chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient developed a 2-inch diameter red spot under injection site
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: - 5cm x 5.5cm erythematous area on L lateral deltoid, mild induration noted at superior aspect and slightly warm to touch. Pt denies pain but appears uncomfortable with palpation. No fluctuance. - 5cm x 4cm erythematous area on the L posterior upper arm. No warmth, induration or pain with palpation. Non-fluctuant -  low-grade fever of 101F x 24-36 hours after vaccines given.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Nausea, Pain, Swelling
Clinical narrative: Patient complaint of redness at injection sites, nausea, pain, swelling for 1-2 days
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Loss of consciousness, Vision blurred, Vomiting
Clinical narrative: Patient was talking after vaccine, once band-aid was applied pt looked unwell. I placed my hands behind him and he passed out. He opened his eyes and asked what happened. I had him lay down with his knees up and hand propped up. He said he felt very weak and that his vision was blurry and then he woke up. Offered pt juice and crackers as well as an ice pack. Had pt lay down for 30 mins rechecked vital signs all were normal. After pt sat up and moved to a chair he vomited x 1, Observed patient for about 20 more mins and once pt felt better he went home with parent.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and mild swelling around injection site, a diameter of around 2.5 inches
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 03/08/2019 Epsom Salt Bath before bed 03/09/2019 NOTICEABLE swelling in thigh around injection sight.  injection sight red, firm and warm to touch being about 2-3 inches diameter.  Diameter of swelling in thigh with redness was at least 5 inches in diameter.  Treatment included Tylenol or Ibuprofen for swelling followed by children's benydral.  Upon taking benydral signs of decreased swelling took place within 24 hours.  Two days after no pain reliever but continued with allergy medication.  Normal thigh size (or no swelling) took the course of about a week and a half.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Measles, Measles post vaccine, Pyrexia, Rash
Clinical narrative: Presented with rash, low grade fever approximately 11 days after receiving Proquad.  Diagnosed with atypical measles.  Was treated with over the counter Benadryl.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: red raised bump on left cheek and right side of nose. Not painful per patient
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blood test normal, Headache, Influenza like illness, Malaise
Clinical narrative: JULY 19 SHOT GIVEN. JULY 20-24 FLU LIKE S/SX. JULY 25 URGENT CARE - GIVEN CIPRO.  JULY 26 DC CIPRO WENT TO LOCAL ER AND GIVEN IV FLUIDS. JULY 27-31 SICKNESS CONT (NAUSEA FEVER HEADACHE BACK PAIN). AUG 1 WENT TO PCP. WAS SENT TO ER. ADMITTED KEPT OVERNIGHT.  AUG 2 TO AUG 5 NAUSEA HEADACHES FEVER SEVERE BACK PAIN.  ** PT STATES HE HAD BLOOD WORK AT BOTH HOSPITALS. PCP WILL BE REFERING TO UROLOGIST NEUROLOGIST AND RHEUMOTOLOGIST.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: JULY 19 SHOT GIVEN. JULY 20-24 FLU LIKE S/SX. JULY 25 URGENT CARE - GIVEN CIPRO.  JULY 26 DC CIPRO WENT TO LOCAL ER AND GIVEN IV FLUIDS. JULY 27-31 SICKNESS CONT (NAUSEA FEVER HEADACHE BACK PAIN). AUG 1 WENT TO PCP. WAS SENT TO ER. ADMITTED KEPT OVERNIGHT.  AUG 2 TO AUG 5 NAUSEA HEADACHES FEVER SEVERE BACK PAIN.  ** PT STATES HE HAD BLOOD WORK AT BOTH HOSPITALS. PCP WILL BE REFERING TO UROLOGIST NEUROLOGIST AND RHEUMOTOLOGIST.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chills, Chromaturia, Dry mouth, Injection site pain
Clinical narrative: JULY 19 SHOT GIVEN. JULY 20-24 FLU LIKE S/SX. JULY 25 URGENT CARE - GIVEN CIPRO.  JULY 26 DC CIPRO WENT TO LOCAL ER AND GIVEN IV FLUIDS. JULY 27-31 SICKNESS CONT (NAUSEA FEVER HEADACHE BACK PAIN). AUG 1 WENT TO PCP. WAS SENT TO ER. ADMITTED KEPT OVERNIGHT.  AUG 2 TO AUG 5 NAUSEA HEADACHES FEVER SEVERE BACK PAIN.  ** PT STATES HE HAD BLOOD WORK AT BOTH HOSPITALS. PCP WILL BE REFERING TO UROLOGIST NEUROLOGIST AND RHEUMOTOLOGIST.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: JULY 19 SHOT GIVEN. JULY 20-24 FLU LIKE S/SX. JULY 25 URGENT CARE - GIVEN CIPRO.  JULY 26 DC CIPRO WENT TO LOCAL ER AND GIVEN IV FLUIDS. JULY 27-31 SICKNESS CONT (NAUSEA FEVER HEADACHE BACK PAIN). AUG 1 WENT TO PCP. WAS SENT TO ER. ADMITTED KEPT OVERNIGHT.  AUG 2 TO AUG 5 NAUSEA HEADACHES FEVER SEVERE BACK PAIN.  ** PT STATES HE HAD BLOOD WORK AT BOTH HOSPITALS. PCP WILL BE REFERING TO UROLOGIST NEUROLOGIST AND RHEUMOTOLOGIST.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Cytogenetic analysis abnormal, Electromyogram, Familial amyotrophic lateral sclerosis
