chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound scan
Clinical narrative: SPONTANEOUS ABORTION; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a physician concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency time 1 total was administered on 27-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-SEP-2021, the patient was vaccinated with Janssen Covid-19 vaccine resulting in vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported.  Before receiving the vaccine the patient had ultra sound and genetic testing which was normal. On 01-OCT-2021, patient had another ultrasound test and it was normal. On 18-OCT-2021, the patient was 14 weeks and 6 days pregnant and she had an ultra sound test that showed that the baby passed away (fetal demise). On 18-OCT-2021, the pregnancy resulted in a spontaneous abortion. On 21-OCT-2021, she had genetic test again and which was normal.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous abortion and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211114914-COVID-19 VACCINE AD26.COV2.S-spontaneous abortion. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: MEDICAL HISTORY  20211114914-COVID-19 VACCINE AD26.COV2.S-vaccine exposure during pregnancy . This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Areflexia, Arthralgia, Gait disturbance, Loss of personal independence in daily activities, Pain
Clinical narrative: She had an almost identical reaction to both dose #2 and dose #3 of her Moderna series. About 12 days after the dose #2, she had all over body tingling, which at the time we attributed to hypokalemia (she had also started a diuretic at that time). This tingling took about 1 week to resolve. We did not make the connection between the vaccine and these symptoms.  She received her third dose of Moderna on 10/29/2021, and on 11/3 she began having itching of her feet. This then spread to diffuse tingling and pain of the feet, legs, and hands, and intensified to the point she needed medical attention. Symptoms have improved with gabapentin but not entirely, and as of today (11/15) she is still having symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Sleep disorder, Tenderness
Clinical narrative: She had an almost identical reaction to both dose #2 and dose #3 of her Moderna series. About 12 days after the dose #2, she had all over body tingling, which at the time we attributed to hypokalemia (she had also started a diuretic at that time). This tingling took about 1 week to resolve. We did not make the connection between the vaccine and these symptoms.  She received her third dose of Moderna on 10/29/2021, and on 11/3 she began having itching of her feet. This then spread to diffuse tingling and pain of the feet, legs, and hands, and intensified to the point she needed medical attention. Symptoms have improved with gabapentin but not entirely, and as of today (11/15) she is still having symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine increased, Blood magnesium increased, Blood potassium normal, Blood urea increased, Electrophoresis protein
Clinical narrative: She had an almost identical reaction to both dose #2 and dose #3 of her Moderna series. About 12 days after the dose #2, she had all over body tingling, which at the time we attributed to hypokalemia (she had also started a diuretic at that time). This tingling took about 1 week to resolve. We did not make the connection between the vaccine and these symptoms.  She received her third dose of Moderna on 10/29/2021, and on 11/3 she began having itching of her feet. This then spread to diffuse tingling and pain of the feet, legs, and hands, and intensified to the point she needed medical attention. Symptoms have improved with gabapentin but not entirely, and as of today (11/15) she is still having symptoms.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrophoresis protein normal, Metabolic function test, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: She had an almost identical reaction to both dose #2 and dose #3 of her Moderna series. About 12 days after the dose #2, she had all over body tingling, which at the time we attributed to hypokalemia (she had also started a diuretic at that time). This tingling took about 1 week to resolve. We did not make the connection between the vaccine and these symptoms.  She received her third dose of Moderna on 10/29/2021, and on 11/3 she began having itching of her feet. This then spread to diffuse tingling and pain of the feet, legs, and hands, and intensified to the point she needed medical attention. Symptoms have improved with gabapentin but not entirely, and as of today (11/15) she is still having symptoms.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry skin, Headache, Immediate post-injection reaction, Skin discolouration, Skin warm
Clinical narrative: Vaccine at 830 - immediately following slight lightheadness,   by 910 very dizzy and unable to walk straight  by 930 laying on floor severe vertigo - Blood pressure found to be 198/130
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Vaccine at 830 - immediately following slight lightheadness,   by 910 very dizzy and unable to walk straight  by 930 laying on floor severe vertigo - Blood pressure found to be 198/130
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Immediate post-injection reaction, Laboratory test, Vertigo
Clinical narrative: Vaccine at 830 - immediately following slight lightheadness,   by 910 very dizzy and unable to walk straight  by 930 laying on floor severe vertigo - Blood pressure found to be 198/130
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Incorrect route of product administration, Pain, Product administered at inappropriate site, Skin warm
