chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 54 year old female consumer with asthma, and drug reactions to LEVAQUIN (reported as "LEVIQUIN") and PERCOCET who on 18-FEB-2010 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23. Concomitant therapy included ADVAIR and XOPENEX. On 19-FEB-2010 the patient experienced "very sore, extremely sore pain". It was reported that the pain went from the injection site to the elbow and up to the shoulder. The patient did not seek medical attention. It was also reported that the pain went away in 3 days (recovered on 22-FEB-2010). Additional information has been requested.
chills with violent shaking; chills with violent shaking; arm stayed sore; several large welts on my left arm.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jan2022 (Lot number: 33036BD) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left), administration date: 16May2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0176, Location of injection: Arm Left), administration date: 25Apr2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious), TREMOR (non-serious) all with onset 16Jan2022, outcome "recovered" and all described as "chills with violent shaking"; PAIN IN EXTREMITY (non-serious) with onset 16Jan2022, outcome "recovered", described as "arm stayed sore"; URTICARIA (non-serious) with onset 16Jan2022, outcome "recovered", described as "several large welts on my left arm.". Therapeutic measures were not taken as a result of chills, tremor, pain in extremity, urticaria.  Additional information: Patient got the booster Sunday morning. By bedtime, had chills with violent shaking. Patient arm stayed sore for several days, and by Wednesday, there were several large welts on my left arm. No other vaccine in four weeks. Other medications in two weeks: multivitamin. No COVID prior vaccination. No COVID tested post vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
injection site pain; crummy/unpleasant; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 4M2C7, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in 3rd week of June 2019 and experienced pain in arm).   On 10th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 10th December 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, injection site pain and discomfort. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were resolved with sequelae and the outcome of the discomfort was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain and discomfort to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The reporter stated that the patient had crummy unpleasant after effects or symptoms. The patient experienced flu like symptoms for 3 days. The patient was in bed Wednesday night by 9 pm and per the reporter he was a big crank head. The patient also experienced arm pain at the injection site. The reporter consented to follow up.
Around 2pm, developed itchy, blotchy, red rash on left elbow, spreading to neck and face, lips began to tingle, went to ED, ED provide PO Benadryl, discharged home, symptoms resolved.
Very anxious about receiving second vaccination, expressed anxiety during vaccination.  Approximately 10 minutes after vaccine given at 11:05, c/o feeling ?warm all over?.  Relevant history ? had onset of severe HA within 3 hours of first vaccine that lasted 2 days ? treated self at home with ibuprofen for same.  T2DM, takes insulin and metformin, took meds today, ate 1 hotdog only for breakfast.  Has not checked blood sugar today.  Remote migraine history, last treated for same 8 years ago.  Primary  11:18:    P 103, R 20, SpO2 99%.  c/o feeling ?warm all over?, skin warm, dry, pale.  No rashes or hives.  No dyspnea or respiratory distress. Lungs clear. Declined to lie down. 11:20:  BP 117/84, P 100, R 20, SpO2 99%.  c/o onset bilateral frontal HA ? this HA feels same as HA after 1st Covid vaccine.  No other neurologic sxs, no dizziness, nausea. Alert, oriented, no speech or motor deficits.  No respiratory distress, no rash/hives.  Taking a few sips of juice. 11:22:  c/o ?head feels really hot? 11:25:  BP 118/84, P 95, R 16, SpO2 98%.  Alert and oriented, sitting up, eating a crackers and juice.  Skin warm, dry, no longer pale.   11:30:  HA remains, focused in frontal area and behind both eyes, again describes as like HA following first Covid vaccine, though ?not as bad?.    11:35:  HA remains, but feels enough better that she wants to go home.   11:39:  Husband present with patient.  Advised both that she should FU after leaving vaccination clinic with her healthcare provider today re: HA. Referred to the after-hours clinic  for further evaluation today. 11:46:  HA remains, no change in mental status or neurologic condition.  Discharged home with husband in stable condition.  Provided with address, phone, and directions to Urgent Care Center. Declined wheelchair to vehicle, walked to POV, escorted by RN.
