chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: unable to lift her arm/patient's difficulty in lifting lasted 3 days; red stripe that appeared 5 inches below and 5 inches above injection site; injection site was hot, swollen, there was pain; injection site was hot, swollen, there was pain; injection site was hot, swollen, there was pain; This spontaneous report was received from an office manager referring to a 38-year-old adult female patient. The patient's concurrent condition included rheumatoid arthritis and immunodeficiency. The patient's medical history and drug allergies were not reported. The patient's concomitant therapy included methotrexate. On 12-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) via intramuscular route for immunodeficiency (lot/batch number and expiry date were reported as S009945 and 10-AUG-2020 respectively) (strength and dose were not reported). On 13-SEP-2019, the patient had complaints of being unable to lift her arm (arm where dose was administered) which lasted for 3 days as her range of motion was limited with swelling (movement disorder), there was a red stripe that appeared 5 inches below and 5 inches above injection site (injection site erythema), injection site was hot (injection site warmth), swollen (injection site swelling) and there was pain to touch (injection site pain). The patient was treated for the events with Benadryl, compresses and ibuprofen and sought medical attention. There was no overdose and product quality complaint reported. The adverse event was not cancer and the patient did not die. The outcome of the events were reported as recovering. The causality of the events with respect to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a physician and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   Concurrent medications included Iron salt (Iron), Vitamin D, Prenatal vitamins and Docusate sodium (Colace).   On 24 August 2011 at 09:30 the subject received a dose of Boostrix (details unknown), and experienced vaccine exposure during pregnancy.  The subject received the vaccine during her 32nd week of pregnancy.  The estimated delivery date was 16 October 2011.  Date of last menstrual period was not provided.   Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: 4 months old  patient who received a dose of Pentacel which had a temperature excursion below zero/No AE; Initial information received and additional information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA255196, 2019SA255155 and 2019SA255195 (same reporter).  This case involves a 4 months old male patient who received a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ135AA, expiry date- 26-02-2021 via unknown route in unknown administration site on 12-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Product dose omission, Wrong product administered
Clinical narrative: patient got Adacel instead of Pentacel; they do not get a 4th dose of Pentacel at 18 months; Initial information received on 11-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 17.5 months old female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that patient got Adacel instead of Pentacel (wrong product administered) and they do not get a 4th dose of Pentacel at 18 months (product dose omission).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB).  On 06-Sep-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6213AA via intramuscular route in the right thigh. On 06-Jun-2018, 08-Aug-2018 and 09-Oct-2018, the patient received 1st, 2nd and 3rd dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Wrong vaccine administered and missed dose.  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: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: an 11 years old  patient who received a dose of Adacel and Menactra which had a temperature excursion below zero/No AE; Initial information received and additional information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA255155, 2019SA255195 and 2019SA254282 (same reporter).  This case involves a 11 years old male patient who received a 0.5 ml first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6214AA, expiry date: 14-Mar-2021 via intramuscular route in the left arm on 12-Jul-2019 and 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6365AA, expiry date: 24-Sep-2020 via intramuscular route in the right arm on 12-Jul-2019 which had a temperature excursion.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  At the time of reporting, adverse event was not reported.  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: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Dtap and IPV component of the Pentacel was administered to the patient and not the ActHib component of pentacel, no AE; Initial information received on 11-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who received 0.5 ml dose of DTAP AND IPV component and not ACT-HIB component of the IPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number: U6327AA and expiry date: 19-Sep-2020) via intramuscular route in right leg, on 11 Sep 2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique. It was reported that 4 year-old patient came in and the Dtap and IPV component of the Pentacel was administered. The ActHib component was not administered. It was 4th IPV and 5th Dtap dose.  At the time of reporting the patient had 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the vaccines were mistakenly given to 8 year female patient / no AE; Initial information received on 11-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA256338.  This case involves a 08 years old female patient who mistakenly received vaccine 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1906 (Expiry date 22-May-2020) via intramuscular route in the left arm on 10-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was unknown if any adverse event occurred.  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.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the vaccines were mistakenly given to 10 year female patient/No AE; Initial information received on 11-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA256298.  This case involves a 10 years old female patient who mistakenly received vaccine 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1906 (Expiry date 22-May-2020) via intramuscular route in the left arm on 10-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was unknown if any adverse event occurred.  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.
