chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to pharmacy for a covid shot and received a dose of pfizer on 6/12/21. Later in the day the pharmacist that administered shot realized that the patient had received a dose of moderna on 5/11/21. She called the patient to discuss the situation and to let us know of any potential side effects.  Tonight 6/16/21 the patient calls the pharmacy and i discuss the situation with her. She said she started having severe body/bone/muscle aches on the afternoon of the pfizer shot which was 6/12. She said she knew that was somewhat normal but on 6/13 the body aches were worse and she started having swelling in her face and couldn't get her legs to work walking up two stairs without assistance. She started taking benadryl "around the clock". On 6/14 she said her symptoms were mostly unchanged, still having swelling in face and legs/arms hurting. On 6/15 she "blacked out" meaning she was sleeping and woke up and when she went to stand up her legs collapsed and she slid off the bed but she said she didn't hit her head. She said that happened two different times on 6/15. Today, 6/16 she called the pharmacy because her lips were the most swollen and sore they have been and it hurt to drink cold water and was hard to talk. She said she had to use her inhaler that morning because her chest was a little tight but she wasnt having any trouble breathing and her throat was fine. She said her face was still swollen and she looked like she'd been punched in the mouth. I counseled her to seek medical help asap since she was having trouble walking and the falling down and the face swelling hadn't gone away and she said she didn't want to go to the ER but would call her dr on the am of 6/17/21. I told her if anything changed she needed to go to ER or call 911. No other info at this time. 8:40 pm 6/16/21
Information has been received from a health professional concerning now a six year old male who on 07/11/1996 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that on 05/07/2001, the pt was diagnosed with a "mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further info is available.
Pt recv vax on 12/2/98; 2 hr post vax pt exp fever (104), shaking, swollen vax site < 24 hr
mom states that pt cried w/high pitch like scream cry/which was different than nl for over 2 hrs; APAP did not reduce crying/sl fever
pt's mom report at 1515 that child had T102 /p .08 gtt tylenol. Dr refused to see pt. T rechecked=107 AXILLARY. Mom told to take child to ER. Given Motrin and cool soaks in ER.
August - cycle began 3 weeks early with spotting and bleeding that continued throughout the entire month (bled from 1-31Aug2021); Extremely irregular menstrual cycles; August - cycle began 3 weeks early with spotting and bleeding that continued throughout the entire month (bled from 1-31Aug2021); This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Jun2021 11:00 (Lot Number: EW0180) as single dose (at the age of 23-years-old) for COVID-19 immunization (Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store). Medical history included none. The patient was not pregnant. 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. Concomitant medications included drospirenone, ethinylestradiol (LORYNA) and ethinylestradiol (NIKKI): both taken for contraception, start and stop dates were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 11:00 AM (Lot Number: EW0178) as single dose (at the age of 23-years-old) for COVID-19 immunization. On 05Jul2021, the patient experienced Extremely irregular menstrual cycles: July - cycle began 2 weeks early. August - cycle began 3 weeks early with spotting and bleeding that continued throughout the entire month (bled from August 1-31). The patient was not hospitalized. No treatment received. The outcome of the events was recovered on an unspecified date in 2021. The events were considered as non-serious. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
lightheaded, dizziness, headache, lethargy, nausea. Lightheaded and dizziness lasted about 24 hours. Often would have to sit down quickly after standing up to avoid passing out. I took naproxen for the headache. Nausea and headache is still present on day 2.
Nausea; Vomiting; Arm Soreness; Fatigue; Inflammation of Joints; Mild Fever; Breakthrough and Menstrual Bleeding (2 weeks early); Brain Fog  / Nausea and vomiting lasting 2 days, mild fever 3 days, and breakthrough bleeding after 3 days.  Fatigue and joint inflammation lasting 4 days.
High pitched crying; change in breathing patterns.  The change in breathing patterns precipitated an emergency room visit. (fyi: ordinarily, She is a happy child who rarely cries (only when she is hungry, wet or sleepy). Fever of 100.5. She was given Tylenol at the hospital which made the symptoms subside.  She also was very fussy the next day and crying at night - fever of 100 the second night (crying less then the night before, Tylenol was given in the evening which again made her more comfortable).
