chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by health care providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient with a history of recuuring shingles was administered a dose of zostavax; between the age of 35 and 40 years old; This spontaneous report was received from a registered nurse regarding a patient of unknown age (between the age 35 and 40 years old) and unknown gender. The patient's historical conditions included herpes zoster. The patient's concurrent conditions and concomitant therapies were not reported. On 09-MAR-2020 (reported as today at the time of call), the patient was vaccinated with Zoster Vaccine Live(ZOSTAVAX) (strength, dose, anatomical location, route, lot and expiry dates were not reported for re-occurrence of shingles (product use in unapproved indication and inappropriate schedule of product administration).
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: began running a low grade fever; This spontaneous report was received from a nurse who refers to himself - a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, after he received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient began running a low grade fever.  The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site haemorrhage
Clinical narrative: As injection was made, blood squirted out and streamed down my arm; This case was reported by a consumer via sales rep and described the occurrence of injection site hemorrhage in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 10 years before reporting date).   On 21st February 2020, the patient received the 1st dose of Shingrix .5 ml. On 21st February 2020, immediately after receiving Shingrix, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient for self. The age at vaccination was not reported. The patient stated that received the vaccine and blood squirted out and streamed down the arm. The pharmacist quickly blotted it and patient had concerned that part of the vaccine was lost with the blood. The patient was concerned that might have lost part or all of the vaccine because of the blood squirt and hence do not get the full protection as the dosage of the vaccine is only 0.5 ml.
Sex: U
Vaccine: VARZOS
Symptoms: Immune system disorder
Clinical narrative: feel like it lowered my immune system; This case was reported by a consumer via call center representative and described the occurrence of immune system disorder in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced immune system disorder. On an unknown date, the outcome of the immune system disorder was unknown.   It was unknown if the reporter considered the immune system disorder to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient took the last injection and felt like it lowered my immune system and was just wondering how long the side effects last. The patient asked how long does the side effects last with the shingles shot.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: I'm aching all over; I'm aching all over mostly in my arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced general body pain and pain in arm. On an unknown date, the outcome of the general body pain and pain in arm were unknown.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient had aching all over, mostly in arm. The patient asked should he take advil or ibuprofen to ease some of the aches.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My legs have soreness; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was unknown.   It was unknown if the reporter considered the leg pain to be related to Shingrix.  Additional case details were reported as follows: The patient experienced leg pain after vaccination. The patient was just wondering what side effects there are with the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain
Clinical narrative: muscle aches; Pain; Headache; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2020, the patient received Shingrix. In February 2020, less than 2 weeks after receiving Shingrix, the patient experienced muscle pain, pain and headache. On an unknown date, the outcome of the muscle pain, pain and headache were unknown.   It was unknown if the reporter considered the muscle pain, pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced muscle pain, pain and headache.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Pain, Vaccine positive rechallenge
Clinical narrative: had body ache / body's ache from head to toe; HEADACHE; discomfort; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced general body pain, headache and general discomfort. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, headache and general discomfort were unknown.   It was unknown if the reporter considered the general body pain, headache and general discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced general body pain, headache and general discomfort. This case was linked with case US2020AMR035766, reported by the same reporter for the same patient.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness
Clinical narrative: has been dizzy since receiving the shot; is having trouble with balance; This case was reported by a consumer via patient support programs and described the occurrence of dizziness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced dizziness and balance disorder. On an unknown date, the outcome of the dizziness and balance disorder were unknown.   It was unknown if the reporter considered the dizziness and balance disorder to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had dizzy and trouble with balance as well and would like to talk someone who was clinical. The caller was not clinical but could had talk to the pharmacy to see about get help with his clinical question.
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Local reaction, Neuralgia
Clinical narrative: localized reaction; neurological pain; fatigue; This case was reported by a consumer via call center representative and described the occurrence of local reaction in a female patient who received HBV (Engerix B) for prophylaxis.   The patient's past medical history included shingles (had Shingles twice). Concurrent medical conditions included shellfish allergy.   On an unknown date, the patient received the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced local reaction, nerve pain and fatigue. On an unknown date, the outcome of the local reaction, nerve pain and fatigue were unknown.   It was unknown if the reporter considered the local reaction, nerve pain and fatigue to be related to Engerix B.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient developed an adverse reaction localized reaction, neurological pain and fatigue.  The patient also mentioned she wanted to receive Shingrix, but she did not know if she can because she was allergic to Shellfish.  The patient also believes that she developed adverse reactions after Engerix-B due to this allergy.
