chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Malaise, Nausea
Clinical narrative: Severe Headache, nausea, stomach upset, diarrhea and overall unease. Took Advil for headache but it didn?t subside until after I fell asleep. Symptoms continued into the early AM hours when I could finally sleep.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Acute kidney injury, Back pain, Blood creatine phosphokinase increased, Blood culture, C-reactive protein increased
Clinical narrative: severe pain in neck, back and legs. loss of feeling in both legs. hospitalized due to pain, neurological issues and elevated CRP, CK levels.  Advised suffered from neuralgia and acute kidney injury
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Magnetic resonance imaging, Metabolic function test, Neck pain, Nervous system disorder, Neuralgia
Clinical narrative: severe pain in neck, back and legs. loss of feeling in both legs. hospitalized due to pain, neurological issues and elevated CRP, CK levels.  Advised suffered from neuralgia and acute kidney injury
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Sensory loss
Clinical narrative: severe pain in neck, back and legs. loss of feeling in both legs. hospitalized due to pain, neurological issues and elevated CRP, CK levels.  Advised suffered from neuralgia and acute kidney injury
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: right arms swelling, erythema, warmth, and tenderness since 9/11/2019 at 8 am and increasingly worsening. Patient re-evaluated on 9/11/19 at 5pm and treatment prescribed.  9/12/19 @ 0816a mother verbalized son feels much better, right arm swelling has decreased to half the size, and son reported been able to move the arm without pain.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: At 4 weeks I still have some redness and occasional itching at injection site
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: varicella to left arm. area (redness) measuring Length15mm x width 20mm, round warm to touch, tender. patient advised to apply  ice to the area,  Benadryl Q 8 hours for redness, pruritus, inflammation of area. Return to the clinic with worsening symptoms.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: Patient came in for second dose today. Not given as she states after the first one she had a large area of redness and swelling to right arm and had a day of fever and flu like symptoms. Resolved after 24-48 hours.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect; the patient received the first dose of PROQUAD on 25-APR-2018, and was inadvently administered a second dose of PROQUAD on 07-AUG-2019; the patient was inadvently administered a second dose of PROQUAD on 07-AUG-2019/mother did not disclose patient had been to another office, we gave PROQUAD then found out after patient left she had been seen elsewhere last year; Information has been received from an office manager referring to a 69 months old female patient. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 25-APR-2018, approximately at the patient's age of 53 months old, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # S002926, expiration date 28-JUL-2020 (possibly incorrect information provided from reporter, as the patient received the second dose with the same lot#), anatomical location was right vastus lateralis, dose and route of administration were not provided) for prophylaxis. On 07-AUG-2019, the patient was inadvertently administered a second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # S002926, expiration date 28-JUL-2020, anatomical location, dose and route of administration were not provided) for prophylaxis. After the patient left, it was found out that she had been seen elsewhere last year (inappropriate schedule of product administration, product prescribing issue). The patient's mother did not disclose that the patient had been to another office previously. No adverse effects were reported. The patient had no illness at time of vaccination. No temperature excursion occurred as a result of a reading from a digital data logger. There was no prescription drug treatment for the experience required.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects; a dose of PROQUAD was inadvertently administered to a 13 year old patient.; This spontaneous report has been received from a nurse referring to a 13-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.     On 13-AUG-2019, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # S006832, expiration date reported as 02-SEP-2020; dose and route were not reported) for prophylaxis (inappropriate age at vaccine administration). No adverse effects was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient received a dose of VARIVAX following a temperature excursion; This spontaneous report was received from an office manager regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On 16-JUN-2019, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX)  batch/lot # N034553, expiration date: 05-DEC-2019 (dose, unit and route of administration were not reported) following a temperature excursion (product storage error) for prophylaxis. There were no previous temperatures excursion. The vaccine was exposed at the temperature from 15 Fahrenheit degrees to 46 Fahrenheit degrees for 30 days. Data digital logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient received a dose of VARIVAX following a temperature excursion; This spontaneous report was received from an office manager referring to a patient(age and gender unknown). The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided. On 16-AUG-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # N034553, expiration date 05-DEC-2019) for prophylaxis, following a temperature excursion (product storage error). Current temperature excursion was 15 Fahrenheit degrees to 46 Fahrenheit degrees for 30 hours. There was no previous temperature excursion. No adverse effects were reported. Data logger was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored dose of PEDVAXHIB was administered to the patient; No adverse effect; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/ reactions and concomitant medications were unknown. On 21-AUG-2019, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 1 dosage form (strength, formulation, frequency, route were unknown) ( lot# S000352 and expiry date 17-OCT-2021) for prophylaxis. On an unknown date, the patient was administered with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (product storage error) and no adverse event was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect reported; 26 year old patient received one dose of PROQUAD; This spontaneous report has been received from a medical assistant referring to a 26-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies.   