chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: tenderness at the injection site/ injection site pain; myalgia; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th May 2019, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On an unknown date, the patient experienced myalgia. On an unknown date, the outcome of the injection site tenderness was unknown and the outcome of the myalgia was recovered/resolved.   It was unknown if the reporter considered the injection site tenderness and myalgia to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. From the day of vaccination, the patient experienced injection site pain. Also,the patient started to experience whole body myalgia, unspecified the start date, but the myalgia did resolve in 2 weeks. Additional information not provided. The reporter consented to follow up. For tolerance to 2nd dose, refer linked case US2019AMR181546. This is 1 of the 2 cases reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Neurological symptom, Product complaint
Clinical narrative: Product Complaint; neurological symptoms; numb tongue; This case was reported by a pharmacist via call center representative and described the occurrence of neurological symptom in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis. The case was associated with product complaint.  On 25th September 2019, the patient received FluLaval Tetra 2019-2020 season. On 27th September 2019, 2 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced neurological symptom and numbness of tongue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the neurological symptom, numbness of tongue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the neurological symptom and numbness of tongue to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient reported to the emergency room with neurological symptoms, specifically numb tongue.   The reporter consented to follow up. The case has been linked to the cases US2019176211, US2019176209, reported by same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever reported of 101F; Whole body aches developed/ Achy; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2019 16:00, the patient received the 1st dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose Shingrix vaccine in her left upper arm. On 30th September 2019, during the middle of the night a fever reported of 101F and whole body aches developed. The events Fever and aches are unresolved. The reporter was consented to follow up. The reporter did not know lot number and expiry date, volume administered or exact route of administration.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Muscle Soreness; Arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th June 2021) for prophylaxis.   On 27th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced muscle soreness and pain in arm. On an unknown date, the outcome of the muscle soreness was not recovered/not resolved and the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the muscle soreness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was still having muscle soreness. Not numbness or shooting pain, just periodic muscle soreness. The reporter was consented to follow up. The reporter batch number T19BR, does not exist in sales datasheet was updated as TT9BR as per sales datasheet. This case has been linked with US2019172823 having same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: Nausea; Headache; 100.9 F fever; Sweaty; Her arm hurt all day; Diarrhea; Injection was very painful the day of vaccination; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 28th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 29th September 2019, the patient experienced nausea, headache, fever, sweating, pain in arm and diarrhea. On 30th September 2019, the outcome of the injection site pain, nausea, headache, fever, sweating and pain in arm were recovered/resolved. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the injection site pain, nausea, headache, fever, sweating, pain in arm and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter reports his mother received 2nd dose of Shingrix and the injection was very painful the day of vaccination. The reporter the next day on 29th September 2019 she had significant nausea, headache, 100.9F fever, diarrhea, sweaty, and that her arm hurt all day. On 30th September 2019, Today, caller reports his mother was coming around everything was all better. The reporter was consented to follow up. The reporter forgot to ask caller for vaccination facility details.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Nausea; Headache; 100.9 F fever; Sweaty; Her arm hurt all day; Diarrhea; Injection was very painful the day of vaccination; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 28th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 29th September 2019, the patient experienced nausea, headache, fever, sweating, pain in arm and diarrhea. On 30th September 2019, the outcome of the injection site pain, nausea, headache, fever, sweating and pain in arm were recovered/resolved. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the injection site pain, nausea, headache, fever, sweating, pain in arm and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter reports his mother received 2nd dose of Shingrix and the injection was very painful the day of vaccination. The reporter the next day on 29th September 2019 she had significant nausea, headache, 100.9F fever, diarrhea, sweaty, and that her arm hurt all day. On 30th September 2019, Today, caller reports his mother was coming around everything was all better. The reporter was consented to follow up. The reporter forgot to ask caller for vaccination facility details.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness began to appear to the left of the injection site; Itchness / Arm was still currently itchy; Fatigue; Soreness at injection site; Difficult to sleep; Injection site started to feel hot / Injection site was now warm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th September 2019, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site pain and difficulty sleeping. On 26th September 2019, the patient experienced fatigue. On 27th September 2019, the patient experienced injection site erythema and pruritus. On an unknown date, the outcome of the injection site erythema, pruritus and injection site warmth were not recovered/not resolved and the outcome of the fatigue and injection site pain were recovered/resolved and the outcome of the difficulty sleeping was unknown.   