chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Discomfort, Pain in extremity
Clinical narrative: burning sensation; Discomfort; intermittent arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix. On 30th July 2019, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced burning sensation and discomfort. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the burning sensation and discomfort were unknown.   It was unknown if the reporter considered the pain in arm, burning sensation and discomfort to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. For a week, the patient felt like she just got the shot and experienced discomfort, sore, hurts not swollen or itchy. The patient thought this pain would go away but she still gets it intermittentenly throughout the day sometimes it wakes her up during the night. The caller's arm was hurting and burning during the call. The caller got the shot at and she had since moved to her winter residence.  The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: rash all over body; itching all over body; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 29th October 2021) for prophylaxis.   Concurrent medical conditions included penicillin allergy.   On 8th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th October 2019, 4 days after receiving Shingrix, the patient experienced generalized rash and generalized pruritus. The patient was treated with prednisone. On an unknown date, the outcome of the generalized rash and generalized pruritus were recovering/resolving.   It was unknown if the reporter considered the generalized rash and generalized pruritus to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on right arm. The patient experienced rash all over body and itching all over body. The registered pharmacist reported that the patient was seen by his physician and was prescribed prednisone.  The reporter consented to follow up. This case has been linked with US2019192706, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash all over body; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2018, the patient received Shingrix. On 1st October 2018, less than a day after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter at Pharmacy reported that a female patient between the age of 55 to 60 years old, stopped by the pharmacy about a year ago, was not a customer of the pharmacy, and reported to him that she received the Shingrix and experienced a rash all over her body. The reporter consent to follow up. This is 2 of the 2 linked cases reported by the same reporter.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema multiforme, Rash
Clinical narrative: Erythemia multiforme; Rash on her bilateral lower extremities; This case was reported by a other health professional via call center representative and described the occurrence of erythema multiforme in a 86-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) for prophylaxis.   On 18th October 2019, the patient received Fluarix Tetra 2019-2020 season. On 20th October 2019, 2 days after receiving Fluarix Tetra 2019-2020 season, the patient experienced erythema multiforme (serious criteria GSK medically significant) and rash. The patient was treated with benadryl (nos) (Benadryl) and steroids nos (Steroid Pack (Nos)). On an unknown date, the outcome of the erythema multiforme and rash were not recovered/not resolved.   It was unknown if the reporter considered the erythema multiforme and rash to be related to Fluarix Tetra 2019-2020 season.  Additional details were provided as follows: The patient had a rash on her bilateral lower extremities. The patient went to the emergency room and was diagnosed with erythemia multiform. Benadryl and a steroid taper was prescribed to her. The rash had not resolved till the time of reporting. The reporter did not have vaccine information for this adverse event and stated it was administered at another facility. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dysphonia, Paraesthesia oral, Throat tightness
Clinical narrative: anaphylaxis; throat tightness; hoarse voice; tingling lips; This case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a 64-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 4MA5A, expiry date 30th June 2020) for prophylaxis.   On 14th October 2019, the patient received FluLaval Tetra 2019-2020 season. On 14th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced anaphylaxis (serious criteria GSK medically significant), throat tightness, hoarse voice and tingling lips. The patient was treated with famotidine (Pepcid), decadron (nos) (Decadron) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis was not recovered/not resolved and the outcome of the throat tightness, hoarse voice and tingling lips were unknown.   It was unknown if the reporter considered the anaphylaxis, throat tightness, hoarse voice and tingling lips to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient had an anaphylactic response including throat tightness, hoarse voice and tingling lips. The side effects occurred the same day and she went to the emergency room (ER), received treatment and her symptoms improved. The patient returned to the ER on 19th October 2019, with the same symptoms. The patient was not admitted overnight and there was no additional update on the patient's symptoms currently.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Squamous cell carcinoma
Clinical narrative: squamous cell carcinoma; Skin lesion; This case was reported by a physician via call center representative and described the occurrence of squamous cell carcinoma in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced squamous cell carcinoma (serious criteria GSK medically significant) and skin lesion. On an unknown date, the outcome of the squamous cell carcinoma and skin lesion were unknown.   It was unknown if the reporter considered the squamous cell carcinoma and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the left arm. On an unknown date, the patient reported to her primary care physician for a skin lesion that appeared on her left arm. The primary care physician referred the patient to a dermatologist and the lesion was diagnosed as squamous cell carcinoma. The treatment for the event was not reported. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Feeling abnormal, Influenza like illness, Sneezing
