chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 24 months old girl was given a expired 0.5 ml dose of Daptacel/No AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 24 months old female patient who was given an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C52818A (exp date: 05 Oct 2019) via intramuscular route in the right vastus lateralis on 09-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) via intramuscular route in the right vastus lateralis.  It was an actual medication error due to expired vaccine used.  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.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: light blue ring at the injection site; she removed the bandage over the injection site the area was puffy like a pillow, hard knot size of nickel and now there is a red spot in the middle, quarter size; she removed the bandage over the injection site the area was puffy like a pillow, hard knot size of nickel; she removed the bandage over the injection site there was a red spot in the middle area; area is about the size of a nickle, it is a hard knot and puffy; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 65 years old female who experienced light blue ring at the injection site (vaccination site discoloration) and she removed the bandage over the injection site the area was puffy like a pillow, hard knot size of nickel and now there is a red spot in the middle, quarter size (vaccination site inflammation) (vaccination site swelling) (vaccination site erythema), area is about the size of a nickle, it is a hard knot and puffy (vaccination site induration) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left deltoid.  On an unknown date, the patient experienced a non-serious light blue ring at the injection site (vaccination site discoloration) and she removed the bandage over the injection site the area was puffy like a pillow, hard knot size of nickel and now there is a red spot in the middle, quarter size (vaccination site inflammation) (vaccination site swelling) (vaccination site erythema) and area is about the size of a nickle, it is a hard knot and puffy (vaccination site induration)(Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was light blue ring at the injection site and she removed the bandage over the injection site the area was puffy like a pillow, hard knot size of nickel and now there is a red spot in the middle, quarter size.   It was not reported if the patient received a corrective treatment.  The patient outcome was not recovered from the area was puffy like a pillow, hard knot size of nickel.  The patient outcome was not reported for other events.  Information on the batch number was requested.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 77 years old female patient received a dose of Adacel vaccine/No AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA284008 (same reporter).  This case involves a 77 years old female patient who received a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6202BA via intramuscular route in the left deltoid on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD).  It was an 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 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: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a nine year old patient received a dose of Flublok vaccine/No AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a nine years old patient (gender unknown) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  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 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 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.  Information on the batch number was requested.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: a four years old female patient was given Flublok quadrivalent influenza vaccine/No AE; 4 year old patient received vaccine in thigh; Initial information received on 10-Oct-2019 and additional information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/ non health care professional (office staff).  This case is linked to case 2019SA284719 (same reporter).  This case involves a four years old female patient who was inadvertently given a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1929, expiry date: 30-Jun-2020 via intramuscular route in the right thigh on 08-Oct-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 inappropriate age at vaccine administration and Vaccine administered at inappropriate site .  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: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 5 years old patient was given a dose of Flublok quadrivalent influenza vaccine/No AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to case 2019SA284455 (same reporter).  This case involves a five years old female patient who was given a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1929, expiry date: 30-Jun-2020 via intramuscular route in the right thigh on 08-Oct-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 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 holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 12 year old female received Flublok Quadrivalent, NO AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA285086 same reporter.  This case involves a 12 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1917, expiry date-30-06-2020 via intramuscular route in the left deltoid on 09-Oct-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 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: 68.0
Sex: U
