chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: while injecting, Typhim vi syringes came apart and the first injection the medicine ran down the patient arm; while injecting Typhim vi syringes came apart; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2019SA121013 (case for pharmacist).  This case involves a 57 years old male patient who received a 0.5ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] prefilled syringes lot N1K81, Box for the 2 syringes Lot: N1K811M, expiration date: 19-Oct-2019 via unknown route in the left arm on 25-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of exposure via skin contact and syringe issue. Reporter had 2 Typhim VI syringes that were pressurized and while giving the injections to the patient the syringe came apart from the syringe. The first injection the medicine ran down the patient's arm and the second injection the medicine shot in reporter's lap. She tried a third typhim VI and she was able to give the dose. The first 2 injections were given in the L arm 2 inches away. The third injection was given in the right arm. The patient didn't receive any other vaccines that day.  At the time of reporting, no adverse event was reported.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered
Clinical narrative: double dose of polio was administered to the child; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a nine-months old male patient who received double dose of polio while received vaccine IPV (VERO) [Ipol] and Pediarix (HepB, Polio and DTAP).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) for Immunisation.  On 29-Apr-2019, the patient received a 0.5 ml  dose of suspect IPV (VERO) lot P1A37, expiry date: 29-Apr-2019 via intramuscular route in left vastus lateralis.  It was as an actual medication error case due extra dose administered. There a concern that a double dose of Polio was administered to the child (Ipol & Pediarix).  It was not reported whether the patient had 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient had an expired Daptacel/ no side effects; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a female patient who received expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received a ActHIB and ProQuad on 29-Apr-2019.   On 29-Apr-2019, the patient received a single 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5190AA via intramuscular route in the right thigh (Expiration Date: 24-Apr-2019).  It was of actual medication error due to expired vaccine used.  It was reported that no side effect 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: while giving the injections to the patient, the second injection the medicine shot ran down in my lap; while injecting Typhim vi syringes came apart; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA120316 (patient's case).  This case involves a patient of unknown demographic who experienced occupational exposure to product, while giving the injection of vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot number N1K81and Exp. Date 19-Oct-2019) to patient on 25-Apr-2019.  The patient's past medical history not reported.   This was a case of occupational exposure to product and Syringe issue as while giving the injections to the patient, the second injection the medicine shot ran down in pharmacist lap as syringe came apart from the syringe.  It was not reported whether patient experienced 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: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received DTap (Daptacel) in place of Tdap (Adacel); Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 23 years old male patient who DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of 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 30-Apr-2019, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5206AA via intramuscular route in the left arm.  It was of actual medication error due to Wrong vaccine administered..  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.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered an expired dose of daptacel/ no adverse event; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old female patient who inadvertently administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. There was no concomitant medication or other vaccines.   On 29-Apr-2019, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5190AA, expiry date: 24-Apr-2019 via intramuscular route in the left thigh.  It was an actual medication error due to expired vaccine used. Nurse inadvertently administered an expired dose of Daptacel. The patient experienced no 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: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: a 6 month old child just received the Dtap- IPV component of the Pentacel vaccine/will give the child the Acthib; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six months old female patient who received a 0.5ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] only with Dtap- IPV component without ACT-HIB part (lot UJ062AAA, Dtap-IPV vial lot- UJ108AA) expiration date: 24-Jul-2020 via intramuscular route in the left thigh on 30-Apr-2019.  The patient's past vaccination(s) included Pentacel on 28-FEB-2018 first dose. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included was PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was an actual medication error due to inappropriate reconstitution technique.   Adverse event was not 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: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: inadvertently administered dose of Pentacel from the late shipment to a patient/temperature excursion it was less than 24hours/ no AE; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who 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) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 29-Apr-2019, the patient received fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Suspension for injection) lot UJ123AA, expiry date- 29-Sep-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to incorrect product storage.  Caller states problem with late shipment has been resolved and the office will be receiving replacement vaccines. Caller states vaccines were put in refrigerator immediately after receiving shipment, but she is unsure of the exact temperature of the vaccines at that time. Caller confirms that cool packs were still in place and believes if there was any temperature excursion it was less than 24hours. Caller reports nurse inadvertently administered dose of Pentacel from the late shipment to a patient.  None adverse event symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: The patient received DTap  IPV but not Hib component of Pentacel; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old female patient who received DTap - IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without Hib component.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Apr-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6215AC.  It was 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.
