chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Cough, Gastrointestinal pain, Influenza like illness
Clinical narrative: Flu-like symptoms started about 12 hours later. Fever, chills, aching joints, intestinal pains, cough. Conditions have persisted for 14 hours with some lessening of symptoms in the last two hours.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Flu-like symptoms started about 12 hours later. Fever, chills, aching joints, intestinal pains, cough. Conditions have persisted for 14 hours with some lessening of symptoms in the last two hours.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Electrocardiogram, Injection site pain, Injection site swelling
Clinical narrative: Much swelling in multiple sites below injection site, swelling, heat and pain lasted til 12/3 4 attack attack of Afib 24 hours later (11/30) that took me to emergency room, treated, kept overnight and released  on 12/1.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Swelling
Clinical narrative: Much swelling in multiple sites below injection site, swelling, heat and pain lasted til 12/3 4 attack attack of Afib 24 hours later (11/30) that took me to emergency room, treated, kept overnight and released  on 12/1.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt complained next day of 103.4 fever, cough, aches, sore arm and cannot lift more than 1/2 inch.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: PATIENT RECEIVED THE SHINGRIX VACCINE ON EXPERIENCED RASH ON INJECTION SITE THE NEXT DAY AND ON BOTH SIDES OF NECK ON 11/30.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: On receiving the flu shot this year in my left arm, I experienced a very sharp pain unlike what I've experienced on previous vaccinations. The pain and soreness in my left arm did not subside, and 2 weeks later I visited occupational health for the first time. I was advised to take ibuprofen three times daily and apply ice. About 3 weeks after my first visit, I returned to occupational health when the pain had not subsided. I was treated with a MEDROL dose pack and experienced some relief of the pain. The pain returned about one week after completing steroid course, and I returned to occupational health. An MRI of the left arm was completed, and the results are pending. 2 months after vaccination, the pain and soreness in my left arm continues.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, Irritability, Pyrexia, Wrong product administered
Clinical narrative: PROQUAD administered instead of MMR that was ordered. Separate Varicella vaccine also administered. Received double the Varicella. Low grade fever and irritable but symptoms resolved 12/4/18.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Around injection site area the size of tennis ball was very red and hot, exact spot where needle went in became severely swollen and stuck out approximately an inch which happened almost immediately after the injection. I became nauseated and dizzy which lasted 3 days.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: THIS PT WAS SEEN IN THE ED 11-07-18 for concerns of vaccine reaction and also for injury to L arm: The patient is a 14-year-old female here with chief complaint of pain, swelling, redness to the left shoulder after a flu shot. She is also describing pain to the left wrist after a fall on her outstretched arm last week and it has been persistently painful. During the course of the patient's ER visit, this left shoulder erythema was suspicious for cellulitis. She was given a tablet of KEFLEX here. She was written for KEFLEX 500 mg 4 times daily for 7 days. Clinic provider note states pt injured L arm day before doctor's appointment (11/05), but in the ED note it is noted as "last week". Unclear as to when pt injured arm.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Laboratory test, Lymphadenopathy, Nerve injury
Clinical narrative: Patient called about having an adverse event from a flu immunization given on 10/8/2018. The patient stated that it has been bothering them since they got it. Symptoms included painful injection site and surrounding area traveling down the arm and redness. They reached out to us within a few days of the getting it and was told to keep icing it and massage it. The patient then spoke with their doctor about it who told them to do the same thing. The patient then went to the ER a few weeks after receiving the vaccination who "ran tests" and they stated that they have nerve damage and swollen lymph nodes from the immunization per the patient.
Age: 70.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Asthenia, Dizziness, Erythema, Hypersensitivity, Swelling face
Clinical narrative: AFTER LEAVING CLINIC PATIENT BEGAN TO HAVE THE FOLLOWING SEVERE ALLERGIC REACTION SWELLING OF THE FACE, BODY TURNED RED, DIZZINESS AND WEAKNESS.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called the pharmacy the day after the immunization was given and stated that the night after the immunization was given she had severe pain in her arm where the injection was given. Patient stated that the area was red at first, however, redness has resolved. Patient stated the area was warm to the touch. Patient stated she took OTC anti- inflammatory meds but area is still really swollen. Patient also stated that she had a previous reaction to a flu shot that required her to call out of work the injection site was so swollen and sore, however, patient did not disclose prior incident to immunizer at time of immunization.
