chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Cardiac ventricular thrombosis, Computerised tomogram thorax, Dyspnoea, Pulmonary embolism
Clinical narrative: This is a patient who presented to the ED with a cc of dyspnea and was found to have left central main pulm artery/left upper lobe/left lower lobe PE's and also has a large clot in transient in his RV. There is no provoking risk factor that I can clearly identify (no recent surgeries, trauma, immobilization, or active cancer). He does have a remote cancer hx of bladder cancer in 2015. He is a former smoker 20+ years ago. However, he is at risk for VTE events by being a ERSD patient and also there's increased risk for VTE for pts >70yo. His COVID vaccination a few months ago is a potential contributing risk factor, will report to VAERS
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pulmonary thrombosis
Clinical narrative: FELT SICK ON JUNE 25TH AND REPORTED TO EMERGENCY ROOM. ADMITTED FOR BLOOD CLOT IN LUNG
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: Pt was administered both PPD (Tubersol) and Anthrax (BioThrax) vaccine at the same time. Both to the left arm. Technician injected 0.1ml Tubersol IM into pt left deltoid, and 0.5ml BioThrax Intradermal into left forearm. Pt reported back to Immunizations clinic during 48-72 hour window for f/u PPD screening. Pt was eval'd and released. Pt still being observed for adverse reactions at this time.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Moderate right side axillary pain. Same side as injection
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Full blood count abnormal, Haemoglobin increased, Hypoaesthesia, Pruritus
Clinical narrative: Numbness in legs no felling itchy, numbness in shoulders, face, head, and weakness. Told my Dr he recommended not O2 hemoglobin elevated CBC elevated. No reason yet.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: Severe itching rash started with legs and moved  to upper body.  Full body looks like measles, at 10 weeks without much regression.  PCP tried Prednisone(ramped up to 60mg) at my request from previous eczema outbreaks.  Predinsone had little effect until hitting 60mg, triamcinolone cream with daily showers seems to be best but the itching puts me backwards to recovery or hard to fully heal.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Peripheral swelling, Pruritus, Sleep disorder
Clinical narrative: I had itching on both legs, and I saw a raised area appearing on the right leg close to 4 hours after the first shot of the Pfizer vaccine. Symptoms resolved in about 1 hour after taking antihistamine and applying hydrocortisone cream. On 6/16/21, I began to feel numbness in the back and leg at about 5 am. I went to an urgent care--no treatment. On 6/23/21 numbness in neck, face, and leg felt worse at about 2 am. I went to ER at about 3 am. No treatment. On 7/5/2021, I had itching from chest up to jaw that woke me at about 12: 55 am. I took an antihistamine and applied hydrocortisone and it relieved the symptom. 7/11/21 numbness in face about 9 pm and shoulder and arm right side at about 1:00 am 7/12/.21.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acute hepatic failure, Alcohol test negative, Analgesic drug level, Autoimmune hepatitis, Drug-induced liver injury
Clinical narrative: Patient presents in fulminant liver failure. Per GI team documentation: "We do not have an etiology for this acute liver injury.  The differential diagnosis includes drug-induced liver injury, acute viral hepatitis, ischemic hepatitis, autoimmune hepatitis and indeterminate.  Acetaminophen and salicylate levels are negative.  Alcohol level is negative.  Although patient does abuse alcohol on a daily basis, her presentation is not consistent with acute alcoholic hepatitis.  Serologies have been sent to evaluate the differential diagnosis and other potential causes of acute liver injury.  Liver imaging including Doppler ultrasound does not reveal any abnormality and there is no evidence of chronic liver disease."  We have found four case reports of hepatitis/autoimmune hepatitis related to mRNA vaccines. We have additionally had a case of fulminant liver failure in our community a few months back of which no other etiology was identified other then mRNA vaccine. Because of such, and with no other identifiable cause, we are concerned her acute sudden liver failure was vaccine induced.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis viral, Ischaemic hepatitis, Ultrasound Doppler normal, Vaccination complication
