chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"87 YO male with h/o hypertension and BPH who presented to the ER for evaluation of acute onset vertigo and projectile vomiting.  At approximately 5:30 p.m. today, he sat down while eating dinner and developed acute onset vertigo characterized as room spinning sensation with subsequent projectile vomiting.  He went to go lay down, which was followed by patient falling off the bed and hitting his left forehead.  He notes chronic dizziness, but this was different from any other episode. He denies any previous history of CVA or TIA.  He denies any history of epilepsy. He follows with a doctor for carotid artery stenosis. Hospitalist team asked to admit for further monitoring. MRI brain obtained revealed multiple cerebellar infarcts. Teleneurology consulted and recommend DAPT for 21 days with Plavix 75mg Monotherapy indefinitely. He is to obtain TEE to assess for vegetations and atrial appendages. He is to wear Zio monitor to assess for arrhythmia with results sent to our cardiology team. He is to follow with Neurology and PCP as able. He is discharged home in stable condition. "
Fever, chills, muscle aches, nausea, headache x 2 days. Tylenol QPRN hydrate rest
flulike symptoms; chills; malaise; arm and shoulder soreness; arm and shoulder soreness; increased itchiness in the left side of neck and torso and back; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dermatitis" (ongoing), notes: Dermatitis -ongoing, taking multivitamin, vitamin c, allegra, fiber pill. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; ALLEGRA. Vaccination history included: Covid-19 vaccine (Dose 3, Unknown Manufacturer), for covid 19 immunization; Covid-19 vaccine (Dose 2, Unknown Manufacturer), for covid 19 immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for covid 19 immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Apr2022, outcome "unknown" and all described as "arm and shoulder soreness"; CHILLS (non-serious) with onset Apr2022, outcome "unknown"; INFLUENZA LIKE ILLNESS (non-serious) with onset Apr2022, outcome "unknown", described as "flulike symptoms"; PRURITUS (non-serious) with onset Apr2022, outcome "unknown", described as "increased itchiness in the left side of neck and torso and back"; MALAISE (non-serious) with onset Apr2022, outcome "unknown". Therapeutic measures were taken as a result of influenza like illness, chills, malaise, arthralgia, pain in extremity, pruritus.  Additional information: 52-year-old woman, 5'1 height, 140 lbs, received 4th covid vaccine on left arm on 25Apr2022. Prior to getting vaccine, took an extra strength Tylenol as prophylaxis. Less than 15 hours later, experienced flulike symptoms, chills, malaise, arm and shoulder soreness, and increased itchiness in the left side of neck and torso and back. Dermatitis -ongoing, taking multivitamin, vitamin c, allegra, fiber pill, cream for itchiness. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
THE PATIENT HAD A SORE ARM THE DAY AFTER SHINGRIX VACCINE AND LASTED FOR ABOUT 2 WEEKS
Severe cramping, shakes, teeth chattering, feeling bloated, slight chest pain. Going to see what the Dr. says.
nerve pain down her groin and down her leg; This is a spontaneous report from a contactable consumer reporting for a patient (reporter's friend). A female patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at dose number unknown, single for COVID-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced nerve pain down her groin and down her leg on an unspecified date. The reporter stated that nothing helps with her pain, however therapeutic interventions were not specified. The reporter stated the patient is a school teacher and the only thing that helps is not moving it. The clinical outcome of the event nerve pain down her groin and down her leg was unknown.  The batch/lot numbers for the vaccine were not provided and will be requested during follow up.
In 8/98, the pt developed varicella and sought unspecified medical attention. No further information is available.
No additional AE; HCP calling to report an AE regarding VARIVAX. HCP calling to report that a patient was administered a improperly stored vaccine. Permission to contact HCP was provided. T.E case 02428709 filed. AE cases 02428861, 02428862, 02428779, 02428868, 024288; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 15-JUL-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # W031810, expiration date not provided but upon internal review stablished as 05-OCT-2024 (strength, route of administration, anatomical location not provided) as prophylaxis; which was improperly stored. No adverse event was reported.