Clinical narrative: on 11/12/21 the patient called the company.  She said her arm was hurting a lot.  She went to the medical clinic and was told by the staff that the vaccination was given "high" and to call the company.  I tried calling the patient back.  No answer.  left a VM with my contact information but she never called back.    A sore arm / red arm / warmth at the vaccination site is a common side effect of the vaccine.  This is likely just a side effect.  No further action taken from our office.  Dr at the medical clinic was made aware via phone / email.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Pain in extremity, Skin reaction, Vaccination site warmth
Clinical narrative: on 11/12/21 the patient called the company.  She said her arm was hurting a lot.  She went to the medical clinic and was told by the staff that the vaccination was given "high" and to call the company.  I tried calling the patient back.  No answer.  left a VM with my contact information but she never called back.    A sore arm / red arm / warmth at the vaccination site is a common side effect of the vaccine.  This is likely just a side effect.  No further action taken from our office.  Dr at the medical clinic was made aware via phone / email.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, Chest pain, Chills, Condition aggravated
Clinical narrative: Hospitalized again(previously 10/3/2021  to 10/6/2021 unknown where) for persistent covid infection due to lymphopenia due to rituximab therapy.   Productive cough and shortness of breath.  Treating again with Remdesivir, convalescent plasma and dexamethasone.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Convalescent plasma transfusion, Cough, Dyspnoea, Dyspnoea exertional, Hypoxia
Clinical narrative: Hospitalized again(previously 10/3/2021  to 10/6/2021 unknown where) for persistent covid infection due to lymphopenia due to rituximab therapy.   Productive cough and shortness of breath.  Treating again with Remdesivir, convalescent plasma and dexamethasone.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Osteoarthritis, Productive cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Hospitalized again(previously 10/3/2021  to 10/6/2021 unknown where) for persistent covid infection due to lymphopenia due to rituximab therapy.   Productive cough and shortness of breath.  Treating again with Remdesivir, convalescent plasma and dexamethasone.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Convalescent plasma transfusion, Dyspnoea, Lymphopenia, Productive cough
Clinical narrative: Hospitalized again(previously 10/3/2021  to 10/6/2021 unknown where) for persistent covid infection due to lymphopenia due to rituximab therapy.   Productive cough and shortness of breath.  Treating again with Remdesivir, convalescent plasma and dexamethasone.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Upper respiratory tract infection
Clinical narrative: breakthrough infection
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Infection, SARS-CoV-2 test positive
Clinical narrative: breakthrough infection
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: Our family went in for Covid-19 shots 2 adults and 1 child My daughter was given a booster shot instead of the pediatric Covid-19 dose Pfizer Lot #FH8028
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Our family went in for Covid-19 shots 2 adults and 1 child My daughter was given a booster shot instead of the pediatric Covid-19 dose Pfizer Lot #FH8028
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Asthenia, Blood thyroid stimulating hormone normal, Chest pain, Drain placement
Clinical narrative: 3 weeks after J&J Vaccine, patient developed a pericardial effusion (acute) that required a surgical procedure known as a Pericardiocentesis based on a viral reaction to the vaccine that filled the pericardial sack with fluid. The symptoms were shortness of breath, chest pain, fatigue, and incapacitation.   The fluid around the heart was tested for culture result, which were negative. The outcome was drainage of the pericardial fluid, but patient recovered.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Fatigue, Full blood count normal, Metabolic function test, Metabolic function test normal
Clinical narrative: 3 weeks after J&J Vaccine, patient developed a pericardial effusion (acute) that required a surgical procedure known as a Pericardiocentesis based on a viral reaction to the vaccine that filled the pericardial sack with fluid. The symptoms were shortness of breath, chest pain, fatigue, and incapacitation.   The fluid around the heart was tested for culture result, which were negative. The outcome was drainage of the pericardial fluid, but patient recovered.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericardial drainage, Pericardial effusion, Pleuritic pain
Clinical narrative: 3 weeks after J&J Vaccine, patient developed a pericardial effusion (acute) that required a surgical procedure known as a Pericardiocentesis based on a viral reaction to the vaccine that filled the pericardial sack with fluid. The symptoms were shortness of breath, chest pain, fatigue, and incapacitation.   The fluid around the heart was tested for culture result, which were negative. The outcome was drainage of the pericardial fluid, but patient recovered.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriogram coronary abnormal, Chest pain, Culture negative, Dyspnoea, Echocardiogram abnormal
Clinical narrative: 3 weeks after J&J Vaccine, patient developed a pericardial effusion (acute) that required a surgical procedure known as a Pericardiocentesis based on a viral reaction to the vaccine that filled the pericardial sack with fluid. The symptoms were shortness of breath, chest pain, fatigue, and incapacitation.   The fluid around the heart was tested for culture result, which were negative. The outcome was drainage of the pericardial fluid, but patient recovered.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pericardial drainage, Pericardial effusion
