chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a patient's parent referring to her son, a 14 year old male patient. Pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 04-AUG-2016 (reported as "on Thursday late afternoon"), the patient was vaccinated with second dose of GARDASIL 9 (route, strength, lot # and expiration date were not reported). On 05-AUG-2016, the patient experienced chills, feeling abnormal and pyrexia (reported as "low-grade fever, chills and generally felt poor"). On 06-AUG-2016, the patient recovered from the aforementioned events as the fever subsided and his energy returned. In August 2016 (referred as "this weekend"), the patient experienced rash papular (referred as "bumps on his fingers primarily on the skin between the cuticle and first finger joint. On his little fingers, the bumps run higher up and cover most of the tip of the pinky"). It was also stated that the "bumps" did not appear to be on the palm side of his fingers. They are not red or itchy, just a raised rash of sorts on the first finger join of all fingers. The outcome of this event was unknown at the time of reporting. The reporter did not know whether the events were related to the use of GARDASIL 9, but it was not something the patient experienced before. Additional information has been requested.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm right, administration date 12Mar2021 09:00 (Lot number: EP6955) at the age of 79 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Time: 9:00 AM, Anatomical Site of injection: Left arm Shoulder, Route of administration: Intramuscular, Batch/Lot number: EL9261), administration date: 12Feb2021, when the patient was 79 years old, for covid-19 immunisation, reaction(s): "Sleepy". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021 13:00, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The vaccine was administered on the right arm shoulder. The patient had no prior vaccinations. The event was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.
morning of 1/26 (day after vaccination) sore right shoulder muscle, chills, fatigue, slight fever; through day into evening. Went to bed very early, 8:30pm. Woke next day 1/27, 7 AM usual time, feel fine, shoulder still slightly sore.
Severe redness, swelling and pain in entire right arm. Fluid accumulation near elbow.
painful lymph node under arm; Swollen lymph node under arm where vaccine was administered; Temperature under that arm was101.4 while under the other arm was99; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 22Apr2021 at 16:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included high liver enzymes and high cholesterol. The patient had no known allergies. Concomitant medications included fish oil (MANUFACTURER UNKNOWN) and silybum marianum (MILK THISTLE) both for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 31Mar2021 at 16:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 10:00, the patient experienced swollen and painful lymph node under arm where vaccine was administered and temperature under that arm was 101.4 (units unspecified) while under the other arm was 99 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node, painful lymph node and temperature under that arm was 101.4 (units unspecified) while under the other arm was 99 (units unspecified) was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient describes arm as very weak - having trouble lifting coffee mug and pocket book  Patient also describes it as very tender when touching injection site  Moving arm around is very painful - patient has to brace herself to dress in the morning and evening  Patient is waking up in the evening during sleep because it is so painful  - Pain worsened a few days after vaccination but has gotten worse in the past two weeks
Extreme fatigue. She was in bed for 2.5 days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue. She was in bed for 2.5 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extreme fatigue. She was in bed for 2.5 days). The patient was treated with Bed rest (for 2.5 days) for Fatigue. At the time of the report, FATIGUE (Extreme fatigue. She was in bed for 2.5 days) outcome was unknown. Not Provided
Raised, mildly tender, erythematous rash on the left lateral thigh where Kinrix and Proquad were administered.
Patient came to ED with shortness of breath and admitted to the hospital with Covid, acute metabolic encephalopathy, and acute hypoxemic respiratory failure due to Covid.  Patient received 2 doses of remdesivir.
Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 016M20A and 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Thyroid disorder and Hypertension. Concomitant products included METFORMIN for Diabetes, OLMESARTAN MEDOXOMIL for Hypertension, LEVOTHYROXINE for Thyroid disorder.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache). On 08-Feb-2021, HEADACHE (Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-335151 (Patient Link).
UNFORTUNATELY PATIENT WAS GIVEN UNDILUTED PEDIATRIC COVID VACCINE, 0.2ML DOSE. HIS SIDE EFFECTS ON 5/7 WERE TIREDNESS AND SORE ARM AT INJECTION SITE. MOM REPORTS THAT HE IS BOUNCING AROUND TODAY ENERGY-WISE. SHE APPLIED ICE TO ARM AT 7AM AND PATIENT SAYS HIS ARM IS FEELING BETTER.  MOM GAVE TYLENOL PREVENTATIVELY PRIOR TO COMING IN FOR THE VACCINE AND 1 MORE TYLENOL DOSE AT 7AM ON SUNDAY 5/8. ( I SPOKE WITH HER 5/8 AT 11:45AM).
