chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistent headache; Body aches; Fatigue; This is a spontaneous report from a contactable company representative, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in left arm on 24Mar2021 at 14:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history provided as not applicable (reported as N/A). The patient had no known allergies to food, medications, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in left arm on 03Mar2021 at 14:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Concomitant medications received within two weeks of vaccination included ibuprofen (ADVIL), loratadine (MANUFACTURER UNKNOWN) 10 mg; pseudoephedrine HCl (MANUFACTURER UNKNOWN) 30 mg, for known indication and from unknown date. On 25Mar2021 at 03:00, the patient experienced persistent headache, body aches and fatigue. The patient did not receive any treatment for events persistent headache, body aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of persistent headache, body aches and fatigue were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
localized erythema, swelling, tenderness & warmth @ inj site-seen 2 days p/vax; rx ice to site QID & Ibuprofen;
3-10-21 2:55PPINK, W/D, RESM PT STATES SHE BECAME 'LIGHTHEADED UPON STANDING UP'.  NO N/V, NO SOB/DYSPNEA, NO PAIN.  A/O X3, RESP WITH EASE. SIPPING WATER, COMFORT GIVEN.  3:10PM 'FEELS BETTER NOW'  AMBULATORY  TO EXIT, GAIT BRISK AND STEADY. 3-15-21 10AM 'FEELS BETTER NOW, NO LIGHTHEADEDNESS'.
On 10/06/1995 the patient was vaccinated with a second dose of varicella virus vaccine live. Subsequently, the patient developed "typical chickenpox". Unspecified medical attention was sought. Additional information has been requested.
fever, runny nose, headache, cough, nausea, vomiting, diarrhea, abdominal pain
Extreme fatigue, SOB especially with exertion, ?dull ache in chest and into back & shoulders, ?dragging?. Lack of energy, muscle weakness, joint pain, general malaise.
No problem 'til 21AUG91 @2AM PT admitted to hospital w/T104R; stayed 3 days 21AUG91 - 24AUG91; mom states all lab work, test were negative, no dx made, states poss viral infect;
Patient states that she started to experience pain after the injection at the site for a few days as expected.  She states that she developed sub acromial bursitis and frozen shoulder of her left shoulder.  Patient is a pediatrician and she immediately felt that it was administered incorrectly.  She began to have joint pain a week later.   The shoulder pain got worse over time and she went in to see a specialist and was dx with the above. She is being seen by Dr. at Facility.  She was seen today for the initial visit.  Received a steroid injection today and will start PT at some point.
Patient reported event on 11/10/20 but received the shot on 11/4/20. A few hours after the patient received the shot, she said hives started forming on her arm.  These eventually spread down her leg.  At the time of the call to our pharmacy, the patient had not yet seen a physician but had made an appointment.  She was treating the hives with benadryl for the time being.
extreme tiredness, vomiting, aches, extreme tiredness, fever, chills, joint pain, headache and rash that looked like measles on my torso, forearms and thighs.  Everything started about an hour after my vaccine, all symptoms cleared up except the rash by the third or fourth day.  The rash is still present and this is week three.  It is less itchy.  Took some advil and tried cortisone for the rash (didn't help)
This initial spontaneous report was received from a physician referring to a patient of unknown age and gender. There was no pertinent medical history or drug allergies/drug reactions described. The physician reported that on 18-JUL-2013, the patient was vaccinated with the first dose in the series of three of GARDASIL and on 13-AUG-2014, the second dose of GARDASIL was administered, (doses, route, lot numbers and expiration dates were not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Administration error: received 2nd dose early, 15th day post 1st vaccine. 1st dose on 12/28/2020
pericarditis; inflammation; weight gain (10 lbs); heart palpitations; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "recovering"; INFLAMMATION (non-serious), outcome "recovering"; WEIGHT INCREASED (non-serious), outcome "recovering", described as "weight gain (10 lbs)"; PALPITATIONS (non-serious), outcome "recovering", described as "heart palpitations". The events "pericarditis", "inflammation", "weight gain (10 lbs)" and "heart palpitations" required physician office visit. The patient underwent the following laboratory tests and procedures: Weight increased: 10lbs.  Clinical information: After 2nd dose of Comirnaty, patient experienced inflammation, pericarditis, weight gain (10 lbs), and heart palpitations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a nurse practitioner concerning a 23 year old female who on 05-FEB-2007 was vaccinated with a first dose of Gardasil (lot# 655618/1427F). On 26-FEB-2007 the patient experienced three separate "vulvar-type blisters" which were "slightly raised" with a white, plaque-like surface. The patient was re-examined on 12-Mar-2007, and the above lesions had completely resolved. No product quality complaint was involved. Additional information has been requested.
