chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered Adacel was exposed to temperature excursions and not acceptable for use, no AE; vaccines were not good/they had already given out 5 of the Adacel vaccines before receiving email; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157616, 2019SA157599, 2019SA157614 and 2019SA157615 (same reporter).  This case involves a 20 years (also reported as 28 years) old female patient who received a second 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5585AA and Exp. Date 06-Mar-2021 via intramuscular route in the left deltoid on 29-May-2019, which was exposed to temperature excursions and not acceptable for use.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage and Poor quality vaccine administered  It was reported that Adacel was ordered on 22-May-2019 and did not arrive until 28-May-2019. Patient was administered Adacel that were exposed to temperature excursions and not acceptable for use.  No reactions reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was administered Adacel that was exposed to temperature excursions and not acceptable for use/no AE; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157616, 2019SA157599, 2019SA157614 and 2019SA157615 (same reporter).  This case involves a 48 years old female patient who received a second 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5585AA and Exp. Date 06-Mar-2021 via intramuscular route in the left deltoid on 31-May-2019, which was exposed to temperature excursions and not acceptable for use.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was reported that Adacel was ordered on 22-May-2019 and did not arrive until 28-May-2019. Patient was administered Adacel that were exposed to temperature excursions and not acceptable for use.  No reactions 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: administered Adacel that were exposed to temperature excursions and not acceptable for use; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157616.  This case involves a 52 years old male patient who was administered with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5585AA, Exp date: 06-MAR-2020) that were exposed to temperature excursions and not acceptable for use.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is a actual medication error due to Incorrect product storage.  It was reported that 5 patients were administered Adacel that were exposed to temperature excursions and not acceptable for use.  It was not reported if the patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: administered Adacel that were exposed to temperature excursions and not acceptable for use; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157613, 2019SA157599, 2019SA157614 and 2019SA157615.  This case involves a 12 years old female patient who received 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5585AA and Exp. Date 06-Mar-2021 via intramuscular route in the left deltoid on 29-May-2019 that was exposed to temperature excursions and not acceptable for use.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  At the time of reporting, no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 6 months old male patient was administered a dose of Menactra instead of Menveo/No AE; a 6 months old male patient was administered a dose of Menactra instead of Menveo/No AE; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six months old male patient who was administered a 0.5ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6347AA, expiration date: 30-Aug-2020 via intramuscular route in the right thigh on 06-Jun-2019 instead of MENVEO.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).   It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  No symptoms were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: scheduled to be delivered on 5/31/19. Caller stated they didnt get the vaccine until 6/4/19. Caller stated when they; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 20 patient with (with unknown demographic) who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. it was reported that Menactra was scheduled to be delivered on 5/31/19. Caller stated they didnt get the vaccine until 6/4/19. Caller stated when they opened ice packs were in the container but it was not frozen.  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.  List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: one patient received a dose of Adacel after the temperature excursion from the stock/no AE; one patient received a dose of Adacel after the temperature excursion from the stock/no AE; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] after there was a temperature excursion from the stock.  The patient's past medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route.  It was of actual medication error due to incorrect product storage and Deteriorated drug administered.  It was reported that no 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.  List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: give the ACTHib (lypholized powder) portion of the Pentacel vaccine/no AE; Initial information received on 07-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that give the ActHib (lypholized powder) portion of the Pentacel vaccine/ no AE.  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); HEPATITIS B VACCINE (HEPATITIS B VACCIN); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 07-Jun-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. Liquid: U6327AA; expiry date: date 20-Sep-2019, Powder: UJ102AA; expiry date: date 20-Sep-2019, Carton: Lot: UJ102AAA; expiry date: date 20-Sep-2019  It was a case of actual medication error due to inappropriate reconstitution technique.  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: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Headache, Nasal congestion
Clinical narrative: headache; stuffy nose; cough; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff).  This case is linked to case 2019SA158639.  This case involves a 63 years old female patient who experienced headache, stuffy nose and cough, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U5875AA and expiry date: 14-Feb-2020) via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious headache, stuffy nose (rhinorrhoea) and cough following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No Lab data was reported.  Final diagnosis was cough, stuffy nose and headache.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Recovering / Resolving for headache, stuffy nose and for cough.  Documents held by the sender: none.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient inadvertently received both ActHib and Pentacel/ no adverse event; Initial information received on 10-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer or non healthcare professional via phone.  This case involves a 12 months old male patient who was inadvertently vaccinated with a 0.5 ml second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number: UJ084AAAand expiry date: 24-Jul-2020) via intramuscular route in the right thigh and 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] (Lot number: UI961AA and expiry date: 27-Jun-2020) via intramuscular route in the left thigh on 10-Jun-2019.  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 VACCIN); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) on an unknown date.  It was a case 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 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 the sender: none.