On 27-AUG-2019, the 26-year-old patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), via subcutaneous route for prophylaxis (Therapy type: rHA, Lot # S006830, expiry date: 02-SEP-2020). Other suspect therapies included sterile diluent (Lot # S013899, expiry date: 07-MAR-2022) (Inappropriate age at vaccine administration). No adverse effect reported. It was unknown if the patient received treatment for the event. It was unknown whether laboratory diagnostics were performed.  This is one of the two report received from the same reporter.; Sender's Comments:  US-009507513-1908USA012364:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored dose administered; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.     On 29-AUG-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), (lot # S00352, expiration date 17-OCT-2020) intramuscularly, for prophylaxis (strength, dose and frequency were not reported) (improper storage of product in use). No adverse effects reported. It was unknown if the patient received treatment for the event. It was unknown whether laboratory diagnostics were performed.  The temperature excursion was below 36 Fahrenheit (F)/2 degree Celsius (35.4F) for 27 minutes and the data logger was involved. There was no previous temperature excursion.  Lot number S00352 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA013017:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; expired dose of MMR II was administered; This spontaneous report was received from a health professional and refers to a patient of unknown age and gender. Concomitant therapies included sterile diluent (STERILE DILUENT). No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-AUG-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # N020923, expiry date 01-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.  The outcome of expired product administered and no adverse event was unknown.
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; Pharmacist reports that the vaccines were not administered within at least 4 weeks apart, as specified by the Prescribing Information.; Information has been received from a pharmacist referring to a unknown gender patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 20-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 03-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R020652, expiration date: 18-JUL-2020, dose, frequency and route were not reported) for prophylaxis (inappropriate schedule of product administration). Other suspect product included sterile diluent (manufacturer unknown)(dose, frequency, route, lot # and expiration date were not reported) used for reconstitute with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX). No adverse effects reported. The sterile diluent (manufacturer unknown) used to reconstitute varicella virus vaccine live (oka/merck)(VARIVAX) was stored in the correct temperature storage range. And the varicella virus vaccine live (oka/merck)(VARIVAX) was stored in the correct temperature storage range as well. It was unknown the temperature storage conditions of the sterile diluent(manufacturer unknown) used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine and the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Syringe issue
Clinical narrative: plunger rod on prefilled syringe was bent and difficult to depress on 9/4/2019; The patient flinched and complained of pain at the injection site; Information has been received from a pharmacy intern referring to a 21 year old female patient. The patient was allergied to eggs, amoxicillin, acetaminophen(+)hydrocodone bitartrate(LORTAB). The patient's historical condition and concomitant medications were not reported.  On 04-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (lot # reported as 1602284, expiration date reported as 03-SEP-2020 and auto generated as 26-SEP-2021, dose, frequency were not reported) for vaccination. The plunger rod on hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe was bent and difficult to depress (Syringe issue) and was not injected into the patient. A few minutes later, the patient received another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, frequency,lot # and expiration date were not reported) without any difficulty.The patient flinched and complained of pain at the injection site. The outcome of product quality issue was unknown. The outcome of injection site pain was reported as recovered on the same day (reported as recovery date: today). No treatment given for the event. No lab diagnostics/studies was provided. The patient wasn't sought medical attention. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse effect reported; one patient received an improperly stored VARIVAX; This spontaneous report as received from a registered nurse and refers to a 4 year old patient (gender not reported). The patient's concurrent and historical conditions, as well as drug reactions or allergies,  were not reported.  On 05-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R006221 with expiration date 29-FEB-2020 R029517 with expiration date reported as 14-2020, but upon internal validation established as 14-OCT-2020). The route and dose was not reported, and the patient was vaccinated for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored Sterile diluent (unspecified).  It was reported that the temperature time frame was -14°C to -10°C (-11.91 °C, multiple), for 8 hours. There were no previous temperature excursions and the call was because of a data logger.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No known adverse effects; A patient received a dose of M-M-RII on 29-SEP-2015, on 12-JUL-2018 and on 03-SEP-2019.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 29-SEP-2015, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. The reporter stated that the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) on 12-JUL-2018 and another one on 03-SEP-2019 (inappropriate schedule of product administration). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster, Tinnitus, Vertigo positional
Clinical narrative: hearing loss; benign paroxymal positinal vertigo; bilateral tinnitus; herpes zoster; Information has been received regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 04-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) for routine health maintenance and for it. s intended purpose: the prevention of shingles. On an unknown date, shortly after receiving, the pt suffered herpes zoster along the left side of abdomen, benign paroxysmal positional vertigo, bilateral tinnitus and hearing loss  (deafness). As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, symptoms have resulted in physical limitations not present prior to vaccination. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the outcome of deafness, herpes zoster, tinnitus and vertigo positional was considered as not recovered. The lawyer considered herpes zoster, deafness, tinnitus and vertigo positional to be related to Zoster Vaccine Live (ZOSTAVAX). Upon internal review, deafness was determined to be medically significant and all the pt experiences were considered as disabling due to the severe and permanent incurable injuries.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse effects; patient received one dose of Gardasil on 22-SEP-2010 and then received one dose of Gardasil 9 on 03-SEP-2019; This spontaneous report was received from a pharmacist referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.   On 22-SEP-2010, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route, lot number and expiration date were not reported) for prophylaxis. Later, on 03-SEP-2019, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number: 1621934, expiration date: 29-JAN-2022, dose and route were not reported) also for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events; Expired dose of VAQTA; This spontaneous report was received from a medical assistant refers to a 66 year old patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 09-SEP-2019, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (strength, dosage information, route of administration and anatomical location were unknown) of lot # R022983 has been verified to be a valid lot number with an expiry date of 09-AUG-2019 for prophylaxis. No adverse events reported. The outcome of expired product administered was unknown. No product quality complaint reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered 1 dose of improperly stored M-M-R II; No adverse effects reported.; This spontaneous report was received from a physician regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 26-JUL-2019, the patient received an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Lot No. R015165 and expiration date 29-MAY-2020 have been verified to be a valid) for prophylaxis (product storage error) (dose, route of administration and anatomical site were not provided). The vaccine was reconstituted with a properly stored Merck STERILE DILUENT. The temperature excursion was of 50 Fahrenheit degrees within a time frame of 4 hours. There was no previous temperature excursion and it was reported that the call was because of data logger. No adverse effects or product quality complaint were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored M-M-R II was administered to a patient; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not reported.  On 02-AUG-2019, the patient was vaccinated with an improperly stored dose of recombinant human albumin (rha) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (M-M-R II) with lot # R015165, expiration date 29-MAY-2020, for prophylaxis (dose, dose number, route and anatomical location were not provided). The vaccine was reconstituted with properly stored sterile diluent. The vaccine was exposed to a temperature of 50 degree Fahrenheit (F) for a time frame of 4 hours. No previous temperature excursions were reported and a digital data logger was involved. No adverse effects and no product quality complaints were reported.
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A
Clinical narrative: The patient was diagnosed with Hepatitis A within the last year after traveling overseas; This spontaneous report was received from a company representative regarding a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were unknown by the reported.   On unspecified date in 2012 (reported as 7 years ago), the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) and in 2013 (reported as 6 years ago) the second dose for prevent hepatitis A (strength, dose, frequency, lot number and expiration date were not reported).   On unspecified date in 2018 (reported as within last year), the patient was diagnosed with hepatitis A after traveling overseas. The patient did not received any treatment, and the patient went to the doctors office for sought medical attention.  At the reporting time, the outcome of the event was reported as recovering (doing well).   The causal relationship between the event and therapy with Hepatitis A Vaccine, Inactivated (VAQTA) was not reported.
Age: 0.33
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; on 10/05/2011, a 4 month old patient received a dose of VAQTA; This spontaneous report was received from a medical assisstant referring to a 4 month old patient of unknown gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.    On 05-OCT-2011, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). There was no known adverse effects.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored dose inadvertantly administered; This spontaneous report as received from a Healthcare business professional refers to a 12-year-old male patient.    The patient's pertinent medical history, concurrent condition and drug reactions/allergies were not reported.  On 12-JUL-2019, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1602283, expiry date: 18-AUG-2021) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis (product storage error).  It was reported that the vaccine was exposed to a temperature below2 degree Celsius (-0.6 degree Celsius) for a time frame of 50 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effect was reported. No additional information provided. No product quality complaint (PQC) was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No dverse effects; patient was administered with 1 dose of Imroperly stored M-M-R II; This spontaneous report was received from a physician refers to a patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent(STERILE DILUENT). On 16-AUG-2019, the patient was vaccinated with 1 dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R015165, expiry date:29-MAY-2020, anatomical location and route was not reported) for prophylaxis (product storage error) which was reconstituted with properly stored sterile diluent(STERILE DILUENT). The vaccine was exposed to a temperature of 50 F for a time frame of 4 hours which was recorded in digital data logger. There was no previous temperature excursion. No adverse effects reported. No PQC was filed.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: adult patient received 0.25 ml doses of Fluzone Quadrivalent/no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a office staff.  This case involves a 40 years old male patient who vaccinated with a 0.25 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number: UT6647JA, expiry date: 30-Jun-2020) via unknown route in the left arm on an unspecified date on 28-AUG-2019 .  It is an actual medication error case due to vaccine underdose. It was reported that a 0.25 mL dose of vaccine FLUZONE was administered to a adult patient.  It was reported that Symptoms were none reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 week old male infant received a dose of Pentacel, no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a two weeks old male patient who was vaccinated with a 0.5 mL dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ071AAB, expiry date: 13-Jun-2020 via intramuscular route in the left thigh on 03-Sep-2019.  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).  It is an actual medication error case due to Inappropriate age at vaccine administration.  Symptoms none reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: IPV, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: by mistake gave a female patient 17yr old Ipol 0.1ml instead of the Tubersol test, Patient has had 4 doses of polio vaccine as a child/ NO AE; by mistake gave a female patient 17yr old Ipol 0.1ml instead of the Tubersol test / NO AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old female patient who received 0.1 mL dose of vaccine IPV (VERO) [IPOL] lot N1K92, Expiry date- 14-11-2019 via unknown route in unknown administration site instead of TUBERCULIN TEST [TUBERSOL].  Patient has had 4 doses of polio vaccine as a child. No other vaccines administered. 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 Wrong product administered and extra dose administered. Nurse by mistake gave a female patient 17years old Ipol 0.1ml instead of the Tubersol test today.  No specific symptoms are being reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient receiving a 3rd dose of Menactra / no AE; Initial information received on 04-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who receive 0.5 ml third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6541AA (Expiry date 31-Mar-2021) via unknown route in unknown administration site on 03-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) (it was reported as Gaurdacel).   It was an actual medication error case due extra dose administered.  At a time of vaccination No adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea
Clinical narrative: patient reported severe flu-like symptoms with nausea
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: Dizziness Fainting
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Patient developed Severe redness at injection site (warm to touch & painful), High Fevers x 3 days, Nausea w/vomiting & diarrhea that lasted from Saturday to Monday 9/9/2019.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient developed Severe redness at injection site (warm to touch & painful), High Fevers x 3 days, Nausea w/vomiting & diarrhea that lasted from Saturday to Monday 9/9/2019.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Computerised tomogram thorax normal, Dyspnoea, Electrocardiogram normal
Clinical narrative: I received my first Shingrix shot on 9/3/19, on 9/5/19 I felt like I was going to be sick and went to the bathroom and blacked out. I was unconscious for 5 minutes. My husband called 911, My breathing was labored and I was pale in color. and was extreemly weak. with my neck and right arm in so much pain. I went to the emergency room and was given IV therapy, labs and a CT scan. was told that this was a reaction of the Shingrix vaccine. Today my right arm and shoulder and neck are still achy. I still have a faint headache and arm still fatigued.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Loss of consciousness, Malaise
