chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Faint two times; This case was reported by a pharmacist via call center representative and described the occurrence of faint in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 9974P, expiry date 9th May 2022) and (batch number CD9MZ, expiry date 4th September 2022) for prophylaxis.   On 17th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 17th November 2020, less than a day after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received second dose of Shingrix and on the same night faint two times. The reporter consented to follow up.
Age: 8.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Wrong product administered
Clinical narrative: Dtap given should have been TD
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Product administered at inappropriate site
Clinical narrative: Oral Rotatrix given as IM injection
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Anxiety, Blood test normal, Feeling abnormal, Head discomfort, Magnetic resonance imaging normal
Clinical narrative: Randomized muscle twitching, anxiety, brain fog, muscle weakness, neck pain, pressure in head
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Muscle twitching, Muscular weakness, Neck pain, Urine analysis normal, X-ray normal
Clinical narrative: Randomized muscle twitching, anxiety, brain fog, muscle weakness, neck pain, pressure in head
Age: 78.0
Sex: M
Vaccine: FLUR4
Symptoms: Rash
Clinical narrative: After receiving the flu vaccine the patient developed a rash. He has had flu vaccines in the past and has never had a reaction. He reported the reaction to the pharmacy on 11/25/20. He stated the rash has resolved. He only received one vaccine on that day and didn't start any new medications or encounter anything out of the ordinary that could lead to the rash.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Product administered at inappropriate site
Clinical narrative: Oral vaccine given as IM injection
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient states that the site of injection is red, hard, swollen (oblong, about 2 inches in size). Patient has no pain or fever.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Body temperature increased, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: A high temperature of 102 within 12 hours, extreme vomiting, aching in joints, and extreme redness in the right arm, and swelling from upper arm to elbow. I took Advil for swelling and Tylenol for fever. After 48 hours the fever is down, the right arm is still red and the swelling is down 30%.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: A high temperature of 102 within 12 hours, extreme vomiting, aching in joints, and extreme redness in the right arm, and swelling from upper arm to elbow. I took Advil for swelling and Tylenol for fever. After 48 hours the fever is down, the right arm is still red and the swelling is down 30%.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Rash papular
Clinical narrative: REDNSESS, PAPULAR RASH
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient reported rash to left hand side of body (upper chest, back, and side of torso) beginning approximately 6 hours after vaccine and ending roughly a day after receiving vaccine. Patient has not had a reaction to vaccine in the past.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia, Rash
Clinical narrative: Patient experienced some body aches/headaches within the following 3 days after her vaccination. However, 6 days after the vaccination (on 11/19) patient began to experience rash that started on arm and spread to entire body. She also reported the "whites" of her eyes were red. She did seek medical care for this and her doctor prescribed her prednisone which did help with the rash.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Pain in extremity, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient received Pneumovax on 11/19/20. Noticed chills and fever starting on 11/20/20, as well as some arm pain and redness at injection site.
Sex: F
Vaccine: FLU4
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: I had a flu vaccine 9/8/20 at 3pm at the Center RX Alfuria Quad 2020-2021 vial 33332-0420-10 Sequirus, Inc. Qty.5 I went into afib 9/8/20 at 10pm which didn't stop until I took flecainide and diltiazem at 2am. I was diagnose with sleep apnea which caused afib for the first time last October 30, 2019. Since diagnosed and on a CPAP haven't had an afib episode since January 2020.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: On Evening of 11/17/2020 Pt had Fever @ home oF 106 degrees Axillary. Went to ER. Temp There 104 degrees (R). Pt observed + discharged. Fever For about 48 hours post immunizations.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the long-term prevention of shingles and zoster-related conditions (dose, dose number, route of administration, anatomical location, lot # and expiration date not provided). On an unknown date, the patient was treated by a healthcare provider for Bell's palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient had and would continue to suffer the ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  Upon internal review, Bell's palsy was considered medically significant.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: a child received injection of two MMR II vaccines in the office today; no adverse event; This spontaneous report was received from a registered nurse referring to a 12-month-old patient of an unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not provided.  On 23-NOV-2020, the patient was vaccinated with 2 doses of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), (lot, expiration date, route of administration, strength and frequency were not reported) for prophylaxis (overdose).   Additionally, it was reported that patient was not currently experiencing signs/symptoms of a reaction to her knowledge (no adverse event). No additional details were provided.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: He got the flu shot and now gets the flu every year; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves male patient who got flu every year (influenza), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment, vaccinations, concomitant medication 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 expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu every year (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.  There will be no information on the batch number for this case.
