chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness; warmth; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported however captured as adult as per the vaccine indication. The nurse reports giving 20 vaccinations this week.  Out of this lot of Shingrix, one patient received the dose of Shingrix and complained of redness at the site, warm to the touch at the injection site.  The nurse reports no reports of adverse experience prior to this lot . The vaccine shortage was mentioned.  No additional details provided.  The nurse stated that due to workload, she was unable to provide requested data but can supply at a later time. This is 1 of the 4 linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: soreness at injection site; redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that she had soreness and redness at the injection site with her 1st dose of Shingrix, but no reaction with the 2nd dose. The reporter gave consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness at injection site; swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number KC9C4, expiry date 30th March 2020) for prophylaxis.   On 30th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The batch number of Shingrix was reported as KC9G4. However, based on a safety lot number review, the batch number was updated to KC9C4.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Varicella virus test positive
Clinical narrative: Myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was not recovered/not resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician was trying to determine if the problem was associated with the vaccine that was given to the patient in October.  The physician inquired if there would be an elevation in Varicella Igm post, vaccination if so, then how long it would be there. The physician also inquired that how long does the Myalgia last and where was it mostly localized. No additional data was supplied. The physician refused to give data due to accountability act.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: rash on her stomach; itchy; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included leukemia, shingles (healing, outbreak with PHN) and post herpetic neuralgia (pre-vaccination). Concurrent medical conditions included immunocompromised. Concomitant products included allergy medication {nos} (Allergy Pill) and silver (Silver Solution).   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 23rd April 2019, 1 days after receiving Shingrix, the patient experienced itchy rash. On 3rd May 2019, the patient experienced rash. On an unknown date, the outcome of the itchy rash and rash were unknown.   It was unknown if the reporter considered the itchy rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On next day of receiving Shingrix, the patient developed an intermittently itchy rash on her entire left arm. At the time of call, the patient reported that she had a rash on her stomach of unknown cause. At the time of the call, the symptoms were not reported to be resolved. The reporter given the permission for physician contact.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Pyrexia, Swelling, Tenderness
Clinical narrative: Redness; Swelling; Itching; Tenderness; Fever; This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number: X39679, Expiration date was not reported) on 24Apr2019 (11:27), with route of administration unspecified, at a single dose for immunization. Medical history included diabetes mellitus 2 (DM2); irritable bowel syndrome (IBS); gastrooesophageal reflux disease; and hypertension (HTN). There were no concomitant medications. On 24Apr2019, the patient had redness. On an unspecified date in 2019, the patient had swelling, itching, tenderness and fever. The outcome of the events, redness, swelling, itching, tenderness and fever, were unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection on a frequent basis; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age and gender receives pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash at site of injection on a frequent basis on an unknown date. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Headache, Pain, Skin warm
Clinical narrative: Patient contacts pharmacy on 5/1/19 concerning symptoms that have developed after receiving  the 2nd Shingrex vaccine on 4/30/19. Patient has been experienceing body aches, temperature (treated with acetaminophen),  shivering, and headache, which started later on 5/1/19.  Upon additional follow-up,  patient reports developing a round, raised welt on 5/2/19 that was feverish to the touch. Patient reports that the welt went away on 5/5/19, and that she used Benadryl to treat it.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient contacts pharmacy on 5/1/19 concerning symptoms that have developed after receiving  the 2nd Shingrex vaccine on 4/30/19. Patient has been experienceing body aches, temperature (treated with acetaminophen),  shivering, and headache, which started later on 5/1/19.  Upon additional follow-up,  patient reports developing a round, raised welt on 5/2/19 that was feverish to the touch. Patient reports that the welt went away on 5/5/19, and that she used Benadryl to treat it.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Dermatitis, Eczema