pt recv vax & devel an inj site rxn;no further info was available @ the date of this report;this is 1 of 6 pt from this facility to devel an inj site rxn p/vax;
sweating overnight; Chills; arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating overnight), CHILLS (Chills) and ARTHRALGIA (arthralgia) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Drug allergy (Allergic to neomycin). Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and LEVALBUTEROL [LEVOSALBUTAMOL] for Asthma.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERHIDROSIS (sweating overnight), CHILLS (Chills) and ARTHRALGIA (arthralgia). On 18-Mar-2021, HYPERHIDROSIS (sweating overnight), CHILLS (Chills) and ARTHRALGIA (arthralgia) had resolved.            Concomitant included vitamins was noted. No treatment information was provided by the reporter.   This case was linked to MOD-2021-022028 (Patient Link).
Patient presented to pharmacy 11/20/18 complaining of muscle soreness in deltoid muscle and experiencing pain rotating and/or lifting arm. She stated her arm was sore after the injection and the pain did not resolve after a couple of days. She has been taking NSAIDs to help alleviate the pain.
Arm numbness and sharp, sudden pain in left arm that goes down to wrist and hand.
Within a couple hours I had a severe headache and slight muscle aches. That night I woke up in the middle of the night with severe back aches and pain in my joints. The worse was in my hips. I was relegated to my bed for over 2 days.  I also began having issues with my vision. I get dizzy and at times have trouble focusing. Also was extremely nauseous for the first week steadily....as time has gone on it is not as bad....though always still there. I kept thinking it would go away...and now 3 weeks later and I am still having issues. I have extreme joint pain, esp in my hips & shoots down my legs and up my back, still issues with my vision, dizziness, stiffness and pain in my neck when I turn it tired all the time, and still have headaches, and an overall feeling of not being right.
The patient was to receive her 2nd vaccine in her primary series however the second vaccine was actually the Bivalent.
This spontaneous report as received from a nurse refers to a 12 months old patient (gender unknown) who on 20-DEC-2012, was inadvertently administered a 0.5 ml dose of MMR II subcutaneously (anatomical location and lot number not provided) and a 0.5 ml dose of PROQUAD (Merck) subcutaneously (anatomical location and lot number not provided). Concomitant medications were not reported. No adverse effect reported. Additional information is not expected.
fever, fatigue. generalized pruritis (began within 2 hrs of vaccine administration), widespread pustular rash (on b/l arms, back, abdomen) which has burning sensation (began on 8/7 and has worsened significantly and is spreading to various areas of body as of 8/9).
Tingling in arm he received vaccine Numb finger tips Hand is colder in comparison to the other
I have not had a period in over 2 years from being pregnant 9 months and having an IUD about 18 months. Then I get a second dose of the Covid vaccine and hours later get my period after over two years of not having it..
Patient received 2 vaccines at 18 month WCC.  Mother reported symptoms started the day after - redness, swelling, warmth, and tenderness at vaccine site (PREVNAR) in left thigh.  Denied elevation of temperature.  Assessed at office on 9/5, confirming reported symptoms; temp 98.9 rectal.  Advised Tylenol/Motrin, cool compresses, and monitoring of symptoms/fever.
