chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Herpes zoster, Rash, Skin fissures
Clinical narrative: Shingles; Rash; Cracking skin; Dry Skin; This case was reported by a physician via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. In May 2019, less than a month after receiving Shingrix, the patient experienced chapped skin and dry skin. On 21st May 2019, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles, rash, chapped skin and dry skin were unknown.   It was unknown if the reporter considered the shingles, rash, chapped skin and dry skin to be related to Shingrix.  Additional details were provided as follows: The patient developed a rash and was diagnosed with Shingles on 23rd May 2019 by one of the other physician in the office.  The physician reported that the patient called on 30th May 2019 and stated she was still having cracking and drying of the skin.  The patient was going to see physician on the day of reporting. No further details were provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Herpes zoster, Hypersensitivity, Pain, Rash
Clinical narrative: outbreaks of Shingles on her right arm/Shingles; sensitivity from breastbone through spine; weird shooting pain; 3 spots of rash on arm; pain in right armpit; This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2019, the patient received the 1st dose of Shingrix. On 2nd February 2019, 3 days after receiving Shingrix, the patient experienced axillary pain. On 3rd April 2019, the patient experienced shooting pain and rash. On 8th April 2019, the patient experienced shingles and hypersensitivity. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the axillary pain, shooting pain, rash and shingles were unknown and the outcome of the hypersensitivity was not recovered/not resolved.   It was unknown if the reporter considered the axillary pain, shooting pain, rash, shingles and hypersensitivity to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. The patient received Shingrix shot, soon after that she had pain in her right armpit. 3 months later, the patient experienced weird shooting pains, she saw her doctor who identified 3 different outbreaks of Shingles on her right arm. The patient then developed a full blown case of Shingles. The patient experienced sensitivity from breastbone through back to her spine. She was in constant pain. The patient completed a course of valacyclovir. The patient did not have her second dose of Shingrix. The reporter gave consent to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: itchy rash; welt like rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   Concomitant products included benadryl (nos) (Benadryl).   On 11th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, 5 days after receiving Shingrix, the patient experienced itchy rash and rash urticaria-like. On an unknown date, the outcome of the itchy rash and rash urticaria-like were recovered/resolved.   It was unknown if the reporter considered the itchy rash and rash urticaria-like to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had an itchy, welt-like rash formed on his arms down to his forearm bilaterally and back.  It occurred 5 days after the injection and had persisted for approximately 4 weeks.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: tiredness; redness at injection site; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix 50 µg. On 3rd June 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 4th June 2019, the patient experienced tiredness. On an unknown date, the outcome of the injection site erythema, injection site pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the wife of the patient. The patient received Shingrix and later that evening experienced redness and pain at the injection site. The reporter noted the area was 2 inches in diameter. The patient also experienced tiredness after about 24 hours. All issues resolved by the third day. The healthcare professional was not made aware of events per reporter.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix and has since contracted shingles.  The patient was inquiring on how to proceed with the 2nd dose.
Age: 0.5
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Feeling abnormal, Injection site swelling, Injection site warmth
Clinical narrative: Mom reported that Patient began to cry and was inconsolable for at least 30 continuous minutes and was "whining and miserable". She said his leg was warm, with " half-dollar " sized swelling at injection site on left thigh. it began about an hour after receiving vaccine. Dr.advised her to give Patient 1/2 tsp. Benadryl .
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Anaphylactic reaction, Dyspnoea, Eye swelling, Lip swelling, Rash
Clinical narrative: Anaphylaxis presenting with eye swelling, lip swelling, rash, and shortness of breath
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: PATIENT COMPLAINED OF FLU-LIKE SYMPTOMS (BODY ACHES, FEVER, CHILLS,  AND FATIGUE) THAT STARTED THE EVENING HE RECEIVED THE VACCINE AND LASTED FOR 3 DAYS. HE TOOK SOME IBUPROFEN AND IT HELPED THE PAIN A LITTLE.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: She had a palpable nodule at the site of injection of 2cm over the injection site with mild ecchymosis over the area.  She has erythema surrounding the left upper extremity near the injection site measuring about 5 cm in diameter.