Clinical narrative: Wide spread dermatitis similar to eczema the day following the booster injection
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth, Product administered at inappropriate site
Clinical narrative: I initially my upper right arm was extremely sore.  I also  had a 3 inch red, raised, hot rash.  It lasted for approximately 10 days.  It also was and continues to be very itchy, even though it is 19 days later.  The symptom that I am most worried about though is pain that exists approximately halfway down the lateral side of my right upper arm.  This is where the deltoid muscle's tendon is.  I believe that the pharmacist, who gave me my injection did so too far down on my arm, thus causing this pain.  I have an image of my arm when it had the rash and you can clearly see that the epicenter of this rash, where she injected me is not in the meaty part of the deltoid.  This pain is becoming increasingly worse as time goes on.  I have images I can share with you if you want to see them.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: I initially my upper right arm was extremely sore.  I also  had a 3 inch red, raised, hot rash.  It lasted for approximately 10 days.  It also was and continues to be very itchy, even though it is 19 days later.  The symptom that I am most worried about though is pain that exists approximately halfway down the lateral side of my right upper arm.  This is where the deltoid muscle's tendon is.  I believe that the pharmacist, who gave me my injection did so too far down on my arm, thus causing this pain.  I have an image of my arm when it had the rash and you can clearly see that the epicenter of this rash, where she injected me is not in the meaty part of the deltoid.  This pain is becoming increasingly worse as time goes on.  I have images I can share with you if you want to see them.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Chest discomfort, Erythema, Retching, Swelling, Urticaria
Clinical narrative: Vomited, dry heave, hives,  redness, tightness, and swollen.  Mother spoke with RN and on call provider. Mother took pt to an urgent care on Saturday. She was instructed to monitor pt. Give benadry and Zyrtec. If becomes worse call PCP.  Pt went to school today. Still has redness.  Offer to be seen at PCP's office to f/u. Mother declined due to conflict with work. Advised to continue monitor pt. Call us back if becomes worse.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Vomiting
Clinical narrative: Vomited, dry heave, hives,  redness, tightness, and swollen.  Mother spoke with RN and on call provider. Mother took pt to an urgent care on Saturday. She was instructed to monitor pt. Give benadry and Zyrtec. If becomes worse call PCP.  Pt went to school today. Still has redness.  Offer to be seen at PCP's office to f/u. Mother declined due to conflict with work. Advised to continue monitor pt. Call us back if becomes worse.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Skin lesion, Urticaria
Clinical narrative: On 12/19/18, patient received a dose of the Shingrix vaccination. Three hours after injection, she broke out in itchy hives. On 12/20/2018, she was treated with Prednisone 40mg x 3 days. The rash did resolve, however reappeared 3 days after being off of the prednisone. On 12/27/2018, patient was given a prednisone taper pack for 13 days. All of her symptoms went away, and then reappeared 3 days later. on 1/14/19, she was seen again due to the rash reappearing. The rash appears as welts and is pruritic. She started taking Zyrtec and occasional benadryl in the evenings. She added pepcid to the mix ans well as a topical triamcinolone cream.  She was seen again on 3/22/19 for the same rash which is on her trunk, arms, and palms. She is prescribed clobetasol 0.0s%Q topical, Prednisone 20mg taper, and is also being referred to dermatology. On 4/11/19, she saw dermatology for the rash. She was prescribed zantac 300mg BID with flare up. She followed up on 4/16 with dermatology having red hive-like patches on her hands, trunk, and hairline that resolve with prednisone. The lesions on the hand look like a bruise and start feeling like a "sticker"sensation, the the palm is red and itchy. The lesions last longer than 24 hours. She is diagnosed with urticaria and dermatology believes her rash may be secondary to the Shingrix vaccine. She has a follow-up appointment in 6 weeks.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pruritus, Skin lesion, Skin warm
Clinical narrative: "Warmth, erythema on lesion with complaint of pruritus."
