chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant (CMA) concerning a 9 year old male with no medical history or allergies who on 09 December 1997, was vaccinated subcutaneously with a 0.5 ml does of varicella virus vaccine live (Oka/Merck) (Lot #622757/0348E). There was no concomitant therapy. The CMA reported that on 11 February 2006, the patient became ill with fever, vomiting, muscle aches and rash with greater than 50 lesions. Unspecified medical attention was sought and the patient was treated with acetaminophen (Tylenol) which decreased his temperature to 97.4 F. At the time of this report, the patient remained ill as his vomiting, muscle aches and rash persisted. Additional information has been requested.
Patient had pain headache or migraine. Onsite EMS was called vitals BP 140/80 HR 80 100% O2.  Patient refused evaluation and care released against medical advise.
All over muscle pain, heart pain, unable to sleep or lie down, up all night. Started to subside at 6am the next morning.
Approximately 2 to 2.5 hours after injection, fatigue and extreme pain in and around the injection site. Pain level was a 10 on scale of 1 to 10. Pain was constant (not stabbing nor throbbing).
Hoarseness and localized skin rash on forehead.  At time of reporting event is ongoing.
Fatigue; Strong aches; Low fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER4733) via an unspecified route of administration in the left arm on 11Apr2021 at 10:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA), sertraline hydrochloride (ZOLOFT) and metoprolol (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. On 11Apr2021 at 13:00, the patient experienced fatigue, strong aches, low fever and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, aches, low grade fever and headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Began to feel chest tightness, breathing a little harder than normal. Started to feel very tired the next day, extreme exhaustion. Had to go to bed. He continued to worsen with the exhaustion daily and now can barely get out of bed, or sit up. Before the vaccine he was not spending time in bed during the day. He now has trouble breathing sitting up.
Information has been received from a registered nurse concerning a 14 week old female who on 22-Nov-2004 was vaccinated with a first dose of Rotateq (human-bovine) (lot# "0942"). The patient was not experiencing any problem post vaccination. Unspecified attention was sought. Additional information has been requested.
Pt was very nervous right before the injection,  I had him take a deep breath and then let it out and administered the immunization.  Pt felt woozy about 30-45 seconds after the immunization.  I offered him a lollipop which he took and then he fell forward, (i caught him) and he fainted.   I repeatedly shook the patient and called his name until he came to about 15 seconds later.   Pt woke up without any recollection of what occurred.   He said he was dreaming and heard the song.  His wife giggled and said that they were listening to that song before they got here.   His wife was present for the whole thing and said her husband is very afraid of needles and that this happens all the time (even when their 5yr old son receives immunizations).   We gave the patient a bottle of water and I sat with him for about 10-15min.     I administered a vaccine to his wife and patient wanted to sit on the bench and wait for her which was about 25ft away.  After I administered hers he came over and said he was going to throw up, but he never did.  His wife just wanted to take him home.
Swelling in lower extremities, severe pain in hips, knees and ankles, unable to walk. Eyes were severely blood shot with blurred vision. Fever blisters on lips. Lab tests showed positive ANA and severe elevation of CRP and ANA and nuclear dots. Treated with Prednisone with relief, but labs were still elevated and referral made to specialist in Immunology.
This spontaneous report was received from a healthcare worker referring to a 53 year old female patient. On 15-OCT-2014 patient received a dose of influenza virus vaccine (unspecified)(manufacturer unknown) (dose, frequency and route unspecified). On 17-OCT-2014 the patient was vaccinated with PNEUMOVAX23 (Lot# was reported as K007826, expired on 03-FEB-2016) injection, 1 dose/once, intramuscular (IM) for chronic risk factors. On 17-OCT-2014, the patient experienced fever, cough, and body aches after receiving PNEUMOVAX23. The reporter stated this patient had missed 2 days of work due to the adverse reactions. The outcome of cough, fever and body aches were reported as not recovered/not resolved. Additional information has been requested.
Redness, warmth, swelling to left upper arm to left subdeltoid. Does have blanched area to center of redness. Tx: topical BENADRYL, ice packs 8/11/11 po BENADRYL QID.
Convulsions - tics - jerking non purposeful movements. (L) leg cellulitis/abscess.
