chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently approximately 59-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 30-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (dose, route of administration, anatomical location, lot # and expiry date were not provided), for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was not reported. The reporter considered the event was related to the suspect vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Problems with vision; This case was reported by a physician via call center representative and described the occurrence of abnormal vision in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced abnormal vision. On an unknown date, the outcome of the abnormal vision was unknown.   It was unknown if the reporter considered the abnormal vision to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced problems with vision after receiving Shingrix.  The reporter did not know if the patient received one or two doses neither when she received the doses and when the symptoms started.  The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: feeling weird; feeling sick; . This case was reported by a consumer via call center representative and described the occurrence of weird feeling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced weird feeling and feeling unwell. On an unknown date, the outcome of the weird feeling and feeling unwell were unknown.   It was unknown if the reporter considered the weird feeling and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the first dose and few days after receiving the vaccine, she remember feeling weird and feeling sick.  The patient did not remember what reaction she had.  She discussed this incident with her physician and the physician recommended that she would not take the second dose. No additional information was provided.  The reporter did not consent to followup
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site area is /  hot to touch; injection site area is / swollen; injection site area is now really red; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2020AMR206581).   On 12th October 2020, the patient received the 2nd dose of Shingrix. On 12th October 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix and injection site area was now really red and swollen and hot to touch.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206581:same reporter.
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pentacel has been administered to a 5 year old boy in place of Dtap Ipv combination vaccine, no AE; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 5 years old male patient who in place of DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE combination was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiration date were not reported for both the vaccines) via unknown route in an unknown administration site for prophylactic vaccination (PT: wrong product administered) on an unspecified date.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Body temperature increased, Feeling abnormal, Headache, Hypoaesthesia, Influenza like illness
Clinical narrative: Within minutes I felt in my face first a numbness on the left side of my face and then my left side of my body.  Went home and felt awful had temperature for four days 101-102 degrees with body aches, HA, joints and bones and muscles awful. Felt like the full flu.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain
Clinical narrative: Within minutes I felt in my face first a numbness on the left side of my face and then my left side of my body.  Went home and felt awful had temperature for four days 101-102 degrees with body aches, HA, joints and bones and muscles awful. Felt like the full flu.
Age: 69.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Injection site swelling
Clinical narrative: Uncontrollable Shaking / Chills Fever Loss of appetite Nausea Violent throwing up Swelling of Left Arm from injection site to below elbow-hot to the touch. Fatigue  Spoke with Nurse at Clinic 10/16 but too ill to go there. Just starting to feel somewhat better 6 days later. Still Fatigued /weak
Age: 69.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site warmth, Malaise, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Uncontrollable Shaking / Chills Fever Loss of appetite Nausea Violent throwing up Swelling of Left Arm from injection site to below elbow-hot to the touch. Fatigue  Spoke with Nurse at Clinic 10/16 but too ill to go there. Just starting to feel somewhat better 6 days later. Still Fatigued /weak
Age: 69.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Skin warm, Vomiting
Clinical narrative: Uncontrollable Shaking / Chills Fever Loss of appetite Nausea Violent throwing up Swelling of Left Arm from injection site to below elbow-hot to the touch. Fatigue  Spoke with Nurse at Clinic 10/16 but too ill to go there. Just starting to feel somewhat better 6 days later. Still Fatigued /weak
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia, Pruritus
Clinical narrative: itching, tingling, burning
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Site of vaccination red and swollen. No fever, not painful
Age: 87.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase increased, Death, Rhabdomyolysis
Clinical narrative: Received a call from beach saying that this patient died. Wife said that she believes it was as a result of a flu-clinic done on 9/28/20 where the patient received a flu-shot. She said that the patient was found dead in his room. Doctor said that he had elevated CPK levels. He died as a result of rhabdomyolysis. Patient's wife said it was the flu-shot that killed him.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Full blood count, Metabolic function test, Papule, Pyrexia, Rash maculo-papular
Clinical narrative: Fever from 101-102 over 24-48 hours from 10/8 to 10/10. Mild-moderate maculopapular rash on trunk from 10/11-10/16, almost complete resolution of that rash, then recurrence of maculopapular rash, but moderate-severe, most concentrated in trunk. Very abundant papules in trunk, back, face with presence, but more scattered on arms and legs. No confluence. No vesicles. No fever with the recurrence of rash. Second rash began 10/17 with significant worsening 10/18 through 10/19.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Respiratory viral panel, SARS-CoV-2 test negative
Clinical narrative: Fever from 101-102 over 24-48 hours from 10/8 to 10/10. Mild-moderate maculopapular rash on trunk from 10/11-10/16, almost complete resolution of that rash, then recurrence of maculopapular rash, but moderate-severe, most concentrated in trunk. Very abundant papules in trunk, back, face with presence, but more scattered on arms and legs. No confluence. No vesicles. No fever with the recurrence of rash. Second rash began 10/17 with significant worsening 10/18 through 10/19.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site abscess
Clinical narrative: Patient was prescribed Bactrim for an abscess on the left thigh, which mother noticed the day after the vaccines were given.