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Joint stiffness, Pain, Pain in extremity
Clinical narrative: Immediately he had upper arm soreness and elbow tightness. Patient reported that it was painful  to pull his arm tight to his chest. The upper arm soreness only lasted 2-3 days but the elbow pain has lasted almost a week.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase increased, Blood urea increased, Differential white blood cell count normal, Erythema, Full blood count normal
Clinical narrative: Day 2 reports a red streak on his arm, and his arm is vary painful Day 2-4 Fevers, Sweats, pain all over body.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Metabolic function test abnormal, Pain, Pain in extremity, Platelet count decreased
Clinical narrative: Day 2 reports a red streak on his arm, and his arm is vary painful Day 2-4 Fevers, Sweats, pain all over body.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Day 2 reports a red streak on his arm, and his arm is vary painful Day 2-4 Fevers, Sweats, pain all over body.
Age: 24.0
Sex: F
Vaccine: PPV, TDAP, TYP
Symptoms: Arthralgia, Chills, Erythema, Headache, Musculoskeletal disorder
Clinical narrative: Left arm with Pneumococcal polysaccharide, fever of 101.7 within 24 hours, extreme pain the next day and vomiting, but large (about 5 1/2 inch spot) swelling and redness appeared on 5/9, and on 5/9 also began having chills, headaches, body aches and join pain - especially ankles, knees and neck. Appearance of redness was consistent with the picture in this study. Doctor has a picture of the reaction if desired for further data collection. Searing pain and left arm unable to use for 4 days, fever and chills subsided on 5/12, redness started to dissipate down the arm on 5/11. Still red from the lower bicep to about 3 in below the elbow as of. 5/13  just regaining movement back in the arm.
Age: 24.0
Sex: F
Vaccine: PPV, TDAP, TYP
Symptoms: Neck pain, Pain, Pyrexia, Swelling, Vomiting
Clinical narrative: Left arm with Pneumococcal polysaccharide, fever of 101.7 within 24 hours, extreme pain the next day and vomiting, but large (about 5 1/2 inch spot) swelling and redness appeared on 5/9, and on 5/9 also began having chills, headaches, body aches and join pain - especially ankles, knees and neck. Appearance of redness was consistent with the picture in this study. Doctor has a picture of the reaction if desired for further data collection. Searing pain and left arm unable to use for 4 days, fever and chills subsided on 5/12, redness started to dissipate down the arm on 5/11. Still red from the lower bicep to about 3 in below the elbow as of. 5/13  just regaining movement back in the arm.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Expired product administered
Clinical narrative: vaccine expired 3 days prior to administration. Manufacture called and stated they support that the vaccine is valid.
Age: 62.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Rash
Clinical narrative: patient received MMR vaccine on 4-30-19 at office visit. patient called office in am on 5-13-19 with chills and rash on chest back and face.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Nodule
Clinical narrative: DONOR FELT PAIN IN HIS LEFT ARM AT THE INJECTION SITE ON 05-09-19, WHEN HE RUBBED HIS ARM  HE FELT A KNOT.  NO TREATMENTS HAVE BEEN DONE. DONOR STATED THAT HE WILL GET IT CHECKED OUT THIS WEEK.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse reaction was reported. No other AE information reported; believes that it was injected into the muscle; This spontaneous report was received from a female patient of unknown age reporting on herself.The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On approximately on April 2019 (reported as about one month ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 0.5 ml, 1 dose, subcutaneous, for prophylaxis(dosage schedule, anatomical location, lot number and expiration date were not reported).       On the same day, the patient believed that she was injected into the muscle (inappropriate route of vaccination).   The outcome of incorrect route of product administration and no adverse event is unknown.  No adverse reaction was reported.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: age 13 years, patient received GARDASIL 9, the first dose/received GARDASIL 9, the second dose on unspecified date at age 15 years; no adverse effects; This spontaneous report was received from a pharmacist and refers to a 15-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date (in an age of 9 years), the patient received first dose of  vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, site and route of administration, lot # and expiration date were not reported).       