chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to a 4-weeks-old female patient (previously considered non-valid).   On 17-JAN-2020, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength not reported) lot # R031056 with expiration date on 04-JUN-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.; Sender's Comments:  US-009507513-2003USA001377: US-009507513-2003USA001374: US-009507513-2003USA001375: US-009507513-2003USA001376: US-009507513-2003USA001378: US-009507513-2001USA006732:
Sex: M
Vaccine: DTAPIPV
Symptoms: Local reaction
Clinical narrative: Local reaction; This case was reported by a nurse via sales rep and described the occurrence of local reaction in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown.   It was unknown if the reporter considered the local reaction to be related to Kinrix.  Additional details were received as follows: The age at vaccination was not reported. It was reported that patient experienced local reaction after receiving Kinrix.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: extremely fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 1st dose of Shingrix. On 19th February 2020, 1 days after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected as an adult as per vaccine indication. The patient received vaccine on day before reporting and on day of reporting experienced extreme fatigue. The patient enquired how long the fatigue would last. The permission to follow up was denied.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: tiredness; achiness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced fatigue and general body pain. On an unknown date, the outcome of the fatigue and general body pain were unknown.   It was unknown if the reporter considered the fatigue and general body pain to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The patient received second dose of Shingrix on  and experienced tiredness and achiness. The reporter did not consent to follow-up.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: 37 years old patient received the first dose of Shingrix; Redness in the injection site; Pain /Pain in the injection site after first dose; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 37-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included leukemia (when patient was younger).   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 erythema, injection site pain and inappropriate age at vaccine administration. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on unknown arm. The medical assistant reported that, the patient received the first dose of Shingrix, which led to inappropriate age at vaccine administration. The patient experienced pain and redness in the injection site that lasted for a week. This was a medication error with harm. For tolerance of 2nd dose refer case US2020AMR031021. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Headache, Induration, Joint swelling
Clinical narrative: Severe edema, swelling, red in color, hard and hot to touch. Swelling and pain from the neck down to the right elbow. Sinus pressure and headache.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Oedema, Pain in extremity, Paranasal sinus discomfort, Peripheral swelling
Clinical narrative: Severe edema, swelling, red in color, hard and hot to touch. Swelling and pain from the neck down to the right elbow. Sinus pressure and headache.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Severe edema, swelling, red in color, hard and hot to touch. Swelling and pain from the neck down to the right elbow. Sinus pressure and headache.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Headache, Nausea, Pyrexia, Thirst
Clinical narrative: The night after the injection, severe dryness, thirstiness. Got up for water 5-6 times.  In the morning I was nauseated,  wanted to vomit but nothing, not even water, came up. Severe headache began. Low-grade fever (99.3)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient stated the arm became red and very sore the day after injection. She came in 2 days later to show me and it was red and warm to the touch about the size of a golf ball. Patient is taking ibuprofen and icing this seems to have  helped with the symptoms. If they persist or does not get better she will go to her PCP.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Righ upper extremity tingling, numbness, pain
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Patient reported  severe arm pain approximately 12 hours after the shot, headache all night, nausea and chills. She did not have a reaction to the first vaccination.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Pt received flu vaccine on yesterday and left arm is very swollen. Father spoke with On call Md last night. Treatment : Cephalexin 250 Mg/5ml Oral Suspension Reconstituted (Cephalexin) .... 10ml orally twice a day for 10 days
Age: 8.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Circumstance or information capable of leading to medication error, Haemorrhage, Scratch
