chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This week i should take my 2nd dose but i was scheduled for surgery on 09Apr2021, so they let me do covid test then the results is positive; This week i should take my 2nd dose but i was scheduled for surgery on 09Apr2021, so they let me do covid test then the results is positive; This is a spontaneous report from a contactable Other-health care professional. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 06Mar2021 13:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient not administered other vaccine in four weeks. This week patient should take her 2nd dose but she was scheduled for surgery on 09Apr2021, so patient underwent lab test on 07Apr2021 14:00, covid test type post vaccination=Nasal Swab, covid test name post vaccination Rapid test, covid test date 07Apr2021, covid test result=Positive. Patient received treatment with Tylenol. Patient not had Covid prior vaccination; Patient was tested Covid post vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a strong temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19.
Persistent arthralgia noted since completing the Lyme vaccine series. The 2nd Lymerix vaccine was lot LY12069, in the RD on 5/14/99 and the 3rd Lymerix vaccine was lot LY144B9, in the LD on 5/5/00.
Sore arm, fatigue, migraine Managed at home.  29w pregnant, gestational diabetes, due date March 20
Patient was feeling a little ligthheaded and warm. She said she has had a history of anxiety around needles.  Blood pressure was taken 2 times with blood pressure cuff pharmacy staff had on hand, readings were 153/130, 165/137. Patient says she "normally runs around normal, 120/80." Patient was given water, patient remained in her seat for about 15 minutes, blood pressure taken again 140/100. Patient remained in waiting area another 15 minutes, patient said she felt fine, and had groceries to get in store. She said that she would contact us if feeling anything else while getting groceries, and then left observation area.
severe chills, nausea, skin irritation and rashes, pressure at back of head, light-headedness: intermittent chills, come in early evening, then again the next morning. This has happened at least once a week since the second vaccine.
104 degree temperature. Seizure 12:45 am 11/28/06. Mother stated no treatment. 12/19/06-records received and reviewed. Consultation report  Impression: Febrile seizure. On arrival to ED temp 104.9. After Motrin temp 100.8 CXR: mild peribronchial thickening suggestive of viral bronchiloitis
A nurse reported the occurrence of injection site pain in an adult female of unspecified age who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. She had no adverse experiences following previous immunizations. On an unspecified date, the subject received her second injection of Engerix B (5362A2). The nurse reported that the injection caused the subject to "scream out in pain." The injection site pain resolved after an unspecified period of time.
Severe Chills, Fever 102.2 on Tylenol, Body Aches, Headache, Arm soreness.  Began about 10 hours after shot.  Next day, fever down to 99 on Tylenol, still body aches.  During severe chills was having hallucinations (I'm sure related to the fever).
4 day after 12 month immunizations including seperate MMR and Varicella immunizations  she had a simple febrile seizure.  She then later that day developed diarrhea that resulted in dehydration and admission to the hospital for 2 nights for observation, IV fluids and supportive care then able to discharge home.
Pityriasis rosea skin reaction throughout the body. Initial large oval bumpy rash in chest and stomach. Smaller itchy bumps in arms, legs and back. Symptoms have been present for about a  week or two.
STRONG PAINS IN MY CHEST AND ARMS, LIGHT HEADED, VERY WEAK FELT LIKE I WAS GOING TO PASS OUT
Pt called on 11/4/2021 to report swelling the size of a golf ball, that site is red, swollen and painful.  She reported that symptoms seemed to get better and today has come back.
Significant increase in arthritic pain, many new arthritic pains. Decreased mobility and quality of life due to worsened chronic pain.
Patient reports consistent pain in site of injection, as well as inability to sleep on left side.  Reports subjective limited range of motion with left arm and pain with other various shoulder movements.  Patient (who is a healthcare professional) is concerned that vaccine was administered too high into the bursa and not deltoid muscle.
Vomiting, fever, Diarrhea, headache, and blood in stool
I started with a really bad headache. I had a fever of 103 degrees. My arm hurt. I was tired and exhausted. I had  body aches. The next day I had horrible severe stomach pain. On the 3rd day I was vomiting nonstop. I called my doctor and she prescribed me with an anti-nausea medication. On the 4th day it was all gone.
