chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For 2.5 days had body aches and chills, all worst in first night; For 2.5 days had body aches and chills, all worst in first night; Some chest pain; Very swollen lymph node in armpit; Very swollen lymph node in armpit painful; Primary immunisation: BNT162b2; Booster: COMIRNATY; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 35-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 05Jan2022 at 09:00 (Lot number: FL3197) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EK8734; Route of administration: unspecified; Anatomical site: Left arm; Administration time: 09:00), administration date: 02Apr2021, when the patient was 34 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: ER8737; Route of administration: unspecified; Anatomical site: Left arm; Administration time: 09:00), administration date: 23Apr2021, when the patient was 35 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 09:00, outcome "unknown", described as "Primary immunisation: BNT162b2; Booster: COMIRNATY"; PAIN (non-serious), CHILLS (non-serious) all with onset 05Jan2022 at 21:00, outcome "recovered" (18Jan2022), and all described as "For 2.5 days had body aches and chills, all worst in first night"; CHEST PAIN (non-serious) with onset 05Jan2022 at 21:00, outcome "recovered" (an unknown date in Jan2022), described as "Some chest pain"; LYMPHADENOPATHY (non-serious) with onset 05Jan2022 at 21:00, outcome "recovered" (an unknown date in Jan2022), described as "Very swollen lymph node in armpit"; LYMPH NODE PAIN (non-serious) with onset 05Jan2022 at 21:00, outcome "recovered" (an unknown date in Jan2022), described as "Very swollen lymph node in armpit painful". Therapeutic measures were not taken as a result of pain, chills, chest pain, lymphadenopathy and lymph node pain.  Additional Information: Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Immediate injection site swelling after needle removal. Administered BENADRYL 50 mg x 1 dose.
The patient had a significant injection site reaction described as hot, swollen and the size of an orange; The patient had a significant injection site reaction described as hot, swollen and the size of an orange; The patient had a significant injection site reaction described as hot, swollen and the size of an orange; The patient had a significant injection site reaction described as hot, swollen and the size of an orange which lasted a few days with a residual knot lasting for quite a while.; This spontaneous report was received from a Certified Pharmacy Technician a female patient reporting on herself via company representative. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  In June 2020 (reported as "last month"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. After vaccination, the patient had a significant injection site reaction described as hot (injection site warmth), swollen (injection site swelling) and the size of an orange which lasted a few days with a residual knot lasting for quite a while (injection site nodule).          At the time of the report, the outcome of injection site reaction, injection site nodule, injection site swelling and injection site warmth was unknown. The reporter did not mention the causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination.
Pfizer / BioNTech Dose Number: 4 / Treatment of COVID-19 start date: 19Aug2022; Pfizer / BioNTech Dose Number: 4 / Treatment of COVID-19 start date: 19Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "stage III Kidney" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "DVT" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN; FENOFIBRATE; WARFARIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovered" (2022) and all described as "Pfizer / BioNTech Dose Number: 4 / Treatment of COVID-19 start date: 19Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid From 19Aug2022 To 20Aug2022 for COVID 19 Treatment. The patient had no known allergies. The patient had Other medication in 2weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient reported severe flu like symptoms for 1.5 days. Patient had no energy, very fatigues, body aches, chills, shivering, could not get out of bed and took tylenol and advil to help with symptoms.
Area of injection site has a 2.2cm X 4.5cm redness, swelling, and bruising noted to right arm. Patient advised per provider to keep area clean and dry. To use warm compress to area. Patient started on Cephalexin 500MG 1 capsule, 4 times a day for 7 days. Patient advised to return in 3 days if area not improved or sooner if area continues to get worse or does not start to look better.
Question 5:   Client contacted and no adverse event to client has occurred at this time.                        Moderna monovalent booster dose was given prior to receiving information to stop giving.
Headache, intense enough to cause a restless sleep.  Worsened by the following day to causing sustained crying.
Left Diaphragm Paralysis identified by a SNIFF test Following 1st flu Vaccination on September 20th 2019.  Four days in ER with Acute respiratory failure on September 29th.  Extensive blood panel test, PFT, EMG, heart echo, Ultrasounds on legs, Xrays, 2 chest CT?s, head & neck MRi, Chem stress test and two visits to ER on September 29th & October 7th.  I have seen numerous doctors with no improvement in my shortness of breath, which is exasperated laying down with CPAP.  I have tried everything recommended to resolve this problem.  My condition has not been identified as GBS, but the flu shot has caused my immune system to damage my nerves and muscles.
Developed papular/vesicular rash with erythematous base on face, thorax, back and arms. Treated with Benadryl OTC 25mg, cold compress, taped baths.
patient said  tongue felt odd and she started to feel funny and left quickly said she was going to er
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient came in today on October 6, 2021 stating she received the Pfizer covid vaccine on 10/1/21. Starting the next day she had a burning and itching feeling. The inject site looks like a little darken as if it was red before and healing. She had not done anything to help it but said it's getting better. I told her to take ibuprofen for pain and benadryl if still itchy. If allergic site is larger see a doctor. Overall she ok.
Arm is red where I got the vx; Arm is swollen where I got the vx; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that his/her arm was red and swollen where he/she received his/her first vaccine. Additional supportive information: Follow-up would not possible as no contact details were available.
3 weeks after my son had his second shot he had what appeared to be a seizure. He does not have a history of seizures. Since July of 2021, he has had 8 seizures.
Approximately 5 minutes into her observation time: she reported feeling hot, sweaty, decreased hearing and vision; ringing in her ears and nausea; able to follow commands. Transported via wheelchair to exam table; lying flat on back with feet elevated. Vitals 85/44(R), 98% on RA; HR 57bpm-2:18p; 96/53 (R), 98%; 64bpm-2:20p Offered sips water: 108/65(R), 100% on RA; HR 62bpm - 2:45p - patient reporting she was 50-75% feeling better. Sat up with legs dangling: 105/67(R), 100% on RA 68bpm - 3:08 p. Able to stand on own and felt back to her baseline/stable and able to walk out of vaccine clinic area on her own (2-friends with her)
Seizure: generalized shaking of arms and legs bilaterally, unresponsive for less than one minute. Post-ictal after seizure. Occurred again at 3pm same day, generalized shaking of arms and legs with post-ictal period afterwards.
Itching at injection site within 3 minutes or less from time of injection, After two to three minutes of the itching episode, heart racing  followed by palpitations. Followed by chest tightness over heart area.  Followed by shaking in upper torso and arms and hands. Became nauseous followed by weakness and a need of a wheel chair to get to my car.  A few hours after arriving at home, itching started  all over my body and nausea persisted through the night. Itching became stronger. The morning after the shot explosive diarrhea. Fatigue, chills and hot and cold feelings the following day as well as itching persisted. Now, two days later, itching remains with intermittent mild chest tightness which is abating and taking zytrec for the itching
Patient reported he had been feeling short of breath since the day he received his COVID booster shot on 10/26/21. He also reported he had been having a dry cough but denied hemoptysis. He reported that since he received his COVID booster he had been immobile because he was weak and tired.  Patient reported that he passed out in his home on 11/4/21  and was taken to the ER where he was admitted for provoked massive pulmonary embolism. He was treated with bilateral tPA infusion and heparin by EKOS catheters for a total of 12 hours which ended on the morning of 11/5/21. He initially required supplemental oxygen but this was able to be weaned. Patient was discharged from the hospital on 11/6/21 and started on anti-coagulation with Xarelto 15 mg BID for 21 days, then Xarelto 20 mg daily for a total of 3-6 months.
Tiredness; Excess pain like I had the flu, body was aching all over; Experiencing itching around the injection site, got too bad; still swollen; bruise; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,lot Number was EW0164, expiry date was not reported), dose 2 via an unspecified route of administration on 26Apr2021 as (Age at vaccination was 56 years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included calcium carbonate, acetylsalicylic acid (ASPIRIN (E.C.)), tocopherol (VITAMIN E AL), vitamins Nos (DAILY VITAMINS), calcium carbonate, colecalciferol (VITAMIN D 2000), calcitriol, simvastatin, diltiazem, loratadine, esomeprazole magnesium, omeprazole (PRILOSEC), diltiazem hydrochloride (CARTIA) taken for an unspecified indication and metformin taken for diabetes mellitus, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number was not reported, expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced tiredness, excess pain like she had the flu, body was aching all over, experiencing itching around the injection site, got too bad, swollen, bruise. Patient had taken extra strength Tylenol and some Motrin and she kind of rested for whatever that have been. She felt better she took a hot bath and everything because her body was aching all over. So, than yesterday she felt better from those aches and pain than she start experiencing itching around the injection site, she mean just itching. So, it got too bad that she went and found some hydrocortisone and put it on my shoulder and it was still swollen and then it was itching and aching. Patient had received treatment for the events. So, then she took an ice pack, no she took some alcohol and rub on it and then now it still feels itching but it's a big bruise. Is that normal? She put some cream on it and she took some Motrin and she had been rubbing alcohol on the top of her arm. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient developed decreased grip strength in right arm and right arm pain, occurred after the 2nd vaccine in the series.
Left upper arm: red, swollen 4 inch puffy circle. Sore per patient.
Pt remained in clinic for 30 min.  Pt had his 2 Moderna vaccines in the past. Was given a Pfizer Booster by mistake.  No adverse reaction that this nurse knows of.