On an unknown date (in an age of 15 years), the patient received second dose of vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (lot number: R02757, expiration date on 23-JUN-2021; site and route of administration were not reported). No adverse effects were reported.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: Redness on arm; Tenderness on arm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 1st May 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were unknown.   It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix in the right deltoid and had experienced red and tender to touch area the size of the palm.  The reporter has been gathered the patient information.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Epistaxis, Feeling of body temperature change, Mouth haemorrhage
Clinical narrative: feeling hot and cold; nosebleed; she was brushing her teeth, she noticed blood in her saliva; This case was reported by a pharmacist via call center representative and described the occurrence of epistaxis in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number HB2B2, expiry date 13th April 2020) for prophylaxis.   On 30th April 2019, the patient received Shingrix (intramuscular) .5 ml. On 2nd May 2019, 2 days after receiving Shingrix, the patient experienced epistaxis and mouth hemorrhage. On an unknown date, the patient experienced feeling hot and cold. On an unknown date, the outcome of the epistaxis, mouth hemorrhage and feeling hot and cold were unknown.   It was unknown if the reporter considered the epistaxis, mouth hemorrhage and feeling hot and cold to be related to Shingrix.  Additional case details were provided as follows: The patient received dose of Shingrix in the left deltoid and was feeling hot and cold, nosebleed and while she was brushing her teeth, she noticed blood in her saliva.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness at injection site; soreness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but taken as an adult as per vaccine indication. The reporter reported that, a lot of patients experienced soarness and redness at the injection site after vaccination. No specific patient demographics provided.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Full blood count normal, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 91-year-old female patient who received SHINGRIX for prophylaxis.  On 30th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2019, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis (serious criteria GSK medically significant), extensive swelling of limb, injection site warmth and injection site pain. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the injection site cellulitis, extensive swelling of vaccinated limb, injection site warmth and injection site pain were unknown. It was unknown if the reporter considered the injection site cellulitis, extensive swelling of vaccinated limb, injection site warmth and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left deltoid. Last night of the reporting day, the patient woke up with a swollen arm around the injection site area. The patient drove herself to the emergency room and she was diagnosed with possible cellulitis and sent home with prescription for antibiotics. The batient's blood count (CBC) was normal and patient did not have a fever. The repojrter described area of swelling as being 3 x 5 inches in size, raised and warm to the touch and painful.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 91-year-old female patient who received SHINGRIX for prophylaxis.  On 30th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2019, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis (serious criteria GSK medically significant), extensive swelling of limb, injection site warmth and injection site pain. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the injection site cellulitis, extensive swelling of vaccinated limb, injection site warmth and injection site pain were unknown. It was unknown if the reporter considered the injection site cellulitis, extensive swelling of vaccinated limb, injection site warmth and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left deltoid. Last night of the reporting day, the patient woke up with a swollen arm around the injection site area. The patient drove herself to the emergency room and she was diagnosed with possible cellulitis and sent home with prescription for antibiotics. The batient's blood count (CBC) was normal and patient did not have a fever. The repojrter described area of swelling as being 3 x 5 inches in size, raised and warm to the touch and painful.
