chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Occupational exposure; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 2 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 28Feb2022 13:58 (Lot number: P221455-0013L, Expiration Date: 30Jun2022) at the age of 2 years as dose 4 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2;placebo (Regimen dose number: Dose 1, Lot number: P221455-0007L, Expire date: 01Aug2022, Route: IM, Anatomical location: Left Thigh, Time of vaccination: 13:28), administration date: 23Jul2021, when the patient was 1 years old, for COVID-19 immunization; Bnt162b2;placebo (Regimen dose number: Dose 2, Lot number: P221455-0007L, Expire date: 01Aug2022, Route: IM, Anatomical location: Left Thigh, Time of vaccination: 13:25), administration date: 16Aug2021, when the patient was 1 years old, for COVID-19 immunization; Bnt162b2 (Regimen dose number: Dose 3, Lot number: P221455-0011L, Expire date: 30Jun2022, Route: IM, Anatomical location: Left Deltoid, Time of vaccination: 13:57), administration date: 07Feb2022, when the patient was 2 years old, for COVID-19 immunization.The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (medically significant) with onset 28Feb2022 12:40, outcome "recovered" (28Feb2022), described as "Occupational exposure".  Clinical course:RN injected patient with 3 mcg close of BNT162B2 (Dose 4), After being injected with needle, patient pulled away causing needle to dislodge from deltoid muscle. As Child pulled Away. RN injected mediation, however, none went into muscle because needle was already removed. Two drops of vaccine ended up on patient arm and one drop on caregiver shirt. It Was determined from amount hand on patients arm no valine was injected into muscle. Patient dosed again. PI discussed with medical monitor and She advised to submit vaccination SAE. Patient monitored and assessed for 30 minutes post vaccination and assessment WNL.Event did not required visit to emergency room and physicians office.   Additional Information:No prior vaccination was done. No AE for prior vaccination within 4 weeks. Query:Event: as child pulled away, RN injected medication, however, none went into muscle because needle was already removed Response: 1.The SAE is already documented. 2.The narrative should read:It was determined from the amount of liquid on patient's arm, no vaccine was injected into muscle.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the event OCCUPATIONAL EXPOSURE TO PRODUCT and BNT162B2.
The patient had a hard, tender, knot appear at the injection site that has moved to the back of the deltoid area.  It is now less tender and some what smaller after the patient took several doses of Benadryl over the past 4 days and Hydrocortisone cream.  Zero redness was noted.
woke up around 2 AM with pain in essentially every joint.    I took 525 mg  Tylenol and was able to sleep after a while.  The pain was completed gone in less than 12 hours.  Other than sore arm for the first two days after the injection,  the joint pain was all I experienced.  It did not interfere with normal activity other than a few hours sleep.
Initial report received from a Healthcare professional on 19 June 2011. A 32-year-old female patient, with no concurrent conditions nor any known allergy, received a second dose of pre-exposure series of Intramuscular IMOVAX rabies vaccine (Batch lot number: G1377-1) on left deltoid on 15 June 2012. The patient had received first dose (dose: 0) of Intramuscular IMOVAX Rabies vaccine in Right Deltoid (Batch lot number: G1377-1) on 12 June 2012. On 15 June 2012, the date of vaccination, the patient had swelling of lymph node under left arm of size of a baseball, had light headed feeling and HA. The lymph node had swelled up to size of baseball. The patient took BENADRYL as corrective treatment and the swelling had gone down. The length of needle was 1 inch. Outcome of Light Headed feeling was not reported. As of 19 June 2012, the patient had not recovered. Follow-up information received on 3 August 2012: The first dose of IMOVAX rabies (Lot number G1377-1) was received in the Left deltoid area intramuscularly on 8 June 2012 and not on 12 June 2012. The date of birth of the patient was updated as 12 June 1988. The second dose of IMOVAX rabies (Lot number G1377-1) was received in the Left deltoid area intramuscularly on 15 June 2012. On an unspecified date, the patient had recovered from the events. List of documents held by sender: none.
