chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest felt odd; then rapid heartbeat began about 25 min after injection; Headache; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 05Feb2021 13:45 (at the age of 72 years-old) as dose 1, single for COVID-19 immunization (Hospital). Patient medical history included ongoing hypothyroidism and insulin resistance, along with supraventricular tachycardia, and obesity unknown if both ongoing. Concomitant medications included levothyroxine sodium (UNITHROID), chlorthalidone (CHLORTHALIDONE), finasteride (FINASTERIDE), and colecalciferol (VIT D3) and zinc all taken for an unspecified indication. The patient previously took codeine, morphine, statins and experienced drug hypersensitivity. On 05Feb2021, after 15 minutes of drug administration, the patient's chest felt odd, followed by rapid heartbeat began about 25 minutes after injection and headache. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Patient took no other vaccine within four weeks of drug administration. Patient did not receive any treatment. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Vaccine was given approx 1330 - later that evening he developed some bursitis/redness and swelling - and then developed some blisters - last x 72 hours.
99.3 fever, headache, stomach ache; better by 10/20/04. Attended school.
33 F who reports that approximately 12hrs after vaccine receipt, her injection site became sore, TTP, and erythematous. She did not think much of it at the time, but when she woke up on Saturday 14 SEP 2013 she noticed more pain, TTP, and an increasing area of erythema. She also reports elevated temperature up to 101 F, rigors, nausea, decrease in appetite, diffuse joint pains, and night sweats at that time which continued through 16 SEP. On  Saturday 14 SEP pt went to the ER. She was given IV clindamycin in the ER and d/ced on TMP/SMX and cephalexin. The erythema was marked and she was instructed that if the erythema grew past the marking that she should return to the ER. Over the course of the next 24hrs the pain, TTP, and erythema worsened. On 16 SEP, she returned to the ER. At that time, she reported improvement of her joint pain, but her other symptoms continued. The redness on her RUE was approx 8 x 15 cm and warm to the touch; enlarged submandibular L/A. She was admitted to the medicine floor of clinic for further evaluation and IV antibiotic therapy. Patient was started on IV vancomycin 1.25 grams every 12 hours for the cellulitis. Overnight the affected area decreased in size, redness, and tenderness. Her vital signs during the hospital stay were within normal limits. No fevers, chills, nausea, joint pain. Appetite was good, patient tolerated her diet, bowel and bladder habits were intact. No dysuria, urinary urgency/frequency. She received two doses of IV vancomycin 1.25grams during her hospital stay. Leukocytosis improved during hospitalization, and ESR was trending down. Infectious disease was consulted and believed that it was infectious process and recommended continuing cephalexin and trimethoprim,/sulfamethoxazole. Rheumatology was consulted and instructed the patient not to take her methotrexate for this week, and to restart the medication the following week. Allergy was consulted and said a vaccine reaction could not be ruled out.
Redness 4.5 cm diameter at site - localized & firm to the touch.  Pt is to return to clinic if worsening symptoms.
Felt terrible; exhausted; arm so sore, felt like she got run over by a truck; diagnosed with Covid19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (diagnosed with Covid19), FEELING ABNORMAL (Felt terrible), FATIGUE (exhausted) and VACCINATION SITE PAIN (arm so sore, felt like she got run over by a truck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (diagnosed with Covid19). On an unknown date, the patient experienced FEELING ABNORMAL (Felt terrible), FATIGUE (exhausted) and VACCINATION SITE PAIN (arm so sore, felt like she got run over by a truck). At the time of the report, SARS-COV-2 TEST POSITIVE (diagnosed with Covid19), FEELING ABNORMAL (Felt terrible), FATIGUE (exhausted) and VACCINATION SITE PAIN (arm so sore, felt like she got run over by a truck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
At approximately 2100 patients mother heard child "struggling to cry" over the baby monitor. Upon entering the room the parent states the childs torso was still eyes were rolled back and left arm and leg were twitching. Father of patient came into room noting all four limbs were shaking/twitching. Episode lasted approximatly 2-3 minutes and child was not"acting like usual" after and parents transported to closest ED. On call pediatrician reccomended over night observation and mother of patient requested a transfer to another hospital. Patient afebrile at time of arrival at ED, temp did increase during visit to 100.3 at 2330.
