chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity
Clinical narrative: Patient had a Pneumovac 23 immunization given on 09/20/2019 at the time of the visit.  Pt called to report to provider at 8:00 pm Friday evening that she had started to have excruciating pain  to her RT arm.  Pt stated to the provider she had minimal redness noted to the area and had applied ice and took some OTC pain medication .  Pt stated after she left the clinic after getting her immunization she headed back to work and did 3 pedicures as she works in a beauty salon.  Pt then indicated that later that evening she was unable to lift her arm to eat.   Provider recommend to have the pt take Benadryl and continue to ice that arm.   Provider requested to have the pt contact her the next day to report how she was doing.  The next morning the patient stated to provider that she had no worsening of symptoms , but no change.  Later that evening the pt stated she was able to attend an event where she was scheduled to serve food and was able to participate in the activity.  The provider requested to have pt continue to notify her how she was doing.  Monday am the provider attempted to contact her to have pt schedule a follow up to be reassessed and provider was unable to reach the pt at the time.  She made several attempts to contact her by phone and by text message.  Provider states the pt did mention to her that her landline was out of service for the last few months .  Provider states that pt lives in a rural area that cell service does not always work.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Rash, Urticaria
Clinical narrative: Hives/ rashes/blisters
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness with swelling and pain in right upper arm developed 5-6 hours after the shot. Went to ER on 9/13/2019  given Decadron 10 mg oral once and discharged. Symptoms resolved over 2 days. Father did not want to bring child for follow up as he was better.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Decreased appetite, Discomfort, Oropharyngeal pain
Clinical narrative: 9/4/19 1PM SORE THROAT DEVELOPED.  9/4/19 11PM BODY ACHES OCCURRED.  9/5/19 2AM BODY CHILLS WITH JOINT ACHES AND FEVER OF 102F WERE RECORDED.  9/5/19 9AM FEVER OF 100 WITH JOINT ACHES AND BODY ACHES AND NASAL PRESSURE.  DECREASE IN APPETITE.  9/6/19 9AM BODY TEMP WAS 99 WITH CONTINUED JOINT PAIN. 9/7/19 FEVER WAS ABSENT AND NO BODY PAIN BUT SORE THROAT WORSENING.  WENT TO SEE URGENT CARE ON 9/7 11AM AND GIVEN AMOXICILLIN FOR POSSIBLE STREP THROAT INFECTION
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Streptococcus test negative
Clinical narrative: 9/4/19 1PM SORE THROAT DEVELOPED.  9/4/19 11PM BODY ACHES OCCURRED.  9/5/19 2AM BODY CHILLS WITH JOINT ACHES AND FEVER OF 102F WERE RECORDED.  9/5/19 9AM FEVER OF 100 WITH JOINT ACHES AND BODY ACHES AND NASAL PRESSURE.  DECREASE IN APPETITE.  9/6/19 9AM BODY TEMP WAS 99 WITH CONTINUED JOINT PAIN. 9/7/19 FEVER WAS ABSENT AND NO BODY PAIN BUT SORE THROAT WORSENING.  WENT TO SEE URGENT CARE ON 9/7 11AM AND GIVEN AMOXICILLIN FOR POSSIBLE STREP THROAT INFECTION
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site mass, Ultrasound scan abnormal
Clinical narrative: Patient received both vaccines in left thigh on 9/9/19. She returned to office on 9/20/19 with large swollen lump on left thigh. No fevers. Area with no redness or tenderness. Ultrasound obtained, result suggested cellulitis with small amount of free fluid. Patient started treatment with keflex on 9/23/19.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 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 pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient received dose of Shingrix and experienced sore arm that had not resolved.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Musculoskeletal pain, Pain in extremity
Clinical narrative: Right shoulder soreness; Right axillary lymph node swelling; This case was reported by a nurse via call center representative and described the occurrence of shoulder soreness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 1st dose of Shingrix. On 13th September 2019, 1 days after receiving Shingrix, the patient experienced shoulder soreness and enlargement of lymph nodes. On an unknown date, the outcome of the shoulder soreness and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the shoulder soreness and enlargement of lymph nodes to be related to Shingrix.  Additional information received were as follows: The nurse reported that she was the patient and experienced right shoulder soreness and right axillary lymph node swelling. The healthcare professional described sore shoulder as sore arm.  The healthcare professional noted that the soreness and swelling began the day after she received dose one of Shingrix.  The reporter was unable to query healthcare professional for lot number, expiration date, consent to follow up, and physician contact details due to healthcare professional's abrupt end to conversation.  The healthcare professional did not provide phone number and address when queried.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: urticarial rash on her abdomen and her legs; This case was reported by a pharmacist via call center representative and described the occurrence of urticarial rash in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix .5 ml. On 10th September 2019, 4 days after receiving Shingrix, the patient experienced urticarial rash. On an unknown date, the outcome of the urticarial rash was not recovered/not resolved.   It was unknown if the reporter considered the urticarial rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed an urticarial rash on her abdomen and her legs. The reporter consented to follow up. The caller did not provide any additional information.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient stated that she got the first dose of the Shingrix vaccine and that night she experienced the fever which lasted for 24 hours.  The patient did not provide additional information. The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: felt like had the flu; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than a day after receiving Shingrix, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination she felt like flu. Next day after vaccination, the influenza like illness was resolved. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: INJECTION SITE PAIN; Radiating pain; pain in arm / Feet pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult 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 years after receiving Shingrix, the patient experienced injection site pain, radiating pain and pain in arm. On an unknown date, the outcome of the injection site pain, radiating pain and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain, radiating pain and pain in arm to be related to Shingrix.  Additioanl details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The pharmacist reported that, there were number of patients(over 10) experienced injection site pain after vaccination with dose of Shingrix. The reporter stated that, some of the patients reported that, the pain radiates over the arm and feet. No additional information provided. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash - spotty rash about 2 inches in diameter (circular presentation) several different ones on abdomen /underarm  started 09/21 reported to pharmacy 09/22 - rash is not itching or painful - pharmacist got a second opinion from Nurse practioner on duty at clinic recommended benadryl . Pharmacist reached out to patient later in the evening and pt did say that benadryl was helping
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Skin mass
Clinical narrative: Today, the patient returned to the clinic 3 days after injection. Yesterday mom noticed a mass under his skin/on top of muscle. No further symptoms.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chest discomfort, Chills
Clinical narrative: Stomach and chest felt uncomfortable. Next chills and shaking for about 30 to 45 min. Approximately a hour and half later had fever and sweating for about 45 min. Checked temp about 30 min later was weak and not eating for a total  36 hours. Body aches all joints
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pain, Pyrexia, Tremor
Clinical narrative: Stomach and chest felt uncomfortable. Next chills and shaking for about 30 to 45 min. Approximately a hour and half later had fever and sweating for about 45 min. Checked temp about 30 min later was weak and not eating for a total  36 hours. Body aches all joints
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Angioedema
Clinical narrative: Left facial and left upper lip angioedema, uncertain if related. Started 9/18/19 at 12 noon after having ricola cough drop denies any other changes
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Paraesthesia
Clinical narrative: A bruising of the left upper lateral side of arm with some redness around it. size of a egg some tingling felt when it was given.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: patient returned to pharmacy 11 days after immunization to report that he is still experiencing arm soreness/pain upon moving arm
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: raised red area with bumps, instructed to treat with ibuprofen and ice pack, ongoing
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Electromyogram, Herpes zoster, Impaired driving ability, Impaired work ability, Magnetic resonance imaging
Clinical narrative: On Monday, right foot broke out and patient was not sure what it was.  Went to the pharmacist and they were not sure what it was either.  On Tuesday, went to the ER on Tuesday (ER) and they were not sure what it was either so just gave patient injection for pain and released them.  Patient kept trying to go to work, wore slipper on foot but could not stand pain.  On Friday went to Hospital and it was diagnosed as shingles. Hospitalized for 11-12 days.  Patient was in isolation since also had chickenpox on back.  An MRI was done in the hospital.  Patient had to file for disability since have not been able to work since 7/5; first could not go to work because sore were open and then after they healed could not go because of the pain. On 7/18 visit with primary for follow-up; filled up paperwork for disability. After hospitalization, visit with RA specialist had her stop weekly Norco injections and just restarted them last week. This is the doctor that prescribes Gabapentin, Norco injections and folic acid. On 7/25 visit with Pain Management doctor prescribes the hydrocodone/Norco and Tizanidine. He increased Gabapentin dose because patient could not take weekly Norco injections.  On 7/25 went to Dr, neurologist, who treated patient at hospital to follow-up on tremors that got worse. In hospital patient received Valacyclovir on a drip and then prescribed Valacyclovir 1 gram.   On 8/12, Dr did an EMG.  Visit with Dr on 8/15 and 8/19 because foot was still so bad that it felt like if walking on lump.  On 8/20 visit with Dr  (podiatrist) who specified it is just related to shingles.   On 8/22 had follow-up visit with Dr.  On 9/10, Dr told patient to go back on Norco injections.  On 9/16 visit with Dr and Dr for follow-up.  On 9/23 visit with Dr for back injection.  In terms of recovery, outbreak has healed but now dealing the pain. Patient is in so much pain that cannot put shoes to or drive to go back to work. She puts foot in a bucket of water to help ease the pain. Recovery at 40%.  In terms of recovery, outbreak has healed but now dealing the pain. Patient is in so much pain that cannot put shoes to or drive to go back to work. She puts foot in a bucket of water to help ease the pain. Recovery at 40%.   Patient had chickenpox when she was little.   She participated in shingles study in 90s; she was in the placebo group but received vaccine for free for participating.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Patient isolation, Rash, Tremor, Varicella
Clinical narrative: On Monday, right foot broke out and patient was not sure what it was.  Went to the pharmacist and they were not sure what it was either.  On Tuesday, went to the ER on Tuesday (ER) and they were not sure what it was either so just gave patient injection for pain and released them.  Patient kept trying to go to work, wore slipper on foot but could not stand pain.  On Friday went to Hospital and it was diagnosed as shingles. Hospitalized for 11-12 days.  Patient was in isolation since also had chickenpox on back.  An MRI was done in the hospital.  Patient had to file for disability since have not been able to work since 7/5; first could not go to work because sore were open and then after they healed could not go because of the pain. On 7/18 visit with primary for follow-up; filled up paperwork for disability. After hospitalization, visit with RA specialist had her stop weekly Norco injections and just restarted them last week. This is the doctor that prescribes Gabapentin, Norco injections and folic acid. On 7/25 visit with Pain Management doctor prescribes the hydrocodone/Norco and Tizanidine. He increased Gabapentin dose because patient could not take weekly Norco injections.  On 7/25 went to Dr, neurologist, who treated patient at hospital to follow-up on tremors that got worse. In hospital patient received Valacyclovir on a drip and then prescribed Valacyclovir 1 gram.   On 8/12, Dr did an EMG.  Visit with Dr on 8/15 and 8/19 because foot was still so bad that it felt like if walking on lump.  On 8/20 visit with Dr  (podiatrist) who specified it is just related to shingles.   On 8/22 had follow-up visit with Dr.  On 9/10, Dr told patient to go back on Norco injections.  On 9/16 visit with Dr and Dr for follow-up.  On 9/23 visit with Dr for back injection.  In terms of recovery, outbreak has healed but now dealing the pain. Patient is in so much pain that cannot put shoes to or drive to go back to work. She puts foot in a bucket of water to help ease the pain. Recovery at 40%.  In terms of recovery, outbreak has healed but now dealing the pain. Patient is in so much pain that cannot put shoes to or drive to go back to work. She puts foot in a bucket of water to help ease the pain. Recovery at 40%.   Patient had chickenpox when she was little.   She participated in shingles study in 90s; she was in the placebo group but received vaccine for free for participating.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Contusion, Diarrhoea, Haematoma, Hyperhidrosis
Clinical narrative: Patient calls the clinic on 9/23 to report symptoms which developed after receiving the Pneumococcal vaccine.   He felt there was no problems with the initial injection. Everything seemed fine." nothing out of the ordinary"  A few hours after returning home he developed Fever of 102, chills, Sweats, diarrhea  and vomiting and pain at the injection site. He later developed swelling of the arm and " Hematoma" Described bruising extending up to shoulder and upper collar bone and down to the forearm. Felt like he could not move his muscle. On 9/22 he was going to seek medical attention if it continued to get worse however the symptoms subsided. Today he is much better and feels the " worst is over" . No further concerns with fever , vomiting /diarrhea . Swelling has gone down with bruising fading.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Patient calls the clinic on 9/23 to report symptoms which developed after receiving the Pneumococcal vaccine.   He felt there was no problems with the initial injection. Everything seemed fine." nothing out of the ordinary"  A few hours after returning home he developed Fever of 102, chills, Sweats, diarrhea  and vomiting and pain at the injection site. He later developed swelling of the arm and " Hematoma" Described bruising extending up to shoulder and upper collar bone and down to the forearm. Felt like he could not move his muscle. On 9/22 he was going to seek medical attention if it continued to get worse however the symptoms subsided. Today he is much better and feels the " worst is over" . No further concerns with fever , vomiting /diarrhea . Swelling has gone down with bruising fading.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle spasms, Nausea