Clinical narrative: Got vaccine october 2018 in left bicep,  next day left hand swelled up and felt broken, 2 days later swelling and pain subsided,  January 2019 started symptoms of muscle twitching in left bicep,  may 2019 final diagnosis of familia ALS,  genetic test confirmed C9ORF72 gene that has to be activated by something to start progression of ALS, causes listed to activate that gene , though listed rare, a vaccine can trigger it
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Muscle twitching, Nuclear magnetic resonance imaging, Pain in extremity, Peripheral swelling
Clinical narrative: Got vaccine october 2018 in left bicep,  next day left hand swelled up and felt broken, 2 days later swelling and pain subsided,  January 2019 started symptoms of muscle twitching in left bicep,  may 2019 final diagnosis of familia ALS,  genetic test confirmed C9ORF72 gene that has to be activated by something to start progression of ALS, causes listed to activate that gene , though listed rare, a vaccine can trigger it
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia
Clinical narrative: woke up with the shivers and headache and then got to work and had muscle pains and stomach problems
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient developed an itchy red rash with bumps on various parts of body including head and torso two days following vaccination.  Patient self treated with diphenhydramine and the reaction resolved after 3 days
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia
Clinical narrative: chills, headache, muscle aches, pain at site of injection
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Disorientation, Dizziness, Hunger, Hyperventilation
Clinical narrative: Patient started to breathe  deep for a bout 30 seconds , skin got a little clammy ,. Was conscious but said he felt "woozy" .  Sat down on his own seemed a little disoriented.  The whole episode took about 3 minutes . Sat down for about 10 minutes and was coherent throughout . left on his own with his cousin after about 10 minutes . Said he had been traveling and was hungry
Age: 24.0
Sex: M
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: syncope. the patient rested and drank some water and recovered.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: patient presented to pharmacy reporting symptoms of chills, headache, fever of 102 F for 1 & 1/2 day, starting the day of the vaccines.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Body temperature increased, Chills, Dizziness, Fatigue
Clinical narrative: 7/31/19-day after vaccine - headache when woke up took 1000mg acetaminophen - extreme fatigue by noon - needing to go to bed, woke up about 2 hrs later with shaking chills, headache and a temp of 101.3,  took 1000mg  acetaminophen and water and back to bed, got up 2 hrs later still tired, headache, not feeling well, sat around and back to bed about 3-4 hrs later til the next morning (took 1000mg acetaminophen q 6 h) was already taking Mobic for back pain next day-8/1/2019 worn out and fatigued all day needing naps during the day Aug 2 , 2019-head felt woozy- sort of off balance- rested- home all day Aug 3- back to normal This also happened with the first vaccine back in December 2018 but only lasted 2 days as I remember
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Tremor
Clinical narrative: 7/31/19-day after vaccine - headache when woke up took 1000mg acetaminophen - extreme fatigue by noon - needing to go to bed, woke up about 2 hrs later with shaking chills, headache and a temp of 101.3,  took 1000mg  acetaminophen and water and back to bed, got up 2 hrs later still tired, headache, not feeling well, sat around and back to bed about 3-4 hrs later til the next morning (took 1000mg acetaminophen q 6 h) was already taking Mobic for back pain next day-8/1/2019 worn out and fatigued all day needing naps during the day Aug 2 , 2019-head felt woozy- sort of off balance- rested- home all day Aug 3- back to normal This also happened with the first vaccine back in December 2018 but only lasted 2 days as I remember
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site haemorrhage
Clinical narrative: Directly after injection, when pulling the shot out of the patients arm, the patient began to excessively bleed and a large hematoma started to appear.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Influenza like illness, Malaise
Clinical narrative: flu like symptoms.  Greatly reduced energy.  Fever.  Lassitude.  Lack of appetite.  Feeling of general malaise.   Too early to tell how long it will last.    My wife had the same vaccine at  the same location a couple days earlier and was fine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: flu like symptoms.  Greatly reduced energy.  Fever.  Lassitude.  Lack of appetite.  Feeling of general malaise.   Too early to tell how long it will last.    My wife had the same vaccine at  the same location a couple days earlier and was fine.
