chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: The pt requested urgent appointment today due to shingrix vaccine reaction. She was given the second dose yesterday and has had low grade fevers as well as redness and pruritus to the site of injection on the right bicep.Start Triamcinolone Acetonide Topical cream, 0.1%, 1 app, applied topically to right arm, 3 times a day, 7 day(s), 30 Gram          Start Zyrtec tablet, 10 mg, 1 tab(s), orally, once a day, 10 days, 10 Tablet          Start Benadryl tablet, 25 mg, 1 tab(s), orally, 4 times a day, 10 days, 40 Tablet
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Influenza like illness, Limb discomfort, Scab
Clinical narrative: PATIENT HAD BEEN VACCINATED ON MORNING OF 5/13/2019. THAT EVENING ABOUT 4PM SHE FELT FLU LIKE SYMPTOMS AND SEVERE CHILLS AND ARM VERY SORE WITH A BUMP. THE NEXT MORNING AFTER TAKING SOME ADVIL PATIENT REPORTED FEELING BETTER BUT ARM STILL VERY SORE AND LUMP STILL PRESENT. THAT EVENING(5/14/19) ABOUT 6PM SHE NOTICED 2 POCK LIKE SPOTS RIGHT SIDE OF HER NAVEL THAT WERE CRUSTED OVER. SHE CALLED US AND HER PHYSICIAN.  SHE WAS SEEN BY NP WHO DIAGNOSED IT AS SHINGLES AND PRESCRIPBED VALTREX 1GM TO BE TAKEN 3 TIMES DAILY FOR 7 DAYS
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: PATIENT HAD BEEN VACCINATED ON MORNING OF 5/13/2019. THAT EVENING ABOUT 4PM SHE FELT FLU LIKE SYMPTOMS AND SEVERE CHILLS AND ARM VERY SORE WITH A BUMP. THE NEXT MORNING AFTER TAKING SOME ADVIL PATIENT REPORTED FEELING BETTER BUT ARM STILL VERY SORE AND LUMP STILL PRESENT. THAT EVENING(5/14/19) ABOUT 6PM SHE NOTICED 2 POCK LIKE SPOTS RIGHT SIDE OF HER NAVEL THAT WERE CRUSTED OVER. SHE CALLED US AND HER PHYSICIAN.  SHE WAS SEEN BY NP WHO DIAGNOSED IT AS SHINGLES AND PRESCRIPBED VALTREX 1GM TO BE TAKEN 3 TIMES DAILY FOR 7 DAYS
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Diarrhoea, Malaise, Vomiting
Clinical narrative: Child came in for DTaP, he received dose in left deltoid, tolerated well. No adverse reaction noted during 15 minute observation period. Mother of child called the next day to report that he had vomited  at 2am, then again at 3am and again at 8am. No fever noted in AM, but at time of the call, 2:30pm, temp of 99. Mom notes poor appetite, malaise. Mom states injection site and arm are unremarkable.  This nurse did suggest she also notify the child's PCP.  Called mother back on Monday to check in and she reports Saturday energy was better but still low appetite but seemingly starting to feel better, then Sunday vomited again and had diarrhea. Explained to mom that it is very possible this illness is unrelated but that I would put in a VAERS just to be cautious.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: patient came to pharamcy with red hot to touch sore,itchy  arm just below injection site , patient advice to take some antihistamine and visit his dr .