Sex: F
Vaccine: HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: Engerix-B series due to having low titers; Engerix-B series due to having low titers; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased and therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased and therapeutic response decreased were unknown.   It was unknown if the reporter considered the therapeutic response decreased and therapeutic response decreased to be related to Hepatitis B vaccine. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the hepatitis vaccine series twice and might receive the Engerix B series due to low titers. The reporter was unsure what hep B vaccines had previously administered by patient. she could not confirm if it was Engerix B.  No other information was received      Lab Comments: On an unknown date, lab test was performed
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash pustular
Clinical narrative: itching; rash is red; rash on the back of her legs / rash is now on her arms and both wrists; small pustules within the rash area; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer (historical cancer 2018 unspecified).   On 20th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th February 2020, 20 days after receiving Shingrix, the patient experienced itchy rash, red rash, rash and pustular rash. On an unknown date, the outcome of the itchy rash, red rash, rash and pustular rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, red rash, rash and pustular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm. The patient developed rash on the back of her legs approximately 20 days after Shingrix vaccine. The patient reports that the rash was red and there are small pustules within the rash area.  The rash and symptoms are intermittent. The rash came, then went away, only to return.  The patient reports that the rash was now on her arms and both wrists, which began before reporting date. The follow up consent was not granted.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 27th January 2020, the patient received the 2nd dose of Shingrix. On 29th January 2020, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and experienced shingles. The follow up consent was granted.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Miliaria, Rash
Clinical narrative: Rash on Right upper arm - Rash does not look like an allergic rash but looks like a heat rash
Age: 0.67
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Cough, Respiratory symptom, Respiratory tract congestion
Clinical narrative: Patient's physician's office called to report the child spiked a 104'F temperature with a cough and congestion. No flu swab performed. Spoke with Mother on 3/10/2020; Mother states child still ill with respiratory symptoms and returning to physician today 3/10/2020.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Extra dose administered, Pain in extremity, Peripheral swelling
Clinical narrative: later the evening of the vaccine, pt noticed pain in the upper arm, redness, swelling. Pt went to pharmacy where vaccine was given was advised to ICE, Tylenol. Pt presents to office today with minimal swelling, redness the size of baseball continues to have pain, but states Tylenol + ICE do HELP. Patient was seen by Dr. on 3/10/2020 and was given an antibiotic for cellulitis Keflex 500 g TID x 10 days It was determined later that this patient has already had both doses of Shingrix in 2018. This was her 3rd dose! All doses were given at local pharmacies. Pt has been given a copy of her updated vaccine record to carry with her.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Dysgeusia, Feeling hot, Glossodynia, Headache
Clinical narrative: 3/10,2020 at approx. 4:30pm at Pharmacy, rec?d initial Shingrex vaccine in left deltoid.  Remained in discussion with the pharmacist for approximately 15 minutes.  I was without any adverse issues when I went to bed at 10:30. 12:30am awakened, urinated. Burning pain all of perineal area. Back in bed, sore mouth and tongue, as if burnt with hot liquid. Tongue, lips, cheeks had pins and needles tingling. I had a metallic taste in my mouth.  Skin over entire body felt very hot, though cool to touch on outside. Had pulse throbbing in head and the sensation of near to losing consciousness (This felt as I have experienced in the few seconds after pre-op anesthesia, only this time sensation cont?d and I did not lose consciousness) My pulse remained  near the usual 70bpm, but stronger throbbing.  