Clinical narrative: Patient jerked away from nurse as vaccine was being administered. As a result, the patient ended up with a superficial scratch on his upper right arm which bled slightly. He also as a result only received part of the dose of Hep B vaccine, and had to be revaccinated for Hep B that same office visit. A band-aid was placed on the scratch, and the patient was able to leave the clinic with no assistance.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Vaccination given at 1:00pm, by 6:00pm that night she had fever, chills and severe arm pain. On 3-4-2020, she had a headache and extreme fatigue. She had no symptoms on 3-5-2020.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Fatigue, Feeling hot, Injection site erythema
Clinical narrative: red puffy warm oval shaped area; Warm oval shaped area near area of injection; puffy/oval shaped area near injection site; achy joints; fatigue; fever; This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 27th September 2019 received 1st dose refer case US2019AMR220055).   On 3rd December 2019, the patient received the 2nd dose of Shingrix. On 4th December 2019, 1 days after receiving Shingrix, the patient experienced localized erythema, localized feeling of warmth, tissue puffing, joint pain, fatigue and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the localized erythema, localized feeling of warmth and tissue puffing were unknown and the outcome of the joint pain, fatigue and fever were recovered/resolved.   It was unknown if the reporter considered the localized erythema, localized feeling of warmth, tissue puffing, joint pain, fatigue and fever to be related to Shingrix.  Additional details were provided as follows: The patient experienced red,warm, puffy, oval shaped area near area of injection. In Addition to that, the patient aslo experienced joint pain, fatigue and fever. The patient felt better after out of bed.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Swelling, Vaccine positive rechallenge
Clinical narrative: red puffy warm oval shaped area; Warm oval shaped area near area of injection; puffy/oval shaped area near injection site; achy joints; fatigue; fever; This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 27th September 2019 received 1st dose refer case US2019AMR220055).   On 3rd December 2019, the patient received the 2nd dose of Shingrix. On 4th December 2019, 1 days after receiving Shingrix, the patient experienced localized erythema, localized feeling of warmth, tissue puffing, joint pain, fatigue and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the localized erythema, localized feeling of warmth and tissue puffing were unknown and the outcome of the joint pain, fatigue and fever were recovered/resolved.   It was unknown if the reporter considered the localized erythema, localized feeling of warmth, tissue puffing, joint pain, fatigue and fever to be related to Shingrix.  Additional details were provided as follows: The patient experienced red,warm, puffy, oval shaped area near area of injection. In Addition to that, the patient aslo experienced joint pain, fatigue and fever. The patient felt better after out of bed.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Incorrect route of product administration, Weight bearing difficulty
Clinical narrative: had a reaction and am still suffering from aching joints /elbow joints have pain; The arm by afternoon was red in a big circle to the elbow.; injection was given in the back of the arm /shot being given in soft tissue instead of the muscle; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (in childhood, had severe chicken pox) and shingles (patient's grandmother, mother, and one daughter all had shingles.The patient's daughter for 2nd time.).   In November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced erythema of extremities and intramuscular formulation administered by other route. On an unknown date, the patient experienced joint pain. On an unknown date, the outcome of the joint pain and erythema of extremities were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the joint pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in unknown arm. The patient experienced aching joints. By afternoon the patient was experienced red in a big circle to the elbow, which was lasted days were not recovered. due to joint pains the patient unable to lift even a cup of coffee. The patient asked that the shot being given in soft tissue instead of muscle made a difference, which led to Intramuscular formulation administered by other route. The patient also asked about having the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at the vaccination site / redness at the vaccination site is getting larger not smaller; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingrix vaccine and experienced redness at the vaccination site which was getting larger. The patient wanted to know regarding need of physician visit.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash; Redness; Hitches/ itching; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, erythema and pruritus. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the erythema and pruritus were unknown.   It was unknown if the reporter considered the rash, erythema and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced rash, erythema and pruritus after receiving Shingrix vaccine.
