chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her throat swollen; difficulty eating; sore throat; This is a spontaneous case received from a contactable reporter for a 74-year-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 09Mar2021 as DOSE 2, SINGLE for COVID-19 immunization and patient also received diphenhydramine hydrochloride, paracetamol (TYLENOL PM EXTRA STRENGTH), via an unspecified route of administration from 11Mar2021 to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced her throat swollen and difficulty eating on 12Mar2021. Patient also experienced sore throat on an unspecified date in Mar2021. Caller reported that, her mother took some Tylenol PM last night and woke up this morning with her throat swollen and difficulty eating. Caller denied compilations with breathing. Caller asking if symptom was possible reaction or not. It was unknown if patient had received any treatment for AEs. The action taken in response to the event(s) for diphenhydramine hydrochloride, paracetamol was unknown.The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
sore arm; headache; floating feeling; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, ), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 23Oct2022, outcome "recovering"; FEELING ABNORMAL (non-serious) with onset 23Oct2022, outcome "recovering", described as "floating feeling"; HEADACHE (non-serious) with onset 23Oct2022, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 23Oct2022, outcome "recovering", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity, headache, feeling abnormal, chills.  Additional information: Facility type vaccine: Doctor's office/urgent care. If other vaccine in four weeks: No. Other medication in two weeks: No. If treatment: No. If covid Prior vaccination: No. If covid tested post vaccination: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient contracted COVID-19 after being fully vaccinated. Patient was also positive for COVID 8/13/2020 Asymptomatic this time, hospitalized for unrelated issues.
local rxn, large red, itchy;pt recv vax 1OCT96 & 2 days later pt exp a large local rxn described as large (apple sized) red & itchy;
patient came in to the pharmacy on 12/15/2020 and described an abdominal rash around her abdomen with pain that had lasted  until today and was almost completely gone when she reported to me.
Covid arm. Swelling,redness,rash,soreness going down the outside and inside of left arm. Not at injection site. About 3 inches down and to the right.
Patient c/o dizziness, weakness, sleepiness, and headache 3 days post vaccination.   While reviewing patient's record, it was noted that she received Pneumococcal Vaccine on the 10th of March.  Moderna vaccine was administered on 3/12/21.   It is unknown at this time if what patient is feeling is correlated to pneumonia vaccine that she received on the 10th.  However, patient has been complaining that she feels tired and weak.  Her vital signs are stable.
I was given Lymerix shot when I was a salesperson in 1998. I was unaware they pulled the vaccine and have had several arthritis, numbness and tingling in my extremities, dizziness, loss of appetite, shooting pains, migraines, severe exhaustion, muscle fatigue and resulting in psychological problems as well.
Patient noticed a lump on her arm at the site of the injection.  She was not sure when it started.  About a 2-in. diameter area around the site of injection is red, raised, and warm.  Patient reports no pain.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Additional Details: The patient described feeling shaky an lightheaded for about 4 min after vaccine was administered .patient had some water to drink, and stated she felt better. Nurse observered for 30 min, then the patient said she felt ok to leave.
OBSTRUCTIVE SLEEP APNEA ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 3/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
A 15 year old child received COVID 19 Pfizer vaccine approximately 12:40PM 7/10/2021; after the vaccine was given and bandaid was applied, the child's body stiffened for less than 60 seconds. The child's arms and legs were stiff and stretched out and per father's observation, he claimed that his child's eyes were rolled backward. The child returned to "normal" status, he claims that he doesn't remember what happened. The child's hands were little shaky as he was attempting to drink water. We asked multiple questions - child claimed he was not nervous about the vaccine. Parents claimed that the child is doing better with vaccine anxiety compare to previous time, The child and parents informed that he did not eat anything yet. The child claimed that he is not dehydrated. 911 was called immediately at sight. EMT took the child's vital and reevaluated the child's condition. family wanted to follow up with their doctors (if correct, I believe EMT's vital check indicated 116/58 for BP) - our temperature measurement showed 97.3.
Had a terrible reaction. Fever; Chills; Headache; Sick; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   On 19th October 2020, the patient received the 2nd dose of Shingrix. On 19th October 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, headache and sickness. On an unknown date, the outcome of the fever, chills, headache and sickness were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, headache and sickness to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient was sick.  She experienced fever, chills and headache.
Started developing what I initially thought was bug bites on my stomach, thighs, arms and upper trunk. Turns out they are hives and they are non stop, new ones keep popping up, but as they go, they dry up and become eczema like. In addition, after the vaccination, my mast cell activation symptoms that were in remission flared up immediately as well as my POTS symptoms flared up that were in remission as well.
Abdominal pain 1 day after ROTATEQ. 5 days later, extreme abdominal pain dx with intussusception. 1 day hospital stay.
rash well below deltoid; pain well below the deltoid; Swelling near elbow; swelling well belowthe delotoid; was given the injection below the deltoid; A spontaneous report was received from health care professional concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced was given injection below the deltoid (Product administered at inappropriate site), pain well below the deltoid (Pain in extremity), swelling well below the deltoid (Peripheral swelling), Swelling near elbow (Joint swelling) and rash well below the deltoid (rash).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 08-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 039K20-24) intramuscularly for prophylaxis of COVID-19 infection.   On 08-Jan-2021, the patient stated that she felt the injection was administered wrong. She received the injection below the deltoid and experienced pain well below the deltoid. Swelling started well below the deltoid as well and on 08-Jan-2021. After 11 days on 19-Jan-2021 she was still having swelling, but it was closer to her elbow and off to the side. She also experienced a rash well below deltoid. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, was given injection below the deltoid, was considered resolved on 08-Jan-2021. The outcome of the events, experienced pain well below the deltoid, swelling below the deltoid, swelling near elbow and rash well below the deltoid, was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced an event of product administered at inappropriate site and a non-serious expected event of peripheral swelling, rash, pain in extremity, joint swelling. There was no AEs associated with product administered at inappropriate site.  The event of peripheral swelling occurred 1 day (same day) after first dose of mRNA-1273, lot # 039K20-24.  The event of rash, and joint swelling occurred 12 days after first dose of mRNA-1273, lot # 039K20-24. The event of pain in extremity occurred on an unspecified date after first dose of mRNA-1273, lot # 039K20-24. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
received the COVID-19 Pfizer EL3302 vaccine at 8:10 am this morning (Jan 23, 2021).  All went well.  He drove home had lunch and then complained of being dizzy.  I got him to lie down.  Then he said he felt nauseated.  Then he vomited up his entire lunch.  He vomited about 5 times over the next hour, and has been resting since then.  I have taken his temperature twice and it is low: 97.4 and 97.1.  At 3:30 PM he said he was feeling better and would like some tea.
Flare up of dermatomyositis; Flare up of polymyositis; Myalgia; Pyrexia; Rash; Discomfort; This case was reported by a consumer via other manufacturer and described the occurrence of dermatomyositis in a 49-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   In September 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On an unknown date, less than 5 months after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced dermatomyositis (serious criteria GSK medically significant), polymyositis (serious criteria GSK medically significant), myalgia, fever, rash and discomfort. On an unknown date, the outcome of the dermatomyositis, polymyositis, myalgia, fever, rash and discomfort were unknown.   It was unknown if the reporter considered the dermatomyositis, polymyositis, myalgia, fever, rash and discomfort to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: The patient received flu vaccine and experienced flare up of dermatomyositis and polymyositis, myalgia, pyrexia, rash and discomfort. No contact details reported.
L local red arm @ vaccination site Vitals:  B/P: 160/82 HR: 87 Resp.: 12 O2sat: 85% Skin signs: Warm and dry Resp.: Breath Sounds Clear Bilaterally  Treatment: Ice   Repeat Assessment @15:45 Vitals: B/P: 140/80 HR: 76 Resp.: 12 O2sat: 95% Skin signs: warm and dry Circulation: Cap refill <2sec Resp.: Breath Sounds Bilaterally Treatment: Released home with spouse
On 5/2/2021 at 5:00 AM, my husband had a major stroke.  He was completely paralyzed on the right side, unable to speak, and totally confused. He was taken by ambulance to the emergency room.  They did an MRI and decided to put him on the clot-busting drug TPA, which began reversing the effects of the stroke. He was admitted to the ICU, where he stayed for 4 days. He came home on 5/7/2021 and was referred for physical therapy and speech therapy. He was also referred to a neurologist. He has also seen a pulmonologist, and a neurointerventionist, . My husband still has short-term and long-term memory loss and limited movement in the right arm and shoulder. He has weakness in the right side of his body, right leg, and right arm. He stumbles and falls and has positional vertigo. He now also suffers from phobias and depression on account of the resulting neurological imbalance and is unable to work. When the doctors described the plaque in his arteries, they said it was gray, which means that it had just recently developed, since older plaque tends to be white.
Patient reported pain in left deltoid that radiated to L elbow, shoulder and collar bone. Pain resolved 7/9/21.  Lightheadedness after vaccine about 30 minutes after vaccine.   Itching, rash and warmth on under arms, injection site, upper torso area 2 hours after vaccine. Rash resolved 7/12/21 and itching resolved 7/13/21.
Flu shot swelled "like egg in there" happened "couple hours" after administration. Lasted for two days, back to normal on day three.
Left axillary swollen lumps/lymph nodes?  Tender to touch.  Hard to move left arm.  Never hapepned before.
Reddened rash like area to (L) deltoid states "a little itchy" at site. Benadryl taken by pt 11/15/07. Spoke to pt 11-16-07 1430 and rash beginning to fade. 11-28-07 Resolved.
Severe itchiness (small hives), scratchy throat, diziness. Took two Benadryl when reaction started, symptoms continued for 35 minutes until Benadryl started to take effect.
First, exhausted. Glands from elbow to ribs sore. Slept fitfully, waking ever few hours. In the morning (6am) I had a fever of 100.2. No appetite for the day. Slept ALL day. Now, 8:30 am almost 48 hours after shot, still sore on left side, and tired.
Information has been received from a registered nurse concerning an approximately 35 month old male patient who on 07/11/2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#639778/0981L).  In February 2004, the patient had a breakout of chickenpox.  Unspecified medical attention was sought, but treatment was not required.  Subsequently, the patient fully recovered.  A product quality complaint was not involved.  Additional information is not expected.
neuro sx 2mo p/vax;fainting, tingling in hands & feet which progressed to losing function in legs & inability to write or use computer keyboard;couldn't rise to standing position, could move arms but couldn't use hands;dx GBS;numbness;rash
NO ADVERSE EFFECT; Patient received the first and second doses of gardasil 9 on unspecified dates when she was 19-year-old and at 24-year-old was on the office for the third dose of gardasil 9.; This spontaneous report was received from a medical assistant and refers to a 24-year-old patient, gender was not reported. Patient's concurrent conditions, medical history, concomitant medications, drug allergies or reactions were not reported.     On an unspecified date in 2014 (reported as when the patient was 19-year-old), the patient was vaccinated with first and second dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and on 04-JUN-2019, the patient went for the third dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, administration route, lot number and expiration date was not provided) for prophylaxis. (inappropriate schedule of product administration). No adverse events were reported. At the reporting time, the event outcome was unknown.
My husband and I both experienced shills, fever, nausea, loss of appetite, headaches, multiple trips to urinate, redness and soreness at site of injection the entire nite and day following our injections on 6/8/19.
no adverse event; administration of VARIVAX via the intramuscular route instead of via the subcutaneous route; This spontaneous report was received from a medical student (pharmacy intern) referring to an unknown age and gender patient. Pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 08-JUL-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot #U015686, expiration date: 18-MAY-2023) for prophylaxis (strength was not provided) via intramuscular instead of subcutaneous (incorrect route of product administration). No additional adverse event (no adverse event) was reported.
Aside from feeling rundown for a couple of days after shot, about 1 week after 1st vaccine: small red itchy bump about 1 inch below the vaccine site. It was on/off/on, lasting for weeks. Didn't think there was a connection then. 5/4/2021 VACCINE #2 Pfizer lot EW0173, State DHHS clinic at Mall: small red itchy bump still active. 11/17/2021 VACCINE BOOSTER #1 Pfizer lot FH8841 Pharmacy, 217 Highway,  week of 12/25/2021 new itchy red bumps plus blotches on trunk and extremities. Home remedies didn't resolve it, and I found a raised ring on left ankle (no itch or pain),  contd
miscarry her baby; vaginal bleeding; back pain; difficulty breathing; body began to shake; felt like passing out; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 29Aug2021 (Lot Number: FF2588, at the age of 37-year-old) as single dose for covid-19 immunisation. Medical history included pregnant at time of vaccination, non smoker and non-alcoholic. The concomitant product included prenatal vitamins. There were no other vaccine in four weeks. There were no covid prior vaccination. There were no covid tested post vaccination. Within one to two hours after the vaccine on 29Aug2021 patient felt like passing out, difficulty breathing and her body began to shake. Patient was pregnant at the time. She was previously healthy with no existing health conditions. She did not smoke, drink, or use drugs. At 24 hours post vaccine on 30Aug2021 she began to miscarry her baby. She had severe back pain with vaginal bleeding. This continues as of today. Treatment for events included blood work, intravenous (IV) fluids, and monitoring. The events resulted in emergency room/department or urgent care. Last menstrual date was on 23Jul2021. The mother was due to deliver on 29Apr2022. Gestational period was 5 weeks. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning her 17 week old niece with no known pertinent medical history and drug reactions/allergies who had been vaccinated with a first dose of ROTATEQ (lot# not reported) at 8 weeks of age. A couple of days after the first dose, the patient developed slight, sporadic rectal bleeding. On 21-JUL-2010, the patient was vaccinated with a second dose of ROTATEQ (lot# not reported). On 21-JUL-2010, immediately after receiving the second dose (reported as "in the evening"), the baby had blood in the stools; the bleeding has continued and she had passed two clots, clots ranged from pea to dime size; in the week preceding this report, there were clots every day and seven BMs without pus per day. No other significant symptoms; baby was sometimes irritable and sometimes looked like she had gas pain. Initially it was thought there was a milk allergy, so diet was changed and baby continued with breast milk; allergy testing came back negative; blood work showed an increased AST (56) and an increased potassium level; baby now was on a "special formula". Colonoscopy performed on 25-AUG-2010; according to the registered nurse, the physician said the results were the "worse he had seen in 30 years"; biopsy results pending. She had been diagnosed with severe ulcerative colitis. Unspecified medical attention was sought. The patient did not recover from severe ulcerative colitis. On 27-AUG-2010, additional information was received from a licensed practical nurse who added that the first dose of ROTATEQ was given on 21-MAY-2010, lot # 665272/0203Z, along with a dose of PREVNAR, PENTACEL, and a dose of hepatitis B virus vaccine (thimerosal free), lot# 666183/1481Y. The second dose of ROTATEQ was administered on 21-JUL-2010, lot # 668213/0512Z, along with a dose of PENTACEL. It was reported that the baby was recently placed on Nutramigen formula. The condition was not disabling or life threatening. Additional allergy testing would be done in three months. In a note from the pediatric GI, the event was suspected to be either allergic colitis or lymphoid nodules in the colon caused by the ROTATEQ. Pathology report was not yet back from the colonoscopy. Upon internal review, rectal haemorrhage was considered to be other important medical events. The reporter requested lot checks for ROTATEQ. A lot check has been initiated. Additional information has been requested.
Shingles outbreak on upper left lip and face, extreme ear and facial nerve pain, burning and tingling, migraine for 4 days, and severe fatigue for 7 days
Approximately one month after my booster, I developed a raised rash that has not subsided. It is itchy and travels around my body reappearing all day. Sometimes they appear as straight lines, sometimes round patches accompanied by itchiness and sometimes my skin feels hot and like it is burning. It is the worst at night time and first thing in the morning. I do not itch AT ALL to see if they will go away and not worsen..... they still reappear. It has been 2 months now and no changes even with allergy medication.
Client was vaccinated with Moderna vaccine for Covid on February 1 and Feb 28, 2021 at clinic.  Became symptomatic for Covid and tested positive PCR on 8/24.  Symptoms: feverish, sweating, fatigue, cough.  This case being reported as a breakthrough Covid case in a fully vaccinated person.