chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Malaise, Syncope
Clinical narrative: Approximately 9 hours after I got the second dose of Moderna, I woke up and didn't feel well. I ended up fainting due to low blood pressure. I was taken to the ER and given an IV. Then a few days later, I felt unsteadiness/lightheadedness for approximately two weeks. Then that subsided and then I was experiencing shortness of breath for one to two weeks. Ever since the second dose of the vaccine, I've felt off.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Syncope
Clinical narrative: Patient got the 1st dose of pfizer and was fine at the time of administration.  However, as she sat down on the chair for observation, that was when she fainted and fell off but someone was there to catch her.  After a minute, she regained her consciousness back.  We took her BLOOD PRESSURE and it was normal.  Ambulance came and took her to hospital.  Yesterday, her sister came to pharmacy and asked if it was normal for her to keep having runny nose.  We told her she might feel like flu-like symptom but to be safe, it's better she goes  to see her primary doctor/urgent care.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Unknown
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: UNKNOWN
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Feeling abnormal, Hypoaesthesia, Joint range of motion decreased, Joint stiffness
Clinical narrative: After getting my 1st dose of the Pfizer COVID shot, the very next morning, i noticed i could no longer bend my ring finger on my right hand.   I have had some "arthritis like symptoms" in my hands since about last summer 2020, and they seemed like they were getting somewhat better, but since getting the Pfizer first dose, those symptoms have gotten worse (like sometimes either of my hands fall asleep for no reason; pain in my hands; very stiff and cannot bend them to make a fist; other wierd feelings or symptoms in my hands).  In addition, i have not been able to bend the ring finger on my right hand anymore since the first dose on 4/11/2021.  This is completely new and the symptoms i have described have not gotten better since the first dose.   I was hoping this would all get better but since it has now been over 2 months, i thought i should report it.    i got the 2nd Pfizer shot on 5/1/2021. Thank you
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: After getting my 1st dose of the Pfizer COVID shot, the very next morning, i noticed i could no longer bend my ring finger on my right hand.   I have had some "arthritis like symptoms" in my hands since about last summer 2020, and they seemed like they were getting somewhat better, but since getting the Pfizer first dose, those symptoms have gotten worse (like sometimes either of my hands fall asleep for no reason; pain in my hands; very stiff and cannot bend them to make a fist; other wierd feelings or symptoms in my hands).  In addition, i have not been able to bend the ring finger on my right hand anymore since the first dose on 4/11/2021.  This is completely new and the symptoms i have described have not gotten better since the first dose.   I was hoping this would all get better but since it has now been over 2 months, i thought i should report it.    i got the 2nd Pfizer shot on 5/1/2021. Thank you
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Culture wound positive, Incisional drainage, Lymphadenitis, Lymphadenopathy, Staphylococcal infection
Clinical narrative: Initially dramatic lymphadenopathy supraclavicular then secondary lymphadenitis with staph aureus.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: UNKNOWN
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Feeling abnormal, Heart rate increased
Clinical narrative: Increased Heart rate, discomfort in left forearm for short periods of time, Fatigue, Anxiety, light headedness / clouded mind, sometimes vertigo like symptoms for a briefs period
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Vertigo
Clinical narrative: Increased Heart rate, discomfort in left forearm for short periods of time, Fatigue, Anxiety, light headedness / clouded mind, sometimes vertigo like symptoms for a briefs period
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Deep vein thrombosis, Dyspnoea, Hypoaesthesia, Laboratory test
Clinical narrative: started with SOB, then got terrible pain in left leg, had called 911 taken to hospital and was Diagnosed with 2 Pulmonary Embolism  and 2  deep vein thrombosis in the right leg and foot drop of the left foot, numbness of the left leg and foot.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peroneal nerve palsy, Pulmonary embolism, Ultrasound Doppler abnormal
Clinical narrative: started with SOB, then got terrible pain in left leg, had called 911 taken to hospital and was Diagnosed with 2 Pulmonary Embolism  and 2  deep vein thrombosis in the right leg and foot drop of the left foot, numbness of the left leg and foot.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Dyspnoea, Fibrin D dimer, Laboratory test normal
Clinical narrative: The patient came to ED c/o sudden onset constant right anterior chest pain radiating to axilla and lateral neck.  Sudden sharp pain 10/10 at rest and worse when supine with associated Short of Breath.  Troponin was elevated at 0.18, d-dimer <200.  All other lab values were normal. The patient is getting admitted for a cardiac workup and further evaluation.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Troponin increased
Clinical narrative: The patient came to ED c/o sudden onset constant right anterior chest pain radiating to axilla and lateral neck.  Sudden sharp pain 10/10 at rest and worse when supine with associated Short of Breath.  Troponin was elevated at 0.18, d-dimer <200.  All other lab values were normal. The patient is getting admitted for a cardiac workup and further evaluation.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Dyskinesia, Fatigue, Limb discomfort
Clinical narrative: That same night there were chills and in my legs I felt bubbles, the next day on Saturday I was very tired and I could not even lift my arms or want to walk because everything hurt, for that same night my body began to shake at times. The next day was Sunday. I felt worse, I could not stay standing because I felt that inside my body was shaking and an hour later my arms and legs began to shake and I could not control them, my husband took me to the hospital and there they did several studies, I was 10 days in Hospital
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Mobility decreased, Pain, Tremor, X-ray
Clinical narrative: That same night there were chills and in my legs I felt bubbles, the next day on Saturday I was very tired and I could not even lift my arms or want to walk because everything hurt, for that same night my body began to shake at times. The next day was Sunday. I felt worse, I could not stay standing because I felt that inside my body was shaking and an hour later my arms and legs began to shake and I could not control them, my husband took me to the hospital and there they did several studies, I was 10 days in Hospital
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Death, Dyspnoea, Fatigue
Clinical narrative: Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sleep disorder, Weight increased
Clinical narrative: Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Burning sensation, Hot flush, Pain in extremity
Clinical narrative: Eight hours after 2nd dose of Moderna was sitting at my desk in study and felt a "hot flush" start at my ankles & move slowly up both legs to waist. Over the next several weeks had bouts of severe pain in legs & feet. Sometimes felt like sunburn, especially on top of feet.  Three months later still have bouts of pain in legs, feet, lower back, hips, but do not last as long. Has crossed my mind that the vaccine may have somehow made an existing medical condition immediately worse.  Just had an MRI and have an appointment scheduled with a Neurologist for early July.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Exercise tolerance decreased, Tremor
Clinical narrative: Severe chest pain for 30-40 seconds. Felt like I was having a heart attack. After pain subsided felt very shakey and light headed. Was hiking at the time. I hike probably over 1,000 miles a year and was on very easy hike.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Bloody stool
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache, arm soreness; treated with ibuprofen
Age: 6.0
Sex: F
Vaccine: JEV1
Symptoms: Seizure
Clinical narrative: Seizure found, resolved after about 3 seconds , answered well . Dr. Monitored pt's medical status. * Mother states no previous side effect or medical reaction to JEV and All other vaccines.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Nausea, Vomiting
Clinical narrative: 24y/o AD female w/Dizziness,nausea,HA,Vomiting,SOB, after receiving Moderna vaccine @0800 today. Denies diarrhea or any other symptoms.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Received vaccination approximately 9:50a 6/23/21, complained of chest pain, Vitals were taken at 9:50a BP 132/93 PR 88, pt was advised to rest and water was given, BP 99/68 PR 78 at 10:05a symptom of chest pain is improving, BP 116/85 PR 73 at 10:27a and symptom of chest pain is completly gone and no other S/S complained by patient
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Nausea, Pain in extremity
Clinical narrative: pt received #1 Moderna vaccine yesterday, pain on left arm, shoulder started around 3 pm, c/o dizziness and nausea*1, denies any blood in the emesis, denies any traumatic injury, last OTC Tyrenol 2 tabs taken at 2200 last night without any relief,
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Pericarditis
Clinical narrative: Pericarditis
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache
Clinical narrative: A week or two after the second injection, I started experiencing headaches and my blood pressure stays elevated
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Shingles
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Neck pain
Clinical narrative: Shingles
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Chest pains, troubling breathing
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: After moderna vaccine he having stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form once. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse event; physician with her practice ordered a V ARlV AX vaccine for a 9 month old, and it was administered; This spontaneous report was received from a nurse and refers to a 9 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 18-MAY-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T029535, expiration date 01-SEP-2022, 0.5 milliliter (route and vaccination site were not provided), for prophylaxis.       .