Clinical narrative: 3 weeks after J&J Vaccine, patient developed a pericardial effusion (acute) that required a surgical procedure known as a Pericardiocentesis based on a viral reaction to the vaccine that filled the pericardial sack with fluid. The symptoms were shortness of breath, chest pain, fatigue, and incapacitation.   The fluid around the heart was tested for culture result, which were negative. The outcome was drainage of the pericardial fluid, but patient recovered.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Pyrexia, Syncope
Clinical narrative: High Fever, dizziness, syncope, chest pain, headache, dry heaves
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Headache, Pyrexia, Retching
Clinical narrative: High Fever, dizziness, syncope, chest pain, headache, dry heaves
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: High Fever, dizziness, syncope, chest pain, headache, dry heaves
Age: 35.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Nurse called to report that a dose of V ARlV AX had been inadvertently administered after the labeled expiry date; This spontaneous report was received from a register nurse and refers to a 35-year-old patient of unspecified gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 03-NOV-2021, the patient was inadvertently vaccinated with one (1) expire dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (concentration, vaccination scheme frequency, route and anatomical site of administration were not reported; lot number S033540 that was verified to be a valid lot number with an expiration date reported and established as 22-OCT-2021) (expired product administered). It was confirmed by the reporter that the diluent used was not expired. There were no temperature excursions involved.  No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional adverse events reported; an expired dose of MMR II was administered yesterday; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.   On 04-NOV-2021 (reported as yesterday), the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S032036, expiration date 10-OCT-2021; strength and route were unknown) for prophylaxis (expired product administered). Caller reported that dose was properly stored up through the time of administration. No further information provided. No additional adverse events reported. No product quality complaints.
Sex: U
Vaccine: HPVX
Symptoms: Psoriasis
Clinical narrative: Transformed my life, gave psoriasis; Ruined my confidence; This case was reported by a consumer via interactive digital media and described the occurrence of psoriasis in a patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced psoriasis and loss of confidence. On an unknown date, the outcome of the psoriasis and loss of confidence were unknown.   It was unknown if the reporter considered the psoriasis and loss of confidence to be related to HPV vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient stated that, the HPV vaccine certainly transformed his/her life, gave him/her psoriasis and ruined his/her confidence for entire adult life. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: had the shot, now has a rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th November 2021, the patient received Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's husband. Age at vaccination was not reported. The patient received a dose of Shingrix vaccine yesterday from the day of reporting and experienced rash. Follow-up would not be possible as no contact details updated.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site discomfort
Clinical narrative: feel horrible, shots knocked me on my can; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site discomfort (received first dose on an unknown date also experienced Injection site discomfort and feeling unwell, refer case US2021AMR190683).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had both shingles shots and felt horrible. The shots knocked him/ her on the can. The patient advised others to get the shots.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190683:same reporter/patient (1st dose)
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Stress
Clinical narrative: pain all over my body; skin is itchy on diferents parts/I'm having ants inside my body; Its so stressful; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced general body pain, generalized pruritus and stress. On an unknown date, the outcome of the general body pain, generalized pruritus and stress were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, generalized pruritus and stress to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first Shingles vaccine 3 days ago and he/she did not even know about this.  The patient had pain in all his/her body and skin was itchy on different parts, it was like "having ants inside body".  The physician did not find the cause it was horrible and so stressful.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: lymph nodes in my underarm now are swollen; I am sore; fever; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 2nd November 2021, the patient received Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced enlargement of lymph nodes, pain and fever. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved and the outcome of the pain and fever were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, pain and fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received booster dose on Tuesday and his/her lymph nodes in his/her underarm were swollen (at the time of reporting). The patient read that it's a common reaction in women after the booster. The patient was sore and bit of fever. The patient felt better after 2 days.
Age: 36.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Nervous system disorder, Product administered to patient of inappropriate age
Clinical narrative: nerve issues; Found it terrible; got the shingles vaccine age 36; This case was reported by a consumer and described the occurrence of nervous system disorder in a 36-year-old 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 nervous system disorder, feels awful and inappropriate age at vaccine administration. On an unknown date, the outcome of the nervous system disorder, feels awful and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the nervous system disorder and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient got the shingles vaccine age 36, which led to inappropriate age at vaccine administration. The patient found it terrible and had some nerve issues too.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the second dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st vaccine on an unknown date more than a year ago).   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 for this report. Till the time of reporting the patient did not receive second dose , which led to incomplete course of vaccination. The health care professional enquired that do the patient just need the second dose have to redo the two shots series again.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Had mine today!! ... My arm is really sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 6th November 2021, the patient received the 1st dose of Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season. On 6th November 2021, less than a day after receiving Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received shingles shot on the day of reporting along with the flu shot on the other arm. The patient's arm was really sore. The patient went to the pharmacy and nobody said anything about a second shot. And hence wanted to go and look at the paper work they gave him/ her.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: Very painful; burning in arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and burning sensation. On an unknown date, the outcome of the pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the pain and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter got the shot and was still feeling burning in arm from having them, was very painful. The reporter stated that, he/she had been down that road and did not ever wanted to again. For tolerance of 2nd dose, refer case US2021AMR231058, reported by same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR231058:2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder
Clinical narrative: trigger an underlying autoimmune disease; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced autoimmune disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the autoimmune disorder was recovered/resolved.   The reporter considered the autoimmune disorder to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got 1st one and then had it triggered an underlying autoimmune disease which no one could name. The patient stated six months of hell. The patient thought the shingles might had been easier. The patient's doctor said a lot of people had reactions to this vaccine. The patient stated that he/she was not saying not to get this but listen to your gut. The follow-up could not be possible as no contact details were available. The case had been linked with case US2021AMR232038, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot around December 2020; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020).   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 case was self reported by the patient. The age at vaccination was not applicable for this report. The patient received 1st shot around December 2020. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose not given in over 1 year; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date ).   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 are as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked if 2nd dose of Shingrix not given in over 1 year, then was it okay to complete the series or need to start over. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Amnesia, Fall, Skin abrasion, Syncope
Clinical narrative: fainted; I have no memory of the circumstances preceding that; had a small abrasion; fallen on the carpet; This case was reported by a consumer via interactive digital media and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 hr after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant), memory loss, skin abrasion and fall. On an unknown date, the outcome of the faint, memory loss, skin abrasion and fall were unknown.   It was unknown if the reporter considered the faint, memory loss, skin abrasion and fall to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix shot and fainted about an hour later. The patient had no memory of the circumstances preceding after that. The patient had a few sips of alcohol, as it was 5:30 pm in the afternoon.  The patient stated that he/she must had fallen on the carpet because the patient had a small abrasion. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injection site pain, Injection site swelling, Rash
Clinical narrative: injection site swelling; minor pain; rash around neck; resembling early symptoms of shingles; This case was reported by a consumer and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a significant outbreak about 4 or 5 years ago).   In September 2021, the patient received Shingrix. On 6th November 2021, between 1 and 3 months after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the patient experienced injection site swelling and pain. The patient was treated with topical antibiotic (nos) (Antibiotic Ointment (Trade Name Unknown)) and corticosteroids, dermatological preparations (nos) (Corticosteroid Ointment). On an unknown date, the outcome of the shingles, injection site swelling, pain and rash were unknown.   It was unknown if the reporter considered the shingles, injection site swelling, pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's wife. The age at vaccination was not reported but it could be 77 or 78 years. The patient received the Shingrix vaccine at the end of this September. The patient observed only the usual injection site swelling and minor pain, however I noticed recently on 6th Nov ember, a rash around her neck, resembling early symptoms of Shingles.  The patient rubbed some antibiotic and corticosteroid ointment on it for the last 2 days. The reporter enquired if this was appropriate and if she could be having a mild case of Shingles. The reporter also enquired about when the patient could take the second dose. This case was linked with US2021AMR232176, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR232176:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Bell's palsy, Facial paralysis, Vaccination complication
