chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave patient vaccine at 4:00 pm, at 4:02 heard patient making what sounded like grunting noises then heard his phone fall.  When we looked out the patient was standing and just staring blankly.  Went out to patient and tried asking him symptoms.  Patient nodded when asked if he was short of breath.  I grabbed patient and got him back into the seat.  He was extremely hot and drenched in sweat.  Patient was still conscious but not responding to any further questions.  At this point decided to administer epipen due to patient previously acknowledging shortness of breath and flushing even though did not notice hives or swelling.  Technician called ems in the meantime, they arrived in about 10 minutes.  Patient was still conscious but still not responding.  EMS put him on stretcher and took to ambulance.  I talked to patient later that night and said he was feeling better but had no recollection of anything until being in ambulance.
Information has been received from an office billing supervisor concerning a female patient who on 11-JUN-2008 was vaccinated with the third dose of GARDASIL (lot # expire date and route not reported). The office billing supervisor reported that on an unspecified date the patient ended up having an abnormal PAP and the patient required colposcopy. It was unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
2 large red rash areas appeared in deltoid area of left arm. Warm and painful to touch.
With in two minutes of injection I started having very rapid heart beat and heaviness in my chest. By four minutes I had throat swelling and pressure and slight difficulty breathing. I did not seek medical attention while at the clinic. Once home I took two Benadryl and contacted my primary provider for advice. She advised that because of my history of anaphylactic reactions to medications and the throat swelling I experienced to not receive the second shot. She suggested I take Benadryl and seek emergent medical attention if my symptoms worsened.   Symptoms continued for several hours. I administered two more pills of Benadryl following the package instructions. The symptoms tapered over time. For days I was wheezy  and my asthma was not controlled. I also had small runny nose and flared up my vocal cord dysfunction and asthma symptoms.   With in a week and a half I was able to run again with out experiencing breathing difficulty that is abnormal. My breathing is still not 100% but I can not confirm that it is a result of the shot or my asthma not being completely stable.
Cellulitis: This is a 4 year old boy admitted with mild fever, decreased appetite, irritability, and expanding ~10 cm indurated, erythematous, nonfluctuatant lesion on his L-thigh after receiving a Pneumovaccine on this leg on Thursday afternoon, concerning for cellulitis.  He was afebrile on admission but spiked to 102.2 11/19, improved with tylenol & motrin. CRP was elevated to 250 and WBC to 19.3 K consistent with local infection. He has improved now with 3 days of iv clindamycin (275 mg q6h) and will be sent home on po clindamycin to complete a 10 day course of antibiotics. 12/21/06-DC Summary for DOS 11/19-11/21/06-received and reviewed.  DX: Cellulitis secondary to vaccination Fever. Treated with IV Clindamycin PMH: developmentally delayed secondary to midbrain pilocytic astrocytoma resection/VP shunt placement and multiple revisions.
Student feeling tired, lightheaded after receiving vaccine - rested in observation 10 extra minutes then feeling better - returned to class. Mom notified via voicemail.
Starting within 24 hours of the vaccine and continuing for a week or more after, the following systems occurred in my baby: (1) a day after the vaccine (11/17/22), was extremely lethargic and hard to wake up (called pediatrician to ask for advice, said he was probably getting sick, which he wasn?t); (2) the next day (11/18/22) red in his diaper, but more active and alert (reached out to pediatrician again by phone and e-mail for advice); (3) 3 days after the shot (11/19/22), he started screaming for 6 hours straight, nothing would console him, barely drank anything during that time, almost took him to ER, but he was exhausted and finally fell asleep; (4) 11/21/22, weird shaking and catching breath during naps, would look scared and start crying when woke up; (5) 11/24/22 slept all day, very lethargic, hard to wake up. Spoke with pediatrician over the phone and he was checked at his 2 month visit.
12/24/2006-rash to trunk and legs, tiny distinct spots, spread to neck and face.  Possible low-grade fever.  Called physicians office, on-call nurse instructed mother to administer diphenhydramine and infant acetominophen as needed, and informed her possible adverse reaction to MMRV vaccine.  Resolved without sequelae in 2-3 days.
