chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: given expired Quadracel to a 4 year old; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a four years old patient (gender not reported) who was vaccinated with a dose of expired vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Exp. Date Jun-2019 ) (lot number, dose, route and site of administration not reported) on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  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: TDAP
Symptoms: Pruritus
Clinical narrative: itching on her back and sides; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 71 years 3 months and 25 day old female patient who experienced itching on her back and sides, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Jul-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in the right arm.  On 16-Jul-2019, the patient developed a non-serious itching on her back and sides (pruritus) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Final diagnosis was itching on her back and sides.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for itching on her back and sides.  Information on the batch number was requested  List of documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received Adacel on 29Jun2014, and then again on 10Jul2019, the dosing interval between two injections of Adacel was less than the labelled 8 year interval; Initial and live follow-up information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 34 years old female patient who was vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] first dose on 29-Jun-2014 and second 0.5 ml dose on 10-Jul-2019 with lot: C5585AA (expiry date: 06 Mar 2012, route and site of administration not reported) and the dosing interval between two injections of Adacel was less than the labelled 8 year interval.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate schedule of vaccine administration.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of document held by sender: none.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Adacel was inadvertently administered to a patient; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 11 years old male patient who received an expired 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5726AA, expiry date: 11-Jul-2019 via intramuscular route in the right deltoid on 16-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: DTaP-IPV portion of Pentacel was inadvertently administered to a 2-month-old patient; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who was first dose vaccinated with DTAP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ014AA, expiry date: 10-Oct-2020 via intramuscular route in the right thigh) On 15-Jul-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  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: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient who inadvertently received pediatric DTaP vaccine- made by GSK. The patient was supposed to receive Adacel/ no symptoms; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 12 years old patient (gender unknown) who received vaccine pediatric DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTaP] vaccine instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, concomitant medication and family history were not provided.   On 17-Jun-2019, the patient received a 0.5ml dose of suspect DTAP not produced by Sanofi Pasteur lot PT2RK via unknown route in the right deltoid instead of dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported.  It was an actual medication error due to wrong vaccine administered.  It was reported that patient who inadvertently received pediatric DTaP vaccine- made by GSK. The patient was supposed to receive Adacel.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: temperature excursion for holding onto a pre-drawn dose of Menactra; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient (age unknown) who reported temperature excursion for holding on to a pre-drawn dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number:U6455CC and expiry date: 15-Nov-2020.  The patient's past vaccination(s) included MENACTRA with last year. The patient's past medical history, medical treatment(s) and family history were not provided.   It was a potential medication error due to incorrect product storage.  Vaccine was not administered to the patient.  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: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired IPOL vaccine was administered to patient; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a patient (unknown demographics) who was administered expired IPV (VERO) [IPOL] vaccine lot number and expiry date 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 due to expired vaccine used.  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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Wrong product administered
Clinical narrative: 20 years old received the Td (Tenivac) Vaccine instead of the Tdap (Adacel) vaccine; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional via phone.  This case involves a 20 years old female patient received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 03-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to wrong vaccine administered.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on batch number was requested.  Document held by the sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia
Clinical narrative: numbness in his arm; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a male patient who experienced numbness in his arm, while he received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In June 2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious numbness in his arm (hypoaesthesia) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was numbness in his arm.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for numbness in his arm.  Information on the batch number was requested.  List of document held by sender: none.
Sex: U
Vaccine: DT
Symptoms: Allergy to vaccine
Clinical narrative: allergy to Tetanus Diphtheria; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a physician via other company Pfizer (Reference number- 2018426188).  This case involves patient (with unknown demographics) who experienced allergy to Tetanus- Diphtheria, while he/she received vaccine DIPHTHERIA AND TETANUS TOXOIDS.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious allergy to Tetanus- Diphtheria (allergy to vaccine) (unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS.  Other relevant tests not reported.  Final diagnosis was allergy to Tetanus- Diphtheria .  It was not reported if the patient received a corrective treatment.  The outcome was unknown for allergy to Tetanus- Diphtheria.  Information on the batch number was requested.  List of documents held by sender none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: vaccination of the Pentacel diluent only to the patient; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of an unknown demographics who received diluent of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 ml (lot U6327AA) via unknown route in the left thigh on 16-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally received Adacel injections from prefilled syringes that expired on 5/2/2019/ No AE; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 11 years old female patient who received 0.5 mL dose of expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5656AA, expiry date: 02-May-2019 via intramuscular route in the arm NOS on 16-Jul-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used.  