chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician via a Pfizer sales representative and from a contactable nurse on behalf of the physician. This contactable physician reported different events with the same suspect product for four patients. This is the second of four reports. An 87 year-old female patient (weight 67 kg, height 165 cm) received PREVNAR 13 (lot number J80525, expiry date Apr2016) on 21Jan2015 around 15:00, intramuscular in right arm, at 0.5 ml single dose. The patient had a medical history of allergies to sulfa, amoxicillin, KEFLEX, NIASPAN, hydrochlorothiazide, VOLTAREN, amiodarone, AFRIN, doxycycline, clindamycin, clotrimazole. Concomitant medications were not provided, however it was reported that the patient was on like 20 unspecified medications. The patient went to the Emergency Room at night after the vaccination for body aches, hard chills and swelling, redness and hot in right arm, at the vaccination site, that developed on 21Jan2015 at 21:00, but was not hospitalized. Flu screen was negative on 21Jan2015. In response to the events she was given an antihistamine treatment. The patient recovered from the reported events on an unspecified date in 2015. The reporting physician stated he wanted to report this because this has happened all of a sudden and he was concerned. The Pfizer sales representative mentioned that the physician believed that the reactions were experienced by the patient because of the PREVNAR 13. Subsequently also the nurse confirmed that there was a reasonable possibility that the events were related to PREVNAR 13. Follow up (23Jan2015): New information reported from the same contactable physician via a Pfizer sales representative includes causality assessment. Follow-up (18Feb2015): New information reported from a contactable nurse on the behalf of the physician includes: details on patient medical history, reaction data (it was specified that swelling, redness and hot occurred at the injection site, updated events outcome), treatment given, nurse causality assessment. Follow-up attempts completed. No further information expected.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (route and dose were unknown; lot number M000996 and expiration date 07-JAN-2018). There were no reports of adverse effects. This is one of the three reports received from the same source. Additional information is not expected as there is no consent to contact the reporter.
R57.0 CARDIOGENIC SHOCK 6/8/2022 AORTIC VALVE STENOSIS R57.0 CARDIOGENIC SHOCK 6/8/2022 NONTRAUMATIC ACUTE KIDNEY INJURY
Woke up 13 hours after vaccination with intense headache and extreme fatigue and body aches. Symptoms resolved by 48 hours post vaccine. Also have had mild tinnitus since 13 hours post vaccine as well, that hasn't resolved as of 72 hours post vaccine.
Lethargy first, extreme fatigue next, cough, throat swelling, rapid heart beat, crying, pain myalgia, arthralgia, high blood pressure 180/110, headache, blurry vision.arm pain,  spine pain...Feeling like I couldn't stand ...dizzy... ..This went on for a day...still dealing with brain pain fog, extreme myalgia, arthralgia,  and spinal pain!!!!
PATIENT RECEIVED VACCINE ON DEC 18TH.  ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THAT SPREAD TO ENTIRE UPPER BODY.  SHOOTING PAINS UP HER NECK AND DOWN HER ARMS.  DEVELOPED ITCHY RASH ALL OVER UPPER BODY AS WELL AS HEADACHE AND SWOLLEN LYMPH NODES.  CRP WAS 3.6 AND SED RATE 25.  COVID TEST WAS NEGATIVE.  PATIENT PUT ON MEDROL DOSE PACK AND SYMPTOMS RESOLVED IN 5 DAYS
Muscle pain & weakness started at bed time on day of vaccination. Woke up next morning still in pain with chills. Slept from noon on 2nd day until 7:00 a.m. the next day, then slept off/on all day & night until the following morning. The muscle pain had mostly subsided when I began to notice more pain in my left shoulder (the injection side) & armpit. My armpit/lymph nodes swelled throughout the day, so I used warm/moist compresses and Tylenol to help alleviate the pain. That was yesterday, and today the area remains painful & I'm continuing my home treatment of compresses & Tylenol.