Sex: U
Vaccine: FLUR4
Symptoms: Incorrect route of product administration
Clinical narrative: administered in the arm subcutaneous instead of intramuscular/no AE; Initial information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 61 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was reported.   On 10-Sep-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QSAA1907 via subcutaneous route in the right deltoid.   It was of actual medication error due to Inappropriate route of vaccination..  It was unknown whether adverse event was experienced..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash morbilliform
Clinical narrative: Measles type rash, full body
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Epistaxis
Clinical narrative: Hepatitis A Vaccine, Nose bleeds suddenly, has never had a nose bleed before, has had 2 within an hour lasting 10-15 minutes each
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: The patient called and said she had experienced severe flu like symptoms (fatigue, headache, chills) and pain and tenderness in armpit area for 2 days after the vaccine was given. Symptoms were improving when she called to report them but they were still present.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: The patient called and said she had experienced severe flu like symptoms (fatigue, headache, chills) and pain and tenderness in armpit area for 2 days after the vaccine was given. Symptoms were improving when she called to report them but they were still present.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Malaise, Pallor, Paraesthesia
Clinical narrative: Felt weak around 5pm, around 6pm I was pale and very weak, had to sit/lie down, tingling in hands. Slight wheezing, but not serious. Wanted to seek Urgen Care, but SO told me to just deal with it. At 7pm a fever with shivers came on, 101.3°F, which went down around 11pm. Now, the next day, I'm still feeling under the weather, but not completely knocked out any more.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Wheezing
Clinical narrative: Felt weak around 5pm, around 6pm I was pale and very weak, had to sit/lie down, tingling in hands. Slight wheezing, but not serious. Wanted to seek Urgen Care, but SO told me to just deal with it. At 7pm a fever with shivers came on, 101.3°F, which went down around 11pm. Now, the next day, I'm still feeling under the weather, but not completely knocked out any more.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Approximately 2 inches below the site of injection patient experiences swelling, redness extending down to the elbow.  Red area is about 1/3 of arm area.  Onset was within 6 hours of administration.  Over the past 48 hours the swelling and redness have reduced but not returned to normal baseline.  No pain except for typical soreness at injection site.  There was an area that was palpable and hard to the touch.  That has softened somewhat but not yet disappeared.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called on 9/17/19 reporting swelling at the site of injection. She stated that it was raised, swollen, and hot to the touch on the date of injection. When she woke up on 9/17 the swelling had gone down at the injection site, but the whole upper arm was significantly swollen, red, and tender to touch.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: Running a fever, loss of appetite.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperhidrosis, Impaired driving ability, Impaired work ability
Clinical narrative: Patient received her second dose of Shingrix vaccination on 9/10/19.  By the time she was at home she had to use the bathroom almost every 5 minutes,  started to develop a migraine, felt nauseous, groggy, fatigue and extreme pain upon touch.  The next morning, 9/11/19, she decided to work from home from 8am but had to stop working at 11am because she did not feel well.  She decided to take a nap and woke up with a fever drenched in sweat.  Today, 9/12/19, she did not feel well enough to drive or work and  called in for work today as well.  She is still experiencing headaches and extreme fatigue.  She will be making an appointment to be seen by a physician.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Migraine, Nausea, Pollakiuria, Pyrexia
