chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMRV, PNC13
Symptoms: Antibody test positive, Erythema of eyelid, Injection site erythema, Injection site mass, Irritability
Clinical narrative: At about 5:30 pm on 2/27/2017 mom noticed local reactions which included a red lump at one of the injections sites  and patient had a  temp of 101.1 degrees. Tylenol was administered to assist with pain, fever and crankiness.  Patient was restless all thru the night and administered more tylenol at about 11pm that evening....mom noticed that patient's face seemed swollen....but wasnt sure.  Patient was still restless at 6 am and he was given  more tylenol and his face and eyes were swollen 3/4 of the way shut. Around his eyes were red with white blotchy spots. At 8a m mom called facility to speak with a nurse and to see if she could bring patient into be seen. Mom was told that it was all normal reactions and not to be worried unless his temp was higher than 103 degrees. At the next office visit we found out that moms call was never recorded in patient's patient chart.
Age: 1.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMRV, PNC13
Symptoms: Local reaction, Measles antibody positive, Mumps antibody test positive, Pain, Pyrexia
Clinical narrative: At about 5:30 pm on 2/27/2017 mom noticed local reactions which included a red lump at one of the injections sites  and patient had a  temp of 101.1 degrees. Tylenol was administered to assist with pain, fever and crankiness.  Patient was restless all thru the night and administered more tylenol at about 11pm that evening....mom noticed that patient's face seemed swollen....but wasnt sure.  Patient was still restless at 6 am and he was given  more tylenol and his face and eyes were swollen 3/4 of the way shut. Around his eyes were red with white blotchy spots. At 8a m mom called facility to speak with a nurse and to see if she could bring patient into be seen. Mom was told that it was all normal reactions and not to be worried unless his temp was higher than 103 degrees. At the next office visit we found out that moms call was never recorded in patient's patient chart.
Age: 1.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMRV, PNC13
Symptoms: Rash macular, Restlessness, Rubella antibody positive, Swelling face, Swelling of eyelid
Clinical narrative: At about 5:30 pm on 2/27/2017 mom noticed local reactions which included a red lump at one of the injections sites  and patient had a  temp of 101.1 degrees. Tylenol was administered to assist with pain, fever and crankiness.  Patient was restless all thru the night and administered more tylenol at about 11pm that evening....mom noticed that patient's face seemed swollen....but wasnt sure.  Patient was still restless at 6 am and he was given  more tylenol and his face and eyes were swollen 3/4 of the way shut. Around his eyes were red with white blotchy spots. At 8a m mom called facility to speak with a nurse and to see if she could bring patient into be seen. Mom was told that it was all normal reactions and not to be worried unless his temp was higher than 103 degrees. At the next office visit we found out that moms call was never recorded in patient's patient chart.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom reports she noticed swelling around the injection site approximately 30 minutes post vaccination.  No redness, heat or pain.  Swelling continued into the evening and Benadryl was given. Area continued to demonstrate swelling and erythema and patient followed up with pediatrician on 12/31/2020.  Pediatrician  advised continued Benadryl as needed for allergic reaction.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Patient had local reaction to injection site with rash, tender touch and warm and no Fever.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Anaphylactic reaction, Dyspnoea, Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Patient experienced nausea/vomiting, throat tightening, shortness of breath, numbness and tingling at the injection site, and inability to maintain consciousness.  She required medical assistance and was treated for anaphylaxis.  These symptoms appeared within 30 minutes of the injection and patient was fully recovered of symptoms after medical treatment and a period of about 6-8 hours of rest.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Throat tightness, Vomiting
Clinical narrative: Patient experienced nausea/vomiting, throat tightening, shortness of breath, numbness and tingling at the injection site, and inability to maintain consciousness.  She required medical assistance and was treated for anaphylaxis.  These symptoms appeared within 30 minutes of the injection and patient was fully recovered of symptoms after medical treatment and a period of about 6-8 hours of rest.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Woke up vomiting and have vomited twice more since waking.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: I received a flu vaccine on Thursday. Late Friday I began to feel very, very fatigued. This lasted all weekend and to a lesser degree for two more weeks. During this time I developed pain in the back of both of my lower legs. As of Nov. 3 I am still experiencing the pain all day and all night.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm >1 week after vaccination
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: none
Age: 71.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Laboratory test
Clinical narrative: Guillain-Barre syndrome
Age: 71.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Induration, Muscular weakness, Musculoskeletal disorder, Nerve injury
Clinical narrative: Guillain-Barre syndrome
Age: 71.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Walking aid user
Clinical narrative: Guillain-Barre syndrome
Age: 71.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Laboratory test
Clinical narrative: Patient started feeling weak in the legs, no use in right arm, hard spots on legs/stomach. Had a ER visit 3 days after vaccination and has been to 4 Hospitals. The 1st visit was at health clinic on 10/10/20. Then went back to same facility, 2nd visit: Heart hospital, 3rd visit (Neurology)-direct admit to 4th facility Hospital for Guillain-Barre Syndrome.  The reporter states patient is in the rehab for Hospital utilizing a                                                      Save        Now he has been moved to Medical Center rehab patient is using a walker to assist with walking and right hand nerves damage will have surgery. Walker to assist with walking and has nerve damage to right arm and will have to surgery done.
