chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: feel that I now have a mild case of shingles on the right side of my stomach; Slight rash that itches a lot; This case was reported by a consumer via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles couple of years before reporting date).   In January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced shingles and itchy rash. On an unknown date, the outcome of the shingles and itchy rash were unknown.   It was unknown if the reporter considered the shingles and itchy rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had a mild case of shingles on the right side of my stomach and slight itchy rash after vaccination. The patient asked is side effect of getting shot.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Drug eruption, Erythema, Injection site erythema, Nausea
Clinical narrative: fine little lesions in various areas; CHILLS; NAUSEA; The rash was described as papular with fine little lesions in various areas all over / drug eruption which is kind of excoriated; drug eruption; excoriated; skin was red on the chest; skin was red on the chest and at injection site; Itching has recently presented on the head back of neck; This case was reported by a physician via call center representative and described the occurrence of papular rash in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2020, the patient received the 2nd dose of Shingrix. On 3rd February 2020, 1 days after receiving Shingrix, the patient experienced papular rash, skin lesion, chills and nausea. In February 2020, the patient experienced drug eruption, excoriation, skin red, injection site erythema and pruritus. On an unknown date, the outcome of the papular rash was not recovered/not resolved and the outcome of the skin lesion, drug eruption, excoriation, skin red, injection site erythema and pruritus were unknown and the outcome of the chills and nausea were recovered/resolved.   It was unknown if the reporter considered the papular rash, skin lesion, drug eruption, excoriation, skin red, injection site erythema, pruritus, chills and nausea to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient received his second dose at a pharmacy but developed a generalized rash. The rash was described as papular with fine little lesions in various areas all over and was described more as a drug eruption which was kind of excoriated. The skin was red on the chest and at injection site and itching was presented on the head back of neck. The nausea and chills resolved within 24 hours.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular, Skin abrasion, Skin lesion
Clinical narrative: fine little lesions in various areas; CHILLS; NAUSEA; The rash was described as papular with fine little lesions in various areas all over / drug eruption which is kind of excoriated; drug eruption; excoriated; skin was red on the chest; skin was red on the chest and at injection site; Itching has recently presented on the head back of neck; This case was reported by a physician via call center representative and described the occurrence of papular rash in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2020, the patient received the 2nd dose of Shingrix. On 3rd February 2020, 1 days after receiving Shingrix, the patient experienced papular rash, skin lesion, chills and nausea. In February 2020, the patient experienced drug eruption, excoriation, skin red, injection site erythema and pruritus. On an unknown date, the outcome of the papular rash was not recovered/not resolved and the outcome of the skin lesion, drug eruption, excoriation, skin red, injection site erythema and pruritus were unknown and the outcome of the chills and nausea were recovered/resolved.   It was unknown if the reporter considered the papular rash, skin lesion, drug eruption, excoriation, skin red, injection site erythema, pruritus, chills and nausea to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient received his second dose at a pharmacy but developed a generalized rash. The rash was described as papular with fine little lesions in various areas all over and was described more as a drug eruption which was kind of excoriated. The skin was red on the chest and at injection site and itching was presented on the head back of neck. The nausea and chills resolved within 24 hours.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: persistent muscle aches and fatigue; fatigue; proximal right thigh" pain is persistent; This case was reported by a physician via call center representative and described the occurrence of muscle pain in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 29th October 2021) for prophylaxis.   On 16th December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th December 2019, 2 days after receiving Shingrix, the patient experienced muscle pain (serious criteria clinically significant/intervention required), fatigue and pain in thigh. The patient was treated with ibuprofen, hydrocodone and prednisone. On an unknown date, the outcome of the muscle pain and pain in thigh were not recovered/not resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the muscle pain, fatigue and pain in thigh to be related to Shingrix.  Additional information was provided as follows: The patient developed persistent muscle aches and fatigue. The patient's proximal right thigh pain was persistent. The patient was treated with ibuprofen at bed time and hydrocodone at bed time for pain. A treatment with prednisone was started, that physician stated, provided relief until 14th February 2020, when the pain re-occurred and persisted till the time of reporting. The reporter consented to follow up. Emergency visit required.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Circumstance or information capable of leading to medication error, Haemorrhage, Scratch
Clinical narrative: Patient jerked away from syringe, causing the needle to scratch the patient's left arm and waste part of the vaccine. The scratch bled lightly and was patted with dry gauze. New Tdap vaccine drawn up and administered to patient.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse effects were reported in the patient; patient received one dose each of PROQUAD and VARIVAX on 1/28/2020; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-JAN-2020, the patient received one dose each of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD), lot number S027467, expiration date 02-MAR-2021, and varicella virus vaccine live (oka/merck) (VARIVAX) lot number S025914, expiration date 20-AUG-2021, both for prophylaxis (exact dose, frequency and route of administration were not reported for either of vaccines). Concomitant medications included sterile diluent. No additional adverse effects were reported in the patient.
