chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered the influenza vaccine IM in Right arm. Denied allergies. Signed consent. Stated had not previously received a flu vaccination. About 5 minutes later returned and stated felt like "lips swelling," dizzy and jittery.  Denied shortness of breath and non observed.  Blood pressure elevated. 145/90. 911 was called and transported to Emergency Department.  Report from workplace on 3/13/20 was that person was not hospitalized and was okay.
This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 31Jan2021 13:45 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had historical vaccine first dose of BNT162B2 (lot number: EL3246), on 09Jan2021 09:00 AM in the left arm at single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the hospital. 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 has not been tested for COVID-19. The patient experienced left armpit soreness on 01Feb2021. The outcome of the event was recovered on unspecified date. No treatment was given to the patient for the event. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and was not a congenital anomaly/birth defect.
headache; swollen lymph nodes; muscle Aches; This is a spontaneous report from a contactable other healthcare professional. This report was received via a sales representative. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date (reported as Wednesday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at single dose for COVID-19 immunization. Patient had swollen lymph nodes, headache plus muscle aches on an unspecified date (reported as Friday). Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt woke up fr nap around 3PM screaming, high-pitched cry; Refused bottle would not settle; Taken to clinic still crying, t99; Given APAP, cool compress to leg & DPH; Began taking bottle & went to sleep;
weakness, SOB, takotsubo  cardiomyopathy , acute systolic heart failure, acute hypoxemic respiratory failure  pt expired
swelling, heat pain vaccination site.; swelling, heat pain vaccination site.; swelling, heat pain vaccination site.; peeling skin at shingrix vaccination site; This case was reported by a consumer via (Shingrix GSK Chatbot) call center representative and described the occurrence of injection site exfoliation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received Shingrix. In October 2021, 2 weeks after receiving Shingrix, the patient experienced injection site exfoliation. On an unknown date, the patient experienced injection site swelling, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site exfoliation was unknown and the outcome of the injection site swelling, injection site warmth and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site exfoliation, injection site swelling, injection site warmth and injection site pain to be related to Shingrix.  Additional details provided were as follows: The case was self-reported by the patient. The patient received a dose of Shingrix vaccine and experienced swelling, heat and pain at the vaccination site and it cleared up. On the reporting week, the patient had peeling skin at the vaccination site. The patient asked if the peeling skin at injection site 2 weeks after the Shingrix vaccine was serious. After reviewing the patient was replied with that they did not see the peeling that the patient had described listed in their adverse events. Follow-up would not be possible as no contact details available.
24 hours of Fever from 100.2 to 102 degrees  Enlarged lymph node near collarbone  Migraine (most days)  Vestibular migraine (14 days after vaccine - 12 hours)  Nausea (with vestibular migraine on 2/29)
Bad headache; Body Aches; Really Tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache), MYALGIA (Body Aches) and FATIGUE (Really Tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Bad headache), MYALGIA (Body Aches) and FATIGUE (Really Tired). At the time of the report, HEADACHE (Bad headache), MYALGIA (Body Aches) and FATIGUE (Really Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.
vasovagal episode & poss anaphylaxis are reported in pt who recvd flu vax; 1 hr p/vax found on the floor not breathing & w/no heartbeat; DPH given & CPR & 02 were administered;
The vaccine doses were administered with diluent volume greater than 1.8ml and syringe containing air bubbles.
Narrative:  On 2/19/21 patient had Moderna Covid-19 vaccine #1, then 2 days later developed a rash on the trunk, which spread to extremities. He also had seafood recently and so cause of rash unclear at the time. He subsequently had vaccine dose #2 in 3/2021 and developed pruritic maculopapular rash again (no recent seafood or other changes) that manifested over the same time course, symptoms appearance and pattern of spread - trunk -> extremeties .
Pt. presented with hypoxia and cough and was tested positive for Covid. During hospital stay pt was diagnosed with Covid PNA and acute hypoxic respiratory failure. She was given supplemental oxygen, rocephin and azythromicin for CAP.
I had extreme body aches for 3 days, extreme fatigue, irritated throat, cough, shortness of breath, and headache. I tested positive for COVID-19. My doctor prescribed me PAXLOVID. I am still fighting fatigue and shortness of breath.
sudden onset hearing loss in L ear, new onset tinnitus L ear. Not resolved as of one month later
mom c/o knot in daughters lower rt thigh;advised mom to keep cool compresses on leg 3 to 4 times a day;HIB vax given in lower rt thigh;
Pt vaccinated with DTP/HIB/OPV cried for 3 1/2 hrs in a different sounding cry - otherwise she developed no other symptoms.
18cm x 10 cm area erythema with heat and swelling (L) upper arm extending around injection site.
10:05 am patient complained of dizziness and burning throat. Patient was asked to wait in the observation area for a few more minutes. Vital Signs: Temp 98.7 Degree F, Hr 74 bpm, BP 134/84 10:48 am patient stated they were feeling better and not dizzy but throat was feeling burning 11:10 am vitals are normal, patient stated they were feeling better and they were released
Patient developed pain, discomfort and immobility in left arm and sought medical care. She was referred to a sports medicine clinic for evaluation and possible physical therapy. Patient's husband reported to County Health Dept on 1/2/01.
