chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted 2 minutes after getting the vaccine. Recovered within  5 -10 minutes. 911 called, vitals checked, all normal.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal
Clinical narrative: I got my second Covid Moderna vaccine on April 8th 2021. I am prediabetic with fairly good control .  I tested my glucose the evening of the 2nd vaccine and my glucose was very low at 66.  I haven't seen lows or very high glucose readings in the past.  I also had a reading the next day that was higher than my normal reading.  The higher reading was 132.  In the ensuing months my glucose readings changed to  higher than normal readings and hypoglycemic, lower, readings,( 1-2 times a month for the low readings). My highest glucose reading is now 265, so far, and my lowest reading has been down to 56.  I don't feel when its low until it gets really low and hard to recover with glucose tablets and the gel when it?s really low.  I am now on Acarbose medicine to balance my glucose. Please add this side effect to your list of reactions to the Covid vaccine. (I did get a fever of 101  after 2nd vaccine)
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Headache, Heavy menstrual bleeding, Impaired work ability, Pain, Pyrexia
Clinical narrative: December 29th fever 101.6F, UTI, headache, body aches monthly cycle was heavy but stopped on the 27th of December. Missed work fever went away December 29th 6pm. 99.6F
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Urinary tract infection
Clinical narrative: December 29th fever 101.6F, UTI, headache, body aches monthly cycle was heavy but stopped on the 27th of December. Missed work fever went away December 29th 6pm. 99.6F
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Skin odour abnormal
Clinical narrative: I also have had symptoms of swollen armpits since my booster vaccine on Nov 2 2021. My armpits are still swollen , (but not as bad  as after my booster),and very smelly to the point I have to wash my underarms a few times a day and change my clothes frequently. I normally don?t need to wear deodorant and don?t smell when I?m warm.  I tried soaking my armpits twice a day with warm water for 5 minutes & for 2 weeks.  The smell is not as bad now, 02/08/2022, as it was in November 2021 and I only have to wash my underarms once a day. If I take a bath the night before, I still have to wash my smelly wet underarms in the morning again. Now the smell only happens in the morning. I am going to see my physician for the swollen armpits to make sure something  else is not going on.  Please add this also to the possible Covid vaccine reaction list.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was requesting a flu shot, and onsite nurse provided incorrect vaccine (Pfizer COVID vaccine)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Cardiac discomfort, Cardiac flutter, Dyspnoea, Electrocardiogram normal
Clinical narrative: Immediately after getting the shot I felt a little nausea, had a headache and soreness in the area that I received the shot. The soreness remained for about 3 days and I was fine after.  At about January 25, is when I started noticing heart palpitations. My heart felt like it was constantly fluttering unevenly and every now and then I could feel a "squeezing" sensation on my heart that would result in a "tingling" in my left hand. It occurred on and off for days.   Before scheduling my appointment to see the doctor, my significant other mentioned that I seemed a lot more of of breath lately when speaking and doing regular tasks.   When I went to the doctor and explaining the situation, they ran an Ekg/ECG to monitor my heart and everything came out normal. Several other blood work tests were ran to look at my levels and all of them came back good. My Potassium was .1 below what was considered the norm so I was given a small dose of Potassium to take over the next few days.  At this time, I am currently not having any palpitations. The last I had them was on 2/5/22.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Nausea, Palpitations
Clinical narrative: Immediately after getting the shot I felt a little nausea, had a headache and soreness in the area that I received the shot. The soreness remained for about 3 days and I was fine after.  At about January 25, is when I started noticing heart palpitations. My heart felt like it was constantly fluttering unevenly and every now and then I could feel a "squeezing" sensation on my heart that would result in a "tingling" in my left hand. It occurred on and off for days.   Before scheduling my appointment to see the doctor, my significant other mentioned that I seemed a lot more of of breath lately when speaking and doing regular tasks.   When I went to the doctor and explaining the situation, they ran an Ekg/ECG to monitor my heart and everything came out normal. Several other blood work tests were ran to look at my levels and all of them came back good. My Potassium was .1 below what was considered the norm so I was given a small dose of Potassium to take over the next few days.  At this time, I am currently not having any palpitations. The last I had them was on 2/5/22.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Immediately after getting the shot I felt a little nausea, had a headache and soreness in the area that I received the shot. The soreness remained for about 3 days and I was fine after.  At about January 25, is when I started noticing heart palpitations. My heart felt like it was constantly fluttering unevenly and every now and then I could feel a "squeezing" sensation on my heart that would result in a "tingling" in my left hand. It occurred on and off for days.   Before scheduling my appointment to see the doctor, my significant other mentioned that I seemed a lot more of of breath lately when speaking and doing regular tasks.   When I went to the doctor and explaining the situation, they ran an Ekg/ECG to monitor my heart and everything came out normal. Several other blood work tests were ran to look at my levels and all of them came back good. My Potassium was .1 below what was considered the norm so I was given a small dose of Potassium to take over the next few days.  At this time, I am currently not having any palpitations. The last I had them was on 2/5/22.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Skin odour abnormal
Clinical narrative: I had the Pfizer vaccines and noticed excessive sweating and a strong smell under my arms. It was after my last vaccine when the event started. I have to change my clothes and wash my armpits frequently.  It is still smelling worse than prior to the vaccine but is a little less smelly. My 3rd vaccine, the booster was Sept 2021.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Costochondritis, Electrocardiogram, X-ray
Clinical narrative: I  was diagnosed with costochondritis , I have a lot of stabbing on my left side in my chest that feel like a heart attack, it hurts all day every day and gets worsen at night to the point I cry myself to sleep.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Face injury, Head injury, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient was instructed to remain in waiting area for 15 min after receiving his 2nd Pfizer shot. He chose to leave without waiting , he left the waiting area but shortly turned around and told the front desk he felt dizzy and then fainted on the floor, face first, causing a forehead laceration. Pt was sweating and was nauseated, when he woke up. He was oriented, BP was 100/60, FSBS 88, given bottle of water. 911 was called due to facial laceration, hitting his head from standing position and blacking out. Pt left on his own with the squad to go to the ER for evaluation.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Skin laceration, Syncope
Clinical narrative: Patient was instructed to remain in waiting area for 15 min after receiving his 2nd Pfizer shot. He chose to leave without waiting , he left the waiting area but shortly turned around and told the front desk he felt dizzy and then fainted on the floor, face first, causing a forehead laceration. Pt was sweating and was nauseated, when he woke up. He was oriented, BP was 100/60, FSBS 88, given bottle of water. 911 was called due to facial laceration, hitting his head from standing position and blacking out. Pt left on his own with the squad to go to the ER for evaluation.
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Chills, Infection, Product dose omission issue, Pyrexia
Clinical narrative: Patient reported she received her Covid booster on 12/7/21. She was having chills and fever and was advised to go to the ER by her MD. The ER discovered she had an infection due to an abscess under her arm and admitted her to the hospital for IV antibiotics. Patient stated the infection is now cleared and her MD gave her the okay to resume her Humira. She stated she missed 1 or 2 doses due to this.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Fatigue, Headache, Nervous system disorder
Clinical narrative: The Maderna booster gave me severe bronchitis, neurological disorder head ache and fatigue. Then 15 days later I tested positive with covid and had repeated symptoms.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: The Maderna booster gave me severe bronchitis, neurological disorder head ache and fatigue. Then 15 days later I tested positive with covid and had repeated symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Superficial vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Occlusive thrombus following covid vaccination. Received J&J vaccine in the left arm on 01/05/2022 at the Pharmacy. On 01/31/22 patient presented with left forearm pain, present for 2 days. Forearm warm to touch and swollen. Started ASA 325mg qd. Returned to office 2/7/22 with no improvement. Sent for DP Venous Upper LT DVT. Results show occlusive thrombus in basilic vein in the mid forearm.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, Chest discomfort, Chest pain, Palpitations
Clinical narrative: Patient is a 29-year-old female with no significant past medical problems who presents emergency department complaining of a 1 month history of chest pain. Patient states symptoms started about 6 days after she got her Pfizer Covid booster. She states the following week she started to have some heart palpitations like her heart was beating out of her chest. States she went to the emergency department due to some chest pain and her heart rate was found to be in the 140s. States that the run emergency department told her that all of her lab work was fine and thought it might be due to anxiety and was advised to follow up with cardiology. Patient states she did not follow-up with cardiology and has had persistent symptoms since then. She states that symptoms occur randomly and are not exertional. Her most recent episode was this morning. States she was driving home after night shift and felt like the chest pain came back with bilateral arm tingling. She states she does not necessarily feel lightheaded or dizzy but feels like she is going to fall down and die. She states she still has some persistent chest pressure but the sensation of dying has passed. States it never feels like "an elephant on (her) chest." No more tingling. She denies any diaphoresis, shortness of breath, vomiting. Patient denies any history of heart problems. Denies any family history of heart problems under the age of 65. She has a ParaGard IUD. No history of blood clots. No other complaints today.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Troponin increased
Clinical narrative: Patient is a 29-year-old female with no significant past medical problems who presents emergency department complaining of a 1 month history of chest pain. Patient states symptoms started about 6 days after she got her Pfizer Covid booster. She states the following week she started to have some heart palpitations like her heart was beating out of her chest. States she went to the emergency department due to some chest pain and her heart rate was found to be in the 140s. States that the run emergency department told her that all of her lab work was fine and thought it might be due to anxiety and was advised to follow up with cardiology. Patient states she did not follow-up with cardiology and has had persistent symptoms since then. She states that symptoms occur randomly and are not exertional. Her most recent episode was this morning. States she was driving home after night shift and felt like the chest pain came back with bilateral arm tingling. She states she does not necessarily feel lightheaded or dizzy but feels like she is going to fall down and die. She states she still has some persistent chest pressure but the sensation of dying has passed. States it never feels like "an elephant on (her) chest." No more tingling. She denies any diaphoresis, shortness of breath, vomiting. Patient denies any history of heart problems. Denies any family history of heart problems under the age of 65. She has a ParaGard IUD. No history of blood clots. No other complaints today.
Sex: U
Vaccine: HPV9
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Nausea and vomiting 12 hours after receiving the 2nd dose of the HPV vaccine. Stomach ache ensues.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Urticaria chronic
Clinical narrative: I developed hives after my Pfizer shots that progressed into chronic urticaria. It improved with antihistamine and recurred after my booster. However this time even worse.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: The team has identified possible quality control issues (intra-lot and inter-lot variability) with MMR vaccine, manufactured by Merck, that may require further investigation. Using non-destructive analytical techniques, FT-NIR spectra were collected for inventory belonging to LotU006488 as part of routine medication quality screening. A representative sample of 12 individual vials were selected for screening and noted to be stored under proper conditions, in their original packaging at between 2 and 8 ?, with an expiration date of 02/26/2023. FT-NIR spectra were collected noninvasively and non-destructively using a Thermo Scientific Antaris II FT-NIR Analyzer. Upon examination of the FT-NIR spectra, absorbance peak location and intensity differences were observed in 6 of 12 vials screened after applying multiplicative signal correction on the spectra. Differences in absorbance peak location were observed at 7000 cm-1, 6050 cm-1, 4700 cm-1, and 4600 cm-1. These findings can be observed directly in the attached image, labeled as MMRB000PPHWR102421. The observation of variability in absorbance peak location differences may indicate the presence of product impurities and/or degradation products. Statistical analysis of the collected FT-NIR spectra indicated the 6 vials that produced the spectra containing variability in absorbance peak location differences suggested intra-lot variability. The 6 outlier vials had a calculated distance of 14.47 multidimensional standard deviations (SDs) from the center of the 6 other vials with the same lot number. Using a group membership range between 0 and 3 SDs, a standard deviation of 14.47 signals potential quality control issue LotU006488. In addition, upon comparing LotU006488 to other lots collected for our spectral library, it was discovered that there is inter-lot variability as well as intra-lot variability. Our library of 198 MMR Vaccine spectra from 11 other lots falls into at least 2 groups, with a large number of observed outlier spectra (see principal component plot). It is not clear which of these groups represent the approved product, or whether they are all the approved product. The 11 other lots forming the spectral library are LotS032826, LotS037501, LotS039310, LotT001213, LotT001214, LotT012807, LotT013725, LotT022310, LotT031436, LotT034389, and LotU011149. The presence of intra-lot and inter-lot variability may warrant further investigation of the product, MMR Vaccine, and the manufacturing process controls of its producer, Merck. 14.47 is the multidimensional standard deviation (SD) value obtained for 6 outlier vials in LotU006488 with respect to the calculated average of 6 additional vials of the same lot number. The low and high test range values are represented by the group membership range, defined as the range between 0 and 3 SDs.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal swelling
Clinical narrative: Symptoms: left side of lips numbing, throat swelling. Treatment: Given EpiPen shot in Right leg upper thigh, Given Benadryl, Admitted to the local ER. Outcome: Stayed in ER for 2-1/2 hours, symptoms went away then sent home.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient came to office today and states that 2 hours second Covid 19 vaccine dose at a pharmacy, patient broke out in hives. Mom took the patient, via personal vehicle, to an Urgent Care Center who instructed mom to administer Benadryl. Benadryl helped and hives resolved.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood blister, Inflammation
Clinical narrative: Systemic: patient metionid inflammation and a blood blister?-Mild, Additional Details: Patient contacting 6 months after booster and complaining of adverse effects
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiopathy, Arthropathy, Autonomic nervous system imbalance, Burning sensation, Contusion
Clinical narrative: Systemic: patient metionid inflammation and a blood blister?-Mild, Additional Details: Patient contacting 6 months after booster and complaining of adverse effects
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Endocrine disorder, Hypoaesthesia, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Systemic: patient metionid inflammation and a blood blister?-Mild, Additional Details: Patient contacting 6 months after booster and complaining of adverse effects
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Magnetic resonance imaging head, Mobility decreased, Musculoskeletal disorder, Nerve conduction studies
Clinical narrative: Systemic: patient metionid inflammation and a blood blister?-Mild, Additional Details: Patient contacting 6 months after booster and complaining of adverse effects
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Palpitations, Paraesthesia, Skin discolouration
Clinical narrative: Systemic: patient metionid inflammation and a blood blister?-Mild, Additional Details: Patient contacting 6 months after booster and complaining of adverse effects
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Tachycardia, Weight decreased
Clinical narrative: Systemic: patient metionid inflammation and a blood blister?-Mild, Additional Details: Patient contacting 6 months after booster and complaining of adverse effects
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Headache, Joint swelling, Magnetic resonance imaging, Myalgia
Clinical narrative: Neuropathy,  severe headaches, joint swelling, and muscle pain
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy,  severe headaches, joint swelling, and muscle pain
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Acute left ventricular failure, Chest X-ray, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: Visited Emergency room 3 different occasions: 10/9/21, 10/14/2021 and 10/23/21. Had continuous shortness of breath, leg swelling and on going chest pain.  On last ER visit of 10/23/21 was taken to be hospitalized for acute systolic heart failure.  Was hospitalized from 10/23/21 to 11/01/2021 at hospital.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Peripheral swelling
Clinical narrative: Visited Emergency room 3 different occasions: 10/9/21, 10/14/2021 and 10/23/21. Had continuous shortness of breath, leg swelling and on going chest pain.  On last ER visit of 10/23/21 was taken to be hospitalized for acute systolic heart failure.  Was hospitalized from 10/23/21 to 11/01/2021 at hospital.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Breast haemorrhage, Fatigue, Inflammation
Clinical narrative: Bleeding from right breast starting on 4-10-2021 and continues to the present. Ringing in ears with a constant hum/whistle, accompanied with vertigo. Overall inflammation that traveled to different parts of my body, bloating and 8lb weight gain, nausea and other GI issues.  Chronic fatigue. Not recovered from most of symptoms except the vertigo
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Nausea, Tinnitus, Ultrasound scan, Vertigo
Clinical narrative: Bleeding from right breast starting on 4-10-2021 and continues to the present. Ringing in ears with a constant hum/whistle, accompanied with vertigo. Overall inflammation that traveled to different parts of my body, bloating and 8lb weight gain, nausea and other GI issues.  Chronic fatigue. Not recovered from most of symptoms except the vertigo
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Bleeding from right breast starting on 4-10-2021 and continues to the present. Ringing in ears with a constant hum/whistle, accompanied with vertigo. Overall inflammation that traveled to different parts of my body, bloating and 8lb weight gain, nausea and other GI issues.  Chronic fatigue. Not recovered from most of symptoms except the vertigo
Age: 44.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Tinnitus
Clinical narrative: Jake stated that he developed tinnitus within a few days of his 3rd Pfizer vaccine on 10/7/21. As of 2/10/22 he still has it. He noted that his father has chronic tinnitus for many years.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Epicondylitis, Pain in extremity
Clinical narrative: lateral epicondylitis pain in my left arm; Pain in my distal left thumb joint; This case was reported by a consumer and described the occurrence of lateral epicondylitis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2021, the patient received the 2nd dose of Shingrix. In May 2021, 3 weeks after receiving Shingrix, the patient experienced lateral epicondylitis and pain in joint involving hand. On an unknown date, the outcome of the lateral epicondylitis and pain in joint involving hand were recovering/resolving.   It was unknown if the reporter considered the lateral epicondylitis and pain in joint involving hand to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix vial kit in left arm and about 3 weeks later developed lateral epicondylitis pain in his/her left arm (the patient was right handed).  In May 2021, the following 3 weeks, the patient also had pain in his/her distal left thumb joint. As of this moment, the patient was only 70 percent recovered for both pains. The physician had now referred physical therapist. The reporter consented to follow-up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chronic lymphocytic leukaemia, Full blood count abnormal, Lymphocyte count increased, White blood cell count increased
Clinical narrative: CHRONIC LYMPHOCYTIC LEUKEMIA; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hyperactive thyroid and hypertension. The patient had no known allergies at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported,1 total, administered to right arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Lymphocytes raised (NR: not provided) elevated, and White blood cells (NR: not provided) elevated. Patient got blood test every 2-3 months. His thyroid related blood levels were normal until vaccine but 4 weeks after he got vaccine shot, white blood cells and lymphocytes elevated and he continued to go up an up for 3-4 tests until referred to oncologist. Patient got tested on NOV (once) and DEC (twice) of 2021. On 20-JAN-2022, the patient was diagnosed with chronic lymphocytic leukemia. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic lymphocytic leukemia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220213155-covid-19 vaccine ad26.cov2.s-chronic lymphocytic leukemia. This event(s) is considered not related. The event(s) shows an incompatible temporal relationship.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chronic lymphocytic leukaemia, Lymphocyte count increased, White blood cell count
Clinical narrative: CHRONIC LYMPHOCYTIC LEUKEMIA; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hyperactive thyroid and hypertension. The patient had no known allergies at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported,1 total, administered to right arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Lymphocytes raised (NR: not provided) elevated, and White blood cells (NR: not provided) elevated. Patient got blood test every 2-3 months. His thyroid related blood levels were normal until vaccine but 4 weeks after he got vaccine shot, white blood cells and lymphocytes elevated and he continued to go up an up for 3-4 tests until referred to oncologist. Patient got tested on NOV (once) and DEC (twice) of 2021. On 20-JAN-2022, the patient was diagnosed with chronic lymphocytic leukemia. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic lymphocytic leukemia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220213155-covid-19 vaccine ad26.cov2.s-chronic lymphocytic leukemia. This event(s) is considered not related. The event(s) shows an incompatible temporal relationship.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood pressure increased, Blood test, Computerised tomogram, Dizziness
Clinical narrative: HEAD IS ON FIRE SOMETIMES; WEAKNESS/ACTIVITY INTOLERANCE; FLUCTUATING/HIGH BLOOD PRESSURE/BLOOD PRESSURE GOING HIGH; NUMBNESS OF LEFT-SIDED FACE/NECK/LEGS/ARMS/ENTIRE BODY; LEG CRAMPS; FEVER/FLU-LIKE SYMPTOMS/FATIGUE; BLURRED VISION; TINGLING OF LEFT SIDE OF BODY ARMS/LEGS; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 182 pounds, and height was 74 inches. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced blurred vision, and tingling of left side of body arms/legs. On 10-JUL-2021, the patient experienced leg cramps, and fever/flu-like symptoms/fatigue. On 11-JUL-2021, the patient experienced numbness of left-sided face/neck/legs/arms/entire body. On 17-JUL-2021, the patient experienced fluctuating/high blood pressure/blood pressure going high. Laboratory data included: Blood pressure (not provided) high. On an unspecified date, the patient experienced head is on fire sometimes, and weakness/activity intolerance. Laboratory data (dates unspecified) included: Lumbar puncture (not provided) Not reported, and MRI (not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/flu-like symptoms/fatigue, numbness of left-sided face/neck/legs/arms/entire body, fluctuating/high blood pressure/blood pressure going high, weakness/activity intolerance, and tingling of left side of body arms/legs, and the outcome of leg cramps, blurred vision and head is on fire sometimes was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Fatigue, Feeling of body temperature change, Hypoaesthesia, Impaired work ability
Clinical narrative: HEAD IS ON FIRE SOMETIMES; WEAKNESS/ACTIVITY INTOLERANCE; FLUCTUATING/HIGH BLOOD PRESSURE/BLOOD PRESSURE GOING HIGH; NUMBNESS OF LEFT-SIDED FACE/NECK/LEGS/ARMS/ENTIRE BODY; LEG CRAMPS; FEVER/FLU-LIKE SYMPTOMS/FATIGUE; BLURRED VISION; TINGLING OF LEFT SIDE OF BODY ARMS/LEGS; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 182 pounds, and height was 74 inches. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced blurred vision, and tingling of left side of body arms/legs. On 10-JUL-2021, the patient experienced leg cramps, and fever/flu-like symptoms/fatigue. On 11-JUL-2021, the patient experienced numbness of left-sided face/neck/legs/arms/entire body. On 17-JUL-2021, the patient experienced fluctuating/high blood pressure/blood pressure going high. Laboratory data included: Blood pressure (not provided) high. On an unspecified date, the patient experienced head is on fire sometimes, and weakness/activity intolerance. Laboratory data (dates unspecified) included: Lumbar puncture (not provided) Not reported, and MRI (not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/flu-like symptoms/fatigue, numbness of left-sided face/neck/legs/arms/entire body, fluctuating/high blood pressure/blood pressure going high, weakness/activity intolerance, and tingling of left side of body arms/legs, and the outcome of leg cramps, blurred vision and head is on fire sometimes was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mobility decreased, Paraesthesia, Paralysis, Pyrexia
Clinical narrative: HEAD IS ON FIRE SOMETIMES; WEAKNESS/ACTIVITY INTOLERANCE; FLUCTUATING/HIGH BLOOD PRESSURE/BLOOD PRESSURE GOING HIGH; NUMBNESS OF LEFT-SIDED FACE/NECK/LEGS/ARMS/ENTIRE BODY; LEG CRAMPS; FEVER/FLU-LIKE SYMPTOMS/FATIGUE; BLURRED VISION; TINGLING OF LEFT SIDE OF BODY ARMS/LEGS; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 182 pounds, and height was 74 inches. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced blurred vision, and tingling of left side of body arms/legs. On 10-JUL-2021, the patient experienced leg cramps, and fever/flu-like symptoms/fatigue. On 11-JUL-2021, the patient experienced numbness of left-sided face/neck/legs/arms/entire body. On 17-JUL-2021, the patient experienced fluctuating/high blood pressure/blood pressure going high. Laboratory data included: Blood pressure (not provided) high. On an unspecified date, the patient experienced head is on fire sometimes, and weakness/activity intolerance. Laboratory data (dates unspecified) included: Lumbar puncture (not provided) Not reported, and MRI (not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/flu-like symptoms/fatigue, numbness of left-sided face/neck/legs/arms/entire body, fluctuating/high blood pressure/blood pressure going high, weakness/activity intolerance, and tingling of left side of body arms/legs, and the outcome of leg cramps, blurred vision and head is on fire sometimes was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Temperature regulation disorder, Tinnitus
Clinical narrative: HEAD IS ON FIRE SOMETIMES; WEAKNESS/ACTIVITY INTOLERANCE; FLUCTUATING/HIGH BLOOD PRESSURE/BLOOD PRESSURE GOING HIGH; NUMBNESS OF LEFT-SIDED FACE/NECK/LEGS/ARMS/ENTIRE BODY; LEG CRAMPS; FEVER/FLU-LIKE SYMPTOMS/FATIGUE; BLURRED VISION; TINGLING OF LEFT SIDE OF BODY ARMS/LEGS; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 182 pounds, and height was 74 inches. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced blurred vision, and tingling of left side of body arms/legs. On 10-JUL-2021, the patient experienced leg cramps, and fever/flu-like symptoms/fatigue. On 11-JUL-2021, the patient experienced numbness of left-sided face/neck/legs/arms/entire body. On 17-JUL-2021, the patient experienced fluctuating/high blood pressure/blood pressure going high. Laboratory data included: Blood pressure (not provided) high. On an unspecified date, the patient experienced head is on fire sometimes, and weakness/activity intolerance. Laboratory data (dates unspecified) included: Lumbar puncture (not provided) Not reported, and MRI (not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/flu-like symptoms/fatigue, numbness of left-sided face/neck/legs/arms/entire body, fluctuating/high blood pressure/blood pressure going high, weakness/activity intolerance, and tingling of left side of body arms/legs, and the outcome of leg cramps, blurred vision and head is on fire sometimes was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure measurement, Head discomfort, Hypertension, Hypoaesthesia
Clinical narrative: HEAD IS ON FIRE SOMETIMES; WEAKNESS/ACTIVITY INTOLERANCE; FLUCTUATING/HIGH BLOOD PRESSURE/BLOOD PRESSURE GOING HIGH; NUMBNESS OF LEFT-SIDED FACE/NECK/LEGS/ARMS/ENTIRE BODY; LEG CRAMPS; FEVER/FLU-LIKE SYMPTOMS/FATIGUE; BLURRED VISION; TINGLING OF LEFT SIDE OF BODY ARMS/LEGS; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 182 pounds, and height was 74 inches. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced blurred vision, and tingling of left side of body arms/legs. On 10-JUL-2021, the patient experienced leg cramps, and fever/flu-like symptoms/fatigue. On 11-JUL-2021, the patient experienced numbness of left-sided face/neck/legs/arms/entire body. On 17-JUL-2021, the patient experienced fluctuating/high blood pressure/blood pressure going high. Laboratory data included: Blood pressure (not provided) high. On an unspecified date, the patient experienced head is on fire sometimes, and weakness/activity intolerance. Laboratory data (dates unspecified) included: Lumbar puncture (not provided) Not reported, and MRI (not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/flu-like symptoms/fatigue, numbness of left-sided face/neck/legs/arms/entire body, fluctuating/high blood pressure/blood pressure going high, weakness/activity intolerance, and tingling of left side of body arms/legs, and the outcome of leg cramps, blurred vision and head is on fire sometimes was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Lumbar puncture, Magnetic resonance imaging, Muscle spasms, Paraesthesia
Clinical narrative: HEAD IS ON FIRE SOMETIMES; WEAKNESS/ACTIVITY INTOLERANCE; FLUCTUATING/HIGH BLOOD PRESSURE/BLOOD PRESSURE GOING HIGH; NUMBNESS OF LEFT-SIDED FACE/NECK/LEGS/ARMS/ENTIRE BODY; LEG CRAMPS; FEVER/FLU-LIKE SYMPTOMS/FATIGUE; BLURRED VISION; TINGLING OF LEFT SIDE OF BODY ARMS/LEGS; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 182 pounds, and height was 74 inches. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced blurred vision, and tingling of left side of body arms/legs. On 10-JUL-2021, the patient experienced leg cramps, and fever/flu-like symptoms/fatigue. On 11-JUL-2021, the patient experienced numbness of left-sided face/neck/legs/arms/entire body. On 17-JUL-2021, the patient experienced fluctuating/high blood pressure/blood pressure going high. Laboratory data included: Blood pressure (not provided) high. On an unspecified date, the patient experienced head is on fire sometimes, and weakness/activity intolerance. Laboratory data (dates unspecified) included: Lumbar puncture (not provided) Not reported, and MRI (not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/flu-like symptoms/fatigue, numbness of left-sided face/neck/legs/arms/entire body, fluctuating/high blood pressure/blood pressure going high, weakness/activity intolerance, and tingling of left side of body arms/legs, and the outcome of leg cramps, blurred vision and head is on fire sometimes was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: HEAD IS ON FIRE SOMETIMES; WEAKNESS/ACTIVITY INTOLERANCE; FLUCTUATING/HIGH BLOOD PRESSURE/BLOOD PRESSURE GOING HIGH; NUMBNESS OF LEFT-SIDED FACE/NECK/LEGS/ARMS/ENTIRE BODY; LEG CRAMPS; FEVER/FLU-LIKE SYMPTOMS/FATIGUE; BLURRED VISION; TINGLING OF LEFT SIDE OF BODY ARMS/LEGS; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 182 pounds, and height was 74 inches. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced blurred vision, and tingling of left side of body arms/legs. On 10-JUL-2021, the patient experienced leg cramps, and fever/flu-like symptoms/fatigue. On 11-JUL-2021, the patient experienced numbness of left-sided face/neck/legs/arms/entire body. On 17-JUL-2021, the patient experienced fluctuating/high blood pressure/blood pressure going high. Laboratory data included: Blood pressure (not provided) high. On an unspecified date, the patient experienced head is on fire sometimes, and weakness/activity intolerance. Laboratory data (dates unspecified) included: Lumbar puncture (not provided) Not reported, and MRI (not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever/flu-like symptoms/fatigue, numbness of left-sided face/neck/legs/arms/entire body, fluctuating/high blood pressure/blood pressure going high, weakness/activity intolerance, and tingling of left side of body arms/legs, and the outcome of leg cramps, blurred vision and head is on fire sometimes was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Chest discomfort, Cough, Deep vein thrombosis, Dyspnoea
Clinical narrative: Patient presented on 2/2/22 with a 4 day history of shortness of breath and chest pressure. Was sent to the local emergency room where he was found to have a very elevated D-Dimer and positive CT angiogram of the chest for a pulmonary embolus and positive left lower extremity doppler for DVT.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea exertional, Electrocardiogram ST segment abnormal, Laboratory test abnormal, Muscle spasms, Pain
Clinical narrative: Patient presented on 2/2/22 with a 4 day history of shortness of breath and chest pressure. Was sent to the local emergency room where he was found to have a very elevated D-Dimer and positive CT angiogram of the chest for a pulmonary embolus and positive left lower extremity doppler for DVT.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pulmonary embolism, Pulmonary imaging procedure abnormal, Troponin increased, Wheezing
Clinical narrative: Patient presented on 2/2/22 with a 4 day history of shortness of breath and chest pressure. Was sent to the local emergency room where he was found to have a very elevated D-Dimer and positive CT angiogram of the chest for a pulmonary embolus and positive left lower extremity doppler for DVT.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Chest discomfort, Deep vein thrombosis, Dyspnoea, Fibrin D dimer
Clinical narrative: Patient presented on 2/2/22 with a 4 day history of shortness of breath and chest pressure. Was sent to the local emergency room where he was found to have a very elevated D-Dimer and positive CT angiogram of the chest for a pulmonary embolus and positive left lower extremity doppler for DVT.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Full blood count normal, International normalised ratio normal, Platelet count normal, Prothrombin time normal
Clinical narrative: Patient presented on 2/2/22 with a 4 day history of shortness of breath and chest pressure. Was sent to the local emergency room where he was found to have a very elevated D-Dimer and positive CT angiogram of the chest for a pulmonary embolus and positive left lower extremity doppler for DVT.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Ultrasound Doppler abnormal
Clinical narrative: Patient presented on 2/2/22 with a 4 day history of shortness of breath and chest pressure. Was sent to the local emergency room where he was found to have a very elevated D-Dimer and positive CT angiogram of the chest for a pulmonary embolus and positive left lower extremity doppler for DVT.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: COVID vaccine given past thaw expiration date.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: COVID vaccine given past thaw expiration date.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: COVID vaccine given past thaw expiration date.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Unable to Sleep-Severe
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Eye swelling, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Unable to Sleep-Severe
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Insomnia
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Unable to Sleep-Severe
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Pruritus, Rash, Swelling face, Swollen tongue
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Unable to Sleep-Severe