chrisvoncsefalvay/vaers-outcomes huggingface dataset:
states began hurting in lt arm, lt shoulder & chest on evening p/vax;redness & swelling of lt arm began 48hr p/along w/fever of 100 until today 3NOV97 arm still ached from elbow to shoulder;swollen & red 3 1/2" x 3" T100;saw MD;
Pt scheduled a visit to be vaccinated upon leaving the office on 6/3/21 (our clinic was held 6/10/21). Pt was 17 yrs. 10 months and was given the Janssen vaccine.
Symptoms per patient report, swelling, arm pain, low grade fever, on 13th and 14th better on 15th then nausea and diarrhea on 16th. By 17th all symptoms were cleared.
Information was received via telephone call from a nurse practitioner regarding a female patient, allergic to aspirin, who in 1993, was vaccinated with 3 doses of RECOMBIVAX from another provider and did not seroconvert. The patient sought medical attention in the form of an office visit for school-required physical. Additional information has been requested.
nose swelling; nose/ tender to touch on both sided; This case was reported by a pharmacist via call center representative and described the occurrence of nasal edema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced nasal edema and nasal soreness. On an unknown date, the outcome of the nasal edema and nasal soreness were recovered/resolved.   It was unknown if the reporter considered the nasal edema and nasal soreness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced nose swelling and tender to touch on both sided.  The event already recovered and the adverse events lasted 3 weeks. The reporter consented to follow up. The reporter did not had patient or vaccine's details and mentioned that she did not had that information but agreed to follow up. No further information was provided.
excursion was 3 hours to a maximum temperature of 12.6°C with no reported adverse event; received IPOL after the punctured vial was exposed to the excursion with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case is linked to case 2023SA239617.  This case involves a 13-year-old female patient who received IPV (VERO) [IPOL] after the punctured vial was exposed to the excursion with no reported adverse event and excursion was 3 hours to a maximum temperature of 12.6°c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 28-Jun-2023, the patient received 0.5 ml total dose of suspect IPV (VERO) Suspension for injection (strength: unknown) (lot: W1A101M, expiry date: 10-Feb-2025) via unknown route in unknown administration site for immunization and excursion was 3 hours to a maximum temperature of 12.6°c with no reported adverse event (product storage error) (unknown latency)  On 28-Jun-2023 the patient received ipol after the punctured vial was exposed to the excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
flushed feeling and dizziness soon after having vaccine.  resolved after 30 min obs.
Patient came in for the 1st dose of Moderna vaccine. Patient was asked to wait 30 minutes as she had a history of shortness of breath due to allergy to naproxen. Patient immediately stated that she had a strange taste after the vaccine was given. I sat in the booth with the patient for the 1st 10 minutes to monitored her. During that time she also described feeling suddenly fatigued/weak. I kept asking if she had any signs of anaphylaxis (shortness of breath, swelling of the month tongue or throat) which she denied. At 12 minutes of observation she rejoined her family at the post observation area and was continued to be monitored. Once her 30 minutes was up she stated that she still felt weak and had a strange taste and she stated that upon simple physical exertion (walking to the allergy aisle from the post observation area) she became short of breath. I did administer a dose of benadryl and and let her know if her if her shortness of breath becomes worsens I have an Epi Pen to administer and I could call emergency services. She declined me calling for emergency services and stated she would just go home and rest. I did give her a dose of Benadryl in the pharmacy and she purchased another bottle of Benadryl to take home, and she said she had Tylenol at home. I did call her again at 7PM just to check on how she was doing. Her husband said that she had been sleeping since she got home. I explained that could be a side effect of the Benadryl but the vaccination can also cause fatigue. Her husband confirmed that she did not have any worsen symptoms but was going to give her tylenol to combat any potential feve
Hospitalized 01/17/2022; COVID-19 positive 01/17/2022; fully vaccinated plus booster  Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 1/17/2022 Discharge Date:  1/19/2022 PRESENTING PROBLEM: Acute respiratory failure with hypoxia  [J96.01] Other acute pulmonary embolism with acute cor pulmonale  [I26.09] Acute pulmonary embolism with acute cor pulmonale, unspecified pulmonary embolism type [I26.09] Suspected COVID-19 virus infection [Z20.822]   HOSPITAL COURSE: The patient is a 71-year-old male with a history of essential tremor as well as diabetes mellitus type 2, mild obesity and dyslipidemia who presented with increasing shortness of breath on 1/17.  At the time of admission, CT showed bilateral ground-glass infiltrates as well as large PE with evidence of right heart strain.  Patient was started on heparin and admitted to the hospital service.  Film array was positive for COVID as well as RSV.  The patient was started on remdesivir and dexamethasone.  An echocardiogram was performed as biomarkers were elevated.  Ultrasound of the lower extremities did show residual clot in the left lower extremity in the popliteal vein.  Echocardiogram showed significant right heart strain and medical team was activated.  After evaluation it was felt the patient would benefit from a thrombectomy, but no need for IVC filter.  Thrombectomy was performed by IR on 01/18/2022.  After undergoing thrombectomy the patient's hypoxia resolved.  The patient was continued on heparin, and transition to Xarelto prior to discharge.  With clinical improvement, it was felt that he did not require further treatment with remdesivir, but was prescribed dexamethasone at the time of discharge.  Patient's thrombosis was considered precipitated by his COVID infection and recent long automobile trip, with 3-6 months of anticoagulation being recommended.  Pulmonary does recommend a repeat echocardiogram to reassess pulmonary hypertension in the next 90 days. As patient was clinically stable, he was discharged to home on 01/19/2022
Vesiculated rash that started at vaccine site (left arm) and has spread to neck, abdomen, legs, face and scalp.