Clinical narrative: Patient presents in fulminant liver failure. Per GI team documentation: "We do not have an etiology for this acute liver injury.  The differential diagnosis includes drug-induced liver injury, acute viral hepatitis, ischemic hepatitis, autoimmune hepatitis and indeterminate.  Acetaminophen and salicylate levels are negative.  Alcohol level is negative.  Although patient does abuse alcohol on a daily basis, her presentation is not consistent with acute alcoholic hepatitis.  Serologies have been sent to evaluate the differential diagnosis and other potential causes of acute liver injury.  Liver imaging including Doppler ultrasound does not reveal any abnormality and there is no evidence of chronic liver disease."  We have found four case reports of hepatitis/autoimmune hepatitis related to mRNA vaccines. We have additionally had a case of fulminant liver failure in our community a few months back of which no other etiology was identified other then mRNA vaccine. Because of such, and with no other identifiable cause, we are concerned her acute sudden liver failure was vaccine induced.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Cerebral venous sinus thrombosis, Computerised tomogram head, Haemorrhage intracranial
Clinical narrative: Venous Sinus Thrombosis, Intracranial Hemorrhage, Seizure
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Venous Sinus Thrombosis, Intracranial Hemorrhage, Seizure
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypoaesthesia, Impaired work ability, Injection site pain, X-ray normal
Clinical narrative: After the second shot, She experienced a sharp pain at the injection site as well as numbness throughout her entire arm to fingertips. It began to get more intense. She took tylenol and other over the counter pain medication without any improvement. She went to the emergency room on 7/5/2021 and urgent care 7/6/2021 due to unbearable pain and numbness. She was prescribed gabapentin 300mg which she takes 2 capsules 3x daily but seems to now built up a tolerance because it is only effective for about a few hours. She is not able to work or have any normalcy. We do not know what else to do. She needs assistance.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Brain injury, Cardiac arrest, Computerised tomogram abdomen, Computerised tomogram head
Clinical narrative: Patient reported to friend she felt ill and had sudden cardiac arrest. ROSC after 1 hour. Found to have STEMI; trop >100 with trending over past 24 hours. Has likely significant anoxic injury, prognosis is grim. Because apparent MI occurred within the original Pfizer trial study period of 14 weeks, and also at our institution we have had 2 other cases of early age and unexpected fatal MI's s/p vaccine, decision made to report this case as potential vaccine adverse reaction.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Electrocardiogram, Laboratory test, Malaise, Troponin increased
Clinical narrative: Patient reported to friend she felt ill and had sudden cardiac arrest. ROSC after 1 hour. Found to have STEMI; trop >100 with trending over past 24 hours. Has likely significant anoxic injury, prognosis is grim. Because apparent MI occurred within the original Pfizer trial study period of 14 weeks, and also at our institution we have had 2 other cases of early age and unexpected fatal MI's s/p vaccine, decision made to report this case as potential vaccine adverse reaction.
Age: 32.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Haemorrhage, Sexual dysfunction
Clinical narrative: I lost a lot of blood on the 11/07/2021 after having sexual intercourse this has never happened before
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Nausea, Tremor
Clinical narrative: Severe chills and shaking, headache, nausea, body numbness
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered
Clinical narrative: the dose of PEDVAXHIB was mixed with sterile diluent so the patient received atotal of 1.2 mL; the dose of PEDVAXHIB was mixed with sterile diluent so the patient received atotal of 1.2 mL; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-JUN-202, the patient was vaccinated with a dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T024020 exp date 31-MAR-2023). The nurse stated that the medical assistant that prepared the dose mixed haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) with sterile diluent so the patient received a total of 1.2 mL. The nurse also stated that the patient received the complete 0.5 mL haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) dose, but it was mixed with 0.7 mL of sterile diluent.
