chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever Chills Whole Body Soreness Nausea Diarrhea Joint Pain
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Hyperacusis, Tinnitus
Clinical narrative: Large tinnitus spike in both ears. I have low level tinnitus and on occasion get spikes. Shortly after the 2nd shot my tinnitus increased dramatically, louder than previous spikes. Stuffy ear feeling and hyperacusis increased as well. My tinnitus spikes can last a week or two in the past but this is much more severe.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash macular, Rash pruritic
Clinical narrative: Patient called the pharmacy 5/6/21 to question a rash on her arm where she received her COVID vaccine.  She stated that she did have a red wheel around the injection site and mild pain after her 4/22/21 vaccine but the redness faded after 5 days.  She said that she woke up this morning (5/6/21) and noticed a rash on both arms and redness around the injection site.  I told her that I wouldn't know if she was experiencing hives unless I saw the rash.  She said that she needed to stop by the store today and would stop by the pharmacy.  A few hours later, patient presented to the pharmacy. I observed her rash.  She has a large wheel of redness on her left deltoid the size of a lime.  She has a red, spotted rash on her bilateral arms and states that she does not have the rash elsewhere on the body. Patient states the rash does mildly itch.  I told her I did not believe that she was experiencing hives but referred her to her physician to determine if it could be a delayed reaction to the vaccine. Patient visited her physician this afternoon and returned to the pharmacy with a prescription for triamcinolone cream.  She also had a letter in hand from her physician stating she was medically cleared to receive her second dose of Moderna vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Diarrhoea, Fatigue, Nausea
Clinical narrative: Per family, pt reported fatigue and elevated glucose, nausea and diarrhea 3-4 days after immunization. She was seen by her PCP following week and again was experiencing elevated blood glucose.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: A week and a half following her first dose of the COVID 19 vaccine the patient reported a swollen rash that covered almost the entire upper half of her left arm.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: I had the following reactions 12 hours after shot.  Which lasted until about noon Saturday. Diarrhea four times Vomiting  three times Headache   Chills Nausea that lasted about most of the day
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot and then a month ago I got shingles/ Suspect vaccination failure; I got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated that she/he got the shot and then a month ago from the time of reporting the patient got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Musculoskeletal stiffness, Nervousness, Paraesthesia oral
Clinical narrative: Second vaccine given at 1627. 1700 pt. Stating having tingling lips and feeling shaky. Taken to sit in observation area to sit and VSS BP178/92, HR 92, sat 98%. Benadryl, 25mg PO given with water. VSS 1705 BP191/88, HR 90 and sat 94%. 1710 162/91, 90, 99%, 1715 158/91,93,96%Patient put on cart with knees up and cont. To complain of dizziness and left neck stiffness. 1720 166/83,85HR,99% 1725  154/83, HR85, 99% 1728  157/91, HR 86, 98% 1732  156/94, HR 86, 99% 1737  175/87, HR 86, 99% Took patient into wheelchair, complaining of head spinning 1741  184/72, HR 90, 97% 1747 155/87, HR 90, 98% 1751  187/91, HR 95, 95% Patient was going to attempt to go to car, but continued with dizziness; EMS called.  1756  182/84, HR 97, 99% EMS arrived at 1800; took down history  1800 182/91, HR 99, 99% Patient transferred to cart and taken to hospital. Patient alert/oriented x3, anxious for the entire encounter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Second vaccine given at 1627. 1700 pt. Stating having tingling lips and feeling shaky. Taken to sit in observation area to sit and VSS BP178/92, HR 92, sat 98%. Benadryl, 25mg PO given with water. VSS 1705 BP191/88, HR 90 and sat 94%. 1710 162/91, 90, 99%, 1715 158/91,93,96%Patient put on cart with knees up and cont. To complain of dizziness and left neck stiffness. 1720 166/83,85HR,99% 1725  154/83, HR85, 99% 1728  157/91, HR 86, 98% 1732  156/94, HR 86, 99% 1737  175/87, HR 86, 99% Took patient into wheelchair, complaining of head spinning 1741  184/72, HR 90, 97% 1747 155/87, HR 90, 98% 1751  187/91, HR 95, 95% Patient was going to attempt to go to car, but continued with dizziness; EMS called.  1756  182/84, HR 97, 99% EMS arrived at 1800; took down history  1800 182/91, HR 99, 99% Patient transferred to cart and taken to hospital. Patient alert/oriented x3, anxious for the entire encounter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Cheilitis, Culture wound, Discharge, Lip swelling
Clinical narrative: Pt had the Vaccine May 1st and the next morning woke up with lower lip swelling and a small sore in center of her lip. Pt is now having yellow discharge from the sore.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient had a fever, aches, pain, tiredness, sore arm lasting 3 days
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Presyncope
Clinical narrative: it seems like patient have vasovagal symptoms 5 minutes right after vaccinated. she was nauseated and  sweat and almost faint. she said that she has hard time breathing. WE gave her 0.3mg epinephrine then she is ok  and better. we called EMS over. and she is all fine after that. SHE did not need to go to hospital.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received vaccine after 13 days from first dose (15 days early for 28 days).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Malaise
Clinical narrative: Patient was waiting/ being observed after receiving the Janssen Covid vaccine. Approximately 10 minutes after the vaccine, he reported feeling very faint and was about to pass out. He wasn't feeling well so 911 was called. He also reported feeling hot and was visibly sweating. He drank some water and sat in front of a small fan until medics arrived. They assessed him and he walked out with them for further evaluation. I called patient at 7:30 to see how he was feeling. There was no answer and his voicemail didn't allow me to leave a message.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, Seizure
Clinical narrative: On 4/23/2021 I suffered a seizure while showering, after meeting with my doctor and a neurologist I was advised to fill out this form while they are still researching what had caused the seizure.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Started to get tired and thirsty the evening of the 30th a few hours after the vaccine. Went to bed around 10:30 and woke up about 3 hours later at 1:30. Had chills and was shaking when I got up. Could not really fall back asleep. Chills turned into a fever. That morning I started to get a headache. I sounded congested at one point, but no runny nose. I also had body and joint aches.  I took Excedrin three times that day. Once in the morning, once in the afternoon, once before bed. I used zquil to sleep a little bit in the afternoon and again at night. I woke up Sunday and felt completely fine except for my arm still being sore.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Respiratory tract congestion, Sleep disorder, Thirst
Clinical narrative: Started to get tired and thirsty the evening of the 30th a few hours after the vaccine. Went to bed around 10:30 and woke up about 3 hours later at 1:30. Had chills and was shaking when I got up. Could not really fall back asleep. Chills turned into a fever. That morning I started to get a headache. I sounded congested at one point, but no runny nose. I also had body and joint aches.  I took Excedrin three times that day. Once in the morning, once in the afternoon, once before bed. I used zquil to sleep a little bit in the afternoon and again at night. I woke up Sunday and felt completely fine except for my arm still being sore.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Started to get tired and thirsty the evening of the 30th a few hours after the vaccine. Went to bed around 10:30 and woke up about 3 hours later at 1:30. Had chills and was shaking when I got up. Could not really fall back asleep. Chills turned into a fever. That morning I started to get a headache. I sounded congested at one point, but no runny nose. I also had body and joint aches.  I took Excedrin three times that day. Once in the morning, once in the afternoon, once before bed. I used zquil to sleep a little bit in the afternoon and again at night. I woke up Sunday and felt completely fine except for my arm still being sore.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, C-reactive protein increased, Chills, Feeling hot, Headache
Clinical narrative: I had stayed awake because I work nights and then I went to sleep. I woke up with excruciating headache - worst I've ever had. I checked my temperature - it was 99.4 and I had chills. I normally run cold.  I felt awful I took a couple of Tylenol and ibuprofen - waited for it to take the bite off so I could go to sleep. I called off into work. I waited until about 11:00 - 11:30 enough so I could go back to sleep. I took two more Tylenol and Ibuprofen and I took Benadryl. I woke up the next day and felt great when I woke up. Sometime in early-mid March, I had a flare up of pain. First it was my hands - from my elbows down to my fingertips - started to hurt. My hands were aching. It started spreading throughout my whole body - hands, knees, ankles, back - it was moving. One day, I couldn't even move. I was taking Ibuprofen non-stop, I was in so much pain. My hands were hot and throbbing like I was sunburnt. My knuckles and joints were aching - everything was swelling up. Mostly staying in the joints - felt hot and achy. I slept with ice on my hands. At work, I kept filling up plastic bags with ice and holding them on my hands. Symptoms were from neck to tailbone  - my whole spine - and my hips. Sometimes it was all the above - everything below my ears along with a very mild headache. And then it became focused in certain spots. It shifts up and down. It definitely stays in my sacral region and my greater trochanter in my hips; in my elbows and in my knees. It is now starting to get a bit better -  it's nothing like it was before.  It took awhile to reach my Primary Dr. to get a  referral for Rheumatologist. Had gone to Urgent Care on  April 7, 2021; Doctor visit 4/29/2021
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Rheumatoid factor
Clinical narrative: I had stayed awake because I work nights and then I went to sleep. I woke up with excruciating headache - worst I've ever had. I checked my temperature - it was 99.4 and I had chills. I normally run cold.  I felt awful I took a couple of Tylenol and ibuprofen - waited for it to take the bite off so I could go to sleep. I called off into work. I waited until about 11:00 - 11:30 enough so I could go back to sleep. I took two more Tylenol and Ibuprofen and I took Benadryl. I woke up the next day and felt great when I woke up. Sometime in early-mid March, I had a flare up of pain. First it was my hands - from my elbows down to my fingertips - started to hurt. My hands were aching. It started spreading throughout my whole body - hands, knees, ankles, back - it was moving. One day, I couldn't even move. I was taking Ibuprofen non-stop, I was in so much pain. My hands were hot and throbbing like I was sunburnt. My knuckles and joints were aching - everything was swelling up. Mostly staying in the joints - felt hot and achy. I slept with ice on my hands. At work, I kept filling up plastic bags with ice and holding them on my hands. Symptoms were from neck to tailbone  - my whole spine - and my hips. Sometimes it was all the above - everything below my ears along with a very mild headache. And then it became focused in certain spots. It shifts up and down. It definitely stays in my sacral region and my greater trochanter in my hips; in my elbows and in my knees. It is now starting to get a bit better -  it's nothing like it was before.  It took awhile to reach my Primary Dr. to get a  referral for Rheumatologist. Had gone to Urgent Care on  April 7, 2021; Doctor visit 4/29/2021
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Sensitive skin
Clinical narrative: fever of 99.5 around 430pm (on a digital thermometer that usually reads 97.5-6, so it may actually be higher) took 200 mg motrin earlier (7am) for body aches/skin sensitivity/chills.  When I realized I had a fever I took another 200mg ibuprofin, applied cold pack to forehead will seek emergency room or urgent care if it doesnt go down in a couple hours
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Hypersensitivity, Malaise, Nasal congestion, Pain
Clinical narrative: Stuffy head stuffy nose; Aches and pains; Chills; Fever; Sick from first dose; I might be allergic; This case was reported by a consumer via (Shingrix GSK  interactive digital media and described the occurrence of nasal stuffiness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced nasal stuffiness, pain, chills, fever, sickness and allergic reaction. On an unknown date, the outcome of the nasal stuffiness, pain, chills, fever, sickness and allergic reaction were unknown.   It was unknown if the reporter considered the nasal stuffiness, pain, chills, fever, sickness and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient was vaccinated with 1st dose of Shingrix a day before reporting. On an unknown date, in May 2021, the patient had stuffy head-stuffy nose aches, pains, chills, fever, allergic reaction and was sick from the shot. The patient was asked about inactive ingredients of vaccine as the patient might be allergic.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Stuffy head stuffy nose; Aches and pains; Chills; Fever; Sick from first dose; I might be allergic; This case was reported by a consumer via (Shingrix GSK  interactive digital media and described the occurrence of nasal stuffiness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced nasal stuffiness, pain, chills, fever, sickness and allergic reaction. On an unknown date, the outcome of the nasal stuffiness, pain, chills, fever, sickness and allergic reaction were unknown.   It was unknown if the reporter considered the nasal stuffiness, pain, chills, fever, sickness and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient was vaccinated with 1st dose of Shingrix a day before reporting. On an unknown date, in May 2021, the patient had stuffy head-stuffy nose aches, pains, chills, fever, allergic reaction and was sick from the shot. The patient was asked about inactive ingredients of vaccine as the patient might be allergic.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Contraception, Mobility decreased, Pain in extremity
Clinical narrative: For a couple of days, patient felt a soreness/little of pain in left arm after vaccinated. She mentioned that she did exercise after vaccination and on 05/06/21, she experienced a strong contraction/pain in left arm down through her wrist/ hand with a lack of ability to move her left arm freely. She took Tylenol but it did not help her much so she is following up with a doctor.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Night sweats, Pyrexia
Clinical narrative: Fever spiked to 100° briefly, Night Sweats every night for a week, Achy joints worse day 5/2 but still ongoing, better each day.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Carotid artery thrombosis, Cerebral artery thrombosis, Cerebral mass effect, Cerebrovascular accident, Rhabdomyolysis
Clinical narrative: Patient presented 3-4 weeks after receiving the Janssen COVID vaccine with right MCA stroke with mass effect, mild midline shift and right MCA thrombus.  Carotid ultrasound showed thrombosis of the right common and internal carotid arteries and right carotid siphon. She was found down, last seen normal 2 days prior to admission. She was not a candidate for tPA given the delayed presentation and unlikely to benefit from  thrombus extraction. She was treated with aspirin and atorvastatin and treated for rhabdomyolysis. Patient is currently still admitted to the hospital but transitioning to comfort focused care.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Ultrasound Doppler abnormal
Clinical narrative: Patient presented 3-4 weeks after receiving the Janssen COVID vaccine with right MCA stroke with mass effect, mild midline shift and right MCA thrombus.  Carotid ultrasound showed thrombosis of the right common and internal carotid arteries and right carotid siphon. She was found down, last seen normal 2 days prior to admission. She was not a candidate for tPA given the delayed presentation and unlikely to benefit from  thrombus extraction. She was treated with aspirin and atorvastatin and treated for rhabdomyolysis. Patient is currently still admitted to the hospital but transitioning to comfort focused care.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Nausea, Vomiting
Clinical narrative: back pain and N/V after 2nd dose of COVID vaccine
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient said day after receiving Pfizer covid vaccine she developed a rash on one breast, the same side her shot was administered (left side). Denies any other symptoms.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Contracted covid-19 . Symptoms (fever, chills, body aches, headache) from 4/19 thru 4/24
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Ear, nose and throat examination, Feeling abnormal, Tinnitus
Clinical narrative: Hearing loss, tinnitus, brain fog
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Herpes virus infection, Streptococcus test, Vaginal ulceration, Vulvovaginal pain
Clinical narrative: 51 hours after receiving the 2nd Pfizer vaccine does, I began to experience pain severe in my vaginal area. This pain grew into an ulcer type of sore. I visited three doctors, was tested once for a yeast infection and twice for herpes.  All three labs results were negative, while a minor strep B growth was identified. The area grew more severely painful over the course of 10 days, then it slowly began to resolve. After 17 days, the pain has gone and the site has almost completely resolved itself.  I am taking penicillin to address the strep.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: little achy painy; very low grade fever; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.  On 3rd May 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain and low grade fever. On an unknown date, the outcome of the pain and low grade fever were recovering/resolving.   It was unknown if the reporter considered the pain and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. On an unknown date, in May 2021, after receiving Shingrix, the patient experienced mild symptoms of little achy pain and low-grade fever and just wondered if he/she could take Tylenol or Ibuprofen. The patient reported that, with some vaccines like Covid vaccine, the patient was told to not take any pain medication. At the time of reporting, the patient was fine and did not experience any major.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: Vaccine administered at 1:20 pm and patient reported feeling hot, dizzy, and was worried he was going to faint at 1:30pm.  The patient laid on the ground and was pale and visibly sweating. Patient was given gatorade and began feeling better within 2 minutes.  Blood Pressure and Heart Rate were taken at 1:32pm and 1:50pm and both within normal limits.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: I have been spotting since my first shot on 4/13/21 which I didn?t think anything of. And then after my second dose on 5/4/21, I started my period today on 5/6/21. I am not supposed to get my period until 10 days from now. I have never had a period come early as my cycle is like clockwork due to my birth control.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Peritonitis, Rash
Clinical narrative: On the 2nd night after receiving the 1st shot of Moderna vaccine, I experienced intense abdominal pain. It was like if someone was pulling and twisting my intestines. The pain was acute  for about 1hr, then it started fading with renewed but shorter periods of more intense pain. I thought of peritonitis, and if the pain didn't subside I might have called an ambulance. I just decided to lay low  and let the pain pass. It was scary.  The next day on May 3rd, I awoke with rush over my upper body,. Little bubbles was dispersed across my abdomen, shoulders, sides but were few and not dense, so I let it pass. Currently the rush is still on, thankfully don't have the abdominal pain any longer.  However, I am not sure that I shall get the 2nd Moderna shot. I won't survive the intestines twisting pain if increased.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Ear pain, Headache, Injection site pain
Clinical narrative: Severe chills, fever, pain at injection site, ears hurt, ears ringing, massive headache, tired, malaise, weakness and sore throat.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Pyrexia, Tinnitus
Clinical narrative: Severe chills, fever, pain at injection site, ears hurt, ears ringing, massive headache, tired, malaise, weakness and sore throat.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fibromyalgia, Headache, Pain, SARS-CoV-2 test negative
Clinical narrative: A few days after receiving the first dose I started experiencing body aches, headache and minor back pain.  The body aches only continued to get worse over time as  well as the back pain. I did not have back problems or pain until the vaccine. I contacted my primary physician and explained that I received the vaccine and told her about my symptoms. She asked me to get a Covid-19 test. I did and the results was negative. At his point, May  6, 2021, the symptoms have only become worse. My back pain is so severe I can barely stand it. I have tried ice packs, a heating pad, over the counter pain medication and nothing has made it better. My physician does not know what to do. Another side effect is it has made my fibromyalgia pain much worse. I have had fibromyalgia for about fifteen years and my pain is tolerable but the past few weeks have been unbearable. I may have a weakened immune system due to the fibromyalgia so maybe  that could be a explanation for my symptoms. I wanted to know if other people have experienced severe side effects. The only treatment is over the counter pain medication and ice packs and a heating pad.  As of today, May 6, the back pain and body aches are still present and I would say severe. The headache is tolerable but still lingers and does not go away. The body aches, headache and back pain is twenty four hours a day and never get better.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Throat tightness, Tongue disorder
Clinical narrative: Patient began experiencing chest tightness between 10-15 minutes after vaccination, followed by throat tightness and tongue thickness. Banophen (diphenhydramine) 50 mg administered PO. Shortness of breath began about 10 minutes after initial complaint, at which time epinephrine 0.3 mg was administered IM R thigh. Patient reported increasing shortness of breath and tightness of chest and throat, 0.3 mg epinephrine administered again IM left thigh about 6 minutes after previous dose. Patient requested additional diphenhydramine, so 50 mg Banophen administered PO. Continued increasing severity of symptoms, another epinephrine 0.3 mg IM right thigh 7-9 minutes after previous dose. Patient care was then transferred to EMS services.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This is my second time with them! / had the shot right after my 1st breakout; They really hurt!; 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.   The patient's past medical history included shingles (1st breakout).   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 unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient had the shot right after 1st shingles breakout. The patient was diagnosed last week from the time of reporting and the patient stated that getting to the physician early really helped. This was patient's second time with shingles and they really hurt. The patient did not know if it was really any milder. The patient was ready to get second round of shots as soon as he/she could.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness
Clinical narrative: Loss of hearing 2 hours after first dose.  Continuous till today's date
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Early pregnancy loss 1/2021
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT RECEIVED VACCINE 15 DAYS EARLY (ACCORDING TO 28 DAY SCHEDULE). WAS INFORMED THAT SECOND DOSE IS 28 DAYS AFTER AND WAS MENTIONED AT TIME OF VACCINE THAT PT MARKED LAST VACCINE WITHIN 14 DAYS BUT DUE TO MISCOMMUNICATION AND OTHER PATIENTS MISTAKING IT FOR THEIR LAST COVID VACCINE WITHIN 28 DAYS THEREFORE SHOT WAS MISTAKENLY GIVEN EARLY.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Patient suffered cardiac arrest today
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Blood test, Computerised tomogram, Echocardiogram, Magnetic resonance imaging
Clinical narrative: Flashes and blurred vision in the left eye, various eye exams conducted and fluid drained in an attempt to lower pressure and remove clot (unsuccessful).  The event resulted in Central Retinal Artery Occlusion and loss of vision.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmic fluid drainage, Ophthalmological examination abnormal, Photopsia, Retinal artery occlusion, Scan with contrast
