chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shoulder tic, arm tic, right eyelid tic; movement of the right eyelid; This case was reported by a other health professional via sales rep and described the occurrence of motor tic in a 4-year-old male patient who received HAV (Havrix) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   On 23rd March 2021, the patient received Havrix. On 26th March 2021, 3 days after receiving Havrix, the patient experienced motor tic and eyelid disorder. On an unknown date, the outcome of the motor tic and eyelid disorder were not recovered/not resolved.   It was unknown if the reporter considered the motor tic and eyelid disorder to be related to Havrix.  Additional details were reported as follows: The patient experienced eyelid tics and movement of the right eyelid, arm and shoulder tic, described as a motor tic.  A pediatric neurologist was consulted and the patient was still being monitored. There was a possibility that this report was reported by the patient's mother, but no record of the patient was found in any database. The reporter consented to follow up.
The patient was set to receive the second dose of the series on 1/25/21 and instead received it on 1/19/21. The patient reported a mild headache and nausea within the 24 hours following vaccination.
band-aid mark on the injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (band-aid mark on the injection site (right arm)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (band-aid mark on the injection site (right arm)). At the time of the report, VACCINATION SITE REACTION (band-aid mark on the injection site (right arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-358960 (Patient Link).
soreness at injection site; Fatigue; Chills; This is a spontaneous report from a non-contactable consumer, the patient.  A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 12Apr2021(at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 12Apr2021 the patient experienced soreness at injection site, fatigue and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event soreness at injection site, fatigue and chills was recovered on unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I felt slightly under the weather at the time I received the vaccination for pneumonia. By the time I arrived home, I felt quite ill and fluey. My symptoms got worse, I developed a cough and wheeziness. Eventually a high fever (102) sent me to the doctor. My symptoms didn't abate for nearly 4 weeks.
12-14 days after vaccines, green discharge, very clingy, screaming at night and most of day prickly rash all over trunk. Over the course of the next 6 months, less eye contact. Would appear to be seeing things on the ceiling or anywhere and laugh, but could not be re-directed. Then over the next two years, regressed socially, very secluded, non social, no speech. Appeared to be deaf at times. I took my son to start his vaccine schedule with the first shot. I was told that this is not how they (the doctors) do it. He would need to be caught up with a booster. I said I had held off on immunizing to let him get a little bigger because I didn't feel it was safe. Received approximately 1 call per week from clinic to say I needed to get him immunized; each time I declined. When I did take him in they said they would not only give him 1, but all four. I told them again at that time that I only wanted him to get the first shot; they assured me it was safe and gave him 4 shots in his legs. 12-14 days later he started getting sick; had been screaming and clingy. Problems sleeping, green discharge. I took him to the doctor again; they said he just had dry skin, and I was told to use 1% HC or use lots of baby oil. Eczema and a cold. Over the course of the next 2 years, development was not happening. Physical ability was up to par, but emotional and social didn't develop. As he reached 18 months, he really began to digress; very secluded, over-stimulated with peer interaction, would just flee, non-social, almost no eye contact and appeared to be deaf almost. Birth 6/13/98; immunized 12/16/98. ED diagnosis of autism 9/21/01. Educational diagnosis of autism 2/5/02. Autism therapy (ABA) at home, dietary and supplement therapy ongoing blood, urine, hair, stool tests resulted in mercury poisoning. Extremely high amounts.  Nurse follow up on 08/19/04 states: "Complete."
Heavy menstrual period for about 3 months after the first and second shot, second shot happened Jan 21 2021, so my Jan, Feb, March, April menstrual blood flow was very heavy. It is getting now and returning to normal.
