chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe swelling on left arm starting several hours after injection on Monday. Visit to ER on Wednesday 8 AM. Swelling had progressed from injection site to just above wrist. No fever, chills or other symptoms. ER PA diagnosed Cellulitis and prescribed Doxycycline 100 mg for 7 day course. On seventh day, swelling has almost completely gone down. No other adverse effects.
Had chest pain, difficulty breathing approximately 30 minutes after shot.  Also sharp pain left forehead.  Lasting approximately 15-20 minutes.
Baby crying at vaccines, face was red, 5 min after injections mother, and grand mother thought baby was having a reaction, face red with some rash, observed child.
This case was reported by a nurse and described the occurrence of a sore throat in a female patient who received hepatitis B vaccine recombinant for prophylaxis. On 6/9/03 the patient received the 1st dose of Engerix B. On 6/10/03, one day post immunization, the subject developed a fever greater than 102 degrees F, severe myalgias, anorexia, and digestive upset. On 6/12/03, the patient experienced sore throat and pain in the back of her neck. The subject was seen by the physician. The fever, myalgias, anorexia, and digestive upset had improved but persisted as of 6/12/03. The sore throat and neck pain were unresolved as of 6/12/03. The nurse considered the events were probably related to vaccination with Engerix B.
Pt received dose at 12:45AM. She passed out at 12:55AM. Her brother caught her before falling. She would come to then pass out again. Called 911. While waiting on EMT's, talked to patient to get her to come to. She stated she was dizzy and her throat hurt. She was coherent enough to swallow 2 benadryls 25mg Called to check on patient she was given prednisone in the ER with Rx to continue. She has swelling in the arm which the vaccine was administered (right arm). Doesn't have a primary care doctor to notify.  Patient was only given two benadryl 25mg capsules before EMT arrived.
This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-FEB-2017, the patient was vaccinated with expired dose of GARDASIL injection, lot # L007531, expiration date 04-NOV-2016 (dose and route of administration were not reported). There was no adverse event reported. No product quality complaint was involved. Additional information is not expected.
I experienced a fever, difficulty breathing, wheezing, headache.  I received the shot about 9:00am and started noticing the symptoms that evening.
Heart palpitations, Tachycardia 120bpm first two days. Dizziness for 10 days. Significant headaches for 10 days. Could not perform normal daily tasks.
No adverse effects reported.; an unspecified patient "in their twenties" was administered the first two doses of the three dose regimen of GARDASIL 9 on schedule but "forgot" about the third dose and it has been two years since the second dose.; This spontaneous report was received from a pharmacist regarding an adult patient (reported as: "in their twenties") of unknown age and gender. There was no information reported about the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On an unknown date, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), and on an unspecified date in 2017 (reported as: "two years since the second dose"), the patient received the second dose (route, anatomical site, lot numbers and expiration dates were not reported) for prophylaxis. It was reported that the patient "forgot" about their third dose and it had been two years. It was not clarified if the patient visited the physician's office on 28-MAY-2019 (reported as: "today") to receive the third dose. No adverse effects were reported.
Patient hospitalized for benign neoplasm of transverse colon within 6 weeks of receiving COVID vaccination.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of PROQUAD (lot # M006106, expiration date 01-AUG-2017 and lot # M035143 expiration date 30-JAN-2018) dose and route of administration were not reported for prophylaxis. It was reported that the vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 74 hours. A previous temperature excursion of 6 to 14 degrees Fahrenheit for 11 hours was reported. No data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA002366:
Received the first of 2 shingles vaccines in Upper left arm. Site quickly developed a red knot about 2 inches in diameter. Haven't felt well since. Tired and achy. Had sudden sharp pains in stomach for a few minutes about 26 hours later.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant medication were not provided. On 30-SEP-2016, the patient was vaccinated with and expired dose of PNEUMOVAX 23 injection (lot # L002310, expiration date 08-JUL-2016). Strength, route of administration and dose number were not reported. No adverse effects were reported. Additional information has been requested.