Clinical narrative: Patient received her second dose of Shingrix vaccination on 9/10/19.  By the time she was at home she had to use the bathroom almost every 5 minutes,  started to develop a migraine, felt nauseous, groggy, fatigue and extreme pain upon touch.  The next morning, 9/11/19, she decided to work from home from 8am but had to stop working at 11am because she did not feel well.  She decided to take a nap and woke up with a fever drenched in sweat.  Today, 9/12/19, she did not feel well enough to drive or work and  called in for work today as well.  She is still experiencing headaches and extreme fatigue.  She will be making an appointment to be seen by a physician.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Tenderness
Clinical narrative: Patient received her second dose of Shingrix vaccination on 9/10/19.  By the time she was at home she had to use the bathroom almost every 5 minutes,  started to develop a migraine, felt nauseous, groggy, fatigue and extreme pain upon touch.  The next morning, 9/11/19, she decided to work from home from 8am but had to stop working at 11am because she did not feel well.  She decided to take a nap and woke up with a fever drenched in sweat.  Today, 9/12/19, she did not feel well enough to drive or work and  called in for work today as well.  She is still experiencing headaches and extreme fatigue.  She will be making an appointment to be seen by a physician.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing, shortness of breath
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis
Clinical narrative: local cellulitis. Treated as possible contaminated needle, injection site with IM antibiotic and follow on po antibiotic. To seek Emergent treatment at ER if symptoms flare
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Post herpetic neuralgia
Clinical narrative: Worsened, severe post-herpetic neuralgia in prior T1-T2 distribution.  Starting on treatment with gabapentin and topical lidocaine.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache, Malaise, Mobility decreased, Muscle spasms
Clinical narrative: BACK SEIZED AND PATIENT COULD NOT MOVE ABOUT 4 TO 6 HOURS AFTER VACCINE, ALSO HAD UPSET STOMCK, HEADCHE AND NOT FEELING WELL. CALLED 911, TRANPORTED TO ER, AFTER SOME TESTING AND EXAMINATION PATIENT WAS TOLD THAT IT WAS BAD REACTION TO VACCINE. BACK GOT BETTER WITHIN 6 HOURS, OTHER SYMPTOMS TOOK LONGER TO RESOLVE.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: BACK SEIZED AND PATIENT COULD NOT MOVE ABOUT 4 TO 6 HOURS AFTER VACCINE, ALSO HAD UPSET STOMCK, HEADCHE AND NOT FEELING WELL. CALLED 911, TRANPORTED TO ER, AFTER SOME TESTING AND EXAMINATION PATIENT WAS TOLD THAT IT WAS BAD REACTION TO VACCINE. BACK GOT BETTER WITHIN 6 HOURS, OTHER SYMPTOMS TOOK LONGER TO RESOLVE.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Retinal detachment, Retinopexy
Clinical narrative: 2.5 hrs after the vaccine I started having a problem in my left eye. it turned out to be a detached retina which required surgery on 6-20-19
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Chills, Cyanosis, Eye movement disorder, Pyrexia, Respiratory arrest
Clinical narrative: at 3 PM patient developed a tactile fever with shaking, chills, rolling her eyes to the back of her head. the seizure lasted 1 minute and family called 911. Patient stopped breathing and turned cyanotic. CPR was performed (2 breaths and 3 chest compressions) prior to spontaneous breathing resumed. Patient was taken to emergency department and Tylenol was given. Patient was seen in the office by dr. on 09/18/19.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Resuscitation, Seizure, Tremor
Clinical narrative: at 3 PM patient developed a tactile fever with shaking, chills, rolling her eyes to the back of her head. the seizure lasted 1 minute and family called 911. Patient stopped breathing and turned cyanotic. CPR was performed (2 breaths and 3 chest compressions) prior to spontaneous breathing resumed. Patient was taken to emergency department and Tylenol was given. Patient was seen in the office by dr. on 09/18/19.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Flushing, Myalgia, Nausea
Clinical narrative: Muscle aches, fatigue, momentary flushing, slight nausea, slight dizxyness for three days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reports experiencing a high fever (103 F) for 3 days.