Clinical narrative: Diagnosed with Afib; Flu like symptoms; Felt differrent; This case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number Y5J27, expiry date 8th November 2021) for prophylaxis.   The patient's past medical history included premature ventricular contractions. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, for tolerance refer case US2019AMR192406).   On 17th October 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In October 2019, less than a week after receiving Shingrix, the patient experienced feeling abnormal. On 17th October 2019, the patient experienced influenza-like symptoms. On 19th October 2019, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation and feeling abnormal were recovered/resolved and the outcome of the influenza-like symptoms was not recovered/not resolved.   It was unknown if the reporter considered the atrial fibrillation, influenza-like symptoms and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. In the evening, the patient got flu like symptoms.  He felt better the next morning, but then worst that night.  By Saturday morning at 2am, the patient was thinking, he had atrial fibrillation and went to the emergency room. The patient were diagnosed with atrial fibrillation and during observation, the patient sneezed and his heart went back into normal rhythm. The patient did have a history of PVCs (premature ventricular contractions), but said this felt different. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: Lost hearing; This case was reported by a physician via sales rep and described the occurrence of hearing loss in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows: The physician reported a patient came back the day after their first dose saying he could not hear anything.  It did not sound like it has resolved.  The patient was not going to get the second dose. Follow-up was not asked. No further details were available.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever, fatigue, tiredness, acheyness,
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Sensation of foreign body, Vomiting
Clinical narrative: Throat felt like there was something stuck in it, vomiting, diarrhea, weakness, chills
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Left arm pain persistent x 3 weeks
Age: 90.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Mobility decreased, Pain
Clinical narrative: Pt reported soreness and difficulty lifting arm plus some mobility issues beginning a few days after the vaccination and has continued. It is unknown if the extent of these s/s has remained constant. Pharmacist on duty at the time the patient came in (10-26, site was unavailable due to maintenance which is why it is being put in today) advised the patient to use cold compresses/tylenol
Age: 90.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt reported soreness and difficulty lifting arm plus some mobility issues beginning a few days after the vaccination and has continued. It is unknown if the extent of these s/s has remained constant. Pharmacist on duty at the time the patient came in (10-26, site was unavailable due to maintenance which is why it is being put in today) advised the patient to use cold compresses/tylenol
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented to Clinic after receiving flu vaccine at a pharmacy 3 days prior. Patient developed swelling, tenderness and itching at injection site. No signs of infection.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: "I woke up at 4:52 am to pain under my arm and noticed my lymph nodes were swollen. I feel them even when I move my arm. There's pain under my arm where the swelling is and at the corners of my armpit in the front and back".
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 10/26/19 :Redness, warmth, and pruritis surrounding  injection site on RT developed 2 days after administration of  vaccine.  Mom administered benadryl with improvement.  Seen in office on 10/26/19.  Symptomatic treatment, mom given s/s to monitor for infection/cellulitis.  12/22/18:  Treated in office for LT cellulitis with benadryl and keflex.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient states that the vaccination hurt more than usual during the shot and the pain in her arm continued over the next few days.  Today 10/28/19 when she reported this event she describes being unable to fully lift her left arm and is still experiencing pain at the injection site.  Patient has been advised to see her PCP, for examination of her left arm.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: It is now 11 days later and the area where the shot was given is red, raised, and painful to the touch.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Erythema, Induration, Swelling
Clinical narrative: 3-4CM Erythema, mild induration and swelling
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea, Vommiting, Diarrhea, Muscle aches
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Choking sensation, Dizziness, Erythema, Flushing
Clinical narrative: Within approximately two minutes of receiving IM flu vaccine employee experienced intense abdominal pain, bright red flushing of face, neck and arms. Additionally she felt a sensation of choking / throat swelling. Was unable to walk due to intense dizziness and feeling faint.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Gait inability, Pharyngeal swelling
Clinical narrative: Within approximately two minutes of receiving IM flu vaccine employee experienced intense abdominal pain, bright red flushing of face, neck and arms. Additionally she felt a sensation of choking / throat swelling. Was unable to walk due to intense dizziness and feeling faint.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Chills, Fatigue, Feeling cold