began with stomach issues, and it stayed with me until I went to bed.  I got up during the night to go to bathroom, and I was sitting on stool, and after I finished voiding, I found myself sitting on the floor in front of stool.  I was unaware how I got there, and needed to just lie down on the floor
This spontaneous report as received from a nurse practitioner (N.P.) refers to a patient of unknown age and gender. It was provided that on 14-AUG-2012 the patient was vaccinated with the first dose of VAQTA (1 mg, route not reported). On 21-AUG-2012 the patient was vaccinated with the second dose of VAQTA (1 mg, route not reported). On 11-SEP-2012 the patient was vaccinated with the third dose of VAQTA (1 mg, route not reported). Concomitant therapy included RECOMBIVAX HB. No adverse effect reported. This case is related with MARRS1308USA003437. Additional information has been requested.
Localized tenderness, redness, erythema.  Responded rapidly, well to cold packs overnight.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 17Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on 01Apr2021. The patient was off his quarantine at the time of the report. The outcome of the event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
This spontaneous report was received from a physician and refers to a 19-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2013, 4 years ago when the patient was 15 years old, he was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date in 2017, the patient came to the office to receive the second dose of GARDASIL 9. It was not reported if the patient was vaccinated with the second dose after 4 years. No adverse effects were reported. The relatedness between the event and therapy with GARDASIL 9 was not reported.
pt was eating fell from chiar to the floor arms turned inward & pt lost control of bowels; No fever @ this time; pt is sleeping but this happened earlier when pt was eating lunch;
Seizure, fever 1.4.4. 2nd seizure after arrival at ER. Full workup for menningitis, no results ready. Ativan-IV, seizure activity controlled. Evaluated by neurologist. Per HCP follow up report-Patient was evaluated by doctor in the Emergency Room, the above missing information is not available to doctor.
Left knee infection and contamination with acid fast bacilli, from unknown source and without obvious punctures or wounds other than vaccination site.
I have not been able to lift my left arm in three days. I believe it is sirva.
6 cm diameter area or edema induration and erythema with tenderness.  Had accompanying low grade fever, malaise and cough.
Pain and sensitivity at injection site, difficulty moving arm. Site felt warm to touch, slight swelling, feels tired. Had a similar reaction to a flu shot (per patient) will take Advil and use ice. Reaction lasted 12 hours.
Patient came back with a pink welt on her arm where the injection was given. It hurt a little bit.
Swelling, redness, induration tenderness at the site of injection, lasting 3 days.
A non-serious spontaneous report of strep throat, itching and hives has been received from a health professional concerning a five-year-old male, subsequent to receiving FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. On 16-Feb-2011, patient's sister came to doctor's office for an ear infection. On 16-Feb-2011, patient received FLUMIST. On 17-Feb-2011, patient experienced hives and itching. On 18-Feb-2011, patient was seen in Dr's office. A rapid strep test was done and the results were lightly positive. Treatment included cephalexin 375 mg twice a day times ten days for strep throat and he received 7.5 cc of diphenhydramine once for the hives and itching. On 19-Feb-2011, the patient had no fever and felt better. On 19-Feb-2011, the hives and itching resolved. The event of strep throat was resolving.
Dry nighttime cough followed by fever 3 days later. Cough has now become chronic (6+ weeks) with no other symptoms. Multiple examinations have shown nothing. Chest xrays are being done today.
SORE THROAT; RUNNY NOSE; COUGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: UNKNOWN) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JAN-2022, the patient experienced sore throat, runny nose, and cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, runny nose, and cough. This report was non-serious.
Information has been received from a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with iron deficiency anaemia and no known drug allergies who on 27-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot# 658554/0928U). On 16-MAY-2008, the patient was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL (Lot# 659964/1978U). The patient was asked if she was pregnant before each dose which she denied. After receiving the second dose, the patient said she might be pregnant. Blood work for pregnancy in the office confirmed the pregnancy (LMP March 2008). There was no concomitant medication. Unspecified medical attention was sought in the office. The patient's outcome is unknown. Follow-up information was received which reported that the patient terminated pregnancy. A phone call was made on 06-APR-2009 but no further information obtained. Upon internal review, the patient terminated pregnancy was considered to be other important medical event. Additional information has been requested.
Pain behind my left  knee began on the January 17th, I used crutches and put leg up. On January 25th I went into get my second Pfizer dose on crutches. It took until the beginning of March for me to seek help. I was in pain, but dealing with it. In March my left foot started to turn purplish blue. My foot was numb, swollen and cold, so I went to clinic. They did a veinous blood clot test which was negative, so they gave me anti-inflammatories. Blood work indicated uric acid levels were elevated so they decided it was gout, and  from there I was treated for gout. My foot continued to be numb and cold so they sent me to a podiatrist (May/June). The podiatrist gave me a shot of cortisone which made it hurt worse for 3 days, but it continued to be numb and cold. The podiatrist sent me for an arterial blood clot test and was sent immediately to the ER (September). The vascular surgeon refused to come in so I was started on blood thinners and told to follow up with the surgeon. I finally saw the vascular surgeon in October. I had to see a cardiologist to make sure it wasn?t my heart throwing clots. I was placed on a Holter monitor and cardiac rehab?cleared for surgery . I also saw a hematologist to see if I had any clotting disorders, those test were negative.  Foot started to make own bypasses Arterial bypass on Dec 8th, a 5 inch blood clot was found. It took me over 9 months to find out what was really wrong. My final diagnosis was (PAD) Peripheral artery disease, with an arterial bypass occlusion. I still have numbness in my foot and my mental health from the trauma of the surgery is suffering.
2 weeks after "SHINGLES SHOT" I developed a red rash on both arms & legs and it burns, feels like shingles without the open sores, 06/05/2015 I still have burning red skin. I've been to 2 Dermatologist for skin patch test & blood food allergy test... nothing found yet.  I need help to conteract this "SHINGLES SHOT VACCINE".
Information has been received from a female consumer with penicillin, naproxen and ezetimibe (MSD) allergies who "14 years ago" in 1994 was vaccinated with MMR II. Concomitant therapy included PENTASA, NEXIUM and ENJUVIA. The patient reported that once a year ever since she received the vaccine she develops rheumatoid arthritis symptoms which last sometimes for a day to a week. The patient said "these symptoms move through her body once a year like an allergic reaction." The patient stated this past weekend (on approximately 09-AUG-2008) she woke up and could not get out of bed. It was noted that every joint on the upper half of her body was stiff, her hands were swollen and the pain progressed as the day went on. Medical attention was sought in the ER. It was unspecified if lab studies were performed. The patient was not hospitalized. At the time of the report, the patient was recovering. There was no product quality complaint involved. Additional information has been requested. The patient also had an adverse event after receiving ezetimibe (MSD) (WAES # 0803USA02130).
Allergic reaction to throat. Difficulty breathing.  School nurse administer 25mg of Benadryl, then I took patient to the ER. She was then given a shot of Prednisone.
She received her 1st dose of the Moderna vaccine on 1/12/2021 in her left deltoid.  She had typical pain and swelling for a couple days after, which resolved, no other side effects or symptoms.  She developed redness and swelling at the injection site approx 5 days after vaccination, which has become increasingly itchy and burning, which woke her from sleep last night.  Denies any fever/body aches/chills, no pain at the injection site.  She has tried ice packs, which helped with the itching.  She takes Zyrtec daily for environmental allergies.  Denies any previous reactions to any vaccines.  She does have an allergy to contrast dye and latex.
