chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother presented on 10/8/2018 with photo of a "Currant Jelly Stool" and the guaiac positive stool in a diaper. The history was one of severe fussiness for several hours prior to presentation, which resolved before attending daycare and acting normally until the concerning stool was produced. She continued to act normally. Aside from daycare, she had nothing raising flags about an infectious gastroenteritis. I think she had a spontaneously resolving intussusception. However, she could have had a viral illness from another cause as she broke out with a rash on 10/12/18, seen by my partner.
injection site pain; injection site swelling; injection site warmth; bumps with a little fluid; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 8th November 2019, the patient received Shingrix (intramuscular). On 9th November 2019, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site warmth. In November 2019, the patient experienced raised rash. On an unknown date, the outcome of the raised rash, injection site pain, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the raised rash, injection site pain, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were received as follows: The patient after vaccination noticed a bump with a little fluid come up on his wrist. The patient had continued to have bumps come up, all consistent in appearance. The bumps were mostly on his arms, with some on his ankles and 1to 2 on his thigh. The patient also has pain, swelling and heat at the injection site that started the day after the vaccine. The patient planed to visit an urgent care clinic regarding the bumps on his body.
pt recv vax & presented to ER @ 1730 w/swollen rt arm-entire arm involved ROM limited-painful;tx EES - moist warm packs TIDx30min;second ER visit 14OCT96 arm improving med changed to ATB cellulitis;
Patient seen on 4-23-11 at U/C for rash on (L) thigh near injection site which showed up 3 days prior. Also seen for diaper rash. Diagnosed as cellulitis of (L) thigh & put on KEFLEX. PCP f/u in 2-3 days.
I felt very tired, but I was doing okay. I was standing at my desk on a video call and started feeling dizzy. My vision started to blur. The next thing I knew, I was on the floor. I fainted. I tried standing back up to finish the call, but I didn't have the energy. It was a few minutes before I could stand again. I was okay for the rest of the day, but I still felt tired.
Booster dose administered after date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Hydrocodone) and Lupus syndrome.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry). On 13-Jul-2022, EXPIRED PRODUCT ADMINISTERED (Booster dose administered after date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No symptoms were reported to the HCP by patient after getting the vaccine.  No vaccines given within 1 month prior to Moderna COVID-19 vaccine. It is unknown that  patient ever had COVID + test or diagnosis. It is unknown if any treatment was given for any symptom after getting the vaccine, and if patient is taking any concomitant or regular medication.
SEIZURE; DIARRHEA; This spontaneous report received from a patient concerned a 37 years old male. The patient's height, and weight were not reported. The patient's concurrent condition included fear of needle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered 1 total on 05-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 05-APR-2021, after receiving vaccination, the patient experienced seizure (fainting, tremor, tachycardia and bladder incontinence) and diarrhea. Upon examination of his vitals, heart rate was 112, showing tachycardia, blood pressure (BP) was 135/83, oxygen saturation was at 98 and glucose was 90. The patient was taken to the emergency room where he was released after evaluation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 05-APR-2021, recovered with sequelae from seizure on 05-APR-2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210411486, 20210411395 and 20210410874.; Sender's Comments: V0: 20210410630 -COVID-19 VACCINE AD26.COV2.S- seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
(per patient) soreness, swelling, no redness at site of injection.  (Chills, shakiness, low temperature next day).  Seen at facility, prescribed antibiotic and BENADRYL. Four days later returned to facility and PREDNISONE prescribed.
chronic  abdominal cramping - (felt like labor pains) in lower region of stomach - (scale 10 0f 10) - lasted 5 days - bile coming up had throat - burning really bad - could not eat anything - for 2 days until I got meds from emergency on  03-08-2021  had same symptoms immediately after second dose  moderna vaccine on 03-29-2021 - lasted 3 days - reported it to the same primary care doctor
Fever to 101.5, dry cough, difficulty breathing, headache and nausea.
