chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lose her short term memory; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AMNESIA (lose her short term memory) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (lose her short term memory). At the time of the report, AMNESIA (lose her short term memory) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.       Concomitant products were not reported.  Treatment medications were not reported.
Inflammatory response affecting area of scoliosis hardware, radiating down left arm and femurs. It felt like severe bone pain. This occurred after the first dosage, too, for about 10-14 days. The second dosage exhibited worse pain.  Treatment has included consistent rounding of NSAIDS.
This is a spontaneous report received from a non-contactable reporter  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient showed her right arm around the injection site swelled up red and is warm , about 4 - 5 inch circle and is sore.  She also has fever and chills.  No hives and no trouble breathing
chills, fever, cough, chest congestion, nasal congestion, HA, nausea, fatigue, body aches. Feel like  I have the flu. Ibuprofen with mild improvement.
patient woke up at 3:30 a.m. the next morning with arm red and swollen. went to emergency room where she was diagnosis with petechiae and allergic reaction according to doctor that treated her at emergency room and expected it to be from pfizer covid vaccine since she had never had a reaction to a flu vaccine. patient was given steroids and benadryl
Pt recv vax on unspecified day;  within 24 hr post vax pt exp red/ hot/ swollen local rxn
Blood spots under skin in arm  vaccination given in. Shortness of breath, chest pain, headaches, tiredness
Monkey pox vaccine dose #1  administered on 8/22/2022 to right forearm. Approximately 4-5 hours after receiving vaccine, she noticed increase redness and itching to right forearm around injection site. Denies any pain. She states at night, swollen lymph under her right armpit area. States she took Benadryl to help with itch. She states she noticed center of injection site to be hard to touch. States today, lymph node disappeared.  Today, complain of swelling, itching and redness to right forearm. Lymph node disappeared. Denies any pain.
A report was received from a healthcare professional on 30 October 2003 concerning a male vaccinee in his forties who inadvertently received 0.5ml of expired Fluvirin on 27 October 2003. On 27 October 2003 the vaccinee inadvertently received 0.5ml of 2002-2003 Fluvirin.  No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 February 2004. A follow up report was received from a healthcare professional indicating that no adverse event had occurred at the time of reporting.  The vaccinee received this year's vaccine 3 weeks later. No follow up pending, all information received.
I awoke itching. Tried to ignore it. When I looked in mirror saw big red blotches all over my torso from bottom of neck to top of hips. Itching couldn't be ignored. While waiting to hear back from Doc, took Benadryl 2 tsps, hives cleared in few minutes, Hives & intense itch came back every 4 hours through 9:00 AM on 4-24-19 when took last Benadryl dose.
I started feeling bloated, and then I got bloated to the point where I was having trouble moving and it just felt like a tightness in my upper stomach and chest area. I thought I might be having a heart attack so I took an aspirin and it went away.  Then I went to sleep. I didn't go to the doctor and I'm not going to .
Injection site, back of left arm a few inches above elbow, red, itchy, painful to touch, welt forming. Early next morning welt area blistered, by 3:00 PM blister was weeping and a 3/16" crater formed.
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, for prophylaxis, reported lot # M037248 expiration date 21-FEB-2019 (dose, frequency, anatomical location and route were not reported). The administered doses of the vaccine experienced a temperature excursion of 0°C to 1°degrees Celsius for 4 hours 39 min. It was also reported that the vaccine experienced  previous excursions of  0°C to 1°degrees Celsius for 5 hours 23 minutes. The temperature excursions were detected by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012671: US-009507513-1703USA012672: US-009507513-1703USA007486.
After a child received the Pfizer pediatric vaccine, they became pale, light headed, and weak. The pharmacist had them lie on the floor and applied a cold compress. Another child who also received the same vaccine saw what occurred to their sibling and became nauseous and vomited. After 30 minutes of the pharmacist observing them, both children felt better and left with their family.
I noticed lower extremity petechiae, and blood blisters in my mouth on 5/22/2021. Next day, on 5/23/2021, the blood blister in  my mouth was significantly larger, size of my thumb. Also blood blisters on my tongue. Petechiae was all over lower legs, and cropping up around bra line, scattered over torso. I went to urgent care where they drew my blood and told me my platelet count was zero. I have no previous history of any of this. They instructed me to go  to the Emergency Department. At the hospital, more labs were drawn, and I was admitted to the oncology unit. I was given a transfusion of platelets. My blood pressure was extremely high, systolic 214.  They started giving me IV hydralazine and metoprolol and I needed these IV blood pressure meds each day while there, although the metoprolol was only used a few times. They started me on lisinopril 5 mg around the 3rd day because IV meds didn't control my blood pressure for very long. They had to increase the dose to Lisinipril 10 mg on my 5th day in the hospital. I developed numerous large bruises all over my arms and some other areas, with more petechiae on my face.  On the day after admission, I was given IVIG and more platelets, and started on a regimen of dexamethasone 40 mg IV times daily 4 days. The course of therapy was completed. I was discharged to home with a platelet count of 24 on 5/27/2021 with follow up with hematology and primary MD follow ups. Platelet count on 6/1/2021 was up to 185.