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient was given 1 additional HPV Vaccine that was not needed.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Expired product administered
Clinical narrative: Patient was given expired by one day influenza vaccine.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema
Clinical narrative: Patient experienced shortness of breath and turning red. Patient was give Benadryl 50mg and Tylenol 1000mg at 4:15pm and monitored until 4:50pm.  Vitals rechecked at that time  129/68 bp, 100% O2, and 64 pulse. Symptoms were resolved after the administration of medication
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: had titers drawn/ did not present enough antibodies for measles; Information has been received from a physician via a field representative referring to a 24 years old female patient without pregnancy. Information about medical history, concurrent condition and concomitant medication was unknown.        On an unknown date (reported as "year ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route, lot# and expiration date were unspecified) for prophylaxis. On an unspecified date in 2019 (reported as "recently"), the patient had titers drawn and did not present enough antibodies for measles. The patient did not seek medical attention and it was unknown if treatment was given for the event. The outcome of titers drawn/ not present enough antibodies for measles and the causality were unknown.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA006158: US-009507513-1905USA006157:
Sex: U
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: An area 1-2 inches from the injection site that was sore and bruised; An area 1-2 inches from the injection site that was sore and bruised; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported same events for two patients. This is the second of two reports.  A patient of an unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced an area 1-2 inches from the injection site that was sore and bruised on an unspecified date. The events recovered on an unspecified date in 7-10 days.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019201602 same reporter/drug/event, different patients
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects; dose of M-M-R II was administered the intramuscular route; Information has been received from a healthcare worker who was also pharmacy intern referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown.       On 19-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R001658 with expiration date of 17-JAN-2020, intramuscular; strength, dose and frequency unspecified) for prophylaxis (incorrect route of product administration). No adverse effects were reported.     This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA010012:
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; the second dose of MMR was administered at a longer than recommended time interval from the first dose; Information has been received from a pharmacist referring to a female child of unknown age. Information about medical history, concurrent condition and concomitant medication was unknown.   On an unspecified date in 1960, the patient was vaccinated with her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (strength, dose, therapy type, route, lot# and expiration date were unspecified) with sterile diluent for prophylaxis. On an unspecified date in 1964 the patient received second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with sterile diluent (inappropriate schedule of product administration). It was unknown how sterile diluent was stored. It was possible that the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) was administered at a longer than recommended time interval from the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) as dosing interval was unknown. No adverse effect was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; patient was administered a dose of MMR II which expired on 3/24/2019; This spontaneous report was received from a medical assistant, referring to a 5 year old patient of unknown gender. Concomitant therapy included sterile diluent (STERILE DILUENT). No information was provided regarding the patient's medical history and concurrent conditions.   On 30-APR-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(RHA)(lot # N009799 (expiration date: 24-MAR-2019) for prophylaxis (strength, frequency and route of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: had titers drawn/ did not present enough antibodies for measles; Information has been received from a physician via a field representative referring to a 10 years old female patient without pregnancy. Information about medical history, concurrent condition and concomitant medication was unknown.        On an unknown date (reported as "year ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route, lot# and expiration date were unspecified) for prophylaxis. On an unspecified date in 2019 (reported as "recently"), the patient had titers drawn and did not present enough antibodies for measles. The patient did not seek medical attention and it was unknown if treatment was given for the event. The outcome of titers drawn/ not present enough antibodies for measles and the causality were unknown.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA006158: US-009507513-1905USA002177:
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: had titers drawn/ did not present enough antibodies for measles; Information has been received from a physician via a field representative referring to a 14 years old female patient without pregnancy. Information about medical history, concurrent condition and concomitant medication was unknown.        On an unknown date (reported as "year ago"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route, lot# and expiration date were unspecified) for prophylaxis. On an unspecified date in 2019 (reported as "recently"), the patient had titers drawn and did not present enough antibodies for measles. The patient did not seek medical attention and it was unknown if treatment was given for the event. The outcome of titers drawn/ not present enough antibodies for measles and the causality were unknown.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA002177: US-009507513-1905USA006157:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Rotateq; no adverse effect; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. Information on pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (strength, dose, lot # and expiry date unknown) for prophylaxis (expired product administered). The re was no known adverse effects (no adverse event).
