chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5-8-11 Clt states developed a sore arm where vaccine was given on 5-4-12. On 5-5-12 upper arm became red, hot, swollen & hard, the evening of 5-7-12 clt states developed flu like sx - HA, fatigue, sore throat. No fever. On 5-8-12 still has sore throat with pain in the shoulder blades & body aches. Advised clt to see health care provider & will f/u with phone call in two days. 5-11-12 T.C. to clt - clt went to doctor on 5-9-11. Per clt, doctor thought flu-like sx not R/T shot. Clt tested for pertussis (lab pending) & put on ZITHROMAX, client states is feeling better & the arm swelling has resolved.
Pt had flu shot in L thigh. Pt had left leg pain that night. The following night pt had been noted to develop a warm, firm, swollen red area covering his left thigh below the injection site. Pt also had a temp to 100.5. Pt was seen today in clinic and put on 5 days of prednisolone. Pt has been given benadryl & at home. Pt was seen 2 days later for f/u in clinic. Pain resolved and per mom, pt was improving. Rash is very faint, shallow and resolving.
First dose was on 9/23/2021, minor chest pain (extending to back), nausea and minor headache.  Second dose was 10/4/2021, worse chest pain (also extending to back), became cold and extremely tired - slept rest of the day.   Fast forward to 10/8/2021, the chest pain became worse and breathing became more difficult. 10/10/2021 my chest began to feel like it was collapsing. I could not catch my breathe, chest pain was unbearable and pace was sporadic. Upon laying down, it felt as though my chest cavity was laying on top of my spine. As the days continue, it feels slightly better but it continues to hurt uncontrollably, difficulty breathing and sporadic heart rate. Also slightly dizzy/confused.
first dose /04-Jan-2019 /not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th January 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix and did not receive dose two. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to the case US2021168351, US2020079556 and US2019096333 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168351:Same reporter US-GLAXOSMITHKLINE-US2020079556:Same reporter US-GLAXOSMITHKLINE-US2019096333:Same reporter
Every time patient took the flu shot got sick; Initial information received on 13-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.   This case involves an unknown age and gender patient who got sick (illness) every time the patient took the INFLUENZA VACCINE [Flu shot].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that the patient reported that every time he/she took the flu shot he/she got sick (illness) (Unknown latency) following the administration of Influenza Vaccine.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information about batch number for this case.
chills intense stomach pain felt like stomach would explode, stomach very bloated,  Vomited green phlegm  Pain subsided after vomiting
complaint of discomfort in the right calf starting approx. 4-5 hours after the vaccination symptoms worsened the next two day with extreme pain and redness, firmness  which required ER visit for evaluation
Joint aching; feeling of weakness in forearms, fingers, left hip and toes; not actively exercising; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, intramuscular on 09Jan2021 16:45 at single dose on left arm for COVID-19 immunization. The patient is not pregnant and has no medical history, no known allergies and no prior vaccination. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC). The patient experienced joint aching and feeling of weakness in forearms, fingers, left hip and toes; not actively exercising on 13Jan2021 at 14:00. The patient had no treatment received. The outcome of the events was not recovered.
Pt has several papules with crusting on torso, arms, face. No school until all papules are crusted, continue Aveeno Oatmeal baths.   .
Pt recv vax on 7/8/98; on 7/10/98 pt exp 25 cm induration to muscle RAT.
Patient was recently hospitalized for pulmonary embolism with acute cor pulmonale. First noticed increased shortness of breath on 4/4/21 when shoveling mulch and describes feeling "more winded than usual" with physical activity. He presented to the outpatient primary care clinic on 4/6/21 for evaluation and serum labs and TTE were ordered. Labs were notable for a WBC 13.22 and Cr 0.76. TTE showed hyperdynamic LV function with EF >65% and no tricuspid regurgitation with no concern for right heart strain. A follow-up d-dimer was ordered and returned at 1661 resulting in the recommendation to present to the ED.    Upon presentation to the ED, he was hemodynamically stable with an SpO2 of 97% on room air. CT Chest PE protocol was ordered and showed multiple bilateral lobar, segmental, and subsegmental PE with findings suggestive of right heart enlargement was well as areas of pulmonary hemorrhage and developing infarcts. He was given a heparin bolus and he was admitted to the Adult Hospitalist Service.   The following morning, patient's hemoglobin remained stable and he continued to feel clinically well. He was transitioned from the heparin infusion to subcutaneous enoxaparin.  He was discharged on 4/9/21 with a plan for self-injection of enoxaparin and close follow-up with his PCP.
