chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate pain at the site of injection that appeared 8hrs after the injection and lasted for 48hrs; This is a spontaneous report from a non-contactable Consumer. This 37-year-old male consumer (patient) reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at single dose for COVID-19 immunication on 20Jan2021.  Relevant history was none. No known allergies. Relevant concomitant drug was none. The patient experienced moderate pain at the site of injection that appeared 8hrs after the injection and lasted for 48hrs. No treatment was received. Outcome of the events was resolved. The patient did not received other vaccine in four weeks. The was not been diagnosed with COVID prior vaccination. The patient did not have COVID test post vaccination.    No follow up attempts are possible. No further information is expected.
Patient received PENTACEL. Immediately had a large amount of swelling. Right vastas lateralis.
10/5/11 Flu vaccine given IM/Rt deltoid. 10/6/11 she noted approx. 1" firm area at injection site with redness  heat (approx 50 cents piece size). 10/7/11 redness now about quarter size. Noted slight itching.
42 days might pass; Patient only 17-years-old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17-years-old) and PRODUCT DOSE OMISSION ISSUE (42 days might pass) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17-years-old). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (42 days might pass). On 14-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17-years-old) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (42 days might pass) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up received on 21-April-2021.updated event
Red, warm raised area 8cm x 7cm on Right arm deltoid area where Adacel was given.
pt recv vax & arm was feeling sore & pt had limited mobility p/vax;pt had a hard time lifting arm up over head;tingling down the arm;pt seen by MD & given med;
This is one case out of a cumulative total of 17 cases received during the surveillance period from 01 January 2010 to 25 March 2011. Initial report received on 25 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance. The subject's vaccine history included one dose of PENTACEL (lot number not reported) received on 19 February 2010, and three prior doses of DAPTACEL; lot number C2958BA received on 05 December 2008, lot number C2957AA received on 19 September 2008 and lot number C2951BA received on 25 July 2008, (routes and sites of administration not reported). The subject developed cold-like symptoms and on 20 January 2011, approximately 11 months after the last dose, developed a cough. On 14 February 2011, the subject developed a paroxysmal cough with a whoop and posttussive vomiting. The subject also experienced sleep disturbance. It was unknown if she experienced apnea. Laboratory testing included negative PCR on 05 March 2011, but the case was epidemiologically linked to a laboratory confirmed case. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of AUGMENTIN/CE starting on 16 February 2011 (duration of treatment not reported). The subject was not hospitalized. At the time of final contact on 10 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 50 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Extreme fatigue, loopiness, slight vomiting in first two days but not since, shaking hands (happened on two days, was worse in the mornings but improved as day went on), cold sweats.
Itchy bumps/rash on legs and torso, but significantly worse on legs.  It?s now been 7 days.  For first 4 days I took Benadryl daily to help with itching. Have now stopped as it?s somewhat better however bumps still there and itchy only at night.
Pt recv vax on 4/14/99; on 4/16/99 pt exp crying, red vax site; tx=Keflex
I experienced complete body aches and joint pains. I kind of just felt like something was wrong, I didn't have a lot of energy, I just felt bad. I lost my appetite. I lost some weight as well. I kind of had nausea. My hands swelled up at the time of my hands. It popped up so much at the time of my hands, it looked like little kids hands. My fingers were all weird. It was hard to bend my hand in a fist. It's still a big problem on my right hand. My middle knuckle turned kind of pinkish. My shoulder blade causes pain as well. That is gradually getting better, but pain is still present. Rheumatologist gave medication for the joint pains.
This spontaneous report was received from a Registered Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 16-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA lot number reported as M005274, expiration date 03-APR-2018 (dose was not reported) for prophylaxis. The temperature reported was 33 grades Fahrenheit for 22 hours. It was not prior temperature excursion, and a data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002271: Original Case : 1706USA002271.
pt stated woke up @ 1AM vomiting; arm had red welt did not come into ofc until 4JUL95; had a red welt 55cm;
Fever, headache, sore throat, persistent cough, difficulty breathing, fatigue, congestion, itching. Treatment: antibiotic, cough meds, analgesic, inhaler.