6 individuals received a 0.3 ml dose of undiluted Pfizer Covid-19 vaccine; 6 individuals received a 0.3 ml dose of undiluted Pfizer Covid-19 vaccine; shakes; chills; This is a spontaneous report from a non-contactable Nurse. This Nurse reported similar events for 6 patients. This report is for 2nd of 6 patient. A patient of unspecified age, male received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route of administration on 05Feb2021 as dose number unknown, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive other vaccines in 4 weeks. Patient did not have COVID prior vaccination. Since the vaccination, patient did not test for COVID-19. No side effects observed/reported 1-hour post-vaccination. No side effects/adverse effects were observed/reported 48 hours post vaccination. On 05Feb2021, the patient experienced 6 individuals received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine, one individual reported a brief period of chills/shakes. No treatment was received for the events. The outcome of the event was recovered, and rest events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130257 same reporter/drug/similar AE with different patient;US-PFIZER INC-2021161829 same reporter/drug/similar AE with different patient
A non-serious spontaneous report of "administration to a 13-month-old" was received from a registered nurse involving a 12-month-old female subsequent to the administration of FLUMIST. No prior medical history or concomitant medications were reported. On 01-Oct-2010, the patient received FLUMIST. There was no adverse event associated with this vaccination error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
Swelling under (L) eye, and pt. f/u with ER and given PEDIAPRED 1 tsp x 5 days.
Child fell to floor after receiving H1N1 shot. Parent at site. Pt has hx of passing out. Pt supine, legs elevated. Cool compress applied to forehead, sat in chair. Drinking fluids. Felt better. Gait steady.
Pt came in with chest pain, diagnosed with myocarditis. We do not have record of third vaccine date. He states that he got COVID vaccine in July before school started. We have the last vaccine that he received dated as March 2022. He was adamant that he received the COVID vaccine in July as well. Was unable to get the records, Did not have it listed on physical vaccine card.
Extreme chest pain, heart palpitations, shortness of breath.  Diagnosed as Pericarditis by cardiologist.
2nd one 3 days nowIt was  kicking my butt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included pneumococcal vaccine (Pneumonia Vaccine) for prophylaxis.   The patient's past medical history included bullous pemphigoid (I felt a bubble rash burning going around my private area.), feeling abnormal (Felt a bite on my butt), stinging (Stinging, Worse pain), pruritus (Pinching itchy.), shingles (Older doctor walk by said that was Shingles), burning sensation (Fire), flaking skin (Flaking) and feeling bad (2 days feeling bad). Previously administered products included shingles vaccine with an associated reaction of pain (1st shingles vaccine in October 2022, refer link case US2023AMR038418).   In MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 03-MAR-2023, the patient started Pneumonia Vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: 2nd one 3 days nowIt was  kicking my butt).  Rechallenge with Shingles vaccine was positive. The outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR038418   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported the patient via interactive digital media. On July 5 th, Wednesday at night the patient felt a bite on butt and went for carenow. The patient got medication. On Saturday morning after having shower, the patient felt a bubble rash-burning going around the private area.  The patient and his wife went for emergency room visit. Older doctor walk by side and reported that was Shingles. The patient got more medicines. It took 4 weeks to go away. On last July, the patient thought that it was a bug bite or boil on the butt three days later worse pain.  The patient experienced Fire, stinging, pinching itchy. On October the patient received 1 st dose of Shingles vaccine. After the first vaccination the patient experienced 2 days bad, pain, itching and flaking. On 3rd march 2023, one day prior to GSK receipt date the patient received 2nd dose of Shingles vaccine. After the second vaccination the patient experienced kicking in the butt and 3 days bad which was ongoing till reporting. It was unknown if the reporter considered the feeling bad to be related to Pneumonia Vaccine.  The follow-up could not be possible as no contact details were available. From narrative it was unclear if patient received vaccine on 3rd March or experiencing events from 3 days. therefore, conservatively captured partial vaccination and event onset date.; Sender's Comments:  US-GSK-US2023AMR038418:Same reporter
Site: Pain at Injection Site-Medium, Additional Details: Flu shot was given on 10/16/22 on left arm, IM, patient came in stating pain has worsened after vaccine.
