chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Speech disorder, Spinal X-ray, Syncope, Vitamin B12
Clinical narrative: Was found by her family after collapsing on 06Jan2021 /syncope; extreme fatigue; sleepiness; headache; vomiting; weakness /notes 3/5 strength; difficulty speaking /speech disorder /vocal weakness; difficulty walking /gait disturbance; lower extremity weakness /progressive lower extremity /Muscular Weakness; hyporeflexia; Vitamin B12 Decreased; difficulty speaking /speech disorder /vocal weakness; This is a spontaneous report from a non-contactable consumer (patient). A (age: 39; unit: unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EJ1686), intramuscularly at left arm on 04Jan2021 at single dose for covid-19 immunisation. Medical history included hypothyroidism, attention deficit hyperactivity disorder, shellfish allergy. Current illness was none. Concomitant medication included levothyroxine, lisdexamfetamine mesilate (VYVANSE). The patient previously took ceclor and experienced drug hypersensitivity, took first dose of bnt162b2 at single dose for covid-19 immunisation and experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time. Patient experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 06Jan2021 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Patient had tele visit consult with Psychiatry and Neurology. She was subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. Symptom: Asthenia, Blood Thyroid Stimulating Hormone Normal, Computerized Tomogram head, Computerized tomogram head normal, CSF cell count normal, CSF culture, CSF protein normal, fatigue, full blood count normal, gait disturbance, headache, Hyporeflexia, Lumbar Puncture Normal, Metabolic Function Test Normal, Muscular Weakness, somnolence, speech disorder, Spinal X-Ray Normal, syncope, Vitamin B12 Decreased, vomiting. Serious criteria was permanent disability and the patient was hospitalized for 4 days and had emergency room vist. Existing hospitalization was not prolonged. Lab Data on 06Jan2021 included: Normal BMP, CBC, normal TSH (thyroid stimulating hormone), low B12, Lumbar Puncture: normal, cell count and protein, culture pending, Cervical Spine X-ray: Normal, CT brain (non contrast): normal. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12 decreased, Vocal cord disorder, Vomiting, X-ray
Clinical narrative: Was found by her family after collapsing on 06Jan2021 /syncope; extreme fatigue; sleepiness; headache; vomiting; weakness /notes 3/5 strength; difficulty speaking /speech disorder /vocal weakness; difficulty walking /gait disturbance; lower extremity weakness /progressive lower extremity /Muscular Weakness; hyporeflexia; Vitamin B12 Decreased; difficulty speaking /speech disorder /vocal weakness; This is a spontaneous report from a non-contactable consumer (patient). A (age: 39; unit: unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EJ1686), intramuscularly at left arm on 04Jan2021 at single dose for covid-19 immunisation. Medical history included hypothyroidism, attention deficit hyperactivity disorder, shellfish allergy. Current illness was none. Concomitant medication included levothyroxine, lisdexamfetamine mesilate (VYVANSE). The patient previously took ceclor and experienced drug hypersensitivity, took first dose of bnt162b2 at single dose for covid-19 immunisation and experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time. Patient experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 06Jan2021 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Patient had tele visit consult with Psychiatry and Neurology. She was subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. Symptom: Asthenia, Blood Thyroid Stimulating Hormone Normal, Computerized Tomogram head, Computerized tomogram head normal, CSF cell count normal, CSF culture, CSF protein normal, fatigue, full blood count normal, gait disturbance, headache, Hyporeflexia, Lumbar Puncture Normal, Metabolic Function Test Normal, Muscular Weakness, somnolence, speech disorder, Spinal X-Ray Normal, syncope, Vitamin B12 Decreased, vomiting. Serious criteria was permanent disability and the patient was hospitalized for 4 days and had emergency room vist. Existing hospitalization was not prolonged. Lab Data on 06Jan2021 included: Normal BMP, CBC, normal TSH (thyroid stimulating hormone), low B12, Lumbar Puncture: normal, cell count and protein, culture pending, Cervical Spine X-ray: Normal, CT brain (non contrast): normal. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Off label use, Product use issue
Clinical narrative: miscarried; patient was pregnant at the time of the vaccine; patient was pregnant at the time of the vaccine; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, at the age of 29-year-old, on 30Jan2021 02:00 AM, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient had no known allergies. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. The patient was pregnant at the time of the vaccine 30Jan2021 and miscarried on 01Feb2021. LMP was provided as 01Jan2021, gestation period was reported as 4 weeks and due date was provided as 08Oct2021. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the event miscarried. Outcome of the event miscarried was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of suspect vaccine BNT162B2 in triggering the misarrange in this 29-year-old pregnant patient cannot be excluded. Additional information regarding relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Coma, SARS-CoV-2 test, Vascular dementia
