chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; HCP confirmed he has covid; his head and eyes felt like it was going to pop out; sinus issues; This is a spontaneous report from a non-contactable consumer or other non HCP (Patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history included sinus issues from an unknown date patient stated he has the same sinus issues every year. The patient's concomitant medications were not reported. The patient was due for second Pfizer covid vaccine shot on 01Apr2021. Had went to the doctor as he had sinus issues, his head and eyes felt like it was going to pop out. Stated he has the same sinus issues every year. On Tuesday, the health care professional (HCP) confirmed he has covid. He has to quarantine 10 days from when he got it. He would be finished his quarantine by his second appointment (the day before). Read on CDC website that he can get the shot as long as he is off of quarantine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Client received H1N1 Nasal Mist in am.  C/O swelling in throat, SOB, headache, heart beating fast.  Advised to get someone to take her to ER. TC from client @ 4pm - she went to ER, MD advised use of OTC Benadryl and return to ER if breathing worsened or swelling in throat increased.  To be off work Wednesday and Thursday.
Information has been received from a physician concerning a 20 year old female patient who on unspecified date was vaccinated with a second dose of GARDASIL (lot number, route and site not reported). There were no drug reactions, allergies and other medical history. In approximately 2008, after receiving the second dose of vaccine, the patient experienced tachycardia, which was transient. The physician reported that the patient did not finish the GARDASIL series. The physician reported that was discontinued in approximately June 2008. The patient did not seek medical attention. No lab diagnostics study was performed. On an unspecified date, the patient recovered. Additional information has been requested.
Patient was administered Moderna vaccine at 1744 and at ~1800, he was no longer seated in his chair and was lying on the floor.  Appears to have a slight tremor to upper torso and stiff muscles viewed for ~3-5 seconds.  Also patient had a blank face and stared blankly for less than 5 seconds.  Patient was able to answer orientation questions as to name, date of birth and where patient current location was.  Assisted patient to a sitting position on the floor.  No physical injuries noted.  Patient was steady when moving from a seated position on the floor to standing and then lying onto the gurney.  Patient denied dizziness, lightheadedness.  Patient reports he had been drinking alcohol the night before and had eaten one time today at 1300 and drank only 1 bottle of water.  Beginning vital signs were HR 4; O2 sats 99%; BP 96/64.  At 1820 vital signs were HR 57; 02 sats 99%; BP 110/70.  Patient asked to consume 500 cc of water during last 15 minutes of evaluation.  Patient did not want any further treatment and a friend took him home after monitoring completed.
Pt states, "within 20 min of vaccine, numbness and tingling in legs and arms. Uncontrollable shaking in arm and legs - worse in legs. Felt like she was going to fall. Sat down 15 min. Took a nap. When up 5-6 hrs after vaccine, sx decreases. Gone by next day."
Patient states she got her flu shot on Monday woke up tuesday with rash and hives. Took benadryl and everything resolved
Got mine last Friday and used cbd to stop the pain; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a patient via social media.  This case involves patient of unknown demography who experienced pain, after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (reported as Friday), the patient developed a non-serious pain (unknown latency) following the administration of INFLUENZA VACCINE. Patient reported that, post was not shareable patient used CBD (cannabidiol) to stop the pain. They hurt but with young ones around, you not only protect yourself but them  too.  No laboratory data reported.  At the time of reporting, the outcome was not reported for the event pain.  There will be no information on the batch number for this case.