Within 24 hours of vaccine became excessively weak, fell, couldn't set up in bed, no appetite, light headed, dizzy, dry mouth, excessive urination, sweats. Symptoms chronic for 24 hours, with continuing weakness for several more days
Moderate tinnitus developing approximately 2-3 months after initial dose.  Sought advice from ENT doctor due to discomfort from tinnitus in May 2022. No correlation to Covid vaccine mentioned at that time.
This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old male patient. On 10-NOV-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Severe body aches, fatigue, vertigo, headaches, severe intermittent back pain. Local arm pain at injection site.
About 10 Minutes after Vaccine I felt a intense heat rising inside my body, I experienced increased heart rate, I felt I was going to faint. I thought I was going to die, but it was over in ??less than 10 minutes. I administered vaccines that day and was fine. The next day I felt tired and injection site medium pain. Rash of site a week later.
4 days after receiving PNEUMOVAX, noticed pain in right upper lateral arm with redness and swelling. Also had sweats and chills, and felt feverish. There is erythema circumferentially around injection site and mild warmth. Placed on cephalexin x 10 days for dx of cellulitis.
dizziness, achy, balance issues, double vision, hands hurting (curled), knees and back sore, high blood sugar, very hot then later very cold, later slight ache in center of stomach and nauseous but didn't throw up - for a time felt almost drugged with a terribly dry mouth (like you would when you get a preop shot) and still double vision and poor balance and no appetite (stayed on couch all of one day and part of the next) - took two full days before I felt well
Sedation, Myalgia, Arthralgia, NauseaVomiting, Chills, pain at injection site Narrative:
Aching, headache, chills, swelling left upper arm and itching, post vax. Examined and treated with ice packs, Benadryl, and prednisone. Prescription for decreasing doses of prednisone called into the pharmacy.
Right parotitis with secondary bacterial infection. Nurse follow up on 05/17/04 states report is complete.
Shingles vaccine administered Friday at 2PM.Reaction started on the next day (Sat)about 4PM while I was driving a car to my house. As soon as entering my house about 6PM, I took 2 pills of Zyrtek. This removed the "bloom" of itching swolen spots in 2 hours. I use this medication when I occasionally get similar, but less extreme, rashes in some skin locations. After 40 hrs have passed since the successful medication result I have received no further reaction to the Shingles vaccination.Ignore 14.
Severe pain at injection site.  Was unable to lift left arm above elbow.  About 24 hrs after injection, came down with body aches, chills and mild fever.   Symptoms lasted for about two days, then disappeared completely.  Pain at injection site lasted for a few more days.
He reports that he had his second Moderna COVID vaccine was 4/20 Tuesday.  The next day, on Wednesday he began having headache, body aches, chills, fevers and mild shortness of breath.  Patient reports that the body aches somewhat resolved on Thursday but he continued to have some intermittent palpitations.  He woke up Friday with self described chest discomfort with persistent palpitations.
Approx. 1 minute after inj. patient stated inj site was itching. Area was slightly red, irregular in shape approx 10mm in size and warm to touch. 0817 c/o itchy/tight throat. 0820 patient was given 25mg BENADRYL PO.
Her family physician put her on an antibiotic, Biaxin for what she thought might be a sinus infection; sore throat; fatigue; headaches; This is a spontaneous report from a contactable consumer (patient).  This 71-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0158) on 14Apr2021, probably in the late morning, at the age of 70 years, in left arm, as the second single dose, for COVID-19 immunisation. The first dose of BNT162B2 vaccine was administered on 18Mar2021, at the age of 70 years, lot: EN6208, in left arm with no adverse event. Medical history included seasonal allergy (had been taking medications for all these for 10 years or at least 8 years), allergy, cholesterol, blood pressure, upper respiratory issues and thyroid. Prior vaccinations (within 4 weeks): no. Family medical history relevant to AE(s): no. Ongoing concomitant medications included guaifenesin (MUCINEX) at 1200 mg twice daily, for allergy, atorvastatin calcium at 10 mg once daily, for cholesterol, irbesartan at 150 mg once daily, for blood pressure, spironolactone at 100 mg once daily, for facial hair growth, desloratadine, pseudoephedrine sulfate (CLARINEX-D) at 120/2.5 once daily, for allergy. On 29Jun2021 the patient began having a sore throat, fatigue and headaches and wondered if that could be related to the vaccine. They all started at the same time and she was still experiencing them at the time of report. She had been to the physician, her family physician, and to the health care clinic and has had no results. They had stayed pretty much the same. One day, she feels better, then the next day it went down worse. After a few days, she felt good and had one good day, then it went down again. Her family physician put her on an antibiotic Biaxin for what she thought might be a sinus infection. She was on her second round of that, which will make it 20 days when she was done. Tests: her thyroid was out of adjustment on her last thyroid test. The events did not require ER visit. The events had not yet resolved.  No follow-up attempts are needed. No further information is expected.