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.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: accidentally received Adacel injections from prefilled syringes that expired on 5/2/2019; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA196355 and 2019SA196388 same reporter.  This case involves patient of an unknown demographics who received expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] expiry date: 02-May-2019 (batch number, route and site of administration and vaccination date were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: accidentally received Adacel injections from prefilled syringes that expired on 5/2/2019; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to the cases 2019SA196355 and 2019SA196387 (same reporter).  This case involves an unknown demographics patient who was vaccinated with an expired dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (prefilled syringe)(lot not reported and Exp. Date 02-May-2019) 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 expired vaccine used.  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: RAB
Symptoms: Syringe issue, Underdose
Clinical narrative: The patient received a partial dose of Imovax, during administration, the syringe leaked around where the needle attaches to the syringe and discontinued giving the dose before the total amount went in because it was "dripping on the floor"; The patient received a partial dose of Imovax, during administration, the syringe leaked around where the needle attaches to the syringe and discontinued giving the dose before the total amount went in because it was "dripping on the floor"; Initial information received on 18-Jul-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 27 years old female patient who received a partial dose of RABIES (HDC) VACCINE [IMOVAX RABIES] vaccine while administering it the syringe leaked around where the needle attaches to the syringe and discontinued giving the dose before the total amount went in because it was dripping on the floor lot P1C851M, Expiration Date: 25-Sep-2020 via intramuscular route in deltoid administration site on 18-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   It was an actual medication error due to inappropriate dose of vaccine administered.  It was also a case of syringe issue.  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: F
Vaccine: FLUX
Symptoms: Aphonia, Dehydration, Vomiting
Clinical narrative: lost her voice; could not keep food down; dehydration; Initial information received on 19-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female patient (age not reported) who lost her voice, could not keep food down and dehydration, while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious lost her voice (aphonia), could not keep food down (movement disorder) and dehydration (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  Final diagnosis was dehydration, movement disorder and aphonia.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for dehydration, movement disorder and aphonia.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Flushing, Injection site erythema
Clinical narrative: Upon awakening the following morning, I saw a huge red welt on my forehead above the right eye. I also felt flushed, muscle soreness, and overall weakness/tiredness. There is redness/swelling at the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Urticaria
Clinical narrative: Upon awakening the following morning, I saw a huge red welt on my forehead above the right eye. I also felt flushed, muscle soreness, and overall weakness/tiredness. There is redness/swelling at the injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: On 7/21/19 I just started feeling bad and I took 2 Tylenol before going to bed.  On 7/22/19 when I got up about 8:00 AM I had a fever of 100 degrees and I was aching all over.  After breakfast, I took 2 Tylenol every 6 hours all day.  I also had a red area around the shot site.  I measured the redness on my arm today 7/23/19 and the redness measures 1 3/4 inches across and 3 1/2 inches long.  My arm has been sore from the beginning and it is still sore today.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Swelling/redness/rash around injections site.  Mild pain and stiffness in left upper arm
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Fatigue, chills, fever and pain at injection site
Age: 19.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Fatigue, Injected limb mobility decreased, Injection site bruising, Pyrexia
Clinical narrative: 5/23/19 WOKE UP WITH FEVER 102 X  2 DAYS, BRUISED ON LEFT DELTOID. PATIENT STAES SHE HAD DECREASED  RANGE OF MOTION TO LEFT SHOULDER. ALSO FEELING TIRED.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Injection site pain
Clinical narrative: pain at injection sight, headache and body aches, chills, diarrhea and abdominal cramping.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain at injection sight, headache and body aches, chills, diarrhea and abdominal cramping.
Age: 44.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult patient was given MMRV vaccine. No adverse reaction noted.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Within a couple of hours, I developed flu like symptoms which included body ache, slight headache, pronounced ringing in the ears, slight temperature (99.6--I am usually sub-normal), and fatigue. Napped for 3 hours the next afternoon--little appetite. Most symptoms receded after 48 hours--still some ringing in ears. NOTE: after the first injection in March 2018, I had the same symptoms, only worse. Took 3 days to recover, instead of two Anecdotally, I have heard similar stories, WARNINGS NEED TO BE BEEFED UP TO STATE ADVERSE REACTIONS ARE PROBABLE OR ARE VERY LIKELY. I am a very healthy person and if I suffered these symptoms, I suspect many others will as well. Need to allow a couple of days to recover. My arm is still sore.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: Within a couple of hours, I developed flu like symptoms which included body ache, slight headache, pronounced ringing in the ears, slight temperature (99.6--I am usually sub-normal), and fatigue. Napped for 3 hours the next afternoon--little appetite. Most symptoms receded after 48 hours--still some ringing in ears. NOTE: after the first injection in March 2018, I had the same symptoms, only worse. Took 3 days to recover, instead of two Anecdotally, I have heard similar stories, WARNINGS NEED TO BE BEEFED UP TO STATE ADVERSE REACTIONS ARE PROBABLE OR ARE VERY LIKELY. I am a very healthy person and if I suffered these symptoms, I suspect many others will as well. Need to allow a couple of days to recover. My arm is still sore.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Five days after the vaccine, the injection site on  my left arm became red, painful,  swollen, warm to the touch, and very itchy.  It is at this time I felt a bump or nodule at the injection site.  With oral diphenhydramine HCL -50mg nightly for three days the swelling and redness decreased. Topical Neosporin antibiotic ointment with itch coverage was applied in the AM and PM for five days.   