chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: YF
Symptoms: Arthralgia, Headache, Loss of consciousness
Clinical narrative: passed out; aching in her joints real bad; headache; Initial information received on 24-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case is linked to cases 2019SA297783 and 2019SA297782 (same reporter).  This case involves a 50 years old female patient who experienced aching in her joints real bad (arthralgia), passed out (loss of consciousness) and headache (headache), while she received vaccine YELLOW FEVER VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Notes: Patient's daughter was just diagnosed with Type 1 DM.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, after the vaccination the patient experienced passed out (loss of consciousness). This event was assessed as medically significant.  On an unknown date, following the vaccination the patient experienced aching in her joints real bad (arthralgia) and headache (headache).  Lab data was not reported.  Final diagnosis was joint pain, passed out and headache.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown at the time of reporting.  Information on the batch number was requested.; Sender's Comments: This case concerns 50 years old female who had joint pain, passed out and headache following the vaccination with YELLOW FEVER VACCINE (unknown manufacturer). The time to onset is unknown. The patient's past medical history, condition at the time of vaccination, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of Fluzone HD in pregnant women, no advesre event; administration of Fluzone HD in 40 years old women, no advesre event; administration of Fluzone HD in 40 years old women, no advesre event; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 40 years old female patient who was pregnant and vaccinated with a 0.5 ml dose of  vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UT6681A via intramuscular route in the left deltoid on 29-Oct-2019.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The gestation period not reported.  The date of last menstrual period was not reported. The estimated due date was unknown date of Jan-2020. The Information regarding  previous pregnancy/ies not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not revived other vaccines.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.  The patient had no adverse event.  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 and Regulatory Authority 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.  The pregnancy outcome was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Deafness unilateral, Neck pain, Tinnitus, Viral infection
Clinical narrative: hearing loss in the left ear; pain on the left side of neck; buzzing in the left ear; Initial information received on 29-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 65 years old female patient who experienced hearing loss in the left ear (deafness), pain on the left side of neck (neck pain) and buzzing in the left ear (tinnitus), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a serious hearing loss in the left ear (deafness), Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious pain on the left side of neck (neck pain) and buzzing in the left ear (tinnitus), Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that patient sought treatment at an ENT (ears, nose and throat) for the ear. She stated the ENT said there was no fluid in the ear but she had hearing loss due to an audible nerve virus.   Other relevant tests were not reported.  Final diagnosis was buzzing in the left ear, pain on the left side of neck and hearing loss in the left ear.   The patient was treated with weekly CORTISONE drops for 4 weeks.  On an unknown date, the  patient had recovered from neck pain (subsided in 3-4 hours without intervention) and not recovered from the other events.  Information on the batch number was requested.; Sender's Comments: Patient experienced deafness, neck pain and tinnitus after vaccination. Time to onset is unknown. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 10.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD was accidentally given to 10 yr old patient, no AE; Fluzone HD was accidentally given to 10 yr old patient, no AE; came to a Flu Shot Clinic yesterday and were inadvertently given a Fluzone HD, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA303347 (same reporter).  This case involves a 10 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (prefilled syringe) (lot number: UJ283AA, Expiration Date: 29-May-2020)  via intramuscular route in the left deltoid inadvertently on 28-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose and wrong vaccine administered.  At the time of reporting, 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 holders 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.
Sex: F
Vaccine: YF
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swelling lymph node underarm; painful lymph node; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via mylan.  This case involves a 56 years old female patient who experienced swelling lymph node  of underarm (lymphadenopathy) and painful lymph node (lymph node pain), while she received vaccine 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 YELLOW FEVER VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious swelling lymph node underarm (lymphadenopathy) and painful lymph node (lymph node pain) (Unknown latency) following the administration of YELLOW FEVER VACCINE.  Lab data was not reported.  Final diagnosis was lymphadenopathy and lymph node pain.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for lymphadenopathy and lymph node pain.  There will be no information available on the batch number for this case.
