chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From Feb. 21 thru approx. Mar. 3 (day 8 - day 18 after vaccaination dose 1), I experienced pain / achiness  as itemized below; first part no unusual, second part unusual (two parts overlapped): Part 1: Feb. 21 thru Feb. 28 (day 8 - day 15): pain / achiness in lower back / kidney area; preceded by some pain in all joints; this time period marks start of needing to take Ibuprofen (either whole tablet or half tablet) to reduce pain, lasting thru Feb. 24. Part 2: Feb. 27 thru approx. Mar. 3 (day 14 - day 18): LOWER LEGS / SHINS / ANKLES PAIN AND SORENESS, needed to rub / massage to reduce pain; pain was at a signficant level and several day duration that surprised and even alarmed me; I considered calling my doctor, but assuming it was a temporary symptom caused by the vaccine, so I did not call, did not take more Ibuprofen, and gradually the pain reduced and petered out. I had not read of any such symptom.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The reporter stated that a booster dose of VAQTA (dose, strength, frequency, site and route of administration not reported) was administered to a patient too close to the first dose of VAQTA. Patient received his first dose of VAQTA on 14-JUL-2014 and a booster dose was administered on 10-OCT-2014. No adverse effects reported. Additional information has been requested.
Mild soreness and itching around vaccine site. Two or three days later I saw a small elongated bubble formed about an inch below the injection site, which is where it was itching. A few days later it popped and some sort of clear liquid came out. My assumption is that it was some sort of blister or other immune system response. If needed I can provide a photo of the bubble.
Shot was administered on a Saturday. Early Monday morning, child woke up with hives/bumps on body. Along with having throat irritation & nasal congestion.
patient reports itching began almost immediately. She did not inform anyone or seek care for 4 days.  She did not get relief from Benadryl. There has been no visible rash at any point.  She also had a headache and arm soreness for the first day. Those resolved spontaneously. She has never had any issues with difficulty breathing.  She has not had resolution of her symptoms.
Information has been received from a physician concerning her son, a 6 year old male who at 12 months of age in approximately June 2000, was vaccinated with a dose of Varivax. In April 2006, the patient developed chickenpox with greater than 50 lesions. Unspecified medical attention was sought. The patient was recovering and was back at school with the crusted over lesions. There was no product quality complaint involved. Additional information has been requested.
insides of mouth/cheeks started to break out but pain is less than on 06Mar2021; insides of mouth/cheeks started to break out but pain is less than on 06Mar2021; tongue started to hurt on sides and pain was such that patient not sure she could eat; Had sore arm for 2 days; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular, administered in left arm on 05Mar2021 at 15:45 (Batch/Lot Number: EMZOS) (at the age of 62 years old) as 1st dose, single dose for COVID-19 immunisation. Medical history included fibromuscular dysplasia. The patient is not pregnant at time of vaccination. The vaccine facility type was reported as Other. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient had no known allergies. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ); nifedipine; cyanocobalamin (VIT B12); and ergocalciferol (VIT D), all taken for an unspecified indication, start and stop dates were not reported. The patient had these concomitant medications in two weeks. On morning of 06Mar2021, the patient's tongue started to hurt on sides and pain was such that patient not sure she could eat. On 09Mar2021, the insides of mouth/cheeks started to break out, but pain is less than on 06Mar2021. The patient had sore arm for 2 days. There was no treatment. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Heart rate went to 280 bpm; Diarrhea; Pain in the feet; Headache; Chills; Muscle pain; Fatigue; Coughed up some yellow mucus; Fever of 102F; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart rate went to 280 BPM (beats per minute)/heart rate increased, headache, fever of 102F for 8 hours/pyrexia, chills, diarrhea, muscle pain/myalgia, pain in the feet/pain in extremity, fatigue, and coughed up some yellow mucus/productive cough.   The patient's medical history, as provided by the reporter, included COVID-19 (which required hospitalization for five days) and some heart and lung disease. Concomitant medications reported included diltiazem, amiodarone, dulaglutide, empagliflozin, evolocumab, hydrochlorothiazide, potassium, citalopram, pantoprazole, apixaban, glimepiride, and buspirone.   On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date the patient experienced, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet, and fatigue.   On 05 Mar 2021, two days after receiving the first dose of the COVID-19 vaccine, his heart rate went to 280 BPM for 32-33, per the loop recorder that he was wearing. His HCP (Health care professional) got EKG (electrocardiography) and blood work done to see what was going on with his heart. HCP decided to bring patient in for a pacemaker surgery. The event is considered as serious.  On 25 Mar 2021, he coughed up some yellow mucus.  Treatment for the events reported included pacemaker and paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, heart rate went to 280 BPM, headache, fever of 102F (Fahrenheit) for 8 hours, chills, diarrhea, muscle pain, pain in the feet and coughed up some yellowmucus are unknown. The outcome of the event fatigue is reported as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Tx: Benadryl. Pt refused Medrol dose pak. Pt received injection of single dose vial/syringe on 4/20/06 and had large mosquito like edema after to right upper arm, 2 days later was feeling extreme fatigue and had right arm to elbow erythema and edema distal to site to elbow.
Client was given the CWY vial of vaccine not mixed with the A part of vaccine in other vial. Client had no reaction. Client notified with guidance from disease control. Child does not need to be vaccinated at this time since A is not prevalent, unless the child will be traveling abroad.
