chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Pain
Clinical narrative: Flu symptoms.  Body aches, chills and headache.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eye irritation
Clinical narrative: Skin around the eye area feels like it us burning. No outward signs or rash, no swelling. Just burning feeling and face feels like it's cracking when blinking or squinting. No fever or rash.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Skin sensitisation
Clinical narrative: The morning after the vaccine when I woke up feeling very run down, tired and very fatigued.  My arm felt really achy and had a lot of body aches and skin sensivity.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: tired, body aches, headache, slightly elevated temperature
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Heart rate increased, Peripheral swelling, Pyrexia
Clinical narrative: At 12:30 a.m. on March 3rd I began having severe shivering for about 3 1/2 hours. This caused my blood pressure to go up to 175/99, pulse 128. I also began running a fever at about that time and ran it for about 24 hours, highest is got was 101 . Arm is swollen. I had covid the first week of October so am not sure if this played into my reaction. I am concerned about taking my second shot if this is what I experienced with my first one.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient was suppose to receive 2nd dose of Pfizer series, but had received Moderna.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Hypoaesthesia, Myalgia, Nausea
Clinical narrative: Muscle ache at vaccination injection site radiating through neck to opposite arm after 6 hours. Tingling numbness in shoulders and arms and slight headache after 10 hours. Treated with 200mg ibuprofen. Slept a few hours. Sensations continued with ringing (buzzing ) in ears 20 hours after vaccination, took additional 200mg ibuprofen. Queasy and weak, no nausea, no diarrhea. Slept 5 hours. Chills with no fever.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Muscle ache at vaccination injection site radiating through neck to opposite arm after 6 hours. Tingling numbness in shoulders and arms and slight headache after 10 hours. Treated with 200mg ibuprofen. Slept a few hours. Sensations continued with ringing (buzzing ) in ears 20 hours after vaccination, took additional 200mg ibuprofen. Queasy and weak, no nausea, no diarrhea. Slept 5 hours. Chills with no fever.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Metabolic encephalopathy, Tremor, Walking aid user
Clinical narrative: I called to speak with patient's wife about getting her scheduled for the first injection. She reported that patient, was hospitalized a week after getting his first injection and stayed in the hospital for 3 days. She states he presented with confusion, weakness, shakiness and was thought to originally have had a TIA and then was diagnosed with metabolic encephalopathy. She states he is completely different and now has to walk with a walker and confusion persists.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Throat tightness
Clinical narrative: Patient stated that she had throat tightness and dizziness with in 15 minutes of receiving the vaccine.  She report this to me on 03/04/2021.  She stated that the sensation lasted about 1hour and 30minutes.  She did not seek medical attention.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of personal independence in daily activities
Clinical narrative: Dizziness impairing ability to perform normal functions 2 days after vaccination
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient was suppose to receive 2nd dose of Pfizer, but accidentally received Moderna.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Colectomy
Clinical narrative: Patient was admitted to undergo a laparoscopic partial transverse colectomy. Patient remains hospitalized. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache
Clinical narrative: chronic headache and dizziness that has persisted through the first and second shots.  Varies in intensity but has not resolved.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient deceased one week post-vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chest pain, Eye irritation, Fatigue, Headache
Clinical narrative: Joint inflammation, skin burning, nausea, vomiting, muscle tightness and pain, burning eyes, sinus Inflammation, chest burning, sore throat, fatigue, headache,
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Nausea, Oropharyngeal pain, Sinusitis
Clinical narrative: Joint inflammation, skin burning, nausea, vomiting, muscle tightness and pain, burning eyes, sinus Inflammation, chest burning, sore throat, fatigue, headache,
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Vomiting
Clinical narrative: Joint inflammation, skin burning, nausea, vomiting, muscle tightness and pain, burning eyes, sinus Inflammation, chest burning, sore throat, fatigue, headache,
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and red lesion around injection site
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: About a 6 inch red circle developed with swelling.  Pain from the shoulder to the elbow.  Chills, headache and very tired.  Have not seen follow up treatment because I did not know if this was normal.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: About a 6 inch red circle developed with swelling.  Pain from the shoulder to the elbow.  Chills, headache and very tired.  Have not seen follow up treatment because I did not know if this was normal.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site erythema, Injection site rash, Nausea, Pain in extremity
Clinical narrative: 2/5/21 sore arm, 2/6/21 nausea then severe vomiting & severe uncontrollable diarrhea with fever to 100.4 with symptoms lasting 24-36 hrs. L arm at injection site red with rash lasting 1 week
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: 2/5/21 sore arm, 2/6/21 nausea then severe vomiting & severe uncontrollable diarrhea with fever to 100.4 with symptoms lasting 24-36 hrs. L arm at injection site red with rash lasting 1 week
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever 101.5, very sore arm, extreme fatigue for about 30 hours
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Continuous glucose monitoring, Fatigue, Headache, Pain
Clinical narrative: Day of injection- I had a sore arm.  )n the day following the injection;  started experiencing the following s/s including arm soreness, body aches, headache, extreme fatigue, and fever (  my normal temperature is 96.4-97.4 F ) My temperature began to increase throughout the day until it reached 99.5 F about 7:30 pm .  The most serious adverse reaction was the 18 hour spike in my blood glucose level which was elevated to the high glucose level .  I ended up taking over 200 units of insulin in a 30+ hour period (normally would use this amount of insulin in a 36 hour period.  I was unable to lower my blood glucose level from the range (200-300mmg) despite repeated doses of insulin during the time period of reaction (8:00am- 4:00 am).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Day of injection- I had a sore arm.  )n the day following the injection;  started experiencing the following s/s including arm soreness, body aches, headache, extreme fatigue, and fever (  my normal temperature is 96.4-97.4 F ) My temperature began to increase throughout the day until it reached 99.5 F about 7:30 pm .  The most serious adverse reaction was the 18 hour spike in my blood glucose level which was elevated to the high glucose level .  I ended up taking over 200 units of insulin in a 30+ hour period (normally would use this amount of insulin in a 36 hour period.  I was unable to lower my blood glucose level from the range (200-300mmg) despite repeated doses of insulin during the time period of reaction (8:00am- 4:00 am).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fall, Fatigue, Headache
Clinical narrative: Moderna COVID-19 Vaccine EUA  In addition to the flu-like symptoms (headache, muscle and joint aches, fatigue, sore arm) I had an episode at 10pm on 3/2/21 where I had a sudden onset of profuse perspiring of the upper body and passed out for a short time. (falling  while at the bathroom sink) I was so weak (could not stand) when I came to that I had to lie on the bathroom floor for 15 min. or so in order to get up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Loss of consciousness, Myalgia, Pain in extremity
Clinical narrative: Moderna COVID-19 Vaccine EUA  In addition to the flu-like symptoms (headache, muscle and joint aches, fatigue, sore arm) I had an episode at 10pm on 3/2/21 where I had a sudden onset of profuse perspiring of the upper body and passed out for a short time. (falling  while at the bathroom sink) I was so weak (could not stand) when I came to that I had to lie on the bathroom floor for 15 min. or so in order to get up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Tinnitus
Clinical narrative: I had several of the common symptoms, cold chills, headache, mild joint pain, but I also had severe ringing in both ears that reduced to moderate ringing after about an hour and then to an acceptable level about 8 hours later.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Light headed/dizzy, nauseated, body aches, chills, headache.  Lasted 24 hours.  First vaccine reaction lasted 48 hrs.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Severe chills and fever of 100.4.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: Zero adverse effects after first dose. Roughly 10 hours after second dose, I had some body aches, injection site soreness, and headache. I took 650mg of acetaminophen. Roughly 12 hours after the second dose I had increased body aches, injection site soreness and swelling, worsening headache, and nausea. Roughly 18 hours after the second dose, I had chills, a low grade fever, worsening body aches, worsening headache, nausea and vomiting. I took 975mg of acetaminophen. At this time, 27 hours after the second dose, I have body aches, exhaustion, and lack of appetite. I have not vomited in 6 hours and temperature is 99.3.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Zero adverse effects after first dose. Roughly 10 hours after second dose, I had some body aches, injection site soreness, and headache. I took 650mg of acetaminophen. Roughly 12 hours after the second dose I had increased body aches, injection site soreness and swelling, worsening headache, and nausea. Roughly 18 hours after the second dose, I had chills, a low grade fever, worsening body aches, worsening headache, nausea and vomiting. I took 975mg of acetaminophen. At this time, 27 hours after the second dose, I have body aches, exhaustion, and lack of appetite. I have not vomited in 6 hours and temperature is 99.3.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Palpitations, Reading disorder
Clinical narrative: Patient received first dose of Pfizer vaccine at 1505. Patient waiting designated 15 minutes under supervision. Patient reported reading email and then noted difficulty reading email and notified RN. Notified to go to Clinic check out due to patient's report of "light headed, like I had a drink or something.". Reported heart racing. Heart rate 112 and BP 130/86 initially.  Upon patient being supine,  heart rate elevated to 123. Symptoms improved and then start again. Flushed area around neck. "I think I'm okay.: "I feel so much better." Patient reported, "I felt out of it. Like I had a drink of something."  Patient continued to wait under supervision of RN. Upon reassessment, sitting blood pressure of 118/78, heart rate 79, and oxygen saturation of 90% on room air.  "I feel fine. After two waves of weirdness."  Patient left at 1540. Patient reported symptoms had resolved.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Pain at injection site and entire muscle within 1 day of injection. Minor swelling and continued pain for 4+ days...to the point I avoided using arm to reach above my head....gradually subsided. Yesterday, 7 days post injection, I noticed itching. Today, 8 days post,  I noticed an oval redden area which is the size of a jumbo hen?s egg, inflamed,  and itching.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: PATIENT CALLED TODAY AND STATED THEY HAVE A RASH THAT DEVELOPED A FEW DAYS AGO AWAY FROM THE SITE OF THE INJECTION.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: lip and facial swelling
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness
Clinical narrative: Started feeling a little dizzy around 8:15 at night, day of shot.  Got up to use restroom at 0300, still dizzy, a little worse.  Up at 0700 next day ,much worse.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Macule
Clinical narrative: consumer developed 5-8 lesions following the VARlVAX administration; This spontaneous report was received from a nurse prescriber and refers to a 12-month-old male patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and his pertinent medical history was reported as none. On 03-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, subcutaneously, as a first dose of immunization, lot # T022315, expiry date was reported as 30-JAN-2022, but upon internal validation was established as 30-JUN-2022 (formulation, concentration and frequency were not reported). The vaccine was reconstituted with sterile diluent 0.5 ml (formulation, concetration, dose number, frequency, indication, lot # and expiry date were not reported). On 03-FEB-2021 (following the varicella virus vaccine live (oka/merck) (VARIVAX) administration), the patient developed 5-8 lesions. It was reported the patient sought medical attention. The patient did not receive any treatment for adverse event. The outcome of the event was reported as not recovered. No product quality complaint (PQC) was involved. The causality assessment was not provided.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Caller reports no additional AE; expired dose of MMRlI was inadvertently administered to a patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-FEB-2021, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 mL, lot # S005249, expiration date 20-FEB-2021 (route of administration and anatomical location were not provided) for prophylaxis. The vaccine did not experience any temperature excursions. No additional adverse event was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Malaise, Nausea, Pyrexia
Clinical narrative: diarrhea; nausea; fever; felt sick; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in 2020 in left arm and experienced chills and flu like symptoms. For the tolerance of 1st dose, refer linked case US2021008406).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced diarrhea, nausea, fever and feeling unwell. On an unknown date, the outcome of the diarrhea, nausea, fever and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the diarrhea, nausea, fever and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. In 2020, the patient received both the doses of Shingrix in his left arm.    After receiving Shingrix, the patient experienced diarrhea, nausea, fever and he felt sick like he should be in bed.   The reporter consented to follow up.  This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR008962:same reporter US-GLAXOSMITHKLINE-US2021008404:same reporter US-GLAXOSMITHKLINE-US2021008406:same patient, 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: slight fever; tiredness; muscle aches; headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2021 11:00, the patient received the 1st dose of Shingrix. On 13th January 2021, 1 days after receiving Shingrix, the patient experienced fever, tiredness, muscle pain and headache. On an unknown date, the outcome of the fever, tiredness, muscle pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever, tiredness, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient experienced slight fever, tiredness, muscle aches and headache. The patient stated that, he/she expected this, but would like to know how long this might persist.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Having body aches; Chills; Slight headache; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On 13th January 2021, the patient received the 2nd dose of Shingrix. On 14th January 2021, 1 days after receiving Shingrix, the patient experienced general body pain, chills and headache. On an unknown date, the outcome of the general body pain, chills and headache were unknown.   It was unknown if the reporter considered the general body pain, chills and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix a day before reporting. The patient experienced general body pain, chills and headache on the day of reporting. The reporter wanted to know were the two shots the same.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headache; Fatigue; Arm very sore; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, headache, fatigue and pain in arm. On an unknown date, the outcome of the fever, headache, fatigue and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, fatigue and pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced fever, headache, fatigue and arm was very sore. The patient wanted to know how long did these side effects would last as patient was concerned since Covid was rampant in his/her location and symptoms were very similar.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Feel like crap; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th January 2021, the patient received the 1st dose of Shingles vaccine. On 27th January 2021, 1 days after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles vaccine in the afternoon of day before reporting date. The patient felt like crap now.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Urticaria
Clinical narrative: broke out in hives / got hives all over; This case was reported by a other health professional and described the occurrence of hives in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 weeks after receiving Shingrix and 1 week after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   The reporter considered the hives to be possibly related to Shingrix. It was unknown if the reporter considered the hives to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. A year or so ago her husband got Shingrix shot and then a week later he got the flu shot. Then a week later he got hives all over. The reporter reported there was polysorbate in Shingrix. He had gotten the flu shot since with no problem. They thought it was the Shingrix shot. The COVID vaccine had polyethylene glycol in it. Caller stated she had previously reported it to Glaxo Smith Kline.
Sex: U
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: How long should a fever last after the Hep A vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Hepatitis A vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Hepatitis A vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient questioned, how long should a fever last after the Hepatitis A vaccine. No other information was provided. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Had it a few years ago on my face, even after the first vaccine; It's very painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles and pain. On an unknown date, the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but considered as adult as per vaccine indication. The patient received 1st dose of shingrix and experienced shingles on his face which was painful. The patient stated that received 2nd dose in 2019. The information rearding consent to follow up was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Feeling sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female 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, 3 days after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be probably related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's spouse. The age at vaccination was not reported. The patient received 1st dose shingles and experienced feeling felt sick. The reporter stated that it was probably due to shingrix vaccine, The information regarding consent to follow up was not reported.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Conjunctivitis, Deafness, Nerve injury, Vertigo
Clinical narrative: balance issues; vestibular neuritis; nerve function in one ear and partial loss in the other ear; vertigo / severe case of vertigo; conjunctivitis / conjunctivitis in the eye; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2020, 5 days after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vertigo and conjunctivitis. On an unknown date, the patient experienced balance disorder, vestibular neuronitis and nerve injury. On an unknown date, the outcome of the vertigo, conjunctivitis, balance disorder, vestibular neuronitis and nerve injury were unknown.   It was unknown if the reporter considered the vertigo, conjunctivitis, balance disorder, vestibular neuronitis and nerve injury 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 reported as follows: The patient developed vertigo and conjunctivitis 5 days after the Fluarix vaccine. No other vaccine data was provided. The patient thinks that it was given in the left arm but was not sure.  5 days later she had a severe case of vertigo with balance issues and conjunctivitis in the eye.  The patient reported having cleaned the eye out with a washcloth, but eventually had to go to the ER and visited the ENT doctor where they performed a bunch of different tests and was diagnosed with vestibular neuritis and complete loss of nerve function in one ear and partial loss in the other ear.  The patient had been suggested to did physical therapy.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Vestibular neuronitis
Clinical narrative: balance issues; vestibular neuritis; nerve function in one ear and partial loss in the other ear; vertigo / severe case of vertigo; conjunctivitis / conjunctivitis in the eye; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th October 2020, 5 days after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vertigo and conjunctivitis. On an unknown date, the patient experienced balance disorder, vestibular neuronitis and nerve injury. On an unknown date, the outcome of the vertigo, conjunctivitis, balance disorder, vestibular neuronitis and nerve injury were unknown.   It was unknown if the reporter considered the vertigo, conjunctivitis, balance disorder, vestibular neuronitis and nerve injury 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 reported as follows: The patient developed vertigo and conjunctivitis 5 days after the Fluarix vaccine. No other vaccine data was provided. The patient thinks that it was given in the left arm but was not sure.  5 days later she had a severe case of vertigo with balance issues and conjunctivitis in the eye.  The patient reported having cleaned the eye out with a washcloth, but eventually had to go to the ER and visited the ENT doctor where they performed a bunch of different tests and was diagnosed with vestibular neuritis and complete loss of nerve function in one ear and partial loss in the other ear.  The patient had been suggested to did physical therapy.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersensitivity, Mobility decreased, Pain, Pyrexia
Clinical narrative: Had a severe Allergic Reaction; Fever; Achiness; Had to stay in bed for a couple of days; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced allergic reaction, fever, pain, mobility decreased and fatigue. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the fever, pain, mobility decreased and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, fever, pain, mobility decreased and fatigue to be related to Shingrix.  Additional details were provided as follows:  The reporter was patient's spouse.  The reporter stated that his wife had a severe Allergic Reaction when she took the first Shingrix vaccine in 2019. He states that she had Fever, Achiness, and had to stay in bed for a couple of days. She did not remember which arm she had the injection. The reporter consented to follow up. All information was not available.