Age: 71.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Induration, Muscular weakness, Musculoskeletal disorder, Nerve injury
Clinical narrative: Patient started feeling weak in the legs, no use in right arm, hard spots on legs/stomach. Had a ER visit 3 days after vaccination and has been to 4 Hospitals. The 1st visit was at health clinic on 10/10/20. Then went back to same facility, 2nd visit: Heart hospital, 3rd visit (Neurology)-direct admit to 4th facility Hospital for Guillain-Barre Syndrome.  The reporter states patient is in the rehab for Hospital utilizing a                                                      Save        Now he has been moved to Medical Center rehab patient is using a walker to assist with walking and right hand nerves damage will have surgery. Walker to assist with walking and has nerve damage to right arm and will have to surgery done.
Age: 71.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Walking aid user
Clinical narrative: Patient started feeling weak in the legs, no use in right arm, hard spots on legs/stomach. Had a ER visit 3 days after vaccination and has been to 4 Hospitals. The 1st visit was at health clinic on 10/10/20. Then went back to same facility, 2nd visit: Heart hospital, 3rd visit (Neurology)-direct admit to 4th facility Hospital for Guillain-Barre Syndrome.  The reporter states patient is in the rehab for Hospital utilizing a                                                      Save        Now he has been moved to Medical Center rehab patient is using a walker to assist with walking and right hand nerves damage will have surgery. Walker to assist with walking and has nerve damage to right arm and will have to surgery done.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Abdominal distension, Haemoptysis, Nausea, Vomiting
Clinical narrative: Patient complained of N/V, stomach bloating, and cough up some blood on 10/30/2020.  She did not take any medications that evening.  When she complained on 11/3/2020, we gave her two 25mg Benadryl capsules.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm >1 week after vaccination
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Joint range of motion decreased, X-ray limb normal
Clinical narrative: Soreness in arm >1 week after vaccination
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chest pain, Diarrhoea, Malaise, Pyrexia, Respiratory rate increased
Clinical narrative: rec'vd flu shot, came home, cooked stuffed cabbage. 1.5 hr later, chest began hurting, breathing rapid. Went to lay down, got up and vomit with diareah. Was too sick to get up, stayed down on the floor, they called 911, stayed in the hospital for 3 days, was tested for covid-neg results. Pt was kept due to fever that was steady.
Age: 71.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: rec'vd flu shot, came home, cooked stuffed cabbage. 1.5 hr later, chest began hurting, breathing rapid. Went to lay down, got up and vomit with diareah. Was too sick to get up, stayed down on the floor, they called 911, stayed in the hospital for 3 days, was tested for covid-neg results. Pt was kept due to fever that was steady.