Age: 90.0
Sex: F
Vaccine: FLUA3
Symptoms: Extra dose administered
Clinical narrative: On 12/3/18, patient came to pharmacy and requested to receive her annual flu vaccine. About 30 minutes after receiving FLUAD, her daughter called to notify me that patient had already received this season's flu vaccine elsewhere prior to that day. Her daughter did not report patient to be experiencing any adverse reactions from her second flu vaccine. Her daughter mentioned that patient has dementia and that vaccines should not be provided to patients aged 90 and over.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Chills after 11 hours, chills and fever and body aching throughout the night, extreme tiredness, symptoms began to diminish after 26 hours post-vaccination.
Age: 25.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope - patient passed out for approximately 2-5 seconds, and he recovered quickly. He was coherent, and able to stand afterward. We took a blood pressure reading, result was 144/75, HR 57.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Pain, Urticaria
Clinical narrative: Three hours after the vaccine, I experienced a large facial hive on each cheek. At about 9 PM, I experienced shivering and could not get warm. I also felt achy.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Patient's PCP called the pharmacy today to notify the patient experienced some swelling and a bruise around the injection site from the shots 1 month ago on 11/2/18.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient called the pharmacy today stating that after she received her vaccines that within a few hours started feeling under the weather with body aches, fever and chills. She wanted us to report this as an adverse reaction.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient had swelling and redness on inner arm, not at the injection site that started after she received the shot.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HEPA, MMR, VARCEL
Symptoms: Dehydration, Pyrexia, Rash erythematous
Clinical narrative: Red spots on torso, fever, dehydration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: 17x14 cm area of erythema and induration that is warm to touch and itchy.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: AFTER ABOUT 45 SECONDS ON ADMINISTRING THE SHOT AND INTERACTING WITH THE PATIENT. HE PASSED OUT AND FELL TO HIS KNEES FROM A SITTING POSITION TO THE FLOOR. WE PICKED HIM UP IMMEDIATELY AND HE RECOVERED ABOUT 3 SECONDS LATER. (SYNCOPE) IT TOOK ABOUT 10 MINUTES FOR HIM TO RECOVER FULLY. PATIENT STATED HE WAS FEELING OK AND DID NOT WANT TO GO TO THE HOSPITAL.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Swelling, redness at injection site, muscle pain, chills.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: Red, rashy bumps from injection site to chest and back. Patient was to try BENADRYL and topical steroid unknown results.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hangover, Headache, Influenza like illness, Pain in extremity
Clinical narrative: PATIENT STATES THAT HE FIRST EXPERIENCED SORENESS IN THE ARM WITHOUT REDNESS, TREATED WITH ICE... ABOUT 6 HOURS LATER (4PM) HE STARTED HAVING FLU-LIKE SYMPTOMS, INCLUDING HEADACHE, PAIN IN JOINTS, COLD HANDS... BY 11PM THAT EVENING, PT FEELING SOMEWHAT BETTER BUT STILL HAVING JOINT PAIN. WHEN PATIENT CALLED THE NEXT DAY TO REPORT THE REACTION, HE SAID HE FELT SOMEWHAT "HUNG OVER" BUT BETTER THAN PREVIOUS DAY.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral coldness
Clinical narrative: PATIENT STATES THAT HE FIRST EXPERIENCED SORENESS IN THE ARM WITHOUT REDNESS, TREATED WITH ICE... ABOUT 6 HOURS LATER (4PM) HE STARTED HAVING FLU-LIKE SYMPTOMS, INCLUDING HEADACHE, PAIN IN JOINTS, COLD HANDS... BY 11PM THAT EVENING, PT FEELING SOMEWHAT BETTER BUT STILL HAVING JOINT PAIN. WHEN PATIENT CALLED THE NEXT DAY TO REPORT THE REACTION, HE SAID HE FELT SOMEWHAT "HUNG OVER" BUT BETTER THAN PREVIOUS DAY.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient called on December 4, in the evening, and wanted to let us know that her arm was very sore, and that she felt the immunization was given too high up on her arm, very near her shoulder bone and was concerned that it might have hit her bone and will come in to our pharmacy to discuss more tomorrow (December 5th, 2018).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site induration, Administration site pain, Administration site warmth, Incorrect route of product administration, Injection site erythema
Clinical narrative: Patient came to the counseling window on 12/4/18 at approximately 6pm inquiring about her SHINGRIX vaccination received on Sunday, 12/02/18. She asked if it was normal to experience severe pain, redness, warmth, and induration at the site of administration. She proceeded to mention how the pharmacist who administered the vaccine mentioned it was to be given SQ in the fat tissue and if this was why it hurt more than other vaccinations administered in the muscle. The area of redness was clearly visible on the posterior aspect of her upper left arm (where ZOSTAVAX would be administered). I advised that although the vaccination was to be administered IM and not SQ. The symptoms she is experiencing were common for this particular vaccine. I attempted to reach GSK for more information on what the patient should expect but they were closed at this hour. I advised Patient to take ibuprofen (as directed on package), apply a cool compress to the area, and BENADRYL (as directed on package) for the symptoms she was experiencing until we were able to get in touch with a representative from GSK.