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspepsia, Hernia pain
Clinical narrative: Lightheaded; Weak; Umbilical Hernia Pain; Indigestion; diarrhea; nausea; Pain; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 41-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included umbilical hernia.   In January 2021, the patient received the 1st dose of Twinrix (intramuscular) and Twinrix Pre-Filled Syringe Device. In January 2021, an unknown time after receiving Twinrix and less than a week after starting Twinrix Pre-Filled Syringe Device, the patient experienced light headedness, weakness, umbilical hernia, indigestion, diarrhea, nausea and pain. On an unknown date, the outcome of the light headedness, weakness, umbilical hernia, indigestion, diarrhea, nausea and pain were unknown.   It was unknown if the reporter considered the light headedness, weakness, umbilical hernia, indigestion, diarrhea, nausea and pain to be related to Twinrix and Twinrix 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 received the Twinrix vaccine and started feeling lightheaded and weak. The patient with Umbilical Hernia also experienced also Umbilical Hernia pain, indigestion, diarrhea and nausea. The patient was vague with start times. The patient was in Urgent Care. The reporter did not consent to follow up.
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Nausea, Pain
Clinical narrative: Lightheaded; Weak; Umbilical Hernia Pain; Indigestion; diarrhea; nausea; Pain; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 41-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included umbilical hernia.   In January 2021, the patient received the 1st dose of Twinrix (intramuscular) and Twinrix Pre-Filled Syringe Device. In January 2021, an unknown time after receiving Twinrix and less than a week after starting Twinrix Pre-Filled Syringe Device, the patient experienced light headedness, weakness, umbilical hernia, indigestion, diarrhea, nausea and pain. On an unknown date, the outcome of the light headedness, weakness, umbilical hernia, indigestion, diarrhea, nausea and pain were unknown.   It was unknown if the reporter considered the light headedness, weakness, umbilical hernia, indigestion, diarrhea, nausea and pain to be related to Twinrix and Twinrix 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 received the Twinrix vaccine and started feeling lightheaded and weak. The patient with Umbilical Hernia also experienced also Umbilical Hernia pain, indigestion, diarrhea and nausea. The patient was vague with start times. The patient was in Urgent Care. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: swelling of both legs; This case was reported by a consumer via call center representative and described the occurrence of swelling of legs in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs was unknown.   It was unknown if the reporter considered the swelling of legs to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported that one week after dose 2, she experienced swelling of both legs. The patient did not have dates.   The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Swelling face
Clinical narrative: Swollen eyes and face; swollen face and eyes; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number CE45H, expiry date 1st October 2022) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2020, less than a day after receiving Shingrix, the patient experienced facial swelling and eye swelling. On an unknown date, the outcome of the facial swelling and eye swelling were recovered/resolved.   The reporter considered the facial swelling and eye swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 51 or 52. The patient was vaccinated with Shingrix in left arm. The patient had a swollen face and eyes within 24 hours after vaccination. The patient was treated with steroids and recovered from the side effects about 2 weeks. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Loss of personal independence in daily activities, Mobility decreased, Nausea, Pain
Clinical narrative: pain all over her body / Laying in bed was painful; nausea; headache; pain on her skin / pain when skin was touched / hurt to have covers on. Laying in bed was painful; could not move her body due to pain when skin was touched; could barely get up the stairs due to the pain; This case was reported by a consumer and described the occurrence of general body pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a day after receiving Shingrix, the patient experienced general body pain, nausea, headache, skin pain, mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the general body pain, nausea, headache, skin pain, mobility decreased and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the general body pain, nausea, headache, skin pain, mobility decreased and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 59 or 60 years. Within 2 hours after vaccination, the patient experienced pain all over her body but was not muscle pain and pain was described as pain on her skin. The patient could not move her body due to pain when skin was touched and said that it hurt to have covers on. Laying in bed was painful for patient and she could barely get up the stairs due to the pain. The patient also had headache and nausea. All the symptoms were lasted 7 days before resolving. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR039701:same patient, same reporter 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin
Clinical narrative: pain all over her body / Laying in bed was painful; nausea; headache; pain on her skin / pain when skin was touched / hurt to have covers on. Laying in bed was painful; could not move her body due to pain when skin was touched; could barely get up the stairs due to the pain; This case was reported by a consumer and described the occurrence of general body pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a day after receiving Shingrix, the patient experienced general body pain, nausea, headache, skin pain, mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the general body pain, nausea, headache, skin pain, mobility decreased and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the general body pain, nausea, headache, skin pain, mobility decreased and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 59 or 60 years. Within 2 hours after vaccination, the patient experienced pain all over her body but was not muscle pain and pain was described as pain on her skin. The patient could not move her body due to pain when skin was touched and said that it hurt to have covers on. Laying in bed was painful for patient and she could barely get up the stairs due to the pain. The patient also had headache and nausea. All the symptoms were lasted 7 days before resolving. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR039701:same patient, same reporter 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had / a shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix).   Co-suspect products included Herpes zoster (Shingrix).   The patient's past medical history included shingles.   On 21st January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after her second dose of Shingrix she had an outbreak in the same exact location of a shingles outbreak she had experienced before her first dose of Shingrix. The shingles were clearing up at the time of reporting. The reporter did not consent to follow up. This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: arm soreness; pain; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient experienced arm soreness and pain. The patient did not receive 2nd dose because of arm soreness and pain. The reporter consented to follow up. This was 1 of 5 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054377:same reporter
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Gastric disorder, Hallucination, Hallucination, auditory, Headache, Mental disorder
Clinical narrative: Hallucinations; Hearing voices; Nervous breakdown; Psychosis; Vomiting; Gastric issues; Severe headache; This case was reported by a physician via sales rep and described the occurrence of hallucination in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2021, the patient received Menveo, the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 26th January 2021, 8 days after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced hallucination (serious criteria GSK medically significant), auditory hallucinations (serious criteria GSK medically significant), nervous breakdown, psychosis, vomiting, gastric disorder and headache. On an unknown date, the outcome of the hallucination, auditory hallucinations, nervous breakdown, psychosis, vomiting, gastric disorder and headache were unknown.   It was unknown if the reporter considered the hallucination, auditory hallucinations, nervous breakdown, psychosis, vomiting, gastric disorder and headache to be related to Menveo, Bexsero and Bexsero 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 reported as follows: The patient suffered with nervous breakdown with psychosis and hallucinations, presented severe headache, gastric issues, vomiting and also hearing voices. The patient never had any of this symptoms before. The reporter did not consented to follow up because sales representative reported this, but doctor wants safety information for the patient.
Age: 16.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Psychotic disorder, Vomiting
Clinical narrative: Hallucinations; Hearing voices; Nervous breakdown; Psychosis; Vomiting; Gastric issues; Severe headache; This case was reported by a physician via sales rep and described the occurrence of hallucination in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2021, the patient received Menveo, the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 26th January 2021, 8 days after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced hallucination (serious criteria GSK medically significant), auditory hallucinations (serious criteria GSK medically significant), nervous breakdown, psychosis, vomiting, gastric disorder and headache. On an unknown date, the outcome of the hallucination, auditory hallucinations, nervous breakdown, psychosis, vomiting, gastric disorder and headache were unknown.   It was unknown if the reporter considered the hallucination, auditory hallucinations, nervous breakdown, psychosis, vomiting, gastric disorder and headache to be related to Menveo, Bexsero and Bexsero 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 reported as follows: The patient suffered with nervous breakdown with psychosis and hallucinations, presented severe headache, gastric issues, vomiting and also hearing voices. The patient never had any of this symptoms before. The reporter did not consented to follow up because sales representative reported this, but doctor wants safety information for the patient.