Age: 19.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: ASSESSMENT/PLAN:   1. Injection site reaction, initial encounter New problem to me. Discussed with patient that it is possible that she may have cellulitis of her left arm vs injection site reaction. Since she has had some improvement in symptoms over the past 2 days patient is going to monitor over the next 24 hours and if she still has pain, swelling, redness, or increased warmth she will start antibiotic as discussed.  Medication side effects were discussed with patient in detail. Patient voiced understanding without any questions or concerns.   Continue to use a warm compress, Motrin, and tylenol as discussed. Return to the office for persistent or worsening symptoms.  Patient advised and voiced understanding of instructions.     - cephalexin (KEFLEX) 500 MG capsule; Take 1 capsule by mouth 3 (three) times daily for 7 days.  Dispense: 21 capsule; Refill: 0      Patient is a 19 y.o. female    Today's visit was done via Telemedicine.     Patient presents today for possible immunization reaction. She had flu and pneumonia shot in her left arm on 10/28/20 and has had redness, swelling, increased warmth, and soreness at the injection site. Patient has had a fever up to 102.2 on Saturday but has not had another fever since that time. No abscess or drainage per patient. She states that her arm pain, swelling, and erythema have been slowing improving. She has been using Tylenol, Motrin, and cold compress with some improvement.    Patient's past medical, surgical, social and family histories as well as medications and allergies were reviewed and updated as appropriate
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm >2 weeks after vaccination
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: complain of pain in site of area 6 inches, no swelling or redness or bumps
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Feeling abnormal, Headache, Nausea, Pain in extremity
Clinical narrative: redness and  large swelling of left arm , 8cm/10 cm in size....painful  Not feeling good all day 11/012020 headache and nauseated Taking Tylenol and with to Advil on 11/02.2020  ice on the arm
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Peripheral swelling
Clinical narrative: redness and  large swelling of left arm , 8cm/10 cm in size....painful  Not feeling good all day 11/012020 headache and nauseated Taking Tylenol and with to Advil on 11/02.2020  ice on the arm
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; Patient was administered Improperly Stored ROTATEQ; This spontaneous report was received from a licensed practical nurse, referring to a 6-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 29-OCT-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number 1660998, which have been verified to be valid, expiration date reported and validated as 03-MAY-2021) as prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion above of 9 degrees Celsius (C) (9.7 degrees C) for 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.; Sender's Comments:  US-009507513-2010USA012044:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Shingrix vaccine soreness; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain 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 it was selected as adult as per the vaccine indication. The pateint asked for recommendation of pain killer for Shingrix vaccine soreness.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Nasopharyngitis, Product administered to patient of inappropriate age, Pyrexia, Rhinorrhoea
Clinical narrative: fever of 102F; administration of Kinrix to a 15 month old; 4th dose of DTaP; sinus sympomts (runny nose); having a cold; This case was reported by a nurse via call center representative and described the occurrence of cold in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2021) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Kinrix (unknown). In October 2020, less than a week after receiving Kinrix, the patient experienced cold and runny nose. On 22nd October 2020, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On 25th October 2020, the patient experienced fever. On an unknown date, the outcome of the cold, runny nose, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the cold, fever and runny nose to be related to Kinrix.  Additional details were provided as follows: The reporter stated that, aaftyer vaccination with Kinrix, the patient experienced fever of 102 farenite, sinus symptoms like runny nose, and diagnosed with cold. The patient received Kinrix at the age of 15 months old, which led to inappropriate age at vaccine administration. The patient received 4th on the series of DTaP, which led to inappropriate schedule of vaccine administered.  The reporter stated that, the patient pulling ears and MD confirmed that, the patient had no ear infection. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198844:same reporter
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Feeling cold, Headache, Inappropriate schedule of product administration