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Got vaccinated with MMR on 08/06/2019 one day later on 08/07/2019 started getting rashes or bumps on her face: neck, with low grade fever
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient reported pain and numbness in deltoid region of arm. She also reported limited mobility and extreme pain in the injected arm. Symptoms started 2 weeks after first vaccination in January. She received a second dose in the same arm on May 23, 2019. Symptoms have not improved several months later. Patient has limited movement of arm, numbness in the deltoid muscle, and stabbing pain in arm with movement. According to patient, the deltoid muscle is in constant contracting state.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Dizziness, Headache, Impaired work ability, Injection site joint pain
Clinical narrative: Intense joint/muscle pain returned the same night, beginning in injection site and spreading to hands/legs/back by the next morning. Began taking the normal treatments for chronic inflammation yet again (meloxicam, turmeric, and Epsom salt soaks). It has yet to resolve or lessen. Began to develop a headache ~8/2 that did not go away, but instead grew until it was so severe 8/5 I could barely do my job and 8/6 I had to leave work early because I could feel my pulse in my eyeballs. Could not take other NSAIDs for it while still taking meloxicam for joint/muscle inflammation. Evening of 8/6 also saw me developing a fever that continues to fluctuate between 99 and 101 degrees. Stopped meloxicam 8/6 in order to take an NSAID that would also help the fever. Currently lying in bed on 8/7 with severe body aches, fever of 100.8, severe headache and dizziness.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: Intense joint/muscle pain returned the same night, beginning in injection site and spreading to hands/legs/back by the next morning. Began taking the normal treatments for chronic inflammation yet again (meloxicam, turmeric, and Epsom salt soaks). It has yet to resolve or lessen. Began to develop a headache ~8/2 that did not go away, but instead grew until it was so severe 8/5 I could barely do my job and 8/6 I had to leave work early because I could feel my pulse in my eyeballs. Could not take other NSAIDs for it while still taking meloxicam for joint/muscle inflammation. Evening of 8/6 also saw me developing a fever that continues to fluctuate between 99 and 101 degrees. Stopped meloxicam 8/6 in order to take an NSAID that would also help the fever. Currently lying in bed on 8/7 with severe body aches, fever of 100.8, severe headache and dizziness.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Rash, Type IV hypersensitivity reaction, Urticaria
Clinical narrative: Delayed Hypersensitivity rash. Generalized urticaria 2 days post shots. Possibly from shots.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Retching, Vomiting projectile
Clinical narrative: Projectile vomiting x 3, then dry heaving. Mom giving clear liquids and sprite. Also with fever 101.3 that responds to Motrin.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Pain
Clinical narrative: Patient reports soreness, redness, and injection site warm to the touch
Age: 1.25
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Abdominal X-ray, Cough, Diarrhoea, Respiratory tract congestion, Ultrasound abdomen normal
Clinical narrative: Patient developed vomiting, diarhea within 12 hours. Seen in ED.   Developed cough/congestion in 24°, seen in ED.   Seen by PCP on day #5, recovered.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Vomiting, X-ray normal
Clinical narrative: Patient developed vomiting, diarhea within 12 hours. Seen in ED.   Developed cough/congestion in 24°, seen in ED.   Seen by PCP on day #5, recovered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: bruising @ L proximal thigh @ injection site 6mm diameter bruising @ R proximal thigh with tenderness and area of induration 9mm diameter patch of erythema without warmth @ R lateral mid thigh
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: patient came in on 8/7/18 complaining of itching and rashes all over her body a couple of days after getting the shingrix vaccine. She said she was taking caladryl lotion to help with the itching. We recommended patient take Benadryl tablets by mouth to help with allergic reaction and to see a doctor for further follow up if needed for further medications to help with the itching
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Syncope