Itchy all over my body, when taking a shower it feels like a thousand tiny needles hitting my body
Generalized tonic clonic seizure. No recorded fever. Lasted 5-10 minutes, spontaneously resolved.
difficulty swallowing  25min after receiving Moderna,  minor itching at injection site.  All vitals stable throughout observation time.  Seen by PA- ordered 50mg Benadryl IM.  Pt was monitored for over an hour.  Upon discharge pt was reporting improvement in swallowing.  Pt was given ER precautions, Benadryl 25mg by mouth every 4 hours as needed.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Lymph Node Swelling-Severe, Systemic: Vomiting-Medium, Additional Details: Patient experienceing muscle twitching in neck, head, face, and upper torso, pain behind both ears, and blurry vision
I woke up around midnight with a headache as bad as I have ever had. Symptom lasted for about 12 hours.
Information had been received from a nurse who reported that a patient received his third dose of GARDASIL "too early'". The nurse stated that the GARDASIL series was administered to the patent as followed: first dose on 21-JUL-2014, second dose on 26-SEP-2014, and third dose on 09-DEC-2014. No adverse effect reported. Additional information has been requested.
No additional AE details provided.; expired dose of PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant condition and drug reactions/allergies were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).  On 28-JUL-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (0.5 mL, lot # U002532, expiration date: 24-JUL-2022; strength, route and anatomical location was not provided) for prophylaxis (expired product administered). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had no temperature excursions through date of administration. There was no additional adverse event reported (no adverse event).  This report was considered as non-valid due to the lack of patient's identifiers.  Follow-up information was received from the medical assistant on 12-SEP-2022. Concomitant medication diphtheria vaccine toxoid, pertussis vaccine acellular 1-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (DTAP IPV SZCZEPIONKA) was added. Information about the patient's gender and age had been updated, it was referring to a 5-years-old male patient. Additionally, patient demographics had been added, and the anatomical location was updated to right vastus lateralis.
24hr post vaccine initial cold, body aches, and pains side effects similar to flu vaccine with a bit more severity.  These subsided after 48hrs post vaccine.  Site of injection became swollen, bruised and painful.  48hr post vaccine mark striking pain in shoulder blade with muscle cramping in the shoulder area.  As the day continued shooting pain through elbow and into forearm.  After several days of this pain, then as it has continued in these areas it began to migrated also into my middle finger with slight numbness (cold and tingling in digits 4 and 5.)  The pain has not eased or subsided.   It does however increase if I lean my body forward (meaning bending at the waist so that weight shifts to shoulders.)  Have been nursing with heating packs and advil  but little over all relieve.
Had Polysaccharide vaccine on 11/5/08 during office physical before a surgery (left hand ring trigger finger) on 11/11/08. Got 102 temp on 11/5/08. To ER hospital on 11/6/08 and temperature was 103 degrees. I still had a 99.2 temperature on the day of my surgery 11/11/08 and surgery was done.  1/19/09 Reviewed ER medical records of 11/06/2008 FINAL DX: febrile reacton s/p pneumovax vaccination Records reveal patient experienced fever, dizziness, fatigue, dry cough, right lower chest pain w/cough.  Temp in Er 103.3. Tx w/antipyretics & d/c to home.
