chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIFFICULTY WALKING; MAJOR FATIGUE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient reportedly was very healthy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination .The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced difficulty walking, and major fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from major fatigue, and difficulty walking. This report was non-serious. This case, from the same reporter is linked to 20210935204.
EE c/o swelling, redness, itchy and pain that began 1-2 hrs after receiving flu shot on 9/8/15. Presents 9/9/15 for treatment. Denies home care.
Chills, fever body aches lasting about 48 hrs. Severe vivid recurring nightmares from 3/6/2021 to present. On 3/31/2021 I had a severe nightmare which caused me to jump out of bed and run. I ran smack into side of door and received injury resulting in fractured optical bone, black eye, swollen left side of face and numbness on left side and across upper lip which continues still today.  Dr cannot say if nerve damage and numbness will be permanent or not. I am terrified I will not get feeling back. Effects my sleep, my eating and my everyday activity. I was scheduled to receive second dose of Moderna on 4/2/2021. I refuse to to severity of nightmares and injury.
Patient with a history of LLE revascularization on 2/1/2021 with fem-bkpop 6mm PTFE bypass for limb salvage in the setting of rest pain and great toe gangrene.  She was discharged on Xarelto.  Patient was admitted to the hospital on 4/13/2021.  Patient reported she noticed return of the rest pain to the left lower extremity starting on 4/12/2021.  Patient was found to have acute on chronic limb ischemia of the LLE and was found to have an occluded left femoropopliteal bypass graft.  She was taken to the OR on 4/14/2021 and underwent a thrombectomy and removal of distal portion of the graft, which appeared to be infected.  Cultures from the left femoral thrombus was positive for gram-negative rods.  Blood cultures from 4/13/2021 were positive for Pseudomonas aeruginosa.  Postoperatively, her left lower extremity continue to be numb, cool, and she was unable to dorsiflex the foot.  Patient ultimately underwent a left lower extremity below the knee amputation on 4/16/2021.  Patient remains hospitalized at this time.
Tiredness; headache; slight numbness of right side of face; slight loss of muscle control in right side of face; This is a spontaneous report received from a non-contactable consumer (patient). A 35-year-old male patient received first dose of bnt162b2 (Batch/Lot Number: 953738), at the age of 35-year-old via an unspecified route of administration, administered in left arm on 21Mar2021 as single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced tiredness, headache, slight numbness of right side of face, slight loss of muscle control in right side of face all on 27Mar2021 16:00. No treatment received for the adverse events. The events were reported as non-serious. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Not allergies to medications, food, or other products. The outcome of events was not resolved.
Very red sore eyes without discharge x 6 days, pressure in eyes, headache, fever 101F, cough, muscle aches, malaise, loss of appetite, nausea.
Pt was seen for a physical 6-1-07. Mom is a CMA in the lab at our facility; she states that 6-3-07 pt had a "25mm x 25 mm" "hard, red area at the sit eof the (ProQuad) injection'. Mom also denied further react. respiratory distress or any pn or pruritus. Mom was advised to bring child in to check area mom declined; she states that the area "almost gone with on problems, no fever, no pn. "PA here at the clinic is aware of pt and situation. "Advised to not ask as mom stated and report reaction/sx as adverse reaction to vaccine.
Rash, hives, swollen, painful joints, chest pains, flu-like symptoms, and itching from 11/12 to present.
at injection date , 3/30/2021, left arm injection site pain a little, next day pain is gone.  After about a week on 4/5/2021, left arm injection site start red, swollen (about the 2.5 inch  in diameter round area, and itch), used ice pad, fell better, next day, red color start to fade away, still last till today, 4/8/2021 still itch.
Eleven days post vax, pt experienced pain, swelling and redness in left deltoid and left shoulder. Swelling and redness progressed throughout the day extending to left elbow area. Remained red and swollen the next day and gradually subsided.
Patient is vaccinated at 11:18 pm and returns at 12:09 pm, which mom indicates that she was in the supermarket and the minor complained that it itched and some yellow things came out. Doctor is called, she indicates to administer 10cc by mouth to the minor and monitor for 30min. n/a.
Swelling started 3/17/10 at 2 am. (L) arm swelled to 4 times regular size from elbow to shoulder. Swelling seems slightly reduced at 1 pm 3/18/2010/
pt recvd hep B at hosp & hep B2 at hlth dept 1jun94;p/ both immun pt devel red raised rash w/ white ctr; no tx given & no oth rxns;
I had my first injection on 7/10/2008.  Since my second injection (9/26/2008), I haven't had a regular menstrual cycle, even while on birth control.  I am very tired and weak all the time. I was also diagnosed with autoimmune thyroiditis (10/20/2008). Prior to the injection, I had hypothyroidism. I have had urinary tract infections/kidney infections.  I have had pain in my left hip area/leg and back. The pain shoots down my left leg, also injection leg. The pain is so annoying and constant it keeps me up at night.  2/2/09 Received OB/GYN medical records 7/10/08-1/28/2009. FINAL DX: dysuria, irregular menses Records reveal patient experienced good health on 7/10/08 & requested to resume BCP(yasmin) after being off x 6 mo.  RTC 11/20/08 w/irregular menses.   Had self d/c'd BCP & thyroid med had been adjusted recently as well.  Contraception changed to nuvaring.  RTC 1/28/09 w/leg pain since 7/08, continued irregular menses & UTI s/s.  Had self d/c nuvaring & bcp.  Recently dx w/Hashimoto's thyroiditis  05/07/09 Received Internal Medicine records 12/10/07-01/14/09 FINAL DX: Hypothyroidism Well patient visits. Adjustment of levothyroxine dosage
Left armpit started to get painful on the evening of 4/28/2018, the day when the MCV shot was administered. The next morning of 4/29/2018, the armpit already appears swollen with intensified pain in the area even without movement. No medications have been taken neither a hospital call/visit.
Subsequent to receiving one dose of varicella virus vaccine live, pt experienced mites and scabies. There was an itchy rash with 25 blisters.
given bivalent booster for the 1st dose primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (given bivalent booster for the 1st dose primary series) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (given bivalent booster for the 1st dose primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (given bivalent booster for the 1st dose primary series) 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 INCORRECT DOSE ADMINISTERED (given bivalent booster for the 1st dose primary series).    No concomitant medication information provided. No treatment information provided.
groin lymph node enlargement after receiving GARDASIL; This spontaneous report has been recieved from a physician regarding an adult female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), intramuscular injection, (strenght, dose, frequency, route of administration, site of vaccination, lot number, and expiration date were not provided) for prophylaxis.  On an unknown date (also reported as more than 10 years ago but less than 15 years ago), the patient (a female in her 20s) experienced groin lymph node enlargement after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lymphadenopathy). The reporter was not sure about the valent number of the vaccine administered, or if the event ocurred after the first or the second dose administration. The outcome of the event was not provided.  The causal relationship regarding the event lymphadenopathy and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
A report has been received from a Health Professional concerning a 12 year old, Female patient, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, unknown. FLUMIST QUADRIVALENT was given on 06-Jan-2016. The patient received expired dose of FLUMIST QUADRIVALENT which started on 06-Jan-2016. The outcome of the event of expired dose of FLUMIST QUADRIVALENT administered was unknown. The report was considered to be non-serious by the company physician.
This is a literature report for the following literature source(s): "Report of three cases of minimal change disease following the second dose of mRNA SARS-CoV-2 COVID-19 vaccine", Kidney International Reports, 2021. A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "steroid-sensitive MCD" (unspecified if ongoing), notes: at age 4 years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for Covid-19 immunisation. The following information was reported: GLOMERULONEPHRITIS MINIMAL LESION (medically significant), outcome "unknown", described as "minimal change disease". The patient underwent the following laboratory tests and procedures: Biopsy kidney: showed features consistent with MCD, notes: Figure 1c, f; Blood albumin: 2.8 g/dl, notes: hypoalbuminemia; Microscopy: Unknown result; Unknown result; Urine protein/creatinine ratio: 12.9, notes: Unit: g/g nephrotic-range proteinuria. No follow-up attempts are needed. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: 'Glomerulonephritis minimal lesion" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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. Linked Report(s): US-PFIZER INC-202101654930 Same article/ drug and different event/patient.
Caregiver called Health Dept on 9-28-17 and reported that on 9-27-17 at approx. 5:30 PM the infants "eyes rolled back in her head" and she called 911. Infant was taken to ER and seen. At the ER, she reports they checked her temp (she does not know the amount of temp), did a CXR, gave her TYLENOL and sent her home. She reports they told her if was a delayed reaction from her shots. She stated that earlier in the day of the 27th, she had checked the temp and it was only 99.6.
Bullous pemphigoid; Rash; Itchy/ itching; knee and foot got swollen; knee and foot got swollen; dry skin; blisters; red bumps; weight has gone down substantially; stinging; burning and itchy and it feels like the worse sunburn; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bullous pemphigoid, rash, itchy/ itching, knee and foot got swollen, dry skin, blisters, red bumps, weight had gone down substantially, stinging and burning and itchy and it feels like the worse sunburn in 2021 with outcome of unknown. All events caused emergency room visit. Reporter's husband had his first dose and 10 days later broke out in a rash. The rash got worse with blisters. One of the doctors he saw said that this was brought on by the Covid-19 vaccine. His weight had gone down substantially, people thought he was ill and sick. She thinks it was stress with what he was going through with this. He started itching a little bit before 02Mar2021, he asked her if she changed the detergent and they did not know why he was starting to itch. He was wondering why he was feeling itchy and had dry skin and that is where it started. He was diagnosed with Bullous Pemphigoid and they said that it was incurable. It is itchy with bubbles and blisters that grow on his body. They have to be popped and drained. The blisters were a quarter to a half inch big. They grow like a bubble. He had burning and itchy and it felt like the worse sunburn, itchy like bugs were on skin, and stinging. There were red bumps that grew to big red bumps that started connecting and looked like burns with patches of red that grew together. Some of them were raised and others had blisters. They were on his chest, back, they spread to his arms and legs. His knee and foot got swollen. Reporter's husband went to urgent care in emergency room. No one knew what it was or knew what to do with him. No one wanted to say it was related to the vaccine because of liability. They had another patient that had the exact same thing.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101515803 same reporter/drug, different patient, similar AE
Started to cry uncontrolable at 11 PM (07/01/2003) and continued to cry until 2 AM (Wednesday 07/02/2003).  At one point became very limp but continued the severe crying.  Seen by MD for treatment.
pt has history of MS arrived via wheelchair to OBS with c/o headache and nausea   pt drowsy arousable to verbal stimuli unable to follow simple commands  cofusion noted  VS stable called pt father   father arrived to bedside  pt and father agreeable to leave via EMS for further evaluation  EMS arrived  report given  father left with patient wheelchair and personal belongings at 1240 VS 1205 bp 129/78 hr 95 rr 18 o2 99   1210 bp 126/78 hr 76 rr 16 o2 96  1215 bp131/76 hr 84 rr 18 o2 96
1/7/21 T/C from recipient, states received vaccine on 12/30/20, had no reactions until 1/7/21, states injection site hard, reddened and raised and tender, sl painful to the touch, afebrile, no other sx, instructed to use cool compresses to site and return call in 48 hours to reassess. 1/8/21 c/o extreme fatigue, a little nausa, and sl stiff neck, area raised and reddened. Taking benadryl, advil, and icing. Following up with PCP, denies fevers. Circled area 1/7 and monitoring size.  1/9/21 Given prednisone by PCP but holding off on taking. No nausea today and inflammation and redness significantly decreased today.
pt recvd vax 11SEP93 & devel a rash on body on 20SEP93; rash began on chest & abdo & spread to back, arm pits, groin, arms, & legs; no fever or cold like sxs;
pt exp sore arm on the evening of 8PAR, c/o itchiness @ inject site 10APR, seen in clinic on 11APR w/c/o a sore arm, noted on site of inject 6 cm firm raised area w/a 5mm hard bump @ center; Md dx pt w/local react to Td;
I have received a total of 2 pfizer vaccines first dose on 8/16/21, second dose on 9/7/21 and the booster on 2/14/22.  Since receiving the three vaccines I have been diagnosed with immune thrombocytopenia, a condition of chronically low platelets.  I am a healthcare professional and know that normal platelet levels are between 150-450.  Mine now frequently drop into the 30s and 40s causing severe bruising and fatigue.  They have not gone higher than 99 in the recent past.  This was discovered during routine bloodwork and I now see a hematologist who told me this is likely due to the vaccine.  I have to be monitored regularly and am told this may provide complication during pregnancy, treatment and/or platelet transfusions.  There are two types of thrombocytopenia, one where your body does not produce enough platelets and one where your body attacks its own platelets thinking they are foreign.  I have the second, so my body is producing platelets but just as quickly destroying them,
I developed some hives, and I contacted my physician and she told me to take Zyrtec. I would take Zyrtec daily. It will take them away but then they gradually progressed more and more up to the point Zyrtec is not helping any more. I was referred to the dermatologist. And they are referring me to an allergist now. I am now taking Montelukast 5 mg twice a day, Levothyroxine one tablet daily, Famotidine 20 mg tablets twice a day, Loratadine or Zyrtec or Allegra twice a day. They also put me on supplements iron, vitamin D3, vitamin B. Now I have to carry and epi pen with me, because at the beginning of this before taking all these medications I had swelling in my lip, tongue, and numbness in my left side. That is why I went to the ER. They did blood work, EKG because I was having chest pain, x-rays of my lungs. These medications are keeping it controlled but if I do not take them I start to get hives all over my body.
