chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: received an Adacel vaccine subcutaneously instead of IM; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, site of administration were unknown) subcutaneously instead of intramuscular on an unknown date.  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 inappropriate route of vaccination.  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.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Quadracel was administered to an 8 year old, no AE; Quadracel was administered to an 8 year old (off-label), no AE; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a eight years old male patient who was administered fifth dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number and Exp. Date not reported) via unknown route in the left arm, on 12-Jul-2019.  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 inappropriate age at vaccine administration.  It was also a case of overdose.  The office has not heard anything from the parents saying there have been any issues.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, Product preparation issue
Clinical narrative: Pentacel and Quadracel were both administered to patient.; ActHib was reconstituted with Quadracel, and Pentacel (DTap and IPV) was given separately.; Initial information received on 19-Aug-2019 regarding an unsolicited non-valid non-serious case received from a nurse.   This case concerns a 04-month old female patient who received DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [QUADRACEL] and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL)   Patients medical history and concomitant therapy not reported.  It was of potential medication error due to Inappropriate reconstitution technique and Extra dose administered.  It was unknown whether adverse event was experirnced.  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, UNK
Symptoms: Injection site erythema, Injection site induration, Wrong product administered
Clinical narrative: redness and induration at the injection site; redness and induration at the injection site; nurse gave a patient 0.1 ML of IPOL instead of Tubersol; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA234233 (same reporter).  This case involves a 12 years old male patient who experienced redness and induration at the injection site, while he received vaccine IPV (VERO) [IPOL] and instead of TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Aug-2019, the patient received a 0.1 ml dose of suspect IPV (VERO) (lot number: P1E701M, expiry date: 09-Nov-2020) via intradermal route in the left forearm instead being tested with Tuberculin test  On an unknown date, the patient had redness and induration at the injection site (vaccination site erythema) and (vaccination site induration) (unknown latency) following the administration of IPV (VERO).  It was an also a case of actual medication error due to wrong product administered (nurse gave a patient 0.1 ml of IPOL instead of TUBERSOL).  Lab data was not reported.  Final diagnosis was vaccination site erythema and vaccination site induration.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for both the events.  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 document held by sender: none.
Age: 18.0
Sex: M
Vaccine: IPV, UNK
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site induration, Wrong product administered
Clinical narrative: nurse gave a patient 0.1 ML of IPOL instead of Tubersol; redness and induration at the injection site; redness and induration at the injection site; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA234226 (same reporter).  This case involves a 18 years old male patient who experienced redness and induration at the injection site, while he received vaccine IPV (VERO) [IPOL] and instead of TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Aug-2019, the patient received a 0.1 ml dose of suspect IPV (VERO) (lot number: P1E701M, expiry date: 09-Nov-2020) via intradermal route in the left forearm instead being tested with Tuberculin test  On an unknown date, the patient had redness and induration at the injection site (vaccination site erythema) and (vaccination site induration) (unknown latency) following the administration of IPV (VERO).  It was an also a case of actual medication error due to wrong product administered (nurse gave a patient 0.1 ml of IPOL instead of TUBERSOL).  Lab data was not reported.  Final diagnosis was vaccination site erythema and vaccination site induration.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for both the events.  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 document held by sender: none.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: 8-year-old female received Ipol 0.5 ml intramuscular in an unknown site on 16Aug2019 inadvertently that had expired on 23Jun2019; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 8 years old female patient who had received 0.5 mL dose of an expired vaccine IPV (VERO) [IPOL] (N1F181M, expiry date: 23-Jun-2019) inadvertently via intramuscular route in an unknown site on 16-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.   It was a case of actual medication error due to expired vaccine used.  It was not reported if 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.  Documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Nodule, Rash
