chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was in his usual state of health. He received the  J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal  pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on  6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction.  He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and  He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence.
Office visit for spreading rash on face, neck , arms, and legs. erythemic papules, vesicular, not pustular with increased number since morning. No involvement or lower trunk or groin. Cold symptoms for 48 hours. Symptomatic care, Benadryl in office.
Bruised from the injection; 1st dose 15-Apr-2021 and 2nd dose 04-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruised from the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-Apr-2021 and 2nd dose 04-May-2021) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-Apr-2021 and 2nd dose 04-May-2021). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Bruised from the injection). At the time of the report, VACCINATION SITE BRUISING (Bruised from the injection) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-Apr-2021 and 2nd dose 04-May-2021) outcome was unknown.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality for the event with Humira was a reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Redness, pain and swelling at site of VZV injection.  Pain noticed first, then upon examination the redness and swelling was discovered. On 01/28 patient took Benadryl and swelling has progressively gone down.  Still some redness and swelling at site, but pain has resolved.
This is a spontaneous report from a contactable consumer (patient). A patient, of an unspecified gender and age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Mar 17, 2021, single dose, for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, on Feb 20, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. On Mar 17, 2021, patient experienced diarrhea, headache, vomiting, muscle pain, tiredness and a little bit of fever (not much). The evening of the Mar 17, 2021, adverse events took place. The patient did not want to know anything and just wanted to inform of the adverse effects after getting the second shot. The patient just wanted to report illness/ill effects after the 2nd shot. They experienced mostly everything on list: diarrhea, vomiting, headache, muscle pain, tiredness and little bit of fever (not much). The outcome of the events: unknown. No follow-up attempts needed. Information about batch/lot number cannot be requested. No further information expected.
Pt sustained seizure like activity for approximately 20 seconds. Pt became postictal without intervention. Pt maintained an open airway and breathing during the seizure activity. Pt was able to ambulate after the activity. Pt's vitals were assessed and found to be within limits. Pt refused transport to a medical facility. Pt was released to parent.
Headache, Myalgia, Fever, Chills, Injection site pain/swelling  Narrative:
Hypertensive, 155/113, dizziness, nausea, shaking, flushing, sweating
I had a miscarriage after receiving the flu vaccine. I was 9 weeks and 1 day pregnant when I received the vaccine. I only got the vaccine at this point in my pregnancy because my job requires it by a certain date (at that point, it was required by February 14, 2022. As of February 11, 2022, it was extended to March 31, 2022). Otherwise, I would've never gotten the flu vaccine while in my first trimester of pregnancy. This was my first pregnancy and my due date was September 6, 2022.
ZOSTAVAX given on 11/14/14. Patient started with rash on "1st part of December 2014".
Headache, Myalgia, Fever, swollen neck glands, stomachache, fatigue for 2 weeks Narrative:
Decreased level on consciousness starting shortly after vaccine administration with excessive sleep and difficulty being roused and then subsequently an hour of decreased responsiveness with a period of several minutes of rhythmic lip biting concerning for seizure activity.
1 week after vaccine itchy red area around vaccine site, feels hard and warm. I put Hydrocortisone  1%. It?s not terrible.
First couple of weeks was extreme mental fogginess.  I am currently experiencing mental fogginess and short term memory loss throughout my daily activities; work, family.
The evening she received the vaccines she had some throat tightness, next day had sore arm.  Three days later she described tightness in her chest that has not resolved
Information has been received from a health professional concerning a child patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed chickenpox. The child was taken to the emergency room three times related to chickenpox. The reporter also mentioned that they have been seeing "alot" of cases of chickenpox post vaccination with varicella virus vaccine live (WAES #0304USA01562). Additional information is not expected.
Increased fatigue, nausea, redness and inflammation at injection site. Numbness and tingling in hands . Muscle aches . Dizziness ,  generalized weakness
Terrible joint pain; Muscle aches; Headaches; Nausea; Terrible fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: PF2590), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EN6201, Anatomical site of vaccine administration: Left arm), administration date: 10Mar2021, for Covid-19 Immunization, reaction(s): "Terrible joint pain", "Muscle aches", "Headaches", "Nausea", "Terrible fatigues"; BNT162b2 (DOSE 2, SINGLE, Lot Number: ER8732, Anatomical site of vaccine administration: Left arm), administration date: 31Mar2021, for Covid-19 Immunization, reaction(s): "Terrible joint pain", "Muscle aches", "Headaches", "Nausea", "Terrible fatigues". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered", described as "Headaches"; MYALGIA (non-serious) with onset 2021, outcome "recovered", described as "Muscle aches"; NAUSEA (non-serious) with onset 2021, outcome "recovered"; FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "Terrible fatigue"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered", described as "Terrible joint pain".  Additional Information: Beginning with the first vaccine, within hours and within minutes for subsequent does she had terrible joint pain and muscle aches in all parts of her body at various times; she also had headaches, nausea and terrible fatigues. The reaction after the first lasted about 2 weeks. She reported this reaction when she went for the second dose. She had the same types of reaction for the 2nd dose, but the issues lasted about 6 weeks. She reported the reaction when she went for the first booster. Again, had a similar reaction which lasted a few months. When she went for the second booster, she reported her previous reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258400 same patient/event, different drug dose;
24 hrs erythema-swelling > 2 inch. No anorexia, can move limbs.
