chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was speaking with his pharmacist about side effects to SHINGRIX and the pharmacist told him that one woman was so tired that, she had to lie in bed for the next day. This case is 1 of the 4 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an unspecified number of adult patient who received SHINGRIX for prophylaxis.  On an unknown date, the patients received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. 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. The reporter was speaking with his pharmacist about side effects to SHINGRIX and the pharmacist told him that several of his patients had complained about a sore arm after getting SHINGRIX. This case is 1 of the 4 cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Formication, Gastrointestinal disorder, Malaise, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of formication in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced formication, reaction gastrointestinal, malaise, fatigue and fever. On an unknown date, the outcome of the formication, reaction gastrointestinal, malaise, fatigue and fever were recovered/resolved. It was unknown if the reporter considered the formication, reaction gastrointestinal, malaise, fatigue and fever to be related to SHINGRIX. Additional details were provided as follows: This information was received via chat. The age at vaccination was not reported. The healthcare professional (HCP) stated that, the patient had a full week of adverse reactions to SHINGRIX that included; fatigue, fever, malaise, gastrointestinal reaction, and formication. The HCP stated that, the SHINGRIX was administered at another location and he did not have vaccine information for the reported adverse events. This case is 1 of the 2 cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Haematocrit decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hematocrit decreased in a 62-year-old male patient who received SHINGRIX for prophylaxis.  On 4th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, 3 days after receiving SHINGRIX, the patient experienced hematocrit decreased. On an unknown date, the outcome of the hematocrit decreased was unknown. It was unknown if the reporter considered the hematocrit decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Three days after receiving SHINGRIX, the patient had a routine annual physical with blood labs and his hematocrit came back low at 38.2. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shingles following day of vaccination. The reporter stated that one of the colleague had a report of a customer receiving a SHINGRIX vaccine and got Shingles the following day. She was following up with the patient on the day of reporting and would involve risk management as necessary. She would ensure it was reported to the authority. Likely that was unrelated, but customer perception was that the vaccine gave her Shingles. Another reporter reported that based on the conversation with the supervisor on the day of reporting, the patient got a clean bill of health just weeks prior with the recommendation from her physician to get the vaccine. It appears to the reporter that the onset of Shingles was well on the way when the patient received the vaccine from their pharmacy.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a physician and described the occurrence of chills in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. On 8th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fatigue and muscle soreness. The patient was treated with antiinflammatory/antirheumatic products (Anti-Inflammatory). On an unknown date, the outcome of the chills, fatigue and muscle soreness were recovering/resolving. The reporter considered the chills, fatigue and muscle soreness to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was stated that the events experienced by the patient were expected adverse events and after taking an anti-inflammatory medication the patient started to feel better in the morning at the date of reporting.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in an unspecified number of the patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2016-2017 season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2016-2017 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2016-2017 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2016-2017 season. Additional details were provided as follows: The age at vaccination was not applicable for this report. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for influenza were not provided. The healthcare professional reported that they found the patients who received flu vaccine early last year got the flu later in the season verses the ones who waited to receive it. No additional details provided by the nurse except that they were using GlaxoSmithKline flu vaccine last year.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, general body pain and fatigue. On an unknown date, the outcome of the fever, general body pain and fatigue were unknown. It was unknown if the reporter considered the fever, general body pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. he patient experienced body aches and soreness. The reporter did not agree to be followed up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Generalised erythema, Nausea, Psychiatric symptom, Psychotic disorder