Onset of Bell's Palsy following flu vaccination. Received Sanofi Pasteur FLUZONE QuadPFS2017-18 QUAD PFS2017-18 vaccine on 10/30/17. Initial onset of paralysis symptoms 11/4/17. Medicated via prednisone and valacyclovir following ER visit after symptoms worsened 11/6/17.
Pt's rt arm where vaccine was given, warm to touch, 8" diameter redness area. No other side effects noted. 2 " hard lump at injection site. Recommended ice , elevation, Ibuprofen age appropriate, and BENADRYL. Return to clinic prn.
Playful then c/o R leg tingling x 20 min, ate little for lunch @ 12:30, then c/o R sided mouth tingling, then R facial palsy/asymmetry confusion. Slurred speech, No headache. 1p Gave Ibuprofen; 2:30p C/o headache 3p naproxen; 'Not feeling well'. Ate small amount dressing/ potatoes. Laid down 30 min; 5p ibuprofen: HA increased; 6p home, started a movie. 6:30p emesis, then movie. Odansatron (Zofran) 7:10p headache >- to bed. Rest 5-10 min, but HA increasing. 7:30p ibuprofen; 7:40p emesis (full Ib tab thrown up). 8:15 head 2 ER. 9p in ER, exam & plan Migraine protocol HA 5/10. 9:15p IV in, HA 3/10, no upset stomach. 9:45p IV Benadryl, Toradol HA relief, c/o stomach pain, HR 100 10:05p emesis, then HR < 77.
Severe cough with mucus; Cough brought up mucus; Feels sleepy all day; Felt like he was going to choke; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING SENSATION (Felt like he was going to choke) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported.   On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 04-Apr-2021, the patient experienced CHOKING SENSATION (Felt like he was going to choke) (seriousness criterion medically significant). The patient and drank some ginger tea which helped alleviate it.  On 05-Apr-2021, the patient woke up and had a severe cough and brought up mucus.  The patient COUGH (Severe cough with mucus), SECRETION DISCHARGE (Cough brought up mucus) and SOMNOLENCE (Feels sleepy all day). The patient was treated with Manual therapy (Ginger tea) for Choking sensation.   At the time of the report, COUGH (Severe cough with mucus), SECRETION DISCHARGE (Cough brought up mucus) and SOMNOLENCE (Feels sleepy all day) had not resolved.       Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded
Healthcare Professional had administered improperly stored VARlVAX to Patient; No additional adverse event; This spontaneous report was received from a nurse referring to an patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 05-OCT-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, route, frequency, were not provided) for prophylaxis; valid Lot No. U020244; has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 28-JUN-2023. And valid Lot No. U010395 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 01-APR-2023, and upon internal validation established as the same. The patient was also vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Albumin status was not provided) (strength, dose, route, frequency, lot number and expiration date were not provided) for prophylaxis, on an unspecified date.   The reporter stated that these vaccines doses were administered and the vaccines were improperly stored (incorrect product storage). They presented a temperature excursion with Temperature: 1.45°C on time frame 6 Hours (Temperature Excursion had occurred on 05-OCT-2021). It was reported that Previous temperature excursion occurred on 04-OCT-2021 at -10°C to 8°C (0.91 °C) for 6 Hours. Additional excursions had occurred after patient was administered the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on 08-OCT-2021 of -50°C to -15°C (-14.6°C) for 15 Hours; and on 13-OCT-2021 of 10°C to 8°C (0.54°C) for 13 Hours.
Developed increased pain and stiffness in hands, approximately 2 months, post vax. No treatment for symptoms to this time.
