chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Resuscitation
Clinical narrative: Exact time of vaccine administration not available, but it is described that this patient collapsed within 1 hour of vaccination on 02/11/2021. The patient's wife states that the patient had slipped and fallen down the stairs when entering their home. She states he was not immediately non-responsive or unconscious after falling/slipping and that he had tried to crawl further into the house. She called 911 and initiated CPR per instruction from the dispatcher.  EMS noted that patient was in v. tach and v. fib and was defibbed multiple times. The patient was non-responsive and had no pulse upon arrival to emergency department. The patient died at the hospital at 16:20 on 02/11/2021 approx. 1 hour after falling. Chief complaint at emergency room presentation  described as cardiac arrest. Physician commented that the patient "possibly suffered traumatic brain injury versus ICH (intracerebral hemorrhage)."
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood lactic acid increased, Cardiac arrest, Cardioversion, Death, Fall
Clinical narrative: Exact time of vaccine administration not available, but it is described that this patient collapsed within 1 hour of vaccination on 02/11/2021. The patient's wife states that the patient had slipped and fallen down the stairs when entering their home. She states he was not immediately non-responsive or unconscious after falling/slipping and that he had tried to crawl further into the house. She called 911 and initiated CPR per instruction from the dispatcher.  EMS noted that patient was in v. tach and v. fib and was defibbed multiple times. The patient was non-responsive and had no pulse upon arrival to emergency department. The patient died at the hospital at 16:20 on 02/11/2021 approx. 1 hour after falling. Chief complaint at emergency room presentation  described as cardiac arrest. Physician commented that the patient "possibly suffered traumatic brain injury versus ICH (intracerebral hemorrhage)."
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperkalaemia, Loss of consciousness, Pulse absent, Resuscitation, Unresponsive to stimuli
Clinical narrative: Exact time of vaccine administration not available, but it is described that this patient collapsed within 1 hour of vaccination on 02/11/2021. The patient's wife states that the patient had slipped and fallen down the stairs when entering their home. She states he was not immediately non-responsive or unconscious after falling/slipping and that he had tried to crawl further into the house. She called 911 and initiated CPR per instruction from the dispatcher.  EMS noted that patient was in v. tach and v. fib and was defibbed multiple times. The patient was non-responsive and had no pulse upon arrival to emergency department. The patient died at the hospital at 16:20 on 02/11/2021 approx. 1 hour after falling. Chief complaint at emergency room presentation  described as cardiac arrest. Physician commented that the patient "possibly suffered traumatic brain injury versus ICH (intracerebral hemorrhage)."
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ventricular fibrillation, Ventricular tachycardia
Clinical narrative: Exact time of vaccine administration not available, but it is described that this patient collapsed within 1 hour of vaccination on 02/11/2021. The patient's wife states that the patient had slipped and fallen down the stairs when entering their home. She states he was not immediately non-responsive or unconscious after falling/slipping and that he had tried to crawl further into the house. She called 911 and initiated CPR per instruction from the dispatcher.  EMS noted that patient was in v. tach and v. fib and was defibbed multiple times. The patient was non-responsive and had no pulse upon arrival to emergency department. The patient died at the hospital at 16:20 on 02/11/2021 approx. 1 hour after falling. Chief complaint at emergency room presentation  described as cardiac arrest. Physician commented that the patient "possibly suffered traumatic brain injury versus ICH (intracerebral hemorrhage)."
