chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, DTAPIPVHIB, PNC13, RVX
Symptoms: Product storage error
Clinical narrative: Pentacel reached 33.5C; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658 and 2019SA192660 (same reporter).  This case involves a four months old patient (gender not reported) who was vaccinated with a 0.5 ml second dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ097AAA and Exp. Date 19-Sep-2020) via intramuscular route in unknown administration site on 09-Jul-2019.  The patient's medical history not reported and concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) both received 0.5 ml dose via intramuscular route on 09-Jul-2019 for Immunisation.  It was an actual medication error case due to incorrect product storage.  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.  List of documents held by sender: none.
Age: 19.0
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: adacel vaccine reached 33.5C; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192654 (same reporter).  This case involves a 19 years old patient (gender not reported) who was vaccinated with a 0.5 ml second dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6273AA and Exp. Date 24-Apr-2021) via intramuscular route in unknown administration site on 09-Jul-2019 .  The patient's medical history not reported and concomitant medications not received.  It was an actual medication error case due to incorrect product storage. Adacel reached 33.5C.  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.  List of documents held by sender: none.
Sex: M
Vaccine: IPV, TD
Symptoms: Product storage error
Clinical narrative: exposed to temperatures below 32 degrees F.; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA192698 and 2019SA192700.  This case involves a 13 years old male patient who received 0.5 ml dose of vaccine IPV (VERO) lot PIA461M (Expiry date 03-May-2020) and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot no U6101AA (Expiry date 23-Oct-2020)  via intramuscular route in unknown administration site on 28-Jun-2019.  It was an actual medication error due to incorrect product storage.   It was reported that received vaccines that were previously exposed to temperatures below 32 degrees Fahrenheit.  It was unknown if any adverse event 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.  List of documents held by sender: none.
Sex: U
Vaccine: HEP, HIBV
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered ActHib when ordered to received a Hepatitis B vaccine; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a patient (with unknown demographics) who was inadvertently administered HIB (PRP/T) VACCINE [ACT-HIB] instead of HEPATITIS B VACCINE lot number not reported via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  It was reported that HCP inadvertently administered ActHib, NDC 42981-547-48, when the patient was ordered to received a Hepatitis B vaccine.  It was unknown whether patient experienced any adverse reaction.    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: U
Vaccine: IPV, MNQ, TD
Symptoms: Product storage error
Clinical narrative: Menactra, IPOL(unopened), and Tenivac. Caller stated that the temperature was 48.4 degrees Fahrenheit for 15 minutes.; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves three patient (with unknown demographic) who received dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6151AA (Expiry date 16-Mar-2020) and same vaccine  lot U6208AD (Expiry date 08-Jul-2020), DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6021AA (Expiry date 27-Jul-2020) and IPV (VERO) lot P1E701M (Expiry date 09-Nov-2020) via unknown route in unknown administration site. On an unknown date.  It is an actual medication error due to incorrect product storage.   It was reported that Menactra, IPOL(unopened), and Tenivac. Caller stated that the temperature was 48.4 degrees Fahrenheit for 15 minutes. Caller stated that the refrigerator's door had been left open for too long while pulling out vaccines for 3 patients..  It was unknown if any adverse event 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.  List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 18 years old patient was inadvertently administered an expired dose of Menactra; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 18 years old male patient who was inadvertently administered an expired 0.5ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5917AA via intramuscular route in the left deltoid on 15-Jul-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) for Immunisation.  It was an actual medication error due to expired vaccine used.  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: TDAP, UNK
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of Adacel to 4 year old patient instead of DTAP; administration of Adacel to 4 year old patient instead of DTAP; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  On 12-Jul-2019, the patient received a 5th dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5979AA and expiry date: 13-Jun-2020 via intramuscular route in the right thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: receiving a double dose of Ipol. We have a baby that received Ipol and Kinrix which also contains IPV.; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old male patient who was vaccinated with 0.5 ml dose of IPV (VERO) lot P1a242m via intramuscular route in the left thigh on 12-Jul-2019 and also receive DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [KINRIX] not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE), HEPATITIS B VACCINE (HEPATITIS B VACCIN) and HIB VACCINE (HIB VACCINE) on 12-Jul-2019.  It was as actual medication error case due extra dose administered. The patient was receiving a double dose of Ipol. "We have a baby that received Ipol and Kinrix which also contains IPV.  At the time of reporting, no adverse reaction 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.  List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: overlapping DTaP and IPV doses at his 2 month visit because male patient received both pediarix and pentacel at his 2 month visit; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received overlapping dtap and ipv doses at his 2 month visit because patient received both DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) at his 2 month visit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 13-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5572AB via unknown route in the left thigh.  On 13-Mar-2019, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.   It was case of actual medication error due to Extra dose administered.  It was not reported whether the patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: DTAPIPVHIB