unable to fell left foot; Supected COVID; chills / shivering / bone chills; arm pain / lost of pain in arm; Fever; Allergic reaction; This case was reported by a consumer via patient support programs and described the occurrence of hypoesthesia in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2020 13:30, the patient received Shingrix. In August 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced hypoesthesia (serious criteria other: serious per reporter), suspected covid-19, chills, pain in arm, fever and allergic reaction. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the hypoesthesia, suspected covid-19, chills, pain in arm, fever and allergic reaction were unknown.   The reporter considered the hypoesthesia, suspected covid-19, chills, pain in arm, fever and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix vaccine on left arm on 22 August 2020 approximately 1:30 pm. The patient went to emergency room due to chills, shivering and arm pain. The patient described it as bone chills.  The patient was unable to feel to her foot. The patient was running a fever and felt lot of of pain in her left arm. The patient had taken Benadryl and ibuprofen for pain and allergic reaction. The thought it might be CCOVID. The reporter consented to follow up.
I notice around 12pm that my eyes were itchy, on the side I received the vaccine also became itchy, my right forearm had bumps and my throat felt slightly closed as if something were stuck there. I took two Benadryl pills when I noticed the itching would not stop.
At 13:40, client received his 1st dose Pfizer vaccination (Lot#FC3183).  At approximately 13:55, the client was sitting in the observation area and got up to leave.  As he was walking down the hallway, the client stated he, ?began to feel a little dizzy,? and returned to the observation area.  He informed EMT and she had him sit down in a chair.  EMT radioed Lead Nurse to come over to assess the patient.  At approximately 13:56, Lead Nurse addressed the client and found he preferred to speak in Spanish.  Lead Nurse requested Co-Lead Nurse come over to translate.  EMT took client?s vitals at 13:56 (HR:  87, BP:  150/100, SpO2:  98).  The client stated he was feeling a little dizzy, but ?felt fine now.?  He stated he was nervous about the getting the vaccine.  He stated he has no underlying medical conditions (including no high blood pressure) and takes no medications.  He then stated he previously had high cholesterol, but has never taken anything for it.  He also stated he had a slight headache this morning, and took Tylenol before he came.  He stated he has no allergies and had eaten within the last couple of hours.  Lead Nurse asked client if he was experiencing any shortness of breath, difficulty breathing, or chest pain, to which the client responded, ?no.?  The client then stated when he felt the dizziness, he also felt a little chest pressure for approximately 1 second and then it went away.  At 14:01, EMT took client?s vitals again (BP:  148/90, HR: 71, SpO2: 99%).  Client stated he did not feel any side effects anymore.  Lead Nurse offered the client some water, which the client accepted and began drinking.  The client then stated he could communicate in English.  Lead Nurse advised client to continue to sit in the observation area for an additional 15 minutes and alert the EMT if he started to experience any discomfort.  Client originally came in with his wife and daughter, but they had to leave.  Client stated he could take the bus home or call his brother-in-law for a ride after waiting.  Client did not have a phone and the Lead Nurse gave him her phone to use.  Client stated his brother-in-law was on the way to pick him up.  The Lead Nurse and EMT approached the client at 14:16 and asked how he was feeling.  The client stated he felt his headache from earlier might be coming back, but overall he ?felt fine.?  The EMT then took client?s vitals (BP:  142/90, HR: 74, SPO2:  97%).  Client finished drinking his water and declined a snack.  Client stated he was ready to go and would meet his brother-in-law downstairs.  At 14:20 Lead Nurse walked client outside.  Client walked with a steady gait when exiting the building and continued to state he was ?fine and ready to go.?  Client stated he would sit and wait for his ride on the bench outside the building.  Lead RN educated client on both the potential side effects and adverse effects of the vaccine, when to seek medical attention, and ER precautions.  Client stated he understood and was ?ready to go.?
