chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning a 2 year old female who on 7/18/01 was vaccinated with varicella virus vaccine live. On 7/20/01, the pt developed injection site irritation. Additional information has been requested.
Patient complained of light headedness and throat feeling "weird." Pt was given water and 25mg Benadryl and taken to observation. Patient was released to her mother and declined EMS transport.
The patient received his vaccine in the. morning of 1/20/2021, while getting into car to go see his pulmonologist, about 2 hours after, collapsed, unresponsive with asystolic cardiac arrest.  No symptoms prior other than chronic dyspnea.  No allergic type symptoms reported by family.  Asystole with EMS, no response to ACLS, presented to ED, DOA.
Just after leaving the vaccination site, about 15 minutes after I received the shot, I got a sharp stabbing pain in the chest.  It was in the left side, felt like I was being stabbed in the heart.  The pain only lasted for 10-15 seconds.   I felt unbelievably tired  for 24 hrs.
8/12/21 @ 03:37 AM - PT NOTED TO HAVE EMESIS ON SHEETS AND GOWN. RESPONSIVE, VITALS STABLE, MD AND FAMILY NOTIFIED, ZOFRAN ORDERED AND GIVEN. NO DISTRESS NOTED. 8/12/21 @ 09:55 AM - PT NOTED TO BE EATING BREAKFAST.  NO DISTRESS NOTED. 8/12/21 @ 8:50 PM - VOMITING, NON-RESPONSIVE, RESPIRATORY DISTRESS. 02 SATS 48-50%. AMBULANCE CALLED, PT TAKEN TO ER. 8/12/21 @  8:58 PM - FACILITY NOTIFIED THAT RESIDENT EXPIRED.
Patient was given her first dose of the moderna covid vaccine. She briefly waited around the pharmacy afterwards then began wandering to the back of the store. Roughly 30 minutes after administering the vaccine, she came back to the pharmacy and vomited. Pharmacy staff checked on her and she stated she felt weak, nauseaus, and sick. She stated she just needed a moment to recover and did not need EMS, but the feeling did not pass, so a code white was called and EMS were called to check out the patient. They checked vitals and spoke with the patient, but she did not want to go to the hospital at that time, so she was allowed to rest in the immunization booth until she felt comfortable driving herself home. However, the feeling still did not pass, so roughly 45 minutes later she requested EMS be called again, and she was taken to the hospital.
Employee in to facility c/o nausea, weakness, light headedness, itchy eyes and SOB, throat itchy and "I have to take quick short breaths". Relates it to the flu shot, states she had it this morning and now she is feeling lousy. States she had the flu shot in 2002 and got the flu, states she knows that shouldn't happen but she felt lousy after receiving it in 2002. She has not had one since. States she is not allergic to any of the components to the flu shot. Her PCP is off site, wheeled her to the ED.  Given Benadryl 25mg Pepcid 20mg, Prednisone 20mg all po in ED.
Approximately 1 hour post vax, pt developed headache, nausea and stomach pain. Symptoms persisted for 7 days. Pt was seen by MD and given an injection of Demerol for headache pain.
Received Tdap on 4/22 in his left deltoid.  On 4/24 he was able to work out.  By 4/25 he had severe pain in the arm, unlike any previous vaccine.  Pain is all in the muscle.  Pain with elevation of the elbow and movement of the shoulder.  Could not find a comfortable position to sleep in, was only able to get a few hours worth of sleep.  Took some Tylenol, which was a bit helpful.  No fevers.  Pain is primarily along the entire deltoid.  No tingling in the hand.  No rash.  Has had prior vaccination without issue.  Has not had any other vaccines in the past 10 years.  Does not think he had pertussis in the 10 years since his last vaccine, though he had a severe "flu" about 6 years ago that lasted only a few days.  left deltoid with small, yellowing bruise at location that is consistent with IM injection.  There is no visible redness, rash, or obvious swelling of the left upper arm.  AC joint is not painful to palpation.   No pain with palpation of the elbow.  Tender along the distal body of the deltoid.  Strong grasp.  Tolerates PROM of the shoulder, but pain with elevation >45 degrees and with internal/external rotation.  Can reach cross-body, but this causes pain.  Negative empty can test.  Reviewed the package insert on the Tdap.  Class 3 pain (quantified as pain the prevents typical activity) can occur in 1.6% of patients in the 15 days post-injection.  He is afebrile, appears well, no alarming findings on exam.  Suspect he is having an exaggerated vaccine response.  Can use ice/heat, OTC lidocaine patches, and NSAIDs.  Will submit VAERS report.  He should reach out if anything is worsening or not starting to improve in the next week or so.  He verbalized understanding and agreed.