Sex: F
Vaccine: HPV9
Symptoms: Infectious mononucleosis, Ovarian failure
Clinical narrative: was diagnosed with mono and other complications; the patient was diagnosed with ovarian failure; was diagnosed with mono and other complications; This spontaneous report as received from a physician via a company representative refers to a 14-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (dose, lot # and expiration date were not reported) for prevention of human papillomavirus (HPV).  On an unknown date, the patient was diagnosed with mononucleosis (reported as mono) and other complications. On an unknown date, the patient was diagnosed with ovarian failure. It was reported that the patient's parents felt that she was diagnosed with the ovarian failure because of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The outcome of the events was reported as not recovered/not resolved.  The relatedness between the events of mononucleosis, other complications and ovarian failure and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided by the physician.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse symptoms reported.; improperly stored doses of PROQUAD were administered; This spontaneous report was received from a pharmacist and refers to a 9 patient of unknown age and gender. No information regarding patients concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. From 19-FEB-2020, the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA (recombinant human albumin) albumin status) injection, lot number S008575, expiration date 16-SEP-2020 (exact dose and route of administration were not provided) for prophylaxis. It was unknow if sterile diluent used to reconstitute the vaccines was properly stored. No adverse effect reported. Administered doses of vaccines experienced temperature excursion in range from  -14 Celsius degree to -10 Celsius degree (-13 Celsius degree) for 7 months. There was no previous temperature excursions. Data logger was involved.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: feels like a mild shingles itching; itching through out the body; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   The patient's past medical history included shingles (had 7 to 8 years before the time of reporting). Concurrent medical conditions included enlarged prostate.   On 13th January 2020, the patient received the 2nd dose of Shingrix. On 16th January 2020, 3 days after receiving Shingrix, the patient experienced shingles and generalized pruritus. The patient was treated with prednisone. On an unknown date, the outcome of the shingles and generalized pruritus were recovering/resolving.   It was unknown if the reporter considered the shingles and generalized pruritus to be related to Shingrix.  Additional information was provided as follows: The patient experienced itching throughout the body that travels sometimes worse and sometimes better, which felt like a mild shingles itching. The patient had been to the doctor and was prescribed a course of prednisone and anti histamines at that time. The patient did not take the antihistamines, and his symptoms were remained unrelieved at the time ofreporting. The reporter consented to follow up. The consumer did not know vaccine details for the adverse events. The outcome of the events were reported in source document as recovering and resolving, however it was reported as not recovered and not resolved in database.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pruritus, Rash, Vaccination site rash
Clinical narrative: recieved the new shingle vaccine on May 20, 2019 and per pt on May 21, 2019 she noticed a rash on her chest and also rash on left deltoid area where she recieved the vaccination. Per pt the rash on her chest has resolved, she still has a rash on her left deltoid area but to her it looks like it is getting smaller. It itches and slight discomfort if you press on it. No oral lesion, no sob, no wheezing, no fever, no chills. -ice -risk, benefit, options, side effects of empirically treat with antibiotic but pt declined for now, she prefers to just observe it for now, per pt it is getting smaller. -advised pt not to scratch at lesion -pt elects not to get the second shingle vaccine. PER GMC NOTE 05/24/2019
Age: 49.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Rash
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 41.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Cough, Lacrimation disorder, Pruritus, Rash
Clinical narrative: Approximately 1 hour after receiving vaccinations patient experienced dry cough, whole body itchiness, left sided facial rash and itchiness, lacrimation
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Fall, Head injury, Hyperhidrosis
