chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 10 hours after the vaccine administration, pt vomited 3-4 times in span of 1 hour and turned blue. May be due to contact with sick cousin.
On approximately 2/25/99 the pt received his first dose of Lymerix.   Subsequently, he experienced extreme fatigue and his legs occasionally buckled.  In 1999, approximately one year ago, the pt received his second dose of Lymerix.  Subsequently, he experienced dizzy spells, muscle and joint pain in the knees and neck. An MD visit was required. Lymerix was discontinued.  The most recent information received on 2/25/00 reports the condition of the pt is ongoing.
patient states that she received covid vaccine on 1/4/2021 to left arm and developed left arm redness and swelling on 1/10/2021. Pt. states that she took motrin and it is helping. Pt. states that left arm is tennis ball size, lightly red
Myalgias, nausea, otitis, rigors, chills, subjective fevers, headache began 12 hours after, resolved within an additional 12 hours
VERY PAINFUL BURNING SENSATION UNDER ARMPIT VERY ITCHY. VERY UGLY RASH STARTED UNDER THE ARMPIT AND SPREAD ALL OVER THE BODY. RED AND SWOLLEN. IT SPREAD VERY QUICKLY. YOU CAN FEEL HOW THE SKIN WAS TURNING INTO LUMPS.
The pt's right arm was red, swollen and hurt to the point he couldn't move it. By the next day, the swelling went down the the pain started to go away.
On 12/18/20 @ 2:58 PM,  the patient experienced a really bad headache directly after received the vaccine. Her heart rate elevated 135 with heart palpation. Her BP was 178/92. She was very dizziness, short of breath, her had a hives all over her chest.
Patient reported that he woke up the day after vaccination with a slightly swollen, tender area  about 1 inch X 1/2 inch on the inner aspect of his left leg below the knee (lateral calf muscle). Fearing he had a deep vein thrombosis, he called the ER. I took the call and agreed with the need for evaluation. At the ER he was examined by a physician. No radiology or laboratory tests were performed. He was released with a prescription for Motrin, PO, prn. Follow up call to the patient today (36 hours after discovery of painful area and 56 hours after vaccination) the patient reports no improvement and no worsening of the painful area.
Pt. reports he passed out while sitting down at Dinner on 07/16/21. He denied any seizure like episode and syncopal episode was witnessed by his father. He states prior to passing out he had some chest pain and had numbness/tingling to fingers when he woke up. Pt. stated lasted about 20 seconds.
Regional lymph nodes enlarged temporarily (& tender), (L) arm "swollen", "muscle aches". As of report date lymph nodes are no longer tender, one in the posterior cervical chain is enlarged. No other symptoms remain.
(My husba.nd is non verbal) Very weak when I woke him up in the am.  Could barely walk.  Got him up to go to the bathroom and he fell to the ground. He had no muscle strengle to get up.  I had to call a neighbor to help.  I called my dr office and they said to keep him hydrated and keep an eye on him.  That's all  My son came and stayed with us on Thursday, the two of us got him into bed.  He slept the night and when he woke in the morning he had his strength back.  I had him rest for the rest of the week. So very scary.
syncope; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 07Mar2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown, Expiration Date: 24Aug2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "recovered". He believes the patient was a gentleman that is no longer with the pharmacy and has not been for a long time. The patient experienced Syncope and came back to his senses. He said that the patient was at their pharmacy for a couple of months and then went to a different state. It has been a while since these adverse events occurred and said that it was close to 1.5 to 2 years ago now. He thinks one was Moderna and the other one was Pfizer. Both Patients had syncope that was momentary and came back, and vitals were ok.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported event Syncope. 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.
PATIENT DEVELOPED BODY HIVES/RASH ALL OVER UPPER TORSO AND ARMS ABOUT A WEEK AFTER INJECTION- TOOK PINK PILLS A FEW DAYS TO HELP WITH ITCH. STILL PRESENTED WITH RASH AFTER 3 WEEKS UPON ARRIVAL FOR 2ND DOSE-DID NOT ALERT MD OR PHARMACY ABOUT REACTION--PHARMACY CALLED MD AND MD ADVISED NOT TO GET 2ND DOSE AND WILL CALL PATIENT TO REFER TO ALLERGIST.
