chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions and medical history of the patients were not reported. Concomitant therapies included sterile diluent. On unknown dates, the patients were vaccinated with multiple improperly stored doses of VARIVAX with lot # M043582 and expiration date of 28-OCT-2018 (strength, dose and route of administration were unknown) for prophylaxis, which were stored from -14 Celsius degrees (°C) to -10°C (-14°C) and from -9°C to 8°C (-7°C) for 50 hours. There were no previous temperature excursions. Moreover, it was reported that the temperature excursions were detected by a data logger. No adverse events were reported. As of 23-MAY-2018, all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from the registered nurse on 05-DEC-2018, who stated that another improperly stored doses of VARIVAX lot # R017643 with expiration date of 20-JUN-2020 (which was stored at -3.9 Celsius for 40 hours), and lot # R017643 with expiration date of 02-JUL-2018 (which was stored at -13.7 Celsius for 5 hours and 51 minutes)  were administered also for prophylaxis There were no previous temperature excursions. The diluent was properly stored (lot and expiration date were not reported).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Aphonia, Endoscopy, Pharyngeal erythema, Viral infection
Clinical narrative: This spontaneous report has been received from the patient's father referring to a 13 year old female patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 11-OCT-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm for prophylaxis (batch/lot # reported as N0035957, expiration date reported as 10-OCT-2020; strength was not reported). On an unknown date in October 2018, the patient experienced unspecified viral symptoms after the injection and lost her voice within a week after being administered GARDASIL 9. The patient had no voice at all and could only whisper. The patient was given a week of prednisone (manufacturer unknown) and was seen by an Ear, Nose and Throat (ENT) physician. The patient had an endoscopy twice and the result of the first one was not reported. In November 2018 (reported as a week ago), the last one showed some redness in the throat but otherwise normal. The patient was going to see a voice specialist. At the time of the report, the outcome of the events was reported as not recovered. No causality assessment was provided.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician refers to a 60-year-old female patient. The patient's current conditions included IA nephropathy and urinary tract infection (UTI). The patient's medical history included renal transplant. The patient's other medications included immunosuppressive therapy VIZ: prednisone 5mg, tacrolimus 3mg (AM) and 2mg (PM), MMF, ascorbic acid and gabapentin. The patient's previous vaccination included PREVNAR (lot #, expiry date not reported). On an unknown date on 30th November 9:45 AM, the patient was vaccinated with PNEUMOVAX 23 lot # R018136. On the same day of vaccine administration at 1:15 PM, the patient experienced local reaction, erythema, feeling hot, peripheral swelling and pain in extremity. The patient was treated with BENADRYL, MOTRIN 100mg. The patient was not allowed non-steroidal anti-inflammatory drugs in higher amounts, which slowed down the recovery. The outcome of local reaction, erythema, feeling hot, peripheral swelling and pain in extremity was unknown. The causality for the adverse events with the suspect drugs were not reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent condition, concomitant therapies, historical drug or allergies were not reported. On 01-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 (anatomical location, strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. On 03-DEC-2018, the patient was vaccinated with the second dose of GARDASIL 9 lot number R017133, expiry date 29-APR-2021 (anatomical location, strength, dose, route and frequency were not provided) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013 the patient's healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. In 2014, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In 2015, the patient was treated by a health care provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a 19 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-OCT-2015, the patient was vaccinated with a dose of HAVRIX Lot # 3RB2E, expiration date: 17-FEB-2017 (dose, strength, anatomical location, administration route was not reported). Later, on 07-APR-2016, the patient received a booster of VAQTA 25/0.5 (dosage form) lot # L043209, expiration date on 17-SEP-2017, intramuscularly (anatomical location was not reported) both vaccines as prophylaxis. No adverse effects were reported.
Age: 0.83
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 10-month-old female patient. The patient received unspecified hepatitis B virus vaccine at birth and did not get any ''shots'' again until she was 7-month-old. The patient was on a new schedule with her physician to ''catch her up on her vaccine'' at the time of this report. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 05-DEC-2018 (reported as yesterday), the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided) and PENTACEL for prophylaxis. No adverse effects were reported.