No additional AE reported; Medical assistant reported that a dose of MMR II was inadvertently administered after its labeled expiry date.  The involved MMR II expired on 3/1/2023 and was administered on 3/3/2023.  The DILUENT used to reconstitute the MMR II was not expired.; This spontaneous report has been received from other health professional (medical assistant) concerning to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications included: sterile diluetnt (MERCK STERILE DILUENT).   On 03-MAR-2023, the patient was inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) subcutaneous injection, at a dose of 0.5 milliliter (ml) (strength, and route of administration were not provided; lot  number U006596 that was verified to be valid, expiration date reported and established as01-MAR-2023) for prophylaxis, after it was labeled expiry date (expired product administered). It was reported that the diluent used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not expired (strength, dose, oral route of administration was not provided; lot number W026513 that was verified to be valid, expiration date reported and established as 15-APR-2025).  No additional adverse event (AE) reported.
hemorrhagic stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 15Aug2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series completed, unknown manufacturer), for COVID-19 immunisation. The following information was reported: HAEMORRHAGIC STROKE (medically significant) with onset 22Dec2022, outcome "unknown", described as "hemorrhagic stroke".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash appeared on April 12, 2007 at site of MMR injection. Dk Red rash appeared several days later. Mother had intensive pain and stiffness after receiving MMR at 15 years of age
Patient received FLUZONE HIGH DOSE 10/25/13 and came on 10/31/13 with complaints of itching around vaccination site and redness around site, slight swelling.
Fever exceeding 100°F even after taking tylenol, body aches, running nose, bedridden for over 20hrs up to now. Symptoms have still not subsided at time of report.
At both the 2 month and 4 month vaccination, my son experienced a seizure lasting approximately 10 seconds. Approximately 1 week after receiving shots he was fussy, ran a temperature, had poor coloring. My son experienced a seizure at his two month and four month vaccination. Both seizures occurred approximately 1 week after the 2 and 4 mth. vaccination. During this time, my son was fussy, ran a fever on and off ranging from 99 degrees to 102 degrees. His coloring was poor as he appeared pale. At birth, he was a normal child. He made eye contact, would respond to voices as any normal child does, however, after the two month vaccination, my child started staring off into space, and would not longer turn his head when hearing a voice, each of the seizures lasted approximately 10 to 20 seconds, with my son's eyes rolling back in his head, body non-responsive. Both incidences occurred at approximately 9:00 PM when I was putting him to sleep for the night. The 2 month vaccination was performed by Dr. of the clinic on 06-18-08. I did not report his to the Dr. because I was notified shortly after that she was no longer in business, so therefore I also do not have information on the manufacturer, lot #, route/site. The 4 mth vaccination was performed by the County Health District on 8/20/08. My child is developmentally delayed and diagnosed Autistic. He is permanently disabled and will never recover! It is so important as patient's parent to report this information. I suspect that vaccinations harm more people in the population that is currently being reports and therefore the statistics are inaccurate on the likelihood of a child being harmed. Parents should have this kind of information available so they can make better choices for their children, and understand how a few unfortunate souls are sacrificed for the common good of society. To put it rather bluntly, being one of those parents of a child harmed by vaccinations kind of sucks. Thank you for your time in allowing me to report this information on my son's behalf.
Usual soreness/stiffness post-shot began evening of shot and has continued since.  Pain and restriction of movement began about a week after shot and have been increasing since.  Full-range of arm motion not possible.  Unable to do "push-ups.
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case is linked to case 2019SA077240 (same reporter). This case involves a 12 months old male patient who was vaccinated with a 0.5 ml dose of ACT-HIB with diluent (lot number: U6001AA and expiry date: 21-Feb-2019, dose in series and route of administration were not reported) in the right deltoid on 14-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine live PROQUAD; PREVENAR 13; PEDIARIX and HAVRIX on an unknown date. It was a case of actual medication error due to expired vaccine used. No side effects reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2011, at approximately age 75, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
After 5 minutes, patient began having joint pain and extreme fatigue. Within 30 minutes, the patient became very nauseous and began sweating.  Later that evening, patient became feverish.  The patient had taken 400mg Ibuprofen 30 minutes prior to the vaccine and took an additional 600mg that evening at 6PM. The following day, the patient had extreme sore arm and was barely able to lift arm.  She slowly started getting tired, chills, fever, and nausea throughout the day.  By the end of the day, the patient was feeling better.  The next day, the patient had mild arm pain, mild tiredness and mild diarrhea.
