chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urticaria
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA164901, 2018SA175593 and 2018SA175612. This case involves Adult female patient who experienced hives, hypertensive, Tachy, panicy, short of breath and swollen face, while she received vaccine INFLUENZA VACCINE (reported as flu vaccine). The patient's past medical history included Rubber sensitivity. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported in unknown administration site. The patient developed a non-serious hives (urticaria), hypertensive (hypertension), tachy (tachycardia), panicy (pain), short of breath (dyspnoea) and swollen face (swelling face) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.). Final diagnosis was swollen face, short of breath, panicy, tachy, hypertensive and hives. The patient was treated with SOLUMEDROL. The patient outcome is reported as Unknown for hives, hypertensive, tachy, panicy, short of breath and swollen face. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dyspnoea, Hypertension, Panic reaction, Swelling face, Tachycardia
Clinical narrative: Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA164901, 2018SA175593 and 2018SA175612. This case involves Adult female patient who experienced hives, hypertensive, Tachy, panicy, short of breath and swollen face, while she received vaccine INFLUENZA VACCINE (reported as flu vaccine). The patient's past medical history included Rubber sensitivity. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported in unknown administration site. The patient developed a non-serious hives (urticaria), hypertensive (hypertension), tachy (tachycardia), panicy (pain), short of breath (dyspnoea) and swollen face (swelling face) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.). Final diagnosis was swollen face, short of breath, panicy, tachy, hypertensive and hives. The patient was treated with SOLUMEDROL. The patient outcome is reported as Unknown for hives, hypertensive, tachy, panicy, short of breath and swollen face. List of documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial unsolicited report received from a nurse on 22-Jun-2018. This case involves a 20-year-old male patient who was vaccinated with a dose of DAPTACEL (batch number, expiration date, dose in series, route and site of administration were not reported) instead of ADACEL (batch number, expiration date, dose in series, route and site of administration were not reported) on an unknown date. The patient's concomitant medications, medical history and previous medications was not reported. The patient had a Laceration of hand on an unknown date. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported whether the patient experienced any adverse reactions following the vaccination. 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 and Module VI of the 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: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 14-Jun-2018 regarding an unsolicited valid non-serious case received from Nurse. This case involves an 18 years old male patient who received a dose on 13 Jun 2018 that had expired on 16 Jan 2018/ no side effects were noted, while he received vaccine MENACTRA. The patients past medical history, concomitant medication and family history were not provided. Patient had no other vaccines. On 13-Jun-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5460BA, expiry date 16 Jan 2018 via unknown route in unknown administration site. It was an actual medication error due to Expired vaccine used. Patient did not experience 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.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Tenderness
Clinical narrative: Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional (Nurse). Linked cases: 2018SA174785 and 2018SA177378 (same reporter). This case involves a 29 years old female patient who experienced tender to touch, site reaction of redness of the site, pea size knot under injection site and had a site reaction, ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 14-Jun-2018, the patient received 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AA (Expiry date: 14-FEB-2020) via intramuscular route in the left deltoid. On 20-Jun-2018, The patient developed a non-serious tender to touch 6 days following the administration of ADACEL. On 20-Jun-2018, The patient developed a non-serious site reaction of redness of the site (vaccination site erythema) 6 days following the administration of ADACEL. On 20-Jun-2018, The patient developed a non-serious pea size knot under injection site 6 days following the administration of ADACEL. Final diagnosis was pea size knot under injection site, site reaction of redness of the site, tender to touch. Lab tests was not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for site reaction of redness of the site, as Unknown for tender to touch, as Unknown for pea size knot under injection site.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Peripheral swelling, Pyrexia
