chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 12 year old female daughter with no drug reactions or pertinent medical history, who one year ago, in April 2010 was vaccinated with the first dose of GARDASIL (Lot# and expiration not reported) and one month ago, on approximately 06-MAR-2011 was vaccinated with the second dose of GARDASIL (Lot# and expiration not reported). No concomitant medications were reported. The consumer reported that her daughter experienced dizziness after receiving first dose and second dose of GARDASIL. The consumer's daughter recovered after sitting few minutes in the office in both incidences. The consumer sought unspecified medical attention. No labs were performed. No treatment was given for this adverse event. Additional information has been requested.
maternal exposure during pregnancy; Expired vaccine used; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A, 003B21 and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Diarrhea. Family history included Family history of cancer (Family history of breast cancer, paternal aunt and grandmother). Concurrent medical conditions included Hyperlipidemia, Hypothyroidism, Migraine headache and Breast nodule (Benign nodule of breast of right). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN ALMUS), RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE ODT), FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D), RIBOFLAVIN SODIUM PHOSPHATE (RIBOFLAVIN [RIBOFLAVIN SODIUM PHOSPHATE]), MAGNESIUM, UBIDECARENONE (COQ 10) and VITAMIN D3 for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. Last menstrual period and estimated date of delivery were not provided. On 24-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 24-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment details were reported. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Exposure via ingestion: not reported not reported. On an unknown date, Investigation: not reported not reported, not reported not reported, not reported not reported, not reported not reported, not reported not reported, not reported not reported and not reported not reported. On an unknown date, Laboratory test: not reported not reported. On an unknown date, Physical examination: not reported not reported.
Acute myocarditis onset 8/3/21 requiring hospitalization for 1 day.  Elevated troponin, sedimentation rate, C-RP, and BNP. Normal LVEF and cardiac function. Evaluated by cardiology. Started on beta blocker. Resolved w/o residual sequalae.
Rash, redness, stinging sensation, and warmness at the injection site (right shoulder) immediately after 1st dose vaccine administration @ 10:46. No itchiness, swelling, or shortness of breath reported, client A/O x4. Onsite MD notified @10:55. Offered Benadryl IM injection, client refused. The client was recommended to take Benadryl OTC at home for symptom relief. 30-minute observation + 15-minute extended observation given. Rash did not develop further, no new symptoms during observation. Client d/c home stable @ 11:25.
We have a patient that received his Janssen vaccination 3/29/21 at 2016 hours.  He had no complaints during the remainder of his dialysis. He left without problems.  His wife called the unit around 0700 this morning.  RN answered the phone and the wife stated that the patient woke up not being able to speak. He was out of sorts and that he had difficulty breathing. Nurse told the wife to call ambulance in case of possible stroke.  The wife verbalized understanding. Ongoing discovery.
Red raised bump started a couple minutes after injection. Area was red and hotter the next day and sore. Red area turned into a bruise after 4-5 days and then went away for about a day. Then it came back and I still have it. Now I have a bad headache and nausea.
Developed suddenly around 21 May 08 profound fatigue, and sleeping 12-14 hours at a time and awakening unrefreshed. Also had increase in HAs, decreased concentration, and post exercise malaise. Relates this to the vaccines she received 3 weeks prior. Full work up revealed no other medical explanations for her abrupt change in sxs. Symptoms: Fatigue, Malaise >60 Days, Headache, Migraine, Abnormal sleep patterns, NOS, Cognitive deficiency.
A nurse reported that an 8 month old infant received an injection of Prevnar on 3/5/01. On 3/6/01, the infant developed a fever of 102F. The infant was treated with acetaminophen and recovered.
1wk p/vax started itching all over body;it lasted about 5 days;day 3 severest;
Extreme hive spots beginning at scalp and spreading to knees between 6-12 midnight. Area between hive welts filling in with rash or redness.  Following day, began to spread again around 5 PM - went to ER - prednisone and benedryl administered.  Hives intensified over night disallowing sleep. Next two days hives continued to welt up especially late in the day (having spread to face and neck).  Sunday night seeing the redness between welts start to subside in some areas completely.  Itching continues into Monday morning but not as intense.
Patient developed L facial herpes zoster-- > was hospitalized 3/30/21-3/31/21  for some IV acyclovir-- > discharged on oral valacyclovir 1gm po daily to complete 10days total
Redness and swelling of L arm after 24hr, resolved during 48-72hrs (in the place of DTP vaccine).
allergy. patient face, lips, cheeks, swelled up. patient went to ER and received medrol. feeling better
Pt. mother noticed a red lump on (L) arm the day after receiving vaccines. On third day there was swelling and a red knot on injection site.
Symptoms:  Headache, Nausea, Fever, Aches, Chills, Ear pain, Swollen glands, Fatigue
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: pt was given 0.3ml of sodium chloride instead of pfizer vaccine but was called back to get the correct dose and vaccine from immunizer, no compliants from pt and no visual adverse effect seen-Mild, Error: Diluent Administered Instead of Vaccine, Additional Details: Mother is requesting antibody test for her mother on account to ensure that her daughter did get the second dose of the pfizer vaccine and not just the sodium chloride. spoke to mother around 12:30pm after the call with dr, also called the pharmacy and is aware of the situation. when talk to to mother she was told no follow up is needed per dr but can call for clarification.
Day 3 of swollen face . started to get rash and eyes all puffy. some rash underneath armpits and right knee randomly. None on the rest of body. Had trouble breathing after first dose of vaccine and was started on steroids. when she went to get her second dose she started the steroids immediately. she ended last Tuesday or Wednesday and the rash and puffy eyes started 3 days ago . was on antibiotic with the first dose but none since . Intermittently has had trouble breathing. breathing felt much better when on steroid.
"Approximately 24 hours after the second dose, fever up to 101 developed, chills, body aches, cough, headache, joint pain, and severe soreness at injection site. Cough lingered longer than 48 hours, and was tested for COVID 1/12/21 (negative)
Patient fainted and hit her head on the floor.  She was extremely pale and dizzy at this time.  Patient had shown anxiety like symptoms prior to injection.
Administered HPV9 and MCV4 vaccine to child too young to receive them. No adverse events noted during or after vaccination - error was caught during record review after clinic.
Headache, Fever, Local symptoms: pain-discomfort, itching. General symptoms: chills, fever, headaches, joint pains, fatigue. Narrative:
Red, swollen and warm to touch (6 cm x 5 cm). Informed Mom the reaction of DTaP and gave Tylenol. No fever. Full range of movement and non tender upper arm. Ice packs advised.
The morning after getting my COVID-19 vaccine I woke with major fatigue. I then developed a mild headache. By Thursday morning I started to notice a rash on my inner calf on my left and it was itchy as well. That then began to spread and is currently on both legs now, it's mostly on the inside of the calves and but it is working its way upward onto the front and back of both knees and into my thighs as well as toward the back of my calves. I also have a patch on my back but the rash is so itchy is and uncomfortable enough that it is affecting sleep at night. I reached out to my health care provider and she gave me a cortisone cream which I pick up today. If that cream does not clear it up then to contact them and go in. I have nothing that changed recently like food or cleaning products, no new sheets- nothing other than the COVID-19 vaccine.
CARDIOGENIC SHOCK 6/29/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Right after the second dose she developed legs weakness, chest pain, SOB, palpitation, recently has been diagnosed with Atrial fibrillation.
C/O feeling dizzy, pale, and cool clammy to touch. BP 110/78, P 60  and thready, resp 12 denies SOB or swallowing problems. EM serv notified and arrived @ site to assess.
Non-stop headache (between 7 - 8 pain level on a 1 - 10 scale) the day after second shot was administered. Nothing over the counter worked. Saw chiropractor on 5/20/21 with no relief.  Saw doctor in  on 05/27/21 and received a Totodol shot with no relief. Saw cranialsacral specialist on 5/28/21 with no relief. Have another call to doctors office.
This spontaneous report as received from a pharmacist refers to a 76 year old female patient. The patient has no known allergies. On 04-FEB-2014, the patient was vaccinated with ZOSTAVAX lot number was reported as J011550 with expiry date of 19-DEC-2014. 07-FEB-2014, patient developed an injection site reaction following vaccination with ZOSTAVAX. She developed a red lump at the injection site with a slight fever. The patient sought medical attention by contacting pharmacist. The patient treated the injection site reaction with ice packs. No lab diagnostics were performed. The outcome of red lump at the injection site and injection site reaction was reported as recovered/resolved on 10-FEB-2014. The outcome of slight fever was unknown. Additional information has been requested.
the above client called on 29APR99 to report had a rash & a lot of itching on the back o both hands & @ the site of inj;2 days p/vax no fever, small amount of swelling @ site;
can not raise my arm; terrible pain in arm; the arm is contracted; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (can not raise my arm), PAIN IN EXTREMITY (terrible pain in arm) and MUSCLE CONTRACTURE (the arm is contracted) in a 56-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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced HYPOKINESIA (can not raise my arm), PAIN IN EXTREMITY (terrible pain in arm) and MUSCLE CONTRACTURE (the arm is contracted). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (can not raise my arm), PAIN IN EXTREMITY (terrible pain in arm) and MUSCLE CONTRACTURE (the arm is contracted) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) degenerative changes in the muscle from before the vaccine.         No concomitant medications were reported.  Based on current available information and the temporal association between product use and the start date of the events a causal cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: TCR - outcome updated; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal cannot be excluded.
slight rash on arm and legs, sore throat, nausea, severe chills, severe headache, jaw ache, tiredness,
Child had to be hospitalized for 6 days (3 days in ICU) for oxygen deficiency following respiratory problems developed exactly 2 weeks after the H1N1 mist administration.  The diagnosis, according to doctor, was asthma.
On 4/2/2021 my dad feel headache and nausea. no power right side arm and leg
Extreme fatigue, chest coughing, felt needed to take deep breaths after few hours let-up with mild congestion, heavy urine output up 4x thru evening every hour upon waking, heavy sweating when moving around, BP 157/92 for hours up and down by 10 on PM of 8/15.   Bp. 135/92 on waking.. .. continued throughout day.
Patient received Gardasil around 8/1/08 in left arm.  While attending a forum for high school students, she presented to ER on 10/19/08 with left arm swelling and pain.  Ultrasound demonstrated LUE DVT, and CT of chest showed small pulmonary emoboli.  Only other risk factor for DVT is birth control pills. 12/04/08-records received for DOS 10/19-10/23/08-DC DX:Left upper extremity deep venous thrombosis with a few very small pulmonary emboli identified in right lung as well on chest computerized tomography. Transient orthostatic hypotension. Thoracic outlet syndrome on left likely contributing to deep venous thrombosis. Oral birth control pills started within last 4-6 months-now discontinued. Presented to ED with acute swelling of left upper extremity. 2/26/09-office visit note for DOS 8/26/08 received follow-up visit for dysmenorrhea now improved.
Legal report of a male pt who experienced neurodevelopmental injuries coincident with Certiva. On an unreported date, the patient received Certiva. On an unreported date, the pt experienced severe neurodevelopmental injuries, which was considered medically significant (OMIC). Pertinent laboratory tests, diagnostic procedures, medical history or concomitant medication was not provided. The pt was a child.
Initial information received on 25-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case SPGLZ9UY (same reporter). This case involves a 11 years old patient (gender unknown) who received vaccines ADACEL and MENACTRA, which were not stored properly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HAVRIX for Immunisation. On 28-Aug-2018, the patient received a dose  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5751AA via intramuscular route in the left deltoid. On 28-Aug-2018, the patient received a dose  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot 3552P via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was reported that there was a temperature excursion event involving MENACTRA and ADACEL that occurred between 16 Aug 2018 and 29Aug2018, duration unknown. Minimum temperature reached was 32 degrees Fahrenheit. The maximum temperatures were in range. 2 patients are known to have received affected MENACTRA and ADACEL products. It was not reported if the patient experienced any adverse event or not. 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 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.
About three days after I received my first dose of the vaccine I began to feel symptoms similar to those described as side effects on the Moderna Covid 19 Fact Sheet. I was short of breath and as the day progressed I experienced what felt like irritation on the right side of my chest (mild pain in my lungs even when I was not taking deep breaths). My throat and nasal passages were irritated as well. I could tell that my tonsils (yes I still have them) were swollen. I was dizzy even when I was seated and I had a mild fever. The feeling of being disoriented came and went.   These symptoms started around 7 am and continued through the day, off and on at first, then worsening in the evening after 4-4:30p. After I took some Advil the symptoms went away but then returned maybe 45-60mins later. The symptoms finally subsided around 8p. I woke this morning with no symptoms whatsoever.   I wanted to make you all aware because I was told the first dose had no side effects and if we did experience them they were supposed to happen immediately or the next day.
fever over 101 on 3/29 and 3/30, I woke up at midnight on 3/31 tightness in chest and cold sweats. I went to the emergency room at 6am.
third dose of quadracel administered to patient under 4 years of age with no reported adverse event; Initial information received on 05-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 8 months old female patient who was administered third dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] under 4 years of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine CONJ (OMPC) (Liquid Pedvaxhib) and Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) both for Prophylactic vaccination.  On 05-May-2023, the patient received a dose of 0.5 ml (dose 3) once of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot C5970AA; strength: standard; expiry date: 02-Feb-2024) via intramuscular route in the left deltoid muscle for immunization.  On 05-May-2023 the patient was administered third dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] under 4 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 guidelines. 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.
Throwing up, hot sweating, cold ,body hurts bad headache this is all on 3rd day 2nd day just tired and my arm hurts and feels like a log
erythema multiforme rash devel 15JUN96, no fever, pt acting fine;
I received the vaccine at 9AM. The next day at around 2AM I started to have a fever, chills, muscle aches, and headaches. Those symptoms lasted until noon the next day. Then when I recovered from those symptoms that night I broke out in hives. I had giant welts over my back, down to my hips, up into my head, and on my ears. My ears popped out from the swelling. The hives are very itchy. I called my doctor and she gave me histamines to take for it, but they didn't work. The histamines never worked in the past either for my hives. They doubled in size over night. I called the doctor again and she ordered a pack of steroids for me to take. I will be seeing an allergist as well because my doctor advised me to see one. I rarely ever get sick, but I noticed that I usually get hives after recovering from being sick.
swelling in injection site; pain in injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (swelling in injection site) and VACCINATION SITE PAIN (pain in injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling in injection site) and VACCINATION SITE PAIN (pain in injection site). At the time of the report, VACCINATION SITE SWELLING (swelling in injection site) and VACCINATION SITE PAIN (pain in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Pt, who is less than 18 years of age, received Moderna instead of Pfizer.
11 year old patient received a 0.3 vc 30 microgram dose of Pfizer Covid vaccine.
This case was reported by a pharmacist via other manufacturer and described the occurrence of needle injury in a adult female patient who received TWINRIX. On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, immediately after receiving the TWINRIX, the patient experienced needle injury and pain in fingers. On an unknown date, the outcome of the needle injury was unknown and the outcome of the pain in fingers was recovered/resolved. It was unknown if the reporter considered the needle injury and pain in fingers to be related to TWINRIX. Additional details were provided as follows: This case was received via Merck National Service Center. About a week ago (before the time of reporting), the patient inadvertently stuck herself with a needle while she was drawing up a dose of TWINRIX. Less than a week after receiving TWINRIX, the patient experienced soreness in the finger she stuck which resolved within an unspecified time frame. No additional information was provided.