Information has been received from a registered nurse for VARIVAX (Merck) and MMR II, a Pregnancy Registry products, concerning a 35 year old female patient with not pertinent medical history and no allergies, who on 07-OCT-2010 was vaccinated in the left side with a 0.5 ml dose of VARIVAX (Merck) (Lot # 665912/1772Y, Exp date 08-APR-2012). On the same day, the patient received a 0.5 ml dose into the right arm of MMR II (Lot # 667188/0444Z, Exp date 26-MAR-2012). There was no concomitant medication. The nurse reported that after receiving the vaccines, on an unknown date, the patient did a home pregnancy test and it was positive. On 01-NOV-2010 the patient went to the clinic and it was confirmed via a pregnancy test that she was approximately 8 weeks pregnant. The last menstrual period was approximately on 06-SEP-2010. The estimated delivery date is on 13-JUN-2011. Follow up information has been received via telephone call from a healthcare worker regarding the patient's pregnancy outcome. The health care worker reported that the patient's pregnancy ended with a spontaneous abortion on 20-DEC-2010 at 16 weeks of gestation. It was also reported that the baby was not viable and fetal demise was due to spontaneous membrane rupture. The pathology report of the maternal/fetal contents of conception revealed there was acute chorioamnionitis with retro-placental hematoma of 90% of placenta. The reporter stated there was no mention of trauma in the record and there was no mention of defects or sex of fetus in the pathology report. At the time of the report the patient's outcome was unknown. It was reported that the patient only received one VARIVAX (Merck) immunization. Upon internal review pregnancy ended with a spontaneous abortion was determined to be an other important medical event. No further information is available.
Following vaccination, the pt developed a fever and a papular rash on trunk and extremities, vesicles on hands, feet and ankles.
pt recvd vax 13JUL95 & vax was administered intradermally;14JUL95 the area of inj was rasied & pink;No further details were provided;
Migraine, nausea, fever, shivering/chills, full body aches, joint/bone pain.
Baby received vaccines on 1/27/12 at 1:11 pm. Parents brought child to ER same night (8pm) for crying uncontrollably. Swelling (R) thigh. Diarrhea since received vaccines. Local reaction. Received KEFLEX x 7 days. Baby better possible reaction to PENTACEL.
SWELLING AT INJECTION SITE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 59 year old female. 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 16-MAR-2021, the subject experienced swelling at injection site. On 16-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling at injection site, and pain at injection site. This report was non-serious.
This spontaneous report as received from a health professional refers to a 13-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
reportedly found in crib in afternoon not breathing & w/o heart beat;to ER by amb-unable to resuscitate;
pt described numbness in arm where he received vaccine from shoulder to elbow about 20 minutes after receiving vaccine
Shortness of Breath began 4 hours after being administered PREVNAR 13 and FLUZONEHD. Patient used oxygen that her husband had at home and felt better after 2 hours.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI 1/25/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report as received from a health professional via Pfizer (manufacturer control #2019137878) refers to a 64 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, lot# and route of administration were not reported) for prophylaxis. On an unknown date, the patient underwent kidney transplant. The consumer wanted to know how soon a patient can receive PREVNAR 13 after receiving PNEUMOVAX 23. The outcome of kidney transplant and causality assessment were unknown. Upon internal review kidney transplant was considered to be medically significant.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 mg. On 24th September 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and pain in arm. On 1st October 2018, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the chills, fever and pain in arm were unknown. It was unknown if the reporter considered the rash, chills, fever and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient received SHINGRIX in the left arm. Seven days after receiving SHINGRIX, the patient experienced rash on his face, neck, and ears. The reporter did not want to answer any further questions, but was willing to be contacted by GlaxoSmithKline Safety. This case has been linked with case US2018180183, reported by same reporter.
Same night a little sow and some swelling.  27th a.m very sore. Headache, chills, achy. 28th a.m very sore. Terrible headache, 102 fever throughout the day. Red blocking going to other side of arm. Constant itching.  Today March 2, all  things subsided except for red swelling and itchy area.
Moderna 4th booster of 0.25ml administered out of vial that had been opened for >12hours. Vial had been opened for approx. 24 hours in the stable temp of 4-5 degrees Celsius. No adverse reactions
Pt says she had a severe headache, lots of swelling, mild fever, and some dizziness. Her arm was still a little red 4 days later. She said it was very bad the first few days.
Fever 103.5 - TYLENOL/IBP at ED - decreased T - 97.8 on discharge. T - 104.5 - continued alternating IBP and TYLENOL. Episode of vomiting after lunch. Gait - uncoordinated with periods of weakness. Outbursts of anger - unprovoked. Recommended hospital after reporting above symptoms to ER Doc.
