chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: She got her vaccine, had nothing immediately.  Hours later, within 24 hours she had a rash on her legs and very itchy, raised red areas.  Then it spread and it still spreading, which it has been over a month and has new eruptions.  It keeps coming, and not getting better.  The itching is very intense and she gets allergy shots once a month and this is worse than any reaction she may have to her shots.  It's on her back, stomach, all over her breats, buttocks, arms and pretty much all over her body.  It is not on her face and minimally on her arms.  It comes on the top of her legs but not under her knees area, but it's becoming a life problem due to all the itching.  Her husband has the same type of reaction from the same vaccine.  She notified the doctors office within 24 hours and put some cortisone on it, but was helping at first and then did not.  She did a video office visit with the NP, and she told her that she knows she has allergies and that she has an allergist Dr.  She thought that he would be more of an expert on this subject, and that office came in.  A week ago today she went to his office and showed him her stomach and he gave her some oral steroids and a topical steroid cream, but said that he did not think it would bring down right away.  She had to set up a 3 part appointment as this was going to be more involved and needed to get a patch test.  Formaldehyde is an ingredient in it that was a problem, and another ingredients that he felt was highly suspect that she was having a reaction to.  It's an inert ingredient that should not be a problem, can be one.  She has to have the patches on, have 2 more appointments to have them looked while they are on and then have them checked.  she was to start with 1 1/2 pills for 4 days, then cut down to 4 days with 1 pill, then 4 days with 1/2 a pill.  The steroids are not helping yet.  She had the COVID vaccines, flu vaccine, Prevnar, RSV and Shingrix with no reactions.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient is having swelling and redness of lower half of upper left arm that extends down a few inches past the elbow joint. Started the day after the vaccine. Patient has been taking Claritin and using cold compresses which have been helping but have not completed rid of the swelling,
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: really severe pain throughout left arm and shoulder right after getting the vaccine.
Age: 85.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Diarrhoea, Dizziness, Gait disturbance, Mobility decreased
Clinical narrative: husband was weak could not get up out of bed, when he finally did could not move legs to walk. was dizzy and had diarrhea
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events/outcomes to be known by PCP or reported by parents as of Sept 27, 2024. Multiple attempts have been made to contact parents since Sept 17th, however, phone numbers on file have been out of service.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Impaired work ability, Nausea, Rash, Rash erythematous
Clinical narrative: Per employee "After I take the flu shot everything was fine I walk back to my department and I start to have lightheaded, nausea and very dizzy,  I seat down in our breakroom my coworkers bring me some ice to put in the back of my neck I stay for about 25 minutes felling like this I get up to try to finished my job but everything start to spin around me again , I inform my supervisors what s going on I wasn t unable to finished my job so I went home around 11:50 am  and take some Claritin went to sleep after I wake up around 5 pm  I notorious red patches on my chest more like a rash so I take more Claritin and went sleep I wake today feeling fine."
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Per employee "After I take the flu shot everything was fine I walk back to my department and I start to have lightheaded, nausea and very dizzy,  I seat down in our breakroom my coworkers bring me some ice to put in the back of my neck I stay for about 25 minutes felling like this I get up to try to finished my job but everything start to spin around me again , I inform my supervisors what s going on I wasn t unable to finished my job so I went home around 11:50 am  and take some Claritin went to sleep after I wake up around 5 pm  I notorious red patches on my chest more like a rash so I take more Claritin and went sleep I wake today feeling fine."
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction to having been given an Adult Hep B.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Dad described redness 24 hours after vaccine.  Then, 48 hours vaccine large area of erythema, swelling, and tenderness with palpation.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECIEVED ADDITIONAL DOSE OF FLUVARIX
Age: 42.0
Sex: M
Vaccine: HEP, HPV9, IPV
Symptoms: Urticaria
Clinical narrative: Hives started within less than 24 hours of receiving the vaccines.  Came to clinic 7 days later and still had hives.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Started with chills about 10pm, progressed to nausea then vomiting, having a scanned temperature of 102.3 degrees. Fever, tiredness and general unwell feeling continued unto afternoon of 9-27
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Started with chills about 10pm, progressed to nausea then vomiting, having a scanned temperature of 102.3 degrees. Fever, tiredness and general unwell feeling continued unto afternoon of 9-27
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Coordination abnormal, Disorientation, Seizure
Clinical narrative: The patient had his influenza vaccine, then a few hours later he had a seizure lasting less than 5 minutes. He was disoriented and uncoordinated for approximately an hour afterwards, but appears to be fine now. We reported the seizure to his neurologist, Dr. at the university. We also reported it to his primary care. He has an appointment to see Dr. made previous to the seizure where we will follow up.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Report of vomiting, headache, fever by parent on 09/27/2024.  School nurse reported no fever (temp 98.2 last 2 days), no vomiting.  Child did report a headache 09/27/24, but child was told by mother to tell the nurse if she had a headache and could be sent home.
Age: 77.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: Severe joint pain, headache, dizziness, extreme fatigue beginning about 12 hours after inoculation.  Headache lasted about 5 hours.  Joint pain and fatigue lasted 7 days, fatigue still ongoing a little, but getting a little better each day.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site reaction, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Report of fever and big round rash with red bumps at site by parent on 09/27/24.  School nurse reported no fever (temp 98.2 last 2 days).  School nurse stated the child does have a tiny red rash below the injection site which is red and slightly raised. less than 2 cm in diameter and appears to be localized as the area is not warm to touch.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Patient was given a Dtap instead of Td that was needed.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: had previously received dose
Age: 1.92
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Patient was given a dose of Hib and did not need it.
Age: 39.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Anxiety, Feeling hot, Gait disturbance, Hypoaesthesia, Paraesthesia
Clinical narrative: Felt fever in their legs, from the knees down, with a feeling of limited circulation. Caused difficulty in walking due to numbness and the sensation of pin needles in their legs. Experienced multiple days ( approx. 2 weeks), with one night causing so much anxiety that they attempted to eat the sensation away.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: Patient had severe pain in arm as well as severe body aches and fever for 6 days.For a couple of days, he could barely move his arm. A couple days after the injection, he also had jaw pain where he had a filling in the past (dentist said COVID vaccines can activate a nerve in the jaw and cause pain). Patient use salt water gargle, took OTC pain relievers, and rested. Patient is 10 days out now and this is the first day he has not had jaw pain. The other symptoms have subsided mostly as well.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: A few hours after vaccine was administered, I began noticing numbness and tingling in 2-3 fingers on my left hand.  Two days later, still present, so went to doctor.  No determination made that it was directly related to vaccine.  However, I had no symptoms before the shot was administered.  It is now 3 days following the vaccine and the fingers are still numb and tingling.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Bursitis, Loss of personal independence in daily activities, Pain, Sleep disorder
Clinical narrative: C/o left should pain that started 9/16/24.  States pain began on the way home after receiving her flu shot in her left shoulder. Tried massaging the area, but it was tender. Then the pain has steadily increased. Is now having pain when raising her arm and when pressure is put on the shoulder stating she is unable to sleep on her left side.  Reports is unable to brush her hair with her left hand and is unable to carry things with her left arm due to the pain.  Has taken ibuprofen without benefit.  Has not noticed redness, warmth or swelling.  Denies fever.   Steroid injection administered today.   Begin prednisone taper tomorrow.   Schedule physical therapy for evaluation and treatment of bursitis.   Follow up in 3-4 weeks for re-check.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tenderness
Clinical narrative: C/o left should pain that started 9/16/24.  States pain began on the way home after receiving her flu shot in her left shoulder. Tried massaging the area, but it was tender. Then the pain has steadily increased. Is now having pain when raising her arm and when pressure is put on the shoulder stating she is unable to sleep on her left side.  Reports is unable to brush her hair with her left hand and is unable to carry things with her left arm due to the pain.  Has taken ibuprofen without benefit.  Has not noticed redness, warmth or swelling.  Denies fever.   Steroid injection administered today.   Begin prednisone taper tomorrow.   Schedule physical therapy for evaluation and treatment of bursitis.   Follow up in 3-4 weeks for re-check.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Injection site pain, Product administered at inappropriate site
Clinical narrative: C/o left should pain that started 9/16/24.  States pain began on the way home after receiving her flu shot in her left shoulder. Tried massaging the area, but it was tender. Then the pain has steadily increased. Is now having pain when raising her arm and when pressure is put on the shoulder stating she is unable to sleep on her left side.  Reports is unable to brush her hair with her left hand and is unable to carry things with her left arm due to the pain.  Has taken ibuprofen without benefit.  Has not noticed redness, warmth or swelling.  Denies fever.   Steroid injection administered today.   Begin prednisone taper tomorrow.   Schedule physical therapy for evaluation and treatment of bursitis.   Follow up in 3-4 weeks for re-check.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Disorientation, Dysphemia, Erythema, Fatigue
Clinical narrative: Approximately 6 minutes after receiving vaccine, rapid onset of symptoms including stuttering, redness to face, jaw felt heavy, right foot numb, gait affected, rapid heart rate, disoriented, severe fatigue At hospital, body experienced uncontrollable shaking (particularly in legs). Transported by coworker to ER, treated with IV fluids, 50 mg IV Benadryl, Prednisone. Monitored x 4 hours. Released home. No additional follow up required if asymptomatic. Rested at home day following incident. Returned to work the on 9/27 and continuing to have fatigue, leg soreness, tingling in feet, slight headache.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Headache, Heart rate increased, Hypoaesthesia, Pain in extremity
Clinical narrative: Approximately 6 minutes after receiving vaccine, rapid onset of symptoms including stuttering, redness to face, jaw felt heavy, right foot numb, gait affected, rapid heart rate, disoriented, severe fatigue At hospital, body experienced uncontrollable shaking (particularly in legs). Transported by coworker to ER, treated with IV fluids, 50 mg IV Benadryl, Prednisone. Monitored x 4 hours. Released home. No additional follow up required if asymptomatic. Rested at home day following incident. Returned to work the on 9/27 and continuing to have fatigue, leg soreness, tingling in feet, slight headache.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Tremor
Clinical narrative: Approximately 6 minutes after receiving vaccine, rapid onset of symptoms including stuttering, redness to face, jaw felt heavy, right foot numb, gait affected, rapid heart rate, disoriented, severe fatigue At hospital, body experienced uncontrollable shaking (particularly in legs). Transported by coworker to ER, treated with IV fluids, 50 mg IV Benadryl, Prednisone. Monitored x 4 hours. Released home. No additional follow up required if asymptomatic. Rested at home day following incident. Returned to work the on 9/27 and continuing to have fatigue, leg soreness, tingling in feet, slight headache.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Wrong product administered
Clinical narrative: Patient was given an MMR vaccine and did not need it.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Upper-airway cough syndrome
Clinical narrative: Sneezing and post-nasal drip for approximately two days starting the day following the injection.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, TDAP, VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Dysstasia, Fatigue
Clinical narrative: Severe joint, head and neck pain.  Head to toe intense skin pain,/sensitivity,  dizzy, blurred vision,  difficult to lift arms, too weak to stand for more than brief moments.  Fever/skin hot from head to toe. 7-8 inch diameter painful, red rash at shingles vaccine site (left arm), with significant swelling.  Significant swelling and intense pain to right arm at injection site.  Symptoms started 5 hours after vaccinations and lasted with intensity for 36+ hours.  Residual fatigue, full body muscle fatigue injection site pain and swelling persisting at this time (62 hours ) post injection
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, TDAP, VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Injection site swelling, Mobility decreased
Clinical narrative: Severe joint, head and neck pain.  Head to toe intense skin pain,/sensitivity,  dizzy, blurred vision,  difficult to lift arms, too weak to stand for more than brief moments.  Fever/skin hot from head to toe. 7-8 inch diameter painful, red rash at shingles vaccine site (left arm), with significant swelling.  Significant swelling and intense pain to right arm at injection site.  Symptoms started 5 hours after vaccinations and lasted with intensity for 36+ hours.  Residual fatigue, full body muscle fatigue injection site pain and swelling persisting at this time (62 hours ) post injection
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, TDAP, VARZOS
Symptoms: Muscle fatigue, Neck pain, Pain of skin, Pyrexia, Rash erythematous
Clinical narrative: Severe joint, head and neck pain.  Head to toe intense skin pain,/sensitivity,  dizzy, blurred vision,  difficult to lift arms, too weak to stand for more than brief moments.  Fever/skin hot from head to toe. 7-8 inch diameter painful, red rash at shingles vaccine site (left arm), with significant swelling.  Significant swelling and intense pain to right arm at injection site.  Symptoms started 5 hours after vaccinations and lasted with intensity for 36+ hours.  Residual fatigue, full body muscle fatigue injection site pain and swelling persisting at this time (62 hours ) post injection
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3, TDAP, VARZOS
Symptoms: Sensitive skin, Skin warm, Vision blurred
Clinical narrative: Severe joint, head and neck pain.  Head to toe intense skin pain,/sensitivity,  dizzy, blurred vision,  difficult to lift arms, too weak to stand for more than brief moments.  Fever/skin hot from head to toe. 7-8 inch diameter painful, red rash at shingles vaccine site (left arm), with significant swelling.  Significant swelling and intense pain to right arm at injection site.  Symptoms started 5 hours after vaccinations and lasted with intensity for 36+ hours.  Residual fatigue, full body muscle fatigue injection site pain and swelling persisting at this time (62 hours ) post injection
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient was given expired vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Dry mouth, Injection site reaction, Muscle tightness
Clinical narrative: After vaccination, patient stated she felt dizzy and her mouth was dry. Patient was asked about swelling of face, mouth, tongue, throat, or difficulty breathing and patient stated none. Patient was offered and given water. Patient stayed in vaccination room for about 30 minutes and had a brief dizzy spell before leaving and sat in the wait room for another 10-15 minutes. She stated a tightness in her upper left deltoid and trapezius. She stated she had a similar response after having the Covid virus and some dizziness after previous vaccines, but not as immediate, about a day later. Recommended the patient take an antihistamine and if symptoms persisted or worsened to seek emergency medical care.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Dyspnoea, Exposure during pregnancy
Clinical narrative: She is 35wks gestations and has a history of premature delivery at 33 wks. EDC is 1030/2024. Within 15 minutes of  Tdap administration, client complained of being short of breath, feeling week and dizzy.  She was then laid down on the exam table with head of bed at 30 degrees and given supplemental 02 at 2 L/ NC.  o2 SAT at 100%.. BP at 96/68 mmHg, HR-90-regular, RR- 22
Age: 63.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Condition aggravated, Injection site pain, Lethargy
Clinical narrative: Patient called pharmacy today to state that he is experiencing extreme lethargy and pain from the injection site down to his elbows on both arms.  He is also experiencing increased arthritis pain in both shoulders.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient states that within 24 hours of receiving this immunization and the seasonal flu vaccine in the same are (Left Deltoid), the arm was "very painful, red, warm to the touch, and it felt like there was a hard ball under my skin." In addition, she states that her "armpit is also swollen and painful."
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Patient states that within 24 hours of receiving this immunization and the seasonal flu vaccine in the same are (Left Deltoid), the arm was "very painful, red, warm to the touch, and it felt like there was a hard ball under my skin." In addition, she states that her "armpit is also swollen and painful."
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: AGE-INAPPROPRIATE ADMINISTRATION PER FDA/CDC GUIDELINES.  PATIENT ADMINISTERED WAS 61 YOA.  FDA-APPROVED AGE IS 65+
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Pt reported swelling from elbow to chest
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Client called the Public Health office around 9:AM reporting she got her COVID Vaccine yesterday at the Flu/COVID clinic. Client reports a lump, redness, tenderness, and warmth to injection site of where the COVID Vaccine was placed. Client was calling to report this but also calling to see if she can use heat and cold packs and take Tylenol and Ibuprofen.  Client was contacted about 3:00 PM to see how she was doing. Client reports she is doing great and has been able to go about her normal day and us currently trying to take a nap.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertonic bladder, Micturition urgency, Pollakiuria, Urine analysis
Clinical narrative: bladder spasms, urgency, frequency for 8 days straight; days 9 and 10 intermittent spasms ; "feeling I need to go constantly"
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Malaise, Retching, Vomiting
Clinical narrative: Patient called me today at 2:50 stating that at 2:30 he became suddenly, and violently ill.  He vomited uncontrollable over and over until he was dry heaving.  He stated that was the worst vomiting he has experienced in his whole life.  He denied eating anything except toast today, and does not believe the vomiting was caused by food poisoning.  He also up until had no symptoms of illness.
Sex: U
Vaccine: COVID19, FLU3
Symptoms: Unevaluable event
Clinical narrative: Patient self-reported at home blood pressures of 40's/30's after vaccine administration.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Bronchitis chronic, Dizziness, Fatigue, Pain
Clinical narrative: feels weak, tired and achy. It continued to progress with severe dizziness that caused some change in vision that corrects itself with closing her eyes and holding still. Also reported the chronic bronchitis symptoms have flared up.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: feels weak, tired and achy. It continued to progress with severe dizziness that caused some change in vision that corrects itself with closing her eyes and holding still. Also reported the chronic bronchitis symptoms have flared up.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Feeding disorder, Influenza like illness, Nausea
Clinical narrative: PATIENT COMPLAINED OF NAUSEA, FLU LIKE SYMPTOMS, NOT BEING ABLE TO EAT,  LOSING TASTE, NOT WANTING TO EAT
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Periarthritis, X-ray
Clinical narrative: Patient  claims shoulder was frozen and hand was numb. Saw her neurologist and orthopedist.Orthopedist  gave cortisone shots and therapy.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Haemorrhage, Limb discomfort, Mobility decreased, Pain
Clinical narrative: I have had extreme stomach cramps, and on Thursday, the 26th, I had some bleeding. I thought this might be due to the pap smear you completed, so I wasn't too worried. However, I am still cramping, and the last two nights I have been in excruciating pain. I had to take 800 ibuprofen and muscle relaxers, and it still did not take away all of the pain.   In addition, the right side of my body (from my right arm down to my right leg) that I received the flu shot on is completely swollen. My right leg feels like I received steriods or rifampin (which I am allergic to). My leg is very heavy, like weights are being pressed down on, and it's difficult to mobilize. It is like I have a whole leg full of hives that are trying to burst out. I am right-hand dominant, so this is usually my smaller size. Is there any information you can give me on the flu shot that I received? I have never been sick after receiving a flu shot.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: I have had extreme stomach cramps, and on Thursday, the 26th, I had some bleeding. I thought this might be due to the pap smear you completed, so I wasn't too worried. However, I am still cramping, and the last two nights I have been in excruciating pain. I had to take 800 ibuprofen and muscle relaxers, and it still did not take away all of the pain.   In addition, the right side of my body (from my right arm down to my right leg) that I received the flu shot on is completely swollen. My right leg feels like I received steriods or rifampin (which I am allergic to). My leg is very heavy, like weights are being pressed down on, and it's difficult to mobilize. It is like I have a whole leg full of hives that are trying to burst out. I am right-hand dominant, so this is usually my smaller size. Is there any information you can give me on the flu shot that I received? I have never been sick after receiving a flu shot.
Age: 77.0
Sex: F
Vaccine: COVID19, HEPAB
Symptoms: Fall, Malaise, Muscular weakness, Sleep apnoea syndrome
Clinical narrative: Patient reports that several hours after getting vaccinated she did not feel well. She indicated that she was at her neighbors house and thought that she was having a conversation with the neighbor but her neighbor told her she was falling in and out of sleep. The neighbor told her she did not look well. She reports one of her legs gave out on her and it caused her to fall. She did not seek medical care but went home to sleep it off. Patient reports feeling better today.
Age: 0.33
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Oral herpes, Rhinorrhoea
Clinical narrative: Cold sore. Runny nose. Itchy eye.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Palpitations, Tinnitus
Clinical narrative: Patient complained of racing heart and buzzing in her ears.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Meningeal headache at base of skull for 2 weeks. Achy next day until slept
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest pain, Diarrhoea, Feeling hot, Injection site pruritus, Paraesthesia
Clinical narrative: Day 1: itchy skin at site of injection. Day 2 and 3: Diarrhea and itchy skin at site of injection: Day 4 (9/26): Chest pain, whole body fely hot and sticky, felt like she had needles all over the body, head to toes. Pt ended up going to the ER and she said she was given IV fluid and anti-diarrhea medication. Pt was discharged on the same day.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pruritus, Sticky skin
Clinical narrative: Day 1: itchy skin at site of injection. Day 2 and 3: Diarrhea and itchy skin at site of injection: Day 4 (9/26): Chest pain, whole body fely hot and sticky, felt like she had needles all over the body, head to toes. Pt ended up going to the ER and she said she was given IV fluid and anti-diarrhea medication. Pt was discharged on the same day.
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cardiac arrest, Death
Clinical narrative: At approximately 10:15AM on 9.12.2024., Flublok and Spikevax were administered concomitantly in different arms for Patient, a 64-year-old patient with a date of birth of (redacted). All the protocols implemented and required by Pharmacy were followed; I thoroughly checked the consent form for completion, verbally verified the patient's personal information and selected answers, offered the patient her receipts and VIS documents, administered both vaccines according to guidelines, counseled the patient on potential side effects, and recommended that the patient remain in the waiting room for at least fifteen minutes after the vaccines. This week, I received a letter from the patient's husband, informing me that she suffered a sudden cardiac arrest on 9.16.2024. According to her husband, she passed away one week after a good annual physical with her primary care physician on 9.9.2024. and four days after receiving the vaccines. He indicated in his letter that his wife was fine and did not exhibit any symptoms until Sunday. The wife has been my patient since 2014, and I have provided her the influenza vaccine ten times and the COVID-19 vaccine a total of eight times. She has never experienced an adverse reaction to the vaccines administered. The patient only received medications for her glaucoma and Barrett?s esophagus from our pharmacy. She temporarily took the anti-hypertensive medication hydrochlorothiazide 12.5MG for six months in 2022, but she was not on any cardiovascular medications recently.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: New COVID vaccination for 2024. Patient had all prior COVID vaccines and boosters without significant adverse side effects. For this dose, patient had typical injection site soreness and body aches during the day after the vaccination. At ~10pm she woke up with a dangerously high fever (104.7 degrees, oral temperature) and significant body pain. Treated with Tylenol and cold compresses. She also had swelling at the injection site several inches around and Monday morning (9/23) following the vaccination woke up with a significant nosebleed covering her sheets, blanket, and body.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Mass
Clinical narrative: The patient has a knot on her right jaw. Approx. 2 inches It resembled a knot you would see with an abscessed tooth. She said it felt swollen but did not hurt. Her teeth were not sore and she was not running any temperature. She also has a  red swollen area on the right arm where the vaccines were given
Age: 1.5
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Product storage error
Clinical narrative: had been stored out of recommended temperature range at some point, with no additional information; The blood of patient was recently tested and caller stated it shows no titers or protection for Hepatitis B; This spontaneous report was received from the patient's father referring to his daughter, an approximately 18-months-old female patient. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.         On an unknown date in January 2024, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # U040097, expiration date not reported but updated upon internal review as 26-FEB-2024, administered for hepatitis b immunisation (strength, route of administration, and anatomical location were not provided). The patient's pediatrician confirmed to the reporter that the vaccine had been stored out of recommended temperature range at some point, with no additional information (product storage error).          On an unknown date in 2024, the patient's blood was recently tested and caller stated it showed no titers or protection for Hepatitis B (hepatitis b antibody negative).      At the time of reporting, the outcome of hepatitis b antibody negative was unknown. The reporter did not assess the causal relationship between hepatitis b antibody negative and Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB).
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported.; HCP called reporting a MMR II vaccine was administered to a patient on 9/20/2024 and expired on 9/15/2024.; This spontaneous report was received from a physician referring to a 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-SEP-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, 0.5ml, lot #W029538, expiration date: 15-SEP-2024, administered for prophylaxis (strength and route of administration were not provided) (Expired product administered). Operator of device was health professional. No prior excursion. No adverse side effects were reported (No adverse event).
Age: 13.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Mistakenly gave a patient a dose of PROQUAD and VARIVAX on the same day; This spontaneous report was received from a registered nurse referring to a 13-year-old patient (gender not reported).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 23-SEP-2024, the patient was mistakenly vaccinated with a dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliters, lot #Y008785, expiration date: 30-OCT-2025; and varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml, lot #Y004554, expiration date: 20-FEB-2026, both administered for prophylaxis (strength and route of administration were not provided) (Accidental overdose).  No symptoms or additional adverse events were reported.
Sex: M
Vaccine: HPV9
Symptoms: Concussion, Fall, Syncope
Clinical narrative: Caller stated the medical assistant reported they have had 3 patients with syncope after receiving GARDASIL 9. One patient (male) ended up falling and had to go to the ER due to a concussion.; One patient (male) ended up falling and had to go to the ER due to a concussion.; This spontaneous report was received from a medical assistant via company representative referring to a male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  It was reported that the patient had syncope after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The medical assistant stated they advised all the patients to wait 15 minutes in the office but they refused and left. The patient ended up falling and had to go to the emergency room (ER) due to a concussion. It was reported this patient was still with the practice and they had seen him since and "he was fine." No additional information available. The action taken was not applicable.  The causal relationship the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the event syncope was determined to be medically significant.  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-009507513-2409USA008821:MSD US-009507513-2409USA008902:MSD US-009507513-2409USA009499:MSD
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported.; HCP calling to report expired MMRII was inadvertently administered after its labeled expiry date; This spontaneous report was received from a pharmacist and referred to a 4-year-old patient of unknown gender.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown).  On 09-SEP-2024, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) after its labeled expiry date (expiration date: 25-MAY-2024), administered for prophylaxis (strength, lot #, dose, and route of administration were not provided) (Expired product administered). No side effects were reported (No adverse event). Moreover, no previous temperature excursions or product quality complaint were reported. No additional information or clarification was provided.  Lot number is being requested and will be submitted if received.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2409USA009238: US-009507513-2409USA009386: US-009507513-2409USA009587: US-009507513-2409USA009513: US-009507513-2409USA009453:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects reported; Expired MMRII was inadvertently administered after its labeled expiry date; This spontaneous report has been received from a pharmacist regarding a 20-month-old patient of unspecified gender. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). Their medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 10-SEP-2024, 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) injection, administered as prophylaxis (expiration date reported as 25-MAY-2024) (strength, dose, vaccination scheme, route of administration, anatomical site of injection, and lot number were not provided) (expired product administered). No previous temperature excursion was reported. No side effects were reported in the patient.   Lot number is being requested and will be submitted if received.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2409USA009168:
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate decreased, Ventricular extrasystoles