Clinical narrative: patient said he was very nauseous. Also felt cramping across his body.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Joint swelling, Skin warm
Clinical narrative: pt presented with a swollen hand  joint at forefinger and middle finger was swollen and hot to touch and painful
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Bronchitis, Cough, Dizziness, Fatigue, Headache
Clinical narrative: Three hours after vax: extreme fatigue, flu symptoms, nausea, dizziness, extreme headache, vomiting lasting 24 hours. One month after vax:  viral infection/bronchial infection. Coughing, phlegm, swollen glands lasting one month.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza, Influenza like illness, Lymphadenopathy, Nausea, Pneumonia
Clinical narrative: Three hours after vax: extreme fatigue, flu symptoms, nausea, dizziness, extreme headache, vomiting lasting 24 hours. One month after vax:  viral infection/bronchial infection. Coughing, phlegm, swollen glands lasting one month.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Productive cough, Viral infection, Vomiting
Clinical narrative: Three hours after vax: extreme fatigue, flu symptoms, nausea, dizziness, extreme headache, vomiting lasting 24 hours. One month after vax:  viral infection/bronchial infection. Coughing, phlegm, swollen glands lasting one month.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Pt arm started to swell right away popping bandaids  off. She took Benadryl and put ice pack on and waited for a bit. I checked no trouble breathing or hives or any other reactions. Pt had to leave so I called her later that night to check but not home so I left message. Pt called next day and said still swollen even more and bruised possible slight fever that night but she wasn?t positive.
Age: 1.25
Sex: M
Vaccine: FLU4
Symptoms: Abnormal behaviour, Psychomotor hyperactivity
Clinical narrative: He was acting like he was on a "sugar high" for a few hours.  He was running around and very hyper and loud.  This lasted a few hours and self resolved. Grandma was watching and said she also gets like this after the flu shot and was concerned.  He was back to normal behavior after a few hours
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Flushing, Grunting, Hyporesponsive to stimuli, Hypoxia, Lethargy
Clinical narrative: Within 5 minutes of receiving vaccine began sneezing abdundantly, then became lethargic, which progressed to listlessness and decreased responsiveness. Retracting, wheezing, hypoxic (sats dropped into 60s), arms and face flushed, grunting. Received oxygen, albuterol and atrovent via nebulizer, epinephrine 0.15 mg IM then 0.3 mg IM 10 minutes later, oral dexamethasone, IM benadryl and transported to Emergency Room. By time transported, oxygen saturations had improved to low 90s. Report from ER that was sitting up, alert and interactive within an hour. Kept overnight for observation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Listless, Oxygen saturation decreased, Sneezing, Use of accessory respiratory muscles, Wheezing
Clinical narrative: Within 5 minutes of receiving vaccine began sneezing abdundantly, then became lethargic, which progressed to listlessness and decreased responsiveness. Retracting, wheezing, hypoxic (sats dropped into 60s), arms and face flushed, grunting. Received oxygen, albuterol and atrovent via nebulizer, epinephrine 0.15 mg IM then 0.3 mg IM 10 minutes later, oral dexamethasone, IM benadryl and transported to Emergency Room. By time transported, oxygen saturations had improved to low 90s. Report from ER that was sitting up, alert and interactive within an hour. Kept overnight for observation.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Feeling unwell began a few hours later. Tired, no energy,  body aches Woke up next morning feeling much worse. Fever started going up. Max measured was 101.7 Chills, body aches, headache, no energy, felt like I couldn?t even move. Stayed in bed all day.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Feeling unwell began a few hours later. Tired, no energy,  body aches Woke up next morning feeling much worse. Fever started going up. Max measured was 101.7 Chills, body aches, headache, no energy, felt like I couldn?t even move. Stayed in bed all day.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash vesicular