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; The primary reporter reports expired dose of M-M-R II was administered; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.   On 14-MAY-2019, the nurse stated that the patient was vaccinated with a expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) rHA, lot number N014486, expiration date 10-MAY-2019 for prophylaxis (dosage, frequency, route of administration, and anatomical location were not reported). Therefore, was unknown if the sterile diluent to reconstitute de vaccine was not expired. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: redness; rash; skin warm (heat to the rash area); This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, rash and skin warm. On an unknown date, the outcome of the erythema, rash and skin warm were unknown.   It was unknown if the reporter considered the erythema, rash and skin warm to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix and experienced redness and rash are common side effects. The patient enquired that does this include heat to the rash area, and asked long these symptoms does would last.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Gastrointestinal disorder, Influenza like illness
Clinical narrative: influenza like illness; Sore  joints; Sore muscles; upper digestive track; felt like crap/Just feel kind of washed out; general feeling of malaise; tossed and turned all night; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019 10:00, the patient received Shingrix. On 18th April 2019, 5 hrs after receiving Shingrix, the patient experienced influenza like illness, joint pain, muscle soreness, gastrointestinal disorder, fatigue, general malaise and sleep restless. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza like illness was not recovered/not resolved and the outcome of the joint pain, muscle soreness, gastrointestinal disorder, fatigue, general malaise and sleep restless were unknown.   It was unknown if the reporter considered the influenza like illness, joint pain, muscle soreness, gastrointestinal disorder, fatigue, general malaise and sleep restless to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After 5 hrs after vaccination with Shingrix, the patient had sore muscles and joints, upper digestive track, general feeling of malaise, just kind of feel like flu. The day before reporting at 10 am and the reporter noticed she felt like crap around 3 pm.  The patient took 2 Tilenol went to bed at 8 pm and several hours after vaccination , the patient tossed and turned all night, and just feel kind of washed out. The patient was asked how long the side effects last, just feel like the patient coming down with the flu. The reporter did not consent to follow up physician.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Poor quality sleep
Clinical narrative: influenza like illness; Sore  joints; Sore muscles; upper digestive track; felt like crap/Just feel kind of washed out; general feeling of malaise; tossed and turned all night; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019 10:00, the patient received Shingrix. On 18th April 2019, 5 hrs after receiving Shingrix, the patient experienced influenza like illness, joint pain, muscle soreness, gastrointestinal disorder, fatigue, general malaise and sleep restless. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza like illness was not recovered/not resolved and the outcome of the joint pain, muscle soreness, gastrointestinal disorder, fatigue, general malaise and sleep restless were unknown.   It was unknown if the reporter considered the influenza like illness, joint pain, muscle soreness, gastrointestinal disorder, fatigue, general malaise and sleep restless to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After 5 hrs after vaccination with Shingrix, the patient had sore muscles and joints, upper digestive track, general feeling of malaise, just kind of feel like flu. The day before reporting at 10 am and the reporter noticed she felt like crap around 3 pm.  The patient took 2 Tilenol went to bed at 8 pm and several hours after vaccination , the patient tossed and turned all night, and just feel kind of washed out. The patient was asked how long the side effects last, just feel like the patient coming down with the flu. The reporter did not consent to follow up physician.
Sex: F
Vaccine: VARZOS
Symptoms: Hyperthyroidism, Thyroid hormones increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hyperthyroidism in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced hyperthyroidism (serious criteria GSK medically significant) and lab test abnormal. On an unknown date, the outcome of the hyperthyroidism and lab test abnormal were unknown. It was unknown if the reporter considered the hyperthyroidism and lab test abnormal to be related to SHINGRIX. Additional details were reported as follows: The patient's age at vaccination was not reported. The patient was newly diagnosed with hyperthyroidism. On an unknown date, the patient had laboratory test after receiving SHINGRIX for thyroid which came abnormal (higher than normal). Lab Comments: On an unknown date, the patient had laboratory test for thyroid which came abnormal.
Sex: M
Vaccine: MENB
Symptoms: Chills, Paraesthesia, Pyrexia
Clinical narrative: complaining of chills and tingling sensation to arm and had fever of 100 degrees F.; complaining of chills and tingling sensation to arm and had fever of 100 degrees F.; complaining of chills and tingling sensation to arm and had fever of 100 degrees F.; This is a spontaneous report from contactable Nurse via Pfizer Sales Representative.  A 16-year-old male patient received the second dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 07Feb2019 at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took the first dose of vaccine on unspecified date.  The patient experienced complaining of chills and tingling sensation to arm and had fever of 100 degrees F. on 08Feb2019. The events were non- serious. The physician advised patient to take Tylenol or Motrin. The outcome of the events was unknown.   The information on the batch/lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Dehydration