Clinical narrative: I received my first Shingrix shot on 9/3/19, on 9/5/19 I felt like I was going to be sick and went to the bathroom and blacked out. I was unconscious for 5 minutes. My husband called 911, My breathing was labored and I was pale in color. and was extreemly weak. with my neck and right arm in so much pain. I went to the emergency room and was given IV therapy, labs and a CT scan. was told that this was a reaction of the Shingrix vaccine. Today my right arm and shoulder and neck are still achy. I still have a faint headache and arm still fatigued.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Pallor, Vaccination complication
Clinical narrative: I received my first Shingrix shot on 9/3/19, on 9/5/19 I felt like I was going to be sick and went to the bathroom and blacked out. I was unconscious for 5 minutes. My husband called 911, My breathing was labored and I was pale in color. and was extreemly weak. with my neck and right arm in so much pain. I went to the emergency room and was given IV therapy, labs and a CT scan. was told that this was a reaction of the Shingrix vaccine. Today my right arm and shoulder and neck are still achy. I still have a faint headache and arm still fatigued.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Muscular weakness, Pyrexia, Tachycardia, White blood cell count increased
Clinical narrative: Patient presented to our hospital with fever of 102 F, elevated white blood count at 30.7, tachycardic at 123 beats/min and respiratory rate of 33 breaths/min. Patient presented with right-sided weakness in both the right arm and right leg. Infectious Disease consult determine patient has received pneumovax 23 within the past 5 years and this reaction could likely be due to an acute allergic reaction. Patient was given cool compresses, as needed acetaminophen for pain and started on piperacillin/tazobactam for empiric antibiotic treatment while cultures were finalizing. Piperacillin/Tazobactam was discontinued on 7/22/2019 due to rule out of infectious processes, symptoms resolved by 7/23/2019 with no further treatment and patient was discharged on 7/24/2019 in stable condition to home.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling cold, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: Pt noted right arm became sore 2-3 hours after administration. Felt warm and swollen. Over night felt chilled and heart racing. Pt came into office at 8am 09/11/2019 for eval.  Redness noted to inner arm, upper arm "well below" the injection site. Swelling with warmth and firmness of proximal upper arm. Pain with movement, is able to move her shoulder joint. Pain extends to axillae and upper back.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Palpitations, Peripheral swelling
Clinical narrative: Pt noted right arm became sore 2-3 hours after administration. Felt warm and swollen. Over night felt chilled and heart racing. Pt came into office at 8am 09/11/2019 for eval.  Redness noted to inner arm, upper arm "well below" the injection site. Swelling with warmth and firmness of proximal upper arm. Pain with movement, is able to move her shoulder joint. Pain extends to axillae and upper back.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus, Rash, Rash vesicular
Clinical narrative: itchy arm and leg and turned red. Then bumps with blister centers. Upper legs and arms and abdomen. Then shingles occurred at the site of the biopsy. The bumps occurred for a few weeks and are now all gone. All that remains is shingles at site of biopsy.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Influenza like illness, Pain
Clinical narrative: The next day after the shot I started to get the aches almost like the flu.  Once I got home and into bed it went down hill from there.  I had aches, chills really bad, fever and stomach ache, nothing would get rid of the aches and chills  I tried everything.  It lasted about 24 hours.  I started to feel better the next day and but was still weak for about two day afterwards.  I am so nervous about the second dose which I am scheduled for next Friday.  I want the weekend to recover if I need to.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The next day after the shot I started to get the aches almost like the flu.  Once I got home and into bed it went down hill from there.  I had aches, chills really bad, fever and stomach ache, nothing would get rid of the aches and chills  I tried everything.  It lasted about 24 hours.  I started to feel better the next day and but was still weak for about two day afterwards.  I am so nervous about the second dose which I am scheduled for next Friday.  I want the weekend to recover if I need to.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Diarrhoea, Dizziness, Vomiting