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Irritability, Rash, Streptococcus test negative
Clinical narrative: Rash on face and stomach, started after shots per mom, more fussy than usual, and decreased appetite. MD discussed with mom not serious reaction. Continue supportive treatment, fluids, and antipyretics.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Anxiety, Condition aggravated, Dysphagia, Sensation of foreign body
Clinical narrative: Mom call into Health Department from her work due to daughter calling her to tell her she felt like she has a lump in her throat and was  not able to swallow her on saliva. I ask mom if patient was  having any breathing problems and mom said she sounded like it but was at work and wasn't sure if it was just her anxiety.  I encourage mom or someone that was with patient to take her to the ER as soon as possible. Mom called back to the Health Department with a update at 135 pm  to let us know it was not a reaction to the Varicella Vaccine she was treated  for her anxiety with medication and sent home.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Blood pressure immeasurable, Dizziness, Hypotension, Nausea, Pallor
Clinical narrative: Client was asymptomatic and responding to questions during the first administration of first two vaccines, Men B and Hep A. Client exhibited faint feelings shortly after receiving the HPV vaccine. This nurse was unable to obtain manual blood pressure reading; client reported that her blood pressure usually runs low. Another nurse called supervisor who arrived shortly with emergency tem members.  EMS was notified as well. Supervisor,  emergency team, and security arrived and automatic blood pressure reading in the upper systolic 90's was obtained. The client appeared nauseated but was still responsive. By the time EMS arrived, client's condition appeared less pale and blood pressure reading improved. Client expressed she felt better,  declined care from EMS, and ambulated out of the area with mother.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: At 5:05 pm on 6/12/19- Quadracel was given to patient instead of Daptacel.  Provider was notified.  Sanofi was contacted as well as Immunization Registry.  Pt had no adverse reactions.  Parents were notified and instructed on signs and symptoms of reaction.  Staff instructed on importance of verifying medication/vaccine name, correct dose, time, patient, route.  Incident was documented in patients chart and incident report completed for Clinic.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site reaction.  Red and hot to touch. Covers most of the deltoid
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain
Clinical narrative: Body aches and pain at injection site.  Felt like mild flu for 24 hours
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Inflammation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has red, warm, swollen area to right upper arm that is palm sized. Sx started on 6/11/19, Mom drew a border with a pen. This border washed off while patient was in kiddie pool. New border was drawn 6/12/19 and today there is slight redness outside the borders. Today in office, 25mg of benadryl was given PO in tablet form. Instructions were given to patient to start using motrin routinely at home to help decrease inflammation/clotting. Antibiotic Augmentin 875/125mg prescribled today for a course of BIDx10 days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash macular, Rash pruritic, Rash vesicular
Clinical narrative: Four days after vaccination approximately 90% of the body was covered in a rash (pictures available);  most of rash was under arms, legs, and back- none on face;  Rash is explained as blister-like, blotchy, and very red and itchy;  The rash lasted approximately 6-7 weeks and is slowly improving.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Decreased activity, Lethargy, Somnolence
Clinical narrative: After taking half the of the Rota virus per mother and nursing staff patient became sleepy and lethargic, other vaccines were given with minimal crying or discomfort, she seemed to go to sleep, difficult to arouse, episode lasted about 1 min, I was called at this point to access, she was awake, less active then she was in the exam room.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: headache and flu-like aches for 1 day
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning a currently 81-year-old female patient (pt). No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (lot number, dose, vaccination site and route of administration were not provided) by a pharmacist for long-term prevention of shingles and zoster-related conditions. On an unknown date, the pt was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event was unknown.  Additional information has been requested.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Influenza, Insomnia, Malaise