On 1/8/02, the pt broke out in a rash similar in appearance to a contact dermatitis (per PMD), non-pruritic. The pt is breast fed.
Localized swelling at injection site. Patient was seen at urgent care. Per mom, within 24 hours, swelling has improved.
pain at injection site; . This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the reporter for her neighbor. The age at vaccination was not reported. The patient received Shingrix and had injection site pain. The reporter did not consent to follow up. This case linked with US2019GSK219141, reported by same reporter.
Fever, chills, feeling faint 6 hours after vaccine, blurry vision, trouble standing
p/vax pt devel puffy area w/dark center & puncture mark on 9/13/99;saw MD & was dx w/subcutaneous necrosis;Md states it should resolve on its own but may leave a knot for 1yr or more;
Erythema, swelling, warmth to the site (5in x 2.5in) sore lymph nodes (axillary, cervical, tonsil)
On 1/12 at about 6:30 AM, I felt muscle tightness on the left side.  The whole right ring finger was numb and lock.  Within minutes, I felt tingling sensations along all my fingers and thumbs.  Then numbness at the tips.  Then, both my hands were very cold. At about 2- 3, I fell groggy, tired.  Then came the chill and fever, also light headaches.  The numbness was gone.  1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight.  I tried to uncurl them.  But they stayed locked.  It lasted about 1-2 minutes.  I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm.  Then at around 10 pm, I had bad warped vertigo.
Bacterium vaginosum 01/22/2008 exhaustion 06/2008. Foot and turning head trouble 06/2008. Left foot and left knee swelling with heat 09/2008. 11/2008 bacteria vaginosum and 3rd shot and spread to rest of joints. Treated with steroids, methotrexate for a year, anti inflammatories for a year. 06/2009 started remicade.
Patient with 2 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "Patient presented to the emergency department after a few days of feeling fatigued with a dry cough, sore throat, body aches, chills.  He notes no fever home subjectively.  Denied chest pain or shortness of breath, though did say that it was hard to take a deep breath.    Patient was noted to have AFib with RVR, thought likely triggered by COVID infection.  He follows with Dr., has been aspirin and atenolol.  Given his chads Vasc score of 3, he was initiated on heparin and eventually transitioned to Xarelto.  He also was treated with amiodarone to normal sinus rhythm, converted to normal sinus rhythm.  Rate control with atenolol.   COVID-19 was treated with remdesivir is he was a high-risk patient.  He was not given steroids as he did not become hypoxic.  Sepsis likely due to COVID-19 was treated with IV fluid boluses.  Due to viral nature of infection, no antibiotics were initiated.  Following IV fluids, his sepsis resolved.  Lactic acidosis also resolved following mass.   Given patient's initial soft blood pressures, his home antihypertensive medications were held.  His blood pressure remained in the normal to slightly elevated range during hospitalization, the highest blood pressure noted to be 136/71.   Discussed patient's alcohol use disorder.  He states that in the past he has quit for 40-50 days at a time, but always returns to drinking.  Discussed possible treatment options including medications and social support groups.  He agreed to start oral naltrexone on discharge.  A prescription for this was sent to his pharmacy."
Had the shot ~ 10am, ran errands, had lunch, came home got severe vertigo. Called 911. They came out & checked her vitals, which was normal. No hospital needed. She took a meclizine and felt better.
Red , feverish , swollen at or right below injection site. looks like a red circle measuring about 3-4 inches in diameter.
Slurred speech; Double vision; little bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSARTHRIA, DIPLOPIA, and NAUSEA 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 06-Dec-2021 at 5:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced DYSARTHRIA, DIPLOPIA, and NAUSEA. At the time of the report, DYSARTHRIA, DIPLOPIA, and NAUSEA outcome was unknown.            It was reported that the patient started exhibiting slurred speech, experiencing double vision and a little bit of nausea around 9:30 on 06 Dec 2021. No concomitant medications were mentioned. No treatment details were reported.