Age: 0.92
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a license practical nurse referring to a 11 month old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 22-AUG-2013, the patient was vaccinated with the first dose of VARIVAX for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported), which was 5 days before her first birthday 27-AUG-2013 with water sterile diluent. On 27-AUG-2016, the patient was administered with the second dose of VARIVAX. No adverse effect reported.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 3 years old patient who received vaccine TYPHIM VI (lot N1K911M and expiration date 27-Oct-2019) via intramuscular route in the left arm on 01-Dec-2018 that underwent a three day shipping excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received no other concomitant vaccines. It was a case of actual medication error due to incorrect product storage. It was not reported if the patient had any adverse event. 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: U
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (2-3 months old patient, gender unknown) who received only DTAP and IPV portion of PENTACEL.(Suspension for injection) without ACTHIB portion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE and HEPATITIS B VACCINE. On 29-Nov-2018, the patient received a single 0.5 ml dose of suspect PENTACEL lot number not reported via intramuscular route in the leg (side unknown). It was a case of actual medication error due to it did not have 0.4NaCl saline solution to reconstitute the vaccine. Patient experienced no adverse event. 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. Documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 34 years old female patient who experienced received expired MENACTRA (lot number: U5766AE expiry date: 02-Dec-2018) on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ADACEL on 03-Dec-2018 and AFLURIA QUADRIVALENT on 03-Dec-2018 for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown if the patient had any adverse event. 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. List of documents held by sender: none.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC, RVX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 months old male patient who received and expired dose of  vaccine PENTACEL (batch number: C526AAA, expiry date: 29-Oct-2018) (dose in series not reported) via intramuscular route in the right thigh on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunization; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization. It was a case of actual medication error due to Expired vaccine used. No adverse event was experienced. It was  reported that there were no side effects. 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: 0.17
Sex: F
Vaccine: FLU4, HIBV, PNC
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two months old female patient who was vaccinated with ACT-HIB (lot number: UI822AAA, expiry date: 05-Jan-2019) in right thigh, which was reconstituted with sterile water instead of saline diluent on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and FLUZONE QUADRIVALENT for Immunisation. It was an actual medication error due to Inappropriate reconstitution technique. Patient did not have any side effects. 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. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 years old male patient who was given 0.25ml of FLUZONE QUADRIVALENT instead of 0.5 ml (lot number: UT6259NA, expiry date: 31-Jul-2023, route, dose in series not reported) in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medication was none. It was reported that no other vaccines given on that day. This was a case of actual medication error due to vaccine underdose. It was not reported if any adverse event occurred or not 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 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from a physician via a Sanofi-employee (accountant). This case involves a patient (age and gender not reported) who was vaccinated with a dose of PENTACEL (lot number and expiry date was not reported) that was diluted with regular saline instead of the diluent provided on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant medications were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported whether the patient has experienced any adverse events or not. 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.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 13 years old female patient who became ill with sore throat and fever, while she received vaccine Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Dec-2018, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number, Exp. Date, route and administration site not reported. On an unknown date, the patient became ill (malaise) with sore throat (oropharyngeal pain) and fever (pyrexia) 1 day following the administration of Influenza Vaccine. It was reported that, the patient felt better next day. Details of lab data not provided. Final diagnosis was became ill with fever and sore throat. It was not reported if the patient received a corrective treatment. On an unknown date, the patient recovered from events. List of documents held by sender- none.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Muscle pain (arms, legs, back, and neck), weakness and shakiness in legs, redness, swelling, and pain at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Muscle pain (arms, legs, back, and neck), weakness and shakiness in legs, redness, swelling, and pain at injection site.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Hypertension, Injection site erythema, Pain in extremity
Clinical narrative: Patient received vaccine on 12/4/2018. On 12/5/18 she reported that her arm really hurt and it was a little red at the shot site. On 12/7 she came to the pharmacy again and the redness was larger than on 12/5 but still within the limits of a normal reaction to a vaccine. She was advised to mark with a black marker and if the redness spreads further to follow up with her physician. On 12/8, she went to the doctor and they diagnosed cellulitis. Treament with Cephalexin for 10 days.
