chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a register nurse who refers to an unknown number of patients (gender and age were unspecified). The reporter mentioned that an unknown number of patients might have received M-M-R II (lot # and exp date were unspecified) (Dose, route and frequency unspecified), GARDASIL (lot # and exp date were unspecified) (Dose, route and frequency unspecified), live, oral, ROTATEQ (lot # and exp date were unspecified) (Dose, route and frequency unspecified), PNEUMOVAX23 (lot # and exp date were unspecified) (Dose, route and frequency unspecified) or RECOMBIVAX HB (lot # and exp date were unspecified) (Dose, route and frequency unspecified); that was stored on 07-FEB-2013 at 9 degrees C for 24 hours and then on 08-FEB-2013 exposed to 9 degrees C for 72 hours and there was no stability data to support. The nurse is part of The Vaccine Program (VFC) at the health department and stated this happened at the two physicians office. No adverse effect reported. Additional information has been requested.
COVID-19 illness after 4 months after receiving both doses in the vaccination series. on 4/16, patient began to complain of a runny nose, headache, sore throat, and cough. COVID-19 test confirmed COVID-19 infection. Vaccinated with Pfizer COVID 19 Vaccine as follows: dose 1 on 12/17/20, dose 2 on 1/4/21.
This spontaneous report has been received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient has not pertinent medical history and there were no drug allergies/drug reactions reported. ON 21-JUL-2015, the patient was vaccinated with (Oka/Merck) VARIVAX (lot number, expiration date, dose and strength were not reported) route default as  subcutaneous. No concomitant medication was reported. The reporter stated, that the patient was vaccinated with (Oka/Merck) VARIVAX, which has been subject to defrost cycling. No adverse event was reported. NO PQC involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a pharmacist via field representative referring to two patients of unknown age and gender. In April 2016 (also reported as on unknown dates), each of the two patients received a dose of ZOSTAVAX subcutaneously in the back of the arm, above the deltoid (dose and lot# were unknown) for prevention of shingles. In 2016 after getting ZOSTAVAX, the patients went back to the pharmacy because they had developed a reddened area at the injection site. The pharmacist prescribed MEDROL as treatment for both patients. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
5 pts experienced fever,chills,nausea,vomiting within 48 hrs after immunization. All pts received immun from same vial between 6-1-90 and 6-15-90.One pt treated with tylenol and compazine.
During 3rd week after vaccine, I experienced severe fluid retention through my body to include chest area; numbness/muscle spasm; and elevated blood pressure.
Diarrhea, joint pain, sleepy, flu like, low grade fever on 6/19/12 then 6/19 6:00pm or so, hives/rash begining at nap, then 6/20/12 full rash/hives back of head. Joint pain very sleepy, flu like lasting until 6/20/12, then flu like until 6/22/12 and very sleepy.
patient filled for out and asked for hd flu shot.  patient forgot she received the flu shot at another facility earlier in sept until she got home and her husband reminded her. insurance system was down so I did not get the therapeutic dup notification until the system came up and at that time I called the patient
Multiple symptoms after AVA #3 Tremors bilateral hand, Memory loss short term, Numbness, fasciculation, Joint pain, multiple joints, fatigue, malaise > 50 days, headache general, tinnitus.
Pt developed fever, and 48 hrs after seizure like episodes with falling to floor. Admitted x 4 days. EEG abnormal. Lab work-up. Discharge Dx-viral illness, suspected post reaction. He is a 21 month old previously health male that received DTaP vaccination on 1/18/03 and on 1/19/03 developed fever of 104 degrees. On 1/20 he had three episodes of tonic extension of all four extremities and falling to the floor, without loss of consciousness or eyes rolled back and continuing with intermittent fever. He was evaluated at hospital where he received a dose of Rocephin IM for pharyngitis and was discharged home. On 1/21 he had another tonic extension of all four extremities and was again seen at hospital where CT scan of the head was negative. He continued having intermittent fever with tnic clonic movement of all four extremities, without loss of consciousness and on day of admission 911 was called and he was transferred to hospital for further management. We assisted one of the episodes that was a focal seizure of the right upper extremity lasting around 15-20 seconds then generalized, but at the time he had no loss of consciousness. Upon physician exam he had no focal symptoms, clear lungs, with no throat swelling, lymphadenopathy, hepatosplenomegaly or jaundice. Cardiovascular exam RR, no murmurs. Skin exam showed three café au lait spots. The second day of admission he developed an erythematous, papular rash on the face and trunk. He was evaluated by MD ID, Gneetics and Neurology. EEG was performed. He started to improve without further medication or management. at the moment of discharge he was in stable condition, with no further seizure episodes in 72 hrs, acting as usual and with a normal physical exam. Spinal tab for bacterial antigens were negative with normal protein and glucose. CSF C/S was negative. Viral C/S is pending. MRI of the brain was normal. Neogen was obtained and pending results. Lactic acid was 2.7 and repeated at discharge was 2.3. Ammonia was normal. Herpes simplex, EBV and Mycoplasma titers were negative.