Age: 10.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Migraine, Photophobia
Clinical narrative: Swelling, pain  and redness of left thigh starting Tuesday and lasting two days. Treated with ice and Ibuprofen.  Migrane headache with photophobia (never had one before) Thursday late afternoon. Treated with Ibuprofen, darkness and sleep.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: PATIENT STARTED HAVING FLU LIKE SYMPTOMS (BODY ACHES, FEVER, CHILLS, FATIGUE) THE EVENING HE RECEIVED THE FIRST AND SECOND DOSES OF THE SHINGRIX VACCINE. HE ALERTED THE PHARMACY OF THE INITIAL REACTION THE DAY HE RECEIVED THE SECOND DOSE. HE SAID THAT HE TOOK SOME IBUPROFEN AND IT HELPED WITH THE PAIN.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Dizziness postural, Feeling hot, Nausea
Clinical narrative: Felt wEak Faint After Standing up FElt NausEa After 10 miN. BP + PulsE StablE Lying down gave water FElt  bEttER After 20 min
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fall, Nausea, Syncope
Clinical narrative: The 2nd shot, 2 months after the first, had many more severe reactions. Accompanying the extremely severe nausea was shivering that went on for hours along with fever within 4 hours of the 2nd injection. I also experienced fainting about 15 hours later which caused falling twice.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Red area around injection site approximately 4 inches in diameter, 10 ml of diphenhydramine  given in office @ 1145, asked  mom to call in the morning if not looking better
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Human chorionic gonadotropin positive, Maternal exposure before pregnancy
Clinical narrative: Patient had a negative serum HCG immediately before (same day) receiving immunizations.  Patient found out 7 days later she was pregnant (serum HCG on 18 Jun 2019).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased
Clinical narrative: Patient describes rapid heartbeat and severe exhaustion starting a few hours after receiving the vaccine.  Symptoms lasted until Sunday evening, gradually dissipating over the course of the couple of days.  Patient had an appointment with MD on the following Monday and mentioned it to her but symptoms had resolved by then and she states that md wasn't overly concerned
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: swelling in the left arm; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 14 years old male patient who experienced swelling in the left arm, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications not reported.   On 14-Jun-2016, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation: unknown, lot U5259AA and Exp. Date 13-May-2017) via intramuscular route in the left deltoid.  On an unknown date, the patient developed swelling in the left arm (vaccination site swelling) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Details of lab data not reported.  Final diagnosis was swelling in the left arm.   It was not reported if the patient received any corrective treatment.  The event outcome was not reported.  List of documents held by sender- none.
Sex: U
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: arm swelling; Initial information received on 14-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.via other company (Pfizer) (Manufacturer Report Number: 2019257707).  This case involves an unknown age patient who experienced arm swelling, while he/she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's had no past medical history.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation.  On 14-Jun-2016, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5259AA via unknown route.  On an unknown date, The patient developed a non-serious arm swelling (peripheral swelling) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No lab test was performed.  Final diagnosis was arm swelling.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for arm swelling.
Sex: M
Vaccine: RAB
Symptoms: Hypersensitivity, Rash
Clinical narrative: rash; hypersensitivity; Initial information received on 14-Jun-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a male patient of unknown age who experienced rash and hypersensitivity, while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past vaccination(s) included 5 doses of Imovax Rabies for post exposure immunization also received immunosuppressant. The patient's past medical history, medical treatment(s) and family history were not provided.   On unknown dates two years ago, the patient received a sixth and seventh doses of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site.  On unknown dates, the patient developed rash and hypersensitivity following the administration of RABIES (HDC) VACCINE. details of lab data not reported.  Final diagnosis was hypersensitivity and rash.   It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: staff person given only the DTAP, without HIB to patient; Initial and Live follow-up information received on 14-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months old male patient who received, 0.5 ml dose DTAP portion without HIB portion DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Formulation: unknown, lot: C5427BA, expiry date: 13-OCT-2019) via intramuscular route in left thigh on 11-Jun-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 reconstitution technique (staff person given only the DTAP, without HIB to patient)  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of document held by sender: none.
