chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; patient received an expired vaccine; This spontaneous report was received from a nurse who refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 03-MAY-2021, the patient was vaccinated with expired measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), lot # S013536 , expiry date 02-MAY-2021, for prophylaxis (formulation, concentration, dose, dose number, route of administration and frequency were not reported). Nurse stated that the vaccine had undergone a previous temperature excursion. However, after discussing time and temperature (-4.45 degree of Celsius (C) for 45 minutes on 08-FEB-2021 and -11.49 C for 45 minutes on 07-APR-2021), the vaccine was actually found to be stored within recommended range and no excursion had occurred. No additional adverse event was reported. No product quality complaint (PQC) was involved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Asthenia, Screaming, Sleep disorder, Tinnitus
Clinical narrative: Tinnitus sound was doubled.  Screaming loud in the middle of the night.  Daytime sound enormously louder as well.  Previous tinnitus very light.  The increase has not diminished since Feb. 16. No effect on hearing.  Very debilitating.    Reaction after the first dose was minimal with no effect on tinnitus. (Received January 16 at .).
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: HAD FEVER TO 101.5F ON THE SECOND DAY, TOOK 1 PILL OF TYLENOL EACH 6 HOURS (TOTAL 2 PILLS), AND RECOVERED ON THE THIRD DATE.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Grunting
Clinical narrative: My son went from talking at 12 months old saying one syllable words to after getting the above injections he only would grunt and point to things.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Confusional state, Panic attack
Clinical narrative: I had confusion with servire mental terror attacks that lasted two days. They lasted a few seconds each.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient states that he began experiencing tinnitus following the administration of second dose of Moderna vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Skin warm
Clinical narrative: Large rash on left arm. Hot, itchy and bumpy.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 4 doses of PFIZER: 12/30/2020; 01/20/2021; 01/22/2021; 02/25/2021.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Loss of consciousness, Syncope, Vital signs measurement
Clinical narrative: pt was hot and lightheaded while sitting  then fainted in his chair  pt reawoke after maybe 2 minutes and then was helped to floor 911 was called and ambulance crew checked pt over he refused to go to hospital after they checked him out and said that he looked fine he sat for maybe 5 more minutes then walked out of pharmacy
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Flushing of skin. No itching or raised hives. No shortness of breath.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Hypotonia, Pregnancy test, Presyncope
Clinical narrative: Pre-syncope while at restraint approximately 45 minutes after vaccine.  She slumped to the ground and lost muscle tone before being caught by her grandparents.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Symptoms: Fever, chills, joint pain, muscle aches, fatigue, headache  Treatment: Acetaminophen  Outcome: Reduced fever and pain after 15 minutes of 1000mg acetaminophen  Time Course: all day 2021-05-06
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Symptoms: Fever, chills, joint pain, muscle aches, fatigue, headache  Treatment: Acetaminophen  Outcome: Reduced fever and pain after 15 minutes of 1000mg acetaminophen  Time Course: all day 2021-05-06
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in Left Ear
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fibrin D dimer, Herpes zoster, Rash
Clinical narrative: left shoulder pain and rash. Pain after injection on 4/20, worsened over the next few days, was seen at UC on 5/1/21 for arm pain and a D-Dimer was done and was negative no rash noted at this time.  onset of very painful rash from neck down to forearm several days after injection. Pain is described as severe, constant and sharp. Rash is classic in appearance and presentation for Shingles. Onset in close, likely causative, temporal and regional association with having received Pfizer COVID vaccine to L deltoid. For Shingles and pain, Rx valacyclovir 1g TID x7d, gabapentin 300-600mg TID PRN, oxycodone 5/325 1-2 q6 PRN, and lidoderm patches. She is overall miserable. I am asking her to f/u with me later this week.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: During routine primary care visit at  facility  system was reviewed and it was discovered that this patient had three documented COVID vaccines in the system. Dose 1: 1/7/2021, Dose 2: 2/11/2021, Dose 3: 3/4/2021. This  facility does not have further details on this error as it did not occur here and we do not have full access to the system. At this time it does not appear that patient suffered any ill effects from third dose of vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache body aches and fatigue over 24 hour period