Sex: M
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Wrong product administered
Clinical narrative: was administered Pentacel/they were supposed to give the child Adacel; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 10 years old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].instead of Adacel..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Apr-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ073AAA via intramuscular route in the right arm.  It was of actual medication error due to wrong vaccine administered..  It was not reported if adverse event was there.  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: 1.25
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: administered Pentacel instead of ordered combination of Daptacel and ActHib; was given a dose Daptacel and a dose of Pentacel; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who was vaccinated with 0.5 ml doses of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5254AAand Exp. Date 18-Sep-2019) in the left Vastus Lateralis and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ066AD and Exp. Date 16-Oct-2020) in the right Vastus Lateralis instead of Daptacel and HIB (PRP/T) VACCINE [ACT-HIB] on 29-Apr-2019.  The patient had receive 3 doses of Pentacel and no concomitant medication given.  It was an actual medication error case due extra dose administered and wrong vaccine administered.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: patient was administered Tenivac Subcutaneously instead of intramuscular; redness at the injection site; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 36 years (also reported as 37 years) old female patient who experienced redness at the injection site, while she received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 29-Apr-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6187AA via subcutaneous route in left back upper arm.  On 29-Apr-2019, on same day after the vaccination, the patient experienced injection site redness (vaccination site erythema).   It was also a case of actual medication error due to inappropriate route of vaccination as Tenivac administered Subcutaneously instead of intramuscular.  (Other relevant tests included no lab data.)  Final diagnosis was injection site redness.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported at the time of reporting. 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: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-NOV-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a nurse for herpes zoster. The outcome of herpes zoster was not reported. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently 73 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.   The patient was prescribed the zoster vaccine live(ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 03-JAN-2013, the patient was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the patient was treated by a physician for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: Herpes Zoster. The outcome of the event was unknown. Causality assessments were related.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction; Improperly stored Proquad; This spontaneous report was received from a registered nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ).  On 11-APR-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, 0.5 ml (lot # R015739, expiry date: 02-DEC-2019) subcutaneously for prophylaxis. It was not known how the sterile diluent (DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored. The vaccine was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001299: US-009507513-1905USA001301: US-009507513-1905USA001304: US-009507513-1905USA001305: US-009507513-1905USA001306:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction; Improperly stored Proquad; This spontaneous report was received from a registered nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ).  On 11-APR-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, 0.5 ml (lot # R015739, expiry date: 02-DEC-2019) subcutaneously for prophylaxis. It was not known how the sterile diluent (DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored. The vaccine was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA000175: US-009507513-1905USA001299: US-009507513-1905USA001301: US-009507513-1905USA001305: US-009507513-1905USA001306:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 992H3, expiry date 23rd May 2021) for prophylaxis.   On 29th December 2018, the patient received Shingrix. In January 2019, 21 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: Three weeks after vaccination, the patient expereinced shingles. No further information was provided.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: redness and achiness at the injection site, Sometimes the achiness goes down his fingers but is mostly in the upper part of arm; redness and achiness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site redness in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received Shingrix (intramuscular). In March 2019, 2 days after receiving Shingrix, the patient experienced injection site redness. In April 2019, the patient experienced pain in arm. On an unknown date, the outcome of the injection site redness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site redness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The patient received the Shingrix vaccine about 6 weeks ago before the date of reporting.  A couple of days after receiving the vaccine, the patient developed redness and achiness at the injection site. This lasted about 2 to 2.5 weeks before resolving.  A week before the date of reporting, the achiness returned and had lasted for 1 to 1.5 weeks. Sometimes the achiness went down to his fingers, but it was mostly in the upper part of his arm. The patient provided the consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza, Influenza like illness, Malaise, Pain
Clinical narrative: Flu; Sinus infection; flu-like symptoms; Malaise; Body aches; Felt bad; This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number A5X5B, expiry date 7th March 2021) for prophylaxis.   On 15th October 2018, the patient received the 1st dose of Shingrix (intramuscular). In October 2018, 6 hrs after receiving Shingrix, the patient experienced influenza, sinus infection, influenza-like symptoms, malaise, general body pain and feeling bad. The patient was treated with steroids nos (Steroids). In October 2018, the outcome of the influenza-like symptoms, malaise, general body pain and feeling bad were recovered/resolved. On an unknown date, the outcome of the influenza and sinus infection were not reported.   It was unknown if the reporter considered the influenza, sinus infection, influenza-like symptoms, malaise, general body pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: On 15th October 2018, the patient received Shingrix in right deltoid. After 6 to 7 hours, the patient had flu-like symptoms like malaise and body aches. She just felt bad. The symptoms lasted for a day and a half, for about 36 hours. The patient also had intermittent illnesses, like the flu and sinus infections and they were taking a lot time to treat due to their chronic nature during the 6 month window for the 2nd dose. The patient was on steroids off and on during the 6 months time period and due to these reasons did not get the 2nd dose. At the time of reporting, the patient was wanting to receive the 2nd dose.