Sex: U
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: received Tenivac after temperature excursion / No adverse event; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA164978, 2019SA166193, 2019SA166194, 2019SA166195 and 2019SA166196.  This case involves 66 years old patient (with unknown demographic) who was vaccinated with 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] lot U6101AA (Expiry date 23-Oct-2020) via intramuscular route in the left deltoid, On 20-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage.  It was reported that had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of documents held by sender: none.
Sex: U
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month/ no adverse event; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant).  This case is linked to cases 2019SA166192, 2019SA164978, 2019SA166194, 2019SA166195 and 2019SA166196, same reporter.  This case involves a 28 years old patient (gender unknown) who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given.   On 07-Jun-2019, the patient received once a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6101AA, expiry date 23-Oct-2020 via intramuscular route in the left thigh.  It was an actual medication error due to incorrect product storage.  It was reported that had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month, vaccine was administered/ no adverse event; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant).  This case is linked to cases 2019SA166192, 2019SA166193, 2019SA164978, 2019SA166195 and 2019SA166196, same reporter.  This case involves a 31 years old patient (gender unknown) who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given.   On 22-May-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6141AB, expiry date 15-Dec-2020 via intramuscular route in the left deltoid.  It was an actual medication error due to incorrect product storage.  It was reported that had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant).  This case is linked to cases 2019SA166192, 2019SA166193, 2019SA166194, 2019SA164978 and 2019SA166196, same reporter.  This case involves a 48 years old patient (gender unknown) who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given.   On 04-Jun-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6141AB, expiry date 15-Dec-2020 via intramuscular route in the left deltoid.  It was an actual medication error due to incorrect product storage.  It was reported that had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month/ no adverse event; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant).  This case is linked to cases 2019SA166192, 2019SA166193, 2019SA166194, 2019SA166195 and 2019SA164978, same reporter.  This case involves a 48 years old patient (gender unknown) who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given.   On 05-Jun-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6141AB, expiry date 15-Dec-2020 via intramuscular route in the left deltoid.  It was an actual medication error due to incorrect product storage.  It was reported that had a refrigerator on which outside thermometer continued to read 5C even though there were multiple excursions, up to 23C for anywhere between 4 days and 1 month.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: administered just the liquid portion of the Pentacel vaccine/no AE; Initial information received on 14-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that administered just the liquid portion of the Pentacel vaccine/ no AE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6327AA and expiry date: 19-Sep-2020 via intramuscular route in the right thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Herpes simplex, Prenatal screening test, Toxoplasmosis
Clinical narrative: Toxoplasmosis; Herpes simplex 1; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 11-Jun-2019, concerning a 33-year-old, adult female pregnant subject of body weight: 151.5 lbs, height: 68.8 inches and body mass index (BMI): 22.5, enrolled in a prospective observational study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine during pregnancy.   The subject did not have any previous pregnancy. On an unknown date, the subject's family history of major congenital malformation was collected, and the subject had no maternal or paternal history with major congenital malformations. The subject's current condition included fibroadenomas of breast. The subject's concomitant medications included vitamin B6, Prenatal Plus (minerals NOS, vitamins NOS), calcium and vitamin D3; all as a supplement.  The subject's last menstrual period (LMP) date was 26-Dec-2018. The type of pregnancy was singleton. The subject did not consume alcohol, tobacco and illicit-drugs during pregnancy.   On 18-Feb-2019, approximately at gestational age of 7 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL (influenza Vaccine, batch number: YF41608, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On the same day, after vaccination, the subject noticed to have herpes simplex 1 and toxoplasmosis. On the same day of vaccination, the subject underwent ultrasound scan and no major congenital malformations were noted.   On 07-Mar-2019, the subject underwent ultrasound scan, non-invasive prenatal testing and no major congenital malformations were noted. On 22-Apr-2019, the subject underwent (maternal serum alpha-fetoprotein screening) MSAFP/serum marker test and no major congenital malformation were noted.   