No adverse event; Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose).    No concomitant medication details was reported. The vial was initially stored in the refrigerator on 15-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Immediate pain after injection was giving.  Injection placed too high, on top of shoulder. Per Emergency Room MD, Injection was placed in the Left Shoulder Joint.  Symptoms include. Excruciating pain, radiating nerve pain, pulsating muscles pain, numbnessand tingly, swelling of left shoulder and arm. Weakness to left shoulder and arm, elbow and wrist, fingers . Muscle spasms to left arm, constant pain in the shoulder joint socket. Excruciating pain to left trapezius front &back of shoulder.
No additional adverse events reported; Caller is a medical assistant inquiring on next steps regarding a patient who received their first dose of GARDASIL 9 when they were 18 years old and now in their 30s. Caller reports that the patient believes they received their first dose in 2003.; This spontaneous report was received from a medical assistant referring to a currently 30-years-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  In approximately 2003, at the age of 18-years-old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (formulation, exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number and expiration date were unknown). The patient did not receive any of the subsequent doses in the series and the reporter wanted to know what would be next steps with this patient (inappropriate schedule of product administration). No adverse events were reported.
Arm pain and swelling began immediately. Later in the evening on same day of shot, I began to experience nausea.  Next morning pain, swelling and nausea persisted. Medium intensity body aches and headache began late morning. By mid afternoon body pain increased to the point that I was no longer able to function and needed to lie down.  Took a 4 hour nap. Side effects persisted after waking up.  At time of writing, 28hrs after vaccine, I am still feeling the side effect although less severe. Ibuprofen and Tylenol  do seem to help.
Pt vax w/ booster; exp vomiting, wheezing, rhinitis, rash, & periorbital edema.  Tx w/ bronchodilators in ER.
Information has been received from a 73 year old female consumer with a history of "several health conditions" and pneumonia in December 2006, who on 10-JAN-2007 was vaccinated with one dose of Zostavax. Concomitant therapy included an antibiotic to treat the pneumonia along with several other unknown medications. On 13-MAR-2007 the patient developed a "shingles related rash." She stated that the rash began on the back of her neck as a bumpy rash and spread to her collar bone area, arm, shoulder, chest and she felt a shooting pain on the side of her face and a painful ear ache. Medical attention was sought, the physician prescribed VALTREX 1 gm for 7 days to treat the shingles rash. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Information received on 19-MAR-2007 contained the following adverse experience: hospitalization for low sodium levels (February 2007) "related to another medical condition that she has." The length of hospitalization was not provided. Additional information has been requested.
Rig he arm sever pain at elbow. Swelled and painful right axilla lump nodes
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL, start date: Apr2021; CORTEF [HYDROCORTISONE ACETATE], start date: Aug2017. Past drug history included: Tacrolimus ointment, reaction(s): "known allergies:Tacrolimus ointment", notes: known allergies Tacrolimus ointment. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "COVID-19 Treatment".It was reported that the patient took anti-viral treatment for COVID-19 from 26Mar2022 to 29Mar2022.Device timestamp: 30Mar2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6PM started unconsolable crying lasting 2hrs;gave APAP 5PM because felt warm & irritable;called MD @ home;rt leg edematous-red MD did not advise ER visit;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in right arm and on 19May2022 as dose 4 (booster), single (Lot number: PL3198) at the age of 76 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. Concomitant medication(s) included: DONEPEZIL, start date: 25Aug2021; LOSARTIN, start date: 14Apr2021; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE], start date: 25Aug2021; PROZAC; SYNTHROID; WELLBUTRIN; ZOCOR; AZELASTINE HYDROCHLORIDE; ASPIRIN 81; CALTRATE [CALCIUM CARBONATE;COLECALCIFEROL]; NASACORT; VITAMIN D3; VITAMIN E [TOCOPHEROL]; CENTRUM WOMEN. The patient experienced Covid-19 on an unspecified date. The patient received Covid-19 treatment which included PAXLOVID taken from 28May2022 to 01Jun2022. The patient underwent the following laboratory tests and procedures: Covid-19 test: Unknown results. The outcome of the event was unknown.