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: Extreme chills/shakes
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness postural, Hyperhidrosis
Clinical narrative: Dizziness upon standing, sweating for 15 minutes after 15 minutes observation while sitting
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient says the pain started right when she received the vaccination and got worse throughout the day. She said she cannot move her arm at all anymore. She is having a difficult time dressing herself or doing anything around the house. The patient says she felt as thought the vaccinator injected too high on her arm. I asked her where exactly she received her dose and she said it was very close to her shoulder, almost directly below the shoulder.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Sleep disorder
Clinical narrative: Heavy legs,very tired,can?t sleep through the night,headache.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I got a fever 10 hours after receiving the vaccine. It went away temporarily after taking Tylenol. It came back a few times over the following 36 hours.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: DIZZY, SYNCOPE, DIAPHORETIC, PALE, BS: 62, ATE SMALL MEAL EARLY AM,SEEN BY PARAMEDICS, VSS, PROVIDED GATORADE AND FOOD, SX IMPROVED, REFUSED TRANSPORT, AMA SIGNED.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Coronary arterial stent insertion, Intracardiac thrombus, Myocardial infarction, Resuscitation
Clinical narrative: My father suffered a heart attack due to blood clots clogging the artery to his heart.  He coded and was resuscitated  and had four stents installed after the blockage was cleared.   He had a second heart attack several days later when the stents clogged and had to be cleared.   He was hospitalized for several days for each heart attack.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vascular stent occlusion
Clinical narrative: My father suffered a heart attack due to blood clots clogging the artery to his heart.  He coded and was resuscitated  and had four stents installed after the blockage was cleared.   He had a second heart attack several days later when the stents clogged and had to be cleared.   He was hospitalized for several days for each heart attack.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Malaise
Clinical narrative: 1105: Pt c/o feeling warm surge to body; VS: BP 152/82, HR 67, RR 16, 100% RA 1119: BP repeated 148/85, HR 54-64, RR 16 1120: drank 3 bottles of water, feeling better 1122: Pt ambulate in hallway w/ mild light headedness 1139: BP repeated sitting 140/90, RR 16, HR 61, standing BP 158/102, HR 59, associated light-headedness/dizziness. Pt reports "I don't feel well" Case d/w Dr. who recommend pt be seen in ED  1157: Now c/o lightheadedness, BP still elevated. Pt transferred to ED for further evaluation and work up No medications given in ED
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Palpitations
Clinical narrative: CHest pain, heart palpitations fatigue - duration 1 month headaches - duration persistent
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aplastic anaemia, Biopsy bone marrow, Haemoglobin decreased, Increased tendency to bruise, Neutrophil count decreased
Clinical narrative: Pt with increased bruising - presented to ED - admitted to the hospital - continued workup and pt with BM results aplastic anemia.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, White blood cell count decreased
Clinical narrative: Pt with increased bruising - presented to ED - admitted to the hospital - continued workup and pt with BM results aplastic anemia.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aplastic anaemia, Biopsy bone marrow abnormal, Bone marrow failure, Haemoglobin decreased, Platelet count decreased
Clinical narrative: Pt with increased bruising - presented to ED - admitted to the hospital - continued workup and pt with BM results aplastic anemia.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet transfusion, White blood cell count decreased
Clinical narrative: Pt with increased bruising - presented to ED - admitted to the hospital - continued workup and pt with BM results aplastic anemia.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: PT became lightheaded and diaphoretic approx. 6 minutes after receiving J&J dose .5ml. Pt found lying on couch initial BP 80/60 Pulse 50. Pt was placed supine with feet slightly elevated. BP came up to 110/70 with Pulse 50 after 5 minutes. Pt stated that they were feeling better. BP 120/70 Pulse 50 after 10 minutes lying down. PT sat up after 13 minutes BP 126/70 Pulse 50. PT stood up at the 15 after 15 minutes BP 120/70 Pulse 60. PT stated that he felt fine standing. PT released with friend feeling no ill effects.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Paraesthesia
