chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office manager refers to a female patient of unknown age. On 03-AUG-2017, the patient was vaccinated with one dose of PNEUMOVAX 23 Lot # N011305 and expiration date on 20-JAN-2019, intramuscularly for prophylaxis. On an unknown date, the patient experienced injection site pain, pain in extremity, injection site erythema, pain, injection site pain, injection site rash and injection site erythema. The patient visited the physician but it was unknown if she received treatment for the adverse events. No any laboratory study was performed. The outcome of injection site pain, pain, injection site rash and injection site erythema was reported as not recovered/not resolved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1708USA004754: US-009507513-1708USA004753:
C/O large red area 15 x 12cm with welt 2 x 6cm in center of red patch. Red patch was warm and mildly itchy. Noticed 5 hours after vaccine admit. We examined this patient b/c of age, new vaccine for us. Adv patient to take Benadryl 11-8-07 area improvement.
Fever, chills, body aches, dizziness, sore left arm, weak body, brain fog - these signs lasted from 9:30 PM, Tuesday 5/18/21 through 6:00 PM , Wednesday 5/19/21.  On Monday, 5/24/2021, patient experienced 2 bloody noses. One when he woke up at 7:30 AM and then another at 5:15 PM. Bloody noses are not normal for him.
Vaccine #1 had no issues. Vaccine # 2 had the following: Site of shot was hot, large, inflamed  4 days/ started to imrove on day 5 Day #1  Woke up at midnight with severe shooting pain in neck and went straght up head/followed by inability to move legs/eased off and the next morning could use legs and pain gone, but arm had started to swell at site of shot Day #2 Very sick, flu like symptoms, sleepy, no headache, chills Day #3 same as day 2 Day #4 Same as day 2 and arm easing off Days 5-9 severe fatigue , abnormally tired and unable to function normally   Day nine severe dizziness started and has continued to day 13.  Cannot drive, wobbly
Information has been received from a physician concerning a 6-month-old patient who was vaccinated PO with a third dose of rotavirus vaccine (human-bovine). Concomitant therapy included other unspecified 6 month vaccinations. Subsequently, one day after vaccination, the patient experienced diaper rash. The patient was given unspecified antibiotics. The outcome was recovering. Unspecified medical attention was sought. No other information was reported. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
pt recvd vax 9AM began high pitched shrill cry @ 130PM for 2 hrs went to MD; DPT leg red, swollen, knot @ site, t100;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: GU5342) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Lot number: EK9321), in left arm, in Jan2021 as dose 2, single (Lot number: EL3248), in left arm, in Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and in Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Mar2018; ATORVASTATIN, start date: Mar2018, stop date: 05Feb2023. Past drug history included: Ace inhibitors, reaction(s): "Known allergies: Sensitivity to Ace Inhibitors", notes: Sensitivity to Ace Inhibitors. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid treatment from 06Feb2023 to 10Feb2023.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect can not be ruled out completely.
she has already got all the shots for the Pfizer Covid 19 vaccine and she stated that she tested positive for covid; she has already got all the shots for the Pfizer Covid 19 vaccine and she stated that she tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has already got all the shots for the Pfizer Covid 19 vaccine and she stated that she tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient mentioned that she has already got all the shots for the Pfizer Covid 19 vaccine and she stated that she tested positive for covid and now she is taking the medication Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1/8/2021 vaccination  1/12/2021 Woke up with intense back and neck pain. A really swollen face, nose, swollen 'everywhere'.  I couldn't stand because of so much pain. Fever 101 which is very high for me, swollen eyes; went on for 4 days. The swelling went down after 3 days. The joint pain didn't resolve for 7 days.  I had a teleconference with my Dr. He said if things get worse, call me or go to nearest ER.  I took Tylenol, Advil.  My doctor recommended that I only have the 1 vaccine.  *I had very bad case of COVID in 03/2020. I didn't go to the hospital but I should have. My husband and I both were COVID + and bad cases. My O2 got down to 82. We had traveled a wedding. We didn't want to infect anyone.
This spontaneous case, initially received from other non-health professional on 15-Oct-2018, concerns a 19-year-old, adult female patient. On 08-Oct-2018, around 8 pm, the patient was administered FLUCELVAX QIVc (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 09-Oct-2018, around 1:30 am in morning, after vaccination, the patient was pale with white lips, was sweating, could not feel legs and could not close her hands. Those symptoms lasted for about 20 minutes. The patient also complained of pelvic pain. On the same day, the patient's arms and legs were sore. On 12-Oct-2018, reported as Friday, the patient had no other symptoms. On 14-Oct-2018, reported as Sunday, the patient was weak and pinky was tingling. After a week, the aching was still prevailing. At the time of this report, the outcome of the events pelvic pain, weakness and tingling was not reported. The patient had not recovered from the pain in extremities. The patient had recovered from the other events.