left side of my face swelled (mostly in the sinus regions); tooth pain from upper gum swelling under his nose; tooth pain from upper gum swelling under his nose; just thought it was just a sinus issue; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient reported for himself that he received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6205), via an unspecified route, administered in arm left on 20Mar2021 at 14:45 (age at vaccination was 50-year-old) as dose 1, single for covid-19 immunization at public health clinic. No other vaccines were received in four weeks. Medical history included minor asthma and high blood pressure; both from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]), ibuprofen (MOTRIN [IBUPROFEN]), diphenhydramine (DIPHENHYDRAMINE), paracetamol, pseudoephedrine hydrochloride (TYLENOL SINUS [PARACETAMOL; PSEUDOEPHEDRINE HYDROCHLORIDE]); all taken in two weeks for an unspecified indication, start and stop date were not reported. Report stated that, on 21Mar2021 at 13:00, a day or two after the injection the patient's left side of face swelled (mostly in the sinus regions) and tooth pain from upper gum swelling under his nose so the patient just thought it was just a sinus issue so he took unspecified over the counter meds and didn't think anything of it. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD) at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
a patient received an expired dose of ACT-HIB vaccine/ No AE; Initial information received on 29-Mar-2021 and additional information received on 01-Apr-2021 regarding an unsolicited valid non-serious case received from a Other Health Care Professional via nurse via physician via Medical Information (Reference number- 00539890).  This case is linked to case 2021SA112593 (same reporter, sibling).  This case involves a 6 months old male patient who received an expired 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] batch number: UJ143AAA, expiry date: 22-Mar-2021, Frequency: once, Strength: standard via intramuscular route in the left vastus lateralis on 29-Mar-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination respectively.  It was an actual medication error due to expired vaccine used (latency: same day).  Potential Product Technique Complain: No, Caller stated that they gave two different children the product that had expired. Caller wanted to know what should they do. Outbound call made at 1:09 pm on 30-Mar-2021. No response. Voicemail left with case and contact number. Nurse called previously about Act-Hib and is looking for guidance on how to proceed. Treatment: The clinic calling the manufacturer for guidance. Product used, Still using product: No.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Woke up in middle of night w numbness in right arm. Thought it might be a stroke. Following days and nights with tingling in hands and feet, an extreme and persistent pain bottom of right forearm similar to a bad bruise and continuing intermittent numbness in both arms during night while sleeping. No reaction at injection site. I am healthy and this vaccine was the only change in my health history..  Symptoms continued for weeks so I made an Appt for 2-16-2019 for 5 health screenings--Carotid Artery Disease, Atrial Fib,, Abdominal Aortic Aneurysm, Peripheral Arterial Disease and numerous other tests ruling out heart/stroke risks.
After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination  and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.
Vial of Menveo mixed with "generic diluent".; Vial of Menveo mixed with "generic diluent".; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Vial of Menveo mixed with "generic diluent". ) and inappropriate dose of vaccine administered (Verbatim: Vial of Menveo mixed with "generic diluent".). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-AUG-2023 The reporter stated that vial of Menveo was mixed with generic diluent. The vaccine administration facility is the same as primary reporter. No other adverse event (AE) details available.  The patient received Menveo which was mixed with generic diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
congestion; I have inflammation all over; tinnitus; major headaches; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (congestion), INFLAMMATION (I have inflammation all over), TINNITUS (tinnitus) and HEADACHE (major headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (congestion), INFLAMMATION (I have inflammation all over), TINNITUS (tinnitus) and HEADACHE (major headaches). At the time of the report, NASAL CONGESTION (congestion), INFLAMMATION (I have inflammation all over), TINNITUS (tinnitus) and HEADACHE (major headaches) outcome was unknown.            No concomitant medication reported.  No treatment was reported however patient seek information for the treatment.
Pt called on 12/29 to report she is in pain. Reports at around 9:30 PM on 12/28 she had headache. They woke up at around 4 AM in severe pain.  Her head hurt all over as well as the back of her neck down in her legs. Her entire body ached. She felt like she could not get a good breath. Her SaO2 was decreased. Today she is still in pain. Her pulse is 108 lying down and SaO2 88-92%.  Will be going to the ER. Her oncologist is concerned about pneumonnia.
Child had suspected seizure x 2 episodes, 1 wk after the MMR was given. Pt was playing around 7pm when her head fell back, eyes rolled back, and shaking of arms/legs x about 2 minutes 911 was called and Pt was taken to ER and admitted to Pediatrics.  1/2/07 Received medical records from hospital which reveal patient had 3 admissions: #1 -- 10/23/06-10/25/06 Final Dx: seizure like episodes.  No further seizure like episodes were observed while hospitalized.  Family witnessed patient suddenly falling backwards while playing & extremities shook for approx 2 min.  Not responsive during this episode & foamed at the mouth.  Decreased responsiveness for approx 30 min afterwards.  Other symptoms were runny nose, decreased sleep & increased clinginess for approx 1 week prior to admit. #2 -- 11/5/06 was ER visit for seizures x 2 lasting approx 6 min & left eye stye.  During seizure, eyes open, unresponsive, stiff arms & legs lasting approx 2 min.  .  Additional antiseizure meds rxd. #3 -- 11/17/06 admitted overnight for seizures witnessed by EMS staff as grand mal seizure which did not respond to diastat, did resolve with valium IV.  Other symtoms were sinus congestion & cough for 3 days prior to admit.
(See Box 8) Received ER medical records which state patient was in full arrest upon arrival & was unable to be resuscitated. Autopsy report received which revealed COD was undetermined.  Patient was cosleeping with parents in bed which was significantly concave & had blood stains in middle of sheet per investigative report.
diagnosed with a blood clot in her right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (diagnosed with a blood clot in her right leg) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced THROMBOSIS (diagnosed with a blood clot in her right leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. In 2021, THROMBOSIS (diagnosed with a blood clot in her right leg) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Computerised tomogram: blood clot diagnosed with a blood clot in her right leg. In 2021, Blood test: cured of the blood clot.         Consumer called stated that two weeks after she went to the emergency room, got a CAT Scan and was diagnosed with a blood clot in her right leg. The ER did not keep her overnight, they referred her to her PCP doctor. The PCP referred her to a blood specialist, who started her on Eliquis for 3 to 4 months. The specialist performed blood work following the treatment and noted that she was cured of the blood clot.  Company Comment: This case concerns an 80-year-old, female patient, with no medical history reported in this case, who experienced the serious unexpected AESI event of Thrombosis. The event occurred on an unknown date after the administration of the second dose of mRNA-1273 vaccine and was reported with the seriousness criteria of Medically significant. At the time of the report, the outcome of the event was Recovered/Resolved.  The rechallenge is not applicable since the event occurred after the second dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an 80-year-old, female patient, with no medical history reported in this case, who experienced the serious unexpected AESI event of Thrombosis. The event occurred on an unknown date after the administration of the second dose of mRNA-1273 vaccine and was reported with the seriousness criteria of Medically significant. At the time of the report, the outcome of the event was Recovered/Resolved.  The rechallenge is not applicable since the event occurred after the second dose of the of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
ACUTE HYPERCAPNIC RESPIRATORY FAILURE 11/6/2022 HYPERNATREMIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 11/30/2022 HYPERNATREMIA ACUTE HYPERCAPNIC RESPIRATORY FAILURE 11/6/2022 HYPERKALEMIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 11/30/2022 HYPERKALEMIA
Pt has 10 cm x 13 cm area erythema, warmth and tenderness below injection R deltoid. Possibly adm. 5 x dose ie.  2.5 cc as opposed to .5 cc IM.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 09-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
On the evening of 2/25/21 my injection site were extremely itchy.  The next day it was swollen, red and hard the size of my palm.  I contacted the pharmacy they told me to take benadryl.  I did.  I have been taken it since.  It's now 2/27/21 and still experiencing extreme itchiness.
No adverse event, but inadvertently given 1st rotavirus vaccine after 15 weeks old.
Patient stated via phone call that she had a hematoma develop on her left arm approximately 10-12 days after her first Covid 19 injection.
Shot given by pharmacy. The symptoms rash on trunk of body to pubic area & back from neck to buttock fatigue/soreness by injection/site/muscle aches. Rx - MEDROL pack from MD. Shot given 9/12/2012.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Nov2021 at 12:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Apr2022 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker referring to multiple unspecified patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot # L045956 with expiry: 17-NOV-2017 (dose, frequency and anatomical location not reported), for prophylaxis. The vaccine was exposed to a temperature of 10.4 degree Fahrenheit for 252 hours. No adverse effect reported. The vaccine had no previous temperature excursion. The call was because of data logger. Additional information has been requested.
Numbness on the side where the vaccine was administered: Left arm, left leg and calf, left palate, left cheek, left side of the skin of the head. Headache. Especially on the forehead. Shooting pains in left leg and calf. Pain in knee and elbow on the left side. Sensation of compression in the chest. Fever and chills. Decline. Generalized muscle pain. Upper extremities pale especially in the hands.