Clinical narrative: flu symptoms; arm pain; BP elevated; pulse increased; not sleep; Very sick; This case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced flu symptoms, pain in arm, increased blood pressure, pulse increased, insomnia and sickness. On an unknown date, the outcome of the flu symptoms, pain in arm, increased blood pressure, pulse increased, insomnia and sickness were unknown.   It was unknown if the reporter considered the flu symptoms, pain in arm, increased blood pressure, pulse increased, insomnia and sickness to be related to Shingrix.  Additional details were provided as follows: The patient experienced flu symptoms, pain in arm, increased blood pressure, pulse increased and was not able to sleep. The patient's blood pressure was elevated 144/88 mmhg and pulse rate was 101 per min. The patient was very sick.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: flu symptoms; arm pain; BP elevated; pulse increased; not sleep; Very sick; This case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced flu symptoms, pain in arm, increased blood pressure, pulse increased, insomnia and sickness. On an unknown date, the outcome of the flu symptoms, pain in arm, increased blood pressure, pulse increased, insomnia and sickness were unknown.   It was unknown if the reporter considered the flu symptoms, pain in arm, increased blood pressure, pulse increased, insomnia and sickness to be related to Shingrix.  Additional details were provided as follows: The patient experienced flu symptoms, pain in arm, increased blood pressure, pulse increased and was not able to sleep. The patient's blood pressure was elevated 144/88 mmhg and pulse rate was 101 per min. The patient was very sick.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal tenderness, Colitis ulcerative, Condition aggravated
Clinical narrative: ulcerative colitis flare up; abdominal pain; intestinal discomfort; intense pain when having bowel movements; indigestion; tenderness of my abdominal area; fatigue; This case was reported by a consumer and described the occurrence of ulcerative colitis relapse in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ulcerative colitis and autoimmune disorder.   On 21st April 2019, the patient received the 1st dose of Shingrix. On 27th April 2019, 6 days after receiving Shingrix, the patient experienced ulcerative colitis relapse (serious criteria GSK medically significant), abdominal pain, bowel discomfort, intestinal movement disorder, indigestion, abdominal tenderness and fatigue. On an unknown date, the outcome of the ulcerative colitis relapse was recovered/resolved and the outcome of the abdominal pain, bowel discomfort, intestinal movement disorder, indigestion, abdominal tenderness and fatigue were unknown.   It was unknown if the reporter considered the ulcerative colitis relapse, abdominal pain, bowel discomfort, intestinal movement disorder, indigestion, abdominal tenderness and fatigue to be related to Shingrix.  Additional information was provided as follows: The patient had history of ulcerative colitis. The patient was concomitantly taking unspecified medication for ulcerative colitis to kept symptoms under control. The patient received the Shingrix and began having abdominal pain and intestinal discomfort. The patient had a flare and previously not had a flare like this for several years.  The patient experienced intense pain when having bowel movements, indigestion, tenderness of my abdominal area, fatigue and other symptoms general to a flared. The patient read that Shingrix was not tested on people with autoimmune diseases and that there was concern that this new adjuvant might cause flares with people with autoimmune diseases. The patient consulted with her physician's and both advised her to get Shingrix vaccine. The reporter would like to know if anyone else with autoimmune diseases have reported similar side effects after getting the Shingrix vaccine. The patient was very concerned about getting the second dose. The reporter would appreciate any information about this.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspepsia, Fatigue, Gastrointestinal motility disorder
Clinical narrative: ulcerative colitis flare up; abdominal pain; intestinal discomfort; intense pain when having bowel movements; indigestion; tenderness of my abdominal area; fatigue; This case was reported by a consumer and described the occurrence of ulcerative colitis relapse in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ulcerative colitis and autoimmune disorder.   On 21st April 2019, the patient received the 1st dose of Shingrix. On 27th April 2019, 6 days after receiving Shingrix, the patient experienced ulcerative colitis relapse (serious criteria GSK medically significant), abdominal pain, bowel discomfort, intestinal movement disorder, indigestion, abdominal tenderness and fatigue. On an unknown date, the outcome of the ulcerative colitis relapse was recovered/resolved and the outcome of the abdominal pain, bowel discomfort, intestinal movement disorder, indigestion, abdominal tenderness and fatigue were unknown.   It was unknown if the reporter considered the ulcerative colitis relapse, abdominal pain, bowel discomfort, intestinal movement disorder, indigestion, abdominal tenderness and fatigue to be related to Shingrix.  Additional information was provided as follows: The patient had history of ulcerative colitis. The patient was concomitantly taking unspecified medication for ulcerative colitis to kept symptoms under control. The patient received the Shingrix and began having abdominal pain and intestinal discomfort. The patient had a flare and previously not had a flare like this for several years.  The patient experienced intense pain when having bowel movements, indigestion, tenderness of my abdominal area, fatigue and other symptoms general to a flared. The patient read that Shingrix was not tested on people with autoimmune diseases and that there was concern that this new adjuvant might cause flares with people with autoimmune diseases. The patient consulted with her physician's and both advised her to get Shingrix vaccine. The reporter would like to know if anyone else with autoimmune diseases have reported similar side effects after getting the Shingrix vaccine. The patient was very concerned about getting the second dose. The reporter would appreciate any information about this.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: arm hurt; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received 1st shot of Shingrix in afternoon. The patient asked, how long would his arm at shot spot hurt.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Pain
Clinical narrative: chills; feeling tired; aches; fEELING BAD; This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2019, the patient received the 2nd dose of Shingrix. On 3rd June 2019, 1 days after receiving Shingrix, the patient experienced chills, tiredness, pain and feeling bad. On an unknown date, the outcome of the chills, tiredness, pain and feeling bad were unknown.   It was unknown if the reporter considered the chills, tiredness, pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received shingles yesterday, the day before reporting and felt bad on the day of reporting and had chills aches tired and asked how long would this last. The patient asked whether can take anything for it.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Product complaint
Clinical narrative: Pain/ hurt all over; Product Complaint; This case was reported by a pharmacist via call center representative and described the occurrence of generalized aching 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 generalized aching (serious criteria hospitalization) and pharmaceutical product complaint. On an unknown date, the outcome of the generalized aching and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the generalized aching to be related to Shingrix.  Additional case 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. The patient received Shingrix from different batches (batch number was not provided). The patient had increased pain and due to which, the patient had to go to the hospital. The reporter indicated that she was seeing an increase in the number of patients reporting adverse events since GlaxoSmithKline had started to increase production of the Shingrix product. She was wondering if she should continue to administer the product. She believed that there might be something going wrong with the process GlaxoSmithKline was utilizing to manufacture the product more rapidly. The reporter hung up the phone and did not provide any additional details.  It was unknown if the reporter had product to return because she would not continue with the call. Additional information regarding events and seriousness criteria was requested. However, case is closed conservatively. This case has been linked to US2019098383 and US2019098282, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Pain in extremity
Clinical narrative: arm pain; Drug dose administration interval too long; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by the patient who herself was a Retired Nurse. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.   Follow up information received from the nurse on 3rd June 2019. The reporter had spoken with her pharmacist in last contact and the pharmacist advised the patient that she did not need to restart the series of Shingrix. On 31st May 2019, the patient received 2nd dose of Shingrix, which was delayed than the recommended schedule, which led to lengthening of vaccination schedule. Less than a week after receiving 2nd dose of Shingrix, the patient experienced her arm was hurting from the 2nd dose. At the time of report, the arm was still hurting, but was improving. It was unknown if the reporter considered the arm pain to be related to Shingrix administration.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Product complaint
Clinical narrative: Pain/hurt all over; Product Complaint; This case was reported by a pharmacist via call center representative and described the occurrence of generalized aching 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 generalized aching (serious criteria hospitalization) and pharmaceutical product complaint. On an unknown date, the outcome of the generalized aching and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the generalized aching to be related to Shingrix.  Additional case details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix from different batches (batch number not provided). The patient had increased pain and due to which, the patient had to go to the hospital. The reporter indicated that she was seeing an increase in the number of patients reporting adverse events since GlaxoSmithKline had started to increase production of the Shingrix product. She was wondering if she should continue to administer the product. She believed that there might be something going wrong with the process GlaxoSmithKline was utilizing to manufacture the product more rapidly. The reporter hung up the phone and did not provide any additional details.  