Day 4 after injection swelling of anterior deltoid palm sized associated with 1 cm tender non-red, mobile left supraclavicular lymph node.
Mom reports child sent home from school due to "reaction" of flu shot in Left Upper Arm.  Child rec'd the flu shot on 10-25-12. patient states his arm didn't hurt until today. Pain is in the deltoid. No other complaints. Cetirizine 10mg q day x 5-7 days.
Hives - developed hives, edema to feet, rash, fever, 36 hrs after immunizations. Felt to be consistent with serum sickness. Hospitalized overnight for observation. 7/18/08-records received for DOS 5/30/08-DC DX:allergic urticaria. Presented with hives and joint swelling admitted for monitoring of non-anaphylactic reaction. Developed diffuse rash, lower lip swelling, extremity edema. Fever to 38.2. Diarrhea.
Got out of bed day after - 30 min later got super nauseated - passed out face down on ceramic tile in bathroom- broke nose - bruised both knees - busted forehead open- chills  started about 1 hour later and lasted for several hours- temp of 100.4-
expired Pentacel dose was administered to a consumer; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 6 months old patient who received an expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number not reported, expiry date: 17-May-2019 via unknown route in unknown administration site on 24-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Documents held by sender: none.
This spontaneous report was received form a 53 year old female patient, who was reporting on herself. The patient's medical history and concurrent conditions were not reported. On 21-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX 1 injection given in the left arm (lot # and route were not provided). Concomitant therapies included primula vulgaris (reported as "primrose"). On 22-DEC-2015, the patient experienced swelling, redness and warmth at the ZOSTAVAX injection site. She also reported a "low grade fever". No treatment for the events was given. The outcome of the injection site swelling, injection site warmth and injection site redness was reported as recovering/resolving. Since the onset, her arm had reduced in swelling and seemed to be getting better. The outcome of low grade fever was unknown. The patient did not seek medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
I had sore arm, chills, fatigue and dizziness for 2 days. All other symptoms subsided but the dizziness has persisted.
Felt fatigued the day before adverse event, died in his sleep of arterial occlusion
Headache which come and go on regular basis; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache which come and go on regular basis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache which come and go on regular basis). At the time of the report, HEADACHE (Headache which come and go on regular basis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication  was not provided.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 06-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
C/o tenderness, sore at site & tender to move had a routine physical  by Primary MD. Dx with bursitis.
Information has been received from a consumer concerning her 11 year old daughter with type 1 diabetes and no known drug reactions or allergies, who on 01-JUN-2010, was vaccinated with the first 0.5 mL dose of GARDASIL (route not provided) (lot number 661952/1129X). Concomitant therapy included HUMALOG. In June 2010, "recently", the patient experienced a dime sized painful swelling and redness at the injection site. It was also hard to the touch. The patient called the physician. No lab diagnostics studies were performed. At the time of reporting the patient had not recovered. Follow up information has been received from the consumer concerning her 11 year old daughter with type 1 diabetes mellitus, no known drug allergies, no illness at time of vaccination, who on 01-JUN-2010 was vaccinated with a first dose of GARDASIL (Lot # 661952/1129X) in her left deltoid at 10:15. The patient experienced swelling at the injection site, painful at site, redness and hard to touch at the injection site. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.
Injection site soreness, redness and elevated temperature for 2 to 4 days. Also 1 day of mild fatigue and minor joint soreness.
Tinnitus in right ear : after loud sounds or music, wind, etc. Sounds like stereo feedback.
Woke this morning with a brused tongue (bitten), vomited.  Patient also said she had urinated on herself while sleeping.  vomited a few more times after. Felt really tired all day after that.  Patient states her blood sugar was a little high as well.
