chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of fever in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 25 April 2011 the subject received 2nd dose of ROTARIX which had been reconstituted with sterile water for injection (wrong solution used in drug reconstitution) and given intramuscularly in the subject's thigh (inappropriate route of vaccination). On the night of 25 April 2011, within hours of vaccination with ROTARIX, the subject experienced a slight fever (99 degrees Fahrenheit). No other reactions were reported. At the time of reporting the fever was resolved.
Got a flu shot couple years , got the flu anyway; Initial information received on 20-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown age and gender) who got a flu shot couple years, got the flu anyway (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history included mild corona virus disease (COVID-19).  The patient's medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious "got flu shot couple years, got the flu anyway" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got a few shot couple years, got the flu anyway, was way worse than the mild (corona virus disease) Covid I had this year."  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Started 8 p.m.-ish last Sat. Injection arm (right) very swollen, painful, tingly to fingertips. Fever 101. Unable to move arm or sleep for pain. Symptoms bad through Wed. a.m., when fever broke, swelling/pain started to subside. It's now Thurs.: She's still symptomatic but slowly getting better. Tried inserting Julia's current meds/supplements in Continuation Page but wouldn't accept copy so putting here: Aspirin 81 mg/day; clopidegrel 75 mg every other day; hydrochlorothiaziada 12.5 mg/day; amlopidine besylate 5 mg/2x day; losartan potassium 50 mg/2x day; rosuvastatin calcium 41 mg/day; nexium/2 per day; esomeprazole magnesium 20 mg/2x day; vitamin d3 1000 iu/day; calcium carbonate 1200 mg/day; multivitamin Centrum
face was swollen on both side; swelling in her upper lip.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was swollen on both side) and LIP SWELLING (swelling in her upper lip.) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (face was swollen on both side) and LIP SWELLING (swelling in her upper lip.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SWELLING FACE (face was swollen on both side) and LIP SWELLING (swelling in her upper lip.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.
This case was reported by a pharmacist via call center representative and described the occurrence of numbness facial in a 59-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). Concomitant products included BACTRIM DS, gabapentin, phentermine, TOPAMAX, XANAX, ZOCOR, bisoprolol + hydrochlorothiazide and oxybutynin. On 17th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th March 2018, 1 days after receiving SHINGRIX, the patient experienced numbness facial. On an unknown date, the outcome of the numbness facial was not recovered/not resolved. The reporter considered the numbness facial to be related to SHINGRIX. Additional information was reported as follows: Concomitant products included PROTONIX. The patient received SHINGRIX in right deltoid. At 5 am, the patient awoke with a numbing sensation on the forehead.
pt recvd vax;about 5 hrs later taken to MD due to inc T of 103.8;fever,v,rash;shot of vistarvil given & erythromycin;was told allergic rxn to vax;
The shot was not given in the muscle the way it should have been. It was given way below the muscle in the fatty area; I still have swelling, about 2.5 inches of swelling from the second dose; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EN6201, Expiry date not reported), unspecified route of administration in left arm on 11Feb2021 16:00 ( at age of 68-years) as 2nd dose, single for COVID-19 immunization. The patients did not have any history and concomitant medication were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283, Expiry date not reported) via unspecified route of administration in left arm on 19Jan2021 as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The caller stated that she received the second dose of the COVID-19 vaccine on Thursday 11Feb2021. The shot was not given in the muscle the way it should have been. It was given way below the muscle in the fatty area. I still have swelling (unspecified date in Feb2021), about 2.5 inches of swelling from the second dose, does that mean it was given in correctly. Is there anything she should do, not sure it was effective. Shot may not be effective because it was given way below the muscle in the fatty area. The clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
feels like she might have had less than the required second dose; the caller still has pain at the injection site until now occasionally in the arm pit; rash; the caller still has pain at the injection site until now occasionally in the arm pit; pain; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (feels like she might have had less than the required second dose), AXILLARY PAIN (the caller still has pain at the injection site until now occasionally in the arm pit), RASH (rash), VACCINATION SITE PAIN (the caller still has pain at the injection site until now occasionally in the arm pit) and MYALGIA (pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Small lymphocyte B lymphoma (Lukes-Collins Classification) (B cell lymphoma).   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ACCIDENTAL UNDERDOSE (feels like she might have had less than the required second dose), AXILLARY PAIN (the caller still has pain at the injection site until now occasionally in the arm pit), RASH (rash), VACCINATION SITE PAIN (the caller still has pain at the injection site until now occasionally in the arm pit) and MYALGIA (pain). At the time of the report, ACCIDENTAL UNDERDOSE (feels like she might have had less than the required second dose), AXILLARY PAIN (the caller still has pain at the injection site until now occasionally in the arm pit), RASH (rash), VACCINATION SITE PAIN (the caller still has pain at the injection site until now occasionally in the arm pit) and MYALGIA (pain) outcome was unknown.            No concomitant medications were reported.  On an unknown date, the patient had semi-qualitative-IgG antibody testing which reportedly came back negative.
