chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bronchial type infection; His throat was irritated from the coughing; His taste didn't seem to be the same.  He couldn't taste the sugar in his coffee; Severe Coughing; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchial type infection), THROAT IRRITATION (His throat was irritated from the coughing), TASTE DISORDER (His taste didn't seem to be the same.  He couldn't taste the sugar in his coffee) and COUGH (Severe Coughing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 004C21A and 0471321A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced BRONCHITIS (Bronchial type infection), THROAT IRRITATION (His throat was irritated from the coughing), TASTE DISORDER (His taste didn't seem to be the same.  He couldn't taste the sugar in his coffee) and COUGH (Severe Coughing). In December 2021, COUGH (Severe Coughing) had resolved. At the time of the report, BRONCHITIS (Bronchial type infection), THROAT IRRITATION (His throat was irritated from the coughing) and TASTE DISORDER (His taste didn't seem to be the same.  He couldn't taste the sugar in his coffee) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided. Patient believe he had a low level of Omicron.
Client stated he had left arm/shoulder decreased mobility after receiving vaccine.   He saw a neurologist for the complaint and received physical therapy.   Booster dose given in left gluteus medius
4FEB97 moist, non productive cough, afeb;3FEB97 given med x 21 days;
Patient completed the 15 minute Observation period without incident and left the clinic.  She returned 1 hour later complaining of an itchy on Left Forearm just below the elbow .  Nothing noted at injection site.  No other complaints. Also had reddened itchy are in same place on  right arm. Given 25mg of liquid po Benadryl. Observed by onsite paramedic for 45 minutes.  Redness and itching areas resolved.  Left clinic and returned to work.
Assistant checked on Pt at 5min mark  after administration and Pt c/o itchy throat and nose with itchy at injection site. Soft rapid was called and Pt was given 50mg/ml diphenhydramine. RN remained with Pt for 15 minutes after IM administration and Pt stated feeling better with non s/sx. follow up with Provider given.
A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient experienced patient experienced a nose bleed after receiving FLUMIST. The patient recovered from the event of patient experienced a nose bleed after receiving FLUMIST on an unspecified date. The report was considered to be non-serious.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Jan2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) Positive, notes: Tested positive 5 days after finishing Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received PLAXOVID to treatment "drug ineffective" and "covid-19". Treatment start date=26Jul2022; treatment stop date=31Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Per Emergency Room MD: Inflammation with swelling left deltoid area, possibly secondary to Tdap vaccine (7/9/07)
16APR92 420PM mom called & reported pt had sx t102.6 & had jerking motions; tried to give APAP but pt vomited; called ER mom was told to give pt sponge bath; 445PM t101.9; 10PM vomiting again & diarrhea;
Pt reports recurrent frontal headaches noted #6, onset 7 days after injection. Occurring TID daily; episodes 30 minute duration recedes without analgesics
Inability to bear weight, low grade fever 2-3 days after vaccine, increased swelling in right thigh and increase in warmth, possible hematoma developing and possible synovitis.
Arthralgia, fever, sore throat and rash beginning at hair line and progressing down body.
Left arm and hand numbness, pins and needles feeling through the day Dizziness Nausea Tingling in both legs and feet Daily fatigue
Patient developed rash on left thigh approx. 3 hours after vaccine. Painful, unable to walk the next morning. Gave Ibuprofen. Seen at 10:30 AM 3/12 - improved rash and able to walk. Also had fever 101.
Confusion, very tired, joint aches, at first. On Tuesday April 13, my husband woke up in pain to his left leg. The left leg had a painful softball sized hard lump on inside of knee and a little bigger than a golf ball hard lump on his calf.  Had no treatment until April 18th
Fatigue began around bed time (9-10 pm) to a more intense degree than usual (nearly fell asleep on the toilet even though sleep schedule was normal). When I got into bed in a 73 degree home in long sleeves and long pants began Jack hammer shakes that continued until I fell asleep. Slept through alarm the next morning, woke up feeling extremely run down. Checked temperature and it averaged 101.4 Fahrenheit. Went back to bed for two hours, nose is stuffy (may be allergies since that?s back in the sinuses not running), sore muscles, aching bones (particularly jaw, both top and bottom), and a nasty headache. Fever continues at 100-101 farenheight.