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0151), in right arm, on 29Apr2021 as dose 2, single (Lot number: EW0175), in right arm and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8038) at the age of 62 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive, notes: The next day I tested and my result was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that no other medication in 2weeks. patient had no known allergies.
pt recv vax 22NOV95 & 6FEB96 pt devel a fever;the following day pt devel a chicken pox rash on legs, arms, back, chest & genital area;pt was seen in MD office 8FEB96;pt was recently exposed to wild-type virus;
Narrative:  COVID infection following COVID vaccine series 02/15 COvID-19 SCR (ORL) result: not detected 03/09, Pfizer, dose #1 03/30, Pfizer, dose #2 0426 COVID-19 SCR (ORL) result: not detected 08/03 pt cc: chills, cough, diarrhea, fatigue, fever, , loss of taste or smell, myalgias, dyspnea, sore throat exposure: unknown 08/16 COVID swab, result: detected 08/17 clinically resolved esr result: 2
Patient presented with 9cm x 4cm of warmth, swelling, erythema at site of Pentacel injection about 48 hours prior
1st dose; 7-8 day delayed rash on L arm near injection site. Red, raised only slight itch. Disappeared in 2 weeks. Applied cortisone cream a couple times. 2nd dose:  5 days delayed rash on torso, from side to side and up to arm pits, though slightly different each day. Red, raised no itching. Currently on day 7 of the rash, 12  days since the shot, no signs of rash going away. Tried benedryl but did not help.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. The nurse stated that on 30-DEC-2013, the patient (reported as client) was vaccinated with ZOSTAVAX Lot # J00F4211, Expiry date-September 2014, dose 0.65 ml, subcutaneous in the right arm (indication was reported as vaccine). The nurse reported that pharmacy got a call stating that patient had an adverse reaction. On an unknown date the patient developed pain in her right arm and the patient went to see her specialist, a rheumatologist. The rheumatologist diagnosed the patient with Polymyalgia rheumatica. The outcome of polymyalgia rheumatica was reported as not recovered/not resolved. Action taken with suspect product was not applicable. The patient sought medical attention. No product quality complaint was involved. The causality assessment was not provided. Additional information has been requested.
Left arm that received vaccination: could not raise arm and had chills for 3 days. Arm hurt when raised arm for 3 months. Arm hurts when raise arm very high at this time.
Shot given around 1130-12 AM - that afternoon, pain, redness swelling moving around to armpit and (R) breast. Pain down arm to the wrist. Next day redness, moved down around bicep area - saw nurse practitioner at her job 9/26 - prescribed cephalexin. 9/30/19 much better.
Erythema and edema upper rt arm from axilla to elbow. Started immediately after injection and worsened over 48 hrs. Trx: Prednisone and NORCO.
one hour after vaccine given pt broke out in hives, redness and puffiness to face.  parent given instruction to give Benadryl 2.5 ml now.  called parent 30 min after phone call,  hives had started to disappear
He started noticing the improvement more after his 2nd dose and at the end August 2021; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (He started noticing the improvement more after his 2nd dose and at the end August 2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breathing difficult.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (He started noticing the improvement more after his 2nd dose and at the end August 2021). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (He started noticing the improvement more after his 2nd dose and at the end August 2021) outcome was unknown.            Patient stated that prior to receiving his Moderna vaccine he always had problems with his lungs and breathing. During activity he couldn't run without breathing problems.  Concomitant product use was not provided. Treatment information was not provided.
Experienced dizziness the first 15 minutes and that evening around 9 or 10 experienced severe chills. and I took one Tylenol for it that night. I woke up at about 05:00 am with a fever of 101.6. My heart rate was elevated - racing heart. I took some more Tylenol -and I tried to sleep but it was hard to. After a few hours, I felt achy and sore but better. Three days later, had a run of skipped heart beats (Thursday) and heart palpitations. I called my regular doctor on Monday and on Thursday, I called the Cardiologist. I take a beta blocker when I have bad heart palpitations and they continued to happen but were better with the beta blocker. Within a few hours, on Thursday, the symptoms resolved. I still have heart palpitations but the vaccine may have increased them.
Patient received Pediatric Pfizer when they should have received the Adult/Adolescent Formulation.
allergic reaction; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as SINGLEDOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergic reaction (hypersensitivity) (non-serious) on an unspecified date. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
pt recv vax & was dx w/coxsackie virus (hand-foot-& mouth disease);
Starting day after vaccine, area was "red, irritated and itchy". I recommended a cool compress and Benadryl. *irritation was on RA.