Clinical narrative: Freezing and shivering for about 10 hours. Could not get warm. Then outside of body burning hot. Then freezing again. Extreme headache which lasted for at least 36 hours. Advil did not help. Nausea (threw  up). Could not walk for 18 hours. Legs would not bend to walk. Pain in every muscle and ligament throughout my body.  Could not eat for two days. Even water tasted metallic in my mouth. Loud heartbeat in my left ear. This started after the first shingle shot and has continued. Things I could read before are now blurry.  This is now three days later, and my fingers are having a hard time typing this. I am weak, tired, nauseated, and so tired of this pounding in my ear, and am so sorry I got this vaccination. What a big mistake.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Headache, Mobility decreased, Nausea, Palpitations
Clinical narrative: Freezing and shivering for about 10 hours. Could not get warm. Then outside of body burning hot. Then freezing again. Extreme headache which lasted for at least 36 hours. Advil did not help. Nausea (threw  up). Could not walk for 18 hours. Legs would not bend to walk. Pain in every muscle and ligament throughout my body.  Could not eat for two days. Even water tasted metallic in my mouth. Loud heartbeat in my left ear. This started after the first shingle shot and has continued. Things I could read before are now blurry.  This is now three days later, and my fingers are having a hard time typing this. I am weak, tired, nauseated, and so tired of this pounding in my ear, and am so sorry I got this vaccination. What a big mistake.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, Vision blurred, Vomiting
Clinical narrative: Freezing and shivering for about 10 hours. Could not get warm. Then outside of body burning hot. Then freezing again. Extreme headache which lasted for at least 36 hours. Advil did not help. Nausea (threw  up). Could not walk for 18 hours. Legs would not bend to walk. Pain in every muscle and ligament throughout my body.  Could not eat for two days. Even water tasted metallic in my mouth. Loud heartbeat in my left ear. This started after the first shingle shot and has continued. Things I could read before are now blurry.  This is now three days later, and my fingers are having a hard time typing this. I am weak, tired, nauseated, and so tired of this pounding in my ear, and am so sorry I got this vaccination. What a big mistake.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Constipation, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: Patient states she was administered the flu shot at her workplace less than two hours ago, and that she started having symptoms about 30-40 minutes later, including "feeling hot," a rash to the right upper arm (near the injection site), feeling her neck was swollen and a globus sensation (but denies feeling her throat is closing), myalgias, fatigue, arthralgias, nausea, increased sweating, and injection site pain. She does endorse some measure of chronic constipation, and also that she has a history of "scalp dysesthesia" for which she uses a topical medication that she cannot recall the specific name. She endorses now that she is "feeling hot" similarly to how she feels her scalp feels with this condition, but that it is more widespread in her body. She is unsure if she has any egg allergy. She denies current headache, lightheadedness/dizziness, visual disturbance, eye pain, nasal congestion/sinus pressure, sore throat, trouble swallowing, trouble breathing, chest pain/palpitations, or n/v/d.  Administered dexamethasone 10 mg/mL injection solution (4 mg) by injection route for one dose, instructed to take several doses of diphenhydramine by mouth (12.5-25mg), and follow up with PCP later today.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site rash, Myalgia, Nausea, Sensation of foreign body
Clinical narrative: Patient states she was administered the flu shot at her workplace less than two hours ago, and that she started having symptoms about 30-40 minutes later, including "feeling hot," a rash to the right upper arm (near the injection site), feeling her neck was swollen and a globus sensation (but denies feeling her throat is closing), myalgias, fatigue, arthralgias, nausea, increased sweating, and injection site pain. She does endorse some measure of chronic constipation, and also that she has a history of "scalp dysesthesia" for which she uses a topical medication that she cannot recall the specific name. She endorses now that she is "feeling hot" similarly to how she feels her scalp feels with this condition, but that it is more widespread in her body. She is unsure if she has any egg allergy. She denies current headache, lightheadedness/dizziness, visual disturbance, eye pain, nasal congestion/sinus pressure, sore throat, trouble swallowing, trouble breathing, chest pain/palpitations, or n/v/d.  Administered dexamethasone 10 mg/mL injection solution (4 mg) by injection route for one dose, instructed to take several doses of diphenhydramine by mouth (12.5-25mg), and follow up with PCP later today.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Patient states she was administered the flu shot at her workplace less than two hours ago, and that she started having symptoms about 30-40 minutes later, including "feeling hot," a rash to the right upper arm (near the injection site), feeling her neck was swollen and a globus sensation (but denies feeling her throat is closing), myalgias, fatigue, arthralgias, nausea, increased sweating, and injection site pain. She does endorse some measure of chronic constipation, and also that she has a history of "scalp dysesthesia" for which she uses a topical medication that she cannot recall the specific name. She endorses now that she is "feeling hot" similarly to how she feels her scalp feels with this condition, but that it is more widespread in her body. She is unsure if she has any egg allergy. She denies current headache, lightheadedness/dizziness, visual disturbance, eye pain, nasal congestion/sinus pressure, sore throat, trouble swallowing, trouble breathing, chest pain/palpitations, or n/v/d.  Administered dexamethasone 10 mg/mL injection solution (4 mg) by injection route for one dose, instructed to take several doses of diphenhydramine by mouth (12.5-25mg), and follow up with PCP later today.