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic kidney disease, Glucose tolerance impaired, Laboratory test normal, Neuropathy peripheral
Clinical narrative: Peripheral neuropathy - pain in feet. Started in toes, moved down foot, eventually changed to numbness.  Tingling pain in hands. 2 week duration.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Peripheral neuropathy - pain in feet. Started in toes, moved down foot, eventually changed to numbness.  Tingling pain in hands. 2 week duration.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Condition aggravated, Dizziness, Hypertension, Lip swelling
Clinical narrative: Mild anaphylaxis
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pulse abnormal, Swollen tongue
Clinical narrative: Mild anaphylaxis
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Mild anaphylaxis
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Headache, Impaired work ability, Musculoskeletal stiffness, Neck pain
Clinical narrative: stiff neck and headache, vision impairment, spoke with doctor, advised to er on 2/18/21
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Headache, Musculoskeletal stiffness, Urine analysis
Clinical narrative: stiff neck and headache, vision impairment, spoke with doctor, advised to er on 2/18/21
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: stiff neck and headache, vision impairment, spoke with doctor, advised to er on 2/18/21
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head normal, Headache, Neck pain
Clinical narrative: stiff neck and headache, vision impairment, spoke with doctor, advised to er on 2/18/21
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Hypotonia, Sensory loss
Clinical narrative: One hour after the vaccine I experienced loss of sensation of my left cheek from under my eye to my mouth.  My wife noted loss of muscle tone of my cheek and inability to smile on the left side.  Symptoms started about one hour after the injection and resolved after three hours.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypotonia, Sensory loss
Clinical narrative: One hour after the vaccine I experienced loss of sensation of my left cheek from under my eye to my mouth.  My wife noted loss of muscle tone of my cheek and inability to smile on the left side.  Symptoms started about one hour after the injection and resolved after three hours.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Palpitations, Throat tightness, Vomiting
Clinical narrative: 1245; Scratchy throat, nausea, tongue feels fat, nausea; Dipenhydramaine administered , Epi Pen administered. Patient alert 1256 - gagging, throat tightness, tongute better, tight throat, nausea; second Epi Pen administered 1258 - EMS arrived, pateint alert and transported to Emergency Department via EMS
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Retching, Swollen tongue, Throat irritation, Throat tightness
Clinical narrative: 1245; Scratchy throat, nausea, tongue feels fat, nausea; Dipenhydramaine administered , Epi Pen administered. Patient alert 1256 - gagging, throat tightness, tongute better, tight throat, nausea; second Epi Pen administered 1258 - EMS arrived, pateint alert and transported to Emergency Department via EMS
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Muscle tightness, Pain
Clinical narrative: called EH today to report feeling muscle and join pain since 2/3, though it would resolve has set up appointment with primary care on 2/25/21
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: called EH today to report feeling muscle and join pain since 2/3, though it would resolve has set up appointment with primary care on 2/25/21
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Death, husband found dead in sleep that night.  No underlying cardiovascular disease
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death, husband found dead in sleep that night.  No underlying cardiovascular disease
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL, MMRV, VARCEL
Symptoms: Otitis media viral, Pyrexia, Rash, Rash erythematous, Rash macular
Clinical narrative: The patient had fever with a temperature maxinum of 103.5 and"Red Macular rash on her torso" that is being treated as "viral otitis media" bilateral; he patient had fever with a temperature maxinum of 103.5 and"Red Macular rash on her torso" that is being treated as "viral otitis media" bilateral; The patient had fever with a temperature maxinum of 103.5 and"Red Macular rash on her torso" that is being treated as "viral otitis media" bilateral; This spontaneous report was received from a physician and refers to a 12 month old female patient. The patient had no known medication allergies, or significant medical history. The patient's concurrent conditions were not reported.     On 15-JAN-2021, the patient was vaccinated with a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T010651, expiration date 22-SEP-2021 in the right thigh; with a dose of   varicella virus vaccine live (oka/merck)(VARIVAX) lot # S033540, expiration date 22-OCT-2021 in the right thigh (MARRS # 2102USA007091); and with a dose of hepatitis a vaccine, inactivated(VAQTA) lot # T014836, expiration date 17-JUL-2021 in the left thigh for prophylaxis (dose and route were not reported). The vaccines were administered in the private Doctor's office with a private funds. Other suspect therapy included sterile diluent. Concomitant therapy included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR).   On 25-JAN-2021, the patient was in the clinic with a fever with a temperature maximum of 103.5 (units not reported) (pyrexia) and "red macular rash on her torso" (rash macular) that was being treated as "viral otitis media" bilateral (otitis media viral). The patient was being treated "symptomatically and conservatively" with a prescription of amoxicillin, 400 milligrams per 5 milliters, 3 milliters twice a day to begin in 2 to 3 days if symptoms persist or get worse.  At the time of the report, the outcome of the events and the relationship with the vaccines were not reported.  This is on of two reports regarding the same patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014836; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2102USA007091:Original Case : 2101USA009289