Stomach pain; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0162) via an unspecified route of administration in the arm left on 12Apr2021 at 14:45 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 15:00, the patient experienced stomach pain and dizziness. It was unknown  whether any therapeutic measures were taken as a result of the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events stomach pain and dizziness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
The site of the injection is red and is "as if a golf ball was cut in half"; Pain to the touch, redness and swelling around the injection; Pain to the touch, redness and swelling around the injection; Pain to the touch, redness and swelling around the injection/The site of the injection was red and as if a golf ball was cut in half; This spontaneous case  was received on 16-Sep-2020 from a consumer via the agency (reference number: SEQW20-01787) and concerned a 58-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 14-Sep-2020, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was not reported.   On 15-Sep-2020, one day after receiving influenza virus vaccine polyvalent, in the morning, the patient experienced pain to the touch, redness and swelling around the injection. The site of the injection was red and was "as if a golf ball had been cut in half". No corrective treatment was applied for the events.  At the time of initial reporting on 16-Sep-2020, the effects had not stopped, the patient was still experiencing the symptoms and had not recovered from the events.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Case updated on 25-Nov-2020: Correction made to information received on 16-Sep-2020: Suspect product recoded from INN Seasonal to INN Flu Vaccine Seasonal. Narrative and company comment amended accordingly.  Company comment: Vaccination site reactions (induration, pain, swelling and erythema) were associated with the use of the suspect product influenza virus vaccine polyvalent. The events occurred a day after vaccination, making chronology plausible. The events have not been resolved by the time of reporting of this case. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all 4 events due to lack of confounding factors.; Sender's Comments: Vaccination site reactions (induration, pain, swelling and erythema) were associated with the use of the suspect product influenza virus vaccine polyvalent. The events occurred a day after vaccination, making chronology plausible. The events have not been resolved by the time of reporting of this case. The patient's medical history and concomitant medications were not reported. With information presented, causality is assessed as possibly related for all 4 events due to lack of confounding factors.
SHE RECEIVED HER 2ND DOSE 1 WEEK EARLY. SHE UNDERSTANDS HER SERIERS IS COMPLETE
Patient developed muscle twitching, fatigue, dizziness and headache minutes after vaccine was given. Day after vaccine given, patient developed small red area around injection site that also had swelling and was warm to touch. No fever or other complication.
Following the administration of the Flu Mist member states losing his voice. Vaccine received on 5Dec09 1330 and symptoms began at 1630 5Dec09.
This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX. On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The case was reported by a pharmacy intern. The age at vaccination was not reported. The patient broke out in hives for 24 hours. The patient was just wondering how effective it would be against shingles because she probably would not get a 2nd shot due to how bad her reaction was to the 1st one. Pharmacy intern stated that she did fill out a form and sent it to the manufacturer already when asked for vaccine and the patient information. This might have already been reported as an adverse event (no duplicate case was identified). She stated that this reporting was done just in case it had not already been reported.
Coughing; Wheezing; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), WHEEZING (Wheezing) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN (DIOVAN), ROSUVASTATIN CALCIUM (CRESTOR), VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR), CARVEDILOL, TURMERIC [CURCUMA LONGA RHIZOME], APPLE CIDER VINEGAR, COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) and MULTIVITAMIN N [ASCORBIC ACID;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE].    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced COUGH (Coughing), WHEEZING (Wheezing) and HEADACHE (Headache). At the time of the report, COUGH (Coughing), WHEEZING (Wheezing) and HEADACHE (Headache) outcome was unknown.            Treatment information were not provided. Action taken with mRNA-1273 was not spplicable
I had a fever that lasted about 36 -48 hours, body aches, headache and chills the days following the vaccine. I had heart palpitations the following week and almost passed out on 12/29/2021. I was really dizzy for a few days. I saw the doctor the following Monday (01/03/2022). She told me it was because of the vaccine and it should go away. She just told me to keep an eye on it. The palpitations have gotten better in the last few days.