Age: 88.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: hives, redness, itching
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Chills, Fatigue, Headache
Clinical narrative: by 7:30 pm on the day of the vaccine, I noticed all my joints where achy.  I went to bed approximately 10 pm  and during the night I had fever, chills, increasing joint pain and swelling, headache, extreme fatigue and malaise.  I continue to have joint pain and swelling, parathesia, headache and fatigue as of today although it is not as bad as the first day.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Malaise, Paraesthesia, Pyrexia
Clinical narrative: by 7:30 pm on the day of the vaccine, I noticed all my joints where achy.  I went to bed approximately 10 pm  and during the night I had fever, chills, increasing joint pain and swelling, headache, extreme fatigue and malaise.  I continue to have joint pain and swelling, parathesia, headache and fatigue as of today although it is not as bad as the first day.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Limb discomfort
Clinical narrative: REDNESS, HEAVINESS AND HOTNESS OF PUNCTURE AREA, ACOMPANIED WITH ENDURATION
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Myalgia
Clinical narrative: Patient had overall muscle aches and chills for 3 days after the vaccination. No fever.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: pt given .25 of flu vaccine for pediatric, needs to come back in for other .25ml in one month from 10/8/19
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Nasopharyngitis, Pain
Clinical narrative: cold, achy, dizzy, weak
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient received an improperly stored dose of VAQTA; This spontaneous report was received from a medical assistant regarding a 3 years old male patient. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 03-OCT-2019, the patient received an improperly stored dose (product storage error) of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number S016868, expiration date 24-FEB-2022; strength, dose, and route of administration was not provided) for prophylaxis. There was no adverse effect reported. Current temperature excursion was 46.5 degrees Fahrenheit for 5 minutes. There was no previous temperature excursion. Data logger was involved.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA006415: US-009507513-1910USA006268: US-009507513-1910USA006414: US-009507513-1910USA006562: US-009507513-1910USA006576:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects; a first dose of GARDASIL 9 at age 12 (...) a second dose on 15-OCT-2019 at age 14; This spontaneous report as received from a physician assistant refers to a 14-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  In approximately 2017 (reported as "at age 12"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 15-OCT-2019, the patient was in an office to be vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). There was no adverse event reported.