Age: 12.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Depressed level of consciousness, Feeling abnormal, Pallor, Seizure like phenomena
Clinical narrative: Patient attending immunization clinic at Public Health Department to catch up on school required vaccinations. Patient had received two vaccines listed above, when administering nurse realized patient also needed a polio vaccine. She stopped administering vaccines to draw up polio vaccine, and at that time the patient's aunt called out to patient. Nurse looked at patient, who had turned pale and appeared to be starting to pass out. Nurse assisted patient's aunt and mother in  holding patient in chair, when patient began to have seizure like episode including both arms shooting out and up and in front of patient. Patient then relaxed, but almost immediately went into second episode of seizure like activity. Nurse called for help from other nurse in clinic, patient was moved to the floor, 911 was called. Patient recovered from both seizure like episodes, but continued to look pale and state she felt bad.  No loss of consciousness after being moved  to floor. Blood pressure remained stable,  breathes even and unlabored.  Patient and family Spanish speaking. Spanish speaking staff member translated for nurses. Patient history to include epilepsy. Last seizure two years ago. Was on seizure medications when living in another country (mother didnt know exact name but had magnesium in it), but moved from another country and last had medications about six months ago. Hasn't seen a doctor since moving here as she did not have insurance and hadnt had any seizures or other health issues. Patient transported by ambulance to local hospital. Outcome unknown.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of itchiness to site, area was hot to the touch and had a red bump. symptoms started the same day of vaccine a couple of hours later. she is an employee and was sent to a different healthcare professional  office to seek medical attention.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Very red and swollen at injection site. Not sensitive or painful to the touch. Spread very fast
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Red, swollen, inflammation at injection site
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Anxiety, Fatigue, Influenza like illness, Malaise
Clinical narrative: from the patient   I was offered the shingles vaccine on Thursday. I always knew I'd get one bc my mom got shingles. It was an awful experience and I had no idea that there were going to be side effects. I did no research, which was dumb on my part. So, with no questions or more info, I got the shot at about 10 am on Thursday. I started to feel different that evening with tired muscles which usually means I'm getting sick. I felt agitated at bedtime about 12 hours later. about 14 hours after the shot,  I awoke out of a sound sleep with electric shock type feelings in my stomach (the feeling you get if you are looking down at something when someone slams on the breaks - the surge of anxiety you get all at once). When I stood up, I felt like I'd been hit by a train.  I guess you'd say flu-like symptoms. My arm was swollen and super sore too. I was sick for two days and super tired on the third. I felt exhausted again last night. I am telling you all this in case it is supposed to be reported (CDC?) or putting in my record or something. That was horrible and I'm am not looking forward to the second shot!! Should I even get it if it made me sick?
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle fatigue, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: from the patient   I was offered the shingles vaccine on Thursday. I always knew I'd get one bc my mom got shingles. It was an awful experience and I had no idea that there were going to be side effects. I did no research, which was dumb on my part. So, with no questions or more info, I got the shot at about 10 am on Thursday. I started to feel different that evening with tired muscles which usually means I'm getting sick. I felt agitated at bedtime about 12 hours later. about 14 hours after the shot,  I awoke out of a sound sleep with electric shock type feelings in my stomach (the feeling you get if you are looking down at something when someone slams on the breaks - the surge of anxiety you get all at once). When I stood up, I felt like I'd been hit by a train.  I guess you'd say flu-like symptoms. My arm was swollen and super sore too. I was sick for two days and super tired on the third. I felt exhausted again last night. I am telling you all this in case it is supposed to be reported (CDC?) or putting in my record or something. That was horrible and I'm am not looking forward to the second shot!! Should I even get it if it made me sick?