PEA-SIZED GROWTH IN RIGHT AXILLA (ARMPIT AREA); RED SPLOTCHES ON TRUNK (STOMACH AND CHEST) ON FRONT OF BODY; TINNITUS IN RIGHT EAR; RECURRING KNEE ACHES AND JOINT PAIN BEHIND KNEE CAPS (PARTICULARLY RIGHT KNEE); HEAVIER THAN NORMAL MENSTRUAL FLOW; DEBILITATING MENSTRUAL CRAMPS; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced debilitating menstrual cramps. On 10-APR-2021, the subject experienced heavier than normal menstrual flow. On 14-APR-2021, the subject experienced recurring knee aches and joint pain behind knee caps (particularly right knee). On 15-APR-2021, the subject experienced tinnitus in right ear. On 17-APR-2021, the subject experienced red splotches on trunk (stomach and chest) on front of body. On 18-APR-2021, the subject experienced pea-sized growth in right axilla (armpit area). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from debilitating menstrual cramps on 10-APR-2021, and heavier than normal menstrual flow on 11-APR-2021, was recovering from recurring knee aches and joint pain behind knee caps (particularly right knee), and had not recovered from tinnitus in right ear, red splotches on trunk (stomach and chest) on front of body, and pea-sized growth in right axilla (armpit area). This report was non-serious.
Vaccine leaked out of the syringe where the needle and syringe meet with no reported adverse event; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age male patient for it was reported vaccine leaked out of the syringe where the needle and syringe meet (underdose) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 01-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Oral solution ,pre filled syringe,lot UJ763AC and expiry date: 30-Jun-2022] via an intramuscular route in unknown administration site for prophylactic vaccination.  It was reported "FLUZONE HIGH DOSE QUADRIVALENT to a patient today and noted that some of the vaccine leaked out of the syringe where the needle and syringe meet. Leaking (gather as much info as possible)-syringe looked like it was connected-some got out of injection o where is it leaking from? (use vial & syringe guides). Clear location of the leakage (under the Luer-Lok adaptor, out of the vial stopper puncture mark)- leur lok where needed is inserted o When did the leakage occur (e.g. when removing unit from the box, when attaching needle, when injecting diluent into powder vial, when administering the dose)-leaking occurred during injection. leak (e.g. only a few droplets or half the dose)-1/2 Amount o Diluent or vaccine leaking."  No other vaccines were reported.   It was case of actual medication error due to underdose [Latency: on the same day].   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
During the first fifteen minutes after receiving the vaccine, the right side of my face started tingling and became numb. The left side of my face was not affected and there was no respiratory involvement. In the following few hours, my right eye had transient pain and my cheek felt swollen. The next day, I had chills, arm soreness, mild headache at times, and while my facial symptoms were still present, they had improved. The second day I only had mild numbness and tingling on my face with some lip tingling. Day three, four, and five I had slight numbness of the right side of my face and tingling lips, no further symptoms. As of day 6, I have slight eye pressure around my right eye and mild lip tingling.
Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of vaccine is 07-May-2021. Concomitant medications were not provided. Treatment information was not provided.
Headache, arm soreness, rash on site with heat and itchiness, bump on site, fever of 100 26 hours after vaccine, aches, chills, sollen and painful lymph node in arm pit area on 2nd day after
Starting feeling not well right away at second shot (no reaction to first shot). Husband was driving. Just as left site after 15 minutes threw up violently and lost consciousness for several minutes.  (My husband helped me, prayed, and called my name apparently until I regained consciousness.) Weak for a day or so. Okay after that.) Reporting -- and don't want to get additional shots if recommended down the road.
Headache for 5 weeks, found to have acute ischemic injury of L cerebellar hemisphere that likely precipitated symptoms, all starting after first dose of Pfizer COVID vaccine.
