chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid + on 10/27/2021. Vaccinated with Janssen on 05/25/2021. ED Note: History of Present Illness  65-year-old male with a history of CHF, COPD presents to the ED for difficulty in breathing.  Patient denies ever being intubated in the past.  Patient states that he has been feeling this way for the past few days.  Patient also reports that he has had increased cough as well as decreased appetite.  States that he did get the Covid vaccine.  Patient was most recently discharged here less than a week ago for similar complaint.  Patient has a history of fluid overload and states that he has on a water pill.  Patient does not endorse any chest pain at this time.  Patient denies any nausea, vomiting, fever, chills.    65-year-old male who was recently discharged in the hospital 5 days ago presents ED for shortness of breath.  Per EMS patient was satting in the 80s on his home oxygen.  Patient was immediately placed on nonrebreather.  Upon arrival patient is very tachypneic, speaking short word sentences.  We did give patient a breathing treatment 10 mg albuterol, 1 of Atrovent, 2 of magnesium, 125 Solu-Medrol.  At this time we did also obtain blood cultures, lactic acid, basic labs, chest x-ray, Covid test, proBNP.  On exam patient did have diminished breath sounds.  A bedside ultrasound was performed that did not show any B-lines however patient's lower extremities are very edematous noted abdomen is distended.   X-ray did reveal a left lower lobe pneumonia.  Patient was started on HAP coverage on vancomycin and cefepime.  Patient does not have any leukocytosis.  proBNP is elevated greater than 3000.  Troponins 0.09 however patient creatinine is also elevated.  Not likely NSTEMI.  Patient denies chest pain.  Patient will be admitted to previous provider with ID and pulmonology on consult.   We had received patient's Covid result, it was positive.  This time patient be placed on isolation precautions.
at around 3:00pm I started feeling a sensation in my neck - left side...same side as injection - the sensation traveled up to my eye - left side including my face on the left side.  It felt like I had gotten a shot of novocaine (like at the dentist office) - the left side of my face became numb as well as the left side of my mouth and tongue.  My teeth felt funny and I developed a taste of metallic periodically.  My left ear felt clogged and also was numb. It has been almost 24 hours and I still have numbness and ear problems...but it is a little better.  The injection site is red (about the size of a golf ball) and it is very hot to touch.  The pharmacist told me to take tylenol and benadryl .  I am calling my primary Dr. today
Stroke; This is a spontaneous report from a contactable nurse (patient wife). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in right bicep on 11Oct2021 (at the age of 65-years-old) as dose 3 (booster), single for COVID-19 immunisation. Previously the patient received first and second dose of bnt162b2 on an unsoecified date for COVID-19 immunisation. Medical history included hypothyroidism and. Concomitant medications included losartan and levothyroxine, both taken for an unspecified indication, start and stop date were not reported.  The patient experienced on 11Oct2021, 10 hours after vaccination. The patient had lab work done right before he got the shot and he has had done multiple lab works since he  had the stroke. He had a physical, he had his blood work for his physical Monday morning before the stroke. So, he had a CBC, he had a chemistry, he had lipids and cholesterol, he had TSH and T3, T4 and since then he has had every test known. The event was treated with TPA (Alteplase), the dose of TPA was 90 mg, the maximum dose allowed, the complete name is TPA and it is also known as Alteplase (as reported). The outcome of event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of stroke. The case will be reassessed once new information is available. 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
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (lot # L044529 and expiration date 09-FEB-2017, lot number M003486 and expiration date 27-MAR-2017, dose and route of administration were not reported). The temperature of the excursion was 23F with the time frame of 1 hour and 30 minutes. Those conditions were back in range. There was previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient received Kinrix Dtap + IPV instead of Pediarix vaccine. Nurse misread label and vaccination schedule provided by office. Provider notified, patient's mother notified. No adverse reactions reported. Patient to return in 4 weeks for proper vaccine.
Patient presented on 6/28/21  for 2nd dose of COVID vaccine. Patient was previously vaccinated with Moderna on 5/29/2021 He denies any pain or discomfort reported on 6/29/21
I had spine surgery 2 weeks following 2nd injection. Woke up left arm paralyzed elbow down but I also got Meralgia Paresthetica bi-lateral and the thighs burning and nerve pain has not subsided nor responded to any treatments. Could be the vaccine did some sort of nerve damages to my body.