Clinical narrative: headache; uncomfortable stomach; muscle pain presented in his hips.; Felt cold; shivering; Temperature read 98.3.  At 5:00 am his temperature read 99.7; First dose in February 2020; Soreness, redness and rash at the injection site; Redness and rash at the injection site; Rash at the injection site; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2020.).   On 27th October 2020 09:00, the patient received the 9th dose of Shingrix .5 ml. In October 2020, less than a week after receiving Shingrix and an unknown time after starting Aspirin + Caffeine + Salicylamide, the patient experienced injection site pain, injection site erythema and injection site rash. On 27th October 2020, the patient experienced muscle pain, feeling cold, shivering, low grade fever and drug dose administration interval too long. On 28th October 2020, the patient experienced headache and stomach discomfort. The patient was treated with acetylsalicylic acid + caffeine + salicylamide (Aspirin + Caffeine + Salicylamide). In October 2020, the outcome of the muscle pain, feeling cold, shivering, headache and stomach discomfort were recovered/resolved. On 28th October 2020, the outcome of the low grade fever was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site rash were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the muscle pain, feeling cold, shivering, low grade fever, headache, stomach discomfort, injection site pain, injection site erythema and injection site rash to be related to Shingrix.  Additional details were reported as follows: The patient received the vaccine in the left arm and by the afternoon, muscle pain presented in his hips.  That evening he felt cold and was shivering and his temperature read 98.3 degree F at 5:00 am his temperature read 99.7.  He took aspirin and it came down.   A headache and uncomfortable stomach presented the next day.   All symptoms had resolved till the time of reporting except soreness, redness and rash at the injection site.   The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Myalgia, Pyrexia
Clinical narrative: headache; uncomfortable stomach; muscle pain presented in his hips.; Felt cold; shivering; Temperature read 98.3.  At 5:00 am his temperature read 99.7; First dose in February 2020; Soreness, redness and rash at the injection site; Redness and rash at the injection site; Rash at the injection site; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2020.).   On 27th October 2020 09:00, the patient received the 9th dose of Shingrix .5 ml. In October 2020, less than a week after receiving Shingrix and an unknown time after starting Aspirin + Caffeine + Salicylamide, the patient experienced injection site pain, injection site erythema and injection site rash. On 27th October 2020, the patient experienced muscle pain, feeling cold, shivering, low grade fever and drug dose administration interval too long. On 28th October 2020, the patient experienced headache and stomach discomfort. The patient was treated with acetylsalicylic acid + caffeine + salicylamide (Aspirin + Caffeine + Salicylamide). In October 2020, the outcome of the muscle pain, feeling cold, shivering, headache and stomach discomfort were recovered/resolved. On 28th October 2020, the outcome of the low grade fever was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site rash were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the muscle pain, feeling cold, shivering, low grade fever, headache, stomach discomfort, injection site pain, injection site erythema and injection site rash to be related to Shingrix.  Additional details were reported as follows: The patient received the vaccine in the left arm and by the afternoon, muscle pain presented in his hips.  That evening he felt cold and was shivering and his temperature read 98.3 degree F at 5:00 am his temperature read 99.7.  He took aspirin and it came down.   A headache and uncomfortable stomach presented the next day.   All symptoms had resolved till the time of reporting except soreness, redness and rash at the injection site.   The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: suffered from several outbreaks / also between 5-6days after this shot.; On Jul 2019 / received / first dose / today /is asking if/ can get the second; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (suffered from several outbreaks before getting Shingrix first dose).   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were 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 reported. Between 5 to 6 days after receiving firs dose Shingrix, the patient suffered from outbreak of Shingles. For this situation her physician did not authorized to complete the series but today this patient was asking if she can get the second dose. Till the date of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Insomnia, Pain in extremity
Clinical narrative: Woke up all night; Chest Pain; Left arm was painful; This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced difficulty sleeping, chest pain and pain in arm. On an unknown date, the outcome of the difficulty sleeping, chest pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the difficulty sleeping, chest pain and pain in arm to be related to Shingrix.  Additional details were provided as follows:  The patient woke up all night, experienced chest pain, and her left arm was painful for four to five days after the injection. The patient's reaction was very severe. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Incomplete course of vaccination