Normal side effects of nausea, headache, fatigue, and injection site pain followed vaccination in hours 3-8 following vaccination. Approximately 9 hours after the vaccine, the left eyelid started to swell. Benadryl, an extra Zyrtec dose, and Advil  was taken and by the morning time the swelling had not decreased but actually increased on the left eyelid and swelling appeared on the right eyelid. I called up occupational health Covid hotline and since the vaccine was given at my job and the occ health doctor suggested I go to a doctor or urgent care. I went to a local urgent care, associated with my hospital, and they diagnosed me with a delayed allergic reaction to the covid vaccine and prescribed me steroids
Sz x 2 @ 130PM 13MAR91 taken to ER 13MAR91 temp 104; 14MAR91 child scheduled for neuro clinic in MAY91;
Patient came in for office visit on 5/7/2021 and stated she has been having fevers, cough, nausea, diarrhea for the past week.  Diagnosis for visit was diarrhea, unspecified and fever, unspecified. Patient sent home with instructions to drink plenty of fluids, Tylenol or Motrin for pain or fever and return if symptoms worsen or fail to improve.
Patient is suspected to have been given a dose of Pfizer vaccine beyond recommended 6 hour post reconstitution window. Vial of medication was likely 3 hours past recommended disposal time.
Fever of 102 early morning 25th Right hand wouldn?t work, like it fell asleep but wasn?t numb, for about a minute. I felt like I was in another world. The morning of the 26th.  Rash on my back near tailbone mid day 26th
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 03/30/2021. PATIENT FULLY VACCINATED ON 03/19/2021.
Vaccine administered left deltoid. Left arm aching, tingling, felt warm to touch. Began several hours after receiving injection. Continued to worsen and arm began swelling from upper arm down to elbow. Reported to health dept 9/16/03 2:00 PM. Symptoms resolving now.
Complaint of elevated temperature, sore/scratchy throat, headache, runny nose/congestion, and nausea/vomiting.
down for 24 hours chills; Aches and pain; Slept till 4 pm in afternoon; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (down for 24 hours chills), MYALGIA (Aches and pain) and SLEEP DISORDER (Slept till 4 pm in afternoon) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Breast cancer.    The patient's past medical history included Foggy feeling in head (not so much a big deal), Queasy (Queasiness has eased off and comes and goes, does not limit her daily activities.), Fatigue (Periods of fatigue 2-6 hours after taking medication) and Sneezing. Previously administered products included for Flu: INFLUENZA (Flu shoot) on 02-Oct-2021. Past adverse reactions to the above products included No adverse event with INFLUENZA. Concurrent medical conditions included Allergic reaction (Increase in seasonal allergies). Concomitant products included LETROZOLE for an unknown indication.   On 13-Sep-2021, the patient started PALBOCICLIB (IBRANCE) (Oral) 125 milligram once a day. On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (down for 24 hours chills), MYALGIA (Aches and pain) and SLEEP DISORDER (Slept till 4 pm in afternoon). At the time of the report, CHILLS (down for 24 hours chills), MYALGIA (Aches and pain) and SLEEP DISORDER (Slept till 4 pm in afternoon) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  No treatment medication was reported.  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.
Pt. walked in with c/o redness, swelling to the left arm.  She does have an 8 cm tender edematous circle on the left arm and mild erythema.
Patient woke up on 7/30/2021 with a full body itchy rash. Patient took diphenhydramine to help with itch and went to urgent care. Received prescriptions for prednisone and hydroxyzine.
Information has been received from a nurse referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L004014, expiration date 04-MAR-2017) (dose and route unknown). The vaccine was exposed to a temperature described as" "max 47.6F for 10 minutes with three previous excursions of 10 minutes each exposed to a max of 47.6F each time". Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine was administered. Patient contacted me on 1/4/22 and reported spontaneous bruising and itching. No bleeding, shortness of breath, chest pain or headache.
Beginning around 36 hours after 2nd dose of Moderna COVID vaccine, I noticed a red patch on my arm. It was approximately 3-4 inches below the injection site, indurated, warm, and itchy. The patch is around 3? x 6? in size. Moderately painful.
urticarial, erythematous multiform rash 24 hrs following vax; by next day rash nearly faded-few typical urticarial lesion-erythema multiform lesions faded w/some bluish discoloration;
Tired; very sad; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21May2021 at 18:30 (at the age of 13-year-old) as a single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. 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 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26May2021 at 15:30, the patient felt tired and very sad. No previous signs of depression or anxiety ever before. The patient did not receive any treatment for the event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired and very sad was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Flu shot - normal site soreness first 24 hrs. Then muscle pain, spasms & joint pain radiating down arm and into wrist on same arm starting the next day. Over next 7 days more and more body aches & joint/muscle soreness. 1/19/18 began severe joint pain over entire body, wrists, ankles, knees, hips, shoulders, elbows. Muscle soreness and spasms. Tiredness. Headache. No relief from over-the-counter pain relievers. Hot showers relieves pain temporarily (2 hrs). No other cold-type symptoms. Feel healthy otherwise.
