chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm is swollen and red at vaccine  site and hot to the touch 24 hours after given
12/23/22 presents to ED for "shortness of breath". PMHx of "AAA, colon ca, HLD, HTN"
Left leg area measured 2.5 inches in diameter today in the office. Site erythematous, hard, hot to touch. Treated with KEFLEX.
Day 3: Hives on hands and arms. Day 4: Hives on hands, arms and legs Day 5: Hive on Hands, arms, legs, torso, and buttocks.
Patient was taken to the hospital after a seizure-like episode on the night he received vaccines. This episode involved grunting, turning pale. Patient was admitted to hospital for observation, where he was found to have a temperature of 100.7. He was later diagnosed with influenza type B and started on TAMIFLU. Patient was discharged from the hospital the next day, with no more fever of seizure-like episodes. His PCP feels that his symptoms were consistent with a hypotonic-hyporesponsive episode following vaccines.
Patient developed progressive stiffness and soreness in her legs, generalized weakness, dark urine, increased thirst, and nausea. She called me with these symptoms and I evaluated her and ultimately diagnosed her with rhabdomyolysis with acute renal injury. She was hospitalized for IV fluids and serial lab assessments. The rhabdomyolysis resolved and she was discharged home after 48 hours.
Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1 via an unspecified route of administration on 22Dec2020 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included allergy to NSAIDs. The patient previously took buproprion and experienced allergies. No other vaccine was received within 4 weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), and clarithromycin (CLARITIN). The patient experienced throat, ears and nose itching, nose running, and throat tightening on 23Dec2020 01:00. The patient received Benedryl and Prevacid taken at home for the events. The outcome of the events was recovered.
Unsure of signs and symptoms course of time, pt. only been in ER and hospital. Started 11/25/13 w/back pain, S/P fall and paresthesias, discharged 11/29/13 and readmitted 11/30/13 for increased WBC's, w/? Guillain Barre and weakness, currently still in hospital on a rehab unit.
Widespread viral exanthem upon waking up on 2/7/21. Slightly itchy. No treatment.
Sever body ache, stuffy nose, joint pain, headache, neck pain, chest pain
Information has been received from a physician concerning a 28 year old female patient who 2 years ago approximately in September 2007, completed series of GARDASIL. Subsequently the patient was tested positive for Papanicolaou test for high risk human papillomavirus. Lot number was not available. The patient had sought physician for medical attention. It was unknown the outcome of the event at the time of reporting. Additional information has been requested.
Moderna COVID-19 Vaccine  Sore, swollen, feverish lump on left arm that vaccine was administered in. About two 1-2 inches lower than injection sight. Red patch is itchy and hot to the touch and has gotten larger in the past 24 hours. Reaction started 1 week and 2 days after first dose of COVID vaccine.
Fever on third day after receiving vaccine that improved, but was followed by intermittent episodes of generalized body rash that has continued though today, 2/9/2016.
For about 24 hours I had headache, muscle pain, tiredness and fever of 99.5, and mildly painful swelling at the injection site. All symptoms cleared by the second morning following the vaccination.
was to administer MMR and nursing error gave the MMRV which was located in same bin as MMR, client is doing fine no adverse reaction reported to me by student caregiver
Irregular heartbeats detected by my bloodpressure monitor; Sometimes double heartbeats and sometimes triple heartbeats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6198) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "Allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; LEVOTHYROXINE; LISINOPRIL; OMEPRAZOL. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 08Mar2021 07:30, outcome "unknown", described as "Irregular heartbeats detected by my bloodpressure monitor"; EXTRASYSTOLES (non-serious) with onset 08Mar2021 07:30, outcome "unknown", described as "Sometimes double heartbeats and sometimes triple heartbeats". The events "irregular heartbeats detected by my bloodpressure monitor" and "sometimes double heartbeats and sometimes triple heartbeats" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular, extrasystoles.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Vomiting x 4 days after each feed. Watery stool 3 times a day. Fever, max temp at 103F
Disruption of menstrual cycle, spanning either 20 days to 60 days without a period (cycle), hormonal bloating, mood changes, more intense cramping. This was following over two years of extremely regular and predictable menstrual cycles, and absence of above symptoms.
chills, temperature, joint aches, stomach churning, vomiting, diarrhea, delirium, leg weakness, femur aches, nasal drainage, eye tearing, hoarse voice,
Administered with 008C21A on 5/21, date updated to 5/20. Vaccine was administered on 5/20/21 but logged after 12:00am on 5/21/2021.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted after only about 2 minutes in chair.  he came to immediately, was surprised, he sat in observation area for 25min as he recovered.
In a retrospective chart review it was determined that the patient received the Jansen vaccine at age 17.  Vaccine is approved for 18 years of age and older.
