chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, Blood bilirubin, Jaundice
Clinical narrative: "within the last 2 days" on an unspecified date the patient started to experience jaundice; an unspecified patient received his first dose of RECOMBIVAX and "two days later" had a second dose of RECOMBIVAX on an unspecified date; an unspecified patient received his first dose of RECOMBIVAX and "two days later" had a second dose of RECOMBIVAX on an unspecified date; This spontaneous report was received from a pharmacist referring to a neonate male patient of unknown age. The patient had no pertinent medical history, drug reactions/allergies or concomitant therapies.     On an unknown date in October 2019, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (vaccine dosage detail, route of administration, therapy type, lot# and expiration date were not reported) for prophylaxis. And two days later, the patient was vaccinated with second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (vaccine dosage detail, route of administration, therapy type, lot# and expiration date were not reported) for prophylaxis (incorrect dose administered and inappropriate schedule of vaccine administered). On an unspecified date in October 2019, within the last 2 days, the patient started to experience jaundice and was taken to the emergency room on 09-OCT-2019. It could not be confirmed when the jaundice started. Lab diagnostics or studies included bilirubin, aspartate transaminase (AST)/ alanine transaminase (ALT) and albumin. No treatment was given for the jaundice and no intervention was given to prevent serious criteria. There was no product quality complaint (PQC). The outcome of jaundice was not recovered. The causality between the event of jaundice and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; inproperly stored PROQUAD was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 18-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S013712 with expiration date 01-NOV-2020, dose detail and route were not reported) for prophylaxis. The vaccine experienced improperly stored and was stored at minus 13.75 degree Celsius for 68 hours. There was no previous temperature excursion. The call was because of a data logger involved. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; Patient received third dose of VAQTA on 8/22/2019; This spontaneous information has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On 22-AUG-2019, the patient was vaccinated with the third dose of hepatitis a vaccine, inactivated (VAQTA) vial 50 (units not provided) as prophylaxis (lot number S007770 expiration date on 24-JUL-2020) (strength and route of administration were not provided) (extra dose administered).   No adverse effects reported.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Skin warm
Clinical narrative: difficulty moving her arm; her arm was hot to the touch; red from the top of arm to the elbow; soreness; Information was received from a pharmacist referring to a 67 years old female patient. The patient's concomitant medication was unknown by reporter. The patient was allergic to aspirin and codeine.      On 21-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot#R017900, expiration date 26-MAR-2020, dose and strength were unknown) intramuscularly to prevent pneumonia.         On 22-OCT-2019 (reported as subsequently), the patient experienced soreness, difficulty moving her arm, arm hot to touch and red from the top of arm to the elbow. On 23-OCT-2019, the reporter stated that the patient was moving her arm "better today" and the patient stated that her arm "doesn't feel as hot today". The outcome of the other two events were not provided by the reporter. Patient sought for medical attention by contacting the pharmacist. Ice was applied for the events. The causality was not provided by the reporter.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Patient recieved improperly stored vaccine; This spontaneous report was received from a registered nurse refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 30-SEP-2019, the patient was vaccinated with improperly stored therapy type: rHA, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # S001332 (expiry date: 14-JAN-2021), 1 dose for prophylaxis (strength, route and anatomical location were not reported) (product storage error). The vaccine underwent a temperature excursion at 10.5 celsius (C) for a time frame of 56 minutes. There was no previous temperature excursion. The call was because of a data logger. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Primary reporter reports the administration of one dose of an improperly stored vaccine, PROQUAD; No adverse effects reported for the patient; This spontaneous report was received from a vaccine coordinator, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 30-OCT-2019, the patient was vaccinated with one dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number S017243 with expiration date on 01-DEC-2020 (exact dose and route of administration were not reported) for prophylaxis. It was reported that the vaccine was reconstituted with properly stored sterile diluent (lot number and expiration date were unknown).  Administered dose of vaccine experienced temperature excursion of -4.6 degrees Celsius for 1 hour and 1 minute. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported for the patient.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: Flu like symptoms; Sick feeling; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and feeling unwell to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. A year ago from the reporting date, the patient received 1st dose of Shingrix. The patient experienced sick feeling and flu like side effects. Because of shortages the patient was supposed to get his second shot on the reporting date. The patient asked whether there was anything he could do to prevent the sick feeling that comes with it. For tolerance to 2nd dose, refer linked case US2019192807.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Red around the vaccination site; This case was reported by a consumer and described the occurrence of injection site erythema in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient received the vaccine 2 days before the reporting date and the site around the injection was getting red.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Malaise
Clinical narrative: Rash at the site of an injection; General malaise; This case was reported by a consumer and described the occurrence of injection site rash in a female 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 injection site rash and general malaise. On an unknown date, the outcome of the injection site rash and general malaise were unknown.   It was unknown if the reporter considered the injection site rash and general malaise to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had rash at the site of an injection and a feeling of general malaise afterwards. The family member reported that she followed up with her Health care professional who administered the vaccine and was not experiencing any significant or further issues. The reporter was happy to complete any necessary paperwork.