The day after receiving my first dose of the Moderna COVID-19 vaccine (1/8/22), I began to experience tightness in my chest, shortness of breath and feelings of a pounding heart. The current date is 1/10/22 which marks 3 days since I received my vaccination and I am still experiencing these same symptoms. I am concerned that these symptoms might be a sign of Myocarditis. I have not sought out medical attention yet, but plan on going to an ER to ensure I am OK.
Patient reporting injection site is red, swollen, warm to the touch and redness is about 4" thick and wraps 1/2 way around upper arm where shot was given.
inappropriate vaccine schedule; pain/ tender and ached; swelling; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of nausea (sick after receiving flu shot, see case US2019AMR199278).   On 15th August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 15th August 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were resolved with sequelae and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient after 1st dose had injection site painful red, swollen, tender and ached starting on the day of the injection and lasted 2 weeks or beyond. Till the time of reporting, the patient has not receive the 2nd dose which led to  incomplete course of vaccination. The reporter did not consent to follow up.
swelling; chills; This case was reported by a consumer via sales rep and described the occurrence of swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received on an unknown date, refer case US2019AMR087873).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced swelling and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the swelling and chills were unknown.   It was unknown if the reporter considered the swelling and chills to be related to Shingrix.  Additional details were reported as follows: The case was reported by the retired vaccine representative. The age at vaccination was not reported, however it could be 65 or 66 years. The reporter did not know the lot number the second shot was about one month before the date of reporting date. The patient after the 2nd shot of Shingrix had smaller swelling and chills about 12 hours later. The reporter did not agree to follow up with GlaxoSmithKline.
About two weeks after the vaccination a small rash appeared on patient's leg, around the site of injection. These small blisters resolved on their own in about 3-4 days and never seemed to cause him any discomfort. Then, on December 20th, a larger, more widespread rash appeared over the left side of his chest, arm, armpit, neck, and cheek. This round of blisters/pox seemed to bother him more but also resolved on their own in about 4 or 5 days. I have photos available if they would prove useful.
After receiving the vaccine, the client stayed at the vaccine clinic site (VCS) for about 10 minutes for observation.  She left without any expressed concerns.  She returned to VCS about 15 minutes later with complaints of dizziness, feeling shakey, and arms feeling heavy.  She reported having a cough that week.  Her mother was in the building and stayed with her daughter.  After about 30 minutes, her mother reported that daughter could not move left arm well. Client reported that while she was in resting area, her left arm pregressively became more numb or weak. She states legs feel "weird". Vaccine clinic staff referred her to her physician and assisted with the arrangements.  Approximately 10 minutes later, she left the building to go to doctor's appointment.  11/30/09 hospital records and discharge summary received. Service dates 11/18/09 to 11/19/09. Assessment: Extremity weakness involving the left arm and both legs, status post H1N1 vaccination. Patient felt nauseated and did not feel well. Weakness, dizziness, fainted. Indicated that she couldn't move left arm and both legs. Indicated that she could not bear weight. Decreased sensation lower extremities. Headache. Transferred to a higher level facility.  11/25/09 hospital records received. Service dates 11/19/09 to 11/21/09. Assessment: Consistant with conversion reaction. Progressive numbness and weakness of arms. No sensation or control of lower extremities. Has developed cough, chest pain / heaviness, shortness of breath. Transported from another hospital. Poor inspiratory effort. Feet and left hand cold to touch. Neurological examination subjective and nonconsistant.    11/30/09 County Health Care Clinic medical records. Service date 11/18/09. Additional information abstracted. Assessment: Syncopal episode and weakness. Patient presented with complaints of having passed out and being very weak. Abrupt weakness in left upper extremity and both lower extremities. To a lesser degree the right upper extremity. Consider transfer.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. No information provided regarding current conditions and medical history. On an unknown date the patient was vaccinated with ZOSTAVAX, PNEUMOVAX 23 and AFLURIA (dose, route, lot# not reported). No concomitant medication reported. The pharmacist reported that some patients felt ill when ZOSTAVAX, PNEUMOVAX 23 and AFLURIA (also reported as possibly AFLURIA) were administered on the same day. The pharmacist added that now she no longer administers ZOSTAVAX, PNEUMOVAX 23 and AFLURIA on the same day. The outcome of the event felt ill was unknown at the time of the report. Additional information has been requested.
This spontaneous report as received from a license vocational nurse refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On 20-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot number reported as K008821, Expiry date: 19-JUN-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT RECEIVED INCORRECT VACCINE. SHOULD HAVE RECEIVED A PFIZER 6MON PLUS, BUT RECEIVED A BIVALENT DOSE.  PATIENT HAS HAD NO ADVERSE REACTION, AND IS DOING WELL. DR OBSERVED PATIENT AT VACCINE SITE.