chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Extra dose administered, Influenza like illness
Clinical narrative: Flu-like symptoms; Afluria quadrivalent administered on 17-Jan-19 but on 20-Dec-18 had already had another unnamed flu vaccine administered; This is a spontaneous case initially received from other health professional (nurse) on 24-Jan-2019, concerning a 33-year-old, adult male patient.  The patient's current conditions included opioid abuse and muscle spasms.  The patient's concomitant medications included Vivitrol (naltrexone) for opioid abuse, Tizanidine for muscle spasms, clozapine (pregabalin) and naproxen. It was reported that the opioid abuse and muscle spasms had occurred before the administration of the flu vaccines.  On 20-Dec-2018, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication.  On 17-Jan-2019 (in the same season), the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF43809 and expiry date: 30-Jun-2019) (explicitly coded as extra dose administered) for active immunization against influenza.  On an unspecified date, after vaccination with Afluria Quadrivalent, the patient experienced flu-like symptoms and not the flu.  The reporter assessed the case as non-serious.  Follow up received from nurse on 12-Feb-2019: Added start dates for concomitant medications Vivitrol: 17-Jan-2019, Tizanidine: 17-Jan-2019, Naproxen: 17-Jan-2019, Clozapine: 10-May-2017 and concomitant medication's indications for Vivitrol: opioid abuse and Tizanidine: muscle spasms in product tab. The nurse stated they did not see the patient for 1 month. The narrative was amended accordingly.  Follow up received from other health professional (nurse) on 20-Feb-2019: The classification 'special case with no AE' was deleted in the general tab. The event 'flu like symptoms' was added in the event tab. It was reported that the opioid abuse and muscle spasms had occurred before the administration of the flu vaccines. The narrative and case comment were amended accordingly.; Reporter's Comments: A 33-year-old, male patient was administered an INN Flu Vaccine Seasonal and Afluria Quadrivalent in the same season (extra dose administered). On an unspecified date after vaccination with Afluria Quadrivalent, the patient experienced flu-like symptoms. The company assessed the causality of the event extra dose administered as not related to the suspect vaccine due to accidental nature of the event. The company assessed the causality of the event flu-like symptoms as not related to the suspect vaccine INN Flu Vaccine Seasonal due to implausible temporal relationship between event and suspect vaccine. The causality of the event flu-like symptoms with respect to Afluria Quadrivalent vaccine was unassessable due to the lack of information regarding onset latency of the event.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cardiac arrest, Death, Life support, Loss of consciousness, Respiratory failure
Clinical narrative: On 12/10 around 3pm she had a 2 vaccines. Fluzone High Dose 180 mcg/0.5mL and Varicella-zoster 50 mcg/o.5mL. At 9:20pm, after going out to a movie,  she suffered sudden cardiac arrest. 911 was immediately called. She never regained consciousness and was taken off of life support on 12/14. I asked multiple doctors why they thought her heart stopped and none of them knew why. I explained to them that I (her daughter) have a genetic condition called MCAS which has been linked to Kounis Syndrome which can cause coronary vasospasms. I was told it was too rare to consider. A couple of weeks later I found her vaccination papers. I called her doctor's office to let them know. The woman on the phone pulled up her name. As she was reading, she said that they hadn't been informed and thanks for letting them know and suddenly her entire tone changed and she said I'd have to talk to someone else and hung up. I believe she was trying to transfer me but I can't help but wonder if she was having a small reaction earlier that day in the office and they let her go.
