chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 22 months old female patient who received 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (batch number: UT6315PA, expiry date: 30-Jun-2019) 14 hours after a needle was placed. The patient's past vaccination(s) included Flu vaccine (INFLUENZA VACCINE) in SEP-2017 and FLU Vaccine (INFLUENZA VACCINE) in DEC-2017. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant vaccination included a dose of Hepatitis A vaccine in right thigh. It was case of actual medication error due to incorrect product storage. It was reported that Prefilled syringe that tip cap had been removed & needle attached was given the next day after it had been accessed and placed back in the fridge overnight. Nurse reports that FLUZONE QUADRIVALENT 0.25 ml tip cap was removed and needle attached at the end of the day but the patient did not come in as scheduled. When she arrived the next day the same syringe was used for vaccination. No side effects were reported. 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 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. Documents held by sender: none.
I woke up for work the morning after I received the second dose, I could not wake up. I did wake up and felt like I was still asleep, emotionless, like my brain only partially turned on. When I arrived at work at 8:30am, I did not feel right, my eyes started burning and watering, I had sinus problems, I had a headache that went from my nose up to my eyes into my head, I had a 102 degree fever, extremely tired, I was told my eyes looked glossy like I was high. People were talking to me and I was emotionally absent (monotone) , my reaction time was off, people would ask me questions and I had a hard time understanding the question and what to say. I felt ?high? like I had smoked weed or something, my brain was not functioning at normal capacity, I was working and was so embarrassed because I wasn?t on anything, it was the vaccine and that?s why I worked with a fever, because I could not miss work. I had no problems with the first shot, the second was scary, I did not know if my brain was damaged or if it would get better. I will not get another dose after this reaction.
Information has been received from a 70 year old male with gastrooesophageal reflux disease and allergy to antibiotics who on 16-NOV-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX.  Concomitant therapy included rabeprazole sodium (ACIPHEX) and flecainide acetate.  On 20-NOV-2007 the patient developed shingles.  It was reported that the patient had no history of shingles.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been received from the patient who stated that he had no previous history of shingles.  The patient broke out into a dozen hive-like eruptions on his upper left thigh which he thought were bug bites.  The eruptions did not clear up and developed into blisters.  The patient was seen by his physician who confirmed it as shingles.  The patient at the time of report had rash for which the patient's dermatologist stated that it might take 6 months to fade.  Additional information has been requested.
Dry tickly cough and tiredness began 12/31/2022. Positive home test for Covid 19 on 1/1/2023.Went to Urgent Care on 1/2/2023, where positive test was confirmed.  Started paxlovid and benzonate on 1/2/2023.  Symptoms lessened by 1/5/2023 and resolved by 1/10/23. Negative home test on 1/8/2023.  Overall symptoms were mild.
Quick onset vertigo, then dizziness, felt faint, became shaky, then very weak, felt nauseous, very tired.  Called doctor at 10:40, he advised to take Claritin/loratadine, which I did right away. Within two hours, felt fine except a little tired.
pt recv vax 21NOV97 & the next day pt exp a sl rash on chin, a loss of appetite, irritability, extreme thirst, bowel change & fluctuating temp change ( i.e. very warm then back to nl temp);
chills/shivering; headache; sore arm; feverish without a fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: CHILLS (non-serious), outcome "unknown", described as "chills/shivering"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "feverish without a fever". Patient asked why did he feel feverish without a fever.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
40 hours after vax dose 1 at 8:30 am fingers got tingling sensation and spread quickly up my arms like when your foot goes to sleep  felt awful had to call 911. When  at drs got ekg  and then Got a vitamin IV from my dr at 2:00  symptoms. I think the cdc should cover my ambulance and the 250 dollars getting the vitamin infusion. I am VERY apprehensive on getting 2nd dose considering it could be worse.
Patient received monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent vaccine given as booster).    No Concomitant medications were provided.  It was reported that reporter found out that they could not give the Moderna as a booster starting 31 Aug 2022, but administered 15 monovalent doses as boosters. She called public health, who said there was no harm in it. and told that booster that patients received did not cover omicron, so the patients would need to be revaccinated with the bivalent later.   No treatment medications were provided.