It was unknown if the reporter had product to return because she would not continue with the call. The reporter also stated there are 2 more patients who reported adverse events including increased pain and having to go to the hospital, refer linked cases US2019098383 and US2019GSK105628. Additional information regarding event seriousness was requested. However, case is closed conservatively.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Incomplete course of vaccination; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number ML532, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, general body pain and incomplete course of vaccination. Shingrix was discontinued. On an unknown date, the outcome of the fever, general body pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by Medical Assistant. The reporter was inquiring that how much immunity a patient get after the 1st dose. The reporter stated, the patient did not want to receive the 2nd dose due to how the 1st dose reaction of fever and body aches several days after vaccination, which led to incomplete course of vaccination.  The reporter gathered patient information.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Bronchitis, Expired product administered
Clinical narrative: bronchitis; expired vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number N17058, expiry date unknown) for prophylaxis.   On 20th May 2019, the patient received Menveo. On 20th May 2019, unknown after receiving Menveo, the patient experienced expired vaccine used. On 21st May 2019, the patient experienced bronchitis. On an unknown date, the outcome of the bronchitis was not recovered/not resolved and the outcome of the expired vaccine used was unknown.   It was unknown if the reporter considered the bronchitis to be related to Menveo.  Additional details were provided as follows: The reporter stated that the patient received an expired dose of Menveo on left arm. On unknown date, the patient developed symptoms of bronchitis. The bronchitis was ongoing with no improvement at time of reporting. The reporter did not had the expiry date, but provided the lot number. The reporter was consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Malaise, Pain, Rash macular
Clinical narrative: Tenderness; Blotches around the injection site; tired; under the weather; Achy; This case was reported by a consumer via call center representative and described the occurrence of pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (10 years ago).   On 31st May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st June 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling unwell. On 2nd June 2019, the patient experienced skin blotches. On an unknown date, the patient experienced tenderness. On an unknown date, the outcome of the pain, tenderness, tiredness and feeling unwell were recovered/resolved and the outcome of the skin blotches was not recovered/not resolved.   It was unknown if the reporter considered the pain, tenderness, skin blotches, tiredness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix on Friday, before reporting date. On Saturday morning, the patient experienced feeling achy, described as feeling under the weather and tired. These events were resolved. Less than a week after receiving the Shingrix, the patient was feeling very tender to the touch almost like when she had shingles, to the area where the patient was having shingles approximately 10 year ago. The tenderness was getting better and the patient reported that she almost forgot about it until noticing blotches around the injection site last night of the reporting, that was not resolved. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Local reaction, Peripheral swelling
Clinical narrative: Local reaction to vaccine (swelling at least a few inches from the site of administration going down the elbow and wrist (left arm).
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Food refusal, Pyrexia, Rash generalised, Somnolence
Clinical narrative: Full body rash came on suddenly - put child to bed on 6/5/19 with no visible symptoms, upon waking 6/6/19 child had a full body rash. Child was taken back to the doctor's office that provided the vaccine, parents were advised this was an adverse reaction to the MMR vaccine the child had received on 5/29/19. The child was sent to daycare where the child ate and slept as per her normal routine. The child refused food at 5 PM for parents that day and went to bed earlier than normal (approx. 5:30 PM, child normally goes to bed at 6 PM). Ibuprofen 1.875 ML was administered to child at approx. 5:30 PM.  The following morning the rash was greatly improved. The child went to day care, continued to eat normally at the facility. Parents were called at 3 PM, informed child at a fever of 103.5. Parents called the doctor's office, was told this too was an adverse reaction to vaccine and to continue to monitor. Ibuprofen was administered at approx. 4 PM. Child went to sleep at approx. 5:30 PM.  6/8/19 the rash was gone. No fever. Child was more groggy than normal. Child refused solid foods. Parents bottle fed (formula) all day. Child awoke approximately every 2 hours for feeding and went back to sleep. 