chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Fall, Pallor, Syncope
Clinical narrative: Patient stood up from the chair in which she received 2 vaccinations. She walked approximately 100 feet towards the front of the store and fainted. She never lost consciousness. While seated on the floor she was questioned by the pharmacist and reported no difficulty breathing/throat swelling/tongue swelling. She appeared pale and reported no injuries from her fall. The pharmacist took her blood pressure and it was 98/54. At this time she reported to the pharmacist that she gets lightheaded after receiving vaccinations. Paramedics were called to perform an assessment. After about 15 mins and checking her blood pressure both sitting down and standing up, the paramedics said her blood pressure was normal she was ok to go home. Her mother drove her home.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Hypoaesthesia, Pain in extremity
Clinical narrative: Pt with streaking to her L arm, pain, numbness x7days post vaccination. Was seen in the ER and given antibiotics 23Sept18. Pt followed up with PCM and is still being monitored.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Hyperaesthesia, Immediate post-injection reaction, Malaise, Nasal congestion
Clinical narrative: Immediate soreness in arm of vaccination. About 2 hours later skin sensitivity. About 10 hours later chills and total soreness. Felt like I was hit by a truck. Nausea. Stuffiness. Return to former wellness about 20-24 hours later. Have had flu vaccines for many years and have never had any reaction except sore arm.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Immediate soreness in arm of vaccination. About 2 hours later skin sensitivity. About 10 hours later chills and total soreness. Felt like I was hit by a truck. Nausea. Stuffiness. Return to former wellness about 20-24 hours later. Have had flu vaccines for many years and have never had any reaction except sore arm.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Abnormal behaviour, Crying, Decreased eye contact
Clinical narrative: My once happy baby has been crying for four days. The only time he is not crying is when he is sleeping. There is no fever or anything. He is just completely out of it. He does not seem himself. He is not making eye contact and crying unless asleep.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes virus infection, Oropharyngeal blistering
Clinical narrative: Pt had dental work right after getting her flu shot and said that her oral surgeon noticed herpes blisters in the back of her throat. Pt states she has never had any type of cold sore before and believes she got it from the flu shot. She mentioned that her son also had a flu shot around the same time and he got a cold sore on his lip for the first time ever.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, X-ray limb normal
Clinical narrative: PT RECEIVED TDAP VACCINE ON 9/7/2018 DUE TO GETTING CUT ON RUSTY TOMATO CAGE. WAS ADMINISTERED THE INJECTION TO RIGHT DELTOID. AFTER RECEIVING THE VACCINE INCREASED AMOUNT OF PAIN TO RIGHT ARM THAT WAS SHOOTING DOWN TO ELBOW. DECREASED RANGE OF MOTION TO RIGHT ARM AFTER VACCINE THAT HAS BEEN ONGOING FOR >2 WEEKS WITHOUT ANY CHANGE. PT HAD TRIED OTC PAIN RELIEVER, PASSIVE RANGE OF MOTION, AND RELAXING IT WITHOUT ANY IMPROVEMENT. DENIED ANY REDNESS, SWELLING, OR WARMTH AT THE INJECTION SITE OR FEVER. NONE PRESENT ON EXAM ON 9/19/2018. PT WAS ORDERED XRAY OF RIGHT ARM/SHOULDER TO SEE IF ANY ACUTE FINDINGS.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Patient reported pain and swelling in left arm within 5 hours from the shoulder to the elbow. Within 24 hours she reported that it became discolored and bruised on the inside and outside of her arm.