Clinical narrative: Flashes and blurred vision in the left eye, various eye exams conducted and fluid drained in an attempt to lower pressure and remove clot (unsuccessful).  The event resulted in Central Retinal Artery Occlusion and loss of vision.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Flashes and blurred vision in the left eye, various eye exams conducted and fluid drained in an attempt to lower pressure and remove clot (unsuccessful).  The event resulted in Central Retinal Artery Occlusion and loss of vision.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Fever, fatigue, lymph node swelling, body aches, headache, sore throat, chills, muscle and joint pain, nausea, slight breathing difficulty,     Still have chills - shaking while sleeping,  fatigue, body aches.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever, fatigue, lymph node swelling, body aches, headache, sore throat, chills, muscle and joint pain, nausea, slight breathing difficulty,     Still have chills - shaking while sleeping,  fatigue, body aches.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Fever, fatigue, lymph node swelling, body aches, headache, sore throat, chills, muscle and joint pain, nausea, slight breathing difficulty,     Still have chills - shaking while sleeping,  fatigue, body aches.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram
Clinical narrative: Chest pains.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick from first dose; This case was reported by a consumer via (Chatbot) interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details was reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured adult as per vaccine indication. The patient was sick after vaccination. No other information was available.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Rash
Clinical narrative: Upper arm felt swollen about a week after injection, rash began to appear and area felt hot starting 5/3. Rash still visible but is reducing when icing the area.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Herpes zoster, Rash
Clinical narrative: I have been experiencing soreness in my back over the past weekend as if I may have pulled a muscle.   Over the last 48 hours I have developed a rash around my torso in where the soreness is located.  After doing some research, I believe I have a case of shingles.  I scheduled an appointment with my doctor for tomorrow to get checked out and receive treatment.   My rash looks just like pictures of shingles that are on the internet.  I also read that the covid vaccination can trigger shingles in certain recipients.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Redness, swelling, soreness, and fever
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: PATIENT LOST CONSCIOSNESS FOR A SECOND.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred, Vomiting
Clinical narrative: Vertigo and vomiting. Blurred vision and focus.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Dizziness
Clinical narrative: Patient was anxious and reported history of syncope 2 days prior. States he feels dizzy while sitting. His blood pressure was elevated at 179/100 mmHg. Heart rate and oxygen saturation were within normal limits. Retook blood pressure a second time 165/91 mmHg. Third blood pressure 165/87 mmHg. Fourth blood pressure 164/84 mmHg.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea
Clinical narrative: PATIENT BECAME LIGHT HEADED, BEGAN BREATHING HEAVY, AND NAUSEATED
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Apr 19 - felt tired, warm then chills, headache; Apr 20 - fever spiked to 103.6, chills, weakness, headache, nauseated, no food, drank Gatorade; Apr 21 - symptoms continued, took Tylenol, Excedrin Migraine, fever went down to normal, spiked at night; Apr 22 - went to drive-thru clinic, PCR test negative, symptoms continued, profuse sweating at night; Apr 25 - woke up covered in hives, feverish went to Walk-In; Apr 26 - sent Dr. photo of hives, all other symptoms continued, getting weaker; Symptoms continued, hives resolved within 2-3 days, as of today, May 6, 2021 - I am so weak I get dizzy and have to get my breath back at the slightest exertion - no more fever or hives
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Headache, Nausea, Night sweats, Pyrexia
Clinical narrative: Apr 19 - felt tired, warm then chills, headache; Apr 20 - fever spiked to 103.6, chills, weakness, headache, nauseated, no food, drank Gatorade; Apr 21 - symptoms continued, took Tylenol, Excedrin Migraine, fever went down to normal, spiked at night; Apr 22 - went to drive-thru clinic, PCR test negative, symptoms continued, profuse sweating at night; Apr 25 - woke up covered in hives, feverish went to Walk-In; Apr 26 - sent Dr. photo of hives, all other symptoms continued, getting weaker; Symptoms continued, hives resolved within 2-3 days, as of today, May 6, 2021 - I am so weak I get dizzy and have to get my breath back at the slightest exertion - no more fever or hives
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Apr 19 - felt tired, warm then chills, headache; Apr 20 - fever spiked to 103.6, chills, weakness, headache, nauseated, no food, drank Gatorade; Apr 21 - symptoms continued, took Tylenol, Excedrin Migraine, fever went down to normal, spiked at night; Apr 22 - went to drive-thru clinic, PCR test negative, symptoms continued, profuse sweating at night; Apr 25 - woke up covered in hives, feverish went to Walk-In; Apr 26 - sent Dr. photo of hives, all other symptoms continued, getting weaker; Symptoms continued, hives resolved within 2-3 days, as of today, May 6, 2021 - I am so weak I get dizzy and have to get my breath back at the slightest exertion - no more fever or hives
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: still get the shingles even if you have the shot.I have had them 2times/Suspect vaccination failure; still get the shingles/I have had them 2times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got 2 times Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope for about 5 minutes.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Product preparation issue
Clinical narrative: Mixing error occurred, patient may have received only diluent. re-vaccinated 5/5.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia
Clinical narrative: dizziness, could not stand straight,
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardioversion, Electrocardiogram
Clinical narrative: Atrial fibrillation at 11:45pm on 4/14 resulting in carioverson at 2:00am in 4/15
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: At first I thought I was getting a pimple on my left shoulder, but it soon turned into a nasty patch of Shingles.  I have had Shingles before, so I was certain that's what it was!  PCP prescribed Acyclovir, which took care of it!
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Injection site pruritus, Pain
Clinical narrative: Chills  Body pain Fatigue Pain at injection site Itchiness at injection site
Age: 39.0
Sex: M
Vaccine: UNK
Symptoms: Eye swelling, Lip swelling
Clinical narrative: patient c/o swelling to lips and swelling under eyes . treated with hydroxyzine 2mg tid
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had shingles even though I had a shingles shot/ Suspect vaccination failure; I had shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication. The patient had the shingles vaccine and 4 weeks after receiving covid-19 vaccine, the patient experienced shingles.   The reporter reported that understand there was a new shingles vaccine we should all be getting and get it and save yourselves pain. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. It was unknown if the reporter considered the shingles and pain to be related to covid-19 vaccine.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: pediatric second dose on 12/04/2020/received a third adult dose 4/29/2020; administration of a pediatric second dose/ adult pateint; administration of a pediatric second dose/adult pateint; Drug dose administration interval too long; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 58-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose on 5th November 2020).   On 12th April 2021, the patient received the 2nd dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 29th April 2021, the patient received the 3rd dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On 12th April 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product, underdose and drug dose administration interval too long. On 29th April 2021, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the adult use of a child product, underdose, drug dose administration interval too long and drug dose administration interval too short were unknown.   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 age at vaccination was not reported. The patient received 2nd dose paediatirc of Engerix B, which led to adult use of child product and underdose. The patient received 2nd dose paediatirc of Engerix B, more than the recommended interval, which led to lenghtening of vaccination schedule. The patient received 3rd dose of Engerix B, less than the recommended interval, which led to shortening of vaccination schedule. The reporter stated that, 2nd dose was invalid and was not given immediately afterwards. The reporter also stated that, 3rd dose was considered as valid 2nd dose. No reaction reported. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix on 25th May, 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided follows:  The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details could be grabbed during call. Attempted to attain patient and vaccination information from healthcare professional (HCP), but they did not provided. The reporter did not consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the adjuvanted diluent without it being reconstituted; received the adjuvanted diluent without it being reconstituted; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number MM59F, expiry date 14th October 2022) for prophylaxis.   On 1st April 2021, the patient received Shingrix. On 1st April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows:  Medical assistant reported that the patient received only adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a six months patient received Kinrix instead of Pediarix; received Kinrix instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   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: Nurse reported that a 6 month old patient was administered Kinrix instead of Pediarix, which lead to inappropriate age at vaccine administration and wrong vaccine administered. No further information was received. The reporter consented to follow up.