chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation
Clinical narrative: Loss of consciousness; Dizziness; Hyperhidrosis; This case was received via FDA VAERS (Reference number: 1321990) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery bypass graft (X4 vessels). Concurrent medical conditions included Coronary artery disease, Hypertension and Hyperkeratosis lenticularis perstans. Concomitant products included LISINOPRIL, METOPROLOL, ATORVASTATIN and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 16-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness) and HYPERHIDROSIS (Hyperhidrosis). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness) and HYPERHIDROSIS (Hyperhidrosis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 102/70 (Inconclusive) 102/70. On an unknown date, Heart rate: 54 (Inconclusive) 54. On an unknown date, Oxygen saturation: 95 percent (Inconclusive) 95 percent room air.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that he left site in no acute distress, awake alert oriented to person, place time and situation.  No treatment information was given.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Deafness unilateral; This case was received via FDA VAERS (Reference number: 1402921) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DEAFNESS UNILATERAL (Deafness unilateral) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma, Polycystic ovarian syndrome and Idiopathic intracranial hypertension. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (AVIANE) for Birth control, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ESCITALOPRAM OXALATE (LEXAPRO) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DEAFNESS UNILATERAL (Deafness unilateral) (seriousness criteria disability and medically significant). At the time of the report, DEAFNESS UNILATERAL (Deafness unilateral) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.  The patient experienced hearing loss in right ear. Laboratory investigations were Magnetic resonance imaging(may-2021),Acoustic stimulation tests(may-2021). No treatment product information was provided  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dehydration, Diarrhoea, Dry mouth, Rash
Clinical narrative: Rash on his left arm, both legs; Dry mouth; Dehydration; Two days after / vaccine / started to have Diarrhea which is ongoing; This case was reported by a consumer via patient support programs and described the occurrence of diarrhea in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included post-traumatic stress disorder.   On 16th June 2021, the patient received Shingrix. On 18th June 2021, 2 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the patient experienced rash, dry mouth and dehydration. On an unknown date, the outcome of the diarrhea, rash, dry mouth and dehydration were not recovered/not resolved.   The reporter considered the diarrhea to be unrelated to Shingrix. It was unknown if the reporter considered the rash, dry mouth and dehydration to be related to Shingrix.  Additional details were provided as follows: This report was submitted via the online direct entry reporting system.  The patient received Shingrix and 2 days after receiving vaccine, patient started to have diarrhea which was ongoing.  The patient started to get a rash on his left arm and both legs after receiving the Shingrix Vaccine.  Also the patient had dry mouth and dehydration after taking the Shingrix Vaccine. The Health Care professional (HCP) not consented to contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I had the vaccine for shingles in Nov of 2019 and forgot to get my 2nd vaccine until June 0f 2021; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   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 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 was the reporter. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The reporter asked did he/she need to get and additional shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: 2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the 1st dose of adjuvant suspension only, and came back 2 months later and only administered the lyophilized powder mixed with normal saline. No adverse events reported by patient. This was 9 of 9 linked cases reported by same reporter for different patients. The reporter consented to follow up.   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138558:Same reporter US-GLAXOSMITHKLINE-US2021AMR138555:Same reporter US-GLAXOSMITHKLINE-US2021AMR138557:Same reporter US-GLAXOSMITHKLINE-US2021AMR138556:Same reporter US-GLAXOSMITHKLINE-US2021AMR138546:Same reporter US-GLAXOSMITHKLINE-US2021AMR138554:Same reporter US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1 - deleted.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm for fifteen hour; light headaches; This case was reported by a consumer via media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th June 2021, the patient received Shingles vaccine. In June 2021, less than 3 weeks after receiving Shingles vaccine, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. Patient reported that got fully vaccinated on 11th June. Then patient experienced sore arm for fifteen hours and light headaches for a day. The reporter was fully vaccinated and wanted to look at small pox other diseases.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product supply issue
Clinical narrative: first injection / 06/22/2018 but then there were supply problems and I never got the second dose.; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, there were supply problems and I never got the second dose. The patient was going to a new primary care physician. The patient asked did he or she took the second dose now or start over with the first dose.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: vomiting after each dose; This case was reported by a pharmacist via sales rep and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, refer case US2021AMR141807).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR141807:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix 12/2019. does she need to restart and get both shots; This case was reported by a other health professional 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 on an unknown date in December 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 were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the second dose, which led to incomplete course of vaccination. The reporter enquired if the patient had to restart and get both shots or if she could she could just get the second shot.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: symptoms of Shingles / shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2021, the patient received the 1st dose of Shingrix. On 27th June 2021, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Addtional details were provided as follows: The age at vaccination was not reported. 5 days after receiving 1st dose of Shingrix, patient began to develop symptoms of Shingles.  On 1st July 2021, patient came to clinic and was diagnosed with shingles. The provider asked if this was a coincidence or if Shingrix could reactivate shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: severe pain in left arm; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. The patient was treated with non-drug therapy (Ice Pack (No Medication)), paracetamol (Acetaminophen) and non-drug therapy (Acupuncture). On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced severe pain in left arm. The reporter mentioned that, patient sought to outpatient medical care and was treated with ice, acetaminophen and acupuncture. The reporter also mentioned that, pain resolved in several days with no further complications. The reporter consented to follow up.
