chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Following the vaccinations, my baby had severely worsened Moro reflex, especially when she was flat on her back (diaper changes, etc). She would display the Moro reflex 10-20 times in a row in rapid succession then scream, terrified. I'm pretty sure this was not a seizure, since it would stop after I picked her up. She was afebrile at the time. She kicked her toys without difficulty, so it was not from her legs hurting. She was not herself at all for several days after the vaccine. The heightened Moro reflex eventually dissipated and went back to normal after about 4-5 days. I read about this happening to other babies after vaccines on internet forums, but my doctor had never heard of this reaction.
TIREDNESS; COLD; ARM WAS A LITTLE TENDER; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included skin cancer, and mastectomy, and concurrent conditions included environmental allergy, and hay fever.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced cold. On 11-APR-2021, the subject experienced arm was a little tender. On 12-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold on 12-APR-2021, was recovering from arm was a little tender, and had not recovered from tiredness. This report was non-serious.
Chest tightness, pain, palpitations, low heart rate?feeling of his heart is being squeezed.
Had varicella vaccine 04/03/1997. Now (6/18/04) presents with full case of chicken pox.
Evening of 5-8-09.  Mom noticed a rash on child.  Child has had low grade fever.  Decreased appetite and fluid intake.  Fussy more than usual.  Pin head rash under eyes.  Sandpaper rash on torso, arms, legs (very few), & face
Shot given 3-2-15 at pharmacy didn't have AE and didn't hurt. About 3 days later had scarring/bruising rash down (R) arm and on (R) side stomach and breast (R). No pain but cosmetically disturbing. No previous rxns.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Stroke", start date: 2000 (unspecified if ongoing); "Back surgery", start date: 2001 (unspecified if ongoing), notes: Two back surgeries, in 2001 and 2017, both were on lower back. In 2017 they put titanium blocks in; "COVID-19", start date: Feb2021, stop date: 2021; "Used a cane" (unspecified if ongoing). Concomitant medication(s) included: APIXABAN, start date: 2021. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Feeling unwell". Follow-up (27Sep2021): Follow-up attempts completed. No further information expected.
Administered 10/8/07 at 10:42. Fever 102.9, weakness, to ER about 12 hrs after injection. Blood culture negative.
Left arm numbness and tingling from shoulder to tips of fingers, developed 1-2hr after immunization, constant, unresolved; other symptoms include vomiting, diarrhea, and entire arm soreness (unable to raise arm)
J96.00 ACUTE RESPIRATORY FAILURE 4/18/2021 COVID-19 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/18/2021 COVID-19 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 4/18/2021 NONTRAUMATIC ACUTE KIDNEY INJURY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/18/2021 NONTRAUMATIC ACUTE KIDNEY INJURY
Her arm was sore; She had a little headache for the day; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore) and HEADACHE (She had a little headache for the day) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced PAIN IN EXTREMITY (Her arm was sore) and HEADACHE (She had a little headache for the day). At the time of the report, PAIN IN EXTREMITY (Her arm was sore) outcome was unknown and HEADACHE (She had a little headache for the day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. 10-Sep-2021 patient got her second dose in her left arm at 9:40 AM, lot 053E21A, no expiration date reported. The same day around 4 PM her arm was sore, and she had a little headache. By 6 PM she had a chill. At 11:30 PM she woke up burning hot. Patient then felt nauseous, got up, and felt lightheaded. She went into the bathroom because she thought she would be sick to her stomach. She was sweating profusely and laid on the floor. According to her husband she lost consciousness for less than a minute. She came too and her nightgown and hands were drenched in sweat and then she vomited. After a minute or two she sat in the chair until the ambulance came at 11:45PM. They monitored her vitals and they were normal, so she did not go to the hospital. She was exhausted and went back to bed and woke up at 2:45 AM burning up and nauseous. She was propped up in bed, was given a cool washcloth and felt better. She went back to sleep. She woke up dehydrated and exhausted and drank a lot of fluids: 2 bottles of a sports drink and lots of water. By sunday she was fine.   This case was linked to MOD-2021-317642 (Patient Link).
gave the patient a booster even though they just got a booster 2 weeks ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (gave the patient a booster even though they just got a booster 2 weeks ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced EXTRA DOSE ADMINISTERED (gave the patient a booster even though they just got a booster 2 weeks ago). On 22-Dec-2021, EXTRA DOSE ADMINISTERED (gave the patient a booster even though they just got a booster 2 weeks ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided.  The patient was administered with one half dose booster and one full dose booster of vaccine.
rt upper leg puffy where got DTAP that day pt squealing;leg better next day-no lump or redness only sl swollen-smiling next day;
Patient fainted falling forward. Team went in and helped her lay down, took vital signs. Patient was stated she was very dizzy, waited in the room until dizziness went away
Information has been received from a pharmacist concerning a female who was vaccinated with a second dose of Gardasil (lot # not provided).  The patient developed a swollen tongue and edema of the extremities after receiving the second dose.  Subsequently, the patient recovered from a swollen tongue and edema of the extremities.  The patient contacted the pharmacy for medical attention.  No product quality complaint was involved.  Additional information has been requested.
experience his legs and arms shaking/quivering (went to ER for treatment) which resolved but came back the morning of 12Mar2021; This is a spontaneous report received from a contactable pharmacist (patient) via Medical information team. A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation Solution for injection dose, Lot number and expiration date was not reported) via unspecified route of administration on 10Mar2021 at single dose for COVID-19 immunization. The patient medical history concomitant medications were not reported. Historical vaccine included BNT162b2 first Pfizer COVID vaccine dose on 13Feb2021 for COVID-19 immunization, after which he experienced neck tightness and denies any issues with breathing. On 10Mar2021 the patient experienced his legs and arms shaking/quivering went to ER for treatment which resolved but came back the morning of 12Mar2021. As per the reporter seriousness criteria reported as hospitalization. Therapeutic measures were taken as a result of experience his legs and arms shaking/quivering went to ER for treatment which resolved but came back the morning of 12mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event tremor limb and the suspect drug. 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.
I was deathly ill the night of shot with diarrhea and vomiting and severe pain In my arm,  the next morning I was numb and tingling on tight side it has spread to whole body over 6 days and getting worse
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 14-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Erratic, high, unstable Blood Pressure, Joint and muscle aches, extreme fatigue with minimal exertion and random pain still persists intermittently since booster shot.  I take my blood pressure at the same time every day per my Cardiologist direction.  My blood pressure, controlled by medications, has been fine.  The day after the shot , and currently, my blood pressure was high and varied widely from day to day.  On October 6, I saw my Cardiologist and he agreed that it was too much of a coincidence.  Referred to another Cardiologist who did blood work (normal range) and refered me to my Family Doctor who did more blood work (normal range).  Family doctor believes that I've over stimulated muy immune system and It may  take several months to recover.
Patient describes rash as big blotches that are red, big circles, a little white in the middle, in some areas red with some bumps, feel inflamed, and hot. Rash is on patients stomach, arms, legs, says that last night ears were inflamed; Rash started on site of vaccine about 2-3 days after, PT put hydrocortisone cream on it and rash went away, rash came back about February 16th and has progressively worsened
Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Child patient who experienced pentacel vaccine where patient was given the dtap-ipv but not the hib part, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to inappropriate reconstitution technique. (Other relevant tests included No lab data.) Final diagnosis was pentacel vaccine where patient was given the dtap-ipv but not the hib part. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for pentacel vaccine where patient was given the dtap-ipv but not the hib part. 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 Directive 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
Patient experienced visual disburbances where she saw all black and was spotty, she had ringing in her ears, numbness down her arm on the side of the vaccine, felt clammy, and HR was 60. Was dizzy and felt like she was going to pass out. I had her sit for about 20 minutes and drink cold water. She felt better and left. She had a headache later on that night.
p/vax pt noticed raised red area on rt leg; red raised bumps that itched all over arm; legs; back; benadryl for TX
Patient was accidently given a 3rd dose of shingles vaccine. No reported problems yet and no intervention needed. Patient and family members are made aware and will continue to monitor
Within minutes of vaccination I had increased pulse and heart rate, and extreme flushing all over, such as a Niacin Flush. That lasted less that15 minutes.  I felt fine after that until the next morning about 4 am. I woke up with the worst headache of my life. Drove 3 hours to work due to road conditions. Arrived at work at 7am, told my boss, that I would get my work done and leave due to feeling ill. As the morning progressed, I felt progressively worse. My neck was swollen, lymph nodes, to the point of hard to swallow, lymph node in my left arm pit the size of  golf ball, bilateral inguinal gland swelling and pain, felt like hard marbles.   I began experiencing fever and chills, extreme chills, fever up to 101.5 for the next 14 hours.  I have never been this sick.  I continue to have intermittent fever and chills. Swelling of glands has subsided.
After administration, site of injection became itch, warm to touch, red, spreading from site to elbow.  No fever and anti-histamines did not help initially.
Feeling like she has flu; Slight fever; A spontaneous report was received from a consumer concerning herself of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and had a feeling like she had flu / influenza like illness and a slight fever / pyrexia.  The patient's medical history was not provided. Concomitant product use was not provided.  On 27 Feb 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On 01 Mar 2021, the patient had a feeling like she had flu with a slight fever of 101 and the day before i.e. on 28 Feb 2021 she had a fever of 101.5.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events had a feeling like she has flu with a slight fever was unknown.
pain in arm was reported as worsened; pain at the injection site; pain in arm; can't lift arm; This is a spontaneous report from a contactable consumer, the spouse of the patient.  A 58-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (MANUFACTURER UNKNOWN), via an unspecified route of administration in the right arm on 06Jul2020 at 15:30 as a single dose for immunisation.  Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing.  The patient's concomitant medications included unspecified maintenance medications. The patient previously received another pneumonia vaccine (MANUFACTURER UNKNOWN) in 2015 for immunization with no issues.  On 06Jul2020, the patient had pain at the injection site, lot of pain in the arm and he could not lift it. On 07Jul2020, the pain was worse. The clinical outcome of the pain at the injection site, lot of pain in the arm, could not lift the arm, and pain was worse were not recovered.     Pfizer is the Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.                   No follow-up attempts are possible; information about lot number cannot be obtained.
I have been having asthma flair ups since about a month after the vaccine. I has Sport's induced asthma my entire life and after the 3rd dose of the vaccine, my asthma has been more extreme. I was prescribed a steroid inhaler when I went to the doctor on February 16, 2022 for my asthma to try and control my flair up. I have never had an asthma flair up before this time.
Patient received a Fluzone HD. After 5 minutes she returned to the pharmacy stating she had a reaction. Her face was very flushed/red. I brought her to the IMZ booth and asked her if she had any itching or shortness of breathe. The patient stated she had shortness of breathe. I prepared benadryl and Epipen for the patient in case needed. Patients face started to look better and the redness went down. She also stated her breathing was better. She then complained of a lower back spasm. I asked if she wanted to lie down however she preferred to stay seated. The back pain got better however she complained of lower neck/ head pain. A low grade dull pain. EMS arrived and took all vitals, which were normal. They, like myself, assumed it was more of an unexplained reaction than an allergic reaction since no medication was administered. She stated she felt better and spoke with management about filling out forms for the store.
On night 4 after shot developed severe stomach pain at top of stomach.  By Morning 5, had pains across stomach area and was extremely tired.  Night 6 after shot  had night sweats and changed pajama top three times.  On Day 7 I experienced extreme chills twice.  Day 8 I was extremely tired.
Following injection had first four days of body aches, chills and fever. Twelve days following injection - Patient describes pain in his cervical spine that radiates down his right upper extremity into his hand causing numbness and tingling on his fingertips, upper right sided back pain mid scapula, and a band across his lumbar spine that causes pain down one or both of his lower extremities via his buttocks and can shoot all the way to his toes. He has been diagnosed with sciatica in the past. Patient denies preceding injury but did "overdo it" by lifting up wood and fallen branches from the backyard followed by the next day with vigorous vacuuming. He has not had any difficulty holding his bladder or bowel. He denies fever, chills, night sweats, constitutional symptoms. Patient states he has tried ibuprofen and last took it at about 11:00 this morning and it "did nothing". He has not tried any topical medications. He has not tried ice or heat. Patient was unsure whether the pain in his right shoulder be coming from his heart and he does have a history of coronary artery disease so he took 2 nitroglycerin spaced 15 minutes apart just prior to arrival here in the emergency room. The nitroglycerin had no reported effect. Pain suddenly resolved about seven weeks later.
This spontaneous report as received from a healthcare worker refers to a 6 month old male patient. On 26-DEC-2013 the patient was vaccinated with VAQTA 25/0.5 U/ML, lot# CC4735D exp. 15-NOV-2015, 0.5 ml, intramuscular, instead of RECOMBIVAX HB. No adverse effect was reported. Additional information has been requested.
Within 3-4hrs pt became inconsolable w/crying. fussy. Mild fever & local swelling. Sponaneous resolution within 24 hrs.
Stiffness; rigidity in the muscles; tightness; when bending or moving myneck with sharp pain.; Limited range of motion reduced my ability to flex and extendmy neck and bend or rotate my headfrom side to side; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6209) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 04Mar2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Mar2021, at 4:00, the patient experienced stiffness, tightness and rigidity in the muscles, when bending or moving patient felt sharp neck pain, limited range of motion and had reduced her ability to flex, extend neck and bend or rotate her head from side to side. 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. The patient did not receive treatment for the adverse events. The clinical outcomes of the events stiffness, tightness, rigidity in the muscles, neck with sharp pain and limited range of motion were recovering at the time of this report.    No follow up attempts are possible. No further information is expected.
pt recvd vax & exp fatigue, rash, & lightheadedness; No further details are available;
After my 1st dose vaccine, my left arm was swollen and I got a big lump at the injection site. It was very painful upon palpation. I went to the Urgent Care where I was prescribed a steroid cream.  My lump then started to spread to my entire arm, it was hot, burning and very painful to touch. I also had an allergy test which was negative.
Systemic: Hypotension-Mild, Systemic: Fainting / Unresponsive-Mild
Pts right upper arm red, swollen and painful to touch. Also warm to the touch. Area of induration and erythema - 120 x 120mm.