Information has been received from a health professional concerning a 12 month old female who was vaccinated with a 0.5ml dose of MMR II/Varicella vaccine. Suspect vaccination that day included other shots (unspecified). Subsequently the patient experienced an adverse experience/effect (unknown). There was no product quality complaint involved. Additional information has been requested.
pt recvd vax 17MAY93 & 17MAY93 pt exp nausea, joint/neck pain, h/a, sore shoulder;
Collapse, shock-like state. Seizure. Severe redness and swelling at injection site.
Per vaccinator,  while administering vaccine he pushed the dose and after the plunger reached the end of the syringe (full dose given) the needle broke off of the syringe at the hub. Vaccinator gently removed needle and hub from patient's arm. A replacement dose was not needed or administered as the patient received the full dose.  Syringe and needle was different brand.
20 min after injection, I almost lost consciousness and my heart started pounding irregularly, hard, and out of sync. I would say I was 90% passed out, barely hanging on to consciousness. Luckily I was close to a fire department so I ran in there. My heart eventually calmed down after maybe 20 min. Then, March 15 from about 3am-5am,  I woke up & couldn't fall back asleep. My heart was pounding hard and out of sync again, and I almost passed out again. I had the paramedics come and check me out, but they found nothing odd. My pulse oximeter was spiking to 130 bpm and going down to 90. Standard resting bpm for me is 70. I have also had non-stop ringing in my ears ever since Dose #2.
8:40AM HA, Dizziness, N/V, placed pt lying down with feet elevated. Ammonia inhalant used, ice pack for HA.
Facial swelling, angioedema. Entered emergency room on 8/5/2017 at approximately 1:15 PM.  Treatment included IV administration of dipenhydramine, epinephrine, famotidine IVPB, methylprednisone. Discharged at approximately 8:30 PM. NOTE: Spouse recieved same vaccine on the same day, and is experiencing the same symptoms two days later.
PAIN AT INJECTION SITE. Narrative:  EMPLYEE C/O PAIN AT INJECTION SITE, PAINFUL SWOLLEN LYMPH NODE ABOUTTHE SZ OF A WALNUT IN THE  ARMPIT WHICH WAS THE SAME SIDE AS INJECTION SITE/SIDE
Severe headache; Muscle pain as far as in my neck; Sinus pressure; I have been feeling pretty tired off and on; This is a spontaneous report from a contactable other HCP (medical assistant, patient). This 50-year-old female Patient received the 1st dose of BNT162B2 (COVID-19 Vaccine, Batch/lot number: Unknown) on 08Jan2021 at single dose for covid-19 immunization. Patient history was Migraine. Concomitant drug was chronic migraine medications. Patient stated having a severe headache this morning, muscle pain as far as in neck and sinus pressure and felt pretty tired off and on from 12Jan2021 morning. Treatment: just had been taking Tylenol for headache. She took 500 mg, took two of them it is like took 1000 mg till this morning. Outcome of the event was not recovered.  Information about lot/batch number has been requested.
5-10 seconds after injection, I felt a surge of warmth, became flushed and heart began to race a bit.
Patient received two doses of the second booster shots. Patient received their second booster dose on 6/7/22, and then received another booster dose on 6/28/22 in error. Both were Moderna 0.25ml.
Pt had redness starting day after injection. Low grade fever started 4/10 with increased redness. Consulted with MD on 4/11 who diagnosed cellulitis and prescribed an antibiotic.
No additional AE or PQC reported; HCP reported PNEUMOVAX 23 was administered after the expiry date.; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-FEB-2023, the patient vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (expiration date: 14-JAN-2023, strength, dose, frequency, route, and lot # were unknown) for prophylaxis (Expired product administered). No additional AE or PQC reported.