11/4/00, right deltoid slightly warm and swollen and has a varicella lesion above this. Treatment: ibuprofen. On 12/10/00, cerebellar ataxia; treatment: hospitalized; neurologists consulted. They will see him if not recovered in 1 month. Pt is currently in the hospital.
Pt slept afternoon p/vax; mom reports up 3-4 times the night p/vax given; Pt did not have high pitched scream but cried 1-2 hrs @ a time & seemed to beat on mom's chest as tried to comfort pt;
This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergy headache) 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 16-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced HYPERSENSITIVITY (Allergy headache). At the time of the report, HYPERSENSITIVITY (Allergy headache) outcome was unknown. The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable. No concomitant medications were reported. No treatment medications were reported.
arm was red like the size of a baseball and it itched; itching a little bit; red spot with a circle around where got injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (arm was red like the size of a baseball and it itched), PRURITUS (itching a little bit) and VACCINATION SITE ERYTHEMA (red spot with a circle around where got injection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 19-Jan-2021, the patient experienced RASH PRURITIC (arm was red like the size of a baseball and it itched), PRURITUS (itching a little bit) and VACCINATION SITE ERYTHEMA (red spot with a circle around where got injection).   The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency.    At the time of the report, RASH PRURITIC (arm was red like the size of a baseball and it itched) and PRURITUS (itching a little bit) had resolved and VACCINATION SITE ERYTHEMA (red spot with a circle around where got injection) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Patient was supposed to get Prevnar-13 and her daughter the Moderna booster 0.25mL. It was a family of 3. Two were getting Moderna Booster 0.25mL and one getting the Prevnar-13. Scanned the Prevnar-13. Had Prevnar-13 rubber banded to the box to keep them separated, but when administered, the immunizer grabbed one of the Moderna doses by mistake. Patient received 3 previous COVID-19 doses of Pfizer with the last dose being received 10/13/2021 (6 months after the 2nd dose). Now received a 4th dose of COVID-19 Moderna 0.25mL on 11/16/2021.
My face broke out on the right side in two spots. It was swollen. I went to see doctor. I was given a prescription for Keflex and an antibiotic ointment.
The patient developed an allergic reaction to her first Moderna injection she received from the clinic on 03/27/21.   She developed small bumps to the left arm where she was injected about 18 hours after injection, which then progressed to full body hives 24-48 hours later. She was seen in UC and given steroids and is now reporting near full resolution of the rash. She has mild discomfort to her throat but no respiratory distress
travelled to my chest and the rest of my body; itch; rash near the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (travelled to my chest and the rest of my body), PRURITUS (itch) and VACCINATION SITE RASH (rash near the shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE RASH (rash near the shot). On an unknown date, the patient experienced RASH (travelled to my chest and the rest of my body) and PRURITUS (itch). At the time of the report, RASH (travelled to my chest and the rest of my body), PRURITUS (itch) and VACCINATION SITE RASH (rash near the shot) had resolved.            Concomitant medicine was not provided. Treatment included triamcinolone acetonide cream USP 0.1%   This case was linked to MOD-2021-071424 (E2B Linked Report).
Pt received IM shot on 10/25. On 10/26, reported pain shooting/radiating down arm. On 11/15, subsequently reported shooting pain for 2 days following shot, then severe arm then 24 hours of flu symptoms. After 3 days, all sx resolved.
Have been having some heart fluttering like on the chest; Got little short of breath; Heart swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified route in Jul2021 (Batch/Lot Number: EWA96) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated, "I am just calling of this number because it says that possible side effects, I have got the shot like 3 weeks ago and I am due for the second shot today (17Aug2021) but last couple of days (Aug2021) I have been having some heart fluttering like on the chest, so I don't know if I have any heart swelling or what do you call it, you know the heart, something to my heart I am not sure if it is, I have like heart fluttering, it would go away, it come back and go away like I feel like may be got little short of breath, I think that I am not sure about but I am, should I get the second shot that's what I am asking?". The patient was having heart fluttering last for 3 or 4 days but now it seemed to be going hopefully. The outcome of the event "Have been having some heart fluttering like on the chest" was recovering, of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Classic non verbal autism. Sensory processing disorder. Dyspraxia. Severe anxiety. Vmrc and speech diagnosis.
