chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Laboratory test normal, Personality change, Speech disorder
Clinical narrative: The morning after receiving immunization, patient's verbalizations changed to less verbal sounds, more "mmms" with a closed mouth. He was much more muted and nonverbal beginning Day 1 after receiving PEDIARIX. He clearly spoke 7 words prior to immunization at 10 months. His speech began deteriorating by Day 4: his pronunciation of the words "dog" and "book" which he already spoke clearly deteriorated. Eventually he stopped speaking these words altogether. Over the course of the next 4 weeks, he lost all words that he had previously produced except for one: "ball," but no longer pronounces the word fully. About 4-5 weeks later, he did produce one new word, "mama," which he has retained. Now at 4 months after the immunization, he has not produced any other new words or recovered any of the words that he spoke previously (bird, book, dog, etc.). He gets visibly frustrated not being able to communicate what he wants and says "da" a lot. Sometimes he shapes his lips like he's trying to pronounce a word, but no sound comes out. He does not repeat words after us if we try to prompt him to speak. He has also reverted to mouthing things and picking up tiny objects from the floor and eating them, which he had previously stopped doing at 8 or 9 months. He continues to do this at 14 months.  Patient's walking/gait also deteriorated. He was taking about 6 steps at a time prior to the immunization, but the day afterwards, he tried to take steps but kept rolling his ankles and falling - this never happened before. This progressed to the point where de didn't even try to walk. After about 1 month, he started taking steps but his gait has been different and he trips and falls often, doesn't have the same balance that he did before when he was taking steps. He is very bowlegged and pigeon-toed.  His behavior and personality has also changed. He gets frustrated often and almost seems irritable, throwing a fit if he isn't allowed to do what he wants. He used to be a much happier baby. He also is a much pickier eater now, where he used to eat anything we fed him.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Mild fever/chills 6 hours after injection -. arm soreness after injection increasing in intensity.  Take one 500 mg Tylenol tablet for fever. Morning following injection left arm was not usable due to pain and soreness.  Second day after injection arm still sore and of limited use.  Day three arm still sore but usable. Day four most adverse reactions gone
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events happened, vaccine was expired but was given due to not right expiration date in database. So vaccine was not pulled from fridge.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Chills, Headache, Influenza like illness, Malaise
Clinical narrative: Shivers, headache, agitation, malaise,  Can?t function -feels like I have the flu
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess, Injection site swelling, Wrong technique in product usage process
Clinical narrative: Pt was given Shingrix via a 5/8" syringe rather than a 1" syringe. Pt experienced redness and swelling at the site of injection (left deltoid).
Age: 0.33
Sex: U
Vaccine: HIBV, UNK
Symptoms: Incorrect route of product administration, No adverse event, Product administration error
Clinical narrative: No adverse effects reported; a dose of PEDV AXHIB inadvertently had DILUENT injected into the vial; the dose was administered orally to a 4 month old child; This spontaneous report was received from a physician. It was reported that on 15-JUL-2019, a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (PEDVAXHIB) for prophylaxis (lot number and expiration date were not provided), inadvertently had sterile diluent (STERILE DILUENT) (lot number and expiration date were not provided) into the vial and the dose was administered orally to a 4-months-old patient of an unknown gender (product administration error and incorrect route of product administration). Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medications was not provided.  It was reported that the child was in office for well-baby check. No adverse effects were reported. It was mentioned that the baby was doing fine.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No advers effects reported; 2 improperly stored doses of PROQUAD administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R080798, expiration date reported as 22-APR-2020 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature from -9 degree celsius to 8 degree celsius (2.62C), during 4 hours. There was not previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.  Lot number R080798 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.; Sender's Comments:  US-009507513-1907USA015729:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history,  or drug reactions/allergies. Concomitant medications included sterile diluent.     On 19-JUL-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were not reported, lot # S003449, expiration date was 04-FEB-2021) for prophylaxis (product storage error). The sterile diluent (lot# was S007959, expiration date was 19-AUG-2021) used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored. No adverse effects were reported.  There was no previous temperature excursion. The highest temperature was 5.7 Fahrenheit (F) for 1 hour and 32 minutes. It was call because of data logger.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: no known adverse events; a patient received less than a full dose of PROQUAD because the plastic syringe leaked; a patient received less than a full dose of PROQUAD because the plastic syringe leaked; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical histories, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 22-JUL-2019, the patient was vaccinated with less than a full dose (incorrect dose administered) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (POQUAD) rHA, Lot No. R008203 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported as 05-JUL-2020, but upon internal validation established as 16-SEP-2019 (dose, frequency, strength, route of administration were not reported) for prophylaxis. It was reported that the plastic syringe leaked (product leakage) and it was unknown exactly how much of a dose the patient actually received. No known adverse events. The outcome of product leakage was unknown.  The causal relationship between product leakage and therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (POQUAD) was not provided.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Death
Clinical narrative: three days after vaccination the patient died; This spontaneous report was received from a nurse practitioner via a company representative and refers to a healthy female patient of unknown age. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), (unidentified Merck hpv vaccine administered; name, dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, reported as three days after vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was done.   The relatedness between the patient's death and suspect vaccine was not provided.