Clinical narrative: Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2018SA177371 and 2018SA174785. This case involves a 51 years old female patient who experienced redness of the site, tender to touch, right arm swollen, pea size knot under injection site and fever 101, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Jun-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AA via intramuscular route in the right deltoid. The patient developed a non-serious redness of the site 5 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious tender to touch 5 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious right arm swollen 5 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious pea size knot under injection site 5 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious fever 101 5 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included no lab tests). Final diagnosis was fever 101, pea size knot under injection site, right arm swollen, tender to touch and redness of the site. The patient was treated with KEFLEX. The patient outcome is reported as Unknown for redness of the site, as Unknown for tender to touch, as Unknown for right arm swollen, as Unknown for pea size knot under injection site and as Unknown for fever 101.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 14-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves patient (age and gender not reported) who was given a dose of an expired MENACTRA vaccine, while the patient received vaccine MENACTRA. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of MENACTRA (lot U553988, expiry date: 25-Apr-2018, route and site of administration were not reported). It was a case of actual medication error due to expired vaccine use. 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 and Module VI of the 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: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: Moderate headache with early morning (3:00 AM) onset. Onset of low grade fever with general malaise at approximately 10:00 AM the day following the vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient has developed a red rash on the left arm that began this morning (6 days post-injection). The rash begins approximately 3 inches below the injection site and is about 2 inches in diameter. Rash is not raised and there is no blistering. Pt denies a fever. She did not develop any side effects during the first 6 days post-injection. Pt is going to monitor the rash for any spreading and also for warmth or for development of a fever. Suggested follow-up with MD if any of these symptoms develop or worsen.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site reaction, Pruritus, Rash, Rash erythematous
Clinical narrative: Pt was given Tdap vaccine in L delt and HPV GARDASIL vaccine in R delt at appx 8:30 AM by RN. Appx 8:45 AM pt's mom went to Hospital Assistant and stated that her daughter's R arm is "itching and breaking out". Pt was brought back to nurse's office. Pt had red raised rash R arm from forearm to delt area. Pt given 75 mg BENADRYL IM R hip. After waiting in office for 20 mins, rash is noticeably smaller and resolving. Mom told to take pt to ER if any problems occur again. 2:15 PM -- PC to pt's mom. Mom states that pt is doing much better. Has occasional itching still, but no rash. Advised mom to give pt OTC BENADRYL. Mom voiced understanding.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Blood pressure decreased, Body temperature decreased, Dizziness, Heart rate increased, Hyperhidrosis
Clinical narrative: Reports waking in night with increased heart rate, lower blood pressure, temp 95.2, diaphoretic, vomiting, dizziness, muscle weakness, itchiness at injection site. Continued through the night.  She was seen by, PA on 7/2/18 and prescribed ZOFRAN for the nausea.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pruritus, Middle insomnia, Muscular weakness, Nausea, Vomiting
Clinical narrative: Reports waking in night with increased heart rate, lower blood pressure, temp 95.2, diaphoretic, vomiting, dizziness, muscle weakness, itchiness at injection site. Continued through the night.  She was seen by, PA on 7/2/18 and prescribed ZOFRAN for the nausea.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphasia, Blood pressure increased, Blood test, Chest discomfort, Chest pain
Clinical narrative: SOB, chest pain, chest tightness, muscle aches, couldn't speak, elevated blood pressure (203/150) - symptoms started Saturday afternoon and by Sunday evening they were bad enough that she went to the hospital. Patient went to the ER Sunday evening for 4 hours - they gave her NTG and did an X-ray and EKG - said she had no cardiac issues.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Electrocardiogram normal, Myalgia, X-ray
Clinical narrative: SOB, chest pain, chest tightness, muscle aches, couldn't speak, elevated blood pressure (203/150) - symptoms started Saturday afternoon and by Sunday evening they were bad enough that she went to the hospital. Patient went to the ER Sunday evening for 4 hours - they gave her NTG and did an X-ray and EKG - said she had no cardiac issues.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphasia, Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: SOB, chest pain, chest tightness, muscle aches, couldn't speak, elevated blood pressure (203/150) - symptoms started Saturday afternoon and by Sunday evening they were bad enough that she went to the hospital. Patient went to the ER Sunday evening for 4 hours - they gave her NTG and did an X-ray and EKG - said she had no cardiac issues.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram normal, Hypertension
Clinical narrative: SOB, chest pain, chest tightness, muscle aches, couldn't speak, elevated blood pressure (203/150) - symptoms started Saturday afternoon and by Sunday evening they were bad enough that she went to the hospital. Patient went to the ER Sunday evening for 4 hours - they gave her NTG and did an X-ray and EKG - said she had no cardiac issues.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling in his left arm. It travelled down his arm and lasted until 7/2/18.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Redness around injection site and arm was in pain. Patient had a little fever.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: The Patient and her twin brother both fainted after getting TDaP and MENACTRA. Both patients remained in our office for 20 min after episode. We elevated their legs, used cool compresses and gave cup of water. Vital signs taken and normal. Both patients recovered quickly and left office without incident 20 min later. Follow up phone call placed to father 4 hours later, father report both kids went home and took a nap. They ate lunch and are drinking fluids well. No further issues with dizziness or nausea. Off note today is a very hot/humid day, area is under heat advisory.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: The Patient and his twin sister both fainted after getting TDaP and MENACTRA. Both patients remained in our office for 20 min after episode. We elevated their legs, used cool compresses and gave cup of water. Vital signs taken and normal. Both patients recovered quickly and left office without incident 20 min later. Follow up phone call placed to father 4 hours later, father report both kids went home and took a nap. They ate lunch and are drinking fluids well. No further issues with dizziness or nausea. Off note today is a very hot/humid day, area is under heat advisory.
Age: 11.0
Sex: M
Vaccine: DTAP, HEPA, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given wrong immunization . Patient was due for TDAP and was given DTAP. Patient had NO reaction.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Head injury, Laceration, Loss of consciousness, Suture insertion
Clinical narrative: Pt in (w/ mom and grandmother) for a Tdap vaccine on nursing schedule (needed early for camp) at 11:30AM. Tdap was administered while pt was sitting in upright position on bed. Nurse left pt sitting on bed in room with mom and grandma. Nurse came back after 5 minutes and was speaking with mom while pt was sitting on bed. At about 11:45AM Pt stood, lost consciousness, and fell forward. She hit her head on wall and chair, splitting her chin open. At no point did the patient complain of weakness or dizziness. 2 MDs arrived within 5-10 seconds. Pt was arousable after about 30 seconds, was A&Ox3. Care was taken over by MD. Pt was monitored in the office for about 1.5hrs then sent to ED for stitches.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: Small amount of redness to injection sites on right arm. Afebrile. No streaking. No redness to left arm.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt began having itching and hives appx 1hr after vaccine was administered. At home took 100mg BENADRYL and was given 1 dose of EPIPEN in clinic. Evaluated by Medical Director and transferred to ER for further evaluation/treatment.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Allergy test, Streptococcus test, Urticaria
Clinical narrative: Urticaria, "unexplained chronic hives" lasting for 6 months, the hives were on his entire body: stomach, arms, legs, neck, back, and around penis.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Rash
Clinical narrative: This literature marketed report was received from the authors and refers to 18 adult patients of an unspecified age and gender. The patient's medical history was not provided. Methods: 11,533 email invitations delivered to members of the Immune Deficiency Foundation database requesting participation in an online survey about zoster, influenza and varicella experiences. Data from 881 individuals age 19 years old or older with Common Variable Immunodeficiency (CVID) (N=760; mean age 54 years old; 83% Female; 92% of specific origin) or Hypogammaglobulinemia (N=121; mean age 54 years old; 83% Female; 93% of specific origin) were analyzed. On an unspecified dates, close to one fifth (18%, n=105) of adults age 50 or older with CVID or Hypogammaglobulinemia (N=568) had received Zoster Vaccine Live (manufacturer unknown) (reported as shingles vaccination; strength, dose, route of vaccination, lot number and expiration date were not provided). The authors stated that after the first vaccination of zoster vaccine live (manufacturer unknown), 18 patients developed mild side effects like skin rash and muscle pain. No side effects were reported after receiving the booster vaccination and no hospitalizations were reported as a result of receiving zoster vaccine live (manufacturer unknown). The outcome of the events was not provided. Sender's Comments: US-009507513-1807USA000966.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-AUG-2011, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 23-NOV-2016, he was treated by a physician for onset of a vesicular rash, which was diagnosed as  shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 07-MAY-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-JUL-2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-OCT-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On 01-OCT-2015, the patient was treated by a physician for a persistent vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-AUG-2015, the patient was treated at a medical center for a persistent vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Rash
Clinical narrative: This literature marketed report was received from the authors and refers to 18 adult patients of an unspecified age and gender. The patient's medical history was not provided. Methods: 11,533 email invitations delivered to members of the Immune Deficiency Foundation database requesting participation in an online survey about zoster, influenza and varicella experiences. Data from 881 individuals age 19 years old or older with Common Variable Immunodeficiency (CVID) (N=760; mean age 54 years old; 83% Female; 92% of specific origin) or Hypogammaglobulinemia (N=121; mean age 54 years old; 83% Female; 93% of specific origin) were analyzed. On an unspecified dates, close to one fifth (18%, n=105) of adults age 50 or older with CVID or Hypogammaglobulinemia (N=568) had received Zoster Vaccine Live (manufacturer unknown) (reported as shingles vaccination; strength, dose, route of vaccination, lot number and expiration date were not provided). The authors stated that after the first vaccination of zoster vaccine live (manufacturer unknown), 18 patients developed mild side effects like skin rash and muscle pain. No side effects were reported after receiving the booster vaccination and no hospitalizations were reported as a result of receiving zoster vaccine live (manufacturer unknown). The outcome of the events was not provided. Sender's Comments: US-009507513-1806USA003215.
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: Fatique, weakness, headache, thirst, swelling pain at site, heaviness right extremity, loss of appetite.
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site swelling, Limb discomfort, Thirst
Clinical narrative: Fatique, weakness, headache, thirst, swelling pain at site, heaviness right extremity, loss of appetite.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: After receiving the vaccine sometime in the afternoon on Monday, June 26, the patient became symptomatic the following morning. She reported intense body aches, chills, and a fever of 101.6 F. The injection site was red and puffy. She took ADVIL for the aches. Symptoms continued through June 27, but had resolved by June 28th. She experienced similar symptoms with the first dose 3 months prior, except there were no chills the first time around.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature fluctuation, Chills, Confusional state, Dehydration, Disturbance in attention
Clinical narrative: Friday 6/29/2018 Right upper arm became, red, swollen, hot & arm became difficult to move. Later in the evening running a temperature of 100. Took ibuprofen for pain, swelling & temperature. Symptoms decreased. Slept over 12 hours. 6/30/2018 Swelling, redness, heat & difficulty moving arm increased. Temperature now 102. Headache, nausea, inability to eat or drink, body aches, chills, numbness & tingling in fingers, hands & around mouth. Difficulty concentrating. Went to ER at local hospital. Treated with TORADOL for pain, REGLAN for nausea & TYLENOL for fever. After treatment BP 90/66, Temp, 100.7. Sent home with REGLAN Rx. Able to eat & drink very little at home. Started taking 400mg ibuprofen QID. Slept 18+ hours 7/1/2018 Swelling, redness, heat & difficulty moving arm decreased. Horrible body aches & head ache upon waking. Continued taking 400mg ibuprofen QID. Decreased pain for 2 hours & then increased. Temperature fluctuated between 97.0 and 100.0 throughout the day. Still confused. Slept 14+ hours 7/2/2018 Worked 4 hours as pre-op nurse. After shift given 1000 NS via IV Lt AC via 22 gauge IV set. Easily confused & dehydrated 7/3/2018 Continue with ibuprofen as above. Temperatures still fluctuating. Easily confused & dehydrated.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Feeding disorder, Headache, Hypersomnia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Friday 6/29/2018 Right upper arm became, red, swollen, hot & arm became difficult to move. Later in the evening running a temperature of 100. Took ibuprofen for pain, swelling & temperature. Symptoms decreased. Slept over 12 hours. 6/30/2018 Swelling, redness, heat & difficulty moving arm increased. Temperature now 102. Headache, nausea, inability to eat or drink, body aches, chills, numbness & tingling in fingers, hands & around mouth. Difficulty concentrating. Went to ER at local hospital. Treated with TORADOL for pain, REGLAN for nausea & TYLENOL for fever. After treatment BP 90/66, Temp, 100.7. Sent home with REGLAN Rx. Able to eat & drink very little at home. Started taking 400mg ibuprofen QID. Slept 18+ hours 7/1/2018 Swelling, redness, heat & difficulty moving arm decreased. Horrible body aches & head ache upon waking. Continued taking 400mg ibuprofen QID. Decreased pain for 2 hours & then increased. Temperature fluctuated between 97.0 and 100.0 throughout the day. Still confused. Slept 14+ hours 7/2/2018 Worked 4 hours as pre-op nurse. After shift given 1000 NS via IV Lt AC via 22 gauge IV set. Easily confused & dehydrated 7/3/2018 Continue with ibuprofen as above. Temperatures still fluctuating. Easily confused & dehydrated.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Friday 6/29/2018 Right upper arm became, red, swollen, hot & arm became difficult to move. Later in the evening running a temperature of 100. Took ibuprofen for pain, swelling & temperature. Symptoms decreased. Slept over 12 hours. 6/30/2018 Swelling, redness, heat & difficulty moving arm increased. Temperature now 102. Headache, nausea, inability to eat or drink, body aches, chills, numbness & tingling in fingers, hands & around mouth. Difficulty concentrating. Went to ER at local hospital. Treated with TORADOL for pain, REGLAN for nausea & TYLENOL for fever. After treatment BP 90/66, Temp, 100.7. Sent home with REGLAN Rx. Able to eat & drink very little at home. Started taking 400mg ibuprofen QID. Slept 18+ hours 7/1/2018 Swelling, redness, heat & difficulty moving arm decreased. Horrible body aches & head ache upon waking. Continued taking 400mg ibuprofen QID. Decreased pain for 2 hours & then increased. Temperature fluctuated between 97.0 and 100.0 throughout the day. Still confused. Slept 14+ hours 7/2/2018 Worked 4 hours as pre-op nurse. After shift given 1000 NS via IV Lt AC via 22 gauge IV set. Easily confused & dehydrated 7/3/2018 Continue with ibuprofen as above. Temperatures still fluctuating. Easily confused & dehydrated.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Paraesthesia, Paraesthesia oral, Pyrexia
Clinical narrative: Friday 6/29/2018 Right upper arm became, red, swollen, hot & arm became difficult to move. Later in the evening running a temperature of 100. Took ibuprofen for pain, swelling & temperature. Symptoms decreased. Slept over 12 hours. 6/30/2018 Swelling, redness, heat & difficulty moving arm increased. Temperature now 102. Headache, nausea, inability to eat or drink, body aches, chills, numbness & tingling in fingers, hands & around mouth. Difficulty concentrating. Went to ER at local hospital. Treated with TORADOL for pain, REGLAN for nausea & TYLENOL for fever. After treatment BP 90/66, Temp, 100.7. Sent home with REGLAN Rx. Able to eat & drink very little at home. Started taking 400mg ibuprofen QID. Slept 18+ hours 7/1/2018 Swelling, redness, heat & difficulty moving arm decreased. Horrible body aches & head ache upon waking. Continued taking 400mg ibuprofen QID. Decreased pain for 2 hours & then increased. Temperature fluctuated between 97.0 and 100.0 throughout the day. Still confused. Slept 14+ hours 7/2/2018 Worked 4 hours as pre-op nurse. After shift given 1000 NS via IV Lt AC via 22 gauge IV set. Easily confused & dehydrated 7/3/2018 Continue with ibuprofen as above. Temperatures still fluctuating. Easily confused & dehydrated.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain
Clinical narrative: Patient received SHINGRIX on Friday and said that he developed severe abdominal pains and cramps early Sunday morning. He said the pain was so intense that he paged his doctor. The doctor on call told him to use an enema and take milk of magnesia.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: I developed severe shoulder pain that progressed that night to generalized joint pain. Then chills, low grade fever, headache and general malaise. I felt like I was hit by a truck. This lasted till approximately noon on 7/3/2018. Although the joint pain and fever have subsided I still feel very tired.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Musculoskeletal pain, Pyrexia
Clinical narrative: I developed severe shoulder pain that progressed that night to generalized joint pain. Then chills, low grade fever, headache and general malaise. I felt like I was hit by a truck. This lasted till approximately noon on 7/3/2018. Although the joint pain and fever have subsided I still feel very tired.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 6inch x 5inch redness/induration surrounding the site of injection.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Skin irritation
Clinical narrative: 6inch x 5inch redness/induration surrounding the site of injection.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Skin warm
Clinical narrative: 6inch x 5inch redness/induration surrounding the site of injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Scab, Skin exfoliation, Skin weeping
Clinical narrative: Pt had injection on 5/24/18 - she stated that after receiving the injection, her arm near site of injection started weeping and eventually dried into a crusty and scaly area. Today is now 7/3/18 and she stated she still has a bumpy patch near site of injection. She did not receive medical treatment for this.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Client describes dull ache, moving arm is "quite painful" down to elbow.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: PATIENT EXHIBITED ERYTHEMA, PAIN AT THE SITE OF INJECTION AND SLIGHT SWELLING. PATIENT WAS INSTRUCTED TO APPLY A COLD COMPRESS AND TAKE ACETAMINOPHEN FOR THE PAIN (NSAIDS WERE NOT AN OPTION FOR THIS PATIENT). AWAITING FINAL OUTCOME OF TREATMENT FOR SYMPTOMS.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia, Rash
Clinical narrative: Pt states that the day after receiving the vaccine she felt achy with a small fever. She states that the top of her head hurt. She states also that the skin on her face around her eye broke out similar to when she had shingles. She states that it was very mild after her first dose of SHINGRIX, but was more severe after the second dose of SHINGRIX.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Rash, Urticaria
Clinical narrative: MOM NOTICED PT HAD RASH THAT STARTED ON TRUNK A FEW HOURS AFTER VACCINE ADMINISTRATION. THE NEXT MORNING THE RASH HAD SPREAD AND LOOKED LIKE HIVES.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Body temperature increased, Erythema, Headache, Injection site pruritus, Lymphadenopathy
Clinical narrative: Within 15 minutes of receiving vaccine pt felt itchiness at injection site, after about 9 hours pt started to feel swelling, redness, itchiness, pain, headache, temp of 99.4F and lymphadenopathy in left armpit lymph node worsening over past 19+hours w/ history of similar local site reactions to flu shot, mgc vaccine, and most recent rabies/jev vaccines in preparation for upcoming deployment. pt took atarax prior to receiving vaccine w/o any relief.
Age: 33.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Within 15 minutes of receiving vaccine pt felt itchiness at injection site, after about 9 hours pt started to feel swelling, redness, itchiness, pain, headache, temp of 99.4F and lymphadenopathy in left armpit lymph node worsening over past 19+hours w/ history of similar local site reactions to flu shot, mgc vaccine, and most recent rabies/jev vaccines in preparation for upcoming deployment. pt took atarax prior to receiving vaccine w/o any relief.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Back pain
Clinical narrative: Pain in elbows and upper back. The pain was so great and continuous I could barely lift anything. Strength greatly reduced.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Chest X-ray, Chills, Computerised tomogram, Decreased appetite
Clinical narrative: Chills - fever. Weight loss. Loss of appetite. Lethargic; Week of antibiotics. Fainted - head wound located (4-20-2018 6:00 a,m.).
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Pyrexia, Syncope, Weight decreased, Wound
Clinical narrative: Chills - fever. Weight loss. Loss of appetite. Lethargic; Week of antibiotics. Fainted - head wound located (4-20-2018 6:00 a,m.).
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Event was as followed; expired vaccination was administered three days after expiration date to child. Called company stated we should call patient to administer another dose of vaccine in 4 weeks. Patient's mother will be called and will bring patient in for another dose.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Gastrointestinal disorder, Lethargy, Pain, Rash
Clinical narrative: Severe Lethargy, GIT issues: stomach upset, pain on left upper body: chest to back, severe rash on arms. Patient went to ER.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Insomnia, Malaise, Myalgia
Clinical narrative: Approx 12 hours after injection I became very ill. Chills, fever, severe muscle aches, severe nausea - it was a sleepless night and I was very sick. This lasted approx 10 hours although nausea persisted for several hours longer. It left me very weak for a couple of days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Approx 12 hours after injection I became very ill. Chills, fever, severe muscle aches, severe nausea - it was a sleepless night and I was very sick. This lasted approx 10 hours although nausea persisted for several hours longer. It left me very weak for a couple of days.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Burning sensation, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Patient arrived at the pharmacy counter on 07/03/18 and spoke to the pharmacist in charge about possible adverse reaction related to BOOSTRIX vaccine. Her chief complaint was: burning sensation on hands and foot (neuropathy), tingling and numbness sensation on arms / legs and joint pain.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: First day, stiff neck. Second day area below injection extremely sensitive to touch and also itchy; fatigue. Third day fever of 101.5. Thereafter for a week, arm painful and itchy.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: First day, stiff neck. Second day area below injection extremely sensitive to touch and also itchy; fatigue. Third day fever of 101.5. Thereafter for a week, arm painful and itchy.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Injection site warmth, Laboratory test
Clinical narrative: Patient's son called pharmacy on 7/3/2018 to report that there was local site reaction, swelling at site of injection, hot to touch, 3 x 7 inch redness around the injection site. Later she developed shortness of breath and was taken to the hospital or ER. She has difficulty breathing and is hospitalized.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Patient's son called pharmacy on 7/3/2018 to report that there was local site reaction, swelling at site of injection, hot to touch, 3 x 7 inch redness around the injection site. Later she developed shortness of breath and was taken to the hospital or ER. She has difficulty breathing and is hospitalized.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Flushing, Rash pruritic
Clinical narrative: Large circular/oval rash (approximately 4 in x 3 in) appeared 1 week after administration. Rash slightly itches but causes no pain. Patient felt flushed and slightly light headed then noticed rash while taking a shower. Checked for signs of bursitis when patient came into the pharmacy but none present. Patient has no shoulder pain or stiffness. Patient also noted that she noticed her cheeks were red as well and was concerned that the rash may be spreading but also was not sure if the flushing on her cheek was rosacea. Advised patient to take oral BENADRYL at night and use BENADRYL spray or cream if itching increases or becomes uncomfortable. Patient will follow up with pharmacy if symptoms change. UPDATE: Followed up with patient approximately 10 hours from when reaction started/when they came into the pharmacy and rash has not grown in size or spread. Patient reports she believes the redness is going down and her itching as not increased. Patient has not taken BENADRYL or another medication at this time therefore improvement was not due to treatment. Patient will still follow up with pharmacy if symptoms change and then be advised to follow-up with PCP if necessary.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dyspepsia, Headache, Insomnia, Pain
Clinical narrative: Total body aches and burning; stomach burning; headache and fever of 100. Awake all night following the shot. No treatment. Symptoms waned at the end of the day after the shot.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Total body aches and burning; stomach burning; headache and fever of 100. Awake all night following the shot. No treatment. Symptoms waned at the end of the day after the shot.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Developed rash on face and legs after vaccines. Rash noticed 1 hour after Hep B. Examined by MD and rs consistent with urticaria.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain
Clinical narrative: Says has neck pain and throbbing. Was not specific on just how soon this began. No treatment at this time per Dr.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Injection site pain, Swelling, Throat irritation
Clinical narrative: Shot administered, immediate painful within 1 hour swelling occurred, became tired. Next day throat felt "funny" went to physician and started on ZYRTEC 2 x 10 mg now 1 BID. No fever.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Head injury, Syncope
Clinical narrative: Pt fainted and hit his head on the floor from sitting position.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Had vaccine 5/26/18. Husband called 6/21/18 stating wife has had pain in shoulder to elbow since vaccine. Ice, TYLENOL, and ASPERCREAM tried with no relief.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Hep B vaccine given too early.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea, Pain
Clinical narrative: Vaccine on 6/5/18 - Felt nausea, headache and body aches for 2-3 days afterward. The symptoms resolved. Patient was counseled to have 2nd part of the vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Red, warm, tender rash at injection site. Size of 3inx3in square.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Contusion, Erythema, Skin lesion, Urticaria
Clinical narrative: Hives started on hips, then spread to stomach, then to extremities, then head. ER visit 07/01/18 at 10:00 AM--instructed to give ALLEGRA and BENADRYL cream, which did not help and hives continued to get worse. Mother initiated oral BENADRYL (1st dose given 3:30 PM). Two phone calls to ER after that- mother was told nothing more they could do and to keep giving BENADRYL. No wheezing or breathing difficulties. Doctor appointment at 9:00 AM on 07/02/2018 with physician at clinic; steroid shot given. Prednisone prescribed if more lesions noted. BENADRYL continues to be given every 4 hours. Lesions on stomach appear bruised, while lesions on back appear bright red.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Vaccine given 6/27/18 noted reaction 6/28/18 redness, erythema area 10 cm x 7 cm. Pain r-deltoid. Will moist warm compresses TYLENOL 650mg Q 6 hrs.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Injection site reaction, Rash, Skin lesion, Urticaria
Clinical narrative: Vaccines 6/28; started w/ urticaria 7/3; cluster of lesions to (R) thigh surrounding injection site; 10-15 other diffusely spread urticarial lesions to trunk, legs, jaw line - slight cough 1 day prior to rash; no other symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Cellulitis, Erythema, Induration, Skin warm, Tenderness
Clinical narrative: (L) arm red the afternoon vaccine given, began to get larger. When evaluated at appt. on 7/3/18, (positive) 10 cm area redness (L) arm. (Positive) warm/tender/hard. 10mL BENADRYL TID and KEFLEX 250/5 1 1/2 tsp TID x 7 days for cellulitis. Evaluated today, on 7/8/18 - good prognosis.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Erythema, Impaired work ability, Induration, Peripheral swelling
Clinical narrative: Pt developed cough requiring RX for benzonatate, and was unable to go to work for a couple of days. Arm swollen and red, hard to the touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash erythematous
Clinical narrative: 6/25/18 Rash from her L shoulder to the top of her breast area - 1 area blistered, the rest red dots.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: Tactile fever-night of vaccination, swelling, erythema, warmth and tenderness at site (of (L) thigh, MMRV placed), and lack of appetite-vaccine placed 6/25/18. Mom presented with patient 6/27/18-as above and with worsening symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Tactile fever-night of vaccination, swelling, erythema, warmth and tenderness at site (of (L) thigh, MMRV placed), and lack of appetite-vaccine placed 6/25/18. Mom presented with patient 6/27/18-as above and with worsening symptoms.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Local erythema and significant swelling (entire upper arm) within 24 hours of MCV vaccination.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Body temperature, Diarrhoea, Erythema, Swelling
Clinical narrative: Patient reported a temp, diarrhea and local reaction of swelling and redness.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Presented in ER on 7-1-18 with 1 day of swelling of both legs. Reaction in both legs some erythema of (L) thigh. Started on KEFLEX.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient complained of pain at the injection site mild swelling and redness noted. Stated she had fever the night of immunization date.