chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness/tingling in right side arm and leg
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris
Clinical narrative: Approximately 50 hours after receiving the second dose, I experienced angina in the area of the left cardiac artery . This angina lasted all day and into the night. It was gone by the following  morning.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever, headaches, chills
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Eight days after my vaccination, my arm at injection site started really itching and became hot and swollen. Called NP and sent her a picture of my arm. Didn't recommend that I come in but to keep an eye on it. It was just red, warm for several days and then started to get better. It was just strange that it happened 8 days AFTER my vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Chills  Hands & feet extremely cold & with numbness Very bad headache  Joint aches  Mild nausea  Fatigue   Headache & joint ache & fatigue lasted 4-5 days
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea
Clinical narrative: Chills  Hands & feet extremely cold & with numbness Very bad headache  Joint aches  Mild nausea  Fatigue   Headache & joint ache & fatigue lasted 4-5 days
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Patient received a different manufacturer for her second COVID-19 vaccine that her first. She experienced no adverse reaction or illness. The doses were administered 29 pages apart.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headaches starting in late afternoon increasing in intensity towards evening. Feeling feverish by 8:00 PM. Took Tylenol and went to sleep. Woke up in the middle of the night with a fever of 100. Took two more Tylenol and slept until 9:00 AM. Felt fine and temperature was back to normal.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Cold sweat, Dizziness, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: A few minutes after the COVID 19 Moderna immunization, pt became very dizzy, pale, clammy. We made his lean forward and gave him cold ice packs to the wrists. Pt refused to sit on the floor or lay down. he was nervous. we called 911. when paramedics arrived, they assess his BP, O2, sugar and ECG. His BP was elevated (>180). We observed him for 45 minutes. Then paramedics observed redness/rash in upper chest and neck. Pt was escorted to the hospital by paramedics. Pt stated to feel better .
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Pallor
Clinical narrative: A few minutes after the COVID 19 Moderna immunization, pt became very dizzy, pale, clammy. We made his lean forward and gave him cold ice packs to the wrists. Pt refused to sit on the floor or lay down. he was nervous. we called 911. when paramedics arrived, they assess his BP, O2, sugar and ECG. His BP was elevated (>180). We observed him for 45 minutes. Then paramedics observed redness/rash in upper chest and neck. Pt was escorted to the hospital by paramedics. Pt stated to feel better .
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: patient called late afternoon  stating that she is experiencing itching all over the body after taking her 1st Covid dose  in the morning
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea
Clinical narrative: Severe body chills, body temperature checked orally @ 93.9, then 3days of liquid diarrhea.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient inadvertently received a 3rd COVID vaccine dose.  Confirmed via MCIR, 2/04/21, 3/04/21 and 3/09/21.  Patient left one facility after the 2nd dose and received the 3rd dose on 3/9/21
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain
Clinical narrative: Headaches, general achiness, chills, weakness
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swollen left arm with red patch and itchy
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Woke up at 1 am to use restroom and noticed dripping from the nose and noticed it was blood.  I have never had a bloody nose where it actually was running from the nose.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE reported; MMR II involved in temperature excursion on 01/01/2021; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions and allergies were not provided.     On 01-JAN-2021, the administered dose experienced a temperature excursion at 47.01 Fahrenheit for 1 minute 30 seconds. There was no previous temperature excursion. The temperature excursion was detected by a data logger. On 26-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status recombinant Human albumin (rHA) (strength, dose and route were not provided; lot# was S037500 and expiration date was 20-NOV-2021) involved in temperature excursion for prophylaxis (product storage error). No additional adverse event reported.   This is one of the 16 cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA007556: US-009507513-2102USA007557: US-009507513-2102USA007558: US-009507513-2102USA007559: US-009507513-2102USA007568: US-009507513-2102USA007561: US-009507513-2102USA007562: US-009507513-2102USA007564: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Peripheral swelling, Rash
Clinical narrative: my arms swelled, got very hot; my arms swelled; Rash; This spontaneous report was received from a currently 79-year-old female patient reporting on herself via Pfizer. The patient's allergies included allergy to phenoxyethanol (she got rash). Concurrent conditions, concomitant medications and medical history were not provided.  On an unknown date in 2007, the approximately 65-year-old patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in 2007, she had a reaction to the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The patient experienced rash, her arms swelled and got very hot. The patient was given diphenhydramine hydrochloride (BENADRYL) and she was observed. She did not have any breathing difficulties. The patient knew, that administered vaccine had a preservative (unspecified) in it. The outcome of the events was unknown.  The causal relationship between with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events was reported as related.
Age: 0.08
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no other AE symptoms have been observed/ no adverse event from vaccination; a baby 7 weeks old and 1 day was administere VAQTA by mistake instead of a hepatitis B vaccine; Product administered to patient of inappropriate age; This spontaneous report was received from a physician and refers to a 7-week-old patient. The patient's concurrent conditions, concomitant medications, medical history, drugs reactions or allergies were not provided.  On 19-FEB-2021, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) lot # T014835 with expiration date 17-JUL-2021 (dose, route of administration were not provided) for prophylaxis, by mistake, instead of hepatitis B vaccine (manufacturer unknown). There was no adverse event reported. The doctor stated that there was no problem with the baby, it was "completely unremarkable" and no adverse event from vaccination was observed. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T014835; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 29.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PROQUAD given to 29 year old male; This spontaneous report was received from a nurse, who refers to a 29-year-old male patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and his pertinent medical history was not provided. On 25-FEB-2021, the 29-year-old patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter, for prophylaxis (formulation, concentration, dose, number route of administration, frequency, lot # and expiry date were not reported). No further details were provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion for MMR II and VARIVAX; This spontaneous report was received from a medical assistant (also reported as nurse) and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 16-NOV-2020, the patient was vaccinated with incorrectly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose, therapy type: rHA, lot # S015962, with expiration date on 23-MAY-2021 (route of administration was unknown) and varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # S025608 with expiration date on 18-AUG-2021 (route of administration was unknown) for prophylaxis. Administered vaccines underwent the temperature excursion of 16.7 degrees Fahrenheit for 1 hour on 09-NOV-2020 (reported as 09-NOV-2021) and 11.8 degrees Fahrenheit for 1 hour on 06-NOV-2020 (reported as 06-NOV-2021). Digital data logger was not involved. No adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions have been reported since administration; first dose was administered on 10NOV 2017, the second dose given 30 OCT 2020, and a third dose was administered today 26 FEB 2021; This spontaneous report was received from a nurse referring to a 4-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 10-NOV-2017, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), on 30-OCT-2020, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). On 26-FEB-2021 the patient was vaccinated with an additional dose (extra dose administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) lot number T010092 and expiration date of 19-SEP-2021 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).  Other suspect therapies included sterile diluent lot number T002832 with expiration date of 02-OCT-2022. No adverse reactions had been reported since administration.
Age: 53.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AEs.; a 53 year old patient received PROQUAD instead of MMR II on 2/26/2021.; This spontaneous report was received from a registered nurse and refers to a 53 year old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 26-FEB-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 mg injection, for prophylaxis, lot # T009930 with expiration date of 16-SEP-2021 (route of administration was not reported) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). No additional events was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse efect reported; PROQUAD that underwent a temperature excursion was administered.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-FEB-2021, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant Human albumin (rHA) (PROQUAD) lot # T027115, expiration date 07-FEB-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion from -10 degrees Celsius to 8 degrees Celsius (-3.7 degrees Celsius) for 22 hours. There was no previous temperature excursion. Data logger was involved. There was no additional adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding concomitant medication, historical condition or current condition was unknown. On or about 02-MAR-2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, Plaintiff was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not presented prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of post herpetic neuralgia and herpes zoster was considered as not recovered. The reporter considered herpes zoster and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).   Herpes zoster and postherpetic neuralgia were considered as disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Optic neuropathy, Visual acuity reduced
Clinical narrative: Optic Neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information regarding concomitant medication, current condition and historical condition was unknown. On or around 31-AUG-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered drastically visual acuity in both eyes and was diagnosed with optic neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of optic neuropathy was considered as not recovered. The reporter considered optic neuropathy to be related to zoster vaccine live (ZOSTAVAX).     Optic neuropathy was considered as disabling. Upon internal review, optic neuropathy was considered as medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE information; vaccine was going through temperature excursions since 1NOV2020 through the end of Feb 2021 and it was administered to patients during that time; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-NOV-2020, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # S027465, expiration date: 02-MAR-2021 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown dates between 01-NOV-2020 and the end of February 2021, the dose of the vaccine was exposed to unspecified multiple temperature excursions. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the vaccine was going through temperature excursions since 1NOV2020 through the end of Feb 2021 and it was administered to patients during that time; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-FEB-2021 the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S027465, expiration date: 02-MAR-202, 0.5 milliliter (formulation, strength, frequency and route of administration were not reported) for prophylaxis. On an unknown dates between 01-NOV-2020 and the end of February 2021, the dose of the vaccine was exposed to unspecified multiple temperature excursions. The call was due to digital data logger. No additional adverse event was reported.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 72-year-old patient of an unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-SEP-2017, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified) at physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster and post herpetic neuralgia. The outcome of the events herpes zoster and post herpetic neuralgia was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: rash on the right side of the abdomen and was diagnosed with herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 26-FEB-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a rash on the right side of the abdomen and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), his symptoms resulted in physical limitations not presented prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was was determined to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered to be disabling.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller reported a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 01-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme frequency, route of administration, lot number S038177, which has been verified to be valid, expiration date reported and validated as 26-NOV-2021). The vaccine administered experienced a temperature excursion of 30 degrees Fahrenheit (F), for a time frame of 72 hours, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
Sex: U
Vaccine: HIBV, HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event; temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown date, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1637651 with expiration date of 09-JUN-2022, 0.5 milliliter (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. Other suspect therapies included and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number S021456 with expiration date of 25-FEB-2022 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis. The vaccines were exposed to a temperature of 1.6 °C during a time frame of 8 hours.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Patient dies suddenly 4 days after the vaccine
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray normal, Chest discomfort, Chills, Dizziness
Clinical narrative: About 9 hours after vaccine, developed body aches and rigors, low grade temp to ~100.   Fatigued, so went to bed and took ibuprofen.  Continued to have significant body aches and rigors.  While lying in bed, developed nausea.  I got up to go to the bathroom and woke up on the bathroom floor after a syncopal episode.  I returned to bed bed and still felt very lightheaded and laid down.  I had another brief syncopal episode while lying down.  I felt short of breath and had chest tightness when I woke up.  This was around 11pm.  I was evaluated in the ED, where I continued to have body aches and rigors.  I developed fever to 101 and was given Advil and Tylenol as well as IVF.  Symptoms finally resolved.  Had COVID test (which was negative), CBC, chemistries, EKG, chest x-ray, all of which were negative/normal.  Continued to feel significantly fatigued for an additional 48 hours.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Full blood count normal, Human chorionic gonadotropin negative
Clinical narrative: About 9 hours after vaccine, developed body aches and rigors, low grade temp to ~100.   Fatigued, so went to bed and took ibuprofen.  Continued to have significant body aches and rigors.  While lying in bed, developed nausea.  I got up to go to the bathroom and woke up on the bathroom floor after a syncopal episode.  I returned to bed bed and still felt very lightheaded and laid down.  I had another brief syncopal episode while lying down.  I felt short of breath and had chest tightness when I woke up.  This was around 11pm.  I was evaluated in the ED, where I continued to have body aches and rigors.  I developed fever to 101 and was given Advil and Tylenol as well as IVF.  Symptoms finally resolved.  Had COVID test (which was negative), CBC, chemistries, EKG, chest x-ray, all of which were negative/normal.  Continued to feel significantly fatigued for an additional 48 hours.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test negative, Syncope
Clinical narrative: About 9 hours after vaccine, developed body aches and rigors, low grade temp to ~100.   Fatigued, so went to bed and took ibuprofen.  Continued to have significant body aches and rigors.  While lying in bed, developed nausea.  I got up to go to the bathroom and woke up on the bathroom floor after a syncopal episode.  I returned to bed bed and still felt very lightheaded and laid down.  I had another brief syncopal episode while lying down.  I felt short of breath and had chest tightness when I woke up.  This was around 11pm.  I was evaluated in the ED, where I continued to have body aches and rigors.  I developed fever to 101 and was given Advil and Tylenol as well as IVF.  Symptoms finally resolved.  Had COVID test (which was negative), CBC, chemistries, EKG, chest x-ray, all of which were negative/normal.  Continued to feel significantly fatigued for an additional 48 hours.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: About 9 hours after vaccine, developed body aches and rigors, low grade temp to ~100.   Fatigued, so went to bed and took ibuprofen.  Continued to have significant body aches and rigors.  While lying in bed, developed nausea.  I got up to go to the bathroom and woke up on the bathroom floor after a syncopal episode.  I returned to bed bed and still felt very lightheaded and laid down.  I had another brief syncopal episode while lying down.  I felt short of breath and had chest tightness when I woke up.  This was around 11pm.  I was evaluated in the ED, where I continued to have body aches and rigors.  I developed fever to 101 and was given Advil and Tylenol as well as IVF.  Symptoms finally resolved.  Had COVID test (which was negative), CBC, chemistries, EKG, chest x-ray, all of which were negative/normal.  Continued to feel significantly fatigued for an additional 48 hours.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cold sweat, Erythema, Flushing, Heart rate increased
Clinical narrative: Very flush, shaky, elevated HR. Pt states she feels very anxious  Vital signs: BP 120/94 HR 102 Resp 14 O2Sat 97 Skin signs: Clammy, very flush  Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally, HB normal  Monitor  At 10:20 BP 128/84 HR 88 Resp 14 O2Sat 96 Skin signs: Clammy  Circulation: Cap refill >2sec Respiratory: Breath sound clear bilaterally  Monitor. Patient noticeably more calm, less shaky, skin color noticeably improved.  BP 124/78 HR 89 Resp 12 O2sat 98  Skin signs: Clammy  Circulation: Cap refill <2sec Discharged with mother. Escorted to vehicle. States feels ok to drive. Steady. Denies dizziness or vision problems. Has had anxiety attacks.  Vaccine administered L. L skin noticeably darker, dark red. Pt states only oral intake x8 hours coffee.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Very flush, shaky, elevated HR. Pt states she feels very anxious  Vital signs: BP 120/94 HR 102 Resp 14 O2Sat 97 Skin signs: Clammy, very flush  Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally, HB normal  Monitor  At 10:20 BP 128/84 HR 88 Resp 14 O2Sat 96 Skin signs: Clammy  Circulation: Cap refill >2sec Respiratory: Breath sound clear bilaterally  Monitor. Patient noticeably more calm, less shaky, skin color noticeably improved.  BP 124/78 HR 89 Resp 12 O2sat 98  Skin signs: Clammy  Circulation: Cap refill <2sec Discharged with mother. Escorted to vehicle. States feels ok to drive. Steady. Denies dizziness or vision problems. Has had anxiety attacks.  Vaccine administered L. L skin noticeably darker, dark red. Pt states only oral intake x8 hours coffee.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Severe chills - began at 8pm ET 3/7/21 and lasted until approximately 6am 3/8/21 Headache - began at 8pm ET 3/7/21 and lasted until 6pm 3/8/21 Nausea - began at 8pm ET 3/7/21 and lasted until approximately 6am 3/8/21
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Patient stated he started to feel tingling in his lips 10 minutes after he got his vaccine.  At 9:50 am he stated he thinks he just panicked and he feel ok now, but he wants to stay at observation for 10 more minutes.  At 10:06 am he stated he feels good and is ready to go home.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Severe chills.   Moderate body aches.  Moderate headache.  Fever (peaking at 101.3).  Symptoms lasted approximately 30 hours.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Belles palsy
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling cold, Feeling hot, Flushing
Clinical narrative: Chills (inability to get warm) began at 9am for approx 3 hours.  Increased room temp and more blankets.  Finally warmed up enough to fall asleep for 2-3 hours.  Awakened at 3pm flushed and hot.  Began tracking temperature started at 100 increased to 101.8.  Forced water by mouth during the episode.  Took a shower when temperature reached 101.8 and took OTC Tylenol extra strength.  Slowly returned to normal.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: noticed a rash between my breasts down my torso.; This case was reported by a consumer and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2021, the patient received the 2nd dose of Shingrix. On 8th January 2021, 2 days after receiving Shingrix, the patient experienced rash. On 10th January 2021, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced the expected side effects that resolved the next day.  The patient however noticed a rash between breasts down to torso.  The rash was not raised and did not itch.  The reporter had this been reported before. The reporter asked opinion on this, to help decide whether to take the Covid-19 vaccine. The reporter recently sent an AE for rash following the Shingrix vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pain
Clinical narrative: Starting about 10 hours after the vaccine I felt extremely tired, a little achy, had loss of appetite  I slept drank a lot of water and took an advil and a Tylenol
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills and body aches
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy directly after shot
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Eye pain, Rhinorrhoea
Clinical narrative: Strong allergy symptoms. Heavy nose drainage and aching eyes/cheekbones. Lasted one day took Benadryl and slept.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Ffirst shot / made her right arm sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows:  The patient received 1st dose of Shingrix in right arm. After receiving 1st dose of Shingrix, the patient experienced right arm sore. The reporter did not consent to follow up. This case has been linked with US2021004404, reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021004404:Same reporter US-GLAXOSMITHKLINE-US2021004407:Same reporter. Case for reporter's mom.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Exfoliative rash, Pruritus, Rash erythematous
Clinical narrative: Eryhtematous rash, itchy and mild scaling 10 cm in diameter
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Cholelithiasis, Computerised tomogram abdomen, Electrocardiogram
Clinical narrative: Injection in left arm at 4:15 pm.  on Friday 3/5/2021.  At 9pm, 3/5/2021 he complained of chest pain and was taken by ambulance to Medical Center Emergency Room.  He was diagnosed with gallstones and discharged at approx 4:00 am on 3/6/2021.  He found non responsive at home shortly thereafter.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Scan with contrast, Ultrasound biliary tract, Unresponsive to stimuli
Clinical narrative: Injection in left arm at 4:15 pm.  on Friday 3/5/2021.  At 9pm, 3/5/2021 he complained of chest pain and was taken by ambulance to Medical Center Emergency Room.  He was diagnosed with gallstones and discharged at approx 4:00 am on 3/6/2021.  He found non responsive at home shortly thereafter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Imaging procedure
Clinical narrative: BELLS P-ALSY
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash over R arm and back starting 48hrs after first dose, then spreading to trunk, chest, both arms, neck, and face.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills, headache, fatigue
Sex: U
Vaccine: VARZOS
Symptoms: Epistaxis
Clinical narrative: Bloody nose; This case was reported by a consumer and described the occurrence of epistaxis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced epistaxis. On an unknown date, the outcome of the epistaxis was unknown.   It was unknown if the reporter considered the epistaxis to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient asked if a bloody nose be associated with the Shingrix shingles vaccine. The reporter wanted to know if the shingles vaccine (2 doses) need to be repeated or is it a onetime vaccine. This case was identified as duplicate of case US2021AMR017945. All details from the case US2021AMR017945 were already added in this case. The case US2021AMR017945 will be deleted from Argus and the case US2021AMR018024 will stand as case of record for this patient.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5 days out, injection site is still hot & red. 3 1/2"(h) x 3"(l) No pain, occasional itch, warm to touch
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Dizziness, Full blood count abnormal
Clinical narrative: pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, swollen lymph nodes, chills, dizziness, weakness, and had anxiety.  Pt called ambulance and transported to  ER.  She was tested for covid w/ negative results.  Had blood work w/ abnormal results (mild leukopenia).  She was prescribed Benadryl.  Her DX ; Dizziness, uncertain, mild medication reaction to the Covid vax.  She was released and told to FU w/ PCP.  Her FU appt is 3/12/2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Leukopenia, Lymphadenopathy, Metabolic function test, Myalgia
Clinical narrative: pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, swollen lymph nodes, chills, dizziness, weakness, and had anxiety.  Pt called ambulance and transported to  ER.  She was tested for covid w/ negative results.  Had blood work w/ abnormal results (mild leukopenia).  She was prescribed Benadryl.  Her DX ; Dizziness, uncertain, mild medication reaction to the Covid vax.  She was released and told to FU w/ PCP.  Her FU appt is 3/12/2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test negative, Urine analysis, Vaccination complication
Clinical narrative: pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, swollen lymph nodes, chills, dizziness, weakness, and had anxiety.  Pt called ambulance and transported to  ER.  She was tested for covid w/ negative results.  Had blood work w/ abnormal results (mild leukopenia).  She was prescribed Benadryl.  Her DX ; Dizziness, uncertain, mild medication reaction to the Covid vax.  She was released and told to FU w/ PCP.  Her FU appt is 3/12/2021.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Chills fever joint aches lasting about 8 hrs