Sex: F
Vaccine: HEPA, YF
Symptoms: Autoimmune hepatitis, Idiosyncratic drug reaction
Clinical narrative: autoimmune hepatitis; idiosyncratic response; Initial unsolicited valid serious case report received from the literature abstract on 18-Oct-2019.    The following is verbatim from the a abstract:  The pathogenesis of autoimmune hepatitis entails complex interactions between triggering factors, autoantigens, genetic predisposition, and immunoregulatory networks. Implicated triggering factors are numerous and include toxins, medications, and infectious agents. In this article, we present a unique case of a 31-year-old woman with severe autoimmune hepatitis apparently abruptly triggered by vaccination. All evidence suggests this was an idiosyncratic response to either hepatitis A or yellow fever vaccination.   This case involves a 31 years old female patient who experienced autoimmune hepatitis (autoimmune hepatitis) and idiosyncratic response (idiosyncratic drug reaction), while she received vaccines HEPATITIS A VACCINE and YELLOW FEVER VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect HEPATITIS A VACCINE and YELLOW FEVER VACCINE produced produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious autoimmune hepatitis (Unknown latency) following the administration of YELLOW FEVER VACCINE and HEPATITIS A VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a idiosyncratic response (idiosyncratic drug reaction) (Unknown latency) following the administration of YELLOW FEVER VACCINE and of HEPATITIS A VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was idiosyncratic response and autoimmune hepatitis.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for autoimmune hepatitis and idiosyncratic response.  Information on the batch number was requested.; Sender's Comments: This case involves a 31 years old female patient who experienced autoimmune hepatitis (autoimmune hepatitis) and idiosyncratic response (idiosyncratic drug reaction), while she received vaccines HEPATITIS A VACCINE and YELLOW FEVER VACCINE. Time to onset is unknown with the role of vaccine. However, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be individually assessed.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Immediate post-injection reaction, Influenza like illness, Injection site pain
Clinical narrative: I received my second dose of the Shingrix shingles vaccine (Shingrix 50 mcg/0.5 ml inj Glax, NDC: 58160-0823-11) and had immediate, persistent injection site pain. The next day I had "flu-like" symtoms: generalized muscle/joint aches, headache, and general malaise. I had a similar reaction when I received the first dose, on 8/9/2019; and still have occasional injection site pain from that today. I would not classify this as a severe reaction, but felt it should be reported so that you would know how common it may be.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia
Clinical narrative: I received my second dose of the Shingrix shingles vaccine (Shingrix 50 mcg/0.5 ml inj Glax, NDC: 58160-0823-11) and had immediate, persistent injection site pain. The next day I had "flu-like" symtoms: generalized muscle/joint aches, headache, and general malaise. I had a similar reaction when I received the first dose, on 8/9/2019; and still have occasional injection site pain from that today. I would not classify this as a severe reaction, but felt it should be reported so that you would know how common it may be.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Headache, Pain, Pyrexia
Clinical narrative: I got the Shingrix 50 MCG injection and had fever, chills, headache, body aches and sore eyes. Symptoms lasted for about 50 hours.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea
Clinical narrative: I got the flu shot on 10/16/2019. Around 20 hours later I started having a watery diarrhea. On Thursday it started and on Friday it continuous. It got worse on Saturday. The last visit to the toilet happened on Sunday. I visited Clinics and I was examined. I was sent home with a test kit to collect material to be examined. Now, it's Sunday night and I'm doing ok. I'm just wondering if diarrhea was reported from people that took the flu shot. I analyzed what I ate and drunk and was nothing out of normal. Please, let me know.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Needle issue
Clinical narrative: This child was set to be administered the influenza vaccine. After administration, the needle detached from the syringe and remained in the child's thigh until manual removal by the MA. For some reason, the device did not retract like it was supposed to.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states that she had extreme redness, swelling  and pain at the injection site.  She states that she has had the flu shot numerous times and has never had this reaction before.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Dyspnoea, Rash, Rash morbilliform, Wheezing
Clinical narrative: Generalized, diffuse morbilliform rash that started on the face and spread over time. Per parents, patient was having shortness of breath following 12 month vaccines. Patient presented with faint wheezes on day of the appointment.
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: When I went I asked if they could do the injection in my arm because I have Muscular Dystrophy and it's the first time I've remembered to ask since a nurse suggested I don't get it in my arm and I get up my butt off and that year which is about five years ago I had no problems. Pharmacy said they couldn't do it in any area other than my arm and everything went fine until a few days later and then the pain started up again and it hasn't stopped. There's a pain in my arm that leads into my shoulder and it's where the injection site was it's very uncomfortable and it's nonstop. I'm pretty sure I see injection site when I got home because I didn't want to she will the bump but the bump happens for me and wasn't anything abnormal at the same thing that happens every year I get the injection and then it gets a bump it's red it's hot it's sore for a couple days and it goes away this time it came back and it hasn't gone away.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Client came into the clinic for various vaccines including FluMist, Hep B, IPV, DTap, and MMRV. Her brother also needed 5 vaccines. The combo vaccine of HepB - DTap - IPV (Pediarix) was mistaken for DTap. Pediarix was given along with extra doses of Hep B and IPV. No signs or symptoms seen. The language line was called (family's primary language was foreign but spoke well) and explained to the father that extra doses of Hep B and IPV were given because of mistaking the combo vaccine for the singular vaccine of DTap. Explained to him that the child should  not experience any negative side effects from this mistake. Asked him if he had any further questions and to follow up for the child's next vaccines.
