chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of TENIVAC/no AE; Initial information regarding an unsolicited valid non-serious case was received on 21-Apr-2021 from a health care professional via Medical Information (Reference number- 00571113) and transmitted to Sanofi on 21-Apr-2021.  This case involves a 56 year-old female patient who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) on 21-Apr-2021 for prophylactic vaccination.  On 21-Apr-2021, the patient received 0.5 mL (total) dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6265AA and expiry date 19-Apr-2021) via an intramuscular route at the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event 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: F
Vaccine: FLU3
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: developed PoTS syndrome; Initial information was received on 21-Apr-2021 regarding an unsolicited valid non-serious case from a consumer/non-health professional.  This case involves an unknown age female patient who developed pots syndrome (postural orthostatic tachycardia syndrome), after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious pots syndrome (postural orthostatic tachycardia syndrome) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  It was reported that, the patient had to undergo a lot of testing and is now having to take heart medication three times a day.  At time of reporting, the outcome was Unknown for the event.  There will be no information available on the lot number for this case.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Polio is part of PENTACEL; the provider looked at the box and packaging but was focused on looking at the HIB part that he did not focus on the IPV part and received both/  no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number-00573548) and transmitted to Sanofi on  22-Apr-2021.  This case is linked to case 2021SA138518 (same reporter).  This case involves a 2 months old male patient who was vaccinated with a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6986AA and expiry date 22-Jul-2022) once on 21-Apr-2021 and POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] via unknown route in unknown administration site for prophylactic vaccination on an unknown date, Polio is part of PENTACEL; the provider looked at the box and packaging but was focused on looking at the HIB part that he did not focus on the IPV part, what issues might two doses of IPV cause (Extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) for prophylactic vaccination.  This was an actual medication error case due to extra dose administered (latency was same day).   At the time of reporting, no adverse event 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: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: ADACEL was given to the patient at age 11 and then ADACEL was given to the patient again at 15 years of age/no AE; Initial information was received on 23-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.   This case involves a 15-year-old female patient was received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6855AA, expiry date-29-Nov-2022) via an intramuscular route in the left arm for prophylactic vaccination 16-Apr-2021 at the age of 11 years and then again at 15 years of age (inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was a case of actual medication error due to inappropriate schedule of vaccine administered (latency same day).  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 the 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: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site pruritus, Injection site swelling
Clinical narrative: Allergic reaction; Swelling in her left arm at the injection site; Itching in her left arm at the injection site; This spontaneous case was received on 30-Apr-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-01263) and concerned a 39-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2013, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; anatomical location: left arm, dose and route of administration: not reported) for influenza prophylaxis. The batch number reported was 13394P and expiration date: Mar-2014.  On an unspecified date, an unknown amount of time after receiving Fluvirin, the patient experienced an allergic reaction, swelling and itching in her left arm at the injection site. She was treated with Benadryl (diphenhydramine hydrochloride), at dose of 15 mg.   On an unspecified date, 24 hours after the onset, the patient recovered from all events.   The reporter did not provide a causality assessment.  Company comment: All events are assessed as related to Fluvirin.; Sender's Comments: All events are assessed as related to Fluvirin.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Fatigue, Insomnia
Clinical narrative: Dizziness, fatigue, muscle spasms, chills, chest pain, vomiting, insomnia
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vomiting
Clinical narrative: Dizziness, fatigue, muscle spasms, chills, chest pain, vomiting, insomnia
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Major depression, Pyrexia
Clinical narrative: Typical side effects at first  but intermittent headaches and low fever lasted for over a week. Major depressive episode triggered by vaccine and still persisting.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Severe muscle ache, joint pain, 101.3 fever, headache, fatigue, dizziness
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Severe muscle ache, joint pain, 101.3 fever, headache, fatigue, dizziness
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Menstruation irregular, Muscle spasms
Clinical narrative: May 9  have not had a period since December 2020 and was always two days May 10  YES Headache Fatigue or tiredness Nausea &   feet cramp and no longer get periods since before 2021 and have had twice blood flow :(.  Nausea and tiredness have kept me from being able to do my usual workout or other activities. NO Redness/Swelling Muscle pain/Pain Chills/ Fever
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: May 9  have not had a period since December 2020 and was always two days May 10  YES Headache Fatigue or tiredness Nausea &   feet cramp and no longer get periods since before 2021 and have had twice blood flow :(.  Nausea and tiredness have kept me from being able to do my usual workout or other activities. NO Redness/Swelling Muscle pain/Pain Chills/ Fever