Clinical narrative: Patient received vaccines and after getting vaccines fainted in the waiting room. 0 head injury.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Chest pain, Urticaria
Clinical narrative: Patient states that he had hives and chest pain. Patient was taken to the ER by ambulance and given ranitidine 150 MG, prednisone, 10 MG,  diphenhydramine HCl, 25 MG
Age: 37.0
Sex: M
Vaccine: FLU4, YF, FLUX, YF
Symptoms: Blood creatinine normal, CSF culture negative, CSF glucose normal, CSF protein normal, CSF white blood cell count negative
Clinical narrative: 37 year old male presented with a 5 day history of severe headaches associated with fever and photophobia on 3/12. On 2/25, he had received the yellow fever vaccine (Stamaril) and influenza vaccines in preparation for travel. On 3/8 he developed severe diffuse headaches, with subsequent fevers. On 3/11 he presented to an hospital and had a CT head that was normal, and he was discharged with a diagnosis of a viral syndrome. On 3/12 he presented to hospital, and his lumbar puncture studies were concerning for meningitis (WBC 710 -> 480 [83% lymphocytes, 16% monocytes, 1% eosinophils], RBC 12 -> 3, glucose 67, protein 40). He was started on empiric vancomycin, ceftriaxone, and acyclovir while awaiting further studies and his CSF was sent to the CDC for testing for yellow fever virus PCR. Because he was clinically stable with a low suspicion for bacterial meningitis, vancomycin and ceftriaxone were stopped on 3/13. He gradually improved, and on 3/19 he had no headache, focal weakness, or fever, so he was discharged. The presence of yellow fever virus by PCR in the patient's CSF was confirmed. His serum yellow fever IgM and yellow fever PRNT were positive, confirming immunity to yellow fever.
Age: 37.0
Sex: M
Vaccine: FLU4, YF, FLUX, YF
Symptoms: Full blood count normal, Headache, Liver function test normal, Photophobia, Pyrexia
Clinical narrative: 37 year old male presented with a 5 day history of severe headaches associated with fever and photophobia on 3/12. On 2/25, he had received the yellow fever vaccine (Stamaril) and influenza vaccines in preparation for travel. On 3/8 he developed severe diffuse headaches, with subsequent fevers. On 3/11 he presented to an hospital and had a CT head that was normal, and he was discharged with a diagnosis of a viral syndrome. On 3/12 he presented to hospital, and his lumbar puncture studies were concerning for meningitis (WBC 710 -> 480 [83% lymphocytes, 16% monocytes, 1% eosinophils], RBC 12 -> 3, glucose 67, protein 40). He was started on empiric vancomycin, ceftriaxone, and acyclovir while awaiting further studies and his CSF was sent to the CDC for testing for yellow fever virus PCR. Because he was clinically stable with a low suspicion for bacterial meningitis, vancomycin and ceftriaxone were stopped on 3/13. He gradually improved, and on 3/19 he had no headache, focal weakness, or fever, so he was discharged. The presence of yellow fever virus by PCR in the patient's CSF was confirmed. His serum yellow fever IgM and yellow fever PRNT were positive, confirming immunity to yellow fever.
Age: 37.0
Sex: M
Vaccine: FLU4, YF, FLUX, YF
Symptoms: Antibody test positive, CSF eosinophil count, CSF glucose normal, CSF lymphocyte count increased, CSF monocyte count negative
Clinical narrative: 37 year old male presented with a 5 day history of severe headaches associated with fever and photophobia on 3/12. On 2/25, he had received the yellow fever vaccine (Stamaril) and influenza vaccines in preparation for travel. On 3/8 he developed severe diffuse headaches, with subsequent fevers. On 3/11 he presented to an hospital and had a CT head that was normal, and he was discharged with a diagnosis of a viral syndrome. On 3/12 he presented to hospital, and his lumbar puncture studies were concerning for meningitis (WBC 710 -> 480 [83% lymphocytes, 16% monocytes, 1% eosinophils], RBC 12 -> 3, glucose 67, protein 40). He was started on empiric vancomycin, ceftriaxone, and acyclovir while awaiting further studies and his CSF was sent to the CDC for testing for yellow fever virus PCR. Because he was clinically stable with a low suspicion for bacterial meningitis, vancomycin and ceftriaxone were stopped on 3/13. He gradually improved, and on 3/19 he had no headache, focal weakness, or fever, so he was discharged. The presence of yellow fever virus by PCR in the patient's CSF was confirmed. His serum yellow fever IgM and yellow fever PRNT were positive, confirming immunity to yellow fever.