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered the 1st ROTATEQ dose at 13 to 14 months of age; no adverse event; This spontaneous report was received from a other health professional refers to a patient of 13 to 14 months of age of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally (dose, frequency, lot# and expiration date were not provided), for prophylaxis.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no further AE's from the administration; administration of PROQUAD to a patiet intramuscularly instead of subcutaneously; This spontaneous report has been received from a medical assistant, concerning a 4 year old male patient . The patient's medical history and concurrent conditions were not provided.   On 27-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) intramuscularly instead of subcutaneously, at a dose of 0.5 milliliter one time, lot # T037957 with expiration date 09-MAY-2022 for prophylaxis which was reconstituted with sterile diluent. No further adverse events from the administration.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; expired dose of MMR II administered to a patient; This spontaneous report was received from a certified nursing assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reaction or allergise was provided.  On 13-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) one dose, lot # S013683, expiration date 05-MAY-2021 (route of administration was not provided). The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (lot # T002841, expiration date 10-JUL-2022). No adverse events were reported.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX that underwent a temperature excursion was administered; No additional adverse effect reported; This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T012551 with an expiration date on 10-APR-2022) for prophylaxis, which experienced a temperature excursión of -10°C Celsius degrees to 8°C for an unknown amount of time (product storage error).   It was unknown if previous temperature excursions were experienced. The data logger was not involved. No additional adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administration of two 0.5 ml doses of PEDVAXHIB to a 12 month old; administration of two 0.5 ml doses of PEDVAXHIB to a 12 month old; No additional adverse events reported; This spontaneous report was received from a licensed practical nurse and refers to a 12-month-old patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml (formulation, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with an additional dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml (formulation, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration and incorrect dose administered). No additional adverse events reported.
Age: 1.25
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported; GARDASIL 9 was inadvertently administered to a 15 month old instead of the PREVNAR 13; GARDASIL 9 was inadvertently administered to a 15 month old instead of the PREVNAR 13; This spontaneous report was received from a physician and the patient's mother and refers to a 15 months old female patient. There was no information regarding her medical history nor concurrent conditions provided. The patient's concomitant vaccination included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL).  On 18-JUN-2021, the patient was inadvertently vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL once, lot # 1687290, expiration date 06-SEP-2022 (route of administration and anatomical location were not provided) instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) for prophylaxis (wrong vaccine administered, inappropriate age at vaccine administration). No adverse event (AE) was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; temperature excursion / temperature 8.5 C; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 17-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # and expiration date were reported as T023919 and 31-MAR-2022, respectively (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose of the vaccine was stored in a temperature of 8.5 degrees Celsius (C) for 50 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effect was reported.  Lot # T023919 is an invalid lot number for hepatitis A vaccine, inactivated (VAQTA).
Sex: M
Vaccine: PPV
Symptoms: Stevens-Johnson syndrome
Clinical narrative: got Stevens Johnson from the Pneumovax; This spontaneous report was received from a consumer referring via Pfizer to her husband, a male patient of unknown age. He was allergic to lidocaine (also reported as "actually any of the "-caines""). There was no information regarding his concomitant therapies provided.  On an unspecified date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, he developed Stevens-Johnson syndrome. The outcome of the event was unknown.  The reporter considered the event to be related to the suspect vaccine.  Upon internal review, the event of Stevens-Johnson syndrome was considered to be medically significant.
Age: 1.0
Sex: F
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: the patient was inadvertently given PNEUMOVAX instead of PREVNAR13; the patient was inadvertently given PNEUMOVAX instead of PREVNAR13; This spontaneous report was received from an other healthcare professional (HCP) via Pfizer and refers to a 12 months old female patient. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, lot # and expiration date were not provided) instead of her fourth dose of pneumococcal vaccine conj 13V (CRM197) (PREVNAR 13) for prophylaxis (wrong vaccine administered, inappropriate age at vaccine administration).
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Vaccine positive rechallenge
Clinical narrative: I got the shots /felt alittle tinged across my lower back; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of back pain (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2021AMR135358).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced back pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the back pain was recovered/resolved.   It was unknown if the reporter considered the back pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient felt a little tinged across lower back for a few days.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: had side affect pain in my arm for three weeks; arm / could hardly use it,; couldn't sleep on it; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, mobility decreased and difficulty sleeping. On an unknown date, the outcome of the pain in arm, mobility decreased and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the pain in arm, mobility decreased and difficulty sleeping to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had pain in arm for three weeks. The patient could hardly use it, and definitely he/she could not sleep on it. The patient stated that, but after the fact, he/she guessed it was worth it.
