chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Patient has has muscle soreness from the top of her neck down to her knee since the morning after her vaccination. There is erythema distal to the injection site that has warmth to it. She reports no fever, but will continue to monitor.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Surgery
Clinical narrative: Pt states she had some pain immediately after the suregery, but still has some intermittent bouts of pain following the administration
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: C-reactive protein, Full blood count, Metabolic function test, Nausea, Pyrexia
Clinical narrative: Nausea, Fever peak of 101, Fainted, recovered from that and temp back to normal   Shingles feeling over the entire right half of my body from head to toe (shot was given on right half) started 7/3/19   Doctor said I must be allergic to the vaccine but I think it was a strong side effect.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate, Sensory disturbance, Syncope
Clinical narrative: Nausea, Fever peak of 101, Fainted, recovered from that and temp back to normal   Shingles feeling over the entire right half of my body from head to toe (shot was given on right half) started 7/3/19   Doctor said I must be allergic to the vaccine but I think it was a strong side effect.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became red, swollen, sore, and hot 1 day after administration. The patient saw her MD 2 days later and was diagnosed with an infection at the injection site.  Patient was treated with antibiotics.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: INJECTION SITE PAIN THAT RADIATES TO SHOULDER. SAW DOCTOR AND IS NOW ON THERAPY-MD SAID HE HAS SEEN BEFORE WITH FLU VACCINATIONS
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pain and burning in left arm.  Swelling and redness about the size of the baseball.  Can barely left her arm
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness unilateral, Blood test normal, Chorioretinitis, Computerised tomogram thorax normal, Pulmonary function test normal
Clinical narrative: Started losing vision in left eye.  Was diagnosed with bilateral posterior uveitis on 9/11/2017.  Had many tests and diagnosis is presumed occular sarcoidosis.  Took several months of prednisone and then was changed to 2000mg Cellcept, which is still going as of today. 7/3/3019. Sees a rheumatologist and retina specialist every four months.  Next visits are in August.  Vision will not be restored.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Retinogram, Viral test negative
Clinical narrative: Started losing vision in left eye.  Was diagnosed with bilateral posterior uveitis on 9/11/2017.  Had many tests and diagnosis is presumed occular sarcoidosis.  Took several months of prednisone and then was changed to 2000mg Cellcept, which is still going as of today. 7/3/3019. Sees a rheumatologist and retina specialist every four months.  Next visits are in August.  Vision will not be restored.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Breast cancer female, Cytogenetic analysis normal
Clinical narrative: Lyme vaccine shot 11/11/1999 and 12/8/1999 Lot #LY116A2 exp 3/17/2000 12/1/2000 lot #LY146A9 exp 11/18/2001 I was diagnosed with breast cancer 10/2000. I am not sure if the lyme vaccine had anything to do with developing breast cancer. My cancer is not genetic. I had the test done.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Severe pain & stiffness about 3-4 hours after the vaccine, unable to raise arm away from body, pain from injection site up to middle of the right side of my neck, pain in neck muscle when swallowing. Next day, still painful and stiff, developed bright red welt looking spot on inside and outside of bicep that was tender and hot to the touch.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Odynophagia, Pain, Skin warm, Tenderness, Urticaria
Clinical narrative: Severe pain & stiffness about 3-4 hours after the vaccine, unable to raise arm away from body, pain from injection site up to middle of the right side of my neck, pain in neck muscle when swallowing. Next day, still painful and stiff, developed bright red welt looking spot on inside and outside of bicep that was tender and hot to the touch.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Pyrexia
Clinical narrative: At about 7 pm on day of shot, began to feel hot. Took temperature and found it in 99+ range.  Over next few days my fever ranged upwards of 102 degrees F.  It took about 3 days before temperature returned to normal.  Stayed in & out of bed for those days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Pain in arm. Flu-like symptoms that kept me in bed all day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Hypersomnia, Pain in extremity
Clinical narrative: Got extremely, unrelentingly cold which was not mitigated by extra clothing and/or blankets.  Shivered and teeth chattered for 8-10 hours.  Finally took acetaminophen which helped but slept most of next day.  Arm hurt.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash pustular, Tenderness
Clinical narrative: I believe vaccine was administered correctly. I developed a small patch of what appeared to be shingles rash 4 days after the vaccine was administered - about 20 pustules on one hip, 3 of which were moderately painful.  All but those 3 have cleared 4 weeks later, and those 3 are healing but still tender.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Very sore upper left arm (Injection site)  about 12 hrs. later  chills, fever, body aches, very tired  lasted full day
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Differential white blood cell count normal, Full blood count normal, Local reaction
Clinical narrative: Pt developed large local reaction measuring 4.5cm x 3cm on upper left thigh after PCV13 4 hrs later. Had a similar reaction with PCV13#2 though not as severe per reported history