Age: 1.25
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site mass
Clinical narrative: Mild lump at injection site, non-tender, no erythema or drainage, no sign of infection. Warm compress prn for mild lump at vaccination site
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: patient had an allergic reactionand had to admit to the hospital
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Fatigue, Headache, Lethargy, Malaise
Clinical narrative: 7/8/19 12pm MMR injection  5:30pm headache 6:40pm worsening headache, dizziness, nausea, extreme fatigue 8:45pm vomited (As headache became severe I tried to reach his healthcare provider to no avail.)  7/9/19-7/11/19 Malaise, lethargy, runny nose  I was unable to reach his healthcare provider that evening. No treatment was given. Energy returned within a few days. Runny nose persisted for months. I did report to healthcare provider.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Nausea, Rhinorrhoea, Vomiting
Clinical narrative: 7/8/19 12pm MMR injection  5:30pm headache 6:40pm worsening headache, dizziness, nausea, extreme fatigue 8:45pm vomited (As headache became severe I tried to reach his healthcare provider to no avail.)  7/9/19-7/11/19 Malaise, lethargy, runny nose  I was unable to reach his healthcare provider that evening. No treatment was given. Energy returned within a few days. Runny nose persisted for months. I did report to healthcare provider.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Head injury, Syncope
Clinical narrative: Vasovagal syncope after administration of vaccine. Patient collapsed as she was walking out of room and bumped her head. moved patient to nearest room sat patient and took vitals and blood sugar. patient was responsive and able to follow directions. pediatrician evaluated patient and advised to lay patient supine and administer oral glutose and hydrate patient. patient A & O x 3. Dr. re-evaluated patient and advised parent to bring patient back to clinic if she noted any changes.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Muscle tightness, Skin warm, Tenderness
Clinical narrative: Patient stated her right arm became tender and warm after receiving the Shingrix vaccine. She also felt super tired and had deep muscle tension.
Age: 1.0
Sex: F
Vaccine: DTAP, FLU4, HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Proquad and Varivax were both given.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Lymphadenopathy
Clinical narrative: pt called the doctor on cal and stated she had redness, in her arm with swelling  that went into her lymph nose under arm , reaction did last for 2 days
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Mammogram normal, Rash, Swelling
Clinical narrative: Rash and swelling under the right arm and down the right side of  body under the right breast,   treatment was Tylenol,  lasted about 7 days
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: spoke with patients mom , informed her of the vaccines given
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Urticaria
Clinical narrative: Mom reports child started with knees itching then developed hives eight hours after vaccines given. Child was given oral Benadryl by mother. Seen by Pediatrician the next morning. Steroids prescribed then. Mom reports all symptoms resolved. Pediatrician plans to do allergy testing on child.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient younger than 6months of age administered the inactivated flu vaccine.  unknown reaction. pt left with no symptoms
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Hyperhidrosis, Hypersomnia
Clinical narrative: shaking and chills; no energy from Saturday 1:00 am until Sunday sometime between 1 and 3am  when I broke out in a sweat; I did not have a fever; took one 325 mg. Tylenol every 4-6 hours starting at 4:00am Saturday; chills would periodically subside but continued off and on until early Sunday morning.  When I woke at 8:00am on Sunday I felt great - a little weak, but normal.  To reiterate: Was up and restless, chills the night after the shot; during the day slept off and on; slept 12 hours on Saturday night. Very unusual to need so much sleep and to have chills that were uncontrollable at times.  Arm was very sore and remained red for 4 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Restlessness, Tremor
