chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: severe swelling in the thigh and knee after the injection; a 18 months old male patient received a 0.25 ml dose of  Fluzone Quadrivalent vaccine; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a six years old male patient who experienced severe swelling in the thigh and knee after the injection (oedema peripheral), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the right thigh.  On an unknown date, the patient developed a non-serious severe swelling in the thigh and knee after the injection (oedema peripheral) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was a case of vaccine underdose. When he was 18 months old the patient received a 0.25 ml dose of  Fluzone Quadrivalent vaccine.  (Other relevant tests included no lab data.)  Final diagnosis was oedema peripheral.   It was not reported if the patient received a corrective treatment.  The patient was not recovered from the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case from a physician via a non-licensed partner.  This case involves a patient who experienced rash (rash), while he/she received vaccine INFLUENZA VACCINE.  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious rash (rash) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  Final diagnosis was rash (moderate).   It was not reported if the patient received a corrective treatment.  The event outcome was not reported.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction, Urticaria
Clinical narrative: broke out in hives; Local reactions in injection site; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves female patient who experienced hives (urticaria) and local reactions in injection site (injection site reaction), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and other dosing details were not reported] via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious hives (urticaria) and local reactions in injection site (injection site reaction), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  Final diagnosis was urticaria and injection site reaction.   It was not reported if the patient received any corrective treatment.  Event outcome was Unknown for reported events.  Information on the batch number was requested.
Age: 17.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year-old was administered Flublok/No AE; Initial information was received on 11-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 17 year old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment, vaccination and family history were not provided.   On 31-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1951, expiry date-30-06-2020 via unknown route in the left deltoid.  It was a case of actual medication error due to inappropriate age at vaccine administration.  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 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: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a 59 year old patient received the Flublok vaccine twice/No AE; Initial information was received on 11-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 59-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] twice.  Medical history, medical treatment, vaccination and family history were not provided.  On 22-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE twice; lot QFAA1920 via intramuscular route in the right deltoid and on the same day another dose via intramuscular route in the left deltoid.  It was a case of actual medication error due to extra dose administered.  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 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: 12.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: IPV vaccination on  dec10th and it expired  nov14/no AE; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 years old female patient who received an expired dose of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Dec-2019, the patient received a dose of suspect IPV (VERO) lot N1K921M via unknown route in unknown administration site.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced or not..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: an 85 year old female to receive two doses of Fluzone high-Dose this season possibly due to the consumer not remembering the injection was already given, no adverse event; Initial information was received on 13-Dec-2019 and additional information on 16-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 84 year old female patient who was vaccinated with a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number UJ238AA and expiration date 14-Apr-2020) on an unknown date in Sep-2019 and also received 0.5 ml dose of same vaccine, 3-weeks later on an unknown date in Oct-2019 (lot number UJ283AB and expiration date 29-May-2020) via an intramuscular route in the left arm.  Medical history was not reported.  The patient did not receive any other vaccine.  It was an actual medication error case due to extra dose administered.  No adverse event was reported at the time of reporting.  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: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Crying, Feeding disorder, Insomnia, Urine output decreased, Vaccination site erythema