Age: 25.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: None at the time vaccine given and none reported since 3-26-19.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Altered state of consciousness, Asthenia, Injection site pain
Clinical narrative: Patients husband called to state that he believes the patienthad a reaction to the vaccines that she receivedyesterday on 04/04/2019. Husband stated that the wife complained of pain at the injection site where the vaccine was administered. He also stated felt "weak" and almost passed out on 04/05/2019. Reffered husband to take wife to the emergency room.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dehydration, Dizziness, Laboratory test normal, Loss of consciousness, Muscular weakness
Clinical narrative: One Tuesday, March 12, I began to experience dizziness when I got up from a sitting position. I incorrectly reported this as vertigo. Later that day, around 5pm I set out on a 10 minute walk to the bus stop for dinner. I began to feel pronounced muscle weakness in my legs and had to sit down and rest twice in 10 minutes, at the bus stop I settled into a squatting position to wait for the bus. When I tried to get up I blacked out completely. When I came to after perhaps a minute I was completely alert but had numerous cuts and abrasion (all minor) on my hands and face. Witness called for an ambulance to the ER at Heart. There I was told that all my lab results were good and I could go home. My final diagnosis, based on doctor's evaluation and the information provided by the CDC, was that the incident was caused primarily by a bad reaction to the shingirx vaccine aggravated by dehydration. Note that this took place four days after the shot, not minutes or hours as your warning indicated. Future warning given with the shot should include this possibilities so people can maintain reaction caution for several days.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin abrasion, Skin laceration, Vaccination complication
Clinical narrative: One Tuesday, March 12, I began to experience dizziness when I got up from a sitting position. I incorrectly reported this as vertigo. Later that day, around 5pm I set out on a 10 minute walk to the bus stop for dinner. I began to feel pronounced muscle weakness in my legs and had to sit down and rest twice in 10 minutes, at the bus stop I settled into a squatting position to wait for the bus. When I tried to get up I blacked out completely. When I came to after perhaps a minute I was completely alert but had numerous cuts and abrasion (all minor) on my hands and face. Witness called for an ambulance to the ER at Heart. There I was told that all my lab results were good and I could go home. My final diagnosis, based on doctor's evaluation and the information provided by the CDC, was that the incident was caused primarily by a bad reaction to the shingirx vaccine aggravated by dehydration. Note that this took place four days after the shot, not minutes or hours as your warning indicated. Future warning given with the shot should include this possibilities so people can maintain reaction caution for several days.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Swelling, Tenderness
Clinical narrative: tenderness, increased swelling, itching
Age: 0.67
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given at incorrect time.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Developmental regression, Speech disorder developmental
Clinical narrative: Parent states child had reaction to vaccine at 12 months of age - see attached letter. I am writing today to report an adverse side effect to vaccines given to my child back in 2017. My son, was seen at Pediatrics on April 26th, 2017 for his 12 month well check. At this visit, he received the Hep A, MMR, Varicella and Pneumo vaccines. On this date, son was a little over 12 months old. We had no concerns about his development; he was hitting milestones early and his vocabulary was growing. He frequently used simple words, such as Mom, Dad, more, no, and "more bites" just to list some examples. On April 27th, the day after his 12 month doctor visit, we noticed a very sudden change. All of the words he used to say and use properly were now all pronounced as "Buh." His dad and I noticed this immediately, but did not get too concerned until a few days had gone by and his normal speaking habits did not return. Multiple family members noticed this change as well. Son was over 18 months old when he began using simple words again. For over 6 months, the only thing he said was "Buh." After this incident, we have been very reluctant to have any more vaccines administered. Son is now 3 years old and his speech is no longer concern; he has a wide vocabulary and can speak in full sentences. Son's dad and I both believe that his speech regression was a direct effect of one or more of his 12 month vaccines. Please feel free to reach out to me with any questions you may have.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Somnolence
Clinical narrative: Tue Nausea and Headache 15 or so minutes after shot same evening severe shivering Wed Next day tired, drifting off to sleep a lot First noticed hives about 4 pm when I was getting ready to shower