Major arm soreness at injection site for 2 days; Nausea for 2 days; Intermittent headache; Fatigue for 1 day; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 23Dec2020 14:30 at left arm,  at single dose for covid-19 immunization. The patient medical history was not reported, previously healthy, no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced Major arm soreness at injection site for 2 days, Nausea for 2 days, Intermittent headache, Fatigue for 1 day all from 24Dec2020 07:30 AM. No treatment was received for all events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
pt recvd vax;sore throat,hives 3 days p/vax;redness at inject site;resolved p/ tx w/ dph;28feb94 f/u: indicated on form that im vax used to adm ID dose;no lot # listed;event stated as:3 days p/ vax, pt devel generalized urticaria,tx w/ dph
The patient looked at his foot and noticed the worms were gone; chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (The patient looked at his foot and noticed the worms were gone), CHILLS (chills) and FATIGUE (Fatigue) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ringworm of foot (on the bottom of the foot for almost 20 years), Joint pain and Allergy. Concomitant products included GLUCOSAMINE for Joint pain, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced CHILLS (chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (The patient looked at his foot and noticed the worms were gone). On 30-Apr-2021, CHILLS (chills) and FATIGUE (Fatigue) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (The patient looked at his foot and noticed the worms were gone) outcome was unknown.            Concomitant medicine includes histamine for allergy Patient reported a positive event he experienced after receiving the Moderna Covid-19 Vaccine that 2 months after receiving the second dose, the patient looked at his foot and noticed the worms were gone. The patient experienced some chills and fatigue which started 6 hours after receiving.  No treatment information were reported by the reporter   This case was linked to MOD-2021-414609 (Patient Link).
couldn't lift both arms and both legs; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (couldn't lift both arms and both legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.   Concomitant products included GABAPENTIN for Neuropathy, Blood pressure and Thyroid therapy.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSKINESIA (couldn't lift both arms and both legs) (seriousness criterion hospitalization). The patient was hospitalized from sometime in March 2021 to 06-Apr-2021 due to DYSKINESIA. The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) at an unspecified dose and frequency. At the time of the report, DYSKINESIA (couldn't lift both arms and both legs) outcome was unknown.  Patient was having physical therapy due to too much of antibodies (unspecified) were damaging patient's muscle. The patient was hospitalized for 12 days.  Also patient was taking 2 infusions with rituxan caller does not know how to spell Rituxan, actual medicine could not be confirmed.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
C/O heart racing,flushed vital signs monitored, Benadryl offered patient refused
This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011269: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.
Was notified by patients husband that his wife originally received the Pfizer vaccine- He wanted her to have the booster shot and she received the booster of Moderna. Patient became  very sick. Per husband she developed cough and became very weak. She fell down a couple days after dose due to weakness. Patient passed away 2 weeks later. Was told by corner that wife had massive heart attack but he feels it was due to booster shot.
Bump, 1 x 1 inch palpable, not tender.  Skin not drained.
erythema & induration on both thighs @ the site of inj;DPH & cold compresses;
This patient presented to clinic to receive her second COVID-19 vaccine on 06/22/2021. The vaccine the patient was administered was first punctured 6/15/2021. This resulted in the patient being administered an expired vaccine. The patient has been monitored since time of administration and has had no adverse effects.
Paresthesia in face and limbs, fasciculations in all muscle groups, internal tremor, exercise intolerance; episodes of tachycardia with activity; This is a literature report for the following literature source(s):  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "Paresthesia in face and limbs, fasciculations in all muscle groups, internal tremor, exercise intolerance"; TACHYCARDIA (non-serious), 4 days after the suspect product(s) administration, outcome "unknown", described as "episodes of tachycardia with activity". The patient underwent the following laboratory tests and procedures: Biopsy skin: Low small fiber density in distal leg; Skin fiber density distal leg: 0.5; Neurological examination: Normal.Clinical course was reported as the symptom at onset was elevated blood pressure and presyncope and in laboratory tests for EMG-NCV Mild ulnar and median sensory neuropathy, Autonomic testing: Low sudomotor response in feet was noted  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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-202200764439 Same article/patient different drug/event.