Clinical narrative: felt dizzy; received / vaccine in 2018 / not gotten the second dose; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced dizziness and incomplete course of vaccination. On an unknown date, the outcome of the dizziness was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: Reporter was patient's wife. The age at vaccination was not reported. In 2018, the patient received the 1st dose of Shingrix and he felt dizzy and had to sit down in the pharmacy for 20 to 30 minutes before being able to walk to the car. Till the time of reporting, the patient still had not gotten the 2nd dose of Shingrix, but reporter said he was getting it soon, which led to incomplete course of vaccination. The reporter did not consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: feeling unusually tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2020, the patient received Shingrix. In October 2020, 20 days after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and 20 days later, he was feeling unusually tired. The reporter did not consented to follow up.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Muscular weakness
Clinical narrative: no upper body strength; Muscle Weakness / body muscle weakness; This case was reported by a other health professional via call center representative and described the occurrence of strength loss of in a 57-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 22nd October 2020, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular). On 22nd October 2020, 4 hrs after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced strength loss of and muscle weakness. On an unknown date, the outcome of the strength loss of was unknown and the outcome of the muscle weakness was not recovered/not resolved.   It was unknown if the reporter considered the strength loss of and muscle weakness to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient was a healthcare professional. On 22nd October 2020, the patient received Fluarix vaccine and he went for his routine work out at the gym approximately four hours later, and he had no upper body strength. The patient continued to had body muscle weakness after one week since the vaccine. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: patient had stinging pain to bilateral abdomen injection site, the left site hurts more; bilateral injection site swelling; patient had stinging pain and swelling bilateral abdomen injection site; Initial information regarding an unsolicited valid non-serious case was received on 14-Oct-2020 from a nurse (on behalf of consumer) (Reference number- 00315838) and transmitted to Sanofi on 14-OCT-2020.  This case involves a 62 year-old male patient who experienced stinging bilateral abdomen pain (left site hurts more) and bilateral abdomen swelling at injection site (vaccination site inflammation), (vaccination site pain), (vaccination site swelling), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious stinging bilateral abdomen pain (left site hurts more) and bilateral abdomen  swelling at injection site (vaccination site inflammation), (vaccination site pain), (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.  There will be no information available on batch number for this case.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: patient's mother reported 8 hours after vaccination, patient was reported pain between her shoulder blades radiating up to her neck (patient is in remote learning during covid), patient denied swelling, redness, or soreness at injection site.    12 hours after vaccination, patient's mother reported over night patient had a 101 degree fever, treated with tylenol, body ache, vomitted twice, and headache.  patient still denies redness, soreness, and swelling at injection site
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: patient's mother reported 8 hours after vaccination, patient was reported pain between her shoulder blades radiating up to her neck (patient is in remote learning during covid), patient denied swelling, redness, or soreness at injection site.    12 hours after vaccination, patient's mother reported over night patient had a 101 degree fever, treated with tylenol, body ache, vomitted twice, and headache.  patient still denies redness, soreness, and swelling at injection site
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Temperature, up to 101.  Excruciating hives over entire body.
Age: 12.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash at injection site that spread to trunk & legs
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Nausea, Pruritus, Urticaria
Clinical narrative: Patient reported pruritis, nausea/vomiting, uricaria, vertigo, shivering, diarrhea. She has been treated with Tagamet, Prednisone, MEclizine, Zofran, and Clobetasol lotion.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo, Vomiting