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a patient received a 0.5 ml dose of Fluarix Quadrivalent in error instead of Fluzone High Dose/No AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68 years old patient (gender unknown) who a 0.5 ml dose of INFLUENZA VACCINE INACT SPLIT VIRION 4V [FLUARIX QUADRIVALENT] not produced by Sanofi Pasteur lot E5C24 via intramuscular route in the left deltoid on 10-Oct-2019 in error instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  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 wrong vaccine administered.  At the time of report no adverse event was reported.  Treatment: received guidance from their corporate and reached out to the consumer.   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: FLU3
Symptoms: Expired product administered, No adverse event, Product packaging issue
Clinical narrative: a patient received a dose of Fluzone High Dose which had expired on 11May2018/No AE; on 07Oct2019, opened new box of 10 prefilled syringes and two syringes were missing and on 11Oct2019, they opened another box which had three syringes missing/ no AE; Initial and additional information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of an unknown demographics who received an expired dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI871AN/UI871AB, expiry date: 11-May-2018) via unknown route in unknown administration site on an unknown date.  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 expired vaccine used.  It was also a case of Product packaging quantity issue  At the time of report, no adverse event was reported.  It was reported that when last flu season ended, the reporter shipped all remaining vaccine out of the facility. They purchased a new refrigerator this year specifically for the new flu vaccine. There was no way anything was left behind. She maintains that the expired vaccine was part of a new shipment. She does not know in which box of other prefilled syringes that the expired prefilled syringe was located. She has alerted everyone to be diligent and check all the expiration dates. She believes the expired vaccine was given on a weekend and she does not work weekends.  Last week on 07Oct2019, the medical assistant informed the caller they opened new box of 10 prefilled syringes and two syringes were missing. The lot was UJ284AB expiry 25May2020. Then today, 11Oct2019, they opened another box which had three syringes missing. The lot is UJ252AA expiry 01May2020. Both boxes with missing syringes were sealed upon receipt. No other information is available, as the call disconnected when the caller was looking for more information and the consultant was holding.  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.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event, Underdose
Clinical narrative: a 87-year-old male received a dose of Fluzone High-Dose and some of the medication leaked from the site/No AE; while removing the needle from arm, some of the medication ran down his arm/No AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 87 years old male patient who received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ251AD, expiry date: 01-May-2020) via intramuscular route in the left arm on 11-Oct-2019, some of the medication leaked from the site and ran down his arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of vaccine underdose and exposure via skin contact.  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.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 80 year old patient was administer an expired 0.5 ml dose of Fluzone Highdose on 02Oct2019/No AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 80 years old male patient who was administer an expired 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UI985AC, expiry date: 22-Mar-2019 via unknown route in unknown administration site on 02-Oct-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 expired vaccine used.  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: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 9 year old male  received Flublok Quadrivalent/no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA284749 same reporter.  This case involves a 10 years old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1917, expiry date-30-06-2020 via intramuscular route in the left deltoid on 09-Oct-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 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.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublok was given to a 14 year old/no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 years old patient who was given vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route.  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 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  Information on the batch number was requested  List of documents held by sender: none
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was administered to a 17 years old- outside age indication/No AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 17 years old patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in unknown administration site on an unknown date.  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 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.  Information on the batch number was requested.
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: whole body hives; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves male patient of an unknown age who experienced whole body hives (urticaria), while he received vaccine INFLUENZA VACCINE.  The patient's 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 whole body hives (urticaria) (Unknown latency) following the administration of INFLUENZA VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was whole body hives.  It was not reported if the patient received a corrective treatment.  The outcome of the event was Unknown for whole body hives.  Information on the batch number was requested
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Physician mixed ActHIB with a sterile diluent instead of the one that comes with ActHIB, no AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old patient who received 0.5 ml first dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date not reported) which was mixed with a sterile diluent instead of the one that comes with ACT-HIB, via intramuscular route in right thigh on 10-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of reporting, 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.  Information on the batch number was requested.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal pain, Neck pain, Pruritus, Rash pruritic
Clinical narrative: Reported developing ache in shoulder, base of neck and across upper back that persisted over 3 days.  States has happened with 3 or 4 previous flu vaccines in recent years past.  This time also developed an itchy bumpy rash early the next morning across her abdomen and lower  back which faded the next day and then reappeared the following day on her abdomen, R arm, back and also then stated  that her head was itchy.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Erythema, Throat tightness, Urticaria
Clinical narrative: Employee within 15 minutes of receiving vaccine experienced redness in arm with hives over entire body, then throat and chest tightening
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Migraine
Clinical narrative: Have had migraines for over 1 month now since getting the flu vaccine.  Have had over 15 migraines since the vaccine (37 days ago).  Although I have experienced cluster migraines in the past (typically 3 or 4 times a year), I have never had this many migraines in a cluster.  It has averaged about 1 every two days since the vaccine.  I have not experience this level of migraines before.  Since the migraines started the day of the vaccine, I am attributing the number and duration of continuing migraines to the vaccine.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect- Expired diluent was administered with viable vaccine
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Urticaria
Clinical narrative: CHILLS, HEADACHE ON DAY OF ADMINISTRATION, HIVES DEVELOPED ON BELLY, NECK AND ARMS 2 DAYS LATER AND CONTINUE STILL
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Irritability, Papule, Pyrexia, Varicella virus test
Clinical narrative: Red papules on back and one on face in clusters. May be fluid filled. Fevers x 48 hours, very irritable. Rash not itching.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Chills, Feeling cold, Myalgia, Pain
Clinical narrative: On the evening of Oct. 12th, very cold with chills. Throughout the night did not ache but had severe hurt/pain in bones and muscles all over.  Every time I moved it was very painful.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Nausea, Pyrexia
Clinical narrative: After having received my second shingles shot on Wednesday I woke up the next morning with a headache, a fever, and a queasy stomach.   I slept about 24 hours straight and was back to normal this morning.  I guess I'm one of the "one in six" who experience such symptoms.   (a number I learned just now from the CDC website).   Only had a sore arm on the first shingles shot.    No need to contact my doctor or the pharmacy on this - just wanted to report my experience.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: ARM IS RED AND SWOLLEN AFTER 1 WEEK
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Localized hives at the site of the vaccine administrations.  Denies hives anywhere else or any other symptoms including respiratory distress.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Allergic reaction, hives over abdomen, bilateral axilla area , back. Extreme itching
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain, Pyrexia
Clinical narrative: FEVER HIGHEST AT 99.8 VIA EXERGEN, ACHE ALL OVER BODY,  IN BED FOR 11 STRAIGHT HOURS,  SEVERE SHOULDER PAIN
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: First day post vaccine tenderness at site, second day warmth and redness developed in right upper arm around and below injection site.  Not painful but tends to be mildly itchy .  Redness darker in AM .   Have not contacted primary yet unless condition worsens.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Mouth and throat swelling treated with prednisone started 10/2/19 - gradual improvement Fatigue., Headache, lightheadedness -- resolving with time redness and swelling at injection site -- resolving with time
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Mouth swelling, Pharyngeal swelling
Clinical narrative: Mouth and throat swelling treated with prednisone started 10/2/19 - gradual improvement Fatigue., Headache, lightheadedness -- resolving with time redness and swelling at injection site -- resolving with time
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: RASH (3 INCH IN DIAMETER) AROUND INJECTION SIGHT
Age: 70.0
Sex: F
Vaccine: FLUR4
Symptoms: Cough, Influenza like illness, Insomnia, Vomiting
Clinical narrative: Terrible flu like symptoms,throwing up cough, sleeplessness.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Decreased appetite, Discomfort, Headache, Myalgia
Clinical narrative: Per Client feedback.  Reports At 1bout 1:30am the following day she woke up with intense muscle/upper arm pain, pain extended up next into jaws/bilaterally, (states jaw pain may have been from clenching her teeth), chills/shakes, fever of 100 and severe headache.  The next day Headache and arm pain persisted and was "down" all day, no appetite, would not have been able to go so work if she had been scheduled.  Client self medicated with Ibuprofen, cold packs on arm etc.  States today (Oct 19/noon) she is feeling better, has mild headache and arm pain. Discomfort is dissipating.   Client denies any redness or swelling at the site.  Client denies any history of headaches. Client had PPV13 last year with no side effects.   Patient had influenza vaccination last year with not side effects or complaints of.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Pain in jaw, Pyrexia, Tremor
Clinical narrative: Per Client feedback.  Reports At 1bout 1:30am the following day she woke up with intense muscle/upper arm pain, pain extended up next into jaws/bilaterally, (states jaw pain may have been from clenching her teeth), chills/shakes, fever of 100 and severe headache.  The next day Headache and arm pain persisted and was "down" all day, no appetite, would not have been able to go so work if she had been scheduled.  Client self medicated with Ibuprofen, cold packs on arm etc.  States today (Oct 19/noon) she is feeling better, has mild headache and arm pain. Discomfort is dissipating.   Client denies any redness or swelling at the site.  Client denies any history of headaches. Client had PPV13 last year with no side effects.   Patient had influenza vaccination last year with not side effects or complaints of.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: MEMBER WAS FEELING NAUSEATED, DIZZY, AND LIGHTHEADED. EMT'S WERE CALLED AND PATIENT WAS TRANSPORTED TO THE HOSPITAL.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Redness x 2 days (resolving), itching x 2 days (has not resolved)
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Bilateral hives on hands, arm, and back.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticaria for one day, with first wheal over injection site
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Severe shoulder/arm pain since injection.  Cannot move arm without pain.  Pain is constant.  Most severe pain is in shoulder.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Patient presented to the office 2 days after injection with arm pain, headache, fatigue, fever/chills, and upset stomach. She was also lightheaded and found to be hypotensive with BP 93/50. She received 1 liter NS in the office and BP increased to 108/62 and asymptomatic.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Pain in extremity, Pyrexia
Clinical narrative: Patient presented to the office 2 days after injection with arm pain, headache, fatigue, fever/chills, and upset stomach. She was also lightheaded and found to be hypotensive with BP 93/50. She received 1 liter NS in the office and BP increased to 108/62 and asymptomatic.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt returned to the Clinic on 10/18/2019 @ 1345 complaining of injection site reaction. On her right arm just above the Elbow there is a red swollen area that is warm to the touch and very tender.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Expired product administered
Clinical narrative: Expired diluent was administered with active MMRV
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Chills, low grade fever 99.8, mild nausea, moderate to severe headache, body aches, very tired, sore arm ( I wondered at first if I was getting influenza though I had had the immunization a few weeks earlier). It lasted from about 7:15 am on Wednesday and symptoms were completely gone by Friday morning at 7:00 am. On Wednesday I was at  work when I started feeling poorly. I had to stay at work so took ibuprofen until I could get home and go to bed. I stayed in bed and slept until Friday morning (getting up only to use the bathroom.)
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills, low grade fever 99.8, mild nausea, moderate to severe headache, body aches, very tired, sore arm ( I wondered at first if I was getting influenza though I had had the immunization a few weeks earlier). It lasted from about 7:15 am on Wednesday and symptoms were completely gone by Friday morning at 7:00 am. On Wednesday I was at  work when I started feeling poorly. I had to stay at work so took ibuprofen until I could get home and go to bed. I stayed in bed and slept until Friday morning (getting up only to use the bathroom.)
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash near injection site is red, swollen and warm.Rash is not well demarcated. Visible bump where injection was given.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Angina bullosa haemorrhagica, Arthralgia, Blood blister, Chills
Clinical narrative: Pain in stomach, & hip area on the day of injection accompanied by chills & fever, nausea, vomiting & diarrhea.  the following day had blood blisters in her mouth and face and had scattered petechiae.  Saw her allergist on 10/17/19.  Blood work done.  Was called on 10/18/19 to go to the ED due to dangerously low platelets.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Nausea, Petechiae, Platelet count decreased, Pyrexia