Slightly itchy nontender red circular rash at injection site of Yellow fever vaccine right tricep approx 3.8cm.
Initial misuse report received from a healthcare professional on 14 June 2013. Administered 0.4 % saline diluent to a patient. No adverse event was reported. List of documents held by sender: none.
This spontaneous report was received from a nurse and refers to a 16 years old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with PROQUAD by subcutaneous route, for prophylaxis (dose, lot number and expiration date were not reported). Was reported as in approximately 2017, the patient was inadvertently vaccinated (product administered to patient of inappropriate age) with PROQUAD. The patient did not sought medical attention. No adverse effects were reported.
Severe swelling of upper arm/shoulder, slight pinkish tone, muscle is very hardened, painful upon raising, numb and achy area around injection site. Concurrently had swelling and redness of right earlobe and slight swelling of face (cheeks and chin) that lasted several hours then subsided.
Headache; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 64-years) as single dose for COVID-19 immunization. Patient's medical history included: known allergies. It was unknown if patient had received any other vaccine in four weeks. The patient's concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. On an unspecified date in Feb2021, the patient experienced headache and fatigue. The patient did not receive treatment for adverse events. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. information about lot/batch number could not be obtained. No further information is expected
dry mouth; comprehension level went down; elevated blood pressure; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRY MOUTH (non-serious) with onset 13Apr2021, outcome "unknown", described as "dry mouth"; CONFUSIONAL STATE (non-serious) with onset 13Apr2021, outcome "unknown", described as "comprehension level went down"; BLOOD PRESSURE INCREASED (non-serious) with onset 13Apr2021, outcome "unknown", described as "elevated blood pressure"; HEADACHE (non-serious) with onset 13Apr2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Approximately ten minutes after administration patient experienced dry mouth (to the point it was difficult to swallow), comprehension level went down (she didn't recognize that he & the nurse were speaking with her),  elevated blood pressure & headache.
URI symptoms bodyache, fatigue, sinus pressure, nasal congestion, cough, sore throat.  Can use OTC allergy medications like Claritin, Zyrtec and Allegra as needed. OTC Tylenol or ibuprofen for fever, discomfort.  Recommended saltwater gargles, nasal saline sprays, humidifier and vapor rub at night.
Pt had PREVNAR 13 on 6/30/15. That evening he developed fist size area of injection site. Raised, red, not hot to touch. The next day hives developed around bicep. No drainage, pain or itching noted.
