chrisvoncsefalvay/vaers-outcomes huggingface dataset:
out of breath/she is very short of breath; fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Knee replacement" (unspecified if ongoing), notes: She had knee replacement years ago; "Covid" (unspecified if ongoing), notes: She got Covid before getting the Covid vaccine, She had Covid about a year and a half ago; "thyroid" (unspecified if ongoing), notes: pill for her thyroid; "UTI" (unspecified if ongoing), notes: UTI's were before the Covid vaccine. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Lot number and expiration date not provided.), administration date: 02Jul2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "She screamed when she got her Covid shot"; BNT162b2 (DOSE 2, SINGLE , Lot number and expiration date not provided.), administration date: 27Jul2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "feeling very fatigued all the time", "out of breath easily/ Shortness of breath", "she has shrunk", "She screamed when she got her Covid shot"; Flu vaccine (DOSE NUMBER UNKNOWN, SINGLE , Lot number and expiration date not provided., It was for flu and the one that makes you burn and itchy body), for immunisation, reaction(s): "burn and itchy body", "burn and itchy body". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "out of breath/she is very short of breath"; FATIGUE (non-serious), outcome "unknown", described as "fatigued".  Additional Information: She had gotten a paper from Pfizer to fill out more information. She was not sure where it was. She would like another one sent. It was about her after effects from the Pfizer COVID 19 vaccine. It has been terrible. She was a very active person. Whenever she is moving around and doing stuff, she is out of breath a lot. Like if she goes down stairs to do laundry and comes back up when she gets back up there she is very short of breath. She is very fatigued. Her son got the Moderna COVID shot, and was refusing at first. He was 35. As soon as he got the Moderna vaccine, he got that motion in his face. It stretched out or something. Her Pfizer 19 COVID vaccine history: 3 doses of the Pfizer COVID vaccine 02Jul2021,  27Jul2021 27Jan2022 store. No lot numbers listed. Reference number: unknown  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Jansen COVID-19 Vaccine EUA Had high fever 104.2 that lasted for 36 hours, a rash and body aches with headache.
HOT FLASHES; EVERYTHING HURT FOR A SOLID 12 HOURS; CHILL; FEVER OVERNIGHT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hot flashes, everything hurt for a solid 12 hours, chill, and fever overnight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, everything hurt for a solid 12 hours, chill, and fever overnight. This report was non-serious.
Patient came to our office for flu clinic administered and supplied by CNS (Certified Nursing Company) on Saturday Nov 7th at 1pm. At 1:30 pm patient complained of not feeling well. She had hives all over, swollen lips. c/o tightness in chest and "hard to breath". BENADRYL was given and pt went to ER. She improved quickly w/BENADRYL.
After administering vaccination the patient developed vasovagal syncope.  Patient turned pale and started sliding off chair onto floor.  I partially caught patient on the way down and he did not experience any injuries from the fall.  I kept patient on the floor with legs elevated and applied a cold compress to back of neck. The patient regained consciousness after a couple seconds and was able to leave the pharmacy after a period of observation.  Patient said he was feeling fine when leaving pharmacy.
UPPER BODY JOINTS ACHE SINCE THE EVENING THAT THE VACCINATION WAS GIVEN.
Patient fainted while outside doing work. The family took him to the ER and they told him it could have been an adverse event from the vaccine or could have been dehydration.
pt recv vax;noted redness,induration,tenderness,blisters;fussiness & redness;solumedrol given; less redness at site w/ epi;
the healthcare provider used a diluent that did not come with vaccine and administered vaccine to customer; the customer was not provided the diluent for vaccine; no additional adverse events reported; This spontaneous report was received from a male patient of unknown age, who was referring to himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unspecified date, the patient purchased measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, anatomical location, lot # and expiration date were not provided) but was not provided the diluent for the vaccine (product quality complaint). On an unknown date, the healthcare provider used a diluent that did not come with the vaccine to reconstitute the dose and administered it to the patient (wrong diluent used). No additional adverse events were reported.