Clinical narrative: would not sleep; would not eat, had no wet diapers; rectal temp of 100.5 F; inconsolable crying; vaccine site was mildly swollen and had minimal redness; the vaccine site was mildly swollen; the vaccine site was minimal redness; Initial information received on 13-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two months old female patient who experienced would not sleep (sleep disorder), would not eat, had no wet diapers (feeding disorder), rectal temp of 100.5 F (pyrexia), inconsolable crying (crying) and vaccine site was mildly swollen and had minimal redness (vaccination site inflammation), while she received vaccines ROTAVIRUS VACCINE, PREVENAR 13 and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PARACETAMOL (TYLENOL) for Pyrexia.  On 04-Dec-2019, the patient received a first 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ198AAA, expiry date: 02-Mar-2021 via intramuscular route in the left thigh, a dose of suspect PREVENAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site and a dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious would not sleep (sleep disorder), would not eat, had no wet diapers (feeding disorder), rectal temp of 100.5 F (pyrexia), inconsolable crying (crying), vaccine site was mildly swollen and had minimal redness (vaccination site inflammation) (vaccination site swelling)  (vaccination site erythema) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, PREVENAR 13 and ROTAVIRUS VACCINE. It was reported that patient had inconsolable crying, would not eat, nor sleep and had no wet diapers and she tried multiple consoling techniques and nothing worked. Nurse states the vaccine site was mildly swollen and had minimal redness and a rectal temp of 100.5 F.  Relevant laboratory test results included: Body temperature - On an unknown date: 100.5 F  Final diagnosis was Mild vaccine site was mildly swollen and had minimal redness, inconsolable crying, rectal temp of 100.5 f, would not eat, had no wet diapers and would not sleep.  The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia (Nurse states patients mother didn't give the child any tylenol).  The outcome of all the events were not reported.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Vaccination site inflammation, Vaccination site swelling
Clinical narrative: would not sleep; would not eat, had no wet diapers; rectal temp of 100.5 F; inconsolable crying; vaccine site was mildly swollen and had minimal redness; the vaccine site was mildly swollen; the vaccine site was minimal redness; Initial information received on 13-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two months old female patient who experienced would not sleep (sleep disorder), would not eat, had no wet diapers (feeding disorder), rectal temp of 100.5 F (pyrexia), inconsolable crying (crying) and vaccine site was mildly swollen and had minimal redness (vaccination site inflammation), while she received vaccines ROTAVIRUS VACCINE, PREVENAR 13 and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PARACETAMOL (TYLENOL) for Pyrexia.  On 04-Dec-2019, the patient received a first 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ198AAA, expiry date: 02-Mar-2021 via intramuscular route in the left thigh, a dose of suspect PREVENAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site and a dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious would not sleep (sleep disorder), would not eat, had no wet diapers (feeding disorder), rectal temp of 100.5 F (pyrexia), inconsolable crying (crying), vaccine site was mildly swollen and had minimal redness (vaccination site inflammation) (vaccination site swelling)  (vaccination site erythema) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, PREVENAR 13 and ROTAVIRUS VACCINE. It was reported that patient had inconsolable crying, would not eat, nor sleep and had no wet diapers and she tried multiple consoling techniques and nothing worked. Nurse states the vaccine site was mildly swollen and had minimal redness and a rectal temp of 100.5 F.  Relevant laboratory test results included: Body temperature - On an unknown date: 100.5 F  Final diagnosis was Mild vaccine site was mildly swollen and had minimal redness, inconsolable crying, rectal temp of 100.5 f, would not eat, had no wet diapers and would not sleep.  The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia (Nurse states patients mother didn't give the child any tylenol).  The outcome of all the events were not reported.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3y.o. patient who received a Quadracel inadvertantly on 15Nov2019; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and reported that 3y.o. patient who received a Quadracel inadvertantly on 15-Nov-2019 (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT); and HEPATITIS B VACCINE (HEPATITIS B VACCINE).  On 15-Nov-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA and expiry date: 09-Oct-2020 via intramuscular route in the right thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 21.0
Sex: F
Vaccine: FLU3, FLUX, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 21 years old female pregnant patient was administered a dose of Fluzone HD instead of the regular"flu vaccine/No AE; a 21 years old female pregnant patient was administered a dose of Fluzone HD and Adacel/No AE; a 21 years old female pregnant patient was administered a dose of Fluzone HD/No AE; a 21 years old female pregnant patient was administered a dose of Fluzone HD/No AE; Initial information received on 13-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21 years old female patient who was exposed to vaccines INFLUENZA VACCINE, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number: 3YN2L, expiry date: 12-MAR-2021, dose, route and site of administration were unknown) on 12-DEC-2019 and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number: UJ306AA, site of administration left deltoid, expiry date, dose and route) on 12-DEC-2019 instead of INFLUENZA VACCINE (regular flu vaccine), while she was pregnant.  Data regarding this pregnancy were received prospectively. The patient's currently pregnancy status is 34 weeks and 5 days.  The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was case of vaccine exposure during pregnancy. A 21 years old female pregnant patient was administered a dose of Fluzone HD and Adacel.  