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Antinuclear antibody negative, Arthralgia, Biopsy skin abnormal, Borrelia test negative, C-reactive protein increased
Clinical narrative: Rash within 3 days, starting on thighs and spreading over body. Sent to Dermatologist. Given steroid  cream and biopsy done. Returned to PCP 11/6/2018 with continued rash and now joint pain with swelling as well. Told to ice, compression to area and elevation.
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Full blood count normal, Joint swelling, Rash generalised, Red blood cell sedimentation rate normal, Vasculitis
Clinical narrative: Rash within 3 days, starting on thighs and spreading over body. Sent to Dermatologist. Given steroid  cream and biopsy done. Returned to PCP 11/6/2018 with continued rash and now joint pain with swelling as well. Told to ice, compression to area and elevation.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed redness warmth and swelling at inject site in the evening. Also had chills. Called office 12/11/2018 and was brought in for evaluation. Advised to use warm compresses, OTC pain relief and was put on KEFLEX.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site ulcer
Clinical narrative: Shallow ulceration with surrounding erythema at sight of shot.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Patient had a hard red lump on left deltoid. Tried using warm wet compress to help with no success. Patient was seen in ER 3 days later for cellulitis and started on KEFLEX.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash pruritic, Varicella post vaccine
Clinical narrative: Patient presented to office with itchy rash on stomach, arms, legs and back x 4 days. No fever. Rash was diagnosed by PCP, as Varicella.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Feeling cold, Influenza like illness, Nausea, Pruritus
Clinical narrative: 12/5/18 6 PM-felt cold/feverish and nausea. 12/6/18 Flu-like symptoms all day; felt better later in day. 12/7/18 Red, bumpy rash to entire torso to mid neck, sides of neck to ears, pt questions if it was also present on head; itchy back, ears, neck and upper chest; harder than usual to swallow. Had similar symptoms after 1st SHINGRIX-rash, but no flu-like symptoms. Stated that some areas were hot and itchy prior to eruption of rash. Pt took 25 mg BENADRYL QD. Rash went away on 12/9/18. Continued BENADRYL until 12/12. Pt contacted on 12/12/18- Still has rash to back of torso, but not visible on anterior torso. Torso remains a little itchy, but pt states that she is feeling better.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash erythematous, Skin warm
Clinical narrative: 12/5/18 6 PM-felt cold/feverish and nausea. 12/6/18 Flu-like symptoms all day; felt better later in day. 12/7/18 Red, bumpy rash to entire torso to mid neck, sides of neck to ears, pt questions if it was also present on head; itchy back, ears, neck and upper chest; harder than usual to swallow. Had similar symptoms after 1st SHINGRIX-rash, but no flu-like symptoms. Stated that some areas were hot and itchy prior to eruption of rash. Pt took 25 mg BENADRYL QD. Rash went away on 12/9/18. Continued BENADRYL until 12/12. Pt contacted on 12/12/18- Still has rash to back of torso, but not visible on anterior torso. Torso remains a little itchy, but pt states that she is feeling better.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Discomfort, Injection site pain
Clinical narrative: Within an hour of the injection developed pain at the injection site (treated w/ ice and ibuprofen) -- no notable redness or swelling. Approximately 48-hr later began to notice pain in left upper back area. The pain worsened and by another 24-36-hr, the pain was significant and lying down was very uncomfortable and trying to get up even more so. The pain felt deeper than muscular and I became concerned that something was affecting my lungs (did not experience any breathing problems -- no SOB or added discomfort when inhaling or exhaling). I had a viral induced pleuritis and pericarditis several years ago from Coxsakie B and was becoming concerned that was happening again. Treated with 800mg ibuprofen and topical pain relieving rub. By the next morning, pain was lessened enough that I did not seek medical treatment. The pain continued to lessen each day and by one week following the injection, was back to normal.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arteritis, Asthenia, Ataxia, Blood culture negative, Blood sodium decreased
Clinical narrative: Husband states patient developed rash within 24 hours on trunk and both arms, followed by ataxia and weakness and headache within 48 hours of vaccination. Hospitalized several times. Ophthalmologist also consulted and diagnosed arteritis.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Blood urea increased, CSF test normal, Headache, Influenza virus test negative, Rash
Clinical narrative: Husband states patient developed rash within 24 hours on trunk and both arms, followed by ataxia and weakness and headache within 48 hours of vaccination. Hospitalized several times. Ophthalmologist also consulted and diagnosed arteritis.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count increased
Clinical narrative: Husband states patient developed rash within 24 hours on trunk and both arms, followed by ataxia and weakness and headache within 48 hours of vaccination. Hospitalized several times. Ophthalmologist also consulted and diagnosed arteritis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Urticaria
Clinical narrative: The child broke out in hives all over her body about an hour later. Mom was instructed to give BENADRYL and cleared up within 30 to 45 minutes.