Acute hypoxemic respiratory failure due to COVID-19 infection; Sepsis secondary to community-acquired pneumonia superinfection; Strep bacteremia; Acute Encephalopathy; Acute kidney injury; Hypernatremia; Lactic acidosis
Patient recieved High-Dose Fluzone on 09/21/2020 and the following morning was light-headed/dizzy and fainted. This resulted in patient falling hitting his headd and leg and being admitted to the hospital for evaluation. Today, patient is still experiencing dizziness and light-headedness.
Information has been received from a health professional concerning a female employee in her late 30's or early 40's, with chronic Epstein-Barr virus (EBV) and recurrent herpes simplex outbreaks, who worked in a small area where close to 1000 doses of Zostavax (Oka/Merck) was administered to patients since August 2006.  It was confirmed that the patient was not vaccinated with Zostavax (Oka/Merck).  Subsequently the patient was diagnosed with shingles by her physician and treated.  It was noted that the patient had blisters and scabs and was currently experiencing her second episode of shingles since November 2007, which started on 11-DEC-2007.  No product quality complaint was involved.  No other information was provided.  Follow-up information from a health professional indicated that the patient has had 3 cases of shingles since November 2007.  The shingles was diagnosed by a nurse practitioner in a nearby urgent care facility.  Subsequently the patient had either recovered or was recovering.  All lesions were either gone or almost completely dried up.  VZV PCR results showed that all four samples were either inadequate or negative.  This is one of several reports from the same source.
Within a week or so I developed a rash which turned out to be a bad case of eczema. It was on my neck and back. It was red, itchy, bumpy, and scaly. I used OTC medications. I went to see a dermatologist in May 2021. They said I had atopic dermatitis. I haven't had this before . I was prescribed a cream for it, and it worked and was gone within 3 or 4 weeks. When I got the booster on 11/19/2021 it came back. It is going away now after I was prescribed more cream for it.
Patient's wife called patient support this morning that early this morning he began experiencing shortness of breath. At the time of the call symptoms had resolved. Advised to go to ER if symptoms begin again.
Patient received first dose of Pfizer COVID-19 vaccine at a different site 21 days ago and received 2nd dose of series today.  After receiving his vaccination, he stated he received 2 doses of Sinovac a "long time ago."  Patient aware that he was vaccinated against CDC guidelines, since he already received a WHO-approved COVID-19 vaccine.
Impacted my period/ It came the following week, 12 days early/ It never come this early or twice in a month.; This is a spontaneous report from a contactable consumer, the patient. A 36-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 right arm on 13Apr2021 at 08:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included labetalol (MANUFACTURER UNKNOWN). 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 17Apr2021, following the week of vaccination, the patient's period was early by 12 days. The patient stated that the vaccine impacted her periods which was always every 28 days and never came this early or twice in a month. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event impacted her periods, period was early by 12 days and never came this early or twice in a month was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
mom stated pt fell asleep p/receiving vax & slept all afternoon, evening & noc; mom gave sips of water & changed position otherwise pt wouldn't have moved;
Exactly the same reaction that his 2 months vaccinations had. It hit him like a ton of bricks. Out of nowhere he was screaming and crying and was inconsolable. He had a fever and the next day was tired and crabby.
Information has been received from a health professional concerning a 76 year old female who on 06-DEC-2007, was vaccinated with ZOSTAVAX.  On 06-DEC-2007, the patient developed soreness, swelling, and erythema at the injection site.  The patient described it as "a knot" at the injection site and reported that it "was starting to spread to surrounding areas".  She sought medical attention via the phone.  Laboratory and diagnostic studies were not performed.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested.
Extreme pain and moderate swelling of injection site. The following morning 10/6/15 I woke up with a quarter sized red and hot welp over injection site, pain and soreness continued that day. This morning 10/7/15 I woke up with a half dollar sized welp over injection site with minor pain upon palpation and continued moderate swelling and hot to the touch over injection site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Dec2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation. The patient's relevant medical history included: "PTSD" (unspecified if ongoing), notes: Other medical history: PTSD, Anxiety; "Anxiety" (unspecified if ongoing), notes: Other medical history: PTSD, Anxiety. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 30Aug2023 to 04Sep2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tongue and lips are burning; The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg); She is achy; She is not feeling that well; She is having chills; Eyes were burning like when you have a reaction to the chlorine of the pool; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes were burning like when you have a reaction to the chlorine of the pool), ORAL DISCOMFORT (Tongue and lips are burning), PARAESTHESIA (The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg)), PAIN (She is achy) and MALAISE (She is not feeling that well) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Cancer 3 times, nowokay), Kidney absent since an unknown date, Blood pressure high since an unknown date and Vertigo since an unknown date.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced EYE IRRITATION (Eyes were burning like when you have a reaction to the chlorine of the pool). On 28-Jan-2021, the patient experienced ORAL DISCOMFORT (Tongue and lips are burning), PARAESTHESIA (The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg)), PAIN (She is achy), MALAISE (She is not feeling that well) and CHILLS (She is having chills). On 27-Jan-2021, EYE IRRITATION (Eyes were burning like when you have a reaction to the chlorine of the pool) had resolved. At the time of the report, ORAL DISCOMFORT (Tongue and lips are burning), PARAESTHESIA (The side of the body where she got the injection (right) is all tingly (face, shoulder, arm, leg)), PAIN (She is achy), MALAISE (She is not feeling that well) and CHILLS (She is having chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication mentioned something for the thyroid and something for the blood pressure NOS. Treatment information mentioned Benadryl.