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Influenza virus test negative, Nausea, Rash, Streptococcus test positive
Clinical narrative: Rash, sever Headache, nausea/vomiting
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: Rash, sever Headache, nausea/vomiting
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache, Pyrexia, Seizure
Clinical narrative: headache quickly after seizure later in day (has chronic seizure disorder) Fever to 101.6F on 7/2/19
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Blood test normal, Dizziness, Pregnancy test negative, Presyncope
Clinical narrative: patient was at beach 2 hours after receiving vaccine, reported feeling dizzy with stomach pain. Patient then had syncopal episode with convulsions for about 10 minutes. Transported to hospital via ambulance, received IV fluids
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Seizure, Syncope, Toxicologic test normal, Urine analysis normal
Clinical narrative: patient was at beach 2 hours after receiving vaccine, reported feeling dizzy with stomach pain. Patient then had syncopal episode with convulsions for about 10 minutes. Transported to hospital via ambulance, received IV fluids
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mom called us on 5-16-19 to report a large red bump 2 inches under the injection site. Hot to touch, painful. Patient was seen in our office on 5-17-19 and had a fever of 101 at that time. Noted to have an 8x8 cm bump 6cm below the injection site. Benadryl and Tylenol/Motrin and cold compresses were recommended at that time.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eschar, Injection site erythema, Injection site pain, Injection site reaction, Injection site vesicles
Clinical narrative: This was the second of 2 shingle shots; the 1st was several months prior with no reaction. The second shot was administered in the upper portion of the left arm; within hours after it was administered there was prominent needle mark with red surrounding the area and red surrounding the area about 4 in below. That evening when I took my shirt off there was a huge blister filled with fluid. I punctured it to drain the fluid and used a sterile gauze pad on it.  Within two days the skin had peeled off into a very deep wound. I have pictures of that day and days following.  It has almost completely healed now; in speaking with many nurses and also Dr my Doc at the Clinic no one  has ever seen a reaction like I had.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister rupture, Injection site erythema, Injection site reaction, Injection site vesicles, Skin exfoliation
Clinical narrative: This was the second of 2 shingle shots; the 1st was several months prior with no reaction. The second shot was administered in the upper portion of the left arm; within hours after it was administered there was prominent needle mark with red surrounding the area and red surrounding the area about 4 in below. That evening when I took my shirt off there was a huge blister filled with fluid. I punctured it to drain the fluid and used a sterile gauze pad on it.  Within two days the skin had peeled off into a very deep wound. I have pictures of that day and days following.  It has almost completely healed now; in speaking with many nurses and also Dr my Doc at the Clinic no one  has ever seen a reaction like I had.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin wound
Clinical narrative: This was the second of 2 shingle shots; the 1st was several months prior with no reaction. The second shot was administered in the upper portion of the left arm; within hours after it was administered there was prominent needle mark with red surrounding the area and red surrounding the area about 4 in below. That evening when I took my shirt off there was a huge blister filled with fluid. I punctured it to drain the fluid and used a sterile gauze pad on it.  Within two days the skin had peeled off into a very deep wound. I have pictures of that day and days following.  It has almost completely healed now; in speaking with many nurses and also Dr my Doc at the Clinic no one  has ever seen a reaction like I had.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Cold sweat, Fatigue, Headache
Clinical narrative: Woke up several times during first night after injection. Woke up next day extremely tired, aches and soreness in knees and lower back, injection site extremely sore and painful to the touch (but not swollen or red), developed headache late in day behind forehead. During second night after injection, woke up twice with cold sweat - soaked bedclothes, sheets and pillow cases. Woke up on second day feeling somewhat better - no fatigue, with less soreness in back
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Middle insomnia
Clinical narrative: Woke up several times during first night after injection. Woke up next day extremely tired, aches and soreness in knees and lower back, injection site extremely sore and painful to the touch (but not swollen or red), developed headache late in day behind forehead. During second night after injection, woke up twice with cold sweat - soaked bedclothes, sheets and pillow cases. Woke up on second day feeling somewhat better - no fatigue, with less soreness in back
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Feeling jittery, Hypoaesthesia oral
Clinical narrative: The patient said she started experiencing side effects the next day which included:  "jitteriness inside", bone pain from the hips down in both legs (started the day after the vaccine and then went away the next day), and numbness inside of her lips and mouth (started the day after and improved, but was still slightly present as of 7-2-19---She said her tongue, throat and airway were not affected).