A non-serious spontaneous report of administration of full dose (0.2ml) in one nostril was received from a registered nurse/health professional concerning a 47-year-old female. Neither medical history nor concomitant medications was reported for this patient. The patient received H1N1, Intranasal on 10-Nov-2009. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
Information has been received from a registered nurse concerning a 12 month old patient who on 02-APR-2007 was vaccinated with a dose of zoster vaccine (Oka/Merck). The nurse reported that at the time of the incident, they had no measles virus vaccine (+) mumps virus vaccine (+) rubella virus vaccine (+) varicella virus vaccine (Oka/Merck upgrade process) (MSD) in there freezer. She reached into the wrong bin in the freezer and retrieved the zoster vaccine (Oka/Merck) instead of the intended measles virus vaccine (+) mumps virus vaccine (+) rubella virus vaccine (+) varicella virus vaccine (Oka/Merck upgrade process) (MSD). There was no product confusion involved and it was a nursing error. As a corrective measure, the office has separated the vaccines into different bins on different shelves of the refrigerator. The patient had no symptoms. A product quality complaint was no involved. Additional information has been requested.
mild itching; some redness; sore; A spontaneous report was received from a consumer concerning, a 65-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced sore, redness, and very mild itching at the injection site.  The patient's medical history was not provided. Concomitant product use was unknown by the reporter.  On 17 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the same day, the patient experienced some redness right after receiving the vaccine and had a mild itching. On 18 Jan 2021, the injection site was sore.   On 26 Jan 2021, the patient experienced the redness and very mild itching around the injection site.  The patient didn't take any treatment for the events.   Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the event, sore at the injection site was considered resolved at the time of this report. The outcome of the events, the redness and very mild itching around the injection site was unknown at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pfizer orange cap 0.2ml given IM without dilution. No signs nor symptoms.
My menstral cycle was extended and messed up.  2 months after the shot I menstrated for 26 days!  Then 2 weeks I was fine, then started spoting for 5 days.  I believe this is the vaccine because it happened after my second shot too, only I didn't know the vaccine could do this.  Spent money on a OBGYN appt and an invasiv ultra sound to make sure I didn't have a cyst or some other major issue.  This was extremely stressful and costly.  I didn't know there was this reporting available.  My cycle eventually levels out to normal patterns, or it did after the second shot.
Left arm pain (injection arm) from shoulder to wrist for 7 days; severe for 4 days. Right arm pain from shoulder to wrist for 4 days. Upper back pain for 4 days. Frontal headache for 5 days; severe for 2 days. Fatigue for 4 days; severe for 3 days. Weakness for 5 days; sever for 3 days. Nausea and vomiting for 1 1/2 days. Fasting blood sugar elevation to 240 mg/dl day after injection; 212 2nd day after injection.
patients received improperly stored doses of vaccines; No adverse effects reported; This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. Patients' s concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.  Since 12-JUN-2019, on multiple unspecified dates, the patients received improperly stored doses (product storage error) of: (rha) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot numbers R014690 and R002510 with expiration dates on 23-MAY-2020 and 25-JAN-2020 respectively; rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot numbers R035673, R015439, and R003111 with expiration dates on 19-SEP-2020, 19-APR-2020, and 12-SEP-2019 respectively; and hepatitis a vaccine, inactivated (VAQTA) lot numbers R018935, expiration date on R018935 (strength, dose, frequency, route of administration, anatomical location, and indication were not reported for all therapies). The lot number and expiration date for properly stored sterile diluent ( Merck sharp and Dhome) use to reconstitute (rha) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were unknown by the reporter. There was no adverse effect reported.  The administered doses of vaccine experienced a temperature of excursion of 61.5 degrees Fahrenheit and the highest above 47 degrees Fahrenheit (9 degrees Celsius) for 6 hours and 15 minutes. The previous temperature of excursion was 46.7 degrees Fahrenheit and the highest above 47 degrees Fahrenheit (9 degrees Celsius) for 1 hour. Data logger was involved.
Shingles onset in C4 dermatome 6 hrs after Pfizer dose #2 Started Valtrex 4/26/21 after diagnosis by video visit. Seen in person 4/28/21. Dx confirmed.