Clinical narrative: Pain in stomach, & hip area on the day of injection accompanied by chills & fever, nausea, vomiting & diarrhea.  the following day had blood blisters in her mouth and face and had scattered petechiae.  Saw her allergist on 10/17/19.  Blood work done.  Was called on 10/18/19 to go to the ED due to dangerously low platelets.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Pain in stomach, & hip area on the day of injection accompanied by chills & fever, nausea, vomiting & diarrhea.  the following day had blood blisters in her mouth and face and had scattered petechiae.  Saw her allergist on 10/17/19.  Blood work done.  Was called on 10/18/19 to go to the ED due to dangerously low platelets.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient received the vaccine 10/16/19. She woke up on the 17th with redness and swelling to her left arm. She has placed ice packs and taken Benadryl. Today 10/18/2019- the redness and swelling, and heat have increased. Continuing ice packs/medication
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Injection site erythema, Injection site rash, Injection site urticaria, Malaise
Clinical narrative: Pt described feeling sick and "flu like symptoms" for 48 hours after receiving both the prevnar and flu shots. She also presented with a large rash/red/welted area extending the entire of the right shoulder.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Skin warm
Clinical narrative: Rash x1 day, warm to touch, nontender, no itching - monitor
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Expired diluent was administered with active MMRV
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: swollen and red to elbow.  Hot to touch
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC13
Symptoms: Expired product administered
Clinical narrative: Expired diluent was administered with active MMRV
Age: 31.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Discomfort, Erythema, Eye pain, Feeling abnormal, Head discomfort
Clinical narrative: Concern for vaccine reaction - 10/15/19 received both PPSV23 (PMHx asthma) in L deltoid, Tdap given in R deltoid. Later that day at pharmacy was given flu shot in L arm. - Started feeling bad the next day at work, woke up that morning with bad headache, sweaty. Made it through work day, had to leave a little early. That early oral temp, as high as 101, then down to 98 and would feel OK, then back up. Body sweats, needed to change clothes. Headaches that can't go away - History of migraines: on propranolol 20 TWICE DAILY, Mobic 15mg daily. Is on PRN rizatriptan which she uses after aura of smell, sensation in eyes. Has not been taking rizatriptan over the past 2d because this is a different headache than her migraines. Next appt is 11/18 with neuro Dr. - Taking ibuprofen 400mg q4hrs regularly for headache  - Headache in the back of L eye, pounds, pressure feels like head is going to burst. Different than migraines which usually start with smell, visual tunneling, trouble forming sentences - headache wraps around then starts vomiting. - Arm looks red, hot swollen. Feels like someone punched her a lot in the arm. Has not been sick before this in a long time. - Last took ibuprofen around 9am.    Assessment/plan:  Vaccine reaction: 2 days following PPSV23 and flu shot in left deltoid, Tdap and right deltoid, has been experiencing symptoms consistent with vaccine reaction left arm along with systemic manifestations confirmed on physical exam.  Patient's information will be submitted to VAERS system with patient's consent.  Will treat the acute phase of vaccine reaction with Benadryl 50 mg every 8 hours, Tylenol 1000 mg 3 times daily as needed for fever and discomfort.  Advised to stop Mobic while taking ibuprofen, continue ibuprofen as she has been taking.  No signs or symptoms of anaphylaxis, airway clear, counseled on indications to seek emergent management  Headache: Pain around left eye, relieved with massage to left periorbital musculature, similar massage to temporalis and masseter on the left side.  Possible muscular strain related to eyeglasses prescription?patient was advised to return to optometrist whom she saw a few months ago to ensure that prescription does not need to be adjusted.  Otherwise continue with ibuprofen and Tylenol as above.  Seasonal allergies: Boggy nasal mucosa, likely contributing to discomfort.  Reportedly with history of seasonal allergies, less likely in the context of URI?we will trial Flonase for continued symptom medic improvement  Return in about 3 days (around 10/21/2019), or if symptoms worsen or fail to improve.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Headache, Hyperhidrosis, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Concern for vaccine reaction - 10/15/19 received both PPSV23 (PMHx asthma) in L deltoid, Tdap given in R deltoid. Later that day at pharmacy was given flu shot in L arm. - Started feeling bad the next day at work, woke up that morning with bad headache, sweaty. Made it through work day, had to leave a little early. That early oral temp, as high as 101, then down to 98 and would feel OK, then back up. Body sweats, needed to change clothes. Headaches that can't go away - History of migraines: on propranolol 20 TWICE DAILY, Mobic 15mg daily. Is on PRN rizatriptan which she uses after aura of smell, sensation in eyes. Has not been taking rizatriptan over the past 2d because this is a different headache than her migraines. Next appt is 11/18 with neuro Dr. - Taking ibuprofen 400mg q4hrs regularly for headache  - Headache in the back of L eye, pounds, pressure feels like head is going to burst. Different than migraines which usually start with smell, visual tunneling, trouble forming sentences - headache wraps around then starts vomiting. - Arm looks red, hot swollen. Feels like someone punched her a lot in the arm. Has not been sick before this in a long time. - Last took ibuprofen around 9am.    