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Skin discolouration, Swelling, Ultrasound scan
Clinical narrative: patient developed "Lymphadenopathy in the right groin"; This spontaneous report was received from a registered nurse referring to a 15 month old female patient with dermatitis atopic. The patient's concomitant therapy included desonide.   On 07-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R029513, expiration date: 14-OCT-2020) subcutaneous as routine vaccination. On 12-JUL-2019, the patient developed "lymphadenopathy in the right groin". The patient was taken to the emergency room and was prescribed with clindamycin and received an ultrasound of her right groin (results not provided). The reporting nurse mentioned that the patient's right groin was "purple, discolored and swollen." At the reporting time, the outcome of lymphadenopathy was reported as not recovered. The causal relationship between therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the event lymphadenopathy was not provided.
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative, Therapy non-responder
Clinical narrative: she received two separate doses of VARIVAX and "did not seroconvert."; This spontaneous report has been received from a pharmacist concerning a currently 19 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2001 (reported as "around the age of 1 year old"), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, lot number and expiration date were not provided), administered subcutaneously for prophylaxis.   It was reported that the patient needed to have confirmation of positive immunity to varicella for an unspecified reason, therefore the physician ordered a serum testing done on an unknown date, which was negative for titers to varicella (seroconversion test negative).  On 20-JUN-2019, the patient was vaccinated with the second dose (reported as "the first adult") of varicella virus vaccine live (oka/merck (VARIVAX) (dose, lot number and expiration date were not provided), administered subcutaneously as re-vaccination due to failure to seroconvert.   The patient confirmed that the two separate doses of varicella virus vaccine live (oka/merck (VARIVAX) did not seroconvert.  At the time of reporting, the outcome of seroconversion test negative and the causal relationship between the event and varicella virus vaccine live (oka/merck (VARIVAX) were unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No advers effects reported; 2 improperly stored doses of PROQUAD administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 16-JUL-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R080798, expiration date reported as 22-APR-2020 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature from -9 degree celsius to 8 degree celsius (2.62C), during 4 hours. There was not previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.  Lot number R080798 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.; Sender's Comments:  US-009507513-1907USA012694:
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; a 2 month old patient was inadvertently administered a dose of PNEUMOVAX 23; a 2 month old patient was inadvertently administered a dose of PNEUMOVAX 23; This spontaneous report was received from a registered nurse and refers to a 2-month-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not reported.  On 26-JUL-2019, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #, expiry date, exact dose, route of administration and anatomical location were not provided) for prophylaxis.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Fainting; This case was reported by a physician via sales rep and described the occurrence of fainting in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. In July 2019, less than an hour after receiving Bexsero, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero.  Additional details were provided as follows: The patient fainted after vaccination of Bexsero. The patient received vaccine on an unknown arm sometime last week before the date of reporting. This case has been linked to the case US2019133857, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles aggravated; blisters; Pain; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and pain. On an unknown date, the outcome of the vaccination failure, shingles, blister and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had several out breaks of shingles since received both shots. They were coming more often than before the shots. The patient wanted to know is there anything else that could be done to prevent the shingles out break or put on the blisters to make them less painful. This case was considered as suspected vaccination failure as time to onset for the event unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness; swelling; This case was reported by a pharmacist and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient's pre-screening sheet reported nothing. The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced injection site swelling and redness. For tolerance after 2nd dose of Shingrix, refer case US2019106103, reported for same patient.