It was unknown if the reporter considered the injection site erythema, pruritus, injection site warmth, fatigue, injection site pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine on right arm. The reporter indicated that the night after receiving the Shingrix vaccine she developed soreness at the injection site that made it difficult to sleep. The redness began to appear to the left of the injection site (measuring 2 inches long and 1.5 inches wide) on Friday, September 27th, 2019, as well as itchiness. The redness was lighter. The injection site started to feel hot within a day of receiving the vaccination. Currently, the injection site was now warm. The patient arm was still currently itchy. She experienced fatigue that started on Thursday, September 26th, 2019, through Sunday, September 29th, 2019. The reporter did not consent to follow-up. The reporter would not provide any additional information. She was difficult to follow because she kept changing her description of the adverse events.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Redness began to appear to the left of the injection site; Itchness / Arm was still currently itchy; Fatigue; Soreness at injection site; Difficult to sleep; Injection site started to feel hot / Injection site was now warm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th September 2019, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site pain and difficulty sleeping. On 26th September 2019, the patient experienced fatigue. On 27th September 2019, the patient experienced injection site erythema and pruritus. On an unknown date, the outcome of the injection site erythema, pruritus and injection site warmth were not recovered/not resolved and the outcome of the fatigue and injection site pain were recovered/resolved and the outcome of the difficulty sleeping was unknown.   It was unknown if the reporter considered the injection site erythema, pruritus, injection site warmth, fatigue, injection site pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine on right arm. The reporter indicated that the night after receiving the Shingrix vaccine she developed soreness at the injection site that made it difficult to sleep. The redness began to appear to the left of the injection site (measuring 2 inches long and 1.5 inches wide) on Friday, September 27th, 2019, as well as itchiness. The redness was lighter. The injection site started to feel hot within a day of receiving the vaccination. Currently, the injection site was now warm. The patient arm was still currently itchy. She experienced fatigue that started on Thursday, September 26th, 2019, through Sunday, September 29th, 2019. The reporter did not consent to follow-up. The reporter would not provide any additional information. She was difficult to follow because she kept changing her description of the adverse events.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Fatigue; Body Aches; This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date unknown) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix. On 19th August 2019, less than a day after receiving Shingrix, the patient experienced fever, fatigue and general body pain. On an unknown date, the outcome of the fever, fatigue and general body pain were unknown.   It was unknown if the reporter considered the fever, fatigue and general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient that had fever, fatigue, and body aches after receiving the first dose of shingrix. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reports a patient experienced muscle pain after getting the first Shingrix vaccination. The reporter was consented to follow up. The pharmacist stated she was calling from home and did not have other details about the product (lot number, expiration date), or patient details at the time of the initial report. This case has been linked with US2019AMR177866 having same patient (dose 2).
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dizziness, Fatigue, Nausea, Pain
Clinical narrative: Dizziness; Fatigue; Achy all over; fever; Chills; Nauseated; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 4SN3Y, expiry date 21st January 2022) and (batch number 4F7B4, expiry date 15th January 2021) for prophylaxis.   On 18th September 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced dizziness, fatigue, general body pain, fever, chills and nausea. On an unknown date, the outcome of the dizziness, fatigue, general body pain, fever, chills and nausea were unknown.   It was unknown if the reporter considered the dizziness, fatigue, general body pain, fever, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter asked any information on this type of reaction lasting 12 days. The health care professional stated the patient experience dizziness, fatigued, achy all over, fever, chills, nauseated. The adverse event was collected The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Dizziness; Fatigue; Achy all over; fever; Chills; Nauseated; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 4SN3Y, expiry date 21st January 2022) and (batch number 4F7B4, expiry date 15th January 2021) for prophylaxis.   On 18th September 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced dizziness, fatigue, general body pain, fever, chills and nausea. On an unknown date, the outcome of the dizziness, fatigue, general body pain, fever, chills and nausea were unknown.   It was unknown if the reporter considered the dizziness, fatigue, general body pain, fever, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The reporter asked any information on this type of reaction lasting 12 days. The health care professional stated the patient experience dizziness, fatigued, achy all over, fever, chills, nauseated. The adverse event was collected The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on neck; This case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 20 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The dental hygienist reported that she experienced an itchy rash on her neck approximately 20 days after receiving her first dose of Shingrix. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Rash erythematous, Rash pruritic
Clinical narrative: Itchy rash on neck; This case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 20 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The dental hygienist reported that she experienced an itchy rash on her neck approximately 20 days after receiving her first dose of Shingrix. The reporter did not consent to follow-up.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Lip swelling, Nasopharyngitis, Peripheral swelling, Pruritus
Clinical narrative: Morning after flu vaccine, noticed rash on both thighs.  On Sunday am (10/6), face and hands were swollen.  Hives noticed on waking (legs, arms, stomach).  Took Benadryl on Sunday, Monday, Tuesday, and today (2 tablets three times daily).  Hives improving, however, remains itchy.  Face improved but still swollen...lips feel swollen.  Today (10/9/19) has symptoms of a cold (stuffy, cough x 1 week - prior to flu vaccine, itchy eyes - after vaccine).  No fever.  No shortness of breath.  Employee is encouraged to contact her private practitioner or go to ED for evaluation (prefers her private practitioner).