Sex: M
Vaccine: DTAPIPV
Symptoms: Local reaction
Clinical narrative: Local reaction; This case was reported by a nurse via sales rep and described the occurrence of local reaction in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown.   It was unknown if the reporter considered the local reaction to be related to Kinrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced local reaction after receiving Kinrix. The reporter consented to follow up This case has been linked with US2020AMR030159, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: had a sore arm (at injection site); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-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, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received Sningrix and had a sore arm (at injection site). The patient received the first dose about 2.5 months prior to the second dose. She does not have the exact date of the first shot. She does not have the lot number or expiry date of either shot. She believed the shot were given in the left deltoid and was not sure but believed they were given intramuscularly. She did not see how long the needle was but said it felt like it went into the muscle. The patient received Sningrix and had a sore arm (at injection site). This case has been linked with case US2020031394, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: little red; still itchy; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient received Shingrix shot a month before the time of reporting, it was itchy and little red till the time of reporting. The patient wanted to know if it was normal. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tiredness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2020 16:00, the patient received the 1st dose of Shingrix. In February 2020, 19 hrs 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 information was provided as follows: The age at vaccination was not reported. The vaccine was lasted a full dose. Patient reported that she got her dose of Shingrix at 4 pm. At 11 am, the next day the patient started experiencing tiredness. The reporter did not consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Obsessive-compulsive disorder
Clinical narrative: OCD symptoms; This case was reported by a nurse via call center representative and described the occurrence of obsessive-compulsive disorder in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced obsessive-compulsive disorder. On an unknown date, the outcome of the obsessive-compulsive disorder was not recovered/not resolved.   It was unknown if the reporter considered the obsessive-compulsive disorder to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient developed OCD (obsessive-compulsive disorder) symptoms after receiving Bexsero. The symptoms had not improved with treatment. The reporter did not consent to follow up.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Skin warm, Swelling
Clinical narrative: Patient notified medical office today 3/5/2020 about arm red around injection site. Provider FNP looked at patient's arm.  Left arm warm to the touch, swollen and red.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: urticaria, generalized
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Joint swelling, Myalgia, Pain in extremity
Clinical narrative: Gave first dose of Shingrix vaccine. Patient experienced swollen knees, extreme pain and could not work. Pain in muscles and down the legs a bit. Previously had no knee problmes but immediately noticed knee pain in the car on the way home after the shot.  Treated at Medical Clinic- Received prednisone shots .
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Patient experienced palpitations, nausea, headache, along with redness and swelling from the injection site towards her anterior axilla about 1 hour after the injection was given per her. She did not report this reaction until 2/24/20. At that time, she had bruising and a knot at the injection site. Other symptoms had subsided per her. She was advised to report these symptoms to her PCP.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Palpitations
Clinical narrative: Patient experienced palpitations, nausea, headache, along with redness and swelling from the injection site towards her anterior axilla about 1 hour after the injection was given per her. She did not report this reaction until 2/24/20. At that time, she had bruising and a knot at the injection site. Other symptoms had subsided per her. She was advised to report these symptoms to her PCP.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: THE PATIENT RECEIVED A DOSE OF VARIVAX WHICH WAS IMPROPERLY STORED; No adverse event; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were unknown. Concomitant medications included sterile diluent (lot# and expiry date unknown). On 25-FEB-2020, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S024369, expiration date 08-JUN-2021 (strength, dose, route, anatomical location were unknown) for prophylaxis. The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent at a temperature of minus 13.8 degrees Celsius for a time frame of 13 minutes. The previous temperature excursion was 3.4 degree Celsius for 1 hour 30 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: A few hours after receiving the Shingrix vaccine at the clinic at work I started to get severe body aches. A few hours later, after going to bed I started vomiting uncontrollably - about 10 times all night long, even when there was nothing left in my stomach. The next morning I went to visit my PCP who gave me some anti-nausea medication. I fully recovered after 48 hours.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient reports tenderness with internal rotation in the left shoulder joint that started after the injection was given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: swelling occurred at 5:00pm the day of the vaccine followed by itching inside
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: exhausted, sore all over his body,  feels sick to stomach but has not vomited, left side of body behind breast is extremely sore
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Breast pain, Fatigue, Feeling abnormal, Malaise
Clinical narrative: exhausted, sore all over his body,  feels sick to stomach but has not vomited, left side of body behind breast is extremely sore
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: exhausted, sore all over his body,  feels sick to stomach but has not vomited, left side of body behind breast is extremely sore
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Feeling of body temperature change, Headache, Influenza like illness
Clinical narrative: Per patient "When I returned home I started my daily routines and seemed to be fine.  However about 3pm my upper arm was hurting and seemed sore from shoulder to elbow.  By 5pm, my upper arm had swollen up from shot site to just above the elbow and was getting red. Also at this time I was starting to feel like I was coming down with the flu having cold and hot spells and temp rising, by 8pm I was in bed with headache, temp of 101-102, cold/hot spells and shivering.  Arm was very sore and there was a red rash area on my upper arm.  I was starting to have nausea but I didn't vomit. My condition was like this from Tuesday afternoon through Wednesday at approx 10pm when my temp finally broke. I was still in bed through Thursday evening. Arm swollen/rash until Mar 2 and now almost back to normal, arm still achy."