Age: 57.0
Sex: F
Vaccine: FLUX, HEPA, PPV
Symptoms: Corynebacterium test positive, Culture tissue specimen positive, Culture wound positive, Diarrhoea, Erythema
Clinical narrative: Patient states she has noticed these bilateral arm lesions for about 2 months after getting injections. The lesions are located on bilateral deltoids. Patient reports erythema and tenderness. Rates bilateral upper extremity pain 7/10. Patient got vaccination injections and bilateral arms on 10/3/18. Patient had pneumonia and influenza vaccination in right arm and hepatitis A vaccination in left arm. Shortly after getting these injections, patient noticed erythema surrounding injection sites and states she had feverish symptoms. Patient states she has taken 3 antibiotics, and states that I and D has been done on both lesions. States the lesions began to improve, but healing has recently plateaued. Patient reports headaches, nausea, loose stools. Denies fever, chills, sweats, vomiting. Patient states she has had the influenza vaccine before and has never had a reaction like this.
Age: 57.0
Sex: F
Vaccine: FLUX, HEPA, PPV
Symptoms: Headache, Incisional drainage, Injection site erythema, Injection site reaction, Nausea
Clinical narrative: Patient states she has noticed these bilateral arm lesions for about 2 months after getting injections. The lesions are located on bilateral deltoids. Patient reports erythema and tenderness. Rates bilateral upper extremity pain 7/10. Patient got vaccination injections and bilateral arms on 10/3/18. Patient had pneumonia and influenza vaccination in right arm and hepatitis A vaccination in left arm. Shortly after getting these injections, patient noticed erythema surrounding injection sites and states she had feverish symptoms. Patient states she has taken 3 antibiotics, and states that I and D has been done on both lesions. States the lesions began to improve, but healing has recently plateaued. Patient reports headaches, nausea, loose stools. Denies fever, chills, sweats, vomiting. Patient states she has had the influenza vaccine before and has never had a reaction like this.
Age: 57.0
Sex: F
Vaccine: FLUX, HEPA, PPV
Symptoms: Pain in extremity, Pathology test, Pyrexia, Skin lesion, Tenderness
Clinical narrative: Patient states she has noticed these bilateral arm lesions for about 2 months after getting injections. The lesions are located on bilateral deltoids. Patient reports erythema and tenderness. Rates bilateral upper extremity pain 7/10. Patient got vaccination injections and bilateral arms on 10/3/18. Patient had pneumonia and influenza vaccination in right arm and hepatitis A vaccination in left arm. Shortly after getting these injections, patient noticed erythema surrounding injection sites and states she had feverish symptoms. Patient states she has taken 3 antibiotics, and states that I and D has been done on both lesions. States the lesions began to improve, but healing has recently plateaued. Patient reports headaches, nausea, loose stools. Denies fever, chills, sweats, vomiting. Patient states she has had the influenza vaccine before and has never had a reaction like this.
Age: 53.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient presented 11/28/18 with place on Right arm where she recieved flu vaccine at work, area red and swollen was treated with med returned on 12/04/2018 with complaints of skin lesion raised, red draining and painful.
Age: 53.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Skin lesion
Clinical narrative: Patient presented 11/28/18 with place on Right arm where she recieved flu vaccine at work, area red and swollen was treated with med returned on 12/04/2018 with complaints of skin lesion raised, red draining and painful.