Clinical narrative: From patient's medical record: "Patient called and patient has complaints of after she received the shingrix vaccine on Friday 2/21 she went home and felt very chilled, she then developed fever and sweats (she did not check temp.). The next day she still did not feel well and felt like her heart was racing. She then passed out and fell down in her hallway. She is unsure how long she was out for. She hit hear elbow and her head.  She feels fine today, c/o bruise on elbow and small bump on head. Offered appointment and pt refused. She said she doe not like coming to the doctor and only sees the doctor once a year. She said she is a healthy person and is not sure why this happened. She said she no longer wants to receive these types of vaccines.    She reported this to the number on her VIS sheet and was told to notify her PCP. She would like this added to her allergies on her file.  She was told that PCPs office should also report this reaction. "
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint injury, Loss of consciousness, Malaise, Palpitations, Pyrexia
Clinical narrative: From patient's medical record: "Patient called and patient has complaints of after she received the shingrix vaccine on Friday 2/21 she went home and felt very chilled, she then developed fever and sweats (she did not check temp.). The next day she still did not feel well and felt like her heart was racing. She then passed out and fell down in her hallway. She is unsure how long she was out for. She hit hear elbow and her head.  She feels fine today, c/o bruise on elbow and small bump on head. Offered appointment and pt refused. She said she doe not like coming to the doctor and only sees the doctor once a year. She said she is a healthy person and is not sure why this happened. She said she no longer wants to receive these types of vaccines.    She reported this to the number on her VIS sheet and was told to notify her PCP. She would like this added to her allergies on her file.  She was told that PCPs office should also report this reaction. "
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: From patient's medical record: "Patient called and patient has complaints of after she received the shingrix vaccine on Friday 2/21 she went home and felt very chilled, she then developed fever and sweats (she did not check temp.). The next day she still did not feel well and felt like her heart was racing. She then passed out and fell down in her hallway. She is unsure how long she was out for. She hit hear elbow and her head.  She feels fine today, c/o bruise on elbow and small bump on head. Offered appointment and pt refused. She said she doe not like coming to the doctor and only sees the doctor once a year. She said she is a healthy person and is not sure why this happened. She said she no longer wants to receive these types of vaccines.    She reported this to the number on her VIS sheet and was told to notify her PCP. She would like this added to her allergies on her file.  She was told that PCPs office should also report this reaction. "
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Pt reported fever blister like rash on lips
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: REDNESS, SWELLING, PAINFUL LUMP AT INJECTION SITE.  TREATED WITH BENADRYL, TYLENOL, AND ICE X 2 DAYS.  PAIN IMPROVED AFTER 2 DAYS BUT REDNESS AND LUMP REMAINED X 7 DAYS
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Aspiration joint normal, Blood culture negative, Chondrocalcinosis, Culture negative
Clinical narrative: Background: Nov. 26, 2019, annual physical, all test results within acceptable limits, overall good health, exercising/swimming 6 days/week. 5'11", BMI approx. 23. Flu-Hi dose vac. 10/14/19; Recommended Shingrix due to previous shingles/PHN. Dec. 3, 2019, 1st dose of Shingrix. Approx. 3-4 weeks later, slight pain and slight swelling in left knee, no known cause or injury. Rested, ice, pain and swelling increased, Appt. 1/14/20 Primary Care, recommended Appt with Orthopedic Dr., Appt 1/21, X-rays non-conclusive, Ordered MRI, Pain grew severe and wide-spread, both knees, hips, shoulders, arms. Left Knee significantly swelled, warm. Appt. Ortho Dr. 2/29, reviewed MRI, nothing significant. Dr. withdrew left knee fluid, after visual inspection, admitted me to hospital, possible fluid infection or sepsis, Hospitalized 1/29-1/31/2020. Knee fluid didn't show infection after culture time complete. Blood samples didn't show infection after culture wait time complete. Dr. of Rheumatology ordered x-rays of right knee and hip, Initial diagnosis: Chondrocalcinosis, Arthropathic psoriasis unspecified. Pain continued from 1/31 to 2/7, Prednisone/Methotrexate etc. prescribed. Question: Could the Shingrix have over-stimulated neutrophils production resulting in calcium pyrophosphate crystals being released and triggering a severe flare of Chondrocalcinosis, Arthroscopic Psoriasis or both?