Sex: U
Vaccine: TDAP
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: PT COMPLAINED OF FEELING DIZZY A FEW SECONDS AFTER RECEIVING A Tdap vaccine. WITHIN SECONDS, PT FAINTED AND THEN BECAME UNCONSCIOUS. 911 CALL WAS PLACED, THEN IN ABOUT 2 MINUTES PT REGAINED CONSCIOUSNESS. PARAMEDICS WERE AT THE SCENE LATER BUT PT HAD ALREADY REGAINED CONSCIOUSNESS. PT WAS ASKED TO DRING WATER AND LAY DOWN FOR SOMETIME BEFORE GETTING UP. PT LIED DOWN FOR ABOUT 20 MINUTES WHILE BEING MONITORED. THEN LATER WAS ABLE TO GET UP ON HIS FEET AND LEFT OUR FACILITY WITH HIS SPOUSE.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Menstrual disorder
Clinical narrative: Abnormal menstrual cycle
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt received vaccine on 10/24 and called 1025 in the evening after nurse was gone stating that her arm was right arm where she received pneumovax was red, swollen, painful and had a hard knot on it.  When I called pt on Monday am when I got message to check on her she said she was 90% better and had no concerns.  At that time only had mild, redness and swelling and was pain free.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Abdominal pain upper, Pain in extremity
Clinical narrative: Patient stats right arm has had constant pain since receiving immunization on 9/26/19 and the pain is worse in the morning upon waking. Pain has progressed to causing stomach discomfort in the past week. No local reactions or indications the immunization was not given in proper injection site.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Two hours after getting the vaccination Pt. experienced hives all over her body. Still has some hives yet today
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Itchy Rash on upper arms, lower back and lower legs.   Other spotty itching spots.  Itching head and hands, but no rash on hands and head.  after two weeks and treatment with prednisone symptoms have subsided.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: arm swelling md diagnosis with cellulitis
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Sleep disorder
Clinical narrative: Arm pain that initially went away and then worsened and travelled down the arm. Disrupting sleep and daily functioning.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Injection site pain, Musculoskeletal disorder
Clinical narrative: Pt states her symptoms started approx. 4 hours after receving the vaccine (Left arm very sore).  Pt states she woke up the next morning and could not use her left arm.  she states she called her PCP and was seen.  Pt sates she was ordered a CT scan (results were normal). Pt states she is still experience pain in left shoulder as of 10/17/19.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Flublok vaccine prior to her 18th birthday.  Immediately notified the patients provider who discussed vaccination error with patient.  A call was placed by nursing staff to Clinic head of pharmacy.  Pharmacy contacted Flublok manufacturer Sanofi Pasteur, for guidance. Information received from manufacturer was that patient is at no risk from increased harm due to receiving vaccine before turning 18 yrs old.  Informed to watch for standard influenza vaccine side effects and symptoms.  Manufacturer representative requested a VAERS event be reported.   No adverse reaction or events noted or reported by the patient.  No treatment required.  Patient's EDD 4/11/2020.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: It hurt as it went in really bad. My arm was so sore I couldn't lift it and used my other arm to rotate the vaccinated arm with my other arm. Felt feverish around 9pm. Fully body aches. Stayed in bed for 24hrs.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain, Joint range of motion decreased, Muscular weakness, Radiculopathy
Clinical narrative: about 11 days after injection, developed L shoulder pain, decreased range of motion, weakness of left arm. Will be treating with steroid burst, ice, stretches. Suspected deltoid bursitis with nerve impingement.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Pain, Pruritus
Clinical narrative: patient complains of itching and pain. has a red rash appearance around injection site
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Breakthrough pain, Discomfort, Erythema