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Left shoulder & arm reddened, swollen and very painful. After 2 days, severe itching started. One week later, the arm is still sensitive and flushed pink in appearance. I am not looking for compensation but wanted to share this information with the manufacturers.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Erythema, Fatigue, Induration
Clinical narrative: 7/2/19 Local red area around injection site later in the evening of injection.  7/3/19 Next morning larger red area, mid day-nausea, vomiting, fever, chills, body aches all over, fatigue, weakness.  7/4/19 larger area of redness 2.25" across by 3.5" long, now hot to the touch and hard under redness, painful. Nausea has subsided, muscle pain is now only on effected arm and shoulder. Dr. was called and pictures sent to him, he has prescribed Keflex 500 MG TID x 10 days, May use Benadryl 25 mg 1 tablet am, and 1 tablet pm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: 7/2/19 Local red area around injection site later in the evening of injection.  7/3/19 Next morning larger red area, mid day-nausea, vomiting, fever, chills, body aches all over, fatigue, weakness.  7/4/19 larger area of redness 2.25" across by 3.5" long, now hot to the touch and hard under redness, painful. Nausea has subsided, muscle pain is now only on effected arm and shoulder. Dr. was called and pictures sent to him, he has prescribed Keflex 500 MG TID x 10 days, May use Benadryl 25 mg 1 tablet am, and 1 tablet pm.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm, Vomiting
Clinical narrative: 7/2/19 Local red area around injection site later in the evening of injection.  7/3/19 Next morning larger red area, mid day-nausea, vomiting, fever, chills, body aches all over, fatigue, weakness.  7/4/19 larger area of redness 2.25" across by 3.5" long, now hot to the touch and hard under redness, painful. Nausea has subsided, muscle pain is now only on effected arm and shoulder. Dr. was called and pictures sent to him, he has prescribed Keflex 500 MG TID x 10 days, May use Benadryl 25 mg 1 tablet am, and 1 tablet pm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: After receiving the Shingrix Vaccine about 6 to 7 days later I started seeing and feeling itchy hives on the right side of my neck, in cluster. it has now been one week and not getting better. I also got one hive next to my lip and one hive on my left side of neck
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Arthropathy, Asthma, Decreased appetite, Food allergy, Irritable bowel syndrome
Clinical narrative: SLE Lupus Acute Musculoskeletal Dysfunction  Myofascial Pain Syndrome  Sacroiliac Joint Dysfunction Food Allergies  Asthma  Poor appetite  IBS
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Musculoskeletal disorder, Myofascial pain syndrome, Systemic lupus erythematosus
Clinical narrative: SLE Lupus Acute Musculoskeletal Dysfunction  Myofascial Pain Syndrome  Sacroiliac Joint Dysfunction Food Allergies  Asthma  Poor appetite  IBS
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Patient said the night of receiving the vaccine, her arm went numb and then developed sharp pain, it swelled up around the injection site, and she had a severe fever the rest of the night.  The next day, the day of reporting, she says the only symptom she has left is some pain in her arm.  She did not go to the doctor.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Nausea
Clinical narrative: The patient had Nausea, started Today in the morning, Called pharmacy. The patient was provided some OTC Meclizine to prevent/treat  Nausea.  Patient also has some complaint of Joint pain. Patient was prescribed Meloxicam. So, suggested to continue taking it, which could be helpful to Joint pain. Suggested if symptoms getting worsen Call 911 and report to pharmacy.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain, Periarthritis
Clinical narrative: Shoulder is frozen with little or no range of motion; acute pain
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Neuralgia
Clinical narrative: Extreme nerve pain/reduction in range of motion that began shortly after administration. Patient went to PCP the following day and received prednisone and lidocaine patches. Patient contacted us four days after injection and at that time the pain was almost gone and she was beginning to regain her full range of motion.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dry mouth, Pain, Retching
