chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling feeling in my buttock; leg kind of got sore; arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old patient received bnt162b2 (BNT162B2) (Lot number: EW0173, Expiration Date: Aug2021) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "acne" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE taken for acne (ongoing); LOESTRIN taken for contraception (ongoing). Past drug history included: Amox-clav, notes: I was taking it once in the morning and once in the evening. I am not on it anymore I just took it for only 5 days prior to the vaccine. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "tingling feeling in my buttock"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg kind of got sore"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient got the first dose of the Pfizer vaccine yesterday morning and didn't have the arm soreness until last night but it did start probably like 30 minutes after vaccine administered and had like tingling feeling in the buttock and throughout the day, the patient's leg kind of got sore and didn't know it sounds like a normal thing because it was on the same side of the body of the vaccine like where patient got the shot. The patient took Tylenol and then also just got off antibiotic like a day before the vaccine, but the patient was clear that would be ok to take the vaccine could give the name of the antibiotic too. So the abbreviation is Amoxicillin, Amox-clav. The patient was taking it once in the morning and once in the evening and that was for what the patient thought was a reoccurring cyst. The patient was not on that anymore although. It was Amoxicillin and then it was Amoxycillin/Clavulanic acid. The patient was not on it anymore and just took it for only 5 days prior to the vaccine. The patient received another prescription medicine too that was on and off. The patient took Valacyclovir. It's not every day, that the patient took it. It was a Herpes simplex virus pill. HSV-2.  No follow-up attempts are possible. No further information is expected.
19.2 weeks pregnant  Slight itch on left arm at injection site.  March 3 was slightly raised bump at the site. March 4 red circle around injection site with outside of the circle being a darker red than inside
soreness; mild low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and PYREXIA (mild low grade fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 003BZ1A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (soreness) and PYREXIA (mild low grade fever). At the time of the report, PAIN (soreness) and PYREXIA (mild low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-079412 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079412:Cross link with Dose 2
Mother states around 6pm 4/26/06 daughter complained of face looking different.  Right side of face "won't move".  Right eye will not close, right side of lips won't move and she felt dizzy.  To ED 4/26/06 Diagnosis of Bell's Palsy per Mother.  Given prednisone in ED and RX to continued taking as well as Acylovir X 7days per Mom.
body aches; Fever; headache; This is a spontaneous report from a contactable other healthcare professional reported (Patient).  A 58-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Lot no: EM9809) via unspecified route of administration, administrated in left arm on 04Feb2021 15:00, as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included simvastin, ADVIL PM. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications the patient received within 2 weeks of vaccination: Simvastin and Advil PM.  On 05Feb2021 at 13:00 patient experience with fever, headache and body aches. Prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient had been not tested for COVID-19. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Patient reported being light headed seated in chair and proceeded to faint for approximately 30 seconds to 1 minute. Pharmacist was called to check on him, patient had pulse and was breathing steadily. Patient regained consciousness and was given a bottled water to drink. Patient was instructed to lay down and elevate feet to help recover. EMS was called to further evaluate and assist and arrived 5 to 10 minutes after incident. Patient was able to recover enough to walk out of store with EMS following without assistance.
Information has been received from a nurse referring to an unspecified number of unknown patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot#, expiration date, dose and route were unknown). It was reported that the vaccine was improperly stored at 51.2 Fahrenheit for 23 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Two to three hours after the first shot my lips began to tingle. It continued until I went to sleep on the night of the 11th. I woke with dry lips and the corners of my mouth were cracked. Over the next three weeks my lips peeled and cracked every day. After the second shot, the corners of my mouth were very sore and began to bleed.  The condition has not improved.
sore arm pain increased over the course of the initial day.  24-48 hours after the inital shot, I had low grade fever, bodyaches, chills, nausea.   This lasted several hours until I took tylenol to subdue to the fever.  When I woke up the following morning, i had the same symptoms and needed to take tylenol again to bring down the fever.  All symptoms cleared after 4 days from initial shot.