Age: 26.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Syncope
Clinical narrative: Self reported (unwitnessed) syncopial episode in car before he drove off from parking lot.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Aphasia, Chills, Confusional state, Decreased appetite, Depressed level of consciousness
Clinical narrative: viral meningitis with encephalitis secondary to Flu shot,  symptoms: chills, high grade fever, lethargy, loss of appetite, malaise, nausea, vomiting. confusion, aphasia, loss of alertness.  outcome of symptoms: 9 days in ICU followed by recommended 20 sessions of physical and occupational therapy plus Brain injury rehab
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Encephalitis, Intensive care, Laboratory test, Lethargy, Malaise
Clinical narrative: viral meningitis with encephalitis secondary to Flu shot,  symptoms: chills, high grade fever, lethargy, loss of appetite, malaise, nausea, vomiting. confusion, aphasia, loss of alertness.  outcome of symptoms: 9 days in ICU followed by recommended 20 sessions of physical and occupational therapy plus Brain injury rehab
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Meningitis viral, Nausea, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: viral meningitis with encephalitis secondary to Flu shot,  symptoms: chills, high grade fever, lethargy, loss of appetite, malaise, nausea, vomiting. confusion, aphasia, loss of alertness.  outcome of symptoms: 9 days in ICU followed by recommended 20 sessions of physical and occupational therapy plus Brain injury rehab
Age: 4.0
Sex: U
Vaccine: FLU4
Symptoms: Abdominal pain upper, Blood pressure measurement, Fall, Syncope
Clinical narrative: After sitting in the room for about 5min after the vaccine, Pt was walking out of the room and fell to the ground and fainted. Pt woke up quickly but C/o stomach hurting.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: yellowish colored bruising around site of injection.  no pain.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Joint range of motion decreased
Clinical narrative: Pain since day of administration.  L arm assessment 2 weeks after administration: tender to palpate deltoid, lateral head of the triceps, and upper trapezoid. Roundish 1 inch area, 1inch below the acromiom process was tender and erythematous. ROM reduced, extension 10 degrees, forward flexion 45 degrees, abduction 45 degrees.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Irritability, Malaise, Pyrexia
Clinical narrative: Developed a fever of about 99.4 degrees and was not feeling well. She seemed more irritable than usual.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: After child received shot she stated that she felt a little dizzy. Patient was still seating in the chair. Nurse had patient to prop her feet up in another chair. Child was given a coke and some crackers. Child never lost color, just c/o of not feeing good. BP checked 108/84. Child finished coke but didn't want anymore crackers. Child was then escorted to  the school nurse and her parents were called by school nurse. Before leaving the school Health dept County nurse manager checked on child and school nurse stated that her mom was on her way to get her. Called the school on 11/06/2019 around 9:15 am and school nurse reported that child was back at school this morning and that she was fine.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Syringe issue, Underdose
Clinical narrative: Flu shot was administered at around 4:30pm. The luer-lok needle was not screwed on tightly prior to administration which caused some of the vaccine to leak out, resulting in an incomplete dose. Patient has not reported any symptoms before leaving the pharmacy.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Bone pain, Dysphagia, Erythema, Fatigue
Clinical narrative: I had redness, swelling, and itching and sore to touch, as time has gone by, now having achiness in my muscles and bones all over worse as day goes on, blurred vision, unsteady gait at times, fogginess, tiredness, difficulty speaking, sometimes swallowing tingling in hands and feet.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Gait disturbance, Myalgia, Pain, Paraesthesia
Clinical narrative: I had redness, swelling, and itching and sore to touch, as time has gone by, now having achiness in my muscles and bones all over worse as day goes on, blurred vision, unsteady gait at times, fogginess, tiredness, difficulty speaking, sometimes swallowing tingling in hands and feet.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Speech disorder, Swelling, Vision blurred
Clinical narrative: I had redness, swelling, and itching and sore to touch, as time has gone by, now having achiness in my muscles and bones all over worse as day goes on, blurred vision, unsteady gait at times, fogginess, tiredness, difficulty speaking, sometimes swallowing tingling in hands and feet.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improperly stored dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a healthcare professional referring to a patient of unknown age. The patient's concurrent conditions, medical history, drug allergies/ reactions and concomitant medications were not reported. On 01-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, formulation, dose/frequency, route were not reported) lot # R025726 expiration date reported as 26-MAY-2021, but upon internal validation established as 08-OCT-2018, for prophylaxis. On 01-NOV-2019, the patient was administered with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (product storage error). The vaccine was stored at a temperature of 50 Fahrenheit for 2 hours, 20 minutes. Previous temperature excursion was 50 Fahrenheit for 30 minutes. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Pyrexia
Clinical narrative: Fever; Chills; Stomach ache; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills and stomach pain. On an unknown date, the outcome of the fever, chills and stomach pain were unknown.   It was unknown if the reporter considered the fever, chills and stomach pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had fever, chills and stomach pain.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Fever (103); This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix at an unknown dose. On an unknown date, unknown after receiving Pediarix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Pediarix and had fever.      Lab Comments: Lab test performed on unknown date
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash below her elbow; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2019, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The pharmacist reported that the patient developed a rash below her elbow on the arm where she received Shingrix. The rash started a couple days after getting the vaccine. The reporter thinks it was the patient's left arm. The patient was 53 years old, but was not certain. She did not have access to the records during the call.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Fall, Headache, Malaise, Nausea
Clinical narrative: going to fall over; Nauseous; Headache; Wasn't balancing  right/going to fall over; felt sick; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a month after receiving Shingrix, the patient experienced nausea, headache, loss of balance and feeling unwell. On an unknown date, the patient experienced fall. On an unknown date, the outcome of the nausea, headache, loss of balance, feeling unwell and fall were unknown.   It was unknown if the reporter considered the nausea, headache, loss of balance, feeling unwell and fall to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient felt sick for the whole month of September. She was nauseous, had a headache and wasn't balancing right. She felt like she was going to fall over. The reporter did not consented to follow up.  The reporter provide any additional information.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Not feeling good / General malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. Reporter claimd that she has heard from random friends that have received the Shingrix vaccine and experienced not feeling good and general malaise after receiving the vaccination.   No specific individual comes to mind but just general feedback she received from others. The reporter did not consented to follow up.  No follow-up approved.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site indentation, Injection site pain, Injection site paraesthesia
Clinical narrative: redness at injection site; indentation at injection site; tingling at injection site; pain at injection site / Stung during administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 48-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number EF7N4, expiry date 30th June 2020) for prophylaxis.   On 22nd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 22nd October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site erythema, injection site indentation, injection site tingling and injection site stinging. On an unknown date, the outcome of the injection site erythema, injection site indentation, injection site tingling and injection site stinging were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site indentation, injection site tingling and injection site stinging to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient went to urgent care on an unknown date. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact
Clinical narrative: Poison ivy; This case was reported by a pharmacist via call center representative and described the occurrence of poison ivy rash in a female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2020) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced poison ivy rash. On an unknown date, the outcome of the poison ivy rash was unknown.   It was unknown if the reporter considered the poison ivy rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated the patient experienced posion ivy 1 week after receiving the 2nd dose od Shingrix. The reporter stated that the patient needs prednisone but wants to know interaction with Shingrix.  No additional information. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This case was reported by a consumer via call center representative and described the occurrence of malaise in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received Shingrix. On 1st November 2019, 1 days after receiving Shingrix, the patient experienced malaise and headache. On an unknown date, the outcome of the malaise and headache were unknown.   It was unknown if the reporter considered the malaise and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 70 or 71 years. The patient reported having a malaise and a headache the day after receiving Shingrix. The patient did not consent to follow up.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal, Vision blurred
Clinical narrative: Patient had never had a flu shot before, was not allergic to eggs, was feeling well today and had never had Gillian-Barre Syndrome.  He received his shot and sat with my for 15 min.  Reported feeling fine and left.  Following the above incident, he returned to the room stating ?I think I?m having a reaction, I feel like I?m tripping on acid, I feel off, my vision is blurry and I feel dizzy?.  I cleared the room, one employee choose not to leave, patient said it was fine.  Employee who did not leave reported that he was a first responder and wanted to stay in case I needed anything.  BP was 132/82, pulse was regular.  Pupils were equal, round and reactive.  Lung and heart sounds WNL. No other symptoms. Patient sat with me for a bit, then said he was going back to his office.  I requested that he let someone nearby know how he is feeling and let them check in on him, he said he would.  He returned to the room during the clinic and said he was a bit better.  Following the completion of the clinic, I checked in with him. Reported still having difficulty with his vision and felt off, but was OK, ?I do have an issue with vertigo, cutting caffeine out has helped. I still feel like I?m looking through things and not at them?  Reported being in treatment for 2 years for this issue, unable to find a cause.   I requested that he notify his PCP today and report the reaction, as well as not driving himself if he continued to have difficulty seeing.  Also recommended future vaccinations be administered at his medical home for observation following.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Pallor, Tremor
Clinical narrative: Patient's head and upper body started to spasm/shake while sitting in a chair; pale face
Age: 33.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Neck pain, Tenderness
Clinical narrative: Pt presented two days after vaccine administration  to clinic concerned about tenderness, weakness, pain on back of neck, swelling, and redness on site of injections.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test normal, Gait disturbance, Grip strength decreased, Muscle strength abnormal, Nerve conduction studies normal
Clinical narrative: Within a few weeks of receiving my innoculation, I began to exhibit loss of muscle strength and control in my extremities.  I was having difficulties with basic functions such as walking, climbing stairs, holding a glass in one hand, picking up heavy items, etc.  I initially saw my internist, who ran a complete blood panel for 11 items.  All ranges were normal. Dr. referred me to a neurologist, who did a complete evaluation in January, 2019.  He was unable to identify the cause of the condition and discussed the possible need for nerve conduction tests if the condition did not resolve itself.  I had additional blood work done in March, 2019  by Dr. with no change in the results.  In May, 2019, Dr. performed a nerve conduction test and found no systemic issues.  However, my condition persisted without improvement.  It wasn't until I mentioned to Dr. that I had received a flu shot in October, 2018, about two weeks prior to the onset of my symptoms, that he suggested that my condition was the result of the innoculation - that my body was reacting as if it had the flu without all of the side effects. He suggested that my symptoms could take up to 9 months to resolve after the shot.  It wasn't until July, 2019, that I was nearly fully recovered.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Weight bearing difficulty
Clinical narrative: Within a few weeks of receiving my innoculation, I began to exhibit loss of muscle strength and control in my extremities.  I was having difficulties with basic functions such as walking, climbing stairs, holding a glass in one hand, picking up heavy items, etc.  I initially saw my internist, who ran a complete blood panel for 11 items.  All ranges were normal. Dr. referred me to a neurologist, who did a complete evaluation in January, 2019.  He was unable to identify the cause of the condition and discussed the possible need for nerve conduction tests if the condition did not resolve itself.  I had additional blood work done in March, 2019  by Dr. with no change in the results.  In May, 2019, Dr. performed a nerve conduction test and found no systemic issues.  However, my condition persisted without improvement.  It wasn't until I mentioned to Dr. that I had received a flu shot in October, 2018, about two weeks prior to the onset of my symptoms, that he suggested that my condition was the result of the innoculation - that my body was reacting as if it had the flu without all of the side effects. He suggested that my symptoms could take up to 9 months to resolve after the shot.  It wasn't until July, 2019, that I was nearly fully recovered.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blood pressure increased
Clinical narrative: Patient described increased blood pressure since receiving the vaccinations.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: FEVER OF 101.5 BEGAN AT 03:45 PM ON MONDAY NOVEMBER 4, 2019 - ABOUT 28 HRS AFTER SHOT.  BODY ACHES AND EXHAUSTION CONTINUED FOR 48+ HOURS.   SITE OF INJECTION RESULTED  LARGE, RED WELT.  THE SIZE INCREASED TO  3.5" DIAMETER AT 36 HOURS AFTER INJECTION, BECAME HOT  AND ITCHED.  TREATED WITH ICE PACKS.   FEVER RETURNED AFTER 48 HOURS  TYLENOL TAKEN AND FEVER SUSIDED
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: FEVER OF 101.5 BEGAN AT 03:45 PM ON MONDAY NOVEMBER 4, 2019 - ABOUT 28 HRS AFTER SHOT.  BODY ACHES AND EXHAUSTION CONTINUED FOR 48+ HOURS.   SITE OF INJECTION RESULTED  LARGE, RED WELT.  THE SIZE INCREASED TO  3.5" DIAMETER AT 36 HOURS AFTER INJECTION, BECAME HOT  AND ITCHED.  TREATED WITH ICE PACKS.   FEVER RETURNED AFTER 48 HOURS  TYLENOL TAKEN AND FEVER SUSIDED
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Gait disturbance, Malaise, Muscular weakness
