chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB, HIBV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered, Wrong technique in product usage process
Clinical narrative: supposed to receive their 4th Pentacel vaccine. Instead, the MA administered Quadracel and ActHIB separately; administered Quadracel to 15 months old patient; supposed to receive their 4th Pentacel vaccine. Instead, the MA administered Quadracel and ActHIB separately; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 months old patient (unknown gender) who received separate fourth intramuscular  dose of 0.5 ml of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [Quadracel] in right thigh  and HIB (PRP/T) VACCINE [Act-Hib] on 13-Jun-2019 (batch number: C5532AA, expiry date: 09-Oct-2020) instead of fourth dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (Hepatitis A) for Immunization.  It was an actual medication error as Wrong vaccine administered, inappropriate age at vaccine administration and wrong technique in product usage process. It was reported a 15 month old child was supposed to receive their 4th Pentacel vaccine. Instead, the MA administered Quadracel and ActHIB separately   It was not reported if the patient 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.  Information on the batch number was requested.  List of documents held by sender- none.
Sex: U
Vaccine: FLUX
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Patient was supposed to receive a TB shot and was given fluzone quadrivalent instead; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient of an unknown demographics who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED instead of TUBERCULIN TEST [TUBERCULIN PPD].  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 QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI998AD, expiry date: 30-JUL-2019 via intradermal route in unknown administration site.  It was a case of actual medication error due to wrong vaccine administered.  Patient was supposed to receive a TB shot and was given fluzone quadrivalent instead. a patient that was given a flu shot Intradermal versus Intramuscular.  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.  Documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was inadvertently administered to a patient; Initial information received on 18-Jun-2019 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves an 18 months old female patient who was inadvertently vaccinated with an expired fourth dose of 0.5 mL suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (frequency once) lot C5202AA (expiry date: 16-May-2019) via intramuscular route in the right thigh on 12-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATIT A VACCIN (HEPATIT A VACCIN).  It is an actual medication error case due to expired vaccine used.  The patient did not experience 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: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: a patient was given powdered component of the Pentacel vaccine, diluted with sterile water; Initial information received on 18-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7-months old (also reported as 8 months old) female patient who was given powdered component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL], diluted with sterile water (lot UJ134AAA,dose: 0.5ml expiration date: 04-Oct-2020) via intramuscular route in the left thigh on 18-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.   It was an actual medication error due to wrong solution used in drug reconstitution. The Hib lyophilized component administered separately will count as a valid dose only if it was reconstituted with the proper diluent, i.e. 0.4% NaCl saline solution.  At the time of reporting, no adverse event was reported.  The outcome was reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Immunisation, No adverse event, Product preparation error
Clinical narrative: a patient was given powdered component of the Pentacel vaccine, diluted with sterile water; Initial information received on 18-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7-months old (also reported as 8 months old) female patient who was given powdered component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5) /HIB(PRP/T) VACCINE [PENTACEL], diluted with sterile water (lot UJ134AAA,dose: 0.5ml expiration date: 04-Oct-2020) via intramuscular route in the left thigh on 18-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.   It was an actual medication error due to wrong solution used in drug reconstitution. The Hib lyophilized component administered separately will count as a valid dose only if it was reconstituted with the proper diluent, i.e. 0.4% NaCl saline solution.  At the time of reporting, no adverse event was reported.  The outcome was reported as unknown.  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: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Pentacel DTaP-IPV liquid vial given without the ActHIB powder portion; Initial information received on 18-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional.  This case involves a 2 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, concomitant medication and family history were not provided.  On 17-Jun-2019, the patient received a first dose 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due to Inappropriate reconstitution technique.  It was reported that patient was give Pentacel DTaP-IPV liquid vial given without the ActHIB powder portion.  It was unknown whether patient experienced 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. Information on batch number was requested for this case