Age: 37.0
Sex: M
Vaccine: FLU4, YF, FLUX, YF
Symptoms: CSF protein normal, CSF red blood cell count positive, CSF white blood cell count increased, Computerised tomogram head normal, Headache
Clinical narrative: 37 year old male presented with a 5 day history of severe headaches associated with fever and photophobia on 3/12. On 2/25, he had received the yellow fever vaccine (Stamaril) and influenza vaccines in preparation for travel. On 3/8 he developed severe diffuse headaches, with subsequent fevers. On 3/11 he presented to an hospital and had a CT head that was normal, and he was discharged with a diagnosis of a viral syndrome. On 3/12 he presented to hospital, and his lumbar puncture studies were concerning for meningitis (WBC 710 -> 480 [83% lymphocytes, 16% monocytes, 1% eosinophils], RBC 12 -> 3, glucose 67, protein 40). He was started on empiric vancomycin, ceftriaxone, and acyclovir while awaiting further studies and his CSF was sent to the CDC for testing for yellow fever virus PCR. Because he was clinically stable with a low suspicion for bacterial meningitis, vancomycin and ceftriaxone were stopped on 3/13. He gradually improved, and on 3/19 he had no headache, focal weakness, or fever, so he was discharged. The presence of yellow fever virus by PCR in the patient's CSF was confirmed. His serum yellow fever IgM and yellow fever PRNT were positive, confirming immunity to yellow fever.
Age: 37.0
Sex: M
Vaccine: FLU4, YF, FLUX, YF
Symptoms: Lumbar puncture abnormal, Meningitis bacterial, Photophobia, Polymerase chain reaction positive, Pyrexia
Clinical narrative: 37 year old male presented with a 5 day history of severe headaches associated with fever and photophobia on 3/12. On 2/25, he had received the yellow fever vaccine (Stamaril) and influenza vaccines in preparation for travel. On 3/8 he developed severe diffuse headaches, with subsequent fevers. On 3/11 he presented to an hospital and had a CT head that was normal, and he was discharged with a diagnosis of a viral syndrome. On 3/12 he presented to hospital, and his lumbar puncture studies were concerning for meningitis (WBC 710 -> 480 [83% lymphocytes, 16% monocytes, 1% eosinophils], RBC 12 -> 3, glucose 67, protein 40). He was started on empiric vancomycin, ceftriaxone, and acyclovir while awaiting further studies and his CSF was sent to the CDC for testing for yellow fever virus PCR. Because he was clinically stable with a low suspicion for bacterial meningitis, vancomycin and ceftriaxone were stopped on 3/13. He gradually improved, and on 3/19 he had no headache, focal weakness, or fever, so he was discharged. The presence of yellow fever virus by PCR in the patient's CSF was confirmed. His serum yellow fever IgM and yellow fever PRNT were positive, confirming immunity to yellow fever.
Age: 37.0
Sex: M
Vaccine: FLU4, YF, FLUX, YF
Symptoms: Viral infection
Clinical narrative: 37 year old male presented with a 5 day history of severe headaches associated with fever and photophobia on 3/12. On 2/25, he had received the yellow fever vaccine (Stamaril) and influenza vaccines in preparation for travel. On 3/8 he developed severe diffuse headaches, with subsequent fevers. On 3/11 he presented to an hospital and had a CT head that was normal, and he was discharged with a diagnosis of a viral syndrome. On 3/12 he presented to hospital, and his lumbar puncture studies were concerning for meningitis (WBC 710 -> 480 [83% lymphocytes, 16% monocytes, 1% eosinophils], RBC 12 -> 3, glucose 67, protein 40). He was started on empiric vancomycin, ceftriaxone, and acyclovir while awaiting further studies and his CSF was sent to the CDC for testing for yellow fever virus PCR. Because he was clinically stable with a low suspicion for bacterial meningitis, vancomycin and ceftriaxone were stopped on 3/13. He gradually improved, and on 3/19 he had no headache, focal weakness, or fever, so he was discharged. The presence of yellow fever virus by PCR in the patient's CSF was confirmed. His serum yellow fever IgM and yellow fever PRNT were positive, confirming immunity to yellow fever.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dysphagia, Guillain-Barre syndrome, Headache, Loss of personal independence in daily activities, Monoplegia
Clinical narrative: patient has been hospitalized since 05/29 with Guillain-Barre syndrome
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Muscular weakness, Musculoskeletal disorder, Nausea, Nuclear magnetic resonance imaging abnormal, Peripheral swelling
Clinical narrative: patient has been hospitalized since 05/29 with Guillain-Barre syndrome
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scan abnormal
Clinical narrative: patient has been hospitalized since 05/29 with Guillain-Barre syndrome
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Aspiration, Balance disorder, Blood test abnormal, Chest discomfort, Chest pain
Clinical narrative: patient has been hospitalized since 05/29 with Guillain-Barre syndrome
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dysphagia, Dyspnoea, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: patient has been hospitalized since 05/29 with Guillain-Barre syndrome
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Gastrointestinal haemorrhage, Guillain-Barre syndrome, Intensive care, Loss of control of legs
Clinical narrative: patient has been hospitalized since 05/29 with Guillain-Barre syndrome
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal disorder, Packed red blood cell transfusion, Pain, Respiratory failure, Wheelchair user