Sex: M
Vaccine: DTP
Symptoms: Hypersensitivity, Seizure
Clinical narrative: allergic to pertussis (had convulsions); was allergic to pertussis; This case was reported by a consumer via interactive digital media and described the occurrence of convulsion in a male patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced convulsion (serious criteria GSK medically significant) and allergy to vaccine. On an unknown date, the outcome of the convulsion and allergy to vaccine were unknown.   It was unknown if the reporter considered the convulsion and allergy to vaccine to be related to DTP vaccine.  Additional details were provided as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient received DPT vaccine and was allergic to pertussis and had convulsions. The reporter had to sign exempt forms every school year. The reporter stated that for the same reason they would not take pertussis out of the DPT vaccine for people who are allergic to pertussis. The follow-up would not possible as no contact details were available.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: adult patient received a pediatric dose / on 21-Jan-2021 and a second pediatric dose / in 21-Feb-2021; adult patient received a pediatric dose / on 21-Jan-2021 and a second pediatric dose / in 21-Feb-2021; adult patient received a pediatric dose / on 21-Jan-2021 and a second pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 57-year-old female patient who received HAV (Havrix pediatric) for prophylaxis.   Concomitant products included HAV (Havrix pediatric).   On 21st February 2021, the patient received the 2nd dose of Havrix pediatric (intramuscular). On 21st February 2021, unknown after receiving Havrix pediatric, the patient experienced underdose, adult use of a child product and drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult use of a child product and drug dose administration interval too short were unknown.  Additional details were provided as follows: The pharmacist reported that an adult patient received a pediatric dose of Havrix, which led to underdose, adult use of a child product and shortening vaccinations schedule. The reporter mentioned that, both doses were given intramuscularly. The reporter consented to follow up. This case linked with US2021142825, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142825:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Injected limb mobility decreased, Neck pain, Pain
Clinical narrative: upper arm hurt unusually badly / too painful to lift arm / pain / migrated down my arm to my forearm / Weirdest most painful reaction ive ever experienced before / awful pain from left forearm / dangling it is very painful; pain also migrated / up my neck to the base of my left jaw / Weirdest most painful reaction ive ever experienced before /awful pain / up neck to base of jaw; pain also migrated / up my shoulder, across the top of the shoulder / Weirdest most painful reaction ive ever experienced before /awful pain / top of shldr, across top of clavicle; Pain in base of my left; too painful to lift arm but pain; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 65-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date). Concurrent medical conditions included osteoarthritis.   On 2nd July 2021 09:00, the patient received Shingles vaccine. On 2nd July 2021 05:30, 8 hrs 30 min after receiving Shingles vaccine, the patient experienced injected limb mobility decreased, neck pain, shoulder pain and jaw pain. On 2nd July 2021 16:00, the patient experienced pain in arm. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injected limb mobility decreased, pain in arm, neck pain, shoulder pain and jaw pain were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm, neck pain, shoulder pain and jaw pain to be related to Shingles vaccine.  Additional case details were reported as follows: Age at vaccination was not reported but it could be 64 years or 65 years. On the day of vaccination by 4 pm, the patient's upper arm hurt unusually badly.  By 5:30 pm it was too painful to lift arm but pain also migrated down to forearm and up to shoulder, across the top of the shoulder and up the neck to the base of left jaw. Ice had not helped thus far. The patient said that, this was the weirdest most painful reaction ever experienced before. The patient's current situation nearing 23 hrs post injection was, awful pain from left forearm, up over injection site of arm, top of shoulder, across top of clavicle and up neck to base of jaw.  The patient's arm was propped up on a pillow as dangling it was very painful.  Over the counter (OTC) pain medicine ineffective. waiting this out.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: upper arm hurt unusually badly / too painful to lift arm / pain / migrated down my arm to my forearm / Weirdest most painful reaction ive ever experienced before / awful pain from left forearm / dangling it is very painful; pain also migrated / up my neck to the base of my left jaw / Weirdest most painful reaction ive ever experienced before /awful pain / up neck to base of jaw; pain also migrated / up my shoulder, across the top of the shoulder / Weirdest most painful reaction ive ever experienced before /awful pain / top of shldr, across top of clavicle; Pain in base of my left; too painful to lift arm but pain; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 65-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date). Concurrent medical conditions included osteoarthritis.   On 2nd July 2021 09:00, the patient received Shingles vaccine. On 2nd July 2021 05:30, 8 hrs 30 min after receiving Shingles vaccine, the patient experienced injected limb mobility decreased, neck pain, shoulder pain and jaw pain. On 2nd July 2021 16:00, the patient experienced pain in arm. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injected limb mobility decreased, pain in arm, neck pain, shoulder pain and jaw pain were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm, neck pain, shoulder pain and jaw pain to be related to Shingles vaccine.  Additional case details were reported as follows: Age at vaccination was not reported but it could be 64 years or 65 years. On the day of vaccination by 4 pm, the patient's upper arm hurt unusually badly.  By 5:30 pm it was too painful to lift arm but pain also migrated down to forearm and up to shoulder, across the top of the shoulder and up the neck to the base of left jaw. Ice had not helped thus far. The patient said that, this was the weirdest most painful reaction ever experienced before. The patient's current situation nearing 23 hrs post injection was, awful pain from left forearm, up over injection site of arm, top of shoulder, across top of clavicle and up neck to base of jaw.  The patient's arm was propped up on a pillow as dangling it was very painful.  Over the counter (OTC) pain medicine ineffective. waiting this out.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Would having two shots after having a first shot 2-3 years ago be a problem?; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot 2 to 3 years ago from the day 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 case was reported by patient's husband. The age at vaccination was not applicable for this report. 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 reporter was asking if that would be a problem to take two more shots. The patient was advised to take the 2nd shot as soon as possible and to not restart the vaccine series. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: had the shingles.; never went back for the 2nd injection; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The patient received first dose of Shingrix and experienced bad reaction and also had shingles. The patient never went back for second dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue
Clinical narrative: Patient is having dizziness; Tired; This case was reported by a consumer via media and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness and tiredness. On an unknown date, the outcome of the dizziness and tiredness were unknown.   It was unknown if the reporter considered the dizziness and tiredness to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The patient received Shingrix vaccine. After vaccination, the patient experienced dizziness and tired.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never went back for 2nd dose; 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 with an associated reaction of adverse event (received 1st dose 2 years before the date of reporting and had bad reaction) and Shingles vaccine (Original shingles shot received many 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 for this report. The patient never went back for 2nd dose of Shingrix, which led to incomplete course of vaccinations. The reporter asked if it was too late at the time of reporting and if the patient needs to start over.; Reporter's Comments: 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.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: dizzy since getting 1st / shot 2 weeks ago; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received  1st Shingrix and  since then experienced dizziness. The reporter asked how long should this last.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Dyskinesia, Headache, Inappropriate schedule of product administration, Loss of consciousness
Clinical narrative: it may have been a bad batch; I was about to black out/I passed out; felt very heavy; the bathroom started to spin; my vision started to deteriorate; my legs arms started flailing involuntarily; fell asleep; a bad headache; This case was reported by a consumer and described the occurrence of blackout in a patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 10th April 2022) for prophylaxis.   