Clinical narrative: shaking and chills; no energy from Saturday 1:00 am until Sunday sometime between 1 and 3am  when I broke out in a sweat; I did not have a fever; took one 325 mg. Tylenol every 4-6 hours starting at 4:00am Saturday; chills would periodically subside but continued off and on until early Sunday morning.  When I woke at 8:00am on Sunday I felt great - a little weak, but normal.  To reiterate: Was up and restless, chills the night after the shot; during the day slept off and on; slept 12 hours on Saturday night. Very unusual to need so much sleep and to have chills that were uncontrollable at times.  Arm was very sore and remained red for 4 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Chest pain, Chills, Decreased appetite
Clinical narrative: First dose of the SHINGRIX shot was given at the same location on:  8 September 2018.  Adverse reaction after first dose began in January ~ paralyzed bowels, extreme abdominal pain, chills, extreme weakness, nausea, loss of appetite.   4-6 weeks later, I began having extreme chest pain and made numerous trips to the ER.  In June 2019, I began having daily rashes that emerged every morning and every evening, lasting less than 30 min. each time.  Since June 2019, I began having painful lymph nodes in my left breast.  In the past 2 months, the rashes now come randomly throughout the day and last for varying times.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Ileus paralytic, Lymph node pain, Nausea, Rash, Vaccination complication
Clinical narrative: First dose of the SHINGRIX shot was given at the same location on:  8 September 2018.  Adverse reaction after first dose began in January ~ paralyzed bowels, extreme abdominal pain, chills, extreme weakness, nausea, loss of appetite.   4-6 weeks later, I began having extreme chest pain and made numerous trips to the ER.  In June 2019, I began having daily rashes that emerged every morning and every evening, lasting less than 30 min. each time.  Since June 2019, I began having painful lymph nodes in my left breast.  In the past 2 months, the rashes now come randomly throughout the day and last for varying times.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient stated started as sore at injection site on day of injection and continued for 2 days. Soreness then moved to elbow on 4th day  and turned red. A dark ring developed around the elbow on the fifth day. Still hurts a little, but getting better per the patient.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen (golf ball size), painful, left arm/shoulder soreness
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: patient got Shingrix vaccine on 10/23/19  &  she a painful burning rash about 3-4 days after receiving vaccine that resolved in ~1wk. Thereafter,  patient reports she has had an itchy red rash in a band like form on left abdomen that comes and goes, but is relieved when she applies  hydrocortisone to the area.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury, Nausea, Pallor, Tremor
Clinical narrative: pt was given the shot and stood up and walked about 5 feet and fell onto the floor hitting his head on the cabinet on the way down. he then began to shake for about 3-5 seconds. we got patient up off the ground onto the bed. he was very pale and nauseated. we administered epi and dexa and pt was monitored over the next 2 hrs in office.
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Limb discomfort, Muscle tightness
Clinical narrative: PATIENT RECEIVED FLU VACCINE(FLUBLOK QUAD) ON 1/22/2020 AT 2PM.  SHE COMPLAINED ABOUT NUMBNESS IN THE LEFT ARM AT 2:06PM. SHE IS EMPLOYEE AT THIS LOCATION. AFTER COMPLETING HER SHIFT AT 3:00PM SHE STOPPED BY AT PHARMACY AND SAID SHE STILL HAVE NUMBNESS IN LEFT ARM. SHE CAN MOVE HER ARM AND FINGERS BUT SHE FEELS HEAVYNESS/TIGHTNESS/NUMBNESS IN LEFT ARM. SHE WENT HOME AND SHE SAID SHE WILL UPDATE  PHARMACY ABOUT CONDITION . CALLED AT 5:00PM SHE SAID FEELS LOT BETTER BUT STILL GOT TIGHTNESS.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Computerised tomogram, Limb injury, Syncope
Clinical narrative: Patient received Fluad on 12/12/19. On 12/13/19, she states that she was standing in her kitchen and fainted backwards onto a floor tile.  She was taken to the ER with a shoulder injury and had a CT scan done.  Pt believes that the inceident was due to the flu shot.  Patient called and reported this incident on 01/22/2020.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Major joint pain throughout body for 3 days duration.   Customer reported difficulty using stairs, walking, getting out of bed, getting off the toilet.   Customer did not take tylenol or ibuprofen during this time.
