chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients Mother stated that he lost balance and may have experienced a fainting spell approximately 5 minutes after receiving vaccination. During the episode the patient fell forward into a rack scratching his neck on a fixture. Patient was conscious and alert as Pharmacist approached, but Patient was placed in Recovery Position with feet up for a few minutes until patient was ready to leave.
About 12 hours after second dose, I started having tachycardia in the 130s. Woke out of my sleep with the rate this high and could not get it down. Normal resting heart rate is in the high 80s. Also had numbness and tingling of my limbs. This was on top of the typical expected lethargy and body aches from the vaccine. It was enough to scare me and make me go to the ED after midnight. In the ED they had to give me medications to force my heart rate down. They also drew labs and found my d-dimer to be high, but nothing found on xray or ct for it.
fatigue/exhaustion and body/joint aches started around 6pm the evening of the shot , headache , nausea and diarrhea the following day
Subject c/o right arm tingling (like it has fallen asleep) from elbow to hand. Visible redness, warm to touch, with palpable lump at injection site right deltoid. Subject self treated with Tylenol. Symptoms resolved on 7/22/07.
Received Moderna Booster at 11 am on 5/6/22; admitted to ER via ambulance at 7:00 am on 5/9/22 with extreme confusion; inability to speak verbally; incoherency; unable to walk; received CT scan for possible TIA - negative result; admitted at 11:30 am for continued testing; was completed coherent by noon of same day (5/9/22); received MRI of brain; head and neck on 5/10/22 - negative results; received EEG on 5/11/22 - negative result; received Echocardiogram on 5/11/22 - negative result.  Diagnosis: Low Sodium level.
Developed blotchy rash starting on face & arms approx. 10 mins p/vaxs & progressed to trunk & lower extremities; DPH 12.5mg administered IM approx. 20 min p/vax;
Sx started as pain in arm - fever/chills, Temp 101 degrees; relieved with Ibuprofen. Red, warm slightly raised area on anterior (R) upper arm 11.5 x 8.5 cm - sx started improving by 72 hrs post vaccination.
Headache for 48 hours, neck and arm pain, brief temperature.  I do not not consider this an adverse event.  I think there was some confusion re how I filled out the v-safe questionnaire. The v-safe questionnaire asked about events that had occurred since the last time I completed the v-safe questionnaire and because I had had both a long bout with covid (tested positive 8/31 with ER visit and pneumonia on 9/10) and gotten my booster (10/23/21) all those events had occurred since my last v-safe check in they all got rolled into one and someone called and asked me to complete this form.
Vaccination administration error - equipment syringe failure.    While giving the shot, the cap (needle part) of the syringe came off. Nurse vaccinator stated that patient likely received 0.3mL or 0.4mL of the dose (full dose is 0.5mL). The remaining dose was pushed out of the syringe, so unable to see how much of dose was remaining that did not get into the patient. The patient displayed no signs and symptoms at time of this error.  We called Moderna manufacturer after error occurred, while patient was still waiting in the room. Moderna  Medical information stated that they do not have any recommendations outside of the information published to providers and to wait for call back from their experts regarding next steps. Patient was observed for recommended amount of time and then left the facility. We'll contact her if anything is needed besides the second dose that is scheduled in 4 weeks in order to complete the vaccination series.
got very sick; I thought I was having an anaphylactic reaction, i have a nut allergy, but my face never got swollen; woke up with bad headache; terrible asthma attack; This is a spontaneous report from a contactable consumer or other non hcp (Patient) reported himself that.  A 59-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch/Lot Number: EN6204, Expiry date: unknown), dose 1 via an unspecified route of administration on 12Mar2021 at 17:30 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patent medical history included asthma he hasn't had a bad asthma attack like this since he was 5yrs old and Nut allergy. Patient Concomitant medication included Trospium Chloride. After the First 1st dose on Friday (12Mar2021) and 5-6hours later at around 11:30pm he had a terrible asthma attack, he had difficulty breathing, it started out with a cough then wheezing that kept getting worse, he did not have an inhaler that was not at least 10yrs old. He was lying down, so he sat up and that helped him. he didn't' want have the ambulance come over or take him to the hospital because it's too expensive and he don't have insurance. He thought he was having an anaphylactic reaction, like the caption drive ship in the storm. So, he sat up for 2 hours because I could not lie down could not breathe when he lies down. So, he sat up and pulled for breath and he had a terrible asthma attack, terrible wheeze, and coughing. If he would have started to get blotchy and swollen, then he probably would have call back the ambulance. He called the information for the number, hospital, they gave me the neurology department in the hospital for whatever reason he does not know. Then he called the police station and then googled phone number for the hospital that does not work anymore, and he could not call the hospital then he called the police station they tell him not to keep following. That is quite alright he had that Covid shot if he dies overnight then you can document what he told but he did not die overnight because he is feeling better, but the question is has not had an asthma attack like that since he was like 5 years old. The outcome is Unknown for all the events  Response: Unable to determine how someone will react to 1st or 2nd dose. Referred to HCP on recommendations for 2nd dose.