Clinical narrative: never woke up after arrival; Suffered with vascular dementia; Death cause: Covid/Tested positive to Covid 31Jan, tested due to increased lethargy; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient received the vaccine at nursing home/senior living facility. Medical history included dementia, hypertension, past strokes. The patient was exposed to asymptotic staff member on or prior to 25Jan2021. The patient had no known allergy. No COVID prior vaccination. Concomitant medication included lisinopril. No other vaccine was received in four weeks. The patient was tested positive to COVID on 31Jan2021, tested due to increased lethargy started from 26Jan2021. The patient suffered with vascular dementia. She was ambulatory up to 31Jan2021. The patient was sent to hospice that evening on 31Jan2021 to quarantine, never woke up after arrival. Palliative Care started 02Feb2021, the patient expired 12Feb2021. Cause of death was COVID. The patient did not receive treatment for events. The autopsy was not performed. The outcome of events "never woke up, vascular dementia" was unknown.   Information on Lot /Batch Number has been requested.; Reported Cause(s) of Death: Death cause: Covid
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myeloid leukaemia
Clinical narrative: acute myeloid leukemia; This is spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 16Jan2021 at 13:00 (at the age of 80-years-old) at single dose in left arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 28Dec2020 at 13:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has known allergies to penicillin. The patient received no concomitant medications. The patient experienced acute myeloid leukemia. Onset date of the event was reported as 16Feb2021 at 08:00. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, Life threatening illness (immediate risk of death from the event). The paitent was hospitalized for 7 days and was treated with Leukopheresis, Hydrea, Chemotherapy, Vancomycin. The patient had not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  Information about batch/lot number has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got shingles, and continues to get shingles 10 years later; This spontaneous report was received from a male patient concerning to himself. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On an unspecified date in 2011 (reported as 10 years ago), the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, frequency, route, lot#, expiration date were not provided) for prophylaxis.   On an unspecified date in 2011, the patient experienced shingles and continued to have shingles 10 years later. Unspecified treatment was prescribed for the event and the patient sought medical attention. At the time of the report, the outcome of the event was not recovered.  The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 51.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Incorrect dose administered
Clinical narrative: the adult patient received a pediatric dose of RECOMBIVAX due to a human error; the adult patient received a pediatric dose of RECOMBIVAX due to a human error; This spontaneous report was received from a certified medical assistant and refers to a 51-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 24-FEB-2021, the patient was inadvertently vaccinated with a pediatric dose of hepatitis B vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 0.5 ml, once, lot # S002770, expiration date 04-NOV-2021 (route of administration and anatomical location were not provided) for prophylaxis (accidental underdose, wrong vaccine administered). combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S002770; expirationdate: 04-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Pain, Pyrexia
Clinical narrative: mild fever; achy; This case was reported by a consumer and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blood glucose increased (1st dose received on 29th September 2020, reference case US2020206840) and Influenza vaccine quadrivalent 2020-2021 with an associated reaction of blood glucose increased (Received on 15th September 2020, reference case US2020206840).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced mild fever and she felt achy. The doctor seeing the patient seven days after the 2nd dose of Shingrix. The consent to follow-up was granted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206840:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Weird taste / Metal like taste; This case was reported by a consumer and described the occurrence of taste peculiar in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th January 2021, the patient received the 1st dose of Shingles vaccine. On 5th January 2021, 5 min after receiving Shingles vaccine, the patient experienced taste peculiar. On an unknown date, the outcome of the taste peculiar was not recovered/not resolved.   It was unknown if the reporter considered the taste peculiar to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and about 5 minutes later started getting a weird taste in mouth.  