Rash over stomach and lower chest; This is a spontaneous report from a contactable consumer (patient himself). A 71-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- tn6198) via an unspecified route of administration in left arm on 04Mar2021 16:00 as 2nd dose, single dose and had received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- FL9262) via an unspecified route of administration on 09Feb2021 as 1st dose single for COVID-19 immunization. Patient was 71-years-old at the time of vaccination. Patient medical history was reported as blood pressure, hypothyroid, high cholesterol and had no known allergies. The concomitant medications were reported as lisinopril, amlodipine besylate, atorvastatin and levetiracetam (LEV). Facility type vaccine was reported as Other. Patient did not had COVID prior to vaccination. Patient was not tested for COVID post vaccination. Patient did receive other vaccine in four weeks. Other vaccine in four weeks product was reported as COVID-19. On 06Mar2021 at 16:00 patient experienced rash over stomach and lower chest, does not itch, does not hurt. The patient did not receive any treatment for the adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Side effects included 4 bathroom trips in one day (so far), each with burning diarrhea
17JUL93 pt was administered HEP B ax & 222JUL93 had massive coronary;
Patient given COVID-19 vaccine and within 5 minutes patient became unresponsive in and out of consciousness intermittently answering questions, diaphoretic, hypotensive and desaturated.  O2 given, Vitals signs taken , FS checked, IV started, 911 called patient transported to nearest hospital.
Full flu-like symptoms that include high fever, shakes, bone and muscle pain, headache, all over weakness
HCP calling to report an AE regarding PROQUAD. HCP calling to report that a patient was administered a improperly stored vaccine. Permission to contact HCP was provided. T.E case 02428709 filed. AE cases 02428861, 02428862 ,02428865, 02428868, 024288; No additional AE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date (reported as 13-JUL-2024), the patient was vaccinated with a dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # W035460, expiration date: 06-MAY-2024 (strength, route of administration, anatomical location not provided) as prophylaxis; which was improperly stored. No adverse event was reported.
Got shingles shot.got shingals in my 30 s/ Suspected vaccination failure; Got shingles shot.got shingals in my 30 s; Got shingles shot.got shingals in my 30 s; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter got Shingles shot and got shingles in his or her 30s, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
9/8/13 - Pt came into phcy about 4:30 pm complaining of arm pain at injection site. Observed very red, 2-inch dia. red area at site. 9/11/13 - Pt stated she visited MD on 9/10 and MD said it would heal on its own without treatment.
Immediate pain at site, she believes it was given too high, and 8 hours later noticed bruise.   18 hours later R proximal deltoid  woke with bruising and pain that lasted about two weeks, until present.  pain over proximal deltoid and no AC joint pain, occasional tingle down arm, fleeting.
1.75 in x 1.25 in area of erythema no fever no pain.
Leg swelling  (Edema) for at least 10 days that covered both feet and ankles. I would classify the swelling as moderate to substantial.   Mild pain in left arm near injection site.  Although I took the jab on the evening of June 5th, 2021 prior to air travel for attending a medical emergency in I I didn't quite track symptoms until I reached around the 9th. Initially I thought it was due to air travel although I don't usually experience feet swelling, and certainly not the level of inflammation of feet I saw. In rare instances after travelby flight, perhaps for a day or two, that too mildly. But on this instance after vaccination, it lasted nearly two weeks. My mother was disturbed looking at it but I told her it's probably due to air travel and would go away soon but it didn't.   Anyway, I took no medication and it went away by itself in about 2 weeks.   No swelling upon my return on July 24th.  Neither prolonged swelling in my subsequent trip on September 1st, although I had mild swelling for a day.
macular papular rash all over body;some papular rash w/scabs;fever off & on x 1wk up to 102;
09/11/2022 I started a scratchy throat feeling fatigue and headache. The next day I had shortness of breath, cough, fever, and body ache. After testing positive for Covid-19 I was prescribed codeine 100-10 and cough syrup. Symptoms lasted 7 days with ongoing severe migraines.