fever 102, n/v, gen aching/malaise, pain, edema lt arm;
This case was reported by a consumer via call center representative and described the occurrence of raised rash in a female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced raised rash and local swelling. On an unknown date, the outcome of the raised rash and local swelling were unknown. It was unknown if the reporter considered the raised rash and local swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient was out in the garden and came back inside and noted that she had a rash on her back in 3 areas, one of the areas the rash was raised with bumps. The patient was concerned it might be shingles and was planning to see physician as soon as possible. The patient was in a hurry and did not obtain date of birth. The patient had denied permission to contact their physician.
After further inquiry and confirmation, I determined that my son (3 y/o) received Pfizer's Prevnar20 Pneumococcal 20-valent Conjugate Vaccine that is only approved for adults at this time.
tenderness at injection site - 3 days, less each day very tired - through day 3 after injection brain fog - thus far, through day 3 after injection
Severe headaches, nausea, body aches and pains, tiredness, and diarrhea for 5 days after 2nd dose of vaccine. An hour after receiving the 2nd dose my leg was numb for about an hour.
Left shoulder soreness; Stomach discomfort; Tiredness; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left shoulder soreness, stomach discomfort and tiredness.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, prior to onset of the events left shoulder soreness, stomach discomfort and tiredness, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.    On 28 Dec 2020, the patient started having some side effects. The patient experienced left shoulder soreness, stomach discomfort and tiredness. No treatment information reported.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of event stomach discomfort was recovered on 28 Dec 2020. The outcome of events left shoulder soreness and tiredness was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Information has been received from a pharmacist concerning a 4-year-old female with acute lymphoblastic leukaemia (diagnosed in November 2005) and was possibly on chemotherapy who was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX "some time prior to November 2005". On 20-JUL-2007 the patient experienced varicella, a rash on her left foot and was hospitalized. It was reported that the patient was recently exposed to her sister who recently had the wild type disease. Medical attention was sought and isolates from the rash = DNA positive and the pharmacist is requesting A VZV analysis b conducted. It was reported that the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
headache observed; Other vaccine same date vaccine date 30Sep2021; Dose received: 3; Booster; This is a spontaneous report from a contactable consumer.  A 79-year-old female patient received third dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported ), dose 3 via an unspecified route of administration on 30Sep2021 as dose 3 (booster), single (at the age of 79-year-old ) for COVID-19 immunization and influenza vaccine (FLU VACCINE VII), via an unspecified route of administration from 30Sep2021 (Batch/Lot number was not reported) to 30Sep2021, at dose number unknown, single for immunization. Facility type Vaccine was Pharmacy or Drug Store. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination and no covid tested post vaccination. Historical vaccine included bnt162b2 second dose (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), dose 2 via an unspecified route of administration on unspecified date ad dose 2 single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), dose 1 via an unspecified route of administration on unspecified date dose 1 single for COVID-19 immunization. On 30sep2021 the patient received other vaccine same date vaccine date, dose received: 3, booster. On Oct2021, headache observed. No treatment was received for the event headache. The outcome of the event headache was recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a Registered Nurse refers to a 69 years old male patient with diabetes, polyneuropathy and allergy to penicillin. The patient was vaccinated with ZOSTAVAX (single dose, Subcutaneous on left arm, lot # unknown) on 30-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 30-NOV-2012 the patient had developed a 8 cm, area of redness and swelling at the injection site of the left upper arm. The patient was evaluated in the office and the physician had prescribed a 5 day course of MEDROL. The outcome of event was reported as not recovered/not resolved. No lab diagnosis studies performed. The patient sought medical attention via office visiting. Additional information has been requested.
January 10th 2021 1st injection of Moderna Vaccine January 11th 2021 arm hurts January 12th 2021 fatigue and pain and burning from perineum to perianal area [with surrounding skin] January 13th 2021 severe tinnitus still pain and burning from perineum TO perianal area January 14th 2021 Severe nausea-still pain and burning from perineum to perianal area. This goes on still and will never be cured - I NOW HAVE - Lichen Sclerosus et Atrophicus! It TOOK 3 months - numerous doctor visits - numerous Treatments - Final DIAGNOSIS from biopsy April 15, 2021 By my Dermatologist This shot has given me a death sentenance and no chance of a happy life - now and until I die. I can never marry again or have sex - THERE IS NO CURE! All I can do is Treat it with a steroid ointment That does not Take away the pain and burning - I live in pain and burning since January 12, 2021 - 2 days after that horrible shot Oh but That's not all on January 29, 2021 I broke out in this strange rash from my knees up to my groin area - went to urgent care - given steroids - would not say it was from The Moderna Shot - but we know Better - Rash took over 2 weeks to go away Oh but it gets even better on January 31, 2021 Right leg went Totally numb - fell - caused TORN Ligament - high ankle sprain and strain - sprain and strain of foot - I Just started walking normaly the end of July 2021 Doctor had know idea what caused it - oh but we do - that Moderna Shot All of these reactions have been documented by other health care providers and told to people Thru health Agency - Thru TO phones Text whatever with the exception of my life altering diagnosis of Lichen Sclerosus et Atrophicus.  I am so angry and MAD and even your spokesman, said That if you have one auto immune disease This shot can throw you into another Autoimmune disease - Lucky Me - This is a Terrible Vaccine - and I should never had gotten it. Treatments Before finally being diagnosed with -> Lichen Sclerosus et Atrophicus There are The meds They Threw at me because They did not know what to do!  Steriods Fluocinolone Acetonide ointment 0.025% Fluconazole Tablets 150mg Tramadol 100mg Triamcinolone Acetonide Cream 0.1% Calmoseptine ointment Premarin Vaginal cream Pelvic floor ultrasound Treatments Gabepentin - different dosages Desitin cream Vaseline Celebrex I am now on betamethasone [augmented] 0.05% ointment Twice A day - only med out There I can use - clobetasol - can't use because of ingredients - That I would react too. Treatment for Rash January 29, 2021 Prednisone and wait it out Treatment for Right foot injury from numb right Leg January 31, 2021 Diclofenac Ankle brace Adverse outcome: Lichen Sclerosus et Atrophicus - will have the Rest of my Life - NO Quality of Life Only one course of Treatment - That will never eradicate disease I will be in misery The rest of my life Right ankle-foot Injury Finally resolving but still hurts at times - can't walk fast at all Rash Resolved in about 2 weeks
About 2 weeks post vaccine my daughter had flu like symptoms- severe nausea, stomach pain, back pain, headache. All persisted for about 3 weeks. At that point stomach and back pain lessened but nausea has continued 24/7 until the present date. 2 pediatric gastroentrologists could find nothing wrong despite numerous diagnostic tests and blood work. Hospitalized overnight once and to ER 3x for dehydration, refusal to eat, etc. She has lost 14 pounds. At about 8 weeks post injection she began complaining of severe joint pain all over, then tingling and numbness from her knees down-began walking strangely and fell twice per she couldn't feel lower legs. Doctor advised to go the ER. She was admitted overnight and had spinal MRI and full nuerological check that showed nothing wrong. Released - still cannot walk correctly, still has severe nausea and headache. On Zofran for 10 weeks. Has now been referred to infectious disease doctor...My daughter was the picture of health before this injection and no one has been able to find any reason for her illness.  10/13/2008 MR received for 3 ER visits 7/17, 7/19, and 7/27/2008 and Admission 9/29-30/2008. Final D/C DX:  Subjective LE paresthsias and weakness.  L Adrenal fullness on MRI. Initially presented to ER with 4 day hx of nausea, Had vomiting and diarrhea which have resolved. Lightheaded upon standing, mild H/A. PE (+) for epigastric tenderness and an ulceration of the lip. UA c/w UTI. Final DX:  Urinary Tract Infection.  Mild dehydration.  Nausea. Tx with IVF, abx and Zofran. Returned to ER 2 days later with persistant nausea. Now with LLQ gnawing pain. DX:  Nausea, NOS.  Abdominal Pain, undifferentiated.   3rd ER visit to 2nd hospital 7/27/08 with DX: Undifferentiat abdominal pain. Pt still with persistant nausea. Refusing to eat/drink 2' to lost appetite and post-prandial nausea and abdominal pain. D/c with outpt UGI planned. UGI WNL. Returned again 9/29/08 with c/o bilateral leg weakness x 4-5 days. Began with aches, joint soreness, numbness and tingling of the toes.  Legs feel heavy. Has had several falls Pt reports 13# weight loss over past 10 weeks as well as decreased energy, fatigue, H/A and dizziness. PE WNL. W/U (-) and D/C.