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inadvertently given a double dose of the Adacel prefilled syringe, no advesre event; Initial information received on 19-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 7 years old male patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6103AA and Exp. Date 25-Oct-2020) via unknown route in unknown administration site on 13-Jun-2019 and again inadvertently received a dose of same vaccine on 14-Jun-2019 (lot number, route and site of administration not reported.)  The patient's medical history not reported and concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE); HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL); MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) all for Immunisation.  It was an actual medication error case due to extra dose administered.  At the time of reporting, the patient did not experienced any adverse event post vaccination.  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 for second dose.  List of documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: PATIENT CLAIMS HE  DID NOT WANT SHINGRIX VACCINE
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram, Hypertension
Clinical narrative: reaction: chest discomfort, SOB, urinary frequency, redness and swelling at injection site. hypertension, muscle ache and low grade fever of 99.9. Treatment: EKG. tylenol, ice to area Improved at discharge Seen in office on 6/24/19 at 1pm and swelling has gone down, denies chest pain and shortness of breat. Arm is still red, and warm to touch but improving
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pollakiuria, Pyrexia
Clinical narrative: reaction: chest discomfort, SOB, urinary frequency, redness and swelling at injection site. hypertension, muscle ache and low grade fever of 99.9. Treatment: EKG. tylenol, ice to area Improved at discharge Seen in office on 6/24/19 at 1pm and swelling has gone down, denies chest pain and shortness of breat. Arm is still red, and warm to touch but improving
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: reaction: chest discomfort, SOB, urinary frequency, redness and swelling at injection site. hypertension, muscle ache and low grade fever of 99.9. Treatment: EKG. tylenol, ice to area Improved at discharge Seen in office on 6/24/19 at 1pm and swelling has gone down, denies chest pain and shortness of breat. Arm is still red, and warm to touch but improving
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Contusion, Erythema, Fatigue, Headache
Clinical narrative: BRUISING ON RIGHT ARM, SWOLLEN ON ARM, RED/WARM. ITCHING. PATIENT FELT SICK HAD ACHES AND PAINS, GI UPSET, NAUSEA, HEADACHE. PATIENT FELT TIRED. PATIENT CAME IN ON 6/24/19 AND STILL HAD REDNESS, SORENESS, AND SWELLING BUT SAID THE NAUSEA/TIREDNESS HAS SUBSIDED. COUNSELED PATIENT SHE MAY WANT TO TALK TO HER DOCTOR AS INJECTION SITE LOOKED INFECTED.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Malaise, Nausea, Pain, Peripheral swelling
Clinical narrative: BRUISING ON RIGHT ARM, SWOLLEN ON ARM, RED/WARM. ITCHING. PATIENT FELT SICK HAD ACHES AND PAINS, GI UPSET, NAUSEA, HEADACHE. PATIENT FELT TIRED. PATIENT CAME IN ON 6/24/19 AND STILL HAD REDNESS, SORENESS, AND SWELLING BUT SAID THE NAUSEA/TIREDNESS HAS SUBSIDED. COUNSELED PATIENT SHE MAY WANT TO TALK TO HER DOCTOR AS INJECTION SITE LOOKED INFECTED.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: BRUISING ON RIGHT ARM, SWOLLEN ON ARM, RED/WARM. ITCHING. PATIENT FELT SICK HAD ACHES AND PAINS, GI UPSET, NAUSEA, HEADACHE. PATIENT FELT TIRED. PATIENT CAME IN ON 6/24/19 AND STILL HAD REDNESS, SORENESS, AND SWELLING BUT SAID THE NAUSEA/TIREDNESS HAS SUBSIDED. COUNSELED PATIENT SHE MAY WANT TO TALK TO HER DOCTOR AS INJECTION SITE LOOKED INFECTED.
Age: 0.17
Sex: M
Vaccine: IPV, PNC13, RV5
Symptoms: Oral mucosal eruption, Rash
Clinical narrative: almost immediately after vaccines patient developed rash on chest and around mouth
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Inflammation, Injection site induration, Injection site pain, Macule
Clinical narrative: PE localize erythematous warm macule L deltoid tender to touch w slight induration  pcp discussed w mom that this can be a reaction to vacc or vacc components and NOT ALLERGY  to continue w RICE other conservative measures discussed analgesics around the clock x 2 days to help w pain/inflammation ibuprofen as directed advice  to rtc Mo if no changes pt and mom counseled
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pain, Skin warm
Clinical narrative: PE localize erythematous warm macule L deltoid tender to touch w slight induration  pcp discussed w mom that this can be a reaction to vacc or vacc components and NOT ALLERGY  to continue w RICE other conservative measures discussed analgesics around the clock x 2 days to help w pain/inflammation ibuprofen as directed advice  to rtc Mo if no changes pt and mom counseled
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On or about 08-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effects reported; one was administered intramuscular; Extra dose administered; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 19-JUN-2019, the patient received two separate doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), one intramuscularly and the other one subcutaneously (dose, strength, dose number, site of administration, lot # and expiration date were not reported) for prophylaxis. The doses were reconstituted with sterile diluent. No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Immunisation reaction, Injection site cellulitis, Injection site erythema
Clinical narrative: reddness (cellulitis) to Reaction 1cm x 3cm (erythema) left thigh injection site. to see MD 1-2 days. 0 signs at sepsis, meningitis, dehydration or any acute life threating illness. Dx: Immunization reaction - D'c'ed to home Rx (1) Mupirocin oint. (2) Bactrim 200/40mg/5 10mL PO BID #200mL.