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Inflammatory bowel disease
Clinical narrative: Inflammatory bowel disease; Condition aggravated; This case was reported in a literature article and described the occurrence of inflammatory bowel disease in a male patient who received Herpes zoster (Shingrix) for prophylaxis.    Concurrent medical conditions included inflammatory bowel disease.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced inflammatory bowel disease (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the inflammatory bowel disease and condition aggravated were unknown.   The reporter considered the inflammatory bowel disease and condition aggravated to be possibly related to Shingrix.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of an inflammatory bowel disease (IBD) exacerbation in a male aged between 50 and 81years, who was vaccinated with Shingrix vaccine (GlaxoSmithKline) for prophylaxis. The patient was a part of cohort study that aimed to monitor for IBD exacerbation after recombinant zoster vaccine (RZV-Shingrix) administration in a larger cohort of patients. The patient's concurrent condition included IBD. No information on patient's medical history or family history or concomitant medication were provided. On an unspecified date between February 2018 and November 2018, the patient received the 2nd dose of Shingrix vaccine injection (administration route and site unspecified; batch number not provided).  [In this study, most patients received the vaccine at their local pharmacy due to limited availability and insurance preference]. Age of vaccination was not provided. On an unspecified date, 3 days after vaccination, the patient had flare of IBD, as defined by requiring a change in medical therapy. Treatment was unknown. The outcome of the event was not provided. The authors stated, "There was a theoretical concern that patients with immune mediated diseases may develop worsening of their condition after RZV administration. Early results from this study suggest that RZV is safe in IBD patients on immunosuppressive medications. One patient (2% of the cohort) receiving his second dose of RZV had an exacerbation of his IBD. Larger studies with longer follow-up are needed to confirm that IBD and other immune mediated diseases are not worsened after vaccination with RZV."
Sex: F
Vaccine: VARZOS
Symptoms: Faecaloma, Gastrointestinal injury
Clinical narrative: Rupture in gastrointestinal tract; Fecal impaction; This case was reported by a nurse via call center representative and described the occurrence of fecal impaction in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced fecal impaction (serious criteria GSK medically significant) and injury to gastrointestinal tract. On an unknown date, the outcome of the fecal impaction was recovered/resolved and the outcome of the injury to gastrointestinal tract was unknown.   It was unknown if the reporter considered the fecal impaction and injury to gastrointestinal tract to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix vaccine in left deltoid. She stated the next day she experienced fecal impaction and she had to manually remove the fecus because she thought it might rupture her gastrointestinal tract. This incident lasted for about 4 hour and was resolved.  Additional information was unspecified. The reporter gave consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: patient received the diluent portion of the Pentacel vaccine, and did not receive the lyophilized powder portion; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a four years 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 UI953AA and Exp. Date 30-JUN-2020) via intramuscular route in the right vastus lateralis on 28-Jun-2019.  The patient's past vaccination(s) included first and second doses of Pentacel (first dose was Jun2015, second was Aug 2016).  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunization.  It was an actual medication error case due to inappropriate reconstitution technique as the patient received the diluent portion of the Pentacel vaccine, and did not receive the lyophilized powder portion.  It was unknown whether the patient 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.  Follow up information received from an other health professional on 17-Jul-2019.  No new information was reported.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Menactra administered; Initial information received on 22-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 18 years old male patient who was vaccinated with 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5948AB (Expiry date 03-Jul-2019 ) via intramuscular route in the left deltoid, on 22-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines were given.   It was a case of actual medication error due to expired vaccine used. It was reported that expired dose of Menactra administered.  At a time of reporting no adverse reaction 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 party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Henoch-Schonlein purpura, Vasculitis
Clinical narrative: Henoch Schonlein/Vasculitis; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient who experienced henoch schonlein/vasculitis, while he/she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious henoch schonlein/vasculitis (henoch-schonlein purpura) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Other relevant tests were not reported.  Final diagnosis was henoch schonlein/vasculitis.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for henoch schonlein/vasculitis.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: two of the three patients were administered the liquid component only (DTaP-IPV) and not the lyophylized componet (Hib); Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves two patients who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that two of the three patients were administered the liquid component only (Dtap-IPV) and not the lyophylized componet (HIB).