This spontaneous report as received from a registered nurse refers to a 15 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 07-JAN-2016 at 10:22, the patient was vaccinated with the first dos of GARDASIL intramuscularly, in left deltoid, lot number L016428 (strength, dose and expiration date were not reported), which was improperly stored. On an unknown date in approximately 2016, the patient was diagnosed with major depressive disorder with single episode in full remission. The outcome of major depressive disorder with single episode in full remission was not reported. The relatedness between this event and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, Severe Chest congestion w/ wheezing, severe headache, shortness of breath. Diagnosed with pneumonia 3-4 days after vaccination. lasted approx. 2 weeks with symptoms. required 2 trips to urgent care, as of today, I still have minor chest congestion.  Haven't been able to fully get rid of it.
Nearly immediate onset of pain.  Vaccine administered very, very high in my arm.  Range of motion effected.  Seen by orthopedic specialist and showing symptoms of bursitis.  How much of the vaccine went into my muscle vs. my bursa?  Do I need a 3rd booster?
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with a dose of PNEUMOVAX23 (lot #, dose and route not reported)sometime this year, in 2012. No other co-suspects were reported. No concomitant medications were reported. The nurse mentioned that at another office in their practice had a report of cellulitis following vaccination with PNEUMOVAX23 in 2012. No treatment information was reported. It was unknown if the patient sought medical attention. The nurse had no other information about the other office in their practice. The outcome of cellulitis was unknown. The relatedness for cellulitis was not provided for PNEUMOVAX23. The reporting nurse considered cellulitis to be life threatening. This is one of several reports received from the same source. Additional information has been requested.
Patient received Pfizer vaccine. Pt stated he had never received a COVID vaccine before. Upon further investigation while documenting dose given, System showed that patient received Moderna vaccine on 07/15/2021. No treatment given. After discovering patient had received 2 different types of COVID vaccine, RN went to center to notify patient and provide new COVID vaccine card with both doses administered. No adverse events noted.
Day of vaccine - no adverse events (slightly sore arm only) Next day - severe pain in internal organs - similar to an ovarian cyst I had when I was a teenager.  The next morning the pain was not nearly as bad and eventually went away.   I also began to get a very runny and stuffed up nose, with coughing. Following day - Coughing got worse and was very "barky".  As the evening came, I felt like I had something caught in my throat and it became more difficult to breathe. Later in the evening, I really struggled breathing and my chest hurt badly.  It continually got worse and at about 3:30 am I decided to try my nebulizer (which I use rarely) to see if it would help me breathe.  It took an hour to eventually open my airway and I was able to sleep.  The next day I improved as the day went along.  ***It was terrifying and if the nebulizer had not improved my breathing, I would have gone to ER.
Information has been received from a physician concerning a 11 week old female who on 10/13/06 was vaccinated with the first 2.0ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (lot 654504/0695F). The physician reported that on 10/18/06, the pt developed severe vomiting. The pt was vomiting so much that she was hospitalized where an ultra sound was performed and a diagnosis of intussusception was made. On the evening of 10/18/06, the intussusception was reduced by Barium enema. It was noted that the pt experienced cramping, crying and whining until midnight. On 10/19/2006, the pt was discharged from the hospital as her intussusception was considered to be resolved. The physician also considered the intussusception to be life threatening. Additional information has been requested.