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Fatigue, Influenza like illness, Lymphadenitis, Oropharyngeal pain
Clinical narrative: Very strong flu like symptoms; Fatigue; Sore throat; Runny nose; Little bit of tightening of the throat; Sneezing; Persistent cough; Postnasal drip; Inflammation of lymph nodes in the throat; This is a spontaneous report from a contactable consumer (patient's parent). A 39-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number and expiration date were not reported), with route of administration unspecified, on 07Jun2019 at a single dose for immunization.  Medical history included ongoing type 1 diabetes. Concomitant medication included ongoing insulin for type 1 diabetes. On 08Jun2019, the patient had very strong flu-like symptoms; fatigue; sore throat; runny nose; and a little bit of tightening of the throat. In Jun2019, the patient was sneezing; had persistent cough; postnasal drip; and inflammation of lymph nodes in the throat. The outcome of the events, very strong flu-like symptoms, fatigue, sore throat, runny nose, a little bit of tightening of the throat, sneezing, persistent cough, postnasal drip and inflammation of lymph nodes in the throat, was unknown.   Information on the batch/lot number has been requested.
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Rhinorrhoea, Sneezing, Throat tightness, Upper-airway cough syndrome
Clinical narrative: Very strong flu like symptoms; Fatigue; Sore throat; Runny nose; Little bit of tightening of the throat; Sneezing; Persistent cough; Postnasal drip; Inflammation of lymph nodes in the throat; This is a spontaneous report from a contactable consumer (patient's parent). A 39-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number and expiration date were not reported), with route of administration unspecified, on 07Jun2019 at a single dose for immunization.  Medical history included ongoing type 1 diabetes. Concomitant medication included ongoing insulin for type 1 diabetes. On 08Jun2019, the patient had very strong flu-like symptoms; fatigue; sore throat; runny nose; and a little bit of tightening of the throat. In Jun2019, the patient was sneezing; had persistent cough; postnasal drip; and inflammation of lymph nodes in the throat. The outcome of the events, very strong flu-like symptoms, fatigue, sore throat, runny nose, a little bit of tightening of the throat, sneezing, persistent cough, postnasal drip and inflammation of lymph nodes in the throat, was unknown.   Information on the batch/lot number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Feeling abnormal, Urticaria
Clinical narrative: He is miserable; Broke out in massive raised hives all over his body; it is all over his legs, toes; it is on face and on back, feet and legs; This is a spontaneous report from a contactable Nurse. A 3-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Batch/lot number: X93780), via an unspecified route of administration on an unspecified date at single dose for immunization, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL), both via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The pneumococcal 13-val conj vac (dipht crm197 protein) was given at the pediatrics office.The co-suspect product also included unspecified medications. There was no medical history or concomitant medications. The patient broke out in massive raised hives all over his body; it was all over his legs, toes; it was on face and on back, feet and legs on 13Jun2019. The patient went to the hospital. He was given Benadryl but no help. So, his mother ended up taking him to the hospital where they gave him steroids (treatment/unspecified medications) it had started going away and then now it was on his face and the back, and everywhere on the back of his feet and his legs. They had worsened. He was miserable. He had such a bad reaction. The action taken in response to the events for paracetamol and diphenhydramine hydrochloride was unknown. The outcome of the event "broke out in massive raised hives all over his body" was not recovered and the outcome of the other event was unknown.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of event broke out in massive raised hives all over his body cannot be fully excluded.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Drug hypersensitivity
Clinical narrative: Drug Allergies: Prevnar-13- Cellulitis/Allergies: Prevnar-13; Drug Allergies: Prevnar-13- Cellulitis/Allergies: Prevnar-13; This is a spontaneous report from a Pfizer-sponsored program. A contactable Physician reported that a 72-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced drug allergies and cellulitis on an unspecified date with outcome of unknown.; Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of events drug allergies and cellulitis cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: FLU4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Large for dates baby
Clinical narrative: Birth weight 4451 grams at 41 weeks of gestation/large for gestational age; Foetal exposure during pregnancy; This is a serious spontaneous case, initially received from other health professional on 18-Jun-2019, concerning a male neonate patient.   The patient's mother was 21-year-old with no previous pregnancies. The patient's mother did not have any history of offspring with major congenital malformation. Also, had no maternal or paternal history with major congenital malformations. The current conditions of the patient's mother included Rhesus antibodies (Anti-D screening) positive and Rhesus antibodies (Rh D) negative. The concomitant medications of the patient's mother included Rhogam (anti-D Immunoglobulin) for Anti-D screening Positive and prenatal vitamins (minerals Nos; vitamins Nos) as a supplement. The pregnancy status of the patient's mother was collected, and no pregnancy complications were noted.  The last menstrual period (LMP) date of the patient's mother was 28-Aug-2018. The type of pregnancy was singleton. The patient's mother did not use tobacco, alcohol or illicit drugs during pregnancy.   On 07-Nov-2018, at gestational age of 10-weeks, the foetus was exposed to Afluria Quadrivalent [Influenza Vaccine, route of administration: transplacental, batch number: YF42609, dose, anatomical location and expiry date: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On the same day, the patient's mother underwent ultrasound test, and no major congenital malformation was noted.  On 26-Dec-2018, the prenatal tests of the patient's mother included sequential 2 test and inheritest core test done, and no major congenital malformation was noted. On 07-Jan-2019, 2 months after vaccination, the patient's mother developed anaemia and was treated with Iron [dose: 325 mg, frequency: daily (qd), route of administration: oral, start date: 07-Jan-2019 to ongoing].  The corrected estimated date of delivery of the patient's mother was reported as 02-Jun-2019 and estimated date of delivery was reported as 04-Jun-2019.   On 09-Jun-2019, at gestational age of 41 weeks, the mother gave a live birth to a male neonate by vacuum assisted vaginal delivery method. The characteristics of the neonate included birth weight: 4451 grams (coded as large for gestational age), head circumference: no data, body length: no data and appearance, pulse, grimace, activity, and respiration (APGAR) scores were 8 at one minute, 9 at five minutes and no data for ten minutes). No major congenital malformations were identified at birth.  This case is cross-linked to the case: 201903638 (mother case).; Reporter's Comments: A male neonate patient with exposure to Afluria QIV during 10th week of gestation had birth weight of  large for gestational age (4451grams at 41 weeks). Considering the no known biological mechanism the company assessed the event as not related to suspect vaccine. Other risk factors can be considered as post term pregnancy and male fetus.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Dizziness, Laboratory test normal, Nuclear magnetic resonance imaging normal, Vomiting
Clinical narrative: At 8pm on June 8th 2019 I was sitting down about to watch a movie when I suddenly became VERY DIZZY. Called for my daughter to help me. Started severe vomiting which lasted for more Than 1 hour. EMS took me to Hospital. 9-9:30 I was still woozzy until Doctor gave me meclazine + started an IV. I underwent many tests (Negative) and was kept overnight for observation. Released 4 p.m. on the 9th.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: Abnormal gate, leg weakness
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Pt developed redness around injection site, pt was also given 1 oral dose of Benadryl. Pt waited 30 mins & was okay to go home (right thigh).
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Monoplegia, Muscle spasms, Myalgia
Clinical narrative: Shaking, chills/uncontrolled R. Arm felt Paralyzed Temp to 100' Body aches Muscle Pain Cramps Ache/entire body Lasted 24hr.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Tremor
Clinical narrative: Shaking, chills/uncontrolled R. Arm felt Paralyzed Temp to 100' Body aches Muscle Pain Cramps Ache/entire body Lasted 24hr.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: After administer ng varicella & HAVRIX in (L) thigh on 6-6-19 @ 3:30 P. Parent came out 5 min later and noted hives on (L) thigh surrounding vaccine site of varicella. 4 mL of Benadryl was given in office.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Fall, Pyrexia, Vomiting
Clinical narrative: one day later - dizzy + upset stomach, vomited, fever. She fell then after vomiting. She uses a walker also fell in bathroom 2 days later. White soda, rest + light feeding
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: one day later - dizzy + upset stomach, vomited, fever. She fell then after vomiting. She uses a walker also fell in bathroom 2 days later. White soda, rest + light feeding
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: 9 hrs. after injection, when I got into bed, my right leg started twitching uncontrollably for several hours and I had a fever of 100 degrees, next morning I went to urgent care. DO noT remember name of medication given.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Vaccine given 6/12/19. Patient seen 6/14/19 complaining of leg aches, tiredness, easy fatigability. Patient with history of anxiety and mom with hx of vaccine refusal.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Pt was seen in ED for adverse reaction to shingrix vaccine
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Dizziness, Dysgeusia, Feeling abnormal, Nervousness
Clinical narrative: CDC VIS was given to EE and consent signed by EE prior to vaccination. MMR given to LUA SQ without difficulty at 1120am. EE stated immediately she felt some shooting sensation up her arm into her neck. EEAAOX4 at this time in NAD. EE remained in nurse office x20 minutes post vaccination; EE talkative, alert during the 20 minute period.  O: At 1142, EE stated "I feel funny"; stated her throat as feeling "tight" and "tongue tingling". O2 sat RA 100% at this time. EE pointed to throat stating beginning to feel pain in her throat area and c/o "metallic taste", feeling "shaky and weak". 1145: BP 153/79 P67 O2Sat 100% RA. EHS Emergency med box available. 1147: 911 called.  1153: BP 132/87 P 61 O2 sat 100% RA; EE remains alert and anxious stating she doesn't feel right, feeling light-headed.  Approx 1155 EMS arrival; EE able to walk with assistance to stretcher. Report given to EMS; EE agreed to EMS transport to ED for further evaluation and tx.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Paraesthesia oral, Sensory disturbance, Throat tightness
Clinical narrative: CDC VIS was given to EE and consent signed by EE prior to vaccination. MMR given to LUA SQ without difficulty at 1120am. EE stated immediately she felt some shooting sensation up her arm into her neck. EEAAOX4 at this time in NAD. EE remained in nurse office x20 minutes post vaccination; EE talkative, alert during the 20 minute period.  O: At 1142, EE stated "I feel funny"; stated her throat as feeling "tight" and "tongue tingling". O2 sat RA 100% at this time. EE pointed to throat stating beginning to feel pain in her throat area and c/o "metallic taste", feeling "shaky and weak". 1145: BP 153/79 P67 O2Sat 100% RA. EHS Emergency med box available. 1147: 911 called.  1153: BP 132/87 P 61 O2 sat 100% RA; EE remains alert and anxious stating she doesn't feel right, feeling light-headed.  Approx 1155 EMS arrival; EE able to walk with assistance to stretcher. Report given to EMS; EE agreed to EMS transport to ED for further evaluation and tx.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Borrelia test, Facial paralysis
Clinical narrative: Developed Bell's Palsy symptoms (right sided facial nerve paralysis) on 6/10/2019. Vaccinations were given on 6/7/2019.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Morbillivirus test positive, Polymerase chain reaction positive, Pyrexia, Rash
Clinical narrative: From ER History and Physical: Initial Greet Date/Time 05/23/19 0959  Presentation  Chief Complaint Rash  Context  Additional Context  1yo with PMH prematurity at 25 wga presents with 1 week history of low grade  fever, cough and now rash. Mom brought her in for poor PO and rash. Of note,  patient had MMR vaccine 9 days ago. Per mom, rash started on face then spread  downwards and coalesced.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Arm and shoulder pain, tenderness began within an hour and resolved over 3 days. Fever, headache, malaise began approximately 12-14 hours after injections, resolved within 24 hours.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Arm and shoulder pain, tenderness began within an hour and resolved over 3 days. Fever, headache, malaise began approximately 12-14 hours after injections, resolved within 24 hours.
Age: 47.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Developed redness, warmth and pain shortly after the injection was administered and worsened over 2 days. Treated for cellulitis in ED with antibiotics
Age: 31.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Blood potassium decreased, Dizziness, Dyspnoea, Dyspnoea exertional, Electrocardiogram normal
Clinical narrative: The Patient is a 31 year old female.  Source of patient information was patient.  Source of patient information was medical records.  Past medical history reviewed, problem list reviewed, and medication list reviewed.  Family history not reviewed.  Reliability of source of patient information was good.  No systemic symptoms.  No head symptoms.  No pulmonary symptoms.  No neurological symptoms.  No skin symptoms. Patient reports onset of multiple single red dot like macular rash to left arm and leg 5/20/2019 (day 3 after receipt of 5/17/2019 SPV and AVA1 vaccine).  She denied any outside excursions-recent travels, plant exposure or yard work, bug bites, new soaps-lotions, detergents, food, etc.  On 5/24-25 (day 4-5 post vaccination) she reports the red macular rash itched and was spreading all over her body, biceps, thighs, arms, tops hands/feet (not palms/soles and no oral lesions), chest/back and last to abdomen and neck.  She denied any fever, cp, sob, dizziness, fatigue or other systemic s/s.  She presented to medical on  5/26/2019 c/o rash now hive like (groupings raised but not pustular) x24 hours and was treated with oral benadryl 25 mg 4x/day and prednisone 50 mg x5 day. She was diagnosed with urticaria. She presented to ER 5/28 c/o dizziness, sensation of being "out of breath" (especially after activities), hives, fatigue, nausea whle on Benadryl and prednisone. Labs nl with low K 3.24.  Dx with hypokalemia and given 40 mEq KCL po and released. Lungs reported clear with 100% O2 sats room air. On 5/30/19 she returned to ER again, c/o exhaustion, DOE, fatigue....labs nl, dx fatigue secondary to benadryl use and changed to hydroxyzine.  Provider noted faint wheeze on exam.  She presented to ER again 6/2/19 after "passing out" and assisted to floor.  Orthostatic were positive with HR supine 80 bpm and 110 standing. BP/RR normal.  EKG nl, CMP/UA/preg all nl/neg - not dehydrated per lab and clear UA.  Tx with 1 liter IVNS wide open and release to f/u with HCP.  DX dizziness.  6/3/2019 seen by HCP with c/o nausea, dizziness- exam showed nausea increased with positive dix-hallpike maneuver.  (note pt treated for clinical strep throat on 5/7/2019).  6/20/19: Patient stated all s/s have resolved with no further dizziness, n/v, rash or any other systemic s/s.  Patient stated rash duration was about 3 weeks. duration of dizziness began about 5/28 after starting benadryl and prednisone.  Malaise and fatigue began about 1 week after receipt AVA/SPV and persisted for total of 3 weeks.
Age: 31.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Fatigue, Full blood count normal, Hypokalaemia, Loss of consciousness, Malaise
Clinical narrative: The Patient is a 31 year old female.  Source of patient information was patient.  Source of patient information was medical records.  Past medical history reviewed, problem list reviewed, and medication list reviewed.  Family history not reviewed.  Reliability of source of patient information was good.  No systemic symptoms.  No head symptoms.  No pulmonary symptoms.  No neurological symptoms.  No skin symptoms. Patient reports onset of multiple single red dot like macular rash to left arm and leg 5/20/2019 (day 3 after receipt of 5/17/2019 SPV and AVA1 vaccine).  She denied any outside excursions-recent travels, plant exposure or yard work, bug bites, new soaps-lotions, detergents, food, etc.  On 5/24-25 (day 4-5 post vaccination) she reports the red macular rash itched and was spreading all over her body, biceps, thighs, arms, tops hands/feet (not palms/soles and no oral lesions), chest/back and last to abdomen and neck.  She denied any fever, cp, sob, dizziness, fatigue or other systemic s/s.  She presented to medical on  5/26/2019 c/o rash now hive like (groupings raised but not pustular) x24 hours and was treated with oral benadryl 25 mg 4x/day and prednisone 50 mg x5 day. She was diagnosed with urticaria. She presented to ER 5/28 c/o dizziness, sensation of being "out of breath" (especially after activities), hives, fatigue, nausea whle on Benadryl and prednisone. Labs nl with low K 3.24.  Dx with hypokalemia and given 40 mEq KCL po and released. Lungs reported clear with 100% O2 sats room air. On 5/30/19 she returned to ER again, c/o exhaustion, DOE, fatigue....labs nl, dx fatigue secondary to benadryl use and changed to hydroxyzine.  Provider noted faint wheeze on exam.  She presented to ER again 6/2/19 after "passing out" and assisted to floor.  Orthostatic were positive with HR supine 80 bpm and 110 standing. BP/RR normal.  EKG nl, CMP/UA/preg all nl/neg - not dehydrated per lab and clear UA.  Tx with 1 liter IVNS wide open and release to f/u with HCP.  DX dizziness.  6/3/2019 seen by HCP with c/o nausea, dizziness- exam showed nausea increased with positive dix-hallpike maneuver.  (note pt treated for clinical strep throat on 5/7/2019).  6/20/19: Patient stated all s/s have resolved with no further dizziness, n/v, rash or any other systemic s/s.  Patient stated rash duration was about 3 weeks. duration of dizziness began about 5/28 after starting benadryl and prednisone.  Malaise and fatigue began about 1 week after receipt AVA/SPV and persisted for total of 3 weeks.
Age: 31.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Metabolic function test normal, Nausea, Pharyngitis streptococcal, Rash erythematous, Rash generalised
Clinical narrative: The Patient is a 31 year old female.  Source of patient information was patient.  Source of patient information was medical records.  Past medical history reviewed, problem list reviewed, and medication list reviewed.  Family history not reviewed.  Reliability of source of patient information was good.  No systemic symptoms.  No head symptoms.  No pulmonary symptoms.  No neurological symptoms.  No skin symptoms. Patient reports onset of multiple single red dot like macular rash to left arm and leg 5/20/2019 (day 3 after receipt of 5/17/2019 SPV and AVA1 vaccine).  She denied any outside excursions-recent travels, plant exposure or yard work, bug bites, new soaps-lotions, detergents, food, etc.  On 5/24-25 (day 4-5 post vaccination) she reports the red macular rash itched and was spreading all over her body, biceps, thighs, arms, tops hands/feet (not palms/soles and no oral lesions), chest/back and last to abdomen and neck.  She denied any fever, cp, sob, dizziness, fatigue or other systemic s/s.  She presented to medical on  5/26/2019 c/o rash now hive like (groupings raised but not pustular) x24 hours and was treated with oral benadryl 25 mg 4x/day and prednisone 50 mg x5 day. She was diagnosed with urticaria. She presented to ER 5/28 c/o dizziness, sensation of being "out of breath" (especially after activities), hives, fatigue, nausea whle on Benadryl and prednisone. Labs nl with low K 3.24.  Dx with hypokalemia and given 40 mEq KCL po and released. Lungs reported clear with 100% O2 sats room air. On 5/30/19 she returned to ER again, c/o exhaustion, DOE, fatigue....labs nl, dx fatigue secondary to benadryl use and changed to hydroxyzine.  Provider noted faint wheeze on exam.  She presented to ER again 6/2/19 after "passing out" and assisted to floor.  Orthostatic were positive with HR supine 80 bpm and 110 standing. BP/RR normal.  EKG nl, CMP/UA/preg all nl/neg - not dehydrated per lab and clear UA.  Tx with 1 liter IVNS wide open and release to f/u with HCP.  DX dizziness.  6/3/2019 seen by HCP with c/o nausea, dizziness- exam showed nausea increased with positive dix-hallpike maneuver.  (note pt treated for clinical strep throat on 5/7/2019).  6/20/19: Patient stated all s/s have resolved with no further dizziness, n/v, rash or any other systemic s/s.  Patient stated rash duration was about 3 weeks. duration of dizziness began about 5/28 after starting benadryl and prednisone.  Malaise and fatigue began about 1 week after receipt AVA/SPV and persisted for total of 3 weeks.