Clinical narrative: he noted multiple ( about 10) bumps on his right lower leg; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 57 years old male patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and reported that he noted multiple (about 10) bumps on his right lower leg.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  Concomitant medications included JAPANESE ENCEPHALITIS VACCINE (JAPANESE ENCEPHALITIS VACCINE).  On 14-Aug-2019, the patient received a dose of suspect RABIES (HDC) VACCINE lot PID603M and expiry date: 02-Oct-2020 via intramuscular route in the right deltoid.  On an unknown date, following the vaccination the patient experienced nodule.  (Other relevant tests included no lab data.)  Final diagnosis was nodule.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Overdose
Clinical narrative: nurse may have given 3mls instead of 0.5mls of Ipol; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 8 years old patient who received vaccine IPV (VERO) [IPOL] and reported that nurse may have given 3mls instead of 0.5mls of Ipol.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 19-Aug-2019, the patient received a dose of suspect 3 ml IPV (VERO) lot P1A371M and expiry date: 27-Apr-2020 via subcutaneous route in the left arm.  It was a case of actual medication error due to overdose.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: received a Menactra vaccine in the last two days. His mother states that he had received a Menactra vaccination within the last year and a half; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an18 years old male patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] twice (within the last year and a half) (no details were available at this moment) on unknown dates.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to extra dose administered..Patient's mother stated that he had received a Menactra vaccination within the last year and a half. The reporter did not know when the earlier vaccine was given.  It was unknown whether adverse event was experienced..  Information on the batch number was requested.  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.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: patient received a first dose of Menactra December 24, 2010 and a second dose on December 26, 2010/second dose was too early and therefore invalid; patient received a first dose of Menactra December 24, 2010 and a second dose on December 26, 2010/second dose was too early and therefore invalid; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 41 years old patient of unknown gender who received first dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 24-Dec-2010 and second dose on 26-Dec-2010 (lot number not reported via unknown route at unknown sites for both doses).  The patient's past medical history included Asplenia.  The patient's past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   It was of actual medication error case due to Inappropriate schedule of vaccine administered and off-label use.  It was not reported whether adverse event was experienced or not.  Information on the batch number was requested.  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.
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Ipol was inadvertently administered to a patient/no AE; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 4 years old female patient who received an expired dose of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  On 20-Aug-2019, the patient received a 0.5 ml single first dose (unknown whether it was primary/booster dose) of suspect IPV (VERO) lot N1G511M (expiry date: 02-Aug-2019) via intramuscular route in the right thigh.  It was of actual medication error case due to expired vaccine used.  It as reported that no adverse event was experienced by the patient.  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.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 12 year old son received Menactra twice in a year; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old male patient who experienced 12 year old son received menactra twice in a year, 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, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported.  It was of actual medication error due to extra dose administered..  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Eczema
Clinical narrative: Pt noted a flare of her eczema on her arms and legs starting the same day the immunization was given
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 08/12/19 Sore arm same day moderate/severe pain at 6, 2nd day 08/13/2019 came down with fever lasting approx. 8hrs. took 1,000mg. of Tylenol approx. up to 102 degrees, sore arm continuing on for 1.5 weeks total, pain level 1st 7 days or so was 6 after that went down to approx. 3.  08/16/19 5th day came down with fever again lasting approx. 16hrs. (longer than 1st fever) took 1,000MG of Tylenol 1hr. later fever had gone higher took addl. 1,000Mg. to get it under control(so total of 2,000Mg),temp up to 102.5, 08/23/19 12th day came down with fever again lasting approx. 6hrs. took 1,000Mg. of Tylenol, temp. up to approx. 101.5. As of today everything appears to be resolved.....  I do get approx. 2 fevers per yr. for no apparent reason. I have never had so many fevers so close together.....