Age: 28.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Balance disorder, Injection site haemorrhage, Moaning
Clinical narrative: Pharmacist administered Tdap in the patient's left arm.  Patient bled a small amount from the injection site so pharmacist applied pressure to injection site, then applied a bandage. Shortly after bandage was applied, the patient started drifting to his right while sitting in a chair with no arms, and emitting a low groaning noise. Pharmacist held on to patient's left shoulder to prevent him from falling. Patient started to tip forward so pharmacist held patient in place with both shoulders. Approx 3 seconds after incident started, patient made eye contact again and said "hello". Patient said no hx of seizures/fear of needles or blood, and said he was "just tired." Patient spun the chair (on wheels), pharmacist admi Patient said no hx of seizures/fear of needles or blood, and said he was "just tired." Patient was able to spin the chair (on wheels)  around so his right arm was facing the pharmacist. Pharmacist administered flu vaccine in the patient's left arm. Pharmacist observed that the patient was pale and asked him to stay for about 15 minutes or until he felt better. Patient asked for a glass of water and said he would stay. Pharmacist got a glass of water, and patient had left the immunization room and walked across the store to the photo counter. Pharmacy technicians observed the patient was "kind of wobbly". Pharmacist asked patient to stay, patient refused. Patient said he felt better, and left. Pharmacist called the patient's cell phone at approx 5pm and patient said he made it home safely and felt fine now.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Chills, Dehydration, Disturbance in attention, Dizziness, Feeling hot
Clinical narrative: After receiving flu shot on 12/10/2019 patient started filling uncomfortably hot. First symptoms started 10 to 15 min after the imz administration.  Patient started feeling unwell, felt that she is loosing her focus and scratchy trough. She had extreme pain in her left arm that lasted approx 7 days, she had flu like symptoms for approx 7 days (chills, dizziness, nausea and vomiting   , dehydration.) Overall she felt unwell for 7 days and haven't left her house.  She had flu shot before with no known reaction. She have't called to report reactions before ( approx 40 days since administration) because she was sick and busy.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Influenza like illness, Malaise, Nausea, Pain in extremity, Throat irritation
Clinical narrative: After receiving flu shot on 12/10/2019 patient started filling uncomfortably hot. First symptoms started 10 to 15 min after the imz administration.  Patient started feeling unwell, felt that she is loosing her focus and scratchy trough. She had extreme pain in her left arm that lasted approx 7 days, she had flu like symptoms for approx 7 days (chills, dizziness, nausea and vomiting   , dehydration.) Overall she felt unwell for 7 days and haven't left her house.  She had flu shot before with no known reaction. She have't called to report reactions before ( approx 40 days since administration) because she was sick and busy.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Vomiting
Clinical narrative: After receiving flu shot on 12/10/2019 patient started filling uncomfortably hot. First symptoms started 10 to 15 min after the imz administration.  Patient started feeling unwell, felt that she is loosing her focus and scratchy trough. She had extreme pain in her left arm that lasted approx 7 days, she had flu like symptoms for approx 7 days (chills, dizziness, nausea and vomiting   , dehydration.) Overall she felt unwell for 7 days and haven't left her house.  She had flu shot before with no known reaction. She have't called to report reactions before ( approx 40 days since administration) because she was sick and busy.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeling abnormal, Injection site erythema, Injection site pain
Clinical narrative: Fever chills hurt all over. Muscle and joint pain. Nausea, and gerneral awful feeling. Injection site pain. Are at site swollen.   And now have red streaks  3? long in swollen area.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site streaking, Injection site swelling, Myalgia, Nausea, Pain
Clinical narrative: Fever chills hurt all over. Muscle and joint pain. Nausea, and gerneral awful feeling. Injection site pain. Are at site swollen.   And now have red streaks  3? long in swollen area.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever chills hurt all over. Muscle and joint pain. Nausea, and gerneral awful feeling. Injection site pain. Are at site swollen.   And now have red streaks  3? long in swollen area.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Urticaria
Clinical narrative: child developed hives day after vaccination. Resolved over next 2 days-discussed with parent by phone only 1/15/2020 & 1/21/2020
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Periarthritis
Clinical narrative: Frozen shoulder (can't raise arm above head or back to put on clothing or coat or bath my back. Can not participate in any activities I enjoy tx-PT, massage