She immediately got an uncomfortable feeling of medicine going through her veins. From that time until 10/21/06 she had red blotches at the injection site. Her armpit felt swollen and tender to the touch. Arm felt feverish. Her shoulder and left breast felt swollen to touch. Hives red welts around the arm pit but not at the injection site.
Few minutes after MMR vaccine adm hives present on leg near site with redness. BENADRYL given in office/no further reaction.
Patient received 1st COVID dose on 12/31/2020 and 2nd COVID dose on 01/28/2021. Patient then received 3rd COVID dose on 09/23/2021 Lot #062E21A.; and also an additional 4th COVID booster dose on 10/28/2021 Lot #019F21A, which was less than 9 months from the previous COVID dose. No signs and/or symptoms of an adverse reaction occurred.
Constant nagging headache on the left side of the head; Pain in the back of the eye since getting the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included palpitations and tachycardia. It was unknown whether the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), flecainide (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and tocopherol (VITAMIN E), all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 15Apr2021 at 12:00, the patient experienced constant nagging headache on the left side of the head and pain in the back of the eye since getting the vaccine. Headaches might subside, but came back more often and more aggressive. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events headache on the left side of the head and pain in the back of the eye was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Reconstitution with another manufacturer sterile water.; patient was potentially vaccinated with a dose of Hiberix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 4R9T4) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstitution with another manufacturer sterile water.) and inappropriate dose of vaccine administered (Verbatim: patient was potentially vaccinated with a dose of Hiberix). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 02-NOV-2023 The nurse called to inform that a patient was potentially vaccinated with a dose of Hiberix that was reconstituted using sterile water from another manufacturer (Merck), which led wrong solution used and inappropriate dose administered. The reporter did not consent to follow-up.
Put you under the weather; This case was reported by a consumer via other manufacturer and described the occurrence of illness in a 71-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included total hysterectomy and stroke. Previously administered products included Premarin. Concurrent medical conditions included osteoporosis and thyroid activity decreased. Additional patient notes included Patient Ethnicity. Concomitant products included bupropion hydrochloride (Wellbutrin), aspirin, caffeine, salicylamide (Aspirin + Caffeine + Salicylamide), hydrochlorothiazide, triamterene (Hydrochlorothiazide + Triamterene), estradiol, cetirizine hydrochloride (Zyrtec), vitamins nos (Vitamins) and atorvastatin calcium (Lipitor).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient herself.  The age at vaccination was not reported. The patient's past medical history included stroke and total hysterectomy. Concurrent medical conditions included osteoporosis, thyroid activity decreased. Historical drug included included Premarin. Concomitant products included Wellbutrin, aspirin, hydrochlorothiazide, estradiol, Zyrtec, vitamins and Lipitor. The patient received first dose of Shingrix and felt under the weather. The patient had received the vaccine 1.5 to 2 years ago. The lab tests included bone density test with results osteopenia and osteoporosis, CT scan with results unknown, echocardiogram with results normal. The reporter consented to follow up. This case was linked with US2021AMR150392, US2021AMR150409 for same patient. This case was linked with US2021AMR149519, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150392:Same reporter. US-GLAXOSMITHKLINE-US2021AMR150409:Same reporter. US-GLAXOSMITHKLINE-US2021AMR149519:Same reporter.
Baby, cyanotic, flaccid. Possible seizure/postictal state. Vasculitic rash that blanched with pressure. No fever. Pt received O2 blow-by, pinked up, remained lethargic for a bit, but then all resolved within 1/2 hour and pt O2 Sat 100% on room air.
Pt said she noticed several weeks after getting flu shot -1 she said her arm was sore in the same area as where she got the flu shot. Almost like she had gotten the flu shot again.
Patient began experiencing symptoms including cough, shortness of breath, and chest pain approximately 4 days prior to evaluation in the ED. The patient was due for a second dose of vaccine on 8/23/21, but did not receive that dose. Patient is positive for COVID-19. Patient was discharged from the ED.
numbness & tingling of face & head; h/a & body flushing starting 3 days p/vax & lasted 3 days off & on for next wk;
B/L LEG JOINT PAIN, AND MUSCLE PAIN  NAUSEA - DRY HEAVING NECK/SHOULDER PAIN ONSET  12.25.20 DURATION/END 12/.27.2020
severe pain in arm on movement;inj poss given in shoulder joint;inj site 2cm below A/C joint; tx w/NSAID & ATB;cont to have pain & diff moving arm as of 1MAR95;
Fever, headache, muscle aches, joint pains. Took 1000mg acetaminophen and rested
PATIENT HAD A LARGE RED SWOLLEN AREA AT INJECTION SITE. PATIENT HAD ACHY/FLU LIKE SYMPTOMS & A LOW GRADE FEVER PLUS A HEADACHE.
Patient received his flu shot on 11/28/11 at 2:10pm. He complains of dizziness and muscular pain in his both legs that caused him to fall. He has had a time controlling his leg when walking.
In the morning I woke up and by 8:30am, I was having what I thought was vertigo. I layed down and started to having double vision. It got so bad I could not walk and it got very cold. I could not warm up. I had my husband take me to th ER, this was something different than I have ever experienced. I had a MRI and had me stay over night. The found nothing. The 2nd day they did another MRI with contrast, they found nothing. They relased me and had me see a optomologist, my eightsight was fine. I saw a nureologist and my sight was fine. They didn't see it was stroke. It took 24 hours to get over the double vision. I was getting better in zones, if I looked to the florr it would be better. After this around the 5th day it was like nothing had ever happened. And since then this has never happened again.
Case fully vaccinated with Pfizer Vaccine. Last dose given on 1/22/2021. Tested positive for COVID on 9/21/2021. Case expired at Hospital East while in the ED on 9/26/2021.
24 hours of fever, chills, pins and needles feeling over whole body, body aches, weakness, fatigue, nausea, headache. red rash around injection site
Varivax given right thigh 01 24 08. On 02 07 08 parents reported clear vesicle lesions on right thigh. Seen in clinic that day. No further treatment.
I continue to feel numbness that has continued down my Left arm, pain and tingling throughout my arm and fingers are now numb. I feel that the pharmacist gave me the shot intradermally, instead of intramuscular. I was also given the MMR shot in the other arm. As an RN, I am pretty sure the shots were both given intradermal.
Symptoms started 10 min after shot- Lips numb, shaky, no local reaction in arm. Roaring in ears. Was fine after about 30-40 min - no meds required. Received flu shot app 1 hour before pneumonia with no reaction.
Patient called pharmacy mid afternoon regarding vaccination she received late morning. Stated her arm in which she received the Pneumonia shot was itchy, swollen and red. Swollen about the size of her palm. Called patient back later in evening to follow up. She stated she developed a low grade fever; took Tylenol that brought it down and alleviated the pain in her arm, but was doing ok. Her arm did swell up a bit more since we had last talked, about the size of her hand, but was still doing ok.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown umber of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following  information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 13-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 05Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 19Oct2023 to 23Oct2023 as treatment of COVID-19 and received other medications Extra strength Tylenol with pseudoephedrine from 19Oct2023 to 21Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe diarrhea and abdominal pain resulting in rectal prolapse.  Painful bowel movements. Prolapse recurred every time I used toilet x4 days. Had to wear incontinence underwear as there was anal and bladder leakage.  Finally able to have normal bowel movements and urinate normally today, 11-17.
Itchy, raised up rash, hot to the touch. Outlined rash 2 times and both times rash exceeded outline, rapidly. 1st time it appeared was on date 9. Today it has returned larger and its day 13 today. Today just itchy. Almost entire left humerus is covered in rash.
REDNESS, INFLAMMATION, WARMTH AT THE SITE OF INJECTION, NOT ABLE TO LIFT UP THE ARM SYMPTOMS STARTED GETTING BETTER ON DAY 2.
It was the worst last Friday night/ feels it in both breasts. It is getting worse; had subtle gas pains that go from her shoulder to her elbows and sometimes she feels it in her left shoulder/ feels like the gallbladder pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 07:30 (at the age of 76 year) as single dose for covid-19 immunisation at hospital. Medical history included ongoing Atrial fibrillation, thyroid problem and asthma. Patient had gallbladder concerns from twenty years ago. Gallbladder removed years ago. Patient's family history includes heart problems and diabetes. Concomitant medication(s) included apixaban (ELIQUIS) taken for atrial fibrillation, digoxin (DIGOXIN) taken for atrial fibrillation, fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, levothyroxine sodium (SYNTHROID) taken for thyroid disorder, metoprolol tartrate (METOPROLOL TARTRATE) taken for atrial fibrillation, prednisone (PREDNISONE) taken for asthma and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing and Potassium. Patient was not received any other vaccine prior four weeks of vaccination. She states two weeks ago on Friday she got her first dose vaccine COVID 19 vaccine on 22Jan2021 0730 AM in the left arm. Reports a week later on 29Jan2021 she had subtle gas pains that go from her shoulder to her elbows and sometimes she feels it in her left shoulder too. She added it feels like gas pains and it feels like the gallbladder pain she had when she had her gallbladder removed years ago. She added did not feel it every day It was the worst last Friday night. And she also feels it in both breasts It is getting worse. States she didn't have this until she got the shot, she was going to call her doctor, but she thought Pfizer would have more information about other people reporting this. She was scheduled to receive the second dose on 17Feb2021 at 07:00AM. Seriousness reported as non-serious by reporter. The outcome of the events was reported as not resolved and unknown for It was the worst last Friday night/ feels it in both breasts. It was getting worse.  Follow-up attempts are completed. No further information is expected.
Gradual onset of muscle tightness in the lumbar part of the back. Became intense and painful (per patient). Has been slowly improving over the last 7 days
The patient received vaccines on 1/10/03.  That evening he developed inconsolable crying that lasted greater than 3 hours.  He was fussy but seemed improved, but overnight developed a fever to 103.9.  He was evaluated in the emergency room and no other source could be found.  The symptoms resolved later on 1/11/03 with no signs viral infection or other cause of fever.