Patient stated she felt like I can breathe in but I cant breathe out; Flushing; Clammy skin; Coughing; wheezing; Voice changes; This is a spontaneous report from a contactable Nurse. An adult female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), dose 1 intramuscular on 27May2021 as single dose for covid-19 immunisation. Medical history included allergy to eggs, dust, feathers and roach feces all from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. On 27May2021, the patient experienced flushing, clammy skin, coughing, wheezing, dyspnea, voice changes, patient stated she felt like she could breathe in but could not breathe out. The reporter classified the events as non-serious and stated the events result emergency room/department or urgent care. Therapeutic measures were taken as a result of the events with Epinephrine, 0.3 mg, intramuscular (IM) for 2 doses and Benadryl, 50 mg, IM. The outcome of the events was unknown.; Sender's Comments: Based on strong temporal relationship the reported events flushing, clammy skin, coughing, wheezing, dyspnea, voice changes, patient stated she felt like "I can breathe in but I can't breathe out" are assessed as possibly related to the usage of the vaccine BNT612B2. Also consider the possible contributory effect of the patient's medical history. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
reports really awful flares, did not specify symptoms, since receiving 2nd dose of moderna covid-19 vaccine; This spontaneous case was reported by an other health professional and describes the occurrence of RHEUMATOID ARTHRITIS (reports really awful flares, did not specify symptoms, since receiving 2nd dose of moderna covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was not required.  Concomitant products included TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (reports really awful flares, did not specify symptoms, since receiving 2nd dose of moderna covid-19 vaccine) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (reports really awful flares, did not specify symptoms, since receiving 2nd dose of moderna covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment medications were not reported.  Company Comment : Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Swollen lymph node on collarbone; surrounding tenderness on left side (same side as injection); arm pain; low-grade fever; body aches; chills; headache; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:00 at the age of 35-year-old as dose 2, single for covid-19 immunisation from workplace clinic.  The patient medical history was not reported. Concomitant medications included vitamins, tri-femyor, metoprolol, Tylenol and allergy to ceclor. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 16Mar2021 09:00 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced arm pain, low-grade fever, body aches, chills, headache 17Mar2021 02.00 and swollen lymph node on collarbone and surrounding tenderness on left side on 18Mar2021 12:00. The patient did not receive any treatment in response to the events. The outcome of events arm pain, low-grade fever, body aches, chills, headache was recovered while outcome of others was not recovered.  No follow-up attempts are possible. No further information is expected.
inc fever & high pitched screaming & rigidity began approx 2hr post vax;taken to hosp ER;sponged, given motrin;encouraged fluids;discharged to mom & grandma;
Headache, Angina, Severe Migraine and crushing chest pain Narrative: 2 days after Booster vaccination employee experienced Severe migraine and "crushing chest pain" which she went to the ER for. She had a CT scan and CXR and given medication and a referral to Neurology
5 days later my husband had COVID; The first Pfizer vaccine we got it on Monday and on Saturday my husband came down with COVID; We were tested and we had COVID; pretty sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Aug2021 (Lot number: FC3183, Expiration Date: Oct2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: COVID-19 (non-serious) with onset 04Sep2021, outcome "unknown", described as "5 days later my husband had COVID; The first Pfizer vaccine we got it on Monday and on Saturday my husband came down with COVID; We were tested and we had COVID"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "pretty sick". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Patient is a 52 y/o man with a PMHx of liver cirrhosis s/p transplant, CKD IV, and HTN. He presented to the ED today due to worsening renal function noted on routine labs. He was notified by clinic of worsening labs and was instructed to come to the ED. The labs were collected on 1/14 at a routine appt. He has labs every 2 months with his nephrologist, Dr. His Cr was 3.3 back in Nov 2021 and is now up to 5.0. He has a h/o cryptogenic cirrhosis s/p liver transplant back in 2019. He has had steadily worsening renal function since that time. He has had a preliminary meeting with transplant group at hospital to discuss possible kidney transplant. He is on tacrolimus and mycophenolate.   He reports mild cough, fever, loss of appetite, and loss of taste & smell about 2 weeks ago. He was not tested for COVID at that time because the line was very long. He had difficulty acquiring an at home test but finally had a friend give him one 2 days ago. He tested negative at home on 1/15. He reports ongoing fatigue, intermittent cough, and mild shortness of breath. He denies N/V. Reports mild diarrhea and decreased urine output. No significant abdominal pain.   In the ED his BP is stable, HR normal, afebrile. O2 sat 100% on RA. Labs with WBC 8.01, Hgb 12, Na 134, K 5.0, CO2 16, BUN 80.9, Cr. 5.0 , glucose 123. COVID positive. ED physician contacted nephrology & hospital admission recommended. Non-contrast CT of A/P recommended for further evaluation. Test pending at this time. CXR pending. Hospitalist service contacted for admission.    PT IS INPATIENT AT THIS TIME.
Right arm was sore right away and gradually became red and swollen becoming uncomfortable by 9pm. When patient went to the ER at 10pm the redness and swelling had spread from shoulder to elbow. Pt was given benadryl and prednisone in the ER which has stopped the progression of the reaction.
Started breaking out in rash similar to chicken pox--2/30/16-now has over 60 vesicular rash spots.
