chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLU-LIKE S/S THE NIGHT OF THE VACCINE FOLLOWED BY HA ON DAY 2 AND NOSE BLEED & CHEST DISCOMFORT ON DAY 3. THE PT REPORTS THAT THE CHEST DISCOMFORT LASTED X 1 DAY, BUT THE NOSE BLEED PERSISTED. 12 DAYS POST VACCINATION THE PT WAS SEEN AS PART OF HER ANNUAL HEALTH ASSESSMENT AND STILL C/O MILD HA FOR WHICH SHE REPORTS TAKING APAP.
Pt screamed all night following IZ administration.  IZ's were given SQ not IM.  Large red bruise/bumps developed on both arms.
CLIENTS MOTHER CALLED THE HEALTH DEPT CONCERNED ABOUT SWELLING AND REDNESS TO THE LEFT ARM AT THE INJECTION SITE.
9-18-12 6p small rash approx 1 cm, appeared like hives. 9-19-12 evening increased swelling 4x's original. Increased redness, warm to touch. To ER 9-19-12 at 10p. C/o difficulty breathing, leg extremely painful to touch. In ER admin 40mg steroid and ABX 3.5mL KEFLEX. Discharged with dexamethasone 0.5mg/5mL 20mL PO 2 days x4 days. KEFLEX 250mg/5mL 3.05mL q 6 hours x7 days. Reaction located at right thigh, site of PVC 13 administration.
Sore Arm; A spontaneous report was received from a consumer concerning a 69 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a sore arm/injection site pain.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 25 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient experienced pain in her right arm on 26 Jan 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event sore arm was not reported.  Reporter causality for the event was not provided.
Left thigh had redness around area swelling and hot to touch 2 small raised blisters in center-referred to MD for evaluation.
HYPOAESTHESIA; DIZZINESS. Information has been receiving from a physician concerning a 30 year-old white female patient with "no history of previous drug reactions" who on 07-Apr-2003 and 07-MAY-2003 was vaccinated with a first and second dose of hepatitis B virus vaccine rHBsAg (yeast) intramuscularly in the right deltoid with 1 ml (lot number 642096/0069M), respectively. There was no concomitant therapy. On 07-May-2003, "within a couple of minutes", also reported as "around 10 minutes after vaccination", the patient developed "numbness in her opposing arm", (the left arm) with a duration of 2 hours. It was noted that "observation was done at first but with failure to improve' and the patient began with "lightheadedness" with a duration of 15 minutes. It was also noted that there was no previous history of similar problems, "BP, pulse and respirations remained constant, she had full range of motion in the arms and digits, her reflexes were intact and symmetrical, and she was able to distinguish "sensation sharp" but no light touch sensations. The patient received 50 mg of dipehnhydramine HCL (Benadryl) IM and symptoms resolved within 30 minutes (also reported as 1 hour later) and she was discharged. There were no prescription drug treatments required. Medical attention was sought. On 07-May-2003, the patient recovered and on the "following day she was doing well without residual complaints".
Pt developed hives all over body approximately 11 hours after receiving 6 mo vaccines. Pt received Daptacel, Act Hib, PCV 13, Rotateq, and .25ml Fluzone. All vaccines patient has had before without incident except for the Flu Vaccine; this was the first dose.
Mom noticed in PM of 11/16/06 injection site red, warm to touch. Approximate size of egg - lump formed. Child complained of pain; treated with Benadryl/Tylenol.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
fast heartbeat; dizziness; weakness; fever; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat), DIZZINESS (dizziness), ASTHENIA (weakness), MYALGIA (soreness in arm) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced MYALGIA (soreness in arm). On 19-May-2021, the patient experienced HEART RATE INCREASED (fast heartbeat), DIZZINESS (dizziness), ASTHENIA (weakness) and PYREXIA (fever). At the time of the report, HEART RATE INCREASED (fast heartbeat), DIZZINESS (dizziness), ASTHENIA (weakness), MYALGIA (soreness in arm) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. No treatment drugs were reported.