The patient is a 66 y.o. female patient of Physician with a history of atrial fibrillation, IDDM2, asthma, COPD, chronic respiratory failure on 4L of O2, HLD, HTN, and depression/anxiety who initially presented to another hospital and transferred to reporting hospital's ICU on 01/29/23 with respiratory failure requiring BIPAP, found to be in shock secondary to COVID-19, and subsequently intubated on 02/03/23. Hospital course complicated by atrial fibrillation with RVR versus SVT, elevated transaminases requiring N-acetylcysteine, acute parotiditis, and acute encephalopathy. Was eventually extubated on 02/10/23 but rapid clinical decline hours after with hypotension unresponsive to vasopressors. Eventually went into PEA arrest but decision was made to end the code after exhaustive measures were performed and all reversible causes were considered.    Discharge Diagnoses: PEA arrest Shock, unspecified Acute on chronic respiratory failure with hypoxemia  COVID-19 viral pneumonia Atrial fibrillation with RVR Acute parotiditis Acute encephalopathy  Incidental CT finding of adrenal mass - Time of death 23:19. Contacted family during cardiac arrest. Resident met with patient's family on their arrival and offered emotional support (see quick notes).
I had chills, low-grade fever, fatigue for over 24 hours. I was uncomfortable and struggling to focus for 36 hours.
Dose 1: Eight days following the first dose, I developed a red rash around the injection site. It was approximately 4x3", itchy, and warm to the touch. It persisted for three days, getting less red as time went on.   Dose 2: The night of the second dose, I had chills and then around 8pm I developed a fever (100F) and tried to sleep. I woke up around midnight with a temperature of (104F) and a headache. I took 500mg of ibuprofen and stayed in bed. At 2am my temperature was (102F) and stayed around 102 until 8am that morning. I ensured to stay hydrated during this time.The day after the vaccine I had a fever around (100F) until 6:30pm and took an additional 200mg of ibuprofen.
7 days after receiving the first dose of the Moderna Covid19 vaccine, I experienced a quarter sized rash just left of the injection site on my left arm. The rash was red, circular, slightly raised and was itchy. By the next day, the rash had grown in size to about 5 inches long by 3 inches wide, in a more oval shape and continued to itch. By the third day, the rash size was consistent with the day before except that it no longer itched. Today (1/20), the redness remains and the size remains consistent, still does not itch.
Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-28.
Swelling and  pain in my left calf and ankle; the ER performed an ultrasound and determined that I have an extensive deep vein thrombus.
This is a spontaneous report received from a contactable consumer or other non-HCP. A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0183), on Aug 6, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed pain in extremity/sore arm, onset Aug 2021, with outcome of unknown. Additional information: Reporter's husband got the same shot and his card says EW0183. Nothing was wrong with him, except he had a sore arm. Follow-up attempts completed. No further information expected.
Redness (small at first, then grew larger), tenderness, swelling, itching, and an extremely painful-to-touch lump under/at/around at the injection site. Redness is also hot to the touch.  Severe headache bordering on migraine-level.  Treated headache w my normal migraine regime.  Applied cold pack to the injection site.  Used lidocaine topical ointment to numb the skin and help control the itching.  It is 3 days after the injection and whilst the itching is under control the lump is still painful, red, and very warm.
I was outdoors with my grandchildren and wife and all of a sudden I felt like my heart went out of sync with my body. I started to feel weak and a need to sit down. I called my doctor and went in for an appointment on 04/28. He diagnosed me with A-fib. We went through a series of test. They zapped my heart to put it back into rhythm. I had a stress test which didn't show anything wrong. I had an angiogram, where they went up through my arm and noticed some blockage. I needed to have a triple bypass, open heart surgery. I had the surgery on July 21st. Today I'm feeling pretty good.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8730), in right arm, on 13Apr2021 as dose 2, single (Lot number: EW0164), in right arm and on 01Apr2022 as dose 3 (booster), single (Lot number: FJ9943), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Nov2022 at 07:30, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Patient received 2nd dose of Pfizer COVID-19 vaccine on 20Jan21 and tested positive for COVID-19 on 17May21 via nasal swab.