My arm is red and getting redder in the last day at the injection site.  The redness is growing.  I have not gone to my doctor about it yet.
A physician reported that an 18 month old female received Acel-Imune and IPV (PMC France) vaccines on 3/1/00. She subsequently, developed redness, swelling, warmth and pain at the site of Acel-Imune administration. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Acel-Imune, lot 457011.
Vaccine administer 11/8 in R thigh IM. Dx abscess R thigh 2" diameter.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a infant patient who received Hib (Hiberix) (batch number 25Z52) for prophylaxis.   On 12-JAN-2023, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patients age was reported as 0 years. The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR060527:Original Case : US2023AMR056407 US-GSK-US2023AMR060523:Original Case : US2023AMR056407 US-GSK-US2023AMR060577:Original Case : US2023AMR056407 US-GSK-US2023AMR060588:Original Case : US2023AMR056407 US-GSK-US2023AMR060616:Original Case : US2023AMR056407 US-GSK-US2023AMR060635:Original Case : US2023AMR056407 US-GSK-US2023AMR060624:Original Case : US2023AMR056407 US-GSK-US2023AMR060629:Original Case : US2023AMR056407 US-GSK-US2023AMR060632:Original Case : US2023AMR056407
vomiting 3'sx; Abdominal pain; Horrible headache; chills; Joint pain; muscle aches; nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Sep2021 17:30 (Lot number: FC3183) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BYSTOLIC. Vaccination history included: Bnt162b2 (Date of 1st dose - 24Aug2021, Time of 1st dose - Approx 5pm, Anatomical location - left arm, Batch/lot no: Pfizer Biotech FC3183), administration date: 24Aug2021, when the patient was 66 years old, for covid 19 immunization, reaction(s): "diarrhea", "abdominal pain", "nausea", "vomiting", "horrible headache", "chills", "joint pain", "muscle pain". The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting 3'sx"; ABDOMINAL PAIN (non-serious), outcome "not recovered", described as "Abdominal pain"; HEADACHE (non-serious), outcome "unknown", described as "Horrible headache"; CHILLS (non-serious), outcome "not recovered", described as "chills"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; NAUSEA (non-serious), outcome "not recovered", described as "nausea".  No follow-up attempts are possible. No further information is expected.
Mild flu-like symptoms. Left-side hurts more than right. Pocket of fluid under left arm noted.
FAMILY GOT CLIENT VACCINATED WEEKS PRIOR TO ELIGIBILITY BECAUSE SHE WAS GOING TO SCHOOL.
Covid-19 Vaccine-Associated Pericarditis; This is a literature report.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "Chronic kidney disease" (ongoing); "Hyperlipidemia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Covid-19 Vaccine-Associated Pericarditis". The patient underwent the following laboratory tests and procedures: Chest X-ray: Bilateral pleural effusion and atelectasis; Computerised tomogram thorax: Cardiomegaly with bilateral pericardial effusion, notes: and pleural effusion; Echocardiogram: tricuspid regurgitation (mild to moderate), notes: LVEF: 55-60%,; Ejection fraction: 55-60 %; Electrocardiogram: Ectopic atrial rhythm, Lt. ventricular, notes: hypertension, prolonged QTc; Electrocardiogram QT interval: prolonged.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
2/14/03 Hepatitis B vaccine. 3/12/03 #2 Hepatitis B vaccine. 4/23/03 #3 Hepatitis B vaccine. Fatigue, blood sugar. Medical record on 05/03/04 states: new onset insulin-dependent diabetes mellitus, diabetic ketoacidosis, dry mouth, excessive thirst, blood sugar was 869.
Severe migraine; Body aches; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in left arm on 09Feb2021 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. Medical history included tested positive for COVID on 30Dec2020. concomitant medication was not reported.There were no other products. On 10Feb2021 at about 11-12 patient had developed body aches and a severe migraine. The body aches were off and on, sometimes he felt them and sometimes he did not, but they were persisting. The migraine was constant (at the time of report). Outcome of the events were not resolved.  Follow-up attempts completed. No further information expected.