Clinical narrative: This is a spontaneous report from a contactable physician. An 18-year-old male patient received TRUMENBA (Lot Number: S56026, expiration date: 28Feb2019), via an unspecified route of administration on 01Aug2018 at 0.5 mg, single for immunization as he was going off to college and living in the dorm. Medical history included anxiety and ADHD. The patient's concomitant medications were not reported. The patient received a previous dose of TRUMENBA in Oct2017 for immunization. The patient received meningococcal group b rlp2086 on 01Aug2018 and the next day (02Aug2018), the patient started with fever, nausea and weakness. On Friday (03Aug2018), he was red from head to toe. He continued to feel weak and nauseous. The patient had now started with psychiatric symptoms, more of a psychosis on an unspecified date in Aug2018, reported as 2-3 days ago. The physician stated that before the vaccine, the patient was a healthy person, getting ready to go off to college. The psychiatric symptoms were getting worse. The physician sent him to the emergency room to be evaluated for a possible concomitant infection or drug exposure. The physician considered the event of psychiatric symptoms, more of a psychosis as serious (life threatening). The physician assessed the events of fever, nausea, weak and red from head to toe as non-serious. The patient recovered from the event of fever on 03Aug2018. The patient has not recovered from the events of nausea, weakness and psychiatric symptoms, more of a psychosis. The patient was recovering from the red from head to toe event as the redness was now only on his knees, elbows and knuckles. The physician considered the events of red from head to toe and psychiatric symptoms, more of a psychosis as related to meningococcal group b rlp2086.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. An 18-year-old male patient received TRUMENBA (Lot Number: S56026, expiration date: 28Feb2019), via an unspecified route of administration on 01Aug2018 at 0.5 mg, single for immunization as he was going off to college and living in the dorm. Medical history included anxiety and ADHD. The patient's concomitant medications were not reported. The patient received a previous dose of TRUMENBA in Oct2017 for immunization. The patient received meningococcal group b rlp2086 on 01Aug2018 and the next day (02Aug2018), the patient started with fever, nausea and weakness. On Friday (03Aug2018), he was red from head to toe. He continued to feel weak and nauseous. The patient had now started with psychiatric symptoms, more of a psychosis on an unspecified date in Aug2018, reported as 2-3 days ago. The physician stated that before the vaccine, the patient was a healthy person, getting ready to go off to college. The psychiatric symptoms were getting worse. The physician sent him to the emergency room to be evaluated for a possible concomitant infection or drug exposure. The physician considered the event of psychiatric symptoms, more of a psychosis as serious (life threatening). The physician assessed the events of fever, nausea, weak and red from head to toe as non-serious. The patient recovered from the event of fever on 03Aug2018. The patient has not recovered from the events of nausea, weakness and psychiatric symptoms, more of a psychosis. The patient was recovering from the red from head to toe event as the redness was now only on his knees, elbows and knuckles. The physician considered the events of red from head to toe and psychiatric symptoms, more of a psychosis as related to meningococcal group b rlp2086.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Rash Lower extremities.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Eyelid oedema
Clinical narrative: Extreme blistering around my right eye and both ears. Also blistering down my neck on my face and both arms inside at the elbow. My eye was swollen shut the next morning. Follow up on 08/13/2018 with Dr. but I chose to use BENADRYL and IvaRest cream.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Injection site erythema, Myalgia, Vaccination site warmth
Clinical narrative: Patient received second SHINGRIX immunization, called back the next day complaining of red, warm area at vaccination site, myalgia, and a "cold clamy" feeling. Patient is self monitoring and taking ibuprofen.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Rash extremities.
Age: 1.83
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient received incorrect vaccination. Patient received KINRIX, but is not old enough for this vaccine. Should have received PENTACEL vaccination.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Insomnia
Clinical narrative: Headache, joint pain to the degree I was unable to sleep. Symptoms started about nine hours after injection. Reaction similar to symptoms experienced when I contracted Shingles in 2008.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Defaecation urgency
Clinical narrative: Pt described as "urgent evacuation of total bowel: about 15 hrs after vaccine, also experienced chills.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red, raised rash on right thigh. TYLENOL. Cetirizine, BENADRYL.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Crying, Diarrhoea, Drooling, Dyskinesia, Febrile convulsion
Clinical narrative: Pt had a febrile seizure. 8/8/18 2317-Patient is a 12 m.o. female. 12-month old female with no chronic medical conditions brought in by family this evening for evaluation following first-time seizure. Patient had routine 1 year checkup at pediatrician's office yesterday and received both MMR and varicella vaccines. Had been well prior. No cough nasal drainage vomiting. This evening around 10 PM, 2 hours prior to arrival, patient cried out during sleep. Mother found her with rhythmic jerking of upper and lower extremities and upward eye deviation and drooling. The episode lasted 2-3 minutes. She was post ictal for 10 - 15 minutes after the event. Now back to baseline. On arrival to the ED noted to have fever to 103.3. Mother was unaware that she had fever until temperature was taken this evening. No prior history of seizures. No family history of seizures or febrile seizures. Her vaccines are up-to-date. No recent antibiotics. No history of urinary tract infections. Mother does report she developed new onset watery diarrhea today. No blood in stools. No vomiting. No sick contacts and does not attend daycare. The history provided by the mother and a relative. History reviewed. No pertinent past medical history. There are no active problems to display for this patient. History reviewed. No pertinent surgical history.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Full blood count, Gaze palsy, Postictal state, Pyrexia
Clinical narrative: Pt had a febrile seizure. 8/8/18 2317-Patient is a 12 m.o. female. 12-month old female with no chronic medical conditions brought in by family this evening for evaluation following first-time seizure. Patient had routine 1 year checkup at pediatrician's office yesterday and received both MMR and varicella vaccines. Had been well prior. No cough nasal drainage vomiting. This evening around 10 PM, 2 hours prior to arrival, patient cried out during sleep. Mother found her with rhythmic jerking of upper and lower extremities and upward eye deviation and drooling. The episode lasted 2-3 minutes. She was post ictal for 10 - 15 minutes after the event. Now back to baseline. On arrival to the ED noted to have fever to 103.3. Mother was unaware that she had fever until temperature was taken this evening. No prior history of seizures. No family history of seizures or febrile seizures. Her vaccines are up-to-date. No recent antibiotics. No history of urinary tract infections. Mother does report she developed new onset watery diarrhea today. No blood in stools. No vomiting. No sick contacts and does not attend daycare. The history provided by the mother and a relative. History reviewed. No pertinent past medical history. There are no active problems to display for this patient. History reviewed. No pertinent surgical history.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Death
Clinical narrative: On June 8th 2018 death occurred.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: After leaving pharmacy, had a headache within 5 min. site was pink, hot and sore and couldn't touch wake up in middle of night with severe pain even after TYLENOL. 10:AM next day had muscle aches, fever and chills. Went to urgent care, Pulse was 101 normally 80.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: After leaving pharmacy, had a headache within 5 min. site was pink, hot and sore and couldn't touch wake up in middle of night with severe pain even after TYLENOL. 10:AM next day had muscle aches, fever and chills. Went to urgent care, Pulse was 101 normally 80.
Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash, Skin discolouration
Clinical narrative: Purple color/spots resolved after several hours.
Age: 4.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA220766, 2018SA220774, 2018SA220775 and 2018SA218532 (same reporter). This case involves a four years old patient (four years 26 days old, gender not reported) who received a dose of PENTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on 30-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 58 years old female patient who experienced red pin point rash over her torso, thighs and bilateral arms and observed a red pin point rash, which was very itchy, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 02-Aug-2018, the patient received a 0.5 ml dose of suspect ADACEL lot U5656AA in the left deltoid (expiry date, dose in series and route not reported). On an unknown date, 4-5 hours following the vaccination the patient developed a non-serious red pin point rash over her torso, thighs and bilateral arms (injection site erythema) 4-5 hours following the administration of ADACEL. On an unknown date, the patient developed a non-serious observed a red pin point rash, which was very itchy (rash pruritic) following the administration of ADACEL. Other relevant tests included No lab data was reported. Final diagnosis was observed a red pin point rash, which was very itchy and red pin point rash over her torso, thighs and bilateral arms. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for observed a red pin point rash, which was very itchy and as Unknown for red pin point rash over her torso, thighs and bilateral arms. List of documents held by the sender: None.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 12 years old male patient who experienced patient was given two doses of t-dap he wanted to know if there were any side effects, while he received vaccines BOOSTRIX, MENVEO and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENVEO not produced by Sanofi Pasteur lot number not reported. On an unknown date, the patient received a dose of suspect BOOSTRIX not produced by Sanofi Pasteur lot number not reported. On 07-Aug-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5542AA. It was a case of actual medication error due to extra dose administered. One was ADACEL and the other was BOOSTRIX by Glaxo-Smith-Kline. The ADACEL was given in the left arm. 0.5 m. The patient was also given MENVEO by Glaxo-Smith-Kline. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: U
Vaccine: HIBV, IPV
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Initial information received on 09-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old patient (gender unknown) who received (3rd) dose of ACT-HIB instead receiving PCV-13 two weeks after second dose. The patient's past medical history included Seizure with from 2-month vaccine, thinking it was from pertussis in the DTap. The patient's family history was not provided. Concomitant medications included IPOL on an unknown date. On 08-Aug-2018, the patient received a third 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI910AA, expiry date 18 Nov 2019 via intramuscular route in the right thigh instead of PCV-13 vaccine not produced by Sanofi Pasteur lot number not reported. It was an actual medication error due to wrong vaccine administered and extra dose administered. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Seizure
Clinical narrative: Low grade temp of 99.1 and two back-to-back seizures. This occurred 10 days after getting MMR.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Burning upon injection, soreness at injection site several hours later, pain awakened pt in the night, mental confusion and dizziness in the night continuing into the next day, redness and swelling and continued pain at injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Burning upon injection, soreness at injection site several hours later, pain awakened pt in the night, mental confusion and dizziness in the night continuing into the next day, redness and swelling and continued pain at injection site.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Pain, Skin warm, Swelling
Clinical narrative: Redness/swelling on upper arm, pain in shoulder when moving the arm, area is hot to touch, advised ibuprofen, cold compress, return to office if any open sores, oozing, weeping, or fever.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain, Pain in extremity, Skin warm
Clinical narrative: Sore arm, hot to the touch, aches and pains shooting to her back. No temperature and diarrhea.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Hyperhidrosis, Slow response to stimuli
Clinical narrative: Walks into office stating that he needs his scheduled shots before school. Mother was called when explained that she needed to sign consent and arrives shortly after call. Consent given and signed.  VIS given with no questions or concerns at this time. Injection given in left deltoid without incident or difficulty at 12:05pm. Pt. walks 25 feet to from back office to reception area and sits down to wait recommended 15 minutes. At 12:09pm, pt. becomes diaphoretic and less responsive but remains in sitted position with mother be side. Pt. does answer questions but is slow to respond.  Cool cloth applied to back of neck and fan turned to blow on pt. Pt. also complains of headache.  BP checked 102/76 with heart rate of 77. Within 20 minutes pt. alert, no longer diaphoretic and alert and oriented x 3, answers questions without difficulty. BP rechecked 104/72, pulse 78, respirations 16, Temp 97.6 and O2 sat 99% on room air. At 12:40 pm, pt. denies lightheadedness or dizziness, stands up and walks 10 feet with steady gait noted. Sat down for a couple of minutes and then leaves ambulatory in stable condition accompanied by this RN and pt's mother to private vehicle.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Loss of personal independence in daily activities
Clinical narrative: A few hours after receiving the SHINGRIX vaccine on July 17, 2018, patient experienced a headache. He self-treated for several days and we continued to follow-up with him. We advised him to see his doctor for which he did. After a week his headache was started to limit his activities of daily living. On July 27 he saw his doctor. On July 30 he came into the pharmacy and said that his headache was finally easing.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Computerised tomogram head, Erythema, Full blood count, Headache, Heart rate increased
Clinical narrative: Arm swelling, redness, rash, paid up arm to should up to neck and head. Elevated heart rate. Increased WBC. Went to emergency room and was given an IV with Antibiotics and Paid meds.  Pain and swelling persisted for 3 days until a Steroid was given. Once steroid was give swelling and redness went down but shoulder, neck and head pain persisted.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Lumbar puncture, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging brain, Pain in extremity
Clinical narrative: Arm swelling, redness, rash, paid up arm to should up to neck and head. Elevated heart rate. Increased WBC. Went to emergency room and was given an IV with Antibiotics and Paid meds.  Pain and swelling persisted for 3 days until a Steroid was given. Once steroid was give swelling and redness went down but shoulder, neck and head pain persisted.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Rash, Ultrasound scan, Urine analysis, White blood cell count increased
Clinical narrative: Arm swelling, redness, rash, paid up arm to should up to neck and head. Elevated heart rate. Increased WBC. Went to emergency room and was given an IV with Antibiotics and Paid meds.  Pain and swelling persisted for 3 days until a Steroid was given. Once steroid was give swelling and redness went down but shoulder, neck and head pain persisted.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Abnormal behaviour, Cerebral haemorrhage, Imaging procedure abnormal, Malaise, Ocular retrobulbar haemorrhage
Clinical narrative: My daughter received her vaccinations on 6/11/18. She was perfect until then but got a little sick a couple of days later and it went away. On 6/23/18 we had to call the ambulance because she was hot, in a daze like state and just wasn't acting herself. We were taken to the hospital then transferred to another hospital were images were done and they found bleeding on the brain and called an eye doctor in who found bleeding behind her eyes.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Skin warm
Clinical narrative: My daughter received her vaccinations on 6/11/18. She was perfect until then but got a little sick a couple of days later and it went away. On 6/23/18 we had to call the ambulance because she was hot, in a daze like state and just wasn't acting herself. We were taken to the hospital then transferred to another hospital were images were done and they found bleeding on the brain and called an eye doctor in who found bleeding behind her eyes.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Depressed level of consciousness, Malaise, Nausea, Pallor
Clinical narrative: Client started to turn pale and clammy and stated that he was not feeling well. Stated he felt like he needed to throw up and was nauseated. Client began to have dry heeves, but did not vomit.  Client then appeared like he was going to pass out, so laid client on the floor with feet up.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Retching
Clinical narrative: Client started to turn pale and clammy and stated that he was not feeling well. Stated he felt like he needed to throw up and was nauseated. Client began to have dry heeves, but did not vomit.  Client then appeared like he was going to pass out, so laid client on the floor with feet up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Shortly after receiving the SHINGRIX vaccine, patient experienced pain in her arm when she lifted it and moved it in a certain way. It does not hurt 24/7. She went to Dr on 4/5/2018 and 7/5/2018 to check her arm pain. She went to Dr (chiropractor) on 4/25/2018 and 5/6/2018 6/12/2018 and 6/29/2018 since she wanted relief from her arm pain. She also sees the chiropractor for her back issues.
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: 19 year old gave SHINGRIX instead of Men B,. No side effects afterwards. Will follow up and call patient for the next several days to see how she is feeling. Provided the VIS statement and side effects to report and and phone number to call.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Malaise
Clinical narrative: Patient described "started to not feeling well by 6:00pm that night, body aches, muscle and joint ache, headache, started running fever, chills, 101. On Friday, diarrhea. symptoms receded by Saturday PM.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Patient described "started to not feeling well by 6:00pm that night, body aches, muscle and joint ache, headache, started running fever, chills, 101. On Friday, diarrhea. symptoms receded by Saturday PM.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the long-term prevention of shingles and zoster-related injuries. At the time of the vaccination, the patient relied on the information relayed through his healthcare providers, physicians, or pharmacists regarding the efficacy and safety of the ZOSTAVAX, which induced the patient to be vaccinated. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. On or about 18-SEP-2016, the patient was treated at a hospital for the onset of a blistering rash, which was diagnosed as herpes zoster. The patient was prescribed acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving the ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX vaccine, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness around injection site.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Within 30 minutes, moderate pain at shot site. Over the next 4 hours pain increased in severity and expanded to encompass whole arm. Ibuprofen was given and ice applied to site. 24 hours later  fatigue, muscle pain, chills, and headache came on. Ibuprofen being given.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Within 30 minutes, moderate pain at shot site. Over the next 4 hours pain increased in severity and expanded to encompass whole arm. Ibuprofen was given and ice applied to site. 24 hours later  fatigue, muscle pain, chills, and headache came on. Ibuprofen being given.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: Pt states body aches severe headache within 2 hrs after receiving vaccine. Then as day progressed increased temperature increasing to 102.0. Patient states woke up feeling like a bus hit her.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: About 30 seconds after receiving the second shot (FLUZONE HD), patient claimed to be dizzy and sweating. She stayed seated with her head between her knees for 5-10 minutes before saying that she felt better and the dizziness had stopped. Patient stood up and walked away under her own power, denying any need for food water or other treatment. No treatment was needed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Entire upper deltoid area of arm became very swollen, red and itchy (border expanded outside of injection site).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Entire upper deltoid area of arm became very swollen, red and itchy (border expanded outside of injection site). Did not experience this reaction with first dose in series.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Chills, shaking, fever, pounding headache, nausea, joint and muscle pain, sweats. Symptoms lasted from about 9:00 pm on 8/14 until about 2:00 pm on 8/15. Then muscle weakness and fatigue.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia, Nausea, Pyrexia, Tremor
Clinical narrative: Chills, shaking, fever, pounding headache, nausea, joint and muscle pain, sweats. Symptoms lasted from about 9:00 pm on 8/14 until about 2:00 pm on 8/15. Then muscle weakness and fatigue.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt was seen in clinic as walk in for redness, swelling and warmth to L deltoid at injection site. Was given Prescription of BENADRYL and instructions to continue with TYLENOL and MOTRIN as needed and to ice area, reddened area on Deltoid was marked for progression father of patient was advised to return to clinic if symptoms worsen.
Age: 59.0
Sex: F
Vaccine: HEPA
Symptoms: Anaphylactic reaction, Feeling abnormal, Throat tightness
Clinical narrative: Pt's son called and said that she made it to her location and felt like she was having a panic attack and her throat was closing. I asked if they had any BENADRYL. They did not. I told them to go straight to the clinic in that city. I called the clinic and told them they were on their way. Dr. called me back and said that yes it was an anaphylactic reaction. She gave her 0.5mg of EPI and repeated in 5 minutes (1mg total) and 50mg BENADRYL. She was doing much better and finishing a breathing treatment. They called the ambulance to take her to the hospital as well for follow-up.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Defecating bright red blood per rectum and mucus in stool. Happened also with first dose at age 2 months but was assured by pediatrician it wasn't due to vaccine and instead was due to mother's diet. At 2 months patient passed 3 stools with bright red blood 24 hours after 1st dose of rotarix. Mother has eliminated all dairy, soy, and other allergens. 24 hours after receiving second dose of ROTARIX, passing bright red blood again.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm was swollen, warm and red with a raised area of 5 cm below the injection site that started on 8-14-18. Injection was given at 9:59 on 8-13-18. She came in at 12:30 on 8-15-18 to have us look at it. She was given ZYRTEC Children's 10mg tablet to take today and once a day as long as needed. She was instructed to put ice on it and to take Children's Ibuprofen as directed for the discomfort.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, severe muscle soreness, fatigue.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea
Clinical narrative: Trouble breathing, pt called doctor, advised her to go to ER, pt did not go, but layed down for a little while and felt better.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Dyspnoea, Lip swelling, Urticaria
Clinical narrative: Patient was seen in the ED. Received 5yr immunizations and presented 30 min later with anaphylaxis with hives, swelling of her lips, difficulty breathing. She was given her EPIPEN along with BENADRYL by parents. Clinically she looked okay on arrival and ED give dexamethasone and H2-blocker and observed for four hours.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Upper arm swelling, redness, heat, painful from below elbow to shoulder. Peaked 30 hours after vaccination and subsided on day four; upper arm still painful to the touch 7 days after vaccination but swelling and heat gone.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Feeding disorder, Flushing
Clinical narrative: Patient received vaccination at 10am on 8/14/18. At approximately 7pm, patient started experiencing chills, nausea, flushing, and dizziness. She also describes feeling of her skin crawling, she felt weak and feverish. Around 9pm, she went to bed, and awoke at 11pm and was shivering and felt nausea. She went back to bed, and awoke again at 1am on 8/15. At this time, she vomited and then was able to go back to bed. As of 12pm on 8/15, patient still unable to tolerate food and feeling unwell, but symptoms seem to be improving.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient received vaccination at 10am on 8/14/18. At approximately 7pm, patient started experiencing chills, nausea, flushing, and dizziness. She also describes feeling of her skin crawling, she felt weak and feverish. Around 9pm, she went to bed, and awoke at 11pm and was shivering and felt nausea. She went back to bed, and awoke again at 1am on 8/15. At this time, she vomited and then was able to go back to bed. As of 12pm on 8/15, patient still unable to tolerate food and feeling unwell, but symptoms seem to be improving.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Pain, Spinal pain
Clinical narrative: Intense shoulder pain in the back along the scapula, and it radiates towards the spine. 6/10 consistent and constant pain, interrupts daily activites. 8/10 at worst, dull aching pain.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain
Clinical narrative: Patient reports pain 7/10 in the deltoid muscle when she lifts her arm laterally. No pain when lifting arm ventrally/dorsally. Verified it's muscle pain and not joint pain associated with injection bursitis. She confirms it's muscle pain. Somewhat interferes with daily activites and has to be careful. No redness or swelling present at the site of injection. Soreness has not improved or worsened in the last month.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Dizziness, Emotional distress, Pallor, Staring
