chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sat all day/didn't do anything /"I was like cement; Didn't fall asleep; Just exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Sat all day/didn't do anything /"I was like cement), INSOMNIA (Didn't fall asleep) and FATIGUE (Just exhausted) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 025B21A and 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dermatomyositis and Immunocompromised. Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for Dermatomyositis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MOBILITY DECREASED (Sat all day/didn't do anything /"I was like cement), INSOMNIA (Didn't fall asleep) and FATIGUE (Just exhausted). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 31-Mar-2021, MOBILITY DECREASED (Sat all day/didn't do anything /"I was like cement), INSOMNIA (Didn't fall asleep) and FATIGUE (Just exhausted) had resolved.            This case was linked to MOD-2021-310516, MOD-2021-310465 (Patient Link).
Tinnitus-Ringing in the ears.  It is persistent, continuous, loud and maddening.  I have never experienced anything like this in my life.  I have been to the ENT and am now on steroids with no improvement.  I have had a hearing test that showed decreased hearing at higher sounds similar to the ringing.  I am not sleeping and feel hopeless.
IN Mid Mar 2021 - recd the j and j vaccine. About 4 weeks later started having pain in the right thigh. Lasted for 5 mins - was a spasm.  Intermittent.  End april started having pain in the left shoulder - like a knot and then w/ sob / chest pains.  Came to er and was found to have a PE. Also then a right LE DVT.  Started on heparin -- > argatroban HIT panel was neg.  Now on eliquis.
Initial and follow-up information has been received from a certified medical assistant and an other health professional through a Merck pregnancy registry concerning a 16 year old female with depression and a history of "female problems" (unspecified) and miscarriage (prior to 1st GARDASIL), who on 23-JAN-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL.  Concomitant therapy included PAXIL.  Subsequently the patient had a positive home HCG test.  The patient was examined by her obstetrician on 29-JAN-2007 who ordered a serum HCG test.  At the time of this report, results of test were pending.  In early 2007, it was reported that at approximately 5-6 weeks gestation the patient had an "early" spontaneous abortion.  On an unspecified date, the patient received the second dose of GARDASIL and subsequently she had another miscarriage (dates not reported).  Subsequently on an unspecified date, the patient received the third dose of GARDASIL and conceived again (date not reported).  The patient's last menstrual period was approximately November 2007 and her estimated delivery date August 2008.  It was reported that the patient was doing well with no adverse events.  The reporter stated that she did not think any of the events were related to GARDASIL.  After internal review, abortion was considered to be an other important medical event.  Additional information has been requested.
12/16/08 RECIEVED VACCINE.  12/23/08 VISITED DOCTOR COMPLAINING OF UPPER RESPIRATORY INFECTION/ EXACERBATION OF ASTHMA.  WAS TREATED W/ANTIBIOTICS AND STERIODS. DOCTOR CONCLUDED THAT THE SHINGLES SHOT WAS TO BLAME FOR SEVERE COLD SYMPTOMS.
Patient was diagnosed with covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient was diagnosed with covid) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 058E21A, 028L20A and 025J20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer (Patient was on cancer medications from the last two dose.) since 2021. Concomitant products included ANASTROZOLE for Cancer, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM/HCTZ), PRAVASTATIN SODIUM (PRAVACHOL) and ESCITALOPRAM for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient was diagnosed with covid). The patient was treated with MOLNUPIRAVIR for COVID-19, at a dose of 800 milligram every twelve hours. At the time of the report, COVID-19 (Patient was diagnosed with covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Concomitant medications included cancer medications.   This case was linked to MOD-2022-682627 (Patient Link).
Body aches, unable to use right arm, bruised at injection sight, fever 102.4(2 hours after Tylenol), vomiting, diarrhea, cold sensation in chest for 6 hours, fever down to 101.9 by midnight same day, next day low grade fever, fatigue, dizziness, felt faint several times.
Right deltoid IM DTaP reaction 14 X 18 cm redness. Treatment Benadryl or ice pack.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient received 1st dose of moderna vaccine. says sometimes feel faint after. vaccine given and then patient was seated in front of pharamcy for observation. patient was sitting down and then suddenly our colleague noticed patients legs went stiff and he tipped over onto a display stand. patient fainted and bump his head into display stand. I came to the patient immediately and called to wake him. Within 3 secs he became coherent and says he was okay. given OJ and declined ice pack. pt ok
pt recv vax 7JUN95 & 2APR97 pt devel moderate chickenpox consisting of more than 100 lesions;pt also exp fevers;pt recovered from sx;
A staff member received the H1N1 vacc in the right deltoid and 45 minutes later developed raised hives down his right arm. He did not react to the seasonal flu vaccine or any previous INFLUENZA vaccines.