Information has been received from parents, a physician and a medical assistant concerning a 19 year old female with anxiety, depression, asthma, twitching and tremor and a history of spinal fracture who was vaccinated with three doses of GARDASIL. The patient received the first dose of GARDASIL (Lot# 660618/0572X) on 17-NOV-2008. The patient received the second dose of GARDASIL (Lot# 661766/0652X) on 20-FEB-2009. The patient experienced numbness and tingling after the second dose. The numbness and tingling was never reported to the physician. The patient received the third dose of GARDASIL (Lot# 661846/1312X) on 05-JUN-2009. Concomitant therapy included ZOLOFT, hydromorphone, albuterol, montelukast sodium (MSD) and HOMACCORD. The medical assistant also reported that the patient had received a influenza virus vaccine (unspecified) shot on 13-OCT-2008. No other vaccines was given at the time of the GARDASIL doses. The parents reported that on 08-JUN-2009 the patient experienced seizures after the third dose. The patient was hospitalized on 9-JUN-2009 until 11-JUN-2009. The patient was still having seizures even after she was discharged from the hospital. Full blood chemistry panel and electroencephalography (EEG) were performed (results not provided). According to the medical assistant, hospital records from the June 2009 admission had not yet been received by the physician's office, but a written chart note indicated that the event did not look like a seizure. Event was not considered as disabling or life threatening. The patient would see a neurologist on 24JUN-2009. At the report time the outcome was unknown. Additional information has been requested.
Moderate-severe muscle pain in deltoid evening after then pain subsided and soreness remains in bicep and warmth, redness and swelling seen in tricep area.
Too much to type here before the session times out.  Delayed Urticaria after the booster, GERD, breathing issues, swelling, itching.  Antihistamines (Zyrtec, Benadryl), Albuterol, Pepcid, Prilosec, Steroids (prednisone, decadron),
Erythema, edema, heat and tenderness in (R) FA. surrounding KINRIX injection site.
Within 1 minute of injection, patient stated he had funny taste in mouth like sweet antifreeze, also felt funny, lightheaded and strange feeling.   BP was taken 155/99, AP-69, O2 Sat. 98%.  Gave pt. some water and a cracker since he stated earlier he did not like needles. Patient stated he has never felt like this after vaccine injection.  After 5-10 minutes, symptoms began to improve.  Pt. stayed with writer 15-20 minutes and then stated he felt okay to leave, he had another appt. at clinic today.  Final BP 133/87, AP-68, O2 Sat. 98% before released.
Reddness and swelling in arm from shoulder to elbow. Started day after admin, 3 days after she went to urgent care, given antibiotic and steroids.
This spontaneous report as received from a Licensed Practical Nurse. On 29-APR-2013, multiple unspecified patients were vaccinated with GARDASIL (lot # H014645, exp. 27-MAR-2015). The nurse reported the dose of GARDASIL were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
The night of 2nd vaccination of Pfizer patient began to develop symptoms of dizziness/palpitations. Sought out care for cont'd intermittent sx throughout the follow week. Saw our clinic on 09/03.  Pt has also had variable blood sugars since second vaccination ranging from 97-300 per report.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient had 1st dose of vaccine and experienced shingles. The patient had been trying to found a location that had the SHINGRIX vaccine for 2nd dose and had not been successful.
Patient began to feel dizzy and lightheaded about 5 minutes after vaccine was administered. Was given water, began to feel better, asked to go to the bathroom. While walking to bathroom with Pharmacist, began to feel dizzy again, fell (slowed by Pharmacist), did not hit head. Began to feel well a few minutes later
I had a sore throat, cough, chills, body ache and a headache. I had a virtual visit with the doctor and went over my meds and she prescribed PAXLOVID on the 23rd of September. I tested positive on September 22, 2022. I still have a cough, a slight headache and I am tired. I have not fully recovered yet.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a 0.5 ml dose of ProQuad (upgrade process). Subsequently the patient developed a fever. Unspecified medical attention was sought. There were no labs performed. The patient recovered. There was no product quality complaint involved. No additional information was provided.
I'm a healthy 36 year old female and received my first dose of the Pfizer vaccine 2 weeks ago.  A few hours after the shot, I had tingling/numbness on the ulnar side of my shot arm.  The next morning I had some tingling in my foot on that same side as well.  Since then, I've had mild "pins and needles" feelings intermittently in both lower and upper extremities, and a bit in my forehead as well. The "pins and needles" feeling has not subsided. I WOULD LOVE TO BE CONTACTED WITH SOME GUIDANCE AS TO IF I SHOULD RECEIVE THE SECOND DOSE.