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient came to the counseling window on 12/4/18 at approximately 6pm inquiring about her SHINGRIX vaccination received on Sunday, 12/02/18. She asked if it was normal to experience severe pain, redness, warmth, and induration at the site of administration. She proceeded to mention how the pharmacist who administered the vaccine mentioned it was to be given SQ in the fat tissue and if this was why it hurt more than other vaccinations administered in the muscle. The area of redness was clearly visible on the posterior aspect of her upper left arm (where ZOSTAVAX would be administered). I advised that although the vaccination was to be administered IM and not SQ. The symptoms she is experiencing were common for this particular vaccine. I attempted to reach GSK for more information on what the patient should expect but they were closed at this hour. I advised Patient to take ibuprofen (as directed on package), apply a cool compress to the area, and BENADRYL (as directed on package) for the symptoms she was experiencing until we were able to get in touch with a representative from GSK.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Ocular hyperaemia
Clinical narrative: Patient called into the virtual medical team to report shortness of breath, rapid onset of cough and red eyes after receiving flu shot in the office earlier in the day. Breathing difficulty had been present for 1 hour prior to calling. Advised to go to urgent care or ER within the next 20 minutes for evaluation. Did not have anti-histamine on hand to take.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient's son presented to the pharmacy on 12/1/18 to notify us that patient had experienced extreme pain in same arm as vaccination site after receiving vaccine on 11/29/18. Patient was taken to hospital that day with a pain score between 8-10. After staying in hospital, returned home on 12/1/18 while still in extreme pain. Per patient's son, concerned that his father received a bad batch of the SHINGRIX vaccine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills, muscle aches, fever.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Rash macular
Clinical narrative: Patient says about 5 days after imz she started to get itchy and bumps on injected shoulder. Over the next two days the shoulder got redder and splotchy. The splotchiness is slowly spreading down her arm but it's difficult for her to gauge how much due to her skin imperfections. She says she has no fever and feels fine other wise. She also started using diclofec gel but I did not ask her where she is using it.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Lymphadenopathy, Pruritus, Swelling face, Urticaria
Clinical narrative: Hives, swollen face and lymph nodes in upper right arm, itchiness, redness at injection site.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration
Clinical narrative: Patient states there has been a color change to her skin around the area of the injection site. It is not red, puffy, swollen, oozing or painful.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's arm swelled up at the site of injection and was red/hot to the touch. It was approximately the size of a tennis ball.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema, induration, and tenderness to R thigh (DTaP injection site) about 16 hours after immunization; treatment includes ibuprofen and heat packs to area.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Top of arm swollen and very hot to the touch. Started about 30 hours after the shot. Went to urgent care two days later as it wasn't getting better. Doctor just said it was an adverse reaction to the shot and to keep an eye on it. If it grew in size or fever devolves bring him in to pediatrician. It was finally back to normal about 4 days after initial shot.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity, Paraesthesia, Radiculitis brachial
Clinical narrative: Developed left shoulder area pain approx. 3-4 days after influenza vaccine. Pain reported to be moderate to severe and burning in nature. Occasional radiating pain down left arm to left 3rd finger and paresthesias. Plan to follow 12/4/18. When seen on 11/27/18, patient did not have fever, temp was 97.6. Muscle strength intact 5/5 with shoulder abduction, elbow flexion, elbow extension wrist extending hand grasp and finger abduction. Sensation intact left arm, hand and fingers to light touch. DTR Left triceps trace, biceps and brachioradialis lt and symmetric to right upper extremity. Shoulder ROM and strength full and symmetric. No palpable trapezius or paracervical muscle tenderness. No neck or supraclavicular lymphadenopathy. No rashes on shoulder, breast, axilla or trunk to suggest shingles. No redness or swelling at injection site left deltoid. Mild tenderness with deep palpation over left deltoid injection site. No signs of infection at left deltoid injection site. Plan to follow and re-examine patient on 12/4/2018 to check for development of muscle weakness. In the meantime, patient advised to take ALEVE, apply cool compress, perform gentle shoulder ROM and avoid strenuous lifting or activity using left upper extremity. Presentation is most consistent with left brachial neuritis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Red and swollen at injection site. Body aches and low fever.