1:25 am I phoned local ER spoke with triage RN. Temp 96.2   She advised call my personal physician, MD.  1:35am  Spoke with after-hours triage RN. After report, she advised me to go to ER. Since my husband was awake with me, I decided to avoid ER if possible, and wait to see if symptoms changed.  About 2:20am symptoms subsiding. 3am generally comfortable without symptoms. Slept from approx. 3:30am until 8am.  Generally feeling bruised sore all over. Injection site normal color, but moderately swollen, sore and quite tender to pressure. Took Advil 600mg. By 9am  tenderness of arm only discomfort.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Oral pain, Pain, Paraesthesia
Clinical narrative: 3/10,2020 at approx. 4:30pm at Pharmacy, rec?d initial Shingrex vaccine in left deltoid.  Remained in discussion with the pharmacist for approximately 15 minutes.  I was without any adverse issues when I went to bed at 10:30. 12:30am awakened, urinated. Burning pain all of perineal area. Back in bed, sore mouth and tongue, as if burnt with hot liquid. Tongue, lips, cheeks had pins and needles tingling. I had a metallic taste in my mouth.  Skin over entire body felt very hot, though cool to touch on outside. Had pulse throbbing in head and the sensation of near to losing consciousness (This felt as I have experienced in the few seconds after pre-op anesthesia, only this time sensation cont?d and I did not lose consciousness) My pulse remained  near the usual 70bpm, but stronger throbbing.  1:25 am I phoned local ER spoke with triage RN. Temp 96.2   She advised call my personal physician, MD.  1:35am  Spoke with after-hours triage RN. After report, she advised me to go to ER. Since my husband was awake with me, I decided to avoid ER if possible, and wait to see if symptoms changed.  About 2:20am symptoms subsiding. 3am generally comfortable without symptoms. Slept from approx. 3:30am until 8am.  Generally feeling bruised sore all over. Injection site normal color, but moderately swollen, sore and quite tender to pressure. Took Advil 600mg. By 9am  tenderness of arm only discomfort.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Perineal pain
Clinical narrative: 3/10,2020 at approx. 4:30pm at Pharmacy, rec?d initial Shingrex vaccine in left deltoid.  Remained in discussion with the pharmacist for approximately 15 minutes.  I was without any adverse issues when I went to bed at 10:30. 12:30am awakened, urinated. Burning pain all of perineal area. Back in bed, sore mouth and tongue, as if burnt with hot liquid. Tongue, lips, cheeks had pins and needles tingling. I had a metallic taste in my mouth.  Skin over entire body felt very hot, though cool to touch on outside. Had pulse throbbing in head and the sensation of near to losing consciousness (This felt as I have experienced in the few seconds after pre-op anesthesia, only this time sensation cont?d and I did not lose consciousness) My pulse remained  near the usual 70bpm, but stronger throbbing.  1:25 am I phoned local ER spoke with triage RN. Temp 96.2   She advised call my personal physician, MD.  1:35am  Spoke with after-hours triage RN. After report, she advised me to go to ER. Since my husband was awake with me, I decided to avoid ER if possible, and wait to see if symptoms changed.  About 2:20am symptoms subsiding. 3am generally comfortable without symptoms. Slept from approx. 3:30am until 8am.  Generally feeling bruised sore all over. Injection site normal color, but moderately swollen, sore and quite tender to pressure. Took Advil 600mg. By 9am  tenderness of arm only discomfort.
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Hyperhidrosis, Pruritus, Urticaria
Clinical narrative: ITCHY FACE, URTICARIA, DIAPHORESIS.  BENADRYL 25MG IM DECADRON 8MG IM
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: CSF test abnormal, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Lower extremity weakness with unstable gait beginning 2/28/2020. Guillain-Barre syndrome diagnosed 03/09/2020 by MRI and CSF studies. No preceding upper respiratory or gastrointestinal symptoms. Treated with total 2g IVIG over 5 days.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging spinal abnormal, Muscular weakness
Clinical narrative: Lower extremity weakness with unstable gait beginning 2/28/2020. Guillain-Barre syndrome diagnosed 03/09/2020 by MRI and CSF studies. No preceding upper respiratory or gastrointestinal symptoms. Treated with total 2g IVIG over 5 days.