4 days after vaccination, patient was brought to ED after one-day of several episodes of vomiting.  Last bowel movement was approximately 24 hours prior to presentation to the hospital.  A barium enema revealed blockage; patient sent to operating room immediately.  Laporascopic exploration discovered ilean intussusception.  10 cm was resected and both ends re-anastomased.  Patient hospital stay complicated by an intra-abdominal infection which responded piperacillin/tazobactam.  Patient was discharged from hospital on 08/05/2011 to home with parents.
After I administered the vaccine, patient said to  his mother "that was it", he also told his friend on the mobile that he just got the injection, then he said "I feel dizzy", I said "are you serious?"  He said "Yes" and he just went out of consciousness in his mother's arm.  I shout "call 911" and held his head which tilt backwards with eyes rolling back.  together with his mother we lowered him to the floor and I supported his head at all times; as he was flat on the floor, he raised his own head and regained consciousness.  Both mother and I tried to talk to him and keep him awake when he closed his eyes, he was laying on the floor flat and talking until EMT arrived at 16:42.  EMT pulled him off the floor and took him to the ambulance.
I never got sick from the shot just a sore arm; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (Patient)  through social media.  This case was linked to case 2020SA299168 , 2020SA299167 , 2020SA299171, 2020SA299169, 2020SA299080 and 2020SA295988.  This case involves a patient (unknown age and gender) who never got sick from the shot just a sore arm (pain in extremities ), while the patient received vaccine Influenza vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) were not provided.  The patient s family history included  sister got sick, but it came out she took the flu shot only once and doctor said it most likely she had a bit of a bug before she received the shot.  On an unknown date, the patient received a dose of suspect Influenza Vaccine injection produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date (latency unknown ), after starting the suspect vaccine therapy, the patient never got sick from the shot just a sore arm (pain in extremities) and additionally patient reported that , got the flu shot every year now that the patient was passed 65 and was getting a higher dosage. The patient s doctor said flu would not occur from the shot .  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
An in-home fall, dizziness, slurred speech, blurry vision, felt very ill.  Did not lose consciousness. Was able to sleep. Day after event was okay. Two days after event, dizziness and loss of balance re-occurred twice during the day -- but did not precipitate a fall.
Symptoms:  Severe right flank pain, difficulty breathing when lying down, pain resulted in having to have shallow breaths.  Pain woke me up at 1am on June 19 and lasted approx. 45 min.  Pain returned in the middle of the night on June 20 and was significantly more intense, lasting 2 hours and unable to lay back down.  Pain did not go away during the day on June 20 and began to intensify around 4:30pm, followed by 102F fever and tachycardia.  Proceeded to local emergency room, and was diagnosed with a lower right lobe lung infection, very early pneumonia.  Treatment in hospital:  FentaNYL, Dilaudid, Zofran, iohexoL. Treatment out of hospital:  Azithromycin, Dexamethasone, Hydrocodone.
Woke early one morning to a large painful lump on my right forearm. The lump was painful and felt like it was causing my arm to twist. Some hours later, my entire right arm was covered with large, painful, black and purple bruising. I had never experienced anything like this in my life. I often see blood in my urine, and during this time there was an unusually large amount. I don't know how to describe the feeling of lumps moving through my body, but I could definitely feel the movement through my arms and legs.
Information has been received from a physician concerning a 27 year old female who on 05-FEB-2007 was vaccinated with a first dose of Gardasil (lot # 654389/0961F) injection.  There was no adverse event associated with this vaccination.  On 09-APR-2007 the patient was vaccinated with a second dose of Gardasil (lot # 653736/0014U) injection.  On 09-APR-2007 the patient developed swelling, alot of redness and had an increase diameter of the reaction.  Medical attention was sought.  There was no further adverse event information.  At the time of reporting it was unknown if the patient recovered.  Additional information has been requested.
several individuals have recvd as many as 4 doses of Hep B vax & they still don't have protective titers;