Since had the vaccine the metal like taste had not gone away. The reporter was concerned about this and trying to find out if there was anything should did.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: listed side effects / joint pain; stiffness; This case was reported by a consumer and described the occurrence of joint pain in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had it twice before.). Previously administered products included shingrix with an associated reaction of adverse event (1st dose received on an unknown date).  On 1st February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than a week after receiving Shingrix, the patient experienced joint pain and stiffness. On an unknown date, the outcome of the joint pain and stiffness were not recovered/not resolved.   It was unknown if the reporter considered the joint pain and stiffness to be related to Shingrix.  Additional details were provided as follows:  The reporter consent to follow up. After receiving 2nd dose of Shingrix, the patient experienced joint pain and stiffness. The patient was saying hope was the side effects from the second shot would be less difficult, but that has not been experience. The patient was in good health, and never had a significant reaction to a vaccine before and get that it's unpredictable but feel like his/her doctor minimized the potential saying some patients feel a little peeked the next day. The patient believed in vaccinations, but if asked by friends and acquaintances, will provide an honest and unflattering appraisal of his/her experience and understand it's immune response working, but would suggest research to discover a way to mitigate side effects. Otherwise, there will be reluctance from the public to acquire this vaccine as its reputation spreads. This case linked with US2021AMR054924, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR054924:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Made my arm sore many days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult 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 in arm. 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 Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 1st dose of Shingrix, the patient experienced arm sore for many days. The patient said that it was better than shingles. The patient was going to take 2nd dose of Shingles vaccine in few weeks.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Got my 2nd shot yesterday, my / arm is so sore!; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th February 2021, the patient received the 2nd dose of Shingles vaccine. In February 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving 2nd dose of Shingrix, the patient experienced arm sore.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Muscular weakness, Pain, Swelling
Clinical narrative: Muscle weakness; Puffiness; Redness at injection site; feeling sore / hurt /  When sleeping I roll over and it hurt; heaviness; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included simvastatin (Zocor).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle weakness, tissue puffing, injection site erythema, pain and sensation of heaviness. On an unknown date, the outcome of the muscle weakness was not recovered/not resolved and the outcome of the tissue puffing, injection site erythema and pain were recovered/resolved and the outcome of the sensation of heaviness was unknown.   It was unknown if the reporter considered the muscle weakness, tissue puffing, injection site erythema, pain and sensation of heaviness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced injection site redness, heaviness, puffiness, pain and muscle weakness. Till the time of reporting, the events were not recovered. The reporter did not consent to follow up.
Sex: U
Vaccine: RV1
Symptoms: Incomplete course of vaccination, Unevaluable event
Clinical narrative: first dose of Rotarix around 17 weeks of age. Patient still has not received a 2nd dose.; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2 dose of Rotarix, which led to incomplete course of vaccination. The patient had still not received the 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient experienced arm soreness in both arms. The reporter did not consent to follow up. For tolerance with 2nd dose of Shingrix, refer linked case US2021AMR025715.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025715:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: on the left side of her face / red; Mild Swelling; itching (AE) on the left side of her face; This case was reported by a consumer and described the occurrence of red face in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included prednisone.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 hrs after receiving Shingrix, the patient experienced red face, swelling and pruritus. On an unknown date, the outcome of the red face, swelling and pruritus were recovered/resolved.   It was unknown if the reporter considered the red face, swelling and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient reported that about a year ago she had her 1st dose of Shingrix vaccine in her left arm. The patient stated that she had it at 4 PM and at 2 AM in the morning she had a lot of itching on the left side of her face like a circle shape from her forehead, cheek, and down to her neck. It was very red. The patient reported mild swelling. The patient reported it last for 2 to 3 weeks. The patient was prescribed a regimen of Prednisone and health care professional recommended not to get the 2nd dose. The patient reported that it did not affect her breathing. The patient did not consent to follow up with her health care professional because he had moved to another state. The lot and expiration date were unknown.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain at the injection site / still comes and goes; Shivering; Lingering arm pain; throbbing pain and sometimes a pain sharp; Redness at the injections tie; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 2XG53, expiry date 12th February 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in September 2020, refer case US2021AMR030448).   On 17th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, several hours after receiving Shingrix, the patient experienced injection site pain, injection site erythema, shivering, pain in arm and throbbing pain. The patient was treated with cbd. Rechallenge with Shingrix was positive. In November 2020, the outcome of the injection site pain, injection site erythema and shivering were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. On an unknown date, the outcome of the throbbing pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, shivering, pain in arm and throbbing pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received 2nd dose in right arm. The patient had lingering arm pain following the second dose and experienced pain at the injection site a few hours following the injection. The pain resolved a little but it still comes and goes. It was a throbbing pain and sometimes a pain sharp. It was not present all the time. It presented 4-6 times a week.  The patient also had redness at the injections site that resolved after about a week.  The patient experienced shivering either the night of the vaccination or the next night. He could not remember. It lasted a few hours.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR030448:Same reporter
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fall, Loss of personal independence in daily activities
Clinical narrative: extreme Weakness; had a Fall; He was unable to help himself up; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 5th February 2021, 10 days after receiving Shingrix, the patient experienced weakness, fall and activities of daily living impaired. On an unknown date, the outcome of the weakness, fall and activities of daily living impaired were recovering/resolving.   It was unknown if the reporter considered the weakness, fall and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The patient had extreme weakness, he also had a fall and was unable to help himself up. The reporter got him up. The patient's symptoms were beginning to improve at the time of reporting. All information was not available. The repoter consented to follow-up. This case had been linked with US2021030891, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021030891:same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Pain in extremity, Rash
Clinical narrative: blurred vision; back pain; pain in her knee and leg; fatigue; pain in her knee; rash on her face and chest; This case was reported by a consumer and described the occurrence of blurred vision in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced blurred vision, back pain, rash, leg pain, fatigue and knee pain. On an unknown date, the outcome of the blurred vision, back pain, leg pain, fatigue and knee pain were not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the blurred vision, back pain, rash, leg pain, fatigue and knee pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received the first dose of shingrix three and half weeks ago from the reporting date and had rash on her face and chest that last 3 days. The patient also experienced pain in her knee and leg, back pain, blurred vision and fatigue, she was not recovered till the time of reporting. No address where the vaccine was administrated provided and no exact date of vaccination was provided. The customer had a virtual follow up with her doctor. The reporter did not consent to follow-up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: blurred vision; back pain; pain in her knee and leg; fatigue; pain in her knee; rash on her face and chest; This case was reported by a consumer and described the occurrence of blurred vision in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced blurred vision, back pain, rash, leg pain, fatigue and knee pain. On an unknown date, the outcome of the blurred vision, back pain, leg pain, fatigue and knee pain were not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the blurred vision, back pain, rash, leg pain, fatigue and knee pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received the first dose of shingrix three and half weeks ago from the reporting date and had rash on her face and chest that last 3 days. The patient also experienced pain in her knee and leg, back pain, blurred vision and fatigue, she was not recovered till the time of reporting. No address where the vaccine was administrated provided and no exact date of vaccination was provided. The customer had a virtual follow up with her doctor. The reporter did not consent to follow-up.
Sex: F
Vaccine: MENB
Symptoms: Gait inability, Oedema peripheral, Pain in extremity, Ultrasound scan, X-ray normal
Clinical narrative: edema / L>R lower extremity edema / worsening edema and right LE is worse; Unable to walk; hand pain/ unable to walk because of pain; This case was reported by a nurse via call center representative and described the occurrence of edema of lower extremities in a 17-year-old female 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, several days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced edema of lower extremities, unable to walk and pain in extremity. On an unknown date, the outcome of the edema of lower extremities was not recovered/not resolved and the outcome of the unable to walk and pain in extremity were unknown.   It was unknown if the reporter considered the edema of lower extremities, unable to walk and pain in extremity to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked if edema had been reported as an adverse reaction after bexsero.  Few days after taking Bexsero, the patient had lower extremity edema (left more than right).  The patient had negative ultrasound for blood clot and negative xray for fracture. On 8th February 2021, the patient returned with yet worsening edema and right lower extremity was worse as well. The patient was unable to walk because of pain and also had some hand pain. The reporter did not consent to follow-up.  The reporter disconnected the chat abruptly and therefore any additional details could not be gathered.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th November 2020, 1 days after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in arm, tenderness, numbness in hand and injection site pain. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm, tenderness, numbness in hand and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm, tenderness, numbness in hand and injection site pain to be related to Shingrix.  Additional details were provided as follows:  The patient received 1st dose of Shingrix in left arm. After receiving 1st dose of Shingrix, the patient experienced arm soreness, lack of mobility with injected arm, left hand numbness, and pain when injection site is pushed with a finger. The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: received / 1st dose / on 27Nov2020 and / 2nd dose on 28Dec2020; mild sore arm; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On 28th December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and drug dose administration interval too short. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows:  After receiving 2nd dose of Shingrix, the patient experienced mild sore arm that resolved after 1 day. The patient received 2nd dose of Shingrix, before than the recommended interval, which led to shortening of vaccination schedule. The HCP did not have the lot/exp at the time of report. The reporter consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Pain in extremity
Clinical narrative: it was not given in my deltoid but in the fatty portion of my anterior upper arm; arm pain; redness on anterior part of her upper arm; A spontaneous report  was received from a physician concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced events like Inappropriate route of vaccination, Arthralgia and redness at anterior part of left upper arm.  The patient's medical history not provided. The concomitant medications included levothyroxine sodium, Vitamin D, Calcium and Prolia.  On 12th FEB 2021, the patient received their second of two planned doses of mRNA-1273 and the patient claimed that "it was not given in my deltoid but in a fatty portion of my anterior upper arm" for prophylaxis of COVID-19 infection.   The patient experienced onset of events like Inappropriate route of vaccination, Arthralgia and redness at anterior part of left upper arm. The treatment information included paracetamol.   Action taken with mRNA-1273 in response to the events was not applicable.     The outcome of the events unknown.; Reporter'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.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received vaccine; A spontaneous report was received from a nurse concerning a 16 years old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273).  The patient's medical history not provided. The patient's concomitants not provided.  On 26 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (lot #029K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  Treatment was not provided.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events was resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (XX year old) for mRNA-1273 (lot number 029K20A) with no associated AEs reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation, Underdose
Clinical narrative: Big part of the dose dripped out from injection site; Big part of the dose dripped out from injection site; A spontaneous report was received from a Consumer concerning a 74 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a big part of the dose dripped out from injection site/injection site extravasation and underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 13 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 32H20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Feb 2021 during vaccination, the patient experienced the device connection issue (Big part of the dose droped out from injection site) and underdose.  No Laboratory details were provided. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events, a big part of the dose dripped out from injection site/injection site extravasation and underdose was recovered.; Reporter's Comments: This report refers to a case of underdose and injection site extravasation for mRNA-1273 (lot # 32H20A) with no associated AEs reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old patient was given the first dose; A spontaneous report was received from a pharmacist (PharmD) concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patients' medical history was not provided. Concomitant product use was not provided.  On 17 FEB 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.   The reporter was made aware of a 17-year-old that was given the first dose of the vaccine at his clinic.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, 17-year-old patient was given the first dose, was considered recovered/resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 023M20A) with no associated AEs reported.; Sender's Comments:  MOD-2021-015022:different patient, different reporter (from same institution) US-MODERNATX, INC.