Clinical narrative: One month after 1st Shingrix I experienced sudden aversion to oatmeal cereal one morning. On Thanksgiving, 2018 I awoke with soreness in the back of my legs. This began to include the hip area, buttocks and upper inner thighs. Then I developed upper back and neck pain by the end of December. In February of 2019 I had a burning pain in my 2nd distal toe of my left foot. It was a shiny, red distal toe from the nailbed to the tip of the toe. While see the rheumatologist in March, both my legs were deeply purple from below the knees to my feet. There was no pain. A few times in the shower I noticed a blue/purple molting of my feet. I was put on Prednisone 5mg/day for 2 weeks and then saw the doctor again. There was some improvement in the pain after 5-6 days on the Prednisone. The Prednisone was increased to 7.5mg and I remained on that until May 10th, and I was decreased to 6mg. I have been weaning every month. In September, just after decreasing the Prednisone from 3mg to 2mg I began with breakthrough pain. I was increased 0 to 3 mg then 5mg when the pain did not resolve after a week. I still have some residual "seat of my pants" discomfort, but am now on 4mg/d of Prednisone. In the last 2 days, I have had a cold sensation in my Left foot & toes and sort of like vibration sensation in my entire left leg. The doctor diagnosed as sciatica. As of today, Oct 24, the pain in my leg had lessened. Please see my emails to VAERS dated Jan 11, 2019 and Oct 1, 2019 Question #22 - addendum: I did receive that #2 Shingrix vaccine and the Hi-dose influenza vaccine in the same week.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Feeling cold, Food aversion, Livedo reticularis, Musculoskeletal pain, Neck pain
Clinical narrative: One month after 1st Shingrix I experienced sudden aversion to oatmeal cereal one morning. On Thanksgiving, 2018 I awoke with soreness in the back of my legs. This began to include the hip area, buttocks and upper inner thighs. Then I developed upper back and neck pain by the end of December. In February of 2019 I had a burning pain in my 2nd distal toe of my left foot. It was a shiny, red distal toe from the nailbed to the tip of the toe. While see the rheumatologist in March, both my legs were deeply purple from below the knees to my feet. There was no pain. A few times in the shower I noticed a blue/purple molting of my feet. I was put on Prednisone 5mg/day for 2 weeks and then saw the doctor again. There was some improvement in the pain after 5-6 days on the Prednisone. The Prednisone was increased to 7.5mg and I remained on that until May 10th, and I was decreased to 6mg. I have been weaning every month. In September, just after decreasing the Prednisone from 3mg to 2mg I began with breakthrough pain. I was increased 0 to 3 mg then 5mg when the pain did not resolve after a week. I still have some residual "seat of my pants" discomfort, but am now on 4mg/d of Prednisone. In the last 2 days, I have had a cold sensation in my Left foot & toes and sort of like vibration sensation in my entire left leg. The doctor diagnosed as sciatica. As of today, Oct 24, the pain in my leg had lessened. Please see my emails to VAERS dated Jan 11, 2019 and Oct 1, 2019 Question #22 - addendum: I did receive that #2 Shingrix vaccine and the Hi-dose influenza vaccine in the same week.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Sciatica, Sensory disturbance, Skin discolouration
Clinical narrative: One month after 1st Shingrix I experienced sudden aversion to oatmeal cereal one morning. On Thanksgiving, 2018 I awoke with soreness in the back of my legs. This began to include the hip area, buttocks and upper inner thighs. Then I developed upper back and neck pain by the end of December. In February of 2019 I had a burning pain in my 2nd distal toe of my left foot. It was a shiny, red distal toe from the nailbed to the tip of the toe. While see the rheumatologist in March, both my legs were deeply purple from below the knees to my feet. There was no pain. A few times in the shower I noticed a blue/purple molting of my feet. I was put on Prednisone 5mg/day for 2 weeks and then saw the doctor again. There was some improvement in the pain after 5-6 days on the Prednisone. The Prednisone was increased to 7.5mg and I remained on that until May 10th, and I was decreased to 6mg. I have been weaning every month. In September, just after decreasing the Prednisone from 3mg to 2mg I began with breakthrough pain. I was increased 0 to 3 mg then 5mg when the pain did not resolve after a week. I still have some residual "seat of my pants" discomfort, but am now on 4mg/d of Prednisone. In the last 2 days, I have had a cold sensation in my Left foot & toes and sort of like vibration sensation in my entire left leg. The doctor diagnosed as sciatica. As of today, Oct 24, the pain in my leg had lessened. Please see my emails to VAERS dated Jan 11, 2019 and Oct 1, 2019 Question #22 - addendum: I did receive that #2 Shingrix vaccine and the Hi-dose influenza vaccine in the same week.