Age: 58.0
Sex: F
Vaccine: FLUA4
Symptoms: Computerised tomogram, Dysarthria, Eyelid ptosis, Facial paralysis, Headache
Clinical narrative: Next day had a headache that radiant around the back of my head and ear.  By Friday, my left eye was drooping as the day went on I was having trouble chewing on the left side and numbness.  Saturday morning woke up and my entire left side of my face was drooping.  Looked like I had a stroke during my sleep.  Drooping eye, slurred speech, unable to drink from a cup, can articulate correctly with my mouth.
Age: 58.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypoaesthesia, Laboratory test, Loss of personal independence in daily activities, Mastication disorder, Vaccination complication
Clinical narrative: Next day had a headache that radiant around the back of my head and ear.  By Friday, my left eye was drooping as the day went on I was having trouble chewing on the left side and numbness.  Saturday morning woke up and my entire left side of my face was drooping.  Looked like I had a stroke during my sleep.  Drooping eye, slurred speech, unable to drink from a cup, can articulate correctly with my mouth.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Within 10 minutes of receiving injection, injection site became red and patient complained of itching.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall
Clinical narrative: Patient received a flu shot around 3:40pm & 15 minutes later she felt dizzy & fell on her way out. Called 911 & patient was checked out & she was fine Patient's mom was contacted by the administering pharmacist and was told that patient is doing fine and taking a nap at that time (5:30pm). Vaccine Adverse Event was entered in patients profile. Pharmacist will contact the patients primary care to inform them of the adverse event.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram abnormal, Endotracheal intubation, Gastrointestinal tube insertion, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Pt received Fluzone 9/27/20 Symptoms began 10/9/20 (RIGHT LEG WEAKNESS/PAIN) 10/10/20 UPPER EXTREMITY WEAKNESS 10/11/20 RESPIRATORY DEPRESSION AND INTUBATION COVID TEST WAS NEGATIVE
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Respiratory depression, SARS-CoV-2 test negative
Clinical narrative: Pt received Fluzone 9/27/20 Symptoms began 10/9/20 (RIGHT LEG WEAKNESS/PAIN) 10/10/20 UPPER EXTREMITY WEAKNESS 10/11/20 RESPIRATORY DEPRESSION AND INTUBATION COVID TEST WAS NEGATIVE
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: pneumonia; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 12-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event pneumonia was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event pneumonia to be disability.   Upon internal review, pneumonia was determined to be medically significant.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Exercise tolerance decreased, Postural orthostatic tachycardia syndrome
Clinical narrative: Grandmother, reports after patient had second dose of HPV she developed POTS (postural orthostatic tachycardia syndrome). She has been to ER multiple times She required cardiac ablation for SVT in 2018. POTS has interfered with her ability to do physical therapy. Previous provider was informed by grandmother but nothing reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received the vaccine in January / Booster in April / Shingles/ suspected vaccination failure; I seem to have gotten shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. In April 2020, the patient received the 2nd dose of Shingrix. On 9th October 2020, between 8 and 10 months after receiving Shingrix and between 5 and 7 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received the vaccine in January and the booster in April and now seem  to had gotten shingles. The patient was at dermatologist office. The patient wanted to know what was the incidence of shingles after getting the vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product supply issue
Clinical narrative: could not get her 2nd dose/ because the vaccine was not available; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Lot and expiration date of Shingrix vaccine was unknown. The patient reported that, she never completed the series of Shingrix vaccination as she could not get her 2nd dose because it was not available during that time, which led to product supply issue. The patient did not consent to follow-up.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: allergy; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer or non-health care professional via social media.  This case involves an unknown demographic patient who experienced allergy (hypersensitivity), after the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious allergy (hypersensitivity), (unknown latency) following the administration of INFLUENZA VACCINE.  The intensity of the event was severe.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome was not reported for the event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Influenza B virus test positive, Vaccination failure
Clinical narrative: Flu B; patient had Flu B and this year's shot was pretty worthless; Initial information received on 09-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional. This case involves a male patient (age not reported) who experienced flu B (influenza), while he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed flu B (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  It was also a case of vaccination failure, the reporter mentioned that this year's shot was pretty worthless.  Relevant laboratory test results included: Influenza B virus test - On an unknown date: Positive  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome was unknown for influenza.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves an adult male patient who experienced influenza despite of vaccination with INFLUENZA VACCINE. The time to onset was unknown. However, patient's medical condition at time of vaccination was not reported. Based upon the reported information the role of suspect vaccine cannot be assessed.
Age: 66.0
Sex: M
Vaccine: FLUR4
Symptoms: Exposure via skin contact, Needle issue, Underdose
Clinical narrative: only about half of the injection went into the patient, the other half went down his arm/no AE; only about half of the injection went into the patient, the other half went down his arm/no AE; needle on the Flublok prefilled syringe was not seated properly/no AE; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 66 years old male patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] however only about half dose of this vaccine was injected and the other half went down his arm because needle on the syringe was not seated properly (underdose), (exposure via skin contact) and (needle issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was given.  On 28-Sep-2020, the patient received less than 0.5 mL (recommended dose) of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2018 and expiry date 30-Jun-2021) via intramuscular route at the deltoid (not otherwise specified) for prophylactic vaccination.   It was a case of vaccine underdose, exposure via skin contact and needle issue(latency was on same day).  It was reported that dose of the vaccine should be repeated.  At the time of reporting, no adverse event reported.  Product technical complaint (PTC) First Noticed: 28-Sep-2020.  Product used: Used.  First time product used: No.  PTC assessment: Physical.  This suspected adverse reaction report is and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Eye discharge, Eye swelling, Eyelid ptosis
Clinical narrative: droopy eye; had eye discharge after vaccine; eye was swollen; Initial information received on 09-Oct-2020 regarding an unsolicited valid serious case received from a pharmacist.  This case involves a 21 year old male patient who experienced droopy eye (eyelid ptosis), had discharge after vaccine (eye discharge) and eye was swollen (eye swelling), after he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Past vaccination included influenza vaccine (He had similar symptoms last year).  Medical history, medical treatment and family history were not provided.  No concomitant medication or no other vaccines administered to the patient.  On an unknown date, the patient received a 0.5 ml (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious droopy eye (eyelid ptosis) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On an unknown date, the patient had discharge after vaccine (eye discharge) and eye was swollen (eye swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Pharmacist called to report that a patient called after hours about possible side effects from FLUZONE QUAD.  Details of laboratory data not reported.    corrective treatment: patient was prescribed with some antibiotic eye drop.  At the time of reporting, the outcome of events were unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns a 21 year old male patient who had eyelid ptosis, eye discharge and eye swelling, after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Additional information on patient's medical condition at time of vaccination, concomitant medication and investigations 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: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: The following morning after receiving vaccine, left arm became swollen and warm to touch. Fevers T-101.8/102.6 Advised cool compresses, antihistamine, Tylenol or Ibuprofen increasing fluid intake
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema, induration, tenderness @ injection site ~ 24 hrs after vaccination Tx: cold compress, ibuprofen
Age: 44.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: on 10/19/2020 at 9:53am, MMR vaccine administer to right arm SubQ. Almost immediately site was red, swollen, & warm to touch. Patient given an ice pack and monitored for 30 minutes.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Tingling in left arm & pain, 2 out of 10 & weakness. Reports normal grip but slight weakness noted. Tingling in left side of face and left scalp. No impairment in lower extrem- ities or noted inability to perform usual activities or job.  Had similar symptom following flu vaccine in 2019. Symptoms started around 2 weeks following vaccine. Did not realize symptoms could be related to vaccine. Saw physicians for eval and treatment,  including physical therapy. Symptoms lasted about 3 months  before resolution. Was hospitalized twice due to concerns that vaccine reaction was not considered due to the delay in onset of symptoms, vaccinated on 10/7/19 and symptoms onset 10/26/19. Vaccine in 2019 = Fluzone Quad, lot # UT6647MA, exp 6/29/20. Given in (L) deltoid in 2019.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Cardiac disorder, Chills, Fear, Muscle twitching
Clinical narrative: thought I was dying: Uncontrolled shivering, twitching, heart; stomach felt like electrical shock, very scared! Left eye went blurry - discussed this with Opthmolgist. Layed in Bed - Don't know when it passed 5hrs later?! This was the most scarist feeling Ive ever had! I take meds perscribed, nothing I did different that day! Please contact me on this issue.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Vision blurred
Clinical narrative: thought I was dying: Uncontrolled shivering, twitching, heart; stomach felt like electrical shock, very scared! Left eye went blurry - discussed this with Opthmolgist. Layed in Bed - Don't know when it passed 5hrs later?! This was the most scarist feeling Ive ever had! I take meds perscribed, nothing I did different that day! Please contact me on this issue.
Age: 77.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Abdominal discomfort, Blood pressure decreased, Diarrhoea
Clinical narrative: Had an upset stomach for a little over a wk. His BP fell. He usually takes 3 BP meds. He stopped the Amlodipine which he takes 2 times a day. He had trouble with diarrhea for a couple of wks.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Allergy test, Urticaria
Clinical narrative: Hives all over legs and hands
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Loss of personal independence in daily activities
Clinical narrative: SHOULDER PAIN THAT AFFECTED ACTIVITIES OF DAILY LIVING THAT IS RESOLVING PER PATIENT
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Renal pain, Sleep disorder
Clinical narrative: Received initial Shingrix dose in left arm Tuesday morning.  Early AM Wednesday pain in the left kidney area woke me up, significant enough that I could not get back to sleep.  Pain best described as severe soreness as if someone had been punching my left kidney.  Waited until doctor's office opened, they advised dosing with ibuprofen for pain control and to call them if it was worse next morning.  Pain well-controlled via ibuprofen & next morning was no longer painful, so no further followup with any medical provider.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Swelling face, Swelling of eyelid
Clinical narrative: Swelling of lips, eye lids and chin in am of Fri, 10/16/2020.  Swelling decrease next day
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Burning sensation, Electrocardiogram normal, Electroencephalogram abnormal, Electromyogram abnormal
Clinical narrative: I got flu shot on 10/5/2020. I woke up on 10/7/2020 with my feet feeling like pins and needles. The feeling progressed to my hands. My hands and feet felt burning/tingling/numbness and still do. On 10/12/2020, I had an appointment with my PCP who told me to immediately go to a neurologist. On 10/13/2020, I went to neurologist and got numerous tests done and was told I have Guillain-Barré syndrome. I have neuropathy in my hands and feet and still feel the burning/tingling/numbness sensation. I was prescribed gabapentin for nerve pain. On 10/14/2020, I got brain MRI. On 10/15/2020, I began my 3 day EEG study which I completed on 10/18/2020. I am waiting for insurance to approve the IVIG treatment.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging brain, Nerve conduction studies abnormal, Neuralgia
Clinical narrative: I got flu shot on 10/5/2020. I woke up on 10/7/2020 with my feet feeling like pins and needles. The feeling progressed to my hands. My hands and feet felt burning/tingling/numbness and still do. On 10/12/2020, I had an appointment with my PCP who told me to immediately go to a neurologist. On 10/13/2020, I went to neurologist and got numerous tests done and was told I have Guillain-Barré syndrome. I have neuropathy in my hands and feet and still feel the burning/tingling/numbness sensation. I was prescribed gabapentin for nerve pain. On 10/14/2020, I got brain MRI. On 10/15/2020, I began my 3 day EEG study which I completed on 10/18/2020. I am waiting for insurance to approve the IVIG treatment.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Neuropathy peripheral, Paraesthesia, Quantitative sudomotor axon reflex test
Clinical narrative: I got flu shot on 10/5/2020. I woke up on 10/7/2020 with my feet feeling like pins and needles. The feeling progressed to my hands. My hands and feet felt burning/tingling/numbness and still do. On 10/12/2020, I had an appointment with my PCP who told me to immediately go to a neurologist. On 10/13/2020, I went to neurologist and got numerous tests done and was told I have Guillain-Barré syndrome. I have neuropathy in my hands and feet and still feel the burning/tingling/numbness sensation. I was prescribed gabapentin for nerve pain. On 10/14/2020, I got brain MRI. On 10/15/2020, I began my 3 day EEG study which I completed on 10/18/2020. I am waiting for insurance to approve the IVIG treatment.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: site became red and irritated for 3 to 5 days then resolved
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt complained of getting hives the same day as getting flu vaccine
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site mass, Paraesthesia
Clinical narrative: Approximately 2.5 hours after immunization, patient developed a lump on left shoulder area. Within 30 minutes, patient developed numbness and tingling in left arm. Patient went to urgent care clinic. Patient symptoms were still present. Clinic sent her to emergency department. At the emergency department, symptoms were fully resolved by 19:58 on the same day.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient came back at 4pm on the same day of vaccination and had the left arm swelling. I advised the patient to take OTC tylenol and benadryl and call her docter OR go to emergency if worsen symptoms. The day after , patient came back with better symptoms.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Chills, Dizziness, Dysstasia, Limb discomfort
Clinical narrative: I initially some discomfort in both arms (shingles vaccine in left arm was less painful, flu vaccine in right arm was more painful - injection was more challenging for that one, so not surprised), followed by general malaise and an oncoming feeling of chills.  I had a difficult time standing to change clothing and brush my teeth, needing to lay down to avoid passing out.  I then experienced nausea, very bad chills, shaking, and aching for at least a few hours overnight.  I felt sick throughout the night and weak into the next morning.  I felt better as the day progressed, with lessening of arm pain.  The most challenging side effects were the extremely strong chills and weakness to the point of shaking and almost fainting.  This was the first time that I have received the shingles vaccine and I believe these symptoms were related to that injection.  I have had the flu vaccine many times before with minimal issues, usually only a little arm pain.  This was far worse.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Malaise, Nausea, Pain, Pain in extremity, Tremor
Clinical narrative: I initially some discomfort in both arms (shingles vaccine in left arm was less painful, flu vaccine in right arm was more painful - injection was more challenging for that one, so not surprised), followed by general malaise and an oncoming feeling of chills.  I had a difficult time standing to change clothing and brush my teeth, needing to lay down to avoid passing out.  I then experienced nausea, very bad chills, shaking, and aching for at least a few hours overnight.  I felt sick throughout the night and weak into the next morning.  I felt better as the day progressed, with lessening of arm pain.  The most challenging side effects were the extremely strong chills and weakness to the point of shaking and almost fainting.  This was the first time that I have received the shingles vaccine and I believe these symptoms were related to that injection.  I have had the flu vaccine many times before with minimal issues, usually only a little arm pain.  This was far worse.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Skin warm, Stevens-Johnson syndrome
Clinical narrative: The patient broke out in a red hot confluent rash/erythema from her neck to the inner thighs, encompassing the back, chest, abdomen and trunk.  It is not on her face, arms, hands or below the knees.  There are no wheals or singular eruptions.  It resembles a "steven-johnson" type rash.  There are no blisters, bullae or necrolysis.
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Gait disturbance, Head injury, Pollakiuria, Syncope
Clinical narrative: Close to 12 hours after receiving both vaccines, I experienced a need to void several times within an hour which was UNUSUAL for me, then experienced SEVERE chills another UNUSUAL occurrence for me, was able to warm up with extra clothing & sleep, (tho up once or twice more during the night to void & drink water feeling pretty unsteady while walking to the bathroom ~ another UNUSUAL for me), then when leaving the bathroom the following AM (about 19 hours after receiving the vaccinations) I fainted (& whacked my head on the wood frame of my bed which I could hear).  My husband waited about 10 sec before finding me prone on the floor ~ I could answer him & he helped me up to sitting on edge of bed.  He then took my b/p which was 81/53 on an automated arm cuff, pulse was 99.  I was pretty sure I had gotten dehydrated by voiding so much.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient was diagnosed with cellulitis after getting her flu shot - she had pain, itching, redness, and swelling at the site of the injection that was 4 cm wide. Patient was treated with doxycyline hyclate 100 mg.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLUZONE administered to a 60 year old when it is approved for 65 years and older.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Brachial plexus injury, Discomfort, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: The moment the shot was administered, I had a horrible shoot of pain that went up my neck and down my back on the left side.  My fingers felt numb and it was uncomfortable. The pharmacist said he may have hit a nerve, but as long as I moved my arm it would help the pain, and it should go away in a day or so. The lingering pain stayed in my arm for the next two weeks, and I started to notice muscle weakness as well as a loss of range of motion in that shoulder. By week 3 I went to a neurologist and he diagnosed me with a brachial plexus injury. The pain has still gotten worse and I cannot move my shoulder above my head, for if I try I get a horrible piercing pain that feels as if my arm may fall off and my hand goes numb. I am being treated with Gabapentin and Tizanidine.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Muscular weakness, Neck pain, Pain, Pain in extremity
Clinical narrative: The moment the shot was administered, I had a horrible shoot of pain that went up my neck and down my back on the left side.  My fingers felt numb and it was uncomfortable. The pharmacist said he may have hit a nerve, but as long as I moved my arm it would help the pain, and it should go away in a day or so. The lingering pain stayed in my arm for the next two weeks, and I started to notice muscle weakness as well as a loss of range of motion in that shoulder. By week 3 I went to a neurologist and he diagnosed me with a brachial plexus injury. The pain has still gotten worse and I cannot move my shoulder above my head, for if I try I get a horrible piercing pain that feels as if my arm may fall off and my hand goes numb. I am being treated with Gabapentin and Tizanidine.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Patient describes soreness at the injection site lasting several weeks.  She also says there is a hard area that she can feel under the skin.  There is no other swelling.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has a large  ~ 8 inch red circle about 3 inches below the injection site. Site is swollen and warm. Patient is not experiencing any pain nor any other symptoms.
Age: 53.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Injection site pain, Pain, Tremor
Clinical narrative: I experienced a fair amount of injection site pain, more in the right arm where I received the flu shot.  I began to feel a bit achy around bedtime and that proceeded fairly quickly to an onset of severe chills, aching, and shaking, which lasted for a number of hours while I tried to sleep through it.  I had limited chills when I awoke, felt achy, for most of the day, and the arm pain continued to bother me throughout the day.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Mass, Tenderness
Clinical narrative: 3 tiny little lumps/blisters appeared on the left hand near the wrist approximately 10 days after receiving the vaccine. In addition in the wrist, there is a spot that is painful to the touch (possible neuralgia).  The pain still persists to this date (when the area is touched)
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor, Vomiting
Clinical narrative: Patient Called in today and stated that after she got the  2nd shot of shingrix on 10/12/2020 and as the same day at night time she had vomiting and chilling, shaking for few hours but she did not take any medication for those symptoms .  She got better by next day.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chest pain, Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: Patient's shoulder froze, pain in shoulder cap area down into deltoid (towards bicep) Limited range of motion  Pain from mid arm to front of shoulder/chest/anterior of shoulder Generalized muscle pain
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: Patient's shoulder froze, pain in shoulder cap area down into deltoid (towards bicep) Limited range of motion  Pain from mid arm to front of shoulder/chest/anterior of shoulder Generalized muscle pain
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Low grade fever for 24 hours- between 99.6 and 100.6
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chest X-ray normal, Chest pain, Chills, Dizziness, Electrocardiogram normal
Clinical narrative: chills, chest pain, dizziness began 1 hour after injection. Fever of 102 occurred 2 hours after injection
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: chills, chest pain, dizziness began 1 hour after injection. Fever of 102 occurred 2 hours after injection
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Dizziness, Headache, Pain, Rhinorrhoea
Clinical narrative: Body aches, Headache, runny nose, dizziness, Loss of apatite,
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Pain
Clinical narrative: Middle of night after vaccination  awakened with headache, nausea and vomiting. Headache and body aches continued throughout night and next day. Low grade fever until single Tylenol dose taken 2 times during day. Lack of appetite and fatigue. Symptoms gone by 2nd day.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Middle of night after vaccination  awakened with headache, nausea and vomiting. Headache and body aches continued throughout night and next day. Low grade fever until single Tylenol dose taken 2 times during day. Lack of appetite and fatigue. Symptoms gone by 2nd day.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient states that her arm has a sharp pain. States that it is much better now
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain at the time of flu vaccine administration. Reports pain to feel like "sharp pinch nerve"
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Coordination abnormal, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site reaction
Clinical narrative: THE EVENING THE PATIENT RECEIVED THE VACCINE THEY BEGAN EXPERIENCING PAIN, STIFFNESS, AND NUMBNESS THROUGHOUT THE RIGHT ARM FROM THE SHOULDER TO THE HAND. THE PATIENT DESCRIBES THE PAIN AS THROBBING AND RADIATING FROM THE SHOULDER TO THE HAND. THE PATIENT ALSO REPORTS NUMBNESS AND LOSS OF COORDINATION WITH THE RIGHT ARM INCLUDING THE HAND. THE PATIENT DESCRIBES THE PAIN AS "BAD ALL THE TIME BUT WORSE AT NIGHT AND UPON AWAKENING IN THE MORNING." THE PATIENT DID NOT REPORT ANY VISUAL ADVERSE EFFECTS SUCH AS REDNESS.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: THE EVENING THE PATIENT RECEIVED THE VACCINE THEY BEGAN EXPERIENCING PAIN, STIFFNESS, AND NUMBNESS THROUGHOUT THE RIGHT ARM FROM THE SHOULDER TO THE HAND. THE PATIENT DESCRIBES THE PAIN AS THROBBING AND RADIATING FROM THE SHOULDER TO THE HAND. THE PATIENT ALSO REPORTS NUMBNESS AND LOSS OF COORDINATION WITH THE RIGHT ARM INCLUDING THE HAND. THE PATIENT DESCRIBES THE PAIN AS "BAD ALL THE TIME BUT WORSE AT NIGHT AND UPON AWAKENING IN THE MORNING." THE PATIENT DID NOT REPORT ANY VISUAL ADVERSE EFFECTS SUCH AS REDNESS.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Chills
Clinical narrative: patient stated he had chills and a high temp that evening (102-103). woke up feeling a little better. saw dr that day and had a phone conversation. he is also following up with dr this week
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles exactly 2 weeks later after sheltering in place.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: My arm is tender to touch with slight bruising, red and swollen with a red rash spreading around the bi-sept muscle, and it has been 4 days since injection.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: My arm is tender to touch with slight bruising, red and swollen with a red rash spreading around the bi-sept muscle, and it has been 4 days since injection.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Erythema, Induration, Peripheral swelling, Pruritus
Clinical narrative: Rash, itching, hard swollen redness from top of shoulder to elbow, blisters at bandaid adhesive
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash, itching, hard swollen redness from top of shoulder to elbow, blisters at bandaid adhesive
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles in V3 distribution developing 1 day after injection
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Asthenia, Back pain, Chills, Fatigue, Feeling cold
Clinical narrative: Aching in both arms.  Muscle aches.  Aching in lower back by midnight on day of vaccination.  Cold and shivering.  Fever 101. Aching continues in Day 2.  Weakness. Tiredness.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Aching in both arms.  Muscle aches.  Aching in lower back by midnight on day of vaccination.  Cold and shivering.  Fever 101. Aching continues in Day 2.  Weakness. Tiredness.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Agitation, Vomiting
Clinical narrative: Beginning shortly after administration both date 3/12/20 and 7/15/20, patient vomited and became hyperexcitable for 2 days following vaccination
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient went to urgent care due to redness around injection site. Patient was prescribed an antibiotic for possible cellulitis infection.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Headache, SARS-CoV-2 test negative
Clinical narrative: 103.6 temp at highest,  chills and severe headache.  Temperature lasted 2 and half days. Headache began to improve on 5th day.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: CSF protein increased, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Paraesthesia
Clinical narrative: Presented to the ED with 2 day history of progressive lower extremity paresthesia and subjective weakness with ambulating several days after receiving influenza vaccine.  Patient had never had a reaction to influenza in the past.  Patient denies underlying neurologic disorder. The patient was diagnosed with Guillain-Barre Syndrome.  Patient was treated with IVIG .
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches and fatigue. Lightheadedness and fatigue continue
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came in with swelling, pain, and redness on entire left arm.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient states she had sore arm and had a small bruise at the injection site.