chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Everything was good the first day. The next morning, I had severe chills that lasted about 6 hours. During that time, I started getting a temp, the highest was 103.3. I called my doctor and she seemed convinced that it was something else because she hadn't seen that reaction before. I then had developed a headache. The fever took several days to go away. My doctor (via phone) told me to take Tylenol.  I also had tingling in my right hand, extreme fatigue, joint stiffness and swollen lymph nodes, which remained swollen for at least a week. I was in bed for over 24 hours. It eventually started it get better after a few days. I also had an antibodies test before I got the vaccine and two days later I found out I had positive antibodies--and this was 6 months later (I had COVID in July). I had the same reaction with Dose 2.
Rash; Hives; This is a spontaneous report from a contactable consumer, patient.  A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2618) via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease and blood pressure high. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, the patient experienced rash and hives. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events of rash and hives were not recovered at the time of report. Patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EP7533) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Started out as very mild itching just above both ankles but below the  knees.   Starting on Friday, six days after receiving the shot, the itching  was a little more aggressive. I started to use  over the counter Hydrocortisone .5% level, which helped.  The inching is not severe just agitating .
PT's upper arm to elbow was red still on 10-2 after getting shot 9-30. It wasn't painful or itchy. Told him to Monitor if gets worse + call MD if so.
Information has been received from a physician concerning a female child who on 9/27/04 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Seven to ten days after vaccination the patient experienced a rash at the injection site with 5 to 10 lesions. No other symptoms were noted. Subsequently, the patient recovered from rash at the injection site. Unspecified medical attention was sought. There was no product quality complaint involved.
She received her first COVID vaccine on 1-13-21 and her second on on 2-3-21. She was hospitalized for shortness of breath and multiple subsegmental pulomnary emboli without acute cor pulmonnale.  Other active hospital problems were: acute hypoxemic respiratory failure due to CVOID-19, acute kidney injury, lower limb ischemia.  Patient was admitted to the hospital on 6-22-21 and tested positive for COVID-19 on 6-30-21. Patient was put on comfort measures on 7-9-21 and died at the facility on 7-12-21.
Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Employee at SNF experienced the following symptoms: vomiting, fever, shortness of breath, and chest pain. Employee was taken to hospital and discharged on 4/28/21
Patient reports sudden pain and loss of muscle control in the forearm. She says she would be doing regular functions and lose control. Also reports headache, sore throat and generally unwell, also reports body ache and fatigue.
Patient was sent to this office to receive diptheria, tetanus, pertussis immunization following recommendation of pediatrician after delivery.  Medication was ordered from hospital pharmacy and administered.  It was then noted that the medication received was "Infanrix" which is not approved for adults.  CDC notifed, transferred to public health advisor who reports that patient should not experience any serious adverse effects from immunization.  May have slight increase in local reaction if anything.  Indicates that appropriate immunization would be Boostrix or Adacel.
Initial unsolicited report received from a consumer (patient) on 19 April 2016. This case involves 68-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number and site of administration not reported) intramuscularly on an unspecified date in 2014. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions included rheumatoid arthritis (ongoing). Concomitant medications were not reported. On an unspecified date in 2014, four days following the vaccination, the patient's rheumatoid arthritis flared up like never before.The patient had also experienced pain and achiness in her arms, legs and neck. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received methotrexate which she never had before (ongoing) and prednisone received as corrective treatment. On an unspecified date, the patient was recovered from the events. Upon internal review the case was considered as serious because of important medical event rheumatoid arthritis which flared up like never before. List of documents held by sender: none. Sender's Comments: Rheumatoid arthritis is not expected following INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset seems to be compatible with a role of the vaccines. The rheumatoid arthritis is not medically confirmed (because case is reported by consumer). The case is poorly documented. Complementary information regarding patient's condition at the time of vaccination, patient's medical history, concomitant treatment, as well as investigation results confirming the diagnosis (ESR, CRP, CBC, rheumatoid factor, antinuclear antibody assay, anti CCP, CT scan, MRI) and exploring alternative etiologies are needed to further assess the case.
Pt recvd 3 doses (dates not recorded) of Engerix B. Titers checked 6 mos p/ last dose. Titer result was 5.6 indicating a low positive repsonse.