Hello, I received my J&J vaccine on 3/31/2021. 11:00a.m. Here is my results:  3/31/21 Day1: Waited 30 mins at site due to the history of Penicillin and Sulfa issues in the past.  I had a little itching at the shot site.  That went away in about 15 mins.  Late afternoon I had a slight headache. 4/1/21 Day 2:  Morning was normal.  Afternoon I started feeling a little sluggish.  I had a little headache. 4/2/21 Day 3: Morning was slow.  I noticed that I was tired.  Headache was stronger.  I took Ibuprofen 400mg. By mid day, I was on the couch the rest of the day.  My body was telling me to rest.  So I did.  4/2/21 Day 3: Morning was slow.  I noticed that I was tired.  Headache was stronger.  I took Ibuprofen 400mg. By mid day, I was on the couch the rest of the day.  My body was telling me to rest.  So I did. 4/3/21 Day 4: Morning was extremely slow.  I did force myself to get up at the normal time, but I didn't want to.  Headache was still present.  Body sluggish.  I ran an errand for about an hour, and when I returned, I was exhausted, so I took a 3 hour nap.  Headache all day.  Took Ibuprofen 400mg. 4/4/21 Day 5: Headache had gone away.  Today I noticed that I had a rash on my mid to lower back.  We put some cortisone cream on it, and it helped.  I have clear skin and don't normally have any reactions to anything. Very tired 4/5/21 Day 6: Feeling pretty good today.  The rash is still there and itching, but the cream is helping.  I feel like I am 80% back to my normal self. 4/6/21 Day 7: Almost back to normal.  Rash has almost cleared up, and I have my energy back to about 90%. Still a very slight headache. 4/7/21 Day 8:  Still having a slight headache. Skipped from 4/7-13th/21 - Doing much better. Still having a slight headache here and there.  Noticing that I am very tired in the afternoon, and making myself take a nap.
HIGH FEVER, RASHES (HIVES) UPPER AND LOWER EXTREMETIES WARM TO THE TOUCH AND DEEP RED COLOR, UNUSUAL SHORTNESS OF BREATH DURING LIGHT EXERCISES SUCH AS SIT UPS AND PUSH UPS-PATIENT DENIES.
Narrative: COVID infection after completion of COVID vaccine series: 01/05/2021 COVID vaccine dose #1 02/26/2021 COVID vaccine dose #2 07/15/2021 Pt presented to ED c/o 8-day h/o general fatigue/weakness, dyspnea on exertion, and atypical rash covering face, chest, back, and legs. Pt stated he had returned from another country yesterday evening from a mission trip and that he had been off his MH med X 2 weeks. 07/15/2021 COVID positive per nasopharyngeal swab 07/15/2021 Pt admitted to facility given sx and needing 4LPM O2 via NC. Overnight pt became hypotensive and required bolus of NS and methylprednisolone therapy. 07/16/2021 MD attending note reported continued/worsened confusion (AOX2). Continuation of supplemental O2 PRN 2LNC and solumedrol. Pt not candidate for remdesivir at moment due to transaminitis. 07/17/2021 MD attending note reported that pt alert and oriented. Denied any concerns including cough, SOB, CP, or abdominal pain. Continuation of supplemental O2 PRN 2LNC and solumedrol. 07/18/2021 MD attending note reported pt having non-productive cough and mild SOB. Remdesivir started since LFTs normalized and pt hypoxic. Continuation of supplemental O2 and solumedrol. Pt resumed modafinil therapy. 07/19/2021 MD attending note reported pt feeling about the same/fatigued. Continuation of remdesivir and solumedrol. 07/20/2021 MD attending note reported pt not feeling well, slow progression of condition. Continuation of remdesivir and solumedrol. Unclear etiology of rash and labs still pending. Tentative d/c of 07/26/2021. 07/21/2021 MD attending note reported no change in pt condition. Continuation of remdesivir and solumedrol. 07/22/2021 MD attending note reported no clinical improvement. Continuation of remdesivir and solumedrol. Rash resolved, but etiology unclear as syphilis/RPR panel results mixed. 07/23/2021 MD attending note reported pt not feeling well and requested DNR/DNI. Continuation of therapy. 07/23/2021 Pt had elevated NEWS due to low BP and supplemental O2 at 3LNC 07/24/2021 MD attending note reported no clinical improvement. Pt transferred to SDU. Continuation of therapy. 07/26/2021 Pt told chaplain that he was suicidal and planned to OD on antidepressants. RN and MD notified. 07/26/2021 MD attending note reported no clinical improvement. Pt informed likely need SNF. Continuation of remdesivir. End solumedrol and initiated prednisone and vitamin D. 07/27/2021 MD attending note reported pt in better mood and disposition. Last day of remdesivir. Pt on room air. Continuation of prednisone.
Information has been received from a health professional concerning a male (demographics unknown) who on 7/30/01 was vaccinated with 1 dose of MMRII, in the right thigh (lot 637834/0696L). On 8/2/01, the pt was seen in the physician's office for injection site swelling 5" X 4" and injection site erythema 2 1/2" in diameter. It was reported that the pt was treated with cephalexin (Keflex) 250mg/5 ml tid. On 8/4/01, he was seen by the physician again, for increased redness. The regimen of Keflex was continued. Additional information has been requested.
pt recvd booster dose of MMR vax on 24SEP91 & five minutes p/vax stated that everything got black &  then fell & hit head & elbow on floor; pt began shaking, eyes rolled back; later pt regained consciousness;