Initial and follow-up information have been received from a registered nurse and a licensed practical nurse through a Merck pregnancy registry concerning a 19 year old female with papanicolaou smear abnormal and a history of hypothyroidism who on 22-DEC-2009 was vaccinated with the first dose of GARDASIL (Lot #653938/0954F). On 08-MAR-2007, the patient received the second dose of GARDASIL (Lot #655618/0186U). Concomitant medication was not reported. In approximately April 2007, it was determined that the patient was pregnant. On an unspecified date, the patient had a positive urine pregnancy test. The date of the patient's last menstrual period was 19-APR-2007 and estimated delivery date is 24-JAN-2008. On 01-JUN-2007 and 17-JUL-2007, ultrasounds performed were normal. On 31-AUG-2007, was third ultrasound performed showed funneling of the cervix. On 13-SEP-2007, a fourth ultrasound showed a blood clot only. On 03-OCT-2007 at 26 weeks and 2 days of pregnancy, the patient had an emergency caesarean section performed due to the funneling of the cervix. At this time, the patient delivered two normal male infants one weighed 1 lb 12 oz and the second weighed 1 lb 13 oz with no congenital anomalies. Apgar scores were 6/7 for both infants. The infants experienced the following complications or abnormalities prematurity, bronchopulmonary dysplasia and ductus arteriosus. It was reported that there were no infections or illnesses during pregnancy and no complications during labor/delivery. The outcome and causality of these events were not reported. Upon internal review the following were considered to other important medical events: premature baby, bronchopulmonary dysplasia, caesarean section, ductus arteriosus and small for dates baby. Additional information has been requested.
Had a bad MRSA infection; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Had a bad MRSA infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced STAPHYLOCOCCAL INFECTION (Had a bad MRSA infection) (seriousness criterion hospitalization). At the time of the report, STAPHYLOCOCCAL INFECTION (Had a bad MRSA infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Company comment: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced unexpected event of staphylococcal infection (seriousness criterion hospitalization). The event occurred on an unknown date after the administration of mRNA-1273 vaccine. The reporter mentioned that her son had a bad MRSA infection right before Christmas of 2021 and was hospitalized for a week after having the Moderna Covid-19 Vaccine primary series in early 2021. Very limited information regarding this event has been provided at this time.  Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-439087.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced unexpected event of staphylococcal infection (seriousness criterion hospitalization). The event occurred on an unknown date after the administration of mRNA-1273 vaccine. The reporter mentioned that her son had a bad MRSA infection right before Holidays of 2021 and was hospitalized for a week after having the Moderna Covid-19 Vaccine primary series in early 2021. Very limited information regarding this event has been provided at this time.  Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt recvd vax & c/o redness, swelling & fever at inject site; tx w/ apap;
fatigue; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Mar2021 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history included diabetes mellitus and hypertension. The patient took the first dose of BNT162B2 (Batch/Lot Number: ER8733) on 08Mar2021 for COVID-19 immunization and experienced achy in arm. Concomitant medications included ongoing metformin (strength: 1000 mg) taken for diabetes mellitus; ongoing sitagliptin phosphate (JANUVIA, strength: 100 mg) taken for diabetes mellitus; indapamide (strength: 1.25 mg) taken for hypertension; lisinopril (strength: 40 mg) taken for hypertension. The patient experienced fatigue on 30Mar2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Upon getting the vaccine I had the same reaction had I got from receiving the 1st and 2nd dose which was dizziness so I thought noting of it. Then when I got home within a half hour I felt a chill down my spine. I had a shiver go down my spine that felt weird. I had some neck and back pain that felt like spinal pressure. That continued throughout the day on and off. I felt better than I did the first couple of weeks. The pain came and went. I felt discomfort more on some days than other days. Close to the first 5 or 6 days I had felt it the worse. I still feel the lower neck and upper back pain. I also had pain and tingling in my legs. I see an acupuncture to try to help with the pain. When I seen my neurologist they said my immune system started attacking healthy cells and then that affected my nerves. They said that that caused pressure on the nerves. The neurologist said they think I will make a full recovery, but if I don't fell better by next week then I could start getting steriod treatments.