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 16-Jul-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5544AA and expiry date: 06-Oct-2019 via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Menactra administered; Initial information received on 22-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old male patient who was vaccinated with 0.5 ml second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5917AA via intramuscular route in the left deltoid, on 23-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used. It was reported that expired dose of Menactra administered.  At a time of reporting no adverse reaction 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 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: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given Adacel within a 18 month window without looking in chart; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA202447, same reporter.  This case involves a 48 years old male patient received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (HEPLISAV B) and HEPATITIS A VACCINE INACT (VAQTA).  The patient received first dose for suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, lot number unknown on 21-Aug-2018. On 22-Jul-2018, the patient received a pre filled syringe, first dose 0.5ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6226AA, expiry date 10-Apr-2021 via intramuscular route in the left deltoid.  It was an actual medication error due to Drug dose administration interval too short.  It was reported that given Adacel within a 18 month window without looking in chart.  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: 5.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: five years patient received Adacel instead of Daptacel, no advesre event; five years patient received Adacel instead of Daptacel, no advesre event; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a five years old female patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of fifth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot U6202BA via intramuscular route in the left thigh on 08-Jul-2019.  The patient's past vaccination(s) included four doses of daptacel vaccine and  concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Immunization.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event reported 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.  List of documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: flu like symptoms lasted for several days; redness at the injection site lasted for several days; swelling at the injection site lasted for several days; burning at the injection site lasted for several days; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 32 years old female patient who developed flu like symptoms lasted for several days, redness at the injection site lasted for several days, swelling at the injection site lasted for several days and burning at the injection site lasted for several days, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The gestation period at onset was reported as 30 weeks The date of last menstrual period was not reported. The estimated due date was not reported.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication: None.   On 08-Jul-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U62103AA, expiry date: 24-Apr-2021, dose in series not reported) via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious flu like symptoms lasted for several days (influenza like illness), redness at the injection site lasted for several days (vaccination site erythema), swelling at the injection site lasted for several days (vaccination site swelling) and burning at the injection site lasted for several days (vaccination site pain) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No Lab data was reported.  Final diagnosis was burning at the injection site lasted for several days, swelling at the injection site lasted for several days, redness at the injection site lasted for several days and flu like symptoms lasted for several days.   It was not reported if the patient received a corrective treatment.  The events outcome were reported as Recovered / Resolved on an unknown date for all the events.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.   Documents held by the sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose of Menactra was inadvertently administered to a patient on 18Jul2019; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 11 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that expired dose of Menactra was inadvertently administered to a patient on 18Jul2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL); and HPV VACCINE (HPV VACCINE).  On 18-Jul-2019, the patient received a 1 dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5948AB and expiry date: 03-Jul-2019 via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently received second dose of Adacel and Menactra; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6219AA via intramuscular route in the left arm and -2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6202BA via intramuscular route in the right arm on 18-Jul-2019 and also received previously both the vaccines on 24-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to extra dose administered. It was reported that patient inadvertently received second dose of Adacel and Menactra on 18Jul2019 after had previously both the vaccines on 24Apr2019.  It was not reported whether the patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given Adacel within a 18 month window without looking in chart; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA202425, same reporter.  This case involves a female patient of an unknown age who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history and family history were not provided.  On an unknown date, the patient received two doses of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number, expiry date, route and site of administration were unknown).  It was an actual medication error due to Drug dose administration interval too short.  