Pt developed sore throat on 2/22, developed itching, burning, swelling in throat and ears on 2/25.  Tender cervical LAD, felt short of breath.  Red, pruritic rash across abdomen and upper thighs with some involvement of arms, appears allergic in nature.  No source of infection on examination.  Patient d/c'ed from clinic with fexofenadine.
Client came in for flu vaccine. Discussed with client whether she wanted regular flu or high dose flu vaccine. Client stated wanted high dose vaccine. When inputting into system, most recent flu vaccine in system was given on 10/5/22.  Administered high dose flu vaccine to client. Approximately 20-30 minutes later client calls asking if she received the flu vaccine or COVID vaccine, told client she received the high dose flu vaccine. Client then states that she received the flu vaccine already a few weeks ago and intended to get the COVID vaccine, not the flu vaccine. Told client that I could call her PCP, on her behalf and she agreed to this.
Pt received PREVNAR on 10/21/2017 and a second dose on 11/05/2018. No adverse reaction to either dose but reporting due to second dose given.
One day, post vax, Mom called saying that his leg was red and swollen. Mom took him to MD on 11/9/01 and was told to use warm compresses and Advil. She returned to MD on 11/20/01 when his leg continued to swell. Treated with antibiotics for cellulitis. Seen again on 11/21/01 and his leg was improving. On 12/4/01, talked with Mom and his leg is back to normal.
24hr of inconsolable crying & refusal of po feeds starting about 12hr p/vax;first dose of each @ 2mo required admission to hosp NG feed x 24hr;
pt recvd vax & had sz, twitch, jerk & go limp when pt has them; pt goes into shock, passes out & then comes back;
Patient reported running a fever of 102 degrees. Her arm was red and swollen from the site of injection all the way down to her elbow. She reported pain and itching in the area.
Breakout of hives beginning on 3/30/21, intermittent dates and times
Pain in the arm lasting about a weak. Sudden bouts of fatigue, metallic taste that last sever hours after the shot. A sudden feeling of euphoria after the shot that last several hours.
Bicep was swelled, red, hot and itched. Went to walk-in clinic and received prednisone-10 mg and ranitidine-150 mg.
I have lost my sense of taste across the middle part of my tongue. It also feels a bit numb; I have lost my sense of taste across the middle part of my tongue. It also feels a bit numb; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2022 09:30 (Lot number: FJ6369) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID prior vaccination: Yes" (unspecified if ongoing), notes: COVID prior vaccination: Yes; "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN. Vaccination history included: Bnt162b2 (prev dose product= COVID 19,, prev dose brand= Pfizer,, prev dose lot number= ER8737,, prev dose administration time= 08:30 AM,, prev dose-dose number= 1,, prev dose vaccine location= Left arm), administration date: 07Apr2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (prev dose product= COVID 19,, prev dose brand= Pfizer,, prev dose lot number= EW0176,, prev dose administration time= 08:30 AM,, prev dose-dose number= 2,, prev dose vaccine location= Right arm), administration date: 28Apr2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA ORAL (non-serious), AGEUSIA (non-serious) all with onset 24Mar2022 09:00, outcome "not recovered" and all described as "I have lost my sense of taste across the middle part of my tongue. It also feels a bit numb". Therapeutic measures were not taken as a result of hypoaesthesia oral, ageusia.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Reported Event: I have lost my sense of taste across the middle part of my tongue.  It also feels a bit numb. AE resulted in: None of the above. Since the vaccination, has the patient been tested for COVID-19: No. Known allergies: No  Follow-up attempts are completed. No further information is expected.
patient felt sick; sweating; Had cold; experienced chills; 1st dose: 01Jan2021/ 2nd dose: 08Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (patient felt sick), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (Had cold), CHILLS (experienced chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021/ 2nd dose: 08Feb2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Atrial fibrillation since 2018, Drug allergy (sensitive to morphine) and Latex allergy (sensitive to latex). Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, AMIODARONE, ZINC and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced ILLNESS (patient felt sick), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (Had cold), CHILLS (experienced chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021/ 2nd dose: 08Feb2021). On 09-Feb-2021, ILLNESS (patient felt sick), HYPERHIDROSIS (sweating), NASOPHARYNGITIS (Had cold) and CHILLS (experienced chills) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 01Jan2021/ 2nd dose: 08Feb2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, Antibody test: 250 (High) 250 units per mL greater than the normal range.         Amiodarone was started instead of metoprolol since 2 weeks ago. Patient did not seek medical care for the events. Patient got an antibody test on the same day previous to get 1st booster shot. No treatment had been given to the patient.   This case was linked to MOD-2022-542337, MOD-2022-542339 (Patient Link).