The outcome of all the events was not recovered.  The subject's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were reported as 02-Oct-2019.; Reporter's Comments: A 33-year-old pregnant female patient had diagnosis of toxoplasmosis and herpes simplex type 1 on the same day after vaccination with Flu Vaccine Egg Split QIV CSL. Considering the infectious aetiologies of the events and inactivated nature of the vaccine, the causality assessed as not related to suspect vaccine. The event vaccine exposure during pregnancy was assessed as not related to suspect vaccine due to intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Toxoplasmosis; Herpes simplex 1; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 11-Jun-2019, concerning a 33-year-old, adult female pregnant subject of body weight: 151.5 lbs, height: 68.8 inches and body mass index (BMI): 22.5, enrolled in a prospective observational study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine during pregnancy.   The subject did not have any previous pregnancy. On an unknown date, the subject's family history of major congenital malformation was collected, and the subject had no maternal or paternal history with major congenital malformations. The subject's current condition included fibroadenomas of breast. The subject's concomitant medications included vitamin B6, Prenatal Plus (minerals NOS, vitamins NOS), calcium and vitamin D3; all as a supplement.  The subject's last menstrual period (LMP) date was 26-Dec-2018. The type of pregnancy was singleton. The subject did not consume alcohol, tobacco and illicit-drugs during pregnancy.   On 18-Feb-2019, approximately at gestational age of 7 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL (influenza Vaccine, batch number: YF41608, dose, route of administration, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On the same day, after vaccination, the subject noticed to have herpes simplex 1 and toxoplasmosis. On the same day of vaccination, the subject underwent ultrasound scan and no major congenital malformations were noted.   On 07-Mar-2019, the subject underwent ultrasound scan, non-invasive prenatal testing and no major congenital malformations were noted. On 22-Apr-2019, the subject underwent (maternal serum alpha-fetoprotein screening) MSAFP/serum marker test and no major congenital malformation were noted.   The outcome of all the events was not recovered.  The subject's estimated delivery date (EDD) and corrected estimated delivery date (CEDD) were reported as 02-Oct-2019.; Reporter's Comments: A 33-year-old pregnant female patient had diagnosis of toxoplasmosis and herpes simplex type 1 on the same day after vaccination with Flu Vaccine Egg Split QIV CSL. Considering the infectious aetiologies of the events and inactivated nature of the vaccine, the causality assessed as not related to suspect vaccine. The event vaccine exposure during pregnancy was assessed as not related to suspect vaccine due to intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Flushing, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Erythematous raised rash on upper chest, upper back, arms extending from elbows up. Flushing of cheeks.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Patient reported a rash on L biceps, R elbow, L thigh 17 days after receiving smallpox vaccine.  No other systemic or local symptoms.
Age: 33.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: tightness to hands, pain to elbows and wrists - all for 30 minutes after waking up - resolves after one hour of walking around but returns every morning fatigue
Age: 67.0
Sex: M
Vaccine: YF
Symptoms: Cardiac stress test normal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Palpitations
Clinical narrative: numerous heart palpitations throughout the day that have decreased with time but still occur infrequently
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patient had red raised on deltoid
Age: 0.08
Sex: M
Vaccine: DTAPIPV, HIBV, RV1
Symptoms: Somnolence, Wrong product administered
Clinical narrative: Administration error: Given Kinrix instead of Pediarix. Patient hs been more sleepy but reactive and eating well for 2 days according to parents.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: patient received shingrix on 6/9/19. she came in on 6/19/19 and stated that the day after the vaccine she didn't feel well and she continued feeling sick until 6/17 when she felt really sick and "flu-ish". She felt better on 6/19 when she came into the store. She was not sure if these symptoms were a result of the vaccine. She did check her temperature between 6/9 and 6/17 and said it was about 99 degrees but she did not check her temperature on 6/17 when she felt the worst.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Influenza like illness, Loss of consciousness
Clinical narrative: Patient stated at 5:30 am this morning she woke feeling clammy and with flu like symptoms. Patient states when she was walking into bed room, she lost consciousness for around 1-2 minutes.  States she felt better in the day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on legs and hands still active on 6-20-19 . taking  prednisone .