Age: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity, Skin warm, Sleep disorder
Clinical narrative: Severely bruised left arm (dark purple and warm to touch) from shoulder to elbow; Complaining of pain and not being to sleep on the left side; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp (Healthcare professional).  This case involves an 89 years old male patient who experienced severely bruised left arm (dark purple and warm to touch) from shoulder to elbow (contusion) and complaining of pain and not being to sleep on the left side (pain in extremity), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatments, vaccinations, and family history were not provided.   Concomitant medications included WARFARIN (WARFARIN) 5 mg.  On 06-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiration date were not reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 06-Oct-2020, the patient developed a non-serious severely bruised left arm (dark purple and warm to touch) from shoulder to elbow (contusion) and complaining of pain and not being to sleep on the left side (pain in extremity), on same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The intensity for the event contusion was severe.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The patient was recovering from the events at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: sore; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer/non-health professional .  This case involves patient (unknown demography) who was sore (pain), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) 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 at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sore (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (MI)and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via an unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage (latency: same day).  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Global Medical Information (GMI) (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Bedridden, Chills, Dysstasia, Fatigue, Myalgia
Clinical narrative: fever 100.0 Fahrenheit; chills; muscle aches; wiped out it is difficult for her to stand up; she hasn't been able to get out of bed for 3 days; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional.  This case involves a 67 month-old female patient who experienced fever 100.0 Fahrenheit (pyrexia), chills, muscle aches (myalgia), wiped out it is difficult for her to stand up (fatigue), she hasn't been able to get out of bed for 3 days (bedridden), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. She was allergic to: IVP dye and Clyndamycin  On an unknown date, the patient received once 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (pre-filled syringe) (lot UJ442AA and expiry date 30-Jun-2021) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious fever 100.0 Fahrenheit (pyrexia), chills, muscle aches (myalgia), wiped out it is difficult for her to stand up (fatigue), she hasn't been able to get out of bed for 3 days (bedridden) following the administration of INFLUENZA QUADRIVAL A-B VACCINE (unknown latency).  Patient did not receive any corrective treatment.  At the time of report, patient had not recovered from the events.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: fever 100.0 Fahrenheit; chills; muscle aches; wiped out it is difficult for her to stand up; she hasn't been able to get out of bed for 3 days; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional.  This case involves a 67 month-old female patient who experienced fever 100.0 Fahrenheit (pyrexia), chills, muscle aches (myalgia), wiped out it is difficult for her to stand up (fatigue), she hasn't been able to get out of bed for 3 days (bedridden), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. She was allergic to: IVP dye and Clyndamycin  On an unknown date, the patient received once 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (pre-filled syringe) (lot UJ442AA and expiry date 30-Jun-2021) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious fever 100.0 Fahrenheit (pyrexia), chills, muscle aches (myalgia), wiped out it is difficult for her to stand up (fatigue), she hasn't been able to get out of bed for 3 days (bedridden) following the administration of INFLUENZA QUADRIVAL A-B VACCINE (unknown latency).  Patient did not receive any corrective treatment.  At the time of report, patient had not recovered from the events.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gave FLUZONE HIGH DOSE to a 56 year old patient in error with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via agency (Reference number- 00332289) and transmitted to Sanofi on 26-Oct-2020 .  This case involves a 56-years-old female patient who was vaccinated with an unknown dose of QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], (batch number: UJ537AB and expiry date: 30-Jun-2021) via intramuscular route in the left arm (product administered to patient of inappropriate age) on 26-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication of the patient was not reported.  It was an actual medication error case due to Inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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 available on the batch number for this case.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Activated partial thromboplastin time, Back pain, Blood creatine phosphokinase, Blood pressure increased