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain in extremity, Rash erythematous
Clinical narrative: Per patient "When I returned home I started my daily routines and seemed to be fine.  However about 3pm my upper arm was hurting and seemed sore from shoulder to elbow.  By 5pm, my upper arm had swollen up from shot site to just above the elbow and was getting red. Also at this time I was starting to feel like I was coming down with the flu having cold and hot spells and temp rising, by 8pm I was in bed with headache, temp of 101-102, cold/hot spells and shivering.  Arm was very sore and there was a red rash area on my upper arm.  I was starting to have nausea but I didn't vomit. My condition was like this from Tuesday afternoon through Wednesday at approx 10pm when my temp finally broke. I was still in bed through Thursday evening. Arm swollen/rash until Mar 2 and now almost back to normal, arm still achy."
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: PATIENT CALLED AND STATED HE DEVELOPED 12 CHICKEN POX RANDOMLY OVER BODY A FEW DAYS AFTER RECEIVING THE VACCINATION. HE STATED HE JUST WANTED TO LET US KNOW AND WILL BE CALLING HIS DOCTOR.
Sex: F
Vaccine: VARZOS
Symptoms: Eye discharge, Eye pain, Herpes ophthalmic, Ocular hyperaemia, Photophobia
Clinical narrative: left herpetic keratitis; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 07-MAR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered sharp left eye pain with redness, drainage, photophobia and blurred vision. The patient was diagnosed with left herpetic keratitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event left herpetic keratitis was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event left herpetic keratitis to be disability.  Upon internal review, the event left herpetic keratitis was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: left herpetic keratitis; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 07-MAR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered sharp left eye pain with redness, drainage, photophobia and blurred vision. The patient was diagnosed with left herpetic keratitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event left herpetic keratitis was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event left herpetic keratitis to be disability.  Upon internal review, the event left herpetic keratitis was determined to be medically significant.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse reaction. Wrong vaccination given
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Feeling cold, Headache, Nausea
Clinical narrative: HAD EXTREME STOMACH CRAMPS FOR MANY HOURS WITH SOME NAUSEA FOLLOWD BY FEELING VERY COLD WITH EXTREME CHILLS, HOT SKIN, AND LATER EXREME SHAKING ALL HAPPENED IN THE EVENING WOKE IN THE MORNING W/HEADACHE NOTE HUSBAND RECEIVED SAME VACCINE AT SAME TIME WITHOUT REACTIONS
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Tremor
Clinical narrative: HAD EXTREME STOMACH CRAMPS FOR MANY HOURS WITH SOME NAUSEA FOLLOWD BY FEELING VERY COLD WITH EXTREME CHILLS, HOT SKIN, AND LATER EXREME SHAKING ALL HAPPENED IN THE EVENING WOKE IN THE MORNING W/HEADACHE NOTE HUSBAND RECEIVED SAME VACCINE AT SAME TIME WITHOUT REACTIONS
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: SHE RECEIVED HER SECOND DOSE VACCINE ON 10-02-19. AFTER 2 DAYS SHE SAW REDNESS ON HER FOREHEAD LOOK LIKE BUTTERFLY. IT WASN'T ITCHY OR BURNING.  SHE COVERED IT WITH HER BANGS. RASH BECOME LESS AFTER 2 DAYS AND CAME BACK 4-5 DAYS AFTER.  SHE STILL HAS THE RASH ON HER FOREHEAD. SHE SAW HER PCP RECENTLY BUT HE COULD NOT RECALL WHAT IS IT. SHE DIDN'T PUT ANYTHING ON IT.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Abscess drainage, Abscess sterile, Cellulitis, Culture negative, Drain placement
Clinical narrative: The day after vaccination, patient developed fever and pain with walking.  Admitted to the hospital 02/03/2020 to 02/05/2020 with an abscess, cellulitis and leukocytosis.   Taken to OR for drainage on 02/04/2020.  Clinical improvement and discharged home on oral abx.  Readmitted on 02/06/2020 to 02/14/2020.  A drain loops were placed.  Wound vac placement and 2 more surgical procedures.  IV antibiots until discharge on oral antibiotics.  Sterile abscess felt to be a reaction to components of vaccine
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Incisional drainage, Leukocytosis, Pain, Pyrexia
Clinical narrative: The day after vaccination, patient developed fever and pain with walking.  Admitted to the hospital 02/03/2020 to 02/05/2020 with an abscess, cellulitis and leukocytosis.   Taken to OR for drainage on 02/04/2020.  Clinical improvement and discharged home on oral abx.  Readmitted on 02/06/2020 to 02/14/2020.  A drain loops were placed.  Wound vac placement and 2 more surgical procedures.  IV antibiots until discharge on oral antibiotics.  Sterile abscess felt to be a reaction to components of vaccine
