chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored VARIVAX; Information has been received from a pharmacist referring to a 54 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported.  On 01-APR-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R024023 and expiration date 22-AUG-2020; route of administration was not reported) for prophylaxis (incorrect product storage). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported.   The temperature excursion was from 15 Fahrenheit scale to 46 Fahrenheit scale for 744 hours. There was no previous temperature excursion. Data logger was not involved.  This is one of two linked cases received from the same reporter.; Sender's Comments:  US-009507513-1904USA006161:
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Injection site pain, Vaccination failure
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a patient who received Flu vaccine for prophylaxis. Co-suspect products included BENLYSTA unknown for an unknown indication. On an unknown date, the patient received Flu vaccine. In January 2019, the patient started BENLYSTA at an unknown dose and frequency. On an unknown date, unknown after receiving Flu vaccine and not applicable after starting BENLYSTA, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and injection site pain. (Dechallenge was unknown). Rechallenge with BENLYSTA was unknown. On an unknown date, the outcome of the vaccination failure, influenza and injection site pain were unknown. It was unknown if the reporter considered the vaccination failure, influenza and injection site pain to be related to Flu vaccine. It was unknown if the reporter considered the influenza and injection site pain to be related to BENLYSTA. Additional details were provided as follows: The age at vaccination was not reported. The patient received the first 2 doses of BENLYSTA but had to stop because she had the flu. She stated that she had received her influenza vaccine. She also reported that the infusions were painful. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Crying, Immediate post-injection reaction, Injection site pain, Product preparation issue
Clinical narrative: pain during injection; cried with the poke; Inappropriate reconstitution technique; Inappropriate reconstitution technique; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA055A, expiry date 30th November 2019) for prophylaxis.   On 5th April 2019, the patient received Menveo. On 5th April 2019, immediately after receiving Menveo, the patient experienced injection site pain, crying, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, crying, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain and crying to be related to Menveo.  Additional details were provided as follows: The batch number of powder portion of Menveo was reported, that was inadvertently not given. The patient received the liquid component of the Menveo only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter reported, the patient cried with the poke. No additional information was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 61-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 years or 61 years. The case was reported by the patient's brother who stated that the patient experienced tiredness with the SHINGRIX vaccine. The patient recovered the next day. The reporter provided the consent to follow up. No further information was provided. This case has been linked with case US2019061856, reported for the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to SHINGRIX. Additional details were provided as follows: The case was reported by relative of the patient's friend. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient experienced Guillain-Barre receiving SHINGRIX. The reporter did not have any other details, other than what was reported.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 58-year-old female patient who received SHINGRIX (batch number DD43M, expiry date unknown) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 8th March 2019, 190 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with prednisone and valaciclovir (Valacyclovir). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. Around 8th march 2019, the patient experienced Bells Palsy. On 8th March 2019, the patient was prescribed Prednisone 60 mg daily for 7 days and Valacyclovir 1 gram three times a day for 7 days.     Till the time of reporting, the patient did not receive 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The pharmacist consented to follow up. This case has been linked to US2019063122, reported by the same reporter.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Nasopharyngitis, Viral infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of viral infection in a 79-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced viral infection, cold and drug dose administration interval too long. On an unknown date, the outcome of the viral infection was recovered/resolved and the outcome of the cold and drug dose administration interval too long were unknown. It was unknown if the reporter considered the viral infection and cold to be related to SHINGRIX. Additional details were reported as follows: The reporter stated he received 1st SHINGRIX dose in August 2018 and asked if it's too late to take the second dose (late dose). The reporter said his local pharmacy should be receiving it this week, which led to to lengthening of the vaccination schedule. The reporter also mentioned that after his first dose less than a year after vaccination the patient got a viral infection of some kind. Probed further to understand viral infection as a cold. The reporter did not give consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 2nd April 2019, the patient received the 1st dose of SHINGRIX. On 5th April 2019, 3 days after receiving SHINGRIX, the patient experienced shingles, pain and pruritus. On an unknown date, the outcome of the shingles, pain and pruritus were not recovered/not resolved. It was unknown if the reporter considered the shingles, pain and pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician's assistant. The batch number and expiry date were not reported. On 5th April 2019, the patient developed pain and itching of the skin and at the day of reporting had full blown shingles.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 05-Apr-2019 regarding an unsolicited non-valid non-serious case received from a nurse. This case involves a 15 years and 9 months old patient who was vaccinated with MENACTRA and TRUMENBA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Jul-2014, the patient received a MENACTRA (Solution for injection) (lot: U6207AA, expiry date: 25-May-2020) in the left arm. On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. It was an actual medication error due to Inappropriate schedule of vaccine administered. It was reported that the patient had a dose of MENACTRA on 18-Jul-2014 so it hasn't been five years and received TRUMENBA. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Mobility decreased, Pain, Swelling
Clinical narrative: complaining of redness, swelling and pain; could not move her arm enough to remove her coat; Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 17 years old female patient who was complaining of redness, swelling and pain and could not move her arm enough to remove her coat, post she received vaccines MMR VACCIN and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6214AA via unknown route in the left deltoid. On 27-Mar-2019, the patient received a  dose of suspect MMR VACCIN not produced by Sanofi Pasteur lot number not reported via unknown route in the left arm.  On 31-Mar-2019, The patient developed a non-serious complaining of redness, swelling and pain (vaccination site inflammation) 4 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and 9 days following the administration of MMR VACCIN. On 31-Mar-2019, The patient developed a non-serious could not move her arm enough to remove her coat (administration site joint movement impairment) 4 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and 9 days following the administration of MMR VACCIN.  Lab test not reported.  Final diagnosis was could not move her arm enough to remove her coat and complaining of redness, swelling and pain.   The patient was treated with PREDNISONE (PREDNISONE).  The patient outcome is reported as Recovering / Resolving for events ("the redness faded quite a bit and she could use her arm again).
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 62 years old female patient (also reported as 63) who was accidentally vaccinated with twice dose of MENACTRA (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 11-Feb-2019 and again today in error (date not reported) but should had received TRUMENBA. The patient's past medical history included splenectomy in November and Immunodeficiency. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was also a case of actual medication error due to inappropriate age at vaccine administration, extra dose administered and wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: swelling, soreness and a lump at the injection site; Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case was cross-referenced with case 2019SA098659 (same reporter).  This case involves 42-year-old patient who experienced redness and swelling at site of injection, while they received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6128AA, Exp. Date: 15-Dec-2020) in the left deltoid.  On an unknown date, the patient developed non-serious swelling, soreness and a lump at the injection site(injection site inflammation) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of lab data not reported.  Final diagnosis was redness and swelling at site of injection.   It was not reported if the patient received any corrective treatment.  The event outcome was not reported.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: accidentally administered a dose of diluent to a patient, and no vaccine/no AE; Initial information received on 08-Apr-2019 regarding an unsolicited non-valid non-serious case received from a consumer/non-health care professional.  This case involves a 18 months old male patient who accidentally received a dose of diluent of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HAVRIX) for Immunisation.  On 08-Apr-2019, the patient received a 0.5 ml single dose 3 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5444AA via unknown route in the left leg.  It was a case of actual medication error because active ingredient not added to diluent.  It was reported that patient experienced no symptoms.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MNQ
Symptoms: Anaphylactic shock, Throat tightness
Clinical narrative: Initial information received on 08-Apr-2019 regarding an unsolicited valid serious case received from a Pharmacist. This case involves a male patient (age not reported) who experienced severe anaphylactic shock, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6016AA (expiry date: Oct-2019) via unknown route in unknown administration site. On an unknown date, the patient developed a severe anaphylactic shock couple of weeks ago (Unknown latency) with symptom throat closing up (throat tightness) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. These events were assessed as medically significant. Other relevant tests were not reported. Final diagnosis was Severe anaphylactic shock. It was not reported if the patient received a corrective treatment. The outcome was the events was not reported. List of documents held by sender: none.; Sender's Comments: This case concerns a male patient of unknown age who experienced anaphylactic shock with throat closing up after vaccination with MENACTRA. The time to onset is unknown. Further information including patient's medical history of allergies with any product, food, etc, previous vaccination and tolerance, time to onset, allergy testing and laboratory investigations excluding other etiology would be needed to complete assessment of this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: administration of expired Fluzone HD to a patient; Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66 years old female patient who received an expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy taken.   On 08-Apr-2019, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI993AB (expiry date: 18-Mar-2019) via intramuscular route in the right deltoid.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether adverse event was observed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.83
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient received expired Daptacel/ no AE; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional via phone.  This case involves a 10 months old female patient who was vaccinated with an expired 0.5 ml third dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5180AA and expiry date: 06-Apr-2019) via intramuscular route in the left thigh on 09-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) and POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Daptacel was given to a patient; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from an-other healthcare professional by phone.  This case involves a 24 months old female patient who was vaccinated with an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5101AA and expiry date: 26-Nov-2018) via intramuscular route in the right thigh on 05-Apr-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: F
Vaccine: DTAP, UNK
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old, female patient inadvertently received Daptacel vaccine when she was due for a Tdap vaccine; 11 year old, female patient inadvertently received Daptacel vaccine; Initial information received on 08-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 11 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5169AA, expiry date- 16-Mar-2019 via intramuscular route in the right deltoid on 01-Aug-2018 instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Incorrect route of product administration