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Burning sensation, CSF protein increased, Full blood count, Gait inability, Guillain-Barre syndrome
Clinical narrative: I got the flu shot on 12/20/19 and on 12/26/19 I woke up with extreme weakness in my leggs and later pain in my feet and burning in my thighs with tingling in fingers and feet. I went to the Emergency Room on 1/2/20 for extreme weakness with suspicions of Guillain-Barre Syndrome, then discharged. A few days latter on 1/6/20 I returned later to the E.R. and was admitted to the hospital. In the hospital, tests included a spinal-tap that showed high protein and then was diagnosed with Guillain-Barre Syndrome. I spent seven days in the hospital and had 5 day treatments with intravenous immunglobg. I was released on 1/12/20 and started physical therapy to regain my walking ability. Physical therapy will be ongoing.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Immunoglobulin therapy, Lumbar puncture, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: I got the flu shot on 12/20/19 and on 12/26/19 I woke up with extreme weakness in my leggs and later pain in my feet and burning in my thighs with tingling in fingers and feet. I went to the Emergency Room on 1/2/20 for extreme weakness with suspicions of Guillain-Barre Syndrome, then discharged. A few days latter on 1/6/20 I returned later to the E.R. and was admitted to the hospital. In the hospital, tests included a spinal-tap that showed high protein and then was diagnosed with Guillain-Barre Syndrome. I spent seven days in the hospital and had 5 day treatments with intravenous immunglobg. I was released on 1/12/20 and started physical therapy to regain my walking ability. Physical therapy will be ongoing.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Abdominal tenderness, Back pain, Blood magnesium, Chest pain, Dyspnoea
Clinical narrative: Sharp back pain radiating into chest. EMS called. Lasting 1 hour. This 66-year-old female patient presents with sharp back pain. Patient was seen in and given vaccination for pneumonia and influenza in her bilateral deltoids this morning. States she was feeling fine otherwise. She went shopping afterward, and had sudden onset of sharp pain across her entire back which radiated forward into her chest. She said the pain was severe enough that it "took my breath away," and doubled her over. EMS squad was called. By the time they arrived at the scene the patient says her symptoms were beginning to let up. They gave her 324 mg of aspirin, as well as sublingual nitroglycerin. She says that the sublingual nitroglycerin resolved her back pain. Patient does have a history of smoking although she quit a number of years ago. She also has a history of GERD and is on a PPI. Family history of coronary artery disease. Re-eval/course of visit: Concern for acute coronary syndrome or other intrathoracic pathology, as well as possible aneurysm. Patient had some tenderness in the right upper quadrant on exam, plan will be to evaluate her with a right upper quadrant ultrasound as well. Labs to include CBC, CMP, cardiac troponin, d-dimer, magnesium level, hepatic function panel. Patient will be evaluated with a EKG. Patient had an elevated d-dimer. We will proceed with CT angiogram of the chest thoracic aorta protocol. Patent's laboratory studies were largely unremarkable. She remained vitally stable throughout her emergency department course. She remained asymptomatic.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fibrin D dimer increased, Full blood count, Liver function test, Metabolic function test, Pain
Clinical narrative: Sharp back pain radiating into chest. EMS called. Lasting 1 hour. This 66-year-old female patient presents with sharp back pain. Patient was seen in and given vaccination for pneumonia and influenza in her bilateral deltoids this morning. States she was feeling fine otherwise. She went shopping afterward, and had sudden onset of sharp pain across her entire back which radiated forward into her chest. She said the pain was severe enough that it "took my breath away," and doubled her over. EMS squad was called. By the time they arrived at the scene the patient says her symptoms were beginning to let up. They gave her 324 mg of aspirin, as well as sublingual nitroglycerin. She says that the sublingual nitroglycerin resolved her back pain. Patient does have a history of smoking although she quit a number of years ago. She also has a history of GERD and is on a PPI. Family history of coronary artery disease. Re-eval/course of visit: Concern for acute coronary syndrome or other intrathoracic pathology, as well as possible aneurysm. Patient had some tenderness in the right upper quadrant on exam, plan will be to evaluate her with a right upper quadrant ultrasound as well. Labs to include CBC, CMP, cardiac troponin, d-dimer, magnesium level, hepatic function panel. Patient will be evaluated with a EKG. Patient had an elevated d-dimer. We will proceed with CT angiogram of the chest thoracic aorta protocol. Patent's laboratory studies were largely unremarkable. She remained vitally stable throughout her emergency department course. She remained asymptomatic.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Troponin