Symptoms: Device connection issue, Exposure via skin contact, Occupational exposure to product
Clinical narrative: while reconstitute the Diluent DTaP/IPV and the HIB of a Pentacel and the needle came off of the syringe. The pressure of the syringe splashed the Pentacel in the employees face; while reconstitute the Diluent DTaP/IPV and the HIB of a Pentacel and the needle came off of the syringe. The pressure of the syringe splashed the Pentacel in the employees face; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a 33 years old female patient who was exposed to vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, concomitant medication and family history were not provided.   On 15-Jul-2019, the patient was exposed to 0.5ml  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, Pentacel Box Lot: UJ097AAA, Exp. Date: 19-Sep-2020, DTaP/IPV Lot U6327AA, Exp. Date: 19-Sep-2020, HIB Lot UJ097AA, Exp. Date: 19-Sep-2020.  It was an actual medication error due to occupational exposure to product and syringe issue.  It was reported that Medical Office Assistant who tried to reconstitute the Diluent DTaP/IPV and the HIB of a Pentacel and the needle came off of the syringe. The pressure of the syringe splashed the Pentacel in the employees face.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose 27Jun2019 of Menactra was given to patient/ No AE; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who received expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U5916AA, expiry date: 27-Jun-2019 via intramuscular route in the right deltoid on 11-Jul-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) for Immunisation on 11-Jul-2019.  It was a case of actual medication error due to expired vaccine used.  There were no side effects after the vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Dermatitis contact, Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction to meningococcal immunization; Hives all over their body; Contact dermatitis; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 years old male patient who experienced contact dermatitis and allergic reaction to meningococcal immunization, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2015, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5082AA via unknown route in unknown administration site.  On 11-Aug-2015, the patient developed a non-serious contact dermatitis (dermatitis contact), allergic reaction to meningococcal immunization (allergy to vaccine) and hives all over their body (urticaria) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Final diagnosis was allergic reaction to meningococcal immunization and contact dermatitis.   The patient was treated with TRIAMCINOLONE (TRIAMCINOLONE) and METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]).  The patient was recovered from all the events on an unknown date.  List of document held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: nurse gave 1 children only the Dtap-IPV part of the Pentacel vaccine, ActHIB vials were not given; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with 2019SA192664.   This case involves one child patients of unknown demographics who was vaccinated with a dose only the Dtap-IPV part of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ123AAA and Exp. Date 29-Sep-2020) ACT-HIB part was not given via unknown route in unknown administration site on an unknown date.   The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate reconstitution technique.  (DTap-IPV- lot number U6397AA and Exp. Date 09/29/2020 and ActHIB UJ123AA and Exp. Date 09/29/2020)  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.  List of documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Blood creatinine increased, Brain scan normal, Chest X-ray normal, Dyspnoea, Migraine
Clinical narrative: left-sided migraine the following day after vaccination in which this proceeded to progress to a right-sided migraine; palpitations; shortness of breath; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 38 years old female patient who experienced left-sided migraine the following day after vaccination in which this proceeded to progress to a right-sided migraine, palpitations and shortness of breath, while she received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history included Wound (accidentally cutting mouth with piece of metal while eating salad). The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included LISINOPRIL (LISINOPRIL) for Blood pressure measurement.  On 03-Jul-2019, the patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6091AA, expiry date: 12-OCT-2020 via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious left-sided migraine the following day after vaccination in which this proceeded to progress to a right-sided migraine (migraine), palpitations and shortness of breath (dyspnoea) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Returned to ER 09Jul2019 due to worsening symptoms; follow-up HCP visit with primary care on 12Jul2019.  Relevant laboratory test results included:  Blood creatinine increased - On an unknown date: 1.3  Blood pressure systolic - On an unknown date: >190.  (Other relevant tests included Chest x-ray and brain scan were negative.)  Final diagnosis was shortness of breath, palpitations and left-sided migraine the following day after vaccination in which this proceeded to progress to a right-sided migraine.  The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]).  The outcome of the events was Unknown.  Documents held by sender: none.