Clinical narrative: patient has been hospitalized since 05/29 with Guillain-Barre syndrome
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: patient has been hospitalized since 05/29 with Guillain-Barre syndrome
Age: 54.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Altered state of consciousness, Dizziness, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Dizziness/of passing out that she had to lay down; Fever; Redness at injection site; Swelling at injection site; Warmth at injection site; Pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA054A, expiry date 30th November 2019) for prophylaxis.   Co-suspect products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID ACELLULAR + TETANUS TOXOID (TDAP VACCINE) for prophylaxis.   On 26th July 2019, the patient received Menveo (intramuscular) .5 ml and TDAP VACCINE. In July 2019, less than a week after receiving Menveo and not applicable after receiving TDAP VACCINE, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site pain. On 26th July 2019, the patient experienced dizziness and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the dizziness and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, injection site pain, dizziness and fever to be related to Menveo.  Additional details were provided as follows: The patient received a dose of Menveo on the right arm, as well as a dose of Tdap vaccine by Sanofi on the left arm, on the same day. On the day of injection patient experienced dizziness, fever, and feeling of passing out that she had to lay down.  At the time of this reporting, the patient was currently experiencing 3.3 cm of redness, swelling, warmth and pain to touch at the injection site on right arm.  At the time of this report, the patient had redness, swelling, warmth and pain to touch at the injection site on right arm had recovered. It was unknown if the reporter considered the dizziness, fever and and feeling of passing out that she had to lay down to be related to Tdap vaccine (by Sanofi) as well. No further details were provided.
Age: 54.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Dizziness/of passing out that she had to lay down; Fever; Redness at injection site; Swelling at injection site; Warmth at injection site; Pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA054A, expiry date 30th November 2019) for prophylaxis.   Co-suspect products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID ACELLULAR + TETANUS TOXOID (TDAP VACCINE) for prophylaxis.   On 26th July 2019, the patient received Menveo (intramuscular) .5 ml and TDAP VACCINE. In July 2019, less than a week after receiving Menveo and not applicable after receiving TDAP VACCINE, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site pain. On 26th July 2019, the patient experienced dizziness and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the dizziness and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, injection site pain, dizziness and fever to be related to Menveo.  Additional details were provided as follows: The patient received a dose of Menveo on the right arm, as well as a dose of Tdap vaccine by Sanofi on the left arm, on the same day. On the day of injection patient experienced dizziness, fever, and feeling of passing out that she had to lay down.  At the time of this reporting, the patient was currently experiencing 3.3 cm of redness, swelling, warmth and pain to touch at the injection site on right arm.  At the time of this report, the patient had redness, swelling, warmth and pain to touch at the injection site on right arm had recovered. It was unknown if the reporter considered the dizziness, fever and and feeling of passing out that she had to lay down to be related to Tdap vaccine (by Sanofi) as well. No further details were provided.
Age: 54.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Depressed level of consciousness, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Dizziness/of passing out that she had to lay down; Fever; Redness at injection site; Swelling at injection site; Warmth at injection site; Pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA054A, expiry date 30th November 2019) for prophylaxis.   Co-suspect products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID ACELLULAR + TETANUS TOXOID (TDAP VACCINE) for prophylaxis.   On 26th July 2019, the patient received Menveo (intramuscular) .5 ml and TDAP VACCINE. In July 2019, less than a week after receiving Menveo and not applicable after receiving TDAP VACCINE, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site pain. On 26th July 2019, the patient experienced dizziness and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the dizziness and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, injection site pain, dizziness and fever to be related to Menveo.  Additional details were provided as follows: The patient received a dose of Menveo on the right arm, as well as a dose of Tdap vaccine by Sanofi on the left arm, on the same day. On the day of injection patient experienced dizziness, fever, and feeling of passing out that she had to lay down.  At the time of this reporting, the patient was currently experiencing 3.3 cm of redness, swelling, warmth and pain to touch at the injection site on right arm.  At the time of this report, the patient had redness, swelling, warmth and pain to touch at the injection site on right arm had recovered. It was unknown if the reporter considered the dizziness, fever and and feeling of passing out that she had to lay down to be related to Tdap vaccine (by Sanofi) as well. No further details were provided.