Clinical narrative: pt reports just didn't feel well the evening of the shot, but then the next morning stated legs were just not wanting to work and almost gave out when trying to walk
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyskinesia, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Flu vaccine was given with child sitting on her mother's lap with the intention that she sit there for several moments as she has fainted following a flu shot in the past.  After a few minutes, child was pale and sweaty.  Fanned her and gave her some water to drink.  After a couple of minutes, she passed out and was lowered to the floor without injury.  Child had 1 jerky movement of limbs and then opened her eyes and was awake.  Child was allowed to lie there for several moments and then was able to sit up.  After sitting up for several minutes, she felt like standing and did so without dizziness.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Emotional disorder, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: In the past, she has had stomach illness within hours of flu shot, but wanted to try a preservative free influenza vaccination. Last flu vaccine was 15 years ago. Approximately 5 to 6 hours after receiving the preservative free influenza vaccination, she stated that her throat felt like a pin cushion (especially on the right side), then she started to feel achy  and had severe chills. She also became emotional. Did not try eating because she felt that she would not be able to keep food down. She was able to keep fluids down.  She was using ibuprofen and did one dose of benadryl. Had a rough night and did not sleep well. She felt tired the next day, but was improving.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: In the past, she has had stomach illness within hours of flu shot, but wanted to try a preservative free influenza vaccination. Last flu vaccine was 15 years ago. Approximately 5 to 6 hours after receiving the preservative free influenza vaccination, she stated that her throat felt like a pin cushion (especially on the right side), then she started to feel achy  and had severe chills. She also became emotional. Did not try eating because she felt that she would not be able to keep food down. She was able to keep fluids down.  She was using ibuprofen and did one dose of benadryl. Had a rough night and did not sleep well. She felt tired the next day, but was improving.
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Injection site bruising, Skin induration, Skin warm, Swelling
Clinical narrative: The next day after receiving the flu shot, her leg got hot to the touch, bruised, hard under the skin and was swollen near the injection site. These symptoms lasted about a week. However, she still has bruising around the injection site and it is almost two weeks and counting after she received her flu shot.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Nausea, Paraesthesia oral
Clinical narrative: Patient reported tingling of her lips, nausea and fatigue starting 1 hour after receiving injection.  She had the first Hep B injection on 9/25 with the same reaction, but she had a BCC removed that day and thought it was possibly from that, which is why she didn't report it then.  The same symptoms happened again after her second dose and she realized it was a reaction to the shot because it was the same exact symptoms.  Symptoms last about 1 day or so.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: A few days after injection had difficulty with ROM.  Unable to lift arm above shoulder level without pain
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient had vaccine and within 10 hours started to have a reaction. Her arm started to hurt and become red. painful to rotate around. Patient then called her PCP and informed patient to take benadryl every 4-6 hours as needed until it disappeared and to call if it got worse. Patient called the next morning with redness down to her elbow which had surpassed the redness from the night before. Still red swollen and hot to touch. She also now has feelings of malaise and low grade fever
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Patient had vaccine and within 10 hours started to have a reaction. Her arm started to hurt and become red. painful to rotate around. Patient then called her PCP and informed patient to take benadryl every 4-6 hours as needed until it disappeared and to call if it got worse. Patient called the next morning with redness down to her elbow which had surpassed the redness from the night before. Still red swollen and hot to touch. She also now has feelings of malaise and low grade fever
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient received improperly stored varivax; This spontaneous report was received from a registered nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 15-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), (lot # R019237, expiration date 04-JUL-2020 or lot # R019237, expiration date 19-FEB-2021 (the reporter did not know which lot was given to the patient); strength, route of administration and dose were not reported) for prophylaxis. Administered dose of vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14 Celsius degrees (C) to -10 C (also reported as 9.74 C) for an unknown amount of time. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; administered an improperly stored dose of PEDV AXHIB; This spontaneous report was received from a medical assistant 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 01-OCT-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # S000356, expiration date on: 17-OCT-2021; exact dose, route and site of administration were unknown). No adverse effects were reported. Administered dose of vaccine experienced the temperature 46.5 degrees Fahrenheit for 15 minutes.  Data logger was not involved. There were no previous excursions reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product supply issue