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain, Injection site swelling, Malaise
Clinical narrative: On the day (6-19-2019) of the PCV13 injection, there was pain and swelling at the inject site (right upper arm) and I can't lift up the right arm.  Then at around 9 PM, very tired and felt I was running a fever.  I slept earlier than usual and still feel sick/running fever 10 am the next morning.  All these conditions/reactions remain as of the next day, 6/20/2019.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Somnolence
Clinical narrative: On the day (6-19-2019) of the PCV13 injection, there was pain and swelling at the inject site (right upper arm) and I can't lift up the right arm.  Then at around 9 PM, very tired and felt I was running a fever.  I slept earlier than usual and still feel sick/running fever 10 am the next morning.  All these conditions/reactions remain as of the next day, 6/20/2019.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Extremity contracture, Eye movement disorder, Loss of consciousness, Pallor, Tremor
Clinical narrative: She was very nervous prior to vaccine. About 30 seconds to a minute after giving vaccine patient became pale and was guided to laying down by nurse. Her eyes rolled up. Patient then had whole body shakes and her left arm bend and her left hand came up to the left side of her face. Episode lasted about 10 seconds. She then woke up and asked what was going on. She stated that she didn't recall what happened prior to arousing laying down on the exam table. She was able to tell me where she was, who she was, and who was in the room with her. She denied headache. Heart, lung, and abdominal exam normal. Tongue examined and is without bleeding or bite marks. Normal patellar reflexes. She was given a cold washcloth and a cup of water.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Medical Center was contacted by Med Center on 06/20/2019 reporting patient had presented to their facility with redness, swelling and rash to injection site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Chest pain, Dizziness, Hypertension, Monoplegia
Clinical narrative: Pt. reported upon TST reading 6/20/19, that she had a reaction to the vaccine she received on Tuesday approx. 30 minutes after receiving. Pt. describes muscles spasms, nausea, arm pain, fever to 101.5F, high blood pressure (130/70), dizziness and chest pain. Pt. did not seek out medical care Tuesday 6/18/19. When attending classes Wednesday 6/19/19, she reported to instructor that she felt ill, instructor checked her VS and then instructed her to seek out medical care. Pt. went with Mother to Clinic to access care. There, per Pt. "they said that I received the vaccine in error as the timing was wrong, which is why I was having the reaction. I was treated for my fever and observed for several hours." Pt. states that she feels fine today 6/20/19 and that clinic instructed her to get her BP taken while at Public Health for TST read. BP was normal 122/70- taken by RN. Pt. and Mother were unsure if clinic had called to report vaccine reaction to Public Health. Vaccine verified by Public Health, was given within normal time frame per guidelines/GSK insert.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Muscle spasms, Nausea, Pyrexia
Clinical narrative: Pt. reported upon TST reading 6/20/19, that she had a reaction to the vaccine she received on Tuesday approx. 30 minutes after receiving. Pt. describes muscles spasms, nausea, arm pain, fever to 101.5F, high blood pressure (130/70), dizziness and chest pain. Pt. did not seek out medical care Tuesday 6/18/19. When attending classes Wednesday 6/19/19, she reported to instructor that she felt ill, instructor checked her VS and then instructed her to seek out medical care. Pt. went with Mother to Clinic to access care. There, per Pt. "they said that I received the vaccine in error as the timing was wrong, which is why I was having the reaction. I was treated for my fever and observed for several hours." Pt. states that she feels fine today 6/20/19 and that clinic instructed her to get her BP taken while at Public Health for TST read. BP was normal 122/70- taken by RN. Pt. and Mother were unsure if clinic had called to report vaccine reaction to Public Health. Vaccine verified by Public Health, was given within normal time frame per guidelines/GSK insert.