Sex: U
Vaccine: VARZOS
Symptoms: White blood cell count decreased
Clinical narrative: My WBC is low today / had my 2nd Shingrix / on Monday; This case was reported by a consumer via interactive digital media and described the occurrence of white blood cell decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2021, the patient received the 2nd dose of Shingrix. On 18th June 2021, 4 days after receiving Shingrix, the patient experienced white blood cell decreased. On an unknown date, the outcome of the white blood cell decreased was unknown.   It was unknown if the reporter considered the white blood cell decreased to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient had received  2nd dose of Shingrix dose on monday and today experienced white blood cells low. The reporter stated that, if the low WBC could be related to shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Second time was far worse than the first time...; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the dose of Shingles vaccine and patient experienced Shingles. The reporter stated that he/she did not think that patient could get it a second time but one certainly could. The patient stated that the second time it was far worse than the first time and patient did get the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: migraines I'm getting / Are migraines part of the side effects; This case was reported by a consumer via interactive digital media and described the occurrence of migraine in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine. On an unknown date, the outcome of the migraine was not recovered/not resolved.   It was unknown if the reporter considered the migraine to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient had taken Shingrix vaccine and wanted to know that migrane was side effects of Shingrix. The reporter wanted to know was the migraines he/she getting due to Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Ophthalmic herpes zoster, Skin ulcer, Vaccination failure
Clinical narrative: suspected vaccination failure; got them anyway in his eye; sores all over his/ head and on his face; This case was reported by a consumer via social media interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), ophthalmic herpes zoster (serious criteria death and GSK medically significant) and skin ulcer (serious criteria death). On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and skin ulcer were fatal. The reported cause of death was vaccination failure, ophthalmic herpes zoster and skin ulcer.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and skin ulcer to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received the Shingles vaccine and patient got shingles in his eye. The patient also had sores all over his beautiful bald head and on his face. The reporter stated that the patient passed away without his wife being able to directly kiss him because of that. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Reported Cause(s) of Death: Opthalmic herpes zoster; Skin ulcer
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only adjuvant suspension component was given; only adjuvant suspension component was given; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number Y37L9, expiry date 10th October 2022) for prophylaxis.   On 12th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication. On an unknown date, the patient experienced inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only adjuvant suspension component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The nurse reported that when attempting to administer vaccine she had not realize that it needed to be reconstituted. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Patient got the first dose 8-10 years ago; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix with an associated reaction of no adverse event (patient got the first dose 8 to 10 years ago).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: Web request form submitted afterhours and retrieved by Medical Information at start of business. The age at vaccination was not reported. The patient received first dose 8 to 10 years ago and did not receive 2nd dose, which led to incomplete course of vaccination. The reporter wanted to know do they need to restart the cycle and receive a second dose. No further details provided via web form.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: has a doctor prescription for a / third dose. Patient is not immunocompromised; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st june 2018) and Shingrix (received 2nd dose on 23rd august 2018).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional Information was provided as follows: The age at vaccination was not applicable for this report. Pharmacist reported that the patient had received first and second dose of Shingrix. The pharmacist was looking for  information about a booster dose because the patient had a doctor prescription for a Shingrix third dose and till the time of reporting the patient had not received the third dose,which led to intercepted drug prescribing error. Patient was not immunocompromised. The reporter consented to follow up via email.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Adverse event, Chills, Illness, Pyrexia
Clinical narrative: SICK; CHILLS; FEVER; ADVERSE EVENT; This spontaneous report received from a physician 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 ustekinumab (solution for injection, subcutaneous, batch number: Unknown) 90 mg, frequency was not reported from 25-FEB-2021 to 11-JUN-2021, and dose and frequency were not reported from 29-JAN-2021 for crohns disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccoination. The batch number was not reported. Per procedure, no follow-up will be requested for this case as no permission to contact HCP.  No concomitant medications were reported. On 11-JUN-2021, the subject experienced adverse event. On an unspecified date, the subject experienced sick, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ustekinumab was not changed. The patient recovered from adverse event on 11-JUN-2021, and the outcome of fever, chills and sick was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Oropharyngeal pain, Urinary tract infection, Urticaria