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL, MMRV, VARCEL
Symptoms: Otitis media viral, Pyrexia, Rash, Rash erythematous, Rash macular
Clinical narrative: No reaction following the vaccines; The patient was vaccinated with PROQUAD and VARlVAX at the same time; This spontaneous report was received from a physician and refers to a 12 month old female patient. The patient had no known medication allergies, or significant medical history. The patient's concurrent conditions were not reported.     On 15-JAN-2021, the patient was vaccinated with a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T010651, expiration date 22-SEP-2021 in the right thigh for prophylaxis (dose and route were not reported).  On the same date the patient also received a dose of   varicella virus vaccine live (oka/merck)(VARIVAX) lot # S033540, expiration date 22-OCT-2021in the right thigh for prophylaxis (dose and route were not reported). Both vaccines were administered in the private Doctor's office with a private funds. Concomitant therapies included sterile diluent.     The physician also reported there was no reaction following the vaccines.  On 25-JAN-2021, the patient was in the clinic with fever with a temperature maximum of 103.5 (units not reported) and "Red Macular rash on her torso" that was being treated as "viral otitis media" bilateral (MARRS# 2101USA009289)  This is on of two reports regarding the same patient.; Sender's Comments:  US-009507513-2101USA009289:Original Case : 2101USA009289
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No adverse event; incorrect product storage; This spontaneous report was received from an unspecified source via a physician, referring a patient of an unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.  On 18-DEC-2020, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 mL which had a valid lot # T007790 expiration date on 03-DEC-2021) for prophylaxis, however no adverse effects reported.   Administered dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) experienced the temperature excursion above 31.2 F for 430 minutes. Digital data logger was involved. There were no previous temperature excursions reported. No product to retrieve. No Product Quality Complaint reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; Administration of a ROTATEQ dose to a patient / Temperature -7.9 for 53 minutes and -10.5C for 52 minutes; This spontaneous report was received from a licensed practical nurse concerning to a 8-week old patient of unknown gender.  No information regarding the patient's pertinent medical history, historical drugs, drug reactions, allergies, concurrent conditions or concomitant therapies was provided.         On 29-JAN-2021, a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot number reported as 1688504 and expiration date as 19-NOV-2021, had a temperature excursion of -7.9 degrees Celsius (°C) for a time frame of 53 minutes and another temperature excursion of -10.5 degrees Celsius (°C) for a time frame of 52 minutes. It was also reported there was not a previous temperature excursion and digital data logger was not involved. No additional adverse events were reported.  On the same day, the patient was vaccinated with the mentioned improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) per oral route for prophylaxis, (formulation, strength, dose, vaccination scheme and anatomical site of vaccination were not provided).
Age: 1.25
Sex: M
Vaccine: HPV9
Symptoms: Wrong product administered
Clinical narrative: Gardasil 9 was inadvertently administered to a 15 month old child; Gardasil 9 was inadvertently administered to a 15 month old child... MA was supposed to give HIB vaccine, she accidentally gave HPV (Gardasil) instead.; No adverse event experienced; This spontaneous report was been received from a healthcare professional, concerning a 15-month-old male patient. The patient's pertinent medical history, concurrent conditions, and drug reactions/allergies were not provided.   On 01-FEB-2021 the patient was supposed to receive a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (manufacturer unknown), however, the medical assistant accidentally administered to the patient the wrong vaccine and he received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 0.5 milliliter, intramuscularly, in the left thigh, lot # T007035 and expiration date 01-MAY-2022, for prophylaxis. On the same date, the patient also received a first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot # S039311, expiration date on 04-DEC-2021, subcutaneously, left arm; a fourth dose of diphtheria toxoid, Hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) (Lot # UJ1355AA, expiration date on 26-FEB-2021, intramuscularly, on right thigh; and a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot # DN4219, expiration date on 31-JAN-2023, intramuscularly, left thigh.   After the administration of the wrong vaccine, the family was notified. No laboratory tests were necessary. The parent was informed to monitor the patient and inform to the clinic of any side effects or adverse reaction. At the time of the report, the patient had not experienced any adverse reaction/adverse event. The medical assistant was re-educated. 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: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; administered expired dose of M-M-R II.; This spontaneous report was received from a medical director referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported.   On 04-FEB-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength and route were not provided; lot# was R030806 and expiration date was not provided but upon internal validation as 24-OCT-2020) for prophylaxis (expired product administered). No additional adverse event (AE) reported.  This is one of two reports received from same reporter.; Sender's Comments:  US-009507513-2102USA003583:
Age: 82.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Gingival bleeding
Clinical narrative: Bleeding gums; This is an spontaneous report from a contactable consumer based on information received by Pfizer from license party for apixaban (ELIQUIS).  This case was received via Pfizer Inc (Reference number: 2021089295) on 28-Jan-2021 and was forwarded to Company on 29-Jan-2021. This spontaneous case was reported by a patient family member or friend and describes the occurrence of gingival bleeding (Bleeding gums) in 82-year-old male patient who received Apixaban (ELIQUIS) for Cerebrovascular accident prophylaxis. Co-Suspect Products included clopidogrel bisulfate (Plavix) for an unknown indication and Covid-19 Vaccine for COVID-19 prophylaxis. Concurrent medical conditions included Diabetes (Diagnosed 40 years ago, type 2), Blood pressure high and Cardiac disorder NOS. In July 2020, the patient started ELIQUIS (unknown route), 5 milligram twice a day. On an unknown date, the patient started Plavix (unknown route) 75 milligram at an unspecified frequency. On 28-Jan-2021, the patient started Covid-19 Vaccine (unknown route). On the same day, the patient experienced gingival bleeding (Bleeding gums). The dose of ELIQUIS(Unknown) and Plavix (Unknown) was not changed. At the time of the report, gingival bleeding was resolving. For ELIQUIS(Unknown), the reporter did not provide any causality assessments. For Plavix(Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature, Body temperature increased, Headache, Pyrexia
Clinical narrative: headache; 100.2 temp / temp now 97.2; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020 14:30, the patient received the 2nd dose of Shingrix. On 23rd December 2020, 5 days after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient had headache and temperature in the morning of date of reporting. The patient had 100.2 temperature after drinking coffee and 97.2 temperature at 12:30. The reporter asked was it reaction to Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles but early stages; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient just had vaccine shot and unknowingly actually had the Shingles, but early stages so had no idea.  The reporter asked should he or she need to be concerned.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: abdominal rash; This case was reported by a pharmacist and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient had no history of allergic reaction. The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The reporter need to know if patient needs to avoid getting the second dose of Shingrix vaccine due to occurence of abdominal rash. The reporter asked should rechallenge occur at doctors office.
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody negative, Arthralgia, Arthritis, Grip strength decreased, Joint swelling
Clinical narrative: Arthritis in her hands and knees; Soreness in both arms; Palpable swelling; Tenderness in the joints; Hands swollen / couldn't grip anything; Ached over; could not grip anything; Immune complex; Serum-sickness like reaction / thinking it's an immune complex; This case was reported by a physician via call center representative and described the occurrence of immune complex reaction in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included general body pain, polymyalgia (a year ago had potential polymyalgia) and colitis microscopic (had microscopic collits from duloxetine). Previously administered products included Duloxetine (received Duloxetine on an unknown date).   On 9th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a month after receiving Shingrix, the patient experienced immune complex reaction (serious criteria GSK medically significant), serum-sickness like disorder, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased. On 21st December 2020, the patient experienced arthritis. The patient was treated with prednisone. On an unknown date, the outcome of the immune complex reaction, serum-sickness like disorder, arthritis, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased were recovering/resolving.   It was unknown if the reporter considered the immune complex reaction, serum-sickness like disorder, arthritis, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased to be related to Shingrix.  Additional details were provided as follows: The patient had history of general aches, a year ago worked up for potential polymyalgia and received Duloxetine as a historical drug with microscopic colitis. The age at vaccination was not reported. The reporter stated that, by 21st December 2020 after vaccination, the patient had some soreness in both arms, developed arthritis in right hand, then left hand, then knee; palpable swelling and tenderness in the joints, hands swollen, could not grip anything and ached over a fewdays time. On 28th December 2020, the patient visited physician and diagnosed with serum-sickness like disorder, arthritis and thought it was an immune complex reaction. The patient had sedimentaion rte, nuclear antibody and rheum factor negative. When the patient went to office the sedimentation rate was 21. The patient treated with prednisone and the symptoms were improving. No further details provided at this time. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Arthritis in her hands and knees; Soreness in both arms; Palpable swelling; Tenderness in the joints; Hands swollen / couldn't grip anything; Ached over; could not grip anything; Immune complex; Serum-sickness like reaction / thinking it's an immune complex; This case was reported by a physician via call center representative and described the occurrence of immune complex reaction in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included general body pain, polymyalgia (a year ago had potential polymyalgia) and colitis microscopic (had microscopic collits from duloxetine). Previously administered products included Duloxetine (received Duloxetine on an unknown date).   On 9th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a month after receiving Shingrix, the patient experienced immune complex reaction (serious criteria GSK medically significant), serum-sickness like disorder, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased. On 21st December 2020, the patient experienced arthritis. The patient was treated with prednisone. On an unknown date, the outcome of the immune complex reaction, serum-sickness like disorder, arthritis, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased were recovering/resolving.   It was unknown if the reporter considered the immune complex reaction, serum-sickness like disorder, arthritis, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased to be related to Shingrix.  Additional details were provided as follows: The patient had history of general aches, a year ago worked up for potential polymyalgia and received Duloxetine as a historical drug with microscopic colitis. The age at vaccination was not reported. The reporter stated that, by 21st December 2020 after vaccination, the patient had some soreness in both arms, developed arthritis in right hand, then left hand, then knee; palpable swelling and tenderness in the joints, hands swollen, could not grip anything and ached over a fewdays time. On 28th December 2020, the patient visited physician and diagnosed with serum-sickness like disorder, arthritis and thought it was an immune complex reaction. The patient had sedimentaion rte, nuclear antibody and rheum factor negative. When the patient went to office the sedimentation rate was 21. The patient treated with prednisone and the symptoms were improving. No further details provided at this time. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Serum sickness-like reaction, Swelling, Type III immune complex mediated reaction
Clinical narrative: Arthritis in her hands and knees; Soreness in both arms; Palpable swelling; Tenderness in the joints; Hands swollen / couldn't grip anything; Ached over; could not grip anything; Immune complex; Serum-sickness like reaction / thinking it's an immune complex; This case was reported by a physician via call center representative and described the occurrence of immune complex reaction in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included general body pain, polymyalgia (a year ago had potential polymyalgia) and colitis microscopic (had microscopic collits from duloxetine). Previously administered products included Duloxetine (received Duloxetine on an unknown date).   On 9th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a month after receiving Shingrix, the patient experienced immune complex reaction (serious criteria GSK medically significant), serum-sickness like disorder, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased. On 21st December 2020, the patient experienced arthritis. The patient was treated with prednisone. On an unknown date, the outcome of the immune complex reaction, serum-sickness like disorder, arthritis, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased were recovering/resolving.   It was unknown if the reporter considered the immune complex reaction, serum-sickness like disorder, arthritis, pain in arm, swelling, joint tenderness, hand swelling, pain and grip strength decreased to be related to Shingrix.  Additional details were provided as follows: The patient had history of general aches, a year ago worked up for potential polymyalgia and received Duloxetine as a historical drug with microscopic colitis. The age at vaccination was not reported. The reporter stated that, by 21st December 2020 after vaccination, the patient had some soreness in both arms, developed arthritis in right hand, then left hand, then knee; palpable swelling and tenderness in the joints, hands swollen, could not grip anything and ached over a fewdays time. On 28th December 2020, the patient visited physician and diagnosed with serum-sickness like disorder, arthritis and thought it was an immune complex reaction. The patient had sedimentaion rte, nuclear antibody and rheum factor negative. When the patient went to office the sedimentation rate was 21. The patient treated with prednisone and the symptoms were improving. No further details provided at this time. The reporter did not consent to follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Herpes zoster, Myalgia, Pain