It was an actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration. A 21 years old female pregnant patient was administered a dose of Fluzone HD instead of the regular flu vaccine.  It was also a case of overdose.  No adverse event reported.  Pregnancy outcome was unknown at the time of report.  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.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6 week old received a Fluzone Quadrivalent 0.25ml vaccine, no AE; Initial information received on 13-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six weeks old male patient who received 0.25ml dose vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT6709LA and expiry date: 30-Jun-2020) via intramuscular route in the right thigh, on 05-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due Inappropriate age at vaccine administration. It was reported that 6 week old male patient received a Fluzone Quadrivalent 0.25ml vaccine on 05-Dec-2019.  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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a four month old male patient received only the diluent portion of the pentacel vaccine while administrating the vaccine/No AE; Initial information received on 13-Dec-2019 regarding an unsolicited valid non-serious case received from an other health care professional (Medical Assistant).  This case involves a four months old male patient who received only the diluent portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] while administrating the vaccine lot UJ122AAA, expiry date: 29-Sep-2020, dose: 0.5ml via intramuscular route in the right thigh on 12-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) 13.   It was an actual medication error due to Inappropriate reconstitution technique.  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.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: tested positive for A influenza one month after the vaccine; tested positive for A influenza one month after the vaccine; Initial information received on 12-Dec-2019 regarding an unsolicited valid serious case received from a physician.  This case is linked with case 2019SA348219 (same patient)  This case involves a elderly old female patient who experienced Influenza A virus infection (influenza) one month after the vaccine (Influenza A virus test positive), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Patients Family history were not provided. At the time of the event, the patient had ongoing Hypothyroidism and Familial hypercholesterolemia.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, patient developed a serious Influenza A virus infection (influenza) as she was tested positive with  influenza A virus test, one month following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  It is also a case of vaccination failure.  Relevant laboratory test results included: On an unknown date: tested positive for A influenza.  Final diagnosis was Influenza A virus infection.  It was not reported if the patient received a corrective treatment.  The patient event outcome is not reported.  Information on the batch number was requested.; Sender's Comments: This case involves an elderly female patient who tested positive for influenza A one month after and despite vaccination with FLUZONE HIGH DOSE. The time to onset is compatible with the role of the vaccine. However, there is no information regarding patient's condition at time of vaccination, immune status, and predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Rash
Clinical narrative: PATIENT RECEIVED SHINGRIX VACCINE ON MORNING OF 12/19/19 AND DID EXPERIENCE MUSCLE SORENESS ON SAME NIGHT.  THE FOLLOWING MORNING PATIENT HAD RASH IN SAME ARM BUT NOT AT INJECTION SITE.  PATIENT TOOK UBER TO HOSPITAL WHERE SHE WAS ADMITTED FOR 3 DAYS.  SHE WAS TREATED WITH ANTI-VIRAL.  BOTH PATIENT AND HOSPITAL BELIEVE REACTION WAS NOT FROM VACCINE BUT SOMETHING SHE MAY HAVE CAME IN CONTACT WITH.  PATIENT WAS TREATED WITH VALTREX 1000MG BY MOUTH THREE TIMES A DAY FOR 7 DAYS.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray abnormal, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: 13:45: Patient reports feeling hot, chills and shivers and noted to have red patchy rash on neck and face, ears appear bright red.  Benadryl  25 mg administered.  14:05: Pt reports increased chest pain and shortness of breath, pt up to bathroom and came back dizzy and lightheaded and almost fell over. Oxygen sat 68% on 4 liters, O2 turned up to 6 liters 14:12: epinephrine 0.27mg (0.01mg/kg) IM administered. 1413: epinephrine 0.27 mg IM given in left upper mid thigh.  Oxygen sats in 60s on 8 liters face mask and pt struggling to catch breath and heart rate 80.  1420: 911 called and ambulance requested.  1440: ambulance arrived to home, pt on 8L of oxygen and O2 sats 75% pt placed on cardiac monitoring, waveforms very irregular and EMS concerned and requesting to transport pt to hospital. Pt paced and transported to hospital via ambulance.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Feeling hot, Rash erythematous
Clinical narrative: 13:45: Patient reports feeling hot, chills and shivers and noted to have red patchy rash on neck and face, ears appear bright red.  Benadryl  25 mg administered.  14:05: Pt reports increased chest pain and shortness of breath, pt up to bathroom and came back dizzy and lightheaded and almost fell over. Oxygen sat 68% on 4 liters, O2 turned up to 6 liters 14:12: epinephrine 0.27mg (0.01mg/kg) IM administered. 1413: epinephrine 0.27 mg IM given in left upper mid thigh.  Oxygen sats in 60s on 8 liters face mask and pt struggling to catch breath and heart rate 80.  1420: 911 called and ambulance requested.  1440: ambulance arrived to home, pt on 8L of oxygen and O2 sats 75% pt placed on cardiac monitoring, waveforms very irregular and EMS concerned and requesting to transport pt to hospital. Pt paced and transported to hospital via ambulance.