Age: 83.0
Sex: F
Vaccine: FLUA3
Symptoms: Cough, Dizziness, Dry mouth, Eye swelling
Clinical narrative: Patient is reporting a dry mouth, coughing, eyes being swollen, dizziness. Patient had to call a family member to help take care of her.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Decreased appetite, Diplopia, Gait disturbance, Headache, Hyperhidrosis
Clinical narrative: I woke up in the am to a headache, The headache got worse, I started seeing double, I had a slight fever. as the day wore on I lost my appetite. The next day a could not walk without holding on to the wall, I totally lost my appetite. My vision was double and I could not watch TV without my head feel like I was getting hit in the left side of my head. It took 3 days of none eating and only drinking Gatorade before while laying in bed my fever must of broke, I became soaking wet and had to get out of bed and take a shower. The next morning I started feeing better, but my double vision did not go away, and I still had a nasty headache. On Sunday my headache stopped unless I try to read and I cannot, my double vision has not gone away when I try to read.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Pyrexia
Clinical narrative: I woke up in the am to a headache, The headache got worse, I started seeing double, I had a slight fever. as the day wore on I lost my appetite. The next day a could not walk without holding on to the wall, I totally lost my appetite. My vision was double and I could not watch TV without my head feel like I was getting hit in the left side of my head. It took 3 days of none eating and only drinking Gatorade before while laying in bed my fever must of broke, I became soaking wet and had to get out of bed and take a shower. The next morning I started feeing better, but my double vision did not go away, and I still had a nasty headache. On Sunday my headache stopped unless I try to read and I cannot, my double vision has not gone away when I try to read.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Beginning the evening of the event - patient developed fever of 102, chills, fatigue and severe headache. The site of injection is red and swollen. This occurred on Wednesday and symptoms did not resolve until Saturday AM.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: Beginning the evening of the event - patient developed fever of 102, chills, fatigue and severe headache. The site of injection is red and swollen. This occurred on Wednesday and symptoms did not resolve until Saturday AM.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 27-AUG-2018, the patient was vaccinated with less dose than recommended of PNEUMOVAX 23, intramuscularly (lot # R006466, expiration date 24-OCT-2019; strength and dose were not reported), for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a nurse (physician's nurse) via company representative refers to an 11 year old male patient. The patient's pertinent medical history and concurrent condition were not reported. The patient had no concomitant medications. On an unknown date in August 2018 (reported as "last week"), the patient was vaccinated with GARDASIL 9, 0.5 ml once intramuscularly (strength, lot # and expiry date were not reported) to prevent HPV. Other suspect therapies included MENACTRA and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. On an unknown date in August 2018 (reported as "last week"), the patient was given GARDASIL 9 and broke out in a rash on his neck and arms while still in the physician's office. The patient was administered diphenhydramine (BENADRYL) but the rash had begun to recede prior to the diphenhydramine (BENADRYL) being administered. The patient recovered while still at the office and therefore did not seek medical attention. The lab diagnostics/studies was not performed. The outcome of rash was reported as recovered/resolved. The causality assessment was not reported. There was no product quality complaint (PQC) reported.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Feeling abnormal, Induration, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N023650, expiration date: 20-MAY-2019 (also reported as 22-MAY-2018) and a dose of FLUZONE (manufacturer unknown) lot# UJ004AA, expiration date: 09-MAR-2019 in the same arm (dose and route of administration were not reported for both vaccines). On 13-SEP-2018, the patient felt bad with a fever of 101 degrees and had a redness, swelling and hardness spreading up her arm. She took acetaminophen (TYLENOL) as a treatment. On 14-SEP-2018, the patient developed redness and swelling from her elbow to shoulder 13 inches by 6 inches around and sought medical attention. She was diagnosed with possible cellulitis, received clindamycin 2 g for the treatment and was sent home with one week of oral clindamycin. The outcome of cellulitis was unknown. The relatedness between the event and PNEUMOVAX 23 and FLUZONE was not provided. Upon internal review, cellulitis was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 31-OCT-2007, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications.  In or about 19-OCT-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown.  Causality assessment was related.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 18-SEP-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # R013303, expiry date: 08-MAY-2020) and properly stored diluent (N037594, expiry date: 25-AUG-2020) on 18-SEP-2018. The vaccine was stored at a temperature of 6°F to 14°F for 105 minutes and at 15 °F to 46 °F for 75 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Chicken pox like rash appeared 10 days after VARIVAX vaccination with 1 day of a low grade fever. Mother brought toddler into office. BENADRYL prescribed PRN. Spoke to mother of child this morning, 9/24/18. Mother states rash improving and no reported fevers.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Ultrasound abdomen
Clinical narrative: Blood in stool patient transferred to hospital and DX with intussusception.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash vesicular, Scab
Clinical narrative: Blisters on left leg starting just above knee and processing down the leg. The area was about three inches wide and 9-10 inches long. Saw PCM: M.D. at Clinic - Doctor prescribed Triamcinolone Acetonide cream USP 0.1%. The blisters eventually scabbed over and has started to heal but are still red like chicken pox. Dr said it looked like shingles as did the Pharmacist who gave me the shot.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Decreased appetite, Fatigue, Headache
Clinical narrative: All bones ached. Worst was both legs (2 days). Headache. (3 days); fatigue; no appetite.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Headache, Injection site induration, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Fever of 102.6, sore left arm, swelling and hardness at injection site, headaches, body aches. Dissipated day 2, back to normal temp day 3, continued pain, swelling, and hardness on left arm.