Age: 68.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Extreme vertigo for ten minutes - walls were tilting wildy, had to hold onto a railing.  The following 24 hours, frequent dizziness when moving, some mild nausea.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Loss of consciousness, Pain, Vertigo, Vomiting
Clinical narrative: 10/03/19. Early night started aching all over a d chilling - at 7am  passed out for about 5 min and started vomiting.  Lasted about 30 min.  Aching and vertigo lasted 3 days to the degree of total incapacitation.  Gradually improved until about after 2 weeks the vertigo was gone.  Tiredness lasted another week.  By 10/24 no symptoms were remaining.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Erythema multiforme, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: Had a fever of 100.3 the day after shot, gave her some tylenol and she was fine afterwards. Later that night she started having red spots around the shot area, thought it was probably from the bandage. However as days went by the spota got bigger and spreading down and behind her legs. I took her to the doctor twice. First time they said ID reaction second visit they said she has erythema multiforme. This is actually the second time shes had a reaction to these shots. She broke out into hives in 2017.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Head injury, Vomiting
Clinical narrative: Patient became dizzy and fell and hit head.  Did not seem to loose consciousness.  We had her lay  there for several minutes before getting up then had her sit on bench for several more minutes. before leaving.  Called patient later and she had thrown up.  Her father was a doctor and had told mother that was expected.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: pain and inability to move arm anti inflammatory, physical therapy consult for possible bursitis due to injection into bursa
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Burning sensation, Discomfort, Feeling hot, Pruritus
Clinical narrative: Pt reports feeling a hot, itchy sensation at time of vaccination, but that went away shortly after. Then about 10-14 days later patient reports feeling a burning itchy unbearable feeling all over her body and it is still continuing to this day. Pt reached out to her PCP and they prescribed her an allergy medication (cetirizine) to help with the symptoms, but patient still states that she is feeling uncomfortable. Pt. reported that in the past when she's received flu vaccines she has gotten lumps in her nodules after receiving the vaccine, but those would go away in a few days. This is the first time she had this type of reaction.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Full blood count, Hypoaesthesia, Metabolic function test, Pain in extremity, Paraesthesia
Clinical narrative: Prolonged arm pain, swollen neck, numbness and tingling (currently going on 6 weeks)
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Red blood cell sedimentation rate, Swelling
Clinical narrative: Prolonged arm pain, swollen neck, numbness and tingling (currently going on 6 weeks)
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Pyrexia
Clinical narrative: Fever, chills, body ache, redness on arm that spread to entire upper arm over the course of 3-4 days
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: pt was waiting in the waiting room after the vaccination and all of a sudden he passed out. Pt was in and out of conciseness over the next 5 min. I check the pts blood pressure which was 105/60 with pulse of 45. I then called for EMS. They arrived 10 min later and pt still was not alert. The determined it would be best to transport to ED.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Inflammation
Clinical narrative: Patient had a large inflamed area on her inner left arm.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: His right arm is very swollen and red from his pnuemonia shot. He said it was swollen and red down to his elbow.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Ear congestion, Feeling abnormal
Clinical narrative: 10/26/2019, 8:30 a.m. - foggy head, clogged ears, extremely dizzy. Only lasted 30 minutes, then I was fine the rest of the day. 10/27/2019 8:30 a.m. - Diarrhea and vomiting for 8-12 hours. Stomach pain and cramps.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: 10/26/2019, 8:30 a.m. - foggy head, clogged ears, extremely dizzy. Only lasted 30 minutes, then I was fine the rest of the day. 10/27/2019 8:30 a.m. - Diarrhea and vomiting for 8-12 hours. Stomach pain and cramps.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Burning sensation, Immediate post-injection reaction, Injection site pain, Musculoskeletal pain
Clinical narrative: Immediate pain upon injection. Severe burning feeling. Left with severe pain in shoulder, back, and spine. Injection site was too high and given at the wrong angle. I was seated while pharmacist administering the injection stood above me. Still experiencing pain.