chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling on L side of neck; tenderness over Thyroid mid and L side; This is a spontaneous report from a contactable other health care professional (patient). An elderly non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 06Feb2021 as dose 1, single for covid-19 immunization at hospital. The patient medical history included thyroiditis (25 years ago), inc BP, inc cholesterol, hypothyroid. Concomitant medications included atorvastatin, levothyroxine, lisinopril, all taken for unknown indications from an unknown date. Other medications received in two weeks included atorvastatin, levothyroxine, lisinopril. Patient did not receive any other vaccine in four weeks. It was reported that patient had no known allergies and was not to her knowledge. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 16 days after first Pfizer vaccine on 06Feb2021 developed swelling on L side of neck with some tenderness over Thyroid mid and L side. Saw PCP on 26Feb2021 and had thyroid tests that were WNL. Symptoms were resolving. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood work (blood test): unknown result on an unspecified date, thyroid tests (blood thyroid stimulating hormone): that were wnl on an unspecified date, ultrasound (ultrasound scan): unknown result on an unspecified date. Therapeutic measures were taken as a result of swelling on l side of neck, tenderness over thyroid mid and l side. OTC meds, blood work and ultrasound was received as treatment for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Child presented with BL thigh redness and itching . O/E - comfortable child, no respiratory distress. the left thigh -swelling  noted with erythema and tenderness- mild over the injection site . urticaria within the erythema . The entire  upper thigh was affected. The left thigh showed erythema with wheal and flare . the left cheek had erythema also. Pt itching all 3 areas .  applied cool pack as well as given 5 ml Diphenhydramine po . Within 30 mins of observation, all swelling and erythema were significantly decreased. Pt was Dced  home  with q6 Benadryl, cool compress to area  and instructions to go to ER if worse, difficulty breathing or appearance of cough.  Allergy referral done  and mom took pictures of the initial reaction on her phone
I experienced redness from the middle of my calf down to my toes became swollen and progressively traveled to the right leg as well. I went to see my doctor and he ordered lab work and an ultrasound to find out why I was having the symptoms. I was diagnosed me with Venous Insufficiency.
Narrative: COVID infection following COVID vaccine series 02/10, Pfizer, dose #1 03/03, Pfizer, dose #2 08/09 COVID swab, result: detected 08/09 pt cc: cough, fatigue, rhinorrhea, exposure: unknown 08/09 SARS-COV-2 LINEAGE B.1.617.2 08/09 SARS-COV-2 CLADE 21A DELTA 08/10 clinically resolved
Had immun about 10AM 5DEC91 refused APAP prior or p/; felt warm that eve; 6DEC AM took temp 104 R; lt upper arm sl red @ site; 7DEC t104 R to hosp ER;
stiffness from shoulder to hand;soreness & tight in shoulder, elbow, wrist;redness/hot @ site;very tender in axillary lymph area;treated w/ASA
teeth extraction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (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: TOOTH EXTRACTION (non-serious), outcome "unknown", described as "teeth extraction".  Follow-up attempts completed. No further information is expected.
Information has been received from a certified medical assistant (C.M.A.), for the Pregnancy Registry for GARDASIL, concerning an approximately 18 year old female patient who on an unknown dates received all 3 doses of GARDASIL and was pregnant. This is one of several reports received from the same source. Follow up information was received from a physician concerning the 18 year old female with a history of 1 previous pregnancy and one spontaneous abortion, no significant past medical history and no known drug allergies. The physician did not have information regarding the dates of vaccination because the patient was transferred at 28 weeks of gestation. The patient's LMP was 10-OCT-2008. Ultrasounds performed on 30-MAR-2009 and 11-APR-2009 showed a low lying placenta. The Maternal Serum Alpha-Fetoprotein Screening (MSAFP) was not done at the previous doctor's office. On 17-JUN-2009, the patient gave birth to a normal female baby via vacuum assisted delivery, with no congenital anomalies and no other complication or abnormalities, weighing 8 pounds and 10 ounces, length 20.5, apgar score 8/9, head circumference 13.4 inches. The normal prenatal tests were performed during pregnancy (all were within normal limits). During the pregnancy the patient used TERAZON cream for a yeast infection (start date 14-MAY-2009). Additional information is not expected.
