chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/19 chills, fever, headache. 1/23 awful headache and sick to stomach. Went to ER and received fluids, pain and nausea medication.
Stiff neck Wed 11/28 gradually progressed - required visit to Emergency Room.  Dx Bells Palsy by doctor at hospital - visited 12/1/01. 1/18/08 Reviewed ER medical records which reveal patient experienced left lateral neck pain, left side of lips numb, left facial droop x 1 day.  Left eye tearing & unable to close left eye tightly or lift left eyebrow as high as right.  No treatment provided.  Referred to neurologist & opthalmologist for f/u upon d/c from ER w/o any prescriptions. FINAL DX: Left Bell's palsy.
Started having pain in my arm, trouble lifting it, toes started to tingle and burn, trouble standing at work (cashier) getting infections and upper respitory going on antibiotics and only helped for 4 days and would start all over again, trouble walking, had to thrust my hips forward, legs getting numb, walking with a walker then a wheel chair ( too weak to go a few steps) until I could no longer stand or get up my knees kept buckling)
Patient 13-year-old given 0.2ml of COVID vaccine.  No adverse reaction, symptoms, or signs.
Woke up at 2:00 am extreme headache I took ibuprofen 200 ml. 7:00 am very weak headache not as bad. Day 2: dull headache, very fatigued, muscle ache between shoulders into upper neck. Day 3: same as Day 2. Day 4 same as Day 2 but now small rash on hip. Day 5 dull headache and rash, not fatigued and no muscle aches. I hope this info is helpful.
Upset; This is a spontaneous report from a contactable consumer or other non hcp (female).   A female patient of an unspecified age received bnt162b2 (CONMINTARY, Solution for injection, Lot No: EL9266), via an unspecified route of administration on 16Feb2021 as 1stdose, single for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing I just had breast cancer (Intent: History).The patient's concomitant medications were not reported. The patient experienced upset on an unspecified date. Patient stated that they gave me (incomplete sentence), they scheduled me 4 weeks later. Now I am hearing that you should get within 3 weeks. I am wondering why they schedule me for 4 weeks later. I wanted to know proper procedure. They gave me date for 4 weeks later, but I am hearing from other people that it should be 3 weeks later. I wanted to know what correct procedure is. Upon follow -up on 25Feb2021 new information has been updated is a follow-up spontaneous report from a contactable consumer. This consumer reported for herself patient characteristics (Sex), drug information (Pfizer-Biontech Covid-19 Vaccine). Patient received first Pfizer covid vaccine dose on 16Feb2021and currently scheduled for second Pfizer covid vaccine four weeks after her first dose. Patient is asking when she should receive her second dose. Outcome of the event was unknown.    Follow-up (25Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for herself patient characteristics (Sex), drug information (Pfizer-Biontech Covid-19 Vaccine). Patient received first Pfizer covid vaccine dose on 16Feb2021and currently scheduled for second Pfizer covid vaccine four weeks after her first dose. Patient is asking when she should receive her second dose.   Follow-up attempts are completed. No further information is expected.
He started getting hives and itching about 2 days after receiving the Maderna vaccine. Pt states most of the itching is in his trunk and back.
I had pulmonary embolism; I had chest pain; Almost died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 20May2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 10Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CHEST PAIN (hospitalization) with onset 10Dec2021, outcome "unknown", described as "I had chest pain"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 10Dec2021, outcome "unknown", described as "I had pulmonary embolism"; NEAR DEATH EXPERIENCE (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "Almost died". The patient was hospitalized for near death experience, pulmonary embolism, chest pain (start date: 13Dec2021, discharge date: 18Dec2021, hospitalization duration: 5 day(s)). Therapeutic measures were taken as a result of near death experience, pulmonary embolism, chest pain (treated in the hospital).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
30OCT93 extremely dizzy, severe h/a, subsided w/in 48 hrs; 2NOV93 sore throat for approx 1 wk; 15NOV93 swollen, stiff lt knee, progressing into rt knee & foot; difficult walking; 19NOV93 wrists, fingers, feet cont to be affected for 3 wks;
Chills; Fever that has escalated to a temperature of 103 degrees Fahrenheit; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever that has escalated to a temperature of 103 degrees Fahrenheit) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 20-May-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever that has escalated to a temperature of 103 degrees Fahrenheit).      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Reporter did not allow further contact; Sender'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.