Clinical narrative: Within 5 minutes of administration, sweating, headache, nausea, right arm pain and right arm swelling, dizziness, severe back pain and leg pain, and ringing in both ears. Within 20 minutes of administration, numbness and tingling in all extremities: both arms and both legs and pain in the buttocks. health clinic: Within one hour elevated pulse, elevated blood pressure, dry mouth and sore throat, scratchy  throat. Return to  Emergency Room: Within 12 hours of administration heart palpitations, irregular heart beat, abdominal pain, chest pain, chest pressure, continuous belching, severe pain in both arms and both legs, severe headache.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Brain natriuretic peptide, Chest discomfort, Chest pain, Dizziness, Dry mouth
Clinical narrative: Within 5 minutes of administration, sweating, headache, nausea, right arm pain and right arm swelling, dizziness, severe back pain and leg pain, and ringing in both ears. Within 20 minutes of administration, numbness and tingling in all extremities: both arms and both legs and pain in the buttocks. health clinic: Within one hour elevated pulse, elevated blood pressure, dry mouth and sore throat, scratchy  throat. Return to  Emergency Room: Within 12 hours of administration heart palpitations, irregular heart beat, abdominal pain, chest pain, chest pressure, continuous belching, severe pain in both arms and both legs, severe headache.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram, Eructation, Full blood count, Headache, Heart rate increased
Clinical narrative: Within 5 minutes of administration, sweating, headache, nausea, right arm pain and right arm swelling, dizziness, severe back pain and leg pain, and ringing in both ears. Within 20 minutes of administration, numbness and tingling in all extremities: both arms and both legs and pain in the buttocks. health clinic: Within one hour elevated pulse, elevated blood pressure, dry mouth and sore throat, scratchy  throat. Return to  Emergency Room: Within 12 hours of administration heart palpitations, irregular heart beat, abdominal pain, chest pain, chest pressure, continuous belching, severe pain in both arms and both legs, severe headache.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate irregular, Hyperhidrosis, Hypoaesthesia, Metabolic function test, Musculoskeletal pain
Clinical narrative: Within 5 minutes of administration, sweating, headache, nausea, right arm pain and right arm swelling, dizziness, severe back pain and leg pain, and ringing in both ears. Within 20 minutes of administration, numbness and tingling in all extremities: both arms and both legs and pain in the buttocks. health clinic: Within one hour elevated pulse, elevated blood pressure, dry mouth and sore throat, scratchy  throat. Return to  Emergency Room: Within 12 hours of administration heart palpitations, irregular heart beat, abdominal pain, chest pain, chest pressure, continuous belching, severe pain in both arms and both legs, severe headache.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Oropharyngeal pain, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Within 5 minutes of administration, sweating, headache, nausea, right arm pain and right arm swelling, dizziness, severe back pain and leg pain, and ringing in both ears. Within 20 minutes of administration, numbness and tingling in all extremities: both arms and both legs and pain in the buttocks. health clinic: Within one hour elevated pulse, elevated blood pressure, dry mouth and sore throat, scratchy  throat. Return to  Emergency Room: Within 12 hours of administration heart palpitations, irregular heart beat, abdominal pain, chest pain, chest pressure, continuous belching, severe pain in both arms and both legs, severe headache.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Red blood cell sedimentation rate, Throat irritation, Tinnitus, Troponin
Clinical narrative: Within 5 minutes of administration, sweating, headache, nausea, right arm pain and right arm swelling, dizziness, severe back pain and leg pain, and ringing in both ears. Within 20 minutes of administration, numbness and tingling in all extremities: both arms and both legs and pain in the buttocks. health clinic: Within one hour elevated pulse, elevated blood pressure, dry mouth and sore throat, scratchy  throat. Return to  Emergency Room: Within 12 hours of administration heart palpitations, irregular heart beat, abdominal pain, chest pain, chest pressure, continuous belching, severe pain in both arms and both legs, severe headache.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Urine analysis