With no previous symptoms other than soreness at the injection site the day of the injection, woke up a week after the injection with soreness, redness, and heat in a swollen upper arm.  The upper arm felt very tight.  Itching of that arm started an hour or so later.
Palpitation on and off after 2nd shot; Fast heart rate 145 BPM after 2nd shot/ Fast Heart Beat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation on and off after 2nd shot) and TACHYCARDIA (Fast heart rate 145 BPM after 2nd shot/ Fast Heart Beat) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced PALPITATIONS (Palpitation on and off after 2nd shot) and TACHYCARDIA (Fast heart rate 145 BPM after 2nd shot/ Fast Heart Beat). At the time of the report, PALPITATIONS (Palpitation on and off after 2nd shot) and TACHYCARDIA (Fast heart rate 145 BPM after 2nd shot/ Fast Heart Beat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Heart rate: 145 bpm (High) fast heart rate 145 BPM. On an unknown date, Cardiac function test: normal (normal) Normal.         Concomitant medications were not reported.  It was reported that about 4-6 hours after the 2nd shot, she had a fast heart rate 145 beats per minute (BPM). At the time of report, she still had palpitation and increased heart rate on and off specially if she had sugar and coffee. She stated that she did not have any medical history of heart conditions. She visited a cardiologist and wore heart monitor for a while. All tests with cardiologist came back normal. Her diagnosis on 01-Sep-2021, remained fast heart rate.  Treatment medication information was not provided.   This case was linked to MOD-2022-475608 (Patient Link).
I was asleep and woke up and could not breathe. I passed out and when the ambulance came, they took my blood pressure which was 68/39. Heart rate was in the 120?s. Had to be held in observation for 2 days to monitor my vitals.
ADMINISTERED HD VACCINE TO PATIENT THAT WAS UNDER 65 YEARS OF AGE. PATIENT TO MY KNOWLEDGE HAS HAD NO KNOWN SIDE EFFECTS FROM THE VACCINE.
Admitted for COVID pna. Vaccinated x3. Treated with O2, rocephin, doxy, zinc, singulair, vit-c and d, steroids. Improved to RA and discharged home.
Headache started in the evening progressing to migraine by 11pm or so. General muscle aches and loss of appetite same evening.
Patient developed hives and then the hives increased & she sought medical treatment from initially Urgent Care and then her PCP. She received a steroid shot which alleviated the hives.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 043L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 19-Apr-2021 and the estimated date of delivery was 01-Feb-2022. On 22-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 22-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            No concomitant medications was reported. No treatment information was provided.  This case concerns a 31-year-old, female patient with no known  medical history, who experienced the non-serious event of Maternal exposure during pregnancy. The patient received the third dose of vaccine at 26 weeks of gestation. The benefit-risk relationship of Moderna vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Followup information was received on 28-Oct-2021 contains no new information.; Sender's Comments: This case concerns a 31-year-old, female patient with no known  medical history, who experienced the non-serious event of Maternal exposure during pregnancy. The patient received the third dose of vaccine at 26 weeks of gestation. The benefit-risk relationship of Moderna vaccine is not affected by this report.
patient received COVID vaccine on 12/29/2020 and passed away on 1/23/2021
Immediately after receving the shot the client felt like there was an air pocket under the skin. The shot hurt more than the 1st and 2nd Hep B shots.
RINGING IN BOTH MY EARS 24/7 WENT TO MY FAMILY DOCTOR PRESCRIBED  PREDISONE 10MG 4 TABLETS FOR 4 DAYS 3 TABLETS FOR 2 DAYS 2 TABLETS A DAY FOR 2 DAYS 1 TABLET A DAY FOR 2 DAYS     I HAVE ONLY ONE MORE TABLET TO TAKE BEFORE REGIME IS COMPLETE AND THERE IS NO CHANGE TO THE CONSTANT    RINGING
Rashes (arms, hands, chest, face & neck), shortness of breath, itching.
Painful, swollen, warm arm, growing in size over 48 hours at the injection site (still present) fever (maxed at 101.5F), chills, aches, headache that stopped after 24hrs.