Age: 31.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Rash macular, Rash pruritic, Urine analysis normal, Urticaria
Clinical narrative: The Patient is a 31 year old female.  Source of patient information was patient.  Source of patient information was medical records.  Past medical history reviewed, problem list reviewed, and medication list reviewed.  Family history not reviewed.  Reliability of source of patient information was good.  No systemic symptoms.  No head symptoms.  No pulmonary symptoms.  No neurological symptoms.  No skin symptoms. Patient reports onset of multiple single red dot like macular rash to left arm and leg 5/20/2019 (day 3 after receipt of 5/17/2019 SPV and AVA1 vaccine).  She denied any outside excursions-recent travels, plant exposure or yard work, bug bites, new soaps-lotions, detergents, food, etc.  On 5/24-25 (day 4-5 post vaccination) she reports the red macular rash itched and was spreading all over her body, biceps, thighs, arms, tops hands/feet (not palms/soles and no oral lesions), chest/back and last to abdomen and neck.  She denied any fever, cp, sob, dizziness, fatigue or other systemic s/s.  She presented to medical on  5/26/2019 c/o rash now hive like (groupings raised but not pustular) x24 hours and was treated with oral benadryl 25 mg 4x/day and prednisone 50 mg x5 day. She was diagnosed with urticaria. She presented to ER 5/28 c/o dizziness, sensation of being "out of breath" (especially after activities), hives, fatigue, nausea whle on Benadryl and prednisone. Labs nl with low K 3.24.  Dx with hypokalemia and given 40 mEq KCL po and released. Lungs reported clear with 100% O2 sats room air. On 5/30/19 she returned to ER again, c/o exhaustion, DOE, fatigue....labs nl, dx fatigue secondary to benadryl use and changed to hydroxyzine.  Provider noted faint wheeze on exam.  She presented to ER again 6/2/19 after "passing out" and assisted to floor.  Orthostatic were positive with HR supine 80 bpm and 110 standing. BP/RR normal.  EKG nl, CMP/UA/preg all nl/neg - not dehydrated per lab and clear UA.  Tx with 1 liter IVNS wide open and release to f/u with HCP.  DX dizziness.  6/3/2019 seen by HCP with c/o nausea, dizziness- exam showed nausea increased with positive dix-hallpike maneuver.  (note pt treated for clinical strep throat on 5/7/2019).  6/20/19: Patient stated all s/s have resolved with no further dizziness, n/v, rash or any other systemic s/s.  Patient stated rash duration was about 3 weeks. duration of dizziness began about 5/28 after starting benadryl and prednisone.  Malaise and fatigue began about 1 week after receipt AVA/SPV and persisted for total of 3 weeks.
Age: 16.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Patient experienced: pain, redness, or swelling at the injection site fatigue headache muscle pain chills fever vomiting Patient was advised to use cool compress for swelling, increase fluid intake, and rest. Patient stated side affects ended after two days.
Age: 16.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Injection site swelling, Myalgia, Pyrexia, Vomiting
Clinical narrative: Patient experienced: pain, redness, or swelling at the injection site fatigue headache muscle pain chills fever vomiting Patient was advised to use cool compress for swelling, increase fluid intake, and rest. Patient stated side affects ended after two days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Streptococcal infection, Throat irritation
Clinical narrative: child started running 104-105 fever around 12:00 am on 06/03/19. Child was still running fever and started having a spotty rash on 06/06/19. Mom stated he was not wanting to eat or drink. Mom took him to see Dr. 06/06/19. Dr thought child was having an adverse reaction to the vaccines but was not concerned about fever. He stated fever was normal after receiving vaccines. No treatment. Fever stopped 06/07/19. Mom took child to ER on 06/08/19 with rash. ER doctor said child may be having allergic reactio to vaccines. Child also had irritated throat and was treated for strep rash with Amoxicillin. Mom alternated Tylenol and ibuprofen. Rash gone by 06/09/18
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema
Clinical narrative: Patient called pharmacy on Monday, June 24, 2019 and reported he had developed a headache yesterday and still has one today ( this being vaccine number 2 in the shingrix series).  He also reports that he had chills on Sunday and still has a red "golf ball" sized redness at the injection site.  His PCP, was called and RMA was informed of what was going on and stated she would give him a call.  Tried to call the Standing Order physician, but got a message that physician was unable to be reached ( then called the PCP).  This Vaers will be faxed to the Standing Order physician.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented 6/24/19 and stated his arm turned red swelled and had severe itching at the injection site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pruritus, Injection site reaction, Injection site urticaria, Rash erythematous
Clinical narrative: Pt stated left upper arm became itchy on Friday, June 21, 2019. When the pt lifted up sleeve there was a red rash and a few hives. The patient states taking oral Benadryl  but getting no relief. Patient states the redness has spread so pt was instructed to be seen at a local urgent care. Pt verbalized understanding.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Patient called saying the day after vaccine was given patient developed a rash with blister in the crease of elbow that grew and has not gotten any better. Patient was instructed to see physician for medical evaluation and treatment