chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complains of new onset of RIGHT sided facial swelling, CONSTANT DULL ACHE of RIGHT sided upper and lower jaw and teeth, LEFT hand swelling, LEFT HAND digit swelling, numbness and tingling of LEFT HAND and LEFT DIGITS, MOTTLED skin of LEFT palm, soreness and warmth to the touch of the local injection site (LEFT deltoid),
client called 11/08/2007 2:30pm to report reddeness from site of injection striking down arm and arm swollen and hard to use. Spoke to pt on 11/09/07, states seeing Dr on 11/08/07 at 4:00pm. Pt states MD said pt may have had allergic reaction on LA. Pt also told MD about numbing sensation on RA, pt states MD said pt may have pressure on nerve causing numbing sensation on RA. Pt states this is first time having this type of reaction after a vaccine. Pt states MD prescribe pain medication, states being able to sleep on arm and move without difficulty.
No adverse event. We are reporting because vaccination was recalled and we administered the vaccination after recall. However, later it was determined the vaccination was actually still in date
This spontaneous report as received from a office manager regarding several unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not provided. On or after 12-FEB-2015 at unspecified times, the patients were vaccinated with improperly stored GARDASIL lot # K001631; expiration date: 06-NOV-2016 and lot # K007828; expiration date: 02-MAR-2017. This is one of several reports received from the same reporter. Additional information has been requested.
I did not have an adverse reaction to the vaccine. On 06/24/2022, I developed a rash on the inner side of both arms. This has been going on for months. I have talked to my doctor about this, and I was told I am handling it the right way. The rash is mostly isolated to my arms, but it has been on my stomach. I drink ice water when the rash shows up and it will disappear. In 09/2022, the rash has turned to more like hives. Same thing as with the rash, it will just randomly show up and I'll drink some ice water and it will go away. It's not as itchy as it used to be.
Red, blotchy, rash-like mark on upper left arm at sight of injection. Mark spans approx. 4 inches horizontally and 6 inches vertically. Patient outlined marking in pen to monitor for spreading. As of 8:00am following morning (12 hours from when the marking was noticed), it had not spread.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 63 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications (no other medications in 2 weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course (including laboratory tests and procedures): Anti-viral details: COVID-19 treatment (Brand: Pfizer, Lot Number: GA5109) from 16Jun2022 to 20Jun2022. First bout of COVID resolved on 23Jun2022. Patient felt well 22Jun2022- Sunday 27Jun2022. She had a negative BINAX test on 24Jun2022. Bounce back COVID (from 26Jun2022 01:00 am; resulted in none of the above; not recovered; no treatment) was documented with positive BINAX test taken at 7:00 am on 27Jun2022. Prior night felt a little funny but no symptoms. Strong symptoms began on 27Jun2022 with fever up to 100.4, sneezing, runny nose, coughing, slight headache, aches. Symptoms somewhat better on 28Jun2022 fever sub normal, still have sneezing, cough, poor appetite. Oxygen 92-98.
pt recv vax;mom stated pt ran fever for 3 days p/ vax;seemed somewhat disconnected for 4 days;also stated to have a large "lump" at site of inject;
Patient given Hepatitis A vaccine on 03/23/05. On 03/24/05 patient had a fever of 103, screaming hysterically, delusional (complaining of spiders everywhere). This resolved in about 24 hours.
Arm Swollen and RED patch in a 2"diameter was givenn subcutaneous.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (muscle aches), HEADACHE (headaches/foggy like it kind of feels like a headache) and FATIGUE (still felt fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), MYALGIA (muscle aches), HEADACHE (headaches/foggy like it kind of feels like a headache) and FATIGUE (still felt fatigued). At the time of the report, PYREXIA (fever), MYALGIA (muscle aches), HEADACHE (headaches/foggy like it kind of feels like a headache) and FATIGUE (still felt fatigued) outcome was unknown. Patient stated that she visited her health care provider and they stated that she needed to build her immune system back up. She also stated that she has a good immune system and regularly take vitamins like zinc. However, she stopped taking these before the vaccine. No treatment information was provided. No concomitant medication reported.
3 days post vax pt exp lt deltoid pain & subjective swelling of hand then on 13JAN92 felt paresthesia rt hand; Seen by MD; still complains of pain w/swelling off & on & paresthesia;
Was fussy and cried a lot for 2 days, on day 3 she was admitted to the hospital after refusing to eat. She was hospitalized for 5 days!
A fib; This is a spontaneous report from a contactable healthcare professional.  A 76-year-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered on right arm on 26Mar2021 14:30 (Batch/Lot Number: EP6955) at single dose (at the age of 76 years old) for COVID-19 immunisation.  Medical history included have not been in Afib for 4 months prior. Concomitant medication included metoprolol, lisinopril and rivaroxaban (XARELTO), all taken for an unspecified indication, start and stop date were not reported. The patient received BTN162B2, dose 1 for COVID-19 immunisation. 1 hour and 5 minutes after injection (26-MAR-2021 15:35)  of second dose, the patient went into a fib. Have not been in Afib for 4 months prior. The patient received no treatment. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of atrial fibrillation due to temporal relationship.  Case will be re-assessed upon the additional information provided.
pt recvd 1 dose of Engerix-B approx 1 month ago; about 1 wk later p/inject devel joint pain, aches & pains, low grade temp; seen by MD who said it looked like mild serum sickness; still has aches & pains;
3 days after vaccine - Redness, warmth, bruising and edema. Fever 102.9. AM reactions occurring at site of injection. ER trip 5/19/16 with cortisone injection and release to home with dx. "allergic site reaction".