Information has been received from a physician concerning a patient (age not reported) who on an unspecified date was vaccinated with orally 2 ml of ROTATEQ (orally dose and lot number not reported).  The physician reported that the patient developed ROTATEQ after receiving ROTATEQ.  The physician mentioned that the patient may had been "incubating rotavirus prior to vaccination".  At the time of the report the patient recovered on an unspecified date.  The patient sought unspecified medical attention.  Additional information has been requested.
Patient experienced fever, chills, redness on the left arm, and swelling of her lymph nodes. She had very similar symptoms during the first dose of SHINGRIX. The lymph node swelling began yesterday and is still present, is not as severe as during her first dose
Patient was administered higher dose of Janssen, 2.5 ML.  Only saturday, 5/22/21. She felt very tired, but no other symptom, she went to sleep early and sunday she woke up better. Today, 5/24, she feels much better, and has no other symptom.
Daughter was drowsy and napped from 4:30 to 6:30, Did not eat dinner.  Had low-grade fever of 99.2 - I did not administer any medication (Tylenol)  Dad put her to bed at 8:00 - she seemed fine and was talking.  We did not take her temperature again - didn't notice if she was warm/hot to the touch.  She went into full convulsions around 8:15-8:30 - She was not breathing and was turning blue - husband administered cpr and we called 911.  At hospital she was given a double dose of Tylenol and Motrin.  Dr. on staff called it a Febrile Seizure.  Her temp. in the Ambulance was 103.  We were released from Hospital around 12:30-1:00AM.  I scheduled an appt. with her pedriatrician the next day at 2:00 pm.  Had blood work drawn which indicated that she may have a slight virus.  Tested negative for the flu.  Dr. is scheduling a MRI within the next two weeks.
Severe Joint/muscle pain limited mobility.   Chills and headache.  Lasted 24 hours.  Used naproxen for pain.  Symptoms lifted by 6PM 01/24/2021. Got a large fever blister on outside corner of mouth.  Have not had one for 30 yrs.  Believe it  related to shot.
Left leg got very red (size of walnut) no swelling, no fever. 09/03/2002  11am (same day as vaccine)
APPROXIMATELY 8 MINUTES AFTER RECEIVING MODERNA #2 VACCINATION, CLIENT DEVELOPED DIZZINESS, SHORTNESS OF AIR,  PERIPHERAL TREMORS/NUMBNESS.  CLIENT BECAME PALE AND DIAPHORETIC.  CLIENT STILL ALERT AND ORIENTED X3.  BENADRYL 25 MG ORAL GIVEN FOLLOWED IMMEDIATELY WITH EPI PEN ADULT DOSE @ 10:56 AM.  VITAL SIGNS @ 10:54 WITH BP: 146/72, P: 131, REPIRATIONS 30, SKIN PALE/DIPHORETIC PRIOR TO ADMINISTRATION OF EPI.  2ND SET VITAL SIGNS @ 11:00 150/74, P: 119, R: 30 SKIN PINKINING/IMPROVING DIAPHORESIS STILL REPORTS PERIHERAL NUMBNESS/VISUAL PERIPHERAL TREMORS STILL PRESENT/REDUCED. 3RD SET VITAL @ 11:13 AM BP:136/68, P: 100, R: 26 REPORTS HER TONGUE FEELS THICK.  TRANSFERRED TO ER FOR CONTINUATION OF CARE @ 11:20 AM VIA WHEEL CHAIR.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date from 17-NOV2016 to 15-DEC-2016, unspecified number of patients were vaccinated with improperly stored PEDVAXHIB (lot # M001814 and expiry date 15-OCT-2018 or Lot # M027882 and expiry date 14-APR-2019) for prophylaxis. The vaccines were exposed to a temperature of 2.5 C for 1 hour and 10 mins. No adverse effects were reported. The call was because of digital data logger. There was no previous exposure. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013518: US-009507513-1612USA013520: US-009507513-1612USA010663: US-009507513-1612USA013517.