Left arm--biceps severe pain after second vax--then persistent lump 3 mm--aching and lack of muscle power
Headache, Myalgia, Fatigue Narrative:  Received vaccine on 12-20-20. On 12-21, came to work but did not feel and so stayed home from work the following day 12-22. Now feeling better.
Pain in arm day after vax. About 3 wks later c/o both arms from elbow up to shoulder hurting/aching and both jaws, L/lower jaw & R/upper jaw hurting. No temp. Lasting still now 4 wks later.
Weak knees, could no longer walk up or down stairs, extreme fatigue, milk dried up, could not stand from sitting postion without assistance.
chills; fatigue; Slept though most of it; Dull headache; This is a spontaneous report received from a contactable consumer(patient). A 63-year-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EN5318) via an unspecified route of administration right arm on 26Jan2021 at 10:30 AM as single dose for covid-19 immunization. Medical history included psoriasis on my skin and psoriatic arthritis starting, treated for depression & anxiety, mild copd, herniated lumbar disc. Concomitant medications included Effexor XR 225 mg, Lorazepam 2 mg twice daily. The patient experienced Dull headache, some chills, fatigue and Slept though most of it on an unspecified. The outcome of the events was unknown.
Felt light headed immediately (not significant), Pain in right arm continued to increase into the night and through the entire next day. Arm was so painful unable to raise over my head. Also had severe lethargy, stuffy nose and complete malaise. I did not have a temperature but felt the body aches as if I had a temperature. Also became very tearful and I ended up napping multiple times during the day which are two things I NEVER do during the day.
pt recv vax;noc of inject, c/o pain in arm, hot feeling in arm & swelling;also c/o faint & very tired w/ flu like sz;
Prepared a prefilled syringe for prevnar20. Attached needle to syringe. When administering vaccination and pressing in the plunger the contents squirted out of an apparent crack in the neck of the PFS rather than contents going into the arm. Prepared a new dose of Prevnar 20 and administered with out any issues.  No adverse reaction reported from patient.
I developed mild itching of my right forearm and abdomen at 2100 but about 2300 I awoke with severe itching from my head to my hips--no rash.  1 Benadryl did not help, so about another 1.5 hrs later I took another Benadryl and that made the itching tolerable.  Having taken 50mg Benadryl I was not able to work at 0430 the  next morning as scheduled.  The itching continued even with Benadryl every 8 hrs until mid-morning of 12/30. I got the 2nd dose 1/20 & --per the advise of my GP premedicated with 50mg Benadryl, 20mg Pepcid, and 1000mg Tylenol 45 min before the 2nd dose; then I repeated 25 mg Benadryl at bedtime.  I developed itching again about 8 hrs later but it resolved by the next morning and was not as intense as with the first dose.
Arm swelled from top of shoulder to elbow within 5 hours and slowly went down over the next 5 days.  Child complained of joint pain in knees, ankles and wrists. Left knee and top of left foot swelled 6 days after vaccine. Difficult to walk.
After first set of immunizations, infant slept 4 hours. Upon awakening, infant appeared weak, gasping, unable to move air in. NO choking, not struggling. No cyanosis or duskiness. Lasted 20 min self resolved.
4/4- pain in rt thigh w/redness & difficulty walking. ER, - Dx of Cellulitis. D/c'd on Bactrim & Keflix.  4/6- Large area of rt thigh turned deep purple and very painful.  Could not walk. ER at different facility.  Admitted for IV abx- Clindamycin (allergic reaction), Zosyn, Vancomycin.  Had allergic reaction to IV drug combo of Pepcid, Benadryl and Decadron.  D/c'd on 4/8.  Doxycyclin caused severe diarrhea after discharge. 4/9- Readmitted to hospital for IV Vancomycin. Discharged 4/12 on Zyvox for 10 days.  Day 7 on Zyvox, allergic reaction.  Admitted to Medical Ctr on 4/18 for IV Vanc. D/c'd on 4/20.  4/25- two purple marks onrt forearm appeared
Pt felt dizzy after receiving immunizations and PPD placement. Had patient lie down, gave ice pack, juice and snack. BP taken. Patient's sx resolved, cleared to leave by RN and MD.
First dose- itchy throat cough immediately after shot  Second dose-Itchy throat, coughing, swelling of tongue difficult to swallow,  hives on chest.  Doctor over seeing clinic gave me a 2 doses of Benadryl before second shot because I reported symptoms I had after first dose symptoms started within a few minutes of second dose
This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported for himself that a male patient of unknown age received first dose of BNT162B2 (Solution for injection, lot number was not provided) via unknown route of administration on 02Apr2021 as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. It was reported that patient received the first dose of Covid-19 vaccine on 02Apr2021 and has a scheduled second dose due tomorrow morning, 23Apr2021. He had stomach flu last Tuesday and Wednesday on an unknown date in Apr2021. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After receiving flu vaccine the next day there was an area on the arm that was red and raised about the size of a small coffee cup. Patient was given Motrin every 6 hours. Area then had some bruising. Redness and swelling lasted with bruising for about 3 days.
4/3/03, 12:30 PM joint pain, somnolence. 4/4/03 Increased overall body pain, difficulty walking, somnolence, low grade fever and chills. 4/7/03: Dark papular rash, itching beginning at left base of 6cm diameter swollen area to left elbow - used Benedryl topically and PO lasted about ten days.
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported  On 06-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, by intramuscular route (lot number S032355 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (dosage, vaccination scheme, frequency and anatomical site of injection were not reported), as routine vaccination (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number: S032591; expiration date: 16-AUG-2022). The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (13.6 F), during a time frame of 12 hours (multiple excursions); 15 F to 46 F (16.0 F), during a time frame of 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001275: US-009507513-2009USA001278: US-009507513-2009USA001283: US-009507513-2009USA001312: US-009507513-2009USA001399: US-009507513-2009USA001677: US-009507513-2009USA001301:
10 episodes of zoster over the past 16 months, all post varicella vaccine.
reporter stated that p/vax pt exp psynosis, shallow resp & deminished heartsound via stethoscope;taken to ER tx w/epi;pt recovered;
ER called morning of 2-2-17. Child was found unresponsive. Pronounced deceased at the ER. Cause still being investigated, but vaccines were given on 1-31-17.
Initial report received from a consumer on 23 January 2014. A 49 year-old female patient with no reported past medical history had received on 30 September 2013 a 0.5ml dose of FLUZONE QUADRIVALENT (lot number, route and site not reported) and one week later developed a 104 fever. The patient had received the "TIV vaccine for 30 years". No further information was provided at the time of the report. Outcome was not reported. Documents held by sender: none.
patient c/o "feeling dizzy, has not eaten yet today." offered water at 108pm, additional 15 minutes in observation.  Reassessed at 113pm per patient "feel a little better." Continue to observed. at 120pm  fell off of chair and hit right side of head on the floor with eyes closed. vitals taken at 120pm: BP 109/72, P 78, SAT 97% RA, patient woke up patient responsive to questions.  Called 911 at 123pm. Per EMS EKG normal, blood sugar 74 patient was given instant glucose tube by EMS. Guardian was notified. Per EMS recommend patient to eat and guardian to  pick patient up.  Reassessed at 1400 patient alert and oriented x 4, states "feels better"
p/school day of vax pt c/o itchy feeling over stomach area, anterior thighs, hands swollen;red rash small pimples dispersed over legs & arms & stomach;itchy;
1st Hep B vaccine was given 8/5/19 but GSK 3JD32 was used WITHOUT INCIDENT.   Hospital changed to Dynavax for remaining vaccine doses, and 2nd dose was given on 9/4/19 and this incident occurred. Employee contact EH RN (Reporter) on 9/6/19 am and stated she had started having a fever at home on 9/5/19 as high as 102.1 and her right arm, where injection was given, was very sore and hot, and also mild dizziness/fatigue. She came to EH dept as instructed, Rt Deltoid area with approx. 3 inches of erythema in diameter and very warm to touch. No drainage or area of fluid under skin visually noted.  Employee sent to Medical Group for provider exam and recommendations.  Employee was afebrile at the time of exam.  Provider's diagnosis  was Atopic Dermatitis, a minor common local skin reaction to the immunization.  She was prescribed Zyrtex daily x 1 month, Meclizine 25 mg TID x 5 days, and Hydrocortisone cream applied topically for itching prn.
High fever, vomits, diarrhea, dehydration, severe headache, chills, fatigue, muscle and joint pain