Anxiety attack (PAXIL), anxious, nervousness, hyperventilation, tinnitus, cyst allergies, cramps legs, neck rigid, sleep problems, tachycardia
sweating; little appetite; joint pain; pain in the throat; sleeping alot; strange rash; body aches; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced sweating, little appetite, joint pain, pain in the throat, sleeping a lot, strange rash, body aches. She spoke previously with another department of Pfizer, his husband received the second dose of the Pfizer COVID-19 vaccine 8 days ago, since then he haven´t have much progress with his symptoms, the patient is presenting: sweating, little appetite, joint pain and pain in the throat, she wants to know if it is normal for these side effects to be around for this long and what should they do about this. Response: Per PI, 6 OVERALL SAFETY SUMMARY, LAB-1457-7.0, Revised: 06 April 2021. Some of the side effects mentioned are not reported as side effects of the vaccination. Per attached CONS, patients might develop some side effects that are normal signs that your body is building protection. Some side effects like swollen lymph nodes take around 10 days to be resolved, others like injection site swelling take from 1 to 8 days. Referred to his physician for treatment recommendation, Pfizer cannot make treatment recommendations for individual patients. Her husband has been constantly sweating, sleeping a lot, woke up with a strange rash, has sore throat, body aches, no appetite. The clinical outcome of the event was unknown.  No follow up attempts are needed. No further information is expected.
PAIN UNDER LEFT EAR; LOT OF PHLEGM; PAIN IN THROAT WHEN SWALLOWS; COLD IN THROAT; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805018) dose was not reported, once a total administered, start therapy date not reported for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced pain under left ear. On 18-MAR-2021, the subject experienced lot of phlegm. On 18-MAR-2021, the subject experienced pain in throat when swallows. On 18-MAR-2021, the subject experienced cold in throat. Treatment medications included: isopropanol/menthol/thymol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain under left ear, lot of phlegm, pain in throat when swallows and cold in throat was not reported. This report was non-serious.
A report was received from a health care professional on 5 November 2003 concerning a 31 year old female vaccine who experienced a large red painful area on the same day as receiving Fluvirin on 4 November 2003.  On 4 November 2003 the vaccine experienced a experienced a large red painful area.  The vaccine had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.
5/16/05, Pt received Yellow Fever. Pt called 5/23/06 and stated that 20-30 min. after shot, she developed L lower back pain and then headache on R side of base. Headache gone after 30 min. Back pain lasted 4 days. Now has fever, muscle aches, fatigue /// ///.
Knot under injection site, red inflamed skin at injection site. Red sensitive rash of a sort appeared and is spreading about an inch under injection site
A report has been received from a pharmacist concerning an adult, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST(Intranasal) started on 16-Sep-2013. It was reported by the pharmacist that she and her children were administered with full dose of FLUMIST into one nostril which started on 16-Sep-2013. The outcome of the event of given full dose of FLUMIST into one nostril is unknown. The report was considered to be non-serious.
Acute onset of rash and itching on trunk and neck last approx 60 hours.