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Heavy menstrual bleeding, Menstruation irregular, Muscle spasms
Clinical narrative: May 9  have not had a period since December 2020 and was always two days May 10  YES Headache Fatigue or tiredness Nausea &   feet cramp and no longer get periods since before 2021 and have had twice blood flow :(.  Nausea and tiredness have kept me from being able to do my usual workout or other activities. NO Redness/Swelling Muscle pain/Pain Chills/ Fever
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Worse than normal tinnitus in right ear. Normally have mild tinnitus in both ears, but the right ear became worse after the vaccine
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: SEVERE SORE THROAT
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast heart beat
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: I notice a steak of skin turned white on the lower part of my left palm. I had taken a few pictures to document it. I did not feel any adverse sensation. The symptom disappeared when I woke up in the morning.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic, Rash pustular
Clinical narrative: Herpes Zoster; Information was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information regarding the pt's current condition, historical condition and concomitant medication was unknown. On or around 10-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a pustular itchy rash on back and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was considered as not recovered. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).    The event of herpes zoster was considered to be disabled.
Sex: F
Vaccine: PPV
Symptoms: Autoimmune disorder, Vaccination complication
Clinical narrative: a severe allergic reaction to a Pneumococcal 23 causing "two autoimmunes"./Highly allergic to the Pneumococcal-23; a severe allergic reaction to a Pneumococcal 23 causing "two autoimmunes"./Highly allergic to the Pneumococcal-23; This spontaneous report was received from a  female patient of unknown age referring to herself. Information about medical history, concurrent conditions and concomitant therapies was not provided.      In 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.         On an unknown date, the patient experienced highly allergic to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) causing "two autoimmunes" which was severe. The outcome of the events was unknown. The causality assessment was related.  Upon internal review, event autoimmune was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Skin burning sensation
Clinical narrative: Small bite like blister on my left arm/under chin/back/left ankle; Itching; Burning; This case was reported by a consumer via ( Shingrix GSK Chatbot) interactive digital media and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced blister, pruritus and burning sensation. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the pruritus and burning sensation were unknown.   It was unknown if the reporter considered the blister, pruritus and burning sensation 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 captured as an adult as per vaccine indication. The patient received the vaccine and had symptoms that started with small bite like blister on left arm and were currently under the chin and small of back. The patient also had a bit (spit) on left ankle and there was itching and burning. The patient did not have their 2nd dose till the time of reportng.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac discomfort, Cough, Electric shock sensation, Rhinorrhoea
Clinical narrative: when she lays down she feels shock on her heart; got a cough; she has the worst runny nose; This case was reported by a consumer via call center representative and described the occurrence of cardiac discomfort in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced cardiac discomfort, cough and runny nose. On an unknown date, the outcome of the cardiac discomfort, cough and runny nose were unknown.   It was unknown if the reporter considered the cardiac discomfort, cough and runny nose to be related to Shingles vaccine.  Additional details were provided as follows: The reporter is patient's grandchild. The age at vaccination was not reported. The patient got the vaccine and then got a cough, when she layed down she felt shock on her heart and had the worst runny nose. The reporter wanted to know the side effects after shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I was vaccinated from shingles but got them anyway / suspected vaccination failure; I was vaccinated from shingles but got them anyway; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: girlfriends husband got the shot and ended up with shingles in his eyes / suspected vaccination failure; shingles in his eyes; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's wife's boyfriend. The age at vaccination was not reported. The patient received Shingles vaccine and ended up with shingles in his eyes. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I know people who got the new shingles shots and they got the shingles/SUSPECTED VACCINATION FAILURE; I know people who got the new shingles shots and they got the shingles; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (patients got the shingles after the former shots (possible non GSK vaccine) also).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter stated that he/she know patients (people) who got the new shingles shots and they got the shingles and the patients got the shingles after the former shots also, so why the urgency to rush out and get shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot and got shingles, too / Suspected vaccination failure; I got the shot and got shingles, too; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Accidental underdose