Age: 42.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever of 102.6, sore left arm, swelling and hardness at injection site, headaches, body aches. Dissipated day 2, back to normal temp day 3, continued pain, swelling, and hardness on left arm.
Age: 5.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Feeling abnormal, Oropharyngeal pain, Pyrexia, Rash generalised, Streptococcus test negative
Clinical narrative: GRANDMOTHER CALLED AND REPORTED CLIENT RECEIVED VACCINATIONS (HEP A AND MMRV) ON 9/18/18. GRANDMOTHER REPORTED CLIENT STARTED FEELING BAD ON 9/21/18 WITH HIGH FEVER AND SORE THROAT. GRANDMOTHER REPORTED TAKING CLIENT TO URGENT CARE AND SHE WAS TESTED FOR STREP. GRANDMOTHER SAID THEY WERE SENT HOME WITH ANTIBIOTIC (CEFTIN) FOR CLIENT TO TAKE. GRANDMOTHER STATED CLIENT DEVELOPED RASH ON 9/22/18 WITH PINPOINT BUMPS ALL OVER BODY. GRANDMOTHER STATED CALLING URGENT CARE ON 9/23/18 AND SHE WAS TOLD STREP CULTURE CAME BACK NEGATIVE AND WAS TOLD TO STOP CLIENT'S ANTIBIOTIC. GRANDMOTHER STATED URGENT CARE THOUGHT CLIENT HAD SOMETHING VIRAL GOING ON.  GRANDMOTHER CALLED URGENT CARE BACK 9/24/18 AND THEY WANT TO SEE CLIENT IN CLINIC. GRANDMOTHER TAKING CLIENT BACK TO URGENT CARE.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Diaphragm muscle weakness, Dyspnoea, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Bilateral lower extremity/leg weakness occurring 4 days post vaccination. Weakness progressively worsened to mildly include my diaphragm and trouble taking in a big breath. Sought Medical attention by Dr. who sent me to Neurologist.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve conduction studies abnormal
Clinical narrative: Bilateral lower extremity/leg weakness occurring 4 days post vaccination. Weakness progressively worsened to mildly include my diaphragm and trouble taking in a big breath. Sought Medical attention by Dr. who sent me to Neurologist.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal pain upper, Asthenia, Chills
Clinical narrative: Awoke with Major Chills/ Shivering, Muscle Pain over entire body, arm/shot site stiff and hurting, headache, upset stomach cramps, belly hurt and very tired and weak. Hurt everywhere, even Eye sockets.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Fatigue, Headache, Injection site pain, Injection site reaction
Clinical narrative: Awoke with Major Chills/ Shivering, Muscle Pain over entire body, arm/shot site stiff and hurting, headache, upset stomach cramps, belly hurt and very tired and weak. Hurt everywhere, even Eye sockets.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Awoke with Major Chills/ Shivering, Muscle Pain over entire body, arm/shot site stiff and hurting, headache, upset stomach cramps, belly hurt and very tired and weak. Hurt everywhere, even Eye sockets.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chills, Injection site pain, Night sweats, Pain in extremity
Clinical narrative: Very bad pain in the left arm, shoulder and upper back, sudden chills, sweating all night while sleeping, raised red welt extending from the armpit to the elbow with a clear outline around the edge. The welt lasted 3 days and all other symptoms were gone by morning except for some normal soreness. The welt did not itch or hurt.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Skin reaction, Urticaria
Clinical narrative: Very bad pain in the left arm, shoulder and upper back, sudden chills, sweating all night while sleeping, raised red welt extending from the armpit to the elbow with a clear outline around the edge. The welt lasted 3 days and all other symptoms were gone by morning except for some normal soreness. The welt did not itch or hurt.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Pain in extremity
Clinical narrative: After no symptoms other than a sore left arm, patient awoke at 4 a.m. the following morning and passed out while walking to bathroom. Husband called 911. Paramedics arrived and found vital signs to be normal. Suggested follow-up with family doctor.