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Joint swelling, Joint warmth, Magnetic resonance imaging normal, Musculoskeletal pain
Clinical narrative: Background: Nov. 26, 2019, annual physical, all test results within acceptable limits, overall good health, exercising/swimming 6 days/week. 5'11", BMI approx. 23. Flu-Hi dose vac. 10/14/19; Recommended Shingrix due to previous shingles/PHN. Dec. 3, 2019, 1st dose of Shingrix. Approx. 3-4 weeks later, slight pain and slight swelling in left knee, no known cause or injury. Rested, ice, pain and swelling increased, Appt. 1/14/20 Primary Care, recommended Appt with Orthopedic Dr., Appt 1/21, X-rays non-conclusive, Ordered MRI, Pain grew severe and wide-spread, both knees, hips, shoulders, arms. Left Knee significantly swelled, warm. Appt. Ortho Dr. 2/29, reviewed MRI, nothing significant. Dr. withdrew left knee fluid, after visual inspection, admitted me to hospital, possible fluid infection or sepsis, Hospitalized 1/29-1/31/2020. Knee fluid didn't show infection after culture time complete. Blood samples didn't show infection after culture wait time complete. Dr. of Rheumatology ordered x-rays of right knee and hip, Initial diagnosis: Chondrocalcinosis, Arthropathic psoriasis unspecified. Pain continued from 1/31 to 2/7, Prednisone/Methotrexate etc. prescribed. Question: Could the Shingrix have over-stimulated neutrophils production resulting in calcium pyrophosphate crystals being released and triggering a severe flare of Chondrocalcinosis, Arthroscopic Psoriasis or both?
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Neutrophil count decreased, Neutrophil count increased, Pain in extremity, Psoriatic arthropathy, White blood cell count decreased
Clinical narrative: Background: Nov. 26, 2019, annual physical, all test results within acceptable limits, overall good health, exercising/swimming 6 days/week. 5'11", BMI approx. 23. Flu-Hi dose vac. 10/14/19; Recommended Shingrix due to previous shingles/PHN. Dec. 3, 2019, 1st dose of Shingrix. Approx. 3-4 weeks later, slight pain and slight swelling in left knee, no known cause or injury. Rested, ice, pain and swelling increased, Appt. 1/14/20 Primary Care, recommended Appt with Orthopedic Dr., Appt 1/21, X-rays non-conclusive, Ordered MRI, Pain grew severe and wide-spread, both knees, hips, shoulders, arms. Left Knee significantly swelled, warm. Appt. Ortho Dr. 2/29, reviewed MRI, nothing significant. Dr. withdrew left knee fluid, after visual inspection, admitted me to hospital, possible fluid infection or sepsis, Hospitalized 1/29-1/31/2020. Knee fluid didn't show infection after culture time complete. Blood samples didn't show infection after culture wait time complete. Dr. of Rheumatology ordered x-rays of right knee and hip, Initial diagnosis: Chondrocalcinosis, Arthropathic psoriasis unspecified. Pain continued from 1/31 to 2/7, Prednisone/Methotrexate etc. prescribed. Question: Could the Shingrix have over-stimulated neutrophils production resulting in calcium pyrophosphate crystals being released and triggering a severe flare of Chondrocalcinosis, Arthroscopic Psoriasis or both?