30 minutes after vaccine, had a really weird taste in mouth for about 2 hours; This is a spontaneous report from a contactable consumer reported for self. This patient started to receive received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 11:30 at single dose (believe that the LOT# is EK9231) for covid-19 immunisation. Due date for the next dose: 23Jan2021. Medical history and concomitant medications were none. The patient received vaccine 02Jan2021 at 11:30 am and were required to stay until 11:45, 15 minutes after the dose. The patient left in about 15 minutes after that, so, 30 minutes after vaccine on 02Jan2021 at 12:00, the patient had a really weird taste in mouth for about 2 hours. The patient asked if that is something that has been reported as being common. Outcome of the event was unknown.
Tingling, muscle weakness, numbness starting in arm that received injection; symptoms progressed to other arm and some tingling in both legs. As of 11/4 symptoms are starting to diminish.   Progress report: As of 11/17/09, patient's numbness and tingling is still present in all extremities but gradually resolving.
Sore arm; Breastfeeding; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), EXPOSURE VIA BREAST MILK (Breastfeeding) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), EXPOSURE VIA BREAST MILK (Breastfeeding) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown and EXPOSURE VIA BREAST MILK (Breastfeeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
Vaccination completed at 4:35 p.m. At 4:55 p.m. patient c/o dizziness. Patient feet elevated while lying on exam table. By 5:05 p.m. noted feeling better. Stated I'm OK.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with improperly stored GARDASIL (lot#, dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
A 54 year old female patient received a second maintenance instillation on 06/05/2003, and shortly after, developed a fever of 39.1 degrees C, which was treated with Tylenol and was down to 38.1 degrees C the next day.  Prior to the second recent instillation, she was also complaining of dysuria.  A urine exam at that time was negative and the reporting physician does not believe she had a urinary tract infection.  Since the second instillation, the patient began taking Macrodantin independently (not prescribed by reporting physician).
On 10/26/18, patient reported pain at injection site following administration of vaccines. She also reported a small blister at the site. Patient developed induration, blistering and scabbing on upper right arm, which later developed to ulcer with eschar. Patient was referred to Dermatology for follow-up. Biopsy on 1/8/19 revealed ulcer with granulation tissue with mixed acute and chronic inflammation (no evidence of pyoderma gangrenosum). Tissue cultures negative (skin flora on bacterial). Patient has been treated with Cephalexin po and halobetasol to affected area. Some improvement at present.
I was extremely fatigued; had body aches and a headache; had body aches and a headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: En6202) via an unknown route of administration in left arm on 24Feb2021 as single dose for covid-19 immunization. The patient's concomitant medications were not reported. Medical history included hypothyroidism. Previously patient received first dose of BNT162B2, (solution for injection, Batch/Lot Number: EI9269) in left arm via an unknown route of administration on 03Feb2021 at 05:15 pm as single dose for covid-19 immunization. The vaccine was administered at workplace clinic. Patient was neither diagnosed with covid prior vaccination nor tested with covid post vaccination. There were no known allergies. On 25Feb2021 at 06:00 am, the patient was extremely fatigued, had body aches and a headache about 12 hours after second dose. No treatment was received for the events. The outcome of the events was resolved approximately on unknown date in 2021.  No follow-up attempts were possible. No further information was expected.
mistakenly given a PENTACEL injection instead of an intended Tdap vaccination with no reported adverse event; Initial information received on 23-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old male patient who was  mistakenly given a Pentacel injection instead of an intended Tdap vaccination with no reported adverse event , for receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX-23).  On 22-Jun-2022, the patient received a 0.5 ml  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, ( lot: UJ598AAA ; expiry date: 05-Dec-2022) via intramuscular route in the right arm for immunization. It was reported that the patient was mistakenly given a Pentacel injection on 22-Jun-2022 instead of an intended Tdap vaccination with no reported adverse event (off label use) (latency: same day)  Action taken : not applicable.  Outcome: unknown   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.
approx 36hr p/vax;pt devel lt arm weakness-numbness extending down to hand;profound lymphadenopathy noted along lt clavicle region;
Pt recv vax on 3/17/98; on 3/19/98 pt exp sore/ red arm & itchy (x 2 day)
Sore left arm - cannot raise left arm since flu shot administered and continue for 2 weeks. Pt. states that pharmacist administered shot into shoulder instead of Deltoid.
Redness, warmth, and tenderness at site of injection in right triceps. No fevers or drainage. Area of injection was indurated and tender. Treated with Keflex to cover for cellulitis as unsure if it was this or an allergy.