Black and blue arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Black and blue arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 021C21A) for COVID-19 vaccination.     The patient's past medical history included Hypoglycemia, Hypothyroidism, Stent placement (Patient had three cardiac stents) and Arthrodesis. Concurrent medical conditions included Drug allergy, Allergic reaction to antibiotics (Levaquin), Shellfish allergy (shellfish), Coronary artery disease (have three cardiac stents), Asthma, Gastroesophageal reflux disease, Osteoarthritis, Osteoporosis, Epileptic seizure, Hypertension and Drug allergy (Vioxx). Concomitant products included ATENOLOL (TENORMIN) for Arrhythmia, GLYCERYL TRINITRATE (NITROGLYCERIN LINGUAL) for Coronary artery disease, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ACETYLSALICYLIC ACID (ASPIRIN 81), UBIDECARENONE (COQ10 [UBIDECARENONE]), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), GABAPENTIN (NEURONTIN), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LEVOSALBUTAMOL TARTRATE (XOPENEX HFA), EPINEPHRINE (EPIPEN), ALBUTEROL [SALBUTAMOL], BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE SODIUM (SYNTHYROID), ROSUVASTATIN CALCIUM (CRESTOR) and DONEPEZIL HYDROCHLORIDE (ARICEPT) for an unknown indication.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced CONTUSION (Black and blue arm). At the time of the report, CONTUSION (Black and blue arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Rhesus antigen negative: negative (Negative) Rh negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had concomitant medication Xopenex HFA for rescue inhaler  and sublingual Nitroglycerine.  No Treatment medications was provided by the reporter.
4 hours after vaccination, child developed T=100.7; developed apnea of 15 seconds, turned blue, pale, limp afterwards. EMS called; admitted to hospital. Abn EEG - (L) central sharp waves with clinical sz.  11/4/08 Reviewed hospital medical records of 10/24-10/25/2008. FINAL DX: ALTE; hypotensive-hyporesponsive reaction to acellular pertussis; seizures.  Records reveal patient experienced irritability, crying & gurgling, then suddenly stopped breathing for approx 10 sec, pale, lips blue then became very pale & limp.  Had received tylenol in PCP office w/vaccines.  Temp on admit 100.7.  No further episodes in hospital.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (strength, dose and frequency were not provided) reconstituted with MENACTRA. No adverse effect reported. Follow up information has been received on 29-JUL-2013 from the patient's physician. It was reported that the patient experienced redness and swelling at the injection site 1-3 days after receiving ZOSTAVAX. The patient went to the physician's office yesterday (29-JUL-2013), and she reported the redness and swelling had improved since it initially developed. The patient was prescribed mometasone for symptoms. No other adverse effects reported. At the time of the report the outcome of redness and swelling at the injection site was recovering. Additional information has been requested.
Neuropathy in feet and legs immediately after vaccination administered. Same thing happened 8-10 years ago, Neuropathy lasted 6 yrs. Before letting up. Had the flu last 2 yrs and was bullied into getting this shot bad mistake, I'm 78 years old. Information from medical records includes paresthia and pain. msv
Felt like I was starting to lose my voice Friday night - 2 nights after getting the vaccine. I felt a little tired, but otherwise was okay.  When I woke up Saturday morning, I had laryngitis.  By the end of the day, my throat hurt and I was exhausted.  It  is now Sunday morning and I still have laryngitis.  My throat hurts a little. I am trying not to talk so it gets better.   I also had severe arm pain at the injection site that lasted 1 1/2 days.
Pt. Received vaccines (HIB, Influenza, Pneum. 23, approximately 1030 am on 11/18/2004. He returned later that afternoon at approximately 400pm and stated he had felt "sick" since returning home.  The symptoms he felt were short of breath, heavy chest, dizzy, nauseated. He decided he better return when the symptoms did not go away. Upon presentation and assesment of symptoms, it was determined to give the patient 3 tsp. Benadryl by mouth.  V/S assessed, and patient discharged with instructions to go directly to the local Emergency Room, or contact doctor with further concerns. Secretary also stated he showed her his Left arm where pneumonia and influenza were given was red, hot, and swollen within that 5 1/2 hour period of time.  When I viewed his arm however, either the sleeve was not lifted high enough, or his fingers were covering the site.  Pt. stated his arm was very sore, but no local reactions noted as described by secretary.   Note:  pt. requested the HIB vaccine, stating he had his spleen removed, and should have vaccine every 5 years, and was due for the vaccine at this point.