Clinical narrative: PVC; low heart rate; This serious case was reported by a nurse via sales rep and described the occurrence of premature ventricular contractions in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac failure. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date and did not have an adverse reaction).   On 13-SEP-2024, the patient received the 2nd dose of Shingrix. In SEP-2024, an unknown time after receiving Shingrix, the patient experienced premature ventricular contractions (Verbatim: PVC) (serious criteria hospitalization) and heart rate low (Verbatim: low heart rate) (serious criteria hospitalization). The outcome of the premature ventricular contractions and heart rate low were unknown.   It was unknown if the reporter considered the premature ventricular contractions and heart rate low to be related to Shingrix.     The company considered the premature ventricular contractions and heart rate low to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 The patient had received subsequent dose of Shingrix vaccine and experienced low heart rate and PVC (premature ventricular contractions). The reporter mentioned that the patient was hospitalized.; Sender's Comments: Ventricular extrasystoles and Heart rate decreased are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Loss of personal independence in daily activities, Peripheral nerve injury, Post herpetic neuralgia
Clinical narrative: suspected vaccination failure; has damaged the nerves in my whole right arm and hand; shingles; postherpetic neuralgia; cannot work my tools/sell mymotorbikes as I can't ride them.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), peripheral nerve injury (Verbatim: has damaged the nerves in my whole right arm and hand) (serious criteria GSK medically significant), shingles (Verbatim: shingles), post herpetic neuralgia (Verbatim: postherpetic neuralgia) and activities of daily living impaired (Verbatim: cannot work my tools/sell mymotorbikes as I can't ride them.). The outcome of the vaccination failure, peripheral nerve injury, shingles, post herpetic neuralgia and activities of daily living impaired were not reported.   It was unknown if the reporter considered the vaccination failure, peripheral nerve injury, shingles, post herpetic neuralgia and activities of daily living impaired to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. The company considered the peripheral nerve injury to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, post herpetic neuralgia and activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-SEP-2024 This case was reported by the patient via interactive digital media. The patient received the GlaxoSmithKline (GSK's) shingles vaccine and vaccine gave shingles and this developed into postherpetic neuralgia which had damaged the nerves in his whole right arm and hand. The patient had successful business as a sculptor and furniture maker as he/she cannot work on his tools. The patient asks anyone know had this problem please get in touch with him and we could fight the company together. This case was considered as suspected vaccination failure as details regarding, time to onset, laboratory details and shingles were known at a time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.  Peripheral nerve injury is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure; has damaged the nerves in my whole right arm and hand; shingles; postherpetic neuralgia; cannot work my tools/sell mymotorbikes as I can't ride them.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), peripheral nerve injury (Verbatim: has damaged the nerves in my whole right arm and hand) (serious criteria GSK medically significant), shingles (Verbatim: shingles), post herpetic neuralgia (Verbatim: postherpetic neuralgia) and activities of daily living impaired (Verbatim: cannot work my tools/sell mymotorbikes as I can't ride them.). The outcome of the vaccination failure, peripheral nerve injury, shingles, post herpetic neuralgia and activities of daily living impaired were not reported.   It was unknown if the reporter considered the vaccination failure, peripheral nerve injury, shingles, post herpetic neuralgia and activities of daily living impaired to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. The company considered the peripheral nerve injury to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, post herpetic neuralgia and activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-SEP-2024 This case was reported by the patient via interactive digital media. The patient received the GlaxoSmithKline (GSK's) shingles vaccine and vaccine gave shingles and this developed into postherpetic neuralgia which had damaged the nerves in his whole right arm and hand. The patient had successful business as a sculptor and furniture maker as he/she cannot work on his tools. The patient asks anyone know had this problem please get in touch with him and we could fight the company together. This case was considered as suspected vaccination failure as details regarding, time to onset, laboratory details and shingles were known at a time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.  Peripheral nerve injury is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got the shingles; most painful things you can get; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got the shingles) and pain (Verbatim: most painful things you can get). The outcome of the vaccination failure, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-SEP-2024  The case was received from the patient via interactive digital media. The patient had the shingles shot and still got the shingles.  The reporter reported that it was one of the most painful things you could get.  The reporter asked to have 2 shots and not one. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.