Clinical narrative: Shingles; Cannot find drug store/ doctor office who can supply second shot; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2019).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for 2nd dose.  The patient had Shingrix shot and cannot find drug store or doctor office who can supply second shot.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Pain in her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she had developed pain in her arm after receiving flu vaccines in the past (unknown manufacturer). The reporter did not consent to follow up. This case has been linked to US2019196474 (same patient) and US2019196508, reported by same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Magnetic resonance imaging brain normal, Magnetic resonance imaging normal
Clinical narrative: Two days and four days later I had a total loss of strength in both legs that lasted a minute. It was a rapid unset that left me sitting down quickly. No pain before during or after. I recovered completely in about a minute.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle strength abnormal
Clinical narrative: Two days and four days later I had a total loss of strength in both legs that lasted a minute. It was a rapid unset that left me sitting down quickly. No pain before during or after. I recovered completely in about a minute.
Age: 0.17
Sex: F
Vaccine: DTAP, RV5
Symptoms: Gastrointestinal injury, Petit mal epilepsy
Clinical narrative: petit mal seizures, chronic gastro-intestinal damage
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Gait inability, Injection site swelling, Injection site warmth
Clinical narrative: patient's left leg was swollen and warm to touch. per mom patient was unable to walk.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Dyspnoea, Electrocardiogram normal, Fatigue, Hyperthyroidism
Clinical narrative: Woke up in the middle of the night unable to breathe.  Had never happened before in her life.  Tried to calm herself from waking up in panic.  Would happen during day, or in the night more often.  Would happen like this for 2 weeks.  Would get triggered by little things like swallowing something.  Tried allergy medication.  Went to Urgent care, diagnosed as allergies.   After those 2 weeks, felt extremely fatigued for the next two months into August.  Started losing hair around August September, and then in October diagnosed with hyperthyroid.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Panic reaction, X-ray normal
Clinical narrative: Woke up in the middle of the night unable to breathe.  Had never happened before in her life.  Tried to calm herself from waking up in panic.  Would happen during day, or in the night more often.  Would happen like this for 2 weeks.  Would get triggered by little things like swallowing something.  Tried allergy medication.  Went to Urgent care, diagnosed as allergies.   After those 2 weeks, felt extremely fatigued for the next two months into August.  Started losing hair around August September, and then in October diagnosed with hyperthyroid.
Age: 0.33
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Encephalitis, Pyrexia, Screaming
Clinical narrative: Encephalitis like reaction: high pitched screaming for 14 hours, incredibly high fever
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Headache, achy muscles & joints, runny nose, cough, tired, sore throat, vomiting, nausea, direhea, decrease in appetite.  Symptoms started 11/03/2019 ongoing as of 11/06/2019
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Myalgia, Nausea, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Headache, achy muscles & joints, runny nose, cough, tired, sore throat, vomiting, nausea, direhea, decrease in appetite.  Symptoms started 11/03/2019 ongoing as of 11/06/2019
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Headache, achy muscles & joints, runny nose, cough, tired, sore throat, vomiting, nausea, direhea, decrease in appetite.  Symptoms started 11/03/2019 ongoing as of 11/06/2019
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: patient had a 15 cm wide and 6cm long red and hot.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Lethargy, Pain of skin, Rash, Syncope
Clinical narrative: Patient reports a rash from the first shingles shot on her chest and back. The second shot (the one that is being reported) caused adverse reactions including fainting, vomiting, and excessive lethargy including sleeping for about 3/4 of the day following the immunization. The rash was present for the second immunization as well, and the patient reports her skin aching to touch. Patient reported the event to her prescriber, and after sleeping through the night 10/30 felt better.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient reports a rash from the first shingles shot on her chest and back. The second shot (the one that is being reported) caused adverse reactions including fainting, vomiting, and excessive lethargy including sleeping for about 3/4 of the day following the immunization. The rash was present for the second immunization as well, and the patient reports her skin aching to touch. Patient reported the event to her prescriber, and after sleeping through the night 10/30 felt better.
Age: 0.5
Sex: F
Vaccine: HIBV, PNC13, RV5
Symptoms: Encephalitis, Pyrexia, Screaming, Weight bearing difficulty
Clinical narrative: Encephalitis reaction: high pitched screaming for 18 hours, intensely high fever, unable to bear weight on legs the following day
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Cardiac flutter, Dizziness, Electrocardiogram normal, Headache
Clinical narrative: Over two hours after receiving vaccine, patient was sitting in a meeting. States her "heart was fluttering". She continued to attend meeting but symptom never stopped, worsened. She felt like she may faint, Coworker drove her to a local Urgent Care clinic, who advised her to go to ER for cardiac symptoms. She was taken by coworker. Slight headache, blood pressure up some. Given Benadryl and another medicine to help "settle her down". Patient was discharged home with no meds, no instructions to follow up, only if symptoms returned.  11/06/2019 I spoke with patient and doing well. She plans to schedule appt with PCP,  "fluttering" comes and goes, example while combing her hair this morning. Not taking any meds ( cold/cough/OTC) Not drinking excess caffeine or energy drinks, no smoking. Patient will call to let us know  what her diagnosis is.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: She stated that it hurt somewhat when the shot was administered but was fine after that. Later that evening is when her arm started to hurt to lift, to get undressed and dressed, and continued to hurt until now. It is better now, but still hurts as she uses her arm more throughout the day. If she does not use it as much it does not hurt as much.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Shivering started at 8p and Tylenol helped with that.   At 2a I woke with horrible nausea and headache that lasted for 3-4 hours.  I still feel very tired and have a headache .
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Pain, limited mobility and increasing weakness in L arm after receiving flu shot
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin ulcer
Clinical narrative: PATIENT REPORTS GETTING SHINGLES FROM THE VACCINE, HAD FIRST DOSE 6/12 WITH NO REACTION. SEEN BY EMERGENCY DEPARTMENT AND GIVEN ANTIBIOTIC AND ANTIBACTERIAL OINTMENT FOR SORES.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Stomatitis
Clinical narrative: Severe arm pain down to fingers that where swollen & had sores instead my mouth.  Called my health insurance co. that had a 24 hr nurse on call & said to put warm  clothes & take ibuprofen. Had to take tylenol for the extreme pain & for the next day, but had eased up on the Wed.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Oral mucosal blistering, Pain, Peripheral swelling
Clinical narrative: Severe arm pain down to fingers that where swollen & had sores instead my mouth.  Called my health insurance co. that had a 24 hr nurse on call & said to put warm  clothes & take ibuprofen. Had to take tylenol for the extreme pain & for the next day, but had eased up on the Wed.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: About 10 minutes after vaccine was administered as the patient was leaving the office he fainted.   He was given a  pedia pop and an ice pack was put on his neck and he lay on the couch. The doctor examined him and he left the office with his father.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Feeling hot, Heart rate increased, Sensory disturbance
Clinical narrative: Patient felt a sensation from her arm to her neck and started to feel hot, increased heart rate, and overall "weird"
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: patient came on wed 11/6 to show me her arm she had a red patch about 4 inches below where immunization was given it was not hot to touch or raised received shot on 11/4/2019  woke up on 11/5/2019 and it was like that  she took tylenol and today it was still there so she came by to show me