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Red blood cell sedimentation rate increased, Surgery, Viral test negative, White blood cell count increased, Wound closure
Clinical narrative: The day after vaccination, patient developed fever and pain with walking.  Admitted to the hospital 02/03/2020 to 02/05/2020 with an abscess, cellulitis and leukocytosis.   Taken to OR for drainage on 02/04/2020.  Clinical improvement and discharged home on oral abx.  Readmitted on 02/06/2020 to 02/14/2020.  A drain loops were placed.  Wound vac placement and 2 more surgical procedures.  IV antibiots until discharge on oral antibiotics.  Sterile abscess felt to be a reaction to components of vaccine
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Vaccination site inflammation
Clinical narrative: Patient start with pain in the right shoulder , inflammation and redness in the vaccinated area on March 1 2020. Patient visit provider and was prescribed Augmentin and Zyrtec for 7 days
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Clostridium test negative, Culture stool, Diarrhoea, Parasite stool test negative, Polymerase chain reaction
Clinical narrative: Watery/Mucus diarrhea 9-10 times a day  lasting 17 days. Symptoms started 5 days after MMR vaccine.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Rotavirus test negative
Clinical narrative: Watery/Mucus diarrhea 9-10 times a day  lasting 17 days. Symptoms started 5 days after MMR vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site bruising
Clinical narrative: Patient developed large mark around injection site that turned into a bruise (a little larger than a silver dollar). Bruise has faded significantly but faint outline is apparent 16 days after injection. No other pain in the arm and bruising was noticed by patient's husband, not the patient. Patient did develop flu like symptoms 1-2 days after that were completely resolved within 3 days of vaccination and sounded like a normal reaction to the vaccine.
Age: 23.0
Sex: F
Vaccine: MENB, PPV, TDAP
Symptoms: Erythema, Headache, Nausea, Pyrexia, Skin warm
Clinical narrative: Headache, nausea, low grade fever. Large Area Of redness (approx. Softball size) Golf Ball size hard area at Center of redness very warm to touch
Age: 2.67
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Cold sweat, Dyskinesia, Eye movement disorder, Fatigue
Clinical narrative: Child was given vaccines on catch up schedule. Child was screaming and father restrained child for administration. Child screaming throughout injections. Father dressed child pants and coat and took her to waiting room still screaming. Finished documentation and scheduling with mother child & child became limp and eyes rolling back. Brought child to exam room extremely pale diaphoretic and pulse and HR strong & Breathing. Stimulated child not responding took coat off and cool cloth to head, ice pack to back & stimulated talking to child occasionally eyes open slightly. Called 911. Heart decreased and bicycling legs. Color remains remains very pale and skin clammy refused any water given a sip water later. Child slowly woke up but muscle tone was poor and color pale although lips are finally a pale pink vs white. Taken to ER for evaluation discharged by 4pm. Called mother @ 4:39 to follow up. Child alert & talking but now feeling she is getting tired. Dx with vasovagal reaction per ER. Plan to f/u with PCP.
Age: 2.67
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Heart rate decreased, Hyperhidrosis, Hypotonia, Pallor, Presyncope
Clinical narrative: Child was given vaccines on catch up schedule. Child was screaming and father restrained child for administration. Child screaming throughout injections. Father dressed child pants and coat and took her to waiting room still screaming. Finished documentation and scheduling with mother child & child became limp and eyes rolling back. Brought child to exam room extremely pale diaphoretic and pulse and HR strong & Breathing. Stimulated child not responding took coat off and cool cloth to head, ice pack to back & stimulated talking to child occasionally eyes open slightly. Called 911. Heart decreased and bicycling legs. Color remains remains very pale and skin clammy refused any water given a sip water later. Child slowly woke up but muscle tone was poor and color pale although lips are finally a pale pink vs white. Taken to ER for evaluation discharged by 4pm. Called mother @ 4:39 to follow up. Child alert & talking but now feeling she is getting tired. Dx with vasovagal reaction per ER. Plan to f/u with PCP.
