chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain I had been experiencing in my left knee and ankle suddenly disappeared.  I reported the same thing when I received the first two doses of Cominarty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (COMIRNATY), on 19Feb2021 as dose 1, single (Lot number: EL3247) at the age of 45 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "pain I had been experiencing in my left knee and ankle suddenly disappeared.  I reported the same thing when I received the first two doses of Cominarty".  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. It was reported that pain had been experiencing in my left knee and ankle suddenly disappeared. Reported the same thing when patient  received the first two doses of Cominarty. Prior to vaccination, the patient was not diagnosed with COVID-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337257 same patient/drug, different dose/event;US-PFIZER INC-202201337388 Same patient/drug; different dose/event;
Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.; Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.; Body ache; Fatigue; Redness at vaccination site; After second caller had cramping, and spotting for a couple of days; After second caller had cramping, and spotting for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (After second caller had cramping, and spotting for a couple of days), MUSCLE SPASMS (After second caller had cramping, and spotting for a couple of days), CHILLS (Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.), PYREXIA (Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.) and MYALGIA (Body ache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polycystic ovarian syndrome.    On 27-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (After second caller had cramping, and spotting for a couple of days) and MUSCLE SPASMS (After second caller had cramping, and spotting for a couple of days). On 25-Jun-2021, the patient experienced CHILLS (Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.), PYREXIA (Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.), MYALGIA (Body ache), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at vaccination site). On 27-Jun-2021, CHILLS (Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.), PYREXIA (Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.), MYALGIA (Body ache), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at vaccination site) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (After second caller had cramping, and spotting for a couple of days) and MUSCLE SPASMS (After second caller had cramping, and spotting for a couple of days) outcome was unknown.            No concomitant medications are provided. Treatment to the events not provided.   This case was linked to MOD-2021-240214 (Patient Link).
Patient got a full dose as a booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient got a full dose as a booster) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood disorder.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient got a full dose as a booster). At the time of the report, ACCIDENTAL OVERDOSE (Patient got a full dose as a booster) outcome was unknown.            Concomitant medications were not reported. Treatment details were not provided. A patient's has an underlying condition.
Expired FluLaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a specified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number ZD3NZ, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Oct-2022 Reporter's comment: The nurse reported that upto 5 patients might had received an expired dose of Flulaval from the 2021-2022 season. The vaccine administration facility was the same as primary reporter. The reporter said follow-up was ok via email above in reporter's details, she was not sure she could give out any patient information and she was still not sure about what patients might had gotten expired doses. The reporter consented to follow-up. Additional supportive information: The patients received an expired of Flulaval, which led to expired vaccine used.
Information has been received from a registered nurse concerning a 36 year old female who has received two doses of MMR II in the past (date not reported) and still has a low titer for measles, mumps and rubella (date not reported). On 18-SEP-2008, the patient was vaccinated with a "booster" dose of MMR II  that was expired. it is unknown if the patient sought medical attention. A product quality complaint was not involved. Additional information has been requested.
After receiving the vaccine, I didn't have any symptoms. When I caught COVID I had a headache, dizziness, nausea, vomiting, diarrhea, nasal congestion, cough, fatigue, loss of taste and smell, and chills.
The next day, I woke up with a loud noise in my ears. After a month, I went to the doctor and he told me that the problem was due to my age, so I went home, but I still feel a deep noise in my ear (like crickets). I went to a specialist, and he told me there was no cure. He recommended that I go to a throat specialist. My leg also hurts, and they gave me injections for the pain, I went to the emergency room for the first time in 10 years.
Patient said that the initial injection was more painful than previous IM vaccines she has received. Pain at site of injection continued the rest of the day but improved slightly on the next day. Injection site swelled almost immediately. There is a 3 inch diameter hard area around injection site and a 1 inch diameter bruise. On 3/6/18 patient returned to show that she now has slight redness that expands to about a 6 inch diameter. Pain is still improving, but the area is slightly warm to the touch. Patient has full range of movement in arm and shoulder.
itching; Redness; swelling that's getting bigger at the injection site; spontaneous report was received from a non health professional (nurse) of un specified gender, concerning a female patient of 61years age, who received Moderna's COVID-19 vaccine and experienced itching, swelling at  the injection site.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On Jan 8th prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route.  Jan 15th - Itching, Redness and swelling that's getting bigger at the injection site. 17JAN2021  patient  had taken treatment of Benadryl and ibuprofen.  Action taken with mRNA-1273 in response to the event was unknown, de-challenge unknown, re challenge unknown.  The outcome of the event,  was considered to be unknown at the time of this report.; 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.
Presents for generalized weakness & fall, cough/fever. Admit for COVID pneumonia & syncope. Tx: remdesivir, tocilizumab, steroids, abx, embolectomy/angioplasty. Patient stabilized with improved repiratory and mental status, then developed sudden severe encephalopathy and respiratory distress. Family confirmed DNR status, dialysis attempted but patient became hypoxic and unresponsive; developed asystole. Expired on hospital day 12.