Information has been received from a nurse concerning a 75 year old female who on 12-SEP-2007 was vaccinated IM in the left arm with a dose of PNEUMOVAX (Lot# 657525/0554U).  Next day the patient called the physician's office to report warm, raised area at the injection site, that was painful and tender to the touch.  The patient was seen in the office and was diagnosed with cellulitis and treated with amoxicillin (+) Augmentin.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Extremely heavy blood clots in my pad. It was like i was having a miscarriage but i wasn't.  I have never bled this much to the point i bleed through my clothes and was left with a giant blood clot.
This infant had a fever of 104 to 105.7, and a seizure (convulsions), JMH - R10, Bacteremia.
At 8pm felt very ill had to lie down.  Went to bed, awake most of night with severe nausea, some abdominal pain and though I never had diarrhea, felt when I went to bathroom for nausea that it would come out both ends.  Felt feverish but too  sick to get thermometer(live alone). Did vomit a few times but the nausea was severe.  At 4pm of the next day began to feel better, did not return to normal activities until the 26th.
This spontaneous report as received from a physician refers to unspecified patients. It was reported the unspecified patients were vaccinated with improperly stored M-M-R II (lot#, dose, strength and frequency were unknown) subcutaneous. NO adverse effects were reported. Follow up information has been received from registered nurse. 61 unspecified patients received the improperly stored M-M-R II, lot # J003785 and expiration date: 28-MAR-2015. She stated that the dates of administration of the M-M-R II for the 61 unspecified patients were as followed: 09-JAN-2014, 13-JAN-2014, 14-JAN-2014, 15-JAN-2014, 17-JAN-2014, 20-JAN-2014, 21-JAN-2014, 22-JAN-2014, 24-JAN-2014, 27-JAN-2014, 28-JAN-2014, 29-JAN-2014, 31-JAN-2014, 03-FEB-2014, 05-FEB-2014, 06-FEB-2014, 10-FEB-2014, 11-FEB-2014, 12-FEB-2014, 13-FEB-2014, 20-FEB-2014, 21-FEB-2014, 24-FEB-2014, 25-FEB-2014, 26-FEB-2014, and 27-FEB-2014. This is one of several reports received from the same source. Additional information has been requested.
Pt. states that after receiving the 1st dose of Moderna 03/26/2021, started to experience symptoms 04/09/2021 of right back muscle inflammation. Treated with Steroids & Antibiotics and Ibuprofen. 11/2020 Covid + , 12/26/2021 Covid +
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.            Patient received the booster of the Moderna COVID19 vaccine and 11 days after her booster shot patient started to experience hives Concomitant information was not provided. Treatment information was not provided.
Fever, chills/sweats, pain in the back and legs, a red strip down my shoulder to my arm pit, very light headed, head ache.
Developed blood clots in lung; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient (not pregnant) received second dose of BNT162B2 (Pfizer) on 05Apr2021 08:30 AM (at age of 72-year-old) on Left arm at single dose for Covid-19 Immunization. Medical history included Thyroid, cholesterol and high blood pressure. No Known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin calcium (CRESTOR), nebivolol hydrochloride (MAXINEB), metoprolol, d-mannose. No other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (Pfizer) on 15Mar2021 08:30 AM (at age of 72-year-old) on Left arm for Covid-19 Immunization. Facility type vaccine was Hospital. Patient developed blood clots in lung on 06Aug2021 11:00 AM. Ae resulted in: Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). The outcome of the event was recovering. Heparin received as treatment. No covid prior vaccination. No covid tested post vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt began to fell dizzy about one minute after her injection.  Patient remained at vaccine table.  Denies any additional symptoms.  Dizziness resolved after 5 minutes, vitals declined.
Sars-cov-2 test positive: positive on 07Jul2021; sars-cov-2 test positive: positive on 07Jul2021; Cough; Fever; Congestion; Headache; SOB; Fatigue / tired; Dose 1 08Apr2021 / Dose 2 08Apr2021; This is a spontaneous report from a contactable other Health Care Professional. A 44-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736 and Expiry date: Unknown) via an unspecified route of administration on 08Apr2021 (age at the time of vaccination was 50-year-old) as single, first dose via an unspecified route of administration on 08Apr2021, (Lot Number: GN6204 and Expiry date: Unknown) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed COVID prior to the vaccination. On 06Jul2021, the patient experienced cough, fever, congestion, headache, fatigue, tired and SOB (shortness of breath). On 07Jul2021, the patient underwent COVID-19 test and resulted positive. The adverse events resulted in doctor or other healthcare professional office/clinic and Emergency room/department or urgent care visit. The patient received unspecified antibiotics and steroids as treatment medication for the events.; Sender's Comments: Based on Plausible association, there is a casual relationship between the suspected drug BNT162b2 and the reported events COVID-19 along with Drug Ineffective.
Arm got really cold; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Arm got really cold), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (Arm got really cold), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PERIPHERAL COLDNESS (Arm got really cold), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
RASH; This spontaneous report received from a consumer concerned a 54 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash. This report was non-serious.
Inadvertent administration of 0.2 ml of  12 + Moderna vaccine  that was in room temp for more than 12 hours to a recipient who was to receive Moderna vaccine for 6 mos to 5 years (0.25 ml).  The bottle for her age, which was thawing,  was mixed up with the expired adult vaccine when drawn up by myself.   So she received approximately 40 mcg of essentially expired vaccine instead of the 25 mcg of unexpired vaccine she should have received.  Parents were notified immediately after error was realized and before leaving the clinic yesterday afternoon.  I called her mother, this afternoon 12/3/2022, who stated pt had not experienced any untoward signs or symptoms. Pt also spoke with me and was happy and energetic.  I will follow up daily with the family.  Also needing to know how to proceed with finishing her vaccination for COVID.  Not sure if should negate this vaccine as suspect not effective as out of temp range for more than 12 hours.  Previously, the vial had had only one needle puncture for another patient.
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 41-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 27Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "obese" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19. The patient received Paxlovid to treated drug ineffective, Covid-19. Treatment start date: 31May2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Did not administer the liquid (DTAP/IPV) portion and mixed the powder (ACTHIB) portion with normal saline with no adverse event/ no AE; Did not administer the liquid (DTAP/IPV) portion and mixed the powder (ACTHIB) portion with normal saline with no adverse event/ no AE; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via Media Information (under reference- 00824421) and transmitted to Sanofi on 22-Oct-2021.   This case involves a one-year-old male patient while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] did not administer the liquid (DTAP/IPV) portion and mixed the powder (ACTHIB) portion with normal saline with no adverse event (Product preparation error and Underdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 26-Aug-2021, the patient received fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot U6940BA and expiry date 21-May-2022] via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to Active ingredient not added to diluent and Vaccine underdose (latency was on same day).  At the time of reporting, patient had no adverse event.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
c/o tingling sensation going down front of face, down front of body.  EMS present
Low-grade fever 99.9, headache, fatigue (resolved when I saw patient today). Site reaction - 11 x 7.5 cm erythema/mild swelling with mild tenderness.
11/18/07 Attempted to vaccinate pt with influenza vaccine. It appeared that vaccine was leaking from syringe. Not sure of how much vaccine may have been administered; contacted CDC regarding situation and recommendation. CDC did not return call. Called CDC again 11/19/07 and their recommendation was to re-vaccinate pt. Pt came in for revaccination 11/22/07. Pt at the time was feeling well and no complaints.
pt recv vax 30MAY97 & 15JUN97 exp joint pain all over body that has gotten worse;pt referred to MD;
Patient administered immunizations approximately 11:30 AM on 9/27/04. Mother informed our practice child had low grade fever in evening of 9/27/04 and the seizure with apneic spell. Ambulance called and patient transported to hospital. Released after exam in ER. Patient returned when had another seizure when leaving hospital. Medical Record 12/07/2004 states final diagnoses are febrile seizure and gastroenteritis.  Also vomiting.
Within 1 hour of injection: Light headedness (transient ~2 hours), shallow breathing (transient ~1-2 hours)