I am on nexplanon and haven?t had a period in nearly 6 years, replaced 2x now. I maybe have light spotting if anything. Not even a full 48 hours after my vaccine I wake up to the heaviest most painful period of my life, with the hugest clots I have ever seen. Concerned me quite a bit, but heard from other that they had similar experiences after the first shot. When the period ended up lasting  9 days, ended today, that?s when I knew there was an issue. Prior to nexplanon, my periods would average 3-4 days and super light flow. I have never had an issue with heavy bleeding, cramping and clots. And before im told it?s because I haven?t had an actual period in so long, NO! I know my body and that WAS NOT normal! Not to mention, reading about and being told by numerous other females that experienced this EXACT symptom after their first vaccine, that tells me it is related! This needs to be listed as a potential side effect for females or something needs to be changed in this vaccine. That reaction CANNOT be normal, nor healthy.
COVID-19 treatment; COVID-19 treatment; COVID-19 treatment; Vaccine brand other: Moderna/vaccine/dose number: 4; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 70-year-old male patient received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "HLD" (unspecified if ongoing), notes: HLD; "Osteopenia" (unspecified if ongoing). The patient took concomitant medications with in 2 weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Apr2022, outcome "unknown", described as "Vaccine brand other: Moderna/vaccine/dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 treatment"; DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "unknown", described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2022) Positive, notes: rebound positive test, very mild rebound sx (headache) tx'd; (21Aug2022) Negative, notes: negative test and improved sx; (30Aug2022) Positive, notes: positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence with paxlovid from 16Aug2022 to 20Aug2022.  Clinical course: Rebound positive test, very mild rebound sx (headache) tx'd 16Aug, negative test and improved sx 21Aug, positive test 30Aug. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the causal association between the events Drug ineffective, Covid-19, Interchange of vaccine products, Disease recurrence and drug BNT162b2 cannot be excluded completely.
Breakthrough case admission after four vaccines Pfizer 2/4/21 Lot# not given;  Pfizer 2/11/21 Lot#EL9267;  fizer 3/4/21 Lot$ EN6202;  Pfizer 11/4/21 Lot# EW0186
Blister developed on her left hip; Lump on collar bone and chest area; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump on collar bone and chest area) and BLISTER (Blister developed on her left hip) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced MASS (Lump on collar bone and chest area). On 09-Feb-2021, the patient experienced BLISTER (Blister developed on her left hip). At the time of the report, MASS (Lump on collar bone and chest area) had resolved and BLISTER (Blister developed on her left hip) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
due to symptoms was not able to work, too weak; headache; shoulder pain, shoulder pain in the shoulder; arm where he got the shot; chills; body pain; weakness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2023, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced headache, shoulder pain, pain in arm, chills, general body pain and weakness. On 25th January 2023, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the headache, shoulder pain, pain in arm, chills, general body pain, weakness and activities of daily living impaired were not recovered/not resolved.   The reporter considered the headache, shoulder pain, pain in arm, chills, general body pain, weakness and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: The reporter was the wife of patient. She reported that her husband received shot of Shingrix and was not able to go to work on the day of reporting due to his symptoms.  The patient experienced headache, shoulder pain in the shoulder or arm where he got the shot, chills, body pain, weakness (too weak to go to work). These events were not resolved.  No further questions asked such as lot number, route of administration or contact information due to the difficulty of accuracy of using a translator.
Horrible stabbing cramps during my menstrual cycle. I never ever get cramps normally, so this was very unusual for me. It was so bad that I had to leave work and cried in pain on several occasions.
Pt c/o nausea, dizziness, swelling of lower lip 11mins after vaccination.  BP 140/98, HR 71, RR 16, O2 Sat 98%.  Pt saw his PCP and allergist.  Pt was informed by his allergist that it was ok to get 2nd dose.  Pt was instructed by his allergist to take Zyrtec <4hr before 2nd dose of the COVID vaccine.  Pt stable and released from the vaccination site.
2 days after the vaccine, I started having severe pain in my knees down my legs. I'm on day 17 and it is at times unbearable.  My knees don't want to bend.  I can't take an anti-inflammatory because I'm on a blood thinner.  So far just taking Tramadol and Tylenol Arthritis. Doesn't touch the pain.  Still working with doctor to figure out what to do next.
Patient developed fever and  3 episodes of syncope on the day following the vaccine.  The third episode of syncope occurred while being driven to the hospital.  She arrived at the hospital in cardiac arrest with asystole.  She was resuscitated and is currently in the ICU  intubated.
Patient developed sore throat, congestion, sneezing, cough that lasted 3 days=she took covid tests to ensure was not etiology.
Case number PHEH2013US013965, is an initial spontaneous report received from the pharmacist on 26 Jun 2013, and with a follow up report received from pharmacist on 30 Jul 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medication were not reported. He received only MENVEO, (batch number: X11082), intramuscularly without being reconstituted with Men A component on 26 Jun 2013. On the same day he received BOOSTRIX, (batch number: 739Y2) at a dose of 0.5 ml intramuscular. He was revaccinated with the correct dose of MENVEO, (batch number: X11082/A11082) that included liquid and lyophilized conjugate to complete vaccine on 27 Jun 2013. No adverse reaction was reported following this administration error. Follow up report received from pharmacist on 30 Jul 2013. Updated concomitant vaccine and revaccination.
Increased weakness, fell twice at home. Unable to get back into bed. Admitted to observation status at hospital for weakness for until 2/23 when transferred to skilled care. On day of admission, patient was 2 assist when normally he was independent. IV fluids D51/2 normal at 75/hr
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as dose 1, single, then via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation (vaccinated at age 71-year-old). There was no medical history. Patient's son passed away from COVID-19. There were no concomitant medication and no other vaccine received within four weeks. Patient had covid 19 on 23Aug2021 which resulted in physician office visit. She did not get sick, she only had a cough. She didn't lose taste or all these other things they were talking about happening. She wanted to know if it is too soon to get the booster; she was scheduled for the booster dose on Tuesday (unspecified date). Her isolation was over in Sept2021. The patient underwent lab tests and procedures which included Covid 19 Test: positive on 23Aug2021. Outcome of the events was recovered on Sep2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After receiving his anthrax vaccine on 02/04/2004, and before leaving for temporary duty to Iraq in March, patient's co-workers and family members noted significant personality changes.  Specific changes were increased irritability and being short-tempered.  Also, around the same time, he began having Debilitating headaches.  Upon returning from duty in April, has experienced chronic fatigue and changes in sexual functioning.  Mood changes and headaches have been improving, but fatigue and sexual dysfunction continue after 3 months.
nothing reported so far but the pharmacist on duty drew up the adult vaccine and gave it to the technician to administer, which she did (gray cap and not orange cap) so reporting this error
Fever(~38.2°C), sore muscle, headache.  Take ibuprofen and more water and more rest
15OCT97 pt recv vax & 22OCT97 noticed eruption to lt hand,neck, rt FA, also nauseated;23OCT97 seen by MD;28OCT eruptions still present w/nausea;
Patient felt fine. She received shot. We visited, she left. Within 30 to 50 min, she felt faint, dizziness, constricted throat but only mildly. Continued to monitor her and she was not better. Sent her to urgent care Dr. He gave a shot of BENADRYL.
PATIENTS REFERS TO OBSERVE IN THE MORNING RASH, HIVES, ITCHING, ON CHEST AND BACK.
Patient woke up, turned over and was unable to get out of bed because he felt so dizzy and nauseous.  He contacted his physician and was evaluated and prescribed Meclazine (per patient).
Tdap given 8/5/13. Awakened w/ rigors, fatigue, occipital H/A. No fever.
Child developed itchy erythematous variable sized maculopapular on Lt upper arm, shoulder, upper back Rt upper chest. Pt on Benadryl and symptoms resolved within 25 minutes. No longer has rash.
Entire clothes were drenched. Face was red. Very weak. Her left eye was closed. No appetite. Slept all day. Body was hot to touch.  Lasted for 24 hours.
Information has been received from a 66 year old female with no medical history and a penicillin allergy who on 10-Sep-2007 was vaccinated with a single dose of Zostavax.  Concomitant therapy included levothyroxine Na (Synthroid).  On 12-Sep-2007 the patient developed some swelling and redness at injection site accompanied by pain.  Also she stated that she experienced a stomach ache and mild diarrhea.  The patient also had flu-like symptoms like runny nose and achy muscles.  No diagnostic laboratory tests were undertaken.  No medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
pt stated twice to different associates about getting moderna vaccine.  pt was given "2nd dose" moderna instead of 2nd dose shingrix vaccine; this was the 4th dose for the pt for his moderna vaccine, however, pt received the full dose instead of the 1/2 dose.  pt didn't have any adverse effects from the dose at the time he had left the pharmacy
Pt phoned about 18NOV c/o that rt arm was swollen red & painful site of flu immun;
Copied from physician's history and physical: The patient reports that he had his flu vaccine last Tuesday and did fine for a couple days. On Thursday, he developed some flu-like symptoms with upper body muscle aches in the torso, shoulders, and upper back with poor stamina and low-grade fever. He felt better on Friday and managed to work and coach, but was just not quite feeling like himself. He developed a low-grade fever with increasing muscle aches and pains. The symptoms gradually worsened. His temperature got up to 101.9 degrees and he described severe muscle aches in the forearms bilaterally and the proximal legs and torso. He noted decreased hand grip and ability to text on his phone or actually squeeze toothpaste. It affected his ability to hold his utensils and pen. He felt very tired. He described severe pain throughout his body. The patient reports that symptoms got so severe that he felt he should go to the hospital for further evaluation.
Really bad headache; Nauseous; Diarrhea; Maybe she was hyperventilating; She's feeling a little sick; Having a problem breathing a little bit; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), via an intramuscular route on 08Jun2021 at 10:45 (at the age of 60-years) as single dose in the right arm for covid-19 immunisation. The patient's medical history included high cholesterol, temporal arteritis. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin (LIPITOR) with dose 20 mg, daily for high cholesterol, Fish Oil with dose 2000 mg, daily for unspecified indication, venlafaxine hydrochloride (EFFEXOR) with dose 150 mg, daily for depression. The patient previously took Prednisone for temporal arteritis since 24Dec2020 and she had been holding off on getting the COVID 19 vaccine until she was taking a lower dose of the Prednisone. She's taking 8mg of Prednisone. The Prednisone is in a pharmacy bottle. The Prednisone 5mg tablet is in a yellow  pharmacy bottle. She took her Prednisone every day at 2:30PM. Her doctor told her on 07Jun2021, that she was ok to get the COVID 19 vaccine. She was taking 60mg of Prednisone but she's weaning off of the Prednisone. She has gained weight while taking the Prednisone. On unspecified date at 14:30 (4 hours after vaccination), the patient experienced really bad headache, nauseous, having a problem breathing a little bit, maybe she was hyperventilating and She's feeling a little sick. She had diarrhoea when she first got home after getting the COVID 19 vaccine. She's scared. She hadn't reached out to her doctor or gone to the emergency room. She doesn't wanted to got the COVID 19 virus. She was been quarantined for a year. Patient reported that she took Ibuprofen and her headache is going away. She thinks she's feeling better now. She's still a little nauseous. And her breathing, maybe she was hyperventilating because of the nausea. She is starting to feel better. The outcome of the events really bad headache, breathing, maybe she was hyperventilating was recovering and other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
PATIENT STARTING TO HAVE RASH ALL OVER THE BODY NO OTHER SYMPTOMS, NO TREATMENTS.
Painful, firm, red, swelling (L) upper arm within few hours - Fever up to 101. 1 degrees F 48 hrs . Diarrhea, nausea, RIF area pain - local edema - 4" x 6" erythema, induration, swelling, soreness, watch bruising.
My heart began to pound extremely hard as if it was going to explode. It did this on at least 5 occasions and it continued for 20-30 minutes or more each time it occurred.
Nurse made errors in administering vaccine. Lower-than-authorized dose volume administered. Fluid leaked out after removal of the needle. The fluid sat on top of vaccine site. Nurse also had trouble drawing vaccine fluid out of vial into needle, so I am unsure if the proper dosage was in the needle to begin with. Nurse pinched vaccination site, leading to potential subcutaneous injection. I did not see the angle or depth of which the needle entered.   3 hours after vaccination, large bump began to form on vaccination site. Has grown large as of time of writing, currently 1.5inch in diameter. Bump is hot and painful to the touch, and tender. Only other side effect is fatigue.
He has a swollen area in the vaccination site and it is bigger than a golf ball in size and is pretty warm to the touch as well as all red and bruising.  He had a headache and sore yesterday as well.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/27/2021 and 2/26/2021. He tested positive for COVID on 9/20/21 after cough, fever, sob developed on 9/17.  He was brought to the ED by spouse on 9/22 for a mechanical fall and worsening altered mentation with hallucinations. In the ED imaging shows worsening fluid overload, COVID PNA and left femoral neck fracture.  COVID treatment was initiated (Remdesivir and Dexamethasone) and it was the plan for him to go to the OR.  However, he continued to decompensate and O2 demand continued to increase - he was transitioned to high flow nasal cannula. He remained encephalopathic, agitated, and in respiratory distress.  Family requested comfort care in the hospital. He was admitted for EOL cares on GIP service and ultimately expired on 10/3/2021.