chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date in 2011, the patient was vaccinated with dose 1 of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date were not reported) intramuscularly. No concomitant medications were reported. On 02-JAN-2013 (reported as today), the patient had just received her second dose of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date were not reported) intramuscularly. No adverse reaction reported. Additional information has been requested.
2AUG95 t103 c/o h/a APAP relieved sx; 3AUG95 c/o intermittent h/a; APAP relieves q 4 hrs;
Patient's wife returned for second Pfizer CoVid vaccine on 4/1/2021 she told the vaccinator, that her husband, died two days after he received the first Pfizer vaccine. Date of Death - 03/13/2021.  Wife states that husband had a "massive stroke."  EEG indicated no brain activity and it was decided to remove him from life support.
pt recvd vax on 23NOV93 & the next day devel an upper resp infect & a h/a which lasted for 2 days; approx 4 days p/vax exp onset of vomiting & diarrhea; pt was treated by MD;
Not napping, crying/ thrashing fits, suspected joint pain. Rash that I assume to be rubella began 9/9/13.
Itchy; Hard; Red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Hard), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Hard), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Hard), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-077805 (Patient Link).
child's arm is red and swollen; child's arm is red and swollen; 18 month old child was given ADACEL by mistake; Initial information received on 21-Jan-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 months old and unknown gender patient who whose arm is red and swollen, child's arm is red and swollen and 18 month old child was given adacel by mistake while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Jan-2022, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.25 mL to 2mL lot number not reported via unknown route in unknown administration site for immunization.In the context of COVID-19 crisis, the batch no and expiration date were not requested.  On 19-Jan-2022 the patient developed a non-serious event "18 month old child was given adacel by mistake" (product use issue) (latency-Same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 21-JAN-2022 the patient developed a non-serious event "child's arm is red and swollen" (peripheral swelling) (latency-2 days) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 21-JAN-2022 the patient developed a non-serious event child's arm is red and swollen (erythema)(latency-2 days) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported "parents of an 18 month old child brought their child into the pharmacy today 21Jan2022; states 2 days ago they went to an urgent care nearby and the 18 month old child was given ADACEL by mistake. Pharmacist states that today the child's arm is red and swollen. Pharmacist asks what they should do and if there is any information about ADACEL given to a child that young".  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (child's arm is red and swollen, child's arm is red and swollen).  At time of reporting, the outcome was Unknown for the event child's arm is red and swollen, was Unknown for the event child's arm is red and swollen and was Unknown for the event 18 month old child was given adacel by mistake.  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.
During the administration of the patient's 2nd dose of Modena vaccine, the needle detached from the syringe. This caused the patient to not receive the full dosage of the vaccine.
Pulsatile tinnitis, red flushed face, intracranial tension, strong pulse felt in neck, ears, head, symptoms stronger when laying down on my back, less strong when laying on my side. Symptoms make it really hard to fall asleep. So far I have only been doing testing - ENT, and Cardiology. Trying low sodium diet without any animal products except yogurt. Symptoms have been increasing after they first started in December. It is April now.
New onset atrial fibrillation, systemic inflammation, brain demyelination, and possible myocarditis.  On 6/22/23 he awoke a felt a little weird. At about 11 AM he looked up and had vertigo. He saw everything spinning. Any movement of the head would bring on severe vertigo and he started vomiting. It was bad for about 3 weeks and then improved and it went away after a month. It was constant not episodic. He still has a little lightheadedness.  He was admitted 6/22/23 and found to have atrial fibrillation with RVR. He was treated with ASA 81 mg daily. WBC and CRP and BNP elevated. He had event monitor 8/7 to 9/5/23 showing a run of 9 beats of ventricular tachycardia 8/8/23 1227 AM. He was then started on bisoprolol 5 mg daily, now on 2.5 mg qd. He feels pretty well now.   NCCT 6/22/23 showed a hypodense lesion left temporal lobe.  MR noncontrast 6/24/23 showed a left temporal cystic lesion with surrounding edema and a left periatrial lesion and a small right frontal deep white matter lesion. MR with contrast 7/28/23 showed improvement in the left temporal lesion and no change in the others.  Cardiac MRI pending
Large warm area around vaccine site, mild induration with many small varicella spots all over and spreading. No treatment.
2nd dose of the vaccine was given on Thursday April 15 , Three days after the Injection. On Sun the 18 ,  I started have painful rash and deep nerve pain on my upper forehead and left ear.   After a visit to the doctors On Tuesday the 20 It was announced I had Shingles.  It has been slowly spreading over my scalp and on my face.
Potentially got the dose from a vial punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Patient started to experience hives all over his body.  No breathing difficulty.  No other exposure or changes per mom. No further hives today.
Both eyes hurt on 9/20/2010 and 9/21/2010. I tool Benadryl on 9/20/2010 thinking the harvesting was causing allergies. It did not help. I went to the eye doctor on the morning of 9/21/2010 who found nothing wrong with my eyes. I went to my family doctor on the morning of 9/22/2010. The pain in the eyes had diminished but my vision was blurred.  He didn't have an idea of why my eyes hurt and were blurry. The doctor told me to go to the Medical Center as my vision worsened. By noon on 9/22/2010 my vision had worsend significantly. I called my husband who drove me to the hospital mentioned above. We arrived about 3:45 PM. The waiting room was very busy. I waiting and watched my eye sight fade to black, with complete blindness happening around 7:00 PM.  After a night in the Medical Center, I was transferred to another hospital.  Dr. started me on a prednisone IV, did an MRI and other tests.  After 4 or 5 days I was allowed to go home and take medicine orally.  I was completely blind for over 7 weeks. Vision has improved, but I have been told it will never return to normal because the Optic Nerves are both damaged and have atrophied.  I can not drive because I can not see the vehicles or stop signs in front of me.  I do not see colors well so have had to give up art work and photography. I have to have someone drive me to and from work (40 miles one way). I am now off of prednisoe but take Imuran and will for the next year and a half, per Dr.
The evening of injection - warmth at injection site. Increasing pain, swelling and redness until 10-11-09 as of 10-12-09, improving.
Starting in the evening on the day she got her flu vaccination, she reported onset of injection site pain to left arm, with intermittent sharp pain radiating up left side of neck. As of 11/14/23, patient reports ongoing constant sharp left upper arm pain from elbow to superior trapezius area, associated with left upper arm weakness.  No longer shocking pain radiating up arm from elbow. Has tingling to left hand upon waking up if laying on that side. She can lift her arm above her head but she has to do this slowly due to the pain.  She has not tried picking up or grabbing anything with her left arm for fear of triggering increased pain. Patient has been taking tylenol and ibuprofen, applying heating pad and doing massage with no improvement. I prescribed her cyclobenzaprine 10 mg for the myalgias, and as of this morning (11/15/23), after 1 dose of this medication, not much improvement reported. I referred patient to physical therapy and physiatry, these referrals are pending. No recent head, neck or shoulder injuries.
My blood pressure is elevated. I went to the dentist to have my tooth filled and could not due to my elevated blood pressure. I then went to the urgent care.
My right arm was sore I could Raised up to put my clothing on. I had put hot towels on it for three days, and take pain pills
22 weeks pregnant; Expired dose administered; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (22 weeks pregnant) and EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (22 weeks pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (22 weeks pregnant) had resolved and EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. It was reported, the vial was initially stored in the refrigerator on 14-Apr-2022 and the vial underwent no temperature excursions  Company comment: This is a spontaneous case concerning a 22 year-old, female patient with no reported medical history. Maternal exposure during pregnancy and Expired product administered (the second dose expired two days prior to administration) were reported in the case. The patient received the second dose of mRNA-1273 vaccine at 22 weeks gestation. No adverse events were reported. No information regarding first dose was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 22 year-old, female patient with no reported medical history. Maternal exposure during pregnancy and Expired product administered (the second dose expired two days prior to administration) were reported in the case. The patient received the second dose of mRNA-1273 vaccine at 22 weeks gestation. No adverse events were reported. No information regarding first dose was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt recv vax; pain rt axilla early am; mild fever of 99.7;seen by FMD who informed mom,rxn related to Dtap;also has enlarged axillary lymph nodes;tx w/ apap;pt to return in 2 wk if nodes enlarge;pt to check w/ MD once a wk;
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling goes up to bra strap and down to wrist), INJECTION SITE INDURATION (hard and tight around vaccine area), INJECTION SITE ERYTHEMA (arm is red around vaccine area) and INJECTION SITE RASH (blotch around vaccine area) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025-J20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling goes up to bra strap and down to wrist), INJECTION SITE INDURATION (hard and tight around vaccine area), INJECTION SITE ERYTHEMA (arm is red around vaccine area) and INJECTION SITE RASH (blotch around vaccine area). At the time of the report, PERIPHERAL SWELLING (swelling goes up to bra strap and down to wrist), INJECTION SITE INDURATION (hard and tight around vaccine area), INJECTION SITE ERYTHEMA (arm is red around vaccine area) and INJECTION SITE RASH (blotch around vaccine area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.  Injection site erythema, Injection site rash, and injection site induration are consistent with the known safety profile of the vaccine; Reporter's Comments: Based on the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.  Injection site erythema, Injection site rash, and injection site induration are consistent with the known safety profile of the vaccine
RAISED BUMP; SWELLING; PAIN; REDNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced raised bump. On 27-MAR-2021, the subject experienced swelling. On 27-MAR-2021, the subject experienced pain. On 27-MAR-2021, the subject experienced redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on 07-APR-2021, and redness at injection site on APR-2021, and had not recovered from swelling, and raised bump. This report was non-serious.