4/23 10am: Received shot 12pm: fever  6pm: fever, minor muscle aches, left arm sore  8pm: fever, major muscle pain to the point of being very painful to move, left arm painful to lift 10pm: fever and chills, bodily shaking, continued major muscle pain, headache. Took two 500mg Tylenol and slept 4/24 8am: minor muscle aches, minor headache 2pm: minor muscle aches, fever and chills. Took one 500mg Tylenol. Slept 3 hours.  6pm: symptoms mostly gone but tired
Missed dose; not being able to move his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (not being able to move his arm) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (not being able to move his arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). In August 2021, VACCINATION SITE MOVEMENT IMPAIRMENT (not being able to move his arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Patient reported that he never got a chance to get second dose and it's been since 5 months he got the first one.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Non-significant follow up received. On 10-Jan-2022: Significant follow up received added new event missed dose from SD.
congestion; positive for Covid-19; positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (patient).  A 61-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date not reported), via an unspecified route of administration on left arm on 31Dec2020 at 08:15  at a single dose for Covid-19 immunization/precaution because she works with hospice patients. Medical history included blood pressure (abnormal), diabetes, cholesterol (abnormal), and acid reflux, all are ongoing.  The patient has no family medical history. Concomitant medications included amlodipine besilate, benazepril hydrochloride for blood pressure taking about 4-5 years, metformin for diabetes taking about 5 years, rosuvastatin for cholesterol Taking about 5 years, pantoprazole for acid reflux taking 5 years, and vitamin D as supplement taking for 3 years. No previous immunization nor vaccines administered on same date of the suspect drug. The patient was calling about the COVID vaccination, which she received on Thursday, 31Dec2020. Her husband tested positive on Thursday, so she took the test on Thursday after she took the vaccination and they just told her today, 04Jan2021, that she is positive for Covid-19. She wanted to know if that was going to mess up her vaccination in any way and if there are recommendations for second dose. She is a CNA. There was no prescriber. She received it because she works with hospice patients. Test was administered on 31Dec2020. COVID Test resulted on 10:00 04Jan2020 as positive. ER or physician's office required: She just went to get a COVID test when her husband tested and they gave her a azithromycin (Z-PACK) 250 mg because she had congestion. Take two tabs first day and then one daily for 4 more days. She is taking last one today (04Jan2021). Outcome of the events was unknown.; Sender's Comments: A causal association between reported events and BNT162B2 cannot be excluded.
pt recv vax & 6MAR97 pt exp hives & went to ER;
2nd day severe joint pains, 3rd day n/v;4th day felt better but still had joint pain;still have sciatic pain lt side;
101 TEMPERATURE. BODY ACHES FROM HEAD TO TOE.  SHAKING AND CHILLS.
Information has been received from a healthcare worker (also reported as office manager) concerning a female patient who around August 2010, was vaccinated IM with a dose of 0.5 ml GARDASIL (lot # not reported). On an unspecified date the patient received the second dose of GARDASIL (lot # not reported). Around August 2010, the patient experienced injection site pain when she took hot showers and there was noticeable redness associated with that pain. The patient did not seek medical attention. At the time of reporting, the patient's outcome was unknown. Follow up information has been received from the healthcare worker concerning the 15 year old female student patient who on 24-AUG-2010 at 3:30PM was vaccinated IM with her first dose of GARDASIL (lot # 666163/0664Z) in the right deltoid. On 25-OCT-2010 at 10:31AM the patient was vaccinated IM with her second dose of GARDASIL (lot # 666948/0886Z) in the left deltoid. In approximately October 2010 ("after the second dose"), the patient's mother called to tell the office that the patient experienced a lot of redness at the injection site (about 3" in diameter) which was warmed and sore over entire upper arm (not just at injection site). Soreness relieved after a week but returned after any exercise doing even 2 months later. The patient also had some itching in the injection site that came and went. The injection site got very red after any hot shower but went away after wards. Subsequently, the patient recovered from the events. None of the reactions was considered as serious by the patient's doctor or her mother but the patient was advised not to get the third dose of GARDASIL. Additional information is not expected.