shingles/ suspected vaccination failure; Had chicken pox and Bell's palsy and shingles; shingles; chicken pox; skin hurt; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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), bell's palsy (serious criteria GSK medically significant), shingles, chickenpox and skin pain. On an unknown date, the outcome of the vaccination failure, bell's palsy, shingles and chickenpox were unknown and the outcome of the skin pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, bell's palsy, shingles, chickenpox and skin pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had chicken pox and Bell's palsy and shingles. The patient had the vaccination and still had days that skin hurts.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
post flu vax pt presents w/an indentation to lt deltoid area, measuring approx 2cm diameter & 2cm deep;
pt recvd vax & exp vertigo, fatigue, pain about his trunk, neck, & shoulder; all sx resolved;
raised red area with bumps, instructed to treat with ibuprofen and ice pack, ongoing
Chills that evening, red raised circle the next day but then went away, 12 days later woke up with red raised "C" pattern in injection site area
third dose was given late; Early second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 33-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 5th September 2017, the patient received the 3rd dose of Engerix B. On 19th March 2017, the patient received the 2nd dose of Engerix B. On 19th March 2017, not applicable after receiving Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On 5th September 2017, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: The reporter was unknown about batch number and expiration date. The reporter consented to follow-up. Additional supportive information: The patient received the second dose earlier and third dose later than the recommended interval, which led to shortening of vaccine schedule and lengthening of vaccine schedule.
Swelling at injection site with redness, hot to touch, knot, painful, minimal itching.  Started approximately 24 hours s/p injection.  Also, had mild fatigue for approximately 12 hours with mild headache and nausea that started approximately 18 hours s/p injection.  Red area measures 4inches x 2 inches.
Information has been received from a registered nurse concerning a 21 year old female with no pertinent medical history or drug reactions/allergies who "soon" before developing diarrhea on 01-MAY-2009 was vaccinated with the second dose of GARDASIL (lot # 661846/1312X) 0.5ml intramuscular administration.  Concomitant therapy included SEASONIQUE, ascorbic acid, calcium, (unspecified), cyanocobalamin and minerals (unspecified) (+) vitamins (unspecified) (store brand WOMENS DAILY MULTIVITAMIN).  On 01-MAY-2009 the patient experienced diarrhea.  The first three days after onset were pretty bad.  She called the office.  The patient has diarrhea 3-4 times a day now.  At the time of reporting, the patient was not recovered.  Follow up information was received from a registered nurse concerning the 21 year old female student who on 01-MAY-2009 was vaccinated with the second dose of GARDASIL (lot # 661846/1312X) into the left deltoid.  The patient had no illness at time of vaccination.  On 01-MAY-2009, the patient complained with episodes of diarrhea 3-4 times a day from 01-MAY-2009 to 05-MAY-2009.  She was advised to use IMODIUM, clear liquid diet and slowly advance to a bland diet.  The patient was advised to call if symptoms unresolved.  At time of reporting, the reporter had no further contact from the patient.  It was unknown whether the patient recovered.  Additional information has been requested.
Pharmacist calling to report adverse event for administration of extra dose of VARIVAX.  Pharmacist stated that in a conversation with a nurse, they mentioned a patient of 12 years of age in their care received a third dose of VARIVAX.  Pharmacist st; No additional AE/PQC reported.; This spontaneous report was received from a pharmacist from the conversation with the nurse, and refers to a 12-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with the 1st dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, 0.5 milliliter (lot #, expiration date and anatomical location not provided) for prophylaxis.  On an unknown date, the patient was vaccinated with the 2nd dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, 0.5 milliliter (lot #, expiration date and anatomical location not provided) for prophylaxis.  On an unknown date, the patient was vaccinated with the 3rd dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection, 0.5 milliliter (lot #, expiration date and anatomical location not provided) for prophylaxis (extra dose administered). No additional adverse event was reported (no adverse event).
Moderna COVID?19 Vaccine EUA - RN administered 1.0 ml delivering 200 mcg, patient was monitored for 30 minutes, no complaints or symptoms reported at time of administration, day 2-3 complaint of severe headache and arm heaviness w/ pain, and no symptoms or complaints days 4-5.
Information has been received from a physician concerning a female who was vaccinated with two doses of Gardasil and vomited after both doses.  The third dose has not been given yet, but it will be given.  The patient sought medical attention by staying at the physician's office.  Her outcome was not reported.  Additional information has been requested.
A week after the shot I have a rash below my injection site. It is blotchy and about an inch long and an inch wide. It is a bit itchy
Symptoms developed on the 7th day after the 3rd dose: Difficulty breathing, headache, dizziness, nausea, pins and needles in legs. On the 10th day after the 3rd dose: hives red raised - extremely itchy.  flare up on joints, face, neck, ears, lips. Worse with touch.  Steroid cream helps. Continue flaring up on the day I am reporting this - 12th day after the vaccine.