IM was administered too high on the shoulder. IM was more painful than others in the past. Pain and decreased ROM have persisted since injection.
COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Lot number: F75407) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID infection". Therapeutic measures were taken as a result of covid-19.  Clinical information: Altered sense of taste. May be due to COVID infection or the new med. Had taken 1 dose before this started.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Had flu vaccine about 0900. Went back to work area. Because increased SOB almost shivered. Realized "things weren't right" without 15" of injection. Used Albuterol inhaler. Stayed in work area till increased SOB x 2 about 12:00. Came back to RN work area. Sent to health clinic. Given PO BENDARYL. Coworker brought inhaler. Used 2nd time. Back to  baseline by 1300.
infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: INFECTION (non-serious), outcome "unknown", described as "infection". Therapeutic measures were taken as a result of infection.  Additional Information: The reporter received her Pfizer covid vaccine booster and has a prescription for albendazole and azithromycin. She has been taking this because of an infection but two different types of infections. She was taking this prior to her booster dose but not prior to her primary series. She would like to know if taking azithromycin or albendazole would affect the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
some sore at the site of the injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Feb2021 08:10 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis", start date: 05Oct2015 (ongoing), notes: Pertinent Details: (Protia surgical med. Q (every) 6 month SQ (subcutaneous inj).; "Procedure colon", start date: 26Jan2021 (unspecified if ongoing), notes: Removal potyps. The patient's concomitant medications were not reported. Vaccination history included: Shingrix (Manufacturer:, Batch/Lot#: NDC58160-0823-11, Route: Intramuscular,Anatomical site: R arm, No. of previous Doses: 1), administration date: 04Feb2021, for immunization; Bnt162b2 (Dose-1, Batch/Lot number: EM9800, Anatomical site- Right Arm, Route: Intramuscular, Time (24hr): 12 NOON), administration date: 07Feb2021, when the patient was 66 years old, for COVID-19 Immunization, reaction(s): "Sore at injection site", "A little sore, but more in her arms than anything else", "She had some general achiness a couple of days after receiving the Covid vaccine". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "some sore at the site of the injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no Prior vaccinations (within 4 weeks). Family medical history relevant to AE(s): Breast CA, ABD CA, Pancreas CA, Lung CA, Skin CA, Dementia. The patient reported that she did not have any negative reaction only mildly sore at the injection site. During her first vaccine it was snowing and raining and she was not having or wore the proper weather protection. She was three and half hours waiting to get in the center. During this time she was moving constantly, small runs and exercises to avoid to get to frozen. She believed her generalize achiness was because the situation with the weather and exercises but not due to the vaccine. Her side effect during both vaccines was some sore at the site of the injection.  No follow-up attempts are possible. No further information is expected.
April 2, 2021  -   11:30am   -   soreness of arm   -   small round red at injection site April 3, 2021  -  3:30am.   -  woke with chills, shivering, fever of 102.5, shortness of breath  -  took Advil  -  did breathing exercises      arm soreness continues, headache, fever throughout the day (100 to 101.5), trouble focusing, nausea, 2:00pm - chills and shivering April 4, 2021. -  fever continues (99 to 101), nausea, trouble focusing, headache, Tylenol and Advil, arm very sore, swollen, redness growing to size of orange. Ice pack to arm April 5, 2021 -  feeling extremely faint and nausea, lay down and faintness goes away in about 30 minutes, diarrhea.  Ice pack to arm. Fever under 100.  Arm redness is now softball size, hot, swollen and red blotchy patches beginning below the main area and going around to the back of arm.
Spiked blood pressure 187/157. Rapid pounding heart  heaviness in chest nausea  jittery dizziness
Nine days after vaccination, I started having sore throat that night. The next day on 5-16-2022, I started having a slight dry cough, still had the sore throat, fatigue and a slight headache. I done a home test for Covid and it came back positive. I called the doctors office and they told me that I need to quarantine. No medications were ordered. I am feel a lot better with symptoms resolved. I am reporting a breakthrough case of Covid.
Male Received a total of 4 Moderna Covid 19 Vaccines over a 4 month period.  Male had opened two different accounts and did not notify staff that he had all ready completed the series prior to receiving the last 2 doses.  Male recieved doses on 01/05/21, 02/04/21, 03/29/21, and 04/15/21.