High blood sugar levels for 2 days starting the day after injection. Beyond normal Novolog insulin correction levels.
pain in the nipple; breast pain was in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of NIPPLE PAIN (pain in the nipple) and BREAST PAIN (breast pain was in the left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced NIPPLE PAIN (pain in the nipple) and BREAST PAIN (breast pain was in the left arm). At the time of the report, NIPPLE PAIN (pain in the nipple) and BREAST PAIN (breast pain was in the left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: benign benign.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was expected to receive second dose of vaccine on 04-Feb-2021 but she did not decide which arm to get second dose.
Stuttering; Dizzy; Shaking; Light-headed; Can't understand much of anything; he can't get across what's going on; This is a spontaneous report from contactable consumer. This consumer (parent) reported for her son (patient).  A male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via unspecified rout on 23Aug2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced stuttering, dizzy, shaking, light-headed, can't understand much of anything; he can't get across what's going on. Reporter stated, "The thing is he's stuttering and can't understand much of anything. I had to talk to a fellow students because he can't get across what's going on, My son received the Covid-19 vaccination on 23rd from school and today the last 2 hours he is stuttering, he's dizzy, shaking, light headed, we don't know what to do. If this a reaction to the shot, what do we do. The outcome of the events was unknown.  Follow-up attempts has been completed; No further information is expected.
I first had diffuse myalgias, chills and a fever of 102. That lasted for 12 hours. Then, I had an enlarged, tender axillary lymph node in my left axilla. That lasted for 2 days. Then, I had a scintillating scotoma that obscured all of my vision. It lasted for 30 minutes and finally resolved without sequellae. I took 2 tablets of Aleve prophylactically in the event that the scotoma was an aura for a migraine.
we were tested positive for Corona; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (we were tested positive for Corona) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (we were tested positive for Corona). At the time of the report, SARS-COV-2 TEST POSITIVE (we were tested positive for Corona) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 04-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       04-May-2021, the result came negative for Covid-19 infection.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-102840 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102840:Wife Case
Fever after vaccinations; up screaming all night. Stopped talking and became mute was speaking at least 20 words and lost all of them. He started biting his hands and banging his head, spinning and wanting to be by himself. Autism was also dx'd with pervasive developmental disorder.
Pain along the leg.  Internal pain, irradiates and profound.  Use analgesic cream.  Lasted 7 to 8 days.  Then strong pain in the ligaments of the back of the pelvis and the bones on front of the pelvis.  This stills occurs like 5 days of the week.  The pain irradiates is profound.  Natural Doctor mention my pelvis  is weak, i taking from 1200 to 3000 mg of calcium like 5 times a week and exercise, but today still hurts.
Patient c/o feeling "funny" immediately after vaccine administration.  15 minutes after vaccine adminstration,  c/o left sided itching on forearm, upper arm, neck, scalp and foot.  Scattered papular rash observed left forearm.  Sent to ER- received PO prednisone & benadryl with good relief.
8-18-09 pt came in to office to day he was having pain @ the site of Td vaccine - L delt. 9-11-09 pt seen for  pain in L delt. As per dr, moist heat 15 min bid.