Age: 54.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Fatigue, Headache, Loss of consciousness, Mobility decreased, Pain in extremity
Clinical narrative: HAVRIX, Extreme arm pain, loss of function/mobility, loss of consciousness, extreme fatigue, severe headache. (Reaction occurred in right arm).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Chest X-ray normal, Chills, Fatigue, Heart rate increased
Clinical narrative: Fever of 102 degrees and chills. Low blood pressure, 80/50. Elevated heart rate, 105 BPM at rest. Body aches all over. Nausea, fatigue; symptoms lasted appx. 72 hours.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Nausea, Pain, Pyrexia, Urine analysis normal
Clinical narrative: Fever of 102 degrees and chills. Low blood pressure, 80/50. Elevated heart rate, 105 BPM at rest. Body aches all over. Nausea, fatigue; symptoms lasted appx. 72 hours.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Bradycardia, Hyperhidrosis, Hypotension, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Patient had near syncopal episode w/visual disturbance. Diaphoretic, became hypotensive and bradycardic.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Presyncope, Visual impairment
Clinical narrative: Patient had near syncopal episode w/visual disturbance. Diaphoretic, became hypotensive and bradycardic.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea
Clinical narrative: I felt a little nauseous the night I received the vaccine. The next a.m. I got up went to the kitchen and blacked out falling on the floor. I was awake and got up. No injuries and took it easy the balance of the day.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Antibody test negative, Asthenia, CSF oligoclonal band absent, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Partial transverse myelitis (right torso and leg numbness and weakness) and left optic neuritis treated with IV steroids, IVIg and oral steroids. Partial improvement. Ongoing symptoms at this time
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging abnormal, Optic neuritis
Clinical narrative: Partial transverse myelitis (right torso and leg numbness and weakness) and left optic neuritis treated with IV steroids, IVIg and oral steroids. Partial improvement. Ongoing symptoms at this time
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Patient states that she had hives and a rash from the waist up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Extreme fatigue, chills, nausea, extreme muscle aches.
Age: 61.0
Sex: F
Vaccine: CHOL, MNQ, TDAP, TYP, YF
Symptoms: Abdominal pain upper, Asthenia, Back pain, Blood test, Cardiac stress test normal
Clinical narrative: Ct reports onset of symptoms started 9/18/18 around 11pm with back and neck pain. On 9/19/18 woke up with nausea and "flu like" symptoms. Then on 9/20/18 had SOB and felt like having a heart attack. Ct went to ER and was admitted. Stress test and blood work done. Stress test shows inconclusive. Ct was discharged on 9/21/18 and was advised to f/u with PMD. Ct saw PMD on 9/22/18. KENALOG shot, EKG and addition blood work was done. Ct reports she is now having fever, confusion, stomach pain, weakness and lethargic. Instructed client to go to ER or urgent care to follow on symptoms. Ct states that she will call her PMD today.
Age: 61.0
Sex: F
Vaccine: CHOL, MNQ, TDAP, TYP, YF
Symptoms: Confusional state, Dyspnoea, Electrocardiogram, Feeling abnormal, Influenza like illness
Clinical narrative: Ct reports onset of symptoms started 9/18/18 around 11pm with back and neck pain. On 9/19/18 woke up with nausea and "flu like" symptoms. Then on 9/20/18 had SOB and felt like having a heart attack. Ct went to ER and was admitted. Stress test and blood work done. Stress test shows inconclusive. Ct was discharged on 9/21/18 and was advised to f/u with PMD. Ct saw PMD on 9/22/18. KENALOG shot, EKG and addition blood work was done. Ct reports she is now having fever, confusion, stomach pain, weakness and lethargic. Instructed client to go to ER or urgent care to follow on symptoms. Ct states that she will call her PMD today.
