but not itchy. Some swelling of injection site. Told patient to apply some hydrocortisone cream to skin and use Benadryl at night. Also told to take ibuprofen to help with swelling and if did not improve over the next few days or got worse to contact her MD
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Inflammation, Injection site pain
Clinical narrative: Chills, soreness in muscles and joints, tiredness, pain at injection site  This vaccination was 2nd dose and I took Aleve over the counter pain medication for inflammation and pain. When I took Aleve on the 3rd day after injection, I got a little shakey. I don't know if it was adverse reaction from vaccination and aleve combined, or just the vaccination. I will never take Aleve again.  The 1st dose of Shingrix I had 4 months prior and took Tylenol over the counter for pain. I did not have this shaking.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Chills, soreness in muscles and joints, tiredness, pain at injection site  This vaccination was 2nd dose and I took Aleve over the counter pain medication for inflammation and pain. When I took Aleve on the 3rd day after injection, I got a little shakey. I don't know if it was adverse reaction from vaccination and aleve combined, or just the vaccination. I will never take Aleve again.  The 1st dose of Shingrix I had 4 months prior and took Tylenol over the counter for pain. I did not have this shaking.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Eczema
Clinical narrative: Patient received MMR and HIB 3/15/2019, then received the Varicella. On 4/10/2019 he developed new onset eczema- progressed to severe total body eczema over the course of the next month. No other changes in home environment/ no illness
Age: 0.5
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Patient developed rash on his body on 05/23/2019 10 days after he received MMR.  his mother contacted the Doctor office. rash got better by its own.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema
Clinical narrative: Parent called office with sx of redness of left thigh at injection site. Area noted to be 1/2 dollar sized. No fever or discomfort.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Rash
Clinical narrative: Rash, itching, prickly, a few eruptions
Age: 1.58
Sex: M
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: Pt developed seizure activity 11 days after vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypotonia, Musculoskeletal stiffness, Tremor
Clinical narrative: Approx. 1 hour - 1.5 hours after immunizations, while shopping--the child got very stiff all over, then began shaking, and then limp per report from mother.  This occurred in approximately 2 minutes.  911 was contacted and child was transferred to the hospital in an ambulance --.
Age: 14.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Chest discomfort, Dyspnoea, Pyrexia, Rash pruritic
Clinical narrative: Couple of days immediately following vaccines patient had a low-grade fever. One week after vaccinations patient had chest tightness and difficulty breathing, necessitating the use of an inhaler several times throughout the day. 14 days after the vaccinations patient broke out in an extremely itchy rash.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered
Clinical narrative: No adverse effects reported; patient inadvertently received a fourth dose of GARDASIL 9 as a medication error as the dose was intended for sister; patient inadvertently received a fourth dose of GARDASIL 9 as a medication error as the dose was intended for sister; patient inadvertently received a fourth dose of GARDASIL 9 as a medication error as the dose was intended for sister; This spontaneous report was received from a nurse and refers to a 17 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  In October 2013, the patient was vaccinated with their first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route and vaccination site were not provided), with a lot# reported "J009788" and expiration date 17-MAR-2016, for prophylaxis. In January January 2014,  the patient was vaccinated with their second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route and vaccination site were not provided), with a lot# reported "J009788" and expiration date 17-MAR-2016, for prophylaxis. In August 2015,  the patient was vaccinated with their third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route and vaccination site were not provided), with a lot# reported as "L010587" and an expiration date of 03-NOV-2016, for prophylaxis.  On 02-MAY-2019, the patient inadvertently received a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route and vaccination site were not provided), with a lot# of R011630 and expiration date of 12-DEC-2020, for prophylaxis as a medication error as the dose was intended for sister that came in at same time for an office visit.  This is one of two reports form the same reporter.; Sender's Comments:  US-009507513-1905USA011241:
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous report was received from a pharmacist concerning an over 65-years-old male patient.   The patient's medical history, concurrent conditions, drug reactions or allergies were unknown by the reporter.   On an unspecified date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, lot #, expiration date, anatomical location or route of administration were unknown by the reporter), administered for prophylaxis. The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was concomitantly administered with zoster rgE vaccine (mammalian) (SHINGRIX), and then the patient developed a fever. It was unknown if the patient sought medical attention, received treatment, if he had any diagnostic labs or studies performed. No further information was provided.  At the time of the report it was unknown if the patient had recovered from the event.   The causal relationship between the event and the vaccines was not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received a dose of MMR II following a potential temperature excursion.; no adverse event; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 20-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis, subcutaneously, lot # R035701 and expiration date 09-DEC-2020 following a potential temperature excursion (product storage error). The temperature and time frame were unknown by reporter. No previous temperature excursion was reported. No adverse effects were reported in the patient. The outcome of the event product storage error was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently received a fourth dose of GARDASIL 9 as a medication error as the dose was intended for sister; This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 02-MAY-2019, the patient sister inadvertently received a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route and vaccination site were not provided), with a lot# of R011630 and expiration date of 12-DEC-2020, for prophylaxis as a medication error as the dose was intended for the patient's relative that came in at same time for an office visit.  This is one of two reports form the same reporter.; Sender's Comments:  US-009507513-1905USA003273:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient complains of redness around the injection site which is warm and firm to the touch.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure decreased, Erythema, Fatigue, Hypotension, Swelling
Clinical narrative: Swelling, redness (4.0 x 5.0 cm), fatigue, mild hypotension which started the day after the vaccination.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling that extended to the elbow at injection site which appeared today on right deltoid.