H1N1 administer 60-68 hr after-weakness-cognitive motor and processing. Emergency room visit, admitted. Diagnosis toxic encephalopathy Oct 22-discharge to home. Emergency rm Oct 26-diagnosis-ataxia. Follow up neurology dept.  11/12 and 11/13/09 Medical records and discharge summary received for DOS 10/22-10/23.  Final DX:  Toxic metabolic encephalopathy  Presented w/ weakness, dizziness lightheaded. Nausea. Stomach and muscle spasms. Cognitive trouble. Paresthesias. Fatigue. Halting speech. Ataxia. (+) Rhomberg. Etiology poss viral. Unclear.
Patient was provided vaccine, however was only 11 at time of vaccine which is currently an unauthorized age.  Contacted parent/guardian and informed him of error and advised that pt should not receive dose #2 until either she turns 12 years old or the vaccine is authorized for her age group.
Red splotches appeared on chest, stomached, Back, and legs. Benadryl 10ML given in clinic. No shortness of breath was observed. Mother instructed to give Benadryl every 6 hrs for 3 more doses. If child starts to have difficulty breathing to go to the ER AT 1050 pt was discharged with decrease in redness and splotches
Pt. called grocery store pharmacy after clinic, pharmacy closed. Arm where rec'd FLUZONE QUAD 16/17 swelled in egg-shape size reaction. Pt. used ice pk and ZYRTEC as soon as reaction occurred. Pt. slept whole next day.
Initial report received on 08 November 2013 from a health care professional. A 89 year old female, medical history included allergy (not known) and concomitant medications was unknown received a dose of FLUZONE HD at left arm intramuscular on 12-Oct-2013. The day after vaccination (13-Oct-2013) patient experienced cold with chills and felt did not want to do anything. It was reported that patient required emergency room or doctor visit. Events lasted for three weeks. List of documents held by the sender: none
I am having anxiety sense the fourth day of the vaccine and it only was the first one. I can?t sleep or eat and I feel this panic attacks and are awful.
Several hours after vaccine administration, I began to get a headache. That headache intensified over the next 24-36 hours. A severe headache resulted with a painful, stiff neck, occasional fever, occasional diarrhea, confusion, vision changes, and increased imbalance. These symptoms lasted for about 1 week before I sought medical treatment at a virtual urgent care appointment on 1/5/21. They referred me to an in-person urgent care facility that day. At that facility, they said my symptoms were very concerning and said I needed to seek immediate medical assistance at the ED and offered to call me an ambulance. My husband drove me to the ED from the urgent care facility. At the ED, they treated me with a migraine work-up but eventually discharged me with instructions to follow-up as I was "diagnostically unclear" at discharge. After a week, my symptoms had not improved at all and so my previous ED physician suggested that I return to the ED (after being unable to get care in a timely manner in an outpatient setting). At the ED on 1/12/21, they again treated me with a migraine workup but also conducted a CT scan and a COVID test. When both tests came back negative, they conducted a lumbar puncture procedure. Those results came back positive for viral meningitis. As I had no other illness or known exposure to any other virus at that time - and given the timeframe of the vaccine administration - my care team concluded that this was a rare reaction to the COVID vaccine. I was discharged with instructions to follow up with my PCP and a neurologist. My follow-up neurology consult is scheduled for 2/19/21.