This spontaneous report as received form a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 02-JUN-2010, patient received improperly stored VARIVAX dose 2, from batch/lot # 665413/1128Y (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
99.9 degree F.  Temp., Severe Body Ache., Feeling Cold.
Headache, Myalgia, Fever, Fatigue, Malaise, Lymphadenopathy Narrative:
Minutes after receiving the vaccine, I experienced slight heart flutters for less than a minute and slight dizziness also for less than a minute.
2 WEEKS AFTER RECEIVING 2ND VACCINE, BROKE OUT IN SHINGLES, 4 WEEKS AFTER EOSINPHILLIC CONTACT DERMATITIS  Narrative:  2 WEEKS AFTER VACCINE-SHINGLES (PRIOR HISTORY OF SHINGLES) 4 WEEKS AFTER VACCINE-EOSINPHILIC CONTACT DERMATITIS PER HER DERMATOLOGIST CAUSED BY VACCINE.
This spontaneous report as received from a licensed practical nurse refers to an 11 year old male consumer. On an unspecified date, the patient was vaccinated with the first dose of VARIVAX (Merck) (lot#, dose and route was not reported). On 23-AUG-2013, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot# G007580, dose and route was not reported) which was expired on 04-AUG-2013. No adverse effect was reported. It was unspecified if the patient seek medical attention. Additional information has been requested.
Breakthrough case admission after three vaccines Pfizer 3/23/21 Lot# ER8727;  Pfizer 4/13/21 Lot# EW0150;  Moderna 12/1/21 Lot# 039F21A
Area of possible cellulitis contiguous with shot site on left thigh. 6 x 10 cm. in size. Not a vaccine reaction.
Patient called and reported a long, thin, reddish "rash" underneath the injection site on his L arm. Patient stated other than the rash he felt fine. Patient was counseled to continue monitoring the rash (and to look out for severe symptoms such as swelling, itching, and difficulty breathing).
Pain in arm started right away and headache, right leg felt numb like it was sleeping for about 10 minutes afterwards. Right armpit sharp pain, no swelling. Nauseous once I got home and took my methimazole, about 20 minutes after shot. Felt hot on and off all day after shot.
Breakthrough case admission after 5 vaccines Moderna 1/30/21 Lot# 007M20A;  Moderna 2/27/21 Lot# 010A21A;  Moderna 10/4/21 Lot# 048F21A;  Moderna 4/18/22 Lot# 056M21A;  Moderna 9/14/22 Lot# AS7140C
Hospitalization for acute exacerbation of COPD and found to have COVID-19 on dates 1/15/2023- 1/22/2023. Treated with Solu-medrol, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # was reported as L040415, expiration date 13-APR-2017; lot# L040413, expiration date 13-APR-2017; lot# L007230, expiration date 03-SEP-2016; lot# L050907, expiration date 14-JUN-2017; dose and route was unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Admitted on 1/26/22 due to SI in the context of alcohol relapse.
Body aches; Flu like symptoms; Chills; Body sweats; Exhaustion; Temp 102F; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 21Apr2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 at 15:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Apr2021 at 01:30, 12 hours after vaccine, the patient experienced flu like symptoms, chills, body sweats, body aches, exhaustion and temp 102F. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events flu like symptoms, chills, body sweats, body aches, exhaustion and temp 102F were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
While taking a shower Wednesday morning, employee started to feel like she was going to faint. she sat down, hoping it would go away. After so much time of it not going away, she started to crawl out of the shower, but passed out x3, right in a row, for about a second each time.she crawled to bed when she could, but could not relax because her heart rate was very elevated. This happened after receiving the first dose of COVID on Monday night, about 6pm.