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased, X-ray limb abnormal, X-ray of pelvis and hip abnormal
Clinical narrative: Background: Nov. 26, 2019, annual physical, all test results within acceptable limits, overall good health, exercising/swimming 6 days/week. 5'11", BMI approx. 23. Flu-Hi dose vac. 10/14/19; Recommended Shingrix due to previous shingles/PHN. Dec. 3, 2019, 1st dose of Shingrix. Approx. 3-4 weeks later, slight pain and slight swelling in left knee, no known cause or injury. Rested, ice, pain and swelling increased, Appt. 1/14/20 Primary Care, recommended Appt with Orthopedic Dr., Appt 1/21, X-rays non-conclusive, Ordered MRI, Pain grew severe and wide-spread, both knees, hips, shoulders, arms. Left Knee significantly swelled, warm. Appt. Ortho Dr. 2/29, reviewed MRI, nothing significant. Dr. withdrew left knee fluid, after visual inspection, admitted me to hospital, possible fluid infection or sepsis, Hospitalized 1/29-1/31/2020. Knee fluid didn't show infection after culture time complete. Blood samples didn't show infection after culture wait time complete. Dr. of Rheumatology ordered x-rays of right knee and hip, Initial diagnosis: Chondrocalcinosis, Arthropathic psoriasis unspecified. Pain continued from 1/31 to 2/7, Prednisone/Methotrexate etc. prescribed. Question: Could the Shingrix have over-stimulated neutrophils production resulting in calcium pyrophosphate crystals being released and triggering a severe flare of Chondrocalcinosis, Arthroscopic Psoriasis or both?
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus
Clinical narrative: 6cm x 5.5cm erythematous purplish discoloration on (L) central thigh area which developed the day after the vaccine was given. Slightly itchy per patient but mother didn't see her scratch the area.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Wrong technique in product usage process
Clinical narrative: "she was exposed to possible infection because her boyfriend was unfaithful"; she received first dose of GARDASIL QUADRIVALENT on an unspecified date in 2010/ she received the second dose of GARDASIL QUADRIVALENT on an unspecified date in 2011 /She received a third dose of GARDASIL 9 on an unspecified date in 2018; she received first dose of GARDASIL QUADRIVALENT on an unspecified date in 2010/ she received the second dose of GARDASIL QUADRIVALENT on an unspecified date in 2011 /She received a third dose of GARDASIL 9 on an unspecified date in 2018; none of the clinicians shook the vial of vaccine before administering them; This spontaneous report has been received from a female patient of unknown age. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.   On an unknown date in 2010, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date in 2011, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (inappropriate schedule of product administration). On an unknown date in 2018, the patient was vaccinated with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, frequency, route, lot# and expiration date were unknown) for prophylaxis (interchange of vaccine products).   On an unknown date the patient was exposed to possible infection because her boyfriend was unfaithful. The patient reported that none of the clinicians shook the vial of vaccine before administering them (wrong technique in product usage process). The outcome of infection was unknown. The causality assessments between infection and the suspect therapies were not reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash pruritic, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles rash; Itchy / Just itchy; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. On an unknown date, the outcome of the vaccination failure, shingles and itchy rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After 1st dose of Shingrix, the patient experienced broke out with shingles rash with itchy without pain. The patient got 2nd dose of vaccine 2 months after 1st dose and the same reactions were happened. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event were unknown at the time of reporting. The permission to follow was denied.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient received  0.1 cc of vaccine , should have received 0.05 cc as he was not yet 19 years old.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Diarrhoea, Pain in extremity, Vomiting
Clinical narrative: Patient called the pharmacy on the morning of 01/31/2020 and complained of a possible reaction to Shingrix. She complained of vomiting, diarrhea, and sore right arm and chest. The pharmacist on duty advised the patient to contact her primary care provider that morning and be checked out. Will follow up with primary care provider on outcome and eligibility for second dose of Shingrix.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Decreased appetite, Injection site discomfort, Injection site pruritus, Injection site rash
Clinical narrative: Seen by MD on 2/24/2020: Noticed some bumps on the left thigh. The bumps are itchy. Tried some vicks on it but it didn't change. Was previously more swollen and was previously having discomfort to the area but not anymore. No fever. Normal activity. Decreased appetite since 2/22/20. No runny nose, cough, or dyspnea. No vomiting. Peeing and pooping normally.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Mother did a pregnancy test on the day of the vaccine that was negative, so she answered that she was not pregnant at the time of the vaccine.  The next day she called the office late in the day to say that her latest pregnancy test was positive.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Migraine, Nausea