Pt recvd a series of 3 doses of Engerix-B & exp no adverse exp however did not convert; plan to revax;
Child noted to have discrete lesions starting on right arm (vaccination site was right arm) and spreading progressively to face, trunk, back, left arm, both extremities. MD evaluated rash when child returned to clinic for TST reading. None were vesicular or crusted, and MD stated it was "probably a reaction to varicella vaccine".
rash was generally all over; injection site was left deltoid and was descried as a little swollen; injection site was left deltoid and was descried as a tender; Initial information received on 21-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3 years old male patient who had rash was generally all over, injection site was left deltoid and was descried as a little swollen and injection site was left deltoid and was descried as a tender after receiving diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s)and family history were not provided.    On 16-Mar-2023, the patient received a dose 4 at 0.5 mL dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection, strength: standard, lot number: C5864AA, expiry date: 07-Apr-2023, via intramuscular route in the left deltoid for immunisation.  On an unknown date the patient had rash was generally all over (rash), injection site was left deltoid and was descried as a little swollen (injection site swelling) and injection site was left deltoid and was descried as a tender (injection site pain) (unknown latency) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
The patient developed a rapidly progressive lower motor neuron disorder beginning in March 2021 and progressing from her legs to her arms to her bulbar and respiratory muscles, resulting in death in November 2021.
Nausea, diarrhea,  vomiting, malaise, joint pain, muscle pain
Received these vaccines post excursion; Temperature excursion; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion) had not resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Received these vaccines post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported. The nurse reported that, there was temperature excursion on 01-Nov-2022 in the refrigerator. At the time of excursion, the vials were in refrigerated storage. It was individual vials and vial size was unknown. The patient received the vaccine post excursion and remaining vials were discarded.  The maximum or minimum temperatures reached at time of excursion was minimum 34.8 F (Fahrenheit) and maximum at 42.49 F for 14 Minutes duration. The vials were moved from freezer to refrigerator in less than 30 days. On visual inspection vials were in normal state. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number.
2 days after vaccination, patient developed right arm (opposite injection site) swelling, erythema, bruising on her wrist and pain/loss of range of potion in her wrist joint. It gradually worsened over about 2 weeks, then began to improve. She remains with some tenderness and her R wrist and thumb and does not have full range of motion but other symptoms have mostly resolved.
Pfizer-BioNTech COVID-19 Vaccine: Soon after vaccine administration patient reported dizziness, trouble swallowing, paresthesias in both hands, shortness of breath, anxiety, and one episode of vomiting. Patient was transferred to the emergency department where initial vital signs were: blood pressure 161/84 mmHg, pulse 97 beats per minute, temperature 36.9 degrees Celcius, respiratory rate 16 breaths per minute, and oxygen saturation 98%.  The patient presented alert and oriented in no acute distress. On exam no rash,  edema of the uvula or tongue, respiratory distress, wheezing, rhonchi, or rales were noted. Patient was administered one dose each of lorazepam and ondansetron and was discharged.
My heart med became toxic; Nodule on left side of my neck apoearrd; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 (Lot number: EL9264) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: known allergies: Yes; "Afib" (ongoing); "Thyroid" (ongoing); "Asthma" (ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing); BETAPACE taken for atrial fibrillation, stop date: 24Mar2021. Vaccination history included: Bnt162b2 (Dose 1, Time:11:00pm, Batch/Lot number: EL9264), administration date: 28Jan2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: TOXICITY TO VARIOUS AGENTS (hospitalization) with onset 24Mar2021 13:00, outcome "not recovered", described as "My heart med became toxic"; NODULE (non-serious) with onset 24Mar2021 13:00, outcome "not recovered", described as "Nodule on left side of my neck apoearrd". The patient was hospitalized for toxicity to various agents (hospitalization duration: 3 day(s)). The events "my heart med became toxic" and "nodule on left side of my neck apoearrd" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Mar2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of toxicity to various agents. It was unknown if therapeutic measures were taken as a result of nodule.  Additional Information: It was reported that, the patient received other medications within 2 weeks of vaccination. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Prior Vaccinations: None. After receiving vaccine my neck nodule for 2-4 day called Physician didnt get appointment for 26Mar2021.  No follow-up attempts are possible. No further information is expected.