chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal disorder, Throat clearing
Clinical narrative: Severe allergic reaction to 1st does of the Pfizer vaccine.  After 15 minutes "throat clearing" started and between 25-30 minutes my throat got "thick" and my body began tingling all over.   My breathing became labored and difficult, my lips were numb.   I was immediately administered an EPI pen, and was transported by ambulance to the ER .  I was also treated with albuterol, solumedrol, and benedryl.  I remained in the ER for the entire day, and was discharged in the evening.  I was prescribed Claritin, and prednisone, and given an epi pen.  I followed up with my doctor on the following Monday, still experiencing chest pressure and numbness/tingling in my throat/face.  The Claritin was continued, and the prednisone was extended.  I followed up with another doctor on Wednesday as symptoms were not resolved.  Claritin has been increased and am trying to phase out the prednisone. I continue to suffer from tingling in my lips, and chest pressure.  Doctors have no idea how long symptoms would last.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Gait disturbance, Paraesthesia oral, Swelling face
Clinical narrative: At 20 minutes from vacination my face became in flamed below the ear on both sides.  Face became bright red.  Heart rate was taken.  Blood pressure was taken (said to be 182 over 95 - nomal runs 82).  Was given one benydrl. which makes me drozy.  After approximately 30 minutes heart rate lowered.  I wasn't given the full information.  Representatives identified themselves as CDC documented information.  PCP was notified.    I need to get a second vaccine, I need to be advised on how to proceed.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Skin irritation
Clinical narrative: At 20 minutes from vacination my face became in flamed below the ear on both sides.  Face became bright red.  Heart rate was taken.  Blood pressure was taken (said to be 182 over 95 - nomal runs 82).  Was given one benydrl. which makes me drozy.  After approximately 30 minutes heart rate lowered.  I wasn't given the full information.  Representatives identified themselves as CDC documented information.  PCP was notified.    I need to get a second vaccine, I need to be advised on how to proceed.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours later developed a bright red. burning and painful rash on my face. On day 3 I went to work and underneath my right eye started to swell up and a red streak from the inner corner of my eyelid went down my face. On day 4 I woke up with both eyes swollen.  I started on benedryl. 2x a day. The redness,  welts and hives traveled down my face, onto my neck,  then up my forehead and onto my earlobes. On March 22, day 5, I woke with even more swelling on my face and both eyes. The rash was very bad. I called my primary care physician and made an appointment to see him on Tuesday. I went for that appointment and dr. gave me antihistamines, took pictures and reported it to CDC.  I started the antihistamines, but on Day 7, I woke up with the worst of it. Hives all down my neck, lips swollen,  bruising and swollen eyes and itchy red rash everywhere. I called the dr back and started prednizone steriods. Today,  March 26, it is starting to calm down.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Eye swelling, Pain in extremity, Pruritus, Rash
Clinical narrative: Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours later developed a bright red. burning and painful rash on my face. On day 3 I went to work and underneath my right eye started to swell up and a red streak from the inner corner of my eyelid went down my face. On day 4 I woke up with both eyes swollen.  I started on benedryl. 2x a day. The redness,  welts and hives traveled down my face, onto my neck,  then up my forehead and onto my earlobes. On March 22, day 5, I woke with even more swelling on my face and both eyes. The rash was very bad. I called my primary care physician and made an appointment to see him on Tuesday. I went for that appointment and dr. gave me antihistamines, took pictures and reported it to CDC.  I started the antihistamines, but on Day 7, I woke up with the worst of it. Hives all down my neck, lips swollen,  bruising and swollen eyes and itchy red rash everywhere. I called the dr back and started prednizone steriods. Today,  March 26, it is starting to calm down.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Swelling face, Urticaria
Clinical narrative: Really sore arm the day after. Developed a full body rash anout 36 hours after the shot. 48 hours later developed a bright red. burning and painful rash on my face. On day 3 I went to work and underneath my right eye started to swell up and a red streak from the inner corner of my eyelid went down my face. On day 4 I woke up with both eyes swollen.  I started on benedryl. 2x a day. The redness,  welts and hives traveled down my face, onto my neck,  then up my forehead and onto my earlobes. On March 22, day 5, I woke with even more swelling on my face and both eyes. The rash was very bad. I called my primary care physician and made an appointment to see him on Tuesday. I went for that appointment and dr. gave me antihistamines, took pictures and reported it to CDC.  I started the antihistamines, but on Day 7, I woke up with the worst of it. Hives all down my neck, lips swollen,  bruising and swollen eyes and itchy red rash everywhere. I called the dr back and started prednizone steriods. Today,  March 26, it is starting to calm down.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropod sting, Dermatitis atopic, Dyspnoea, Paraesthesia, Skin swelling
Clinical narrative: Shortly after vaccination.  Patient complained of tingling in mouth, throat and lips, and tongue swelling. Patient was evaluated by EMS.  IM Benadryl and nebulizer given by EMS.  Patient was transported by EMS to Emergency Room for further assessment.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Shortly after vaccination.  Patient complained of tingling in mouth, throat and lips, and tongue swelling. Patient was evaluated by EMS.  IM Benadryl and nebulizer given by EMS.  Patient was transported by EMS to Emergency Room for further assessment.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia, Swollen tongue
Clinical narrative: Shortly after vaccination.  Patient complained of tingling in mouth, throat and lips, and tongue swelling. Patient was evaluated by EMS.  IM Benadryl and nebulizer given by EMS.  Patient was transported by EMS to Emergency Room for further assessment.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hyperhidrosis, Malaise, Mobility decreased, Muscle spasms
Clinical narrative: Pain/pressure at injection. Within 2 min. Passed out for 5 to 10 seconds then tingling of arms/hands and legs. Sweating head and neck. Cramping of both hands, unable to move fingers lasting 2 to 4 minutes. Burped almost throwing up twice. Possible rapid heartbeat causing rapid breathing. Was asked to and did stay 30 to 45 minutes. Was better within 10 minutes of injection.   At home experienced being very cold some mild soreness of arm. Temperature of 96 at 3:15 pm. Temp back to normal next day.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia, Syncope
Clinical narrative: Pain/pressure at injection. Within 2 min. Passed out for 5 to 10 seconds then tingling of arms/hands and legs. Sweating head and neck. Cramping of both hands, unable to move fingers lasting 2 to 4 minutes. Burped almost throwing up twice. Possible rapid heartbeat causing rapid breathing. Was asked to and did stay 30 to 45 minutes. Was better within 10 minutes of injection.   At home experienced being very cold some mild soreness of arm. Temperature of 96 at 3:15 pm. Temp back to normal next day.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eructation, Heart rate increased, Hyperhidrosis, Injection site discomfort, Injection site pain
Clinical narrative: Pain/pressure at injection. Within 2 min. Passed out for 5 to 10 seconds then tingling of arms/hands and legs. Sweating head and neck. Cramping of both hands, unable to move fingers lasting 2 to 4 minutes. Burped almost throwing up twice. Possible rapid heartbeat causing rapid breathing. Was asked to and did stay 30 to 45 minutes. Was better within 10 minutes of injection.   At home experienced being very cold some mild soreness of arm. Temperature of 96 at 3:15 pm. Temp back to normal next day.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Mobility decreased, Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: Pain/pressure at injection. Within 2 min. Passed out for 5 to 10 seconds then tingling of arms/hands and legs. Sweating head and neck. Cramping of both hands, unable to move fingers lasting 2 to 4 minutes. Burped almost throwing up twice. Possible rapid heartbeat causing rapid breathing. Was asked to and did stay 30 to 45 minutes. Was better within 10 minutes of injection.   At home experienced being very cold some mild soreness of arm. Temperature of 96 at 3:15 pm. Temp back to normal next day.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiration abnormal, Vomiting
Clinical narrative: Pain/pressure at injection. Within 2 min. Passed out for 5 to 10 seconds then tingling of arms/hands and legs. Sweating head and neck. Cramping of both hands, unable to move fingers lasting 2 to 4 minutes. Burped almost throwing up twice. Possible rapid heartbeat causing rapid breathing. Was asked to and did stay 30 to 45 minutes. Was better within 10 minutes of injection.   At home experienced being very cold some mild soreness of arm. Temperature of 96 at 3:15 pm. Temp back to normal next day.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back of my throat felt numb and had  a significant headache.  I could not sit up straight due to dizziness.  By 11:30 it was hard to talk, my throat felt thick, tight, and like it was getting small. It was difficult to swallow.  I was too dizzy to stand up. I would tip over when I stood up.  The hospital was called and advised my family to closely observe my symptoms.  At 11:20 the pharmacist gave me liquid Benadryl.  At 11:30 I took hydroxyzine, prescribed after an adverse reaction to my first covid vaccine and Tylenol.  At 12:30 my throat felt less enflamed but sore and scratchy.  At this time my whole head was itchy and the headache was not reduced.  I had a difficult time walking due to the dizziness.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Headache, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back of my throat felt numb and had  a significant headache.  I could not sit up straight due to dizziness.  By 11:30 it was hard to talk, my throat felt thick, tight, and like it was getting small. It was difficult to swallow.  I was too dizzy to stand up. I would tip over when I stood up.  The hospital was called and advised my family to closely observe my symptoms.  At 11:20 the pharmacist gave me liquid Benadryl.  At 11:30 I took hydroxyzine, prescribed after an adverse reaction to my first covid vaccine and Tylenol.  At 12:30 my throat felt less enflamed but sore and scratchy.  At this time my whole head was itchy and the headache was not reduced.  I had a difficult time walking due to the dizziness.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral pruritus, Oropharyngeal pain, Pharyngeal hypoaesthesia, Pharyngeal swelling, Throat irritation
Clinical narrative: I received the shot at 11:00 am. By 11:20 I was dizzy, lightheaded, my mouth was itchy and the back of my throat felt numb and had  a significant headache.  I could not sit up straight due to dizziness.  By 11:30 it was hard to talk, my throat felt thick, tight, and like it was getting small. It was difficult to swallow.  I was too dizzy to stand up. I would tip over when I stood up.  The hospital was called and advised my family to closely observe my symptoms.  At 11:20 the pharmacist gave me liquid Benadryl.  At 11:30 I took hydroxyzine, prescribed after an adverse reaction to my first covid vaccine and Tylenol.  At 12:30 my throat felt less enflamed but sore and scratchy.  At this time my whole head was itchy and the headache was not reduced.  I had a difficult time walking due to the dizziness.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient had a headache and a sore arm the following day.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Patient had a headache and a sore arm the following day.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Pallor
Clinical narrative: Vasovagal within 2 minutes. Sweats blurred vision almost syncope. Numbness and tingling in arms lasting 10 minutes.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Paraesthesia, Presyncope, Vision blurred
Clinical narrative: Vasovagal within 2 minutes. Sweats blurred vision almost syncope. Numbness and tingling in arms lasting 10 minutes.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: The patient did not experience any other AE; Expired MMRlI was administered; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.    On 01-MAR-2021, the patient was vaccinated with an expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # s005249, expiration date 20-FEB-2021 (dose and route were not reported) for prophylaxis. The vaccine did not have any prior temperature excursions. The patient did not experience any other adverse event.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received her first dose in NOV 2020 and she will getting the 2nd dose in March 2021; This spontaneous report has been received from a physician referring to a female patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unspecified date in November 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that on an unspecified date in March 2021, the patient received the second dose (inappropriate schedule of product administration).
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pain and soreness in my right arm at the injection site; This spontaneous report has been received from a pharmacist referring to a male patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 13-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S005857 in the right arm (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that since the vaccination, the patient had pain and soreness in my right arm at the injection site (vaccination site pain). The outcome of vaccination site pain was unknown. The causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S005857; expirationdate: 03-DEC-2020; 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 suggest a causal association with the device or device constituent
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: he had a delayed reaction to MMR II, which was a temperature of 103 Fahrenheit; This spontaneous report as received from a consumer refers to a 13-month-old male patient. The patient had no pertinent medical history, drug reactions, allergies and concomitant medications.   On 04-MAR-2021, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number, expiration date, dose and route of administration were not provided) as prevention of measles, mumps, and rubella diluted in sterile diluent.   On 17-MAR-2021, the patient had a temperature of 103 Fahrenheit (fever). The patient sought medical attention. No lab diagnostics and studies were performed. No treatment was given for the event.  The outcome of fever was reported as not recovered.  The relatedness between the vaccine and fever was not reported. However, a child's pediatrician stated the child had a delayed reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), which was a temperature of 103 Fahrenheit.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No other adverse events reported; Improperly stored vaccine was administered yesterday; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, historical conditions and drug allergies or reactions were not reported.   On 18-MAR-2021 (also reported as "yesterday"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), prefilled syringe,  lot # 1687292 with an expiration date reported and validated as 25-AUG-2022 , at the dose of 0.5 milliliter intramuscular for prophylaxis (strength, anatomical location, dose number were not reported) that was improperly stored (product storage error). No other adverse events/effects reported. No product quality complaint.  The administered vaccine experienced a temperature of 47.1 Fahrenheit for a time frame of 10 minutes. It was stated that no previous temperature excursion and a data logger was involved.  This is one of the several reports received from the same reporter. 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: 1687292; expirationdate: 25-AUG-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; Sender's Comments:  US-009507513-2103USA006091: US-009507513-2103USA006100: US-009507513-2103USA006101:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Patient recived a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 23-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Patient recived a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 24-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Nausea, Pyrexia
Clinical narrative: shingles shot / 2nd dose / weak, headache, Nauseated, and a fever of 100; shingles shot / 2nd dose / headache; shingles shot / 2nd dose / Nauseated; shingles shot / 2nd dose / fever of 100; This case was reported by a consumer via interactive digital media and described the occurrence of weakness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 16th March 2021, the patient received the 2nd dose of Shingles vaccine. On 17th March 2021, 1 days after receiving Shingles vaccine, the patient experienced weakness, headache, nausea and fever. On an unknown date, the outcome of the weakness, headache, nausea and fever were unknown.   It was unknown if the reporter considered the weakness, headache, nausea and fever to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 2nd dose of Shingles vaccine and next day experienced fever of 100 F with weakness, headache, nausea. The follow-up would not possible as no contact details were available. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot...still got shingles / shot doesn´t work/ suspected vaccination failure; I got the shot...still got shingles / shot doesn´t work; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient got the shot and still got shingles. The patient commented that the shot does not work. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Pretty sick after the second shot, too; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself or herself. The age at vaccination was not reported.  The age group was selected as an adult as per vaccine indication. The reporter stated that, got sick after 1st shot of Shingles vaccine. The reporter had a feeling how he/she was going to feel after his or her 2nd COVID vaccine next week. For the tolerance in 2nd dose refer case US2021AMR069288, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR069288:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: Shingrix knocked her out; This case was reported by a consumer via other manufacturer and described the occurrence of loss of consciousness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 7th November 2020).   On 20th February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced loss of consciousness (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of consciousness was unknown.   It was unknown if the reporter considered the loss of consciousness to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient's boyfriend. The age at vaccination was not reported. The patient got the Shingrix shot a month prior to having the Pfizer COVID vaccine and the Shingrix affected patient in terms of side effects and Shingrix knocked her out. On an unknown date patient received Pfizer COVID19 Vaccine, lot no: EN6207, expiry date: unknown. The reporter consented to follow up. This case has been linked with US2021AMR069448, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR069448:same reporter - reporter´s case
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: some lost of eye sight on left side; Headache; Fever; Throwing up; Nausea; A spontaneous report  was received from a consumer concerning her husband who is a 54-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced headache, fever, nausea, and loss of sight on the left side.  The patient's medical history cataract surgery in summer 2020, current conditions were reported as high blood pressure and glaucoma. Concomitant medications were reported as benazepril for high blood pressure and unknown eye drops for glaucoma .  On 09-JAN-2021, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On 11-JAN-2021, the patient experienced headache the worse he ever had on left side, nausea and fever. She stated that he started to lose sight on the left side but can see some light which is assessed as medically significant.  Treatment for the events included ibuprofen for headache, Lotensin and eye drops.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, headache, fever, nausea, loss of sight on the left side, were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Prior history of glaucoma may be contributory to the occurrence of the headache and unilateral vision lost.
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Incoherent, Pneumonia, Pyrexia, Thrombosis
Clinical narrative: Pneumonia; Thrombus; Incoherent; dehydrated; threw up; Fever; A Spontaneous report was received from Consumer concerning 73-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fever, incoherent, threw up, dehydrated, blood clot and he was diagnosed with Pneumonia.  The patients relevant medical history included. The concomitant medication was not reported.  On 28 Jan 2021, prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 012M20A, Expiration date: not provided) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On same day, after vaccination patient experienced fever, incoherent, threw up, dehydrated.  Few days later he went to the hospital because of shortness of breath, the hospital diagnosed him with a blood clot (on 31 Jan 2021), Then on 09 Feb 2021, he went to see his family doctor because he still did not feel well and he was diagnosed with Pneumonia.  Treatment was included as Eliquis and Antibiotic.  Action taken with the mRNA-1273 in response to the events was not provided.   On 29 Jan 2021 the outcome were recovered for fever, incoherent, threw up, dehydrated. The outcome were unknown for pneumonia and shortness of breath.  On 01 Feb 2021 the outcome blood clot was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of pyrexia, vomiting, dehydration , incoherent and thrombosis, a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of pneumonia is assessed as unlikely related. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pneumonia; Thrombus; Incoherent; dehydrated; threw up; Fever; A Spontaneous report was received from Consumer concerning 73-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fever, incoherent, threw up, dehydrated, blood clot and he was diagnosed with Pneumonia.  The patients relevant medical history included. The concomitant medication was not reported.  On 28 Jan 2021, prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 012M20A, Expiration date: not provided) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On same day, after vaccination patient experienced fever, incoherent, threw up, dehydrated.  Few days later he went to the hospital because of shortness of breath, the hospital diagnosed him with a blood clot (on 31 Jan 2021), Then on 09 Feb 2021, he went to see his family doctor because he still did not feel well and he was diagnosed with Pneumonia.  Treatment was included as Eliquis and Antibiotic.  Action taken with the mRNA-1273 in response to the events was not provided.   On 29 Jan 2021 the outcome were recovered for fever, incoherent, threw up, dehydrated. The outcome were unknown for pneumonia and shortness of breath.  On 01 Feb 2021 the outcome blood clot was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of pyrexia, vomiting, dehydration , incoherent and thrombosis, a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of pneumonia is assessed as unlikely related. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus inadequate control, Drug interaction, Hyperglycaemia
Clinical narrative: He cant seem to get his sugar under control; Blood sugar started to rise ever since vaccine; Insulin is not as effective as it used to be prior to taken the Moderna vaccine; A spontaneous report was received from a consumer (patient), elderly male patient of unknown age, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, blood sugar started to rise ever since vaccine (hyperglycaemia), he can't seem to get his sugar under control (diabetes mellitus inadequate control), and insulin is not as effective as it used to be prior to taken the Moderna vaccine (drug interaction).  The patient's current condition included diabetic. There was no medical history reported. Concomitant medication reported included are insulin.  On an unknown date, few weeks ago prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: unknown), intramuscular for the prophylaxis of COVID-19 infection.  On an unknown date, three to four days later, after administering COVID-19 vaccine, the patient's blood sugar level started to rise ever since the vaccine was given. The patient's blood sugar can't seem to get down under control which was assessed as medically significant. The patient feels that the insulin was not as effective as it used to be prior to taken the Moderna vaccine. No treatment medication information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, blood sugar started to rise ever since vaccine, he can't seem to get his sugar under control, and insulin is not as effective as it used to be prior to taken the Moderna vaccine, were not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dyschromatopsia, Macular degeneration
Clinical narrative: Macular degeneration; I had little spurts of turquoise and a dark shade of yellow; A spontaneous report was received from a Consumer concerning a 88-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events macular degeneration, everything was a beautiful shade of turquoise, it lasted about an hour, an hour and a half, and then dissipated, i had little spurts of turquoise and a dark shade of yellow.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the events everything was a beautiful shade of turquoise. it lasted about an hour, an hour and a half, and then dissipated. On 31 Jan 2021, the patient experienced the events macular degeneration and i had little spurts of turquoise and a dark shade of yellow.  Treatment details included Not provided  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, everything was a beautiful shade of turquoise, it lasted about an hour, an hour and a half, and then dissipated, macular degeneration, i had little spurts of turquoise and a dark shade of yellow was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Glaucoma, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Glaucoma diagnosis; Had the COVID arm; Arm was hot; Arm was itchy; Injection site was hard; Had a like a little rash; Arm was red; Arm was swollen; A spontaneous report was received from a consumer (patient), concerning herself, a 71 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced glaucoma diagnosis (glaucoma), had the COVID arm (vaccination site reaction), arm was hot (vaccination site warmth), arm was itchy (vaccination site pruritus), injection site was hard (vaccination site induration), had a like a little rash (rash), arm was red (vaccination site erythema), and arm was swollen (vaccination site swelling).  The patient's medical history was not provided. No concomitant product use was reported.  On 22 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 042L20A), intramuscularly in the arm for the prophylaxis of COVID-19 infection.   On 29-Jan-2021, seven days after the vaccine was administered, the patient experienced COVID arm, arm was itchy, red, swollen, hot and the injection site was hard, had a like a little rash. The rash went down to their elbow and up to top of the patient's shoulder. The symptoms calmed down in three days. On an unspecified date, the patient was diagnosed with glaucoma after getting the first dose of vaccine. The patient was due for the second dose vaccine on 01 Mar 2021. The patient was scheduled to have glaucoma surgery on 08 Mar 2021. Treatment medications included to take diphenhydramine and put ice and hydrocortisone cream on it.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of the event, glaucoma diagnosis was considered as unknown, and that of events had the COVID arm, arm was hot, arm was itchy, injection site was hard, had a like a little rash, arm was red, and arm was swollen were considered as recovered/resolved on 01 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Glaucoma diagnosis; Had the COVID arm; Arm was hot; Arm was itchy; Injection site was hard; Had a like a little rash; Arm was red; Arm was swollen; A spontaneous report was received from a consumer (patient), concerning herself, a 71 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced glaucoma diagnosis (glaucoma), had the COVID arm (vaccination site reaction), arm was hot (vaccination site warmth), arm was itchy (vaccination site pruritus), injection site was hard (vaccination site induration), had a like a little rash (rash), arm was red (vaccination site erythema), and arm was swollen (vaccination site swelling).  The patient's medical history was not provided. No concomitant product use was reported.  On 22 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 042L20A), intramuscularly in the arm for the prophylaxis of COVID-19 infection.   On 29-Jan-2021, seven days after the vaccine was administered, the patient experienced COVID arm, arm was itchy, red, swollen, hot and the injection site was hard, had a like a little rash. The rash went down to their elbow and up to top of the patient's shoulder. The symptoms calmed down in three days. On an unspecified date, the patient was diagnosed with glaucoma after getting the first dose of vaccine. The patient was due for the second dose vaccine on 01 Mar 2021. The patient was scheduled to have glaucoma surgery on 08 Mar 2021. Treatment medications included to take diphenhydramine and put ice and hydrocortisone cream on it.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of the event, glaucoma diagnosis was considered as unknown, and that of events had the COVID arm, arm was hot, arm was itchy, injection site was hard, had a like a little rash, arm was red, and arm was swollen were considered as recovered/resolved on 01 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Dyspnoea