Sex: F
Vaccine: TD
Symptoms: Palpitations
Clinical narrative: left-sided migraine the following day after vaccination in which this proceeded to progress to a right-sided migraine; palpitations; shortness of breath; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 38 years old female patient who experienced left-sided migraine the following day after vaccination in which this proceeded to progress to a right-sided migraine, palpitations and shortness of breath, while she received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history included Wound (accidentally cutting mouth with piece of metal while eating salad). The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included LISINOPRIL (LISINOPRIL) for Blood pressure measurement.  On 03-Jul-2019, the patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6091AA, expiry date: 12-OCT-2020 via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious left-sided migraine the following day after vaccination in which this proceeded to progress to a right-sided migraine (migraine), palpitations and shortness of breath (dyspnoea) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Returned to ER 09Jul2019 due to worsening symptoms; follow-up HCP visit with primary care on 12Jul2019.  Relevant laboratory test results included:  Blood creatinine increased - On an unknown date: 1.3  Blood pressure systolic - On an unknown date: >190.  (Other relevant tests included Chest x-ray and brain scan were negative.)  Final diagnosis was shortness of breath, palpitations and left-sided migraine the following day after vaccination in which this proceeded to progress to a right-sided migraine.  The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]).  The outcome of the events was Unknown.  Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient reported she had redness in the same arm as the vaccination.
Age: 1.67
Sex: M
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: no adverse reaction
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site scab
Clinical narrative: At the time of vaccination the arm was free of any scabs/sores/abrasions, etc.  After the vaccination, patient came in and showed me his arm.  The injection site had a local scab at the injection site.   Additionally, what likely was the site of the FIRST Shingrix injection was also scabbed.  The area was about the size of a quarter, local, circular shape.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Dyspnoea, Muscular weakness, Myalgia
Clinical narrative: Pain in arm, for 8 days. Fever 101F, for 4 days. Chills, for 4 days.  Muscle pain and weakness in legs and bladder muscles, for 5 days.  Muscle weakness in legs continued for 4 more days (9 total).  Mild nonspecific chest pain for 3 days, shortness of breath for 8 days.  Took ibuprofen for fever and muscle pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain in arm, for 8 days. Fever 101F, for 4 days. Chills, for 4 days.  Muscle pain and weakness in legs and bladder muscles, for 5 days.  Muscle weakness in legs continued for 4 more days (9 total).  Mild nonspecific chest pain for 3 days, shortness of breath for 8 days.  Took ibuprofen for fever and muscle pain.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix .5 ml. In July 2019, 1 day after receiving Shingrix, the patient experienced vesicular rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: A day or two later receiving Shingrix, the shingles rash was presented on the patient's truck and down his arm on the right side. He was treated at a walk in clinic and given steroids. The reporter consented to follow up. There is a discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Pruritus, Urticaria
Clinical narrative: hives worsened; Itching; This case was reported by a consumer via call center representative and described the occurrence of condition aggravated in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of urticaria (1st dose received at the end of February or early March 2019, see case US2019123826).   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced condition aggravated and hives. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the condition aggravated was not recovered/not resolved and the outcome of the hives was unknown.   It was unknown if the reporter considered the condition aggravated and hives to be related to Shingrix.  Additional details were provided as follows: The reporter not provided the lot numbers for either of the vaccines dose 1 and 2. The reporter did not know the specific dates or which arm the vaccines were administered. In June 2019, the patient went to get the 2nd dose of Shingrix. When the daughter of the patient questioned whether the patient should receive the 2nd dose at that time, the doctor said the hives were not associated with the vaccine, so the 2nd dose was administered. The hives worsened and were very itchy. Emergency room (ER) visit required.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Nausea, Pain