Clinical narrative: feeling like he has shingles in his whole body; severe muscle / pain; joint pain / right shoulder / aching; pain is excruciating / disabling / "jumps around a little bit," / going on for almost a month / still ongoing; his head / aching; intense pain / to both legs / right arm / aching; right kidney "feels like there is a knife in it" / new shooting pain; intense pain from the testicles; is having to wake up every couple of hours to take pills; This case was reported by a consumer and described the occurrence of shingles in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th December 2020, 3 days after receiving Shingrix, the patient experienced shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain, testicular pain and poor sleep. The patient was treated with naproxen (Aleve), ibuprofen, prednisone and naproxen. On an unknown date, the outcome of the shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain and testicular pain were not recovered/not resolved and the outcome of the poor sleep was unknown.   It was unknown if the reporter considered the shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain, testicular pain and poor sleep to be related to Shingrix.  Additional details were reported as follows: The patient received the vaccine in the upper left arm. The patient experienced severe muscle and joint pain after receiving the vaccine. The pain started 2 to 3 days after getting the vaccine.  He stated that the pain was excruciating and disabling.  He had intense pain from the testicles down to both legs.  He stated that the pain "jumps around a little bit" but reported his head, right shoulder and right arm were aching at the time of report.  His right kidney "feels like there was a knife in it" and it was a new shooting pain as of yesterday that was on the right side of the body and both legs.  He waked up every couple of hours to take pills.  He stated he had taken more ibuprofen and naproxen in the last 20 days than he had in his whole life.  He had taken 2 pills of Aleve every 8 hours and had been given prednisone to knock out the pain.  He reported that the Aleve was "only knocking half of it out unlike before".  He felt like he had shingles in his whole body.  He reported being healthy, but the pain had been going on for almost a month and was ongoing The reporter did not consent to follow-up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Poor quality sleep, Renal pain, Sleep disorder, Testicular pain
Clinical narrative: feeling like he has shingles in his whole body; severe muscle / pain; joint pain / right shoulder / aching; pain is excruciating / disabling / "jumps around a little bit," / going on for almost a month / still ongoing; his head / aching; intense pain / to both legs / right arm / aching; right kidney "feels like there is a knife in it" / new shooting pain; intense pain from the testicles; is having to wake up every couple of hours to take pills; This case was reported by a consumer and described the occurrence of shingles in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th December 2020, 3 days after receiving Shingrix, the patient experienced shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain, testicular pain and poor sleep. The patient was treated with naproxen (Aleve), ibuprofen, prednisone and naproxen. On an unknown date, the outcome of the shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain and testicular pain were not recovered/not resolved and the outcome of the poor sleep was unknown.   It was unknown if the reporter considered the shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain, testicular pain and poor sleep to be related to Shingrix.  Additional details were reported as follows: The patient received the vaccine in the upper left arm. The patient experienced severe muscle and joint pain after receiving the vaccine. The pain started 2 to 3 days after getting the vaccine.  He stated that the pain was excruciating and disabling.  He had intense pain from the testicles down to both legs.  He stated that the pain "jumps around a little bit" but reported his head, right shoulder and right arm were aching at the time of report.  His right kidney "feels like there was a knife in it" and it was a new shooting pain as of yesterday that was on the right side of the body and both legs.  He waked up every couple of hours to take pills.  He stated he had taken more ibuprofen and naproxen in the last 20 days than he had in his whole life.  He had taken 2 pills of Aleve every 8 hours and had been given prednisone to knock out the pain.  He reported that the Aleve was "only knocking half of it out unlike before".  He felt like he had shingles in his whole body.  He reported being healthy, but the pain had been going on for almost a month and was ongoing The reporter did not consent to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain
Clinical narrative: first dose / on 3/22/2018 / never able to get the second dose; arm was sore for 5 days at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 22nd March 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient's arm was sore for 5 days at the injection site after the 1st dose. The patient was never able to get the second dose. Till the time of reporting the patient had not received 2nd dose of Shingrix which led to incomplete course of vaccination.  The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed an adverse reaction.    The patient's medical history was not provided. Concomitant product use was not provided.  On 13 Jan 2021 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient stated she experienced an adverse reaction. Treatment for the event included hospitalization.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, adverse reaction, was considered unknown.; Reporter's Comments: This case concerns a female patient of unknow age patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly for prophylaxis of COVID-19 infection and developed a serious medically significant unlisted event of adverse reaction. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site abscess, Vaccination site necrosis, Vaccination site scar