Sex: F
Vaccine: UNK
Symptoms: Feeling hot, Nausea, Peripheral swelling, Rash
Clinical narrative: Nausea; Hot, heat upper arm, chest and upper back; Rash upper arm, chest and upper back; Arm swelling elbow to shoulder; This case was reported by a other health professional via sales rep and described the occurrence of nausea in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number JC9EM, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season .5 ml. On an unknown date, 3 hrs after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced nausea, swelling arm, feeling of warmth and rash. The patient was treated with triamcinolone acetonide (Kenalog). On an unknown date, the outcome of the nausea, feeling of warmth and rash were unknown and the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the nausea, swelling arm, feeling of warmth and rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by the Medical Assistant. The age at vaccination was not reported. The reporter stated that, the patient experienced nausea, arm swelling elbow to shoulder, hot, swelling, heat rash upper arm, chest and upper back. The kenelog was given as treatment for swelling, and swelling resolved after kenelog on day 2 or 3.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever of 101-102; Sore arm; This case was reported by a other health professional via sales rep and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were unknown.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  After vaccination, the patient had fever of 101-102 degree Fahrenheit and very sore arm. This was 1 of the 10 cases reported by same reporter.       Lab Comments: Lab test performed on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. The patient was treated with ibuprofen and paracetamol (Acetaminophen). On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced flu like symptoms for about 48 hours. The patient used both ibuprofen and actemenophin and resolved on its own. For tolerance to the 2nd dose of Shingrix, US2019AMR194572. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on an unknown date, for tolerance refer case US2019AMR194568).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. The patient was treated with ibuprofen and paracetamol (Acetaminophen). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient was 50 plus. The patient had flu like symptoms for about 48 hours after receiving Shingrix. It was resolved on an unknown date. The reporter denied to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Bad flu like symptoms; This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that had very bad flu like symptoms after vaccination. The symptoms resolved within two to three days and the patient plans to still get their second dose. The representative has no further details to provide. The Follow up not required.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: pain in his left armpit; expected pain in his arm; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves an 11 years old male patient who experienced pain in his left armpit (axillary pain)  and expected pain in his arm (vaccination site pain), while he received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported.  On 16-Oct-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a pain in his left armpit (axillary pain) and  expected pain in his arm (vaccination site pain) ( latency unknown) following the administration of INFLUENZA VACCINE.  Details of lab data not reported.  Final diagnosis was expected pain in his arm and pain in his left armpit.   It was not reported if the patient received any corrective treatment.  The event outcome was not reported at the time of reporting.  Information on the batch number was requested
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pentacel and Quadracel were both administered to a 4 month old patient on the same day, no AE; Pentacel and Quadracel were both administered to a 4 month old patient on the same day, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old patient (gender unknown) received a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] on the same day (lot number and expiry date not reported) via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was a case of actual medication error due to inappropriate age at vaccine administration and extra dose administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered a high dose flu shot to a 63 year old patient / no AE; inadvertently administered a high dose flu shot to a 63 year old patient / no AE; Initial information and additional information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 63 years old patient who received  0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ284aa (Expiry date 25-May-2020) via intramuscular route in the left deltoid on 22-Oct-2019 inadvertently.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At a time of reporting 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.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok: was given to a 16 or 17 year old patient / no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves unknown gender patient (16 or 17 year old) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that Flublok was given to a 16 or 17 year old patient.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 89.0
Sex: F