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Tue Nausea and Headache 15 or so minutes after shot same evening severe shivering Wed Next day tired, drifting off to sleep a lot First noticed hives about 4 pm when I was getting ready to shower
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Lumbar puncture normal, Pyrexia, Seizure, Septic screen
Clinical narrative: Seizure 1.5 hr. Tactile fever - hospitalized for 3 days.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Vaccination site bruising, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: red raised area at vaccination site. centralized bruising. tenderness with touching. warm to touch
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Shoulder/Neck pain reaction
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Local reaction, Pyrexia
Clinical narrative: localized reaction. fever
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Mobility decreased, Nausea, Pain
Clinical narrative: I had a severe case of the flu, terrible body aches, could not get out of bed for two days, nausea, etc.  The same thing happened when I received the first dose.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: redness and tenderness at vaccination site
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Feeling abnormal, Injection site erythema, Injection site pain, Pain
Clinical narrative: 5/09/2019-99.8 FEVER AND ACHY ALL OVER, STOMACH ACH --STARTED LAST NIGHT , BEEN TAKING APAP Q4HRS STILL DOES NOT FEEL GOOD.---5/10/2019-SORENESS STILL AND A RED RECTANGLE NEAR THE SHOT ABOUT 3 INCHES AWAY. 5/12-SYMPTOMS ALL RESOLVED
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 5/09/2019-99.8 FEVER AND ACHY ALL OVER, STOMACH ACH --STARTED LAST NIGHT , BEEN TAKING APAP Q4HRS STILL DOES NOT FEEL GOOD.---5/10/2019-SORENESS STILL AND A RED RECTANGLE NEAR THE SHOT ABOUT 3 INCHES AWAY. 5/12-SYMPTOMS ALL RESOLVED
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Chest X-ray, Chest pain, Electrocardiogram normal, Pain in extremity
Clinical narrative: PT C/O PAIN IN BOTH ARMS THEN CHEST PAIN, NO CHEST PAIN ON FRIDAY OR SATURDAY, THEN CHEST PAIN RETURNED ON SUNDAY RETURNED TO CLINIC ON 5-13-19 WITH CONTINUED INTERMITTENT CHEST PAIN
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersomnia, Influenza like illness, Lethargy, Pyrexia
Clinical narrative: Pt reported fever for 4 days, flu like symptoms for 7 days, lethargic sleeping day and night for 2 days, patch of redness 4 inches in diameter (soft to touch but very hot) for 3 weeks - still some redness but about 1/4 the size.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Pt reported fever for 4 days, flu like symptoms for 7 days, lethargic sleeping day and night for 2 days, patch of redness 4 inches in diameter (soft to touch but very hot) for 3 weeks - still some redness but about 1/4 the size.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Onset within  3-4 hours. Nausea, vomiting, feverish, chills, shaking, headache, injection site pain, fatigue, tiredness.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Onset within  3-4 hours. Nausea, vomiting, feverish, chills, shaking, headache, injection site pain, fatigue, tiredness.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Headache, Fever, Chills, Sweats for 48 hours, Left arm extremely sore  for 72 hours
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Bronchitis, Chills, Hyperhidrosis, Injection site swelling, Pain
Clinical narrative: Patient went to urgent care that evening with fever, chills, sweats, body aches and swelling in both injection sites. He has since seen multiple doctors and is convinced his symptoms are a result of the vaccination.  He was told by the urgent care physician the two vaccines should not have been given together.  He states he was given steroid injections and has had 3 rounds of antibiotics.  He was diagnosed with bronchitis today.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient went to urgent care that evening with fever, chills, sweats, body aches and swelling in both injection sites. He has since seen multiple doctors and is convinced his symptoms are a result of the vaccination.  He was told by the urgent care physician the two vaccines should not have been given together.  He states he was given steroid injections and has had 3 rounds of antibiotics.  He was diagnosed with bronchitis today.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site swelling, Pyrexia, Supraventricular tachycardia
Clinical narrative: swollen injection site, fever, pt has history of SVT and had to go to Hospital with SVT on Thursday,  5/9, shot was given on 5/6
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Exposure via skin contact, Herpes zoster, Injection site discharge, Rash
Clinical narrative: Patient massaged her arm 15 minutes after injection and got "exudate that squirted out" on her finger. She then rubbed her nose "and got shingles on her nose" which showed as numerous bumps with white heads. She started acyclovir topically and orally which she had on hand because she uses for HSV and "within a couple of days they dried up and are now flaky".
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Purplish- Red Bruising, not blotchy, Slight Swelling, annoying pain with movement but able to complete activities of daily living first noticed May 5th continually spreading now approximately 7 inches in length.