Sex: M
Vaccine: HEP
Symptoms: Bacterial test, Biopsy skin, Blister, Eczema, Rash pruritic
Clinical narrative: Two different kinds of eczema; itchy blisters on feet and hands, spots on torso that got worse with each subsequent shot. Eczema appeared on torso when he was about 2-4 weeks old. Took to pcp who then told us to go to a dermatologist. Dermatologist did a bacteria culture, prescribed an oral (amoxicillin) and a topical (mupirocin) antibiotic, an antifungal and later a sulphur based antibiotic as they thought it was impetigo. All of this within the first six months of life.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal, Gaze palsy, Heart rate decreased, Hypotonia, Muscular weakness
Clinical narrative: Vaso-Vagal syncope with small seizure. Immediately upon receiving the vaccine, the patient?s head fell back, all the color drained from his face, his eyes rolled back. He had been sitting up in a chair at the time of the shot. His dad caught him as he slumped over. He jerked three times (his whole body) as if having a very brief seizure, then went limp. Dad laid him down on the floor. The nurse went to get the doctor (myself). I found the patient lying on the floor, eyes half open, and slightly disoriented. Dad said he did not fall and hit his head. I found his pulse to be 40 BPM. He was pale, not sweaty. Within about 15 seconds he become more oriented and stated he knew he was at Dr. office. HR continued to be low at 40 BPM. BP was 110/70. After several more minutes his HR improved to 60. The child rested on the floor for another 20 minutes. HR came up to 80 BPM. More alert. He was still complaining of feeling faint and ?weird? and wanted to keep lying down. Neuro exam was grossing WNL except that his left arm was slightly weaker than his right arm on exam. Injection site appeared normal. This report is being filed about 3 hours later.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor, Posture abnormal, Seizure, Syncope
Clinical narrative: Vaso-Vagal syncope with small seizure. Immediately upon receiving the vaccine, the patient?s head fell back, all the color drained from his face, his eyes rolled back. He had been sitting up in a chair at the time of the shot. His dad caught him as he slumped over. He jerked three times (his whole body) as if having a very brief seizure, then went limp. Dad laid him down on the floor. The nurse went to get the doctor (myself). I found the patient lying on the floor, eyes half open, and slightly disoriented. Dad said he did not fall and hit his head. I found his pulse to be 40 BPM. He was pale, not sweaty. Within about 15 seconds he become more oriented and stated he knew he was at Dr. office. HR continued to be low at 40 BPM. BP was 110/70. After several more minutes his HR improved to 60. The child rested on the floor for another 20 minutes. HR came up to 80 BPM. More alert. He was still complaining of feeling faint and ?weird? and wanted to keep lying down. Neuro exam was grossing WNL except that his left arm was slightly weaker than his right arm on exam. Injection site appeared normal. This report is being filed about 3 hours later.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient was given the Quadracel  in the right deltoid on 5/22/19. Mother reported baseball size area of redness, swelling to area of right deltoid on 5/23/19. Mom also said it was painful and warm to touch. She also noticed a red rash on abdomen and right forearm that had mostly resolved on 5/24/19. Treatment included cool compresses and Benadryl.  Mother was advised to notify clinic if no improvement or worsening of symptoms.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Rash macular
Clinical narrative: Spotted rash on both arms extending the full length of the arms appearing several days- 1 week after receiving vaccine.  Was prescribed prednisolone by doctor and was referred to dermatologist
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Disorientation, Dizziness, Impaired healing, Syncope, Tinnitus
Clinical narrative: After vaccine was administered the patient stated she felt dizzy and as I was helping her to lay on the floor she seemed to faint. Her body went face-down and fully straight on the floor. After 3 seconds, her body shook briefly and she rolled over onto her back with her eyes open. She smiled and said she was just "a little disoriented". I had her stay on the floor with her feet elevated and a cushion under her head while she hydrated. After 15 minutes she sat up on the floor for 15 more minutes. We then helped her into a chair for 15 additional minutes while she continued hydrating for a total of 3 water bottles. Her 2 sons drove her home, stopping for food along the way at restaurant. I then called at 8pm and suggested she see her physician the following day which she said she may go to the Urgent Care. Her main complaint after the event (while laying on the floor) was that her right ear was ringing and she was unable to hear out of it normally.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Developed rash on both arms extending the entire length of both arms several days to 1 week after administration.  Very itchy.  Pt was given prednisone and referred to dermatologist
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Diarrhoea, Irritability
Clinical narrative: She had explosive diarrhea for an entire month, along with extreme irritability and fussiness.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Inappropriate Schedule of Vaccine; Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number H547E, expiry date 22nd February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On 1st December 2018, 91 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for 2nd dose of Shingrix. The pharmacy technician reported a patient received Shingrix and broke out with Shingles in December. The reporter asked if patient could receive 2nd dose or restart series and till the time of reporting did not receive the 2nd dose, which led to incomplete course of vaccination.  It was unknown when Shingles resolved.  Technician said physician said to wait 6 months after Shingles clear prior to receiving 2nd dose. Provided phone number to MI and transferred, however, caller abandoned.
Sex: U
Vaccine: PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizures; This is a spontaneous report from a contactable physician received via a sales representative. A 12-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported) and flu vaccine, both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered flu and pneumococcal 13-val conj vac (dipht crm197 protein) in the same visit and experienced febrile seizure. The outcome of the event was unknown.  The information on the batch/lot number and expiration date has been requested.; Sender's Comments: Based on the information currently available, a contributory role of both suspected vaccines towards the occurrence of event febrile seizure cannot be fully excluded.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Nausea, Pain, Pain in extremity
Clinical narrative: 2 hours after injection left arm began to hurt intensely.  It felt like someone had hit me with a baseball bat.  Developed a high level of nausea and ache over entire body.  Was unable to get much sleep the night of the injection.  Day 2 - generally the same, very tired, still nauseous.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Face injury, Neck injury, Syncope
Clinical narrative: patient fainted while standing, hitting chin and neck on check out counter