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Rash, Swelling, Urticaria
Clinical narrative: Hives, swelling, erythema - by next day (within 12 hours) progressive rash with welts over next 36 hours at time of clinic visit.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Patient reported having a very sore arm almost immediately after administration, a few hours later he started to have a general malaise feeling (mild fever, fatigue). During the night, around 2am, he reported waking up out of sleep with severe chills. He is feeling slightly better the following morning (today) but is still unwell.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient presented dizziness,nausea and mild swelling at injection site. Fever of 102.No vomiting.Patient was seen by Dr. Tylenol was administered.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nasopharyngitis
Clinical narrative: Cold; Pain in arm; This case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix .5 ml. In June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 22nd June 2019, the patient experienced cold. On an unknown date, the outcome of the injection site pain and cold were unknown.   It was unknown if the reporter considered the injection site pain and cold to be related to Shingrix.  Additional details were provided as follows: This case was received from the vaccine patient assistance program. The patient received Shingrix in left arm. The patient experienced pain in her left arm (injections site) after receiving 1st dose of the Shingrix vaccine. The patient also stated that she experienced a cold 3 days later.  The patient was agreed to follow up. No further information was given.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Epileptic aura, Quality of life decreased, Seizure
Clinical narrative: No longer controlled epilepsy with daily seizures with auras and getting worse; This is a spontaneous case initially received from an other non-health professional on 19-Aug-2019, concerning a 59-year-old, male patient (race and ethnic group were not provided).   The patient's relevant medical history included epilepsy.  The patient's concomitant medications included Trileptal (Oxcarbazepine) and Depakote (Valproate semisodium).  On 11-Aug-2019, the patient was administered with Afluria QUAD (influenza vaccine, inactivated influenza virus egg split CSL, dose: 0,5 ml, route of administration: intramuscularly, anatomical location: deltoid, batch number, expiration date: not reported) for influenza prophylaxis.   On 12-Aug-2019 during morning, within 20 hours after vaccination, the patient started experiencing seizures with auras daily.  On 19-Aug-2019, the patient stated that his epilepsy had been controlled for 35 years and now it is no longer controlled and daily auras were getting worse. The patient also stated it has ruined his life and nothing in his life has changed except he had the injection. On the same day, the patient had appointment with his physician.   The outcome of no longer controlled epilepsy with daily seizures with auras and getting worse was not resolved.  Company comment: Day after administration of Afluria QUAD vaccine the patient began experiencing worsening of underlying epilepsy including associated daily auras. Temporal proximity to development of adverse event is suggestive for causal role of vaccine. Patient's concomitant medications included oxcarbazepine and valproate. Indication for use of these drugs was not specified, however these drugs are known anti-epileptics. Dosing of these drugs is unknown, however patient reported no other changes aside from vaccination. Causal role of Afluria QUAD in exacerbation of epilepsy cannot be excluded based on the available information, therefore this event is assessed as related.; Reporter's Comments: Day after administration of Afluria QUAD vaccine the patient began experiencing worsening of underlying epilepsy including associated daily auras. Temporal proximity to development of adverse event is suggestive for causal role of vaccine. Patient's concomitant medications included oxcarbazepine and valproate. Indication for use of these drugs was not specified, however these drugs are known anti-epileptics. Dosing of these drugs is unknown, however patient reported no other changes aside from vaccination. Causal role of Afluria QUAD in exacerbation of epilepsy cannot be excluded based on the available information, therefore this event is assessed as related.
Age: 31.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Dizziness, Electrocardiogram