Age: 53.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented 11/28/18 with place on Right arm where she recieved flu vaccine at work, area red and swollen was treated with med returned on 12/04/2018 with complaints of skin lesion raised, red draining and painful.
Age: 53.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient reports a bump appeared at the injection site after her vaccination; she reports the bump became red and swollen.
Age: 53.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Skin lesion
Clinical narrative: Patient reports a bump appeared at the injection site after her vaccination; she reports the bump became red and swollen.
Age: 53.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reports a bump appeared at the injection site after her vaccination; she reports the bump became red and swollen.
Age: 25.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient is pregnant - no reaction reported as of yesterday still but patient was made aware by the doctor of the risks.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Culture tissue specimen, Culture wound, Fluid retention, Fungal test, Incisional drainage
Clinical narrative: Patient is a 24-year-old female who is seen for evaluation of right arm injection site. Patient had hepatitis A injection in right arm on 10/3/18. Patient was given antibiotics about 2-3 weeks ago, but states she did not complete these antibiotics. Patient states the injection site became hard and erythematous at first, but progressed to current state of soft, fluctuant, and with dark/purple coloration of skin. Denies drainage. Reports itching. Denies fever, sweats, chills. States that the area overlying her right deltoid where injection site was placed is tender to touch. States that the lesion has not opened, but states it appears to have a pocket of fluid underneath the dark skin discoloration. Denies ever having a reaction like this before to an injection.  I and D performed.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Patient is a 24-year-old female who is seen for evaluation of right arm injection site. Patient had hepatitis A injection in right arm on 10/3/18. Patient was given antibiotics about 2-3 weeks ago, but states she did not complete these antibiotics. Patient states the injection site became hard and erythematous at first, but progressed to current state of soft, fluctuant, and with dark/purple coloration of skin. Denies drainage. Reports itching. Denies fever, sweats, chills. States that the area overlying her right deltoid where injection site was placed is tender to touch. States that the lesion has not opened, but states it appears to have a pocket of fluid underneath the dark skin discoloration. Denies ever having a reaction like this before to an injection.  I and D performed.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Mycobacterium test, Pruritus
Clinical narrative: Patient is a 24-year-old female who is seen for evaluation of right arm injection site. Patient had hepatitis A injection in right arm on 10/3/18. Patient was given antibiotics about 2-3 weeks ago, but states she did not complete these antibiotics. Patient states the injection site became hard and erythematous at first, but progressed to current state of soft, fluctuant, and with dark/purple coloration of skin. Denies drainage. Reports itching. Denies fever, sweats, chills. States that the area overlying her right deltoid where injection site was placed is tender to touch. States that the lesion has not opened, but states it appears to have a pocket of fluid underneath the dark skin discoloration. Denies ever having a reaction like this before to an injection.  I and D performed.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: 49yr old patient presented to PCP and was ordered flu vaccine to be administered during visit on 12/6/18. CMA prepared and administered FLULAVAL QUAD 2018-19 vaccine IM in patient's left deltoid. CMA noted patient tolerated injection well. On 12/10, patient sent email to provider stating "experiencing lot of pain at injection site on left shoulder...pain 8/10 with movement, 4/10 at rest...ability to dress and work limited" patient stated pain increasing day by day, using ibuprofen 600mg BID as well as ice/heat. Multiple requests by office to have patient present for office visit, no response noted.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Influenza like illness, Pain
Clinical narrative: SHINGRIX, dose 2. Flu-like symptoms. Body aches, chills, and lightheaded. Patient treating with TYLENOL and bed rest. Prognosis good.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discharge, Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: Erythema on right arm following injection. Patient had pneumonia injection and right arm on 10/3/18. Patient states that the injection site in her right arm overlying the right deltoid became erythematous following injection. Reports she was given antibiotics, KEFLEX ×10 days, 2 weeks following the injection from her PCP. Patient reports 4/10 pain currently. States that the lesion has opened twice on its own, and has drained both times. Reports a cream-colored/brown colored fluid coming from the lesion. Denies malodorous drainage. Denies ever having any reaction like this before with prior injections. Denies fever, sweats, chills. BACTRIM DS BID x 10 days ordered.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Injection site pain, Pain, Pyrexia
Clinical narrative: Unable to go to work. Fever of 100.1, aches, injection site pain-started about 1 hour after vaccine given- took TYLENOL, headache.
