chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Having much Pain in right Leg and back when standing or Walking. After One month of Physical Theropy my theropist said see your doctor ASAP. He measured my leg circumferance to other Leg and was 1.5 inches bigger and was warm to touch. Limp to Car and Go to Walk in clinic. Doctor there sends me over to Hospital for ultra sound. From 9-30-21 thru 10-3-21 they Keep me on IVS for Deep Vain Trombosis. As of 12-28-21 I was able to stand and take a shower As of Today able to Walk to mail Box and shop a little. I Am on Eliquis 5 mG (2) Daily and off Brilinta Blood Thinners. The Febuary ultra sound shows jagged vain scars along with Swollen leg. I need lots of Exersice Daily + Hard to get better. bat Weather has been my biggest Drawl Back. Got Electric Bike and all the Safty features to help Kick start my recovery. Work is a thing of the Past. MY old retirement Dreams are gone. Now just survival mode. Well Thank workers for getting the vaccine to save the world. I Am not complaining I got it. Maybe my shingles Vaccination should of held off longer. Who knows but the ER Doctor almost took my Leg- off. He thought I was sucicsidle. I thought No Pain No Gain at the Physical theropist office. My Syattic Nerve no longer bothers me. That was also a first. Now my heart Doctor is keeping a close eye on my heart. He Says everything is fine just a little Swollen. I have been in intense pain trying to get Better for over a Year now and was better off being a cough Potatoe.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling, Therapeutic response unexpected, Ultrasound Doppler abnormal, Vein disorder
Clinical narrative: Having much Pain in right Leg and back when standing or Walking. After One month of Physical Theropy my theropist said see your doctor ASAP. He measured my leg circumferance to other Leg and was 1.5 inches bigger and was warm to touch. Limp to Car and Go to Walk in clinic. Doctor there sends me over to Hospital for ultra sound. From 9-30-21 thru 10-3-21 they Keep me on IVS for Deep Vain Trombosis. As of 12-28-21 I was able to stand and take a shower As of Today able to Walk to mail Box and shop a little. I Am on Eliquis 5 mG (2) Daily and off Brilinta Blood Thinners. The Febuary ultra sound shows jagged vain scars along with Swollen leg. I need lots of Exersice Daily + Hard to get better. bat Weather has been my biggest Drawl Back. Got Electric Bike and all the Safty features to help Kick start my recovery. Work is a thing of the Past. MY old retirement Dreams are gone. Now just survival mode. Well Thank workers for getting the vaccine to save the world. I Am not complaining I got it. Maybe my shingles Vaccination should of held off longer. Who knows but the ER Doctor almost took my Leg- off. He thought I was sucicsidle. I thought No Pain No Gain at the Physical theropist office. My Syattic Nerve no longer bothers me. That was also a first. Now my heart Doctor is keeping a close eye on my heart. He Says everything is fine just a little Swollen. I have been in intense pain trying to get Better for over a Year now and was better off being a cough Potatoe.
Age: 52.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Per hospital report Havrix Hep A given up to 18years of age, instead of adult Havrix.
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Bone pain, Chills, Contusion
Clinical narrative: Per hospital event report "Pt given TDAP vaccine per order. Vaccine given in L deltoid, no problems documented at time of injection. Pt called 2/14/22 to report: She feels she has had a reaction to it. Had chills and pain in the shoulder. She is bruised and until yesterday was unable to move her left shoulder higher than 45 degrees. Has a difficult time dressing due to the pain in the shoulder joint. The shot was given very high on the shoulder. Has not used any ice or tylenol. Her shoulder does not look swollen to her. Dr suggested seeing PT in office to evaluate, pt scheduled with NP for 2/15. Pt was encouraged to use OTC for pain, heat and ice at injection site. Called again 2/25/22 to report intense L shoulder pain. Dr suggested Ibuprofen, pt requested appointment. Brought in on 3/1/22 to see Dr documentation: 3 weeks ago she had her tetanus shot. She shows pictures of where the shot was with her associated bruise and is high on the deltoid muscle just below the acromion process on the left side. Since having the shot she has had pain in her left shoulder that has been debilitating and severely limiting her left arm movement. She says that she is not been able to raise her arm above her shoulder and has severe pain with putting on a seatbelt, putting on clothing and cannot lie on that side. She has never had pain like this before. The pain seems to be on top of the bone and not in the joint. She is very frustrated about the limitations in her movement and the pain. She has been taking Advil twice a day and does not take it any more than that because she only eats a couple times a day. There is a dull ache in the pain all the time. She did not have any rash, swelling with the shot. Left shoulder she has significant decreased range of motion on initial evaluation and is not able to abduct the shoulder greater than 45 degrees, flex shoulder greater than 70 degrees or externally rotate shoulder greater than 45 degrees. Passively she is able to go through almost complete range of motion all these movements. Dr L performed manipulation (OMM) on shoulder, documented after manipulation completed she was able to raise arm above her head before becoming painful actually rotate fully and able to flex joint to greater than 90 degrees. Pt called on 3/10/22 to update PCP that left arm/shoulder still painful. Will be going to PT."