Clinical narrative: Sharp back pain radiating into chest. EMS called. Lasting 1 hour. This 66-year-old female patient presents with sharp back pain. Patient was seen in and given vaccination for pneumonia and influenza in her bilateral deltoids this morning. States she was feeling fine otherwise. She went shopping afterward, and had sudden onset of sharp pain across her entire back which radiated forward into her chest. She said the pain was severe enough that it "took my breath away," and doubled her over. EMS squad was called. By the time they arrived at the scene the patient says her symptoms were beginning to let up. They gave her 324 mg of aspirin, as well as sublingual nitroglycerin. She says that the sublingual nitroglycerin resolved her back pain. Patient does have a history of smoking although she quit a number of years ago. She also has a history of GERD and is on a PPI. Family history of coronary artery disease. Re-eval/course of visit: Concern for acute coronary syndrome or other intrathoracic pathology, as well as possible aneurysm. Patient had some tenderness in the right upper quadrant on exam, plan will be to evaluate her with a right upper quadrant ultrasound as well. Labs to include CBC, CMP, cardiac troponin, d-dimer, magnesium level, hepatic function panel. Patient will be evaluated with a EKG. Patient had an elevated d-dimer. We will proceed with CT angiogram of the chest thoracic aorta protocol. Patent's laboratory studies were largely unremarkable. She remained vitally stable throughout her emergency department course. She remained asymptomatic.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, DTAPHEPBIP, UNK, UNK, UNK
Symptoms: Unevaluable event
Clinical narrative: NO ENCOUNTERS OR TELEPHONE MESSAGES RECEIVED FROM PATIENT FAMILY. NO ADVERSE EVENTS, TREATMENTS, OR OUTCOMES CAN BE VERIFIED.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, DTAPHEPBIP, UNK, UNK, UNK
Symptoms: Crying, Musculoskeletal stiffness, Pain
Clinical narrative: NO ENCOUNTERS OR TELEPHONE MESSAGES RECEIVED FROM PATIENT FAMILY. NO ADVERSE EVENTS, TREATMENTS, OR OUTCOMES CAN BE VERIFIED.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Swelling
Clinical narrative: Patient received flu vaccine FLUAD at around 8:25pm about 30 minutes later patient called pharmacy stating her eye feels like it's swelling, the eyelid, not sure about her arm. She says she's going to try some allergy medication first since it's not severe swelling and will monitor and if worsens will go to hospital.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness
Clinical narrative: Dizziness approximately 10 minutes after vaccination. Patient fully recovered after ~ 15 minutes. Normal B.P.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Erythema, Gait disturbance, Injection site erythema, Injection site swelling, Rash erythematous
Clinical narrative: Parents stated, child woke up c/o hurting on the inside. He was limping & had a stiff walk. The next day woke up with a red rash on leg where the vaccine was given.  Parents ended up putting Cortizone OTC cream on it and it had improved by next day 1/13/2020
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Vaccination site rash
Clinical narrative: Parents stated, child woke up c/o hurting on the inside. He was limping & had a stiff walk. The next day woke up with a red rash on leg where the vaccine was given.  Parents ended up putting Cortizone OTC cream on it and it had improved by next day 1/13/2020
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Gait disturbance, Pain, Rash erythematous, Vaccination site reaction
Clinical narrative: Parents stated, child woke up c/o hurting on the inside. He was limping & had a stiff walk. The next day woke up with a red rash on leg where the vaccine was given.  Parents ended up putting Cortizone OTC cream on it and it had improved by next day 1/13/2020
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Abdominal pain upper, Rash, Somnolence, Unresponsive to stimuli, Urticaria
Clinical narrative: sleepy and unresponsive; sleepy and unresponsive; spots on his back and hives on his abdomen; stomach pain; vomited; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient. The patient had no  pertinent medical history. Drug reactions/allergies included fish allergies. Concomitant vaccine included diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL).   On 06-JAN-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (subcutaneous, lot# was reported as reported S017238, expiration date 01-DEC-2020; dose detail was unknown) for prophylaxis.   On the same day, the patient began to complain of stomach pain and vomited while still in the physician's office. After examination, the patient had spots on his back and hives on his abdomen. The patient was administered diphenhydramine hydrochloride (BENADRYL). Then the patient became sleepy and unresponsive. The patient was taken to an unspecified hospital, where he was admitted and given glucocorticoids (PREDNISONE). On the same day, the patient was discharged. The patient didn't perform the lab diagnostics. The outcome of events was reported as recovered on 06-JAN-2020. The causality between events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Vomiting