Age: 27.0
Sex: M
Vaccine: MMR
Symptoms: Presyncope
Clinical narrative: Patient had brief (appx 10-15 seconds) vasovagal episode approximately 5 minutes after vaccine was given.  He was seated in a chair and observed by NP during the episode.  HR 50s. BP stable.  No injuries.  Recovered quickly.  Stated afterwards that he has this reaction with needle sticks.  discharged home
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Peripheral coldness, Pyrexia, Skin warm
Clinical narrative: Right arm pain/hot arm starting the next day for 5 days. It was severe for 4 days. Fever 3 days 99.3-102.8. Chills with cold hands and feet for 3 days with fever. Treated with Aleve and Ibuprofen 4 days. Hot pack on 4th day to arm with moderate relief
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging, Nerve conduction studies
Clinical narrative: Patient's wife left a voicemail at the Research Unit on 3/8/2020 notifying staff that the patient had been hospitalized and diagnosed with Guillain-Barre Syndrome. A nurse returned the phone call on 3/9/2020 and spoke with patient's wife. She reported that his symptoms began on 3/4/2020 and continued to progress. He was hospitalized on 3/5/2020 and diagnosed with GBS. At the time of this report, patient remains hospitalized.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache, Influenza like illness
Clinical narrative: Flu-like episode. Vomiting, watery diarrhea. Forehead pain [different than usual], extreme chills, no fever. Neck extremely sore. [Sore due to gardening the day before plus vomiting 6 times]. Upset stomach tasting like eggs. The extreme chills is unusual for me. Every other time in my entire life after I have thrown up, I have run a fever/had hot flashes. Not this time. I also have apx. 2 inch bruise on my left arm. I do not normally bruise after injections. Maybe a small bruise, but not one of this size.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Neck pain, Pain, Vomiting
Clinical narrative: Flu-like episode. Vomiting, watery diarrhea. Forehead pain [different than usual], extreme chills, no fever. Neck extremely sore. [Sore due to gardening the day before plus vomiting 6 times]. Upset stomach tasting like eggs. The extreme chills is unusual for me. Every other time in my entire life after I have thrown up, I have run a fever/had hot flashes. Not this time. I also have apx. 2 inch bruise on my left arm. I do not normally bruise after injections. Maybe a small bruise, but not one of this size.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: Blotchy Red spot about 2 inches below where injection was given
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal X-ray, Back pain, Culture urine negative, Rash, Urine analysis normal
Clinical narrative: A lot of pain in lower back (left side). Three days later broke out in a rash.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray normal
Clinical narrative: A lot of pain in lower back (left side). Three days later broke out in a rash.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reported to the pharmacy 4 days after receiving his second dose of Shingrix stating that he had loss of strength in his left hand, Patient states that it is warm to the touch, and that he cannot touch his pinky to his thumb. Upon looking at the patient's hand it is quite swollen compared to the other hand, particularly at the thumb. Patient reports that does hurt, but it is not unbearable pain.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash
Clinical narrative: Mother states she noticed a rash at injection site on the night the vaccine was administered. Left arm is not swollen or warm to touch.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, MNQ
Symptoms: Extra dose administered, Wrong patient received product
Clinical narrative: Immunizations were given in error to the wrong student. The student who received the immunizations had a complete immunization record for school prior to these vaccines being administered.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Dizziness, Myalgia, Pyrexia, Vomiting
Clinical narrative: Fever, dizziness, vomiting, muscle aches, upper stomach pain
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: (L) upper arm redness & induration, 9x8cm. Pain onset immediately after injection 3/9/20 Redness & swelling notice by patient later that evening. No systemic RXN.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: (L) upper arm redness & induration, 9x8cm. Pain onset immediately after injection 3/9/20 Redness & swelling notice by patient later that evening. No systemic RXN.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Rash, Rash macular, Rash papular
Clinical narrative: erythematous macular papular rash over trunk 2 days after vaccine (3/4)
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash, Urticaria
Clinical narrative: Patient returned same day after receiving vaccines, approximately 4 hours later mom noted urticaria on face (cheeks bilateral) and then arm. Reaction disappears and reappears, spreading. Following day rash was spreading. Mom advised to give BENADRYL, which helped a little. Following 2 days mom still noted waxing and waning of symptoms, but baby comfortable, feeding well.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash & RASH VALACYCLOVIR 1000 MG TID TAKE ONE TABLET BY MOUTH THREE TIMES DAILY