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: second dose of ROTATEQ was administered to the 14 month old patient as a make up dose; This spontaneous report as received from a certified medical assistant refers to a 14 month old patient of unknown gender. On 22-JUN-2021, the patient was vaccinated with a second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742460 exp date 16-NOV-2021) orally.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a patient (pt) of unknown age or gender. No information was provided regarding concomitant medications, concurrent conditions, or medical history. On or about 22-MAR-2016, the pt was administered zoster vaccine live (ZOSTAVAX) at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers for the following injuries resulting from the pt zoster vaccine live (ZOSTAVAX) use: hearing loss (Deafness). Outcome of the event was not provided. Causal relationship of deafness was reported as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, deafness was determined to be medically significant event.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Computerised tomogram, Electrocardiogram, Headache, Heart rate
Clinical narrative: Atrial fibrillation; Loss of consciousness; Headache; Nausea; This case was received via FDA VAERS (Reference number: 1317402) 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 ATRIAL FIBRILLATION (Atrial fibrillation) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE and FISH OIL for an unknown indication.   On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 27-Apr-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and METOPROLOL at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), LOSS OF CONSCIOUSNESS (Loss of consciousness), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Computerised tomogram: negative Negative. On 27-Apr-2021, Electrocardiogram: normal normal. On 27-Apr-2021, Heart rate: 160 beats per minute.. On 27-Apr-2021, Toxicologic test: negative (Negative) Diagnosis vasovagal syncope and atrial fibrillation.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Magnetic resonance imaging head and Magnetic resonance imaging heart test was done 27-APR-2021.  Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Toxicologic test
Clinical narrative: Atrial fibrillation; Loss of consciousness; Headache; Nausea; This case was received via FDA VAERS (Reference number: 1317402) 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 ATRIAL FIBRILLATION (Atrial fibrillation) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE and FISH OIL for an unknown indication.   On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 27-Apr-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and METOPROLOL at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), LOSS OF CONSCIOUSNESS (Loss of consciousness), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Computerised tomogram: negative Negative. On 27-Apr-2021, Electrocardiogram: normal normal. On 27-Apr-2021, Heart rate: 160 beats per minute.. On 27-Apr-2021, Toxicologic test: negative (Negative) Diagnosis vasovagal syncope and atrial fibrillation.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Magnetic resonance imaging head and Magnetic resonance imaging heart test was done 27-APR-2021.  Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: Sudden hearing loss; Tinnitus; This case was received via FDA VAERS (Reference number: 1422022) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included LOSARTAN and MELOXICAM for an unknown indication.    On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant) and TINNITUS (Tinnitus). At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) and TINNITUS (Tinnitus) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had flu symptoms after shingles vaccine.  On an unknown date, the patient did a 15 day oral steroid dose which did not help. That was followed by 3 steroid injections through the ear drum. On an unknown date, about 1 month after the second Moderna vaccine the patient had ringing in left ear ended with substantial sudden hearing loss.  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.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: It was sore for a couple days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. Patient just received dose and experienced sore for a couple days. The patient did not want Shingles. Patient reported that her husband had Shingles vaccine after his heart attack and it was not good.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: got both shots / one in each arm  / arms were sore for a couple of days but was fine after that!; got two shots one in each arm / got both shots on the same day / that was in 5/18/2021; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th May 2021, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 18th May 2021, not applicable after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced overdose. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and overdose were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient got both shots on the same day one in each arm which led to Over dose. The patient experienced sore arms for a couple of days after receiving vaccine and was fine after that. This case has been linked with case US2021AMR148491, reported by the same reporter.   Follow up information was received from consumer on 7th July 2021: The patient got the vaccine for shingles a long time ago, one shot in each arm. The reporter mentioned that if he/she wanted it otherwise patient would come back for the second and took in each arm.