chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke on the morning of 16 Oct with a knot at the injection site along with pronounced redness, swelling and warmth.  The redness extended about 2 inches by 6 inches in my upper arm.  While the symptoms are improving, they  have persisted and today the area is still red, and swollen although less so) with the involved area still about 2 inches by 3 inches.  It is sore to the touch, but there is no change to range of motion.
Woke up this morning w/"rash". Generalized but heavier in trunk. No fever. Given Benadryl for itching.
Swelling at the injection site; There is a lump and it is slightly warm to the touch; Swelling underneath the arm of the injection site and at the breast area near the armpit; There is a lump and it is slightly warm to the touch; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration on 04Aug2021 at 13:30 (on Wednesday, at the age of 52-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included High Blood pressure. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for hypertension, start and stop date were not reported; naproxen (NAPROXEN) taken for pain, start and stop date were not reported. On 07Aug2021 (more towards to the noon), the patient experienced swelling at the injection site, there is a lump and it is slightly warm to the touch, swelling underneath the arm of the injection site and at the breast area near the armpit, there is a lump and it is slightly warm to the touch. No treatment was received for events. The outcomes of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
I31.1 PERICARDIAL CALCIFICATION 4/28/2023 PERICARDIAL CALCIFICATION
Symptoms began on the third day following the vaccine administration Husband living in the home whom, was not vaccinated and was showing cold/flu symptoms for approximately one week prior to this writer receiving the vaccine. Treated by his primary care physician and prescribed an antibiotic for chronic sinus  infection the same day this writer received the vaccine   Chills and fatigue began the third day following the vaccine administration and  lasted for three days Headache began the third day following the vaccine administration and  lasted for one day; relieved with Ibuprofen  Joint pain in my fingers began the third day following the vaccine administration and  lasted for one day; relieved with Ibuprofen  Body aches in my legs, back and arms  began the third day following the vaccine administration and  lasted for three days; relieved by Ibuprofen
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from an office staff. This case involves an adult female patient (age was not reported) who was vaccinated once with a 0.5 ml dose of FLUZONE QUADRIVALENT (lot number: UT6262KA; expiry date: 30-Jun-2019) on 04-Sep-2018. The patient's medical history, previous medications and concomitant medication were not reported. It was a case of actual medication error due to poor quality vaccine administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. It was not reported whether the patient experienced any adverse event following the vaccination. List of documents held by sender: none.
Patient received second dose of covid 19-pfizer at our facility. accidentally given SQ instead of IM. No adverse reactions at this time but asked patient to report any reactions to the pharmacy.
Vaccine #1 given on 04/23/2021 and vaccine #2 given on 05/10/2021 one week early
Usual sore arm; Frozen shoulder.  Hurts just to touch; Frozen shoulder.  Hurts just to touch; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 18Mar2021 as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated second dose on 18Mar2021. It was reported that usual sore arm for a week following vaccine getting more sore. Also frozen shoulder, hurts just to touch on Mar2021. It was advised that mention it to family doctor. The patient inquired as it was safe getting another vaccine in the future. The outcome of event usual sore arm was not recovered and other events was unknown.  No follow-up attempts are possible. No further information is expected.
Pain in my arm from my elbow all the way down to my spine. Redness, swelling, fatigue, chills, headache.
By evening on 1st day swollen and sore at shot site. Headache. By next morning rash along both inside arms, across chest and all around torso. Lasted 3 days, then acute itching for 3 days. Unable to lift left arm higher than shoulder for over one week without aching muscles round site of shot. Ok now but still a blue/black bruise where shot given.
I woke up at 2:30 with severe chest pain, heart fluttering, rapid heart beat, severe pectoral pain on both right and left chest as well as severe back pain. Couldn't stop shaking. My symptoms fit the Myocarditis symptoms.
OK 1st day; took APAP q 4 hrs; 2nd noc screamed & cried so much mom took to ER MD suggested cont APAP & was react to shots;
Arm Pain; Tingling/Numbness; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), HYPOAESTHESIA ORAL (Tingling/Numbness) and SOMNOLENCE (sleepy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Pain), HYPOAESTHESIA ORAL (Tingling/Numbness) and SOMNOLENCE (sleepy). At the time of the report, PAIN IN EXTREMITY (Arm Pain), HYPOAESTHESIA ORAL (Tingling/Numbness) and SOMNOLENCE (sleepy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Vitamins.