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received PREVNAR 13, via an unspecified route of administration in 2018 at single dose for pneumococcal pneumonia. One year ago, the patient got both a pneumonia shot and a shingles shot. The patient thought the old pneumonia shot she got was "plain" PREVNAR and the one she received a year ago might have been PREVNAR 13. She was not sure exactly which one it was. The patient medical history and concomitant medications were not reported. On 13Jan2018, the patient woke up with a scratchy throat. Every day that went by, she felt worse. On an unknown date (reported as on Wed the 16th), she started to run a 100- 101 degree fever. By Thursday, she was really sick and did an online chat with a doctor. Her temperature was 104 at that time. She was sick to stomach, coughing, and had chills. It was like being in shock. It was found the patient had bacterial pneumonia in the upper lobe of the right lung. She was pretty dehydrated and was given an IV bag of an antibiotic and an oral antibiotic. The patient felt slow, with no energy. She was exhausted and wiped out. She didn't have issues with breathing. She thought she might die from this. To go from Sunday to Thursday to feel progressively worse, she thought it was an acute illness. She had a scratchy throat, problems with hearing due to congestion, and nausea. Part of the nausea was because of the cough. She was gagging. She was afraid she would be contagious, so she drove herself to urgent care even though she was so weak at that point. She couldn't eat anything. All she did was lying in bed. She got pneumonia and it was devastating. She felt it would have been worse if not having got the pneumonia shot and it could have been deadly. Treatment was received for the events bacterial pneumonia and dehydrated. The outcome of the event scratchy throat was not recovered and for the other events was unknown. The information on batch/ lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Ear congestion, Fatigue, Hypoacusis, Malaise, Nausea
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received PREVNAR 13, via an unspecified route of administration in 2018 at single dose for pneumococcal pneumonia. One year ago, the patient got both a pneumonia shot and a shingles shot. The patient thought the old pneumonia shot she got was "plain" PREVNAR and the one she received a year ago might have been PREVNAR 13. She was not sure exactly which one it was. The patient medical history and concomitant medications were not reported. On 13Jan2018, the patient woke up with a scratchy throat. Every day that went by, she felt worse. On an unknown date (reported as on Wed the 16th), she started to run a 100- 101 degree fever. By Thursday, she was really sick and did an online chat with a doctor. Her temperature was 104 at that time. She was sick to stomach, coughing, and had chills. It was like being in shock. It was found the patient had bacterial pneumonia in the upper lobe of the right lung. She was pretty dehydrated and was given an IV bag of an antibiotic and an oral antibiotic. The patient felt slow, with no energy. She was exhausted and wiped out. She didn't have issues with breathing. She thought she might die from this. To go from Sunday to Thursday to feel progressively worse, she thought it was an acute illness. She had a scratchy throat, problems with hearing due to congestion, and nausea. Part of the nausea was because of the cough. She was gagging. She was afraid she would be contagious, so she drove herself to urgent care even though she was so weak at that point. She couldn't eat anything. All she did was lying in bed. She got pneumonia and it was devastating. She felt it would have been worse if not having got the pneumonia shot and it could have been deadly. Treatment was received for the events bacterial pneumonia and dehydrated. The outcome of the event scratchy throat was not recovered and for the other events was unknown. The information on batch/ lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia bacterial, Pyrexia, Retching, Throat irritation
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received PREVNAR 13, via an unspecified route of administration in 2018 at single dose for pneumococcal pneumonia. One year ago, the patient got both a pneumonia shot and a shingles shot. The patient thought the old pneumonia shot she got was "plain" PREVNAR and the one she received a year ago might have been PREVNAR 13. She was not sure exactly which one it was. The patient medical history and concomitant medications were not reported. On 13Jan2018, the patient woke up with a scratchy throat. Every day that went by, she felt worse. On an unknown date (reported as on Wed the 16th), she started to run a 100- 101 degree fever. By Thursday, she was really sick and did an online chat with a doctor. Her temperature was 104 at that time. She was sick to stomach, coughing, and had chills. It was like being in shock. It was found the patient had bacterial pneumonia in the upper lobe of the right lung. She was pretty dehydrated and was given an IV bag of an antibiotic and an oral antibiotic. The patient felt slow, with no energy. She was exhausted and wiped out. She didn't have issues with breathing. She thought she might die from this. To go from Sunday to Thursday to feel progressively worse, she thought it was an acute illness. She had a scratchy throat, problems with hearing due to congestion, and nausea. Part of the nausea was because of the cough. She was gagging. She was afraid she would be contagious, so she drove herself to urgent care even though she was so weak at that point. She couldn't eat anything. All she did was lying in bed. She got pneumonia and it was devastating. She felt it would have been worse if not having got the pneumonia shot and it could have been deadly. Treatment was received for the events bacterial pneumonia and dehydrated. The outcome of the event scratchy throat was not recovered and for the other events was unknown. The information on batch/ lot number has been requested.