Age: 54.0
Sex: F
Vaccine: MNQ, TDAP, TDAP, MNQ, TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Dizziness/of passing out that she had to lay down; Fever; Redness at injection site; Swelling at injection site; Warmth at injection site; Pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 54-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA054A, expiry date 30th November 2019) for prophylaxis.   Co-suspect products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID ACELLULAR + TETANUS TOXOID (TDAP VACCINE) for prophylaxis.   On 26th July 2019, the patient received Menveo (intramuscular) .5 ml and TDAP VACCINE. In July 2019, less than a week after receiving Menveo and not applicable after receiving TDAP VACCINE, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site pain. On 26th July 2019, the patient experienced dizziness and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site pain were not recovered/not resolved and the outcome of the dizziness and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, injection site pain, dizziness and fever to be related to Menveo.  Additional details were provided as follows: The patient received a dose of Menveo on the right arm, as well as a dose of Tdap vaccine by Sanofi on the left arm, on the same day. On the day of injection patient experienced dizziness, fever, and feeling of passing out that she had to lay down.  At the time of this reporting, the patient was currently experiencing 3.3 cm of redness, swelling, warmth and pain to touch at the injection site on right arm.  At the time of this report, the patient had redness, swelling, warmth and pain to touch at the injection site on right arm had recovered. It was unknown if the reporter considered the dizziness, fever and and feeling of passing out that she had to lay down to be related to Tdap vaccine (by Sanofi) as well. No further details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angiogram, Chest X-ray, Computerised tomogram head, Headache, Laboratory test
Clinical narrative: fever; chills; headache; This case was reported by a nurse via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), headache and chills. On an unknown date, the outcome of the fever and headache were recovered/resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the fever, headache and chills to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but it could be 53 years or 54 years. Within 6 hours of Shingrix administration, the patient developed fever, chills and headache. The patient had high fever as 103 degree F.   Fever lasted for 18 days and headache for 22 days. The reporter consented to follow up. The batch number of Shingrix was reported as AE79X, which was corrected to AC79X as per sales data sheet.      Lab Comments: on an unknown date, patient had high fever
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lumbar puncture, Meningitis viral, Neck pain, Nuclear magnetic resonance imaging brain, Overdose
Clinical narrative: fever; chills; headache; This case was reported by a nurse via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), headache and chills. On an unknown date, the outcome of the fever and headache were recovered/resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the fever, headache and chills to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but it could be 53 years or 54 years. Within 6 hours of Shingrix administration, the patient developed fever, chills and headache. The patient had high fever as 103 degree F.   Fever lasted for 18 days and headache for 22 days. The reporter consented to follow up. The batch number of Shingrix was reported as AE79X, which was corrected to AC79X as per sales data sheet.      Lab Comments: on an unknown date, patient had high fever
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Ultrasound abdomen
Clinical narrative: fever; chills; headache; This case was reported by a nurse via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), headache and chills. On an unknown date, the outcome of the fever and headache were recovered/resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the fever, headache and chills to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but it could be 53 years or 54 years. Within 6 hours of Shingrix administration, the patient developed fever, chills and headache. The patient had high fever as 103 degree F.   Fever lasted for 18 days and headache for 22 days. The reporter consented to follow up. The batch number of Shingrix was reported as AE79X, which was corrected to AC79X as per sales data sheet.      Lab Comments: on an unknown date, patient had high fever
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; chills; headache; This case was reported by a nurse via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), headache and chills. On an unknown date, the outcome of the fever and headache were recovered/resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the fever, headache and chills to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but it could be 53 years or 54 years. Within 6 hours of Shingrix administration, the patient developed fever, chills and headache. The patient had high fever as 103 degree F.   Fever lasted for 18 days and headache for 22 days. The reporter consented to follow up. The batch number of Shingrix was reported as AE79X, which was corrected to AC79X as per sales data sheet.      Lab Comments: on an unknown date, patient had high fever
Age: 24.0
Sex: F
Vaccine: MMR, MMR, TDAP
Symptoms: Fall, Headache, Presyncope, Skin laceration
Clinical narrative: Patient was given Tdap Immunization and then MMR. Patient tolerated Tdap well, after MMR was administered patient had a vasovagal response. Patient was sitting on exam table when immunizations were administered. After MMR was given patient stated that her arm was burning due to shot. Provider (myself) turned around to place needle in the sharps container. Patient had vasovagal response and fell off of exam table. I tried to stop patient from falling as she was already falling I was unable to break the fall. Patient was wearing glasses which broke and cut her right eyebrow during incident. No testing was completed. Patient advised to go to ER.