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Breath sounds abnormal, Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: It went into a cough gradually and somewhat of a fever; I was getting over it when I came down with another fever with a cough you could not get over; sounds in my throat (like the windpipe); weak too, very weak; It went into a cough gradually and somewhat of a fever; I was getting over it when I came down with another fever with a cough you could not get over; throat is a little itching; terrible sore throat; This spontaneous report refers to a 67-year-old male patient, who was reporting on himself. The patient's concomitant therapies included unspecified blood thinner. His drug reactions or allergies included penicillin (unspecified) and acetaminophen (TYLENOL). No information regarding the patient's pertinent medical history was provided.  On 11-DEC-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 13-DEC-2019, the patient experienced a terrible sore throat. It went into a cough gradually and somewhat of a fever. He was very weak too. The patient was getting over it when he came down with another fever with a cough which he could not get over on an unspecified date. When he breathed in, there were sounds in his throat like the windpipe. On an unknown dates, the patient took cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D), eucalyptus oil (+) menthol (FISHERMAN'S FRIEND) and diphenhydramine hydrochloride (BENADRYL) for cough. On 20-FEB-2020, the patient reported his throat was a little itching.  The outcome of the events "terrible sore throat, it went into a cough gradually and somewhat of a fever, he was very weak too" was reported as recovering. The outcome of "another fever with a cough, throat is a little itching and sounds in my throat" was unknown. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: M
Vaccine: PPV
Symptoms: Throat irritation
Clinical narrative: It went into a cough gradually and somewhat of a fever; I was getting over it when I came down with another fever with a cough you could not get over; sounds in my throat (like the windpipe); weak too, very weak; It went into a cough gradually and somewhat of a fever; I was getting over it when I came down with another fever with a cough you could not get over; throat is a little itching; terrible sore throat; This spontaneous report refers to a 67-year-old male patient, who was reporting on himself. The patient's concomitant therapies included unspecified blood thinner. His drug reactions or allergies included penicillin (unspecified) and acetaminophen (TYLENOL). No information regarding the patient's pertinent medical history was provided.  On 11-DEC-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 13-DEC-2019, the patient experienced a terrible sore throat. It went into a cough gradually and somewhat of a fever. He was very weak too. The patient was getting over it when he came down with another fever with a cough which he could not get over on an unspecified date. When he breathed in, there were sounds in his throat like the windpipe. On an unknown dates, the patient took cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D), eucalyptus oil (+) menthol (FISHERMAN'S FRIEND) and diphenhydramine hydrochloride (BENADRYL) for cough. On 20-FEB-2020, the patient reported his throat was a little itching.  The outcome of the events "terrible sore throat, it went into a cough gradually and somewhat of a fever, he was very weak too" was reported as recovering. The outcome of "another fever with a cough, throat is a little itching and sounds in my throat" was unknown. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   In 2014, the patient was vaccinated with a dose of the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, anatomical location and administration route were not reported) at a medicine institute, for the long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX inoculation, patient was treated by a physician for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (on an unknown date), physician care, monitoring, treatment, medications, and supplies. By the time of the report, the patient did not recover from shingles. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster
Clinical narrative: shingles; On or about February 3, 2016 and on April 19, 2016, pt was inoculated with ZOSTAVAX; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   On 03-FEB-2016 and on 19-APR-2016, the patient was vaccinated with two doses of the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, anatomical location and administration route were not reported) at a clinic, for the long-term prevention of shingles and/or zoster-related conditions (extra dose administered) at a pharmacy. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX inoculation, patient was treated by a healthcare provider at emergency department for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization (on an unknown date), physician care, monitoring, treatment, medications, and supplies. By the time of the report, the patient did not recover from shingles. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions as prescribed and/or administered by a pharmacist. Subsequent to the patient zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a healthcare provider in a hospital for shingles (herpes zoster). As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, plaintiff had and would continue suffer ongoing injuries, including but no limited to: mental and physical pain and suffering; medical care and treatment for this injury; significant medical and related expenses as a result of these injuries. The outcome of the event was considered not recovered. The event was considered related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: MMRV