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Intense redness, swelling, and inflammation at injection site
Sex: F
Vaccine: UNK
Symptoms: Jaundice
Clinical narrative: Jaundice within 6 hours.  Lasted 3 weeks
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Bursitis, Dyspnoea, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Shoulder Pain   The pain is present in the left shoulder. This is a new problem. Episode onset: 11 days. There has been no history of extremity trauma (had shingrix shot 9/5/19). The problem occurs constantly. The problem has been gradually worsening. The quality of the pain is described as sharp and pounding. The pain is at a severity of 9/10. The pain is severe. Associated symptoms include an inability to bear weight and a limited range of motion. Pertinent negatives include no fever, itching, joint locking, joint swelling, numbness or tingling. The symptoms are aggravated by activity. He has tried rest for the symptoms. The treatment provided mild relief.  Nausea  The primary symptoms include nausea. Primary symptoms do not include fever, abdominal pain, vomiting, diarrhea or rash. The illness began more than 7 days ago. The onset was sudden. Progression since onset: comes and goes.  Associated with: occurs randomly, lasts a few seconds. Exacerbated by: nothing.  The illness does not include chills, anorexia, dysphagia, odynophagia, bloating, constipation, tenesmus, back pain or itching.  Shortness of Breath  This is a new problem. The current episode started in the past 7 days. The problem occurs intermittently. The problem has been waxing and waning. Pertinent negatives include no abdominal pain, chest pain, claudication, coryza, ear pain, fever, headaches, hemoptysis, leg pain, leg swelling, neck pain, orthopnea, rash, rhinorrhea, sore throat, sputum production, vomiting or wheezing.      11 days ago pt got his second shingrix immunization. That night he got all achy, nauseous, felt terrible for 24 hours. The area of injection had pain and swelling, x 5 days. Then it's still a little tender by day 8. Then last 3-4 days it's worse.  Today it's at 9/10, making him nauseous again.  Per pt nausea still coming and going.  Also noted he's feeling more easily winded when walking around.    Patient to MD  9/17/19 12:11 PM  Hi Dr,  I visited the Ortho this morning about my shoulder pain. I asked Dr about the Shingrix vaccine and if there was a possibility of the vaccine being the culprit for the shoulder pain flare up. He said there are others who have come in with this same condition and he believes is related to the vaccine.  Proposed diagnosis: The vaccine initial shoulder pain went away after 6 days but only for a day or two then came back more powerful and painful until I couldn't stand it anymore. The vaccine most likely caused shoulder pain as inflammation to the subacrominal bursa causing a painful bursitis condition. This has been treated with a cortisone to expedite healing coupled with a two week follow up with Dr who suggested cancelling the appointment if I have made a full recovery within two weeks.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Malaise, Nausea, Pain, Weight bearing difficulty
Clinical narrative: Shoulder Pain   The pain is present in the left shoulder. This is a new problem. Episode onset: 11 days. There has been no history of extremity trauma (had shingrix shot 9/5/19). The problem occurs constantly. The problem has been gradually worsening. The quality of the pain is described as sharp and pounding. The pain is at a severity of 9/10. The pain is severe. Associated symptoms include an inability to bear weight and a limited range of motion. Pertinent negatives include no fever, itching, joint locking, joint swelling, numbness or tingling. The symptoms are aggravated by activity. He has tried rest for the symptoms. The treatment provided mild relief.  Nausea  The primary symptoms include nausea. Primary symptoms do not include fever, abdominal pain, vomiting, diarrhea or rash. The illness began more than 7 days ago. The onset was sudden. Progression since onset: comes and goes.  Associated with: occurs randomly, lasts a few seconds. Exacerbated by: nothing.  The illness does not include chills, anorexia, dysphagia, odynophagia, bloating, constipation, tenesmus, back pain or itching.  Shortness of Breath  This is a new problem. The current episode started in the past 7 days. The problem occurs intermittently. The problem has been waxing and waning. Pertinent negatives include no abdominal pain, chest pain, claudication, coryza, ear pain, fever, headaches, hemoptysis, leg pain, leg swelling, neck pain, orthopnea, rash, rhinorrhea, sore throat, sputum production, vomiting or wheezing.      