Clinical narrative: sleepy and unresponsive; sleepy and unresponsive; spots on his back and hives on his abdomen; stomach pain; vomited; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient. The patient had no  pertinent medical history. Drug reactions/allergies included fish allergies. Concomitant vaccine included diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL).   On 06-JAN-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (subcutaneous, lot# was reported as reported S017238, expiration date 01-DEC-2020; dose detail was unknown) for prophylaxis.   On the same day, the patient began to complain of stomach pain and vomited while still in the physician's office. After examination, the patient had spots on his back and hives on his abdomen. The patient was administered diphenhydramine hydrochloride (BENADRYL). Then the patient became sleepy and unresponsive. The patient was taken to an unspecified hospital, where he was admitted and given glucocorticoids (PREDNISONE). On the same day, the patient was discharged. The patient didn't perform the lab diagnostics. The outcome of events was reported as recovered on 06-JAN-2020. The causality between events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes zoster
Clinical narrative: Stroke; shingles; Information has been received regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 13-FEB-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, the pt suffered a stroke and shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine,symptoms have resulted in physical limitations not present prior to vaccination. The pt 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. The pt sustained severe and permanent personal injuries. At the time of the report, the outcome of herpes zoster and cerebrovascular accident were determined as not recovered. The lawyer considered herpes zoster and cerebrovascular accident to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, cerebrovascular accident was determined to be medically significant. Cerebrovascular accident and stroke were determined to be serious due to disabling.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: rha), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 Fahrenheit ), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the Digital Data Logger.  No additional adverse symptoms were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA005521: US-009507513-2001USA005516: US-009507513-2001USA005523: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005519: US-009507513-2001USA005518: US-009507513-2001USA005520:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: rha), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 Fahrenheit), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the Digital Data Logger.  No additional adverse symptoms were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA005521: US-009507513-2001USA005522: US-009507513-2001USA005516: US-009507513-2001USA005524: US-009507513-2001USA005525: US-009507513-2001USA005519: US-009507513-2001USA005518: US-009507513-2001USA005520:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type:rha), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 Fahrenheit), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the Digital Data Logger.  No additional adverse symptoms were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA005521: US-009507513-2001USA005522: US-009507513-2001USA005523: US-009507513-2001USA005516: US-009507513-2001USA005525: US-009507513-2001USA005519: US-009507513-2001USA005518: US-009507513-2001USA005520:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: doses of improperly stored MMR II were administered to 9 patients on  unspecified dates; No additional adverse symptoms reported; This spontaneous report has been received from an officer manager, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drugs reactions or allergies were not provided by the reporter.  On an unknown date, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: rha), lot number S006051, and expiration date 27-FEB-2021 for prophylaxis. Details about strength, dose, dose number, route of administration, and anatomical location were not provided. It was unknown if the sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) used for reconstitution of the vaccine, was stored at proper temperature.  The highest temperature was above 47 degree Fahrenheit (°F) (53 Fahrenheit ), for a timeframe of 17 hours, with no previous temperature excursion. The call was due to the Digital Data Logger.  No additional adverse symptoms were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA005521: US-009507513-2001USA005522: US-009507513-2001USA005523: US-009507513-2001USA005524: US-009507513-2001USA005516: US-009507513-2001USA005519: US-009507513-2001USA005518: US-009507513-2001USA005520:
Sex: F
Vaccine: MMR
Symptoms: Tuberculosis