This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates, between 02-AUG-2015 and 31-AUG-2015, the unspecified patients were4 vaccinated with RECOMBIVAX HB that was improperly stored (dose, strength and route of administration were not provided). Co-suspect or concomitant therapies were not reported. The lot number reported for RECOMBIVAX HB was K010535 with expiration date on 27-AUG-2016. This is one of several reports from the same source. Additional information has been requested.
No additional AE information; Customer calling to report MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient.; Customer calling to report MMRII that had been reconstituted with expired diluent had been inadvertently administered to a patient.; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.     On 30-MAR-2022, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (indication: prophylaxis; strength, dose, route, lot# and expiration date were not reported) that had been reconstituted with expired sterile diluent (strength, route, indication were not reported; 1 dose, lot # S025290, expiration date: 20-MAR-2022) had been inadvertently administered to the patient (expired product administered and product preparation error).  Vaccine was not expired and did not experience any temperature excursions. Sterile diluent had not experienced any temperature excursions. No additional adverse event information was reported.
Swelling of lateral aspect of left upper arm; pink, hard and warm 18 x 15 cm on 7/22/14.
arm hurt; lethargic; achy; tired; felt weirded out that she drank coffee and went back to bed; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm hurt), LETHARGY (lethargic), PAIN (achy), FATIGUE (tired) and FEELING ABNORMAL (felt weirded out that she drank coffee and went back to bed) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included BIOTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and SACCHAROMYCES BOULARDII (FLORASTOR KIDS) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), LETHARGY (lethargic), PAIN (achy), FATIGUE (tired) and FEELING ABNORMAL (felt weirded out that she drank coffee and went back to bed). On 21-Feb-2021, PAIN IN EXTREMITY (arm hurt), LETHARGY (lethargic), PAIN (achy), FATIGUE (tired) and FEELING ABNORMAL (felt weirded out that she drank coffee and went back to bed) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reported considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a health care professional who reported on 16-JUN-2009 normal baby was born with congenital anomaly. The mother of the baby was vaccinated with a first dose of GARDASIL (lot # not reported) on 23-SEP-2009. Also the mother's baby received concomitant therapy MOTRIN and promethazine. At the time of this report, the baby's outcome was unknown. The mother adverse event was capture WAES# 0810USA04931. Additional information has been requested.
About 3 hr later I got a headache/migrane which remained the remainer of the day. The next morning the area around the injection site was a raised,  warm, red golf ball sized so I went to UTC who advise to monitor and return if it got larger.  The next day it was larger, redder and still warm so I went back to UTC who prescribed Cephalexin but was only advised to use if it got even larger.  During the day it seemed as if it disappeared and returned at night for about 9days. After it never disappered I began taking the 7 day course of the Cephalexin.  On 1/6 and 1/8 after the starting the antibiotic I got a massive headache preventing me from going to work and afterwards no other symptoms but my arm still has a slight greenish/blue looking bruise on it.
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently, one month post vaccination the patient experienced idiopathic thrombocytopenic purpura. The patient sought medical attention. The patient's mother stated that her daughter will not receive the rest of the vaccine series. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, idiopathic thrombocytopenic purpura was considered to be an other important medical event. Additional information has been requested.
got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID". The reporter stated both of her kids got their booster doses too and both of them got COVID-19. The patient had flu-like symptoms for a couple of days but no one ended up needing to go to the hospital and no one ended up dying.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
When patient woke up the morning after the vaccine (given on 7/19; symptoms started 7/20), he experienced tingling feet; body aches; shortness of breath; chest tightness.
Pt stated that she noticed the pain and redness on the right arm close to the elbow. There was no pain or redness at the injection site.
The patient stated that she received a flu shot from us and had a lot of pain in her arm afterwards.  She said she had trouble sleeping because of it and since the pain didn't subside, she went to her doctor's office.  She took pain medications to help with the pain but it still hadn't gone away.  She went to the doctor's office on 12/19/13 again and they gave her a cortisol shot which finally helped her pain "by 80%" and is finally feeling better.