Clinical narrative: Pt injected / when needle retracted, most of) the content still in needle; This case was reported by a consumer via sales rep and described the occurrence of accidental underdose in a 2-month-old patient who received Hib (Hiberix) (batch number AF3TY, expiry date 20th May 2021) for prophylaxis.   On 4th May 2021, the patient received Hiberix. On 4th May 2021, unknown after receiving Hiberix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The patient was injected with Hiberix but when needle retracted, most of the content was still in the needle which led to accidental underdose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: received the shot and in less than a week came down with it; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient received the shot and in less than a week came down with shingles. The patient returned to the place where he or she had received the vaccine and the doctor stated that, this vaccine wasn't even 50 percent able to keep from getting the disease. The patient was given medicines to counter act and was over it quite rapidly.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I had my first vaccine 5 days ago and still have a fever; This case was reported by a consumer via(Shingrix GSK Chatbot) interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2021, the patient received the 1st dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient received dose of Shingrix 5 days ago and still experienced fever. The reporter wanted to know was that normal.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix in 2018/never received a second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018 on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). 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: The age at vaccination was not applicable for this report. The case was reported by the patient himself. Till the time of reporting patient did not receive the 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The reporter did not consent to follow up. No Lot or Expiration date was known for 1st dose. Limited information was provided and declined to provide address and did not give permission to be contacted (by phone or mail). The reporter declined to provide HCP information.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Lymphadenopathy, Malaise
Clinical narrative: neck pain; second dose was on 3/24/2021; swollen lymph nodes / flare up; tired/ super tired; did not feel good; Achy / body aches; fever; headache; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 24th March 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 24th March 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after receiving Bexsero, the patient experienced enlargement of lymph nodes, tiredness, feeling unwell, general body pain, fever, headache and drug dose administration interval too short. On 2nd April 2021, the patient experienced neck pain. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the enlargement of lymph nodes, tiredness, feeling unwell, general body pain, fever, headache and neck pain were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, tiredness, feeling unwell, general body pain, fever, headache and neck pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the mother of the patient. The patient received 2nd dose of Bexsero, before than the recommended interval, which led to shortening of vaccination schedule. The patient received his 2nd dose of Bexsero and the night of the vaccination he was achy, tired and had a headache, had swollen lymph nodes and fever with body aches. The patient did not feel good and this event resolved within a couple of days. On 25th March 2021, the patient had a little fever and on 29th March 2021, the patient was still super tired. On 2nd April 2021, 9 days after vaccination, the patient experienced a flare up and his lymph nodes in his neck were swollen.  The neck pain and tired feeling lasted for a day or two and then he was fine.   All of his symptoms have since resolved. The reporter consented to follow up. For tolerance after 1st dose refer case US2021AMR100254.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100254:same reporter
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: neck pain; second dose was on 3/24/2021; swollen lymph nodes / flare up; tired/ super tired; did not feel good; Achy / body aches; fever; headache; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 24th March 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 24th March 2021, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after receiving Bexsero, the patient experienced enlargement of lymph nodes, tiredness, feeling unwell, general body pain, fever, headache and drug dose administration interval too short. On 2nd April 2021, the patient experienced neck pain. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the enlargement of lymph nodes, tiredness, feeling unwell, general body pain, fever, headache and neck pain were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, tiredness, feeling unwell, general body pain, fever, headache and neck pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the mother of the patient. The patient received 2nd dose of Bexsero, before than the recommended interval, which led to shortening of vaccination schedule. The patient received his 2nd dose of Bexsero and the night of the vaccination he was achy, tired and had a headache, had swollen lymph nodes and fever with body aches. The patient did not feel good and this event resolved within a couple of days. On 25th March 2021, the patient had a little fever and on 29th March 2021, the patient was still super tired. On 2nd April 2021, 9 days after vaccination, the patient experienced a flare up and his lymph nodes in his neck were swollen.  The neck pain and tired feeling lasted for a day or two and then he was fine.   All of his symptoms have since resolved. The reporter consented to follow up. For tolerance after 1st dose refer case US2021AMR100254.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100254:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose 1 of Shingrix back in 2018; This case was reported by a pharmacist 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 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: The age at vaccination was not applicable to this report. The  pharmacist reported that till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination. The reporter stated that it had been a long period of time they did not know if to administer 2nd shot or restart the series. The pharmacist not completely sure to provide Follow Up when agent asked.  No data from patient was provided, only gender but this information was not certain as per HCP statement.  