Sex: U
Vaccine: HEPA, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; since 22-APR-2019, multiple unspecified patients received improperly stored vaccine; This non valid spontaneous report was received from a medical assistant and referred to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.   On  an unknown dates in 2019 (reported as "since 22-APR-2019"), the multiple unspecified patients were vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # R027157, expiration date 14-JUL-2020, and lot # R034700, expiration date 16-JUN-2020, (strength, dose, dose number, route, frequency, anatomical location were not reported), for prophylaxis. Other suspect therapies included hepatitis a vaccine, inactivated(VAQTA), lot # S002459, expiration date 15-MAY-2020, (strength, dose, dose number, route, frequency, anatomical location were not reported), for prophylaxis; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot # R027997, expiration date 01-OCT-2020, (strength, dose, dose number, route, frequency, anatomical location were not reported), for prophylaxis; the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was reconstituted with properly stored sterile diluent, lot # R036399, expiration date 20-JUL-2021, and lot # S000977, expiration date 14-SEP-2021.  The temperature/time frame had a duration of 49 hours with a temperature of 9 Celsius Degrees with a highest of 10.4 Celsius Degrees. The vaccines did not experienced any previous temperature excursion. The Digital Data Logger was involved. No adverse effects were reported. It was also reported that the office of the reporter would run a report for the vaccines to determine the patients information.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Feeling hot, Myalgia, Pain, Poor quality sleep
Clinical narrative: myalgia, arthralgia, hot feelings in palms and soles, aches all over, poor sleep due to pain
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticarial rash, onset 1 hour post vaccination. Symptoms refractory to p.o. Zyrtec. Responded to epinephrine without incident.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate increased
Clinical narrative: Rapid heart beat
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Nausea
Clinical narrative: Dizziness, nausea, diarrhea, severe stomach pain after standing up from sitting
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain
Clinical narrative: Muscle soreness at the injection site when moving arm or laying on arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site rash
Clinical narrative: Rash at site of injection. Supportive care/wet compresses, tylenol prn for pain, benadryl q8 for 48 hrs, Cephalexin 250/5ml Oral suspension 3 ml po tid x 10days. Drew around margins of erythematous patch. Instructed dad to RTC in 24 hrs if redness/spreading worsens. Follow-up in 48 hours if rash persists or new fever/sx.
Age: 6.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site joint swelling, Injection site swelling
Clinical narrative: Whole right knee/thigh swelled up
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Gait disturbance, Hyperhidrosis, Influenza like illness
Clinical narrative: Flu like symptoms, never been this sick, barley able to walk from pain in lower back, fever of 102.2, feel very weak, this lasted one day, next day just sweaty and stayed in bed, with wet sheets, third day, today, feel normal, vaccine should not make this happen, shingles never made me this sick. First shot did nothing, second shot was like live virus.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Flu like symptoms, never been this sick, barley able to walk from pain in lower back, fever of 102.2, feel very weak, this lasted one day, next day just sweaty and stayed in bed, with wet sheets, third day, today, feel normal, vaccine should not make this happen, shingles never made me this sick. First shot did nothing, second shot was like live virus.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Injection site swelling, Pain
Clinical narrative: severe injection site reaction - pain, swelling 2 days of "flu-like symptoms" - fatigue, aches
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Within 15-minutes of being vaccinated patient reports numbness and tingling to right side of check and upper gum-line, and numbness in part of upper lip, along with dry cough. Symptoms persisted about 2 hours. No treatment initiated. Patient denied wheezing, hives, shortness of breath, or dizziness. *ACTUAL VACCINE ADMINISTERED:  [Afluria IIV4 PFS]      Vaccine Manufacturer: [Seqirus, Inc.], Lot YF36305
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Rash, Rash vesicular
Clinical narrative: pain at site, joint pain next day (wrist& ankles), shingles like rash on neck face and side by saturday.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Computerised tomogram, Cough, Dysstasia, Nuclear magnetic resonance imaging
Clinical narrative: Coughing started about three hours after the shot and my throat was so sore the next morning, went to doctor thinking it might be strep . It was not strep or flu but three days later (night of 4-27-19) completely lost balance and was unable to stand without assistance.  Went to Emergency Room and was admitted.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, X-ray
Clinical narrative: Coughing started about three hours after the shot and my throat was so sore the next morning, went to doctor thinking it might be strep . It was not strep or flu but three days later (night of 4-27-19) completely lost balance and was unable to stand without assistance.  Went to Emergency Room and was admitted.