Age: 61.0
Sex: F
Vaccine: CHOL, MNQ, TDAP, TYP, YF
Symptoms: Lethargy, Nausea, Neck pain, Pyrexia
Clinical narrative: Ct reports onset of symptoms started 9/18/18 around 11pm with back and neck pain. On 9/19/18 woke up with nausea and "flu like" symptoms. Then on 9/20/18 had SOB and felt like having a heart attack. Ct went to ER and was admitted. Stress test and blood work done. Stress test shows inconclusive. Ct was discharged on 9/21/18 and was advised to f/u with PMD. Ct saw PMD on 9/22/18. KENALOG shot, EKG and addition blood work was done. Ct reports she is now having fever, confusion, stomach pain, weakness and lethargic. Instructed client to go to ER or urgent care to follow on symptoms. Ct states that she will call her PMD today.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Immediate post-injection reaction, Injection site pain
Clinical narrative: IMMEDIATELY AT ADMINISTRATION PT SAID INJECTION WAS PAINFUL AND WAS QUITE UPSET. SHE IS STILL EXPERIENCING PAIN TWO WEEKS LATER AND WANTS TO HAVE AN MRI DONE IN OCTOBER TO SEE IF DAMAGE WAS DONE AT SHOT ADMINISTRATION.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blister, Injection site bruising, Injection site pain, Injection site pruritus
Clinical narrative: Following morning had itchy/burning band across bicep/left arm. Since then bruise developed below where shots were given and there are fluid-filled pockets drooping off of arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt complained of area being red, warm and raised.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Lethargy, Mobility decreased, Pain, Pyrexia
Clinical narrative: Fever, body aches, severe headache, inability to lift arm, lethargy I did phone my Doctor on Thursday morning 09/20 I'd never had a flu shot and a pneumonia shot together. My doctors over the years have given them separately. The Pharmacist also did both injections in same arm. Don't know if that would have any bearing on the adverse reaction.
Age: 96.0
Sex: F
Vaccine: FLU3
Symptoms: Gait inability, Hyperhidrosis, Tremor, Walking aid user, Wheelchair user
Clinical narrative: Patients daughter (also a physician) stated by 7 PM of the night of the vaccine that she was unable to walk. Normally patient uses walker but had to use wheelchair. She had lower extremities were shaking. She fell in a deep sleep around 10 PM and was sweating. No fever present. Physician daughter started her on a MEDROL dose pack on 9/23 and symptoms resolved around 9 PM.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: Two days after receiving vaccines, patient presented to the office with right upper extremity redness. Patient was sent to the emergency department at Hospital. Patient was diagnosed with cellulitis and received antibiotics. Patient was admitted to the hospital on 09/20/2018 and discharged on 09/24/2018.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Insomnia, Joint swelling, Myalgia, Tendon pain
Clinical narrative: First of all I am a Registered Pharmacist. I also consider myself very healthy and in good shape. 3-4 days after my vaccine my left knee got swollen and I experienced severe muscle and tendon pain. I had problems sleeping, walking up steps, basically Grade 3 pain. This went on for 5 days before things started to get better. I made an appt with my Orthopedic Office and saw the Physicians Asst. (9/21/18). I have both hips and rt knee totally replaced.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray limb normal
Clinical narrative: First of all I am a Registered Pharmacist. I also consider myself very healthy and in good shape. 3-4 days after my vaccine my left knee got swollen and I experienced severe muscle and tendon pain. I had problems sleeping, walking up steps, basically Grade 3 pain. This went on for 5 days before things started to get better. I made an appt with my Orthopedic Office and saw the Physicians Asst. (9/21/18). I have both hips and rt knee totally replaced.