almost fainted, room was spinning; Dizzy spells; room was spinning; blood pressure reading low; chills; body aches; feeling really worn out and tired; A spontaneous report was received from a consumer concerning a 70- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, body aches/Myalgia, feeling really worn out and tired/Fatigue, almost fainted/Presyncope and the room was spinning/Vertigo, dizzy spells/Dizziness, and blood pressure reading low/Hypotension.  The patient's medical history included, hypertension.  Concomitant medications included, Amlodipine/Benazepril once daily for blood pressure and Clonidine as needed for extremely high blood pressure.   On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch 016M20A) intramuscularly on upper left arm for prophylaxis of COVID-19 infection.  On 11-Mar-2021, prior to the onset of events,the patient received their second of two planned doses of mRNA-1273 (lot/batch 011A21A) intramuscularly on upper left arm for prophylaxis of COVID-19 infection.  On 12-Mar-2021,the patient experienced chills, body aches, feeling really worn out and tired, almost fainted and the room was spinning.  Her blood pressure after the "dizzy spell" was lower than her normal. It was recorded as 115/67. Per the consumer, her normal systolic blood pressure ranges between 130 to 150.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events  was not applicable.  The outcome of the events presyncope, dizzy spells, myalgia, chills, fatigue, vertigo and blood pressure reading low was considered as resolved on 12 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient reported no adverse reactions after and the days after receiving JJ Covid vaccine.  Fast forward, as he was talking to me on 4/16/21, he revealed that he did have one event that occurred the morning after he received the vaccine which was 3/9/21.  He said that he had reservations reporting it to me at the time.  He did contact his primary doctor about it and had a check up.  On the morning for 4/9/21, he walked into his shower then looked down at his feet, he notice blood on the floor of the shower.  At this time, the water was not on yet.  He described the blood as pink.  He said he thought he lost about 1-2 ounces of blood.  He only had one incident and none other.
Swollen lips that have dried and cracked; Swollen lips that have dried and cracked; Swollen lips that have dried and cracked; become uncomfortable apparent skip rash/reaction around mouth, temple, back of knees and groin; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 13Apr2021 at 16:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included 1.5 functioning kidneys, double ureters on both and known allergy to penicillin, other antibiotics, red dye 40, gluten, bananas and other food sensitives. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021, the patient experienced swollen lips that have dried and cracked and become uncomfortable apparent skip rash/reaction around mouth, temple, back of knees and groin. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lips that have dried and cracked and become uncomfortable apparent skip rash/reaction around mouth, temple, back of knees and groin was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
A few days after receiving the Jansen Covid vaccine I noticed a significant increase and amplification of ringing in my ears.  I had some low grade tinnitus, probably from age and sound exposure, but it was barely noticeable and did not effect my daily health. I would say a scale of 3 out of 10.   Starting 3-4 days after the vaccine there was a dramatic increase in tinnitus volume and amplitude. Within two weeks the ringing was (and still is) almost unbearable.  This ringing  has not subsided to this day. I would rank it as a 9 out of 10.  It is affecting my health due to sleepless nights and the tinnitus intensity overwhelms my hearing most of the time.   After struggling with this for a year I made several appointments with hearing specialists.
Pt recvd 1st dose of Engerix-B on 4OCT91 & 2 hrs p/inject pt exp BP down, bright red rash, eyes blurry & bloodshot, muscles became rigid & pt began sweating profusely; treated in ER;
This spontaneous report was received from a healthcare worker regarding a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot, dosing details not reported. It was reported that the patient had completed the recommended 3 dose vaccination series with RECOMBIVAX HB.  Concomitant medications were not reported. On an unknown date the patient had negative titers for Hepatitis B 'anti-HBs antibody negative'. The outcome of the event was not reported. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been requested.
bilateral thigh pain, leg pain with whole body aches 10 days  after vaccination follow by weakness of both lower limbs
Awoke the morning after vaccination with low fever and mild bronchial congestion. Developed aches in joints as day went on. Developed moderate headache in afternoon. I was very tired and went to bed early. Awoke second day with no fever but mild sore throat and headache. As the day went on, I became quite dizzy and nauseous. Took a nap but no improvement.
Felt extremely lightheaded as if I was going to pass out about 5 minutes in. That initially passed and then I just had the normal low grade temp and body aches for about 12 hours. On Monday 10/4/21 I started with Vertigo sensation and almost fainted at work. The vertigo has not yet gone away.
Chill, fever (highest 102 degree F), severe joint pain, severe migraines and headaches between 12 to 24 hours after injection.  Took ibuprofen and acetaminophen.
extreme fatigue and malaise for 11-12 days, with very little appetite, nausea, and abdominal pain.  No fever, chills, vomiting.   Mother is an MD and started Amoxicillin TID for presumed sinusitis on 5/30, two days after vaccine.