no adverse event this lot number was incorrectly communicated information recieved from Pfizer that product was stable Oct 1 thru 19th beyond expiration date of 9/30/2022 on packaging
Right ear became sore and swollen about 10 hours after vaccination on 10/24/22 with influenza (right arm) and COVID bivalent (left arm) - only right ear became sore and swollen; it had resolved by the next morning 10/25/22
3/16 RIGHT ARM ITCHING HAD HIVES ON  SHOT SITE FOR A COUPLE DAYS THEN LOOKED LIKE BRUISES FOR A COUPLE DAYS. STILL ITCHES ALITTLE
pt was found limp, unresponsive, & cyanotic about 18 hr p/vax;pt recv bolus of nl saline & was fully alert & responsive by the time reached a hosp;fully recovered in hosp
pt exp itching of throat, tightness of chest, swelling sensation in arms, chest, face;no LOC;
Rash over entire body - some maculopapular, some vesicles, some scabbed, even in mouth, rash itches, denies fever, runny nose.
Starting in January, I have had joint pain in my left knee as well as swelling behind the knee joint.  It has increasingly got worse to the point it is waking me at night.  I have also had pain in my right elbow that never existed before the vaccine.  The bicep muscle gets inflamed right at the insertion point into the joint.
Allergic reaction at injection site. Arm looks swollen around site, feels hot, big bumps and feels hard.
Patient went to doctor after receiving flu shot. Tendonitis and bursitis was reported from flu shot. Pt recovered.
This is a spontaneous report from a non-contactable consumer reporting for her mother in law. This female patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date after the vaccination the patient was achy and she had fever. Outcome was unknown. The reporter considered these conditions as adverse events to the vaccine and she believed that they were know side effects from the vaccine. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to an approximately 17 or 18 year old twin male patient. On 06-AUG-2013 the patient was vaccinated with GARDASIL lot # H020002, expiring 08-AUG-2015 dose 1 (dose, route and site not provided). On 06-AUG-2013, about 10 minutes following GARDASIL vaccination, the patient experienced syncope with tonic-clonic movements; however the patient remained awake and alert during the syncope. The syncope lasted about 15 minutes. No lab diagnostic tests were performed. The patient sought medical attention by office visiting. On 06-AUG-2013, the patient recovered from the events. The casual relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
Patient developed fever, dyspnea and headache on 5/12/2021; tested positive for COVID-19 on 5/12/2021; patient died on 5/20/21
COVID19 Vaccine EVA; Seven days post vaccination Left deltoid skin: hives, redness,  swelling, painful to the touch and itchy. As of today continues to be red (decrease area), decrease itchy & swelling, and minimal/trace pain to touch.
For the first 2 days I was very cold, shivering. I couldn't warm up even though I had the house at 70 degrees.  I wore sweaters, winter coats, and covered myself in blankets.  Then, 2 weeks later, I have an unexplained fever of 101 degrees and a headache with no other symptoms.
By evening the evening of March 25, 2021, the date I received the second dose of the Pfizer vaccine, I was feeling feverish and having chills. I went to bed early and slept little because of my high fever alternating with icy chills. I didn't have any Tylenol on hand. By morning, I decided to take ibuprofen. Fever and chills subsided. Although I was very tired, I was able to maintain my usual daily routine. Close to noon I decided that I felt well enough to go to mass. I sat in the back in case I had to leave early. By the time I walked to the last pew, I was exhausted. I decided just to sit through mass. Once it started, I realized that I was too worn out to make the responses, so I prayed silently in my heart. Shortly I began to feel lightheaded; then felt nauseated. Decided I needed to get home. Left the church and and walked and then stumbled down the corridor toward the door. Quickly I felt I couldn't get enough air through my mask; removed the string from one ear. Legs gave out. Slid to floor to get blood to my brain and give legs a rest. DIdn't seem to help. At last decided to walk to car although I felt I couldn't walk. Managed to get up, got through door to outside, laid on ground for a few minutes to rest. Trying to get to my nearby car, got back to my feet (though unable to actually stand), went about 2-3 feet, collapsed on ground again, unable to move. Some people saw me, called 911, rescue squad came. Loaded me in to take me to hospital. I protested. Did not want to go to hospital. Called neighbor who came to get me. Took me. home. I rested in bed until next day. Have spotty memory of incident . Slowly regained strength over next week or 10 days.