Clinical narrative: The patient developed tuberculosis at an unspecified time in the recent past; This spontaneous report was received from a pharmacist concerning a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies.  On an unknown date, (reported as in childhood), she may have received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as measles mumps rubella prevention (dosage schedule, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine was reconstituted with diluent (MRK) (lot number and expiration date were not reported).    On an unspecified date, reported as (in the recent past), the patient developed tuberculosis. Furthermore, the patient was treated with rifampin, 300 mg twice daily. According to the reporter, the patient was starting medical school and it had been determined she needed  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination.   The outcome of tuberculosis was recovering. The causal relationship between the event and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  Upon internal review, the event of tuberculosis was determined to be medically significant.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site induration, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: approximately 3 inches big with black and blue discolored skin; it was so tender it kept her from sleeping on her side at night; large, indurated swelling; large, indurated swelling at the injection site/approximately 3 inches big/the swelling was approximately the size of a golf ball; injection site "was so tender"; This spontaneous report was received from a dentist referring to a 24-year-old female patient. The patient's concomitant medications, concurrent conditions and past medical history were unknown.   On an unspecified date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, frequency, route were not provided), for prophylaxis. She received the first quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection with no issues. On 13-DEC-2019, the patient was vaccinated with the second quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), intramuscularly (strength, dose, frequency were not provided) for prophylaxis. The lot number and expiration date were requested but unknown to the reporter or the patient.  On 18-JAN-2020, the patient presented to the reporter's office with a large, indurated swelling at the injection site approximately of 3 inches big (vaccination site induration and vaccination site swelling), with black and blue discolored skin (skin discolouration) that was so tender (vaccination site pain) it kept her from sleeping on her side at night (insomnia). The swelling was approximately the size of a golf ball. The patient reported no acute injury to the injection site other than the injection itself. The outcome of insomnia, skin discolouration, vaccination site pain, vaccination site swelling and vaccination site induration was reported as not resolved by the time of reporting.   The causal relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; A patient was admnistered an expired properly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 16-JAN-2020, the patient was vaccinated with an expired properly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # R030115, expiration date 29-DEC-2019 for prophylaxis (strength, dose, route, anatomical site and frequency were unknown). No adverse event was reported.
Sex: F
Vaccine: RAB
Symptoms: Antibody test negative, Inappropriate schedule of product administration
Clinical narrative: ran the titer on her and found that the geometric mean titer is not sufficient (virtually no immunity after two years); patient received Imovax 2-dose series in 2017, no AE; Initial information received on 06-Dec-2019 and additional live follow-up information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an adult female patient who received only two doses of RABIES (HDC) VACCINE [IMOVAX RABIES] and found that geometric mean titer is not sufficient (virtually no immunity after two years) (PT: antibody test negative).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in May-2017, the patient received two doses of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date not reported) via unknown route and unknown administration site.  It was a case of actual medication error due to inappropriate schedule of vaccine administered (Inappropriate schedule of product administration). After two years titer was run and found that the geometric mean titer is not sufficient (virtually no immunity after two years) (PT: antibody test negative).   It was considered that the patient had to get a booster for the vaccine. She is requesting the booster vaccine be provided without charge to her, based on her belief that there must have been a problem with the original vaccine (vaccine was faulty).  Outcome was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose, Wrong technique in product usage process
Clinical narrative: the needle inserted into the left deltoid when vaccine squirted out at the connection between the syringe and the needle NO AE; Most of the vaccine went down the patient's arm/no ae; Most of the vaccine went down the patient's arm/no ae; the needle inserted into the left deltoid when vaccine squirted out at the connection between the syringe and the needle NO AE; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 66 years old patient to whom most of the INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE] vaccine went down the patient's arm as the needle inserted into the left deltoid when vaccine squirted out at the connection between the syringe and the needle (lot: UJ308AA, expiry date: 30-Jun-2020), via unknown route, on an unknown date.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Vaccine underdose, Wrong injection technique, exposure via skin contact. It was also a case of syringe issue.   It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.