Clinical narrative: I woke at 12:15 in the morning, chills, achy bocy, stomach pain and proceeded to vomit for the next 6 hours, even when there wasn't any thing else in my stomach. Stomach contracting with dry heaves, would take a tablespoon of water after there wasn't anything left, felt deyhdrate, dry mouth and couldn't keep it down.  I almost asked him to take me to the hospital for some compazine suppostories or something to stop my stomach,it was awful. My husband who had the shot, too, had only the chills.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: I woke at 12:15 in the morning, chills, achy bocy, stomach pain and proceeded to vomit for the next 6 hours, even when there wasn't any thing else in my stomach. Stomach contracting with dry heaves, would take a tablespoon of water after there wasn't anything left, felt deyhdrate, dry mouth and couldn't keep it down.  I almost asked him to take me to the hospital for some compazine suppostories or something to stop my stomach,it was awful. My husband who had the shot, too, had only the chills.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Started with pain about 5 hours after injection at injection site. On 7/4/19 at 0800 noted to be very red (3 inches in diameter), hot and indurated, centered around injection site and still quite painful. THis was Second Shingrix he had (previous shingrix about  4 months earlier).
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Seizure
Clinical narrative: GAVE PATIENT ADACEL AND WAS ABOUT TO PREPARE SHINGRIX VACCINE. PATIENTS WIFE ALERTED ME THAT PATIENT WAS PASSING OUT. I CAME INTO ROOM AND HE WAS UNCONSCIOUS AND WAS HAVING A SEIZURE. THE SEIZURE LASTED ABOUT 30 SECONDS. AMBULANCE ARRIVED WITHIN 5 MINUTES AND TOOK CARE OF SITUATION FROM THERE.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Body temperature increased, Chills, Dizziness
Clinical narrative: At 1:30 AM on 06/22/2019 I awoke from sleep with extreme chills and 99.9 temperature. temperature went up and down over next 8-9 hours. Temperature would drop each time I would take small dose of Tylenol. Temperature returned to normal in afternoon of 22nd (97.6). Experience dizziness and occasional loss of balance over next 36-48 hours. I was unable to leave my apartment on Saturday or Sunday.  By  Monday morning the 24th I felt fine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Erythema, Heart rate increased, Rash, Swelling
Clinical narrative: patient received vaccine on 06/26/2019 and reports: *increased heart rate and anxious feeling on 06/27/19 that lasted mid day to evening  *rash on 06/29/2019 and included swelling, tenderness, and redness *was evaluated by PCP on 7/01/2019 and was told by PCP that she had a "reaction" to the vaccine  *via telephone conversation on 07/04/2019 ***rash and swelling is resolving over time and no further increased heart rate
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Vaccination complication
Clinical narrative: patient received vaccine on 06/26/2019 and reports: *increased heart rate and anxious feeling on 06/27/19 that lasted mid day to evening  *rash on 06/29/2019 and included swelling, tenderness, and redness *was evaluated by PCP on 7/01/2019 and was told by PCP that she had a "reaction" to the vaccine  *via telephone conversation on 07/04/2019 ***rash and swelling is resolving over time and no further increased heart rate
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Rash
Clinical narrative: PATIENT HAS LARGE RASH ON LEFT ARM FROM SITE OF INJECTION AND FEW INCHES DOWN AND LEFT AND RIGHT. AREA IS RED, WARM TO TOUCH. SAW URGENT CARE MD WHO PRESCRIBED CEPHALEXIN AND TRIAMCINOLONE TO CALM REACTION WITH FOLLOW UP IN TWO DAYS.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into pharmacy on 7/4/19 stating she had received a Pneumovax-23 vaccine the day before and had a reaction to it. Her left arm was swollen from the injection site down to her elbow. The area was red, swollen, and warm to touch. The patient stated she did not have any other symptoms. I, the pharmacist, told her to take a Benadryl and monitor it.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Had vaccine at 1:05 pm on 7/1/19 & was tender/sore with some swelling that night.   Next day on 7/2/19 had same symptoms as on 7/1/19. On 7/3/19 woke up at 6:50 am with 6 mild red hives starting at injecton site on upper left arm extending down approximately 2 inches.  It turned into red blotches after a few hours, was tender/sore with a swollen hard lump which my PA-C thought might be cellulitis so she had me go for an office visit.  It was not cellulitis, but  a side effect reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria, Pain, Rash macular, Swelling
Clinical narrative: Had vaccine at 1:05 pm on 7/1/19 & was tender/sore with some swelling that night.   Next day on 7/2/19 had same symptoms as on 7/1/19. On 7/3/19 woke up at 6:50 am with 6 mild red hives starting at injecton site on upper left arm extending down approximately 2 inches.  It turned into red blotches after a few hours, was tender/sore with a swollen hard lump which my PA-C thought might be cellulitis so she had me go for an office visit.  It was not cellulitis, but  a side effect reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Urticaria