Patient was given Pfizer Covid vaccine 5 through 11 years, "orange" label 0.2ml, should have received Pfizer 12 years and older vaccine
Swollen lymph node jaw/face , as large as a tangerine. heating pad and hot cloth decrease the size and thobbing. I've never been in the ER, hospital (except as an RRT), never an EKG or anything until after the 2nd vaccine. I ended up in ICU with rapid a-fib. ( >200 bpm) and spent 3 days in ICU. So, there has to be a connection. I'm 66 and have NEVER been ill. I walk 5 miles a day and now I'm leery of being  out walking alone. What's UP ? Now swollen lymph (without tooth pain).  HELP
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 24-year-old female patient who received RABAVERT (batch number 566011A, expiry date 20th June 2018). On 24th May 2017, the patient received the 1st dose of RABAVERT (intramuscular) 1 ml. In May 2017, less than a week after receiving RABAVERT, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to RABAVERT. Additional details were reported as follows: The reporter did not know when the fever started in relation to the vaccination and or the severity of the fever. The patient had a tuberculosis test given within 4 weeks of the RABAVERT vaccine.
PT RECEIVED THE BLUE CAP/GRAY LABEL MODERNA COVID VACCINE 0.25CC INSTEAD OF THE MODERNA COVID BOOSTER FOR 2M-5YO.  NO ADVERSE EVENTS WERE SEEN WHILE PT AND FAMILY WAITED IN WAITING ROOM FOR 30 MINUTES. CDC GUIDANCE IS TO NOT REPEAT THE DOSE.
Hives to body and "hard induration", tenderness to right injection site starting about 26 hours after injection, lasting for about 4 days. Mom treated with Benadryl/Hydrocortisone cream. All symptoms now gone.
High Fever and severe Chills/shaking. Fever was a high as 103.6 and was over 103 for several hours. Eventually responded to tylenol-- fever dropped after 12 hours to 101 and then after 24 hours to 100.
Tightness in chest, difficulty breathing, hypertensive, headache, 4 lead showed normal sinus rhythm, repeat blood pressure showed 180/100, Patient transported to hospital ER.   178/106, 68, 16, 100 % RA, BS 214
About 20 hours after the injection, my right eye started twitching, and within 5 seconds, the bottom half of my face (from my cheekbones down) went numb, and my mouth drooped open on both sides. The muscles in my lips were not working, and I had a hard time speaking. I could force a smile if I tried really hard, but if I was relaxed, the corners of my mouth were low on my face, and my mouth hung open.  It lasted about 5 minutes and over a minute faded back to normal. I went to urgent care after speaking with a triage nurse.
107 patients received the expired vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine.) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021 at 11:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 09-Sep-2021 at 11:51 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine.). On 09-Sep-2021 at 11:51 AM, EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine No concomitant medicines were reported No treatment medicines were reported
Headache, body aches, exhaustion, slight chills with no fever. Lasted until sometime in the late night of 1/21.
A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient received expired FLUMIST that were two days expired. Patient have reported no adverse effects. The patient experienced SIXTEEN PATIENTS RECEIVED EXPIRED FLUMIST which started on 15-Jan-2014. The outcome of the event of SIXTEEN PATIENTS RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Pt came to HC c/o sore (L) arm and a headache. Pt had 103 temp. - Given 600mg Ibuprofen within 30mins temp decreased 102.1 in 1 hour temp decreased to 100.7 Pt was feeling better H/A was gone.
Narrative: Patient did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for squamous cell carcinoma, t2dm, copd, CAD, pulmonary nodule. Per note on 4/20 Patient received #1 Moderna vaccine on 4/14. Wife said that the following day he started having side effects of productive cough, fatigue, chills, headache, nausea, and diarrhea. However, last night wife said that her husband started coughing up blood and hyperventilating. Patient was admitted to hospital with diagnosis of moderate case of Covid with probable exposure prior to vaccination. Wife said that church had several cases and had recently close so feel he was exposed while in attendance. Patient wife said that treating with steroids, breathing treatments, and currently on O2 6L. Patient received care for covid-19 at outside facility on 4/20. Patient deceased 4/22 but no cause of death was documented. Patient got covid before he could build a immune response to his first dose of moderna.