Pt recvd DTP/OPV/HBCV on 23MAY91; mom reported pt cried for 3 hrs, had stiffness of arms & legs w/movement, eyes rolled back & infant did not respond; Taken to ER; irritability; dx w/OM given ATB;
The has been feeling non-stop pain at back of her neck, head, shoulder blades, and the arm; The has been feeling non-stop pain at back of her neck, head, shoulder blades, and the arm.; The has been feeling non-stop pain at shoulder blades/joint pain; Caller had developed a painful lump on her neck.; feeling strain and pain in the arm; She said she isn't bothered by the lump but instead of the pain.; feeling strain and pain in the arm; pain in the arm where she got the 2nd shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm on Mar2021 as dose 2, single for covid-19 immunization. Previously on an unknown date, the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient has been feeling non-stop pain at back of her neck, head, shoulder blades and joint pain, the patient had developed a painful lump on her neck, feeling strain and pain in the arm. Patient stated she had both shots and noticed a side effect. Reportedly, soon after the vaccine, she had a lump on her neck, and went to the doctor. Patient does not know what the lump is. The patient reported she was not bothered by the lump but instead of the pain. She also had been feeling strain and pain in the arm where she got the 2nd shot. The patient had to visit the doctor due to painful lump in the neck and non-stop pain. There the doctor advised few tests which included biopsy, colonoscopy, mammogram and all the results were negative for cancer but lump was still there. Patient has every test possible. The patient took Advil and tried warm compress to relive the pain, but it still would not go away. The patient informed that this has been affecting her day to day in general and had concern if this was a lifelong pain. Patient asked if she can be on the clinical trial mentioned -How long side effects last from the paragraph which read "The safety evaluation of participants was still ongoing. The report was not related to a study or programme. Patient declined to complete a safety report. Patient questioned do other people have this, how long do they have it, was this a short term or long term effect. Treatment was received for the events. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
pt recv vax 4APR95 & pt exp lightheadedness & weakness sometime p/vax;the exp resolved in 1hr;
Information has been received on 10/14/02 from a nurse concerning a 58 year old female patient with a history of right mastectomy for breast cancer and cellulitis on the right mastectomy site who on 9/25/02, was vaccinated with a dose of TD ADS Adult in the right deltoid after a lacerated index finger. The lot number is U01520AA. Patient developed a recurrent cellulitis at the mastectomy site on 9/27/02. No injection site reaction was noted. The patient was hospitalized for 3 days on antibiotics.
pt recv vax 13APR99 & c/o itching 30min later;mom noted roseola type rash on arms;no other sx;later in day c/o itching & devel rash on arms & hands which progressed to other areas of body by AM;
This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 15:15 (at the age of 38-year-old) as a single dose (0.3 mL) for COVID-19 immunisation. The medical history was reported as none. Concomitant medications included cetirizine hydrochloride (ZYRTEC) 10 mg started on an unknown date for allergy and norethisterone acetate and ethinylestradiol (HAILEY 1.5/30) on unknown date for birth control. The patient had minor skin allergies to some soaps, lotions and detergents. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced dizzy and lightheaded in the evening. On 04Apr2021, in the morning and during 1.5 hour drive the patient experienced nauseous that continued on the day and worsened while reaching home. On 05Apr2021, the patient experienced no longer nauseous but still a little dizzy. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care The clinical outcome of the events dizzy, light headed was not recovered and that of nausea was recovered on 05Apr2021. No follow-up attempts are needed. No further information is expected.
thought she had the flu; fever; chills; arm sore; Lump on left arm/very painful lump under the armpit/lump under the armpit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), AXILLARY MASS (Lump on left arm/very painful lump under the armpit/lump under the armpit), INFLUENZA (thought she had the flu), PYREXIA (fever) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022-B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for an unknown indication.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and AXILLARY MASS (Lump on left arm/very painful lump under the armpit/lump under the armpit). On 08-May-2021, the patient experienced INFLUENZA (thought she had the flu), PYREXIA (fever) and CHILLS (chills). On 09-May-2021, INFLUENZA (thought she had the flu), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (arm sore) and AXILLARY MASS (Lump on left arm/very painful lump under the armpit/lump under the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication  include anxiety medication. Treatment medication include Ibuprofen .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
C/O dizziness. Denies chest discomfort. C/O HA  Hx of anxiety with needles per Dad.  Vital Signs: BP 104/64 HR 88 Resp 18 O2sat 99 Skin Signs: Warm and dry  Circulation: Cap refill <3 sec  Respiratory: Breath sound clear bilaterally  Initial Treatment: Full set of vitals and observe. Bottled water and granola bar  11:35 AM Vital Signs: BP 104/62 HR 68 Resp 18 O2sat 98 Skin Signs: Warm and dry  Follow up Treatment: Moved from triage to observation area for additional 15 min  Patient smiling and conversing with RN. Driven home by parents
minutes after injection started reacting with, palpitations, shortness of air and nausea. went to Ed and received IM epi\listed vaccine as allergy
Severe Headache within 1 hour of vaccination (01/20/21 @1330hours), followed by a slight fever within 6 hours and fatigue. Overnight, I experienced severe chills and body aches, and severe fatigue, which followed the rest of the morning (01/21/21) with general discomfort. By that early afternoon the chills subsided, and I continued to feel body aches with minimal joint pain. By 4 pm, I began to develop an itchy rash on my left wrist under my wristwatch, left hand and on my right forearm. I experience fatigue throughout the rest of the day. I used over the counter Benadryl Extra Strength Itch Stopping Cream to alleviate the itch.  On the Morning of 01/22/23, I woke up to a itchy rash over my torso and my hands. I continued to apply the cream and I took an OTC Benadryl allergy pill, which seems to subside the rash.  On 01/23/21, I woke up the the same  rash over my feet and overall, the rash over my torso and hands had substantially subsided.
Information has been received from a physician concerning patient who on 26-JUN-2009, 14-SEP-2009 and 04-FEB-2010 was vaccinated with the first, second and third dose of ROTATEQ respectively. The patient received the third dose of ROTATEQ after 32 weeks of age. At the time of the report, the patient was not experiencing any known symptoms. Additional information has been requested.
J&J taken previouslyand Moderna taken on Apr-2021; J&J taken previouslyand Moderna taken on Apr-2021; permanent tachycardia; hear problems; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (permanent tachycardia), HYPOACUSIS (hear problems), COVID-19 IMMUNISATION (J&J taken previouslyand Moderna taken on Apr-2021) and INTERCHANGE OF VACCINE PRODUCTS (J&J taken previouslyand Moderna taken on Apr-2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced TACHYCARDIA (permanent tachycardia) and HYPOACUSIS (hear problems). On an unknown date, the patient experienced COVID-19 IMMUNISATION (J&J taken previouslyand Moderna taken on Apr-2021) and INTERCHANGE OF VACCINE PRODUCTS (J&J taken previouslyand Moderna taken on Apr-2021). At the time of the report, TACHYCARDIA (permanent tachycardia) had not resolved and HYPOACUSIS (hear problems), COVID-19 IMMUNISATION (J&J taken previouslyand Moderna taken on Apr-2021) and INTERCHANGE OF VACCINE PRODUCTS (J&J taken previouslyand Moderna taken on Apr-2021) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       She stated she unfortunately, received the Moderna vaccine last in April. She stated she had negative side effects from the shot and she does not ever want the Moderna vaccine again. Patient had permanent tachycardia and hear problems 1.5 weeks after and she was surprised and wished she would have gotten Pfizer. She reported others she knows doing well with the Pfizer Vaccine. She questions since they are both mRNA could she now receive the Pfizer COVID booster dose after previously having J&J.She wished she would have gotten Pfizer in the first place. She stated that she has several friends who are also wanting to know this information and she felt that this would be the best way to go.   Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in