Vaccine: FLU3, FLUA3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: medical assistant administered a Fluzone High-Dose to a patient who already had a Fluad injection on 25sep2019, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 89 years old female patient who received vaccines INFLUENZA VACCINE INACT SAG 3V [FLUAD] (not produced by Sanofi Pasteur lot number not reported via unknown route in the left arm) on 25-Sep-2019 and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ251AB, Exp. Date 01-May-2020 via intramuscular route in the left deltoid) on 22-Oct-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Dementia.  It was a case of actual medication error due to extra dose administered.  It was reported that medical assistant administered a Fluzone High-Dose to a dementia patient and the patient had already had a Fluad injection on 25-Sep-2019.  At the time of reporting, no adverse reactions were 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: 6.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of IPOL was given to a patient, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 6 years old male patient who received a 0.5 mL dose of expired vaccine IPV (VERO) [IPOL] (4th dose in series) lot N1J451M and expiry date: 05-Oct-2019 via intramuscular route in the left deltoid on 09-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, 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.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 month old who received Quadracel immunization; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 13 months old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT).  On 17-Oct-2019, the patient received 4th dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5635AA and expiry date: 18-Jun-2021 via intramuscular route in right thigh.  It was a case of actual medication error due to inappropriate age at 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.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a third Menactra vaccine, one month from his second Menactra vaccine in error, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old male patient who received 0.5 ml third dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6521AA, Exp. Date 26-Jan-2021) via intramuscular route in the right deltoid on 26-Sep-2019 and patient was previously vaccinated with the second dose of the same vaccine on an unknown date (one month ago).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLULAVAL) for Immunisation.  It was a case of actual medication error due to extra dose administered.  It was reported that a patient received a third Menactra vaccine, one month from his second Menactra vaccine in error.   At the time of reporting, no adverse reactions were 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: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Canalith repositioning procedure, Dizziness, Vertigo
Clinical narrative: Prolonged dizziness/vertigo for 1 week from later day of vaccine to when seen 10/29/19 in office. Required Meclizine, improved on Meclizine but still mildly symptomatic.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: 11/1/19 at 8:14 am, Patient called and said her shoulder has been hurting ever since she received the influenza vaccine on 10/9/2019. She said she did not schedule an appointment with her Primary Care Physician nor took any medication for this pain but did use warm compress on her arm as needed. She was informed to either see her Primary Care Physician or go to Urgent Care for Worker's Comp. She said she will go to Urgent Care.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vertigo
Clinical narrative: 10/24/19 Patient reported to Occupational Health, " I woke up around 2 am 10/10/2019 with severe vertigo and nausea. I have never had vertigo. I reported to my PCP. It is now 2 weeks later and i am better, but still have vertigo with certain position changes and head movements."
Age: 55.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Chills and fever started about 11 hours after the shot.  Took Tylenol and went to bed.  Those symptoms gone next morning. About 36 hours after shot right shoulder which got the shingrix has a red rash about 3 inches in diameter.  Shoulder still tender to touch after 48 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side Effects; This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The reporter wanted to know were side effects different after second dose.
Sex: U
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Headaches; This case was reported by a other health professional via sales rep and described the occurrence of headache in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional stated that he has seen headaches reported frequently after having been vaccinated with Bexsero.
Sex: F
Vaccine: MENB
Symptoms: Skin mass
Clinical narrative: knot in her arm from when she received Bexsero a few years ago; This case was reported by a nurse via sales rep and described the occurrence of skin mass in a 20-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than a year after receiving Bexsero, the patient experienced skin mass. On an unknown date, the outcome of the skin mass was not recovered/not resolved.   It was unknown if the reporter considered the skin mass to be related to Bexsero.  Additional case details were provided as follows: The reporter was patient's mother. The age at vaccination was not reported. The patient still complained about a knot in her arm from when she received Bexsero, a few years ago. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Erythema around injection site; Blistering around injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in an unspecified number of adult patients 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 injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site erythema and injection site blisters were unknown.   It was unknown if the reporter considered the injection site erythema and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient experienced erythema and blistering around injection site. No demographic details were provided. No lot number or expiration dates were provided. No additional details provided. The healthcare professional did not wish to file adverse event. This case has been linked with cases US2019193803 and US2019194494, reported by the same reporter.