On 4/9/2022, I received my second Pfizer booster for COVID-19. On 4/14/2022, I wasn't feeling well. The day started off well, because I felt fine. I rode my bike for about 5.5 miles. I later went to the store. When I got back home, I did some woodworking. At between 4 and 5 PM, I noticed that my heart was racing. I was also dizzy and fatigued. I checked my blood pressure, which was 140/86. My heartrate was 105 or 106. I lay down for few minutes. I then took a shower and then lay back down for a while. I checked my blood pressure again, and it was now higher, and so was my heartrate. My sister took me to the ER at around 6 or 6:30PM. When I got to the ER, I was put on a heart monitor, and the staff remarked that my blood pressure and heartrate were pretty high. They also did a chest X-ray and some bloodwork. The ER doctor told me that my bloodwork and heart looked fine. He said I was a bit dehydrated, though, and he put me on a drip. After the drip, everything returned to normal.
Patient broke out with rash on left torso. Rash was painful and contained blisters. Diagnosed as shingles outbreak by visit to primary care physician. Patient was given prescription for Valacyclovir 1000 mg to be taken 3 times per day for the next 7 days.
her heart rate was sky high; had an allergic reaction which was probably from the lidocaine in it and was intubated; coughing; oxygen was very low; wheezing; having a hard time breathing; This is a spontaneous report from a contactable consumer. A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 23-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter reported that the patient received the second dose and within 2 hours had an allergic reaction which was probably from the lidocaine in it and was intubated. Reporter also added that patient was the one who rushed her to code and that the nurse was a 23-year-old co-worker who ended up with tubes in her throat. Reporter said the patient ended up coughing and all of a sudden, her heart rate was sky high, oxygen was very low, and she was wheezing and having a hard time breathing. The case assessed as serious (medically significant). The patient underwent lab tests and procedures which included heart rate: high and oxygen saturation: very low on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
On Sunday pt noticed her arm was sore but on Monday it became red, started to swell and was hot to touch/itchy. When reported it was the size of a baseball. Pt already reported to MD. I advised her take BENADRYL.
was diagnosed with a heart attack at the hospital; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01May2021 at 14:00 (Lot Number: EW0173; Expiration Date: Aug2021) as 1st dose, single for covid-19 immunisation. Medical history included cardiac catherization, 2 weeks ago (Apr2021). The patient's concomitant medications were not reported. The patient had his 1st dose of the Pfizer COVID Vaccine last Saturday, 01May2021 at 2:00PM and between 7:30 to 7:45 PM, he started having chest issues. He said he felt like something was pushing down on his chest, like he was having a heart attack. He sat and waited, and then the feeling got into his arm. He said as soon as the pain went into his arm, he knew it was a heart attack. He said he got 2 nitroglycerin and took them. He said the feeling in his chest and arm didn't go away, so he called 911, and an ambulance took him to the hospital and went to the ER. He said the first blood draw on 01May2021 that was done at the hospital didn't show anything. He said the second blood draw on 01May2021 showed his cardiac enzymes were elevated, and that he had a heart attack. He was diagnosed with a heart attack at the hospital. He said 2 weeks prior (Apr2021), he had a procedure done (clarified as a cardiac catheterization). He said his cardiologist checked his stents, and the stents were all OK, and there were no issues with his heart. He said his cardiologist just did the same procedure again (cardiac catheterization) on 01May2021, and it was normal, there was nothing there (in his heart). He said he was putting his heart attack as caused by the COVID-19 Vaccine shot. He said he knows about a study that reported people were having heart attacks after getting the COVID-19 Vaccine. Clarified that he had a cardiac catheterization through his wrist while at the hospital, and it was same procedure he had 2 weeks earlier with his cardiologist. He said both cardiac catheterizations didn't show anything wrong with his heart. He was asking that if should he get the second dose if he had a side effect after the first dose of the vaccine. The patient was hospitalized for the event from 01May2021 to 04May2021. Outcome of the event was unknown.
Swollen bottom   Lip, tongue, prickly skin, burnining nostril, headache, fatigue
During hospital public flu clinic, patient was noted to have a red spot after receiving flu vaccine. Pt was sent to the ED.