Age: 70.0
Sex: F
Vaccine: YF
Symptoms: CSF glucose normal, CSF lymphocyte count normal, CSF protein normal, CSF white blood cell count increased, Headache
Clinical narrative: Patient presented to emergency room on 5/14/2019 about one week after receiving vaccine after developing a severe headache that started around Noon on 5/14/19. In emergency department was found to have a fever of 102 F. Given fever and headache patient was hospitalized for possible infection and concern for encephalitis/meningitis.
Age: 70.0
Sex: F
Vaccine: YF
Symptoms: Polymerase chain reaction, Pyrexia, Viral test
Clinical narrative: Patient presented to emergency room on 5/14/2019 about one week after receiving vaccine after developing a severe headache that started around Noon on 5/14/19. In emergency department was found to have a fever of 102 F. Given fever and headache patient was hospitalized for possible infection and concern for encephalitis/meningitis.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cyanosis, Pyrexia, Seizure
Clinical narrative: He had a high fever, a seizure and turned blue. He was rushed to the ER by ambulance. It was horrific.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Approximately one week after receiving immunes, pt broke out in a red, raised rash on abdomen, back, forehead
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Skin discolouration
Clinical narrative: Bilateral rash to axilla and lower legs.  Pink
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: SHE REPORTED RASH ABOUT 2 TO 3 INSHCES BELOW THE INJECTION SITE
Age: 3.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient was in office for routine visit and immunizations and medical assistant gave expired vaccine (dated 5/4/19) to patient.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Gait disturbance, Pain in extremity, Swelling face, Urticaria, Wheezing
Clinical narrative: Within 5 hours of vaccine being given: hives, facial swelling, wheezing, complained of leg pain and didn't want to walk. Mom gave Benadryl and symptoms resolved within and hour. Mom did not give Epi pen.
Age: 3.0
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: Varicella given IM vs Subcut in left thigh.  Supervisor, Mom and Medical Director notified.   Mom instructed on increased reaction due to IM vs subcut. Need for Tylenol and cool compress needed and to notify office if reactions outside of original directions given.  Mom verbalized good understanding and will monitor child.  Mom is an RN.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Nodule, X-ray limb
Clinical narrative: There is a knot that developed after injection, and has remained there since injection.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Middle insomnia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: That evening after the vaccine patient was awakened by a sharp burning and tingling sensation in the arm vaccinated which radiated to through the shoulder , back and other arm. Nothing in the stomach area. Took 2 Excedrin tablets and pain somewhat relieved  and gradually got better and as of 5/15/2019 when she stopped in she now had only a pain and a little weakness in the left arm vaccinated. No doctor was called at time of incident but had  a scheduled appointment  with heart doctor and he said all was good. No heart new heart issues.
Age: 48.0
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received Yellow fever vaccine over deltoid at 45 degree angle.  Potentially and IM administration and not Subcutaneous. reached out to Office and they did not recommend revaccination but recommended a VAERS be submitted.  Pt did not experience and adverse issues related to immunization.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dry throat, Feeling cold, Headache, Pain
Clinical narrative: c/o headache, body aches ,shivering, dry throat ,felt cold
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram head, Headache, Lethargy, Myalgia
Clinical narrative: Muscle pain, headache, lethargy day after administration leading to admission to hospital, also concern for GI infection which was never definitively diagnosed
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt presented to the Allergy/Immunizations clinic on 14 May 2019.    Pt states that he received anthrax and typhoid on 08 may 2019.  States that arm was sore x 2 days and that on the morning of 13 May 2019, his arm was red, swollen and warm to the touch.  Pt states that he seen his flight doctor in his squadron and was informed that he had cellulitis and that he had an antibiotic prescription placed to the pharmacy.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Dyspnoea, Electrocardiogram, Hypopnoea, Livedo reticularis
Clinical narrative: After immunizations administered and staff left the room, parents noted the infant was crying very hard, they tried to feed her a bottle but she would not take it,  followed by emesis, then turned purple from waist down and seemed to have diff breating. They opened the door, I was in the hallway at that moment and I came in. At that time the baby was resting on the bed,  breathing shallowly. She was not crying. Pulse ox was 100% and pulse 144. PERRLA and RRR, lungs clear. She did respond to stimulus, moving her and examining her.  There was some mottling of the legs and purplish discoloration of diaper area that resolved completely  in 10 minutes. Within moments she was breathing comfortably and was interacting and sucking a pacifier. We did recommend ER eval and ambulance had arrived within 10 minutes. Parent eventually refused the ambulance and stated they would take the infant themselves. They were aware of the recommendations. I feel this was a vasovagal response and not an allergic reaction to the vaccine