Prenatal vitamins, indication: pregnancy; No additional AE reported; Nurse reported RECOMBIVAX HB was administered after a temperature excursion to a patient on Feb 13, 2023. No further information provided. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): RECOMBIVAX HB (W03; This spontaneous prospective pregnancy report was received from a registered Nurse referring to a 25-year-old female patient with no immune hepatitis B, anemia and hyperemesis (conflicting information, also reported as no illness at the time of vaccination by the same reporter). There was no information about the patient's medical history provided.  Concomitant therapies included minerals nos, vitamins nos(PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), ferrous sulfate, pyridoxine hydrochloride(VITAMIN B6) and fluconazole(FLUZONE [FLUCONAZOLE]).   Last read on 10-FEB-2023 at 16:15, where current temperature was 37 (units not provided), with min and max of 36 and 41 (units not provided). Total time out of recommended storage temperature was approximately 72 hours. Upon discovery, medications placed in bag with "Do Not Use." Moved to different refrigerator which was within range.  Thermostat of Side A fridge adjusted to lower temperature. Supervisor aware of the issue. Pharmaceutical Companies contacted to determine viability of vaccines. Patient's Providers made aware of situation. Risk Management made aware. Medication Safety Officer made aware. Facilities Work Order placed for fridge inspection.  Upon review of temperature log, min and max temperatures were out of range on 13-FEB-2023 as well. Management not made aware until 14-FEB-2023, at 9:40.  At 9:40, on 14-FEB-2023, the temperature alarm went off on the Side A refrigerator. The digital readout on data logger at that time read 35(units not provided) for current temperature, with min and max temps of 25 (units not provided) and 35 (units not provided) respectively. Data logger located in center of fridge with probe in glycol.   On 14-FEB-2023, the patient was vaccinated with an improperly stored first dose of   hepatitis b vaccine (recombinant) (RECOMBIVAX HB), thimerosal free, intramuscularly, lot # W036194, expiration date reported as 23-MAY-2025, but upon internal validation established as 29-SEP-2025, in the left deltoid for prophylaxis (product storage error).  On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. No prenatal tests or results were reported. Pregnancy outcome was pending and the fetal outcome was unknown at the time of the report. The therapy was taken during the first trimester of pregnancy (maternal exposure during pregnancy). There was no adverse effect reported.  The reporter considered exposure during pregnancy, product storage error to be medically significant reported as important medical event, also reported as the patient had repeat dose of vaccine in the next visit.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA003161: US-009507513-2302USA004804:
Fatigue, pain at vaccination site and underarm, and headache 3-4 hours after injection. Extreme fatigue and some body ache 24 hours after vaccination. Sneezing and fatigue as of now (86 hours after vaccination)
Pt presented to the ER complaining of ' my heart trying to beat itself out of my chest, and when I try to take a deep breath it feels like someone is sitting on my chest." Pt HR mildly elevated at 94 with a BP of 138/82. SPO2 98% ORA. After sitting for a short period pt seen by provider and discharged home to monitor for an increase in severity of symptoms and to contact 911 to return to the ER if necessary.
Pt and her husband approached the pharmacy stating she didn't feel well, he complaint was of feeling dizzy and light headed.  Pt was concerned her blood sugar was low due to how she was feeling. we tested her blood sugar and her result was 217mg/dl.  I checked pt's blood pressure and it was 165/98 at this time the paramedics showed up and took over and I never took a pulse.  When the paramedics were here they asked questions of the patient and mostly seem concerned with how she was hyperventilating.  In talking to patient and her husband it was determined she was not in need of emergent care and was likely experiencing some anxiety due to flu vaccine.
On 1/31/01 at 05:30, pt awoke with a fever of 104F and vomiting which continued. We went back to the doctor at 11:00 and he gave a prescription for Phenergan suppository. Vomiting stopped, controlled temperature with Tylenol and Motrin. On 2/1/01, diarrhea started and continued until the late evening of 2/4/01. Fever and diarrhea stopped on 2/5/01.
Left deltoid tender, 1/2cm induration at vaccine site, no redness, not warm to touch.  Submitted per doctor's request.
Moderna COVID-19 (mRNA-1273) vaccine treatment under Emergency Use Authorization(EUA): The decedent received the shot at 4:30pm and was found deceased at 10pm the same day.
This case was reported by a physician and described the occurrence of heart murmur in a 5-month-old female subject who was vaccinated with ROTARIX. Concurrent vaccination included Haemophilius influenzae type B vaccine; manufacturer unspecified; unknown; unknown given in 2012; combined diphtheria, tetanus, pertussis (A or W not known) vaccine; manufacturer unspecified; unknown; unknown given in 2012; hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given in 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given in 2012. In 2012 the subject received 1st dose of ROTARIX (oral). On 14 August 2012, less than one year after vaccination with ROTARIX, the subject experienced heart murmur. The physician reported that she diagnosed the subject, who had been vaccinated elsewhere with one dose of ROTARIX with a heart murmur. The physician had limited information regarding previous history because the subject has recently moved from a different treating physician. At the time of reporting the outcome of the event was unspecified.
Fever; Body aches; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 31 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: PYREXIA (non-serious) with onset Mar2021, outcome "recovered", described as "Fever"; PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Body aches". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
When the VAR was processed and billed to pt's insurance, it was discovered the pt had already received two doses, making this one the third. The nursing home was notified and the pt was monitored. No issues reported yet.
I had vaccination on 10/12/2022. I started to experience on 03/08/2023 congestion headache body aches cough and a temperature of 102. I tested COVID-19 positive on 03/08/2023. I contacted my physician on 03/09/2023 and was prescribed PAXLOVID. I am feeling better on 04/17/2023 but my arthritis is the worst it has ever been.
Upon arrival, patient had stated that she was wanting to receive a Covid vaccine and had not received any in the past. Moderna was administered on 7/25/21. When patient came for second dose of Moderna, we noticed she had received J & J on 4/8/21 at competitor pharmacy. She claims she did not receive it but that other pharmacy said she did. We refused her second dose of Moderna  since she already received J & J.
on 22APR93 pt recvd 3rd vax exp dizziness & weakness;
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: unconscious not responsive-Severe, Systemic: Shakiness-Mild, Additional Details: Pt.  unconscious, not responsive fell off his seat on face
MEDI-0003816 is a non serious spontaneous case from a consumer involving red pimple like dots around the nose. The reporter causality is not proved to FluMist. A consumer reported that her 38 year old husband developed red pimple like, non-pruritic, dots around the nose one week after receipt of FluMist vaccine on 12Oct05 from his children's pediatrician's office. As of 08Nov05, the dots persisted, but are now less and brownish in color. The reporter causality is not provided. The reporter also reported that she experience the same adverse event two weeks after receiving FluMist vaccine. This case is linked to AER # MEDI-0003810.
Hives, both lower extremities, L>R, approximately 5 minutes following vaccinations. BENADRYL, O2 - 2 LTRS x 5-10 MIN. Erythema >5" on left thigh, pale, cyanotic, limp, SAT 96%; HR 142. Observed.
very fatigued; arm started jabbing; pain into shoulder to arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included has a lot of allergies. The patient's concomitant medications were not reported. The family history includes pancreatic cancer, her mother has had pancreatic cancer for over ten years which is rare. Patient experienced stated that she was in a lot of pain in her arm and she has a feeling she did it wrong from the get go. She assed that she was very fatigued. She is very small, she is not young, but she is very small. She gave her the shot and waited 45 minutes because she has a lot of allergies. She stated that once she got into the car, she used her left turn signal and her arm started jabbing. This was a normal reaction from the shot, and then when she reached for the refrigerator she felt jabbing. The only symptoms were pain into shoulder to arm. The events outcome was reported as unknown.   No follow-up attempts are completed; information about lot/batch number cannot be obtained
Information has been received from a health professional concerning a 9 month old female who was vaccinated on approx. 3/26/01 with a dose of haemophilus b conjugate vaccine + Hep-B vaccine recombinant (yeast). On 5/5/01, the pt developed meningitis and bacteremia. Upon internal review the pt's experiences were considered an "Important Medical Event". No further information is available. The follow-up states that the pt was admitted to the hospital. Relevant lab tests indicate that the pt had a positive blood culture. It was noted that on 11/22/2000 and 01/16/2001 the pt was vaccinated with a first dose IM in the right leg and a second dose IM in the left leg  of HibTITER. Follow-up info has been received from a health care professional who reports the pt had residual hearing loss on the right side. Upon internal review, residual hearing loss was considered an other important medical event. Additional info has been requested.
Right arm swelling and itching; Right arm swelling and itching; Hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): LRN4531462.  A 59-year-old female patient received bnt162b2 (BNT162B2), administration date 20May2021 (Batch/Lot number: unknown) at the age of 58 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Back surgery" (unspecified if ongoing); "COVID with pneumonia" (unspecified if ongoing); "A-fib" (unspecified if ongoing); "Fluid around heart" (unspecified if ongoing), notes: Fluid around heart; "C-section" (unspecified if ongoing); "Cabbage allergy" (unspecified if ongoing), notes: cabbage allergy; "Antibiotic allergy" (unspecified if ongoing); "Crawfish allergy" (unspecified if ongoing), notes: Crawfish allergy. Concomitant medication(s) included: XOLAIR. The following information was reported: PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious) all with onset 10Jun2021, outcome "recovered", and all described as "Right arm swelling and itching"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Hives".  Additional Information: Patient's concurrent condition included: Hives. On 20May2021, patient started therapy with Pfizer Covid Vaccine. We have no further information regarding the reported event(s) described above. Any additional material information received will be forwarded to you in accordance with RA's policies and procedures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Constant 10 hrs screaming episode the day of shot 230PM to about MN;
About 15 min after receiving vaccine, pt mom call and says pt is having a seizure.