9/30/10 fever 102 degrees the evening of injection. Per phone message from mom 10/1/10 redness and swelling at injection site - clindamycin. To hospital ER and dx with cellulitis. 10/3/10 to another hospital ER with same symptoms and given injection of antibiotic (ceftriaxone). Per mom by phone encounter. Epic web - No H1N1 given last year.
pt recvd vax & 36 hrs p/vax pt devel brachial neuritis; @ the time of report, pt was unable to work; MD felt that the pt's exp was related to therapy w/Hep B vax; addtl details are being requested;
pt recv vax 17FEB98 & a few hr later pt devel inj site pain, neck stiffness, bloodshot eyes, h/a, knee pain & difficulty walking;tx w/APAP which helped to alleviate sx;h/a resolved;
Chills, body ache, head ache, nausea for 24 hours. Followed by nausea and diarrhea
Feeling unsteady; Burning sensation; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): AE-2021-4752.  A 46 year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BALANCE DISORDER (non-serious), outcome "unknown", described as "Feeling unsteady"; BURNING SENSATION (non-serious), outcome "unknown", described as "Burning sensation"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT RECEIVED COVPF19 VACCINE AT 1108AM VIA IM INJECTION INTO LA.  PATIENT DEVELOPED NO ADVERSE AFFECTS. NO REDNESS, SWELLING, OR RASH. NO SOB. RESPIRATIONS EVEN. PATIENT WAS MONITORED FOR 30MINUTES. PATIENT STATED HE FEELS FINE.
24 hrs p/vax felt like had the flu; no fever but chills & body aches;
Patient reported systemic urticaria beginning approximately 5 hours following vaccination. Patient medicated with dose of diphenhydramine and symptoms abated soon thereafter with no further reported effects.
101 degree fever for four days. Fever exceeded 103 day two; joint pain; back pain; headache; chills; muscle pain; injection site pain; nausea; lethargy; swollen lymph nodes in breasts; swelling of face and eyes; swelling of face and eyes; dizziness; weakness; This is a spontaneous report from a contactable consumer (reported for herself). A 52-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6200/Batch was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Mar2021 at 11:45 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation at Public Health Clinic/Administration facility. Medical history included congenital cystic kidney disease from an unknown date and unknown if ongoing and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM), olmesartan (OLMESARTAN), zinc chloride (ZINC CHLORIDE), silicon dioxide (VIVISCAL [SILICON DIOXIDE]) and vitamin d nos (VITAMIN D NOS), all the drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021 at 12:45, the patient experienced 101-degree fever for four days. fever exceeded 103 day two, joint pain, back pain, headache, chills, muscle pain, injection site pain, nausea, lethargy, swollen lymph nodes in breasts, swelling of face and eyes, dizziness and weakness. No treatment was given for the events. The patient underwent lab tests and procedures which included body temperature: 101 on 02Mar2021 (101-degree fever for four days) and body temperature: 103 on 04Mar2021 (Fever exceeded 103 day two). The outcome of the events was resolving.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
no adverse effects were reported; The patient was administered improperly stored Varivax; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 30-JUL-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R002506, expiration date reported as 25-JAN-2020 for prophylaxis.  (strength, dosage schedule, route and anatomical location were not reported) which was reconstituted with sterile diluent (DILUENT MRK).  The varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature range of 6°F to 14°F (7.7 °F) for the time frame of 3 hours and 55 minutes. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects reported.
Patient received 0.3ml Pfizer Covid vaccine injection into the right deltoid. About 10 seconds after receiving the injection, she stood up and started to feel dizzy. About 5 seconds later, patient fainted. Patient was caught by pharmacy staff and was lowered to the ground. After about 10 seconds, patient regained consciousness and was aware of the surroundings. Patient was able to answer questions regarding her name, her location. Pharmacy staff called 911 when patient fainted and paramedic staff came within 8 minutes. Patient was accessed by paramedic staff and was transported to hospital per request of her mother.  The vital signs reported by paramedic was as followed: Blood pressure 96/52 , Heart Rate 98.
Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by sweating hands/palms followed by feeling very cold and then cycling back to hot flash, more sweaty palms, & back to chills. Minor nausea.  Lasted from 8:15am til 11:30am.  I called my care team at clinic they suggested that I call "911", but I did not call "911".  My daughter who is a nurse came over to my house & stayed with me until 11:30am.  On 03/05/2021 I woke up at 8:00am with a mild headache, minor muscle aches, tired, a little brain fog, & minor nausea which is continuing as of 10:35am as I am completing this form.
Headache, Fever, NauseaVomiting, CHILLS, SWEATING Narrative: