chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Immediate post-injection reaction, Palpitations, Tachycardia
Clinical narrative: My heart started pounding irregularly and rapidly and I felt like I was going to faint/except for tachycardia and irregular heartbeat- a sinus rhythm; I felt like I was going to faint; My heart started pounding irregularly and rapidly and I felt like I was going to faint/except for tachycardia and irregular heartbeat- a sinus rhythm; they feel tired; They had an "immediate allergic reaction, or what I feel was an allergic reaction"; This spontaneous report has been received from a 72-year-old female patient, referring to herself. The patient's medical history and concomitant medications were not provided. The patient's concurrent conditions included an allergy to penicillin and sulfa. The patient did not receive any other vaccine or begun a new medication in the last fourteen days.  On 01-OCT-2020 (in the afternoon), the patient was vaccinated with pneumococcal vaccine PNEUMOVAX23 0.5 milliliter once a year, subcutaneously (lot number and expiration date were not provided) for prevention of pneumococcal disease caused by 23 serotypes contained in the vaccine.  On 01-OCT-2020, the patient stated that had an immediate allergic reaction or what she felt that was an allergic reaction. The reporter stated that her heart started pounding irregularly and rapidly and felt like she was going to faint (dizziness). Due to the patient was in the doctor's office (also reported that the patient was hospitalized), the physician performed a blood pressure check which was normal and an electrocardiogram (EKG) which was normal except for tachycardia and irregular heartbeat related with sinus rhythm. The reporter stated that she was fully recovered, but she felt tired.  The patient did not receive any treatment for the adverse events.  The outcome of tachycardia, sinus rhythm, dizziness and allergic reaction was recovering. The outcome of felt tired was not recovered. The reporter did not provide a relationship between the adverse events and the therapy.
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Herpes zoster, Rash
Clinical narrative: herpes zoster; dermatitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 05-OCT-2016, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose; the prevention of shingles (herpes zoster) (prophylaxis).Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered painful rashes across his waistline and back and was diagnosed with herpes zoster. Subsequently, suffered another rash outbreak and was diagnosed with dermatitis. All these injuries were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate results of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations do not present prior to using zoster vaccine live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Also, the patient sustained severe and permanent personal injuries. Therefore, 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. Also, suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event was not recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak/multiple shingles outbreaks; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 12-OCT-2012, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose; the prevention of shingles (herpes zoster) (prophylaxis).Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a shingles outbreak, and had since suffered multiple shingles outbreaks which persist to the present date. As a result, her husband had suffered loss of services and society and asserts a loss of consortium claim. As a direct and proximate results of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations do not present prior to using zoster vaccine live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Also, the patient sustained severe and permanent personal injuries. Therefore, 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. Also, suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event was not recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Painful rashes across her legs, and she was diagnosed with shingles/additional suffered shingles outbreak; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 28-SEP-2009, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose; the prevention of shingles (herpes zoster) (prophylaxis).Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered painful rashes across her legs, and she was diagnosed with shingles. Also, the patient suffered an additional shingles outbreak thereafter. These injuries, which lasted for weeks and resulted in scarring, were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate results of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations do not present prior to using zoster vaccine live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Also, the patient sustained severe and permanent personal injuries. Therefore, 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. Also, suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event was not recovered.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site rash, Rash macular
Clinical narrative: injection site Areas was hurting; injection site Areas was red / pink; spot at the injection site; area was bruising; Area was Blotchy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number T7S73, expiry date 17th September 2022) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 18th September 2020, less than an hour after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site rash, injection site bruising and skin blotches. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site rash, injection site bruising and skin blotches were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site rash, injection site bruising and skin blotches to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in right arm. Within an hour after vaccination, the patient had a spot between the size of a quarter and a half dollar at the injection site on her right arm that was pink and bruised.  The patient claimed that the areas was hurting, red, blotchy and bruising.  The symptoms had not resolved till the time of reporting. The reported called back with batch number and expiry date for the Shingrix administered. No further follow up information reported.
Age: 75.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: itchy, redness, and "bumpy skin like a mosquito bite" at the site of injection; redness, and "bumpy skin like a mosquito bite" at the site of injection/redness is "an inch and a half around the two shots"; "bumpy skin like a mosquito bite" at the site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingle with an associated reaction of no adverse event. Concurrent medical conditions included autoimmune disorder and sensitive skin.   On 25th September 2020, the patient received the 1st dose of Shingrix and the 1st dose of Influenza vaccine Quadrivalent 2020-2021 season. On 29th September 2020, 4 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site itching, injection site erythema and injection site rash. The patient was treated with hydrocortisone (Topical Hydrocortisone). On an unknown date, the outcome of the injection site itching, injection site erythema and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema and injection site rash to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced itchy, redness, and bumpy skin like a mosquito bite at the site of injection. The patient noticed the reaction on tuesday night and used a hydrocortisone topical which helped calm the itchiness (which was on and off).  Both vaccines were given on the right arm two to three inches apart.  The redness was an inch and a half around the two shots. The patient reports no fever, swelling, or diarrhea.  The reporter did not consent to follow-up.
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Feeling hot, SARS-CoV-2 test negative, Somnolence
Clinical narrative: Felt severe chills for about 2 hours; became very warm, then fell asleep; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a non health care professional .This case involves a male patient (age not reported) who experienced severe chills for about 2 hours (chills) and became very warm, then fell asleep (body temperature increased), while he received vaccine INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date at 2:30 p.m., the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date at about 10:30 p.m., the patient developed non-serious severe chills for about 2 hours (chills) and became very warm (body temperature increased) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Patient started feeling chills at about 10:30 pm. He took his temperature but did not have a fever then he felt severe chills for about 2 hours, then became very warm, then fell asleep  Relevant laboratory test results included: Body temperature - On an unknown date: 100.1 [100.1] and COVID-19 - On an unknown date: Negative.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from both the events (Woke up in the morning and felt fine).  There will be no information available on batch number for this case.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Injection site rash, Pruritus
Clinical narrative: Day after vaccination, felt itchy, by Sunday could see 4-5 red dots that "looked like fingerprints," today was ~1"x8" rash below injection site
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT STATES SHE HAS A 2 INCH PINK CIRCLE AROUND THE INJECTION SITE. THIS STARTED ONCE SHE GOT HOME AFTER THE VACCINATION. IT IS NOT SWOLLEN OR SORE, JUST ITCHY. ADVISED PATIENT TO APPLY HYDROCORTISONE, MONITOR, AND CONTACT HER DOCTOR.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: patient got red bull eye type of rash around the injection site, she says it sore and painful, recommended to put some ice on it , no fever per patient. told her to monitor and let me know if it worsens.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: The patient received PCV13 on 29 Sept 2020. The patient reported localized redness, swelling and lump under the skin to left deltoid around the injection site that occurred for several days after the injection. The patient reported the symptoms to medical provider during an appointment 07 Oct 2020, after the symptoms have resolved. There is a remaining small palpable lump under the skin at the injection site that the patient reports still itches.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pain in extremity, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Patient starting feeling pain and swelling in her arm the night that she received the vaccine. The next day she ran a fever of 101 all day and began getting hives across her chest. She took 3 aspirin. The 3rd day the hives were gone and the swelling reduced, but there was still a dark red spot at the injection site.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Hot flush, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Erythema at and around the injection site. Swelling at and around the injection site. High fever, hot flashes, nausea, loose stool, facial and extremity swelling, swelling of the throat.  The appropriate dose of Benadryl was taken and ice was administered to reduce redness, heat, and swelling.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pharyngeal swelling, Pyrexia, Swelling face
Clinical narrative: Erythema at and around the injection site. Swelling at and around the injection site. High fever, hot flashes, nausea, loose stool, facial and extremity swelling, swelling of the throat.  The appropriate dose of Benadryl was taken and ice was administered to reduce redness, heat, and swelling.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Flushing, Rash, Urticaria
Clinical narrative: After approximately 5 minutes of the vaccines was administered to the patient, she starts developing short of breath, facial flushing, and a generalized rash with some hives. Immediately Benadryl 25 mg IM and Kenalog-40 - 20 mg was administered to the patient in right and left tight. Furthermore, oxygen was administered via cannula to the patient. 20 minutes later patient resolved all issues, she is breathing perfectly, with no rash, oriented in time and space.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Received flu vaccine on 09/21/20 and developed a rash and hives on both arms, legs, back and neck.  Rash, pruritis and hives improve with oral BENADRYL but comes back daily.  Had shingles vaccine on 08/14/20. Has multiple food allergies.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Swollen and red arm from below the vaccination spot to fingers. It was very painful and burning.  Nausea, low grade fever. All lasted for 4 days.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin burning sensation
Clinical narrative: Swollen and red arm from below the vaccination spot to fingers. It was very painful and burning.  Nausea, low grade fever. All lasted for 4 days.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling
Clinical narrative: Swollen and red arm from below the vaccination spot to fingers. It was very painful and burning.  Nausea, low grade fever. All lasted for 4 days.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and Redness on site.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache, Impaired work ability, Nausea
Clinical narrative: Experienced severe headache at 10pm on day of flu shot 10/5/2020 which didn't resolve with Aleve.  Headache persisted until the next day10/6/2020 (missing a day of work) with an episode of dizziness at 845pm.  10/7/2020 - woke up without headache but returned at 12 noon with nausea.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Eye irritation, Lacrimation increased, Stridor, Vomiting
Clinical narrative: High dose flu shot, unknown manufacturer, lot number entered above by Walgreens  Patient developed acute onset vomiting, stridor and difficulty breathing, and mucosal irritation including eyes watering and burning within 10 hours after injection
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Injection site erythema, Injection site pain, Tenderness
Clinical narrative: Beginning day of injection, had left arm soreness and local erythema where got Shingrex. Beginning 1 day after administration, started to have severe unilateral facial pain.  Then spread to both sides. Prevented her from moving her face normally. Extreme tenderness to palpation of soft tissue over zygomatic arches. No skin changes. No difficulty chewing or swallowing.  No breathing difficulties.
Age: 19.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest X-ray normal, Full blood count normal, Lymphadenopathy, Metabolic function test normal
Clinical narrative: Patient has presented with a swollen left supraclavicular lymph node measuring in 1 cm several days after flu shot. Dr unsure if related.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: red, swollen, sore bump about 4 inches wide and 2 inches tall. started yesterday and still there.  patient is waiting another day or two before contacting provider.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Patient had fever, chills and vomiting. The symptoms started 2 hours after vaccination and resolved by next morning.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Swelling
Clinical narrative: Localized swelling, and warmth.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Laboratory test normal, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Patient developed fever, chills, and whole body aches. He went to the ER and they ran tests and everything came back clear.  They did do a Covid 19 test and results are pending
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: red, swollen, painful lump the size of a peach.  she stated the reaction is an inch below the injection site.  She said the reaction is still growing in size. Suggested the customer reach out to her provider tomorrow if not improved.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Neuropathy peripheral, Pyrexia
Clinical narrative: Patient became febrile after flu shot for 48 hrs then states has developed neuropathy in her feet since having flu vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Feeling abnormal, Feeling hot, Headache
Clinical narrative: about 15 hours after receiving the injection I woke up with chills and headache and felt like my skin was very sensitive.  Then hours later I felt hot and feverish. I continued to feel "off" all the next day and anything that touched my skin caused discomfort.  I felt that way all day and then the next day woke up fine but it was like flu  (or shingles) symptoms along with the skin sensitivity.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain of skin, Pyrexia, Sensitive skin
Clinical narrative: about 15 hours after receiving the injection I woke up with chills and headache and felt like my skin was very sensitive.  Then hours later I felt hot and feverish. I continued to feel "off" all the next day and anything that touched my skin caused discomfort.  I felt that way all day and then the next day woke up fine but it was like flu  (or shingles) symptoms along with the skin sensitivity.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia
Clinical narrative: very high fever 105 degF after vaccination. Fevers started late in the same night as vaccines were given per mom.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abscess drainage, Culture positive, Injection site abscess, Injection site erythema, Injection site pain
Clinical narrative: Patient developed what appears to be sterile abscesses on both arms few days after the injections were given, She had persistent drainage for multiple weeks, cultures sent on 10/27/2019 grew 1 colony of coagulase negative staphylococcus, and a culture sent on 11/12/2019 showed no growth. both areas eventually healed by December 2019. She again developed right sided swelling, pain and redness and was diagnosed with an abscess in march 2020, I&D was performed and there was no growth on cultures. she now healed scars on both arms
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Patient developed what appears to be sterile abscesses on both arms few days after the injections were given, She had persistent drainage for multiple weeks, cultures sent on 10/27/2019 grew 1 colony of coagulase negative staphylococcus, and a culture sent on 11/12/2019 showed no growth. both areas eventually healed by December 2019. She again developed right sided swelling, pain and redness and was diagnosed with an abscess in march 2020, I&D was performed and there was no growth on cultures. she now healed scars on both arms
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No patient harm. Patient was given a Proquad plus a Varicella. Patients mother informed. Instructed to call if any reactions or symptoms.
Age: 80.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Patient's left arm is swollen and red from the shoulder to the elbow. Patient stated that he felt pain when he got home and saw that his arm was starting to get red. He came to the pharmacy the following day and he said it is a little better but still a little red and swollen. I told the pain to take Benadryl for the rash and Ibuprofen for the swelling and pain
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: My upper left arm muscle is still painful in the area of the injection when the left arm is first moved.  I rate the pain at a 2.5 on a 10 scale.  It is in no way getting less painful over time as of today's date on 10-07-2020.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Malaise, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: patient reported not feeling well last night, vomiting and stomach upset. She felt feverish but did not check her temperature. I checked today and she was normal. She reported extremely sore arm, very painful.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Patient received flu shot on 10/3. Patient returned to pharmacy on 10/7. Patient had a very large area of diffuse redness that was warm to the touch located from her elbow to her wrist in her left arm. The area at and surrounding the site of injection was normal from the shoulder to the elbow. I recommended she see her physician.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Pt. complained of severe shaking several hours after the administration
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: Patient has inflammation and swelling, pain in arm going through bicep.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Balance disorder, CSF protein normal, Dysstasia, Loss of personal independence in daily activities
Clinical narrative: influenza, injectable, quadrivalent, preservative free given 9/3 at pediatrics.  Following a cheerleading/tumbling practice on Friday, 9/25, she began to feel soreness in the BLE over the weekend. The following Monday, 9/28, she started to complain of neck pain, as well as pain and weakness from the waist down (especially in the popliteal region). She was evaluated by a chiropractor and proceeded to participate in intense tumbling sessions totaling 8 hours over the next several days. By Thursday, 10/1, her neck and shoulder pain had not resolved and, over the following weekend, she proceeded to cancel the coming week's worth of tumbling classes due to pain and weakness in the neck, shoulder, and legs. On the morning of Monday, 10/5, she attempted to step on the bus to school but was unable to pull herself onto the first step. She needed to be carried onto the bus and was evaluated at her school by the school nurse, where instability in standing was noted. She attempted to attend tumble practice that afternoon but was unable to physically participate. Later that night, her family again noticed her to be "unsteady" on her feet. She was evaluated by her PCP on the morning of Tuesday, 10/6, at which point she was referred to the hospital. 10/7 MRI Spine Cervical-Thoracic-Lumbar W W/O Contrast showed diffuse cauda equina nerve root enhancement and Lumbar Puncture  preformed CSF showed elevated protein 23, and normal WBC count of 7.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Lumbar puncture, Magnetic resonance imaging spinal abnormal, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: influenza, injectable, quadrivalent, preservative free given 9/3 at pediatrics.  Following a cheerleading/tumbling practice on Friday, 9/25, she began to feel soreness in the BLE over the weekend. The following Monday, 9/28, she started to complain of neck pain, as well as pain and weakness from the waist down (especially in the popliteal region). She was evaluated by a chiropractor and proceeded to participate in intense tumbling sessions totaling 8 hours over the next several days. By Thursday, 10/1, her neck and shoulder pain had not resolved and, over the following weekend, she proceeded to cancel the coming week's worth of tumbling classes due to pain and weakness in the neck, shoulder, and legs. On the morning of Monday, 10/5, she attempted to step on the bus to school but was unable to pull herself onto the first step. She needed to be carried onto the bus and was evaluated at her school by the school nurse, where instability in standing was noted. She attempted to attend tumble practice that afternoon but was unable to physically participate. Later that night, her family again noticed her to be "unsteady" on her feet. She was evaluated by her PCP on the morning of Tuesday, 10/6, at which point she was referred to the hospital. 10/7 MRI Spine Cervical-Thoracic-Lumbar W W/O Contrast showed diffuse cauda equina nerve root enhancement and Lumbar Puncture  preformed CSF showed elevated protein 23, and normal WBC count of 7.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Scan with contrast abnormal, White blood cell count normal
Clinical narrative: influenza, injectable, quadrivalent, preservative free given 9/3 at pediatrics.  Following a cheerleading/tumbling practice on Friday, 9/25, she began to feel soreness in the BLE over the weekend. The following Monday, 9/28, she started to complain of neck pain, as well as pain and weakness from the waist down (especially in the popliteal region). She was evaluated by a chiropractor and proceeded to participate in intense tumbling sessions totaling 8 hours over the next several days. By Thursday, 10/1, her neck and shoulder pain had not resolved and, over the following weekend, she proceeded to cancel the coming week's worth of tumbling classes due to pain and weakness in the neck, shoulder, and legs. On the morning of Monday, 10/5, she attempted to step on the bus to school but was unable to pull herself onto the first step. She needed to be carried onto the bus and was evaluated at her school by the school nurse, where instability in standing was noted. She attempted to attend tumble practice that afternoon but was unable to physically participate. Later that night, her family again noticed her to be "unsteady" on her feet. She was evaluated by her PCP on the morning of Tuesday, 10/6, at which point she was referred to the hospital. 10/7 MRI Spine Cervical-Thoracic-Lumbar W W/O Contrast showed diffuse cauda equina nerve root enhancement and Lumbar Puncture  preformed CSF showed elevated protein 23, and normal WBC count of 7.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: arm and hand numb some swelling in hand
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Very sore arm for 3 weeks after the injection
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: right arm pain, swelling, headaches, fever. pt states it was right arm injections. documented in clinic as left deltoid.
Age: 40.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Blood test, Cellulitis, Erythema, Induration, Influenza like illness
Clinical narrative: Pt felt very sick at 10pm that night flu like symptoms.  next day could not move arm. Arm was red and it was a hard ball. Pt went to the ER. Given clindamycin and ibuprofen for cellulitis and pain. Pt still in pain 10/7/20
Age: 40.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Malaise, Mobility decreased, Pain, Ultrasound scan
Clinical narrative: Pt felt very sick at 10pm that night flu like symptoms.  next day could not move arm. Arm was red and it was a hard ball. Pt went to the ER. Given clindamycin and ibuprofen for cellulitis and pain. Pt still in pain 10/7/20
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Muscular weakness, Paraesthesia
Clinical narrative: Injection given 10/6/20- left deltoid- 20 minutes after injection left hand started to tingle and left arm weak. Today, 10/7/20, left hand still tingling and injection site warm to the touch.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: Patient had a blister like bubble at the site of the injection. Patient did not have any other symptoms besides the blister like reaction. It is now getting a little bit bigger. She never had reactions to vaccines before and does not have any other allergies. Patient is being followed by her primary care provider and was suggested to wait until Thursday to reasses.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: I gave patient the vaccine that had expired 08/10/2020, no reaction known
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site swelling, Limb discomfort, Pain in extremity, Sleep disorder
Clinical narrative: Patient reports that she experienced no issue or discomfort immediately following vaccine administration. She states later that night she was woken up by intense pain in her shoulder/shoulder blade area. The next morning she reports having significant swelling on her left arm at and around the injection site. She reports having sensitivity in her left shoulder/upper arm due to pre-existing nerve issues and associated physical therapy. Continued pain/discomfort of the affected arm caused her to make an appointment with the doctor. Her doctor was unsure of the exact nature of the reaction and suspected it could be related to her nerve sensitivity and vaccine administration in the area. She was advised to utilize ice packs to address the swelling and she reports she additionally used Advil OTC to help with some of the pain. She claims to have some lingering aches in the arm, though the swelling and more intense pain have subsided.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: Injection given 10/6/20- right deltoid- joint pain all over- had an enlarged lymph node on right side of neck but is larger today, 10/7/2020.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Peripheral swelling, Restlessness
Clinical narrative: Same day started with right arm burning, hot, down to finger tips, swollen and red to elbow, elbow not even visible .Took Tylenol PM to help sleep, still restless all night with pain.  Next day having chills, couldn't take temp,  swelling continued into elbow, no longer effecting fingertips.  Took Tylenol & Advil in the morning, then felt worse around 4pm, took 2 Tylenol, arm still swollen. Called pharmacy, advised to take 2 Benedryl, then instead of Tylenol take Advil for next dose.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Skin burning sensation, Skin warm, Sleep disorder
Clinical narrative: Same day started with right arm burning, hot, down to finger tips, swollen and red to elbow, elbow not even visible .Took Tylenol PM to help sleep, still restless all night with pain.  Next day having chills, couldn't take temp,  swelling continued into elbow, no longer effecting fingertips.  Took Tylenol & Advil in the morning, then felt worse around 4pm, took 2 Tylenol, arm still swollen. Called pharmacy, advised to take 2 Benedryl, then instead of Tylenol take Advil for next dose.
Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain
Clinical narrative: PT COMPLAINED OF SORENESS SINCE DAY OF FLU SHOT, PAST 2 WEEKS, WENT TO MD AND RECEIVED STEROID TX
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Pain in shoulder (rotator cuff). Couldn't raise arm up or to the side. Severe pain. Couldn't sleep at night. It's been 9 days and I feel a lot better however, I still have pain and ice my shoulder and take ibuprofen every day. The pain seems to be lessening with each day so I did not go to see my doctor. My had also swells up with the use of that arm.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Injection site joint pain, Muscular weakness, Pain in extremity
Clinical narrative: injection given 9/25/20 ?left deltoid- symptoms started that evening, joint pain and weakness in right arm, Saturday moved to right knee and foot, Saturday evening went to her back. Sunday left arm, shoulder and hand, Monday joint pain in right arm and hand.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient received shot and fainted. Parametric reported patient declined medical attention.
Age: 55.0
Sex: M
Vaccine: FLUR4
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy Rash on arm and leg
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Patient reported an egg intolerance at time of flu shot. then reported back that she has a scratchy  throat.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Slight redness at site with swelling from deltoid down to the elbow.....warm to touch.  It was not tight but was uncomfortable to patient.  It started out more swollen at the injection site the night of the vaccination, then swelling slightly increased down the arm and stopped shy of the elbow. She says it is slowly getting better.  She is going to ice it and take IBU for pain/swelling.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Pain
Clinical narrative: I received the current flu vaccine for 65 and older.  About 8 hours after receiving the vaccine, I began having lower back pain. It was challenging to go from sitting to standing. I could walk without pain. It hurt when sitting or laying down depending on my position. Advil helped. After 5 days, it began to get better but still is slightly sore. This is the first type of reaction I have ever had for a flu vaccine.
Age: 18.0
Sex: M
Vaccine: FLUR4
Symptoms: Loss of consciousness
Clinical narrative: PATIENT PASSED OUT FOR ABOUT 15 SECONDS AFTER THE SECOND ATTEMPT OF INJECTION. PATIENT REVIVED WITHIN 30 SECONDS WITHOUT INTERVENTION. NO HOSPITALIZATION WAS INVOLVED, THE PATIENT WAS OBSERVED FOR 15 MINUTES AFTERWARDS AND THERE WAS NO FURTHER WORSENING OF THE SYMPTOMS.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: "Bursitis" like pain described by patient, still ongoing since day of immunization (2 months later)
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Bedridden, Dyspnoea, Fatigue, Mobility decreased, Myalgia
Clinical narrative: Pt states experienced severe fatigue, fever over 100, shortness of breath, muscle aches, says was bedridden and unable to lift arm for 4 days
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Pt states experienced severe fatigue, fever over 100, shortness of breath, muscle aches, says was bedridden and unable to lift arm for 4 days
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Pain in extremity, Rash
Clinical narrative: Arm was sore. Didn't feel later that evening and woke up with a severe headache, nausea and slight rash on chest and left side just under collar bone.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Electrocardiogram, Extrasystoles, Fatigue, Headache
Clinical narrative: Painful arm into neck, Headache, Fatique,  Rapid heart beat, Palpitations, Skipped Heart Beats Told by pharmacist to contact primary care physician. Got sent to Clinic where an EKG was taken, skipped heart beats noted. Got sent to Emergency Room and monitored for 2-3 hours. Rapid heart beat slowed down as did palpitations that night which was the 3rd day after vaccine was given. Was then referred to Cardiologist who detected skipped heart beats but said I was healthy and not to be concerned. He suggested not getting another Pneumo  Vaccine.  Though most of the reactions ceased after third day I still have skipped heart beats and palpitations at times.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Heart rate increased, Neck pain, Pain in extremity, Palpitations, X-ray
Clinical narrative: Painful arm into neck, Headache, Fatique,  Rapid heart beat, Palpitations, Skipped Heart Beats Told by pharmacist to contact primary care physician. Got sent to Clinic where an EKG was taken, skipped heart beats noted. Got sent to Emergency Room and monitored for 2-3 hours. Rapid heart beat slowed down as did palpitations that night which was the 3rd day after vaccine was given. Was then referred to Cardiologist who detected skipped heart beats but said I was healthy and not to be concerned. He suggested not getting another Pneumo  Vaccine.  Though most of the reactions ceased after third day I still have skipped heart beats and palpitations at times.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: PATIENT COMPLAINING OF VACCINE BEING GIVEN TOO UP TO THE SHOULDER BONE, PAIN, HARD TIME LIFTING THE ARM
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Joint range of motion decreased, Product administered at inappropriate site, X-ray
Clinical narrative: Patient states that shot was administered too high on the arm causing pain and not being able to bend arm after shot was given and thru the evening
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Muscle spasms
Clinical narrative: Pain in left shoulder developing 2 days after vaccination, resulting in now muscle spasms in neck, now pain in both shoulders.  Spasms continuing currently - day 6 post -vaccination.  No previous episodes of shoulder, neck pain or muscle spasms.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: The evening after the injection, patient is experiencing pain in upper arm and shoulder near collar bone/neck. She doesn't report any redness or swelling. She states that she is able to lift and move her arm.
Age: 78.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Dyspnoea
Clinical narrative: Patient reported having difficulty or labored breathing starting about 24 hours after vaccinations.  Patient's daughter said she normally has trouble breathing but this was a little more difficult than usual. Patients doctor was notified and the patient was instructed to go to the ER if breathing became severe or worse.  Patient was going to call primary care doctor and wait it out.
Age: 93.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: SPOUSE CALLED APPROXIMATELY 4 HOURS AFTER VACCINATION AND REPORTED THAT PATIENT WAS EXPERIENCING NAUSEA AND VOMITING;
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There was not an adverse reaction to the vaccine.  The wrong vaccination was given to the patient.  The patient was supposed to receive Fluzone Quad but received Fluzone High Dose
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Limb injury
Clinical narrative: Patient received Influenza vaccination in the deltoid of the right arm on 9/11/2020 in the am. MD indicated she presented today with an injury in the arm. Patient claimed shot was delivered intravenously in the elbow and was having a reaction on 10/7. MD indicated that the patient was ok and recovering with treatment. I indicated I would report and investigate the incident.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Joint range of motion decreased, Malaise, Pain
Clinical narrative: red, warm, swollen arm about the size of a tennis ball. Painful to the touch or move.  Patient reported feeling sick also. Patient treated with a few doses of advil and warm compresses. by 10/6/2020 patient reports increased mobility (able to raise arm straight over shoulder, and just a little soreness left).  Patient was visiting a doctor for unrelated  other arm issue the next day and was advised to take some more advil and consult md to see if a steroid would be appropriate to help reduce inflammation.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pain of skin, Peripheral swelling, Skin warm
Clinical narrative: red, warm, swollen arm about the size of a tennis ball. Painful to the touch or move.  Patient reported feeling sick also. Patient treated with a few doses of advil and warm compresses. by 10/6/2020 patient reports increased mobility (able to raise arm straight over shoulder, and just a little soreness left).  Patient was visiting a doctor for unrelated  other arm issue the next day and was advised to take some more advil and consult md to see if a steroid would be appropriate to help reduce inflammation.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cluster headache, Headache, Hyperhidrosis, Immobile
Clinical narrative: When I awoke on 10/4 I had a substantial headache which aspirin had absolutely zero effect. I was pretty much immobile the entire day. When I awoke on 10/5 my headache was much worse, comparable to a cluster headache, I had the chills and then almost at the same time I experienced profuse sweating (these were experienced throughout the entire day). I laid down from 0930 am until 1930 waking and getting up only to urinate and vomit. As I had no breakfast that morning once that was expelled from vomiting I began the dry heaves. The dry heaves continued throughout the day. I tried to get some liquids in me but they came right up. At 1930 I went to bed where I was in and out of sleep getting up only to dry heave. When I awoke on 10/6 I had a slight headache that lingered until the afternoon. I sent an email to Dr explaining  my condition and I also did not know if this was a reaction to the flu vaccine or not.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Retching, Vomiting
Clinical narrative: When I awoke on 10/4 I had a substantial headache which aspirin had absolutely zero effect. I was pretty much immobile the entire day. When I awoke on 10/5 my headache was much worse, comparable to a cluster headache, I had the chills and then almost at the same time I experienced profuse sweating (these were experienced throughout the entire day). I laid down from 0930 am until 1930 waking and getting up only to urinate and vomit. As I had no breakfast that morning once that was expelled from vomiting I began the dry heaves. The dry heaves continued throughout the day. I tried to get some liquids in me but they came right up. At 1930 I went to bed where I was in and out of sleep getting up only to dry heave. When I awoke on 10/6 I had a slight headache that lingered until the afternoon. I sent an email to Dr explaining  my condition and I also did not know if this was a reaction to the flu vaccine or not.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: RED SWOLLEN, WARM ARM; FEVER; BODY ACHES
Age: 16.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Neuropathy peripheral
Clinical narrative: Parent/doctor mentioned the patient has developed neuropathy after receiving flu shot.
Age: 16.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Magnetic resonance imaging brain, Magnetic resonance imaging neck, Radial nerve palsy
Clinical narrative: Parent/doctor mentioned the patient has developed neuropathy after receiving flu shot.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Aphonia, Cough, Headache, Nervousness, Ocular hyperaemia
Clinical narrative: Patient said that 3 to 4 hours after receiving the flu shot she had wheezing, coughing, and blood shot eyes. She felt like her throat was tight.  She did not seek medical care or call pharmacy at that time.  She went to bed and felt shaky.  The next day she didn't have a voice and had a mild headache.  She called the pharmacy a few days later (after returning to normal) because someone she knew advised her to in case this was a reaction from the immunization.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Wheezing
Clinical narrative: Patient said that 3 to 4 hours after receiving the flu shot she had wheezing, coughing, and blood shot eyes. She felt like her throat was tight.  She did not seek medical care or call pharmacy at that time.  She went to bed and felt shaky.  The next day she didn't have a voice and had a mild headache.  She called the pharmacy a few days later (after returning to normal) because someone she knew advised her to in case this was a reaction from the immunization.
Age: 83.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Loss of personal independence in daily activities
Clinical narrative: No effect on the day of injection, but the following morning I experienced dizziness that prevented me from leaving the house.  I did not contact the primary care doctor since August and hoped the dizziness would ease as I was preparing for morning chores.  I spent the entire morning seated.  After lunch the  dizziness had gone.