Not in good shape; Hardly has any strength; Tingling; Weakness; Arms and legs numb; Shortness of breath; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Feb2021 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation (reported as preventative). The patient has no medical history. There were no concomitant medications. The patient did not received any additional vaccines on same date of Pfizer suspect. The patient did not receive prior vaccinations within 4 weeks. On 08Feb2021, the patient experienced weakness, arms and legs numb, shortness of breath. On an unspecified date, the patient was not in good shape, hardly has any strength and tingling. It was reported that she had first COVID-19 Vaccine on Monday (08Feb2021). Ever since then felt so weak, she has almost fallen a couple times. Finally took a shower on the day of reporting because she wasn't up to it before. For a couple of days her arms and legs were numb, which was weird. She was short of breath when she gets up to go to the bathroom. Hardly has any strength. The patient stated that she hasn't been in shape to contact Pfizer. Has been in bad shape and that was the first dose. The patient stated that she did not know if she needs the second dose or what to do about that. She further stated that weakness was within hours of the COVID-19 Vaccine. Almost fell a couple of times and was a little better. Tingling and numbness was getting better, but not 100%. Wanted to see her family again who was high risk. The patient thought about going to the Emergency room (ER) but stated that as long as she was able to get up and go to the bathroom she will not go to the ER. The patient has not felt like going to a regular doctor and was not in good shape because she was afraid that her doctor would advise her to go the ER. She did not want to go to the ER. The patient clarified she did not fall, but almost. The outcome of events arms and legs numb and weakness, tingling was recovering whereas the outcome of all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient waited the 15 mins and was driving home with mother - developed nausea and had an episode of vomiting
I do not have a menstrual cycle with the Nexplanon birth control implant but after receiving the second dose of Moderna I starting spotting and ended up having a full period in June/July. Spotting has persisted since then. Additionally, I also experienced breast tenderness since the second dose. After two months of near constant pain I went to my doctor for an ultrasound and they reported no issues. I am still experiencing this pain, five months after the second dose.
First dose vaccine on 2/5/2021 developed a cough that never resolved. Second dose woke up at 11:00 pm with fever chills, blinding headache, nausea, sever coughing, SOB and chest tightness. Called caregiver hotline the next day and they sent me to the Care where it was found my BP to be 225/120 and pulse 100. They sent me to the emergency department at Hospital where I was treated for hypertensive urgency and immunization reaction. Still suffering from elevated BP and pulse beyond what was normal prior to vaccine. Still experiencing fatigue and weakness that was not present prior to vaccine.
Self reported (unwitnessed) syncopial episode in car before he drove off from parking lot.
4/8 an hour after shot - fatigue. A few hours later arm pain. 4/9 arm pain 4/10 - 4/11 no pain or symptoms 4/12 - 4/15 fatigue, nausea, and mild constant headache
ARM SORENESS 1-3 DAYS AFTER FIRST DOSE INJECTION Narrative:
Patient has confirmed phlebitis from moderna vaccine. Followed up with MD but otherwise ok. no hospitalization.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot# M020521 with expiry date: 17-NOV-2017, lot# M024673 with expiry date: 17-NOV-2017, lot# M038216 with expiry date: 09-MAY-2018, lot# M043987 with expiry date: 30-JUN-2018, lot# M039060 with expiry date: 22-MAY-2018, (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that all lots except lot# M039060 of PNEUMOVAX 23 were exposed to a temperature range of 47F to 77F. The duration of exposure was 33 minutes for lot# M020521, lot# M024673, lot# M038216 and 70 minutes for lot#M043987. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011339.
Uveitis, which had been dormant for 4 years returned. Permanent scarring to my eye has been done.
This is a spontaneous report from a contactable physician via a Pfizer-sales representative. A patient of unspecified age and gender started to receive TRUMENBA (Lot number and Expiration date: Unknown), via an unspecified route of administration in the arm, single dose, from an unspecified date for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tingling in upper thigh as a result of receiving meningococcal group b rlp2086 in upper arm. The outcome of the event was unknown. Information on the lot number and expiration date has been requested.
Four (4) days of severe body aches, disabiling fatigue, chills, feeling feverish, mild nausea, and headache. Extremely sore and swollen at the injection site with redness and itching. Soreness far exceeded past experience with Moderna vaccines. Symptoms lingered but did not lessen until the third day. Total of four days out of commission with three of those spent mostly in bed.
Information has been received from a pharmacist concerning a 62 year old male pt with no known drug allergies who on 12/17/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included simvastatin, Ditropan, Tricor, and amitriptyline. On 12/17/02 the pt developed warmth and swelling in his arm at the injection site two hours post vaccination. Eight hours later, the arm was swollen from the injection site to the elbow. The pt presented to the ER and was given ibuprofen and was told to apply ice at the injection site. At the time of this report, the pt's condition was unknown. Additional info has been requested.
Soreness, bump, and rash at vaccination site. Next fat began with headache, fever, chills, aches. Continued all day into the night. Next morning I feel fine, still a little tired, but overall back to normal
Got vaccine on 12/30, next day had significant arm pain (7-8) and N/dry heave (? due to pain), was referred to Call Center to get covid testing, went to Urgent Care on 1/3/21 for testing-pain was decreasing and mobility better, pain at rest 2/10, wasn't throbbing;  site was observed and ? too high; Covid test neg, RTW on 1/6/21 (0/10 at rest but had position pain, arm was overall improved), had tried to return to jogging , 1/7/21 woke with inc pain again 4-5/10, pain inc again by 1/9/21 to 6-7/10; saw NP/PCP on 1/12/21 and xray was done, MRI done
Patient was present with her mother. At appox 3:15 pm mother came up to me with daughter present and showed me her left (deltoid) arm. Noted red rash around injection site (1/2 dollar size) warm to touch. No respiratory distress noted. Administered 2 tablets of Benadryl (25 mg each) per emergency policy and procedure @ 3:22 pm.  With enough water for the patient to swallow  the tablets.  Their was no discomfort with swallowing noted. Vital signs taken every 5 min.  1)   3:22pm BP 98/74 P 80 R 16, T 97.9,             Pulse Ox 98 % 2)    3:27pm BP 88/74 P 74 R 16, T 97.6,              Pulse Ox 98%.  3)    3:32pm  BP 102/64, P 79, R 16,  T 98.2         Pulse ox 99%.  Patient was laughing and talking with sibling the whole time.   Mother was instructed on if the rash gets worse, Respiratory distress,  Fever, the redness or tenderness where you got the shot gets worse notify her Doctor. I asked Mom if she would like the ambulance to come and check her out. She stated "No, I feel she will be okay".  Notified Dr @ 3:50pm and Manager @ 6:50 pm. Patient left  with mother and two siblings @ 3:55 pm no discomfort noted.
I am experiencing pins and needles sensation in both feet which is continuing a month later.  It seems to be worsening and affecting both leg shins as well.  I need to seek medical advice as I thought this would be temporary and now that does not seem to be the case.
Right arm and shoulder pain with numbness and tingling at times in fingers.  Painful to lift right arm at times with pain concentrated in shoulder and tricep area.  Difficultly sleeping as arm pain persists.  Pain continues currently.  Regular icing of shoulder area and visits to Chiropractor to lessen pain.  Topical pain relief.  Ibuprofen as needed.
Presented with gross lymphadenopathy to left axilla, left upper breast and small amount to left anterior cervical neck. No fever, chills or night sweats. Advised, ice, gentle exercises, rotation of NSAIDS and Tylenol for pain.
Patient received the third dose of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received the third dose of Moderna vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A, 004M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received the third dose of Moderna vaccine). On 30-Apr-2021, EXTRA DOSE ADMINISTERED (Patient received the third dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication information provided. No concomitant medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Non significant follow up
UrticariaPruritus Narrative: C/O itchy, hot, red at injection site, but no rash or fever
Patient was here to get her Pfizer booster. She previously had received the J+J vaccine.  She did warn me that she often faints with immunizations/blood work/stressful events.  She did have a friend with her who stayed in the room with her throughout the immunization.  After the immunization I kept talking to her for a few minutes and she seemed okay.  I then asked her to stay in the immunization room while she waited her 15 minutes just in case she did not feel well.  I then stepped out and told her I would be back in a few minutes to check on her.  About two minutes later I heard a crash and her friend yelling my name.  I ran into the immunization room and saw she had fainted and fell against the small table in the room.  Her friend said that the patient was not feeling well and was attempting to sit on the floor when she fainted.  I then proceeded to gently help bring her to the floor on her back and was attempting to wake her by calling her name and rubbing her sternum.  After a few moments she came to.  We let her lay on the floor with her feet up on a chair for another couple minutes.  After she felt more stable she then asked to sit back up in the chair.  I helped her up and she was able to get into the chair safely.   I asked her if she wanted me to call EMS and if she was injured in any way from her fall.  She did not want me to call and she said she was not hurt.  She then stayed in the immunization room drinking water for about 20-30 minutes.  She then said she was ready to go.  I had her stand up with me and she said she felt okay to leave.  I offered a technician to help walk her to her vehicle but she denied this offer.  She also was going to have her friend drive her home.
Bell's Palsy started pain up arm and up neck 30 minutes after vaccine; Bad migraine for days leading up to bell's Palsy; numb tongue; dismissed taste; bad neck pain; pain up arm; This is a spontaneous report from a contactable other healthcare professional (patient). An adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 09Mar2021 as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. Medical history included obese, diabetes, and high blood pressure. The patient previously took clindamycin and losartan and both experienced drug allergy. It was reported that the patient experienced on 09Mar2021 were bell's palsy started pain up arm and up neck 30 minutes after vaccine, bad migraine for days leading up to bell's palsy, numb tongue, dismissed taste days before, bad neck pain. The patient was perfectly fine weeks before vaccine and not very happy with Pfizer right now this was his first dose. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (nasal swab): negative on 18Mar2021. The reported events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events as the patient received antivirals and steroids. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of vaccination with BNT162B2 to the reported events bell's palsy, migraine, numb tongue, dismissed taste, neck pain and pain in arm cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a nurse, referring to a 38 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was inadvertently administered a dose of PROQUAD, subcutaneous (dose, anatomical location of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
loss of smell and taste; loss of smell and taste; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age (as reported 34; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 as 1st dose, single for Covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient reported loss of smell and taste after the first dose of the pfizer covid 19 vaccine on 05Feb2021. Patient wanted to know if there were reports of this side effect after the first dose. Case reported as non-serious. The outcome of events was unknown.   Information about lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Beginning ~2:00 AM following day, chills, muscle aches, general fatigue, loss of appetite. Lasted most of 02/12/2021. No fever, no headache, no other symptoms. Treatment: Tylenol and rest. Good sleep 02/12/21. Much improved morning of 02/13/21. Some lingering fatigue, other symptoms gone.
Myocarditis with effusion.   Hospitalized at hospital and then other hospital and then discharged.   Readmitted at hospital with  infected gallbladder but myocarditis limited treatment.   Now deceased.  Happened over 3 weeks.
I am post menopause and 6 days after 2nd shot I started bleeding. My period started.
Syncope--light headed, flushed, dizzy. Patient's friend notified pharmacist that he was not feeling well only a few minutes after vaccination. We had him lie down on floor with feet elevated. He immediately stated he felt better. Had him remain laying for 10 minutes. He said he felt better so we sat him up and checked blood pressure at that time. Reading was 125/81. He remained seated until approximately 8:00pm. Store management took his statement and he was feeling fine so he got up and left the store. Advised him to notify emergency services if his condition changed.
PMH:  remote lymphoma, HTN, CHF (no meds x 3 months due to lack of money), alcohol abuse; presents to ED with chest pain, SOB, abdominal pain; O2 sats 78% on RA, EMS started pt on NRB; positive for COVID pneumonia; placed on BiPAP; dexamethasone, antibiotics; ICU; vasopressors; worsening hypotension; transitioned to comfort care and pt died in the hospital
Pt. received MENACTRA booster and influenza shot on 8/16/12. MENACTRA #2 but never previously immunized against flu. Pt. c/o joint pain, joint swelling, urticaria and headache the morning after shots. Took MOTRIN and BENADRYL. Seen in MD office on 8/17/12 then ER later that night. Given Prednisone.