Age: 73.0
Sex: M
Vaccine: MMR
Symptoms: Pain, Rash, Rash macular, Rash pruritic
Clinical narrative: On the day after vaccination, patient has a raised, blotchy rash extensively on the back that is quite itchy with slight burning pain sensation. Patient came into pharmacy two days post vaccination will rash still present.
Age: 41.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Fatigue, Hypoaesthesia, Pain in extremity
Clinical narrative: Pt received "Hep A" vaccine (unknown if Havrix or Vaqta).  Developed severe fatigue with joint achiness following day.  5 days after receiving vaccine, pt developed intermittent tingling/numbness in bilateral hands with bilateral upper arm achiness with associated mild weakness.  Saw me (PCP) in office on 5/13 with ongoing (but nonprogressive) symptoms (although fatigue was improving).
Age: 41.0
Sex: M
Vaccine: UNK
Symptoms: Paraesthesia
Clinical narrative: Pt received "Hep A" vaccine (unknown if Havrix or Vaqta).  Developed severe fatigue with joint achiness following day.  5 days after receiving vaccine, pt developed intermittent tingling/numbness in bilateral hands with bilateral upper arm achiness with associated mild weakness.  Saw me (PCP) in office on 5/13 with ongoing (but nonprogressive) symptoms (although fatigue was improving).
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling cold, Myalgia, Tachycardia
Clinical narrative: day after receiving shingrix second shot reported muscle and joint pain, cold sensation, and tachycardia. The tachycardia was alarming to the patient and lasted several hours
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Induration, Pruritus, Rash
Clinical narrative: (R) arm with rash and red circular enduration itchy
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Pain in extremity
Clinical narrative: headache 1/18/19 - 1/19/19 R arm pain 1/16/19 - Still present Urgent care 7/21/19 injection of antiinflammatory PCP 7/22/19 FU Appointment 2/1/2019
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient's mother states child had a fever on the night of 05/01/2019. Patient states that on 05/02/2019 child has redness and swelling on right arm. Redness and swelling starts at injection site and ends halfway between the injection site and elbow. Right arm is also warm to touch and child states that it hurts. Mother states she administered Tylenol.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child is under 4 years of age and was given the vaccine "Kinrix" which is licensed for 4 years through 6 years of age.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Gastrointestinal disorder, Vomiting
Clinical narrative: I had the first dose of Shingrix vaccine for Shingles prevention on 5/7. Early the following morning, I woke with severe gastrointestinal issues - diarrhea and vomiting - that lasted about 5 hours. I also experienced significant joint pains in my knees. This lasted about 24 hours and the side effects seem to have abated.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Local swelling/redness L thigh at vaccine site- 4cm circumference. Occurred about 24 hours after vaccines were given. Parents to apply warm compresses.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: fainting post vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Pruritus generalised
Clinical narrative: Pt was seen today 5/13/19 complaining of rash, warmth around injection site on (R) arm, and general pruritis. Has been taking Benadryl. Site on (R) arm is 10x15cm - warm, red, and tender. Started on prednisone, doxycycline and triamcinolone.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Tired, weak. Headache. Shivering. Vomiting Stomach pain.  Lasted day of injection into the night. Let up next day except tiredness & weakness.  3rd day was better
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Tired, weak. Headache. Shivering. Vomiting Stomach pain.  Lasted day of injection into the night. Let up next day except tiredness & weakness.  3rd day was better