Severe case of Shingles; This is a spontaneous report from a contactable consumer (patient). This 76-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 06Feb2021 at 09:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines with 4-weeks prior to the COVID vaccine. The patient had no allergies to medications, food or other products. Concomitant medications included amlodipine besylate from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number unknown) on 16Jan2021 at 09:30 (at the age of 76-years-old) in the left arm for COVID-19 immunisation. The patient reported she contracted a severe case of shingles on 12Mar (2021). The event required a doctor or other healthcare professional office/clinic visit and the patient was treated with valacyclovir. The clinical outcome of shingles was not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient reported some lip swelling/tingling at 11 AM soon after SHINGRIX. Took 2 BENADRYL, slept, reported symptoms mostly subsided at 7:30 PM - felt a bit nauseous still but mostly better.
Large red rash at injection site that is hot to the touch, very itchy, tender and swollen.
headache; dizziness; sweating on forehead; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERHIDROSIS (sweating on forehead) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METFORMIN, VITAMIN D3, women's multivitamin, FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL], CINNAMOMUM CASSIA BARK, THIOCTIC ACID (CINNAMON ALPHA LIPOIC ACID), MAGNESIUM, OMEPRAZOLE and ATENOLOL for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizziness) and HYPERHIDROSIS (sweating on forehead). On 25-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), HYPERHIDROSIS (sweating on forehead) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment taken was unknown   Reporter did not allow further contact
I was a completely healthy person, I never had any medication reactions, I eat correctly, since I received a single dose of the Janssen COVID-19 vaccine Vaccinate. I am not the same as before,  different reactions have appeared in my body,  I have different symptoms,  such as loss of muscle mass, loss of weight, since I got that single dose  I sleep a lot, I have cramps in my calves, I  show glycoidal phlegm in the form of jelly,  and a vision appeared in my vision that I can see very thin fibers in the form of a spider web and black dots in my vision,  apart from a lot of nervousness and a constant itching in the lower parts of my legs and in my testicles.  When they applied that dose to me, a ball grew in my testicles that grew and they stripped it off.  It appeared as a small ball and it grew until it reached 2.5 cm when I consulted the doctor, which was they did some cancer despite me and they told me no it was malignant,  if this vaccine accelerated something in my body I want to see how I can get some compensation for the inconvenience this vaccine has caused me, the vaccine was received locally where they gave me a record card from the CDC  I am 60 years old and I will be turning 61 soon.
Fever with Temp of 101.5; chills; body ache; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 57-year-old, via an unspecified route of administration, administered in left arm on 08Mar2021 17:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 (Covid prior vaccination). The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included other medications (unspecified) within two weeks. The patient experienced fever with temp of 101.5, chills, and body ache on 09Mar2021 12:00. The patient did not receive treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
48 hours later, I had really bad ringing in my ears both ears. I still have the ear the ringing now but it comes and goes. I have notices that if I hear something really loud it sets it off and its very painful. I have tried over the counter aspirin and it doesn't do anything. Deafness does run in my family so I am not sure if that matters.
PT REPORTED SENSATION OF HER THROAT SWELLING CLOSED, SIMILAR TO WHEN SHE IS EXPOSED TO MUSHROOMS (ALLERGIC TO MUSHROOMS).
At 8 days post vaccine (shot 1) I developed a large itchy lump at injection site.
Pt was given vaccination for hepatitis A and hepatitis B combination. Pt had previous vaccines like flu  in past with no issues. Pt had COVID vaccine in January with no issues. Injection site immediately after administration had no reaction whatsoever . Patient mentioned that she did not even feel the vaccine pain. After immunization, patient complained of "not feeling too well' and told pharmacist and husband this. She asked for water which was given to her. She was in chair and her husband sat next to her. She then asked for paramedic to be called.  Paramedics were called and they came and took her vitals. She was then ferried on gurney and paramedics said they would take her to Hospital. Patient was apologizing to pharmacist and staff for the situation
Mom called into County Public Health Dept on 10/22/2015 at 8:45 am. She stated patient had approx. 10 bumps starting late Wednesday, 10/21/2015 from head to toe. Mom stated child has no fever, eating, drinking, and sleeping normally. Daycare sent child home. Instructed mom that a VAERS report would be done and to notify pediatrician. Noted chart.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician reporting for a nurse (patient) from a Pfizer-sponsored program Pfizer First Connect.  A 43-year-old female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation.  There were no medical history and concomitant medications. The physician was reporting that a nurse received the vaccine and had a headache after receiving it. She also tested positive for Covid 6 days after getting the vaccine (on 28Dec2020). He was asking if there was any connection with getting the first shot and testing positive. She was very keen with social distancing and wearing a mask. The physician is a medical oncologist. He was reporting on one of the nurses that worked at the hospital. She also developed nasopharyngeal congestion 4-5 days later. The nurse was at work today. She was disappointed because she had to go home. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 28Dec2020. The outcome of the events was unknown.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19  cannot be totally excluded.  The case will be reassessed if additional information becomes available.