11 days ago pt got his second shingrix immunization. That night he got all achy, nauseous, felt terrible for 24 hours. The area of injection had pain and swelling, x 5 days. Then it's still a little tender by day 8. Then last 3-4 days it's worse.  Today it's at 9/10, making him nauseous again.  Per pt nausea still coming and going.  Also noted he's feeling more easily winded when walking around.    Patient to MD  9/17/19 12:11 PM  Hi Dr,  I visited the Ortho this morning about my shoulder pain. I asked Dr about the Shingrix vaccine and if there was a possibility of the vaccine being the culprit for the shoulder pain flare up. He said there are others who have come in with this same condition and he believes is related to the vaccine.  Proposed diagnosis: The vaccine initial shoulder pain went away after 6 days but only for a day or two then came back more powerful and painful until I couldn't stand it anymore. The vaccine most likely caused shoulder pain as inflammation to the subacrominal bursa causing a painful bursitis condition. This has been treated with a cortisone to expedite healing coupled with a two week follow up with Dr who suggested cancelling the appointment if I have made a full recovery within two weeks.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Patient reported extreme swelling and redness in the days after the vaccine, for which she was seen at her primary care physician's office.  She received no treatment; the physician referred her back to the pharmacy to report the adverse event.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Condition aggravated, Hyperhidrosis, Impaired work ability, Pain
Clinical narrative: Sore arm on day post vaccination. Two days post vaccination she developed a red rash under left breast and in the groin area. The areas were sweating profusely. Her arthritis also flared up and she could not go to work for two days she was so sore all over.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: Sore arm on day post vaccination. Two days post vaccination she developed a red rash under left breast and in the groin area. The areas were sweating profusely. Her arthritis also flared up and she could not go to work for two days she was so sore all over.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Patient says she has a numbing sensation in her right jaw. She claims it is like when you go to dentist and they numb the area, but it has been numb for several hours and she cannot drink out of a cup, etc.
Age: 62.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: patient experienced arm swelling, redness, hot to the touch, and itching which was noticed when they woke up the day after vaccination. Patient went to the doctor and was told there was no cellulitis and could only relate the symptoms to the vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Hot flush, Influenza like illness
Clinical narrative: Arm starting hurting and swelling before leaving doctors office, at 11:00 pm started chilling got up the next morning with headache, joint and body aches this lasted for two days.  On third day my left arm turned red  at site of injection and by the fourth day redness and swelling had grown to 10 centimeters by 20 centimeters.  Doctor gave me a steroid shot and prescribed an antibiotic and steroid pills, steroid shot took the redness and swelling down by day five, but by end of day it was back even worse.  Day six I picked up the steroid pills (did not want these) started on them now redness and swelling has gone done, but now all of this has started me with hot flashes and just feeling like I have a touch of the flu.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Arm starting hurting and swelling before leaving doctors office, at 11:00 pm started chilling got up the next morning with headache, joint and body aches this lasted for two days.  On third day my left arm turned red  at site of injection and by the fourth day redness and swelling had grown to 10 centimeters by 20 centimeters.  Doctor gave me a steroid shot and prescribed an antibiotic and steroid pills, steroid shot took the redness and swelling down by day five, but by end of day it was back even worse.  Day six I picked up the steroid pills (did not want these) started on them now redness and swelling has gone done, but now all of this has started me with hot flashes and just feeling like I have a touch of the flu.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Scab, Skin lesion, Skin warm
Clinical narrative: According to patient, approximately 4-5 days after receiving the Shingrix vaccination, she developed two lesions on her face (on the right side, near nose and mouth) and one on her trunk (left side). She described them as itchy, hot, fluid-filled lesions which eventually crusted over.