tested positive; This is a spontaneous report from a contactable consumer (Patient). A female patient (Age: 66; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown) via unspecified route of administration on 22Mar2021 (Monday) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. On 26Mar2021, the patient was tested positive to COVID-19. Patient enquired about when she should receive the second dose. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive, on 26Mar2021. The clinical outcome of the event was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
short of breath (had to rest to catch my breath); catching cough; feeling exhausted; Intermittent weakness; feeling out of it; pain at injection site to shoulder up to left side of neck; pain at injection site to shoulder up to left side of neck; pain at injection site to shoulder up to left side of neck; experienced GI symptoms started bloating and cramping led to profuse water diarrhea; experienced GI symptoms started bloating and cramping led to profuse water diarrhea; water diarrhea started in the evening and stopped around 8pm; Slightly lightheaded; mild headache; This is a spontaneous report from a non-contactable nurse, the patient. A 54-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on an unknown date in Apr2021 at 08:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer with no recurrence. Concomitant medications included levothyroxine sodium (SYNTHYROID), omeprazole magnesium (PRILOSEC OTC), loratadine (CLARITIN), paracetamol (TYLENOL) and vitamin d nos (VIT D); all from an unknown date for an unknown indication. The patient previously took Influenza vaccine on unknown date in 2010 or 20211 and Zantac on unknown date; both for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 the patient experienced mild headache. On 02Apr2021 the patient experienced Slightly lightheaded. On 02Apr2021 at 13:00 the patient experienced GI symptoms started bloating and cramping led to profuse water diarrhea started in the evening and stopped around 8pm. On 02Apr2021 at 13:00 the patient experienced Intermittent weakness, feeling out of it, pain at injection site to shoulder up to left side of neck (no headache). On 02Apr2021 at 19:00 the patient experienced short of breath (had to rest to catch my breath) and had a catching cough, and feeling exhausted. Short of breath with a cough to Monday and then intermittent until Wednesday. Thurs and Fri starting to feel better but still have moments of weakness and a mild headache. On 05Apr2021, the patient underwent Nasal Swab and the result was Negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the event Slightly lightheaded and GI symptoms started bloating and cramping led to profuse water diarrhea was recovered on 02Apr2021 and of the intermittent weakness, feeling out of it, pain at injection site to shoulder up to left side of neck, short of breath (had to rest to catch my breath), catching cough, feeling exhausted and mild headache was recovered with sequelae.  No follow-up attempts are needed. No further information is expected.
Within 30-45 minutes of receiving my first dose of the vaccine, my left shin and right knee felt very cold but also had a burning sensation. Within several hours, this sensation had spread to both shins and knees, my right hip, and my lower back.  Within 24 hours post shot, the burning/cold sensation had spread to my mid and upper back, toes, forearms, and eyelids, and part of my face. Today is now the 7th day since I received the shot, and I am still experiencing this sensation all over my body. It feels very similar to having muscle rub all over your body and it's very uncomfortable. Last night, the sensation spread to my throat and mouth. All of the previously mentioned areas are still affected.
All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No treatment information was reported.  None of the patients have reported side effects, so far.
Child had no appetite on 10/18/1007, she had vomiting for 24 hours with the vomiting stopped by 10/20/2007.  A rash appeared on her trunk, arms, face and legs on 10/19/2007.  She c/o of itching.  Mom compared the rash to a "heat rash".  Mom states the child has continued her normal activities. The rash has not subsided.
Information has been received from a certified medical assistant, referring to an unspecified number of patient of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored VAQTA injection (lot # M017982, expiration date 13-SEP-2017; dose and route unknown) for prophylaxis. No adverse effect was reported. The vaccines were stored under temperature -0.24 Celsius degree (C) for 193.5 hours. There was no previous temperature excursion. Digital data logger was involved. Additional information has been requested.
DURING THE OBSERVATION PERIOD AFTER PATIENT HAD RECIVED THE VACCINE, THE PATIENT  FAINTED.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
This spontaneous report as received from a healthcare worker refers to a 18 year old female patient with epinephrine allergy. Patients pertinent medical history was none. On 19-OCT-2012, the patient was vaccinated with first dose of GARDASIL (lot number H014615, expiry date 27-MAR-2015 and dose was not reported) intramuscularly. On 28-DEC-2012, the patient was vaccinated with a second dose of GARDASIL (Lot number, expiry date and dose were not reported) intramuscularly. Concomitant therapies included ethinyl estradiol, AVIANE, propanolol hydrochloride(reported as propanolol), PROAIR and MAXALT. On 30-DEC-2012 (reported as 1-2 days after receiving the send dose of vaccination) the patient experienced itchy rash on the trunk and abdomen. The patient sought medical attention (visited the physician). No laboratory test was performed. The event was treated with BENADRYL, CLARITIN and prednisone. The outcome of itchy rash on the trunk and abdomen was unknown. Additional information has been requested,
Elevated heart rate and chest pain, shortness of breath and difficulty breathing. Ended up in the Emergency Room on 08/16/2021  and now have follow up appointments and blood work to be completed on 08/23/2021.  No treatments or outcomes have been found. COVID test was taken to rule out symptom but it came back NEGATIVE.
Growing rash at injection site. Feels hotter (not just warmer) and harder than surrounding skin. Started Monday late night/Tuesday early morning. Only taken Aleve for fever/chills. Rash has continued to itch, feel hot, and spread.
Disorientated, fainting, diarrhea, vomiting, chills, about 10 hours after injection.