This spontaneous report received from an office manager for a physician vaccine practice via company representative refers to an unknown number of female patients. No concurrent conditions or medical history were reported. On unspecified dates between September 2015 and March 2016, an unspecified number of female patients all under age of 18 years were inadvertently administered with subcutaneous doses of improperly stored VARIVAX lot# K011182; exp. date: 08-AUG-2016 or K011184; exp date: 16-AUG-2016 (dose not provided). Concomitant therapy was not reported. Office Manager could not specify how many patients received vaccine from each lot. No adverse effects or PQC were reported. This is one of two cases from the same reporter (#1607USA009540). Additional information is not expected because there is no consent to contact the physician.
Fever, chills, extreme fatigue, trembling, severe headache, body aches (joint and muscular), nausea, loss of appetite, weakness, lightheadedness   Symptoms began approximately 12.5 hours after receiving the vaccine and were in full effect for at least 24 hours before beginning to subside. Some reduced symptoms (moderate headache, slight body aches, and slight fatigue) are still lingering at 32 hours.
This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (Rash in the neck below the jaw) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash in the neck below the jaw). At the time of the report, VACCINATION SITE RASH (Rash in the neck below the jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Treatment information or concomitant medications were provided.
Body aches; Nausea; Nausea followed by vomiting.; Then extreme chills, headache and fever of 102.7; Then extreme chills, headache and fever of 102.7; Then extreme chills, headache and fever of 102.7; Currently still have fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 21Apr2021 at 15:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), rosuvastatin (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 30Mar2021 at 15:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 14:45, approximately 24 hours after second dose, the patient experienced body aches, nausea followed by vomiting, then extreme chills, headache, fatigue and fever of 102.7, which lasted for approximately 11 hours. On 22Apr2021, the patient underwent lab test which included body temperature test and the result was found to be 102.7 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, nausea followed by vomiting, then extreme chills, headache and fever of 102.7 were resolved on an unknown date in Apr2021; while that of the event fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
bilateral DVT confired with D-dimer and ultrasound.  Treated with apixaban 5mg BID
16 year old s/p receiving HPV #2 on 4/6/07. Presented 4/9/07 with possible focal seizure (contracture right hand) sent to ER then admitted with Grand Mal seizure episode that evening. Patient placed on Dilantin discharged home on Dilantin PO. No FMH of seizure episodes. 06/06/07-records received for DOS 4/10-4/11/07-DC DX:Seizures Partial complex. Intermittent periods of right hand pain and shaking. Subsequent period of shaking episode of right hand progressed to generalized tonic clonic shaking of arms and legs associated with loss of consciousness and post ictal period. Received HPV vaccine 3 days before.
Developed a blistering rash with temperature to 103.8 F  2 days post vaccine and remained febrile x 6 days. Developed Pericarditis and hospitalized for same 2 weeks post vaccine.
Dizzy; Severe headache; Nausea; Severe diarrhea; Low Body Temperature 95.9 degrees; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: cpt1533) via an unspecified route of administration in the left arm on 01Apr2021 at 10:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, minimal change disease and asthmatic. Concomitant medications included insulin (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN). The patient's allergies to medications, food or other products included penicillin allergy. Prior to the 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 four weeks prior to the vaccination. On 02Apr2021 at 04:15, the patient experienced dizzy, severe headache, nausea, severe diarrhea, low body temperature 95.9 degrees. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events dizzy, severe headache, nausea, severe diarrhea and low body temperature 95.9 degrees were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Parent brought child in for vaccines.  Noted on L deltoid large reddened area aprox the size of an orange warm to the touch.  Posterior side of right forearm small red area size quarter.
Chills, fever 104, swelling in arm, pain, pt called back to report pneumonia shot was given at 10:00am and symptoms started at 4:00pm. Pt went to ER and was admitted. Diagnosis unk. 01/09/07-records received and reviewed for DOS 10/28-10/28/06. DC DX: cellulitis left upper extremity. Developed fever and redness spreading down her arm almost to wrist area. In ER treated with Vancomycin IV, but developed "red man syndrome". Changed to IV Levaquin.  PMH: Hypertension, Cerebrovascular accident, congestive heart failure and osteoporosis.  PE: Erythema remaining in her left upper extremity extends through the antecubital area and down towards wrist, she does not have any erythema in the actual injection site.  Follow-up: Spoke with pt on 11/1/06 and patient was home from hospital and on antibiotics. She stated that her arm still appeared red and told her to call the doctors office. Spoke with pt on 11/8/06 and she stated that she did not call the doctor back on 11/1/06, however she finished her antibiotics and has had no problems since. The arm has no discoloration of any kind and she feels fine.