Clinical narrative: After 15 min waiting period, patient was walking to his car when he started with tingling to bilateral feet and hand. VS 152/100 P 61 R 16. Lungs clear, temp 97.8, 99% pulse ox. No dizziness, no flushing. At 15 minutes, slightly clammy to touch on upper extremities. Patient reports feeling well and tingling subsiding (none in L foot; only very slightly in bilateral hands, r foot). By 1140, back to baseline. Escorted to car in good condition.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Walking aid user
Clinical narrative: pain on my left side / was in the hospital for almost four weeks / back, side, and half of my stomach on the left side; still on a walker and cane / not able to go back to my home because of the steps and even know I can not go up or downstairs; God to heal my back, side, and half of my stomach on the left side; God to heal my back, side, and half of my stomach on the left side; what was going on with me at the time, but 11-3-19 / mine agin in March 20 so I don't have to get any more; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In 2019, the patient received the 1st dose of Shingles vaccine. In March 2020, the patient received the 2nd dose of Shingles vaccine. In March 2020, not applicable after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced pain (serious criteria hospitalization), mobility decreased (serious criteria hospitalization), back pain (serious criteria hospitalization) and stomach pain (serious criteria hospitalization). On an unknown date, the outcome of the pain, mobility decreased, back pain, stomach pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain, mobility decreased, back pain and stomach pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient stated that he/she did not know what was going on but on 11th March he/she went to his/her doctor to find out what was going on with the pain on patient's left side. The patient drove himself/herself, was in the physician's office maybe for 10 minutes and they called to go in the room, and the next thing patient knew was he/she was in the emergency room of the hospital and then was in the hospital for almost four weeks and the patient was still on the walker and cane as of 30th April 2021. The patient was not able to go back to his/her home because of the steps and even knew that he/she could not go up or downstairs. The patient had two months after he/she got out, and then the patient received the vaccine again in March 20, almost late by a year which led to lengthening of the vaccination schedule. The patient was on a walker. The patient stated there was nothing they could give for his/her pain that helped him/her and it was the worst thing and lasted about four or five weeks after the patient came to his/her sisters house.  For three months three times a week the physiotherapist, occupational therapist and the nurse came to work with the patient.  The patient prayed all the time to the God to heal his/her back, side, and half of the stomach on the left side.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer normal, Mobility decreased, Pain in extremity
Clinical narrative: For the initial 24 hours after receiving the first dose of Pfizer COVID-19 vaccine, patient had arm soreness that resolved. About a week later, she began to experience severe significant right arm pain. It is limiting her range of motion significantly. At this point, it is unclear whether or not this is related to the vaccine. She continues to have significant arm pain.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: patient was light headed and blurred vision, this occurred almost immediately after the injection by, imz tech.  Immunization tech called for me, rph.  I took her BP AT 610PM, it was normal at 128/78 and immunization tech held an ice back on the back of her neck.  She recovered quickly and we waited with her for the remainder of her 15 minute wait.  Two people were with her.  We got a motorized cart for her.  She left after the 15 minutes and felt fine, stating no residual issues.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large swollen lymph node in my neck left side.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Head discomfort, Tinnitus
Clinical narrative: Pressure behind left ear causing dizziness/lightheadedness. The pressure is accompanied with occasional ringing in the left ear, sometimes very loud ringing.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Discomfort, Feeling abnormal, Feeling cold, Limb discomfort
Clinical narrative: Arm soreness that was  mild went away after the shot.  Then the "weird" or uncomfortable soreness that feels to her like cold nerve pain or just super mild discomfort did not go away completely and has still not gone away so far 5 days after the vaccine.. Patient also leg discomfort (super mild but also not totally normal) for 1-2 days after the vaccine. She is not sure if the neck moderate pain  that radiates to the back is associated and it started on Tuesday or 4-5 days after the vaccine. Like a cold numbness is how she would describe it.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Neuralgia, Pain in extremity
Clinical narrative: Arm soreness that was  mild went away after the shot.  Then the "weird" or uncomfortable soreness that feels to her like cold nerve pain or just super mild discomfort did not go away completely and has still not gone away so far 5 days after the vaccine.. Patient also leg discomfort (super mild but also not totally normal) for 1-2 days after the vaccine. She is not sure if the neck moderate pain  that radiates to the back is associated and it started on Tuesday or 4-5 days after the vaccine. Like a cold numbness is how she would describe it.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Premenstrual syndrome
Clinical narrative: I am 54 and post menopause (last period over 14 months ago.)  After first shot I began to experience some PMS symptoms.  They became significantly more pronounced after the 2nd shot, and today, 9 days post 2nd shot, I woke up to menstrual bleeding.  I have not had a period in well over a year and the timing is troubling.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Injection site rash, Injection site urticaria, Rash, SARS-CoV-2 test positive
Clinical narrative: Rashes/Hives all over the lower back, legs, hands, arms, elbow and small rashes and hives in the area where vaccinated (pictures available, if requested).  Doctor's diagnosis was "Urticaria, unspecified"   Taking Benadryl, applying cortizone cream, and received prescription called Hydroxyzine 25 mg
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Rashes/Hives all over the lower back, legs, hands, arms, elbow and small rashes and hives in the area where vaccinated (pictures available, if requested).  Doctor's diagnosis was "Urticaria, unspecified"   Taking Benadryl, applying cortizone cream, and received prescription called Hydroxyzine 25 mg
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: First shingles shot didn't work and I got it on my back and my stomach area; It was painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were 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 had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient mentioned that, his/her first shingles shot did not work and he/she got shingles on back and stomach area. The patient mentioned that it was painful and did not take pain pills. The patient mentioned that second shot seems to be working better. The follow-up would not possible, as no contact details were available.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Facial paralysis, Magnetic resonance imaging
Clinical narrative: Patient received Moderna vaccine on 4/7/21 and on 4/19/21 woke up to facial paralysis and left facial drooping.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: PATIENT SLUMPED OVER THE CHAIR AFTER THE VACCINE. DIDN'T PASS OUT.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Magnetic resonance imaging normal, Muscular weakness, Nervousness, Sensory disturbance
Clinical narrative: note time of vaccination unknown Morning of 4/18 after up for a few hours noted "humming sensation" "internally shaking" mostly on left side - shoulder, chest, abdomen - less in leg.   She didn't think these were palpatations.   This symptom decreased some over time but still present today.  Afternoon 4/18 - left arm felt "tired" ? weak for about 3 days - resolved before I saw her in clinic on 4/22
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: During the 1st dose on 3/3/2021, about a week later I notice that had a few hives spots on my body.  During the 2nd dose on 5/3/2021,  after the shot on 5/5/2021 I broke out in a really mild case of hives all over my body.  I had to take Zyrtec and the symptoms went away after an hour or so.  I also contacted  Dr. on 5/5/2021 about my hives.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Emotional disorder, Fatigue, Headache, Herpes virus infection
Clinical narrative: A vice like head pain that hasn't gone away. Makes thinking hard, light sensitive and exhaustion. Advil doesn't help. Feels like my brain is swollen and I can't think. I wake up with it, nothing changes the feeling. Massive herpes outbreak. Haven't had one in 2 years.  Angry and emotional when I wasn't feeling this way before hand. Exhausted, sleeping 12-14 hours a day with naps in between. Extreme lethargy.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Lethargy, Photophobia
Clinical narrative: A vice like head pain that hasn't gone away. Makes thinking hard, light sensitive and exhaustion. Advil doesn't help. Feels like my brain is swollen and I can't think. I wake up with it, nothing changes the feeling. Massive herpes outbreak. Haven't had one in 2 years.  Angry and emotional when I wasn't feeling this way before hand. Exhausted, sleeping 12-14 hours a day with naps in between. Extreme lethargy.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Nausea, Paraesthesia oral
Clinical narrative: Patient arrived to post vaccine area after receiving second dose of Pfizer COVID 19 vaccine. Patient reported to post vaccine nurse feeling lightheaded with tongue tingling, headache, nausea and feeling flushed/itchy. Initial vital signs 123/83 85bpm 99% O2. At 1730 patient given 25mg PO Benadryl per standing orders. Patient monitored by post vaccine nurse. Symptoms resolved at 6:15pm, and requested to leave. Last vitals: 117/78 HR 90 O2 99%. Patient had arrived with mother and agreed not to drive. Instructed to call 911/emergency services if symptoms return/worsen.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient arrived to post vaccine area after receiving second dose of Pfizer COVID 19 vaccine. Patient reported to post vaccine nurse feeling lightheaded with tongue tingling, headache, nausea and feeling flushed/itchy. Initial vital signs 123/83 85bpm 99% O2. At 1730 patient given 25mg PO Benadryl per standing orders. Patient monitored by post vaccine nurse. Symptoms resolved at 6:15pm, and requested to leave. Last vitals: 117/78 HR 90 O2 99%. Patient had arrived with mother and agreed not to drive. Instructed to call 911/emergency services if symptoms return/worsen.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Syncope
Clinical narrative: Five minutes  after vaccine patient got nausea, light headed, sweating and fainting patient said this happens when ever he gets a vaccination.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Lip blister, Oral mucosal blistering, Rash, Rash erythematous, Rash macular
Clinical narrative: Blisters to mouth/lips with itchy, red macular rash to hand and arms.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Blisters to mouth/lips with itchy, red macular rash to hand and arms.
Sex: U
Vaccine: VARZOS
Symptoms: Cystitis, Herpes zoster, Insomnia, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shingle shot a few yrs ago / shingles / said it was contagious / came back Its in my breast; Diagnose with a bad bladder infection; My back was itchy / wouldnt go away; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, bladder infection and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, bladder infection and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, bladder infection and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got the shingle shot a few years ago and now the patient suffering today went into the emergency thinking had a heart and patient's back was itchy. The patient was end up with diagnose with a bad bladder infection The itch wouldn't go away. The patient went to the doctor did not know what it was but the patient's neighbor told it was shingles and seek a dermatologist. The patient went to dermatologist and they said it was contagious. The patient stated that shingles came back in patient's breast and it feels like someone was standing patient and patient could not sleep. The patient was afraid of taking COVID vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation were not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Dysgeusia, Fatigue
Clinical narrative: That same evening I began to feel chills, woke up sweating the next day and progressively got worse the closer I got to the 24 hour mark. Jitters, joint pain, abdominal pain, nausea, metal taste, even felt numbness near joints on my thighs. Fatigue of course. About 48 hours later those symptoms started to subside.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: That same evening I began to feel chills, woke up sweating the next day and progressively got worse the closer I got to the 24 hour mark. Jitters, joint pain, abdominal pain, nausea, metal taste, even felt numbness near joints on my thighs. Fatigue of course. About 48 hours later those symptoms started to subside.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vial was punctured at 9:05 AM, vaccine was stored in fridge and labeled with a "beyond use date/time" of 5/5/21 at 3:05 PM.  Vaccine was administered to patient at 3:57 PM (52 minutes beyond expiration time). Pharmacy tried to contact patient but no answer, voicemail left.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product container issue, Product storage error
Clinical narrative: Vial was punctured at 9:05 AM, vaccine was stored in fridge and labeled with a "beyond use date/time" of 5/5/21 at 3:05 PM.  Vaccine was administered to patient at 3:57 PM (52 minutes beyond expiration time). Pharmacy tried to contact patient but no answer, voicemail left.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PRODUCT VIAL BREAKAGE; OFF LABEL USE; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a pharmacist concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced off label use. On 05-MAY-2021 09:05, the subject experienced product vial breakage. The action taken with covid-19 vaccine  was not applicable. The outcome of the incorrect storage of vaccine, off label use and product vial breakage was not reported. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product container issue, Product storage error
Clinical narrative: PRODUCT VIAL BREAKAGE; OFF LABEL USE; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a pharmacist concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced off label use. On 05-MAY-2021 09:05, the subject experienced product vial breakage. The action taken with covid-19 vaccine  was not applicable. The outcome of the incorrect storage of vaccine, off label use and product vial breakage was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus - loud ringing started in both ears3 days after 2nd covid-19 vaccine shot and has not stopped.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Lymphadenopathy, Peak expiratory flow rate decreased
Clinical narrative: Shortness of breath (decreased peak flow and fev for 10 days as of time of report), brain fog, fatigue, enlarged lymp nodes still exist as of time of report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Shortness of breath (decreased peak flow and fev for 10 days as of time of report), brain fog, fatigue, enlarged lymp nodes still exist as of time of report.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia, Pallor, Paraesthesia
Clinical narrative: Dizziness, tingling/numbness of bilateral hands, pale. Vitals wnl. Water given.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Influenza like illness, Mobility decreased, Myalgia
Clinical narrative: The side effects were terrible. It has been 12 hours and  I still feel like I?m dying... a terrible headache,  muscles pain, nausea of the highest sort, I couldn?t eat at all and drink. Whenever I was standing from the bed to go to the restroom I felt I?m about to faint. I needed to lie on the cold tile stone to actually not faint and come back to bed. At 3 pm I nearly lost consciousness. I ate an apple that was miraculously in my room and I felt a bit better, I had the power to walk to the kitchen to pick up the juice. I still experience headache and flue like symptoms but I feel they are wearing off slowly - the reason I?m typing this message. However, the entire day I was dying. I had a breakup at some point and wanted to call for the ambulance ... seriously, terrible side effects. After first dose I felt bad too, but after the second dose I was literally dying and I still do not feel the best.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: The side effects were terrible. It has been 12 hours and  I still feel like I?m dying... a terrible headache,  muscles pain, nausea of the highest sort, I couldn?t eat at all and drink. Whenever I was standing from the bed to go to the restroom I felt I?m about to faint. I needed to lie on the cold tile stone to actually not faint and come back to bed. At 3 pm I nearly lost consciousness. I ate an apple that was miraculously in my room and I felt a bit better, I had the power to walk to the kitchen to pick up the juice. I still experience headache and flue like symptoms but I feel they are wearing off slowly - the reason I?m typing this message. However, the entire day I was dying. I had a breakup at some point and wanted to call for the ambulance ... seriously, terrible side effects. After first dose I felt bad too, but after the second dose I was literally dying and I still do not feel the best.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Staff combined the 2 liquids together and administered to patient; Staff combined the 2 liquids together and administered to patient; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 details were provided as follows: The reporter stated that, when reconstituting menveo the staff combined the 2 liquids together and administered to patient in left arm, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired work ability, Nausea
Clinical narrative: Dizziness and nausea. Dizziness subsided after 30 minutes but nausea continued and she had to go home, couldn't finish her work shift.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose of Moderna was given to 17 year old patient
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received one dose of Pfizer vaccine while in the community on 3/25/201.  Patient received on dose of Janssen on 4/28/21. No adverse effects were noted or disclosed  when the patient was consulted on 5/6/2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: Weird pains for a few days - followed by major rash / blisters - still have significant pain  Diagnosed with shingles
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Joint stiffness, Limb discomfort, Paraesthesia
Clinical narrative: Patient states she felt numbness and tingling in left arm immediately when vaccine was given to her.  "I can feel the vaccine moving through my arm."  When checked at 15 minutes post injection she said her arm was bothering her and she was shaking her hand and holding her arm.  One hour later she noticed her watch was tight on her wrist.  Two hours later she had the sensation she was floating through the air and was lightheaded.  She took her watch off 2-3 hours post injection and noticed that she had "sausage fingers".  She had difficulty getting her rings off her fingers due to the swelling. Patient calls to report these symptoms 5/6/2021 at 9:40 am.  She states the swelling is resolving and her fingers are almost
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Patient states she felt numbness and tingling in left arm immediately when vaccine was given to her.  "I can feel the vaccine moving through my arm."  When checked at 15 minutes post injection she said her arm was bothering her and she was shaking her hand and holding her arm.  One hour later she noticed her watch was tight on her wrist.  Two hours later she had the sensation she was floating through the air and was lightheaded.  She took her watch off 2-3 hours post injection and noticed that she had "sausage fingers".  She had difficulty getting her rings off her fingers due to the swelling. Patient calls to report these symptoms 5/6/2021 at 9:40 am.  She states the swelling is resolving and her fingers are almost
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival oedema, Conjunctivitis allergic, Heart rate increased, Rash
Clinical narrative: 2 Days after immunization Patient experience increased heart rate for 5 minutes. Swollen and rash on conjunctiva sac of left eye for 1 week. After 2 weeks patient start having rash on arms.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I know someone got the vaccine shot and got the 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 age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Electrocardiogram, Thrombosis, Urine analysis
Clinical narrative: BLOOD CLOTS IN BOTH ARMS  AND BRUISERS BACKS ON BOTH LEGS SOME WHEEZING
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: BLOOD CLOTS IN BOTH ARMS  AND BRUISERS BACKS ON BOTH LEGS SOME WHEEZING
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Haematochezia, Nausea
Clinical narrative: Nausea, lightheadedness, abdominal cramps and blood in stool. There was also blood in stool 4 days after the first round of the vaccine but not with nausea and lightheadedness.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Patient stated to monitoring staff that he felt "nauseous." He stood up from his chair and was able to vomit on his own.  Remains A&O x3. He was given a cool fan and cool compresses to face. Patient was also given gatorade water for hydration and electrolyte replacement.  No acute distress noted. Patient held in observation area for additional 20 minutes for monitoring. Patient declined further evaluation/treatment from EMS.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain getting worse as the weeks go by since my shot.  Likely SIRVA as the shot was administered extremely high on my arm.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Fatigue, Headache, Pain
Clinical narrative: Fatigue, headache, body ache but most concerning is that EYES ARE SWELLING
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Flushing; sweating; dizziness. BPs 147/94 (pulse 87), 136/78 (pulse 86).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Nausea
Clinical narrative: Client (DOB:09/26/1965) received the 2nd dose of Pfizer COVID vaccine lot # EW0179 and expiration date 5/10/21 at 2:25pm.  Client reports to EMT that he feels nausea and sat down at 2:10pm.  PHN arrived to assist and found client sitting upright alert and oriented x 4.  Client reports to PHN that he has a bubbling feeling in his stomach "like the feeling you get before you throw up". Client reports that since he stopped exercising and  has not been feeling as good and has an appointment with primary and lab work later today. Vitals at 2:25pm blood pressure: 138/94, oxygen: 96% and pulse 58. Client denies, headache and chest pain and shortness of breath.  Vitals at 2:30pm blood pressure: 145/94, oxygen: 97%, and pulse: 62.  At 2:42pm blood pressure: 140/90, oxygen: 98% and pulse:69, Client reports nausea is slightly improved and that "bubbling" feels better.  At 2:52pm vitals are blood pressure:140/85, oxygen: 97%, and pulse:66.  Client reports nausea is slightly improved and that "bubbling" feels better. At 2:56pm vitals are blood pressure: 138/90, oxygen:97%,  and pulse:53. Client reports feeling better and that nausea and stomach pain have resolved.  Client left facility unassisted with a steady gait at 2:59pm.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Pain in extremity, Pyrexia, Tremor
Clinical narrative: I had an adverse reaction 10 hours after getting the vaccine a month ago. I got a bad fever and started to uncontrollably violently shake for an hour and a half. I had sevier leg pain and soreness. I also had a terrible headache. The symptoms eventually eased after taking Advil and Tylenol after a few hours. The next day I still had all of those reactions again, but the shaking was not as bad and didn't last more than a half an hour. Symptoms continued to fluctuate, but generally got better over 4 days.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had an adverse reaction 10 hours after getting the vaccine a month ago. I got a bad fever and started to uncontrollably violently shake for an hour and a half. I had sevier leg pain and soreness. I also had a terrible headache. The symptoms eventually eased after taking Advil and Tylenol after a few hours. The next day I still had all of those reactions again, but the shaking was not as bad and didn't last more than a half an hour. Symptoms continued to fluctuate, but generally got better over 4 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Large hard red mark at the injection site; Large hard red mark at the injection site; Flu like symptoms; Lightheaded; This case was reported by a nurse and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2020, the patient received the 1st dose of Shingrix. On 7th January 2020, immediately after receiving Shingrix, the patient experienced injection site erythema, injection site induration, influenza-like symptoms and light headedness. On an unknown date, the outcome of the injection site erythema and injection site induration were unknown and the outcome of the influenza-like symptoms and light headedness were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site induration, influenza-like symptoms and light headedness to be related to Shingrix.  Additional details were provided as follows: The registered nurse reported case for herself. The patient stated that shortly after the Shingrix dose, she had flu like symptoms, along with lightheaded and had a large hard red mark at the injection site. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020153365.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020153365:same reporter
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Sore arm shortly after shot that continued for three days.  Aches and chills with no fever that lasted for 24 hours.  Also, after I got better I wanted to run mask-free through fields of wildflowers, but that was probably me not the vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Malaise, Odynophagia, Otitis media
Clinical narrative: Sick after 2nd shot, fatigue, headaches, body aches 17 days later severe ear infection. I am 64 and have never had an  ear infection in my life.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in jaw
Clinical narrative: Sick after 2nd shot, fatigue, headaches, body aches 17 days later severe ear infection. I am 64 and have never had an  ear infection in my life.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Computerised tomogram thorax, Pulmonary embolism, Speech disorder, Ultrasound Doppler abnormal
Clinical narrative: 3/12/21 had few minutes of speaking incorrect words which led to eval for TIA 3/17/21 had dopplers of carotid with unequal blood velocities 3/24/21 covid vaccine #1 4/15/21 covid vaccine #2 4/21/21 CTA chest to look for cause of carotid velocities being different and pulmonary emboli were found
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm is swollen and has minor consistent pain.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted during the 15 minute observation period after getting  her vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Bicuspid aortic valve, Dizziness, Echocardiogram abnormal, Electrocardiogram abnormal, Hot flush
Clinical narrative: Within a minute I had a hot flash that started in my calf and went through my body. In less than a minute I was lightheaded and almost passed out (or fell asleep). I beeped my horn and the nurse came right over. They took my blood pressure and it was 150 over 120. (I've never had high blood pressure before. The second reading was 140 over 110. In about 5 minutes my BP was normal 120 over 80.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Within a minute I had a hot flash that started in my calf and went through my body. In less than a minute I was lightheaded and almost passed out (or fell asleep). I beeped my horn and the nurse came right over. They took my blood pressure and it was 150 over 120. (I've never had high blood pressure before. The second reading was 140 over 110. In about 5 minutes my BP was normal 120 over 80.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nervousness, Palpitations, Tremor
Clinical narrative: Right hand/arm tremors, sometimes when they happen I feel like I?m shaking on the inside and my heart started pounding hard and a little faster.
Sex: U
Vaccine: VARZOS
Symptoms: Crying, Pain, Product prescribing error, Pruritus, Thermal burn
Clinical narrative: a year for the last one my doctor explains to me very well so is time for my second one; This case was reported by a consumer via media and described the occurrence of drug schedule prescribing error in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, crying (day and night), pain (really hurt), burn and pruritus.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug schedule prescribing error. On an unknown date, the outcome of the drug schedule prescribing error was unknown.  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 reported that he/she had shingles in past. The patient was crying day and night and stated that that's really hurt and reported about itch and burn. The patient hope that he/she never got it again, so patient got the first shot of vaccine. The patient stated that his/her physician explained that patient need second dose after 6 months and 3rd dose after a year, which led to drug schedule prescribing error.  No other information was reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: The patient stated that a few days following his 1st covid vaccine he developed a rash on his chest and left arm. He went to the doctor and they diagnosed him with shingles. Patient is still experiencing actue rash.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Nausea, Pain
Clinical narrative: Fever Chills Whole Body Soreness Nausea Diarrhea Joint Pain