Clinical narrative: Within 5 minutes of administration, sweating, headache, nausea, right arm pain and right arm swelling, dizziness, severe back pain and leg pain, and ringing in both ears. Within 20 minutes of administration, numbness and tingling in all extremities: both arms and both legs and pain in the buttocks. health clinic: Within one hour elevated pulse, elevated blood pressure, dry mouth and sore throat, scratchy  throat. Return to  Emergency Room: Within 12 hours of administration heart palpitations, irregular heart beat, abdominal pain, chest pain, chest pressure, continuous belching, severe pain in both arms and both legs, severe headache.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: My husband and I went to get our a flu shot and I rcvd flu shot high up on arm almost by my shoulder on the side. A few hour later I started experiencing a sharp pain. Unable to lift my arm without pain. I called the pharmacist about the paint and he said I must be having an allergic reaction. The pain is from my shoulder to a little bit past my elbow.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Pt reporting on 11/25 (4 days after vaccine administration): Woke up on 11/22 with feeling of fever (heat) in the shoulder/upper arm.  When asked, no fever reported for the whole body.  Over the next two days, the red swelling made it down to about an inch above the elbow joint and swelled up "like a fat sausage" and was not able to lift the arm above shoulder level for that time.  Swelling had since resided to normal on the 25th, though some redness was reported to remain.   I was not able to directly observe the rash, but informed pt that if the swelling or rash were to get worse to report to the Dr.  Following up with the dr about the appropriateness of a second observation was also suggested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever, chills, pain and swelling at injection site, body aches
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient experienced nausea and fever (100 degree)
Age: 23.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: a few days after immunization, began having swelling/tenderness in the area of the HPV shot, not itchy
Age: 70.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Migraine, Peripheral swelling
Clinical narrative: red swollen bicep, migraine, advised to take benadryl
Age: 1.08
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Rash
Clinical narrative: Rash to local area
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Patient did not contact pharmacy to report event until Tues 11/24/20.  Stated that about 30 minutes after vaccination she had redness on face, neck, and chest.  Redness turned to itching.  She appied calamine lotion to soothe itching, did not seek medical treatment.  Patient said symptoms were improved, gone by next morning.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Headache, Hypoaesthesia, Injection site discolouration
Clinical narrative: Patient took first Shingrix dose 2 months ago and experienced swollen area on the shot site about the size of a large lemon maybe 3 inches. The skin was very dark, really red on the site. Patient had pain in her temples on each side of her head and area felt warm on the touch.  Patient took second dose Monday 11/23 at the same pharmacy and this time experience added symptoms such as bad fever 101.4F, body shaking, hard time walking, pain at the injection site, numbness on face (whole face) for about 4 hours, pain in temple area and other parts of head, pain in  hips, very sharp pain in legs making it very hard to ambulate. The symptoms stayed for the whole day. Patient woke up this morning 11/25 feeling normal other  than soreness on the injection site - about the size of a quarter on the injection site. Did not have any problems when she took it first time in 2012.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Skin warm
Clinical narrative: Patient took first Shingrix dose 2 months ago and experienced swollen area on the shot site about the size of a large lemon maybe 3 inches. The skin was very dark, really red on the site. Patient had pain in her temples on each side of her head and area felt warm on the touch.  Patient took second dose Monday 11/23 at the same pharmacy and this time experience added symptoms such as bad fever 101.4F, body shaking, hard time walking, pain at the injection site, numbness on face (whole face) for about 4 hours, pain in temple area and other parts of head, pain in  hips, very sharp pain in legs making it very hard to ambulate. The symptoms stayed for the whole day. Patient woke up this morning 11/25 feeling normal other  than soreness on the injection site - about the size of a quarter on the injection site. Did not have any problems when she took it first time in 2012.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Patient took first Shingrix dose 2 months ago and experienced swollen area on the shot site about the size of a large lemon maybe 3 inches. The skin was very dark, really red on the site. Patient had pain in her temples on each side of her head and area felt warm on the touch.  Patient took second dose Monday 11/23 at the same pharmacy and this time experience added symptoms such as bad fever 101.4F, body shaking, hard time walking, pain at the injection site, numbness on face (whole face) for about 4 hours, pain in temple area and other parts of head, pain in  hips, very sharp pain in legs making it very hard to ambulate. The symptoms stayed for the whole day. Patient woke up this morning 11/25 feeling normal other  than soreness on the injection site - about the size of a quarter on the injection site. Did not have any problems when she took it first time in 2012.