chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Registration number: 501547786. Patient is a 12 year 7 month old female. Upon getting ready to leave, after her 15 minute wait post receiving her Pfizer COVID19 vaccine, her parent noted flushing of the cheeks. EMS and medical staff on site called to assist. Redness of both cheeks was observed. No other skin findings. Child was calm, not in respiratory distress. She denied hives, fever, abdominal pain, nausea  or dizziness. No tongue or lip swelling. Vital signs were stable, BP 120/66-114/72; HR 73-74; RR 15. Patient was observed for over 35 minutes. No additional skin findings or complaints. Flushing of the cheeks appeared to diminish by the end of the observation time. Child responded feeling fine throughout the time she was observed and did not have additional symptom. She was discharged to her mother who verbalized feeling comfortable taking her home.
Information has been received from a pharmacist concerning a 45 year old female patient with no pertinent medical history who as a child was vaccinated with a dose of MMR II. In July 2008 a rubeola titer was performed and the result was negative. Then the patient was vaccinated with a second and third dose of MMR II in August 2008 and in September 2008 respectively. Then in October 2009 a rubeola titer was performed and the result still negative. At the time of the report the patient had not recovered. Additional information has been requested.
Difficulty breathing,  I felt like my throat was closing up, very fast heart beat, hives, shaking, and dizziness. Immediately, contacted my physcian and she advised me to come to her office.  She determined that I was having an allergic reaction to the flu shot.  She adminstered shots to counteract the symptons and give me to prescriptions to have filled. They are:  Prednisone 10mg and Diphenhydramin HCL 50 100.
Visual Hallucinations Midafternoon at my house lasted two or three seconds. Two days later, I had an auditory hallucination which was also in the afternoon I heard a woman say my name. It was very quick amount of time when it happened. There was a little bit of time when I didn't have any but a week later there were more visual hallucinations. There were about five or 6 times total. I waited to get the second vaccine a little bit longer instead of three weeks, I waited for 6 weeks. I may have had insomnia that began before the second vaccine. Around July 1st or somewhere around there, I did experience a visual hallucination while on vacation. Note: I did have muscle aches and fatigue, etc. immediately after the date of vaccination that lasted about a week and a half.
About 48 hours after vaccine administration, Patient noticed redness at the site of vaccination about 1" in diameter. She also noticed swelling and tenderness under her left armpit.
Developed shingles rash on the left arm.  Treated with ValACYclovir for 7 days.  Total 21 tablets, 1 gm each.  Resolved in 3 days after finishing the medicine.
itchy shoulder for ten minutes very minor/little itchy at the wound site; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information Team. A female patient (age of 92) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 12Feb2021 at 15:00 as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Enquired, the caller did not wish to be transferred to HCF but was okay with a call back if more information was needed. It was reported that, a week ago today, the patient went and received the Pfizer vaccine, everything went well, nice experience. Stated that, no after effects. The only thing was she should have been given a card and it would tell her when her next appointment was. Stated that, her granddaughter took her cause she was on oxygen. Just a couple of days later, she had an itchy shoulder for ten minutes very minor, on 14Feb2021, Sunday morning, following vaccine on Friday afternoon at 3 pm of first dose of the Pfizer vaccine. It was a little itchy at the wound site, that's all and she didn't do anything about that. Stated that, she didn't think anything of that, it was on her right side. Treatment was not received for the event. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Redness and swelling on the arm of injection, covered lateral portion of upper arm from shoulder to elbow. Patient applied OTC hydrocortisone cream to the area and used oral loratadine 10mg for 15 days. Currently symptoms are improving but not completely resolved (4/5/2016).
fever, throwing up, and labored breathing. If this worsens he is going to go to the hospital ER
Developed hives and dermatographia exactly 10 days after moderna booster. Both are now considered chronic since they have lasted more than 6 weeks. On daily antihistamines to be able to function and sleep through the itch and discomfort.
Per history and physical on 1/11/2022: An 84-year-old male with PMH significant for DM 2, HTN, HLD, CAD s/p CABG, atrial fibrillation (on Xarelto), CHF, CVA, carotid disease, hypothyroid and GERD, presented to the ED with complaint of altered mental status and weakness. Per EMS report, family stated he began to have urinary incontinence yesterday and was leaning to the left. He had no obvious facial droop and grips were equal and round. Patient has known dementia at baseline. He is unable to contribute to HPI. Family is unable to contacted. Both phone numbers listed go directly to voicemail. Upon arrival to the ED, he is noted to have elevated troponin and BNP. CXR is concerning for LLL infiltrate and found to be COVID-19 positive. Per medical record, he is vaccinated x3. CT head notes old infarct.
he had to get couple teeth removed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH EXTRACTION (non-serious), outcome "unknown", described as "he had to get couple teeth removed". Therapeutic measures were taken as a result of tooth extraction. Clinical course: Verbatim and event description included that he was scheduled 1st dose of vaccine for Feb. Found out he had to get couple teeth removed and would be getting Novocain. Spoke to someone and said it would be ok to have Novocain. No unaddressed medical questions were referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fainting reaction: occurred 1-2 minutes after vaccine administration. Non-responsive for a few seconds, then brief response. Cold paper towels were applied to face and patient responded to questions. Patient drank some bottled water. Time from initial reaction  to recovery was approximately 20 minutes.
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 54 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included: The patient stated he was not taking any other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 in total was administered on 12-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. The patient age at time of vaccination was 53 years old. No concomitant medications were reported. The patient additionally received non-company suspect vaccine Moderna Covid-19 vaccine (elasomeran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, administered on 15-NOV-2021 to left arm for prophylactic vaccination. On 09-MAY-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 13-MAY-2022. On 15-MAY-2022, 2 days after non company suspect drug paxlovid treatment (for covid-19) laboratory data included: COVID-19 virus test (NR: not provided) Negative.  On 17-MAY-2022, three days after non company suspect drug paxlovid treatment symptoms returned the patient had confirmed covid-19 infection (dose number in series 2) and confirmed clinical vaccination failure (dose number in series 1). On same day laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with Paxlovid was drug discontinued on 13-MAY-2022. . The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number requested.; Sender's Comments: V0: 20220551187- COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
8 year old patient was administered a covid 19 vaccine for patients 12 years and older.  Patients mother was contacted by the provider and support staff the day this was discovered. Patients mother reports patient has experienced headache and felt warm. Mother denies fever. Patients mother has office contact info in the case of any worsening symptoms.
Approximately 2-3 hours later patient became dizzy, nausea, chest pain, abdominal pain, leg pain, joint aches, was unable to walk alone, actually fell to the floor once and patient was admitted to hospital for 24 hours for observation. There were no other significant events to attribute to this acute change in patient's status.
Pt presented with coffee ground emesis and acute st elevation myocardia infarction. She was DNR. She was admitted and expired in a few hours.
Swelling right deltoid, facial rash, difficulty breathing/swallowing 24 hours after administration.
very dry nose; sometimes had red hands; cold sweat; inflammation at the injection site palm-size; red, very hot (injection site); red, very hot (injection site); rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin); felt very bad; stomach pain; sore arm; itches; numb fingers in her hand; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand), NASAL DRYNESS (very dry nose) and ERYTHEMA (sometimes had red hands) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand) and HEADACHE (headache). On 27-Mar-2021 at 2:30 PM, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 29-Mar-2021, the patient experienced FEELING ABNORMAL (felt very bad). On 30-Mar-2021, the patient experienced RASH (rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin)). On an unknown date, the patient experienced NASAL DRYNESS (very dry nose), ERYTHEMA (sometimes had red hands), COLD SWEAT (cold sweat), VACCINATION SITE INFLAMMATION (inflammation at the injection site palm-size), VACCINATION SITE WARMTH (red, very hot (injection site)) and VACCINATION SITE ERYTHEMA (red, very hot (injection site)). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand), NASAL DRYNESS (very dry nose), ERYTHEMA (sometimes had red hands), ABDOMINAL PAIN UPPER (stomach pain), FEELING ABNORMAL (felt very bad), COLD SWEAT (cold sweat), VACCINATION SITE INFLAMMATION (inflammation at the injection site palm-size), VACCINATION SITE WARMTH (red, very hot (injection site)), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (red, very hot (injection site)) outcome was unknown and RASH (rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included cream Sheffield and ice.   Patient clarify that she was born on March 2 1937, but her birthday card says she was born on Feb 2 1937.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up information was received on 06 Apr 2021 in which event verbatim was updated.
Information has been received from a physician concerning a male pt who on 6/22/06 was vaccinated with a dose of MMR II/Varicella vaccine (lot 652328/0956R). Subsequently, on 7/4/06, 12 days after vaccination, the pt developed a rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
headache; body ache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration in Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date in 2021, she wanted to know if she can get the second dose a week later or earlier than the scheduled time like 2 days earlier. On unspecified date 2021 patient experienced headache and body ache upon receiving first dose of bnt162b2. The case was classified as non-serious. The outcome of the event was unknown.  Information about lot/batch number has been requested.
PATIENT RECEIVED VACCINE. STATED HE FELT FLUSHED A SHORT TIME AFTER ADMINISTRATION, BUT THIS DID NOT PERSIST. AROUND 2AM NEXT MORNING PATIENT REPORTS FEELING BAD AND HAD 103 DEGREE TEMPERATURE. WENT TO ER. PATIENT'S BLOOD PRESSURE WAS VERY LOW. PATIENT CONTINUED TO DECLINE AND WAS HOSPITALIZED FOR 5 DAYS IN ICU. DOCTORS TOLD PATIENT THEY THOUGHT THIS WAS CAUSED BY REACTION TO VACCINE.
Major dizziness; Breathing like a fish out of water; Wheezing; Squeaking; Coughing; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 03Sep2021 at 08:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, allergy to lots of things, environmental, food, and chemical 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 ARMOUR THYROID and LORATSDINE for an unknown indication from an unknown date and unknown if ongoing. On 03Sep2021, the patient experienced major dizziness within 2 minutes of injection which lasted continually for 5 hours, intermittently for 7 days with breathing like a fish out of water, wheezing, squeaking and coughing started an hour after injection and was continued badly for an hour, reasonably for 2 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included ALBUTEROL inhaler 2 times, hot packs, hot tea, and bed. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events major dizziness, breathing like a fish out of water, wheezing, squeaking and coughing was resolved with lasting effects on an unknown date in Sep2021 at the time of report. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Rash on upper torso and arm; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12BA, expiry date 28th February 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On an unknown date, less than a week after receiving Bexsero, the patient experienced rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Bexsero.  Additional details were provided as follows: The medical assistant stated that the patient was given the Bexsero and developed rash on upper torso and arm.  The patient was prescribed Benadryl to treat the rash. The reporter consented to follow up.
broke out with brown spots, scabs all over face, neck and chest.  Biopsy came back as drug related,   Lasted some over a perod of a fe months.  Went off Imbruvica but then went back on and most disappeared with a week.  Was scheduled for carotoid artery surgery but had to be canceled because of neck reactions in March.
Patient had first shot on 9/9/2021. She subsequently developed chest pain on 9/20/2021 and was evaluated at ER. She had D dimer elevated at 0.7, Troponins x 2 were negative. CTA revealed no nodules or PE but revealed a mosaic attenuation throughout her lung fields. She had her second shot 10/2021 specific date  not listed. She followed up with Cardiology due to persistent symptoms in October 2021.  She was known to have normal Stress Pet 1/2021. Due to persistent symptoms,  she had heart cath on 11/2/2021 with stent placement in LAD.
pt recv vax;exp severe pain in shoulder; weakness & pain in the neck area; lab eval showed anti HBs less than 10;pt refused booster doses;RN stated pt seemed recovered;pt feels exp due to vax;
Headache, UrticariaPruritis, 1/5 injection site swelling & tingling, chills, sweating, low grade fever. 1/6 injection site itchiness headache, body aches. 1/7 sweating, lethargic, SOB, low grade fever. 1/8 low grade fever. 1/11 injection site itchiness. Narrative:  1/5 injection site swelling & tingling, chills, sweating, low grade fever 99. 1/6 injection site itchiness, headache, body aches. 1/7 sent home from work due to sweating, lethargic/SOB, low grade fever 99. Contacted PCP for  COVID test. 1/8 low grade fever, took Tylenol, effective. 1/9 COVID test negative. 1/11 injection site itchiness.
