chrisvoncsefalvay/vaers-outcomes huggingface dataset:
syncopal episode; Initial information regarding an unsolicited valid serious case was received from a Physician via Regulatory Authority inbound (reference number-00652162) and transmitted to Sanofi on 22-Jun-2021.   This case involves a male patient of unknown age who had syncopal episode (syncope) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL VACCINE B [MEN B]  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE B [MEN B] not produced by Sanofi Pasteur via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious syncopal episode (syncope) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and MENINGOCOCCAL VACCINE B [MEN B] This event was assessed as medically significant.   The reporter stated, she did have a patient in the past who received MENACTRA and MENB vaccine and experienced a syncopal episode. Also, the reporter thinks patient may have been dehydrated when he received the vaccine. At, the time of reporting, the reporter wanted to know if it was safe to administer MENACTRA and MEN B or TRUMENBA at the same office visit.  No laboratory data was reported.  It was unknown if the patient received any corrective treatment for the events.  At the time of this report, the outcome of the events were unknown.  Information on the batch/lot number for the suspect vaccines requested.; Sender's Comments: This case concerns a male patient who had syncope after vaccination with MENACTRA and MENB. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Patient hospitalized for Left - ARTHRODESIS ANKLE Left with subtalar fusion and Reamer irrigator aspirator bone graft harvest within 6 weeks of receiving covid vaccination.
severe occipital HA, severe shaking, fever 102-103, tachypnea; tx EPi, Methylpred, DPH;
grogginess; no appetite; sore jaw; extreme headaches; flu like symptoms; dizziness; achy body; pain in arm near injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left unknown on 09Mar2021 08:00 (Batch/Lot Number: EN6205) as a Single dose for covid-19 immunization. The patient past Medical history included asthma and breast cancer in remission 11yrs out. The patient's concomitant medications were not reported. The patient had Allergic to Codiene. 8hrs after the administration of vaccine the patient experienced flu like symptoms, dizziness, achy body, pain in arm near injection site on 09Mar2021 at 4:00pm, after the 17hrs the patient reported extreme headaches and 24hrs after reported grogginess, tension headache, dizziness, no appetite and sore jaw on 10Mar2021 at 01:00. The patient did not take any other vaccine within 4 weeks. The patient was not tested for Covid-19 prior to vaccination. The outcome of the events were recovering.  No follow-up attempts are possible; No further information is expected.
This spontaneous report was received from the healthcare worker refers to a 19 year old female patient. On 28-DEC-1992 the patient was vaccinated with the first dose of RECOMBIVAX HB 2.5 mcg/0.5 ml (dose and route not reported), on 27-JAN-1993 the patient was vaccinated with the second dose of RECOMBIVAX HB 2.5 mcg/0.5 ml (dose and route not reported) and on 27-SEP-1993 the patient was vaccinated with the third dose of RECOMBIVAX HB 2.5 mcg/0.5 ml (dose and route not reported). On 10-JUL-2013, 7500 days after onset of therapy the patient who had RECOMBIVAX HB series had indeterminate titers. The titers were drawn on 10-JUL-2013 and the results were indeterminate. The patient sought medical attention. No treatment was given for the adverse event. The outcome was reported as not recovered/not resolved. Additional information has been requested.
Immediate severe heart palpitations, chest pain, and dizziness. Went to urgent care, they rushed me to the ER. Chest pain went away, still have palpitations and can?t do anything physical without my heat racing and feeling like I?m going to pass out.
Started with a rash to left hand and rest that spread to bilateral upper arms with scalp itching
Flu Injection was given (too high) in the joint of my Left shoulder. I experienced severe shooting pains immediately following the injection. My arm proceeded to swell up over the next few hours. I was unable to move or raise my arm and continued to have severe pain and swelling from the time of the injection to the present. I have seen three physicians for my shoulder pain and inflammation. I have been treated with pain medication, anti-inflammatory medication, nerve medication, electric stimulation therapy, physical therapy, MRI before and after surgery, Left shoulder decompression and excision of bursa. Since surgery my MRI shows further deterioration of the joint and tendon and excessive inflammation. I have also had problems controlling my blood glucose since the injection. The doctor has tested me for diabetes several times since the injection and I am not a diabetic but my sugars have to be maintained through the use of medication (Metformin 500mg daily). I have not been able to perform my duties as a nurse since I had the shot last year.
received a dose past 30-day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-355908 (Patient Link).