Upon getting second vaccine dose, patient immediately lost consciousness and appeared to be having a seizure and difficulty breathing.  Patient became responsive and was talking to EMS upon their arrival. Pt then lost consciousness for second episode and EMS transported to local ER.
At 12:30 a.m. on March 3rd I began having severe shivering for about 3 1/2 hours. This caused my blood pressure to go up to 175/99, pulse 128. I also began running a fever at about that time and ran it for about 24 hours, highest is got was 101 . Arm is swollen. I had covid the first week of October so am not sure if this played into my reaction. I am concerned about taking my second shot if this is what I experienced with my first one.
temp elevated 103.5;very fussy x 8-9hr w/crying when awake-alternating w/sleep;
pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of a BP cuff (4" x 10");this case was reported by MD;cross reference w/DER 0010150960093 to DER 0010150960100, DER 0010150960102;
A report received from a health professional on 06Feb03, concerning a 40 year old female vaccinee who developed flu with fever, body aches and pains an unspecified length of time after receiving Fluvirin on an unspecified date between Nov and Dec 2002. On an unspecified date the vaccinee developed the flu with fever, body aches and pain. A nasal swab on an unspecified date in Feb03 was positive for Type A and Type B antigens. There was insufficient information to determine the reporters causality assessment. Cross ref with: PJP200300059; PJP200300060, PJP200300062.
11/03/2022 I had fever, chills, headache, coughing, cold sweats, chest and nasal congestion and fatigue. Symptoms have been constant for 2 months. Dr. and I agreed that I would not take Paxlovid since I currently take intravenous vitamin supplements and I would have to stop. I have heard that Paxlovid may also cause a rebound case of COVID-19, so I treated my symptoms with Mucinex, Albuterol sulfate inhaler and OTC Tylenol.
4 year-old child who received 1 PENTACEL vaccine at 4 months of age and has had no others since then/no AE; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from another healthcare professional via Medical Information (under reference:00826706).  This case involves a four-year-old female patient who received one DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] at 4 months of age and has had no others since then (product dose omission issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  It was an actual case of medication error due to missed dose (latency unknown).  It was reported "4 year-old child who received 1 PENTACEL vaccine at 4 months of age and has had no others since then."  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the lot number for this case.
(L) upper arm pain, numbness (L) hand especially around 4th and 5th fingers. Tx: Naproxen 500mg BID with food. F/U one week or sooner if sx worsen.
Nurse gave Comvax and IPV in right leg (thigh) DTaP in left leg (thigh). Immediately (10mon) right leg turned red from thigh to knee swelling around vaccination site, baby crying and fussy Tylenol given, cool compress, Motrin. Improved-normal looking approx 20 mins later.
Blister, redness and swelling at injection site on (L) thigh. Rx given for amoxicillin, BACTROBAN ointment and continue CLARITIN for seasonal allergies. This was the initial dose of FLUZONE that we think he reacted to, as he had other immunizations in past.
Itching first at site of injection, then intense warming and itching all over, then swelling  over an area from shoulder to elbow. We called the Dr. and they told him to take an allergy pill.  (loratadine)
Syncope, pale, dizziness, Pass out when receives vaccines.  Went out for fresh air, felt better. Given water and snacks.
Pt diaphoretic, pale, nauseas, blurred vision, difficulty hearing, lightheaded, SOB, 10 minutes after receiving pfizer. Given water, vital signs obtained. HR low into the 50s, O2 sat 93-94%. Placed on a stretcher. After vitals obtained pt color returned and she stated she started feeling better. HR improved to 70s, O2 sat 97% on RA. BP stable throughout.
The patient said he felt numb all over his body, chest tightness, and reported feeling light headed
Intermittent tinnitus that occurs multiple times daily as a high pitch sound in both ears that can feel overwhelming.  This began within a few weeks after I received the 2nd dose of Moderna.