Age: 0.33
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The wrong vaccine was given for this patient. PCV-13 was suppose to be given. PPV was given. No adverse reaction noted. Mother notified of incident.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Fatigue, Nausea, Pharyngeal swelling, Pyrexia
Clinical narrative: Extreme tiredness the day after along with fever and nausea 2-3 days after vaccine a gradual onset of swollen throat without pain. Patient reported difficulty swallowing anything not heated. Patient said throat issues still persisting but improving 2 weeks after vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: THE PATIENT STATED THAT 2 WEEKS AFTER SHE RECEIVED THE FIRST DOSE OF SHINGRIX VACCINE, SHE BROKE OUT ON SHINGLES, THE REACTION STARTED ON THE LEFT SIDE OF HER FOREHEAD AND SPREAD AROUND HER EYE, NOSE AND FACE ( ALL IN THE LEFT SIDE). SHE WENT TO THE DERMATOLOGIST  WHO PRESCRIBED HER ZOVIRAX CREAM AND ZOVIRAX TABLETS. SHE ALSO STATED SHE RECEIVED ZOSTAVAX 5 YEARS AGO BUT DIDN'T HAVE A REACTION.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema multiforme, Rash, Target skin lesion, Urticaria
Clinical narrative: Rash, probably erythema multiforme, to face, trunk, back and extremities; with generalized erythematous urticarial rash with some target lesions.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Limb discomfort, Pyrexia
Clinical narrative: patients arm very sore , and she got 99.5 F FEVER
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; Expired dose of PROQUAD; This spontaneous report was received from a medical assistant referringto a 4-year-old-child patient. Information on patient's medical history, concurrent conditions and concomitant therapies was not reported. On 18-JUN-2019 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, frequency were not reported, lot # N035172 with expiration date 09JUN-2019) via subcutaneous route for prophylaxis. On 18-JUN-2019 the patient was administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (expired product administered). No adverse effects were reported (no adverse event). There was no involvement of product quality complaint (PQC).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal disorder, Pyrexia, Rash, Rash pruritic
Clinical narrative: Headache & fever of 99-100 degrees lasting 1 week.  No redness or swelling of arm, but still have discomfort when lifting any weight with that arm.  Two days after shot, very itchy rash appeared on both shins.  By 5/28 rash & itchiness on left leg gone, but not on right leg.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth, Swelling
Clinical narrative: 2 1/2 inch red raised area warm to the touch, seen in office given 5 ml of benadryl
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Eye irritation, Eye pruritus, Eyelids pruritus, Injection site pain, Ocular hyperaemia
Clinical narrative: Boostrix - got injection on Tue afternoon.  Tues night, eyes started to feel itchy. Tried moisturizing eye drops w/out relief.  Eyes and lids started turning red, itchy, and burning. Next am, red hot itchy rash on appeared on area under eyes and on lids, right cheek and temple, forehead and along hair line, with a few spots down neck. Injection site was just a little sore as patient expected. No other symptoms manifested at all anywhere else. Symptoms today, 2 days later, are slowly resolving. Using hydrocortisone cream lightly on face, as well as moisturizing eye drops. Pt will be trying oral benadryl this evening, and will be discussing with primary care provider at next scheduled visit which is tomorrow, Fri 6/21/19.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous
Clinical narrative: Boostrix - got injection on Tue afternoon.  Tues night, eyes started to feel itchy. Tried moisturizing eye drops w/out relief.  Eyes and lids started turning red, itchy, and burning. Next am, red hot itchy rash on appeared on area under eyes and on lids, right cheek and temple, forehead and along hair line, with a few spots down neck. Injection site was just a little sore as patient expected. No other symptoms manifested at all anywhere else. Symptoms today, 2 days later, are slowly resolving. Using hydrocortisone cream lightly on face, as well as moisturizing eye drops. Pt will be trying oral benadryl this evening, and will be discussing with primary care provider at next scheduled visit which is tomorrow, Fri 6/21/19.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Injection site nodule