First shot 11/6/21 Sat; on Tues 11/9/21 started diarrhea and overall icky feeling. Wed 11/10/21 start experiencing dizziness and tinnitus (never had tinnitus before).  All symptoms except tinnitus left on Friday, 11/12/21. Second shot 11/27/21 Sat around 12 noon (time not noted on my card).  At 8pm the same day, my left foot and joints in both hands swelled and the tinnitus got far worse. The tinnitus has remained ever since and it has stunted the progress I was making with my RA.  To this day it has remained. I may have to start taking injections for my RA that I cannot afford.  Silence is deafening to me now and I cannot wait until this vile "vaccine" leaves my body.  I will never take any boosters due to these medical issues.
Sedation, Myalgia, Fever, NauseaVomiting, chills Narrative:  Other Relevant History:
Felt flushed and arm swelled up at injection site to size of a gold ball. Hospital staff supervising required ingestion of 25 mg Benadryl immediately upon reaction. Was monitored for 40 min and sent home from work. Within  a few hours began to feel body aches and headache.  Over the next few hours developed low grade fever 99.6. Pain at the injection site , which I was expecting.  I called employee health and reported my symptoms. Was instructed to take ibuprofen or Tylenol for symptom management, to hydrate and rest. Took 600mg ibuprofen. That evening, the same symptoms became worse and I became very weak and nauseous. Also my heart rate became elevated . I usually sit in the 50-60s as I?m an avid exerciser. My HR remained in the 90s- low 100s over the next 48 hrs . The following day (day 2) I had all the same symptoms despite taking 600 mg ibuprofen around the clock. Continued to notify employee health as instructed.  Day 3, I had to return to work, temp (with 600 mg ibuprofen on board) was 99.2. I was still achy and headache and weak but less than the previous days. Notified employee health again & was instructed to get a covid test the following day if symptoms didn?t subside.  Day 4 , the symptoms mostly passed. No fever . No body aches. No more heart racing only very slight nausea . Very slight headache. Energy mostly returned. Pain at injection site replaced by itching and bruise at injection site.
Guillain-Barre Syndrome Dx at hospital 7/13/07-Spinal Tap 6/25/08-Started falling down-Then became weaker loss of function of upper and lower extremities-Pain in arms and legs- TMT at hospital IVIG-5 tmts-Extensive Rehab. 10/28/08 Reviewed hospital medical records of 7/4-7/10/2007. FINAL DX: likely acute inflammatory demyelinating polyneuropathy. Records reveal patient experienced fatigue, anorexia & progressively ascending weakness x 10 days.  Recent UTI tx w/antibiotics.  Exam revealed areflexia throughout. Tx w/IVIG x 5 days.  Improved but still w/significant weakness & d/c to rehab facility.    10/31/08 Reviewed EMG/NCS report of 7/5/07 which states findings c/w primarily axonal motor sensory polyneuropathy with suggestion of mild conduction block that implies superimposed demyelinating component.  Diabetic neuropathy w/possible superimposed acute or subacute inflammatory process suspected.
Information has been received regarding a case in litigation concerning a male child who on 12/18/95 (lot # 616351/1204B), 1/18/96 (lot # 616351/1204B), and on 9/18/96 (lot # 619088/0135D) was vaccinated with three doses of hepatitis B virus vaccine. It was alleged that as a result of exposure to thimerosal, and the mercury contained in thimerosal, from vaccines, he sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder. It was also noted that on 3/13/97 the patient received a dose of MMR (second generation) (lot # 618453/0473D). Upon internal review, neurological injuries and autism spectrum disorder were considered to be other important medical events (OMIC). No further information is available.
Patient received two doses of Pedvax Hib on 08/10/22 and it should have only been one dose. The patient had no adverse reactions.
A non-serious, spontaneous report of fever was received from a consumer concerning a 47-month-old female patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No relevant medical history was reported for this patient and the patient was not receiving any concomitant medications. The patient received FLUMIST intranasal on 17 Aug 2009 at 9:30 AM for INFLUENZA vaccination. The patient has not previously been exposed to FLUMIST. On 17 Aug 2009 around 2:00 PM the patient experienced a fever reaching 102.2 Degrees Fahrenheit which was treated at home with acetaminophen. It was noted the patient's 18-month-old sibling was sick with diarrhea at the same time. The fever lasted for approximately 36 hours and was considered resolved on 19 Aug 2009.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' current conditions, concomitant therapies or medical history provided. On unknown dates, patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB lot # L045117, expiration date 06-OCT-2018 (dose was not reported). There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion of 29 degree Fahrenheit for 1 hour on unknown date. Data logger was involved. This is several report received from the same source. Additional information is not expected because there was no consent to contact physician.