Clinical narrative: 4-6 WEEKS AFTER RECIEVING SECOND DOSE OF SHINGRIX, PATIENT STARTED TO NOTICE 5 SMALL RED "CHICKEN POX" LIKE DOTS APPEARED  ON HIS RIGHT FORE ARM.  5 DAYS AFTER IT'S APPEARANCE,  IT BURSTED AND BECAME 5 LITTLE SORES THAT ITCHES ALL THE TIME. THE SMALL RED DOTS HAVE MIGRATED TO ALL OF HIS RIGHT ARM, TO HIS LEFT ARM, TOP OF SHOULDERS, AND BELLLY BUTTON. THESE SMALL RED DOTS TURNS INTO BLISTERS THAT BURSTS, HEALS UP, AND ITCHES ALL THE TIME.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: IM right deltoid region. Right shoulder pain after receiving injection that has progressively worsened since. Difficulty with abduction/internal rotation of the right shoulder. Suspect injection placed into subacromial space.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pancreatic carcinoma, Pancreatitis, Pneumonia
Clinical narrative: APPROXIMATELY 7 1/2 months later on 8/7/2016 Admitted TO MEDICAL CTR FOR SHORTNESS OF BREATH AND PNEUMONIA TO THE EMERGENCY ROOM THEN ADMITTED OVERNIGHT. On 12/15/2015 - patient received the Zostavax vaccine in the doctor office. Interestingly, the insurance companies, or the supplemental insurance would not cover the vaccine, the vaccine from Merck pharma has been removed from public use. Subsequently, patient had developed pneumonia 7 1/2 mo. later, in the summer, as well as shortness of breath. These were unusual occurrences in a short span of time, occurring in the summer & no prior history of pneumonia; After a follow up visit with the pulmonologist in November 2017, he advised an inflamation of the pancreas which led to a further diagnosis of cancer. I believe this accelerated patient's condition, whereby, there was no family history on her side of any cancer.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: Diarrhea, vomiting, loss of apetite, no energy. Mostly recovered by 9/13.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Skin abrasion, Underdose
Clinical narrative: During administration, the patient pulled her arm away and she received only part of the vaccine. The rest went to the outside of her arm. Slight scrape from needle on the outside of her arm where she pulled away. Contacted the pediatrician to determine if an additional dose is needed and emailed her the information on I found from the CDC.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; received improperly stored PEDVAXHIB; This spontaneous report was received from a nurse refers to a 9 week old male patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On 06-SEP-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) of lot # S000353 with expiry date 09-SEP-2021 (strength, dose, frequency, route of administration date unspecified) for prophylaxis (product storage error). On an unknown date, the vaccine was exposed above 47 Degree Fahrenheit (47.4 F) temperature for 23 hours. There was no previous excursion reported. Digital data logger was involved and no adverse effects reported (no adverse event). The outcome of the events was unknown.  This is one of three reports received from the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebral disorder, Disorientation
Clinical narrative: brain shut down; This case was reported by a pharmacist via call center representative and described the occurrence of disorientation in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received Shingrix (intramuscular) .5 ml. On 20th August 2019, 1 days after receiving Shingrix, the patient experienced disorientation. On an unknown date, the outcome of the disorientation was recovering/resolving.   It was unknown if the reporter considered the disorientation to be related to Shingrix.  Additional details were provided as follows: The patient experienced a brain shut down. She would run a stop light or walk into a room and not realize she was in that room. The pharmacist referred to it as a possible loss of time.  At the time of reporting, the patient started to get better. The pharmacist was transferred to medical information for additional assistance.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Angiogram, Blood test, Computerised tomogram head, Computerised tomogram neck, Computerised tomogram spine
Clinical narrative: Neuromuscular loss of dexterity of lower extremities occurring the morning after vaccine and following evening resulting in fall with laceration of multiple sites on face. Admitted to Hospital. Admitting physician Dr.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Computerised tomogram thorax, Fall, Fine motor skill dysfunction, Magnetic resonance imaging brain, Skin laceration
Clinical narrative: Neuromuscular loss of dexterity of lower extremities occurring the morning after vaccine and following evening resulting in fall with laceration of multiple sites on face. Admitted to Hospital. Admitting physician Dr.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Immunisation, Limb mass, Needle issue, Pain in extremity
Clinical narrative: INJECTION WAS STARTED IN LEFT ARM, NEEDLE ON HUB WAS LOOSE AND LEAKED OUT THE SIDE.  IMMUNIZATION WAS REGIVEN ON RIGHT ARM.  PATIENT STATES BOTH ARMS ARE SORE AND THERE FEELS LIKE A "BALL" IN HER LEFT ARM.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Body temperature increased, Chills, Headache, Injection site erythema, Injection site mass
Clinical narrative: Patient was given influenza shot and pneumonia vaccine.  (pt does not know which pneumonia vaccine) in a different facility. Pt had visit with our provider after going to the ER and leaving before being seen due to wait time. Pt states about 4 hours after receiving the vaccines he had arm pain, headaches, shivers and had a temp of 104 that has since resolved. The back of his head is sore with general headache. His left arm where the injection was has been red and feels a lump, but no spreading red skin rash or pus. No current signs of cellulitis. Pt referred to follow up with primary care provider as well as Doctor on Demand provider. Pt to seek immediate medical attention if persistent temp above 100.6, nausea and vomiting, or severe worsening of your skin condition.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Patient was given influenza shot and pneumonia vaccine.  (pt does not know which pneumonia vaccine) in a different facility. Pt had visit with our provider after going to the ER and leaving before being seen due to wait time. Pt states about 4 hours after receiving the vaccines he had arm pain, headaches, shivers and had a temp of 104 that has since resolved. The back of his head is sore with general headache. His left arm where the injection was has been red and feels a lump, but no spreading red skin rash or pus. No current signs of cellulitis. Pt referred to follow up with primary care provider as well as Doctor on Demand provider. Pt to seek immediate medical attention if persistent temp above 100.6, nausea and vomiting, or severe worsening of your skin condition.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Contusion, Hypersensitivity, Induration, Infection, Injection site reaction
Clinical narrative: Hard knot (golf ball sized) 1 - 2 hours after injection. Next morning upper left arm swelled to twice normal size. Bicep muscle clearly outlined in red itchy rash moving down forearm. That evening urgent care clinic diagnosed with allergic reaction and infection - steroids and antibiotics prescribed to clear out infection and reaction. 3 days later rash still visible and bicep muscle outlined in bruising of skin.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site swelling, Nodule, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Hard knot (golf ball sized) 1 - 2 hours after injection. Next morning upper left arm swelled to twice normal size. Bicep muscle clearly outlined in red itchy rash moving down forearm. That evening urgent care clinic diagnosed with allergic reaction and infection - steroids and antibiotics prescribed to clear out infection and reaction. 3 days later rash still visible and bicep muscle outlined in bruising of skin.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Arthropod bite, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Mother noticed redness,swelling posterior left arm at injection site day after vaccines given  when she picked him up from Daycare.  Symptoms became worse over the following 12 hours.  Does have insect bites on L side of trunk and on L forearm.  2 indurated ares noted L posterior upper arm
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: A KNOT AT SITE OF INJECTION, RED, HOT AND ITCHY.  PT NOTICED WHEN SHE AWOKE NEXT MORNING, STILL HAS IT 4 DAYS LATER. RECOMMENDED ANTIHISTAMINE BUT PT HAD NOT TRIED ANYTHING YET
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: CONCERNS WITH IMMUNIZATION REACTION FROM FLU SHOT, RECEIVED ON WEDNESDAY   an hour later ARM RED, SWOLLEN, BRUISED AND WARM TO THE TOUCH    HURTS WHEN SHE MOVES OR TOUCHES IT    no fevers, no other sick symptoms  Denies any trouble breathing   cool compress to area  no concerns for cellulitis at this time, if redness continues to spread would consider antibiotic
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neuralgia
Clinical narrative: Nerve pain in the left arm
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cold sweat, Dizziness, Influenza, Injection site pain, Malaise
Clinical narrative: Nerve pain in the left arm
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Mass, Nerve injury, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Nerve pain in the left arm
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Skin warm, Syncope, Ultrasound scan
Clinical narrative: Nerve pain in the left arm
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Axillary pain, Chills, Decreased appetite, Fatigue
Clinical narrative: Achiness, chills, fever (101.6), lack of appetite, painful injection site, underarm (nerve?) pain, small pimples at hairline, exhaustion
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Achiness, chills, fever (101.6), lack of appetite, painful injection site, underarm (nerve?) pain, small pimples at hairline, exhaustion
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm
Clinical narrative: Red area and hot to touch
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Syncope
Clinical narrative: Rapid heartbeat  Weakness  Dizziness Fainting  Difficulty breathing
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: "Pt had the shingles vaccination on the 13th. Last night she noticed her lymph nodes on her L neck feel swollen. She has been feeling body aches and tenderness in her lymph node."
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Hot flush, Tinnitus
Clinical narrative: Woke up with ringing in the ears and hot flashes without fever
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: Initial small rash, size of about 2" x 2" south of injection site, increased rash area over the day to eventually a 3-1/2" x 5" area with a very small raised "dot" kind of near the middle of the initial rash appearance.  Mild headache began around 9:30 pm. the same day.  Increased headache next morning and a feeling of being not quite right.  Mid-afternoon, around 3 pm, felt tired, and really overall sick feeling, but no temperature ? not exactly nausea, but just feeling very tired, sleepy and sick with no appetite. Shooting pains in bottom of feet started in the evening around 6:30 pm,  also aches in right leg bone and both arms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise, Pain, Pain in extremity, Somnolence
Clinical narrative: Initial small rash, size of about 2" x 2" south of injection site, increased rash area over the day to eventually a 3-1/2" x 5" area with a very small raised "dot" kind of near the middle of the initial rash appearance.  Mild headache began around 9:30 pm. the same day.  Increased headache next morning and a feeling of being not quite right.  Mid-afternoon, around 3 pm, felt tired, and really overall sick feeling, but no temperature ? not exactly nausea, but just feeling very tired, sleepy and sick with no appetite. Shooting pains in bottom of feet started in the evening around 6:30 pm,  also aches in right leg bone and both arms.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Malaise, Pallor, Visual impairment
Clinical narrative: A couple minutes after the patient received the vaccine, she reported that she "didn't feel well" and that she "could not see". Pt laid down on the exam table and feet were elevated. Patient became pale and clammy. Vitals were taken and patient was monitored. After about 10 minutes, patient reported she felt better. Color returned to her skin and she returned to normal.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Severe redness and swelling at the injection site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: pt received vaccine 9/17, came in pharmacy 9/23 to show bruised right arm (as result of immunization per patient). pt claimes day after immnuization (9/18) arm was sore and bruised, and has not resolved as of 9/23. c/o soreness, pain, no numbness,tingling, or "frozen" feeling.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Vision blurred
Clinical narrative: Patient indicated that Dizziness, Headache, and Blurred Vision started after receiving the flu shot
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Temperature for day and a half, achy all over, sore left arm-couldn't move it
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Hypoaesthesia, Joint range of motion decreased, Muscular weakness, Otitis media acute
Clinical narrative: Numbness/loss of range of motion in arm/shoulder of arm receiving the injection lasting 6-12 hours; weakness in injection arm lasting 2+ days Acute otitis media (bilateral) Diarrhea
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Erythema, Pain in extremity
Clinical narrative: The patient came into the pharmacy today stating she had been in bed the past two days with little strength. Her left arm was red about 2 inches below the injection site and she stated it was sore to the touch. She said she was feeling a lot better now than she had the last few days.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Vaccination site swelling
Clinical narrative: Patient says she felt very faint and weak about 2 hours after the vaccine was given, and the area around the vaccine became very swollen.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pustule, Vaccination complication
Clinical narrative: Pt states 3-4 weeks after getting shot, she got pustules in right mid section (looked like pimples) that had intense itch, this has persisted till today. pt thought this was not due to shot so she   got  the 2 nd shot 8-21 which made this worse the condition worse.  Pt saw PMD today 9-23, dr feels this is side effect of shot pt received. Pt wrote script for Medrol dose pack
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient has about a 5 inch red circle around the injection site and heat in that area. She said it was not painful.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Feeling hot, Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: Pt said she felt a little warm, burning and numb for a few seconds after receiving the flu vaccine but it went away. Later on that night, she felt pain & could not move her arm. She went to see her doctor on 9/23/19 in am. She said she was diagnosed with adhesive capsulitis (frozen shoulder) & due to incorredt flu shot.administration site. She said she would need to see a physical therapist. She was prescribed meloxicam, tylenol & ice pack for her current treatment.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis, Product administered at inappropriate site