Clinical narrative: Had vaccine at 1:05 pm on 7/1/19 & was tender/sore with some swelling that night.   Next day on 7/2/19 had same symptoms as on 7/1/19. On 7/3/19 woke up at 6:50 am with 6 mild red hives starting at injecton site on upper left arm extending down approximately 2 inches.  It turned into red blotches after a few hours, was tender/sore with a swollen hard lump which my PA-C thought might be cellulitis so she had me go for an office visit.  It was not cellulitis, but  a side effect reaction.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Head injury, Syncope
Clinical narrative: The patient received her vaccine at 2:08 around 2:42 she fainted at a register, fell and hit her head.  According to the patient a the time of the event she didn't remember anything right before the event.  She did not remember doing anything different other than getting her shingrix vaccine about 30 min prior.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Rash, Skin warm
Clinical narrative: Patient state that on Day 2 she received fever. Day 3 rash appeared & it was warm to touch Fever broke. Rash stayed for a couple more days before disappearing. Muscle ache daily since receiving vaccine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Skin warm
Clinical narrative: Rash that is warm to touch appeared on day 2. Soreness every day, even on day 6 after shot given
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Area of injection red and inflamed
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: After receiving the vaccine, injection site was sore for 4 days. On 4th day, it was hot and red. On 5th day, redness was larger. Patient consulted the emergency room and received a 5 day course of cefuroxime 500mg. It resolved after treatment.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: chills, fever, headache, sweating, myalgia
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: possible cellulitis (red inflammation surrounding injection site, very sore, spreading quickly)
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Shivering uncontrollably, muscle aches, headache
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Developed moderate soreness at injection site and flu-like symptoms including moderate fatigue, slight fever and moderate joint pain. No treatment is being sought.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Skin ulcer
Clinical narrative: & ulceration of skin
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Unresponsive to stimuli
Clinical narrative: & unresponsive, "fist" sized swelling at injection site
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Eye oedema, Oedema mouth
Clinical narrative: Got shingrix vaccine and started celecoxib on same day. Shingrix at 11:00am, then first does of celecoxib around 12:30pm. About 3 hours later, developed redness on face, trunk, and legs. Edematous (swelling) mouth and eyes. Felt like burning inside. Improved overnight but still present the next day. No breathing issues.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Got injection site reaction - redness, pain, swelling. & irritation at injection site; pain, redness, swelling
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: & Edema
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Incomplete course of vaccination, Myopathy, Wheelchair user
Clinical narrative: Pt received immunization on 8/27/18 (1st dose). Pt admitted 10/17/18 for critical illness statin-induced myopathy (atorvastatin). The concerning thing is that the patient had been on atorvastatin for a long time (years) without problem. He was discharged in a wheelchair 10/31/18. Able to walk now (12/31/18). He never received the 2nd dose of Shingrix due to they myopathy admission and concern for the drug's involvement with it.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: & flu-like symptoms
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: edema & edema
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: UrticariaPruritus DIPHENHYDRAMINE
Age: 74.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site swelling
Clinical narrative: & Walnut sized bump at injection site
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiform
Age: 75.0
Sex: M
Vaccine: DTP, FLU4
Symptoms: Alcohol use, Tremor
Clinical narrative: Had "severe tremor" for 4 hours after receiving both vaccines. Also has high EtOH use and was out of opioid medication at the time. & tremor
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Pt received flu shot in Employee Health, within 15 minutes began having difficulty breathing and was taken to ED, later transferred to hospital for observation. Received epi x 2, solumedrol, Ativan, Zofran before transfer. Anaphylaxis
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash CETIRIZINE 10 MG EVERY  DAY, METHYLPREDNISOLONE 4 MG Other as directed