Age: 0.08
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Eye discharge, Eyelid margin crusting, Screaming, Swelling
Clinical narrative: Inconsolable screaming crying that evening.   Head size swelling .  Increased from 30 percentile to 80 percentile by next well visit.  Left eye crusted and discharge.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt reported 1 week after receiving vaccine developed red rash with small speckled dots 1/8-1/4 inch in diameter. Rash on the upper chest about 12 inches across and 8 inches tall. Pt stated rash developed overnight and did not heal for 6 weeks. Only complaint from pt was that it was very itchy. Rash did not spread, was not painful, and did not scab.
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Dyspnoea, Flushing
Clinical narrative: Pharmacist administered vaccine, Patient started to have difficulty breathing and was turning red, pharmacist administered Epipen. Pharmacy called 911, Ambulance/EMTs took her to the ER.
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Blood test, Chest discomfort, Dyspnoea, Electrocardiogram, Syncope
Clinical narrative: Pharmacist administered vaccine, Patient started to have difficulty breathing and was turning red, pharmacist administered Epipen. Pharmacy called 911, Ambulance/EMTs took her to the ER.
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Urine analysis
Clinical narrative: Pharmacist administered vaccine, Patient started to have difficulty breathing and was turning red, pharmacist administered Epipen. Pharmacy called 911, Ambulance/EMTs took her to the ER.
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Electrocardiogram, Mobility decreased
Clinical narrative: Pharmacist administered vaccine, Patient started to have difficulty breathing and was turning red, pharmacist administered Epipen. Pharmacy called 911, Ambulance/EMTs took her to the ER.
Age: 88.0
Sex: F
Vaccine: PPV, PPV, UNK, PPV
Symptoms: Speech disorder
Clinical narrative: Pharmacist administered vaccine, Patient started to have difficulty breathing and was turning red, pharmacist administered Epipen. Pharmacy called 911, Ambulance/EMTs took her to the ER.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: redness and inflammation at injection site, pt claim injection was not deep enough and into the muscles
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling that wrapped around bicep, also a bruise at injection site over the course of 1 to 2 days
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: severe pain at injection site and bicept area
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm  became  hot and feverish.    Arm  became  swollen.   Arm  was throbbing and  continuously  itchy.   There  was  raised  spots on  arm. Could  not  sleep  at  night.    lasted  for about  a week.    My concern  is  with  the affect  of the SECOND  shot  that I might  experience
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Arm  became  hot and feverish.    Arm  became  swollen.   Arm  was throbbing and  continuously  itchy.   There  was  raised  spots on  arm. Could  not  sleep  at  night.    lasted  for about  a week.    My concern  is  with  the affect  of the SECOND  shot  that I might  experience
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Insomnia, Peripheral swelling, Pruritus, Rash
Clinical narrative: Arm  became  hot and feverish.    Arm  became  swollen.   Arm  was throbbing and  continuously  itchy.   There  was  raised  spots on  arm. Could  not  sleep  at  night.    lasted  for about  a week.    My concern  is  with  the affect  of the SECOND  shot  that I might  experience
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dizziness, Pallor, Syncope
Clinical narrative: 2 minutes after receiving a flu shot, patient told her father she was  dizzy, then fainted immediately.  Her father stated this had happened many times before, due to anxiety.  Her father,  tried to rouse her,and we applied cold packs and cloths to her head.  She briefly came around and spoke to her father, but continued to be pale and dizzy.  After about 5 minutes she fainted again.  She was responsive after a couple more minutes, and started to feel better.  Her father thought she would do best to go home but I asked them to stay for further monitoring, as she was not able to walk or support herself.  I took her blood pressure at approximately 15 and 25 minutes after the initial fainting, with readings of 116/75 P96 and 114/76 P87, respectively.  Normal breathing and absence of allergic signs such as hives, rash, and angioedema were noted, and she gradually became less pale and more responsive.  