Day six my left arm at the injection site has returned to my baseline normal - but the nodule / bump is still present, and at times my left arm - deltoid area where the vaccine was injected is still sore and stiff at times.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Five days after the vaccine, the injection site on  my left arm became red, painful,  swollen, warm to the touch, and very itchy.  It is at this time I felt a bump or nodule at the injection site.  With oral diphenhydramine HCL -50mg nightly for three days the swelling and redness decreased. Topical Neosporin antibiotic ointment with itch coverage was applied in the AM and PM for five days.   Day six my left arm at the injection site has returned to my baseline normal - but the nodule / bump is still present, and at times my left arm - deltoid area where the vaccine was injected is still sore and stiff at times.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abdominal pain upper, Blood glucose normal, Fatigue, Feeling abnormal, Laboratory test normal
Clinical narrative: migraine, fatigue, fogginess, stomach ache, tingling in arms and back
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Migraine, Paraesthesia, Streptococcus test negative
Clinical narrative: migraine, fatigue, fogginess, stomach ache, tingling in arms and back
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Abdominal pain upper, Blood glucose normal, DNA antibody negative, Fatigue, Feeling abnormal
Clinical narrative: migraine, fatigue, fogginess, stomach ache, tingling in arms and back
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccines administered on 7/16/2019. Right arm became red and swollen on 7/17/19 in the evening. Reddness and swelling noted when bathing the child. Minimal pain expressed per father of child. Child active, acting normal. father applied cold compress and administered Tylenol. Father did not take child to the doctor. Arm swelling decreased over 5 days.  Father called today, July 23 at 830 am. Child continues to do well... per father, "arm looks better".  Patient did not experience other signs or symptoms.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Pain in extremity
Clinical narrative: Hours after the shot, I experienced soreness in my right arm requiring pain medication to sleep.  The next morning, I have experiencing mild flu-like symptoms and diahhrea.
Age: 50.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Pyrexia
Clinical narrative: Pt. reported "feeling feverish" Friday afternoon through Saturday or Sunday.  Reports temperature 100-100.2 degrees F.  Stated that he did not experience any achiness or other symptoms.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at injection site after 4 hours. Pain extended from there down arm and then severe headache began within 8 hours. Muscle aches started in neck and went south around midnight on day of vaccination. Fever for 36 hours and only a few hours sleep over 48 hours.  Spent the entire time in bed. Better today, but feel weak.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pyrexia
Clinical narrative: Redness and swelling at injection site after 4 hours. Pain extended from there down arm and then severe headache began within 8 hours. Muscle aches started in neck and went south around midnight on day of vaccination. Fever for 36 hours and only a few hours sleep over 48 hours.  Spent the entire time in bed. Better today, but feel weak.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 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 unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the events shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Dose inadvertently administered post expiry/ Nurse states patient inadvertently received a unspecified pediatric dose of VAQTA that had expired.; Information has been received from a nurse referring to an 18 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies,concurrent condition and concomitant medication were not provided.   On 11-JUL-2019 the patient inadvertently received a unspecified pediatric dose of hepatitis a vaccine, inactivated (VAQTA) injection 25/0.5 unit unknown (lot # R012988, expiration date 30-MAY-2019) intramuscularly for prophylaxis. The hepatitis a vaccine, inactivated (VAQTA) had expired (expired product administered). No adverse effects were reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 22-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 29-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2007, 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 unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a nurse practitioner for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2011, 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 unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2006, 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 unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; post herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 19-DEC-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 unspecified dates, the patient experienced shingles and post berpetic neuralgia. On unspecified dates, the patient was treated by a healthcare provider for shingles and post berpetic neuralgia. The outcome of both events was not reported. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: UNK, UNK, VARZOS
Symptoms: Concussion, Dizziness, Fall, Fatigue, Head injury
Clinical narrative: flu like symptoms; falling off a ladder and hitting head; concussion; Head injury; dizzy; occasional fatigue; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included palbociclib (Ibrance) for metastatic breast cancer and anastrozole (Arimidex) for metastatic breast cancer.   On an unknown date, the patient received the 1st dose of Shingrix. In April 2017, the patient started Ibrance 125 mg once daily (125 mg daily). In April 2019, the patient started Arimidex 1 mg once daily (1 mg daily). On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria hospitalization), fall, concussion, head injury, dizziness and fatigue. On an unknown date, the outcome of the influenza-like symptoms, fall, concussion, head injury, dizziness and fatigue were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fall, concussion, head injury, dizziness and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 27th February. The patient developed flu like symptoms for which he was on rest. The patient fell off a ladder and hit her head, the ladder incident was not related to the ibrance but was patient's stupidity in placing the ladder into the damp soil and the ladder was shifted once weight was too high. The patient experienced concussion but no broken bones and stated no more ladder the patient had to visit emergency room.. There was no side effect from the Ibrance except for occasional fatigue, especially around 14th day of pill cycle. It was unknown if the reporter considered the influenza-like symptoms, fall, concussion, head injury, dizziness and fatigue to be related palbociclib (Ibrance) and anastrozole (Arimidex). For tolerance to 2nd dose of Shingrix, refer case US2019GSK133032. Clarification was raised to confirm vaccination date and event onset dates. However, no reply received hence case processed as per worst case scenario.