Age: 86.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Infection, Skin necrosis, Skin operation, Swelling
Clinical narrative: Patient received both vaccines in one arm, new needle was used for each vaccine, alcohol pad was used to wipe skin clean by immunizer. Patient complained of redness and swelling within 12 hours of vaccinations. Skin was necrotizing within 12 hours of vaccination and infection occcurred. Patient had to get surgery to have top dermal layer of skin removed on 11/1/19.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea
Clinical narrative: Pt. called and reported nausea and headache after she received the vaccines. Denies emesis, stiff neck, fever, diarrhea, infection at site, unsteadiness, and did not take any medication.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Insomnia, Myalgia
Clinical narrative: First time I read the side effects was this a.m.  I have 2 big welts one on and below the injection site.  Tired, muscle pain that shot all over the body.  Went across chest, then in lower back, calves, hip, forearms, then center of knee, the spine, shoulders, hands, tops of feet, toes.  nausea, somach pain, fever, shivering, head - 2 days.   Felt like body was under attack.  Took 1 tyelenol. able to sleep for about 90 mins. woke up again.  Continued all night.   Today for first time I feel like me again.   This is the second does of zoster.  wondering if there is a base ingredient that may have a sensitivity.  Please call if wanting to discuss further.  It was  really brutal.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: First time I read the side effects was this a.m.  I have 2 big welts one on and below the injection site.  Tired, muscle pain that shot all over the body.  Went across chest, then in lower back, calves, hip, forearms, then center of knee, the spine, shoulders, hands, tops of feet, toes.  nausea, somach pain, fever, shivering, head - 2 days.   Felt like body was under attack.  Took 1 tyelenol. able to sleep for about 90 mins. woke up again.  Continued all night.   Today for first time I feel like me again.   This is the second does of zoster.  wondering if there is a base ingredient that may have a sensitivity.  Please call if wanting to discuss further.  It was  really brutal.
Age: 43.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Fatigue, Pain, Pruritus, Pyrexia, Rash papular
Clinical narrative: Patient reported that he developed multiple lesions on back of neck. The following day he was feeling achy with a low grade fever and got fatigued during his run. Denied chest pain, SOB. Reported slight itching of lesions. Pictures provided for review. Rash consists of multiple papules and few pustules on back of neck, just above collar.  Reported other than rash he is feeling well.   Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 43.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Rash pustular, Skin lesion
Clinical narrative: Patient reported that he developed multiple lesions on back of neck. The following day he was feeling achy with a low grade fever and got fatigued during his run. Denied chest pain, SOB. Reported slight itching of lesions. Pictures provided for review. Rash consists of multiple papules and few pustules on back of neck, just above collar.  Reported other than rash he is feeling well.   Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 67.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Back pain, Feeling cold, Pain, Pyrexia, Rash erythematous
Clinical narrative: Within 30 minutes of receiving the Shingrix injection, the patient experienced symptoms of a relapse of tick fever. He had chills, fever, body aches and was in bed for 2+ days. He also had severe pain in back, unlike his usual back problems. When I (his spouse) looked 2 days later he had red spots following nerve tracts of center back. That is where the pain was concentrated. The spots did not blister or weep. He recovered in 4 days.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Developed soreness in left arm.  Experiencing pain in shoulder and neck area the next day.  Hurts to turn my head/neck.  Cramps when I turned my head/neck.  This pain and soreness has continued.