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR148491:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: first dose in her arm caused major swelling; first dose in her arm caused / pain; This case was reported by a other health professional via interactive digital media and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy bilateral and lymph node excision.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were unknown.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had had a double mastectomy and lymph nodes removed. Health care professional reported that, the patient received 1st dose of Shingrix and experienced major swelling and pain in her arm. Health care professional enquired that if he/she could give second dose in different muscle.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: severe muscle pain; headaches; Fever; Utter exhaustion; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, 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 and exhaustion. On an unknown date, the outcome of the muscle pain, headache, fever and exhaustion were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, headache, fever and exhaustion to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination not reported. The patient received 1st dose of Shingrix 11 days ago of reporting date and still patient had severe muscle pain, headaches, fever and utter exhaustion. The reporter asked that was this normal.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the original vaccination / then the new double one / still got shingles last month/Suspected Vaccination failure; got shingles last month; pure agony; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. In June 2021, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional information was provided as follows: The case was reported by patient for self. The age at vaccination was not reported. The patient had the original vaccination and then the new double one. The patient still got shingles a month before reporting, pure agony. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: Due to Covid, I waited to get my second/ after I received my Covid Vaccines. Now I am ready/ It's been 11 mos.; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in august 2020). Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: This case was reported by the patient himself. The age vaccination was not applicable for this report. The concomitant medication included covid 19 vaccine. The patient received first dose of Shingrix and due to Covid waited to get the second dose, which led to social problem. The patient was ready for the second Shingrix vaccine and enquired if it was too late as it had been 11 months.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose /on 3/26/2018/ administered the second  / on 3/30/2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 299BM, expiry date 22nd October 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 26th March 2018).   On 30th March 2021, the patient received the 2nd dose of Shingrix. On 30th March 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The pharmacy intern reported that a patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: developed Guillain Barre Syndrome; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 3 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The reporter was the wife of the patient. The age at vaccination was not reported.  The reporter declined to provide healthcare professional (HCP) information.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Axillary pain, Blister, Body temperature, Chills
Clinical narrative: STOMACH PAIN; BLISTERS IN MOUTH AND LIPS; SEVERE NECK PAIN LIKE SWOLLEN LYMPH NODES; FEVER; VAGINAL BLEEDING; RECTAL BLEEDING; ALMOST FAINT; COULD NOT MOVE AT ALL; UNDER ARM HURT; CHILLS; ARM AND LEG PAIN; HEADACHE; SEVERE NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included no uterus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 26-JUN-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 26-JUN-2021, the patient experienced severe nausea, almost fainted, experienced leg pain at the point to where she could not move at all, arm and under arm hurt her terribly bad, had uncontrollable chills and headache. On 27-JUN-2021, the patient had fever 102.6, experienced chills, nausea, leg pain, headache, vaginal bleeding, rectal bleeding and continued with all above symptoms. Laboratory data included: Body temperature (NR: not provided) 102.6. On 28-JUN-2021 and on 29-JUN-2021, the patient continued symptoms and no fever. On 30-JUN-2021, the patient had fever, blisters in mouth and lips, experienced severe neck pain like swollen lymph nodes and she could not move her neck at all. On 01-JUL-2021, the patient was feeling better but the leg pain was still very painful, had headache, nausea, and stomach pain. The patient just wanted to report her symptoms, like a dummy she went to get the shot and got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rectal bleeding, almost faint, under arm hurt, chills, fever, vaginal bleeding, blisters in mouth and lips, severe neck pain like swollen lymph nodes, and could not move at all, and had not recovered from severe nausea, arm and leg pain, headache, and stomach pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210708845-covid-19 vaccine ad26.cov2.s- rectal bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: STOMACH PAIN; BLISTERS IN MOUTH AND LIPS; SEVERE NECK PAIN LIKE SWOLLEN