Clinical narrative: Directly after injection patient became blank faced. When I asked if she was ok, she started crying saying that she was just overly emotional. Provider went in the room to talk with patient (pt)family during their 15 min waiting period. When she came out the timer had gone off for the pt to able to leave. She stated that the pt had become pale and stated she felt light headed. Pt did not lose consciousness but remained lightheaded and pale faced for over 10 min. Once she regained color and felt better they were released to go home.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Intentional self-injury, Pyrexia, Screaming
Clinical narrative: Patient had a fever of 103 for 3 days straight even AFTER TYLENOL. She screamed all day and night long. She kept trying to rip her hair out and scratching profusely at her head while she screamed.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Head injury, Syncope, Vomiting
Clinical narrative: Patient fainted 15 minutes after receiving the vaccine. Patient hit head on floor. Stood up under own power and walked back to pharmacy. Patient vomited after 2-3 minutes of sitting in a chair. Patient was brought a cold Coke. Stated he felt fine.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Pt had an episode of lightheadedness after vaccine.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Oropharyngeal pain, Pyrexia, Throat irritation
Clinical narrative: Sore/scratchy throat, weakness, fever.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: I developed flu like symptom approximated 10 hours after receiving the vaccine. Chills, fever, achy. Symptoms much better after 15 hours and gone by 30 hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Polymerase chain reaction positive, Rash papular, Secondary transmission
Clinical narrative: Patient had no reaction. Her sister, broke out in a papular rash on 8/9/18.  Sister has JIA and takes Humira weekly. She was started on antiviral medication and we sent vzv IgG and IgM and pcr of a lesion. IgG was consistent with immunity and IgM was low. PCR was positive for varicella zoster.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin lesion, Varicella virus test positive
Clinical narrative: Patient had no reaction. Her sister, broke out in a papular rash on 8/9/18.  Sister has JIA and takes Humira weekly. She was started on antiviral medication and we sent vzv IgG and IgM and pcr of a lesion. IgG was consistent with immunity and IgM was low. PCR was positive for varicella zoster.
Age: 44.0
Sex: F
Vaccine: HEP, HEPA, MNQ
Symptoms: Acne, Rash, Swelling face
Clinical narrative: Patient complains that her face is puffy with pimples on rashes.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Diarrhoea, Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen injection site for 2-3 days, chills, temperature over 100, muscle aches, diarrhea.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Red and swollen injection site for 2-3 days, chills, temperature over 100, muscle aches, diarrhea.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms... lasts 3 days on the first shot and 1.5 days for the second shot.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: Body ache, chills, fever, flu like symptoms, redness to left deltoid area approx 4 inches lasting x5 days joint pain, fatigue up to 8 days.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Body ache, chills, fever, flu like symptoms, redness to left deltoid area approx 4 inches lasting x5 days joint pain, fatigue up to 8 days.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR
Symptoms: Gait inability, Pyrexia, Weight bearing difficulty
Clinical narrative: Unable to bear weight on left side or walk, fever.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Nausea, feeling tired, dizzy, headache within 15 min. Rested and drank water.
Age: 45.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Dizziness, Heart rate decreased, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Dizziness, loss of consciousness/faint, vision changes, ringing in ears, sweating, lowered heart rate, nausea.
Age: 45.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Syncope, Tinnitus, Visual impairment
Clinical narrative: Dizziness, loss of consciousness/faint, vision changes, ringing in ears, sweating, lowered heart rate, nausea.