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Contusion, Pain, Pain in extremity
Clinical narrative: Patient complained she cannot raise her arm above her ear without a lot of pain, also arm feels bruised and she has pains going down the side of her body.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to a 19 year old male patient. The patient did not have any concomitant medications, concurrent conditions, medical history and drug reaction or allergies. On 14-SEP-2018, the patient was vaccinated with an expired dose of VAQTA lot # N020503, expiration date 04-SEP-2018, intramuscularly, (dose was not reported) for prevention of Hepatitis A. No adverse events were reported. It was also mentioned that no treatment or laboratory tests were performed. Also, no product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report was received from a female patient of unknown age who was reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 0.5 ml (route of administration, lot # and expiration date were not provided) for prophylaxis. Since an unknown date (reported as for the last couple of days), the patient's arm felt like it had been hit by a baseball bat and there was a tingling feeling going down through her fingers. The patient did not seek medical attention. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 20-OCT-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a nurse practitioner referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On an unknown date in the past, the patient received unspecified doses of VARIVAX (dose, batch/lot number and expiration date were not provided)  subcutaneously for prophylaxis. On an unknown date, the patient had an unspecified blood work performed, which indicated no immunity to varicella. The reporter said that the patient did have received at least one dose (therapy non-responder). The patient had sought medical attention  by seeing the nurse practitioner. The outcome of the event was unknown. The causality assessment was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in an elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by an advanced registered nurse practitioner via chat. The age at vaccination was not reported. The healthcare professional reported that the patient developed a non-vesicular rash on her abdomen, under her breast and a little on her back after receipt of her 2nd dose of SHINGRIX. The healthcare professional did not administer the vaccine, patient got it at a pharmacy so no vaccine information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site reaction, Local reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a certified nurse practitioner (CNP) via chat. The age at vaccination was not reported. The healthcare professional reported that the patient received SHINGRIX subcutaneously, which led to incorrect route of vaccine administration. The patient had a localized reaction at the site of injection. The healthcare professional only provided gender of patient and did not administer the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included muscle pain. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain, injection site bruising and injection site swelling. In May 2018, the outcome of the injection site bruising and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site muscle pain was recovering/resolving. It was unknown if the reporter considered the injection site muscle pain, injection site bruising and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in early May 2018. Within 24 hours after receiving the SHINGRIX, the patient developed significant pain, swelling and bruising at the injection site which lasted over 2 weeks. The pain was significant enough that she could not sleep on that side. The patient showed the reaction to the pharmacist around on 10th day. The swelling and bruising have resolved, but she had some muscular pain, though it had improved. The patient had a history of muscular pain, so she was not sure if the pain she experienced was related to the SHINGRIX or not. The patient denied permission to contact their physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX (batch number 4492P, expiry date unknown) for prophylaxis. On 27th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 6 months after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patients did not want the 2nd dose of SHINGRIX. Onset date and duration of symptoms were unknown. Expiration date was unknown. The reporter had information for only one patient. This case was linked with the case US2018GSK173030, reported by the same reporter.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a female patient who received Flu Seasonal TIV Dresden for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. Approximately 6 to 7 years before the reporting date, the patient had an anaphylactic reaction after receipt of a flu vaccine. The vaccine was not given in pharmacist's facility. This case has been linked to the US2018GSK172895, reported by the same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient was hospitalized after receiving a flu vaccine due to the egg protein in the vaccine. The pharmacist did not know when this occurred, or what flu vaccine it was, just that it was some time in the past. The patient did not tell the pharmacist what reaction she had that caused her to be hospitalized.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia and chills. On an unknown date, the outcome of the myalgia and chills were recovered/resolved. It was unknown if the reporter considered the myalgia and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced myalgia and chills lasted at least 8 hours. The reporter agreed to be followed up. This case has been linked with the case US2018GSK172977, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia and chills. On an unknown date, the outcome of the myalgia and chills were recovered/resolved. It was unknown if the reporter considered the myalgia and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient experienced myalgia and chills lasted at least 8 hours. The reporter agreed to be followed up. This case has been linked with the case US2018GSK168760, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, myalgia, fatigue, chills and influenza-like symptoms. On an unknown date, the outcome of the fever, myalgia, fatigue, chills and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, myalgia, fatigue, chills and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was 101 degrees F. The reporter did not agree to be contacted for follow up. No additional information was provided. Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a female patient who received Flu Seasonal TIV Dresden for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient developed redness after receipt of a flu vaccine (unknown brand) several years in a row. The vaccine was not given in pharmacist's facility. This case has been linked to the US2018169158, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported for the patients. The age group was not reported, but was selected adult as per vaccine indication. The reporter stated that a handful of patients experienced flu-like symptoms after receiving SHINGRIX, and that they do not want the 2nd dose. The reporter had information for only 1 affected patient. Onset date and duration of symptoms were unknown. Expiration date was unknown. This case was linked with the case US2018167875, reported by the same reporter.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 19-year-old male patient received TRUMENBA (lot number and expiration date unknown), via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced supraclavicular lymph node on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested
Age: 14.0
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 14-year-old male patient received TRUMENBA, via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced acute flu-like syndrome for 24hours on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Lethargy
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lethargy on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information on the batch number cannot be obtained.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Nightmare, Somnolence
Clinical narrative: Bad headache the day after, drowsiness. Bad dreams during daytime nap (R/T headache?).