An expired dose of the flu vaccine was given on 10/12/19. Patient is being contacted to return to the office for an updated vaccination.
Starting the next day after the 2nd dose vaccine, I had very bad chills and migraines. I took some ibuprofen. It did not help relieve my symptoms. The chills and migraines lasted about 2 days. I noticed I also developed a stye on my left eye which lasted about a week and it went away on it own. About a week after the vaccine, I started getting chronic migraines about 2-3 times a week. I would take ibuprofen and BC powder. The migraines did not go away. I have made an appointment to see my doctor.
Headache, low grade fever, chills, hives broke out on left side of of back, on the side of both thighs, and calves.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN
Patient received a Janssen vaccine on 3-26-2021 and received a second Janssen vaccine today (4-7-2021).
cellulitis RA AM; hard lump w/overlying erythema area 6cm x 4 1/2 cm; On Duricef;
2 days ago rec'd Men B vaccine in Rt. arm. Presents today with pain, redness over most of upper arm. Treating today with antibiotic, orally.
Patient fainted during vaccination and when she came to she complained about feeling. She also complained about her hands felling numb. She was in a cold sweeet and appeared distressed. I called 911 and by the time the paramedics arrived she seemed to be felling normal again and refused transport. The paramedics did check her vitals. She then left the store.
This spontaneous report as received from a pharmacy student refers to a 74 year old female patient with drug allergy to amoxicillin, clindamycin, sulfa drugs, and gentamicin. On 21-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # H020844, expiration date 10-FEB-2014 subcutaneously. Concomitant medications included blood pressure and migraine medicine. Within a couple of minutes after vaccination, the patient developed tingling in the same arm in which ZOSTAVAX was injected all the way down to her fingers, the injection site was painful and tender to the touch, and she also had a one centimeter raised red wheal that was one-by-one-and-a-half inches big. This reaction was still there the next day but was gone by 24-FEB-2013. The reaction occurred at the pharmacy. Additional information has been requested.
about 5 minutes after receiving vaccine, she notified me she was not feeling good, and she wanted to lay down ,  she laid down gently  i sat with her about 10 min  she carried on conversation  pulse steady ,  was nauseous at one point wth dry heave  said she had not eaten ' eventually took some water m0 symptoms resolved,  seemed consistent with vagal reaction
Information has been received from a registered nurse concerning a female patient who on 20-DEC-2010 was vaccinated with the first dose of GARDASIL (lot #, expire date and route not reported), in the gluteal region. On 21-FEB-2011, the patient was vaccinated with the second dose of dose of GARDASIL (Lot #, expire date and route not reported), in the deltoid. Registered nurse stated that the patient claimed that the dose of GARDASIL injection administered on 20-DEC-2010, was less painful that the one administered on 21-FEB-2011 in her arm. At the time of the report, patient's outcome was unknown. Additional information has been requested.
This spontaneous report was received from a licensed Practical Nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 08-AUG-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M002418, expiry date 12-JAN-2018 (dose, strength, route, vaccination site unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Medium
This case was reported by a and described the occurrence of incorrect storage of drug in a patient who received PEDIARIX (batch number 4233K, expiry date 6th September 2016). On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Nurse at this time did not have any other information. Six patients received PEDIARIX that was exposed to temperature of 30.4F. Three lot numbers LK94M exp 05Sep2015, 4233K exp 05Sep2016, 43GM4 exp 30Aug2016.