Age: 62.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: States she got the shot on the 17th and it didn't bother her at the time but by 11pm the next night it started hurting and when she woke up the next morning she felt like her R shoulder was dislocated she couldn't lift it or move it much.  She stated the pain got worse, no redness that she could tell or swelling that she could see.  She was icing it and taking warm showers and letting the water run on it, she was taking Alieve for the pain but nothing was really helping it. She finally went to the doctors on 10/31/2019 and it was swollen and still painful.  She was prescribed a steroid dose pack to take.  She states  the pain is a little less the past 2 nights she has been able to sleep.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Left arm sore immediately following vaccine. Continued soreness over next few weeks.  During routine annual mammogram/sonogram, radiologist noted an enlarged lymph node in left armpit attributed to the vaccine.  Follow-up sonogram is scheduled for Jan. 2020.  Arm pain continued with pain radiating from left shoulder to left hand.  Followup with primary physician and 5 day course of steriods prescribed and started 10/30/2019.  I have not completed the course of steriods yet.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included premature ventricular contractions (but says this felt different).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient only reports a sore arm after the first dose of Shingrix. For tolerances of 2nd dose, refer case US2019191731, reported by same reporter for the same patient.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain at the injection site; Sore arm; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Bexsero.  Additional details were provided as follows: This case was reported by the patient who herself was a physician (MD). The age at vaccination was not reported. After receiving Bexsero, the patient experienced pain at the injection site and a sore arm for 2 weeks.
Sex: F
Vaccine: VARZOS
Symptoms: Vulvovaginal mycotic infection
Clinical narrative: Vaginal yeast infection; This case was reported by a consumer and described the occurrence of vaginal yeast infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced vaginal yeast infection. On an unknown date, the outcome of the vaginal yeast infection was unknown.   It was unknown if the reporter considered the vaginal yeast infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had vaginal yeast infection for few days
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Injection site mass, Lethargy, Pain
Clinical narrative: Lethargic; Lump below the injection site; Achy; Dizzy when I first get up in the morning; This case was reported by a consumer via sales rep and described the occurrence of lethargy in a 79-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than 3 weeks after receiving Shingrix, the patient experienced lethargy, injection site lump, pain and dizziness. On an unknown date, the outcome of the lethargy, injection site lump, pain and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the lethargy, injection site lump, pain and dizziness to be related to Shingrix.  Additional details were received as follows: The patient received 2nd dose of Shingrix two and half weeks before the date of reporting. The patient experienced lump below the injection site and was lethargic and achy. The patient felt dizzy when first get up in the mornings. The patient was concerned about the dizziness. The patient asked is it uncommon for these effects to be continuing 18 days after the injection. The patient asked are there any treatments to alleviate the symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever of 101-102; Sore arm; This case was reported by a other health professional via sales rep and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were unknown.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  After vaccination, the patient had fever of 101-102 degree Fahrenheit and very sore arm. This was 1 of the 10 cases reported by same reporter.      Lab Comments: Lab test performed on an unknown date.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Impaired work ability, Insomnia, Malaise
Clinical narrative: Weak; Felt depleted like she had been hit by a truck / it took everything out of me; sickness.; Not sleeping; Hives; Itching; This case was reported by a consumer via call center representative and described the occurrence of hives in a 38-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 947BS, expiry date 30th June 2020) for prophylaxis.   Previously administered products included Flu vaccine (had flu shot and did not had a problem previously). Concurrent medical conditions included shellfish allergy and iodine allergy.   On 1st October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced weakness, exhaustion and sickness. In October 2019, the patient experienced hives, generalized pruritus and insomnia. On 22nd October 2019, the outcome of the weakness, insomnia, exhaustion and sickness were recovered/resolved. On an unknown date, the outcome of the hives and generalized pruritus were recovered/resolved.   It was unknown if the reporter considered the hives, generalized pruritus, weakness, insomnia, exhaustion and sickness to be related to Fluarix Quadrivalent 2019-2020 season.Additional details were provided as follows: The reporter was the patient. The patient received dose of Fluarix Quadrivalent 2019-2020 season in left deltoid at the pharmacy. Less than 3 weeks, the patient experienced hives, generalized pruritus and insomnia.  The patient at 1st stated that, 24 hours later got sick, but later stated that in the afternoon on the day of vaccination, started feeling symptoms. The patient felt depleted like she had been hit by a truck. The patient did not go to the work on thursday 3rd October 2019 and Friday, 4th October 2019. The patient reported that not sleeping because of itching all over the body,  The patient had hives and itching for 4 days. By saturday 5th October, the patient was not fully recovered. On 22nd October 2019, the patient called to GlaxosmithKline response center and stated that, all events were recovered. The reporter consented to follow up.