Tongue swelling, difficulty breathing, needed Benadryl Prednisone, Albuterol.
he got his 1st dose of the vaccine on 01Apr2021 and tested positive with the Covid-19 after he got the 1st dose.; he got his 1st dose of the vaccine on 01Apr2021 and tested positive with the Covid-19 after he got the 1st dose.; This is a spontaneous report from a contactable consumer (patient) reporting himself. A male patient of an unspecified age received BNT162B2 (Solution for injection; PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: Unknown) dose 1 via an unspecified route of administration on 01Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, he got his 1st dose of the vaccine on 01apr2021 and tested positive with the covid-19 after he got the 1st dose. (drug ineffective) (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Apr2021. The outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received form a registered nurse refers to a 8 year old female patient. On an unknown date the patient was vaccinated with hepatitis b vaccine shortly after birth (manufacturer unspecified). The patient then on an unknown date received 2 doses of RECOMBIVAX HB (5mcg/0.5 ml) (lot #, expiration date and route not reported) at appropriate intervals. On an unknown date the patient developed autism. The outcome of autism was reported as not recovered. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 36-year-old female patient who received TWINRIX adult (batch number 7C4Z3, expiry date 6th May 2018). This case was associated with a product complaint. On 21st December 2015, the patient received TWINRIX adult 1 ml. On 21st December 2015, less than a day after receiving TWINRIX adult, the patient experienced injection site pain. On 22nd December 2015, the patient experienced injection site swelling. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site pain, injection site swelling and pharmaceutical product complaint were unknown. The reporter considered the injection site pain and injection site swelling to be related to TWINRIX adult. Additional details provided were as follows: This case was reported by a Certified Medical Assistant. No other vaccines were administered on the vaccination day or 4 weeks prior to suspected vaccine. On 21st December 2015, at 11:00, the patient received a dose of TWINRIX adult vaccine in an unspecified deltoid. The reporter stated that, the TWINRIX adult vaccine would not re-suspend and contained chunky white matter while administration to the patient. On 21st December 2015, less than a day after vaccination, the patient experienced localized site reaction (pain). On 22 December 2015, 1 day after vaccination, the patient called the reporter and stated that she experienced a localized site reaction (swelling the size of a 2 by 2 goose egg). The reporter does not know, if the patient took anything for the pain and swelling. On 22nd December 2015, the reporter instructed the patient to go to an urgent care facility. The reporter filed a QA report and stated that, normally when the vaccine sits for a while she was able to re-suspend the vaccine in order to obtain a cloudy suspension. There were 4 vaccines left in a box that would not mix up or re-suspend. The reporter stated chunks were visible in the vaccine. The reporter discussed the appearance of the vaccine according to Package Insert. In addition, called stated the office gives this vaccine very frequently and prior to administering she normally does not see any chunky material. A wholesale credit template has been completed and submitted.
Within 4 hrs of receiving several immunization, patient became drowsy uncomfortable with full body rash, hives, lips and eyes swelling, low grade fever; lasted approximately 2 days.
16 year old pt received Pfizer booster. Booster is only indicated for patients 18+
1 hour after injection I started to feel my throat swell, and I had difficultly swallowing. It subsided after 2 hours.
Nurse states the vaccine leaked out the needle/patient right arm during ID administration; patient did not receive a full ID dose.  Same nurse repeated another ID dose on the opposite arm (left arm) successfully. No patient complications.
Have bright red patch from her shoulder down to her elbow on the next day. It doesn't hurt or itch. The symptoms subside after 4 days. Didn't take any medication for that.
Within 4 hours after injection: muscle stiffness and soreness. Within 9 hours after injection: brain fogginess, mild upset stomach, chills and violent shivering. 2nd and 3rd day after injection: mild brain fogginess, fatigue.
Headache, Myalgia, Arthralgia, Pain in fingers Narrative:   Other Relevant History:
I had abdominal pain. The pain was right underneath my sternum. It was about the size of a baseball. I was sweating profusely from one minute to another. I was dripping off of my nose - really bad sweating. I got light-headed and the room started spinning a little bit. It felt like I had to defecate but when I sat down, I couldn't do anything. It also gave me nausea, but I couldn't throw up. It went away after about an hour and a half. I didn't call the ambulance because I was in the hotel with my daughter - 13 and 17 and I didn't want to scare them. I waited it out and walked around the room and then I went to bed when it went away. Four days later, Monday night, I was at a conference, and we had just had a few beers and I went to a restaurant and before I ate, I got that same pain in my stomach. I went to restroom. From the time I got up from the table to get to the restroom - I was sweating profusely and got a little dizzy. That pain was in that same spot under the sternum and the pain was probably twice as bad. A waitress saw me and called 9-1-1. I was with my boss, and they called him to come into the restroom and he thought I was having a heart attack. In both instances, I was short of breath - gasping for breath. But I could only get air in in short little bursts. They did take me to a hospital. The pain was intense. They gave me Fentanyl in the ambulance, and it did not take the pain away (Fentanyl) They triaged me in the hospital, and they took my blood but I was never seen because I had been in there for 6 hours and so I asked them to take the thing out of my arm because they hadn't seen me. The put Fentanyl in my arm and something for an allergy in case I was having an allergic reaction. Within three hours of onset, I didn't feel sick at all anymore. The pain was gone, and the sweating was gone. Everything was gone. About 10 days ago, I woke up and was short of breath. I had no pain - or very little pain in my stomach but it felt like something was there in that same place as before in my stomach. I wasn't sweating at all. I did have a little bit of labored breathing. I broke out in the worst case of hives - all over my body. It started in my pubic area where I could feel the itching. Right above me tailbone - right on top of my butt, I was itching bad. My body turned beet red all over and even on my skull and that was itchy, too. After about 45 minutes, that subsided. I waited that episode out without calling an ambulance.  Four or about five days - Hives all over my body and labored breathing - the same symptoms as 10 days ago and that again lasted about 45 minutes. I went to see my Internal Medicine doctor. He prescribed me something for allergy - Prednisone - to take in case it happens again. He took blood to see if it could be an allergy. He sent me to Gastroenterologist. Tomorrow, I will have a colonoscopy and endoscopy. Note: I had the flu shot about a month and a half ago. I got it at my doctor's office. In my right shoulder.
Injection local site reaction. Redness, itchy arm after vaccine for 2 days. Ice packs.
23MAY2003 sought treatment for burning/ itching "blisters" in groin region: practitioner observed "papules" on right hand and groin region: over the ensuing months he received multiple types of treatment including "antifungals/ antihistamines/ antibiotics / total + for staph in October 2003) with symptomatic relief temporary and ultimately spreading term elbows, knees, axilla to trunk, buttocks, abdomen and scalp. Referred to dermatology 31MAR2004. Biopsies were done to rule out dermatitis herpetiforms. (I can fin no evidence viral cultures were obtained at any time of the lesions). See attached list meds given.
Later in the day patient visited ER due to body aches, chills, SOB, heart palpitations.   Patient states feels fine now, first time getting high dose flu vaccine as she turned 65 this year, and she usually fells effects from flu vaccine up to 3 weeks after receiving it.
This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included marjuana, and concurrent conditions included allergy to skunks, non alcohol user, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: not reported) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced flush. On 02-APR-2021, the subject experienced ringing in ears. On 02-APR-2021, the subject experienced sweating to feet. On 02-APR-2021, the subject experienced sore arm/aching to legs. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced aching to back. On 03-APR-2021, the subject experienced morning wood. On 03-APR-2021, the subject experienced increased appetite. On 03-APR-2021, the subject experienced aching to neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flush, and headache on 02-APR-2021, ringing in ears, and aching to back, and sweating to feet on 04-APR-2021, was recovering from sore arm/aching to legs, had not recovered from increased appetite, and morning wood, and the outcome of aching to neck was not reported. This report was non-serious.
Patient reported getting the 2nd injection of the Pfizer COVID-19 vaccine in the "end of February".  Patient was seen in the emergency department on 3/31/21 and diagnosed with COVID-19 via  positive SARS-CoV-2 PCR.  CDC guidelines recommend filling out VAERS for patients fully vaccinated who then develop COVID-19.  Laboratory has been notified and will hold the sample until 4/30/21.  Plan to notify PAas well.
Pain, swelling, chills, rash, discoloration/bruising of the skin below the injection site.