PAIN IN ARM 2 TO 3 INCHES BELOW SITE OF INJECTION - LOW GRADE FEVER FOR 24 HOURS - SHINGLES RASH ON BACK 4 DAYS LATER ITCHY AND PAINFUL (STARTED TO SUBSIDE AFTER A COUPLE OF DAYS).
Patient received vaccine and was driving to observation where he went over curb and hit the back of fort pos. loc approximately one minute. Responsive to sternal rub. No airbags deployed. Restrained driver, and no damage to vehicle.  He was driving approximately 5MPH when he regained consciousness AOx3, strong pulse, respiratory even and unlabored, diaphoretic, lightheaded. 911 was called at 1207. Patient refused EMS and police on scene. Three staff members inside Fort that was hit. No injuries reported. Patient vomiting in AC and being observed. Patient did not want EMS being called again. Friend came and picked him up at 1420. Patient checked out with weakness, dizziness, respiratory even unlabored, 2+ pulse, skin pink, warm, and dry. Patient still did not want to be assessed by EMS again and wanted to go home.
Twitching after each Dtap - starts approx 2 weeks after vaccination and continues for about 1 month.  Twitches for varying lengths of time usually just as she is going to sleep.
Disorientation, chills, fever 101.3 then 100.2. HR 113  O2 Saturation 89%. Oxygen 0.2 liters given. CEFAZOLIN 2000mg IV given.
Pt recvd 2 doses of Engerix-B & exp numbness in feet p/2nd dose;
Information has been received from a Pharm D concerning her 19 year old son who was vaccinated with MMRII at 12 months of age and pre-kindergarten (in approx. 1988). It was reported on 2/22/02, that the pt "now" developed rubella. The pt did seek medical attention. Additional info has been requested.
Patient came to office on 2/22/15 for fever and follow up of a seizure. She has been ill for 5 days with fevers reaching 103 on the first day of the illness. She had some shaking with eyes rolling back on the day following her 6 month vaccines which included PENTACEL, Hep B, PCV13 and ROTATEQ. She was taken to the ER on 2/11/15 where diagnosed with febrile seizure. No work up for the fever was done as the fever was attributed to the vaccines received the day prior. Her mother has been giving her ibuprofen and TYLENOL "around the clock" but she has continued to run fever without any further seizures. Her mother feels she is irritable, not sleeping well and not eating well. She is taking fluids ok without emesis and does better when she has taken a dose of ibuprofen.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 20 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309987, 20220309972, 20220310306, 20220310363, 20220309858, 20220310590 and 20220310631.
Approximately two hours after the shot, a cold sore/blister popped up on my bottom lip. Within minutes, I felt  my tongue begin to swell and then my airway began to swell/constrict and it was difficult to breathe.  This caused my heart rate to increase and I was forced to lie down. I took an antihistamine and monitored my oxygen and had to remain lying down for about two hours. I then began to feel better. I did not have to use an Epi pen. I still felt dizzy with an increased heart rate and some difficulty breathing from time to time that evening, but it was better than the initial reaction. After that I had two incidents within the month after the shot of feeling like it was difficult to breathe again. Since April, I have not had any more incidents of difficulty breathing/constricted airway/heart racing. I was advised not to get the second dose due to my reaction. I informed my doctor of the reaction and then went for a doctor's visit a couple of months later to get a full check up  due to the two other incidents of difficulty breathing after the vaccine and to make sure everything seemed okay.
This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 13-month-old female patient who received BOOSTRIX (batch number 33AG5, expiry date 18th September 2015). Concomitant products included Hepatitis A, MMR, PCV13 and Varicella vaccine. On 6th January 2015, the patient received the 4th dose of BOOSTRIX (intramuscular) .5 ml. On 6th January 2015, an unknown time after receiving BOOSTRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: a nurse reported that a one year old child was administered the BOOSTRIX vaccine by mistake which lead to an inappropriate age at vaccination and incorrect vaccine administered.