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: Flu; Sinus infection; flu-like symptoms; Malaise; Body aches; Felt bad; This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number A5X5B, expiry date 7th March 2021) for prophylaxis.   On 15th October 2018, the patient received the 1st dose of Shingrix (intramuscular). In October 2018, 6 hrs after receiving Shingrix, the patient experienced influenza, sinus infection, influenza-like symptoms, malaise, general body pain and feeling bad. The patient was treated with steroids nos (Steroids). In October 2018, the outcome of the influenza-like symptoms, malaise, general body pain and feeling bad were recovered/resolved. On an unknown date, the outcome of the influenza and sinus infection were not reported.   It was unknown if the reporter considered the influenza, sinus infection, influenza-like symptoms, malaise, general body pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: On 15th October 2018, the patient received Shingrix in right deltoid. After 6 to 7 hours, the patient had flu-like symptoms like malaise and body aches. She just felt bad. The symptoms lasted for a day and a half, for about 36 hours. The patient also had intermittent illnesses, like the flu and sinus infections and they were taking a lot time to treat due to their chronic nature during the 6 month window for the 2nd dose. The patient was on steroids off and on during the 6 months time period and due to these reasons did not get the 2nd dose. At the time of reporting, the patient was wanting to receive the 2nd dose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Injection site red rash; Injection site red rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date unknown) for prophylaxis.   On 25th April 2019, the patient received Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the injection site erythema and injection site rash to be related to Shingrix.  Additional details were provided as follows: The reporter did not have the expiration date of Shingrix. The patient developed a red, round rash at the injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth, and redness at both injection sites
Age: 54.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: fever, generalized joint pain
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Fungal infection, Rash
Clinical narrative: Symptoms; yeast infection, rash on abdomen
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain
Clinical narrative: Patient experienced breast pain starting 3 days after vaccination and the pain has continued until the time it was reported to the pharmacy.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 63-year-old female patient. No information was provided regarding medical history, concurrent conditions or concomitant medications. On an unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of herpes zoster was not reported. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: swelling at the site of injection; injection site pain; nausea; vomiting; headache; fever; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, 1 day after receiving Shingrix, the patient experienced injection site swelling, injection site pain, nausea, vomiting, headache and fever. On an unknown date, the outcome of the injection site swelling, injection site pain, nausea, vomiting, headache and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, nausea, vomiting, headache and fever to be related to Shingrix.  Additional details were provided as follows: In February 2019, the patient in her late 50's received her first dose of Shingrix. The patient experienced injection site swelling, injection site pain, nausea, vomiting, headache and fever. The patient has declined the second dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: swelling at the site of injection; injection site pain; nausea; vomiting; headache; fever; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, 1 day after receiving Shingrix, the patient experienced injection site swelling, injection site pain, nausea, vomiting, headache and fever. On an unknown date, the outcome of the injection site swelling, injection site pain, nausea, vomiting, headache and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, nausea, vomiting, headache and fever to be related to Shingrix.  Additional details were provided as follows: In February 2019, the patient in her late 50's received her first dose of Shingrix. The patient experienced injection site swelling, injection site pain, nausea, vomiting, headache and fever. The patient has declined the second dose of Shingrix.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Musculoskeletal pain, Pyrexia
Clinical narrative: Very tender, sore shoulder.  "fever chills".  Very tired.  Bad headache.  Friday night, Saturday and Saturday night.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Very tender, sore shoulder.  "fever chills".  Very tired.  Bad headache.  Friday night, Saturday and Saturday night.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blood test normal, Eye contusion, Syncope
Clinical narrative: I had also received a tetanus shot the previous Tuesday, April 2.  The morning after the Shingrix vaccination, I had a bad stomach ache causing a vasovagal syncope reaction and fainted.  I ended up going to the ER.  The only adverse outcome was a black eye from fainting in the bathroom.  Not sure if the two shots days apart were the cause or if this was coincidental.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Seizure, White matter lesion
Clinical narrative: Seizure events.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Exercise tolerance decreased, Fatigue, Fibromyalgia
Clinical narrative: Within 24 hours, developed fever, body aches, and fatigue; resolved after one day. Two weeks later developed severe fatigue, tinnitus, exercise intolerance, and joint pain which has continued to this day. Recently developed tingling in upper extremities. Diagnosed with fibromyalgia.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Metabolic function test normal, Pain, Paraesthesia, Pyrexia
Clinical narrative: Within 24 hours, developed fever, body aches, and fatigue; resolved after one day. Two weeks later developed severe fatigue, tinnitus, exercise intolerance, and joint pain which has continued to this day. Recently developed tingling in upper extremities. Diagnosed with fibromyalgia.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Within 24 hours, developed fever, body aches, and fatigue; resolved after one day. Two weeks later developed severe fatigue, tinnitus, exercise intolerance, and joint pain which has continued to this day. Recently developed tingling in upper extremities. Diagnosed with fibromyalgia.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Dysphagia, Throat tightness