Diagnosed with shingles on 13 October 2021. I am a 32 year old healthy male.
pt states she blacked out the next day and fell down stairs, hit her head and was hospitalized
Shot given high on shoulder, swelling burning pain, extending from shot site to back of shoulder and into neck, woke up with heart attack symptoms, radiating pain to fingers and neck, jaw, mid back,  wednesday 11/17    11/18-  thru  11/23 All joints burning, swollen lymph nodes, muscle and eyelid twitches, dry blurry vision, eyes not working together, Cold sore, Canker sore,Chills, Lowback pain, Brain Fog, Tired,  Dry cough, Runny Nose, Post Nasal Drip with pressure, White fluid on tongue, dizzy,  Sore throat, Nausea.        NO  FEVER.    All symptoms happened for 6 days.
Vaccine expired 8/31/22 and given, unknowingly on 9/1/22. No reaction noted.
A hard lump showed up a bit lower than the base of my left thumb above my wrist. I felt the vaccine flow down my arm immediately but didn?t think anything of it until the lump showed. The size of a large pea. Very hard. Like a ganglion cyst. It?s not going away. In addition my left ring finger got a rash about a week later. Tiny white bumps. Swollen joint. Had to take off wedding ring as it was squeezed so tight. Haven?t been able to put it back on since. Got second shot April 30. Ring finger still swollen but not worse. Hard lump still present.
no other AE occurred; an expired dose of VARlVAX that was administered to a patient; This spontaneous report as received from a customer refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 05-NOV-2021, the patient was vaccinated with 1 expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S019583, expiry date 25-JUN-2021, for prophylaxis (exact dose, route and anatomical location of administration were not reported) (expired product administered). No other adverse event occurred (no adverse event).
The pt developed significant cellulitis "well demarcated pink slightly indurated exanthem inferior to the injection site, 1 1/2" in diameter, irregular area of ecchymosis, pain in right shoulder, biceps, and anterior chest as well. Pectorals are tender, as is biceps and deltoid. Limited Range of motion.
Information has been received from a medical assistant concerning a 14 year old male, with no pertinent medical history, drug reactions or allergies; who on 17-JAN-1997 was vaccinated with 0.5 ml of varicella virus vaccine live (Oka/Merck) (Lot#620617/1105D), and subsequently on 02-MAR-2007 was diagnosed with breakthrough chickenpox. No details were provided regarding the number of lesions, present status of patient, etc.  Unspecified medical attention was sought. There was no product quality complaint. No lab diagnostic studies were performed. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was acute respiratory failure with hypoxia and acute diastolic heart failure.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "LBBB" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "asthma" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "anxiety" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension; "orthostatic hypotension" (unspecified if ongoing), notes: Other medical history: LBBB, asthma, anxiety, orthostatic hypotension. Concomitant medication(s) included: PROGESTERONE, start date: May2015; VIVELLE DOT, start date: May2015; SYMBICORT, start date: Dec2014; SODIUM CHLORIDE, start date: Jan2010; MONTELUKAST SODIUM, start date: Jan2010; PROZAC, start date: May2015, stop date: 08Jun2022; B100, start date: May2015; AZELASTINE HYDROCHLORIDE, start date: May2015; LEVOCETIRIZINE, start date: May2020. Past drug history included: Doxicyclin, reaction(s): "Known allergies: Doxicyclin", notes: Known allergies: Doxicyclin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Other medication in 2weeks product: Multivitamin. Other medication in 2weeks brand: Solo. Other medication in 2weeks start date: 04Jun2015.
DVT/PE with complete occlusion of in the left leg and partial occultation of right leg.  Clots from knee's to belly button and in the lungs.  Requiring 2 extensive surgeries and 4 stint implants.
Multiple non specific c/o that pt reports to getting the flu shot including dizziness, neuralgias, headache, feeling jittery.
first in November 2019, second July of 2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   In July 2021, the patient received the 2nd dose of Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter stated her healthcare provider told her she should receive a third dose due to the timing between the first two doses.The reporter inquired if there was a third dose recommended and if her insurance would pay for it.  The reporter consented to follow up.
On 2/4/21 had a seizure which he has not had in 16 years.  He then started to get really tired, and still having that today 2/9/21.   Had the feeling of having a heavy flu.   No treatment, no other seizures.