No more information was reported. The VAERS details were provided for 1st dose. The reporter did not consented to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received on 07-May-2021 a dose that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number 4RB3J, expiry date 3rd April 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th May 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 7th May 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that on 7th May 2021, the patient received Engerix B, which was expired on 3rd April 2021. No further information was reported. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose/to a male adult patient.; pediatric dose/to a male adult patient.; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 64-year-old male patient who received HBV (Engerix B pediatric) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 6th May 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The reporter called to report that a medical assistant of the center where she works, applied a pediatric dose of Engerix-B vaccine to adult patient, which led to adult use of a child product and underdose. At the time of the reporting, the patient was doing well. No further details were reported. The reporter consented to follow up by email.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: inadvertently administered frozen vaccine / frozen temp ranging -8.2 to -13.4 C for 7 hrs; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the incorrect storage of drug to be related to Havrix.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follow: The patient was administered with frozen vaccine Havrix which was kept on temp ranging from 8.2 to 13.4 Celsius for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The medical assistant wanted to know, if the patient could be re-vaccinated. The vaccine details were available. The reporter consented to follow up. This case is one of the several cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100521:same reporter US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter US-GLAXOSMITHKLINE-US2021100517:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; PAIN IN CALVES; TIRED; This spontaneous report received from a patient and patient's mother and  concerned a white, not Hispanic/Latino female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 in the right arm for prophylactic vaccination.  No concomitant medications were reported.  On 12-APR-2021, 7 days after receiving the injection, the patient experienced pain in calves, felt tired and had hard time breathing. She went to the doctor, and unspecified tests were run.  On 20-APR-2021, the physician called and told her to go to the ER  (Emergency Room) right away, which is when the patient was diagnosed with pulmonary embolism, further described as right below the right lung. The patient's mother took the patient back to the ER a few days later.  The patient now "seems better", and is able to breathe better again, but was still having a hard time breathing. Treatment medications (dates unspecified) included: XARELTO (rivaroxaban). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired, and had not recovered from pulmonary embolism and pain in calves. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210505298-covid-19 vaccine ad26.cov2.s -Pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fatigue
Clinical narrative: JOINT INFLAMMATION; TIREDNESS; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Concomitant medications included adalimumab for moderate to severe adult crohn's disease. On an unspecified date, the subject experienced joint inflammation, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and joint inflammation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as case is assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient was previously treated with estradiol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: POSSIBLE GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The patient's vaccine Anatomical Approach site was not reported. The batch number was not reported and has been requested.  No concomitant medications were reported.  On Easter (04-APR-2021), 12 days after vaccine administration, the patient started having symptoms which led to the patient being tentatively diagnosed with Guillain-Barre syndrome.  No further details provided.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210510750-covid-19 vaccine ad26.cov2.s-possible Guillain-Barre syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Thrombophlebitis superficial, Ultrasound scan, Vertigo
Clinical narrative: VERTIGO; CLOGGED AND HOLLOW EARS; SUPERFICIAL THROMBOSIS OF LEG; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's past medical history included right leg amputated below the knee, and concurrent conditions included varicose veins in legs. The patient was previously treated with acetylsalicylic acid for right leg amputated below the knee. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced superficial thrombosis of leg. On 12-APR-2021, Laboratory data included: Ultrasonography (NR: not provided) no deep vein thrombosis. had a "superficial thrombosis. On 13-APR-2021, the subject experienced vertigo. On 13-APR-2021, the subject experienced clogged and hollow ears. Treatment medications (dates unspecified) included: meclozine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo on 04-MAY-2021, and had not recovered from superficial thrombosis of leg, and clogged and hollow ears. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Hidradenitis
Clinical narrative: FLARE UP OF HIDRADENITIS SUPPURATIVA; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hidradenitis suppurativa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flare up of hidradenitis suppurativa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flare up of hidradenitis suppurativa. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: EXTENSIVE DEEP VEIN THROMBOSIS; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced extensive deep vein thrombosis after the vaccine was released to the public. She began feeling symptoms seven days after getting the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extensive deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210514131- COVID-19 VACCINE AD26.COV2.S -Extensive Deep Vein Thrombosis. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.