Mom noted redness, swelling, heat, induration on right arm, size 1 day vaccine 12 x 6cm area of redness. today on right arm, no pain, swelling, heat, induration
Narrative:  Patient received first COVID-19 vaccine dose on 3/26/21 and the second dose appropriately on 4/16/21. Following the second dose he experienced flu-like symptoms which he was counseled were normal symptoms following a vaccination. About 5 days later on 4/23/21, he reported to an outside hospital complaining of chest pain that was "0/10" at present time. No medications were  given.
The baby refused to take her bottle; had only 4 oz at 03:00 and then none until she had 1 oz at 17:00. She slept all day, color dusky. Capillary refill in feet 5 seconds, hands/arms 3-4 seconds. Admitted for observation. She started to perk up around 19:00. Slept all night. Awake and alert the next morning. Then on 2/1/02, early afternoon, the baby developed a generalized erythematous maculopapular rash over her entire body. She was alert and smiling and eating well. Dx'd viral exanthem versus a drug reaction.
Flu vaccine 10/9 - started with chills, headache, muscle aches. Fatigue within 3 hours, symptoms lasted approx 3 day resolved with conservative rx.
Information has been received from a nurse concerning a 7 year old male who on 29-JUL-2009 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (Lot# 0508Y). The patient's mother called the office on 30-JUL-2009 and stated that on 27-Jul-2009 her son developed a headache and nausea. On 28-JUL-2009, when the patient awoke, the injection site was red, swollen, and itchy and there was a blister (one pox) at the site. The patient's mother had called about a year ago and mentioned that she thought her son had had a breakthrough case of the chicken pox. The patient was never seen in the office to have a diagnosis made. The patient was recovering. Additional information has been requested.
Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy.  Patient reports feeling short of breath but no noted drop in oxygen saturation.  Oral diphenhydramine 50mg administered.
The night of the vaccination, I felt fine until I went to bed, around 9:30pm.  I noticed my arm around injection site was swollen, hot and sore. When I laid my head down my head started to hurt. As the night went on I took pain reliever but to no avail. By morning, I had a moderate fever of 102, my head was pounding as it had been all night, waking me out of sleep, and I had body aches and chills. I spent the next two  days mostly in bed with these symptoms. I had an ease the third day, then the following day was fatigued and sore again but the headache was mostly gone. The symptoms worsen with movement . Around the 4th day after the vaccine, vertigo/ dizziness started. It is now 6 days after vaccination and I am still struggling with vertigo and cannot move my head quickly or turn fast otherwise I almost fall over. I have never had vertigo like this. The symptoms ebb and flow. I have not been to the doctor yet but have talked with the nurse at my doctor's office.
Arm pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Mar2021, outcome "not recovered", described as "Arm pain at injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021344405 Same reporter/drug, similar event, different patient
Continuoius muscle pain under/around left scapula, extending into left Bicep and tricep, with limited range of motion when truning head to the left. Contcted physician who stated that these are not side effects of teh drug, even though listed on CDC site. Pain has continued for more than 2 weeks, wil be seeking additonal medical treatment.
Narrative: Patient reported numbness in lower extremities and dizziness while siting. No additional information provided. Patient did not require additional intervention or follow up.
Vaccine expired on 13-Oct-2021 and placed in refrigerator on 18-Oct-2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 18-Oct-2021) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 18-Oct-2021.  No treatment medications were reported.
This spontaneous report was received from patient's friend refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (lot number and dosage not reported). On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and ZOSTAVAX. Additional information is not expected, as no contact details were provided.
Approximately 15 minutes after receiving vaccination, patient complained of burning and itching of her tongue.  No tongue swelling or any other symptoms at all.  After 45 minutes of observation, her symptoms were starting to abate.  No treatment other than water was given.  BP was notably elevated at 178/88, pulse 66.
Menopausal symptoms beginning again day after vaccine, including: hot flashes, night sweats, and fatigue.  Symptoms lessened over time, but continue mildly to date (Nov 5, 2021)
Swelling in armpit and knot at injection site, nausea, dizziness and feeling of extremely low blood pressure, paleness
grandma state's w/in 2 hrs of receiving shots, pt legs were swollen, shaking of body x 7 hrs, denies sz activity; state's t103.5; grandma called MD & instructed to watch pt & advise give DT only;
Redness, swelling 10 x 12 cm right upper arm, non-tender. Fever day after immunizations none today.