Clinical narrative: Post Tdap and Hep A vaccinations patient told RN she felt "woozy", had tonic clonic seizure lasting 30-45 seconds. Code blue was called, EMS called. Fingerstick 133, VS stable. Placed on non-rebreather o2. Several minutes later pt again didn't feel well, had second seizure lasting about 10-15 seconds. Post seizure was +diaphoretic, spotty vision, pale. Was not postictal after either seizure, was able to recall what happened, understood where she was.  No vomiting, loss of urine.  Reports she felt like she was dreaming during the seizure. Denied chest pain, dyspnea. Sent to ER via ambulance
Age: 31.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Generalised tonic-clonic seizure, Hyperhidrosis, Malaise, Pallor, Visual impairment
Clinical narrative: Post Tdap and Hep A vaccinations patient told RN she felt "woozy", had tonic clonic seizure lasting 30-45 seconds. Code blue was called, EMS called. Fingerstick 133, VS stable. Placed on non-rebreather o2. Several minutes later pt again didn't feel well, had second seizure lasting about 10-15 seconds. Post seizure was +diaphoretic, spotty vision, pale. Was not postictal after either seizure, was able to recall what happened, understood where she was.  No vomiting, loss of urine.  Reports she felt like she was dreaming during the seizure. Denied chest pain, dyspnea. Sent to ER via ambulance
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chest X-ray abnormal, Cough, Fatigue, Feeling abnormal
Clinical narrative: HPI Started feeling ill the evening after she received the pneumonia vaccine. Fever up to 103 and feels terrible.  Body aches, cough. The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, past family history, past medical history, past social history, past surgical history and problem list.   Review of Systems  Constitutional: Positive for fatigue and fever. Negative for chills.  Respiratory: Negative for cough and shortness of breath.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for constipation and diarrhea.  Neurological: Positive for weakness. Negative for dizziness and headaches.  Psychiatric/Behavioral: Negative for dysphoric mood. The patient is not nervous/anxious.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Lung opacity, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: HPI Started feeling ill the evening after she received the pneumonia vaccine. Fever up to 103 and feels terrible.  Body aches, cough. The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, past family history, past medical history, past social history, past surgical history and problem list.   Review of Systems  Constitutional: Positive for fatigue and fever. Negative for chills.  Respiratory: Negative for cough and shortness of breath.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for constipation and diarrhea.  Neurological: Positive for weakness. Negative for dizziness and headaches.  Psychiatric/Behavioral: Negative for dysphoric mood. The patient is not nervous/anxious.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Computerised tomogram abnormal, Computerised tomogram head normal, Ear swelling, Erythema, Gingival erythema
Clinical narrative: Patient had equivocal titer. Given vaccine on 8/19/19. Lesion developed left lower face, near but not touching lip on 8/20/19, progressed to lesion inside of left nose, swelling/itchiness under left eye  itchiness, redness left upper gum near tooth #12, and left earlobe swelling/redness/itchiness. Seen initially for symptoms on 8/23/19 in my office, separate from site of immunization. Referral to ED, given Valtrex 1 gram po tid x 7 days. Follow up same day from this office. Ordered CT left orbit, CT brain without contrast, referral to Opthalmologist - test and specialty visit done same day 8/23/19. F/U 8/26/19 in office, improved. Given Bactroban, bid x 5 days for lesion inside of left nose.  F/U 8/30.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin lesion, Swelling of eyelid
Clinical narrative: Patient had equivocal titer. Given vaccine on 8/19/19. Lesion developed left lower face, near but not touching lip on 8/20/19, progressed to lesion inside of left nose, swelling/itchiness under left eye  itchiness, redness left upper gum near tooth #12, and left earlobe swelling/redness/itchiness. Seen initially for symptoms on 8/23/19 in my office, separate from site of immunization. Referral to ED, given Valtrex 1 gram po tid x 7 days. Follow up same day from this office. Ordered CT left orbit, CT brain without contrast, referral to Opthalmologist - test and specialty visit done same day 8/23/19. F/U 8/26/19 in office, improved. Given Bactroban, bid x 5 days for lesion inside of left nose.  F/U 8/30.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Mother called on Thursday 8/15/19 asking which vaccine patient got in Right arm. Patient complaining of redness, swelling and pain in right arm starting on Monday 8/12/19. Mom gave ibuprofen. Instructed mom to take to PCP Dr. for assessment.  Talked with Mom later that day. Mom reports started on Bactrim for 10 days and to return for f/u next day. Mom took child for F/U. Nothing new to report.  Patient had Follow up again on Friday 8/23/19 still complaining of pain in arm. Xrays ordered. No further reports received from PCP office.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Intussusception, X-ray