I had acute artistes flare up in my right foot. My left leg muscle weakness and pain. I have been noticing more and more weakness in my leg. I could not hardly walk on it. I went to the ER. They did x-rays and physical movements. I continue with my leg pain. I went to my doctor about it. She gave me pain medicine and physical therapy for awhile. My pain and weakness are still increasing. I went back to the doctor, and was refer to an ortho specialist. My appointment is Sept 27th for that. I can not walk very far or go up and down the stairs anymore due to my leg.
Vaccine was mistakenly administered without proper dilution.  Unknown if any symptoms occurred.  Pharmacy attempted to call patient phone number 4 times but did not receive a return call to the message left.  Pharmacist also called patient's doctor to alert them in case patient presented to the office.
Shingles vaccine given on 3-20-12 and she was fine until the following day - she then noted her arm was warm/red, this got worse and worse. BENADRYL did not help. Came in office to be seen 3-22-12.
pt recv vax & devel tinnitus in the rt ear;pt was seen by otolaryngologist who stated audiometric workup revealed a markedly asymmetric nerve deafness;pt was to have an MRI to r/o a retrocochlear lesion;
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated IM with dose 1, 0.5 ml GARDASIL (Lot number not reported) in July 2011. On 17-AUG-2012, the patient received IM, dose 2, 0.5 ml GARDASIL (Lot number not reported). No adverse effect was reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Patient states the day after flu vaccine was administered she noted on the left side, above her collar bone, at the base of her neck a small marble size not appeared.  States the it is sore to the touch and tender.  Patient calls the health department on 12/16/11 at approximatley 2:00pm and states she will be going to a doctor or an urgent care after she get's off work this evening.
sore arm at injection location; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-year-old male patient received BNT162b2 (BNT162B2), on 24Jul2022 as dose 3 (booster), single (Lot number: FLZ757) at the age of 8 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FKS618), administration date: 11Nov2021, when the patient was 7-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: FKS618), administration date: 02Dec2021, when the patient was 7-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Jul2022, outcome "unknown", described as "sore arm at injection location". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: 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.  No follow-up attempts are possible. No further information is expected.
After being pre-medicated by my Allergist with Prednisone and Benadryl, I had no allergic reaction for 48 hours following the booster vaccination. I woke up on the third day with slowly developing red blotchy rash appearing on my abdomen and back. I continued on oral Benadryl and applied topical Benadryl cream. The rash worsened over a few hours and began to spread to my armpits, thighs, and entire torso. I felt asthma-like symptoms of airway tightness, and I felt lightheaded. I was seen again by my Allergist 2.5 days after vaccination, and prescribed 40 mg Prednisone to be taken for the next 5 days. After the first dose the rash has stopped spreading and is beginning to fade. Breathing symptoms have also improved.
Severe Vertigo.   I have never had vertigo before.  Severty decreased over 4 days until gone.
Decreased appetite for one day. Bilious emesis times one in the evening of the same day. Tender abdomen. Lethargy. Treatment included an air enema in radiology for reduction.
Severe sinus pressure. Dizzy at first. Took 2 rounds of antibiotics before I started feeling better but have had balance and equilibrium problems since. Was checked by neurologist, cardiologist, ENT with no resolution and no evidence of any cause.
Baby received MMR on 1-16-07.  On 1-17-07 baby spiked fevr 105.  Went to urgent care.  Dx'd with pind eye and bilat otitis media.  Amoxicillin started on 1-18-07. Improved and then on 1-29-07, developed rash on trunk and neck.  Went to urgent care at hospital, dx'd with suspect measles (no blood work done).  On 1-30-07, Health Dept. called another Health Dept. regarding suspect measles.  RN talked to mother, child feeling fine, just had resolving rash.
Patient said evening of receiving vaccines she experienced a very sore arm and severe chills. When she woke up the next morning she still had chills and felt faint. The symptoms lasted for 24 hours and the sore arm continues until today, 11/12/18.
terrible h/a, runny nose, back aches, hacking cough & nausea;It lasted about 1wk w/sx diminishing p/about the third day x/for hacking cough;
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route were not reported) lot # L002213, expiration date 21-JUL-2016. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough COVID-19 case: I started to feel fatigue and have a dry cough. The next day I had took a rapid test because my son contracted COVID-19 first. the test came back positive. I did start to experience some headaches and I had a cough that was a mix of dry and wet cough. On 04/13/2022 I contacted my doctor and was given a prescription for Paxlovid.
It started with a rash on my upper arm near the injection site. I noticed a lump under arm and side of breast. Started feeling swelling and pain and tenderness. That lasted for about 2 weeks.