Pt developed fever 101 F, then felt achy 9May90  approx. 2 wks later,then proceded to numbness in rt leg (knee, foot, hip) & down both arms, pain in shoulders, neck & head, Short trem memory loss &problems concentrating-symptoms lasted 3wks
36 HOURS AFTER VACCINE - DIFFUSE ERYTHEMA ABDOMEN & CHEST LASTED 4 DAYS - HEADACHE 1 WEEK FLARE UP OF RA - INTENSE PAIN HANDS, WRISTS, R ELBOW, HIPS - SWELLING, STIFFNESS AND FATIQUE MD O/C MTX WITH RASH - RENEWED MTX WITH FLAREUP
When I got the shot, It was painful but everything was fine. I was fatigued that evening and then when I went to bed I slept excessively. On a scale of 1-10 I was experiencing a 4 in pain. I took Extra Strength Tylenol and am still having pain. I feel tired.
cough; diarrhoea; injection site erythema; injection site induration; injection site sweeling; injection site warmth; pyrexia; rhinorrhoea; This case was reported by a consumer via other manufacturer and described the occurrence of cough in a adult patient who received HAV (Havrix) for prophylaxis.   On 29th March 2019, the patient received Havrix. On an unknown date, less than a month after receiving Havrix, the patient experienced cough, diarrhea, injection site erythema, injection site induration, injection site swelling, injection site warmth, fever and rhinorrhea. On an unknown date, the outcome of the cough, diarrhea, injection site erythema, injection site induration, injection site swelling, injection site warmth, fever and rhinorrhea were unknown.   It was unknown if the reporter considered the cough, diarrhea, injection site erythema, injection site induration, injection site swelling, injection site warmth, fever and rhinorrhea to be related to Havrix.  Additional details were reported as follows: The age at vaccination was not provided. On 29th March 2019, Havrix was received by one of their associate during the normal course of business. No additional information was provided.
This case was reported by a healthcare professional and described the occurrence of upper respiratory symptoms in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy and sinusitis. Concurrent medications included SYNTHROID, ATENOLOL, ZYRTEC, BEXTRA and NASONEX. On 24 October 2007 the subject received a dose of FLULAVAL at 0.5 ml in the right arm. In December 2007, after vaccination with FLULAVAL, the subject experienced upper respiratory symptoms, sinusitis and bronchitis. In January 2008, with continued symptoms, the subject had a quanitative blood test where she tested positive for influenza A and B. The subject experienced a systemic reaction. At the time of reporting the events were unresolved. Follow-up information was received on 14 March 2008, via healthcare professional, who reported the events had resolved. The healthcare professional clarified that the laboratory results reflected a positive titer for influenza A and B and the patient had not necessarily contracted influenza. The reporting healthcare professional considered the events possibly related to vaccination with FLULAVAL.
headache and nausea started about 24 hours after vaccine and lasted about 12 hours
Initial report received from a healthcare professional on 08 August 2013. A female patient had received an intramuscular dose of ADACEL vaccine (lot number: U4646AA, dose in series and site of administration was not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period date was 04 January 2013 and the estimated date of delivery was 11 October 2013. Laboratory investigations were not reported. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "NA". Medical history and concomitant medications were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: None.
Extremely and persistently ?foggy? brain and general mental fatigue that lasted for about 5+ days.
Immediately upon giving the vaccination the patient's arm began to swell in the area of injection and around it, it turned purple/red in color.  The reaction measured at 2"x2" area.