Arm itchy / extremely itchy all over/extremely itchy all over/Itching persisted; Arm hurt; Vision loss; developed a rash on his arms, upper chest, legs, tops of his feet and stomach/; Arm hurt; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Vision loss) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0110(orD)21A and s 033821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Reported that, he had first symptoms on 13-MAR-2021.).   On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. In May 2021, the patient experienced VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Vaccination site pruritus). On 31-May-2021, the patient experienced RASH (developed a rash on his arms, upper chest, legs, tops of his feet and stomach/). In June 2021, the patient experienced BLINDNESS (Vision loss) (seriousness criterion medically significant). On 25-Jun-2021, the patient experienced PRURITUS (Arm itchy / extremely itchy all over/extremely itchy all over/Itching persisted) and PAIN IN EXTREMITY (Arm hurt). At the time of the report, BLINDNESS (Vision loss), PAIN IN EXTREMITY (Arm hurt), RASH (developed a rash on his arms, upper chest, legs, tops of his feet and stomach/), VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE PRURITUS (Vaccination site pruritus) outcome was unknown and PRURITUS (Arm itchy / extremely itchy all over/extremely itchy all over/Itching persisted) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no concomitant medication reported. There was no treatment medication reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow-up received on 01-SEP-2021 Contains No new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
From the date of his vaccine til the date he  went to the hospital (August 22, 2021) he felt these symptoms more and more. Soar arm, chills, body aches, fatigue, fever, lost of taste, cough, shortness of breath, excessive sweating, heavy chest, couldn?t walk or use legs, couldn?t urinate after drinking water. He took  Advil(red pill). He died August 23, 2021
Pt came into the internal vax clinic and received a Pfizer booster.  It was later found out after looking at the white COVID card that he had actually gotten Moderna for his original series. Health department has recommended that we submit a VAERS for this.
Pt presented to hospital with shortness of breath. Diagnosed with COVID-19, pneumonia due to COVID-19, acute respiratory failure with hypoxia, acidosis,  IBS, nicotine dependence, encephalopathy, ulcerative colitis, CHF, hypertension, kidney disease. 12/12-12/13/2021 severe decomp with worsening multifocal pneumonia on chest xray and a new mrsa bacteremia and worsening kidney function, transitioned to comfort care
Immediately after receiving the 4th vaccine (Typhoid VI, YFV, Rabies & Influenza) pt's face became pale and she closed her eyes.  She was seated. Lowered her to supine.  She became rigid then twitched several times.  Used ammonia inhalant, pt responded by opening her eyes but staring blankly.  She was anxious and started thrashing side to side.  She sat up suddenly and asked what happened.  Initially she didn't understand what was being said to her.  She expressed confusion.  This happened over 3-5 minutes.  Returned her to supine and applied a cool pack.  She was diaphoretic and still pale but spoke coherently.  She sat on and off to drink apple juice.  Each time she stated that her head felt heavy and she was dizzy.  It took about 20 minutes before she felt well enough to sit for about 10 more min. before standing and leaving with her mother.  Her mother and I assisted her down the stairs and into the car.  Called mother's cell phone at 1:45 PM left VM.
Metallic taste in mouth; Headache; flu like symptoms; achy body; kind of sick; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (achy body) and ILLNESS (kind of sick) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Atrial fibrillation medication for Product used for unknown indication, Thyroid medication for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (achy body) and ILLNESS (kind of sick). At the time of the report, DYSGEUSIA (Metallic taste in mouth), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (achy body) and ILLNESS (kind of sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-139311 (Patient Link).
Arm pain so severe that resulted in the necessity of  immobility 6 hours after injection, began experiencing episodes of lightheadedness 9 hours after injection, and suddenly fainted 12 hours after injection
Fatigue and headache starting about 7 hours after vaccine.  18 hours after, vaccine site was very sore; that resolved 36 hours later.  However, vaccine site remained mildly itchy for a week and then redness increased again and so did the itch.  It is very strange.  11 days later (today) it is even itchier than yesterday.  Otherwise I feel fine.
Symptoms of sweating, Extreme dizziness and nausea presented 5 minutes after vaccine administration
Fever; chills; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 42-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: Not reported) via an unspecified route of administration in arm left on 24Feb2021 13:15 (at the age of vaccination of 42-year-old) as dose number unknown, single for COVID-19 immunization at workplace clinic. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no known allergies. Patient did not have COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 25Feb2021 14:00, patient experienced with fever and chills which lasted for approximately 3 hours. Patient did not take any other vaccine within four weeks and no other medications in two weeks of vaccination. Patient received ibuprofen as treatment for the reported events. Outcome of the events was recovered on 25Feb2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information expected.
Seizure day off and the next day. Each during lunch time. Assumed to be within normal seizure activity for patient per the parent. Witnessed by daycare teacher. Denies fever.
About 2-3 hours after the first shot, I was extremely tired and disoriented but was unable to sleep. That lasted through Saturday. Now yesterday I started to develop an extremely sore throat with a swollen neck and lymph nodes. The exhaustion has returned and it hurts to keep my eyes open. The injection site has been sore with a lump since the day I got it. My shoulders and chest feel stiff and tight and it hurts to move. Please note that I tested positive for COVID-19 back in April and this was way worse than any symptoms I experienced back then. Stop forcing people to put an unapproved "vaccine" into their bodies, this is so wrong.
No adverse events have been reported, but patient received second dose of vaccination too early. First dose was 4/22/21 and second dose was 5/5/21 this was not discovered until after the fact. Patient was informed and counseled to sign up and to report any adverse events.
How long do i have to wait to take otc pain meds after vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long do i have to wait to take otc pain meds after vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long do i have to wait to take otc pain meds after vaccine.). At the time of the report, VACCINATION COMPLICATION (How long do i have to wait to take otc pain meds after vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Pt recv vax on 10/26/98; on 10/27/98 pt exp sore/ unable to move/ red/ swollen/ warm Rt arm, headache, became sick w/ fever (102)
Information has been received from a registered nurse concerning a 26 year old black female with no allergies or medical history who on 24-APR-2006 and28-JUN-2006 was vaccinated SC in the left upper arm with a two doses adult series of Varivax (lot numbers 649734/0789R and 652552/0022F respectively).There was no illness at the time of vaccination. on 31-AUG-2006, the patient tested negative for seroconversion for varicella at less than 0.91. At the time of the report, the patient had not recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the nurse who reported that there was no adverse event. It was noted that the patient had a hepatitis B surface antibody screen of less than 3.0 mU/mL and inconsistent with immunity. The patient's vaccination status with hepatitis B virus vaccine was not known.
Fever, sore swollen arm, aches/pains, chills, cough, headache, fatigue, lethargic, stomachache, sharp pains in arm.  Feeling better on third day, fever continues, sore arm.  Day 4, pain in arm, lethargic, upset stomach, fever, asthmatic. Day 5, same symptoms.  Today is day 12, I'm continuing to spike fevers, low grade up to 100, but I run a low body temp, usually 96-97.  General feeling of being ill, upset stomach continues, fatigue.  Been staying down as much as possible last few days, still not feeling well along with fever.
Large rash below injection site on 3/4/2021. INjection received 2/20/2021.
Client c/o sore throat, body aches, swollen left deltoid (Tdap), within 6-8 hours following vaccination. The following day, client noticed a rash on her trunk and back (wheels, some smaller fluid-filled bumps, and other red bumps). Client denies itching. Client continued to experience increased body aches, rash, left deltoid swelling and pain. On day 5, client took Benedryl and reported some improvement. Client presented to Health Dept. with scant rash on trunk. Some hive-like wheels noted under breastline. Client plans to visit urgent care center for follow-up.
Left arm red knot - hard - the size of quarter next to injection site. Sore. Red and swollen LAC.