Sex: F
Vaccine: TDAP
Symptoms: Frustration tolerance decreased, Injected limb mobility decreased, Joint manipulation, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: Per hospital event report "Pt given TDAP vaccine per order. Vaccine given in L deltoid, no problems documented at time of injection. Pt called 2/14/22 to report: She feels she has had a reaction to it. Had chills and pain in the shoulder. She is bruised and until yesterday was unable to move her left shoulder higher than 45 degrees. Has a difficult time dressing due to the pain in the shoulder joint. The shot was given very high on the shoulder. Has not used any ice or tylenol. Her shoulder does not look swollen to her. Dr suggested seeing PT in office to evaluate, pt scheduled with NP for 2/15. Pt was encouraged to use OTC for pain, heat and ice at injection site. Called again 2/25/22 to report intense L shoulder pain. Dr suggested Ibuprofen, pt requested appointment. Brought in on 3/1/22 to see Dr documentation: 3 weeks ago she had her tetanus shot. She shows pictures of where the shot was with her associated bruise and is high on the deltoid muscle just below the acromion process on the left side. Since having the shot she has had pain in her left shoulder that has been debilitating and severely limiting her left arm movement. She says that she is not been able to raise her arm above her shoulder and has severe pain with putting on a seatbelt, putting on clothing and cannot lie on that side. She has never had pain like this before. The pain seems to be on top of the bone and not in the joint. She is very frustrated about the limitations in her movement and the pain. She has been taking Advil twice a day and does not take it any more than that because she only eats a couple times a day. There is a dull ache in the pain all the time. She did not have any rash, swelling with the shot. Left shoulder she has significant decreased range of motion on initial evaluation and is not able to abduct the shoulder greater than 45 degrees, flex shoulder greater than 70 degrees or externally rotate shoulder greater than 45 degrees. Passively she is able to go through almost complete range of motion all these movements. Dr L performed manipulation (OMM) on shoulder, documented after manipulation completed she was able to raise arm above her head before becoming painful actually rotate fully and able to flex joint to greater than 90 degrees. Pt called on 3/10/22 to update PCP that left arm/shoulder still painful. Will be going to PT."
Sex: F
Vaccine: TDAP
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Per hospital event report "Pt given TDAP vaccine per order. Vaccine given in L deltoid, no problems documented at time of injection. Pt called 2/14/22 to report: She feels she has had a reaction to it. Had chills and pain in the shoulder. She is bruised and until yesterday was unable to move her left shoulder higher than 45 degrees. Has a difficult time dressing due to the pain in the shoulder joint. The shot was given very high on the shoulder. Has not used any ice or tylenol. Her shoulder does not look swollen to her. Dr suggested seeing PT in office to evaluate, pt scheduled with NP for 2/15. Pt was encouraged to use OTC for pain, heat and ice at injection site. Called again 2/25/22 to report intense L shoulder pain. Dr suggested Ibuprofen, pt requested appointment. Brought in on 3/1/22 to see Dr documentation: 3 weeks ago she had her tetanus shot. She shows pictures of where the shot was with her associated bruise and is high on the deltoid muscle just below the acromion process on the left side. Since having the shot she has had pain in her left shoulder that has been debilitating and severely limiting her left arm movement. She says that she is not been able to raise her arm above her shoulder and has severe pain with putting on a seatbelt, putting on clothing and cannot lie on that side. She has never had pain like this before. The pain seems to be on top of the bone and not in the joint. She is very frustrated about the limitations in her movement and the pain. She has been taking Advil twice a day and does not take it any more than that because she only eats a couple times a day. There is a dull ache in the pain all the time. She did not have any rash, swelling with the shot. Left shoulder she has significant decreased range of motion on initial evaluation and is not able to abduct the shoulder greater than 45 degrees, flex shoulder greater than 70 degrees or externally rotate shoulder greater than 45 degrees. Passively she is able to go through almost complete range of motion all these movements. Dr L performed manipulation (OMM) on shoulder, documented after manipulation completed she was able to raise arm above her head before becoming painful actually rotate fully and able to flex joint to greater than 90 degrees. Pt called on 3/10/22 to update PCP that left arm/shoulder still painful. Will be going to PT."