Shortly after receiving the vaccine, patient complained of coughing, shortness of breath, neck pain.  HR=119 and unable to auscultate blood pressure.  C/o warmth and feeling of throat swelling, burning in throat after coughing.  Patient was placed on floor initially supine and then onto right side.  Bluish discoloration around eyes and lips, and encouraged patient to use her inhaler.  Ox reading 98% after a few minutes.  EMTs present and took blood sugar, 87 and given dextrose orally followed by water.  Patient stated that she had a donut and waffle for breakfast.  Encouraged to eat lunch with some protein.  Relayed that she had an ablation and tubes tied last week.  Received allergy shot recently but not new formulatin. She also mentioned that she received a steroid injection for her migraines.
numbness in face,ear,neck throat closing fever chills upset stomach  headache swollen lymph nods  throbbing pain in arm
temp 103, crying, dec feeding;went to ER 16JUN97;LP, CBC, UA, UC all nl;to hosp observed x 18JUN97 d/c home;
Patient received vaccine 11/8 afternoon, she later started experiencing pain & inflammation, burning, etc. Informed patient to take MOTRIN for the pain and inflammation. Also an ice pack, if no improvement see a doctor.
THE REFRIGERATOR WHERE THE VACCINES WERE STORED EXPERIENCED A TEMPERATURE EXCURSION AFFECTING THE IPOL AND MMR VACCINES. NO ADVERSE EFFECTS WERE REPORTED. THE PATIENT WILL BE RE VACCINATED.
hearing was seriously impaired; felt groggy; Felt tired; This is a spontaneous report from contactable consumer (patient) via Pfizer-sponsored program COVAX US SUPPORT. A female patient that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported) via an unspecified route on an unknown date as DOSE 1, SINGLE for COVID-19 immunization. The patients medical history and concomitant medication(s) are not reported. On an unknown date the Caller stated she had the first dose of the Pfizer vaccine late in the afternoon. She got home and felt tired. Took a nap and when she woke up her hearing was seriously impaired. She felt groggy and went back to bed. By the morning everything was fine. This has happened 5 times in a 3 week period. She saw a doctor and they did some tests and did agree her hearing was impaired. She really wants to get the second dose but she is afraid. She wanted to know what caused this to happen. relayed number to PMI. read ISI, declined drug and safety because she already reported this to VEARS. Transferred to (Withheld) in PMI. The outcome of the event was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up(16Sep2021):  Information about lot/batch number cannot be obtained. No further information expected
Approximately 2 weeks post vaccination, pt developed multiple vesicular lesions to face, multiple papules spread to trunk, back and extremities with dry erythematous areas on chin.
30 minutes after second dose, tinnitus started. Tinnitus has continued 24/7 since that moment, it has been 2 months so far. Tinnitus pitches and tones vary across 3 types but remains constant.
Arm pain; This is a spontaneous report from a contactable other health care professional. A 38-year-old female patient received bnt162b2 (BNT162B2; lot number: EJ1685), via an unspecified route of administration on 22Dec2020 09:15 in left arm for COVID-19 immunization. Medical history included allergic rhinitis. Concomitant medication included oseltamivir phosphate (TAMIFLU), meloxicam (MOBIC). The patient previously took dexilant and experienced drug hypersensitivity. No COVID prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 22Dec2020 09:30, the patient experienced arm pain. The event was assessed as non-serious. The outcome of the event was recovering.
Nauseous for a week or more; Pain at auxiliary lymph node; Hard Knot in LE; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient felt nauseous for a week or more, experienced pain at axillary lymph node and hard knot in LE. The clinical outcome of the events nauseous, pain at axillary lymph node and hard knot in LE were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Serious arm pain that radiated to hand and across my back with inflamed lymph nodes on left side of my body. Inflammation of lymph nodes  lasted for 2 weeks arm pain continues almost 3 months later.
Administered powder reconstituting it with non-GSK diluent; Administered powder reconstituting it with non-GSK diluent; This case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva677a, expiry date 30th April 2023) for prophylaxis.   Concurrent medical conditions included anxiety (had anxiety on 24th August 2022).   On 24th August 2022, the patient received the 1st dose of Menveo (intramuscular). On 24th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter reported that the patient received Menveo in that administered powder reconstituting it with non-GSK diluent. The patient was revaccinated on 1st September 2022. All five potential patients were recalled for revaccination. No adverse reactions known. The reporter stated that the system was utilized from 6th September 2022. Diluent would be dispensed with the powder in this machine. Agency to check all vials for vaccines prior to administration. The reporter did consent to follow up. Additional supportive information: Menveo reconstituted with non-GSK diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was one of 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022124956:Same reporter/ original report US-GSK-US2022AMR131228:Same reporter US-GSK-US2022AMR131247:Same reporter US-GSK-US2022AMR131240:Same reporter
day p/vax pt exp fever x6 days, uri sx, diaper rash, otitis, bacterial conjunctivitis.
100.5 fever. Chills. Headache. Body aches/soreness. Restlessness.