Clinical narrative: Pt said she felt a little warm, burning and numb for a few seconds after receiving the flu vaccine but it went away. Later on that night, she felt pain & could not move her arm. She went to see her doctor on 9/23/19 in am. She said she was diagnosed with adhesive capsulitis (frozen shoulder) & due to incorredt flu shot.administration site. She said she would need to see a physical therapist. She was prescribed meloxicam, tylenol & ice pack for her current treatment.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported.; the patient received a dose of MMRII which was reconstituted with expired STERILE DILUENT; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies or concomitant therapies were not provided.  On 13-SEP-2019, the patient was vaccinated with a dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) a dose, for prophylaxis (concentration, dose, frequency and route of administration were not reported; lot number reported as R031679, valid upon internal review, and expiration date reported and determined on 01-NOV-2020). It was reported that the vaccine was reconstituted with expired sterile diluent (MERCK STERILE DILUENT) (concentration, dose, frequency and route of administration were not reported; lot number reported as N011475, valid upon internal review, and expiration date reported and determined on 08-AUG-2019) (expired product administered). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Gastric haemorrhage, Immune thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: The patient experienced chronic inflammatory demylenating polyneuropathy, Idiopathic Tbrombocytopenic Purpurn(ITP), and gastric bleed after receiving ZOSTAVAX vaccine in 2016". The patient was hospitalized; The patient experienced chronic inflammatory demylenating polyneuropathy, Idiopathic Tbrombocytopenic Purpurn(ITP), and gastric bleed after receiving ZOSTAVAX vaccine in 2016". The patient was hospitalized; The patient experienced chronic inflammatory demylenating polyneuropathy, Idiopathic Tbrombocytopenic Purpurn(ITP), and gastric bleed after receiving ZOSTAVAX vaccine in 2016". The patient was hospitalized; Information has been received regarding a case in litigation involving an approximately 68 year old female patient (pt), reporting herself, with plantar fasciitis and drug reaction/allergy to nalidixic acid (NEGGRAM). Concomitant therapies included eltrombopag olamine (PROMACTA), gabapentin  and pantoprazole (indications not reported).     "Sometime on 2016", the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), for singles, in her arm (unspecified) (route, lot/batch # and expiration date were not reported).     It was reported that the pt experienced chronic inflammatory demylenating polyneuropathy (chronic inflammatory demyelinating polyradiculoneuropathy), Idiopathic Thrombocytopenic Purpurn (ITP) (immune thrombocytopenic purpura), and gastric bleed (gastric haemorrhage) after receiving zoster vaccine live (ZOSTAVAX) in 2016. Subsequently, the pt was hospitalized for about two weeks (unspecified date in 2016). The pt had a routine blood work on an unknown date, results not reported. She received immunoglobulin infusion as treatment on an unknown date.   The outcome of chronic inflammatory demyelinating polyradiculoneuropathy, gastric haemorrhage and immune thrombocytopenic purpura was reported as not resolved.  The causality assessment between chronic inflammatory demyelinating polyradiculoneuropathy, gastric haemorrhage and immune thrombocytopenic purpura with zoster vaccine live (ZOSTAVAX) was not reported.   The reporter considered chronic inflammatory demyelinating polyradiculoneuropathy, gastric haemorrhage and immune thrombocytopenic purpura as disabling and life threatening, however, it was also reported that no intervention was need to prevent serious criteria.   Upon internal review, chronic inflammatory demyelinating polyradiculoneuropathy, gastric haemorrhage and immune thrombocytopenic purpura were determined to be medically significant events.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: dizziness; vomiting; queasiness; This spontaneous report was received from a pharmacist and refers to a 17 year old female patient. The patient did not have any known allergy, medical history or concomitant medications. On 24-JUL-2019, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) route intramuscular for prophylaxis(lot # and expiration date were not provided). Subsequently, the patient developed dizziness, queasiness with vomiting. No treatment was administered for the adverse event and all symptoms resolved within about 15 minutes with no further sequelae. The reporter did not provide the causality assessment between the aforementioned events and therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose, Injection site extravasation, Injection site pain, Injection site rash, Wrong technique in product usage process
Clinical narrative: Sensation of the vaccine running down her arm on the inside of her arm; She experienced soreness; rash near injection site; Possibly some of the vaccine may not have be injected correctly into her muscle; Wrong technique in device usage process; This case was reported by a consumer via call center representative and described the occurrence of injection site leaking in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 5th March 2019, refer linked case US2019AMR167804).   On 21st May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 21st May 2019, less than a day after receiving Shingrix, the patient experienced injection site leaking, injection site pain, injection site rash, accidental underdose and wrong technique in device usage process. On an unknown date, the outcome of the injection site leaking, injection site pain and injection site rash were recovered/resolved and the outcome of the accidental underdose was not recovered/not resolved and the outcome of the wrong technique in device usage process was unknown.   It was unknown if the reporter considered the injection site leaking, injection site pain and injection site rash to be related to Shingrix.  Additional information received were as follows: The patient reported that she experienced a sensation of the vaccine running down her arm on the inside of her arm, no medication was visible on the outside of her arm, and believed that possibly some of the vaccine may not have be injected correctly into her muscle, which led to injection site leaking, wrong technique in device usage process and accidental underdose. The patient experienced soreness at injection site and rash near injection site. The patient planned to follow-up with her physician and pharmacy on an unknown date.  The reporter consented to follow up.