A few days after the vaccine my daughter noticed that her eyes changed in size. I suspected thyroid eye disease and took her to her dr for labs. The results were presence of thyroidglobulin antibody (4 - the normal range is under 1). Today her eyes look more disproportionate and swollen, her hair started falling too.
17 yo Client here for vaccines prior to travel with organized travel company. Vaccine record obtained and downloaded, consent obtained from MOC. Reviewed all travel vaccine information, TD, YF/Malaria, Rabies PEP, possible side effects, etc. Client and MOC voiced understanding, all questions answered. MOC very anxious about vaccines and kept asking client, "Are you okay?" and stated that she, herself may pass out. Client stated that she was not nervous and denied any issues with prior vaccines. Upon receiving vaccines, MOC was complimentary of child, client stated she felt like she was "going to pass out". Pt had vasovagal response to stress of injections, syncope occurred x approx 30-40 seconds with breath holding, involuntary movements, pale, slightly diaphoretic skin. Moved to floor with RN holding pt at side for safety, with resp and head support. MOC very anxious and stating "Do something, help her". I assured MOC client would be fine and would become alert and awake shortly. MOC dialed 911 but hung up as client awakened, answered questions and was appropriate. Pt moved to recliner, provided water and fanned with cool air. MOC sitting on floor, pale and nervous, provided water to MOC also. Pt observed for 10 additional minutes. MOC stated that she needed to get child something to eat. MOC & client to car, both walking well, stating they feel fine at this point. Grandfather in car waiting for family. Event reported to RN at the Nurse Hotline and form completed and sent to corp for documentation per policy.
Activation and outbreak of Herpes Zoster under where the vaccine was administered in the left arm. Never before has an outbreak of Herpes Zoster been activated in that area.
Deep lines around the bottom of my mouth; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6205 and expiry date: unknown), via an unspecified route of administration on 04Mar2021 as a single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. On 05Mar2021, the next morning patient have deep lines around the bottom of mouth. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Pt to ED 5/30 for altered mental status and recent COVID+. 5/30 Pt appears to be having a seizure, diminished lungs sounds bilaterally on auscultation. 5/31 pt sepsis score 15, code sepsis called. 6/1 midline placed, pt maintained on Vanco cefepime and azithromycin. 6/2 pt's blood sugar was low. 6/3 pt calm and cooperative, A&Ox2. 6/4 pt with complaints of "arms hurting and being sore". 6/7 pt is currently maintained on cefepime, white count is normal, pt afebrile, doing better. 6//1 antibiotics discontinued, sepsis BPA firing score 7, vital signs stable. Pt is aox2 with confusion, on RA not in distress, denies pain or sob. 6/13 pt showing no s/s of distress, pt discharged.
"huge round circle" rash swollen and dense; arm sore; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (arm sore) and VACCINATION SITE RASH ("huge round circle" rash swollen and dense) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm sore). On 20-Feb-2021, the patient experienced VACCINATION SITE RASH ("huge round circle" rash swollen and dense). At the time of the report, VACCINATION SITE PAIN (arm sore) and VACCINATION SITE RASH ("huge round circle" rash swollen and dense) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Vaccine was given on Sunday, April 22, 2018. Sunday evening, patient began to develop a fever and body hurt...her eye(s) also began hurting. She reported feeling achy with no energy and her left arm was very sore and felt very heavy, like she couldn't lift it. On Monday night, she noticed a rash all over her body of fine, little dots. These spots were/are very itchy! On Tuesday, patient contacted the prescriber and was instructed to take BENADRYL to help with itchy rash. It has been close to a week now and the rash has not resolved on its own.
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received PREVNAR 13, (lot number: X13882, expiration date: 30Sep2020), intramuscular on left deltoid from 10Dec2018 to 10Dec2018 at 0.5 ml, single for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on 10Dec2018, the patient got a PREVNAR 13 injection, 1M 0.5 mL, on left deltoid. After two days, the patient still had the soreness, pain, and hardness on arm. He or she got a red, bumpy, itchy rash across the arm. On 13Dec2018, at 9 am, the patient went again to the clinic to have arm checked. The nurse practitioner gave and had the patient take 2 tablets of ZANTAC, 1 tablet of ALAVERT and 1 tablet of prednisone. She asked the patient to come back at 4 pm to check on the outcome from taking the medication. The rash has turned to pinkish color, and apparently slowly disappearing. The nurse prescribed prednisone 20 mg to with the loratadine and ranitidine for three days. The patient was recovering from the vaccination site erythema and vaccination site rash; unknown for the event vaccination site pruritus; and not recovered for the rest of the events.
DAY OF: INJECTION SITE TENDERNESS DAY 1: HEADACHE, FATIGUE, LOW GRADE TEMP, MUSCLE SORENESS DAY 3: NOTHING DAY 4: LYMPH NODE SWELLING IN LEFT ARM PIT AND LEFT SIDE OF NECK