Age: 77.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Balance disorder, Chills, Fatigue, Headache
Clinical narrative: First Day August 31: nausea, chills, headache, weakness, went to sleep for about 5 hours and woke up  sweating and  had to change into dryer PJ's went back to sleep and woke up feeling a little better (no headache, or chills, or nausea) still felt very wobbly and tired until the afternoon of the second day,  September 1
Age: 77.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: First Day August 31: nausea, chills, headache, weakness, went to sleep for about 5 hours and woke up  sweating and  had to change into dryer PJ's went back to sleep and woke up feeling a little better (no headache, or chills, or nausea) still felt very wobbly and tired until the afternoon of the second day,  September 1
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: ProQuad was stored in refrigerator for 6 days prior to administration.  No reaction or adverse event.  Will re-immunize in 4 weeks.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: ProQuad was stored in the refrigerator for 6 days prior to administration.  No reaction or adverse event.  Will re-immunize in 4 weeks
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Local reaction, Swelling
Clinical narrative: localized adverse reaction to administration of drug, told parent swelling should slowly resolve, if any increased swelling redness etc call
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Pyrexia, Tremor
Clinical narrative: Elevated blood pressure of  178/80, fever 100.2 oral and shakes
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Patient complained of arm pain that did not resolve since flu shot given.  She visited her primary care doctor and received ibuprofen on 10-17-19 and cyclobenzaprine on 11-21-19.  She says the pain is worse at night after sleeping and can't sleep on her left side.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: First few days (12/23-12/26) she described feeling very sick, stayed in bed, mild pain and swelling at injection site. Unsure if afebrile or not. Noticed upon waking on 12/27/19, large red, swollen, painful area on left upper arm. Came into clinic for eval. Affected area red, swollen, warm to touch and measures 20cm long X 10cm wide.  Possibly cellulitis, provider prescribed abx.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased, Herpes zoster, Nausea
Clinical narrative: fast heart rate 115 b/m, headache, uncontralible shivering, nausea, outbreak of shingles on my stomach.
Age: 34.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Bone pain, Groin pain, Muscle strain
Clinical narrative: Constant pain in upper right groin. Pain in lower outside of right hip. Pain in right tibia that comes & goes, not always same area. Pain in right patella tendon.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Tendon pain, X-ray of pelvis and hip abnormal
Clinical narrative: Constant pain in upper right groin. Pain in lower outside of right hip. Pain in right tibia that comes & goes, not always same area. Pain in right patella tendon.
Age: 12.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Wrong product administered
Clinical narrative: vaccine given was incorrect
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Acute disseminated encephalomyelitis, Biopsy brain, Chest pain, Computerised tomogram abdomen, Computerised tomogram head
Clinical narrative: Adverse event: Morning of 11/27/2019 the patient woke up with chest pain , difficulty in breathing , urine retention , headache, fever 38C , vision problem, difficulty walking,  disoriented , not being able to swallow water and vomiting after the first trial.  Treatment : call 911 , transfer to hospital ( first to  ER then to ICU ), MRI , lumber puncture , biopsy from the brain then dated 12/17/2019 , the result was inconclusive therefore the patient  was  transfered to surgical intensive care for higher care .
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram thorax, Disorientation, Dysphagia, Dyspnoea, Gait disturbance
Clinical narrative: Adverse event: Morning of 11/27/2019 the patient woke up with chest pain , difficulty in breathing , urine retention , headache, fever 38C , vision problem, difficulty walking,  disoriented , not being able to swallow water and vomiting after the first trial.  Treatment : call 911 , transfer to hospital ( first to  ER then to ICU ), MRI , lumber puncture , biopsy from the brain then dated 12/17/2019 , the result was inconclusive therefore the patient  was  transfered to surgical intensive care for higher care .
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Intensive care, Lumbar puncture, Magnetic resonance imaging brain, Magnetic resonance imaging spinal
Clinical narrative: Adverse event: Morning of 11/27/2019 the patient woke up with chest pain , difficulty in breathing , urine retention , headache, fever 38C , vision problem, difficulty walking,  disoriented , not being able to swallow water and vomiting after the first trial.  Treatment : call 911 , transfer to hospital ( first to  ER then to ICU ), MRI , lumber puncture , biopsy from the brain then dated 12/17/2019 , the result was inconclusive therefore the patient  was  transfered to surgical intensive care for higher care .
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Plasmapheresis, Pyrexia, Urinary retention, Visual impairment, Vomiting
Clinical narrative: Adverse event: Morning of 11/27/2019 the patient woke up with chest pain , difficulty in breathing , urine retention , headache, fever 38C , vision problem, difficulty walking,  disoriented , not being able to swallow water and vomiting after the first trial.  Treatment : call 911 , transfer to hospital ( first to  ER then to ICU ), MRI , lumber puncture , biopsy from the brain then dated 12/17/2019 , the result was inconclusive therefore the patient  was  transfered to surgical intensive care for higher care .
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Vaccination complication
Clinical narrative: PATIENT CAME BACK TO GET SHINGRIX VACCINE AND SAID SHE HAD A BAD REACTION TO THE PNEUMOVAX VACCINE. SHE BELIEVED THE PHARMACIST HAD PLACED IT IN THE WRONG SPOT (SLIGHTLY BEHIND THE ARM). SHE COULD NOT LIFT OR MOVE HER ARM/SHOULDER FOR SEVERAL DAYS AND IT HURT VERY BADLY.  PATIENT DID GET BETTER AND SHE WAS GOOD BY TIME SHE GOT HER SHINGRIX VACCINE TODAY.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Constant ache left upper arm
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Fatigue, Pain, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: PATIENT COMPLAINED OF BODY ACHE, FEVER, FATIGUE, CHEST CONGESTION, AND UPPER BODY RASH LASTED 12 HOURS ONLY.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injection site inflammation, Injection site pain, Pain
Clinical narrative: local inflammation at injection site Left arm swelling, redness, pain and fatigue today after pneumonia shot today The incident occurred 3 to 6 hours ago. The incident occurred at home. Injury mechanism: received pneumococcal vaccine this morning. The pain is present in the left shoulder. The quality of the pain is described as aching. The pain radiates to the left arm. The pain has been worsening since the incident. Pertinent negatives include no chest pain, numbness or tingling. She has tried nothing for the symptoms.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: local inflammation at injection site Left arm swelling, redness, pain and fatigue today after pneumonia shot today The incident occurred 3 to 6 hours ago. The incident occurred at home. Injury mechanism: received pneumococcal vaccine this morning. The pain is present in the left shoulder. The quality of the pain is described as aching. The pain radiates to the left arm. The pain has been worsening since the incident. Pertinent negatives include no chest pain, numbness or tingling. She has tried nothing for the symptoms.
Age: 45.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Erythema, Pruritus, Rash, Swelling, Swelling face
Clinical narrative: PATIENT REPORTS THAT SHE NOTED REDNESS. SWELLING & ITCHING AROUND THE MOUTH FIRST & SPREAD ALL OVER HER FACE. SHE NOTED RASH ON HER LEGS. FEELS SWOLLEN BUT NO PROBLEM WITH BREATHING. 4-5 HOURS AFTER VACCINATIONS
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood culture negative, C-reactive protein normal, Full blood count normal, Injection site erythema
Clinical narrative: Received Shingrix on 12/10/19. Woke up on 12/11/19 with pain in Rt wrist along with tightness. Also noticed redness and soreness in Rt upper arm - below the injection site. CBC, CRP done. Rocephin 1g given IM, started on Bactrim DS BID x 10 days. Pt went to ER on 12/13/19 with increased pain & redness - given vancomycin 1g IV. Remained on oral Bactrim. Patient follow up in office on 12/16/19 - No redness, pain or swelling. Instructed to finish Bactrim DS
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Joint stiffness
Clinical narrative: Received Shingrix on 12/10/19. Woke up on 12/11/19 with pain in Rt wrist along with tightness. Also noticed redness and soreness in Rt upper arm - below the injection site. CBC, CRP done. Rocephin 1g given IM, started on Bactrim DS BID x 10 days. Pt went to ER on 12/13/19 with increased pain & redness - given vancomycin 1g IV. Remained on oral Bactrim. Patient follow up in office on 12/16/19 - No redness, pain or swelling. Instructed to finish Bactrim DS
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye injury, Eye pain, Eyelid ptosis, Facial paralysis, Magnetic resonance imaging brain
Clinical narrative: diagnosed by M.D. Bells Palsy. Left side of face & eye paralyzed 12/26/2019 eye sight effected. Taping eye at night. Still no releaf. Started PT 2/17 & continuing 2x week. Purchased Tens Unit using 3x day. Mouth & muscles do not move Left eye droops & pain & trauma in eye
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmoplegia, Visual impairment