Positive for COVID on Nov 10.  Symptoms began on Nov 9 and included a fever of up to 100.1 with chills.  Also experience dry cough, fatigue, and muscles/joint aches.    Experienced brief tingling/fizzing inside mouth and brief painful scalp on right side of head.  Fever ended on Nov 10 and slow recovery since then.  Mostly recovered today (Nov 16).
Moderna monovalent at unknown temp for 48 hours, subpotent dose given.  Upon review patient had received Janssen 7/15/2021.  So patient should have received bivalent dose.
Terrible headache,  body aches, tiredness, arm hurts from shot, nausea  all were gone with in 2 days of the vaccine.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:46 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 29.49 for dose administered on 13-Feb-2021 and 29.59 for dose administered on 20-Mar-2021.  Concomitant products were not provided.  On 13-Jan-2021. 30 vials with batch number 031L20A were sent to clinic. On 09-Feb-2021, The vial was moved to fridge. On 13-Feb-2021 at 09 am, Temperature excursion was reported as 32, total doses given for the day was 152 and vaccine BUD date was reported as 10-Mar-2021.  On 09-Mar-2021, The vaccine with batch number 031A21A was moved to fridge. On 20-Mar-2021, 19 vial was moved to clinic and Temperature excursion was reported as 34 at 09 AM and 37 at 10 AM. Vaccine BUD date was reported as 08-Apr-2021  Condition of vaccine prior to administration was not frozen. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
2 hours after Hep B experienced headache, flushing, fever, fatigue, muscle aches. Scratchy throat, nausea, anorexia, vomiting, photo sensitivity. Denise allergy.
Pt had her BP 150/109, HR 102, her forehead got swollen, baggy water under eyes. She got treated with EPIPEN, BENADRYL, Steroid at ER on Saturday at approx. 8:30PM and sent home. Her condition got worse the next morning Sunday 03/31/2019, she returned to ER again.
12/11/99:Pt was exposed to chicken pox at school approx. 12/1. This evening,pt broke out w/ a rash & T102(which persisted 48 hrs).Pt was fussy & had poor appetite & constipation.12/12/99: Pt was dxed w/ varicella.Tx w/Tylenol for fever.
1712 tongue tingling, 02: 100% 1725 complain lip tingling, transferred to ED
Body shaking, Dizziness upon postural body changes (laying to sitting), Increased heart rate (baseline 64-70, post injection HR mid 90s).  Body shaking resolved around 12 noon.  Dizziness and increased heart rate continue.  Called into work today and will follow up with physician in AM in symptoms continue. 11/18/2009 MD records, pregnant patient with c/o's shakines, dizziness and increased heart rate post vaccine. No tx noted.
Pt developed a fever the evening after receiving his routine 6 month immunizations and his first influenza vaccine. Then he had a prolonged SZ. ER W/U: negative. Sent home.
Congestion,  breathing abnormal,  elevated heartrate , 02 lower then usual , tired , exhausted,  fatigue,  not usual self , fussy , incosebale.  Patient is a non verbal child
slight chest pain; Lethargy; weakness; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST PAIN (slight chest pain), LETHARGY (Lethargy), ASTHENIA (weakness) and HEADACHE (Headache) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 022A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced CHEST PAIN (slight chest pain), LETHARGY (Lethargy), ASTHENIA (weakness) and HEADACHE (Headache). At the time of the report, CHEST PAIN (slight chest pain), LETHARGY (Lethargy), ASTHENIA (weakness) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided  Treatment medication was not reported Action taken mRNA-1273 in response to the event was not applicable
severe allergic reactions; dizziness, weakness, rapid heart beat; dizziness, weakness, rapid heart beat; dizziness, weakness, rapid heart beat; This is a spontaneous report from a contactable consumer (patient). A female patient (Age 49; units: Unspecified) received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiry date were not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe allergic reactions, dizziness, weakness, and rapid heartbeat. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Itching on right arm; Rash on right arm near injection site; Raised area near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE RASH (Rash on right arm near injection site) and VACCINATION SITE INDURATION (Raised area near injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE RASH (Rash on right arm near injection site) and VACCINATION SITE INDURATION (Raised area near injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE RASH (Rash on right arm near injection site) and VACCINATION SITE INDURATION (Raised area near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.