Back pain; Muscle pain; Fever/ at 8am fever is gone back up; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PYREXIA (Fever/ at 8am fever is gone back up) and MYALGIA (Muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever/ at 8am fever is gone back up). On an unknown date, the patient experienced BACK PAIN (Back pain) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain) and MYALGIA (Muscle pain) outcome was unknown and PYREXIA (Fever/ at 8am fever is gone back up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient experienced fever gave paracetamol at 5am and went down. But on 12-Mar-2021, at 8am it is gone back up.   Reporter did not allow further contact
Employee reports pain when raising arm above head and laterally above shoulder height. It was recommended that the employee see their primary care provider. Employee has not yet seen provider. For treatment, the employee tried Ibuprofen 3 pills two times a day for a week. She now takes it as needed for pain.
See page 2. 1250- Became pale and lost consciousness briefly - did not fall and was able to walk to the bed. Skin pale but dry. 1255 B/P 90/70 P-64 130 B/P 100/70 P- 64 1205 - BP 100/70 P-74 Awake oriented, but continued to feel weak and nauseous. Transported to hosp at 1310.
This spontaneous report was received from a nurse practitioner via a company representative, concerning an 11 months-old child of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. The 11 months old child was babysited by a female who has a 61 weeks old son. Her son was vaccinated with VARIVAX (Lot #, expiration date, strength, dose, frequency and anatomical location were not provided) on 30-JAN-2017 for prophylaxis. It was reported that the 11 months old patient broke out which chickenpox within 24 hours of being exposed to the vaccinated 61 weeks old male patient (secondary transmission and chickenpox). At the reporting time, the outcome of the events was not reported. The causal relationship between the VARIVAX and the events was not provided. No product quality complain (PQC) was involved. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009916: US-009507513-1703USA006978:
Pre-vaccination - the pt. reported experiencing dizziness immediately following her last dose of Pfizer.  Pt was agreeable to observation period following today's vaccination.  5 mins post vaccination, the pt. reported mild dizziness, lightheadedness, (confirmed it was similar to the symptoms she previously experienced with her last dose).  Fluids provided.  VSS - BP-128/74, 02-99%, HR-75.  NKA, Med regimen includes OTC Vitamins.  Pt also has h/o anxiety.  Pt reported only having coffee this morning before coming to clinic to be vaccinated.  After being observed for 20 mins, she verbalized feeling better and requested to leave.  The pt appeared stable when she left.
magnets sticking to me; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (magnets sticking to me) and MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (magnets sticking to me) and MYALGIA (sore arm). At the time of the report, FEELING ABNORMAL (magnets sticking to me) and MYALGIA (sore arm) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
lymph nodes were swollen; felt like her nerves were wild; could not sleep; her throat was rough; light fever; throw up bile not food; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (felt like her nerves were wild), SLEEP DEFICIT (could not sleep), OROPHARYNGEAL PAIN (her throat was rough), LYMPHADENOPATHY (lymph nodes were swollen) and VOMITING (throw up bile not food) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VOMITING (throw up bile not food). On 20-Feb-2021, the patient experienced PARAESTHESIA (felt like her nerves were wild), SLEEP DEFICIT (could not sleep), OROPHARYNGEAL PAIN (her throat was rough) and PYREXIA (light fever). On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes were swollen). On 21-Feb-2021, PARAESTHESIA (felt like her nerves were wild), SLEEP DEFICIT (could not sleep), OROPHARYNGEAL PAIN (her throat was rough), VOMITING (throw up bile not food) and PYREXIA (light fever) had resolved. At the time of the report, LYMPHADENOPATHY (lymph nodes were swollen) outcome was unknown.            No concomitant medication were reported. No treatment information was provided. The action taken with mRNA-1273 with the events was considered as not applicable   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: fallow up received on 14-may-2021 includes contact information of the reporter was added
Sore arm at site of injection only Narrative:  Sore arm at site of injection only
pt recv vax & exp t102.7,5 convuls,encephalitis  &/or encephalopathy;coma or marked alteration of LOC;pt had sz then resp arrest in postictal stat
6/16/22 EMS found pt down and unresponsive in house with a broken air conditioner, brought to ED; unsure how long she had been there; 6/14/22 pt had a positive COVID test from Walkin Clinic; intubated by EMS; admitted; rectal temp 107F; imaging showed COVID pneumonia and diffuse cerebral and cerebellum edema with effacement of sulci and basilar cisterns; experienced PEA; ACLS with ROSC achieved briefly before pt repeatedly had PEA; ACLS x4 with additional vasopressors added; pt transitioned to DNR and passed away in the hospital
Pt admitted to hospital positive for COVID 10/7/21 s/p 2 doses of Pfizer (last dose was 2/23/21)
Low grade fever, lymph node swelling under left arm, headache, fatigue,  chills.  I still have the headache and low grade fever.