-MOD-2021-015022:different patient, same reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: part of the vaccine went into the patients arm and part of the vaccine was excreted from the arm; A spontaneous report was received from a caregiver  regarding a patient (age and gender not identified) who received Moderna's mRNA-1273 vaccine and part of the dose was excreted from the arm/accidental underdose. The patient's medical history was not provided. Concomitant medications were not provided.   On 17 February 2021, the patient received the second of two planned doses of mRNA-1273 (Batch: unknown) in the arm for prophylaxis of COVID-19 infection. As the vaccine was being given, some of the dose went into the arm and part of the dose was excreted from the arm.  Treatment information was not provided.  Action taken with mRNA-1273 was not applicable.  The outcome of the event, part of the dose being excreted from the arm, was considered resolved.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273, with no associated AEs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: needle separated from the syringe and only partial dose was administered; only partial dose was administered; A spontaneous report was received from a nurse concerning a 72-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced needle separated from the syringe and only partial dose was administered (device connection issue) (underdose).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 17 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 023M20A] intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 17 Feb 2021, when the vaccinator (nurse) pushed the plunger down, the needle separated from the syringe and only partial dose was administered to the patient. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events needle separated from the syringe and only partial dose was administered was resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of Syringe connection issue and Vaccine underdose for mRNA-1273, lot # 023M20A  with no associated AEs.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine liquid spilled from syringe during administration; Vaccine liquid spilled from syringe during administration; A spontaneous report was received from a pharmacist concerning a 74-years-old, female patient who experienced vaccine liquid spilled from syringe during administration.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Feb 2021, prior to the onset of the symptoms, the patient received their planned dose of mRNA-1273 [Lot number 023M20A] for prophylaxis of COVID-19 infection.   On 17 Feb 2021, the pharmacist reported that some of the vaccine spilled from the syringe during administration. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event vaccine liquid spilled from syringe during administration was considered recovered/resolved on 17 Feb 2021.; Reporter's Comments: This report refers to a case of Vaccine underdose and syringe connection issues for mRNA-1273 [Lot number 023M20A]  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given to 16 year old; A spontaneous report was received from a pharmacist  concerning a 16-year-old, female patient who experienced: Vaccine was given to 16-year-old.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.     On 17FEB2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.   Director of pharmacy reported that the first dose of the vaccine was given to a 16 year old patient and wanted to see if they could register for clinical trials.   Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event  was unknown.  The event, vaccine was given to 16-year-old was considered recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014927:different patient, same reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses were withdrawn from a vial punctured more than 6 hours ago; A spontaneous report ( was received from a healthcare professional, concerning a unknown patient of unknown age and gender, unknow race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced 5 doses were withdrawn from a vial punctured more than 6 hours ago (expired product administered) and error was made and 5 doses were given that were not valid.  The patient's medical history was not reported. No Relevant concomitant medications were reported like  On an unknown date, prior to the onset of the events, the patient received their unknown planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly for the prophylaxis of COVID-19 infection.   On unknown date, the health care professional mentioned and reported that an error was made, and 5 doses were given that were not valid since doses were withdrawn from a vial punctured more than six hours ago. The vial was refrigerated. Five patients received an invalid dose and there was an error made for those five patients. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events, 5 doses were withdrawn from a vial punctured more than 6 hours ago and error was made and 5 doses were given that were not valid, were reported as recovered.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot/batch: unknown) with no associated AEs. The expired product was administered to five patients.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: portion of the medication came out of the syringe; VACCINE UNDERDOSE; A spontaneous report  received from a health care professional concerning a 37 years old male patient who received Moderna's COVID-19 (mRNA-1273)vaccine and experienced device connection issue and vaccination under dose.  The medical history of the patient was not provided. No relevant concomitant medication were provided.  On  17-feb-2021 prior to onset of the event, the patient received the first of two planned doses of COVID-19 (mRNA-1273)vaccine (batch no.023M20A) via unknown route in left non-dominant arm for prophylaxis of COVID-19 infection.  The pharmacist reported  that a portion of the medication came out of the syringe.  Action taken in response to  (mRNA-1273) vaccine event  was not reported.  The outcome of event was not reported.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Patient reports approximately 45 minutes after administration of the vaccine she developed a metallic taste in her mouth, followed by tingling and numbness in her lips, tongue, and tingling in her throat. She reports she took Benadryl sometime after this, and then eventually the sensation and taste resolved.