Clinical narrative: Intussuseption
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMRV
Symptoms: Diarrhoea, Pyrexia, Rash morbilliform
Clinical narrative: 1 yr old received MMRV 8/15 and was noted to have a measles like rash on trunk + extending to extremities on 8/26/19, about 2 days of diarrhea + fever
Age: 43.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red - mild swelling - mild to moderate      } all to Rt upper arm Tender - moderate warm to touch mild
Age: 30.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Headache, Injection site pain, Nausea, Vertigo
Clinical narrative: Pt informed me that she has experienced vertigo, nausea, and headache that started the morning after receiving the vaccine. Denies any fevers, vomiting, or syncopal episodes. Denies any local reaction at the site of injection besides mild soreness. No rash, itching or  shortness of breath. Pt has not taken any medications for the symptoms.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: HCW states once she received the TDAP her arm where she received the vaccine became increasingly  swollen, red, painful, hot to touch
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Patient developed cellulitis at the injection site as well upper forearm
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Neurological symptom, Neuropathy peripheral, Pain in extremity
Clinical narrative: I gave an IM  TDAP injection on 8-19-19 in patient's left arm for work purposes. He did not have any symptoms immediately after the vaccine. He left my clinic and went back to work.  I received an email from patient at 0733 om 8-20-19 stating he  began to have symptoms last night (8-19-19) including significant pain, neuropathy and other neurologic symptoms in the left lower extremity. He was directed to go to PCM/ER  on 8-20-19 to be evaluated. He went to ER and was evaluated and discharged. He stated he was diagnosed with peripheral neuropathy. I spoke with him again on 8-22-19 and he stated his symptoms were getting worse as the peripheral neuropathy had spread to his mid-thigh on his left leg. He stated he had a Neurology appointment the next day (8-23-19). I spoke with him again on 8-27-19. He states he was admitted to the hospital the same day as his Neurology appointment and was still in the hospital. He stated the neuropathy is worse still extending through his left leg, right leg, right arm, and lower back. He stated he thinks he will be in the hospital for about a month.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Acute disseminated encephalomyelitis, Adverse reaction, Burning sensation, Central venous catheterisation, Deafness
Clinical narrative: I gave an IM  TDAP injection on 8-19-19 in patient's left arm for work purposes. He did not have any symptoms immediately after the vaccine. He left my clinic and went back to work.  I received an email from patient at 0733 om 8-20-19 stating he  began to have symptoms last night (8-19-19) including significant pain, neuropathy and other neurologic symptoms in the left lower extremity. He was directed to go to PCM/ER  on 8-20-19 to be evaluated. He went to ER and was evaluated and discharged. He stated he was diagnosed with peripheral neuropathy. I spoke with him again on 8-22-19 and he stated his symptoms were getting worse as the peripheral neuropathy had spread to his mid-thigh on his left leg. He stated he had a Neurology appointment the next day (8-23-19). I spoke with him again on 8-27-19. He states he was admitted to the hospital the same day as his Neurology appointment and was still in the hospital. He stated the neuropathy is worse still extending through his left leg, right leg, right arm, and lower back. He stated he thinks he will be in the hospital for about a month.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Demyelination, Feeling hot, Full blood count normal, Hypoaesthesia, Impaired work ability