LYMPH NODES; FEVER; VAGINAL BLEEDING; RECTAL BLEEDING; ALMOST FAINT; COULD NOT MOVE AT ALL; UNDER ARM HURT; CHILLS; ARM AND LEG PAIN; HEADACHE; SEVERE NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included no uterus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 26-JUN-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 26-JUN-2021, the patient experienced severe nausea, almost fainted, experienced leg pain at the point to where she could not move at all, arm and under arm hurt her terribly bad, had uncontrollable chills and headache. On 27-JUN-2021, the patient had fever 102.6, experienced chills, nausea, leg pain, headache, vaginal bleeding, rectal bleeding and continued with all above symptoms. Laboratory data included: Body temperature (NR: not provided) 102.6. On 28-JUN-2021 and on 29-JUN-2021, the patient continued symptoms and no fever. On 30-JUN-2021, the patient had fever, blisters in mouth and lips, experienced severe neck pain like swollen lymph nodes and she could not move her neck at all. On 01-JUL-2021, the patient was feeling better but the leg pain was still very painful, had headache, nausea, and stomach pain. The patient just wanted to report her symptoms, like a dummy she went to get the shot and got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rectal bleeding, almost faint, under arm hurt, chills, fever, vaginal bleeding, blisters in mouth and lips, severe neck pain like swollen lymph nodes, and could not move at all, and had not recovered from severe nausea, arm and leg pain, headache, and stomach pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210708845-covid-19 vaccine ad26.cov2.s- rectal bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia, Rectal haemorrhage, Vaginal haemorrhage
Clinical narrative: STOMACH PAIN; BLISTERS IN MOUTH AND LIPS; SEVERE NECK PAIN LIKE SWOLLEN LYMPH NODES; FEVER; VAGINAL BLEEDING; RECTAL BLEEDING; ALMOST FAINT; COULD NOT MOVE AT ALL; UNDER ARM HURT; CHILLS; ARM AND LEG PAIN; HEADACHE; SEVERE NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included no uterus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 26-JUN-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 26-JUN-2021, the patient experienced severe nausea, almost fainted, experienced leg pain at the point to where she could not move at all, arm and under arm hurt her terribly bad, had uncontrollable chills and headache. On 27-JUN-2021, the patient had fever 102.6, experienced chills, nausea, leg pain, headache, vaginal bleeding, rectal bleeding and continued with all above symptoms. Laboratory data included: Body temperature (NR: not provided) 102.6. On 28-JUN-2021 and on 29-JUN-2021, the patient continued symptoms and no fever. On 30-JUN-2021, the patient had fever, blisters in mouth and lips, experienced severe neck pain like swollen lymph nodes and she could not move her neck at all. On 01-JUL-2021, the patient was feeling better but the leg pain was still very painful, had headache, nausea, and stomach pain. The patient just wanted to report her symptoms, like a dummy she went to get the shot and got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rectal bleeding, almost faint, under arm hurt, chills, fever, vaginal bleeding, blisters in mouth and lips, severe neck pain like swollen lymph nodes, and could not move at all, and had not recovered from severe nausea, arm and leg pain, headache, and stomach pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210708845-covid-19 vaccine ad26.cov2.s- rectal bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Fatigue, Heart rate, Hypersomnia
Clinical narrative: TIREDNESS; ANAPHYLAXIS (SEVERE ALLERGIC REACTION, ITCHING IN HAND AND NAPE OF NECK, VOIDED AND VOMITED FOR THREE HOURS, SWELLING IN HANDS, SWELLING ON FACE, RED HANDS AND LEG AND DRIPPING WET WITH SWEAT); SLEPT FOR MOST OF THE NEXT DAY; GENERAL MALAISE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, penicillin allergy, and allergy to wasps. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 025A21A, expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 at right arm for prophylactic vaccination. Concomitant medications included naproxen sodium for arthritis, chlorphenamine maleate for itchy skin, cyanocobalamin, and fluticasone propionate. Patient experienced tiredness, some general malaise and slept for most of the next day of vaccination, but did not experienced other significant symptoms after the vaccination. However, on 29-JUN-2021, patient had severe allergic reaction included anaphylaxis and her hand started itching then swelling spread to the hands and face. She had put her hands under cold water and by then they were completely red, Legs then became red, then the nape of the neck began to itch, She was dripping wet with sweat at that point. She then had to immediately get to the bathroom as she voided and vomited for the next three hours. EMS was called at 10 o'clock and was taken to the hospital. At the hospital no medications were given. Vitals were fine, Blood pressure was 128/76 mmHg, pulse was 83 bpm, and oxygen saturation was 97%. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for most of the next day on 30-APR-2021, and the outcome of general malaise, anaphylaxis (severe allergic reaction, itching in hand and nape of neck, voided and vomited for three hours, swelling in hands, swelling on face, red hands and leg and dripping wet with sweat) and tiredness was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 02-JUL-2021. Upon review the following information was amended: Onset date for event general malaise was updated in event section and vaccination site was updated into the narrative.; Sender's Comments: V1: This version is updates, Onset date for event general malaise and vaccination site. This does not change the causality of the previously reported events. 20210710040-COVID-19 VACCINE AD26.COV2.S-anaphylaxis. This event(s) is labeled per Safety Information and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oxygen saturation