Age: 56.0
Sex: M
Vaccine: FLU4, HEPA, TDAP
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient stated 3 days after vaccines numbness, pain, tingling started in both arms.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Immediate post-injection reaction, Inflammation, Mobility decreased, Myalgia
Clinical narrative: Patient experienced muscle pain and limited arm movement immediately after and still has some discomfort. Physician did some deep tissue massage and prescribed a muscle relaxant and MEDROL DOSEPAK to help relieve pain and inflammation.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: This is a spontaneous case, initially received from physician on 21-Nov-2018, concerning a 28-year-old, adult female patient. The patient had unspecified respiratory allergies in the past (reported as medical history). The patient did not receive any concomitant medications. On an unspecified date in 2015, the patient was administered influenza vaccine (route of administration: intramuscular, anatomical location: deltoid, dose, batch number, expiry date, trade name and manufacture: not reported). On the same day, 6 hours after vaccination, the patient experienced respiratory difficulties. The patient was treated with albuterol and the event resolved on the same day. The reporter assessed this case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: (L) arm pain, swelling, mild fever, chills (L) arm 3 cm induration w/ mild erythema and slight heat. No nodes, no D/C or streaks.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia, Skin warm
Clinical narrative: (L) arm pain, swelling, mild fever, chills (L) arm 3 cm induration w/ mild erythema and slight heat. No nodes, no D/C or streaks.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Arm pain and tingling in fingers.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on face.
Age: 1.25
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd Hep A to early.
Age: 70.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain in left upper arm x 2 months - still tender at injection site 11/29/18 appt.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Chills, Erythema, Flushing, Skin warm, Urticaria
Clinical narrative: Patient was flushed, warm to touch, shivering, redness and urticaria to his face, trunk, arms and inner thighs. BENADRYL 12.5 ml given PO. Symptoms resolved and discharged at 11:39.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 14-NOV-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 14-NOV-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Pain, Pain in extremity
Clinical narrative: About 2 hours after the vaccine the patient experienced throbbing pain and a knot in her arm for the next 4 weeks. She did not report to the doctor. However, she did get some Prednisone 10mg taper dose on 11/30 and Doxycycline 100mg twice daily on 12/4.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Feeling abnormal, Generalised erythema
Clinical narrative: Felt overall "sick" after dose #1 recv'd 3 mths ago. Then recv'd Dose 2 at work yesterday. Began to feel "sick" by 9 PM. Body hurt all over, joint pain, chills, and fever of 102.8 noted by midnight - even after 2 doses of TYLENOL taken 1 hr prior to taking temp. My entire body was red and blotchy, especially my hands. Not itchy. No other symptoms other than feeling AWFUL and weak!
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia, Rash macular
Clinical narrative: Felt overall "sick" after dose #1 recv'd 3 mths ago. Then recv'd Dose 2 at work yesterday. Began to feel "sick" by 9 PM. Body hurt all over, joint pain, chills, and fever of 102.8 noted by midnight - even after 2 doses of TYLENOL taken 1 hr prior to taking temp. My entire body was red and blotchy, especially my hands. Not itchy. No other symptoms other than feeling AWFUL and weak!
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Over the course of 8 hours the headache has gotten gradually worse. It is keeping me awake and I'm unable to sleep. The injection site burns and is slightly swollen.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: I experienced extreme soreness at the injection site, fatigue, fever, chills, muscle and joint aches for two straight days following the injection. I had to stay in bed for two full days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I experienced extreme soreness at the injection site, fatigue, fever, chills, muscle and joint aches for two straight days following the injection. I had to stay in bed for two full days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Insomnia, Myalgia, Pain
Clinical narrative: In addition to extreme soreness at the injection site, I experienced sleeplessness, fever, chills, muscle and body aches. I also fainted.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Syncope
Clinical narrative: In addition to extreme soreness at the injection site, I experienced sleeplessness, fever, chills, muscle and body aches. I also fainted.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Asthma, Constipation, Dry mouth, Fatigue
Clinical narrative: Extreme pain in both arms to a point I could not lift them. Low Grade fever of 2-3 degrees, headache, body ache, muscle weakness and cramps, dry mouth, nausea, constipation. Not able to perform any activity because of weakness and fatigue. The early reactions also caused sinus congestion, chest congestion, and asthma like symptoms. These passed after about 14 hours. I contacted the pharmacist after 24 hours and she told me I could take Aleeve. I did this, and within about 2 more hours, started feeling relief of symptoms. About 30 hours after the injection, all symptoms were gone except soreness at the injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Extreme pain in both arms to a point I could not lift them. Low Grade fever of 2-3 degrees, headache, body ache, muscle weakness and cramps, dry mouth, nausea, constipation. Not able to perform any activity because of weakness and fatigue. The early reactions also caused sinus congestion, chest congestion, and asthma like symptoms. These passed after about 14 hours. I contacted the pharmacist after 24 hours and she told me I could take Aleeve. I did this, and within about 2 more hours, started feeling relief of symptoms. About 30 hours after the injection, all symptoms were gone except soreness at the injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Muscular weakness, Nausea, Pain, Pain in extremity
Clinical narrative: Extreme pain in both arms to a point I could not lift them. Low Grade fever of 2-3 degrees, headache, body ache, muscle weakness and cramps, dry mouth, nausea, constipation. Not able to perform any activity because of weakness and fatigue. The early reactions also caused sinus congestion, chest congestion, and asthma like symptoms. These passed after about 14 hours. I contacted the pharmacist after 24 hours and she told me I could take Aleeve. I did this, and within about 2 more hours, started feeling relief of symptoms. About 30 hours after the injection, all symptoms were gone except soreness at the injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Respiratory tract congestion, Sinus congestion
Clinical narrative: Extreme pain in both arms to a point I could not lift them. Low Grade fever of 2-3 degrees, headache, body ache, muscle weakness and cramps, dry mouth, nausea, constipation. Not able to perform any activity because of weakness and fatigue. The early reactions also caused sinus congestion, chest congestion, and asthma like symptoms. These passed after about 14 hours. I contacted the pharmacist after 24 hours and she told me I could take Aleeve. I did this, and within about 2 more hours, started feeling relief of symptoms. About 30 hours after the injection, all symptoms were gone except soreness at the injection site.
Age: 49.0
Sex: F
Vaccine: HEPA, FLU4, HEPA
Symptoms: Culture negative, Incisional drainage, Injection site erythema, Injection site infection, Injection site nodule
Clinical narrative: Pt came to our office on 11/6/2018 complaining of a knot on right upper arm after receiving a Hep A vaccine at work. It was a 3cmx3cm red, warm area on her right, lateral arm, 2 inches below the acromial process. We treated her with  mupirocin ointment and drained the infection from the site. We sent fluid for culture but nothing grew from it. She was then rx'd bactrim ds, prednisone, and methylprednisolone from the doctor who ran the immunization clinic.
Age: 49.0
Sex: F
Vaccine: HEPA, FLU4, HEPA
Symptoms: Injection site warmth
Clinical narrative: Pt came to our office on 11/6/2018 complaining of a knot on right upper arm after receiving a Hep A vaccine at work. It was a 3cmx3cm red, warm area on her right, lateral arm, 2 inches below the acromial process. We treated her with  mupirocin ointment and drained the infection from the site. We sent fluid for culture but nothing grew from it. She was then rx'd bactrim ds, prednisone, and methylprednisolone from the doctor who ran the immunization clinic.
Age: 49.0
Sex: F
Vaccine: HEPA, FLU4, HEPA
Symptoms: Erythema, Inflammation, Needle issue, Nodule, Syringe issue
Clinical narrative: Pt came to our office on 11/6/2018 complaining of a knot on right upper arm after receiving a Hep A vaccine at work. It was a 3cmx3cm red, warm area on her right, lateral arm, 2 inches below the acromial process. We treated her with  mupirocin ointment and drained the infection from the site. We sent fluid for culture but nothing grew from it. She was then rx'd bactrim ds, prednisone, and methylprednisolone from the doctor who ran the immunization clinic.