Clinical narrative: Patient reported severe diarrhea, vomiting, and dizziness. Patient went to emergency room where she reported receiving IV fluids.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient was administered an expired dose of Vaqta; Improperly stored and administered vaccine; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-AUG-2019, the patient was vaccinated with an improperly stored and expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R018775, expiration date 09-AUG-2019 (exact dose, injection site and route of administration were not reported) for prophylaxis. There were no details about improper storage provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects; improperly stored MMR II was administered; Information has been received from a pharmacy technician referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 15-AUG-2019, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot # R027063, expiration date: 20-SEP-2020, strength, dose, frequency and route were unknown) that was improperly stored (incorrect product storage). Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was exposed to temperature at 70 Fahrenheit degrees for 4 days. The data logger was involved. No previous excursions were reported. No adverse effects were reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; one male patient received improperly stored PROQUAD/ Vaccine administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient. There was no information about the patient's concurrent condition, concomitant medication and medically history provided.   On 03-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot number: R015741, expiration date: 02-DEC-2019 (dose, indication and route of administration were not reported) reconstituted with properly stored sterile diluent. No adverse effect reported.  The administrated dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was exposed to the highest temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour and 8 minutes. The previous temperature excursion was 15 degree Fahrenheit to 46 degree Fahrenheit (42.8) for 37 hours and 7 minutes. The digital data logger was involved.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea, Enema administration, Gastroenteritis rotavirus, Intussusception, Laboratory test normal
Clinical narrative: Vomiting; Intussusception; Rotavirus infection/diarrhea; This case was reported by a physician via sales rep and described the occurrence of intussusception in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 4TB5G, expiry date unknown) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Rotarix lyophilized formulation (oral). In August 2019, less than a week after receiving Rotarix lyophilized formulation, the patient experienced vomiting (serious criteria hospitalization). On 30th August 2019, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant) and diarrhea rotavirus (serious criteria hospitalization and GSK medically significant). The patient was treated with enema preparations (nos) (Enema (Nos)). In August 2019, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the intussusception and diarrhea rotavirus were recovered/resolved.   The reporter considered the intussusception, diarrhea rotavirus and vomiting to be possibly related to Rotarix lyophilized formulation.  Additional details were provided as follows: On 27th August 2019, the patient came back and complaining of vomiting and diarrhea. On 29th August 2019, the patient's mother took the patient to hospital and performed the laboratory tests, but the all tests were negative. On 30th August 2019, the patient's mother went to another hospital and tested positive for rotavirus. The patient was given an enema for the diagnosis of intussusception. No surgery needed because the enema resolved the problem. The patient followed up with on 4th September 2019 and the patient was much improved. The patient had no symptoms after leaving the overnight stay in the hospital. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Rotavirus test positive, Vomiting
Clinical narrative: Vomiting; Intussusception; Rotavirus infection/diarrhea; This case was reported by a physician via sales rep and described the occurrence of intussusception in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 4TB5G, expiry date unknown) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Rotarix lyophilized formulation (oral). In August 2019, less than a week after receiving Rotarix lyophilized formulation, the patient experienced vomiting (serious criteria hospitalization). On 30th August 2019, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant) and diarrhea rotavirus (serious criteria hospitalization and GSK medically significant). The patient was treated with enema preparations (nos) (Enema (Nos)). In August 2019, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the intussusception and diarrhea rotavirus were recovered/resolved.   The reporter considered the intussusception, diarrhea rotavirus and vomiting to be possibly related to Rotarix lyophilized formulation.  Additional details were provided as follows: On 27th August 2019, the patient came back and complaining of vomiting and diarrhea. On 29th August 2019, the patient's mother took the patient to hospital and performed the laboratory tests, but the all tests were negative. On 30th August 2019, the patient's mother went to another hospital and tested positive for rotavirus. The patient was given an enema for the diagnosis of intussusception. No surgery needed because the enema resolved the problem. The patient followed up with on 4th September 2019 and the patient was much improved. The patient had no symptoms after leaving the overnight stay in the hospital. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The patient was unable to obtain a second dose until at the time of reporting. How effective would a second dose be now since it is over a year since my first dose, which led to incomplete course of vaccination.
Age: 55.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product supply issue
Clinical narrative: product supply issue; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In June 2019, less than 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were received as follows: The pharmacist inquiring about the recommendations for a patient who went over the time frame for the 2nd dose.  The late dose was due to product shortage.  The reporter consented to follow up.