Clinical narrative: I gave an IM  TDAP injection on 8-19-19 in patient's left arm for work purposes. He did not have any symptoms immediately after the vaccine. He left my clinic and went back to work.  I received an email from patient at 0733 om 8-20-19 stating he  began to have symptoms last night (8-19-19) including significant pain, neuropathy and other neurologic symptoms in the left lower extremity. He was directed to go to PCM/ER  on 8-20-19 to be evaluated. He went to ER and was evaluated and discharged. He stated he was diagnosed with peripheral neuropathy. I spoke with him again on 8-22-19 and he stated his symptoms were getting worse as the peripheral neuropathy had spread to his mid-thigh on his left leg. He stated he had a Neurology appointment the next day (8-23-19). I spoke with him again on 8-27-19. He states he was admitted to the hospital the same day as his Neurology appointment and was still in the hospital. He stated the neuropathy is worse still extending through his left leg, right leg, right arm, and lower back. He stated he thinks he will be in the hospital for about a month.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Lumbar puncture normal, Magnetic resonance imaging brain abnormal, Magnetic resonance imaging spinal abnormal, Metabolic function test normal, Musculoskeletal disorder
Clinical narrative: I gave an IM  TDAP injection on 8-19-19 in patient's left arm for work purposes. He did not have any symptoms immediately after the vaccine. He left my clinic and went back to work.  I received an email from patient at 0733 om 8-20-19 stating he  began to have symptoms last night (8-19-19) including significant pain, neuropathy and other neurologic symptoms in the left lower extremity. He was directed to go to PCM/ER  on 8-20-19 to be evaluated. He went to ER and was evaluated and discharged. He stated he was diagnosed with peripheral neuropathy. I spoke with him again on 8-22-19 and he stated his symptoms were getting worse as the peripheral neuropathy had spread to his mid-thigh on his left leg. He stated he had a Neurology appointment the next day (8-23-19). I spoke with him again on 8-27-19. He states he was admitted to the hospital the same day as his Neurology appointment and was still in the hospital. He stated the neuropathy is worse still extending through his left leg, right leg, right arm, and lower back. He stated he thinks he will be in the hospital for about a month.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Myelitis transverse, Neurological examination, Paraesthesia, Plasmapheresis, Radiculitis brachial
Clinical narrative: I gave an IM  TDAP injection on 8-19-19 in patient's left arm for work purposes. He did not have any symptoms immediately after the vaccine. He left my clinic and went back to work.  I received an email from patient at 0733 om 8-20-19 stating he  began to have symptoms last night (8-19-19) including significant pain, neuropathy and other neurologic symptoms in the left lower extremity. He was directed to go to PCM/ER  on 8-20-19 to be evaluated. He went to ER and was evaluated and discharged. He stated he was diagnosed with peripheral neuropathy. I spoke with him again on 8-22-19 and he stated his symptoms were getting worse as the peripheral neuropathy had spread to his mid-thigh on his left leg. He stated he had a Neurology appointment the next day (8-23-19). I spoke with him again on 8-27-19. He states he was admitted to the hospital the same day as his Neurology appointment and was still in the hospital. He stated the neuropathy is worse still extending through his left leg, right leg, right arm, and lower back. He stated he thinks he will be in the hospital for about a month.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Scan with contrast abnormal, Vestibular disorder
Clinical narrative: I gave an IM  TDAP injection on 8-19-19 in patient's left arm for work purposes. He did not have any symptoms immediately after the vaccine. He left my clinic and went back to work.  I received an email from patient at 0733 om 8-20-19 stating he  began to have symptoms last night (8-19-19) including significant pain, neuropathy and other neurologic symptoms in the left lower extremity. He was directed to go to PCM/ER  on 8-20-19 to be evaluated. He went to ER and was evaluated and discharged. He stated he was diagnosed with peripheral neuropathy. I spoke with him again on 8-22-19 and he stated his symptoms were getting worse as the peripheral neuropathy had spread to his mid-thigh on his left leg. He stated he had a Neurology appointment the next day (8-23-19). I spoke with him again on 8-27-19. He states he was admitted to the hospital the same day as his Neurology appointment and was still in the hospital. He stated the neuropathy is worse still extending through his left leg, right leg, right arm, and lower back. He stated he thinks he will be in the hospital for about a month.
Age: 31.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Erythema, Granuloma annulare, Loss of personal independence in daily activities, Skin lesion
Clinical narrative: On 8/22 I woke up with large red lesions all over my body. On 8/26 I was diagnosed with Granuloma Annulare by my primary care doctor. One week later I am still suffering from the lesions all over my body. I have missed one week of work so far due to this condition.