weakness accompanied by joint pain beginning in left elbow (vaccination performed in left deltoid) and proceeding to other joints in left arm including fingers and then to right elbow and vertabrae from T6 into neck area -- suspected sulfites because of pimple breakout and muscle spasms in face and jaw
COVID-19; COVID-19; Pneumonia; respiratory failure; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Jan2021 for COVID-19 immunization. Medical history included Alzheimer's and others. No known allergies. Concomitant medications included unspecified medications. The reporter's mother in law was tested for COVID-19 at a nursing facility on 25Dec2020 and she was negative. On 02Jan2021, she received the first dose of Pfizer vaccine. On 04Jan2020, she developed a high fever, needed oxygen and was positive for COVID-19. Date of death was 04Jan2021. The cause of her death was listed as pneumonia, respiratory failure and COVID-19. No autopsy performed. No treatment received. No one knew if the vaccination contributed to her death. It was hard to know if her death was due to the administration of the vaccine or it exacerbated the COVID19 symptoms which led to her death. Since this was unknown, it could have been a possibility. The reporter wanted to give us this information because we might want to consider having high risk population, patients with underlying conditions, older population tested for COVID-19 prior to the vaccination, as this is not currently a recommendation or a requirement. All is very new and they are all learning so the reporter wanted to share this information with us. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was fatal.   Information about Lot/Batch has been requested.; Sender's Comments: The association between the fatal event lack of effect (pneumonia, respiratory failure and COVID-19) with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.; Reported Cause(s) of Death: Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19
pt recvd vax;devel redness,induration,edema & warmth at inject site;tx w/ dph & cold compresses to the site;as of 11nov94,inject site sl red & pruritic;
Information has been received from a physician concerning a 26 year old female who on 19-JAN-2007 was vaccinated intramuscularly in left arm (upper outer quadrant) with the first dose of GARDASIL vaccine (lot # 655619/1427F). On approximately 21-JAN-2007, "within about three days", the patient reported that both her arms were itchy and red. The patient sought unspecified medical attention. The physician reported that she told the patient to take some BENADRYL to treat the symptoms. The physician reported that she did not plan to re-vaccinate the patient with GARDASIL vaccine. No lot number was provided. At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Additional information was received from a health professional. Lot number was provided and added to the report. The injection site was more affected that the opposite arm. The outcome was not reported. No additional information is expected.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Flushed / Sweating-Mild
numbness in legs is reported in a pt receiving 1 dose of fluogen for influenza prophylaxis; pt recently had back surgery; this case was reported by pt's wife, who is hlth care professional;
severe arm soreness, neck pain, body aches, nausea, headache, dizziness
Pt called Pharmacy on 12/07/2021 and reported adverse reaction to Pfizer vaccine that she received on 12/02/2021. Pt reported, swelling, redness spreading up to 4x5 inches around injection site, fever for 3 days. Arm is still bruised, swollen, knotty. Pt can touch and feel but cannot press the arm. Pt reported throbbing pain in the injection arm.
2 hours after administration, pt has nausea and vomiting. Vomiting lasted 2 days and nausea x 1 week. Pt also experienced headache, body aches, chills and fatigue. No fevers. Pt did note within 1-2 weeks racing heart at times and recurrence of sore throat and mouth blisters (which is chronic/recurrent and being worked up).
4 days post first dose of COVID-19 unilateral eye symptoms associated with conjunctivitis (eye soreness, discharge, crusty eye, teary eye) in left eye only lasting 4 days. Also, the same evening short lived chills began lasting 15 minutes. The Following day cold symptoms began. (Congestion, runny nose, general malaise) lasting 5days. 1 day post second dose (9/7/21), crusty eye left eye lasting 2 days. Tender, swollen cervical lymph node on left side of neck lasting one week. Tender, swollen lymph on left side of umbilicus lasting one week in the beginning of October. Also, missed menstrual cycle for the month of October
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Medium
Expired doses administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
I received the Moderna Bivalent COVID-19 booster on 10/14/2022. On 10/26/2022, my daughter-in-law tested positive for COVID-19. I had recently spent time with her, so I decided to test myself. I took a home antigen test and got a positive result. I tested myself during the following days, and I didn't test negative until 10/30/2022. I never really had any symptoms, but I contacted my NP, who prescribed me PAXLOVID, which I started taking on 10/26/2022.
Pt had pain, inconsolable crying and breath holding spell. Called 911, evaluated by paramedics.
He got the vaccine, he did not have any reactions.  He had the soreness the next day, but in the evening on the 7th around 11:00 PM he had his elbow on the armrest and went into the bathroom and found a rash on back of both of his arms there are black rashy bumps when he looks in the mirror.  On the underneath area of his arm from elbow to upper arm, but not into the armpit.  The left arm is prickly areas on both arms.   They are not itchy to touch, only noticed it when he placed it on the arm rest of the sofa.   He has not put anything on it or called his doctor.
Initial report received from a health care professional on 19 September 2012. Two female patients (date of birth not reported) had received a dose of FLUZONE HD vaccine (dose no. not reported) on an unspecified date (lot number: not reported). It was stated that after administration of vaccine they experienced flu like symptoms. At the time of report laboratory investigations and corrective measures were not reported. At the time of this report, the patient's outcome was not reported. Documents held by sender: none.
Swelling at injection site, bruising at injection site, hives all over body, fever, high-pitch scream, constant crying, lethargic, wouldn't eat or sleep, loss of happy personality. I noticed the swelling hours after injection and then the next day he was a different baby.
101.5 degrees F temperature, severe arm swelling, body aches, numbness & tingling in hands & feet.
Rash, 1 inch in diameter around injection site. Noticed rash 6 days after injection. No rash noticeable 48 hours after injections