This spontaneous report was received from a physician concerning to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 29-DEC-2016, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, route of administration was not provided (lot number K001500, expiration date 06-NOV-2016) (expired vaccine used) for prophylaxis. No adverse effects reported.   Additional information has been requested.
fever 102 for 2 days; high pitched screaming for 2 days; leg swollen & red from hip to the knee; a lot of pain in leg when touched;
Broke into target hives after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke into target hives after vaccination) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Broke into target hives after vaccination). At the time of the report, URTICARIA (Broke into target hives after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke into target hives after vaccination) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Broke into target hives after vaccination). At the time of the report, URTICARIA (Broke into target hives after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Narrative:  Patient presented for covid test with runny nose and loss of smell. COVID test positive despite 2 doses of moderna vaccine. Given monoclonal antibody treatment.
After two weeks, the injection site is still sore, but mostly, my joints including wrists, knee, ankles are still extremely achy and throbbing persistently. I have experienced sinus pressure headaches as well. My legs and arms feel tingly and numb at times - more often my left side which is where I got injection. I feel weakness and fatigue most afternoons. My body didn't feel this way before the vaccine and it seems as though my body hasn't fully recovered from the shot and has flared up these symptoms. I feel all of a sudden that I have arthritis.
Pain; Axillary swelling; Fever 102F; Muscle aches in the vaccination arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Axillary swelling), PYREXIA (Fever 102F), MYALGIA (Muscle aches in the vaccination arm) and HEADACHE (Headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 mcg. On 01-Dec-2021, the patient experienced PAIN (Pain) and MYALGIA (Muscle aches in the vaccination arm). 01-Dec-2021, the patient experienced SWELLING (Axillary swelling), PYREXIA (Fever 102F) and HEADACHE (Headache). On 01-Dec-2021, PYREXIA (Fever 102F) had resolved. On 02-Dec-2021, PAIN (Pain), SWELLING (Axillary swelling) and MYALGIA (Muscle aches in the vaccination arm) had resolved. On 04-Dec-2021, HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, Body temperature: 102 (High) 102F.         No Concomitant medications were reported.  No Treatment details were reported.  All symptoms were resolved by 05 December 2021
covid arm; rash on right arm at site if injection. Itchy; swelling; persists still
Approx 2 min after receiving vaccination pt complained of throat swelling, toes tingling, and headache. VS: 158/64, P 66, 02 98% RA, R 18. Benadryl 50 mg  IM R deltoid administered. Transferred by EMS to hospital.
There was not an adverse event, but the vaccination was short-dated and therefore had been given after the manufacturers expiration date.
Large volume pericardial effusion.  1.2 Liters removed via paracentesis.
Extreme irritability, inconsolable crying at night, 2-3 hours the last 4 nights...child previously slept through the night or was given a pacifier and comforted.
-Rash in left deltoid -10 cm in size, localized -Slight itch -Still present on 02/26/2021
SINUS ISSUES (SNEEZING, COUGHING); This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sinus issues (sneezing, coughing) that has been diagnosed (dose number in series 2). Patient did not mention if it was related to J&J covid 19 vaccine primary and booster shots or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sinus issues (sneezing, coughing) was not reported. This report was non-serious. This case is a duplicate of 20220531526.  It was determined that Manufacturer Case Number 20220531526 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20220531993.
I had a flu vaccine on 10-18-26 on the advise of my Doctor.  I noticed no adverse effects until 01-17-2007, when my wife discovered me down on the bedroom floor moaning she woke me and dressed me. I couldn't walk or hold things.  Sh managed to get me to the Hospital where I was incubated and admitted to the hospital.  I do not remember what occurred the next week or two I did end up having advanced physical therepy.  I could not walk or get up or out of bed on my own after about 40 days I was released to home therapy
Rash and swelling and heat and pain around injection site - not subsiding after almost 2 weeks
From initial information received on 11/8/04 from a healthcare facility regarding an adverse event occurring in the USA, it was reported that a 3 year old female patient received ACTHIB, lot number UA171AA, TRIPEDIA, lot number U0581CA, VARIVAX, lot number 0602M, and PREVNAR, lot number 490370 (routes of administration were not reported) on 10/31/02. Soon after the vaccinations (exact date was not reported), the patient experienced developmental delays. She was seen at the physician's office on 6/10/04 and diagnosed with severe speech delays, questionable regression and fine motor delay. This office did not see the patient from 10/31/04 until 6/10/04. The patient's recovery status was not reported.
After shot a got pain in hip and knee like a knife stuck in the two spots, Pain slowed on 9-4-21 after taking methyipednisolone and gabapentin still fell it.
This spontaneous report as received from a pharmacist via company representative refers to a 75 year old patient. The patient's medical history included shingles. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J001005, expiration date 24-APR-2014) in the arm, dose and route unspecified. Soon after ZOSTAVAX vaccination, the patient developed "bump or lump" at the injection site where shingles had in the past. The outcome of the patient was unknown. Additional information has been requested.
2 days after my first Moderna vaccine-I developed a facial rash on cheeks, forehead, upper lip,nose. 2 months later I still have the rash.  I was recently prescribed a Clindamycin cream, but have not started yet. I also was told to stop my Lisinopril for 1 week to see if the rash went away-it did not.
THE PATIENT IMMEDIATELY HAD A SEIZURE UPON ADMINISTRATION. SHE DOES HAVE A SEIZURE DISORDER AND IS ON DEPAKOTE FOR THE CONDITION. THE PATIENT HAD NO PREVIOUS ISSUES WITH DOSES 1 AND 2. SHE HAD 2 SEIZURES, CAME OUT OF THEM PRETTY QUICKLY. SHE WAS THEN NAUSEOUS AND HAS BEEN NAUSEOUS THE REST OF THE DAY. I JUST CHECKED IN ON HER THIS EVENING. SHE IS RESTING AT HOME.
hot flashes; night sweats; extremely heavy menstrual periods; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 02Apr2021 13:00 (Batch/Lot Number: ER8733) as dose 2, single (age at vaccination 37-year-old) for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on Mar2021, administration site (Left arm), administered at 01:00 PM (age at vaccination 37-year-old), lot number EN6204 for Covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. The patient was not pregnant at the time of vaccination. On 02Apr2021, the patient experienced hot flashes, night sweats, extremely heavy menstrual periods. Adverse event: New gynecological symptoms: hot flashes, night sweats, extremely heavy menstrual periods. Patient did not received treatment for events.The outcome for all events was not recovered.   Follow-up attempts are completed. No further information is expected.
pt admitted to hosp 18dec96 for febrile illness w/ severe myalgias.  recv antiviral med for a single episode. Also had implanted antibiotic tx for dental abscess. Pt is in a wheel chair w/ acute ascending paralysis; GBS
Scratch in throat. Patient states has history of severe allergic reactions, states does not feel that sore
Right lower arm became very sore and was oozing blood and clear fluid from injection site. Area appears bruised and excoriated-not warm to the touch, but remains sore. Area measures 1&1/4" long and 1&1/4" wide. Patient applied ice packs and too Acetaminophen for pain. It has been 2 months since receiving vaccine and area is not improving, though there has been no more drainage. Patient instructed to see MD to have area evaluated.
Received Varivax on 3/13/02.  Got a mild case of varicella 2/21/04
local pain,aching lt deltoid for 1 wk following vax,no redness or swelling;subsided approx 6 days p/inj;28MAR96 abrupt onset of extreme deep,burning anterolateral shoulder pain;weakness of lt shoulder 8APR96;atrophy of biceps muscle;
Four days after receiving my second COVID-19 shot, I developed a lump on the left-side of my head, between eye and ear. About 1½ inch in diameter and it swelled out 3/8 of an inch. It went away in 3 days. My lips swelled up really bad. This took about 2 days to go away. My lower leg swelled up around my ankle. I couldn't walk for 2 days. That took about a week to go away. All these conditions started at the same time. A month after the vaccine, I still have some pain and swelling in my legs and feet.  Seems to go away on its own after a week or two.
headache, nausea, neck and back pain that progressed into full body pain, chills, fever of 102, chest pain for a period of roughly 30 min
received the first dose / on 14Aug2019 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 14th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
I actually had been feeling great and at ten AM on Sunday morning, it was like a ton of bricks hit me, fatigue and a tightness in my chest it lasted about five minutes. I wanted to go home so fifteen minutes later total, my son drove me home and I had a sickness and fatigue all over, and halfway home I asked to go to the ER. So thirty minutes later total I am at the ER. The nurse asked me if I was alright but I said I am going to faint and they wheeled me into the triage my BP was 196/92. EKG was ran. Over the next three hours my BP was slowly coming down. An odd tightness in my chest lasted three days.
having a heavy headache continuously...include when I sleep/continuous and severe headache; having problems concentrating on my job, read, work on the computer; Neck and back pain; Neck and back pain; Fever; This is a spontaneous report from a contactable other hcp (patient).   A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW5318, Expiration date not reported), via an unspecified route of administration in arm left on 30Jan2021 18:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history allergies to medications, food and other products was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included fish oil (FISH OIL) and tocopherol (VITAMIN E [TOCOPHEROL]) both taken for an unspecified indication. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date not reported), via an unspecified route of administration in arm left on 09Jan2021 11:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Beginning (24/36hs), after the vaccination the patient experienced neck and back pain, neck and back pain and fever on 31Jan2021 22:30, (01Feb2021) Monday, Tuesday, Wednesday, Thursday I'm having a heavy headache continuously include when i sleep/continuous and severe headache, having problems concentrating on my job, read, work on the computer on 01Feb2021. The patient received Tylenol for 24 hs as treatment for neck and back pain and fever and no treatment received for having a heavy headache continuously include when i sleep/continuous and severe headache, having problems concentrating on my job, read, work on the computer. The seriousness of all the events was reported as non-serious. The outcome of all the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.