Clinical narrative: a patient received Imovax which was administered subcutaneously rather than intramuscular; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves a female patient (age at the time of vaccination) who received a dose of RABIES (HDC) VACCINE [IMOVAX RABIES] lot N1K30, expiration date: 28-Oct-2019 via subcutaneous route in the right arm on 09-Apr-2019.  The patient had monkey bite.  The patient's other past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  It was an actual medication error due to inappropriate route of vaccination. A patient received Imovax which was administered subcutaneously rather than intramuscular.  It was unknown whether patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Body temperature increased, Extra dose administered, Wrong product administered
Clinical narrative: 99.3 fahrenheit  temperature; Pentacel was ordered, but a dose of ActHib was inadvertently given; Pentacel was ordered, but a dose of ActHib was inadvertently given; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months old male patient who experienced 99.3 fahrenheit temperature, while he received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 08-Apr-2019, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UJ072AAA via intramuscular route in the right deltoid.  On 08-Apr-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious 99.3 fahrenheit temperature (body temperature increased) following the administration of HIB (PRP/T) VACCINE and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was also the case of actual medication error due to wrong vaccine administered and Extra dose administered. It was reported that the patient received an extra dose of the Hib, on 08 Apr 2019. Pentacel was ordered, but a dose of ActHib was inadvertently given   (Other relevant tests included no lab data.)  Final diagnosis was 99.3 fahrenheit temperature.   It was not reported if the patient received a corrective treatment.  The outcome of the event body temperature increased was not 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.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: had an allergic reaction, developed hives; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from a Non-health care professional (Office staff member).  This case involves a 2 months old male patient who had an allergic reaction, developed hives, while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history and family history were not provided. At the time of the event, the patient had ongoing latex allergy.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) on 09-Apr-2019.  On 09-Apr-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ062AAA, expiry date 13-Jun-2020 via unknown route in the left thigh.  On an unknown date, the patient developed a non-serious had an allergic reaction, developed hives (urticaria) with unknown latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Lab data was not provided.  Final diagnosis was had an allergic reaction, developed hives.   The infant was monitored, injection site was wiped off and Benadryl 1.5 ml oral suspension was given as a corrective treatment.  The patient outcome is reported as Unknown for had an allergic reaction, developed hives.  List of documents held by sender- none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: the patient did not receive the ActHib portion of the Pentacel vaccine, she asks if she can go ahead and administer it now and if so what diluent to use; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient of unknown age who did not receive the Act-HIB portion of the Pentacel vaccine, she asks if she can go ahead and administer it now and if so what diluent to use, while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 09-Apr-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6138AB via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: After approximately 7 hours after receiving injection, I started to experience some pain in the injection site.  This rapidly got worse and within half an hour, I had extreme pain from shoulder area to fingertips and inability to move my arm.  I took ibuprofen and applied ice for the pain.  Little relief.  After about 7 hours, I was able to move my arm slightly.  The pain gradually eased up over the next 24 hours as ability to move the arm gradually improved.  However, injection site remained sore for several days.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Fall, Nuclear magnetic resonance imaging normal, Skin laceration, Tinnitus
Clinical narrative: Vaccine was give one Saturday afternoon at Pharmacy (walk-in). Was awaken early next morning with very loud ringing in ear (right) and discovered NO hearing in left ear. Not sure of cause, I made an appointment with an ENT Dr. I fell on brick steps that Sunday and torn skin off shins forcing a visit to a wound clinic for care. Dr there did not know why the ear loss happened, but encouraged me to see ENT immediately. Still have no hearing in left ear, had MRI done that did not show tumor or aware of any recent traumatic event of cause. I am on last week of prednisone. Was advised NOT to get second shot.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX (lot # and route not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. As a direct and proximate result, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result the patient sustained severe and permanent personal injuries. Further as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, anguish, emotional distress, loss of enjoyment of life, physical impairment in injury. Shingles and vaccination failure were reported to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: painful burning mouth rash; painful buring rash on legs and arms; pain ful burning rash on groin; did not prevent shingles; Information was received on 05-APR-2019 from a lawyer regarding a case in litigation involving a male patient, age and history unknown.  On an unspecified date the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles.  The vaccine did not prevent shingles but rather cause the patient to suffer a painful burning rash all over hands, arms, mouth, groin and legs.  As a result the patient suffered significant medical expenses, pain and suffering.  Outcome of the rashes was not provided.    Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) PROQUAD was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 04-APR-2019, the patient was administered improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number R020815, expiration date 16-JAN-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (No lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA004258: US-009507513-1904USA005133: US-009507513-1904USA005129: US-009507513-1904USA005627: US-009507513-1904USA005628: US-009507513-1904USA005629: US-009507513-1904USA005630: US-009507513-1904USA005631:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) PROQUAD was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 04-APR-2019, the patient was administered improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number R020815, expiration date 16-JAN-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (No lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA004258: US-009507513-1904USA005130: US-009507513-1904USA005133: US-009507513-1904USA005129: US-009507513-1904USA005627: US-009507513-1904USA005628: US-009507513-1904USA005629: US-009507513-1904USA005630: US-009507513-1904USA005631:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 30-MAR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (No lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005630: US-009507513-1904USA005629: US-009507513-1904USA005628: US-009507513-1904USA005631: US-009507513-1904USA005627:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 05-APR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (No lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005133: US-009507513-1904USA005629: US-009507513-1904USA005628: US-009507513-1904USA005631: US-009507513-1904USA005627:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 05-APR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (No lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005630: US-009507513-1904USA005629: US-009507513-1904USA005628: US-009507513-1904USA005133: US-009507513-1904USA005627:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Disturbance in attention, Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included TYLENOL. On 2nd April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 3rd April 2019, the patient experienced dizziness, headache, weakness, heart racing, nausea, rash, chills, diarrhea, lower extremities weakness of, mental concentration difficult, pulse increased and fever. On an unknown date, the outcome of the injection site pain, weakness, lower extremities weakness of and mental concentration difficult were not recovered/not resolved and the outcome of the dizziness, headache, heart racing, nausea, rash, chills, diarrhea, pulse increased and fever were recovered/resolved. It was unknown if the reporter considered the injection site pain, dizziness, headache, weakness, heart racing, nausea, rash, chills, diarrhea, lower extremities weakness of, mental concentration difficult, pulse increased and fever to be related to SHINGRIX. Additional details were reported as follows: The patient was vaccinated on left arm, intramuscularly. The patient planned to follow-up with his physician on an unknown date.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Injection site pain, Muscular weakness, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included TYLENOL. On 2nd April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 3rd April 2019, the patient experienced dizziness, headache, weakness, heart racing, nausea, rash, chills, diarrhea, lower extremities weakness of, mental concentration difficult, pulse increased and fever. On an unknown date, the outcome of the injection site pain, weakness, lower extremities weakness of and mental concentration difficult were not recovered/not resolved and the outcome of the dizziness, headache, heart racing, nausea, rash, chills, diarrhea, pulse increased and fever were recovered/resolved. It was unknown if the reporter considered the injection site pain, dizziness, headache, weakness, heart racing, nausea, rash, chills, diarrhea, lower extremities weakness of, mental concentration difficult, pulse increased and fever to be related to SHINGRIX. Additional details were reported as follows: The patient was vaccinated on left arm, intramuscularly. The patient planned to follow-up with his physician on an unknown date.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included TYLENOL. On 2nd April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 3rd April 2019, the patient experienced dizziness, headache, weakness, heart racing, nausea, rash, chills, diarrhea, lower extremities weakness of, mental concentration difficult, pulse increased and fever. On an unknown date, the outcome of the injection site pain, weakness, lower extremities weakness of and mental concentration difficult were not recovered/not resolved and the outcome of the dizziness, headache, heart racing, nausea, rash, chills, diarrhea, pulse increased and fever were recovered/resolved. It was unknown if the reporter considered the injection site pain, dizziness, headache, weakness, heart racing, nausea, rash, chills, diarrhea, lower extremities weakness of, mental concentration difficult, pulse increased and fever to be related to SHINGRIX. Additional details were reported as follows: The patient was vaccinated on left arm, intramuscularly. The patient planned to follow-up with his physician on an unknown date.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: INJECTION SITE HAD A LARGE RED WELT WITHIN MINUTES, THAT WAS ABOUT 1 INCH IN DIAMETER. IT WAS BRIGHT RED, RAISED, AND VERY FIRM TO THE TOUCH.  BY 2PM AFTER THE INJECTION, SHE WAS COVERED IN MILD HIVES ALL OVER HER CHEST, STOMACH, BACK, AND BUTTOCKS.  BOTH THE RED WELT AND HIVES STAYED CONSISTENT IN APPEARANCE FOR 3 DAYS. UPON WAKING ON THE 4TH DAY, THE HIVES WERE GONE.  THE REDNESS AT THE INJECTION SITE WAS GONE, BUT THE INJECTION SITE IS STILL RAISED AND FIRM TO THE TOUCH (TODAY IS DAY 5).