Mild pain at injection site turned to severe pain at injection site by 10pm night of vaccine (9/22).  When I awoke the next morning (9/23)  I felt very tired, out of sorts and the pain in my right arm had grown significantly worse.  By noon the pain had migrated to back and neck, I was experiencing flu like symptoms (nausea, dizziness, overly tired, body aches throughout the body and had a fever of 102).  I went to bed for the night at 4pm.  Sweats and chills alternated throughout the night.  Awoke 9/24 feeling significantly better.  Fever gone, still dizzy, mild body aches and still moderate pain in right shoulder/arm.
Patient came to pharmacy 9-16 to show us her arm where she received two vaccinations. PNEUMOVAX 23 and  FLUZONE HD, her arm was red from shoulder to elbow. She stated it started on 9-15 and was painful. It looks the reddness may go down past the elbow. she said it is no longer as painful as the day before she had no problem breathing or no itching. She wanted to report the reaction to us. I advised her we notify her PCP and report the adverse reaction on VAERS reporting system. I told her to take IBU for pain and if she does have itching or difficulty breathing to take beanadryl. I also advised her to speak to her PCP as well and to go to them if the condition worsens. she said that the pain was less and felt it was going away.
110 mm warm/sts area at site of Kinrix/slightly pruritic/good gait. Ibuprofen and Benadryl 1.5 tsp. every 6 hrs. x 48, cool compress today and warm sit bath with epsom salt tomorrow.
Information has been received from a health professional concerning a 15 year old female with no known medical history, who on 29-DEC-2008 was vaccinated with a second dose of GARDASIL (lot # 661044/0548X), intramuscularly in the right arm at 16:45. Concomitant therapy included a second dose HAVRIX (lot # AHAVB319AA), intramuscularly in the left arm on 29-DEC-2009 at 16:45. On 29-DEC-2008 the patient received the GARDASIL vaccine in the right arm and HAVRIX in the left arm. The patient fainted but regained conscience immediately. After taking vital signs, the patients blood pressure was low. The patient was monitored until the blood pressure came up in about 15 minutes. The patient recovered on 29-DEC-2008. No further information is available.
A female patient (age unknown) received a booster vaccination with RabAvert (batch # 338011) on 12/16/04. About 10-15 minutes after the vaccination she developed difficulties in breathing, 45 minutes later she became light-headed and had to sit down the rest of the day. That morning she began having frequent dizzy spells and recurrent small black dots in the center of her vision (lasting for 6 days). She also developed muscle pain and cramping in the night after the vaccine was given, lasting for approximately 2 days. Patient felt very angry. The patient was given Benadryl, Epinephrine and Tylenol. She recovered completely. Relevant history: Patient has an allergy to food and Levoquin. Vaccination history: after vaccination with Imovax in 2000 and 2002 she developed hives and difficulties in breathing. No seriousness criterion given. Causality: possible. Expectedness assessment: The reported symptoms are expected, except for muscle cramping and feeling angry, after vaccination with RabAvert. On a case level, the case is considered expected. No change in benefit-risk-ratio. No measures necessary. Addendum 2/7/05: Reporter fells she qualifies for retrobulbar neuritis and encephalitis after reading the package information leaflet. Seriousness criterion: medically significant (OMIC). Causality: not related (questionable diagnosis; interval too short for causality).
Information has been received concerning a 28 year old female who on 6/12/99 was vaccinated with the first dose of Hep B. On approximately 6/15/99, the pt experienced a rash and fever. On 6/25/99, the pt discovered she was pregnant.  No further information was available.
Cellulitis - seen in office 9/4/14 by CNP. Given BACTRIM DS 800-160 mg 1 tab BID x 10 days. Being reseen for f/u on 9/8/14 with CNP.
allergic reaction; Hard to swallow and to catch breath; Throat started closing; Hard to swallow and to catch breath; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: EL9263), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced hard to swallow and to catch breath, throat started closing on 16Feb2021 and allergic reaction on an unspecified date. The patient was treated with 2 Benadryl to help calm this down. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Bell's Palsy, drooping and extreme pain started behind ear on February 22.  Getting worse each day.  Extreme headache immediately after injection and continues to this day.