Clinical narrative: diagnosed by M.D. Bells Palsy. Left side of face & eye paralyzed 12/26/2019 eye sight effected. Taping eye at night. Still no releaf. Started PT 2/17 & continuing 2x week. Purchased Tens Unit using 3x day. Mouth & muscles do not move Left eye droops & pain & trauma in eye
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Pain, Pyrexia, Rash
Clinical narrative: MOC states body ache, fever, headache and rash on Pt face. Pt is abroad at present time and MOC did not state any treatment being done for child. We suggested alternate Ibuprofen and Tylenol to control the fever. Subject in question is over seas and has not been back in our office as of 12/18/19 all symptoms are from Mothers statement.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood cholesterol increased, Blood pressure increased, Chest pain, Contraindication to vaccination, Herpes zoster
Clinical narrative: FACIAL RASH WHICH HAS NOW PERSISTED SINCE SHINGRIX 2 ON 06/28/2019///I AM STILL SUFFERING FROM THE FACIAL RASHES AND PHN. MY DOCTOR AUTHORIZED THE VACCINE ON 04/2019 AND 06/2019 WHEN IT WAS IN HIS NOTES THAT A RASH WAS UNDER MY EYE AND THE O.D. SUSPECTED SHINGLES. MY BODY WIDE PAIN IS HORRIBLE AND PERSISTS TO THIS DAY.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test normal, Liver function test increased, Neck pain, Weight decreased
Clinical narrative: FACIAL RASH WHICH HAS NOW PERSISTED SINCE SHINGRIX 2 ON 06/28/2019///I AM STILL SUFFERING FROM THE FACIAL RASHES AND PHN. MY DOCTOR AUTHORIZED THE VACCINE ON 04/2019 AND 06/2019 WHEN IT WAS IN HIS NOTES THAT A RASH WAS UNDER MY EYE AND THE O.D. SUSPECTED SHINGLES. MY BODY WIDE PAIN IS HORRIBLE AND PERSISTS TO THIS DAY.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash, Varicella virus test
Clinical narrative: FACIAL RASH WHICH HAS NOW PERSISTED SINCE SHINGRIX 2 ON 06/28/2019///I AM STILL SUFFERING FROM THE FACIAL RASHES AND PHN. MY DOCTOR AUTHORIZED THE VACCINE ON 04/2019 AND 06/2019 WHEN IT WAS IN HIS NOTES THAT A RASH WAS UNDER MY EYE AND THE O.D. SUSPECTED SHINGLES. MY BODY WIDE PAIN IS HORRIBLE AND PERSISTS TO THIS DAY.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Fatigue, Headache
Clinical narrative: dose 1. Pain, redness, swelling ,heat at the injection site. Acute flu like symptoms approximately 8 hours after receiving the vaccine, fever chills, muscle joint ache, deep bone pain, etc. Severity reduced with Tylenol- but not completely masked.  Acute flu like symptoms eased to regular flu like symptoms lasting for 3 days, fatigue sissiness headache  lingered for 2 more.  Interrupted routine significantly. Symptoms dissipated and on the advice of pharmacist returned for dose 2 on 12/26/2019 same facility  Same pattern returned unfortunately. Injection site bled slightly on dose 2.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: dose 1. Pain, redness, swelling ,heat at the injection site. Acute flu like symptoms approximately 8 hours after receiving the vaccine, fever chills, muscle joint ache, deep bone pain, etc. Severity reduced with Tylenol- but not completely masked.  Acute flu like symptoms eased to regular flu like symptoms lasting for 3 days, fatigue sissiness headache  lingered for 2 more.  Interrupted routine significantly. Symptoms dissipated and on the advice of pharmacist returned for dose 2 on 12/26/2019 same facility  Same pattern returned unfortunately. Injection site bled slightly on dose 2.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pyrexia
Clinical narrative: dose 1. Pain, redness, swelling ,heat at the injection site. Acute flu like symptoms approximately 8 hours after receiving the vaccine, fever chills, muscle joint ache, deep bone pain, etc. Severity reduced with Tylenol- but not completely masked.  Acute flu like symptoms eased to regular flu like symptoms lasting for 3 days, fatigue sissiness headache  lingered for 2 more.  Interrupted routine significantly. Symptoms dissipated and on the advice of pharmacist returned for dose 2 on 12/26/2019 same facility  Same pattern returned unfortunately. Injection site bled slightly on dose 2.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Back Ache, Muscle Ache in Arm, Headache (strong), Nasal Congestion, Feverish Overnight
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, slight fever (99.6) , chills
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Middle insomnia, Motor dysfunction, Musculoskeletal pain, Pain in extremity
Clinical narrative: Hands and shoulders became increasingly painful during the night to where it would wake me up.  Hand joints became increasingly swollen making it hard to grasp things.  Mornings were the worst and then the pain would subside by midmorning.  It slowly started to resolve in September and by December the left shoulder finally stopped hurting.