Fever (101 degrees); Extreme aching; skin was sore to touch all over body. Headache lasting well into next day.
Participant experienced severe migraines. 4 days after the migraine. Blurry vision. 2 weeks straight. Doctor advised advil every 4 hours.
I had vaccination on 09/20/2022. On 01/16/2023 I tested COVID-19 Negative. On 01/17/2023 I tested COVID-19 Positive. I contacted my physician on 01/18/2023 and prescribed me the Paxlovid. I finished the medication. I tested COVID-19 Positive 3 days after being COVID-19 Negative. I have continuation of my headaches since COVID-19.
Chest pains so bad I had to go  to emergency room. Pain started 2 days after and another day to subside in chest. Arm that was injected took an additional 2 days to feel better.
Flu vaccine was given on 10/21. Patient received flu vaccine on 10/07 at another location. Patient was suppose to receive Meningitis B vaccine.   Patient has had cold like symptoms.
Initial report received on 13 March 2008 from another manufacturer, (a report number was not identified).  The initial reporter to this manufacturer had been the patient's parent.  A 10-month-old male patient had received an injection of ACTHIB, lot number not reported, on 28 November 2007.  One day post-vaccination, the patient "experienced diarrhea and mucus and is currently still having the experience two weeks after vaccination."  The event required unspecified medical attention.  Diagnostic testing was none.  Recovery status was not recovered.
This spontaneous report was received from a licensed practical nurse, referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 27-MAY-2015, the patient was vaccinated with the first dose of ROTATEQ by oral route (dose, lot# and expiration date were not reported). On 09-SEP-2015, the patient received an improperly stored second dose of ROTATEQ oral, lot# K013410, expiration date 27-FEB-2016 (dose, was not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. No product quality complaint was involve. Additional information has been requested.
Soon after the vaccination she began having arm pain that lasted for 3 days. That has resolved, but now she is having nerve pain in her right thumb.
Narrative: Patient report: "I want to file a report with the vaccine division.  shortly after taking my second dose in march a started having numbness in my left hand and right arm. the ortho dept have attributed the right arm to my neck issues from my TBI and the left hand due to carpel tunnel from a test they performed. i  have not had the recommended surgery for my hand carpel tunnel how ever the numbness has subsided about 90% in direct correspondence with my subsequent acupuncture. in my mind from doing research to effects from the second shot there is no doubt i am having adverse reaction to that shot. i would like this documented with the CDC.  please know what steps i need to take. i am very afraid that without the acupuncture treatment i may lose the use of my hand." Medical center will work closely with patient and treatment team to ensure patient is properly treated and addressed. Actions completed: Actions: 1) Pharmacy will report to the FDA Vaccine Event Reporting System (VAER) on the patients behalf by using the Adverse Drug Event Reporting System. 2. Follow up phone call with the patient completed. The patient was very appreciative of the call and had no additional questions.
BLOOD PRESSURE WENT CRAZY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient blood pressure numbers were better than they had been for years just 3 months before taking the shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood pressure went crazy. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure went crazy was not reported. This report was non-serious.
PATIENT CALLED 10/22/10 AND STATED THAT AFTER TAKING PNU VACCINE THAT EVEING HIS ARM WAS SORE WITH SWELLING AND RED WHICH CONTINUED THROUGHOUT THE NIGHT; IN THE  MORNING THE ARM WAS SWOLLEN AND TENDER TO THE WRIST BUT MUCH BETTER TODAY 10/22/10.
I was diagnosed with a mild heart attack on February 9, 2023 I was having issues with my vision and it felt like I having hiccups in my chest. No blockage.
4 hours after vaccination pt experienced body chills/aches, vomiting, and diarrhea. Symptoms had passed by 10/3/14 AM when he called us.
22DEC92 pt recvd vax 26DEC92 having episodes of startling/uncontrolled crying & stiffening of extremities; adm to hosp for work up & medication;
Severe outbreak of psoriasis like never before all over my legs, back, arms and even face. It started after 1st dose and it got horrible after 2nd dose.
This case was reported by a healthcare professional and described the occurrence of Bordetella pertussis test positive in a subject of unspecified age and gender who was vaccinated with DTPa (manufacturer unspecified). On an unspecified date the subject received unspecified dose of DTPa (unknown). At an unspecified time after vaccination with DTPa, the subject experienced Bordetella pertussis test positive. At the time of reporting the outcome of the event was unspecified. The healthcare professional had no further information at the time of reporting.
despondent; pale; vomiting; fell asleep for about 1-2 minutes; Initial and additional information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a four years old female patient who experienced pale (pallor), despondent (feeling of despair), vomiting (vomiting) and fell asleep for about 1-2 minutes (somnolence), while she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]..  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  On 10-Feb-2020, the patient received a 5th 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5688AA, expiry date: 26-NOV-2021 via intramuscular route in the right thigh for prophylactic vaccination.  On 10-Feb-2020, the patient developed a non-serious pale (pallor), despondent (feeling of despair), vomiting (vomiting) and fell asleep for about 1-2 minutes (somnolence) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Events occurred following administration while patient was walking to the waiting room to check out.  Patient was transported to the local hospital/emergency room immediately following incident.  No lab data reported.  Final diagnosis was pallor, feeling of despair, vomiting and somnolence.   The patient was treated with EPINEPHRINE injection and 911 was contacted.  The patient had recovered from all the events.
considerable pain/ache in the mid to lower right back area, took ibuprofen to ease the pain
This is a spontaneous report from a contactable consumer (patient) reported that: A 31-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ew0175) via an unspecified route of administration, administered in Arm Left on 26Apr2021 14:30 (Age at Vaccination 31-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included Known allergies of bananas, carrots, tree nuts, chocolate, lavender and zpack.Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported, vitamins, and Birth control. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: eiu6202) via an unspecified route of administration, administered in Arm Left on 07Apr2021 01:45 PM (Age at Vaccination 31-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Past drug included bactrim for allergies. Patient did not receive covid prior vaccination. No other vaccine in four weeks. The patient experienced hives on 26Apr2021 19:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Apr2021 Nasal Swab, NAAT, sars-cov-2 test: negative on 19Apr2021 Nasal Swab,Antigen. Ae resulted in: [Doctor or other healthcare professional office/clinic visit] ae treatment Doctors appointment. Therapeutic measures were taken as a result of hives.The outcome of the event was not recovered.No follow-up attempts are possible. No further information is expected.
Gave vaccine subq instead of im in left arm 2/3/18. On 2/5/18 patient presented with welt, redness, swelling, pain and numbness.
Incorrect vaccine administered.  Child was given IPV instead of Prevnar 13 booster.  IPV was drawn up for 15 month old sister, and then administered to 3 year old child.
Narrative:  Patient called PCP to report he experienced a hypoglycemic episode after receiving the first of two injections of the Moderna COVID vaccine at public vaccination site (church). The episode was level 3 episode hypoglycemia (Standards of Medical Care in Diabetes 2021). His travelling companion thought he fell asleep on the ride to his home but had difficulty arousing him and called 911. The paramedics advised his blood glucose was 29 mg/dl and that they and other emergency personnel have responded to similar calls for patients experiencing severe hypoglycemia after receiving the vaccine. Patient reports receiving assistance from first responders/paramedics and not recurrence. Specific treatment not documented. Of note, patient with T2DM and CKD on HD, on insulin glargine and insulin aspart. At 2/23/21 pharmacotherapy appointment, reported eating healthier and eating less. Blood glucose of 29 confirmed by patient's continuous blood glucose monitoring device. No other significant lows (AM readings in 70s) noted on log.
Diagnosis: allergic urticaria. Allergic hives over my whole body, very itchy.
Briefly after administering (2 mins after) of vaccine patient passed out and suffered a head injury. Patient did not remember falling and was responsive. Rescue came to the scene and patient was transported to the hospital
No reaction to a vaccine however we had a temp excursion with the unit the Moderna vaccine was stored in. We had lot numbers: 026B21A, 038B21A, 026B21A. The temp went up to 49.2 for approx 21 hours. The manufactor and CDC was contacted. They did deem the vaccines could be use if used within 2 hours of being out of the fridge. No patients have had a reaction at this time.
I've have them twice/Suspected vaccination failure; I've have them twice; Miserable pain; Miserable pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles, pain and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles twice, which was most miserable painful anyone could have, and they sucked him/her both the times. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
The vaccine was expired past the 30-day recommendation. At this time there have not been any s/s of an adverse event.
3 days p/vax pt devel high fever (not checked), vomited once & had 2 or 3 loose stools per day for couple of days; saw MD-no treatment no tests
G62.9 PERIPHERAL NEUROPATHY 10/6/2022 COVID-19 DISEASE R57.0 CARDIOGENIC SHOCK 10/29/2022 COVID-19 DISEASE R57.9 SHOCK, UNSPECIFIED 10/29/2022 COVID-19 DISEASE G62.9 PERIPHERAL NEUROPATHY 10/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R57.0 CARDIOGENIC SHOCK 10/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R57.9 SHOCK, UNSPECIFIED 10/29/2022 NONTRAUMATIC ACUTE KIDNEY INJURY G62.9 PERIPHERAL NEUROPATHY 10/6/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 10/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.9 SHOCK, UNSPECIFIED 10/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G62.9 PERIPHERAL NEUROPATHY 10/6/2022 ESRD (END STAGE RENAL DISEASE) R57.0 CARDIOGENIC SHOCK 10/29/2022 ESRD (END STAGE RENAL DISEASE) R57.9 SHOCK, UNSPECIFIED 10/29/2022 ESRD (END STAGE RENAL DISEASE)
Site of injection swollen, red, warm, tender. Systemic low grade fever, sweats, chills, diffuse body ache, fatigue, feels dehydrated.