PATIENT WAS ADMINISTERED FLUMIST QUADRIVALENT AFTER SEVERAL TEMPERATURE EXCURSIONS BELOW 35F INCLUDING ONE AT 33.98F; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender of Unknown ethnic origin born in 2013.    No medical history was reported.     Concomitant medication included amlodipine besilate, valsartan.     The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number TH2108) (expiration date 10-DEC-2023), via nasal route, on an unknown date.     A Unknown administered FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced patient was administered flumist quadrivalent after several temperature excursions below 35f including one at 33.98f (preferred term: Body temperature).    Action taken with  flumist quadrivalent was reported as not applicable.     The outcome of the event was unknown.    The event was considered non-serious.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
tender at the injection spot; vomiting,; chills; dizziness; headache; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 29Mar2021 at 10:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hypertension from an unknown date. Medications the patient received within 2 weeks of vaccination included nystatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 08Mar2021 at 10:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 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. Patient did not have allergies to medications, food, or other products. On 29Mar2021 at 22:00, the patient experienced vaccination site tenderness, vomiting, chills, dizziness, headache. (Initially felt fine after the second vaccine, a bit tender at the injection spot. 12 hours later was seriously ill with severe vomiting, chills, dizziness, headache). The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Clinical outcome of vaccination site tenderness, vomiting, chills, dizziness, headache was resolving at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Flu like symptoms; Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles on face).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were unknown.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles on his/her face. So he/she was in line for vaccine.  The patient stated that, it was not painful. The patient had some flu like symptoms next day and sore arm .  The patient further stated that, If offered any protection it was certainly a win for him/her. Additional Supportive Information: the follow up would not possible as no contact details were available.
Immediate pain upon injection.  Left arm injection (Meningococcal conjugate) hurt worse than right arm (HPV).  I (mom) had her take Naproxen (220 mg) for 3/10 left arm pain with movement  (especially extending and lifting).  She tends to under-rate her pain as opposed to over-rate it.  By 8:30 PM she was running a fever, having significant increase in pain, 6/10.  She took 2 Naproxen at 9PM, and went to bed.  Also, she was very emotional.  She rarely ever cries about anything, but she was crying/sobbing uncontrollably for over an hour.  Patient woke up at 3 AM, very hot to touch, with fever and chills.  She took a shower, got dizzy, had to sit down in the bottom of the tub because she felt like she was going to  fall.  She was nauseated, weak, and hurting.  She had lower back, hip pain, and knee pain.  Hip and back pain was 8/10 pain on 0-10 scale.  Muscle weakness, legs weak, and ears stuffy.  She says the feel very full, and had a noise in her ears, like the sound of static (off and on). This has been going on all day.  We've used naproxen and alternating Tylenol now, but symptoms get worse as meds near wearing off. She also feels disoriented at times, as if she don't know which direction to turn, left or right, to go to the bathroom.
First onset consisted of severe headache, facial pain, muscle spasms in the neck and upper back. Pain moved throughout the back region and mainly settled in the face, neck and upper back. Daily ongoing headaches and pain have persisted for over 15 months. Treatment has consisted of multiple medications, physcial therapy, multiple test with multiple physicians/ specialists.
I had my 6-month regular checkup with Dr on Jan.21, 2021. My blood pressure was around 120/70 as It had been consistently for several years (never high).  Two days later I received my first Pfizer vaccine injection & then 28 days later my second Pfizer injection. During the next two months I began to notice swelling in my feet and lower legs. There were no medical issues during that same time that I know of. I made an appointment with Dr on April 22, 2021 to see what what going on. That's when he discovered my atrial fibrillation. I consulted Dr, cardiologist with Cardiology Specialists on July 21, who referred me to another dr, their electro physiologist after consulting with him on  October 6, 2021 he scheduled me for a cardiac ablation which was performed at hospital on November 9, 2021. The ablation was very successful and have experienced no more Afib episodes since that time. Before the ablation  in I had extensive symptoms, heart fluttering and in  shoulders and neck high blood pressure, inability to sleep in bed (spent many nights in chair). Symptoms were not predictable. Sometimes they lasted as long as 25 hours. I experienced none of this until after I received my first two Pfizer vaccine injections.  I believe it was not coincidental that these unexpected symptoms occurred within two months of the injections.
Atopic dermatitis, large (various & 2 inch patches) raised, red, cracking on arms, torso, legs and feet. Onset within days of second dose. Started on right side of body and within weeks spread to left side and persists to today. Fluocinonide 0.05 % Cream prescribed and used including currently.
Patient was 17 years old when she received the first injection. She tolerated it well overall and reported some arm soreness.
Patient reported fever, redness and swelling of feet. Seen in ER by ER physicain and given dose of BENADRYL. Mother reports symptoms subsequently resolved and no other problems.
I had my the 2nd dose of Pfizer in 02/18/2021, I missed my period in February and March, spotted a day or 2 in April and May, and skipped June. I may have turned the corner in July, I did have my period. In August I just spotted. I saw my GYN and asked why I was irregular and they said it could have been from the vaccine or from the getting off my oral contraceptives in July 2020. I had an acute blood clot in 5 different veins in my right leg, in July of last summer in 2020 I had to go off my oral contraceptives, Gianvi, that I had been on for over 16  years. When I went off the oral contraceptives, I was menstruating up until January every 2 weeks. It is unknown, because we are still monitoring my menstrual. May have turned the corner but otherwise feel fine. I don't know if my body is adjusting to that or it was just the vaccine.
20 minute episode of shaking head back and forth, punching movements, tongue thrusting and back arching. Added term from Discharge summary is cyanosis.