Patient received 0.5mL of the original moderna vaccination, instead of the bivalent booster. Patient was informed.
patient reported developing a bump below the injection site.   It was red, itchy and warm according to patient.  It developed mid arm, well below the injection site per a photo taken by the patient.  Rash started developing in the evening of 10/14/2020 and became worse each day.  The rash persisted until 10/16 which was the worse day for the reaction.  After that day it subsided and she was told by someone in her family it could have been lymphatic drainage.
Complaining of Nausea and Emesis (moderate amount) Patient Sweaty and Diaphoretic Cold and Clammy, chilled then warm Pulse up @132 steady and strong Blood Pressure 164/82, respiration - 22 patient sat on floor with head between legs Had sips of cold water Episodes of hot and cold Nausea x1 Emesis Alert and Oriented x3 10:38 patient states feeling better - pulse 72, respirations 16 no treatment needed monitored until she felt better
Hives all over the body; A spontaneous report was received from a Consumer concerning a unknown age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, hives all over the body after receiving the first dose of moderna covid-19 vaccine on January.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, Hives all over the body after receiving the first dose of Moderna COVID-19 Vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events, hives all over the body after receiving the first dose of Moderna covid-19 vaccine was not reported.   On an unknown date the outcome of events include, hives all over the body after receiving the first dose of Moderna covid-19 vaccine was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
hemophagocytic lymphohistiocytosis (HLH) on 4/30/99, 20 days p/vax;studies including bone marrow @ hosp revealed dx on 9th day of fever;pt on chemotherapy awaiting marrow transplant;viral infect, including varicella vax are known triggers
Patient complains of persistent pain around the right shoulder. Stated that the administrator might have given the shot too high up the shoulder. Pain has not been resolved after 3 weeks of administration.
Got a rash like I used to get when I was a kid in the bend of my arms. Looks like eczema, and it itches. I called the doctor and had a phone visit. The doctor prescribed a cream, and I'm going to pick it up today.
p/vax pt exp rash on leg & marked induration w/generalized urticaria; also conjunctivitis;
Information has been received from a physician concerning a 19-week-old female with no medical history who on 09-AUG-2007 was vaccinated PO with the first dose of Rotateq.  On the morning of 11-OCT-2007, the patient was vaccinated PO with second dose of Rotateq (Lot #656838/0968U).  Concomitant vaccinations administered in the morning of 11-OCT-2007 included the second IM dose of Daptacel (Lot #C2657AA), the second IM dose of Comvax (OMPC) (MSD) (Lot #657180/0224U) and the second IM dose of PREVNAR (Lot #C45888).  There was no illness at the time of vaccination.  The physician reported that on 12-OCT-2007, the patient developed meconium-like stool and diarrhea.  The stool was not tested and no other laboratory/diagnostic tests were performed.  On 14-OCT-2007, 36 hours after onset, the patient's black meconium-like stool and diarrhea resolved.  No further information is available.
Received flu shot at 0715. 1 hour after had a cough and symptoms progressed to sore throat, difficulty swallowing and throat feels tight. Reported rash and hives. Returned to school nurse. EMS called 11 AM and O2 given, Refused to go to hospital. Pt took 2 Benadryl tabs at home. Call made to pt at 5:45. She states feeling better.
Redness and swelling to LL. Advised to apply cool compress and give Tylenol for discomfort.
Continued and progressing weakness in arm and shoulder where some days I can barely hold an iPad, much less pick up a pan to cook.
10cm hot edematous red itchy welt at site of hep A/Dtap shot.
On Thursday, 7/1/21 I became very short of breath; by Sat pm 7/3/21, it had worsened such that I could only walk about 10 steps before almost passing out.  I was  out of town in a rural area, so the next am I drove 4 hours home (to  and then to  Hospital Emergency where I was promptly admitted for 5 days on cardiac telemetry and blood thinner medication.  The diagnosis was a large mid-thigh to mid-calf blood clot in my left leg, and a large saddle pulmonary embolism extending to the lower lobe of both right and left lungs.  Multiple doctors told me I was lucky to have survived.
Pt vaccinated with TD  developed pain & soreness starting on rt side of neck becoming bilateral extending into shoulder & upper back-intense at night. After 19 days symptoms subsided. Some relief w/muscle relaxer. On 13AUG90 developed rash.
Headache, fever, malaise began evening after getting the vaccine and more notable the next morning.