She left with her family with assistance, and her called me 1 our later to let us know that she was better, and walked for the vehicle to her home unassisted, and had no new symptoms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Pt came in today and told me her arm was red and swollen from injection site to her elbow (left arm.) She'd gotten shingrix and pneumovax in left arm (and got fluzone hd in right arm which had no rxn.) She also said she was feeling hot last night but now not feeling hot. Pt had an ice pack on her arm when she came in, which i recommended to keep using, along with ibuprofen. Pt said she "wasn't complaining" that she just wanted to notify us. I thanked her and said i'd fill out vaers.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Pt came in today and told me her arm was red and swollen from injection site to her elbow (left arm.) She'd gotten shingrix and pneumovax in left arm (and got fluzone hd in right arm which had no rxn.) She also said she was feeling hot last night but now not feeling hot. Pt had an ice pack on her arm when she came in, which i recommended to keep using, along with ibuprofen. Pt said she "wasn't complaining" that she just wanted to notify us. I thanked her and said i'd fill out vaers.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Axillary pain, Breast pain, Breast swelling, Inflammation, Oedema peripheral
Clinical narrative: pt says she has swollen area by breast and underarm. a little painful. pt is taking motrin to help with pain/inflammation.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The vaccine area became significantly swollen, very red, not to the touch, and extremely painful in that area. It's been a week since I received the first of two Shingrex shots and the swelling has gone down, but the skin is still red, the area is still much warmer than the rest of my arm. Initially, the swelling and redness covered an area of about three inches. Now, the swelling is reduced, but covers an area of about six inches long by three inches wide. and the area has started to itch.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Crying, Developmental delay, Eye discharge, Listless, Screaming
Clinical narrative: Inconsolable crying and screaming first night. Next few days listless, Head size swelled.  Increased from 80th percentile to 90th percentile.  Failed to reach milestones..  Left eye discharge.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Swelling
Clinical narrative: Inconsolable crying and screaming first night. Next few days listless, Head size swelled.  Increased from 80th percentile to 90th percentile.  Failed to reach milestones..  Left eye discharge.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: We did not mix the vaccine and only injected the patient with adjuvant suspension component.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: pt called days later with large bruise on arm where shot was given does not hurt is not red
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema
Clinical narrative: Pt received her PPSV23 on 9/14/19.  She states her arm was red on the morning of 9/15/19.  She showed me her arm today which was a little red and she said the redness was almost all gone.
Age: 53.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Skin infection
Clinical narrative: Patient got 2 immunizations (1 Flublok on right arm and 1 Pneumovax 23 on left arm) on 09/16/19.  I tell every single customer that most common side effect with immunization is hot to touch, red to see and painful at injection for couple days.   She came back to pharmacy on 09/18/19 and complaining  about soreness, redness and hot area on triceps area of left arm which is away from injection site.  There was no sign of any visual adverse effect on injection site. She also complain about shoulder pain.  Patient also took ibuprofen 200 mg, 1 tablet by mouth 3 times a day yesterday.  I did call her doctor office and spoke to staff for follow up appointment.  There was not sign of infection, but md is treating her with antibiotic for skin infection.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood urine present, Chills, Frequent bowel movements, Headache, Pain
Clinical narrative: Chills, body aches, headache, fever, blood in urine, frequent bowel movements
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, body aches, headache, fever, blood in urine, frequent bowel movements
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, UNK
Symptoms: Crying, Decreased eye contact, Developmental delay, Food aversion, Gross motor delay
Clinical narrative: Crying and screaming that evening.   Loss of eye contact.  Lethargic for the next few days.  No new milestones. Won't eat solid foods..  No crawling , clapping babbling.  gross motor skills delay.   Swollen head.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, UNK
Symptoms: Lethargy, Screaming, Swelling
Clinical narrative: Crying and screaming that evening.   Loss of eye contact.  Lethargic for the next few days.  No new milestones. Won't eat solid foods..  No crawling , clapping babbling.  gross motor skills delay.   Swollen head.