Age: 24.0
Sex: F
Vaccine: MMR, MMR, TDAP
Symptoms: Burning sensation, Fall, Presyncope, Skin laceration
Clinical narrative: Patient was given Tdap Immunization and then MMR. Patient tolerated Tdap well, after MMR was administered patient had a vasovagal response. Patient was sitting on exam table when immunizations were administered. After MMR was given patient stated that her arm was burning due to shot. Provider (myself) turned around to place needle in the sharps container. Patient had vasovagal response and fell off of exam table. I tried to stop patient from falling as she was already falling I was unable to break the fall. Patient was wearing glasses which broke and cut her right eyebrow during incident. No testing was completed. Patient advised to go to ER.
Sex: U
Vaccine: VARCEL, UNK, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: no adverse effect reported; patient received a dose of VARIVAX via intramuscular route; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, past drugs and allergies were unknown.  On 06-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) via intramuscular route (incorrect route of product administration) (lot # R002051 and expiration date: 22-JAN-2020) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). No adverse effects reported. The outcome of incorrect route of product administration and no adverse event was unknown.
Sex: U
Vaccine: VARCEL, UNK, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effect reported; patient received a dose of VARIVAX via intramuscular route; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, past drugs and allergies were unknown.  On 06-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) via intramuscular route (incorrect route of product administration) (lot # R002051 and expiration date: 22-JAN-2020) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). No adverse effects reported. The outcome of incorrect route of product administration and no adverse event was unknown.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Limb discomfort, Pain in extremity, Vaccination site induration
Clinical narrative: Patient experienced extreme swelling 4inch about 6inch in diameter, hard to touch, and red on vaccine injection site within couple hours of administration.  On 7/31/19 the swelling significantly reduced but redness travel below elbow and experience slight pain and discomfort.  Swelling and redness disappeared on 8/4/19.  Patient was closely monitored by pharmacy staffs, and on 7/30/19 was advised to take diphenhydramine 50mg and to apply ice and heat alternatively
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site swelling
Clinical narrative: Patient experienced extreme swelling 4inch about 6inch in diameter, hard to touch, and red on vaccine injection site within couple hours of administration.  On 7/31/19 the swelling significantly reduced but redness travel below elbow and experience slight pain and discomfort.  Swelling and redness disappeared on 8/4/19.  Patient was closely monitored by pharmacy staffs, and on 7/30/19 was advised to take diphenhydramine 50mg and to apply ice and heat alternatively
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site joint pain, Injection site swelling, Vaccination complication
Clinical narrative: patient complained of joints aching in shoulder and then redness spread to left elbow where elbow was enlarged.  she went to clinic and they said it was probably due to vaccine
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperaesthesia, Influenza like illness, Pain
Clinical narrative: Flu like symptoms, overall body aches, sensitive skin, chills
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Confusional state, Dizziness
Clinical narrative: patient stated he woke up with dizziness and confusion the morning after the vaccine
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Rubella antibody negative
Clinical narrative: had titers done/the titers were negative/Rubella (German measles) - negative; Information has been received from a 33 years old female pharmacist, who is also the patient,  referring to herself. The patient had no drug reactions/allergies. Information about concurrent condition, concomitant medication and medical history was not provided.  On unspecified dates as a child, the patient received two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. Other suspect therapy included sterile diluent (STERILE DILUENT) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis.  The patient reported she was pregnant (pregnancy gestation 36 weeks) at the reporting time, and had titers done on an unknown date in May 2019 (reported as approximately one and a half months ago), and was told by her unspecified physician, that the titers were negative. Rubella (German measles) was negative and unsure of the remaining results for measles and mumps (Rubella antibody negative). The patient followed by physician to seek medical attention. No treatment was given. Date of LMP was 01-NOV-2018, due date was 08-AUG-2019, date of conception was 15-NOV-2018. The pregnancy outcome was outcome pending.  The outcome of the event was unknown (present status was also reported as "no problems", unspecified). The event was considered to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). The causality between the event and sterile diluent (STERILE DILUENT) was not reported.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect reported; patient received first dose 2017 and received second dose 2019; Information has been received from a physician referring to a 15 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history and and drug reactions/allergies was not provided.   On an unspecified date in 2017, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number, expiration date and route of administration were not provided) for prophylaxis at age 14 years old. On 09-JUL-2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9)  (lot number, expiration date and route of administration were not provided) for prophylaxis at age 16 years old (inappropriate schedule of product administration). No adverse effect were reported. No product quality complaint (PQC) was identified.