On 23rd December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced blackout (serious criteria GSK medically significant), sensation of heaviness, spinning sensation, deterioration of visual acuity, movements involuntary of limbs, sleepiness and headache. On an unknown date, the patient experienced pharmaceutical product complaint. Shingrix was discontinued. On an unknown date, the outcome of the blackout, sensation of heaviness, spinning sensation, deterioration of visual acuity, movements involuntary of limbs, sleepiness, headache and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the blackout, sensation of heaviness, spinning sensation, deterioration of visual acuity, movements involuntary of limbs, sleepiness and headache to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient's doctor recommended him/her to contact GSK regarding an unusual and very scary reaction to the Shingrix vaccine. Less than 24 hours after vaccination, the patient got in the shower and felt very heavy. Within one minute of being in the shower, the bathroom started to spin and patient was about to black out as his/her vision started to deteriorate. The patient stepped out covered in soap and his/her legs, arms started flailing involuntarily so badly that he/she could not dry himself/herself. The patient sat down on the toilet before he/she passed out and after several minutes, it let up a little and he/she dragged himself/herself into bed and fell asleep, woke up with a bad headache. The patient did not call the ambulance or immediately go the physician due to the holiday and when patient followed up with his/her physician, she was surprised and a bit baffled. The patient requested the batch number to ask if it might have been a bad batch and a photo was attached. The patient requested to respond and he/she refused to get the second shot. The consent to follow-up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Product complaint, Refusal of vaccination, Somnolence, Vertigo, Visual acuity reduced
Clinical narrative: it may have been a bad batch; I was about to black out/I passed out; felt very heavy; the bathroom started to spin; my vision started to deteriorate; my legs arms started flailing involuntarily; fell asleep; a bad headache; This case was reported by a consumer and described the occurrence of blackout in a patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 10th April 2022) for prophylaxis.   On 23rd December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced blackout (serious criteria GSK medically significant), sensation of heaviness, spinning sensation, deterioration of visual acuity, movements involuntary of limbs, sleepiness and headache. On an unknown date, the patient experienced pharmaceutical product complaint. Shingrix was discontinued. On an unknown date, the outcome of the blackout, sensation of heaviness, spinning sensation, deterioration of visual acuity, movements involuntary of limbs, sleepiness, headache and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the blackout, sensation of heaviness, spinning sensation, deterioration of visual acuity, movements involuntary of limbs, sleepiness and headache to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient's doctor recommended him/her to contact GSK regarding an unusual and very scary reaction to the Shingrix vaccine. Less than 24 hours after vaccination, the patient got in the shower and felt very heavy. Within one minute of being in the shower, the bathroom started to spin and patient was about to black out as his/her vision started to deteriorate. The patient stepped out covered in soap and his/her legs, arms started flailing involuntarily so badly that he/she could not dry himself/herself. The patient sat down on the toilet before he/she passed out and after several minutes, it let up a little and he/she dragged himself/herself into bed and fell asleep, woke up with a bad headache. The patient did not call the ambulance or immediately go the physician due to the holiday and when patient followed up with his/her physician, she was surprised and a bit baffled. The patient requested the batch number to ask if it might have been a bad batch and a photo was attached. The patient requested to respond and he/she refused to get the second shot. The consent to follow-up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received Shingrix in October 2020 and never received second shot; 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 October 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 patient had reported for him/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient asked, what should he/she do.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: had this reaction to the DTap / at 2 months old / whooping cough; This case was reported by a consumer via interactive digital media and described the occurrence of pertussis in a 21-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the pertussis was unknown.   It was unknown if the reporter considered the pertussis to be related to DTaP vaccine.  Additional details were provided as follows: The patient received DTaP vaccine and had pertussis. The patient never had the vaccine again or whooping cough.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: muscle pain/severe muscle pain; headaches; fever/occasional fever; utter exhaustion; body aches; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced muscle pain, headache, fever, exhaustion and general body pain. On an unknown date, the outcome of the muscle pain, headache, fever, exhaustion and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, headache, fever, exhaustion and general body pain to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient got 1st dose of Shingrix 11 days ago of reporting date and still had severe muscle pain, headaches, occasional fever, utter exhaustion and body aches. The patient enquired was this normal and how many days can side effects last. The patient reported that all the above symptoms come and go and seem to get worse at night.