she has lymph node swelling and incidental palpable lump at right under armpit after the vaccine injection x 1 day
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Warm to touch at injection site; Left arm itching; Left arm got red; Left arm got swollen; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch at injection site), MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), VACCINATION SITE PRURITUS (Left arm itching), VACCINATION SITE ERYTHEMA (Left arm got red) and VACCINATION SITE SWELLING (Left arm got swollen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Mar-2021. On 10-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 17-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE PRURITUS (Left arm itching), VACCINATION SITE ERYTHEMA (Left arm got red) and VACCINATION SITE SWELLING (Left arm got swollen). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 10-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE PRURITUS (Left arm itching), VACCINATION SITE ERYTHEMA (Left arm got red) and VACCINATION SITE SWELLING (Left arm got swollen) outcome was unknown.        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.   No concomitant medications and treatment medications were provided. Patient was 28 weeks pregnant at the time of this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: Additional initial document attached.
Patient reported swelling of arm below injection site and increased temperature of skin on arm. She took BENADRYL and symptoms resolved after a few hours.
Within 1-2 minutes, post vax, a quarter-sized welt was observed at injection site and the area was warm to touch. Child was crying, no acute distress noted. Cool compress applied then ice pack applied to site. Phone call advised mother to check with pharmacist for possible over the counter antihistimine. Mother to follow-up with MD if problems occur. Child left with mother, ambulatory and playful.
husband tested positive for the virus; husband tested positive for the virus; This is a spontaneous report from a Pfizer sponsored program. A Contactable consumer reported for a male patient (husband) that he received the COVAX series of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration as a SINGLE DOSE for COVID-19 immunization in Jan2021. The patients past medical history and concomitant medications were not reported. Approximately, on an unknown date in 2021, the patient tested positive for the virus (COVID-19 and drug ineffective). The outcome of the events was unknown. It was unknown if the reporter was a health care professional. Information on the Lot/Batch number has been requested. The reporters contact information available to you or a sub-contracted party. It was unknown if the reporter the prescribing HCP.
NUMBNESS  IN THE RIGHT ARM.  CAUSES PATIENT TO WAKE UP IN THE MIDDLE OF THE NIGHT. CANNOT LIFT ARM.   HEADACHE.
Child had verbalized to her mother that she was nervous about receiving vaccinations today.  Child received three vaccines and appeared to have tolerated them well.  Upon leaving our clinic with her mother she said good-bye to two staff members.  Mother states as she was opening the car door, child sunk to the ground.  Mother picked child up and brought her into the clinic.  Child was awake and able to respond to questions.  Mother denies that child hit her head.  The only appears to be a small scrape on the left elbow.
Information has been received from a Certified Medical Assistant concerning a 16 year old female with physical therapy for hip issues who on 17-AUG-2010 was vaccinated with the first dose of GARDASIL (lot # 663559/1178Y). On 22-AUG-2010 the patient experienced pain in the groin which was diagnosed on 24-AUG-2010 as a swollen lymphoid in the left leg. The patient's swollen lymphoid in the left leg persisted. The patient sought unspecified medical attention. No further information is available.
PATIENT WAS GIVEN RECOMMENDED VACCINES FOR HIS AGE WHEN HE CAME IN TODAY FOR A WELL CHILD EXAM, PATIENT LATER WAS BROUGHT IN BY HIS MOTHER WITH A RASH TO HIS FACE, APPEARED TO BE A PRURITIC RASH, PATIENT WAS IN NO DISTRESS, NO FACIAL OR LIP SWELLING.  I GAVE PATIENT BENADRYL 12.5 / 5ML Q 4-6 hrs. PRN ITCHING/ALLERGY. PATIENT MOTHER INSTRUCTED IF ANY SYMPTOMS OF ALLERGY/RASH, STARTS WHEEZYING, ITCHING TO CALL ME IMMEDIATELY AND CALL 911-GO TO E.R. ITCHING.
Head ache,  body ache,  chills, moderate fever,  stomach cramps,  vomiting,  diarrhea weakness,  ear ache,  eye ache all within 4 hours of vaccine and continues on to now 48÷hours
Redness; swelling; Itching; Pain in arm; Heat in the arm; A spontaneous report was received from a nurse  concerning a 60 year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness, swelling, itching, pain in the arm, and heat in the arm.  The patient's medical history was not provided. Products known to have been used by the patient were not provided.  On 23 Dec 2020, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.    On an unknown date, the patient experienced delayed adverse reaction reported redness, swelling, itching, pain in the arm, and heat in the arm.   Consent obtained for follow up.  Treatment information was not provided.    Action taken with mRNA-1273 in response was not reported.   The outcome of the events, redness, swelling, itching, pain in the arm, heat in the arm were not reported.; Reporter's Comments: This case concerns a 60-year-old patient of unknown gender who experienced NS unexpected events of pain in extremity, pruritus, swelling and skin warmth and NS expected events of erythema. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-003304: US-MODERNATX, INC.-MOD-2021-003308: