chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hip joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Mar2021 14:30 (Lot number: ER2613) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 1993, stop date: 1996, notes: Stop Date-1996, Pertinent details: Jan-1996; "Chronic back pain", start date: 2003 (ongoing); "Mastectomy", start date: Jan1996 (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for hypertension (ongoing); LOSARTAN taken for hypertension (ongoing); ROSUVASTATIN taken for blood cholesterol abnormal (ongoing). Vaccination history included: Bnt162b2 (Dose-1, Administration time-15:30, Anatomical site of injection-Right upper arm, Route of administration-Intramuscular, Batch/Lot No-DN6200), administration date: 22Feb2021, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 23Mar2021, outcome "recovered" (26Mar2021), described as "hip joint pain". Therapeutic measures were not taken as a result of arthralgia.  Additional information: no prior vaccinations.  No follow-up attempts are possible. No further information is expected. No relevant tests done.  Follow-Up (05Nov2021): Follow-up attempts are completed. No further information is expected.
1st dose on 12/31/20, developed itching and rash under arms and across abdomen (minor) did not associate with vaccine. 2nd dose on 1/28/21 within 2 hours, itching and hives under arms and across abdomen, worsening over last 4 days, now going down inside of legs and upper abdomen
At 6:30 p.m.  I began with palpitations of heart, lasted about 90 minutes.  The palpitations were intermittent.   The night and next day I had musculoskeletal pains, and tiredness.  The primary thing I would like to report is that starting on Saturday, Feb. 13th around 8 pm, I began with a cold sore, or fever blister of upper lip. Over the course of the next 24-36 hours, I developed at least 4 more fever blisters. I am not prone to fever blisters, and have never in my life had more than one, infrequently. They are on upper and lower lip, and one is even immediately below my lip, on my skin that is not mouth mucosa. They are painful .
I broke out in about 4 large hives on Sunday after receiving my shot on Wed.  I have had hives everyday since, sometimes one and sometimes as many as 4.  They itch and Benadryl helps.  It has been a week since they began and although these are not bad I wonder if when I get my second dose if they will worse.  I have never in my life had hives.
not known adverse event; a patient received an expired dose of M-M-R; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided.  On 05-DEC-2019, the patient was vaccinated an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA, lot # N034411, expiration date 04-DEC-2019 (dose and route of administration were not provided) for prophylaxis. No adverse event was reported.   The outcome was unknown.
Reported cause(s) of patient death: Heart failure; chills; fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) at the age of 59-years-old, via an unspecified route of administration in left arm on 17Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included congestive heart failure, diabetes, and high blood pressure. He has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included olmesartan medoxomil, furosemide, repaglinide, metformin, amlodipine, atorvastatin, carvedilol, hydrochlorothiazide, and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced chills, fever, and heart failure on 18Mar2021. The events resulted in emergency room/department or urgent care, doctor or other healthcare professional office/clinic visit, and hospitalization for 8 days from Mar2021 to Mar2021. He eventually passed away on 31Mar2021. Treatment received for the events was reported as unknown. The patient underwent lab test and procedure which included nasal swab for COVID which was negative on 20Mar2021. The outcome of the events chills and fever were unknown. The patient died on 31Mar2021. The cause of death was heart failure. An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Heart failure
Severe myalgias of L shoulder, neck,. SOB and sore throat with inability to complete household activities. Symptoms developed about 24 hours after injection and lasted for about 6-7 days. She required ibuprofen and acetaminophen to make pain tolerable
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No medical history or concurrent conditions were provided. On an unknown date in December 2013, the patients were vaccinated with oral ROTATEQ (dose, route and lot numbers were not provided). No co-suspect or concomitant therapies were reported. The registered nurse reported that the oral ROTATEQ administered to the patients had been improperly stored. The registered nurse was unable to confirm the exact number or identities of the patients involved at the time of the report. No adverse effects were reported. This case is linked to cases MARRS # 1402USA010128 and MARRS # 1402USA010129 (same reporter link). Additional information has been requested.
Dx in SEP93 w/large cell lymphoma of abdomen; recvd 3 courses of chemotherapy; 08OCT93 recvd vax; 28OCT93 exp weakness & skeletal pain; fell several times; admitted to hosp 29OCT93, dx of rule out GBS;
MA accidentally mixed vaccine with diluent meant for varicella. Patient has no adverse reactions reported.
Low blood pressure that persists to today 4/8/2021.  Systolic BP in 80s - 110.
skin started peeling off my hands and feet on day four post shot. I had a sore arm for two days which resolved quickly and my temperature spiked 1.5 degrees 18 hours after the injection and resolved in four hours
This spontaneous report was received from a other health professional refers to an unspecified patients of unknown age and gender. On 02-AUG-2014, doses of RECOMBIVAX HB were exposed to an unsupported temperature excursion of -1C for "5 to 16 hours". On an unspecified dates since 02-AUG-2014, RECOMBIVAX HB (lot # J012567; expiration date 30-JAN-2016) (dose and route were not reported were administered to unspecified patients. No adverse effect has been observed or reported.  Follow up has been received from a pharmacist on 14-OCT-2014 concerning 12 patients. For the 7 patients demographics was updated. This is one of several report received from the same reporter.   Follow up has been received from a pharmacist on 20-OCT-2014 concerning a patient of unknown age and gender. The reporter provided another RECOMBIVAX HB lot number J012520, expiration date: 30-JAN-2016 that was improperly stored and would have been included in the original report. Additional information has been requested.
4/26/20 - Patient came in to pharmacy and stated that after he went home from receiving vaccine on 4/24/20 he developing swelling upper arm, felt tired and arm was hurting. On 4/26/20 he reported swelling had extended to elbow. Advised to go ER. Called Dr. office told pt had ar to vacc on 4/24/20
Patient complaints of "allergic reaction" s/p receiving second dose of SHINGRIX vaccine on 3/25/2018.  Patient states she noted a pruritic rash to her face and chest that she "thought was pimples" on 3/27/18. Patient also reports of onset of headache, fever, chills, and tachycardia started the evening of 3/25/18 and that which lasted until 3/26/18. Patient states she has taken Claritin and Cortisone cream for her symptoms, and has reported her symptoms to GlaxoSmith&Kline. On exam patient without signs and symptoms of distress. Exam unremarkable except for a rash present: multiple small pinpoint erythematous prutitic maculopapular pustular rash present to left mandible, extending to left upper lip, close to left nare. 2 small pinpoint erythematous maculopapular rash to right maxilla. 1 small pinpoint erythematous maculopapular rash to left upper chest present. At visit complete, patient sent  home with recommendations to return to clinic in 24 hrs; instructed to go to ER or Urgent Care center if symptoms worsen, and instructed to go to Opthalmology immediately if rash extends to eye or eye becomes reddened or painful.
This spontaneous report was received from a medical assistant concerning an approximately 59 year old female patient with no drug reactions/allergies. Current conditions of the patient included asthma and osteoporosis. The medical history of the patient included shingles on forehead on 11-JUN-2013. On 06-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J002241 and 21-MAy-2014 respectively), subcutaneously in the right arm. Concomitant therapies included ADVAIR, ACTONEL, and VAGIFEM. On 09-SEP-2013, the patient was diagnosed with lesions at the injection site of the right upper arm. The patient sought medical attention (office visit). It was unspecified if any treatment was provided. No lab tests were performed. The chart dictation for the office visit was pending. The patient was not recovered from the event. The relatedness for the event was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information has been requested.
Patient receive COVID vaccine Pfizer 2 dose series on 3/5/21 and 3/26/21. On 8/11/21, patient presented to our facility with 2 days history of fever and generalized weakness.  He was admitted for acute stroke with hypoxia due to COVID pneumonia. Patient discharged home on 8/13/21 in stable condition.
Initial misuse report received from a healthcare professional on 03 February 2014. A patient had received a dose of DAPTACEL that was expired 5 days ago, on an unspecified date. No adverse event was reported. List of documents held by sender: none.
devastated and sad; back injury; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK INJURY (back injury), DEPRESSED MOOD (devastated and sad), FATIGUE (Fatigue) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma (8 year history). Concomitant products included MULTIVITAMINS [VITAMINS NOS], ROSUVASTATIN CALCIUM (CRESTOR), BUPROPION HYDROCHLORIDE (WELLBUTRIN), AZELASTINE and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (Fatigue). On 29-Jan-2021, the patient experienced HEADACHE (Headache). On 13-Feb-2021, the patient experienced BACK INJURY (back injury). On an unknown date, the patient experienced DEPRESSED MOOD (devastated and sad). The patient was treated with PREDNISONE on 19-Feb-2021 for Back injury, at a dose of 5 milligram and PREDNISONE from 17-Feb-2021 to 18-Feb-2021 for Back injury, at a dose of 10 milligram. On 30-Jan-2021, FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. At the time of the report, BACK INJURY (back injury) and DEPRESSED MOOD (devastated and sad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial report received on 14/Feb/2006 from a physician. A 17 year old female patient with a concurrent viral illness with cough had received an administration (route and site not reported) of Menactra, lot number U18592AA on 09/Feb/2006. Two days later, she developed a low grade fever, headache, local reaction and rash. She was treated with Zyrtec and Tagamet. The patient had not recovered from these events at the time of this report.
A report has been received from a Health Professional concerning a 1 year old, Female subject, who had been received Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that the patient experienced 21 month old female received FLUMIST which started on 24-Oct-2014. The outcome of the event of 21 MONTH OLD FEMALE RECEIVED FLUMIST is unknown. The reporter was considered to be non-serious.
Systemic: pt had lipschutz ulcer-Severe, Additional Details: patient got flu shot not covid. Had a headache and fever(flu-like symptoms) for 2 days. Then had extreme pain and ulcer on vagina. Patient went to the doctor and was told she had lipschutz ulcer and was screened for cancer. Unknown if the vaccine triggered the response at this time.
First I noticed a red spot on my son's face and then he ran a fever in the afternoon before his afternoon nap. While I was changing his diaper I noticed red spots appearing in front of his body, stomach region and a large blister on his anus.  The next day blisters started appearing more at least 5 spots. There was a blister with fluid on it on his back. The following day that was when I decided to call to get him in to the ped's office because more blisters where forming all over his body and he had a low grade temperature. At least now 50 blisters on his body by the 3rd day 7/9/2015.  No treatment was given by the ped's office.  Was told that the illness is mild chickenpox outbreak due to the vaccine and should resolved in a week.  By the evening, more blisters appeared (at least 50 plus blisters on his face).  Blisters have been forming at the strangest places.  Terrible.  My son wasn't able to sleep at night and he has been itchy all over.  Today, I have given him bath in the morning and bath last night before dinner. Now, I am making a report on the adverse reaction to the MMRV vaccine my son received 3 days ago on 7/7/2015 at his 12 months well check.  Please advise what action will be taken.  Thank you.
Adverse event was contraction of COVID 3 months after 5th injection. Initial symptoms were mild body ache and fever of 101. My physician prescribed Paxlovid, which I began the day after the positive test. Fever was short-lived. There was some heavier coughing than usual and some nasal congestion. Possibly some fatigue. I possibly am more fatigued still, but cannot say that is an aftereffect, since I am sometimes sleep deprived. I also am able to walk up to five miles a day and can climb several flights of stairs without difficulty. I feel that being fully vaccinated and taking a retroviral possibly mitigated symptoms and am grateful it was not worse.
Patient noticed a yellow tinge (similar to yellow mark left behind from Iodine tincture) that radiated down her arm up to elbow. She noticed it 2 days after shot but does not feel pain or discomfort - Unable to reach patient since phone number is not valid. It seemed to be getting better when she came in to show us.
30 minutes p/MMR HR 38, lost consciousness, taken to ER, hypotension, required 3 liters lactated ringers before postural hypotension began to resolve; also treated w/epi
Pregnant at the time of vaccination?: Yes/is pregnant: Yes; Pregnant at the time of vaccination?: Yes/is pregnant: Yes; Pregnant at the time of vaccination?: Yes/is pregnant: Yes; some tenderness at injection site day of; This is a spontaneous report from a contactable consumer. A 28-year-old female patient  received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient was pregnant and gestational period was 34 weeks. On an unknown date, the patient experienced some tenderness at injection site day of. No treatment was received for the events. The outcome of the events was unknown.  Information about lot/batch has been requested.
pt was given vax by MD who recommended that pt receive a tetanus booster, no hx of booster since military service pt felt pain immediately up receiving inject & pain has persisted for 1 yr w/numbness in rt arm;
ACHES AND PAINS; HEADACHE; EXTREME EXHAUSTION; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the patient experienced aches and pains. On 06-MAY-2021, the patient experienced headache. On 06-MAY-2021, the patient experienced extreme exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains, headache, and extreme exhaustion on MAY-2021. This report was non-serious.
Patient was given vaccines on 10/31/06, patient had a seizure while at school on 11/1/06. she was unconcious for about 2 minutes. She was then seen at clinic on 11/2/06.
within 3 hours body aches, chills, SOB, severe headaches, vertigo, hives all over body
Headache and dizziness right after the shot. Upset stomach, tiredness, and muscle aches at 7:30pm. Vomiting and diarrhea every 30min from 8pm to 5am. Fever started at 1pm the next day. Body aches and joint aches continue.
Headache; Muscle ache; Fever; Chills; Painful redness in her left arm where she received the vaccine; painful redness in my left arm where she received the vaccine; Malaise; Rash and redness; rash and redness; she might be allergic to that product; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was none. There were no concomitant medications. The patient was next in line to get the COVID vaccine but has a little concern about the COVID vaccine. When she got the PREVNAR 13 shot she had all the side effects, she got it 2 years ago (unspecified date). She reported fever, chills, malaise, pretty much almost all the side effects listed. She had a headache, muscle ache in her right thigh, fever, chills and painful redness in her left arm where she received the vaccine. Her doctor said she might be allergic to that product. She asked her doctor about the ingredients for the COVID but the doctor didn't know any of the ingredients so she wanted to call us to find out if the same ones in the PREVNAR 13 are found in the COVID vaccine. The reporter explained the side effects of fever, chills, and malaise lasted a day or two and resolved. She also had a rash and redness which lasted longer. They did all go away eventually but she doesn't remember how long it took or what she did to treat. She knew she did not get a prescription. She thought Tylenol was taken but doesn't remember what else, she mentioned maybe Benadryl. She did go back to the doctor's office, nothing was done, just told to take some over the counter products but she doesn't remember what. The first day she was kind of worried. The outcome of the events headache and muscle ache was unknown. The outcome of the events was recovered on an unspecified date.  No follow up attempts are needed; information about lot batch number cannot be obtained.
Chronic urticaria and dermatographia. Persistent Hives, painful rashes, wheals, itching all over head, face, neck, torso, limbs, hands, and feet since 12/20/21.
couldn't stop urinating; lost of feeling; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (couldn't stop urinating) and FEELING ABNORMAL (lost of feeling) in an 84-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 prophylaxis.     Concurrent medical conditions included Breast cancer and Allergy (Allergic to suffer).    On 13-Sep-2022, the patient received fifth 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 POLLAKIURIA (couldn't stop urinating) and FEELING ABNORMAL (lost of feeling). At the time of the report, POLLAKIURIA (couldn't stop urinating) and FEELING ABNORMAL (lost of feeling) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. Patient had received monovalent dose 3 on 31-Aug-2021, lot number 045LZ1A and dose 4 on 17-Mar-2022.  No treatment drug information was provided.   This case was linked to MOD-2023-733251 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2023: Follow-up received, updated the events.
Child develop severe low back pain within several hours of first rabies imm. 16 hrs after imm. transient confusion LBPx2 days. 3rd shot within minutes developed flank and low back pain, nausea, penile pain lasted x24 hrs. 2nd shot-severe LBP and flank pain. Doubled him over lasted x24hrs. 3rd injection redness and swelling at injection site.
Tingling in fingers, hospital visit, diagnosed as Guillain-Barre. This was reported by human resources for the employer.
Irregular menstrual cycles after the 1st dose of COVID-19 Pfizer vaccine.  1) First cycle after the vaccine was supposed to start on May 14th. Instead, it started  3 days early, on May 11th. 2) Second cycle started 4 days late, on June 12th, instead of June 8th. 3) Third cycle started on June 25th, within 2 weeks of the previous cycle.
A pharmacist reported that her 3 year old son received 23-valent pneumococcal vaccine on 5/8/01. That evening, the child developed a "low grade" fever of 100F-101F, as well as, pain at the injection site. By the evening of 5/9/01, the child had a fever of 104F with swollen glands. He was treated with Tylenol and Motrin. On 5/10/01, the child was seen by the physician and was subsequently, treated with Augmentin. An unspecified strep culture, taken the same day, was reportedly negative. As of 5/11/01, the injection site pain had resolved, but the fever and swollen glands persisted. The reporter indicated that the child had a cold a "few weeks ago" and that his glands were "slightly" swollen prior to vaccination. Follow-up information received from the reporter on 7/2/01, indicated that a "blood test" for Epstein-Barr virus was positive. The reporter considered the event to be unrelated to 23-valent pneumococcal vaccine administration.
Coronary artery bypass grafting x3 - left internal mammary artery grafted to LAD and reverse saphenous vein grafts placed to diagonal and right posterior descending coronary arteries on cardiopulmonary bypass. The patient was discharged on ASA, statin and beta blocker therapy. Plavix was added by CT surgery post-op and should be continued for one year (smaller targets). ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Patient was over the age of 12 but received age 5-11 dose for second dose
Prolonged (over 3 hrs) crying/screaming spell on evening of day of vax 5FEB91;