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Morning after flu vaccine, noticed rash on both thighs.  On Sunday am (10/6), face and hands were swollen.  Hives noticed on waking (legs, arms, stomach).  Took Benadryl on Sunday, Monday, Tuesday, and today (2 tablets three times daily).  Hives improving, however, remains itchy.  Face improved but still swollen...lips feel swollen.  Today (10/9/19) has symptoms of a cold (stuffy, cough x 1 week - prior to flu vaccine, itchy eyes - after vaccine).  No fever.  No shortness of breath.  Employee is encouraged to contact her private practitioner or go to ED for evaluation (prefers her private practitioner).
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Erythema, Immediate post-injection reaction
Clinical narrative: Pt immediately turned a deep red color to her face arms and chest.  She stated that she felt pressure in her chest causes respiratory compromise as if she couldn't breathe.  I had a epi-pen in my office and I immediately gave her the epi-pen in her thigh.  She became better within a few seconds.  911 was called and the paramedics came.  Pt. refused to go to the ED but did go to her PCP.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory disorder
Clinical narrative: Pt immediately turned a deep red color to her face arms and chest.  She stated that she felt pressure in her chest causes respiratory compromise as if she couldn't breathe.  I had a epi-pen in my office and I immediately gave her the epi-pen in her thigh.  She became better within a few seconds.  911 was called and the paramedics came.  Pt. refused to go to the ED but did go to her PCP.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe headache, significant left arm and site of injection pain, sit of injection swollen, red and hot to the touch
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Severe headache, significant left arm and site of injection pain, sit of injection swollen, red and hot to the touch
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: flu like symptoms for 3 days - achey body, headache, diarrhea, nausea, fatigue
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: flu like symptoms for 3 days - achey body, headache, diarrhea, nausea, fatigue
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain
Clinical narrative: Painful red appeared approximately 48 hours after injection administration; ~6inches below the injection site.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose, Diplopia, Disorientation, Dizziness, Headache
Clinical narrative: Pt did not have reaction until about 25  min after shot administered. He began feeling dizzy, had headache and double vision once he got to his vehicle. Also had disorientation of location and who was with him. Once brought back the clinic he was given juice and snack. Vitals and glucose taken. Medicine given for headache. Provider in room to assess pt. Monitored for about an hour until recovery. Pt double vision resolved along with headache and dizziness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Trigeminal neuralgia
Clinical narrative: The next morning, patient's trigeminal neuralgia flared up.  There were no other events (weather, wind, etc) that precipitated the outbreak.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Musculoskeletal pain, Neuralgia, Pain in extremity
Clinical narrative: Patient reports severe arm swelling. She reports having nerve pain that started in her arm and went to her neck followed by a headache.  She also reported spiking a fever and feeling sick for about 3 days after the vaccine. 4 days after administration the nerve pain went to L4 in her back and she is experiencing pain in her buttocks down through her left thigh. It is now day 9 since her vaccine, it has not spread any further but the pain is still residing in her buttocks/thigh. She has been treating with Acetaminophen and Ibuprofen with minimal relief.  Today (10/09/19) she was prescribed a medrol dose pack.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient reports severe arm swelling. She reports having nerve pain that started in her arm and went to her neck followed by a headache.  She also reported spiking a fever and feeling sick for about 3 days after the vaccine. 4 days after administration the nerve pain went to L4 in her back and she is experiencing pain in her buttocks down through her left thigh. It is now day 9 since her vaccine, it has not spread any further but the pain is still residing in her buttocks/thigh. She has been treating with Acetaminophen and Ibuprofen with minimal relief.  Today (10/09/19) she was prescribed a medrol dose pack.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient presented to health unit on 10.09.19 reporting had Flu vaccine on 10.07.19 and onset of rash and hives 10.08.19. Diffuse rash all over body noted, more concentrated in trunk and abdomen and neck area. Extends to arms and legs but less intense. C/O itching. Denies new medications, or exposure to any other allergic items. Only thing patient thinks that he did different is to get the flu vaccine. Is taking numerous meds and has hx of psoriasis and there are obvious patches of psoriasis but the rash is different in appearance. No sob, difficulty swallowing  or fever reported. APRN did examine patient and prescribe Benadryl otc as directed, and steroid dose pack.