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: Swelling in axilla area of left arm approximately 12 hours after receiving COVID-19 booster (Phizer Lot#FM0698 Exp:05/31/2022). Minor pain is felt when palpated and when left arm is extended overhead. Area of swelling is approximately 10cm x 15cm. Depth of swelling is approximately 1.5-2cm. Booster was administered in the deltoid area of the left arm.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Describe Event, Problem, or Product Use Error: Patient was to receive Pfizer Covid-19 vaccination for age > 12 years old but received dose for 5-11 year olds.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient received first dose of Moderna Covid Vaccine Lot:026c21a and had hives 7-14 days after initial dose. Second dose was a normal unreactive reaction.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy artery abnormal, Disorientation, Eye movement disorder, Giant cell arteritis, IIIrd nerve paralysis
Clinical narrative: This is a probable COVID Pfizer vaccine long term effect. I took the Pfizer shots in Jan & Feb. 2021. I took the booster in Sept. 2021. My age is 80 and I have had no health problems. On Feb. 11, 2022, I experienced the onset of a 3rd Cranial Palsy on the left side that left my eye out of focus (rotated to the left corner). In March, 2022, I had a bilateral temporal artery biopsy that identified the cause as Temporal Arteritis. I now have to cover the left eye to prevent disorientation. Prognosis is for the eye to recover focus ability in a few months. I am taking Prednisone to eliminate the inflammation. My opinion is that the COVID vaccine overwhelms the immune system such that it 'forgets' to handle anything other than the COVID, permitting long term problems. Since there is 'long term COVID' associated with those who actually had the disease, it makes sense that the vaccine can have the same detrimental effects. I have 2 friends who have suddenly developed heart problems: a-fib (Moderna); and arrythmia (Pfizer) after taking the vaccines.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Vision blurred
Clinical narrative: This is a probable COVID Pfizer vaccine long term effect. I took the Pfizer shots in Jan & Feb. 2021. I took the booster in Sept. 2021. My age is 80 and I have had no health problems. On Feb. 11, 2022, I experienced the onset of a 3rd Cranial Palsy on the left side that left my eye out of focus (rotated to the left corner). In March, 2022, I had a bilateral temporal artery biopsy that identified the cause as Temporal Arteritis. I now have to cover the left eye to prevent disorientation. Prognosis is for the eye to recover focus ability in a few months. I am taking Prednisone to eliminate the inflammation. My opinion is that the COVID vaccine overwhelms the immune system such that it 'forgets' to handle anything other than the COVID, permitting long term problems. Since there is 'long term COVID' associated with those who actually had the disease, it makes sense that the vaccine can have the same detrimental effects. I have 2 friends who have suddenly developed heart problems: a-fib (Moderna); and arrythmia (Pfizer) after taking the vaccines.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Tinnitus
Clinical narrative: constant buzzing in both ear Right after my regular shower I felt my ears were plugged, just like when going swimming and water gets in though the sensation and sound never went away nor hasn't changed since then. Went to urgent care and was prescribed decongestants even though I wasn't congested. This treatment was unsuccessful. I'm waiting to see an ent doctor. I'm reporting because I am reading others are experiencing the symptom after receiving the Pfizer Covid vaccine. I have three of them and Im worried the buzz would not go away. Thank you
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination error
Clinical narrative: Per hospital report Accidentally injected Shingrix diluent prior to mixing with vaccine vial.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Describe Event, Problem, or Product Use Error: [Jansen] use for COVID-19 under Emergency Use Authorization (EUA): Gave a Covid 19 Janssen immunization that was expired. Manager notified, who contacted the Johnson and Johnson medical directors who stated no data to confirm whether patient considered immunized. Per medical director patient should be revaccinated as soon as possible. Contacted patient by phone to explain what had happened and that it was recommended he get revaccinated. He said he would "think about it"-and discuss with his family.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Describe Event, Problem, or Product Use Error: [Pfizer booster] use for COVID-19 under Emergency Use Authorization (EUA):Gave an employee a Covid 19 Pfizer Booster that was expired by 10 hours. Manager contacted Pfizer and per Pfizer was considered safe to patient-no action needed.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Hypoaesthesia, Paraesthesia
Clinical narrative: I received the Shingles vaccination on 1/17/2022. Since then I've had tingling and numbness in my lower arms, fingers, toes and lower legs since the vaccine and double vision.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Laboratory test normal
Clinical narrative: No period! I received dose 2 of the Pfizer vaccine, and I have not had a period since. My doctors are baffled as to how this could happen as my periods are normally clockwork, and all levels are normal.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dyskinesia, Loss of consciousness, Seizure
Clinical narrative: seizure with loss of consciousness and whole body jerking
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Influenza like illness, Malaise, Pain, Peripheral swelling
Clinical narrative: Vaccine administered 3/24/22 ~435pm. No issues until 3/28/22 ~3-4 pm. Pt alleges redness and swollen arm. Was not feeling well. Pt sates took 2 tylenol and after 5 hours took Ibuprofen, pt c/o fever and body aches (flu like symptoms) and stated she laid down whole day. 3/29/22 ~1103 AM pt states feels a lot better but arm still feels swollen, red and tender but not any worse (was in 2 spots now 1 spot) redness is little better but still swollen
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia, Tenderness
Clinical narrative: Vaccine administered 3/24/22 ~435pm. No issues until 3/28/22 ~3-4 pm. Pt alleges redness and swollen arm. Was not feeling well. Pt sates took 2 tylenol and after 5 hours took Ibuprofen, pt c/o fever and body aches (flu like symptoms) and stated she laid down whole day. 3/29/22 ~1103 AM pt states feels a lot better but arm still feels swollen, red and tender but not any worse (was in 2 spots now 1 spot) redness is little better but still swollen
Age: 5.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: VIS given to mother. Verified with provider. Kept tp 10-15 mins.  no a/r.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Heart rate increased, Hypoaesthesia, Migraine
Clinical narrative: Severe reoccuring mouth sores, still present tingling and numbness in extremities, subsided. Migraines and tinnitus, still present. Tremors (external), subsided increased heart rate. Subsided fatigue and weakness throughout body, still present
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Stomatitis, Tinnitus, Tremor
Clinical narrative: Severe reoccuring mouth sores, still present tingling and numbness in extremities, subsided. Migraines and tinnitus, still present. Tremors (external), subsided increased heart rate. Subsided fatigue and weakness throughout body, still present
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Foot fracture, Gait disturbance, Headache, Malaise
Clinical narrative: The evening of the shot, I was not feeling well. The next day I had a bad headache went to the bathroom to get something to take for it. I turned around and grab the rack and fell down. I fractured my foot; I had to crawl back to bed.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, Migraine, Therapeutic response unexpected
Clinical narrative: I no longer get tension headaches; migraines; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 (Lot number: EL9261) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seasonal allergy" (unspecified if ongoing); "Asthama" (unspecified if ongoing); "chronic pain" (unspecified if ongoing). Concomitant medication(s) included: VIT D [ERGOCALCIFEROL]; ALLEGRA D; ESCITALOPRAM; LOSARTAN; SINGULAIR. Past drug history included: Lisinopril, reaction(s): "Allergy: Lisinopril"; Advil, reaction(s): "Allergy: Advil". Vaccination history included: Bnt162b2 (Manufacturer name- Pfizer, Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left), administration date: 25Jan2021, for COVID-19 immunisation. The following information was reported: MIGRAINE (non-serious) with onset 01Mar2021, outcome "unknown", described as "migraines"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I no longer get tension headaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine. No follow-up attempts are possible. No further information is expected. Additional Information: The patient did not receive any other vaccine within 4 weeks of vaccination. The patient did not have covid prior to the vaccination. The patient was tested covid positive post vaccination. The reported that she had tension headaches her whole life. Within days the headaches changed. They turned into migraines. She no longer get tension headaches but getting migraines 4-5 days per week. She was now seeing 4 different specialist and call in sick 3-4 days per week.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I no longer get tension headaches; migraines; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 (Lot number: EL9261) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seasonal allergy" (unspecified if ongoing); "Asthama" (unspecified if ongoing); "chronic pain" (unspecified if ongoing). Concomitant medication(s) included: VIT D [ERGOCALCIFEROL]; ALLEGRA D; ESCITALOPRAM; LOSARTAN; SINGULAIR. Past drug history included: Lisinopril, reaction(s): "Allergy: Lisinopril"; Advil, reaction(s): "Allergy: Advil". Vaccination history included: Bnt162b2 (Manufacturer name- Pfizer, Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left), administration date: 25Jan2021, for COVID-19 immunisation. The following information was reported: MIGRAINE (non-serious) with onset 01Mar2021, outcome "unknown", described as "migraines"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I no longer get tension headaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine. No follow-up attempts are possible. No further information is expected. Additional Information: The patient did not receive any other vaccine within 4 weeks of vaccination. The patient did not have covid prior to the vaccination. The patient was tested covid positive post vaccination. The reported that she had tension headaches her whole life. Within days the headaches changed. They turned into migraines. She no longer get tension headaches but getting migraines 4-5 days per week. She was now seeing 4 different specialist and call in sick 3-4 days per week.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Disability, Dizziness, Dysgeusia, Epilepsy, General physical health deterioration
Clinical narrative: Unconsciousness, metallic taste, ringing in the ears, blurry vision, nausea, dizziness, low heart rate. Declining health, epileptic type seizures, and full disability.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Loss of consciousness, Nausea, Tinnitus, Vision blurred
Clinical narrative: Unconsciousness, metallic taste, ringing in the ears, blurry vision, nausea, dizziness, low heart rate. Declining health, epileptic type seizures, and full disability.
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Headache, Hunger, Wrong product administered
Clinical narrative: Pharmacist there gave the Prevnar 13 instead of 23; I already had the P 13 vaccination when I turned 65 in 2018; headache; I am hungry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as single dose for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13, administration date: 2018, when the patient was 65 years old, for Immunisation. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Pharmacist there gave the Prevnar 13 instead of 23"; EXTRA DOSE ADMINISTERED (non-serious), outcome "unknown", described as "I already had the P 13 vaccination when I turned 65 in 2018"; HEADACHE (non-serious), outcome "unknown", described as "headache"; HUNGER (non-serious), outcome "unknown", described as "I am hungry".  Additional information: The patient went to the pharmacy to get Pneumococcal 23 (Pneumovax 23) but instead got Prevnar 13. Patient stated that when she turned 65 years old 3 years ago she got Prevnar 13.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pharyngeal swelling
Clinical narrative: Patient presented to the ED after having receiving covid vaccination with chest tightness, difficulty breathing, and felt like his throat was closing. Pt received epi at clinic and 50 mg IM benadryl from EMS.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Anxiety, Brain natriuretic peptide normal, C-reactive protein normal, Chest X-ray normal
Clinical narrative: The patient received COVID #1 Pfizer (FF839) 15 SEP 21 and reports developed a cough about 24 hours later. He states  day 4 he tried to go for a run and experienced mild dyspnea and difficulty with effort above his usual. He states He saw providers several times and was treated with Z pack and albuterol but continued to have symptoms. He states he decreased activity to walks and after several weeks tried to run again. The next day his left leg was swollen and the following day his Right leg was swollen and his wife noted it was red and hot. He was seen in ER 1-2 days later and then hospitalized for PE/DVT.  Extensive evaluation by hematology revealed no etiology to explain the event.  Per chart review: -15 SEP 21 COVID vaccine receipt -21 SEP 21 PCP visit c/o HA, congestion starting after vaccine receipt. Exam normal except dry cough observed. POC COVID testing -30 SEP 21 T-CON c/o productive cough, CP tightness -30 SEP IIV receipt -01 OCT 21 c/o productive cough, CP tightness,; CXR WNL rx Zpack -13 OCT 21 CRP,ESR, BNP, trops, ECG, Exam unremarkable. -20 OCT 21 reviewed labs, exam normal;  diff dx anxiety, PE, pericarditis, unlikely myocarditis. -26 OCT 21 c/o R leg edema. Sent to ER  and subsequently admitted. Found bilat extensive life-threatening PE R leg Extensive DVT SFV, popliteal, peroneal and posterior tibial veins. -03 DEC Hematology note states unremarkable thrombophilia workup and event appears unprovoked. .
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Decreased activity, Deep vein thrombosis, Dyspnoea exertional
Clinical narrative: The patient received COVID #1 Pfizer (FF839) 15 SEP 21 and reports developed a cough about 24 hours later. He states  day 4 he tried to go for a run and experienced mild dyspnea and difficulty with effort above his usual. He states He saw providers several times and was treated with Z pack and albuterol but continued to have symptoms. He states he decreased activity to walks and after several weeks tried to run again. The next day his left leg was swollen and the following day his Right leg was swollen and his wife noted it was red and hot. He was seen in ER 1-2 days later and then hospitalized for PE/DVT.  Extensive evaluation by hematology revealed no etiology to explain the event.  Per chart review: -15 SEP 21 COVID vaccine receipt -21 SEP 21 PCP visit c/o HA, congestion starting after vaccine receipt. Exam normal except dry cough observed. POC COVID testing -30 SEP 21 T-CON c/o productive cough, CP tightness -30 SEP IIV receipt -01 OCT 21 c/o productive cough, CP tightness,; CXR WNL rx Zpack -13 OCT 21 CRP,ESR, BNP, trops, ECG, Exam unremarkable. -20 OCT 21 reviewed labs, exam normal;  diff dx anxiety, PE, pericarditis, unlikely myocarditis. -26 OCT 21 c/o R leg edema. Sent to ER  and subsequently admitted. Found bilat extensive life-threatening PE R leg Extensive DVT SFV, popliteal, peroneal and posterior tibial veins. -03 DEC Hematology note states unremarkable thrombophilia workup and event appears unprovoked. .
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Erythema, Fibrin D dimer, Full blood count normal, Haematology test normal
Clinical narrative: The patient received COVID #1 Pfizer (FF839) 15 SEP 21 and reports developed a cough about 24 hours later. He states  day 4 he tried to go for a run and experienced mild dyspnea and difficulty with effort above his usual. He states He saw providers several times and was treated with Z pack and albuterol but continued to have symptoms. He states he decreased activity to walks and after several weeks tried to run again. The next day his left leg was swollen and the following day his Right leg was swollen and his wife noted it was red and hot. He was seen in ER 1-2 days later and then hospitalized for PE/DVT.  Extensive evaluation by hematology revealed no etiology to explain the event.  Per chart review: -15 SEP 21 COVID vaccine receipt -21 SEP 21 PCP visit c/o HA, congestion starting after vaccine receipt. Exam normal except dry cough observed. POC COVID testing -30 SEP 21 T-CON c/o productive cough, CP tightness -30 SEP IIV receipt -01 OCT 21 c/o productive cough, CP tightness,; CXR WNL rx Zpack -13 OCT 21 CRP,ESR, BNP, trops, ECG, Exam unremarkable. -20 OCT 21 reviewed labs, exam normal;  diff dx anxiety, PE, pericarditis, unlikely myocarditis. -26 OCT 21 c/o R leg edema. Sent to ER  and subsequently admitted. Found bilat extensive life-threatening PE R leg Extensive DVT SFV, popliteal, peroneal and posterior tibial veins. -03 DEC Hematology note states unremarkable thrombophilia workup and event appears unprovoked. .
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Metabolic function test normal, Oedema peripheral, Pericarditis
Clinical narrative: The patient received COVID #1 Pfizer (FF839) 15 SEP 21 and reports developed a cough about 24 hours later. He states  day 4 he tried to go for a run and experienced mild dyspnea and difficulty with effort above his usual. He states He saw providers several times and was treated with Z pack and albuterol but continued to have symptoms. He states he decreased activity to walks and after several weeks tried to run again. The next day his left leg was swollen and the following day his Right leg was swollen and his wife noted it was red and hot. He was seen in ER 1-2 days later and then hospitalized for PE/DVT.  Extensive evaluation by hematology revealed no etiology to explain the event.  Per chart review: -15 SEP 21 COVID vaccine receipt -21 SEP 21 PCP visit c/o HA, congestion starting after vaccine receipt. Exam normal except dry cough observed. POC COVID testing -30 SEP 21 T-CON c/o productive cough, CP tightness -30 SEP IIV receipt -01 OCT 21 c/o productive cough, CP tightness,; CXR WNL rx Zpack -13 OCT 21 CRP,ESR, BNP, trops, ECG, Exam unremarkable. -20 OCT 21 reviewed labs, exam normal;  diff dx anxiety, PE, pericarditis, unlikely myocarditis. -26 OCT 21 c/o R leg edema. Sent to ER  and subsequently admitted. Found bilat extensive life-threatening PE R leg Extensive DVT SFV, popliteal, peroneal and posterior tibial veins. -03 DEC Hematology note states unremarkable thrombophilia workup and event appears unprovoked. .