Pt developed knots on legs at injection sites. Pt was taken to ER after having rubbed left leg and knot started draining green drainage. When in ER 2 abscesses were found and drained at injection sites. Only 1 injection given on 5/26/00; the other injection site abscessed also and it was given on 3/18/00 and both were Hib/Hep-B vaccines. Child to see Pediatric surgeon on 7/13/00.
Patient had arm pain that got worse in the 48 hours after injection. Developed a hematoma and ended up being hospitalized for monitoring. Underwent some occupational physical therapy prior to going back to her apartment. She was back in her home on 10/17.
Retinol migraine six days post vaccination followed by several days of extreme fatigue; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took rheum palmatum (RHUBARB) and doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced retinol migraine six days post vaccination followed by several days of extreme fatigue. The event resulted in emergency room/department or urgent care. On 13Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was pending. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event retinol migraine six days post vaccination followed by several days of extreme fatigue was resolved with sequelae On an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
After 7 days from the jhonson and jhonson vaccine, I had the worse headache that had in my life with a pain level to a 8 level of 10 it last for 6 hrs. I took Excedrin to help relive the pain.
BODY ACHES, MUSCLE WEAKNESS. FIRST THREE WEEKS FATIGUE, DIFFICULTY BREATHING SPECIALLY WHEN TALKING FOR MORE THAN 20 MINUTES. 11/13/09 Medical records received for dates 9/2/09 to 11/10/09. OV 9/2 received gardasil vax dose 1. OV 9/10 wellness exam visit pap WNL. OV 10/9 pt c/o body aches, muscle pain, dizziness, SOB. DX: fatigue, dyspnea, impacted cerumen. OV 10/13 c/o SOB, allergies, fatigue. Referral given cardio/pulm eval. 11/9 pt called MD stated left side muscle weakness where gardasil vax given, difficulty breathing. 11/10 pt called MD stated sx resolved. Declined further gardasil vax.
Husband also took vaccine with no problem.  Very drastic.  Diarrhea, sore stomach, IMODIUM stopped it, & PEPTO BISMOL, helped her to evacuate.  Slept through.
Subchorionic hematoma; Vaginal bleeding; Maternal exposure during pregnancy; Sore throat; Sore arm; Fatigue; Headache; This solicited pregnancy report received from a consumer concerned a 38-year-old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 53.061 kilograms, and height was 168 centimeters.  The patient past medical history included COVID-19 infection prior to pregnancy and was diagnosed on 19-Dec-2020. The patient's history also included three previous pregnancies, of which two resulted in a live newborn and one ended with miscarriage. The patient had no history of exposure to drugs for recreational use, non-tobacco user, and abstains from alcohol. The first day of the last menstrual period (LMP) was calculated to be 10-Feb-2021. The estimated delivery date (EDD) was reported to be 17-Nov-2021. The type of pregnancy was singleton. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805070, expiry: Unknown) dose was not reported, 1 total administered on 19-MAR-2021 for COVID-19 immunisation. Concomitant medications included multivitamin or prenatal vitamin 4 to 6 times a week. The patient's body Mass Index (BMI) was 18.7. On 19-MAR-2021, after receiving the vaccine, patient experienced fatigue, headache, sore arm, sore throat and maternal exposure during pregnancy, On 25-Mar-2021, she experienced vaginal bleeding with large subchorionic haematoma (up to 3.1cm) and was evaluated day later without any findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 19-MAR-2021, sore arm on 21-MAR-2021, and fatigue, and headache on 20-MAR-2021, and the outcome of subchorionic hematoma, vaginal bleeding and maternal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and subchorionic hematoma, vaginal bleeding, sore throat, sore arm, fatigue, and headache as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and subchorionic hematoma, vaginal bleeding, and maternal exposure during pregnancy was not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211106386-covid-19 vaccine ad26.cov2.s-Subchorionic hematoma, Vaginal bleeding. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY   20211106386-covid-19 vaccine ad26.cov2.s- Maternal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
get really sick; Initial information was received on 28-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional (under reference number: US-SA-SAC20211103000726).  This case involves an adult patient with an unknown gender who got really sick (illness) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious get really sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "And every time I get it, I get really sick. So, I'm going to keep me safe."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.