so painful all the time/felt like her arm was broken/ She is still experiencing the pain in her right arm even though it subsided/When she moves her arm just slightly, it was very painful and she had to slowly figure out to how to move her arm; had a really bad reaction in her right arm; felt like the circulation was off; her right arm gets colder than her left arm; excruciating pain at the injection site; This spontaneous case was reported by a dental assistant and describes the occurrence of PAIN IN EXTREMITY (so painful all the time/felt like her arm was broken/ She is still experiencing the pain in her right arm even though it subsided/When she moves her arm just slightly, it was very painful and she had to slowly figure out to how to move her arm), VACCINATION SITE REACTION (had a really bad reaction in her right arm), HYPOAESTHESIA (felt like the circulation was off), FEELING COLD (her right arm gets colder than her left arm) and VACCINATION SITE PAIN (excruciating pain at the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 immunisation.     The patient's past medical history included Perimenopause (perimenopause diagnosed in mid-February) in February 2021. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Perimenopause.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (so painful all the time/felt like her arm was broken/ She is still experiencing the pain in her right arm even though it subsided/When she moves her arm just slightly, it was very painful and she had to slowly figure out to how to move her arm), VACCINATION SITE REACTION (had a really bad reaction in her right arm), HYPOAESTHESIA (felt like the circulation was off), FEELING COLD (her right arm gets colder than her left arm) and VACCINATION SITE PAIN (excruciating pain at the injection site). At the time of the report, PAIN IN EXTREMITY (so painful all the time/felt like her arm was broken/ She is still experiencing the pain in her right arm even though it subsided/When she moves her arm just slightly, it was very painful and she had to slowly figure out to how to move her arm) and VACCINATION SITE PAIN (excruciating pain at the injection site) had not resolved and VACCINATION SITE REACTION (had a really bad reaction in her right arm), HYPOAESTHESIA (felt like the circulation was off) and FEELING COLD (her right arm gets colder than her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's additional concomitant medications included all natural supplement herbs for perimenopause.  The  patient did not receive any treatment medications for side effects.
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around March 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered a shingles and post herpetic neuralgia. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. Shingles and post herpetic neuralgia were considered disabling. Additional information has been requested.
Patient was very nervous before vaccine, stayed in exam room for 20 minutes with cold compress, no syncope noted however mom said he felt horrible the entire day could not practice with marching band just layed down on the field, said he was weak, faint nauseated, felt better at 1130 pm that same evening.
patient was treated with the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine on Saturday April 10, 2021 and she relates having had symptomatic problems since that time stating prior to administration of the vaccine she was in her normal state of health.  She relates that on the evening of April 10 she had chills but otherwise no other major symptoms and the next day felt fine as well as during that week.  However she states that starting 1 week later on Saturday, April 17 she began feeling poorly characterized by a recurrence of hives that she has had in the past along with a sore throat.  She states this occurred while she was at work and describes the sore throat as unusual from prior sore throat she has had in the past with a description of a globus-like sensation along with some difficulties swallowing for more pressure than overt pain.  She attempted salt water gargles without benefit.  The rash was the characteristic hives rash that she has had on 2 prior occasions with rapid development of itchy red lesions scattered throughout especially in her proximal extremities and torso region.  She relates the hives worsened on Sunday, April 18 essentially from "head to toe" although not actually involving her face.  She also related new accompanying symptoms including diffuse arthralgias, stiffness and swollen painful muscles and joints.  This was throughout her entire body and somewhat of a migratory nature involving all of her major joints including the hands, wrists, shoulders, feet, ankles, knees and hips.  She states that because of the severity of symptoms she had an urgent care appointment on Sunday, April 18 and felt to have a exacerbation of urticaria for which she was prescribed montelukast, loratadine cimetidine and a Solu-Medrol Dosepak.  She states she was unable to fill the Solu-Medrol Dosepak initially but took the other medications without relief and then presented to the emergency room here at Hospital on Monday, April 19 where she had an evaluation which was largely unremarkable other than laboratory testing with a nonspecific elevation in inflammatory markers including a CRP of 5.7, ESR 34 and white blood count 15.92.  She was notably COVID-19 negative at that time as well as Monospot negative.  She was discharged home and ended up filling the Solu-Medrol Dosepak which she took and noted some improvement in her hives but has been continue to experience this ongoing sore throat, arthralgias, myalgias and diffuse swelling which is quite painful.  She specifically relates "every time I use a muscle it seems to inflame."
INCAPACITATING MUSCLE TIGHTNESS BILATERAL NECK & SHOULDERS, RADIATING DOWN BACK; TX SOMA, AP&P WITH CODEINE; X 3 DAYS; IBUPROFEN FOURTH AND FIFTH DAY
On 1/31/00, pt was seen for a sick visit. At that time he had a mild URI with bilateral AOM.  Pt was behind on immunization sot MD administered MMR and Varicella. On 2/4/00 pt developed a rash. 2/8/00 he had erythema multi forme.