Age: 29.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Asthenia, Chills, Headache, Myalgia, Pain
Clinical narrative: Fever, muscle sore, body ache, headache, weakness, chills and shaking.
Age: 29.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever, muscle sore, body ache, headache, weakness, chills and shaking.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: 4 hours of chills/shivering with slight fever
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Has a bruise like pain in the back of their arm that is triggered by touching the area or moving the arm up and down.  Nothing makes it better, touching it makes it worse.  Had soreness after the injection and the bruise like pain is still there 2 months after.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Injection site bruising, Injection site haemorrhage, Oropharyngeal pain
Clinical narrative: Pt reported waking up the next morning with a headache and sore throat, and a quarter-sized bruise at the injection site. She also voiced concern that bleeding occurred from the injection site for ~20 minutes after the injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reaction began with swelling, pain, and redness in right upper arm on Friday night.  Fevers on Saturday and Sunday as well as headache and continued extreme pain/sensitivity in arm.  Following on-call nurse directions, Saturday night began using Ibuprofen and acetaminophen alternately to reduce fever and pain. Was still not feeling well Monday and Tuesday. Fever and headache returned on Wednesday. Arm finally began to feel better late Thursday into Friday, but began to itch. Arm still slightly itchy eight days following injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: Reaction began with swelling, pain, and redness in right upper arm on Friday night.  Fevers on Saturday and Sunday as well as headache and continued extreme pain/sensitivity in arm.  Following on-call nurse directions, Saturday night began using Ibuprofen and acetaminophen alternately to reduce fever and pain. Was still not feeling well Monday and Tuesday. Fever and headache returned on Wednesday. Arm finally began to feel better late Thursday into Friday, but began to itch. Arm still slightly itchy eight days following injection.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient reported very sore arm starting about a week after flu shot in right arm. Patient reported sharp shooting pain in arm at times that lasted about an hour. She said this lasted about a week. She said she did not see a doctor and it resolved in about a week.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Induration
Clinical narrative: Flu like symptoms with fever severe headache and nausea  all joints were painful and muscle weakness very tired Large hard painful red spot about 2 inches down the arm from injection site all of these symptoms lasted about 48 hours
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Muscular weakness, Nausea, Pain, Pyrexia
Clinical narrative: Flu like symptoms with fever severe headache and nausea  all joints were painful and muscle weakness very tired Large hard painful red spot about 2 inches down the arm from injection site all of these symptoms lasted about 48 hours
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Skin discolouration
Clinical narrative: Patient experienced "excruciating" paint radiating from inside muscle all the way to tips of fingers. Patient stated fingers turned "colors" as well. This occurred approx. 3 hours after the shot and last over night. The pain lessened  over the next several days. By the time she reported the incident to the pharmacy on 12/24/2019 the pain had subsided all together and there was no physical abnormality. She had no reaction to the first shot.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation
Clinical narrative: Patient reports problems with her right eye 7 to 10 days after vaccination. She tried lubricating drops for her burning eye (right). Went to an eye specialist who believes it is related to her shingles vaccination.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chiropractic, Gait disturbance, Mobility decreased, Pain
Clinical narrative: Lower back pain first appeared on bending over, in the morning, 40 hours after vaccination. No other apparent cause.  Condition worsened throughout the day. Could remain sitting and standing without discomfort, but difficulty getting up, sitting down, walking and negotiating steps. Sitting on rolling chair at a short distance from desk and grasping edge of desk, could not pull myself back to the desk. By end of work day, could not walk without support. Next day, had chiropractic treatment and began a 30-day course of daily meloxicam 7.5 mg. Condition resolved fully within a week.