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Dizziness, Headache, X-ray normal
Clinical narrative: Computerised tomogram head normal; X-ray normal; Dizziness; Headache; pharyngitis; This spontaneous report was received from a Regulatory Authority refers to a 11-year-old female patient. The patient's historical condition included chronic constipation. The patient's concurrent conditions included seasonal allergy. Other medications included olyethylene glycol 3350 (MIRALAX).   On 30-AUG-2017, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly, in the left arm, lot # N013276, expiration date 21-JAN-2020 (dose was not provided) for prophylaxis. On the same day, the patient was additionally vaccinated with a dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (injection, intramuscularly, in the left arm, lot# U5752AB; dose and expiration date not provided) and with a dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) injection, intramuscularly, in the right arm, lot# PY273; dose and expiration date not provided) for prophylaxis. On 30-AUG-2017 (also reported as since received HPV 9), the patient experienced intermittent headaches and dizziness. On 30-AUG-2017, the patient had computerised tomogram head performed with normal result and x-ray with normal result. The outcome of computerised tomogram head normal, x-ray normal, headache and dizziness was unknown.   Causality assessment was not reported.  Follow up information was received from a registered nurse on 25-JUN-2019.  The patient's demographics were updated.  It was reported that on 30-AUG-2017, the patient received third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left deltoid, the second dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) in the right deltoid and the second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) in the left deltoid.  On 22-NOV-2017, the parents or child informed about 4 days lasting dizziness. The patient was treated as sinusitis. On 28-NOV-2017 (also reported as approximately 3 months after the vaccines were given), the patient visited to emergency room due to headache and dizziness. On 27-DEC-2017, the parent or child informed, that the patient experienced pharyngitis. The outcome of pharyngitis was unknown. The relatedness between pharyngitis and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Groin pain, Injection site pain, Joint stiffness, Musculoskeletal pain
Clinical narrative: Neck pain; Hip pain; radiating pain in leg; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 58160-0819-12 ?, expiry date unknown) for prophylaxis.   On 3rd June 2019, the patient received the 2nd dose of Shingrix. On 4th June 2019, 1 days after receiving Shingrix, the patient experienced neck pain and pain in hip. In June 2019, the patient experienced leg pain. On an unknown date, the outcome of the neck pain was recovering/resolving and the outcome of the pain in hip was not recovered/not resolved and the outcome of the leg pain was unknown.   It was unknown if the reporter considered the neck pain, pain in hip and leg pain to be related to Shingrix.  Additional details were provided as follows: The reported batch number 58160-0819-12 seems to be adjuvant's batch number and was not available in sales data base, however it was captured as 58160-0819-12 ? The patient got his 2nd dose of Shingrix vaccine on his left arm. The next day, he woke up with pain in his neck and hip.  The patient was under the care of his doctor and physiotherapist.   The patient's neck pain was resolving but he continued to experience hip pain with pain radiating down his leg.  The patient did not know the route of administration and batch number of the Shignrix vaccine. The patient consented to follow up and provided his physician's details. There is a discrepancy with respect to the outcome of the event pain in hip. In source document, the outcome is reported as recovering/ resolving, however as per narrative description it is not recovered/ not resolved. The outcome of the event pain in hip retained as per the narrative description.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Neck pain; Hip pain; radiating pain in leg; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 58160-0819-12 ?, expiry date unknown) for prophylaxis.   On 3rd June 2019, the patient received the 2nd dose of Shingrix. On 4th June 2019, 1 days after receiving Shingrix, the patient experienced neck pain and pain in hip. In June 2019, the patient experienced leg pain. On an unknown date, the outcome of the neck pain was recovering/resolving and the outcome of the pain in hip was not recovered/not resolved and the outcome of the leg pain was unknown.   It was unknown if the reporter considered the neck pain, pain in hip and leg pain to be related to Shingrix.  