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had a sore arm the next day. I had a lot of health issues but not sure they are related to the vaccine.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: MMR vaccine was given on 3/9/21 and the expiration date was 2/27/21
Sex: F
Vaccine: FLUX
Symptoms: Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Couldn't get out of bed for a day; This case was reported by a pharmacist via other manufacturer and described the occurrence of mobility decreased in a 76-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included tmj syndrome (Her jaw pain was still a problem after she received her COVIS-19 vaccine).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. When the patient had the flu shot, she could not get out of the bed for the day. The case had been linked with US2021AMR020839 same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR020839:Same reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear congestion, Fatigue, Headache, Migraine
Clinical narrative: Body aches, chills, fatigue, ear blockage; tinnitus; migraine/headache no medical treatment was sought; took Advil for the migraine
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: Body aches, chills, fatigue, ear blockage; tinnitus; migraine/headache no medical treatment was sought; took Advil for the migraine
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: On the ninth evening after vaccination large red hives appeared near the vaccination site. The area got quite swollen and hot to touch.  There was no itching or pain, just swelling and hives.  The next day the swelling subsided, hives got smaller, but the area of sking was still red and warm. That same day, I also got chills and felt like I was coming down with a cold, but that went away by the next day.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: On the ninth evening after vaccination large red hives appeared near the vaccination site. The area got quite swollen and hot to touch.  There was no itching or pain, just swelling and hives.  The next day the swelling subsided, hives got smaller, but the area of sking was still red and warm. That same day, I also got chills and felt like I was coming down with a cold, but that went away by the next day.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: Severe chills, fever and weakness
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Hyperhidrosis
Clinical narrative: Chills, sweating, back ache
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Gastrointestinal disorder, Vasculitis
Clinical narrative: vaculitis; GI symptoms; This case was reported by a physician via sales rep and described the occurrence of gastrointestinal disorder in a 6-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included premature birth (Patient was born 6 weeks premature).   On 16th October 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2020, 10 days after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced gastrointestinal disorder. On 29th October 2020, the patient experienced vasculitis. On an unknown date, the outcome of the gastrointestinal disorder and vasculitis were unknown.   It was unknown if the reporter considered the gastrointestinal disorder and vasculitis to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient along with her mother returned to physician's office on 26th October 2020 with gastrointestinal symptoms and was seen. The patient was seen again by physician on 29th October 2020 and presented with vasculitis. This was 1 of 3 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR047386:same reporter US-GLAXOSMITHKLINE-US2021AMR022342:twin´s case
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: Headache, muscle aches, stuffy nose, chills, fatigue. All very mild. All gone by the following morning.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: had a sore arm; hives from her neck down to her thighs; terrible itching; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in end of October 2020 refer case US2021021105).   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix and an unknown time after starting Atarax, the patient experienced pain in arm, hives and pruritus. The patient was treated with hydroxyzine hydrochloride (Atarax), prednisone and cimetidine (H2 Blocker). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, hives and pruritus were recovered/resolved.   It was unknown if the reporter considered the pain in arm, hives and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. Age at vaccination was not reported. The patient received 2nd dose of Shingrix at the end of December 2020.  The patient had a sore arm from 2nd injections that resolved quickly.  1 week after her 2nd dose, the patient developed hives from her neck down to her thighs that caused terrible itching.  The patient taken prednisone, Atarax and a H2 blocker to treat this.  Her symptoms resolved after one week of treatment.  No lot number or expiration date for either vaccine was known. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021021105:same reporter
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Fatigue, Feeling cold
Clinical narrative: Cold chills, intense arm pain, heavy sweats, nausea, joint/bone pain, headaches, fatigue
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: Cold chills, intense arm pain, heavy sweats, nausea, joint/bone pain, headaches, fatigue