chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it felt like she had the flu.; there was a red bump and the area was swollen for a week after.; there was a red bump and the area was swollen for a week after.; Sick; vomite; Aching; having no energy; sleeping all day; This case was reported by a consumer via patient support programs and described the occurrence of sickness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on 2nd January 2019, refer case US2019AMR106750).   On 29th April 2019, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness, vomiting, pain, asthenia, somnolence, injection site swelling and injection site erythema were recovered/resolved and the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the sickness, vomiting, pain, asthenia, somnolence, influenza-like symptoms, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient called and advise that the shingrix medication made her sick.  The patient stated that she had been vomiting, aching, having no energy, sleeping all day and the symptoms lasted 1 and half days.  The patient felt like she had the flu. The patient stated that where the pharmacist injected the vaccine, there was a red bump and the area was swollen for a week after.  The patient also stated the same thing happened both times she received the injections.
Pt admitted for severe sepsis and septic shock. Pt also had UTI, right foot diabetic ulcer and osteomyelitis. Pt was positive for COVID with mild symptoms.
Day 8, woke up with very itchy arm around injection site. As the day wore on rash appeared around injection site and my arm swelled up.  No symptoms before day 8 other than a sore arm for a day or so.
experienced the predicted side effects; additionally experienced a painful burning sensation in my internal organs that lasted for days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (experienced the predicted side effects) and BURNING SENSATION (additionally experienced a painful burning sensation in my internal organs that lasted for days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE EVENT (experienced the predicted side effects) and BURNING SENSATION (additionally experienced a painful burning sensation in my internal organs that lasted for days). At the time of the report, ADVERSE EVENT (experienced the predicted side effects) and BURNING SENSATION (additionally experienced a painful burning sensation in my internal organs that lasted for days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Joint Pain; joint pain felt low; Headache;  headache wasn't down; Nausea; Feeling unwell/I feel lousy; Muscle Pain; muscle pain is much worse; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: ER8731; Expiration Date: 30Jul2021) as single dose for COVID-19 immunisation. The patient medical history included a back issue, but nothing really, overall, patient was pretty healthy. The patient's concomitant medications were not reported.  The patient previously took oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET) for back pain (pain reliever for back) and the dose was 5 to 325 mg. It was reported that possible side effects were muscle pain, joint pain, feeling of unwell, headache, all of those symptoms applied to patient. Patient had not taken anything. Patient just woke, yesterday (14Apr2021) patient felt lousy, the pain in the muscle drop (voice breaking) and he woke up this morning (15Apr2021) and that was when the headache was not down and the muscle pain was much worse, the joint pain felt low, nausea. No treatment was received for the events. Outcome of the events was unknown.  No follow up attempts are needed. No further information is expected.
Approx 18 hrs p/vax pt noticed "ball on lt deltoid @ inject site; 4 days later there was a raised red itchy area extending down the arm 15 cm by 12 1/2 cm 3.5 days p/pt began taking DPH; next AM itching was resolved & reddened area better;
Starting day of, fever of 102, lasting 2 days, despite taking Advil throughout. Chills, fatigue.  The next day, started experiencing BPPV.  This last 2 days. This was helped slightly  by Hallpike maneuver.   Sense of haziness, inability to concentrate/focus, irritable, difficulty sleeping, tired, which are all still here to the time of this reporting.
couldn't sleep; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (couldn't sleep) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, INSOMNIA (couldn't sleep) and HEADACHE (headache) outcome was unknown.            No Concomitant medications were reported.
hearing loss in her right ear; Vertigo; Lightheadedness; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm  on 22Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  On 22Mar2021, the patient experienced hearing loss in her right ear, vertigo, lightheadedness. The clinical course was as follows: Patient says she received her first dose of the Pfizer COVID-19 vaccine the 22Mar2021 and she has some questions. She says she had hearing loss in her right ear after the first shot which she got in her right arm. She says she also had vertigo, is that a side effect? She says she is still feeling lightheaded, and she has been taking Tylenol, and she doesn't know why her hearing went away. She says she also used some sweet oil that she sometimes used years ago like her mom used to use, to see if it would clear up. She asks is this a side effect and should she get the second dose? The outcome of the events was not reported.  Information on the lot/Batch number has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 03-JUN-2018, the patient was vaccinated with a dose of VAQTA (dose, frequency and route were unknown) lot # N031940 for prophylaxis. However, due to syringe malfunction, the vaccine leaked onto patient's skin and the patient did not receive 1/4 of the dose (underdose). It was specified that the VAQTA did not come from a prefilled syringe. No adverse effects were reported.
my underarm at my armpit is very swollen and over into my chest. my chest is starting to swell. my wife says she sees swelling in my arm and I feel soreness in my back. its all annoyingly painful. wife also sees swelling on the side of my face ( left side)
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted within 3 minutes of vaccine administration. He never fully lost conciousness and pharmacist was able to get to him promptly. Water was given and 911 was called to assist in checking the patient out to make sure further care and intervention was not needed. Patient returned home after and did not require further evaluation.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A211A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1-2 glasses/week) on 12-Jul-2020. Concurrent medical conditions included Subfertility. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-May-2020 to an unknown date, VITAMIN D [VITAMIN D NOS], IRON and OMEGA-3 [OMEGA-3 NOS] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Jun-2020 and the estimated date of delivery was 21-Mar-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 26-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2020, Pregnancy test: positive (Positive) Positive. On 07-Jan-2021, Glucose tolerance test: no findings (normal) No findings. On 03-Nov-2021, Ultrasound scan: no findings (normal) No findings.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.  Estimated date of conception was reported as 08-Jul-2021. The number of fetus was reported as 1 and prenatal care was established. There was no complications or acute illness during the pregnancy.
The next morning I woke up  around 6 am feeling ill and  exhausted. I had 101 fever all day. I finally felt better about 6pm. Very sore arm.
Patient comes in with chills, fever of 102 F, fatigue, sore throat, headaches x 1 day. Patient reports she had the Shingles vaccine on 8/18/21 and began having symptoms 8/19/21.
peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Information has been received from a RN concerning a 12 yr old white female with no known drug allergies who on 25Oct98 was vaccinated in the left arm with a first dose of varicella virus vaccine live (624449/1422E). There was no illness at the time of vaccination. On 14Apr04 the pt developed chickenpox. The pt's father reporter that her brother (WAES0404USA01707) has chickenpox and now the pt has them. The pt's father reported that no tests were done and there was no need to be seen. The nurse reviewed the varicella protocol. Follow up information indicated that the pt subsequently recovered with no ill effects. No further information is expected.
Ever since being vaccinated, my period has been irregular. I used to have a calendar reminder set for every 28 days, but it stopped being accurate after the second dose. My period is now unpredictable, sometimes going as long as 40 days between cycles. I thought I was pregnant twice due to the lateness.
After my first Pfizer dose I developed myositis ossificans. I was having trouble putting shirt and had to get help from my wife. This lasted for about 13 months. There are several ultrasounds for the diagnosis. Ultrasounds show the progression.
19JUL97 4 days p/vax 6" erythematous area was noted lt upper arm w/pain & warmth to touch;22JUL97 was seen by MD;tx w/med;4AUG97 erythema, warmth & pain resolved;
Testing positive for covid-19; Testing positive for covid-19; Pregnant; This is a spontaneous report from a contactable consumer (Patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 32-years-old pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection; Lot Number: EP6955) dose 2 via intramuscular route of administration, administered in Arm Left on 26Mar2021 12:00 as dose 2, single and first dose of bnt162b2 (BNT162B2, solution for injection; Lot Number: EL3248) dose 1 via intramuscular route of administration, administered in Arm Left on 05Mar2021 13:00 as dose 1, single (At the age of 31-year) for covid-19 immunization. Medical history was not reported. Concomitant medication(s) included ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromium nicotinate, colecalciferol, cupric oxide, cyanocobalamin, ferrous fumarate, folic acid, magnesium hydroxide, manganese gluconate, nicotinamide, Phyto menadione, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, selenomethionine, sodium molybdate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTIVITAMIN FOR WOMEN) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 12Sep2021 07:00 the patient experienced testing positive for covid-19 on sept 13, 2021, and pregnant. The mother reported she became pregnant while taking bnt162b2. The mother was 28 Weeks pregnant at the onset of the event. The mother was due to deliver. On 13Sep2021 the patient underwent lab tests and procedures which included sars-cov-2 test result was positive, Nasal Swab. The outcome of the event testing positive for covid-19 was recovering for and it was unknown for the rest.
Patient was given a 12+ Moderna 0.5ml vaccine instead of the 6mo-11year Moderna 0.25ml vaccine. Patient was monitored 15 minutes after, Mom was informed.  No reaction noted, mom states patient doing okay. Explained to call with any changes.
14:45 Patient returned to office after being discharged. Patient was shaking, cold, vomiting and getting hives. Benadryl given PO and on O2 for comfort. Hives progressed and another dose given PO. Medics called at 15:00 and patient was transported to hospital ER for evaluation. Medical records state vasodilateion, nausea, allergic reaction. msv
Information has been received from a health care professional concerning a 6-year-old male who was vaccinated with the first and second dose of hepatitis b vaccine (recombivax) on 13FEB96 and 19MAR96, respectively. pt recv vax 19MAR96 & 30MAR96 or 1APR96 pt exp flu-like sx, fever of 102-103 & myalgia;pt exp pain & weakness in legs, could not walk properly;dx w/influenza & myositis;By 8APR96 all sx had resolved; This is in follow-up to report (s) previously submitted on 3/6/1997. Initial information has been received from a health care professional concerning a 6-year-old male who was vaccinated with the first and second dose of RECOMBIVAX HB on 13-FEB-1996 (Lot not reported) and 19-MAR-1996 (Lot#618632/1534B), respectively. On 30-MAR-1996 or 01-APR-1996, the patient experienced flu-like symptoms, fever of 102-103.8 degrees and myalgia. He experienced pain and weakness in legs, and he could not walk properly. Unspecified medical attention was sought. No lab studies were performed. He was diagnosed with influenza and myositis. By 08-APR-1996, all symptoms had resolved. Follow up information was received from the patient's father. We noted that the patient had muscle weakness of his legs after the second dose of vaccine, which lasted 1-2 days and completely resolved without treatment. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center and was released by the regulatory agency. No further information is expected.
On 08/24/2000 the patient developed a rash consistent with erythema multiforme 3 days post-vaccination. The patient sought medical attention from a physician for diagnosis. It was noted that the event was self-limited with no sequelae. No further information is expected.
Body aches, fatigue, very sore bruise at injection site 18 hours after injection.  High fever (102+) and ear ache about 30 hours after injection.   Treated with Tylenol and sleep.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX vaccine (date of vaccination, lot# and route not specified) for routine health maintenance for the prevention of shingles. The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster in 2017. After receiving ZOSTAVAX the patient developed a painful rash accompanied by persistent pain. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt recvd vax 13JUN95 & 17JUN95 pt devel vomiting & a rash w/approx 15 lesions on feet;later pt devel full-body urticaria & a fever of 103; 19JUN95 pt skin was bright red over chest, body & legs & fever resolved;
Sore arm for the first few days after Friday vaccination. On Wednesday, a pinching feeling/heaviness under left breast, mild shortness of breath, and some dizziness .
Patient given DTaP #4 IM right thigh on 7/22/10, then developed 2 days later red papular macule, Pt moved during administration of vaccine & kicked her right leg. There was no needle stick administered in injury. The other 2 vaccines given in (L) thigh were done without incident - pt's (L) thigh is normal. Pt has tenderness red spot on (R) thigh x 5 days. Treatment - 7 day course of KEFLEX for cellulitis.
Approx 17 hours after vaccine, pt was observed shaking and coughing, c/o chills and SOB. Mild respiratory distress noted, pt was given a nebulizer treatment which was not effective. Vs were obtained and on call provider was contacted. Order for Solumedrol 125mg injection IM was completed. Pt was observed following the injection and was instructed to drink water and rest. Provider f/u in the morning. Pt reports he is feeling much better today. He reports he ate this morning, is awake and alert and oriented. Pt reports he has not been coughing and no longer feels short of breath. Reports he has some lingering muscle aches related to the vaccination, denies fever or chills, nausea or vomiting. Tylenol for Myalgia
Noticed red ea under left arm pit which enlarged about 6 inches down body at woest point. little itch an small blisters which secreced bront liquid noticed on undershirt for about two weeks. gradually stopped and redness slowly subsided. Little discomfert.  first belived it might be caused by deoderant, but lasted after that was stopped. Had shingel shot. As no discomfort did not seek medical advice. Saw article which thought me thinking rash might have been result of vaccine. I can't come up for another reason for the rash.
Patient had weakness in both feet and legs 2 days following HPV injection.  weakness and fatigue have progressed.  Patient also had viral symptoms the following week and a low grade fever.  He was tested for strep and COVID 9/25 with negative results. He continues to have fatigue, and weakness. Labs have been negative for mono, CMV, and ana, rheumatoid factor, CMP, CBC,  all remain basically wnl.   LUQ mass palpable on exam 9/27/23 consistent with spleen enlargement, US ordered,  test has not yet been performed.
Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient reported that got second dose of bnt162b2 yesterday (09Jan2021) and now the patient had fever in Jan2021, patient wanted to know if its okay to take paracetamol (TYLENOL) or fever reducer or no. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Acute onset of raised rash with central clearing and itching and fever; consistent with erythema multiforme.  Treated with oral antihistamines and fever reducer.