Clinical narrative: Patient had numbness in her hand as well as a knot at the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red area on left leg.  Per chart had MMRV on left leg. 4 cm area of redness and mild swelling on left thigh, no warmth, mild TTP.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site paraesthesia, Injection site swelling, Neurological examination normal
Clinical narrative: Patient with swelling, significant pain, and tingling after vaccination. Symptoms persistent at time of evaluation 30 hours later. Had not tried any medication to help with symptoms. No neurologic abnormalities on exam. Symptoms only at site of Bexsero (had second Menveo shot in left arm at same time).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Paraesthesia oral, Vomiting
Clinical narrative: Pt received shingles vaccine around 1530 or so. Developed tingling in  lips afterwards so was watched by pharmacy. Those sx resolved but pt then  developed headache, nausea, and felt light headed. She vomited a few times at  home. Denies lip, perioral/tongue swelling, difficulty swallowing, dyspnea,  wheezing.    sx completely resolved with symptomatic treatment below. Discussed  return precautions.   ORDERS FOR TODAY:   SODIUM CHLORIDE 0.9% INJ,SOLN  1000 ml IV BOLUS@0   DIPHENHYDRAMINE INJ,SOLN   25MG/0.5ML IVP NOW   ONDANSETRON INJ,SOLN   4MG/2ML IVP NOW for nausea and vomiting   KETOROLAC TROMETHAMINE INJ   15MG/0.5ML IV PUSH NOW
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Limb discomfort, Peripheral swelling, Vomiting
Clinical narrative: pt complained of sore, swelled arm.  she also had vomiting and diarrhea today. suggested ice pack for arm and tylenol or ibuprofen for swelling/pain, forced hydration for other symptoms.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Patient stated she was in extreme pain during the injection and after. Pain was tolerable after ice pack was given and 5-10 minutes had passed
Age: 51.0
Sex: M
Vaccine: RAB
Symptoms: Fatigue, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: severe arm pain and fatigue. possible low grade fever for 24 hours. Overall flu like symptoms that have since subsided in about 48 hours, but pt does not want to finish the series.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: Raised 7cm x 4cm welt over injection site. Localized, tender to touch.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given an adult dosage of Hepatitis A Havrix vaccine, instead of a pediatric dosage.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea (>8 watery stools per day) for 7 days No dehydration, no weight loss Treating  with probiotic and binding foods
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Anxiety, Cough, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Enlarged lymph nodes, fever, rush, cough, anxiety
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: DTAP was ordered by Dr. (Pediatrician), DTAP-IPV was administered IM to RVL site by Medical Assistant.  No adverse reaction was noted.  Dr. was notified and stated that there should not be any adverse harm to the patient.  The mother was notified of the incident.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient acquired some pain and swelling of the right arm and a patch of the arm described as about 1"x2" turned a light pink color about 1 - 2 days after injection. It was not red or hot to the touch. She applied some ice for the pain and inflammation on 6/19/19 and today the arm is less painful and the pink has receded some.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: Patient woke up with flu-like symptoms and "achy".
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Lethargy, Pyrexia, Rash
Clinical narrative: Lethargic, fever, rash covering waist down.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Nausea, low abdominal pain, fever,achy,  muscle pain, headache, diarrhea starting about 24 hrs after vaccine was administered
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Nausea, low abdominal pain, fever,achy,  muscle pain, headache, diarrhea starting about 24 hrs after vaccine was administered
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt called the pharmacy and stated she had a rash on her torso.  She was instructed to contact her MD.  She went to the md and they prescribed prednisone and diphenhydramine
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Symptoms within first 24 hrs of receiving vaccine: warmth, pain at injection site, headache, muscle pain, tiredness, fever, nausea, weakness, tiredness, chills.   Symptoms continued for next 24 - 48 hrs: warmth, pain at injection site, muscle pain, itching, baseball size strawberry color appearance on arm around the injection site