Clinical narrative: Angioedema; Difficulty breathing; A spontaneous report was received from a pharmacist, concerning a 68 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced angioedema and difficulty breathing (dyspnea).  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 04 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for the prophylaxis of COVID-19 infection.   On 16 Feb 2021, approximately 12 days after receiving vaccine, the patient was hospitalized for angioedema with swollen oral cavities, swollen lips and difficulty breathing. He was treated with diphenhydramine, famotidine and methylprednisolone. The patient was discharged from the hospital on 19 Feb 2021. The patient did not have any changes in his diet or at home medications.   Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of events, angioedema and difficulty breathing was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of these products and the start date of the event, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Big hives went up her neck and big patches of hives up her face; A spontaneous report was received from a consumer concerning a 42 year old female patient who experienced big hives that went up her neck and big patches of hives up her face (angioedema).  The patient's medical history included high immunoglobulin E. No concomitant product use was reported.  On 12 FEB 2021, the patient received first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On an unspecified date, after receiving the vaccine, the patient broke out into hives.   On 24 FEB 2021, the patient got big hives that went up her neck and big patches of hives up her face. The patient's allergist told her that it was normal as she had high immunoglobulin E (IgE) and she was susceptible to allergies. The patient's allergist gave her a Medrol (methylprednisolone) dose pack and hives were not as itchy anymore and patient felt better. Treatment included Medrol dosepack.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, big hives went up her neck and big patches of hives up her face (angioedema) was considered as recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Left arm was swollen and red from shoulder to hand, had the appearance of cellulitis; Left arm was swollen and red from shoulder to hand; Left arm was swollen and red from shoulder to hand; Chills; Fever; A spontaneous report , was received from a Healthcare Professional concerning a unidentified patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, fever, red, swollen arm from shoulder to hand, and had the appearance of cellulitis .  The patient's medical history or concomitant medications were not provided.  On 01-FEB-2021,  the patient received their first of two planned doses of mRNA-1273 (batch number: 013L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 02-FEB-2021, the patient experienced chills, fever.   On 04-FEB-2021 the patient experienced red, swollen arm from shoulder to hand, had the appearance of cellulitis .  Laboratory reports were not provided. Treatment information included antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of the events were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Cold sweat, Loss of consciousness
Clinical narrative: A spontaneous report was received from a Consumer concerning himself, a 45-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced uncontrollable extreme abdominal pain/abdominal pain, cold sweats/cold sweat and passed out/loss of consciousness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) in his left upper arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient experienced uncontrollable extreme abdominal pain, and passed out. He also had cold sweats.   Lab data was not provided.  No treatment was taken, just rehydrated.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events -uncontrollable extreme abdominal pain, cold sweat  and passed out so badly was considered resolved within 24 hours on 16 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Malaise
Clinical narrative: Nose bleeding; Feeling sick; Headaches; A spontaneous report was received from a physician assistant concerning herself, a 52-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nose bleeding (epistaxis), headaches and sickness (malaise).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 010m20a) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, after the vaccination, the patient experienced sickness and headaches. On 18 Feb 2021, the patient experienced nose bleeding. The patient visited the emergency room on 18 Feb 2021 and 19 Feb 2021. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  Laboratory information included MIT, in which no capillary injury was found.  The outcome of the event, nose bleeding, was not recovered.   The outcome of the events, headaches and sickness, was considered as resolved on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.