Information has been received from a nurse concerning a 36 month old male who on 07-MAR-2006 was vaccinated with a first dose of PEDVAXHIB (OMPC) (lot number, injection site and route not reported). On 10-MAY-2006 the patient was vaccinated with a second dose of PEDVAXHIB (OMPC) (lot number 652699/0890R) (injection site and route not reported). On 11-JAN-2007, the patient was vaccinated with a third dose of PEDVAXHIB (OMPC) (lot number 653769/0406F) (injection site and route not reported). On 04-APR-2007 the patient was vaccination with a fourth dose of PEDVAXHIB (OMPC) (lot number 654910/1270F) (injection site and route not reported). Subsequently the nurse reported that the patient "may have autism". It had not been officially diagnosed. The patient was brought to the physician's office. The patient's event persisted. Upon internal review, autism is considered to be an other important medical event. Additional information has been requested.
So there are five of us that were infected.; No one else in the family had received a full dose for their booster.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (So there are five of us that were infected.) and ACCIDENTAL UNDERDOSE (No one else in the family had received a full dose for their booster.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1), Moderna COVID-19 Vaccine (Dose 4), Moderna COVID-19 Vaccine (Dose 3) and Moderna COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (No one else in the family had received a full dose for their booster.). In December 2022, the patient experienced COVID-19 (So there are five of us that were infected.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (So there are five of us that were infected.) had resolved and ACCIDENTAL UNDERDOSE (No one else in the family had received a full dose for their booster.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Reported that patient has received Moderna boosters around October November.  Reported that patient was sick and did not got seriously ill and sick.   This case was linked to US-MODERNATX, INC.-MOD-2023-745748 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2023: Live Follow-up received that contains significant information: Reporter, patient detail, medical history, treatment medication, event details and Refence Ids updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745748:Father's or Reporter's case
The patient developed severe pain in her right arm where the second Garadsil vaccine was placed. I saw her 1 week after the vaccine was administered, and the site of the vaccine was swollen and the pt had excruciating pain.
first dose received on 29th March, still has not taken second dose (36 days passed since first dose); This spontaneous case was reported by a patient and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (first dose received on 29th March, still has not taken second dose (36 days passed since first dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (first dose received on 29th March, still has not taken second dose (36 days passed since first dose)). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (first dose received on 29th March, still has not taken second dose (36 days passed since first dose)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Headache, Malaise, rash, Pharyngitis, Information has been received from a health care professional concerning a 25 year old Hispanic female patient with no known medical history or allergies who on 8 Jun 2000.  In the morning, was vaccinated in the right upper arm with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #633016/12803).  Concominant vaccinations that same they were a second dose of hepatitis b vaccine recombinant (yeast) (MSD lot # 630591/17353) given vie the left deltoid.  On 12 Jun 2000 the patient developed a diffuse red rash associated with headache,  slight general malaise and sore throat.  The rash on her arms, trunk, and thighs was approximately 20 pustules which were were separate raised and red fluid filled.  These pustules were tender and painful, no itching was noted and they lasted approximately 4 days.  Medical attention was sought.  Subsequently the patient has recovered. No further information is expected.
Patient stated a few hours (early afternoon) developed tongue swelling, heart racing, itchiness on top of head. Reported to her PCP, and was seen in ER for BENADRYL and steroids (RX home steroids and BENADRYL) T/C to BD: no latex in cap on packaging. No BAND-AID used (gauze post vax) no gloves used, hand sani: alcohol 65%).
On 4/3 observed rash arms, hands, face and neck woke developing a redness that I first thought was sun burn. Over the course of the next two days it appeared to be getting worse and I was experiencing itching in all those areas. 4/6/09 I went to the Clinic and saw Doctor. I was sent to ER. I was seen by Doctor and PAC in the emergency room. I was given a BENADRYL injection and a steroid injection. I was released from the ER with prescriptions for HYDROXYZINE formula and PREDNISONE with instructions to see my dermatologist. I saw the dermatologist on 4/9/09. She felt that the rash was improving, however she did prescribe a topical ointment for the arms, face and neck. I am to follow up with her on Friday April 17th.
Rash on inside of both elbows and beneath chin. Rash itches and burns. Rash first presented about 10 p.m. and worsened overnight. Managing symptoms with OTC Benadryl.
MMR administered Left anteriolateral aspect of thigh.  Couple minutes after vaccine  administration small rash developed upon injection sight. PCP notified of reaction. Patient  treated with diphenhydramine HCL 12.5/5ml elixe. 6.25mg po
SARS-CoV-2 Ag Resp Ql IA.rapid~SARS-CoV-2 Ag Resp Ql IA.rapid performed on 7/26/21. Test came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
Flu-like symptoms: Chills, shakes, body ache, diarrhea, headache for approximately 8 hours.
