chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the HPV vaccine in the late afternoon of Wednesday, May 6, 2009. Early on Thursday morning she woke up with pain in her right leg which had started during bedtime. She went to school, and there patient experienced severe pain in her right leg accompanied with pain and numbness on her left arm. she said she couldn't move her forearm and her ring and pinky fingers fo a period of about 5 minutes. About an hour later, around 9 to 9:30 a.m. patient had such pain in her right leg that she fell down. That pain was accompanied by spams in her lower leg and in her foot and toes. She could not walk without help and she was taken to the school nurse from where they called patient's mother. Mother picked her up in less than 20 minutes and took her to the ER. No tests (blood nor ultrasound) were performed. She was given Motrin for the pain and was dismissed with instructions to see pediatrician if she  got worse. From Friday through Sunday patient stayed home resting her leg. She had pain on and off and she had difficulty walking most of the weekend. On Monday, May 11, at school, patient's pain got severe again, Mother picked patient up and took her to the pediatrician. Pediatrician ordered blood to be drawn for tests and said she would refer patient to a specialist. On Tuesday, May 12, patient's pain was so severe that she was taken in a wheelchair from the classroom to the nurse's office. Mother picked her up and had to take her home since specialists were not going to see her until the coming week. On Wednesday, May 13, patient had severe pain in the morning while at school, she fell down, Mother picked her up from nurse's office where they had lent her a pair of cruthches to be able to get to the car. Parents called pediatrician to request testing to rule out DVT and parents requested an order for crutches for patient to be able to move around in school. Thursday, May 14, patient was still in pain, and was taken for an ultrasound. No DVT was found. Friday, May 15, patient was able to stay in school with the crutches. Monday, May 18, patient was able to walk most of the day without the crutches. Also, on Monday, May 18, a doctor saw patient. Tuesday, May 19, patient was able to walk without the crutches. Patient still complains on and off of weird feeling in her leg.  6/4/09 Hospital records received DOS 5/7/2009 and 5/18/09. Include bone age radiograph reports fron several prior years. FINAL DIAGNOSIS: Probable post Gardasil vaccination resulting in paresthesias. Post vaccination presents with right knee pain radiating to foot, leg cramps, twisted ankle, left hand tightness, forearm pain, numbness, myalgia, limping, dizziness. Motrin. Tylenol.
Headache started on day 3 after the initial dose and lasted a month. A few days after headache started, woke up with bloodshot eyes, especially the left one.   2-3 weeks post-shot, developed a dry cough and a bit of shortness of breath. Cough remains 6 weeks later. Doctor decided to try a corticosteroid and antibiotic to see if that helps. (I'm presently on day 3 of both medications).
5cm area of induration on right thigh and increased warmth and redness around the needle mark. No tenderness and no purulent discharge.
Pt lied and said she had never received any covid vaccine and was administered Pfizer.  B/c we had a system outage, we cannot verify her statement.  Later we found out pt had received J&J in March 2021. Pt did not have a reaction following vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "asthma secondary to them" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: elevated. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Oct2023 to 21Oct2023.  Additional information: Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Itchiness at site of injection, (L) deltoid & periods of "off balance" feeling.
PATIENT HAS 2 INCH INDURATION FROM INJECTION SITE WITH EDEMA, REDNESS, WARMTH, AND TENDERNESS.
Inadvertantly removed adult Hep A vaccine instead of pediatric dose, child received vaccine via IM injection to the LVL  prior to the recognition that it was an adult dose.
Received Tdap IM Left deltoid. Within the hour after vaccine given Left axilla and area began to swell. Unable to use arm much for 1 week and swelling continues 2 weeks post shot. Ran some fever. Parent notified health department on day #12 after shot given. Had not seen physician.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable. This case was previously reported to the physician. The age group was not provided, but was selected as adult as per the vaccine indication. The reporter stated that, she heard about 3 people while in line at her local pharmacy mention that they all had terrible reaction to the SHINGRIX vaccine. The patient had denied permission to contact their physician. This case was linked with case US2018192637, reported by the same reporter.
pt recvd vax;approx 2 wks later,devel 1 day fever,v,then devel acute autoimmune hemolytic anemia;
No adverse event; Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife)) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 02-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Today 2Jun2023 she gave a vaccine that expired three days ago to two patients (husband and wife)).    Patient did not received any other vaccine 4 weeks prior to Covid-19 vaccine. No concomitant medication details was reported. It was reported that the patient received 5 previous Moderna doses. The vial was initially stored in the refrigerator 19-May-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727348 (E2B Linked Report). This case was linked to MOD-2023-727348 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727348:Wife case
Pt received vaccine on 8/14/09.  Pt developed fever (101-102) on 8/23/09 with generalized tonic clonic seizure.
Employee received 2nd dose of Pfizer COVID-19 vaccine on January 18th at about 2pm.  By 6 pm, she noticed that she had bilateral swelling of lymph nodes in neck by the clavicle bone (more prominent on right hand side - same side as injection).  She also experienced difficulty swallowing and went to the ER at 9pm.  At the ER she received solumedrol IV, Pepcid IV and was discharged with hydroxyzine, Pepcid, solumedrol dosepak, zofran and epi-pen. At this time she was diagnosed with angioedema.  Swelling persisted and she contacted an allergist who prescribed additional antihistamines.  The allergist advised to her take Zyrtec or Claritin in addition to hydroxyzine day and night. The swelling continued to persist and two weeks later after returning to work for one day, she experienced feeling hot and flushed on right side, increased swelling and difficulty swallowing again and returned to ER on 1/25/21 and was treated with solumedrol and hydroxyzine and was discharged with solumedrol dosepak in addition to continuing antihistamines.  Upon returning to allergist, she was advised to take 4 zyrtec, 4 Claritin, Pepcid 40mg bid and hydroxyzine 10mg at bedtime.  PCP referred her to oncologist. After CT, oncologist diagnosed condition as bilateral lymphadenopathy and to return in 3 months for follow up.  PMH significant for ALL as a child (8 yrs), went into remission at 13yrs. PMH also includes DM2.
My whole body tensed up and I began shaking and my arms and legs pulled up into the fetal position and I couldn't breathe all I could do was stare. It felt like a seizure.
Patient presented 3 weeks after the vaccine with worsening dyspnea on exertion, orthopnea, cough that began 2 days after vaccine administration. Two days prior to presentation to Harbor ER on 7/1/2021 he had nausea and  vomiting with a fever 101F on day of presentation. He was found to be in congestive heart failure with severely diminished biventricular function. While inpatient he had worsening respiratory status requiring CPAP and O2 though he improved with initiation of diuresis.  His inflammatory markers were not elevated and he had negative troponins. cMRI revealed an LVEF 13% with no signs of active myocarditis. Viral studies were negative and there was no evidence of bacterial infection. Prior to this, he was in his USOH with no limitations. He was seen in cardiology clinic 5/2021 and was stable at that time.  He required initiation of diuretics and oral heart failure management and was discharged with close follow-up.
Hypertension episode that began approximately 2 hours post vaccine administration.  BP at wellness check was 116\64 on 3/08/21. Went to Cancer center for treatment and BP became abnormally high until 8 pm. Highest reading was 219/100.  Treated with Norvasc 5mgx2. Bp at discharge  from ER 161/87.
I had nasal congestion and a cough. I took a COVID-19 test at home and it was positive. I talked to my doctor and because my symptoms were so mild, he did not prescribe me anything. My doctor checked on me everyday to log my symptoms. I checked my fever for 6 days, but I did not have fever. My doctor told me to try to stay away from people for a couple of weeks because I still may have COVID-19 particles. I am still having sinus issues.
felt bad for a day; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for her sister in law. The age at vaccination was not reported. IT was reported that the patient received dose of Shin US2019163768 No further details were available. The reporter did not consent to follow-up.
Tachycardia; This is a spontaneous report from a contactable nurse (patient herself) via Medical Information Team.   A 44-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at vaccination: 44 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, about 7-8 hours after that administration, the patient experienced tachycardia. She described the tachycardia was pretty significant and ongoing. She saw her HCP and was referred to a Cardiologist. She has gone to the doctor since onset of this event and her heart rate has been in the 130s, was 136 when she saw the doctor. Her second dose was scheduled for 21Oct2021 at this time. She was asking if tachycardia has been reported or was listed as a side effect from the Pfizer Covid-19 Vaccine. The patient underwent lab test and procedure which include 136 beats per minute on 13oct2021. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information expected.   Follow up (15Oct2021): This is a follow-up spontaneous report from a contactable nurse. This female nurse (patient) reported for herself that: The event of tachycardia was assessed to be medically significant.   The lot number for the vaccine, bnt162b2 (COMIRNATY) was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of tachycardia . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Nausea, lightheaded, chills, body aches, fatigue, headache. Most of these resolved over the weekend but since I had the vaccine I?ve had daily headaches and fatigue which are going on 2 weeks today.
High fever peaking at 103.4.  2 hours after shot started to get muscle aches and mild fever. Fever got far worse into evening with extreme body chills. Fever in the evening was 102.2. Was 101.5 in middle of night and  morning.  Fever in middle of day 1/15/21 briefly spiked to 103.4.  Was about to go to hospital since >103 degrees but fever reduced to 102.4 quickly. Took Tylenol, fluids and consulted with Doctor over phone.
Patient came to this PCP office and received a COVID and flu vaccine.  Per ED attending report,  she felt well initially but at home (about 6 hours later) became lightheaded. She subsequently went to the bathroom thinking that would resolve it but fainted. She had LOC, waking with bleeding to posterior scalp. She does not remember ever experiencing chest pain or SOB before the fall.