Age: 19.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain
Clinical narrative: Severe headache, moderate nausea and vomiting, moderate to severe  body aches/muscle pain throughout body, moderate to severe fatigue. Treating with APAP, warm baths, rest, clear fluids.
Age: 19.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Vomiting
Clinical narrative: Severe headache, moderate nausea and vomiting, moderate to severe  body aches/muscle pain throughout body, moderate to severe fatigue. Treating with APAP, warm baths, rest, clear fluids.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: Within 10 minutes of receiving Pneumovax, she began to struggle for breath.  She was still able to speak, was sitting upright in chair, but was holding her chest saying she was having difficulty breathing.  Administered Epipen as manager dialed 911.  I continued to monitor her as manager continued call to 911.  About 5-7 minutes after Epipen, she stated that her breathing was becoming easier.  Fire and Paramedics arrived shortly after this.  They decided to go ahead and take her to Hospital because they were afraid her breathing may have become difficult again as the Epipen left her system.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site erythema
Clinical narrative: Nickel sized redness at injection site, 103 temp x2 days
Age: 78.0
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: patient reports difficulty catching his breath beginning 5 to 6 hours after injection and lasting 3 to 4 hours.  breathing was helped by using albuterol (inhaler did not belong to him) and he reports that the next day he felt fine.
Age: 12.0
Sex: F
Vaccine: YF
Symptoms: CSF glucose normal, CSF immunoglobulin increased, CSF protein increased, CSF red blood cell count positive, CSF virus identified
Clinical narrative: Encephalitis/meningitis (sore throat, vomiting, neck pain)  Patient recently returned from trip where traveled from 6/27/19 to 7/5/19. She received YF vaccine on 6/13/2019 (only vaccine that day)
Age: 12.0
Sex: F
Vaccine: YF
Symptoms: CSF white blood cell count increased, Dengue virus test negative, Encephalitis, Flavivirus test negative, Flavivirus test positive
Clinical narrative: Encephalitis/meningitis (sore throat, vomiting, neck pain)  Patient recently returned from trip where traveled from 6/27/19 to 7/5/19. She received YF vaccine on 6/13/2019 (only vaccine that day)
Age: 12.0
Sex: F
Vaccine: YF
Symptoms: Foreign travel, Meningitis, Neck pain, Oropharyngeal pain, Polymerase chain reaction
Clinical narrative: Encephalitis/meningitis (sore throat, vomiting, neck pain)  Patient recently returned from trip where traveled from 6/27/19 to 7/5/19. She received YF vaccine on 6/13/2019 (only vaccine that day)
Age: 12.0
Sex: F
Vaccine: YF
Symptoms: Viral test negative, Vomiting, West Nile virus test negative
Clinical narrative: Encephalitis/meningitis (sore throat, vomiting, neck pain)  Patient recently returned from trip where traveled from 6/27/19 to 7/5/19. She received YF vaccine on 6/13/2019 (only vaccine that day)
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Wrong technique in product usage process
Clinical narrative: Instead of the Flu-Mist being given 0.1 ml in each nostril the whole 0.2mL was given in one nostril.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: Saturday patient started having swelling, redness and inflammation of the left arm with difficulty raising arm. patient stated that it got better by Monday. Patient applied cold compress 15-20 minutes about 4 times a day.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient called reporting she had a fever and was nauseous. I recommended she go to her PCP. Patient called back after being seen by PCP. They gave her something for the nausea and told her to take tylenol for the fever.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Initial pain and swelling, patient is still experiencing reduced pain and swelling at localized injection site.