Clinical narrative: weakness; chills; severe headache; body aches; nausea; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a day after receiving Shingrix, the patient experienced general body pain, nausea, weakness, headache and chills. On an unknown date, the outcome of the general body pain, nausea, weakness, headache and chills were recovered/resolved.   It was unknown if the reporter considered the general body pain, nausea, weakness, headache and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received the vaccine at the same location and time where her friend received the vaccine. Within few hours of vaccination, the patient developed body aches, nausea, weakness, chills and severe headache. Body aches, nausea, and headache resolved after 4 days. Chills resolved after 2.5 days. Weakness resolved after 6.5 days. The reporter consented to follow-up. This case had been linked to US2019123836, reported by the same reporter. The reporter consented to health care professional (HCP) follow up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Balance disorder, Decreased activity, Fatigue
Clinical narrative: Muscle Aches; Joint Aches; Nerve Aches; Extreme Fatigue; Loss of Strength; Weight Loss; Lack of balance; Decreased physical activity; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriasis and psoriatic arthritis. Concomitant products included dabigatran etexilate mesilate (Pradaxa).   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 18th April 2019, the patient experienced muscle pain, joint pain, nerve pain, fatigue, strength loss of, weight loss, balance disorder and decreased activity. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and weight loss were recovered/resolved and the outcome of the muscle pain, joint pain, nerve pain, fatigue, strength loss of, balance disorder and decreased activity were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle pain, joint pain, nerve pain, fatigue, strength loss of, weight loss, balance disorder and decreased activity to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for himself. The patient had received the acupuncture treatment for psoriatic arthritis for approximately 5 years. The patient was able to walk his dog 5 times daily. On the same night, when the patient received Shingrix in the left arm, he complained of sore arm. One day after receiving Shingrix, the patient complained of aching muscles, joints and nerves in the body, also extreme fatigue and loss of strength resulting in lack of desire to get out of bed except to use bathroom and to eat but still experienced weight loss at the time of reporting. After vaccination, the patient could not walk his dog 1 block and it took 1.5 months to be able to walk 1/2 a mile. The patient mentioned it felt as if he had a heart attack due to lack of balance and decreased physical activity. The patient reported that he was feeling as if just getting better, but still not fully recovered at the time of report. The caller left feedback to update warning should be mentioned for psoriatic arthritis patients and even rheumatoid arthritis patients in general due to boost in immune response and these patients try to decrease immune-mediated responses. The patient would not receive 2nd dose. The reporter consented to follow up. This case had been linked with case US2019123865 reported by the same reporter for multiple patients and US2019123863, reported by the same reporter for his wife.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia, Neuralgia, Pain in extremity, Weight decreased
Clinical narrative: Muscle Aches; Joint Aches; Nerve Aches; Extreme Fatigue; Loss of Strength; Weight Loss; Lack of balance; Decreased physical activity; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriasis and psoriatic arthritis. Concomitant products included dabigatran etexilate mesilate (Pradaxa).   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 18th April 2019, the patient experienced muscle pain, joint pain, nerve pain, fatigue, strength loss of, weight loss, balance disorder and decreased activity. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and weight loss were recovered/resolved and the outcome of the muscle pain, joint pain, nerve pain, fatigue, strength loss of, balance disorder and decreased activity were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle pain, joint pain, nerve pain, fatigue, strength loss of, weight loss, balance disorder and decreased activity to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for himself. The patient had received the acupuncture treatment for psoriatic arthritis for approximately 5 years. The patient was able to walk his dog 5 times daily. On the same night, when the patient received Shingrix in the left arm, he complained of sore arm. One day after receiving Shingrix, the patient complained of aching muscles, joints and nerves in the body, also extreme fatigue and loss of strength resulting in lack of desire to get out of bed except to use bathroom and to eat but still experienced weight loss at the time of reporting. After vaccination, the patient could not walk his dog 1 block and it took 1.5 months to be able to walk 1/2 a mile. The patient mentioned it felt as if he had a heart attack due to lack of balance and decreased physical activity. The patient reported that he was feeling as if just getting better, but still not fully recovered at the time of report. The caller left feedback to update warning should be mentioned for psoriatic arthritis patients and even rheumatoid arthritis patients in general due to boost in immune response and these patients try to decrease immune-mediated responses. The patient would not receive 2nd dose. The reporter consented to follow up. This case had been linked with case US2019123865 reported by the same reporter for multiple patients and US2019123863, reported by the same reporter for his wife.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Pain in arm, severe headache,  severe nausea,