Age: 31.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Lip swelling, Rash erythematous, Swelling face
Clinical narrative: On 8/22 I woke up with large red lesions all over my body. On 8/26 I was diagnosed with Granuloma Annulare by my primary care doctor. One week later I am still suffering from the lesions all over my body. I have missed one week of work so far due to this condition.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Measles, Rash, Vaccination complication
Clinical narrative: Woke up with rash covering body. Hospital confirmed she contracted measles from the mmr vaccine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site reaction, Insomnia, Pyrexia
Clinical narrative: Tennis ball sized welt at injection site within 3 hrs, aching joints, headache within 2 hrs, fever 101-102°  F within 8 hrs persisting overnight, sleeplessness overnight. acetaminophen, 500 mg twice. Fever reduced, aching persists 24 hrs later
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Tennis ball sized welt at injection site within 3 hrs, aching joints, headache within 2 hrs, fever 101-102°  F within 8 hrs persisting overnight, sleeplessness overnight. acetaminophen, 500 mg twice. Fever reduced, aching persists 24 hrs later
Age: 1.08
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Unknown
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mother of pt reports swelling and heat of upper arm area. Mother of pt administered Tylenol and Ibuprofen. Also alternated hot and cold compresses to area.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Deafness unilateral, Facial nerve disorder, Herpes zoster oticus, Vaccination failure, Vestibular disorder
Clinical narrative: Suspected vaccination failure; believe Shingrix has reactivated the virus in the geniculate ganglion; deafness/profound hearing loss in her right ear; affected facial nerve; affected vestibular nerve; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), geniculate herpes zoster (serious criteria GSK medically significant), deafness (serious criteria GSK medically significant), facial nerve disorder and vestibular disorder. On an unknown date, the outcome of the vaccination failure, geniculate herpes zoster, deafness, facial nerve disorder and vestibular disorder were unknown.   It was unknown if the reporter considered the vaccination failure, geniculate herpes zoster, deafness, facial nerve disorder and vestibular disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, Shingrix had affected her facial nerve and vestibular nerve in addition to profound hearing loss in her right ear. She believed that, Shingrix had reactivated the virus in the geniculate ganglion, which affected her nerves. The reporter contacted an attorney again. She was provided the address to the legal department. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation were unknown. This case had been linked with case US2019153169 reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acoustic stimulation tests abnormal, Balance disorder, Deafness unilateral, Middle ear inflammation
Clinical narrative: Suspected vaccination failure; believe Shingrix has reactivated the virus in the geniculate ganglion; deafness/profound hearing loss in her right ear; affected facial nerve; affected vestibular nerve; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), geniculate herpes zoster (serious criteria GSK medically significant), deafness (serious criteria GSK medically significant), facial nerve disorder and vestibular disorder. On an unknown date, the outcome of the vaccination failure, geniculate herpes zoster, deafness, facial nerve disorder and vestibular disorder were unknown.   It was unknown if the reporter considered the vaccination failure, geniculate herpes zoster, deafness, facial nerve disorder and vestibular disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, Shingrix had affected her facial nerve and vestibular nerve in addition to profound hearing loss in her right ear. She believed that, Shingrix had reactivated the virus in the geniculate ganglion, which affected her nerves. The reporter contacted an attorney again. She was provided the address to the legal department. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset for the event and laboratory test confirmation were unknown. This case had been linked with case US2019153169 reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Deafness unilateral, Facial nerve disorder, Herpes zoster oticus, Vaccination failure, Vestibular disorder
Clinical narrative: equilibrium off; inflammation middle ear; hear loss/hearing loss in her right ear/ deaf in her ear/deafness; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) (batch number 49Y35, expiry date unknown) and (batch number 92NA4, expiry date unknown) for prophylaxis.   Previously administered products included zostavax (vaccine several years ago from the date of reporting).   On 6th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 13th August 2019, 7 days after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant) and middle ear inflammation. On 16th August 2019, the patient experienced disorder equilibrium. The patient was treated with ambiguous medication nos (Cortisone (Nos)) and antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the hearing loss was not recovered/not resolved and the outcome of the disorder equilibrium and middle ear inflammation were unknown.   The reporter considered the hearing loss and disorder equilibrium to be related to Shingrix. It was unknown if the reporter considered the middle ear inflammation to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. Seven days later the patient found to be hearing loss in her right ear.    She noted she was deaf in her ear, and there had been no change or improvement.    The patient went to see her primary physician on 13th August 2019, who noted the issue as inflammation of the ear and referred her to an ENT (ears, nose, and throat).  He did prescribe a nasal spray  with cortisone  for inflammation.  Three days later she saw an ENT. She initially saw a Physician Assistant, who had an audiology test peformed with results of deafness in right  ear or profound hearing loss in Right ear.  The patient then was seen by  another physician due to the results of the test. She noted he checked her equilibrium which was off, and prescribed her prednisone and an anti-viral. The physician planned to give her a shot of cortisone in the middle ear.  The patient noted she had no history of hearing loss or issues and none in her family.  She noted the cause of the events directly related to the product. The reporter consented to follow up. This case is linked with case US2019153177, reported by the same reporter.