Information has been received from a registered nurse concerning a baby with no drug allergies who on 04-FEB-2008 was vaccinated PO with a 2.0 ml dose of Rotateq (lot# 658379/1388U). Concomitant vaccination administered on that same day included a dose of Prevnar. Subsequently the patient's mother contacted the office to mention that the patient was "acting odd" and not wanting to suck or swallow after vaccination. The patient sought unspecified medical attention. No labs or diagnostic studies were performed. The outcome was unknown at the time of this report. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Patient reports tingling sensation to area administered. Patient noted with erythema to back left upper arm to site of ZOSTAVAX administered 7/25/18, presents with redness, inflammation 6cm wide and 10cm length, noted to be warm to touch, no pain on palpation.
4 mo old vaccines given on 6/24/2004 (Thurs.) with Tylenol- Sat. 6/26/2004 parents noticed tremors (left arm) x2 - at office visit on 6/28/2004 MD witnessed 1 episode of left arm tremors stating pt looked startled and lost but quickly recovered. Pt still under observation.
Had the new shingles shot 1 of 2 parts. Later on had high temp then chills like a flu reaction also arm was sore where needle went in.
22/Mar/2021 1st Moderna COVID Vaccination Injection L Arm 13/Apr/2021- 23 days post first Moderna COVID vaccination Left Ear Fullness, L Ear Tinnitus,  16/Apr/2021- Patient saw ENT, Dr. MD: 30 decibel hearing loss confirmed L Ear. Started 1st L Inner Ear Steroid Injection.  - Blood work for Immune disorders completed and no abnormalities found - Brain MRI concentration L Ear completed and no abnormalities found - Confirmed no vertigo associated with disorder 19/Apr/2021 2nd Moderna COVID Vaccination Injection L Arm 21/Apr/2021 Follow up visit ENT, Dr., MD -  received second L Inner Ear Steroid Injection 28/Apr/2021 Follow up Visit ENT, Dr., MD - Hearing test shows hearing returns to normal, no further steroid injections. 12/May/2021 - 23 days post second Moderna COVID Vaccination, L Ear fullness, L Ear Tinnitus return, patient feels this is greater than first episode. 18/May/2021 -Return to see ENT, Dr. ,MD, confirm L Ear Hearing loss has returned. Started 60 mg Prednisone Oral QD x 14 days_ Diagnosis: AIED Autoimmune Inner Ear Disorder
Had vaccination at 2:30 PM at 7:00AMthe following morning my left leg/knee was in horrible unbearable pain.Have seen several MDs and had Venus Doppler, mri and xrays. Nothing significant was shown but I could not move  for 6 days and gradually I am getting better, I use a walker to assist me. This is 61/2 we
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 15-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Extreme pain redness and swelling of face. Body and joint pain, diabetes lethargic. I took Advil and put ice packs on my face for 3 days.
Parent signed child up for Moderna booster and his age was not noticed until after dose had been administered.
A nurse reported that an 18 month old male received an injection of Flu Shield (2001-2002 Formula) on 28 DEC 2001. Immediately following immunization, the child developed an injection site reaction characterized by a 12 mm by 13 mm reddened, raised, hive.
endometrial carcinoma / type 1 endometrial carcinoma; This is a spontaneous report received from a contactable reporter (Consumer (patient's husband)) from medical information team.  A 31-year-old (as reported) female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown) at the age of 30 years (as reported), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ENDOMETRIAL CANCER (medically significant), outcome "unknown", described as "endometrial carcinoma / type 1 endometrial carcinoma". The patient underwent the following laboratory tests and procedures: Uterine polypectomy: type 1 endometrial carcinoma. Therapeutic measures were taken as a result of endometrial cancer. Clinical course information: The reporter's wife took the Pfizer BioNTech COVID vaccine, the first and second dose a little under a year ago. Shortly after, she developed side effect symptoms and was recently diagnosed with endometrial carcinoma. The test was endometrial polypectomy. The result was type 1 endometrial carcinoma. The reporter would like to know how he can contact damages or settlement department.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.