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Productive cough, Red blood cell sedimentation rate normal, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: The patient received COVID #1 Pfizer (FF839) 15 SEP 21 and reports developed a cough about 24 hours later. He states  day 4 he tried to go for a run and experienced mild dyspnea and difficulty with effort above his usual. He states He saw providers several times and was treated with Z pack and albuterol but continued to have symptoms. He states he decreased activity to walks and after several weeks tried to run again. The next day his left leg was swollen and the following day his Right leg was swollen and his wife noted it was red and hot. He was seen in ER 1-2 days later and then hospitalized for PE/DVT.  Extensive evaluation by hematology revealed no etiology to explain the event.  Per chart review: -15 SEP 21 COVID vaccine receipt -21 SEP 21 PCP visit c/o HA, congestion starting after vaccine receipt. Exam normal except dry cough observed. POC COVID testing -30 SEP 21 T-CON c/o productive cough, CP tightness -30 SEP IIV receipt -01 OCT 21 c/o productive cough, CP tightness,; CXR WNL rx Zpack -13 OCT 21 CRP,ESR, BNP, trops, ECG, Exam unremarkable. -20 OCT 21 reviewed labs, exam normal;  diff dx anxiety, PE, pericarditis, unlikely myocarditis. -26 OCT 21 c/o R leg edema. Sent to ER  and subsequently admitted. Found bilat extensive life-threatening PE R leg Extensive DVT SFV, popliteal, peroneal and posterior tibial veins. -03 DEC Hematology note states unremarkable thrombophilia workup and event appears unprovoked. .
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm, Troponin T normal, Troponin normal
Clinical narrative: The patient received COVID #1 Pfizer (FF839) 15 SEP 21 and reports developed a cough about 24 hours later. He states  day 4 he tried to go for a run and experienced mild dyspnea and difficulty with effort above his usual. He states He saw providers several times and was treated with Z pack and albuterol but continued to have symptoms. He states he decreased activity to walks and after several weeks tried to run again. The next day his left leg was swollen and the following day his Right leg was swollen and his wife noted it was red and hot. He was seen in ER 1-2 days later and then hospitalized for PE/DVT.  Extensive evaluation by hematology revealed no etiology to explain the event.  Per chart review: -15 SEP 21 COVID vaccine receipt -21 SEP 21 PCP visit c/o HA, congestion starting after vaccine receipt. Exam normal except dry cough observed. POC COVID testing -30 SEP 21 T-CON c/o productive cough, CP tightness -30 SEP IIV receipt -01 OCT 21 c/o productive cough, CP tightness,; CXR WNL rx Zpack -13 OCT 21 CRP,ESR, BNP, trops, ECG, Exam unremarkable. -20 OCT 21 reviewed labs, exam normal;  diff dx anxiety, PE, pericarditis, unlikely myocarditis. -26 OCT 21 c/o R leg edema. Sent to ER  and subsequently admitted. Found bilat extensive life-threatening PE R leg Extensive DVT SFV, popliteal, peroneal and posterior tibial veins. -03 DEC Hematology note states unremarkable thrombophilia workup and event appears unprovoked. .
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Vaccination site warmth; Vaccination site erythema; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jan-2022 with the following VAERS Primary ID 1840096. The original narrative from the sender is the following:   Mild erythema and warmth surrounding vaccine site of bilateral thighs.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "mild erythema and warmth surrounding the vaccine site of both thighs".   No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Pemphigoid
Clinical narrative: Developed Bullous Pemphigoid following my Moderna Booster shot on 10/26/21; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGOID (Developed Bullous Pemphigoid following my Moderna Booster shot on 10/26/21) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PEMPHIGOID (Developed Bullous Pemphigoid following my Moderna Booster shot on 10/26/21) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Bullous pemphigoid, at an unspecified dose and frequency; DOXYCYCLINE for Bullous pemphigoid, at an unspecified dose and frequency; NIACINAMIDE for Bullous pemphigoid, at an unspecified dose and frequency and HALOBETASOL for Bullous pemphigoid, at an unspecified dose and frequency. At the time of the report, PEMPHIGOID (Developed Bullous Pemphigoid following my Moderna Booster shot on 10/26/21) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: bullous pemphigoid (abnormal) Bullous Pemphigoid.         No concomitant medications were reported.  Patient stated that it was horrible disease that came about after the booster. Patient never heard of it before. Patient also went to an immunologist who said it was a result of PEG in the vaccine.  Company comment: This spontaneous case concerns a 69-year-old male patient, with no medical history reported, who experienced the unexpected medically significant event of bullous pemphigoid. The event occurred on an unknown date after the booster dose of mRNA-1273. As reported, Bullous Pemphigoid was confirmed by biopsy. The patient was followed by dermatologist and treated with prednisone, doxycycline, niacinamide and halobetasol. Reportedly, patient also visited immunologist who said it was a result of PEG in the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient, with no medical history reported, who experienced the unexpected medically significant event of bullous pemphigoid. The event occurred on an unknown date after the booster dose of mRNA-1273. As reported, Bullous Pemphigoid was confirmed by biopsy. The patient was followed by dermatologist and treated with prednisone, doxycycline, niacinamide and halobetasol. Reportedly, patient also visited immunologist who said it was a result of PEG in the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given the wrong vaccine for his age. He was suppose to get Pfizer.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Atelectasis, Chest X-ray abnormal, Dyspnoea, Electrocardiogram normal
Clinical narrative: Patient presented to the ED with complaints of 15-20lbs weight gain over the past several weeks, with chronic lower extremity swelling and paroxysmal nocturnal dyspnea. He was subsequently admitted for management of acute on chronic congestive heart failure. He was discharged home 3 days later in stable condition.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lung infiltration, Lung opacity, Pleural effusion, Pulmonary congestion
Clinical narrative: Patient presented to the ED with complaints of 15-20lbs weight gain over the past several weeks, with chronic lower extremity swelling and paroxysmal nocturnal dyspnea. He was subsequently admitted for management of acute on chronic congestive heart failure. He was discharged home 3 days later in stable condition.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure acute, Cardiac failure congestive, Dyspnoea paroxysmal nocturnal, Peripheral swelling, Weight increased
Clinical narrative: Patient presented to the ED with complaints of 15-20lbs weight gain over the past several weeks, with chronic lower extremity swelling and paroxysmal nocturnal dyspnea. He was subsequently admitted for management of acute on chronic congestive heart failure. He was discharged home 3 days later in stable condition.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Hypophagia
Clinical narrative: the patient was feeling unwell in the bathroom on the commode, called for his wife, that became unresponsive.  Wife started CPR prior to EMS arrival.  Pfizer dose #3 1/18/2022
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Resuscitation, Unresponsive to stimuli
Clinical narrative: the patient was feeling unwell in the bathroom on the commode, called for his wife, that became unresponsive.  Wife started CPR prior to EMS arrival.  Pfizer dose #3 1/18/2022
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given wrong vaccine for age at that time. She was suppose to receive Pfizer.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient was given wrong vaccine for age at that time. She was suppose to receive Pfizer.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Autopsy, Death, Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: Pulmonary Embolism; did not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Dec2021 (Lot number: 33130BA) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical Location:  Arm, unknown if right or left arm), administration date: Apr2021, when the patient was 58 years old, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, Anatomical Location:  Arm, unknown if right or left arm), for COVID-19 immunization, reaction(s): "sore arm ". The following information was reported: PULMONARY EMBOLISM (death, medically significant), outcome "fatal", described as "Pulmonary Embolism"; MALAISE (non-serious), outcome "unknown", described as "did not feel well". The patient date of death was 01Jan2022. The reported cause of death was pulmonary embolism. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.Vaccination facility type was clinic.  The patient was back to work and working and active until receiving third dose. The patient had no other condition. The patient had no investigations. The reporter reported that the patient received the booster dose on 28Dec2021. The patient just did not feel well after receiving the booster dose and the reporter was told this by the patient's son who lived with the patient at the time. The reporter did not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller stated the cause of death was pulmonary Embolism. The reporter reported The reporter did not believe additional vaccines administered on same date of the Pfizer Suspect. The reporter did not visit Emergency Room or Physician Office. The patient had no relevant tests.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474100 Same reporter/patient, different dose/events; Reported Cause(s) of Death: Pulmonary Embolism
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary Embolism; did not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Dec2021 (Lot number: 33130BA) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical Location:  Arm, unknown if right or left arm), administration date: Apr2021, when the patient was 58 years old, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, Anatomical Location:  Arm, unknown if right or left arm), for COVID-19 immunization, reaction(s): "sore arm ". The following information was reported: PULMONARY EMBOLISM (death, medically significant), outcome "fatal", described as "Pulmonary Embolism"; MALAISE (non-serious), outcome "unknown", described as "did not feel well". The patient date of death was 01Jan2022. The reported cause of death was pulmonary embolism. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.Vaccination facility type was clinic.  The patient was back to work and working and active until receiving third dose. The patient had no other condition. The patient had no investigations. The reporter reported that the patient received the booster dose on 28Dec2021. The patient just did not feel well after receiving the booster dose and the reporter was told this by the patient's son who lived with the patient at the time. The reporter did not know exactly what it meant that the patient did not feel well, except that the patient postponed a Christmas gathering with family and friends. The patient passed away on 01Jan2022. The caller stated the cause of death was pulmonary Embolism. The reporter reported The reporter did not believe additional vaccines administered on same date of the Pfizer Suspect. The reporter did not visit Emergency Room or Physician Office. The patient had no relevant tests.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200474100 Same reporter/patient, different dose/events; Reported Cause(s) of Death: Pulmonary Embolism