Clinical narrative: Patient reported pruritis, nausea/vomiting, uricaria, vertigo, shivering, diarrhea. She has been treated with Tagamet, Prednisone, MEclizine, Zofran, and Clobetasol lotion.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Left arm feels heavy and sore, unable to lift and painful to move since it was administered.  Ibuprofen recommended.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Aldolase normal, Arthralgia, Asthenia, Blood creatine phosphokinase normal, C-reactive protein increased
Clinical narrative: Long standing hx of myalgia (fibromyagia). with neg Rheum labs. Pt received her first Shingrix vaccine in her right arm on 09OCT2020. No other vaccines have been administered in the past 11 months. That evening, she experienced a local site reaction described as swelling, redness, and pain around the injection site, as well as general malaise.  The next morning she states she was unable to move.  Her husband had to assist her out of bed. He describes her extremities a being stiff (not flaccid).  With movement, there was symmetrical pain in her shoulders, hips, thighs, hands and feet.  Over the next few days, she experienced weakness and pain (with motion) in her pelvic girdle making walking difficult. She recently has begun to use a wheelchair at providers' appointments.  Although she has seemingly FROM of all joints, here ADLs are limited by generalized weakness and pain, principally axially, but also involving her hands and feet.  She has noted some bilateral swelling of hands (and wrists) and ankles as well. There has been no noted warmth or erythema of any joints. These symptoms are most prominent upon awakening in the morning and better, albeit still present, by noon/early afternoon. She has noted mild global headache since vaccination.  She had a recent transient low-grade fever (COVID negative), but denies fevers in the past.  Laboratory evaluation reveals mildly elevated inflammatory markers (ESR/CRP), but little else.  CK, urine myoglobin, CBC. CMP,  COVID, c1q, aldolase all WNL. Started on low dose steroid for 7 days, to f/u Rheum and PCP, follow inflammatory markers
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Gait disturbance, Headache, Immune complex assay, Inflammatory marker increased
Clinical narrative: Long standing hx of myalgia (fibromyagia). with neg Rheum labs. Pt received her first Shingrix vaccine in her right arm on 09OCT2020. No other vaccines have been administered in the past 11 months. That evening, she experienced a local site reaction described as swelling, redness, and pain around the injection site, as well as general malaise.  The next morning she states she was unable to move.  Her husband had to assist her out of bed. He describes her extremities a being stiff (not flaccid).  With movement, there was symmetrical pain in her shoulders, hips, thighs, hands and feet.  Over the next few days, she experienced weakness and pain (with motion) in her pelvic girdle making walking difficult. She recently has begun to use a wheelchair at providers' appointments.  Although she has seemingly FROM of all joints, here ADLs are limited by generalized weakness and pain, principally axially, but also involving her hands and feet.  She has noted some bilateral swelling of hands (and wrists) and ankles as well. There has been no noted warmth or erythema of any joints. These symptoms are most prominent upon awakening in the morning and better, albeit still present, by noon/early afternoon. She has noted mild global headache since vaccination.  She had a recent transient low-grade fever (COVID negative), but denies fevers in the past.  Laboratory evaluation reveals mildly elevated inflammatory markers (ESR/CRP), but little else.  CK, urine myoglobin, CBC. CMP,  COVID, c1q, aldolase all WNL. Started on low dose steroid for 7 days, to f/u Rheum and PCP, follow inflammatory markers
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Joint swelling, Loss of personal independence in daily activities
Clinical narrative: Long standing hx of myalgia (fibromyagia). with neg Rheum labs. Pt received her first Shingrix vaccine in her right arm on 09OCT2020. No other vaccines have been administered in the past 11 months. That evening, she experienced a local site reaction described as swelling, redness, and pain around the injection site, as well as general malaise.  The next morning she states she was unable to move.  Her husband had to assist her out of bed. He describes her extremities a being stiff (not flaccid).  With movement, there was symmetrical pain in her shoulders, hips, thighs, hands and feet.  Over the next few days, she experienced weakness and pain (with motion) in her pelvic girdle making walking difficult. She recently has begun to use a wheelchair at providers' appointments.  Although she has seemingly FROM of all joints, here ADLs are limited by generalized weakness and pain, principally axially, but also involving her hands and feet.  She has noted some bilateral swelling of hands (and wrists) and ankles as well. There has been no noted warmth or erythema of any joints. These symptoms are most prominent upon awakening in the morning and better, albeit still present, by noon/early afternoon. She has noted mild global headache since vaccination.  She had a recent transient low-grade fever (COVID negative), but denies fevers in the past.  Laboratory evaluation reveals mildly elevated inflammatory markers (ESR/CRP), but little else.  CK, urine myoglobin, CBC. CMP,  COVID, c1q, aldolase all WNL. Started on low dose steroid for 7 days, to f/u Rheum and PCP, follow inflammatory markers