Clinical narrative: A PINECONE SHOVED DOWN HER THROAT; SEVERE HIVES; RECURRENT URINARY TRACT INFECTION; CHEST PAINS/HEART PAINS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic shock, anaphylaxis, and urinary tract infection, and concurrent conditions included penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included allergy to 20 unspecified drugs. The patient was previously treated with doxycycline for urinary tract infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chest pains/heart pains. On APR-2021, the subject experienced recurrent urinary tract infection. Treatment medications included: doxycycline. On an unspecified date, the subject experienced a pinecone shoved down her throat, and severe hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pains/heart pains, a pinecone shoved down her throat, and severe hives, and the outcome of recurrent urinary tract infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: F
Vaccine: COVID19
Symptoms: Death, Nightmare
Clinical narrative: DEATH; SHEER NIGHTMARE THE SPIKE PROTEINS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up was requested for this case. No concomitant medications were reported.  On 14-JUN-2021, the patient experienced sheer nightmare the spike proteins and died from unknown cause of death on 14-JUN-2021, and the outcome of sheer nightmare the spike proteins was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210633197-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Coma, Death
Clinical narrative: DEATH; COMA; BLOOD CLOTS ON BRAIN; This spontaneous report received from a consumer 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, and batch number were not reported) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced death, coma, and blood clots on brain. On an unspecified date, the patient died from blood clots on brain, and coma. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20210637172-COVID VACCINE AD26.COV2.S-Death, Coma, Blood clots on brain. This events are considered un-assessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: BLOOD CLOTS ON BRAIN; COMA
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE SYRINGE REMOVED FROM FRIDGE AT 08:11 AND ADMINISTERED AT 11:53 TODAY(OUT OF SPECIFICATION PRODUCT USE); VACCINE KEPT FOR OUT OF FRIDGE FROM 8:11 TO 11:53(INCORRECT PRODUCT STORAGE); This spontaneous report received from a pharmacist 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: Unk) dose was not reported, administered on 18-JUN-2021 11:53 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-JUN-2021, the subject experienced vaccine syringe removed from fridge at 08:11 h and administered at 11:53 h today (out of specification product use). On 18-JUN-2021, the subject experienced vaccine kept for out of fridge from 8:11 to 11:53 (incorrect product storage). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine syringe removed from fridge at 08:11 h and administered at 11:53 h today(out of specification product use) and vaccine kept for out of fridge from 8:11 to 11:53(incorrect product storage) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall
Clinical narrative: STILL WOBBLY; STILL FALLING; This spontaneous report received from a consumer concerned an 8 decade 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, batch number: Unk) 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 still wobbly, and still falling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the still wobbly and still falling was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS; This spontaneous report received from a consumer via a company representative concerned a male 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 was not reported, administered on 15-MAY-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 MAY-2021, the subject experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sickness. This report was non-serious. This case, from the same reporter is linked to 20210642873.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEG PAIN; This spontaneous report received from a patient concerned a 50 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, batch number: 1808980) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain on 28-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic, Melaena, Pericardial effusion, Peripheral swelling
Clinical narrative: BLACK TARRY STOOLS; FLUID AROUND THE HEART; FEET SWELLING; BLOODY DIARRHEA; This spontaneous report received from a consumer concerned a 90 year old male. The patient's height, and weight were not reported. The patient's past medical history included cardiac stent placement, and concurrent conditions included Alzheimer's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: unknown) dose was not reported, one total administered in left arm on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the patient was started to have swelling in feet. Patient went to the hospital for heart trouble because had fluid around heart. On 05-MAY-2021, Patient had bloody diarrhea. On an unspecified date, patient also complained of stomach pain and black tarry stools. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feet swelling, fluid around the heart, bloody diarrhea, and black tarry stools. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210643383 and 20210642487.; Sender's Comments: V0:20210644172-covid-19 vaccine ad26.cov2.s-Black tarry stools, fluid around the heart, bloody diarrhea.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: Intracardiac thrombus, Off label use, Product use issue
Clinical narrative: THREW A BLOOD CLOT IN HEART; OFF LABEL USE; DRUG USE FOR UNAPPROVED DOSING REGIMEN; This spontaneous report received from a patient via social media (Facebook) 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 and expiry: UNKNOWN) dose, start therapy date were not reported, 2 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient got the second J&J Covid shot (off label use and drug use for unapproved dosing regimen), and experienced a blood clot in heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from threw a blood clot in heart, and the outcome of off label use and drug use for unapproved dosing regimen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This report received via social media concerns a female of unspecified age and race/ethnicity who "threw a blood clot in her heart" an unspecified time after receiving a second Janssen Covid-19 vaccination. Medical history, concomitant medications, diagnosis, latency, diagnostic testing, corrective treatments, and outcome were not reported. At this time, this case does not appear to be consistent with recently reported Thrombosis with Thrombocytopenia Syndrome following Covid-19 vaccine administration. In light of missing information (medical history, concomitant medications, diagnosis, latency, diagnostic testing to clarify the type of clot, platelet counts, anti-PF4 antibody, tests for hypercoagulability, corrective treatments), the relationship with Janssen Covid-19 vaccine is considered unclassifiable.