Clinical narrative: I had the 2nd Shingrix shot Friday 1/10 around 4pm at the pharmacy. I woke up Saturday morning at 4:30 feeling awful. All day I had a fever of 100, horrible headache, aches, chills, a bit of nausea. I felt better that night, after taking Ibuprofen and Excedrin Migraine during the day. Sunday it had passed by the afternoon.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I had the 2nd Shingrix shot Friday 1/10 around 4pm at the pharmacy. I woke up Saturday morning at 4:30 feeling awful. All day I had a fever of 100, horrible headache, aches, chills, a bit of nausea. I felt better that night, after taking Ibuprofen and Excedrin Migraine during the day. Sunday it had passed by the afternoon.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Patient got severe chills and was feverish starting about 12 hours after receiving the vaccine. She states that she felt "flu-ish" for the following day. These side effects were so severe that she could not leave her bed for most of the day. All side effects resolved within 48 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Eczema, Eosinophilia, Hypersensitivity, Injection site pruritus
Clinical narrative: - rash that started one day after receiving the second dose of Shingrix vaccine  - started as one or two pink bumps on left arm distal to injection site (near elbow) then over the subsequent few days noticed more pink bumps coming up in clusters or pairs on left wrist and then few on left upper arm, mid chest and right upper arm and left cheek near eye - did not appear as true blisters - mild itching. No pain or burning - had chickenpox as a child - not immunosuppressed  - does not recall having any bug bites but has spent time outside. No travel or hotel stays - felt well otherwise  Treatment- time and topical steroid- Triamcinolone 0.1% cream   Resolved
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pruritus, Rash, Rash erythematous
Clinical narrative: - rash that started one day after receiving the second dose of Shingrix vaccine  - started as one or two pink bumps on left arm distal to injection site (near elbow) then over the subsequent few days noticed more pink bumps coming up in clusters or pairs on left wrist and then few on left upper arm, mid chest and right upper arm and left cheek near eye - did not appear as true blisters - mild itching. No pain or burning - had chickenpox as a child - not immunosuppressed  - does not recall having any bug bites but has spent time outside. No travel or hotel stays - felt well otherwise  Treatment- time and topical steroid- Triamcinolone 0.1% cream   Resolved
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling cold, Headache
Clinical narrative: About 2:30 am I awoke with my teeth chattering and my body shaking with cold. For about 2 hours I had to stay really warm or the shaking would start. That part subsided and I transitioned into feeling like I had the flu. Body aches and sore skin, very very tired. I slept a lot. That lasted until late afternoon. Then I had a bad headache for the rest of the evening. I took over the counter pain reliever for the headache (probably Advil). I did not seek medical attention. The next day I felt great!!
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Influenza like illness, Pain, Pain of skin, Tremor
Clinical narrative: About 2:30 am I awoke with my teeth chattering and my body shaking with cold. For about 2 hours I had to stay really warm or the shaking would start. That part subsided and I transitioned into feeling like I had the flu. Body aches and sore skin, very very tired. I slept a lot. That lasted until late afternoon. Then I had a bad headache for the rest of the evening. I took over the counter pain reliever for the headache (probably Advil). I did not seek medical attention. The next day I felt great!!
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nasal congestion, Pyrexia
Clinical narrative: Fever ranging from 99.9 to 101.0 Stuffy nose Headache
Age: 58.0
Sex: M
Vaccine: HEP, TDAP, VARZOS
Symptoms: Abdominal pain upper, Back pain, Chills, Fatigue, Feeling cold
Clinical narrative: Patient reports that he developed shoulder pain, lower back pain, feeling of cold and chills last night at about 1900. He states that he feels a little warm, but has not checked his temperature. He denies any additional symptoms, including runny nose. He has not taken anything for it. Informed him that this can be common side effects from vaccines that he received, including the muscle pain, soreness and not feeling well; informed him that the symptoms can also include tiredness, headache, shivering, fever, stomach pain and nausea and these symptoms usually go away on their own in 2 to 3 days. Advised him to take OTC tylenol or motrin, push fluids and rest.
Age: 58.0
Sex: M
Vaccine: HEP, TDAP, VARZOS
Symptoms: Feeling hot, Headache, Malaise, Musculoskeletal pain, Myalgia
Clinical narrative: Patient reports that he developed shoulder pain, lower back pain, feeling of cold and chills last night at about 1900. He states that he feels a little warm, but has not checked his temperature. He denies any additional symptoms, including runny nose. He has not taken anything for it. Informed him that this can be common side effects from vaccines that he received, including the muscle pain, soreness and not feeling well; informed him that the symptoms can also include tiredness, headache, shivering, fever, stomach pain and nausea and these symptoms usually go away on their own in 2 to 3 days. Advised him to take OTC tylenol or motrin, push fluids and rest.