Age: 7.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event reported. The vaccine was given out of manufacturer guidelines. (child was too young to receive vaccine)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypersensitivity, Injection site pain, Rash, Skin hyperpigmentation
Clinical narrative: According to patient's husband who is a physician, patient has a rash on her back dermatone on right side. Patient experienced pain at site of injection and hypersensitivity after 3 days of the vaccination. Pigmentation up to upper back. Patient visited Dr. for treatment of the adverse side effects and  was given a course of Valtrex after 5 days of vaccination.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Lip pruritus, Pain, Pruritus, Rash
Clinical narrative: Within 10 minutes, itching at the site.  Itching spread to arm and trunk, then noted rash down arm and trunk.  Within 2 hours, Itching began on lips, body aches began and care was provided to reduce the reaction, Hydroxyzine 50 mg po.  Symptoms resolved but body aches continued x 2 days.
Age: 40.0
Sex: F
Vaccine: FLUN4
Symptoms: Wrong technique in product usage process
Clinical narrative: Nasal Flu Vaccine was given the full dose in one nostril (0.2ml) instead of 0.1ml given in each nostril.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Cough, Dry throat, Hypoaesthesia oral, Lip swelling
Clinical narrative: Bottom lip tingly, puffy and numb.  Also, top of throat felt that it was swollen and dry.  Coughing as well. Chest area felt a burning sensation.  Took a dose of oral Benadryl and that helped and the symptoms are waning after 2 hours post vaccination, but still have some tingling to the lower lip.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Pharyngeal swelling
Clinical narrative: Bottom lip tingly, puffy and numb.  Also, top of throat felt that it was swollen and dry.  Coughing as well. Chest area felt a burning sensation.  Took a dose of oral Benadryl and that helped and the symptoms are waning after 2 hours post vaccination, but still have some tingling to the lower lip.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dyspnoea, Erythema, Flushing, Headache
Clinical narrative: Patient received a Fluzone HD. After 5 minutes she returned to the pharmacy stating she had a reaction. Her face was very flushed/red. I brought her to the IMZ booth and asked her if she had any itching or shortness of breathe. The patient stated she had shortness of breathe. I prepared benadryl and Epipen for the patient in case needed. Patients face started to look better and the redness went down. She also stated her breathing was better. She then complained of a lower back spasm. I asked if she wanted to lie down however she preferred to stay seated. The back pain got better however she complained of lower neck/ head pain. A low grade dull pain. EMS arrived and took all vitals, which were normal. They, like myself, assumed it was more of an unexplained reaction than an allergic reaction since no medication was administered. She stated she felt better and spoke with management about filling out forms for the store.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Neck pain
Clinical narrative: Patient received a Fluzone HD. After 5 minutes she returned to the pharmacy stating she had a reaction. Her face was very flushed/red. I brought her to the IMZ booth and asked her if she had any itching or shortness of breathe. The patient stated she had shortness of breathe. I prepared benadryl and Epipen for the patient in case needed. Patients face started to look better and the redness went down. She also stated her breathing was better. She then complained of a lower back spasm. I asked if she wanted to lie down however she preferred to stay seated. The back pain got better however she complained of lower neck/ head pain. A low grade dull pain. EMS arrived and took all vitals, which were normal. They, like myself, assumed it was more of an unexplained reaction than an allergic reaction since no medication was administered. She stated she felt better and spoke with management about filling out forms for the store.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Echocardiogram, Fatigue, Heart rate irregular, Influenza like illness
Clinical narrative: flulike symptoms for a week, sore arm for several days, fatigue, irregular heart beat and severe burning in chest when taking a walk.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Scan myocardial perfusion
Clinical narrative: flulike symptoms for a week, sore arm for several days, fatigue, irregular heart beat and severe burning in chest when taking a walk.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Discomfort, Limb discomfort, Peripheral swelling, Pruritus