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Metabolic function test normal, Mobility decreased, Musculoskeletal stiffness, Myoglobin urine absent
Clinical narrative: Long standing hx of myalgia (fibromyagia). with neg Rheum labs. Pt received her first Shingrix vaccine in her right arm on 09OCT2020. No other vaccines have been administered in the past 11 months. That evening, she experienced a local site reaction described as swelling, redness, and pain around the injection site, as well as general malaise.  The next morning she states she was unable to move.  Her husband had to assist her out of bed. He describes her extremities a being stiff (not flaccid).  With movement, there was symmetrical pain in her shoulders, hips, thighs, hands and feet.  Over the next few days, she experienced weakness and pain (with motion) in her pelvic girdle making walking difficult. She recently has begun to use a wheelchair at providers' appointments.  Although she has seemingly FROM of all joints, here ADLs are limited by generalized weakness and pain, principally axially, but also involving her hands and feet.  She has noted some bilateral swelling of hands (and wrists) and ankles as well. There has been no noted warmth or erythema of any joints. These symptoms are most prominent upon awakening in the morning and better, albeit still present, by noon/early afternoon. She has noted mild global headache since vaccination.  She had a recent transient low-grade fever (COVID negative), but denies fevers in the past.  Laboratory evaluation reveals mildly elevated inflammatory markers (ESR/CRP), but little else.  CK, urine myoglobin, CBC. CMP,  COVID, c1q, aldolase all WNL. Started on low dose steroid for 7 days, to f/u Rheum and PCP, follow inflammatory markers
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pelvic girdle pain, Peripheral swelling, Pyrexia
Clinical narrative: Long standing hx of myalgia (fibromyagia). with neg Rheum labs. Pt received her first Shingrix vaccine in her right arm on 09OCT2020. No other vaccines have been administered in the past 11 months. That evening, she experienced a local site reaction described as swelling, redness, and pain around the injection site, as well as general malaise.  The next morning she states she was unable to move.  Her husband had to assist her out of bed. He describes her extremities a being stiff (not flaccid).  With movement, there was symmetrical pain in her shoulders, hips, thighs, hands and feet.  Over the next few days, she experienced weakness and pain (with motion) in her pelvic girdle making walking difficult. She recently has begun to use a wheelchair at providers' appointments.  Although she has seemingly FROM of all joints, here ADLs are limited by generalized weakness and pain, principally axially, but also involving her hands and feet.  She has noted some bilateral swelling of hands (and wrists) and ankles as well. There has been no noted warmth or erythema of any joints. These symptoms are most prominent upon awakening in the morning and better, albeit still present, by noon/early afternoon. She has noted mild global headache since vaccination.  She had a recent transient low-grade fever (COVID negative), but denies fevers in the past.  Laboratory evaluation reveals mildly elevated inflammatory markers (ESR/CRP), but little else.  CK, urine myoglobin, CBC. CMP,  COVID, c1q, aldolase all WNL. Started on low dose steroid for 7 days, to f/u Rheum and PCP, follow inflammatory markers
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate increased, SARS-CoV-2 test negative, Wheelchair user
Clinical narrative: Long standing hx of myalgia (fibromyagia). with neg Rheum labs. Pt received her first Shingrix vaccine in her right arm on 09OCT2020. No other vaccines have been administered in the past 11 months. That evening, she experienced a local site reaction described as swelling, redness, and pain around the injection site, as well as general malaise.  The next morning she states she was unable to move.  Her husband had to assist her out of bed. He describes her extremities a being stiff (not flaccid).  With movement, there was symmetrical pain in her shoulders, hips, thighs, hands and feet.  Over the next few days, she experienced weakness and pain (with motion) in her pelvic girdle making walking difficult. She recently has begun to use a wheelchair at providers' appointments.  Although she has seemingly FROM of all joints, here ADLs are limited by generalized weakness and pain, principally axially, but also involving her hands and feet.  She has noted some bilateral swelling of hands (and wrists) and ankles as well. There has been no noted warmth or erythema of any joints. These symptoms are most prominent upon awakening in the morning and better, albeit still present, by noon/early afternoon. She has noted mild global headache since vaccination.  She had a recent transient low-grade fever (COVID negative), but denies fevers in the past.  Laboratory evaluation reveals mildly elevated inflammatory markers (ESR/CRP), but little else.  CK, urine myoglobin, CBC. CMP,  COVID, c1q, aldolase all WNL. Started on low dose steroid for 7 days, to f/u Rheum and PCP, follow inflammatory markers