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: A dark red coloring , just below the injection site, warm to the touch on the right bicep, measuring about 2 inches high and 3 inches wide. Then a lighter red area spread beyond the borders of the first red area. A rash developed from the spine to the hip area, along the waistband area, and up to mid rib cage. There was also a rash on the underside of the right arm from the armpit to mid bicep. Benadryl and Tylenol were given for the first two days, and then just the Benedryl twice a day for the next 5 days.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Gaze palsy, Immediate post-injection reaction, Muscle twitching, Pallor, Unresponsive to stimuli
Clinical narrative: After receiving other vaccines without incident, patient was injected with HPV vaccine. Within seconds the patient became unresponsive. Her body went completely ridged, her face became very pale, her eyes rolled, and her left arm twitched a few times. Patient was laid down on the table with knees up. After a few seconds the patient started talking and moving again. Patient was asked to stay lying down for 15 minutes. She was given 2 popsicles. Her vitals were recorded 3 times at 5-minute intervals. Initial BP was 96/42 HR 70, 2nd 108/70 HR 88, 3rd 102/66 HR 74. After second set of vitals were taken patient's color returned to face, she was speaking coherently, and eating her popsicle. Patient did start to shake when 2nd set of vitals were taken but parent said it was probably from the popsicle. After 3rd set of vitals was taken patient expressed that she felt ok and was ready to go home. Patient was allowed to leave ambulatory under her own power.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Trunk, shoulder, popliteal fossa pruritic hives only lasting overnight
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Immediately after I rcvd the shingles vaccine my arm became sore. Few hours I started developing a  redness, lump, swollen hot to touch to the injection site. Symptoms lasted over a week, but the pain has not gone a way. I still have a lump in my arm as well. I'm also experiencing weakness in my arm.  I have been applying a heating pad and using voltran cream. About a month ago I tried to schedule an appointment with my PCP but it's not until Jan 6, 2021.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Immediately after I rcvd the shingles vaccine my arm became sore. Few hours I started developing a  redness, lump, swollen hot to touch to the injection site. Symptoms lasted over a week, but the pain has not gone a way. I still have a lump in my arm as well. I'm also experiencing weakness in my arm.  I have been applying a heating pad and using voltran cream. About a month ago I tried to schedule an appointment with my PCP but it's not until Jan 6, 2021.
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient had received Flu vaccine on 9/30/20, and when in office on 11/25/20 she received flu vaccine when requested to have one. Due to short staffing chart was not reviewed to see if pt already received before administration and pt accidently received 2 doses of flu vaccine. This was caught right away and physician notified, patient was notified as well. Physician reports that pt should be ok, pt notified if she has any problem to call physician office.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Insomnia
Clinical narrative: Significant insomnia after Gardisil vaccine. Spoke with Dr. and advised to start melatonin to help correct disruption.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dysphemia, Pyrexia, Tic
Clinical narrative: Tics & stutter, started 9/30/20. Fever of 100.8 on 10/5. Sent to ER & f/u w/neuro.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Pt called saying she felt dizzy about 2 hours after Shingrix administered and wondered if it was from the vaccination. It can happen in roughly 1% of patients so I am documenting. I did follow up with a phone call to pt but had to leave a message.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Hypopnoea, Pyrexia
Clinical narrative: Caller is experiencing fever, chills, severe headache, pain in right hip, shallow breathing and shock like symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Shock symptom
Clinical narrative: Caller is experiencing fever, chills, severe headache, pain in right hip, shallow breathing and shock like symptoms.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Started with Stomach Ache on 11/21/2020, Fever of 101.3 started on 11/22/2020 combined with headache and muscle aches.  Fever on 11/23/2020 combined with headache. Extremely tired and Low grade fever on 11/24/2020. We alternate Advil and Tylenol to keep the fever down.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Started with Stomach Ache on 11/21/2020, Fever of 101.3 started on 11/22/2020 combined with headache and muscle aches.  Fever on 11/23/2020 combined with headache. Extremely tired and Low grade fever on 11/24/2020. We alternate Advil and Tylenol to keep the fever down.