Clinical narrative: Bell's palsy; partial facial paralysis on the right side; This case was reported by a consumer and described the occurrence of bell's palsy in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) (batch number 54C23, expiry date unknown) for prophylaxis.   On 15th October 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On 22nd October 2021, 7 days after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced bell's palsy (serious criteria GSK medically significant) and facial paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy and facial paralysis were unknown.   It was unknown if the reporter considered the bell's palsy and facial paralysis to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient received flu vaccine manufactured by GlaxoSmithKline and one week later was diagnosed with bell's palsy and partial facial paralysis on right side. The patient reported that the physician believed that the adverse event occurred due to flu shot. The patient wanted to report this adverse event properly. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Pt had 1st Shingrix 8yrs ago and never got second; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date 8 years before the time of reporting).   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 patient self-reported this case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The patient enquired if he had the need to restart schedule or in other words one or two doses.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, does she have to start over?; This case was reported by a other health professional (Shingrix GSK Chatbot) via interactive digital media 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 (received 1st dose of Shingrix approximately 2 years ago).   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 provided were as follows: Age at vaccination was not applicable for this case. Till the time of reporting, the patient did not received the second dose of Shingrix, which led to incomplete course of vaccination. The patient received the first dose approximately 2 years ago and reporter enquired if she had to start the series over or she could get the second shot and be considered fully vaccinated. Follow-up would not be possible as no contact details available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 or 3 years ago, not received a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix 2 or 3 years ago).   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. The patient missed second dose of Shingrix, which led to incomplete course of vaccination. The reporter provided consent to follow up. VAERS details were reported for the 1st dose of Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in April 2018, has not received the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix. In April 2018, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete couzrse of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report.. The pharmacist reported that a patient received the first dose of Shingrix and had not received the second dose yet which led to Incomplete course of vaccination. The reporter consented to follow up
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Lip blister, Lip erythema, Lip swelling
Clinical narrative: rash on upper lip; blisters on upper lip; lip was swollen; lip was red; This case was reported by a physician via call center representative and described the occurrence of rash lips in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC).   On 26th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2021, 48 hrs after receiving Shingrix, the patient experienced rash lips, lip blister, lip swelling and lip redness. On an unknown date, the outcome of the rash lips and lip blister were recovered/resolved and the outcome of the lip swelling and lip redness were not recovered/not resolved.   It was unknown if the reporter considered the rash lips, lip blister, lip swelling and lip redness to be related to Shingrix.  Additional details were provided are as follows: The case was reported physician on behalf of the patient. The patient received a dose of Shingrix and within 48 hours patient had developed blisters/rash on upper lip and upper lip was red and swollen. The blisters/rash had resolved but the patient's upper lip was still red and swollen.   The patient had received Zyrtec as concomitant. Spoke per PI that rash could be a hypersensitivity reaction.  Sent copy of PI per health care professional request.   No lot or expiration date was known as vaccine was given at the pharmacy. The reporter consented to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B pediatric dose to adult patient; Adult patient received a pediatric dose; This case was reported by a nurse and described the occurrence of underdose in a 26-year-old male patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 provided as follows: The age at vaccination was not reported. The adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 2019, not received second dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 19th July 2019).   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 provided were as follows: Age at vaccination was not applicable for this report. Till the time of the reporting, patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. She did not went back to receive the second dose to complete the series. Health care professional contact information was not collected. She chose not to provide her email address. She agreed to receive an acknowledgement letter via mail. The reporter forgot to collect the following information of  lot number and expiry date, dosage, route of administration, and whether the vaccine was given on left or right deltoid. The reporter did not provided consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter reported that, "My mother died from vaccine injuries." Cause of death was unknown and it was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:  20211127835-Covid-19 vaccine ad26.cov2.s- Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTTING; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, 1 total, 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 numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clotting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clotting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211128043-Covid-19 vaccine ad26.cov2.s-Blood clotting. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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. The company is unable to perform follow-up to request batch or lot number. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.