6/9/19 No rash and no fever. Child continued to refuse solid foods. The same pattern was previous day.  6/10/19 Child went to daycare facility. Ate solid foods and napped as usual. Normal pattern resumed - with the exception that child was more tired that usual upon arriving home 6/10/19 through 6/13/19.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: Full body rash came on suddenly - put child to bed on 6/5/19 with no visible symptoms, upon waking 6/6/19 child had a full body rash. Child was taken back to the doctor's office that provided the vaccine, parents were advised this was an adverse reaction to the MMR vaccine the child had received on 5/29/19. The child was sent to daycare where the child ate and slept as per her normal routine. The child refused food at 5 PM for parents that day and went to bed earlier than normal (approx. 5:30 PM, child normally goes to bed at 6 PM). Ibuprofen 1.875 ML was administered to child at approx. 5:30 PM.  The following morning the rash was greatly improved. The child went to day care, continued to eat normally at the facility. Parents were called at 3 PM, informed child at a fever of 103.5. Parents called the doctor's office, was told this too was an adverse reaction to vaccine and to continue to monitor. Ibuprofen was administered at approx. 4 PM. Child went to sleep at approx. 5:30 PM.  6/8/19 the rash was gone. No fever. Child was more groggy than normal. Child refused solid foods. Parents bottle fed (formula) all day. Child awoke approximately every 2 hours for feeding and went back to sleep. 6/9/19 No rash and no fever. Child continued to refuse solid foods. The same pattern was previous day.  6/10/19 Child went to daycare facility. Ate solid foods and napped as usual. Normal pattern resumed - with the exception that child was more tired that usual upon arriving home 6/10/19 through 6/13/19.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: I've had pain in the injection site ever since.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient presented to health center with left upper arm red, warm to touch and tender to touch where immunization was given on 6/11/19. Patient reports that the night the injection was given her arm was lame, but was not red and tender until this morning, 6/13/19. Patient seen by a provider 6/13/19 advised cool compresses and Benadryl as needed.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT HAS LARGE RED AREA EXTENDING FROM INJECTION SITE TO A COUPLE INCHES ABOVE THE ELBOW.  SHE SAID IT WAS SWOLLEN BUT IS NOT ANY LONGER.  IT IS NOT PAINFUL OR ITCHY, JUST RED.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Rash, Rash erythematous
Clinical narrative: slightly red raised rash on cheeks.  temperature of 101 deg.F.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Cough, Dark circles under eyes, Feeling cold, Headache
Clinical narrative: About 1 hour after the vaccine she became weak, shaking - "couldn't warm up", had dark circles under her eyes, and looked pale. She had a severe headache, sore throat and cough. Motrin was given and symptoms resolved.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Oropharyngeal pain, Pallor, Tremor
Clinical narrative: About 1 hour after the vaccine she became weak, shaking - "couldn't warm up", had dark circles under her eyes, and looked pale. She had a severe headache, sore throat and cough. Motrin was given and symptoms resolved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Peripheral swelling
Clinical narrative: Swollen arm below the injection (red)  Flu-like symptoms for  3 days after - one week after  continued to feel achy. Arm  still not back to normal. Going  on 2 weeks. Attaching copy of vaccines
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemorrhage, Immediate post-injection reaction, Swelling
Clinical narrative: Patient received vaccination and immediately started to bleed - not a large amount but some.  After about two minutes, I noticed what appeared to be blood pooling under the skin and the area began to become raised.  The patient did not complain of any swelling or itching.  I then applied a cold compress.  After about five minutes, the swelling had diminished so I had the patient continue with the cold compress for 15 minutes and follow up with Tylenol or Ibuprofen if swelling continued.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Asthenia, Cough, Dyskinesia, Febrile convulsion, Musculoskeletal stiffness
Clinical narrative: Patient seen in Emergency room 03/05/19 with fever, abnormal movement episode, cough and congestion. The primary encounter diagnosis was Febrile seizure. Mother reported mild dry cough and nasal congestion over the previous 1-2 days; woke that AM with tactile fever. Pt was reported to have arched her back and became stiff with arms stretched out. No eye rolling noted. Unsure if arms stiffened. Entire episode lasted 3-4 seconds. No LOC. No SOB noted. No obvious color change reported during event. Child appeared to have less energy afterwards. Measured temp 101.5F at home after the event. Parents attempted to give Tylenol, but child vomited the med. 4 episodes of NBNB emesis between episode and when seen in the ED. Also reported to ED staff to have recent flu-like illness for about 1-2 weeks at the time seen in the ED.