Additional details were provided as follows: The reported batch number 58160-0819-12 seems to be adjuvant's batch number and was not available in sales data base, however it was captured as 58160-0819-12 ? The patient got his 2nd dose of Shingrix vaccine on his left arm. The next day, he woke up with pain in his neck and hip.  The patient was under the care of his doctor and physiotherapist.   The patient's neck pain was resolving but he continued to experience hip pain with pain radiating down his leg.  The patient did not know the route of administration and batch number of the Shignrix vaccine. The patient consented to follow up and provided his physician's details. There is a discrepancy with respect to the outcome of the event pain in hip. In source document, the outcome is reported as recovering/ resolving, however as per narrative description it is not recovered/ not resolved. The outcome of the event pain in hip retained as per the narrative description.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Neck pain; Hip pain; radiating pain in leg; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 58160-0819-12 ?, expiry date unknown) for prophylaxis.   On 3rd June 2019, the patient received the 2nd dose of Shingrix. On 4th June 2019, 1 days after receiving Shingrix, the patient experienced neck pain and pain in hip. In June 2019, the patient experienced leg pain. On an unknown date, the outcome of the neck pain was recovering/resolving and the outcome of the pain in hip was not recovered/not resolved and the outcome of the leg pain was unknown.   It was unknown if the reporter considered the neck pain, pain in hip and leg pain to be related to Shingrix.  Additional details were provided as follows: The reported batch number 58160-0819-12 seems to be adjuvant's batch number and was not available in sales data base, however it was captured as 58160-0819-12 ? The patient got his 2nd dose of Shingrix vaccine on his left arm. The next day, he woke up with pain in his neck and hip.  The patient was under the care of his doctor and physiotherapist.   The patient's neck pain was resolving but he continued to experience hip pain with pain radiating down his leg.  The patient did not know the route of administration and batch number of the Shignrix vaccine. The patient consented to follow up and provided his physician's details. There is a discrepancy with respect to the outcome of the event pain in hip. In source document, the outcome is reported as recovering/ resolving, however as per narrative description it is not recovered/ not resolved. The outcome of the event pain in hip retained as per the narrative description.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse event.  The medical assistant used sterile water with the HIB (powder portion) instead of the Dtap/ipv diluent that comes with the powder.  Our nurse contacted Sanofi and was instructed to repeat the pentacel.  Patient received the a repeat Pentacel on 06/21/19.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Immunisation, No adverse event, Product preparation error
Clinical narrative: No adverse event.  The medical assistant used sterile water with the HIB (powder portion) instead of the Dtap/ipv diluent that comes with the powder.  Our nurse contacted Sanofi and was instructed to repeat the pentacel.  Patient received the a repeat Pentacel on 06/21/19.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Upper Chest Rash/ Upper Chest Rash appears in resemblance to shingles; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on the abdominal area, 1 year ago).   On 17th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 1st dose on left deltoid and experienced upper chest rash near where the injection as administered. The patient stated it appeared in resemblance to shingles on the abdominal area she had 1 year ago. The reporter gathered the patient information.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Upper Chest Rash/ Upper Chest Rash appears in resemblance to shingles; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on the abdominal area, 1 year ago).   On 17th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 1st dose on left deltoid and experienced upper chest rash near where the injection as administered. The patient stated it appeared in resemblance to shingles on the abdominal area she had 1 year ago. The reporter gathered the patient information.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anxiety, Asthenia, Herpes zoster, Hypersensitivity, Injection site pain