Moderna COVID vaccines received on 2/26/2021 and 3/26/2021 Hospitalized at Hospital on 10/31/2021 Diagnosis: Positive COVID 19 with rapid but repeat PCR test was negative, partial small bowel obstruction, Acute UTI, Hypertension, Umbilical Hernia Treatment related to bowel obstruction, removed COVID restrictions due to negative PCR test, rapid likely false positive since asymptomatic and vaccinated per report
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 28-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Comirnaty, batch/lot# FL3180), at the age of 28, in right arm, on Aug 14, 2021, at 08:00, single dose, for COVID-19 immunisation. Medical history included asthma (unspecified if ongoing), and allergy to sulfa drugs. Concomitant medication included: Lo Loestrin FE. The patient reported pain in extremity/arm soreness/pain for about 2 days/difficult to breathe, heaviness on chest, dyspnea/difficult to breathe and chest discomfort/heaviness on chest, onset Aug 14, 2021, with outcome of recovered (Aug 16, 2021). No therapeutic measures taken as a result of pain in extremity, dyspnea and chest discomfort. Additional information: Patient did not take any other vaccine in the past four weeks. Patient did not have COVID-19 prior to vaccination nor test for COVID-19 post vaccination. No follow-up attempts possible. No further information expected.
lt warm swelled & felt warm starting evening of 16SEP93; cont spreading redness & swelling & seen by MD 20SEP93; dx w/cellulitis;
Varicella shot given on 8/2/00. Call today from pt complaining of red, swollen right arm "where I got the chickenpox shot on Wednesday". Taking Tylenol 2 every 4 hours. Denies fever and no complaint of increased warmth to right arm.
Took the vaccine shot at 3 PM By 6:30 I had some swelling on eye lids, lips, throat and even tongue and inside mouth. By 08:00 PM, I was in the emergency room. I was in the Hospital till 02:30 next day.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Medical history and concurrent conditions were reported as none. On 18-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous, lot # K008880 expiry date 20-SEP-2015 (also reported as 09-SEP-2014), (dose was not reported). Concomitant medications were reported as none. The pharmacist reported that the patient presented to the pharmacy on 20-OCT-2014, with a 2.5 inch in diameter, red, hard injection site reaction from ZOSTAVAX also reported as adverse event onset date as 18-OCT-2014. Pharmacist stated that the patient would treat with a topical cortisone cream. It was verified that this was an injection site reaction and not a rash. The patient sought medical attention and none laboratory diagnostics were performed. The outcome of 2.5 inch in diameter, red, hard injection site reaction was reported as not recovered at the time of the report. Additional information has been requested.
IMMEDIATELY AFTER INJECTION PATIENT STATED TO FEEL UNWELL, FLUSH, AND DIZZY. SHE STARTED TO SHAKE AND WE CHECKED HER BLOOD PRESSURE AND IT WAS EXTREMELY HIGH 150/81 HEARTRATE OF 113. SHE WENT TO LOCAL URGENT CARE FOR EVALUATION
3rd vaccine given  Narrative:  Report entered to document 3rd dose to Pfizer covid vaccine given by mistake in outpatient clinic. Patient is elderly and noted to have memory  problems. Did not recall receiving second covid vaccine on 3/4/2021. Came to clinic for a lab/PCP appointment on 3/17/2021 and was taken back for a covid injection before the nursing staff could verify and check the medical record to see if he was already fully vaccinated. No adverse effects reported from any of the vaccinations.
Injection arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm is sore) 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 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PAIN (Injection arm is sore). At the time of the report, VACCINATION SITE PAIN (Injection arm is sore) outcome was unknown.            No concomitant medications were reported. No treatment information were reported.