Stroke; Mild headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at right arm on 23Mar2021 (68-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient had no COVID prior vaccination and no known allergies. There were other concomitant medications (unspecified) in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 02Mar2021 at 16:15 (68-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. On an unspecified date in 2021, the patient experienced mild headache day after second vaccine. On 27Mar2021 at 09:45, patient had a stroke. The adverse events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 4 days. Therapeutic measures were taken as a result of the events and included "testing regarding stroke" (as reported). The outcome of the events was recovering.  Information on the lot/batch number has been requested.
her heart was racing due to "adrenaline rush"; heart was racing; dry mouth increased; felt lightheaded; numbness in her hands and feet worsened; tingling in her hands and feet worsened; tingling in her hands and feet worsened; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 vaccine with an associated reaction of dizziness (received COVID-19 vaccine on an unknown date). Concurrent medical conditions included cerebral palsy, paresthesia, dry mouth and numbness. Concomitant products included botulinum toxin type a (Botox).   On 10th March 2022, the patient received the 1st dose of Shingrix (intramuscular). On 10th March 2022, less than a day after receiving Shingrix, the patient experienced tachycardia, heart racing, mouth dry aggravated, light headedness, numbness of extremities, tingling feet/hands and condition aggravated. The patient was treated with glucose oxidase + lactoferrin + lactoperoxidase + lysozyme (Biotene) and muscle relaxants. On an unknown date, the outcome of the tachycardia, heart racing, mouth dry aggravated and light headedness were recovered/resolved and the outcome of the numbness of extremities, tingling feet/hands and condition aggravated were unknown.   It was unknown if the reporter considered the tachycardia, heart racing, mouth dry aggravated, light headedness, numbness of extremities, tingling feet/hands and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient also had lightheadedness, tachycardia, dry mouth and paresthesia after receiving a COVID vaccine at an unknown time in the past. The patient received dose of Shingrix vaccine at a pharmacy about 2 hours ago and immediately felt lightheaded. The patient felt her heart was racing. She was not sure if the racing heart was due to the vaccine or walking up a flight of stairs. The patient had a history of chronic dry mouth. The dry mouth increased immediately after the injection. The patient also had a history of numbness and tingling in her hands and feet and it worsened. The patient took Biotene to treat the dry mouth and was recovered. The patient also took Botox and muscle relaxants as a treatment medication. The patient consulted the pharmacist who administered the vaccine and he felt the effects were due to adrenaline rush after getting a vaccine. The reporter consented to follow-up.
Patient was eligible for Pfizer booster, but received Moderna due to lack of query and checking her vaccine card.
Received MENACTRA and GARDASIL. 5 min. later passed out for "10 seconds" per dad.
shpulder pain for 30 days after, lethagic, ra symptoms, flu like sdymptoms, migraines, joint pain
2-24 hours post injection - inject site soreness, chills, flu-like symptoms 24-33-symptoms diminished-only site soreness 40 thru 96 hours - EVENT - repeat of increased site soreness, flu-like symptoms, achiness w/ radiating pain (various locations) esp thorasic muscles
Information has been received from a pharmacist concerning a 66 year old female patient with no pertinent medical history who on 06-JUN-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). On 07-JUN-2010 the pharmacist called the patient to check on her and the patient stated that the injection site was a little red and she had a rash on her chest that was the size of a hand, but it's not itchy, spreading or raised. It was reported the patient did not seek any medical attention. No laboratory diagnostics studies were performed. At the time of the report, the patient was not recovered. Follow up information was received from the pharmacist concerning a 65 year old (previous reported as 66 year old) retired female patient who on 06-JUN-2010 at 13:00, was vaccinated with the first 0.65 ml dose of ZOSTAVAX (Merck) (lot # 664636/0847Y) SC into the right side. There was no illness at time of vaccination. On 07-JUN-2010 at 08:00 ("one day after vaccine"), the patient developed a self-limiting rash on her chest and neck. On 09-JUN-2010, the patient was recovered. The patient did not seek medical attention. Additional information has been requested.