Assessment/plan:  Vaccine reaction: 2 days following PPSV23 and flu shot in left deltoid, Tdap and right deltoid, has been experiencing symptoms consistent with vaccine reaction left arm along with systemic manifestations confirmed on physical exam.  Patient's information will be submitted to VAERS system with patient's consent.  Will treat the acute phase of vaccine reaction with Benadryl 50 mg every 8 hours, Tylenol 1000 mg 3 times daily as needed for fever and discomfort.  Advised to stop Mobic while taking ibuprofen, continue ibuprofen as she has been taking.  No signs or symptoms of anaphylaxis, airway clear, counseled on indications to seek emergent management  Headache: Pain around left eye, relieved with massage to left periorbital musculature, similar massage to temporalis and masseter on the left side.  Possible muscular strain related to eyeglasses prescription?patient was advised to return to optometrist whom she saw a few months ago to ensure that prescription does not need to be adjusted.  Otherwise continue with ibuprofen and Tylenol as above.  Seasonal allergies: Boggy nasal mucosa, likely contributing to discomfort.  Reportedly with history of seasonal allergies, less likely in the context of URI?we will trial Flonase for continued symptom medic improvement  Return in about 3 days (around 10/21/2019), or if symptoms worsen or fail to improve.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Skin warm, Vomiting
Clinical narrative: Concern for vaccine reaction - 10/15/19 received both PPSV23 (PMHx asthma) in L deltoid, Tdap given in R deltoid. Later that day at pharmacy was given flu shot in L arm. - Started feeling bad the next day at work, woke up that morning with bad headache, sweaty. Made it through work day, had to leave a little early. That early oral temp, as high as 101, then down to 98 and would feel OK, then back up. Body sweats, needed to change clothes. Headaches that can't go away - History of migraines: on propranolol 20 TWICE DAILY, Mobic 15mg daily. Is on PRN rizatriptan which she uses after aura of smell, sensation in eyes. Has not been taking rizatriptan over the past 2d because this is a different headache than her migraines. Next appt is 11/18 with neuro Dr. - Taking ibuprofen 400mg q4hrs regularly for headache  - Headache in the back of L eye, pounds, pressure feels like head is going to burst. Different than migraines which usually start with smell, visual tunneling, trouble forming sentences - headache wraps around then starts vomiting. - Arm looks red, hot swollen. Feels like someone punched her a lot in the arm. Has not been sick before this in a long time. - Last took ibuprofen around 9am.    Assessment/plan:  Vaccine reaction: 2 days following PPSV23 and flu shot in left deltoid, Tdap and right deltoid, has been experiencing symptoms consistent with vaccine reaction left arm along with systemic manifestations confirmed on physical exam.  Patient's information will be submitted to VAERS system with patient's consent.  Will treat the acute phase of vaccine reaction with Benadryl 50 mg every 8 hours, Tylenol 1000 mg 3 times daily as needed for fever and discomfort.  Advised to stop Mobic while taking ibuprofen, continue ibuprofen as she has been taking.  No signs or symptoms of anaphylaxis, airway clear, counseled on indications to seek emergent management  Headache: Pain around left eye, relieved with massage to left periorbital musculature, similar massage to temporalis and masseter on the left side.  Possible muscular strain related to eyeglasses prescription?patient was advised to return to optometrist whom she saw a few months ago to ensure that prescription does not need to be adjusted.  Otherwise continue with ibuprofen and Tylenol as above.  Seasonal allergies: Boggy nasal mucosa, likely contributing to discomfort.  Reportedly with history of seasonal allergies, less likely in the context of URI?we will trial Flonase for continued symptom medic improvement  Return in about 3 days (around 10/21/2019), or if symptoms worsen or fail to improve.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Skin warm
Clinical narrative: rash; Warm to touch; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2019, the patient received Shingrix. On 5th October 2019, 1 days after receiving Shingrix, the patient experienced injection site rash and skin warm. On an unknown date, the outcome of the injection site rash and skin warm were unknown.   It was unknown if the reporter considered the injection site rash and skin warm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy intern. The age at vaccination was not reported. Right after receiving the Shingrix, the patient experienced rash on the vaccinated arm. Warm to touch appeared quickly a day after vaccination. The rash was worst on the first day, and had gotten smaller by the time the patient went to the pharmacy on the 2nd or 3rd day. The reporter was unable to provide full details. The reporter did not consent to follow up. Time to onset had been considered precisely in this case instead of immediately as it seems a general statement and there was a discrepancy in 2 source documents. This case is for 1 of the 3 patients, reported by the same reporter.