This spontaneous case reported by a pharmacist, describes the occurrence of vaccination site swelling (has swelling at injection site about the size of a cup) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 0.25mL. On an unknown date, patient had vaccination site swelling (has swelling at injection site about the size of a cup). At the time of the report, vaccination site swelling (has swelling at injection site about the size of a cup) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Inconsolable crying, fever, lethargy. Was taken to Pediatrician who said it was ?fussy baby?
Patient experienced erythema in injection arm - diffuse at site and spread to below elbow. Patient reported warmth and itching. Pharmacist recommended patient go to MD.
8/2 Annular rash started on neck and has since moved to chest.  8/11 electric feeling in arm, swelling, heat and red
about two weeks after second vaccine her blood sugar was low, lot of trouble getting it to stabilize; struggled little bit with blood sugar sometimes dropping, was more intense; Only thing she figured out was her body was fighting hard to build the antibody and that's how it affected it; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP6955, 55-years-old at the time of vaccination), via an unspecified route of administration on 27Mar2021 as single dose for covid-19 immunization. Medical history included menopause and low thyroid (had low thyroid. She had a little bit of subpar thyroid, mild like borderline hypothyroid). Concomitant medications included fluoxetine (took a very low dose, that was 16 mg total, a 10 mg capsule and 6 mg liquid) and thyroid (ARMOUR THYROID) (took little, tiny bit of thyroid medication and thyroid was almost nothing, she took about 5 mcg a day. It was a natural thyroid). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6199, 55-years-old at the time of vaccination), via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunization and experienced hypoglycaemia. On an unknown date in 2021, She reported that, about two weeks after second vaccine her blood sugar was low, lot of trouble getting it to stabilize; struggled little bit with blood sugar sometimes dropping, was more intense and the only thing she figured out was her body was fighting hard to build the antibody and that's how it affected it. Consumer stated, she was not diabetic, but she did get hypoglycemic at times. She just had like this thing with low where she got, it's not true hypoglycemia because she didn't go super low. Not really, she had a single mutation for iron so it's not clear because she had gone through menopause, it's not clear if she was going to have trouble with holding too much iron so they were just watching it, it was nothing diagnosed. She didn't undergo any laboratory test. Patient did not receive any treatment for the events. Outcome of the events was resolved on an unknown date in 2021.  Information on Lot/Batch number was available. Additional information has been requested
Almost full loss of taste and smell post covid vaccination due to increased risk of illness because of lowered immunity. Tried many different neurological receptor improvement supplements and breathing treatments with essential oils. Only minor improvements took place over time. Arthritis flare-ups happened in the past month or so. Specifically my left pointer finger.
Rught MCA Stroke; This is a spontaneous report from a contactable nurse (patient). A 39 years old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 16Dec2020 10:15 at the first single dose at right arm for covid-19 immunisation.  Medical history included Hodgkin's disease.  Concomitant medication included colecalciferol (VITAMIN D3 1000).  The patient experienced rught MCA stroke on 25Dec2020 06:15. Seriousness criteria reported as hospitalization, life threatening. The patient was hospitalized for rught MCA stroke for 3 days.  The patient underwent lab tests and procedures which included Nasal Swab: negative on 25Dec2020.  The patient received unspecified treatment  for rught MCA stroke. The outcome of event was recovered.; Sender's Comments: The subject had medical history included Hodgkin's disease.  The reported stroke was more likely an intercurrent disease, and unlikely causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Localized arm pain, redness, swelling, warmth, area of 4 by 6 inches.  Fever to 100.5 F, headache, severe body aches, nausea, severe abdominal pain, malaise, anorexia.  Symptoms lasted through 4th day after received injection.
Severe tinnitus began about 6 weeks after second Covid vaccine (around June 1, 2021).
70 doses of Pfizer-BioTech Covid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
From initial information received on Aug 18 2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a five year old female patient received a dose of Daptacel, lot number C1699AA, administered in the right thigh, a dose of Ipol, lot number X0138, administered in the right thigh and a dose of MMR-Measles, Mumps and Rubella vaccine, lot number 1033N, administered in the left thigh on Jul 30 2004. The routes of administration were not reported. 20 minutes later, the patient developed red itchy hives, as well as swelling on one side of her face. The patient also vomited. On Aug 20 2004, the patient also developed an area of redness, warmth and bruising measuring seven inches in diameter on her right thigh, Per the reporter, the hives, swelling of the eyes and hands lasted for two days. The patient was treated with Benadryl. It was not reported whether the patient recovered from the remaining events. From additional information received on Oct 20 2004 from the initial reporter, it was reported that the patient was seen by a physician on Aug 02 2004. She was treated with anitbiotics and has recovered from these events. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter as for case 200402696.
Fever , joint pain, headache, weakness, nausea since 5 pm last night.
Large red area surrounding injection site >4 inches and swelling and hot to touch in red area surrounding injection site.