Age: 52.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to the pharmacy after noticing the injection site causing a red bump at the back of the right arm. She does not complain of pain, but does say that it was red and warm to the touch. Did not describe any treatment options tried at this time. She is seeking medical opinion from her doctor for treatment options at this time.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Date of 2nd SHINGRIX injection 12/8/2018. 1st dose: pain at injection site with swelling, skin very warm to touch. Flu-like symptoms (headache, muscle ache, joint pain, feverish). Duration 4 days. 2nd dose: lesser pain at injection site, little to no swelling, skin mildly warm to touch. Flu-like symptoms as above. Duration 36 hours. Mild headache for 2 days.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Date of 2nd SHINGRIX injection 12/8/2018. 1st dose: pain at injection site with swelling, skin very warm to touch. Flu-like symptoms (headache, muscle ache, joint pain, feverish). Duration 4 days. 2nd dose: lesser pain at injection site, little to no swelling, skin mildly warm to touch. Flu-like symptoms as above. Duration 36 hours. Mild headache for 2 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Injection site pain
Clinical narrative: Pain at shot site (expected); unexpected side effects - missing 2 days of work for fever, chills, stomach nausea, headache, muscular and lymph node pain along right side and under arm, severe tiredness.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Pain at shot site (expected); unexpected side effects - missing 2 days of work for fever, chills, stomach nausea, headache, muscular and lymph node pain along right side and under arm, severe tiredness.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Myalgia, Nausea
Clinical narrative: Extreme vertigo and nausea began a little after 48 hrs after vaccine administered. (I was already having redness and pain at injection site as well as moderate myalgia. Those symptoms started very soon after I received the vaccine.) Today is day 5 after vaccination and I am still having vertigo off and on depending on my body positioning. Nausea has subsided. I took ZOFRAN and Meclizine which helped a bit. But symptoms were debilitating yesterday.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Extreme vertigo and nausea began a little after 48 hrs after vaccine administered. (I was already having redness and pain at injection site as well as moderate myalgia. Those symptoms started very soon after I received the vaccine.) Today is day 5 after vaccination and I am still having vertigo off and on depending on my body positioning. Nausea has subsided. I took ZOFRAN and Meclizine which helped a bit. But symptoms were debilitating yesterday.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Headache, Incontinence, Nausea, Syncope
Clinical narrative: Within minutes of administering the influenza and HPV vaccine, the patient fainted. The patient experienced incontinence during this event. It took over an hour for the patient to recover. During the time of recovery, vitals were stable. Patient experienced severe headache, nausea and dizziness. Patient was given ZOFRAN, apple juice, crackers and water.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Headache, Influenza like illness, Migraine
Clinical narrative: Vomiting, flu-like symptoms, migraine, no appetite, severe arm tenderness/redness and swelling day following shot Headache continued through day 2 with arm tenderness and nausea (decreased from previous day).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Swelling, Tenderness, Vomiting
Clinical narrative: Vomiting, flu-like symptoms, migraine, no appetite, severe arm tenderness/redness and swelling day following shot Headache continued through day 2 with arm tenderness and nausea (decreased from previous day).