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Presyncope, Skin discolouration, Unresponsive to stimuli, Vomiting
Clinical narrative: After immunizations administered and staff left the room, parents noted the infant was crying very hard, they tried to feed her a bottle but she would not take it,  followed by emesis, then turned purple from waist down and seemed to have diff breating. They opened the door, I was in the hallway at that moment and I came in. At that time the baby was resting on the bed,  breathing shallowly. She was not crying. Pulse ox was 100% and pulse 144. PERRLA and RRR, lungs clear. She did respond to stimulus, moving her and examining her.  There was some mottling of the legs and purplish discoloration of diaper area that resolved completely  in 10 minutes. Within moments she was breathing comfortably and was interacting and sucking a pacifier. We did recommend ER eval and ambulance had arrived within 10 minutes. Parent eventually refused the ambulance and stated they would take the infant themselves. They were aware of the recommendations. I feel this was a vasovagal response and not an allergic reaction to the vaccine
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Swelling
Clinical narrative: Inflamed; Ankle pain/knee pain; Swollen; This case was reported by a physician via call center representative and described the occurrence of joint inflammation in a adult patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 30th April 2021) for prophylaxis.   Concomitant products included cefalexin (Keflex).   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced joint inflammation, pain ankle and swelling. On an unknown date, the outcome of the joint inflammation, pain ankle and swelling were unknown.   It was unknown if the reporter considered the joint inflammation, pain ankle and swelling to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix experienced the rare side effect of ankle, knee, joint pain with inflammation and swelling. No additional details were provided. The reporter refused to provide more data and referred to the patient's physician.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This case was reported by a physician via call center representative and described the occurrence of herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown.   It was unknown if the reporter considered the herpes zoster to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and after 2 days the patient experienced herpes zoster. The reporter was on chat and was not at the office. The reporter did not have the patient initials, age, date of vaccination and lot number or expiration date.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a non-serious spontaneous case initially received from other non-health professional on 13-Dec-2018, concerning a 63-year-old, adult male patient. On 02-Oct-2018, the suspect vaccine was frozen. On the same day, the patient was administered FLUCELVAX QUADRIVALENT (QIV) which was frozen, (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252660, expiry date: 31-May-2019) for influenza prophylaxis. The patient did not experience any adverse events after vaccination. Follow up received from the reporter on 28-Jan-2019: The reporter stated that the vaccine was frozen on 02-Oct-2018 (added in event tab). The reporter county was updated in the general tab and the patient details were updated in the patient tab. Narrative was amended accordingly. Reporter's Comments: A 63-year-old, male patient administered FLUCELVAX QUADRIVALENT vaccine which was frozen. The company assessed the causality of the event incorrect product storage as not related to the suspect vaccine due to incidental nature of the event and event drug administration error as not related to the suspect vaccine due to accidental nature of the event.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Heart rate increased
Clinical narrative: PATIENT STATES THAT AFTER HE RECEIVED SHINGRIX SHOT HE FELT STRANGE LATER THAT AFTERNOON BUT HE HAD TO CALL HIS WIFE THE NEXT DAY AT 10:15  TO PICK HIM UP FROM WORK BECAUSE HE WAS FEELING BAD.  HE EXPERIENCED FATIGUE, DIZZINESS, SHORTNESS OF BREATH,  REDNESS AT INJECTION SITE, A LITTLE SWELLING , AND INCREASED HEART RATE. HE ENDED UP IN EMERGENCY ROOM DUE TO PAST HEART ISSUES.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT STATES THAT AFTER HE RECEIVED SHINGRIX SHOT HE FELT STRANGE LATER THAT AFTERNOON BUT HE HAD TO CALL HIS WIFE THE NEXT DAY AT 10:15  TO PICK HIM UP FROM WORK BECAUSE HE WAS FEELING BAD.  HE EXPERIENCED FATIGUE, DIZZINESS, SHORTNESS OF BREATH,  REDNESS AT INJECTION SITE, A LITTLE SWELLING , AND INCREASED HEART RATE. HE ENDED UP IN EMERGENCY ROOM DUE TO PAST HEART ISSUES.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: No adverse event