A report has been received from a Physician concerning a 5 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 03-Oct-2012. The patient experienced sore throat which started on 07-Oct-2012 and oral yeast or thrush. The outcome of the event of sore throat and oral yeast or thrush is unknown. The report was considered to be non-serious by a company physician. Corrected Report 25-Oct-2012 typing mistake for primary reporters address corrected, ?Form Completed By? box ticked, relation to patient chosen, Have you reported this adverse event previously box ticked, Vaccinated at and Vaccine purchased with fields filled out, manufacturer added, event onset date or oral yeast or thrush added.
feel bad after second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel bad after second shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel bad after second shot). At the time of the report, FEELING ABNORMAL (feel bad after second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
5 hours post vax pt developed a sudden and severe headache that lasted about one hour.  Pt had trouble focusing on anything, had a fast heart beat, and very high blood pressure.  Symptoms last approximately 6 hours.
Pt. received vaccines on 4-16-12 and returned to clinic on 4-18-12 with L forearm swollen and red. Pt was treated for cellulitis with clindamycin. Pt with fever m 4/17. Per phone call via mother patient recovered.
Fatigue starting at 20:25 on 1/27/2021.  Ended on arising on 1/29/2021 at 0530 Nausea  with vomiting starting at 2200 on 1/27/2021. Continued thru the night and early morning hours stopped at approximately 0930 on 1/28/2021 Diarrhea starting after midnight on 1/28/2021 Ended at 0700 on 1/28/2021
Forehead tingling neck tingling swollen lymph node same arm as the injection Injection site was swollen, red and warm to touch
(L) arm red, swollen, hard and warm to touch, Tx with Prednisone for Cellulitis (L) arm.
Localized swelling of left thigh with patches of warm erythema. No fevers. Prescribed Cephalexin 400 mg TID for 5 days. Area returned to normal (swelling/ redness) within 3-4 days.
This RN gave the Moderna vaccination to a 17yr 5 month old Male when currently it is only been approved for 18 y.o. or older.  The individuals mother was present during the incident. We at the clinic had the individual wait the appropriate time after the vaccination which he had no adverse reactions. The child & mother were educated that he would not be see back
MUSCLE ACHES; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 11:00 a.m. to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021 19:00 p.m., the patient experienced muscle aches. On 08-MAR-2021 19:00 p.m., the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and muscle aches. This report was non-serious.
constant headache on the left posterior side that is a zapping pain; 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 44 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 16:00 (Lot number: EL9264) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: diagnosed as a child; "Thyroidectomy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 2007 (ongoing). The following information was reported: HEADACHE (non-serious) with onset 11Mar2021, outcome "recovering", described as "constant headache on the left posterior side that is a zapping pain". Therapeutic measures were taken as a result of headache.  Additional information: The patient had not received any other vaccines within 4 weeks prior vaccination. The patient had no additional vaccines administered on same date of BNT162B2. The events did not require a visit to physician office or emergency room. Advil Liqui-gels and Tylenol were taken as treatment of the events. The patient had minimal relief with any pain reliever.   No follow-up attempts are possible. No further information is expected.
Four day incapacitation;followed by 3 days of lessening symptoms of fever, bone and body ache, weakness , headache, mental confusion,  diahrea and dehydration
This spontaneous report as received from a consumer refers to her daughter of unknown age. On an unknown date of February 2012 (a year a half ago) the patient was vaccinated with the first dose of GARDASIL (dose and lot # were not provided). On an unknown date the patient was vaccinated with the second dose of GARDASIL (dose and lot # were not provided) as recommended. However the patient did not received the third dose for a year. Additional information has been requested.
pt recv vax & devel a rash on face, chest & trunk;pt also devel a low grade fever;pt was seen by MD who dx chickenpox;
In the same day as the first shot, the area behind my right ear got really swollen, so I assumed it was my lymph node. I just left it because I knew swollen lymph nodes were normal with the shot. The swelling went down a tad over time, but then there was still a lump there after 5 weeks (it got slightly bigger again after the second shot), so I went to my primary care doctor and he said it was a cyst. So, I scheduled an appointment to have it removed by a dermatologist in early July.   By June 11th the cyst was much larger, but not swollen, and had opened while sleeping. I went to a different doctor on June 11th to check it and prevent infection. She said the main sack hadn't come out, so I will still be getting it surgically removed in early July. I believe this may have originally been a lymph node issue, that turned into a cyst, but I can't be sure.
PT reports receiving covid vaccine Pizer dose 1  around 11 am at a vaccine site. Around 3 Pm she began feeling dizzy and like the room was spinning Shave continued for about 2 hours, No trouble breathing, rash. SOB no vomiting, but she does report nausea. Pt reports no new medications change in health, Pt was advised to increase fluid intake and be evaluated urgently. She will have family take her or will call 911- She was advised not to drive.
patient received moderna vaccine on 5/26/21 and said there was a little redness around the injection site since that time but that it just got bigger on 6/3/21...there is redness, warmth, itching, burning to the area around the injection site in a circular pattern.   patient is going to go to her pcp and informed her to take benadryl and uses cold compresses in the mean time