Several symptoms acute during first two weeks including weakness, neuropathy, fatigue, headache, stomach issues including diarrhea, sore throat, ear ache.  Eventually tested for mono is week 5 of sickness.  Epstein Barre values very high.  Treated with antiviral for two weeks.  All other testing came back negative, including strep covid, lyme.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female who on 27-APR-2009 was vaccinated IM with the second 0.5ml dose of GARDASIL (lot# 661952/1129X). There was no concomitant medication. The patient discovered that she was pregnant during the GARDASIL series. The patient's last menstrual period (LMP) was reported as 21-MAY-2009. The estimated delivery date (EDD) would be on 25-FEB-2010. On 26-DEC-2009, 31 weeks from LMP, the mother developed premature rupture of membranes. The infant was in the breech position so the mother had to have a Cesarean section to deliver the baby. The infant was reported to be abnormal with an intraventricular bleed. He weighed 3 pounds and 15 ounces. His Apgar score was 3/7. It was also reported that the mother experienced urinary tract infection during pregnancy and was treated with MACROBID 100mg, which started on 30-JUL-2009 for 7 days. The mother got a shot of flu vaccine on 12-OCT-2009. The mother developed preterm premature rupture of membranes during pregnancy. During delivery, the baby was in a breech position and then the mother had a cesarean. The infant had intraventricular bleed. At the time of the report, the baby's outcome was unknown. Upon internal review, intraventricular bleed and born at 31 weeks from LMP were considered to be other important medical events. The mother's experience has been captured in WAES# 0907USA03082. Additional information has been requested.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 36 years and 07 months. No concomitant medications were reported. On 10-Jun-2022, the vaccine facility staff was notified of an audit that was done and they were made aware of vaccines that were administered beyond use date after the thaw process. Patient had not reported any adverse reactions after the administration of the vaccine. No treatment medications were reported.
Patient stated that she became light headed the same day that has not gone away. The patient stated that she received a few seconds where her left arm went numb. She tried to lay down but she was getting short of breath. She went to sleep for a few hours. The next day she was very weak and still light headed. She felt faint, could not breathe and heart was beating at a rapid rate. Took a over the counter Medication.  Husband called 911. The EMT did not take her to the hospital. Husband took her to the hospital the next day. PCP prescribed heart medication.
patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 27-Aug-2021 from a Physician via Medical Information (Reference number- 00743910) and transmitted to Sanofi on 27-Aug-2021.  This case involves a 21-year-old male patient who was given an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no adverse event (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 27-Aug-2021, the patient received 0.5 mL (total) dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5624AA and expiry date 10-Jun-2021] via unknown route in right thigh for prophylactic vaccination.  It was reported, "A patient was given expired vaccine this morning. Caller wanted to know the recommendations on what to do".  It was a case of actual medication error due to expired vaccine used (latency was on the 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.
Narrative:  Patient contacted telephone triage nurse today requesting advice. Patient states he received his second covid vaccine on 4/8/2021, "starting feeling very bad right afterward - just a little nauseated, weak, tired, muscle pains all over." Patient states symptoms progressed over the next few days, "I was very nauseated all day yesterday and more tired out, then when I woke up today I started vomiting up some blood." States he vomited a large amount of bright red blood. No abdominal pain, "Just heartburn very bad, and I just feel sick." States he is also very weak "and my forehead is all broke out into a sweat - hot and cold flashes." Patient reported to hospital yesterday as recommended. States he was given an IV for hydration, along with Zofran, and was also checked for Covid. PLAN/FOLLOW-UP (Describe): Covid test was negative, no further nausea or vomiting. Taking in fluids well today and was also able to eat. States "I'm on the upswing". Advised to call clinic or report back to ER if symptoms recurr.
body aches; chills; joint pain; fever; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 592671000001) via an unspecified route of administration in the left arm on 01Aug2021 at 11:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Aug2021 at 23:00 the patient experienced body aches, chills, joint pain and fever. Therapeutic measures were taken as a result of events included treatment with paracetamol (TYLENOL) for pain and fever. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events general body pain, chills, joint pain and fever were recovering at the time of this report.
Pt was brought in by grandmother on 1/4/02, complaining of swelling and itching to vaccine site on left thigh. Seen per doctor and given RX for Benadryl. Grandmother was instructed that if pt started to have a fever, to start RX of Keflex antibiotic and return to clinic.
he developed tinnitus; he is panicking; Started having tendinitis in ear.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "he developed tinnitus"; PANIC REACTION (non-serious) with onset 14Apr2021, outcome "not recovered", described as "he is panicking"; TENDONITIS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "Started having tendinitis in ear.". Additional information: Patient stated that he received the second dose of the pfizer covid 19 vaccine on Tuesday and on Wednesday he developed tinnitus describing it as a high pitch ringing in his head in his ears. Patient stated he was panicking now and wanted to know was this reported and will it go away. Patient stated it is continuing and does not stop. It was unknown if Reporter was a Healthcare Professional and prescribing HCP. Reporter's contact information was not available to a sub-contracted party.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.