Age: 58.0
Sex: M
Vaccine: HEP, TDAP, VARZOS
Symptoms: Nausea, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Patient reports that he developed shoulder pain, lower back pain, feeling of cold and chills last night at about 1900. He states that he feels a little warm, but has not checked his temperature. He denies any additional symptoms, including runny nose. He has not taken anything for it. Informed him that this can be common side effects from vaccines that he received, including the muscle pain, soreness and not feeling well; informed him that the symptoms can also include tiredness, headache, shivering, fever, stomach pain and nausea and these symptoms usually go away on their own in 2 to 3 days. Advised him to take OTC tylenol or motrin, push fluids and rest.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Nausea
Clinical narrative: Patient reported that he developed diarrhea/nausea within 24 hours of receiving vaccine. No record in Agency of where the vaccine was given, what manufacturer, lot number, etc that it was, other than it was given on 09/12/18.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: daughter received her third GARDASIL 9 vaccination a month earlier than scheduled; daughter received her third GARDASIL 9 vaccination a month earlier than scheduled; no adverse reactions reported; This spontaneous report was received from a consumer and refers to a female patient of an unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates, the patient was vaccinated with her first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (frequency, route of administration, anatomical location, lot # and expiration date were not provided). On an unknown date, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) a month earlier than scheduled. There were no adverse reactions reported.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; a patient was administered improperly stored M-M-R II; Information has been received from a immunization official who was also a nurse referring to a 4 years old patient of unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not provided.       On 27-JAN-2020, the patient was administered improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose, frequency and route were unknown;  lot # S004118 and expiration date 11-FEB-2021) for prophylaxis. The vaccine was exposed to temperature excursion above 9 degrees Celsius (10.9 degrees Celsius) for 8 hours and 15 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with sterile diluent, which was unknown if there was previous temperature excursions. No additional adverse effects were reported.
Sex: F
Vaccine: TYP
Symptoms: Haematemesis, Incomplete course of vaccination, Vomiting
Clinical narrative: Vomited some blood; Vomited profusely; Spontaneous report received on 14FEB2020.  A nurse reported that a female consumer vomited profusely (PT: Vomiting) and also vomited some blood (PT: Haematemesis) after receiving first dose of Vivotif for immunisation. The consumer took first dose of Vivotif on 12FEB2020 and 3 hours later, she started vomiting profusely as well as she vomited some blood. She did not receive any treatment but was hydrated for her symptoms. The nurse reported that she did not continue with Vivotif after her first dose. Her symptoms were resolved at the time of report.  Concomitant medication included antidepressant Wellbutrin SR (bupropion; 300 mg daily) and birth control medication (10 mg) for menstrual cycle.  Company Comment: A consumer took first dose of Vivotif and after three hours she started vomiting profusely, and she also vomited some blood (Haematemesis). The consumer was hydrated in response to these events, and both events were resolved. The consumer did not take the next doses of Vivotif. Profuse vomiting might have led to some blood in the vomit of the consumer. Considering the potential of Vivotif to cause vomiting and the case information, the causality of vomiting and haematemesis is assessed as possible. The case is considered serious due to the medical significance of haematemesis. Vomiting is listed and haematemesis is unlisted as per CCDS.; Sender's Comments: Company Comment: A consumer took first dose of Vivotif and after three hours she started vomiting profusely, and she also vomited some blood (Haematemesis). The consumer was hydrated in response to these events, and both events were resolved. The consumer did not take the next doses of Vivotif. Profuse vomiting might have led to some blood in the vomit of the consumer. Considering the potential of Vivotif to cause vomiting and the case information, the causality of vomiting and haematemesis is assessed as possible. The case is considered serious due to the medical significance of haematemesis. Vomiting is listed and haematemesis is unlisted as per CCDS.