Flu vaccine given at school. States patient's left arm became red and also had swelling that was not resolved with Tylenol or Benadryl. Symptoms began same day vaccine was given.
high fever; vomiting; hives (lower body); This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 3 (booster), 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 (Dose 1), administration date: 06Nov2021, for COVID-19 immunization; BNT162b2 (Dose 2), administration date: 27Nov2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever"; VOMITING (non-serious), outcome "unknown"; URTICARIA (non-serious), outcome "unknown", described as "hives (lower body)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: Event took place after use of product. Patient took TYLENOL for the fever.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning an approximately over 60 year old male with a history of hepatitis A exposure in approximately 2007 who on 19-JUN-2007 was vaccinated with his first dose of VAQTA after hepatitis A exposure.  On 21-NOV-2007 the patient was administered with the second dose of VAQTA too soon.  No adverse reaction was noted.  Medical attention was sought in the physician's office.  There was no product quality complaint.  No further information is available.
diarrhea  started around mid to late morning the day after vaccine received;  continued for few hours and then mild chills started during the afternoon; diarrhea lessened during evening.  No chills on the next day but mild diarrhea started again later that afternoon/evening.  Early the next morning another occurrence of mild diarrhea.  After that time no additional episodes.  Home treatment consisted of drinking fluids including an electrolyte drink mix and bland diet.
After giving vaccines pt was talking with Dad & brother. Approx 2 min after giving vaccines pt had sudden onset unconsciousness, body stiffing, arching back, leaning back on the exam table sliding down the wall. Staff with pt during this entire time assisting pt with seizure precautions, no injury at that time. Pt incont of urine, pupils fixed and dilated. Seizure lasted approx 20-30 seconds, generalized contraction of the muscles of the four extremities, slight tremors noted in lower arms & hands. Activity ceased and pt became conscious not knowing what happened, facial coloring grayish-green. Pt denies injury, mouth/tongue checked --- normal. Pt requesting water to drink. Dr. in room assessing pt.
PROBLEM WITH SKIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: afib. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced problem with skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of problem with skin was not reported. This report was non-serious.
I already filled this out. Pt. experienced hypnotic effects, with hallucinations both audio & visual. These side effects started again in 2007, pt diagnosed with chronic schizophrenia 2009.
Patient reports pain and swelling to right arm where vaccine was given. Pain was present on the first and second day after administration. Rash is reported as well on right arm.  Patient was advice to apply cold compress and take Benadryl.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient presented after doctors visit where she discovered red, swelled rash on right arm from COVID vaccine she recieved on 3/1/21. Will advise patient to premedicate with bendryl before second vaccine appointment
This case was reported by a physician via a sales representative and described the occurrence of swelling at injection site in a subject of unspecified age and gender who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On 09 August 2007, the subject received unspecified dose of Infanrix (.5 mL, unknown). On 9 August 2007, less than one day after vaccination with Infanrix, the subject experienced swelling at injection site. The physician noted that the Infanrix was "from a particular lot" (lot number not provided), and that two to three other patients had also developed injection site swelling after receiving Infanrix from the same lot (please reference GSK reference number A0670239A). At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with Infanrix.
Patient presented the day after receiving the flu shot with a "spidery-looking" bruising at the injection site. Patient said her arm hurt that night after receiving the flu shot and applied topical Biofreeze which said provided relief. Patient states the bruising was continuing to worsen and wanted to report the adverse event. Patient presented not in acute pain and was advised to apply a cold compress, if needed, and to continue to monitor if the bruise worsens. Advised patient to seek medical attention if bruise worsens or acute pain occurs and report the information to the pharmacy.
That evening chills, fever, headache started, little nausea, more frequent urination.  Continued into the next day.  Dizziness started 03-20-21.  Blacked out if stood up too fast, but didn't hit your head.  Severe dizziness, fainting spells continued with fever.  At that point went 2 PM.
Bodyache for 3 days, soreness of arm for 5 days, redness, ichy,
This spontaneous report was received from a medical assistant concerning a 4 month old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 05-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US-009507513-1701USA005974. The WWID US-009507513- 1701USA005974 refers to the linked report (and therefore not being nullified). The correct WWID is now referenced in this safety report (US-009507513-1704USA007664). Additional information has been requested.; Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1704USA007655: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673: US-009507513-1701USA005974:
mild flu like symptoms; muscle aches; headache; bone pain; fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st February 2020, the patient received the 1st dose of Shingrix. On 22nd February 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, myalgia, headache, bone pain and fever. On 26th February 2020, the outcome of the influenza-like symptoms, myalgia, headache, bone pain and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, myalgia, headache, bone pain and fever to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient started having mild flu like symptoms. He experienced muscle aches, headache, bone pain and fever.  On the second day, the symptoms became worse and lessened on third day. The symptoms resolved on the fourth day. The reporter did not consented to follow up.