Clinical narrative: TIREDNESS; ANAPHYLAXIS (SEVERE ALLERGIC REACTION, ITCHING IN HAND AND NAPE OF NECK, VOIDED AND VOMITED FOR THREE HOURS, SWELLING IN HANDS, SWELLING ON FACE, RED HANDS AND LEG AND DRIPPING WET WITH SWEAT); SLEPT FOR MOST OF THE NEXT DAY; GENERAL MALAISE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, penicillin allergy, and allergy to wasps. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 025A21A, expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 at right arm for prophylactic vaccination. Concomitant medications included naproxen sodium for arthritis, chlorphenamine maleate for itchy skin, cyanocobalamin, and fluticasone propionate. Patient experienced tiredness, some general malaise and slept for most of the next day of vaccination, but did not experienced other significant symptoms after the vaccination. However, on 29-JUN-2021, patient had severe allergic reaction included anaphylaxis and her hand started itching then swelling spread to the hands and face. She had put her hands under cold water and by then they were completely red, Legs then became red, then the nape of the neck began to itch, She was dripping wet with sweat at that point. She then had to immediately get to the bathroom as she voided and vomited for the next three hours. EMS was called at 10 o'clock and was taken to the hospital. At the hospital no medications were given. Vitals were fine, Blood pressure was 128/76 mmHg, pulse was 83 bpm, and oxygen saturation was 97%. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for most of the next day on 30-APR-2021, and the outcome of general malaise, anaphylaxis (severe allergic reaction, itching in hand and nape of neck, voided and vomited for three hours, swelling in hands, swelling on face, red hands and leg and dripping wet with sweat) and tiredness was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 02-JUL-2021. Upon review the following information was amended: Onset date for event general malaise was updated in event section and vaccination site was updated into the narrative.; Sender's Comments: V1: This version is updates, Onset date for event general malaise and vaccination site. This does not change the causality of the previously reported events. 20210710040-COVID-19 VACCINE AD26.COV2.S-anaphylaxis. This event(s) is labeled per Safety Information and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Pyrexia
Clinical narrative: SYMPTOMS ARE INSANE; FEVER FOR 2 DAYS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included get sick quickly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:Unknown ,expiry:unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced symptoms are insane, and fever for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for 2 days, and the outcome of symptoms are insane was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS IN FEET AND HANDS; TINGLING IN NERVES; CHILLS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced numbness in feet and hands, tingling in nerves, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, numbness in feet and hands and tingling in nerves was not reported. This report was non-serious. This case, from the same reporter is linked to 20210710727.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: THE MUSCLES THAT I PUMPED WERE SORE FOR 4 DAYS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced the muscles that i pumped were sore for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscles that i pumped were sore for 4 days was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 13 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced drug administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAINFUL AND SORE ARM; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAY-2021, the subject experienced painful and sore arm. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful and sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 104 FEVER FOR LIKE 5 DAYS; This spontaneous report received from a patient . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced 104 fever for like 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 104 fever for like 5 days was not reported. This report was non-serious. This case, from the same reporter is linked to 20210716818.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Dyspnoea, Pyrexia
Clinical narrative: CRAZY DREAMS; SHORT OF BREATH; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced crazy dreams, short of breath, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, crazy dreams and short of breath was not reported. This report was non-serious. This case, from the same reporter is linked to 20210714512.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: ACHY JOINTS; This spontaneous report received from a patient via a company representative concerned a 74 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic leukemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced achy joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy joints on APR-2021. This report was non-serious.