Symptoms: Contraindication to vaccination, Disseminated varicella zoster vaccine virus infection, Rash, Vaccination error
Clinical narrative: he had inadvertently had the MMR-varicella vaccine (MMRV, ProQuad); Contraindicated product administered;   This literature marketed report was received from the authors of a published literature article, and refers to a 4-year-old male patient. The patient's medical history included end-stage kidney disease (ESKD) secondary to kidney dysplasia, peritoneal dialysis and hemodialysis prior to transplant. His post-transplant course had been complicated by recurrent Clostridium difficile colitis, which had responded well to treatment. He had no history of rejection. He had demonstrated positive varicella, measles, mumps, and rubella IgG titers prior to his kidney transplant and after his primary vaccinations, which were given at one year of age, with a second dose 7 months later. Both were given while the patient was receiving maintenance dialysis.  On an unknown date, the child inadvertently received measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # and expiration date were not reported) at a routine well-child visit 16 months after receiving a living donor kidney transplant (vaccination error) which was contraindicated for children after solid organ transplantation. The patient was admitted with rash and documented disseminated varicella infection 5 weeks later. He was treated with intravenous acyclovir followed by oral therapy and recovered fully. The outcome of vaccination error and contraindicated product administered was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was treated by a healthcare provider. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unspecified date, the patient experienced shingles and was treated by a healthcare provider. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 30-APR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia, Vaccine positive rechallenge
Clinical narrative: myalgia; mild-fever; mild headache; This case was reported by a other health professional and described the occurrence of myalgia in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (on 19th September 2019, received 1st dose For tolerance of 1st dose, refer linked case US2019AMR172657.).   On 17th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced myalgia, fever and headache. Rechallenge with Shingrix was positive. On 19th February 2020, the outcome of the myalgia, fever and headache were recovered/resolved.   It was unknown if the reporter considered the myalgia, fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced myalgia, mild fever and mild headache. This case was linked with case US2019AMR172657, reported by the same reporter for the same patient.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Loss of consciousness
Clinical narrative: After giving the HPV vaccine, I asked the patient if she was feeling ok. She replied yes. As I was talking to mother about patients sibling, I heard a noise. The patient got off the exam table when I was talking to mother and she had fallen back against the wall. The physician came in and checked her vitals. She regained consciousness and was told to sit in the chair. After a few minutes she was helped on the exam table to lie down. Vitals were rechecked and did not leave until the physician gave the ok for her to leave.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, C-reactive protein normal, Computerised tomogram head normal, Culture urine negative, Full blood count normal
Clinical narrative: Patient presented to office on 2/24/2020 with fussiness and decreased intake. He was noted to have poor muscle tone and pain with flexion/extension of neck. Patient was sent to ER by private vehicle with parents where he diagnosed with HHV 6 encephalitis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Herpes simplex test negative, Human herpesvirus 6 encephalitis, Hypophagia, Hypotonia, Influenza virus test negative
Clinical narrative: Patient presented to office on 2/24/2020 with fussiness and decreased intake. He was noted to have poor muscle tone and pain with flexion/extension of neck. Patient was sent to ER by private vehicle with parents where he diagnosed with HHV 6 encephalitis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Lumbar puncture normal, Metabolic function test normal, Neck pain, Pain
Clinical narrative: Patient presented to office on 2/24/2020 with fussiness and decreased intake. He was noted to have poor muscle tone and pain with flexion/extension of neck. Patient was sent to ER by private vehicle with parents where he diagnosed with HHV 6 encephalitis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Polymerase chain reaction, Procalcitonin normal, Respiratory syncytial virus test negative, Roseolovirus test positive, Urine analysis normal
Clinical narrative: Patient presented to office on 2/24/2020 with fussiness and decreased intake. He was noted to have poor muscle tone and pain with flexion/extension of neck. Patient was sent to ER by private vehicle with parents where he diagnosed with HHV 6 encephalitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting and diarrhea starting the evening after immunizations.  worsened the next evening with nonbloody liquid diarrhea several times each hour and nonbloody nonbilious emesis.  supportive care with Zofran and fluids.