Age: 2.67
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Screaming, Unresponsive to stimuli
Clinical narrative: Child was given vaccines on catch up schedule. Child was screaming and father restrained child for administration. Child screaming throughout injections. Father dressed child pants and coat and took her to waiting room still screaming. Finished documentation and scheduling with mother child & child became limp and eyes rolling back. Brought child to exam room extremely pale diaphoretic and pulse and HR strong & Breathing. Stimulated child not responding took coat off and cool cloth to head, ice pack to back & stimulated talking to child occasionally eyes open slightly. Called 911. Heart decreased and bicycling legs. Color remains remains very pale and skin clammy refused any water given a sip water later. Child slowly woke up but muscle tone was poor and color pale although lips are finally a pale pink vs white. Taken to ER for evaluation discharged by 4pm. Called mother @ 4:39 to follow up. Child alert & talking but now feeling she is getting tired. Dx with vasovagal reaction per ER. Plan to f/u with PCP.
Sex: F
Vaccine: FLUX, HEP
Symptoms: Hepatitis A, Hepatitis B antibody positive, Liver disorder, Pyrexia
Clinical narrative: attacking her liver; hepatitis a; Fevers over 100 degrees all day long; This spontaneous report was received from a female patient of unknown age (reported also as registered nurse) who reported about herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown date in 1985 (reported as between January and March 1985), the patient was vaccinated with two doses of hepatitis b vaccine (recombinant) (HEPTAVAX B) (strength, dose, route of administration and expiration date were not reported), for prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified) (strength, dose, route of administration and expiration date were not reported).  On an unknown date (reported as when she was 8 years old), the patient had Hepatitis A. On unknown date, the patient experienced fevers over 100 degrees all day long. The titers still showed immunity to Hepatitis B, even though she only had the two doses. The patient stated that she was told she should "not take any other flu shots" and she asked for a letter that explain why "she should not be vaccinated, as it was attacking her liver". The outcome of the events was unknown.  The causality assessment between the event and the suspect vaccines was not reported.
Age: 20.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event; 20 years-old patient was administered PROQUAD; This spontaneous report was received from a nurse prescriber referring to a 20 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 12-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R030802 (verified to be a valid lot number), expiration date not reported, but upon internal validation established as 22-APR-2020, for prophylaxis.  Other suspect therapies included sterile diluent (STERILE DILUENT). No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse symptoms reported; Patient was inadvertently administered a 4th dose of ROTATEQ; This spontaneous report was received from a nurse and refers to a 7-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient started series of vaccination with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral (formulation, strength, frequency, lot number and expiry date were not reported) for prophylaxis. On 14-FEB-2020 (also reported as one month after the third dose), the patient was inadvertently vaccinated with the 4th dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral, with a lot number S014947 and expiration date 10-DEC-2020 (formulation, strength and frequency were not reported) for prophylaxis. No adverse event was reported.
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A dose of PROQUAD was inadvertently administered to a 25 year old male; This spontaneous report has been received from a health care professional referring to a 25 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided. Concomitant therapies included sterile diluent.   On an unknown date, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (indication, strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.
Age: 0.58
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effect reported; a patient was administered a dose of improperly stored PEDVAXHIB; This spontaneous report was received from a registered nurse and refers to 7-month-old patient of unknown gender. No information regarding drug reactions or allergies and concomitant therapy was provided. On an unknown date, the patient was vaccinated with a first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB).  On 18-FEB-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) intramuscularly, lot # S023219 has been verified to be a valid lot number, expiry date: 03-MAR-2022, for prophylaxis (dose number was not provided). No adverse effects reported. Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit for 2 hours and 15 minutes. There were no previous excursions related. Data logger was involved.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: the patient experienced no symptoms; 6 month old patient received a thrid dose of PEDVAX HIB; This spontaneous report was received from a medical assistant referring to a 6 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 13-FEB-2020, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S021457 (verified to be a valid lot number), expiration date reported and established as 03-MAR-2022, for prophylaxis. The patient experienced no symptoms.