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Injection site erythema, Pyrexia, Ventricular extrasystoles
Clinical narrative: 2 hours after vaccination, there was approximately 1 inchX 0.5 inch redness half inch below the injection site.  The next day at 7 AM, I was having chills and frequent cough spells precipitated by PVCs and in the evening I developed worsening chills and a fever with temperature of 101.9 to 102.4.  Also, the redness on my arm increased in size to 3 or 4 times larger.  Its size once again incread significantly on 11/1/2020.  I went to an urgent clinic for evaluation and treatment. I am currently being treated with Cephalexin 500 mg 4 times a day for 10 days.  On 11/2/2020-seen at another medical facility to report adverse reactions.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Gait disturbance, Irritability, Lethargy, Moaning
Clinical narrative: 10/22 -MMR vaccine  10/29 full body rash  later comes high fever  10/30 projectile vomiting high fever over 103  10/31 projectile vomiting high fever 104 11/1 104.2 fever lethargic vomiting -goes to ER - swabbed for everything all negative  11/2 pediatrician follow up 104.7 in office.  Re swabbed for flu and strep. All negative.  Wouldn?t eat or drink  11/3 body aches and pain  moaning in his sleep irritable restless doesn?t want to walk without fretting like in pain
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Pain, Pyrexia, Rash, Restlessness, Vomiting
Clinical narrative: 10/22 -MMR vaccine  10/29 full body rash  later comes high fever  10/30 projectile vomiting high fever over 103  10/31 projectile vomiting high fever 104 11/1 104.2 fever lethargic vomiting -goes to ER - swabbed for everything all negative  11/2 pediatrician follow up 104.7 in office.  Re swabbed for flu and strep. All negative.  Wouldn?t eat or drink  11/3 body aches and pain  moaning in his sleep irritable restless doesn?t want to walk without fretting like in pain
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Vomiting projectile
Clinical narrative: 10/22 -MMR vaccine  10/29 full body rash  later comes high fever  10/30 projectile vomiting high fever over 103  10/31 projectile vomiting high fever 104 11/1 104.2 fever lethargic vomiting -goes to ER - swabbed for everything all negative  11/2 pediatrician follow up 104.7 in office.  Re swabbed for flu and strep. All negative.  Wouldn?t eat or drink  11/3 body aches and pain  moaning in his sleep irritable restless doesn?t want to walk without fretting like in pain
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Electrocardiogram normal, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Headache,aches, stiff neck & along spine, heart racing, bouts of high anxiety lasting 6 plus hours.  Duration- 2weeks.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations
Clinical narrative: Headache,aches, stiff neck & along spine, heart racing, bouts of high anxiety lasting 6 plus hours.  Duration- 2weeks.
Age: 30.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Allergy test, Allergy to vaccine, Hypersensitivity, Obstructive airways disorder
Clinical narrative: Patient recieved his first Gardisil shot when he was 30 years of age. The exact date of his shot was July 3, 2019, and within 9 days (precisely July 12, 2019), Patient was rushed to a nearby Urgent Care facility and injected with a steroid to stop the closing of his airways due to a severe allergic reaction. For the next several months patient suffered multiple (continued on next page).
Age: 30.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abnormal behaviour, Agoraphobia, Allergy test, Asthenia, Emotional disorder
Clinical narrative: Patient recieved his first Gardisil shot when he was 30 years of age. The exact date of his shot was July 3, 2019, and within 9 days (precisely July 12, 2019), Patient was rushed to a nearby Urgent Care facility and injected with a steroid to stop the closing of his airways due to a severe allergic reaction. For the next several months patient suffered multiple (continued on next page).
Age: 30.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Fear-related avoidance of activities, Food allergy, Frustration tolerance decreased, Helplessness, Hypersensitivity
Clinical narrative: Patient recieved his first Gardisil shot when he was 30 years of age. The exact date of his shot was July 3, 2019, and within 9 days (precisely July 12, 2019), Patient was rushed to a nearby Urgent Care facility and injected with a steroid to stop the closing of his airways due to a severe allergic reaction. For the next several months patient suffered multiple (continued on next page).
Age: 30.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Mental disorder, Obstructive airways disorder, Panic attack
Clinical narrative: Patient recieved his first Gardisil shot when he was 30 years of age. The exact date of his shot was July 3, 2019, and within 9 days (precisely July 12, 2019), Patient was rushed to a nearby Urgent Care facility and injected with a steroid to stop the closing of his airways due to a severe allergic reaction. For the next several months patient suffered multiple (continued on next page).