Clinical narrative: after she left to go home, cx said her throat was closing and could not swallow food and went to er.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Pain, Pain in extremity
Clinical narrative: The patient stated that the shot gave her a sore arm and hurt similar to the first shot, but now a month and a half later still have slight pain and discomfort with activity.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Memory impairment
Clinical narrative: Patient came in to the pharmacy on 5/2/19 to pick up medication and stated that he did not want the second shot.  He stated he did not remember anything for 4 days after receiving the vaccination.  I asked further questions but all he could tell be was that he couldn't remember anything for the 4 days.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No symptoms reported; the first pneumonia vaccine was PREVNAR 13 on 7/17/2018. The second was PNEUMOVAX 23 on 9/25/2018.; This spontaneous report was received from a pharmacist referring to a 67 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 17-JUL-2018, the patient received the first pneumonia vaccine with pneumococcal 13v conj vaccine (crm197) (PREVNAR). Then, on 25-SEP-2018, after an inappropriate dosing interval, the patient received the second pneumonia vaccine with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, anatomical location, lot # and expiration date were not reported). No symptoms were reported.; Sender's Comments:  US-009507513-1904USA010206:
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported for either vaccine; first GARDASIL 9 vaccine on 12/20/2017 at the age of 15 / the second GARDASIL 9 vaccine was given on 4/22/2019; This spontaneous report as received from a pharmacist refers to a currently 16-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 20-DEC-2017, the patient, at the age of 15, was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On 22-APR-2019, the patient, at the age of 16, was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot number R024264, expiration date 29-OCT-2019 (dose and route of administration were not provided) for prophylaxis. No adverse effects were reported for either vaccine.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles, including any and all of its sequelae; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 71 year old male patient.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On 04-AUG-2016, at age 70, the patient was administered zoster vaccine live (ZOSTAVAX) at a facility (dose, route, and lot # not provided).  As a result of his receipt of zoster vaccine live (ZOSTAVAX), on 28-APR-2017, the patient was caused to suffer shingles, including any and all of its sequelae.  As a result of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages.  The outcome of the shingles was unknown.  Causality assessment was related.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; patient was inadvertently administered one expired dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 29-APR-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 dose, intramuscularly, lot # R002487, expiry date 21-APR-2019 for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: little itchy bumps around the site of the shot; injection site pain; injection site itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site rash, injection site pain and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were unknown and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site pain and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrex shot about 6-7 months ago, and its hurt terribly bad and a still aches like the patient had a hot poker in it. That shot felt like the old penicillin shots that the patient had as a kid.  The patient also had little itchy bumps around the site of the shot. The patient received 2nd shot on right arm had no problems. The patient just caught the end of a radio show where the announcer was talking about the pain he had with his Shingrix shot, the patient wish that he could talk to him.  The patient would take the series again but I would take a NSAID before the shot.  The patient asked are those normal reactions. This case is linked with US2019GSK080239, by same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the radio announcer was talking about the pain he had with his Shingrix shot. This case linked with US2019AMR078115, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Dizziness, Myocardial infarction, Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart attack in a female patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced vertigo (serious criteria hospitalization) and dizziness (serious criteria hospitalization). On 26th March 2019, the patient experienced heart attack (serious criteria hospitalization and GSK medically significant). On 29th March 2019, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the heart attack and stroke were unknown and the outcome of the vertigo and dizziness were recovered/resolved. It was unknown if the reporter considered the heart attack, stroke, vertigo and dizziness to be related to SHINGRIX. Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient experienced dizziness or vertigo and symptoms lasted 2 to 3 days afterwards. The patient was not completely certain of the dates, but thinks that was when the events occurred. On 31st March 2019, the patient was hospitalized and they had not been able to determine the cause of the heart attack and stroke. The patient went cardiologists just gave her medicines and devices when the patient tries to follow up with them. The reporter did not consent to follow up with physician and declined to provide address, however gave permission to follow up via phone. No further details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Myocardial infarction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart attack in a female patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced vertigo (serious criteria hospitalization) and dizziness (serious criteria hospitalization). On 26th March 2019, the patient experienced heart attack (serious criteria hospitalization and GSK medically significant). On 29th March 2019, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the heart attack and stroke were unknown and the outcome of the vertigo and dizziness were recovered/resolved. It was unknown if the reporter considered the heart attack, stroke, vertigo and dizziness to be related to SHINGRIX. Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient experienced dizziness or vertigo and symptoms lasted 2 to 3 days afterwards. The patient was not completely certain of the dates, but thinks that was when the events occurred. On 31st March 2019, the patient was hospitalized and they had not been able to determine the cause of the heart attack and stroke. The patient went cardiologists just gave her medicines and devices when the patient tries to follow up with them. The reporter did not consent to follow up with physician and declined to provide address, however gave permission to follow up via phone. No further details were provided.