Clinical narrative: Abscess and tissue necrosis at the injection site; Abscess and tissue necrosis at the injection site; Scarred; A spontaneous report was received from a nurse who is a 58-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an abscess and tissue necrosis at the injection site and scarred.  The patient's medical history was not provided. No concomitant product use was reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Approximately 6 to 7 days after the patient received the Moderna COVID-19 vaccine, the patient had an abscess and tissue necrosis at the injection site. The patient did not require hospitalization and self-treated it with polysporin.   On 20 Dec 2020, the patient reported the reaction had not resolved and was now scarred.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, abscess and tissue necrosis at the injection site and scarred, were considered not resolved.; Reporter's Comments: This case concerns a 58 year-old, male patient, who experienced events of an abscess and tissue necrosis at the injection site and scarred. The events occurred 6 days after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Blood pressure measurement, Heart rate, Lip swelling, Oxygen saturation
Clinical narrative: Facial edema, oropharyngeal edema; Lip swelling; Throat itching; Tachycardia; A spontaneous report was received from a healthcare professional concerning a 28-year-old female, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed lips swelling, throat itching, facial edema, and oropharyngeal edema.    The patient's medical history was not provided. Concomitant product use was not reported.  On 15 Jan 2021, approximately five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, five minutes after the vaccine was administered, at 11:15am, the patient complained of lip swelling and throat itching. A healthcare provider assessed the patient and vital signs included, pressure 132/103 mmHg, heart rate 95 beats per minute, and 100 percent oxygen saturation. At 11:22am, the patient had facial edema, oropharyngeal edema and attempted to clear her throat. Vital signs reported at that time included, blood pressure 143/106 mmHg, heart rate 121 beats per minute, and oxygen saturation 99 percent. Treatment for the event included diphenhydramine 50mg and epinephrine by injection twice. Emergency services were called to transport the patient, however, the patient declined transport.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, lip swelling, throat itching, facial edema, and oropharyngeal edema, was unknown.; Reporter's Comments: This case concerns a 28 year-old, female patient, who experienced events of lips swelling, throat itching, facial edema, and oropharyngeal edema. The events occurred within minutes after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Throat irritation
Clinical narrative: Facial edema, oropharyngeal edema; Lip swelling; Throat itching; Tachycardia; A spontaneous report was received from a healthcare professional concerning a 28-year-old female, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed lips swelling, throat itching, facial edema, and oropharyngeal edema.    The patient's medical history was not provided. Concomitant product use was not reported.  On 15 Jan 2021, approximately five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, five minutes after the vaccine was administered, at 11:15am, the patient complained of lip swelling and throat itching. A healthcare provider assessed the patient and vital signs included, pressure 132/103 mmHg, heart rate 95 beats per minute, and 100 percent oxygen saturation. At 11:22am, the patient had facial edema, oropharyngeal edema and attempted to clear her throat. Vital signs reported at that time included, blood pressure 143/106 mmHg, heart rate 121 beats per minute, and oxygen saturation 99 percent. Treatment for the event included diphenhydramine 50mg and epinephrine by injection twice. Emergency services were called to transport the patient, however, the patient declined transport.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, lip swelling, throat itching, facial edema, and oropharyngeal edema, was unknown.; Reporter's Comments: This case concerns a 28 year-old, female patient, who experienced events of lips swelling, throat itching, facial edema, and oropharyngeal edema. The events occurred within minutes after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Loss of consciousness
Clinical narrative: Blacked out; Anaphylactic reaction; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction and blacked out.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, after receiving the vaccine, the patient experienced an anaphylactic reaction and blacked out. The patient was placed on a ventilator for the events.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, anaphylactic reaction and blacked out, was unknown.; Reporter's Comments: This case concerns a patient of unknown of age and gender. The medical history is not provided. On unknown date after receiving their first of two planned doses of mRNA-1273 (Lot unknown), the patient experienced medically significant events of Anaphylactic reaction and Loss of consciousness. Treatment included placed on a ventilator for the events. Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.