It was reported that given Adacel within a 18 month window without looking in chart.  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.  Information on batch number was requested for this case.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient inadvertently received second dose of Adacel and Menactra on 18-Jul-2019, patient had previously received both vaccines on 24-Apr-2019/ no symptoms; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 11 years old male patient who received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) on 24-Apr-2019.  On 18-Jul-2019, the patient received a second dose 0.5ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6202BA via intramuscular route in the right arm. On 24-Apr-2019 he also received a first dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. On 18-Jul-2019, the patient received a second dose 0.5ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6219AA via intramuscular route in the left arm. On 24-Apr-2019 he also received a first of the same vaccine with an unknown batch number via unknown route in unknown administration site.  It was an actual medication error due to extra dose administered.  It was reported that patient inadvertently received second dose of Adacel and Menactra on 18-Jul-2019, patient had previously received both vaccines on 24-Apr-2019.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: TYP
Symptoms: Adverse event, Incorrect route of product administration
Clinical narrative: 8 year old patient who took 1 oral dosage instead of injectable and he didn't tolerate it; 8 year old patient who took 1 oral dosage instead of injectable; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 8 years old patient who was vaccinated with a dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] lot number not reported via oral route.  The patients medical history and concomitant medications were not reported.  It was an actual medication error due to inappropriate route of vaccination (8 year old patient who took 1 oral dosage instead of injectable).  On unknown date,  patient experienced an adverse event following vaccination. It was reported as an 8 year old patient who took 1 oral dosage last Wednesday, and he didn't tolerate it.  No lab data or corrective treatment provided.  Patient's outcome for adverse event NOS was 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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP, HIBV, IPV, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel, ActHIB, Daptacel and opened IPOL that reached 54 degrees F. for 15 hours vaccine at 1730 on 23JUL2019. This morning, 24JUL2019 at 0845 the refrigerator door was discovered to be open; Initial information received on 24-Jul-2019 regarding an unsolicited valid non-serious case received from a Consumer.  This case involves child male patient who was vaccinated with IPV (VERO) lot NIG51 (Expiry date 02-Aug-2019) on 23 July 2019.  It was reported that there were unopened HIB (PRP/T) VACCINE lot UI990AAA (Expiry date 01-Apr-2020), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5254AA (Expiry date 14-Mar-2021),  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6214AA (Expiry date 18-Sep-2019) in the refrigerator.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage, it was reported that Adacel, ActHIB, Daptacel and opened IPOL that reached 54 degrees F. for 15 hours vaccine at 1730 on 23JUL2019. This morning, 24JUL2019 at 0845 the refrigerator door was discovered to be open.  It was reported that, no adverse reaction 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.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave Daptacel to a 7-year old; Initial information received on 24-Jul-2019 regarding an unsolicited valid non-serious case received from a physician Assistant.  This case involves a 7 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history and family history were not provided. The patient did not receive any concomitant medication.   On 23-Jul-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date not reported via unknown route in unknown site.  It was an actual medication error due to inappropriate age at vaccine administration. It was reported that gave Daptacel to a 7-year old patient.  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: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: erythrema, swelling
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Herpes zoster, Muscle spasms, Muscle strain
Clinical narrative: I have had 2 shingles outbreaks previous to receiving Shingrix. My outbreaks weren't exactly typical as the rashes were small and in unusual places - I had one outbreak on the sole of my foot. The pain would be intense but manageable before the outbreak, easing off once the blisters surfaced. All told an outbreak would last a week to 10 days.   I had Shingrix about 6 months ago. Several weeks ago I pulled a muscle in my back. My back was seizing up, and the pain was migrating around the front of my torso and into my stomach. My whole left side of my torso was in excruciating pain. I first went to an urgent care clinic and was prescribed muscle relaxers. They did nothing. That night the pain was so bad I went to the emergency room. I was given an IV anti-inflammatory drug - nothing. I was then given an IV opioid, which took the edge off.   I was prescribed opioids, and they helped if I took enough. Then the skin on my stomach started to get that burning/itching feeling and I recognized it as shingles. I had a rash on my left buttocks. I went to my provider and she confirmed my condition. I was prescribed neurontin.   Instead of my normal 7 - 10 day manageable outbreak, this one has lasted 18 days and counting. Not only that, but the pain was at a level I never experienced. I've done a full course of Valtrex, but the shingles remains. The rash has now cleared up, but the skin and stomach pain remain.  In my experience, Shingrix not only didn't prevent an outbreak it actually intensified the symptoms X3.   I have HSV2, if that has any bearing on anything.