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Patient had rapid heart rate and trouble catching breath on her way home.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Full blood count, Immobile, Laboratory test, Unresponsive to stimuli
Clinical narrative: Patient was completely unresponsive by 4:45-5:00 pm. BP was over 220/100+. Eyes were closed and could not move. EMS transported to ER where pt was admitted until Sunday evening. All test were done with no answers to what caused this. It was found that the patient had a mini stroke earlier that year with some neurological troubles. This was not known until admitted to hospital.
Age: 86.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cellulitis
Clinical narrative: MD ADVISED US THAT PATIENT EXPERIENCED CELLULITIS.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: Red around arm about 4 inches. Treated with ice and ibuprofen.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: About 1-2 minutes after immunizing, patient stated she was light headed. We stayed with the patient as she passed out in the chair. We supported the patient in the chair, checked for breathing (yes), and called for code white. We tapped patient on shoulder and called out her name repeatedly. She regain consciousness in about 5 minutes as management and EMS arrived. Patient was taken to local hospital for observation and we notified her family doctor. We have not heard back from family doctor as to her current health status.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Urticaria
Clinical narrative: Welts on both sides, flu like symptoms, pain. Taking ibuprofen and diphenhydramine.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Hallucination, Influenza like illness, Nightmare, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS, NIGHTMARES/HULLICINATIONS, FEVER.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Drooling, Dysarthria, Dyspnoea, Erythema, Skin warm
Clinical narrative: Arm became red and hot, started slurring and drooling and found it hard to breathe.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site reaction, Insomnia, Pain
Clinical narrative: I received the flu shot, administered by an RN, on Thursday, September 20, 2018. Almost immediately my left arm began to hurt but I attributed that to the shot. Late Friday evening on the 21st into Saturday afternoon on the 22nd I began to feel greater pain and a decrease in the range of motion of my left shoulder joint. I was unable to sleep on Saturday night into Sunday morning. When I awoke on Sunday, September 23, 2018 I was unable to move my arm above chest high without pain. I went to an orthopedic urgent care where I was treated for an inflammation to the bursa sac in my left shoulder as the injection was administered too high. I was given a cortisone shot to help with the inflammation but the pain and range of motion have not gone away (as of Monday, September 24, 2018).
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Product administered at inappropriate site, Ultrasound scan abnormal
Clinical narrative: I received the flu shot, administered by an RN, on Thursday, September 20, 2018. Almost immediately my left arm began to hurt but I attributed that to the shot. Late Friday evening on the 21st into Saturday afternoon on the 22nd I began to feel greater pain and a decrease in the range of motion of my left shoulder joint. I was unable to sleep on Saturday night into Sunday morning. When I awoke on Sunday, September 23, 2018 I was unable to move my arm above chest high without pain. I went to an orthopedic urgent care where I was treated for an inflammation to the bursa sac in my left shoulder as the injection was administered too high. I was given a cortisone shot to help with the inflammation but the pain and range of motion have not gone away (as of Monday, September 24, 2018).
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: Starting 10 days after shot was administered, patient noticed 607 itchy red spots on various parts of his body, followed by very stiff neck, fever, aching joints, headache, tiredness, and general malaise. As of 9/24 (14 days after vaccine given) symptoms have improved, still a few spots but less red and aching joints still present but improved. Patient is under care of PCP and will also be consulting an immunologist to determine if he should receive the second dose or not. PCP is observing and did not suggest any specific treatment.