Clinical narrative: Upper Chest Rash/ Upper Chest Rash appears in resemblance to shingles; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on the abdominal area, 1 year ago).   On 17th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 1st dose on left deltoid and experienced upper chest rash near where the injection as administered. The patient stated it appeared in resemblance to shingles on the abdominal area she had 1 year ago. The reporter gathered the patient information.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Upper Chest Rash/ Upper Chest Rash appears in resemblance to shingles; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on the abdominal area, 1 year ago).   On 17th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 1st dose on left deltoid and experienced upper chest rash near where the injection as administered. The patient stated it appeared in resemblance to shingles on the abdominal area she had 1 year ago. The reporter gathered the patient information.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R034548, expiry date 29-DEC-2019 for prophylaxis. No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.  This is one of several reports received from the same reporter.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pruritus, Injection site rash, Lacrimation increased, Pruritus, Pruritus generalised
Clinical narrative: Patient had itching nose and face approximately 30 minutes after Dtap. Patient also reported itching tongue. 10 mL benedryl given. Symptoms seemed to resolve quickly however about an hour later, even after benedryl, patient then reported itching all over the body. Approx 30 minutes after that, patient reported and was seen to have severely watering eyes.  Symptoms seemed to then resolve except for small bumps and itching at injection site 2 days later.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Tongue pruritus
Clinical narrative: Patient had itching nose and face approximately 30 minutes after Dtap. Patient also reported itching tongue. 10 mL benedryl given. Symptoms seemed to resolve quickly however about an hour later, even after benedryl, patient then reported itching all over the body. Approx 30 minutes after that, patient reported and was seen to have severely watering eyes.  Symptoms seemed to then resolve except for small bumps and itching at injection site 2 days later.
Age: 16.0
Sex: F
Vaccine: CHOL, UNK
Symptoms: Contraindication to vaccination
Clinical narrative: TOOK VAXCHORA WHILE ON ANTIBIOTIC; 16-YEAR-OLD FEMALE CONSUMER WHO TOOK VAXCHORA; This spontaneous case (PVX2019-1462) was received from a consumer on 06-Jun-2019. It describes a "16-year-old female consumer who took Vaxchora" and she "took Vaxchora while on antibiotic". She was receiving oral Vaxchora (lot no: 7000011 and expiry date: 31-May-2019) for cholera prophylaxis and oral Targadox (doxycycline; 50 mg; twice a day) for acne.  Case report: A 16-year-old, adolescent female consumer took a dose of Vaxchora on 29-May-2019, while she was taking Targadox for acne. She stopped taking Targadox on 29-May-2019.   Action taken with Vaxchora and Targadox was not applicable.  The clinical outcome of the events was unknown.; Sender's Comments: Company's Comment: The causality of the event"16-year-old female consumer who took Vaxchora" and she "took Vaxchora while on antibiotic" was considered as not applicable.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inadvertently administered a dose of VARIVAX and a dose of PROQUAD at the same time in opposite legs; No adverse effects were reported; Information has been received from a medical assistant referring to a currently 1 years old unknown gender patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #: R030605, expiration date: 23-OCT-2020, dose and frequency were not reported) and a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R030798,Therapy type: rHA (recombinant Human albumin), expiration date: 22-APR-2020, dose and frequency not reported) subcutaneously at the same time in opposite legs for prophylaxis (incorrect dose administered). It was not product confusion and no adverse effects were reported.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: the patient had generalized joint pain on 9/26/2018; Information has been received from a nurse prescriber referring to a 49-year-old female patient. The patient's pertinent medical history included asthma. The concomitant medications included unknown asthma medication. The drug reactions or allergies were not reported.  On 25-SEP-2018, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #: N032750, expiration date: 20-NOV-2019, dose, frequency and route were not reported) for prophylaxis (reported as "immigration medical exam").         On 26-SEP-2018, the patient had generalized joint pain and went to an unspecified emergency room.The patient "received an unspecified pain shot". On the same date, the patient went home from the unspecified Emergency Room. The patient had unspecified steroid treatment on unspecified dates and had continued generalized joint pain. Information about lab diagnostics/studies was not provided. The patient did seek medical attention. The causality assessment was not provided.