Developed intussusception 6 days after administration of 2 month vaccines including Rotarix.  Required reduction with air enema.
THE PATIENT STARTED GETTING AN ITCHY THROAT AND FELT LIKE IT WAS HARDER TO SWALLER. SHE ALSO COMPLAINED OF SLIGHT CHEST TIGHTNESS, SO WE ADMINISTERED 1 BENADRYL 25MG CAPSULE. AFTER 15 MINUTES WE ADMINISTERED ONE MORE 25MG CAPSULE. SHE WAS MONITORED FOR 2 HOURS AND THEN FELT BETTER AND WENT HOME.
Information has been received from a physician concerning a 10 year old female who was vaccinated with Gardasil. It was reported that the patient fainted shortly after receiving Gardasil. The patient sought unspecified medical attention. No further information was available. Additional information has been requested.
Initial report received on 26 October 2009 from a health care professional. A cluster of patients which contains a ten year old male patient and two other unidentified patients walked approximately ten feet and fainted after receiving FLUZONE SV (lot number, route, site not reported). They regained consciousness when they fell to the floor. This reaction was similar in the three patients. Recovery status was not reported. List of Documents held by sender: none.
Patient received Polio vaccine and he is to old for the vaccine. Patient has not experienced any signs or symptoms from the vaccine.
I received the Zoster Vaccine (Recombinant) on 6/15/18. This was my first injection of the vaccine. On 6/16 I was outdoors in the sun for about 1/12 hours. On 6/17 I started developing a severe red rash and burning sensation with some blisters where my skin was exposed to sun on 6/16. Over the next several days the rash and burning intensified. The pharmacist who gave the injection saw it and said it was a photosensitivity. On 6/20 I saw a PA who diagnosed polymorphus light eruption, plaque type. I was given a 5 day Rx for prednisone. Neither the printed vaccine information from the pharmacy nor the CDC website listed photosensitivity as a possible side effect of the vaccine. (After 3 doses of prednisone, I developed an additional rash on the remainder of my body and stopped taking prednisone). The rash, blisters, pain and burning on the exposed areas of my skin took two weeks to go away. Because of this photosensitivity, I will not be getting the second dose of the vaccine. Why was this possible side effect and an appropriate caution statement not listed on the information from the pharmacy that administered the vaccine or on the CDC website? This reaction was very painful.
Chills, fatigue, body & joint ache 102 degree fever. Brain function impaired. Pain at injection site. Swelling & very hot to the touch. Lasting symptoms for at least 48 hours. Took TYLENOL to stop fever.
positive COVID-19 test with symptoms; ear pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program . A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Mar2021, she experienced ear pain and sore throat. She had no other symptoms such as fever. A covid-19 test was administered and she tested positive in Mar2021. She went into quarantine for 11 days and was fully recovered from her symptoms. She is almost finished with being quarantined. She got her 1st Covid dose and a week later got COVID on 28Mar2021. She was supposed to get her second dose on 12Apr2021 and was wanting to know when she can get her 2nd dose. But she called CVS and cancelled the second dose. Her doctor and one person at CVS told her she could get the second dose of BNT162B2 after 1 month, 30 days after the COVID. Another person at CVS told her that she needed to wait 3 months after COVID to get the second dose of BNT162B2. The outcome of events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
9 days post vaccination pt developed a hard lump at injection site along with redness. States redness was itchy and warm like a "sunburn" approximately 3" x 2". As of date of report pt states symptoms are increasing.
Immunization given in right upper lateral thigh IM on 06/30/03.  07/02/03 mother noticed right lower,medial aspect of thigh was red, swollem and slightly warm to touch.  No evidence of reaction at injection site.  Patient was examined by doctor today.