Age: 52.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Persistent pain in the arm in the area of the injection site.   Pain and restricted motion range of thumb on the  hand of the same arm.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted 20 min after shot given
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient called the pharmacy on 11/23/20 reporting extended pain in the shoulder near the injection site of seasonal flu immunization. Patient states that 24 -48 hours after immunization there was mild/moderate pain. Patient reports extended soreness and pain with certain motions with in injection arm.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Chills and a low grade fever, Fatigue, Headache and dizziness for two days.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Vasovagal syncope; patient was uneasy about needles
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Atrial fibrillation, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Atrial Fibrulatio/ Tachycardia weakness fever dizzyness shortness of breath sore throat
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Oropharyngeal pain, Tachycardia
Clinical narrative: Atrial Fibrulatio/ Tachycardia weakness fever dizzyness shortness of breath sore throat
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Headache, Tinnitus
Clinical narrative: About 10 minutes after hep b vaccine given, employee started complaining of feeling head/neck pounding, ringing in the ears, and hot.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Product administered at inappropriate site, Quality of life decreased
Clinical narrative: Patient contacted us on Friday, November 13th stating she had received a flu shot which has affected her quality of life. She has been experiencing limited mobility for approximately 3 weeks and she also had to get a decadron shot from her doctor's office. Her doctor informed her that the shot was given too high up on her arm thus causing discomfort for this extended period of time.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeling hot, Hyperaesthesia, Sleep disorder
Clinical narrative: On the same day of vaccination, patient was experiencing warmness on the arm. Patient was not able to sleep at night. On Tuesday morning, patient experienced fatigue, along with redness and sensitivity to the touch. No febrile symptoms. Symptoms are getting better, she just wanted us to report it.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Welp at injection site, itching throught body and burning at site. Started day after vaccine given. (Given 11/17, symptoms started 11/18, symptoms cleared by 11/ 23. Advised to do cold compressions and benadryl
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain in extremity
Clinical narrative: when patient came in to get 2nd vaccine. asked her about the 1st shot and she said her arm got red/bruised from shoulder to elbow. this lasted about a month and it was sore for about a week. patient never went to md or reported to pharmacy
Age: 71.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chills, Nausea, Pain
Clinical narrative: On the same day (11/18/20) that patient received the vaccinations, at 9 PM patient had shivers, achiness and nausea. Patient took 1 dose of aspirin at 10 PM and went to bed at  10:30 PM. Patient better the next morning and all symptoms listed above were gone.