Sex: U
Vaccine: MENB
Symptoms: Accidental overdose
Clinical narrative: Most, if not all/ contents spilled/unknown quantity went into the patient's arm; This case was reported by a nurse via sales rep and described the occurrence of accidental underdose in a 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.   On 5th July 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 5th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose 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 was administering a dose of Bexsero to a patient in deltoid muscle and the needle apparently was not connected properly to the syringe. As per the nurse, most, if not all of the syringe contents spilled onto the exam table and an unknown quantity went into the patient's arm, which led to accidental underdose. The nurse believed that none of the vaccine went into the arm but she did inject the needle into the deltoid muscle as planned.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Injection site pain, Pain in extremity
Clinical narrative: I got first one. Sore where shot was; Sore / continued down my arm / shoulders / back / right arm. 2 weeks I hurt so bad; Sore where shot was then continued down my arm,then continued across shoulders; Sore where shot was then continued down my arm,then continued across shoulders then my whole back, then down my right arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site 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 injection site pain, pain in arm, shoulder pain and back pain. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the shoulder pain and back pain were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, shoulder pain and back pain to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient received 1st dose and had sore where shot was given and then continued down in her/his arm, then continued across shoulders then in whole back, then down in right arm for two weeks and it hurt so bad.  The patient received 2nd dose on the 12th.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a 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 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 patient was reporter's sister. The age at vaccination was not reported. The patient got the vaccine but she still got the 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 be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Got my second shot / Very painful; 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.   In June 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 2nd shot of shingles last Wednesday of reporting date and it was very painful. No further details were provided.
Age: 46.0
Sex: U
Vaccine: FLUX
Symptoms: Ageusia, Anosmia, COVID-19, Culture urine, Dyspnoea
Clinical narrative: shortness of breath; fatique; loss of taste and smell; loss of taste and smell; received the "flu vaccine" 3 days before contracting COVID; This case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a 47-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included post concussion syndrome, irritable bowel syndrome (gastro symptoms were similar but differrent than IBS in 2017), covid-19 (Family History) (1stly patient's brother got infected and then father got infected on 7th October 2020 and then whole family) and diabetes (Family History) (father was diabetic). Concurrent medical conditions included hormonal imbalance (had low progesterone and was taking supplemental progesterone monthly) and drug allergy. Concomitant products included pregabalin (Lyrica), progesterone and ibuprofen.   On 28th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 31st October 2020, 3 days after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced covid-19. On an unknown date, the patient experienced shortness of breath, fatigue, taste loss and loss of smell. On an unknown date, the outcome of the covid-19, shortness of breath, fatigue, taste loss and loss of smell were unknown.   It was unknown if the reporter considered the covid-19, shortness of breath, fatigue, taste loss and loss of smell to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided are as follows: The patient received flu vaccine 3 days prior to contracting COVID-19 On 17th October 2020,14th October 2020 and 21st October 2020, the patient was tested Covid negative but on 31st October 2020, the patient's Covid test was positive for the 1st time. On 5th February 2021, the patient received 1st dose of Covid vaccine from pfizer along with some Pharma products and experienced some adverse events, for tolerance refer linked case US2021AMR147346 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR147346:Same reporter
Age: 46.0
Sex: U
Vaccine: FLUX
Symptoms: Epstein-Barr virus test, Fatigue, SARS-CoV-2 antibody test positive
Clinical narrative: shortness of breath; fatique; loss of taste and smell; loss of taste and smell; received the "flu vaccine" 3 days before contracting COVID; This case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a 47-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included post concussion syndrome, irritable bowel syndrome (gastro symptoms were similar but differrent than IBS in 2017), covid-19 (Family History) (1stly patient's brother got infected and then father got infected on 7th October 2020 and then whole family) and diabetes (Family History) (father was diabetic). Concurrent medical conditions included hormonal imbalance (had low progesterone and was taking supplemental progesterone monthly) and drug allergy. Concomitant products included pregabalin (Lyrica), progesterone and ibuprofen.   On 28th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 31st October 2020, 3 days after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced covid-19. On an unknown date, the patient experienced shortness of breath, fatigue, taste loss and loss of smell. On an unknown date, the outcome of the covid-19, shortness of breath, fatigue, taste loss and loss of smell were unknown.   It was unknown if the reporter considered the covid-19, shortness of breath, fatigue, taste loss and loss of smell to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided are as follows: The patient received flu vaccine 3 days prior to contracting COVID-19 On 17th October 2020,14th October 2020 and 21st October 2020, the patient was tested Covid negative but on 31st October 2020, the patient's Covid test was positive for the 1st time. On 5th February 2021, the patient received 1st dose of Covid vaccine from pfizer along with some Pharma products and experienced some adverse events, for tolerance refer linked case US2021AMR147346 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR147346:Same reporter