Age: 49.0
Sex: F
Vaccine: HEPA, FLU4, HEPA
Symptoms: Tenderness
Clinical narrative: Pt came to our office on 11/6/2018 complaining of a knot on right upper arm after receiving a Hep A vaccine at work. It was a 3cmx3cm red, warm area on her right, lateral arm, 2 inches below the acromial process. We treated her with  mupirocin ointment and drained the infection from the site. We sent fluid for culture but nothing grew from it. She was then rx'd bactrim ds, prednisone, and methylprednisolone from the doctor who ran the immunization clinic.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death, Sudden infant death syndrome
Clinical narrative: Baby put down for afternoon nap and found deceased by mother approximately 3pm.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 01-NOV-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # R016127, expiration date: 22-MAR-2018, (exact dose was not provided) intramuscularly for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced temperatures of 32 Fahrenheit degrees (F) up to 35 F (32.5F) for 82 hours and 47 F to 77 F (55.6 F) for 6 hours. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to patient of unknown age and gender. The patient's concomitant medications, medical history and drug reactions was not provided. On an unspecified date, the patient received an intramuscular dose of VARIVAX (lot# reported as R008197 and expiration date 16-SEP-2019) for prophylaxis instead of subcutaneous(incorrect route of product administration). No adverse effects were reported. Lot number R008197 is an invalid lot number for VARIVAX.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to her son, a male patient of unknown age. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 21-NOV-2018, the patient was vaccinated with VARIVAX (dose, lot number and expiration date were not provided) administered intramuscularly (incorrect route of product administration) as prophylaxis. No adverse effects were reported for the patient. No further information was provided.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Hip arthroplasty, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report was received from a consumer, referring to herself, a 66-year-old female patient. The patient's drug allergies included allergy to hydromorphone hydrochloride (DILAUDID) pain medication and scopolamine. On an unspecified date in November 2017, the patient was vaccinated with an unspecified pneumococcal vaccine; the patient said she believed this unspecified pneumococcal vaccination may have been with PREVNAR 13 but she said she was not certain, and PNEUMOVAX 23 could not be ruled out. Additionally, the patient was hospitalized because of a hip replacement that was scheduled prior to receiving the unspecified pneumococcal vaccine. Then, on unknown dates, the patient experienced hardening at the injection site, redness and pain that lasted about a week. Subsequently, the patient received an unspecified treatment for the events and  recovered from them on an unspecified date. On 26-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 in left arm (route, lot # and expiration date were not provided). Patient reported no injection site reaction at all after recent vaccination. At the time of this report, the causality assessment between the aforementioned events and PNEUMOVAX 23 was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 2016, the patient was treated by a healthcare provider for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2015, the patient was administered ZOSTAVAX, (lot# and route unknown) at a pharmacy. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 23-OCT-2016, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 17-OCT-2012, a pharmacist administered ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries and conditions (dose, route, and lot number not provided). On or about 01-MAY-2014, the patient was treated by a healthcare professional for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Intercepted medication error
Clinical narrative: This spontaneous report was received from a nurse concerning a male patient of unknown age. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 31-MAY-2018, the patient was vaccinated with the first dose of GARDASIL 9 (anatomical location, strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. On 29-NOV-2018, also reported as at the time of the call, the patient was in the office requesting a second dose of GARDASIL 9 to be administered early (approximately on 31-JUL-2018). Second dose was not administered.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown demographics. The patient's medical history, concurrent conditions, concomitant medications, and drug interactions/allergies were unknown. On 29-NOV-2018, the patient was vaccinated with expired (Expired product administered) VAQTA lot # N02699, Expiry: 10-NOV-2018, 1 dose (frequency and route of administration unknown) for prophylaxis. No adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were not reported. On 28-NOV-2018 the patient was vaccinated with a pediatric dose of VAQTA 25/0.5 (1 dosage form; lot # R010368, expiration date 25-MAR-2019) via intramuscular for prophylaxis (inappropriate dose of vaccine administered). No adverse effects were reported in the patient.
Age: 21.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified patient of approximately 21-years-old of unknown gender. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 26-NOV-2018, the patient was vaccinated with an expired dose of VAQTA injection, 50 / 1.0 units per milliliters (U/ml) lot number N028743, expiry date 30-NOV-2018 (dose, route and frequency were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated subcutaneously with an improperly dose of either PROQUAD lot # R015739, or VARIVAX lot # R010469, for prophylaxis. No adverse effect was reported. The temperature excursion was from -14°C to -10°C during 88 hours and 30 minutes. Digital data logger involved.