pt recv vax & approx 24hr p/vax rt deltoid became swollen size of lemon;pt c/o chills, muscle aches then devel red, prickley rash on stomach, arms & face later that evening;seen in ER 23MAY97 given IV hydration,DPH given;
chills, fever got up to 103.8, body aches all over, skin all over felt like a sunburn, nausea, vomiting, headache, fatigue, pale, clammy, chest tightness, tachycardia
Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6203) via an unspecified route of administration in the arm left on 28Feb2021 at 17:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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. Concomitant medications included atorvastatin calcium (LIPITOR), tadalafil (CIALIS) and sertraline hydrochloride (ZOLOFT) all from unknown date for unknown indication and unknown if ongoing. On 02Mar2021 at 17:00, the patient experienced vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been been tested for COVID-19. The clinical outcome of the event vomiting was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
My (lt) arm is in pain with a knot in the upper arm. The  whole arm , all the way to  the neck  has been aggravating me every since I received the vaccine I was skeptical about getting it and now I'm in pain every day I haven't been to the Doctor . I have been suffering in silence, literally. Each day say it will get better and it hasn't. I will not be getting #2 vaccine. My job has threaten all employees to get the vaccine or no job, I receive the vaccine and now my arm is in sad repair." What's up with this".
Received DTaP/IPV left thigh 6/16/08.  24 hrs later red, swollen.  Seen 6/18/08 upper site measures 9.5x8cm medial site measures 3.5x4.5cm.
Labored breathing, tightness in the back of the throat, headache, dizziness
Three days after I received the vaccination I woke up with a fever, sweats, body aches, and headache that lasted all day.
Client vaccinated today at 1200. Started having itchy and swelling lips. Client denied any tongue or throat itchiness or swelling. Client has hx of Bee and wasp anaphylaxis. BP 110/82, HR 96, O2sat 98%. Epi was not given as the swelling and itchiness did not worsen. Pt reported improvement at 1238. Client's provider called recommended client be monitored for 2 hours. Client stayed until 1320, stated she is not staying any longer and she is driving herself to work at a healthcare facility. Client left.
Asymptomatic, but COVID-19 positive beginning 7/20/21. Individual delivered baby on 7/20/2021.
Pruritic rash on extremities began 3/11/21 and on 3/14/21 developed lip and facial swelling on right side of face requiring trip to emergency room at hospital
SERIOUS MIGRAINE EVER SINCE; FOOT SWELLING; AREAS FELT REALLY HOT; SEVERE PAIN IN CALF MUSCLE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 18-OCT-2021, the patient experienced foot swelling. On 18-OCT-2021, the patient experienced areas felt really hot. On 18-OCT-2021, the patient experienced severe pain in calf muscle. On an unspecified date, the patient experienced serious migraine ever since. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from serious migraine ever since, and the outcome of foot swelling, severe pain in calf muscle and areas felt really hot was not reported. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of gingival bleeding in a 61-year-old patient who received SHINGRIX for prophylaxis. Co-suspect products included Aspirin for an unknown indication. On 12th March 2019, the patient received SHINGRIX. On 13th March 2019, the patient started Aspirin at an unknown dose and frequency. On 13th March 2019, 1 days after receiving SHINGRIX, the patient experienced gingival bleeding. In March 2019, the patient experienced drug interaction. On an unknown date, the outcome of the gingival bleeding and drug interaction were unknown. It was unknown if the reporter considered the gingival bleeding to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the morning, and on next day the patient took some aspirin and his gums started bleeding. The patient asked, did aspirin do this when taken with the SHINGRIX. The pharmacist was not seeing aspirin specifically, as per SHINGRIX package insert reference. Therefore, it did not appear that they have studied SHINGRIX with aspirin. The patient said, the only thing he took was aspirin and he had two times of his gums bleeding. The patient had no major health problems. It had to be the interaction with the shot.