Clinical narrative: The inside of my arm was swollen by the morning after receiving the shot. This swelling was not around the site of injection, it was under my armpit. The area was extremely tender and somewhat itchy.  I felt it was my lymph node but it was hard to place my arm down flat. By Sunday (shot was on Friday), the swelling was starting to decrease.  The other symptom included burning sensation going down the inside of my arm to my elbow the first day and by the second day the burning and discomfort went to my forearm/wrist. I felt like I had a softball under my arm. There was no drainage or redness at the site. Today I still feel a small amount of discomfort and swelling but it has mostly subsided.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: The inside of my arm was swollen by the morning after receiving the shot. This swelling was not around the site of injection, it was under my armpit. The area was extremely tender and somewhat itchy.  I felt it was my lymph node but it was hard to place my arm down flat. By Sunday (shot was on Friday), the swelling was starting to decrease.  The other symptom included burning sensation going down the inside of my arm to my elbow the first day and by the second day the burning and discomfort went to my forearm/wrist. I felt like I had a softball under my arm. There was no drainage or redness at the site. Today I still feel a small amount of discomfort and swelling but it has mostly subsided.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: vague stippled itchy erythematous rash at site of influenza vaccination - brand of vaccine is unknown.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Onset of injection site swelling, redness and warmth ~ 2 inch in diameter.
Age: 67.0
Sex: M
Vaccine: FLUR4
Symptoms: Discomfort, Injection site pain, Tenderness
Clinical narrative: Patient reports onset of burning pain down back of left upper arm to elbow within 1-2 hours after vaccine administration. Patient states arm is tender to touch and burning pain is constant, limiting comfort when lying in bed, etc. No rash, redness, swelling visible upon observation.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Antibody test, Anxiety, Blood creatine phosphokinase, Diarrhoea
Clinical narrative: Received 2nd MMR vaccine on Friday 10/4/19, hx of rash after getting vaccines per mother.  PCP encouraged her to come in if this happens again for complete and accurate documentation.  10/6/19- Rash/hives with associated symptoms of  headache and abdominal pain, denies vomiting. 10/7/19- Temperature of  99.0, headache which was more occipital, diarrhea and abdominal pain, no family with GI sx. 10/8/19- Home again from school with complaints of abdominal pain around the umbilicus), no vomiting, afebrile.   Reports feeling 88% herself today.  Abdominal pain intermittent today, BM do make this feel better.  Hx of stomach pain, seems to have gotten better since last year.  Likely related to anxiety but 5th grade seems to have improved this.   Previous reaction to immunization, Tdap, reported by mother.  Child was not seen for evaluation although mother does have pictures of this reaction.    Tetanus was given on 9/12/19, home on 13th with sore throat,  9/14/19- Atarted with URI symptoms. 9/15/19- Fever low grade 100 9/16/19- Hives started on arm and torso.  Reports this reaction as not as severe,  one large hive that began 2 days after receiving vaccine.    Had given benadryl 3 days prior for both vaccines, currently still taking for this reaction at night.  Hives went away in the middle of the night, This morning petechial rash present (5inches  x 3inches), No respiratory symptoms at any time during reactions.        .
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count, Headache, Loss of personal independence in daily activities, Metabolic function test, Petechiae
Clinical narrative: Received 2nd MMR vaccine on Friday 10/4/19, hx of rash after getting vaccines per mother.  PCP encouraged her to come in if this happens again for complete and accurate documentation.  10/6/19- Rash/hives with associated symptoms of  headache and abdominal pain, denies vomiting. 10/7/19- Temperature of  99.0, headache which was more occipital, diarrhea and abdominal pain, no family with GI sx. 10/8/19- Home again from school with complaints of abdominal pain around the umbilicus), no vomiting, afebrile.   Reports feeling 88% herself today.  Abdominal pain intermittent today, BM do make this feel better.  Hx of stomach pain, seems to have gotten better since last year.  Likely related to anxiety but 5th grade seems to have improved this.   Previous reaction to immunization, Tdap, reported by mother.  Child was not seen for evaluation although mother does have pictures of this reaction.    Tetanus was given on 9/12/19, home on 13th with sore throat,  9/14/19- Atarted with URI symptoms. 9/15/19- Fever low grade 100 9/16/19- Hives started on arm and torso.  Reports this reaction as not as severe,  one large hive that began 2 days after receiving vaccine.    Had given benadryl 3 days prior for both vaccines, currently still taking for this reaction at night.  Hives went away in the middle of the night, This morning petechial rash present (5inches  x 3inches), No respiratory symptoms at any time during reactions.        .