Chest pain, SOB 3 days after vaccine. Myopericarditis with elevated troponin, abnormal ECG. Recovered without intervention
Client experienced throat spasm for 1-2 seconds, dizziness, flushing, tingling, and back pain about 10 minutes after vaccination. Client immediately seated and cold rags applied. BP 116/76, pulse 60. Started feeling better within 5 minutes of onset of symptoms. Back pain and tingling resolved. Gave juice. About 20 minutes after incident client states symptoms resolved except mild headache.
Information has been received from a nurse practitioner concerning an approximately 16 year old male patient who on 26-JUN-2012 was inadvertently vaccinated with two doses of GARDASIL (Lot # unspecified). This was human error. It was unknown if the patient was sought medical attention. No adverse symptoms noted. Follow up information has been received from nurse practitioner. It was reported that the same patient was accidentally vaccinated with 2 dose of GARDASIL (Lot #1696AA) intramuscularly in left deltoid on 26-JUN-2012. Concomitant medications included BOOSTRIX (Lot # AC52B074) vaccinated intramuscularly in right deltoid on 26-JUN-2012 and Naproxen. No adverse event. Additional information is not expected.
Had MMR & Hep booster earlier this month; No adverse rxn until woke up yesterday 25SEP91 & felt aching, soreness @ bilateral arms & hands; Swelling @ wrists noted today & aching, soreness starts @ mid forearms down to finger tips;
Pain/tenderness at injection site for about 4 days;  pain subsided but red rash about 3"x4" appeared about day 6 with moderate itchiness. Does not seem to be getting worse over next 2 days.
Information has been received from a health professional concerning a patient (18 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Within a few minutes of receiving the vaccine, the patient reported feeling dizzy.  She sat down and started to go unconscious.  The pharmacist called for help.  The store manager called 911, and a physician, who happened to be in the store shopping, came over offering to help.  The physician checked the patient's pulse and respiratory rate.  An Epi-pen was available for administration, but the physician felt the patient was not going into anaphylatic shock and the Epipen was not needed.  The patient was unconscious for several minutes.  The EMS arrived, and the patient started to regain consciousness.  The EMS remained with the patient and monitored her vital signs.  The patient left a short time later under her own power.  A follow-up call was made to the patient on 11/18, and she reported that she was doing well, with no further adverse events.  She also would be following up with her physician on 11/19/2013.
pt recv vax 1130AM;returned to MD 12PM c/o diff breathing, lacrimation & puffiness of eyes;rales + bilat lung fields;given epi & DPH;
Within 24 hours of vaccination there were bouts of shaking head which became worse over 48 hours.  He was seen at facility and then sent to hospital for further evaluation.  All vital signs were normal and was afebrile.
Patient did not receive second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the 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 reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) had resolved.            No Concomitant medications were reported.   Reporter did not allow further contact
PT STATED THAT BOTH SHOTS HURT UPON ADMINISTRATION (WHICH THEY HAVE NOT DONE IN THE PAST). ALSO THE VACCINATOR USED THE INJECTION SITE BARRIER BANDAGES WHICH HAVE NOT BEEN USED ON HER BEFORE (LATEX ALLERGY). SHE CALLED AT ABOUT 8:17 AND STATED THAT BOTH ARMS WERE SWOLLEN AND HAD A HARD KNOT ON BOTH. SHE SAID THAT IT HURT TO MOVE EITHER ARM. I ASKED IF TAKEN IBUPROFEN AND SHE SAID THAT SHE COULDN'T TAKE IT DUE TO ULCER. I TOLD HER TO PUT ICE ON BOTH ARMS AND TAKE A BENADRYL. I THEN CALLED THE MANUFACTURER OF THE BARRIER BANDAGES TO SEE IF THEY HAD LATEX IN THEM.
Patient was at a dress rehearsal in the evening where she c/o blurry vision, tinnitus and began shaking. EMS was called and she was transported to the ED.