PATIENT RECEIVED PNEUMONIA AND SHINGLES SHOT ON THURSDAY 31 JUL @ APPROXIMATLEY 1100-1300. SHE STATED THAT SHE BEGIN TO FEEL FEVERISH AND COMPLAINED OF HEADACHE AND BODY ACHES AROUND 1900. SHE CALLED ME ON FRIDAY MORNING AND DESCRIBED HER SYMPTOMS. SINCE THE SYMPTOMS SHE WAS HAVING AT THE TIME WAS NOT AN UNCOMMON ONE, AND SHE DID NOT HAVE ANY CHEST PAIN, DIFFICULTY BREATHING OR GENERALIZED ITCHINESS I TOLD HER TO TAKE TYLENOL OR MOTRIN (OR WHATEVER SHE NORMALLY TAKED FOR ACHES AND PAINS) AND USE A WARM COMPRESS FOR THE SWELLING AND IF IT DID NOT GET ANY BETTER TO FOLLOW UP WITH US. SHE PRESENTED TO THE CLINIC TODAY (MONDAY 5 AUG) TO SHOW ME HER ARM AND TO ASK ME TO FILL OUT A VAERS FORM SINCE SHE HAD TO GO TO A DOCOTR OVER THE WEEKEND BECAUSE HER SYPMTOMS GOT WORSE. SHE SAID THAT OVER THE WEEKEND SHE PROGRESSIVLE HAD INCREASED BODY ACHES, EXTREME FATIGUE, PAIN IN THE RIGHT SIDE OF HER RIBS (NOT CHEST/HEART PAIN), LOW GRADE FEVER AND EXTREME SWELLING AT THE INJECTION SITE. WHEN I ASKED TO LOOK AT HER ARM THERE WAS A BLACKISH COLORED BLISTER APPROXIMATLEY THE SIZE OF A HALF DOLLAR. SHE SAID THAT SHE WAS STILL HAVING THE BODY ACHES, FEVERS AND FATIGUE BUT IT HAD GOTTEN BETTER THAN WHAT IT WAS OVER THE WEEKEND. SHE SAID THAT HER DOCTOR PUT HER ON A DECREASING DOSE OF STEROID AND TOLD HER TO FOLLOW UP IF NEEDED.
About a week ago patient noticed slight sag in lip. Now she has paralysis of left mouth and eye impeding speech, eating and drinking. She is following up with MD today.
Urticaria, total body and no other symptoms at 24 hours after immunizations. Treated with Benadryl. No sequela.
Swelling, redness and now tenderness that has been getting progressively worse. No treatment yet - just prescribed naproxen twice daily.
Felt wiped out; 100 degrees Fahrenheit body temperature; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left(at unknown time in late afternoon), administration date 23Mar2021 (Lot number: ED7534) at the age of 63 years as dose 1, single and administered in arm left,(at unknown time in late afternoon) administration date 13Apr2021 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Shingles vaccine (Verbatim: other vaccines in the past like the shingles vaccine), for Immunization; Flu vaccine (Verbatim: had flu vaccines in the last 5-10 years which he did not have those regular side effects), for Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "Felt wiped out"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "100 degrees Fahrenheit body temperature". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: He additionally mentioned later in report having had what he referred to as regular side effects with the first two doses of Pfizer Covid Vaccine which he further described as being that he felt wiped out and 100 degrees Fahrenheit body temperature. He had these with both of the first two doses. He recovered completely from events after about 2-3 days. No follow-up attempts are possible. No further information is expected.
cough started 4/12, still coughing as of 5/4.  Taking prescription suppressants,  atovaquone, and nebulizer treatment which is helping, but still coughing. achy and tired started approx 4/14 for about 5 days.  Still a tiny bit achy today, but worst lasted about 5 days.
Intusssception in 2 places. One of which required air enema, the other needed surgical reduction.  2/15/07 Received medical records from PCP which included vax records.  Patient seen on 12/28 w/nasal congestion & right nasolacrimal duct obstruction.  Next visit on 1/2/07 for vomiting, listless, diarrhea.  Other family members ill w/stomach flu. Exam revealed afebrile, good hydration.  Dx w/gastroenteritis.  Next seen 1/25/07 for vomiting, crankiness, decreased appetite, nasal congestion. Dx/vomiting secondary to unspecified acute illness, posible gastroenteritis.  Seen for vax on 2/7.  Then next seen on 2/10 for emesis, dry heaves, no diarrhea, normal stools.  With other episodes, had some loose stools that were mucousy & little bit of blood at time.  2/11/07 phone call revealed patient continued to have vomiting.  UA revealed UTI & was sent to hospital for admission for UTI, vomiting & dehydration.  At hospital was found to have IS. 3/13/07 Medical records reviewed which reveal patient admitted 2/11/07 s/p vomiting for 1-2 days, 1 bloody mucous stool & having a UTI.  Exam revealed VSS, abdomen soft & diffusely tender w/o masses palpable.  ALso noted erythematous rash on back & arms.  Lungs were clear w/mild subcostal retractions.  Ped surgery consulted.  Taken to OR after BE failed to reduce.  Procedure was attempted laparoscopic reduction of IS; open resection of ileoileal IS, including Meckel's diverticulectomy; & appendectomy. No D/C summary available.  T/C to hospital to request d/c date which was 2/15/07. Final Dx: Ileoileal intussusception w/Meckels diverticulum as the lead point.
Pt complained of abnormal soreness in arm day after shot which continued for a week or two after nerve pain extending down arm into hand and a limited range of motion in shoulder also presented.
Pt presented 6/2/04 with viral syndrome with exam then with noted right thigh that had erythematous macule around 1cm diameter, central 1mm nodular cutaneous NT. Mass at immunization site. No pus drainage.
I received #5 Covid (Moderna bivalent booster) at 2:30 p.m. on Mon 10/10.  I began feeling mild muscle aches and headache at about 10 p.m.  (I always get fever, aches and headache pretty substantially with Covid shots so this was as expected. ) At 6:30 am, I got up, walked a few feet and suddenly fainted, momentarily losing consciousness, and falling to the floor forcefully.  I sat up, collected myself, got up, walked a few more feet, and suddenly fainted again.  This time I hit my right hip and right occiput.  I was only momentarily unconscious, just a couple of seconds. I was quite shaken up, since I never faint and this was so sudden and unpredictable. I could have been severely injured since the floor was tile, and there were sharp cabinet corners all around.  I was fortunate not to be hurt.  I was also having mild headache and lots of muscle aches at that time, as I had expected.  I got chills, then mounted a fever to 99.6 which persisted all day.  Took ibuprofen  400 mg twice during the day. Still have sore bruising on right hip and right occiput as of midday on 10/12.  I comunicated with my GP but (as a physician myself) did not feel the need to be seen in person.
forgot to dilute vial before administering 0.2 ml  IM once to patient. Advised parents of potential for local and systemic adverse events
Fatigue; Headache; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 17:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to steroids. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paroxetine (MANUFACTURER UNKNOWN), zaleplon (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), withania somnifera (ASHWAGANDHA) and ibuprofen (IBUPROF); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 the patient experienced fatigue, headache and pain at injection site. The event 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 tested for COVID-19. The clinical outcome of the events fatigue, headache and pain at injection site was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
1ST DOSE - 04/21/21 - PFIZER LOT# ER8731 2ND DOSE - 05/12/21 - PFIZER LOT# EW0170 3RD DOSE - 12/27/21 - PFIZER LOT# FL3197 I have had a cough every day since 05/13/21 after my 2nd dose of the Pfizer vaccine, and I have been feeling rundown and worn out with no energy every day since then.
DTaP vaccine was given w/ exp. date of 2/12/15. Given on 2/20/15.
Nausea - 12 hours Headache - 12 hours Body Aches - 12 hours Brain fog - 12 hours Fever (101 degrees F) - 12 hours, mitigated by Tylenol every 6 hours Sore Arm at site of injection - 12 hours
Swelling of the right side of the face, right arm, right leg and right foot. There was also some swelling of the left foot. Had low grade fever day of the immunizations.
AFIB;  This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from License Party (Bristol-Myers Squibb). Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2022-092533 (Bristol-Myers Squibb Company).  Information was received from a Consumer/other non health professional concerning a 63 Year(s) old Male patient, enrolled in the post marketing study who received Suspect product apixaban for Product used for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for covid-19 prophylaxis, lot number: Unknown. On an unknown date, the patient experienced atrial fibrillation(afib) which was considered serious due to the following criteria: life-threatening, hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. Concomitant medications were not reported. The reporter considered event atrial fibrillation not related to product APIXABAN. The reporter considered event atrial fibrillation related to product COVID-19 VACCINE. Patient's wife reported that her husband was in the ICU and went into AFIB after getting the COVID shot. No additional information reported Tracking of Changes: 18-Aug-2022: Initial information was received.  Eliquis is under agreement with BRISTOL-MYERS SQUIBB.  BMS Comments: This patient had life threatening atrial fibrillation after receiving apixaban therapy along with COVID - 19 vaccine. Atrial fibrillation is a cardiac electrophysiological disorder and it is considered not related to apixaban due to lack of pharmacological plausibility.; Sender's Comments: Based on the available information, a contributory role of suspect drug COVID - 19 vaccine cannot be entirely excluded for the reported event of atrial fibrillation. Patient's wife reported that her husband was in the ICU and went into AFIB after getting the COVID shot. Case will be reassessed upon receipt of additional information.