Clinical narrative: No adverse reaction observed or reported.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction observed or reported.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Cough, Erythema, Increased viscosity of upper respiratory secretion, Inflammation
Clinical narrative: Within two hours of receiving the immunization, my right arm became very painful. I could not lift my arm. The pain was severe. I began to feel sick and feverish, but my temp was not elevated. The right side of my chest, neck and face was swollen but I did not have any problem breathing. The next day, the pain in my arm continued and after several doses of Tylenol the pain lessened and finally subsided the next day. The swell lasted about 5-7 days. However, during this period the skin on my face became very red and inflamed. I could not use any skin care products without severe burning. I called the Dr. for help but her office refused to see me, stating that the dr. was on spring break and I could just go to urgent care. They did not ask for any details of my reaction. I went to urgent care and was put on a 7 day series of prednisone. The symptoms improved, but the day after my last dose of prednisone, I became gradually sicker and sicker. It started with a harsh dry cough. Over the next few days, it became productive for thick yellow mucus. Sometimes when I awakened in the morning, I would throw up from coughing and gagging on this mucus. I never experienced anything like this. I took OTC cough suppressants and mucus medications, which did not help. The most acute sx lasted for about 2 weeks, but to this day I still have thick mucus and the occasional emesis in the am.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain in extremity, Productive cough, Pyrexia, Retching
Clinical narrative: Within two hours of receiving the immunization, my right arm became very painful. I could not lift my arm. The pain was severe. I began to feel sick and feverish, but my temp was not elevated. The right side of my chest, neck and face was swollen but I did not have any problem breathing. The next day, the pain in my arm continued and after several doses of Tylenol the pain lessened and finally subsided the next day. The swell lasted about 5-7 days. However, during this period the skin on my face became very red and inflamed. I could not use any skin care products without severe burning. I called the Dr. for help but her office refused to see me, stating that the dr. was on spring break and I could just go to urgent care. They did not ask for any details of my reaction. I went to urgent care and was put on a 7 day series of prednisone. The symptoms improved, but the day after my last dose of prednisone, I became gradually sicker and sicker. It started with a harsh dry cough. Over the next few days, it became productive for thick yellow mucus. Sometimes when I awakened in the morning, I would throw up from coughing and gagging on this mucus. I never experienced anything like this. I took OTC cough suppressants and mucus medications, which did not help. The most acute sx lasted for about 2 weeks, but to this day I still have thick mucus and the occasional emesis in the am.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Swelling face, Vomiting
Clinical narrative: Within two hours of receiving the immunization, my right arm became very painful. I could not lift my arm. The pain was severe. I began to feel sick and feverish, but my temp was not elevated. The right side of my chest, neck and face was swollen but I did not have any problem breathing. The next day, the pain in my arm continued and after several doses of Tylenol the pain lessened and finally subsided the next day. The swell lasted about 5-7 days. However, during this period the skin on my face became very red and inflamed. I could not use any skin care products without severe burning. I called the Dr. for help but her office refused to see me, stating that the dr. was on spring break and I could just go to urgent care. They did not ask for any details of my reaction. I went to urgent care and was put on a 7 day series of prednisone. The symptoms improved, but the day after my last dose of prednisone, I became gradually sicker and sicker. It started with a harsh dry cough. Over the next few days, it became productive for thick yellow mucus. Sometimes when I awakened in the morning, I would throw up from coughing and gagging on this mucus. I never experienced anything like this. I took OTC cough suppressants and mucus medications, which did not help. The most acute sx lasted for about 2 weeks, but to this day I still have thick mucus and the occasional emesis in the am.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Blindness, Dizziness, Nausea
Clinical narrative: PT felt dizzy after vaccination and complaining of loosing vision. She complained of being nauseated.  Patient was accompanied by her mom. She was holding her hand and I asked patient to relax and take deep breath.  She felt better after few minutes.   I advised patient to keep sitting for 15 minutes before leaving. Patient and MOM both left once she felt better. I advised patient to call us if there is any more question or reaction.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever, myalgia
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient called on 5/14/19 @1400  re: s/s reaction on Left arm with red/swelling/warmth  to touch and resolved on 5/15/19.
Age: 70.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Patient experienced  several blister appear on 05/13/19 after receiving shingrix and boostrix on 05/10/19.  Md dignosied patient with shingles on 05/15/ and prescribed Valtrex  for treatment.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Painful respiration
Clinical narrative: When talking to the patient to remind him it was time for his second dose he mentioned that with the first dose around 4 to 5 days after the vaccine he experienced what felt like a heavy chest and hurt to breath when he took deep breaths.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event occurred. This was a medication error. Patient was eligible and due for a PPSV23 but received a Prevnar vaccine.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Blood potassium decreased, Blood test, Body temperature fluctuation, Cellulitis, Dizziness
Clinical narrative: Flu like symptoms. Temperature fluctuations between 97.5 to 101 in 8 minutes. Wanted to crawl out of my skin. Dizziness. Excessive sweating. Nausea.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Hyperhidrosis, Impaired driving ability, Influenza like illness, Influenza virus test negative
Clinical narrative: Flu like symptoms. Temperature fluctuations between 97.5 to 101 in 8 minutes. Wanted to crawl out of my skin. Dizziness. Excessive sweating. Nausea.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Nausea, Sepsis, Viral test positive
Clinical narrative: Flu like symptoms. Temperature fluctuations between 97.5 to 101 in 8 minutes. Wanted to crawl out of my skin. Dizziness. Excessive sweating. Nausea.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Patient is experiencing general malaise. Patient was advised to take Tylenol or Motrin for pain
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has redness at injection site approximately 3 inches in diameter. It is raised and warm to the touch. He was advised to take Tylenol or Ibuprofen for pain and use a cold compress as needed
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Muscle spasms
Clinical narrative: Pt presented to clinic with fever, chills, site of injection with intense pain, swelling and redness, with right sided body pain and feeling like she has knots to her right arm and right legs.  States she feels like her fingers are cramping up.  Pt also with bilateral wheezing (has a history of COPD).
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Nodule, Pain, Pyrexia, Wheezing
Clinical narrative: Pt presented to clinic with fever, chills, site of injection with intense pain, swelling and redness, with right sided body pain and feeling like she has knots to her right arm and right legs.  States she feels like her fingers are cramping up.  Pt also with bilateral wheezing (has a history of COPD).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia
Clinical narrative: Fever, nausea, extreme shivering, headache, upset stomach.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Muscle disorder
Clinical narrative: Muscle in right leg up to hip and very red injection site area approximately 2" x 3"
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Headache, Influenza like illness, Influenza virus test negative
Clinical narrative: ACCORDING TO HIS WIFE: PATIENT STARTED FEELING SICK IN THE EVENING 3 HOURS AFTER HE RECEIVED THE 2ND IMZ OF SHINGRIX (5/14/2019). HE HAD FLU LIKE SYMPTOMS THE NEXT DAY (5/15/2019). HE HAD FEVER, CHILL, HEADACHE, NAUSEA, DIFFICULTY BREATHING. HE SAW HIS PCP. HE WAS TESTED FOR FLU. NEGATIVE RESULT. DR. GAVE HIM RX FOR ZOFRAN AND ALBUTEROL INHALER.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: ACCORDING TO HIS WIFE: PATIENT STARTED FEELING SICK IN THE EVENING 3 HOURS AFTER HE RECEIVED THE 2ND IMZ OF SHINGRIX (5/14/2019). HE HAD FLU LIKE SYMPTOMS THE NEXT DAY (5/15/2019). HE HAD FEVER, CHILL, HEADACHE, NAUSEA, DIFFICULTY BREATHING. HE SAW HIS PCP. HE WAS TESTED FOR FLU. NEGATIVE RESULT. DR. GAVE HIM RX FOR ZOFRAN AND ALBUTEROL INHALER.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Diarrhoea, Erythema, Headache, Malaise
Clinical narrative: patient experienced body aches, shivers, headache, diarrhea, vomiting and reddness/swelling  in the left arm  the first day. symptoms improved day 2 but still wasnt feeling well with continued swelling of the left arm and slight body aches and headache.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain, Peripheral swelling, Vomiting
Clinical narrative: patient experienced body aches, shivers, headache, diarrhea, vomiting and reddness/swelling  in the left arm  the first day. symptoms improved day 2 but still wasnt feeling well with continued swelling of the left arm and slight body aches and headache.