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Nurse practitioner cannot be certain it was caused by vaccine, but thought it looked like cellulitis; Patient presented with a painful, warm, red, slightly swollen arm approximately 5"x3" at/near the site of the injection; Patient presented with a painful, warm, red, slightly swollen arm approximately 5"x3" at/near the site of the injection; Patient presented with a painful, warm, red, slightly swollen arm approximately 5"x3" at/near the site of the injection; Patient presented with a painful, warm, red, slightly swollen arm approximately 5"x3" at/near the site of the injection; This is a spontaneous report from a contactable other healthcare professional via Pfizer sales representative.   A 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13; lot# CG9017 Exp. date: Feb2022) on 14Feb2020 at single dose in arm for immunization and levofloxacin (LEVAQUIN) from an unspecified date to an unspecified date at 500 mg once a day for 14 days for an unspecified indication. The patient was on multiple medications for other health conditions at the time of injection (no other details reported). Medical history included unspecified health conditions; concomitant medications were not reported. A day later vaccination (Feb2020) the patient was seen back in the office and she presented with a painful, warm, red, slightly swollen arm approximately 5"x3" at/near the site of the injection. Nurse practitioner cannot be certain it was caused by vaccine, but thought it looked like cellulitis.Patient was taking levofloxacin at time of vaccination for another condition, so no other antibiotic was prescribed.  The final outcome of the events was unknown. Action taken for levofloxacin was unknown.; Sender's Comments: Based on the information available, it cannot be fully excluded that the vaccination with PREVNAR 13 might have played a contributory role in triggering the onset of cellulitis suspected at the vaccination site.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: severe redness and swelling in her arm; severe redness and swelling in her arm; This is a spontaneous report from a contactable physician via Pfizer Sales Representative. An 84-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at a pharmacy, via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included diabetes. The patient's concomitant medications were not reported. The patient experienced severe redness and swelling in her arm on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Feeling of despair, Pallor, Somnolence, Vomiting
Clinical narrative: despondent; pale; vomiting; fell asleep for about 1-2 minutes; Initial and additional information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a four years old female patient who experienced pale (pallor), despondent (feeling of despair), vomiting (vomiting) and fell asleep for about 1-2 minutes (somnolence), while she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]..  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  On 10-Feb-2020, the patient received a 5th 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5688AA, expiry date: 26-NOV-2021 via intramuscular route in the right thigh for prophylactic vaccination.  On 10-Feb-2020, the patient developed a non-serious pale (pallor), despondent (feeling of despair), vomiting (vomiting) and fell asleep for about 1-2 minutes (somnolence) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Events occurred following administration while patient was walking to the waiting room to check out.  Patient was transported to the local hospital/emergency room immediately following incident.  No lab data reported.  Final diagnosis was pallor, feeling of despair, vomiting and somnolence.   The patient was treated with EPINEPHRINE injection and 911 was contacted.  The patient had recovered from all the events.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: experienced redness at the injection site, swelling and pain; redness at the injection site; swelling at the injection site; pain at the injection site; Initial information was received on 14-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old female patient who experienced redness at the injection site, swelling and pain (vaccination site inflammation with vaccination site erythema, vaccination site pain and vaccination site swelling), while she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's ongoing medical condition included allergy to thimerosal.  Medical history, past medical treatment, past vaccination and family history were not provided.   The patient received concomitant vaccination of VARICELLA ZOSTER VACCINE in left arm on 28-Oct-2019.  On 28-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot QSAA1965, Expiration date- 14-Jun-2020) via an unknown route in the left arm for prophylactic vaccination.  On 28-Oct-2019, the patient developed a non-serious redness at the injection site, swelling and pain (vaccination site inflammation) as diagnosis and (vaccination site erythema), (vaccination site swelling), (vaccination site pain) as symptoms after a couple of hours following the administration of INFLUENZA QUADRIVAL A-B VACCIN.  Laboratory data was not provided.  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of the events was unknown.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: child was administered an expired dose of adcel vaccine/No AE; Initial information was received on 18-Feb-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4-year-old female patient who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  On 13-Feb-2020, the patient received concomitant medications included MMR, IPOL and "Afluria", a Flu vaccine (no dosing details reported) .  On 13-Feb-2020, the patient received a 0.5 mL second dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5367AA, expiry date: 30-Jan-2020] via an intramuscular route at the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.