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Swelling face, Urticaria
Clinical narrative: Facial swelling, hives, SOB 8 hours after vaccine was given. Went to hospital 11/28/18, given oral BENADRYL. Returned to Clinic on 11/2/18 due to not resolving symptoms, given prescription for MEDROL DOSEPAK. Had follow up apt on 12/4/18 facial swelling, SOB resolved. Experienced intermittent hives given prescription for calamine and keep up with OTC BENADRYL PRN.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Chills, Erythema
Clinical narrative: Pt developed severe headache, myalgias and fever 102. He had chills, nausea as well as pain and swelling at the site. On exam 26x16cm area of erythema, warmth and swelling. HA and fatigue persisted. Pt treated with antihistamine and prednisone. Symptoms recovered by 1 month.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Pt developed severe headache, myalgias and fever 102. He had chills, nausea as well as pain and swelling at the site. On exam 26x16cm area of erythema, warmth and swelling. HA and fatigue persisted. Pt treated with antihistamine and prednisone. Symptoms recovered by 1 month.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Red blood cell sedimentation rate increased, Skin warm, Swelling
Clinical narrative: Pt developed severe headache, myalgias and fever 102. He had chills, nausea as well as pain and swelling at the site. On exam 26x16cm area of erythema, warmth and swelling. HA and fatigue persisted. Pt treated with antihistamine and prednisone. Symptoms recovered by 1 month.
Age: 2.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Pt called afternoon of 5th concerned about swelling in right leg tight size of baseball and red brought pt in the am pt leg still swollen and a little warm dr told parent to use ice and come back if condition worsened.
Age: 35.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Flushing, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at site, swollen, sore muscle up to pec area, flushing of face, cannot move arm above head, headache.
Age: 35.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Mobility decreased
Clinical narrative: Redness at site, swollen, sore muscle up to pec area, flushing of face, cannot move arm above head, headache.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood test abnormal, Gait disturbance, Inflammation, Injected limb mobility decreased
Clinical narrative: 9/28 Almost immediate left shoulder pain, spreading down from deltoid muscle. 9/30 Limited ROM, left arm. 10/6 Pain begins in right hand, stiff and swollen by evening, increasing ROM problems. 10/8 Trouble dressing. Right shoulder pain begins, hand gets better, extreme pain in shoulder at night. 10/10 ROM better and pain decreased. 10/11 Left hand symptoms begin swelling, pain, difficulty with dressing, neither heat nor ice is a relief. 10/13 Swelling decreases, much improved. 10/24 Left shoulder pain begins, increases overnight, limited ROM. 10/26 More limiting ROM and pain. Trouble drying after shower, applying deodorant. 10/27 Slowly improved. 11/10 Right arm pain begins, decreases next day. 11/16 Left hip pain begins after nap,  still limping next day. 11/18 Left arm pain begins, not near joint. 11/19 Limited ROM in dressing in the AM, got better throughout the day.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: 9/28 Almost immediate left shoulder pain, spreading down from deltoid muscle. 9/30 Limited ROM, left arm. 10/6 Pain begins in right hand, stiff and swollen by evening, increasing ROM problems. 10/8 Trouble dressing. Right shoulder pain begins, hand gets better, extreme pain in shoulder at night. 10/10 ROM better and pain decreased. 10/11 Left hand symptoms begin swelling, pain, difficulty with dressing, neither heat nor ice is a relief. 10/13 Swelling decreases, much improved. 10/24 Left shoulder pain begins, increases overnight, limited ROM. 10/26 More limiting ROM and pain. Trouble drying after shower, applying deodorant. 10/27 Slowly improved. 11/10 Right arm pain begins, decreases next day. 11/16 Left hip pain begins after nap,  still limping next day. 11/18 Left arm pain begins, not near joint. 11/19 Limited ROM in dressing in the AM, got better throughout the day.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: 9/28 Almost immediate left shoulder pain, spreading down from deltoid muscle. 9/30 Limited ROM, left arm. 10/6 Pain begins in right hand, stiff and swollen by evening, increasing ROM problems. 10/8 Trouble dressing. Right shoulder pain begins, hand gets better, extreme pain in shoulder at night. 10/10 ROM better and pain decreased. 10/11 Left hand symptoms begin swelling, pain, difficulty with dressing, neither heat nor ice is a relief. 10/13 Swelling decreases, much improved. 10/24 Left shoulder pain begins, increases overnight, limited ROM. 10/26 More limiting ROM and pain. Trouble drying after shower, applying deodorant. 10/27 Slowly improved. 11/10 Right arm pain begins, decreases next day. 11/16 Left hip pain begins after nap,  still limping next day. 11/18 Left arm pain begins, not near joint. 11/19 Limited ROM in dressing in the AM, got better throughout the day.