I had a sore arm at injection site for 3 days, no change in my activity level. On 2/25/2021 my arm became itchy and began to swell.  By evening when I was able to examine the arm the deltoid was swollen to twice it's normal size and a red diffuse itchy rash approximately 4cm by 6cm.  I took zyrtec and applied ice.  Swelling went down somewhat and itching relieved. 2/26/2021 swelling and itching continued. I iced at 1pm to get some relief.  7:30 feel really run down. will need to ice again to be able to get sleep. I am concerned that a delayed histamine reaction like this may get worse after the next dosage.
pt c/o lt arm swelling @ inj site extending to elbow; pt took a shower & applied heat; swelling painful & inc; difficult breathing; @ ER pt was resuscitated but pronounced dead of heart failure;
No additional adverse effect reported; the patient received one improperly stored dose of VARIVAX on 2/26/2020; This spontaneous report as received from a nurse prescriber refers to a patient of unknown age and gender. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided.   On 26-MAR-2020, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S028920, expiration date 19-SEP-2021 (route of administration, dose and frequency not reported) for prophylaxis.   The vaccine was reconstituted with a properly stored sterile diluent. Digital Data logger was involved. The vaccine was stored at the temperature reported as from 6 degrees of F to 14 degrees of F (5.69 degrees of F), the time frame as 1 second. There was a previous temperature excursion: reported as from 6 degrees of F to 14 degrees of F (5.81 degrees of F) for 28 minutes.   No adverse effect reported.
felt very warm, overheated; clammy; started feeling slightly light headed; Thought I would pass out; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received the first dose of bnt162b2 (BNT162B2; lot:eh9899) via an unspecified route of administration in the left arm on 16Dec2020 10:00 at a single dose for immunization. Medical history was reported as none. Concomitant medication included paracetamol (TYLENOL) for an unspecified indication. On 16Dec2020 11:30, the patient started feeling slightly light headed and thought she was going to pass out. On 16Dec2020 11:50, she felt very warm, overheated and clammy. The patient sat down, attempted to eat her lunch and the events slowly subsided. The patient's blood pressure and pulse were checked on 16Dec2020 and they were relatively normal. The events were reported as non-serious and the patient did not receive treatment for the reported events. Outcome of the events was recovering.
pain in her arm; swelling on her upper chest on the left side where she got her shot and then on the left side of her throat coming down to her shoulder/swollen on top; feeling some type of way/not normal; whole left side of her back and under her shoulder blade are also concerning her with muscle and joint pain.; whole left side of her back and under her shoulder blade are also concerning her with muscle and joint pain.; rising under her armpit; This is a spontaneous report from a contactable consumer (patient herself). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 19Jul2021 08:00 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient received the Pfizer COVID-19 Vaccination on Monday 08:00 AM and was concerned with the duration of her side effects that she seemed to be occurring, still, today (unspecified date). Caller would like to know if there were other side effects noted other than what she has on the paperwork she received when she got the vaccination. On an unspecified date she stated that she had swelling on her upper chest on the left side where she got her shot and then on the left side of her throat coming down to her shoulder. She felt pain in her arm as well that was slightly swollen. She stated the whole left side of her back and under her shoulder blade were also concerning her with muscle and joint pain. She thought there might be a boil or rising under her arm pit. She stated she knew this was not normal. She felt off. She knew she was not supposed to feel this way. Patient wanted to call and see what were the other side effects. She got the shot on Monday and today was Wednesday and she was still feeling some type of way. It was swollen on top and rising under her armpit. It was not normal. This report was not serious. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Breastfeeding; A report was received from a consumer, who was a 37-year-old female patient and was breastfeeding.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020, intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient received the vaccine and was currently breastfeeding. The subject did not experience symptoms.   Action taken with mRNA-1273 in response to the event was not reported  The outcome for the event, breastfeeding, was unknown.  The causality assessment for the event, breastfeeding, was not provided.; Reporter's Comments: This case concerns a 37-year-old female patient who received their first of two planned doses of mRNA-1273, reporting breastfeeding without any associated adverse events.