Age: 46.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Pruritus, Tachycardia
Clinical narrative: Tachycardia, dizziness, prurititis, after receiving  vaccine.  Resolved on its own minutes later.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: Patient stated that in the evening after receiving the vaccine on 8/28/2020 she was experiencing extreme myalgia of the right shoulder where injection was administered. Later in the evening while watching TV, the patient went to grab remote control and had "dead arm". The patient has continued to struggle with myalgias in her right shoulder for 3 months after obtaining the Shingrix vaccine. The patient does have a past medical history of a musculoskeletal disorder and visits a chiropractor clinic. She has been visiting the chiropractor after the adverse event to the vaccine. At the chiropractor clinic she has been completing physical therapy treatments and exercise to help with the myalgia over the past 3 months. Patient reported the adverse event on 11/20/2020.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Electrocardiogram, Heart rate increased
Clinical narrative: Fast heart rate approximately 115 and temperature of approximately 99.7F around midnight for approximately 5 hours
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling of injection arm starting at armpit and ending at elbow. Redness and itching. Swelling subsided significantly when the patient came in on 11/25 to talk to pharmacist about it. Recommended Benadryl if itching continued. Patient said that it had improved a lot in 24 hours and didn't really itch too much anymore.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Tenderness
Clinical narrative: brain fog x 2 days, muscle ache x 5 days, soreness to touch x 7 days
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity
Clinical narrative: The patient presented stating her arm hurts and she has pain when she tries to lift her arm. She is trying to work out the pain using ibuprofen and range of motion exercises.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Patient did not go see doctor to get a diagnosis, but said she got the chicken pox show up on her face about 1-2 weeks after getting her Shingrix shot. Patient said that she has puss coming out back in Aug, but it is getting better now. She is reluctant to get the 2nd dose, but is worried that she may get shingles later down the line. I told patient that she needs to talk with her doctor and decide if that is the right decision for herself. She felt better after our talk will come back in December to do the 2nd dose.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Moaning, Peripheral swelling, Pyrexia
Clinical narrative: Had achey joints. Arm got a little swollen and hurt to sleep on that side. Had a big red rash on the upper arm/shoulder. Had fever/chills. Was moaning and groaning. Still has a little rash on arm but otherwise recovered.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Rash erythematous, Sleep disorder
Clinical narrative: Had achey joints. Arm got a little swollen and hurt to sleep on that side. Had a big red rash on the upper arm/shoulder. Had fever/chills. Was moaning and groaning. Still has a little rash on arm but otherwise recovered.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: I have been experiencing a mild fever (100 degrees F) for more than five days since the day (11.21.2020) after I received the shot.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: The patient reports pain in arm since injection which has continued to increase with time
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Erythema, Fall, Loss of consciousness
Clinical narrative: Pt got up from IMZ booth and got in line to pick up other meds, about 5 minutes later he told his wife he was dizzy then passed out, fell into someone else which slowed his fall. He was breathing hard and his face got red.  We took his mask off and his dentures were falling out so his wife removed them. The ambulance was called. Pt looked at his wife when she said his name once and started to roll over as the paramedics came in. He responded to them a little, and they took him to the hospital. Per the pt's wife-he got to go home this afternoon.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Nausea, headache, body ache, exhausted
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Patient received 3 vaccines on 08/18/2020. 2 (Havrix and Engerix) in the left arm, and 1 (Fluzone) in the right arm.  Patient reported to pharmacist on 11/25/2020 that she has been having pain in her right arm since the vaccination.  She consulted with her physician on and on 11/24/2020, the physician prescribed MAPAP Arthritis strength and Gabapentin 100 mg for 10 days.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Heart rate increased, Influenza, Vomiting, Wheezing
Clinical narrative: Sunday night started not feeling good I did vomit and had diarrhea and felt like I was getting the flu, got it on the 6th and started feeling bad on the 8th. I had some wheezing and a fast heart beat the following Friday. First day was more flu feeling with the diarrhea and vomiting. Didn't start feeling back to myself for 2 weeks after. I called my doctor on the 16-17 th they called me back  18th and doctor wanted me to come in for a COVID test but I was starting to feel better and not see why go in to be seen for a test. She quarantined herself instead, before going out again to be safe.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pyrexia, Tinnitus
Clinical narrative: Sudden onset at 6:15pm of severe chills and ear ringing. Later that evening chills started to slightly subside with onset of fever (101.9) and diaphoresis. Chills and sweating continued throughout the evening with temperature drop to 99.7 in the morning at 6:45am. Onset of headache at 7am that persisted 8hours despite use of aspirin/acetaminophen (Excedrin).