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Thyroid function test, Urticaria
Clinical narrative: Received 2nd MMR vaccine on Friday 10/4/19, hx of rash after getting vaccines per mother.  PCP encouraged her to come in if this happens again for complete and accurate documentation.  10/6/19- Rash/hives with associated symptoms of  headache and abdominal pain, denies vomiting. 10/7/19- Temperature of  99.0, headache which was more occipital, diarrhea and abdominal pain, no family with GI sx. 10/8/19- Home again from school with complaints of abdominal pain around the umbilicus), no vomiting, afebrile.   Reports feeling 88% herself today.  Abdominal pain intermittent today, BM do make this feel better.  Hx of stomach pain, seems to have gotten better since last year.  Likely related to anxiety but 5th grade seems to have improved this.   Previous reaction to immunization, Tdap, reported by mother.  Child was not seen for evaluation although mother does have pictures of this reaction.    Tetanus was given on 9/12/19, home on 13th with sore throat,  9/14/19- Atarted with URI symptoms. 9/15/19- Fever low grade 100 9/16/19- Hives started on arm and torso.  Reports this reaction as not as severe,  one large hive that began 2 days after receiving vaccine.    Had given benadryl 3 days prior for both vaccines, currently still taking for this reaction at night.  Hives went away in the middle of the night, This morning petechial rash present (5inches  x 3inches), No respiratory symptoms at any time during reactions.        .
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Rash
Clinical narrative: Patient reported small rash to pharmacy early evening of 10/8. Patient was advised to take benadryl. Patient's rash continued to spread and she began to have breathing difficulty. She reported to local hospital (Medical Center) where she was administered steroids and other injections (patient did not know names of medications). Patient's husband came to pharmacy next day and presented a Rx for Prednisone tablets which we filled for the patient
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; A patient was administered improperly stored VARlVAX; This spontaneous report was received from a medical assistant concerning a currently 3 year old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 19-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number S012040, expiration date 17-APR-2021 for prophylaxis (dosage schedule and anatomical location were not reported) (product storage error). The diluent that was used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored (lot number and expiration date were not reported).   The administered dose of the vaccine experienced a temperature excursion of 5°F to 46°F (17.6 F) for 6 hours and 15 minutes. No previous excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1910USA007021:
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects noted; a patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient's concurrent condition and medical history were unknown. Concomitant medication included sterile diluent. On 30-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) of lot # S011951 with expiry date 16-APR-2021 (dose, frequency, route of administration unspecified) for prophylaxis (product storage error). The diluent used to reconstitute the vaccine was properly stored. On an unknown date, the vaccine was exposed to -12.3 Celsius temperature for 6.05 hours. No previous temperature excursion was reported. Digital data logger was involved. No adverse effects reported (no adverse event). The outcome of the events was unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: bad reaction; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 29th October 2021) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced adverse event. Shingrix was discontinued. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient received first dose of Shingrix and experienced a very bad reaction that took several weeks to recover. The reporter stated that the patient will not be getting the 2nd dose. The reporter obtain permission from the patient for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: Tingling in tongue and lip; This case was reported by a consumer via call center representative and described the occurrence of tingling tongue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tingling tongue. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the tingling tongue was unknown.   It was unknown if the reporter considered the tingling tongue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after getting Shingrix, he had tingling in his tongue and lip. The patient stated that  the drug store told him to take Benadryl and was asking if he should be concerned. The patient did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Foot fracture, Inappropriate schedule of product administration
Clinical narrative: Broke her foot; Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of foot fracture in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included back disorder.   On 14th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 122 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced foot fracture and drug dose administration interval too long. On an unknown date, the outcome of the foot fracture and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the foot fracture to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 2nd dose. Four months later of receiving 1st dose of Shingrix, the patient broke her foot. The patient just had back surgery, but had back problems for years. The patient received her 2nd dose of Shingrix passed 6 months, delayed than recommended schedule, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up and declined to provide physicians contact information. This case was considered as medication error with harm.