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: She said her arm a lot. I asked her if she felt the vaccine was administered properly and she said yes. I recommended she continue current meds, add ibuprofen for pain, use and ice pack, and to rest/not over exert herself until the pain has deceased significantly. She said the same reaction occurred on dose 1 of the series apparently.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Large bump at site of vaccination formed after intramuscular injection of 0.5 mL.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: chills, headache, body ache
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Chest pain, Discomfort, Mobility decreased
Clinical narrative: PT'S SPOUSE STATED MORNING AFTER VACCINATION PT EXPERIENCED SEVERE RIGHT ARM, UNDERARM, UPPER BACK AND CHEST PAIN. THE PAIN WAS SO SEVERE THAT PT COULD NOT MOVE. THE SEVERE PAIN LASTED FOR 2 DAYS. PT'S SPOUSE WENT ONLINE AN READ THAT NSAIDS COULD HELP FOR DISCOMFORT. SHE HAD ASPIRIN AT HOME SO GAVE PT ASPIRIN. PAIN BEGAN TO SUBSIDE ON THIRD DAY. PAIN LASTED OVER PERIOD OF 5 DAYS. AT TIME OF REPORTING, 7/12/2019 PT WAS HAVING ONLY RESIDUAL DISCOMFORT AND NO LONGER IN PAIN. PT ' S WIFE CONFIRMED PAIN WAS ON RIGHT SIDE OF THE BODY ON 7/18/2019.. PT DID NOT WANT TO GO TO THE MD. PT'S WIFE'S MAIN CONCERN IS SHOULD HE RECEIVE THE SECOND SHOT OR NOT. PT IS CURRENTLY ON VACATION.  PT'S SPOUSE WOULD LIKE US TO LEAVE MESSAGE ON THEIR PHONE. THEY WILL RETURN ON WEEKEND. MD WILL BE CONTACTED AT CONCLUSION OF THIS REPORT.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: PT'S SPOUSE STATED MORNING AFTER VACCINATION PT EXPERIENCED SEVERE RIGHT ARM, UNDERARM, UPPER BACK AND CHEST PAIN. THE PAIN WAS SO SEVERE THAT PT COULD NOT MOVE. THE SEVERE PAIN LASTED FOR 2 DAYS. PT'S SPOUSE WENT ONLINE AN READ THAT NSAIDS COULD HELP FOR DISCOMFORT. SHE HAD ASPIRIN AT HOME SO GAVE PT ASPIRIN. PAIN BEGAN TO SUBSIDE ON THIRD DAY. PAIN LASTED OVER PERIOD OF 5 DAYS. AT TIME OF REPORTING, 7/12/2019 PT WAS HAVING ONLY RESIDUAL DISCOMFORT AND NO LONGER IN PAIN. PT ' S WIFE CONFIRMED PAIN WAS ON RIGHT SIDE OF THE BODY ON 7/18/2019.. PT DID NOT WANT TO GO TO THE MD. PT'S WIFE'S MAIN CONCERN IS SHOULD HE RECEIVE THE SECOND SHOT OR NOT. PT IS CURRENTLY ON VACATION.  PT'S SPOUSE WOULD LIKE US TO LEAVE MESSAGE ON THEIR PHONE. THEY WILL RETURN ON WEEKEND. MD WILL BE CONTACTED AT CONCLUSION OF THIS REPORT.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye pruritus, Needle issue
Clinical narrative: During the process of mixing the Shingrix vaccination, the slip tip needle popped off as I was starting to inject the adjuvant into the antigen component vial. Pressure from pushing the plunger of the syringe down caused the liquid to splash upwards into my eye. Only the adjuvant came in contact with my eye. After rinsing my eye with water and an eye wash, my eye itched for a few minutes, but it resolved on its own. No other adverse events to report.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypoaesthesia, Injection site hypoaesthesia, Injection site mass, Injection site swelling
Clinical narrative: Numbness in the whole injection arm  Shivering Fever feeling hot at the site of injection Swelling & lump formation at the site of injection
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Numbness in the whole injection arm  Shivering Fever feeling hot at the site of injection Swelling & lump formation at the site of injection
Age: 61.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Chills, Headache, Nausea, Presyncope
Clinical narrative: Chills, nausea, headache, near fainting
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT HAD FLU-LIKE SYMPTOMS (MALAISE, FEVER, SHIVERS) THE NIGHT AFTER RECEIVING HER SECOND DOSE OF SHINGRIX AND CALLED TODAY (2 DAYS AFTER) TO COMPLAIN OF A 2"x4" RAISED, RED AND PAINFUL WELT AT THE INJECTION SITE. SHE SAID SHE HAD A SIMILAR REACTION WITH THE FIRST SHOT BUT THE WELT WAS NOT AS LARGE AND IT TOOK ABOUT 10 DAYS TO RESOLVE.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Malaise, Pyrexia
Clinical narrative: PATIENT HAD FLU-LIKE SYMPTOMS (MALAISE, FEVER, SHIVERS) THE NIGHT AFTER RECEIVING HER SECOND DOSE OF SHINGRIX AND CALLED TODAY (2 DAYS AFTER) TO COMPLAIN OF A 2"x4" RAISED, RED AND PAINFUL WELT AT THE INJECTION SITE. SHE SAID SHE HAD A SIMILAR REACTION WITH THE FIRST SHOT BUT THE WELT WAS NOT AS LARGE AND IT TOOK ABOUT 10 DAYS TO RESOLVE.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted after giving the injection.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR
Symptoms: Pyrexia, Rash, Vomiting, Yellow skin
Clinical narrative: 7/11/19 mother reports "almost exactly 24 hours" after receiving vaccinations the patient "turned yellow color and vomited.  On 7/12/19 rectal temp was 102.6.  Remained febrile 7/12/19-7/14/19 then resolved.  On 7/15/19 slightly raised rash appeared on chest and groin then moved upward toward neck and chest.  Mother did not notice child itching and child played as if was well physically.  Rash resolved  6/17/19.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Mass, Tenderness
Clinical narrative: Patient reports feeling a "marble-sized" lump near her left collarbone this morning that is mildly painful to touch (rates it 3/10).  Denies any other associated symptoms - no fevers, flu-like symptoms, difficult breathing, chest pain, redness/warmth at site and does not affect ability to perform activities of daily living.  Has not done anything for it.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, heated and painful area 2 inches around the injection site and it lasted 4-5 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient reported a fist size bump on her arm at the injection site.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Hypersomnia, Hypophagia, Screaming
Clinical narrative: 3 days after getting the vaccine he started constantly sleeping and not waking up to eat. He won?t open his eyes and just screams. He?s awake for very short periods of time.  I took him the the ER and was brushed off and was told that babies sleep.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Fatigue, Malaise, Musculoskeletal pain
Clinical narrative: Starting the day of the vaccine 7/15/19 - patient reported feeling dizzy and unsteady, fatigue/malaise, extremely sore arm/shoulder, tingling in lips/tongue (no swelling of throat/tongue or difficulty swallowing/breathing) - pt said she spent all day in bed.  As of 7/18/19, pt said she is slowly getting better. Pt said that she did not have any reaction at all to the first dose given 5/16/19.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia oral
Clinical narrative: Starting the day of the vaccine 7/15/19 - patient reported feeling dizzy and unsteady, fatigue/malaise, extremely sore arm/shoulder, tingling in lips/tongue (no swelling of throat/tongue or difficulty swallowing/breathing) - pt said she spent all day in bed.  As of 7/18/19, pt said she is slowly getting better. Pt said that she did not have any reaction at all to the first dose given 5/16/19.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Fluid retention, Pain in extremity, Tendonitis, Vaccination complication
Clinical narrative: PAIN IN ARM, PATIENT REPORTED FLUID IN ARM. I ADVISED HER TO GO TO THE MD. MD DIAGNOSED TENDONITIS AND REACTION TO THE VACCINE. PATIENT REPORTED THAT HER ARM FELT BETTER ON 7/19/19 TO ME.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Hyperhidrosis, Injection site warmth, Nausea, Peripheral swelling
Clinical narrative: Patient reports feeling hot and sweating, nauseous, and warm swollen arm. After 2 days patient went to the hospital and was put on an antibiotic and anti-nausea medications
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pyrexia, Walking aid user
Clinical narrative: Patient stated that starting the day after receiving his Shingrix vaccine, he felt very ill and had extreme fatigue to the point where he needed assistance walking. He also had a low grade fever. The symptoms lasted about a week and then he recovered fully.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: The patient called to complain of severe arm pain following the administration of his second dose of the vaccine.  He later was called and stated that he went to an urgent care, and the provider told him that they thought the vaccine may have aggravated his arthritis in his shoulder.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother states that her left upper arm were she received vaccines  its swollen and hot and red today, not fever, nausea or sob, not hx of reaction in the past
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches and fever. In the morning he felt okay
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: fever of 101, achy, flu-like symptoms
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site reaction
Clinical narrative: Pt's wife stated pt developed a fever of approximately 100.8 the night he received the vaccine.  He was also experiencing chills and a headache as well as a vaccine site reaction which was hot to the touch.  Advised that pt could take acetaminophen and/or ibuprofen to help with fever and pain, to maintain hydration, and to put on ice on the injection site.  Also advised that if symptoms had not resolved in a couple days or got worse, particularly if vaccine site reaction started spreading, or pt started to become disoriented, he should see medical attention.