Red rash on face, neck, and chest. Prednisone 20mg 1xday. Triamcinolone Acetonide Cream, applied on skin 2xday. Ache in left arm. All symptoms are still present after one week.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild
Vomiting 2 times; nausea, pale face and blue lips for 6 hours; dizziness, fever, fatigue for 4 days.
The above employee was given the Hepatitis B vaccine on 1/3/2007. Second dose of Hepatitis B was administered on 2/7/2007. The above employee stated no adverse effects from first dose. The employee was notified on 7/30/2007 of third dose being due earlier this month(employee did receive a written notice) and state she did not want to continue because she experienced dizziness, irritability, and cold-like symptoms after each dose. The above employee seeked no treatment and did not notify private physician nor Employee Health nurse (vaccine administrator).
This spontaneous report as received from a 68 year old female register nurse reporting on herself with hypertension, cardiomegaly, sulfa allergy and other unspecified allergy. On 10-JUN-2014, the patient was vaccinated with ZOSTAVAX in the left arm (dose, strength, lot number and expiration date were not reported). Secondary therapies were not reported. Concomitant therapies included unspecified angiotensin-converting-enzyme (ACE) inhibitor and "a lot of blood meds". Nurse reported that she began to experience and adverse effect "almost immediately" after receiving ZOSTAVAX. She did not know whether these effects began to developed in the same day the dose was administered, but on 11-JUN-2014 (also reported as following day) the patient noticed that injection site was red, tender and swollen. Patient also stated that she began to experience fever of 101 or 102 and headache, for which she took TYLENOL. She reported that over the next "few days" (in June 2014), the injection site became hard. She did not experience a rash. On 18-JUN-2014 (reported as "on day 8"), the patient noticed when she was putting deodorant that her lymph nodes in her armpit were swollen and tender. On 24-JUL-2014 (reported also as currently) the injection site was "a little bump" but her headaches and fevers had persisted. Patient had not notified her healthcare provider nor sought medical attention. Outcome for injection site red, tender and swollen, injection site hard, lymph nodes swollen and tender and injection site was a "little bump" was reported as recovering. Additional information has been requested.
Patient reports having pain in left side of chest when breathing in deep or laughing that started 3 days after receiving the vaccine.
2/4/21 at 4pm: arm soreness,  fatigue. 2/5/21 at approx. 4am: low fever (~100), chills, body aches, headaches, injection site was red, earlier symptoms continued. Persisted until  2/7. Tylenol taken 2x. Injection site on arm was itchy from  2/7-2/11 but redness at injection site went away.
large area of ecchymosis 3 days after injection site - extending from mid-deltoid on left arm, down towards antecubital fossa.  stable now for the last 5 days. without evidence of expansion, nerve compression, or pain. will likely self-resolve.
This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 14-APR-2017, the patient was vaccinated with an expired dose of PROQUAD rHA (lot# L031600 and expiration date: 18-FEB-2017) (dose, route of administration, and anatomical location were not provided) for prophylaxis. No adverse effect was reported. No product quality complaint (PQC) was involved. The outcome of the reported event was not reported. Additional information has been requested.
Initial report was received from a patient on 21 October 2011. A 26-year-old female patient had received an intramuscular (IM) injection of FLUZONE in right deltoid; lot number UT447AA on 18 October 2011. On the same day of the injection, the patient experienced a sore arm and chest tightness which resolved within twenty four hours. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 19-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administratio not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
No addittional adverse event; Inappropriate administration schedule; This spontaneous report as received from a physician refers to a 45-year-old male patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# expiry date, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis. Approximately on an unknown date in 2020, the patient was getting his third dose and was late due to COVID-19. It was confirmed that the patient did not have COVID-19. No additional adverse event were reported (inappropriate schedule of product administration).
BLOOD CLOTS IN THE LUNGS; CHEST PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 year old of unspecified sex. 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: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination in the left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-APR-2021, the subject experienced chest pain and shortness of breath and was taken to the Emergency Room. The patient was hospitalized and a diagnosis of blood clots in the lungs was made. The patient was hospitalized for 4 days. Corrective treatment included blood thinners ( to be taken for 6 months) and a follow-up appointment with the pulmonologist was scheduled.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in the lungs, chest pain and shortness of breath was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210454248-Covid-19 vaccine ad26.cov2.s-Blood clots in the lungs, chest pain and shortness of breath. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Site: Pain at Injection Site-Medium, Additional Details: Patient was given one dose of Pfizer vaccine in two separate injections. Needle and Syringe failed to administer dose during first injection. Patient was stuck again to administer dose. Magellan 25G 1" hypodermic safety needle was used.
Alpha-Gal Syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of alpha-gal allergy in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced alpha-gal allergy. On an unknown date, the outcome of the alpha-gal allergy was unknown.   It was unknown if the reporter considered the alpha-gal allergy to be related to Shingrix.  Additional details were reported as follows: The pharmacist did not have specifics or additional patient demographics. The patient was bitten by a tick recently, specific date unknown, and developed Alpha-Gal Syndrome.   Consented to follow up.
Although I do not see a connection, I was advised to report it anyway.  Three lumps found in left breast  six months after first Pfizer vaccine. Second Pfizer vaccine was received on Feb 14,2021.
Patient had shingles a year ago, two days later, and exacerbation occurred and he started to have shingles symptoms again.
No adverse effects but on 1/5/23 pt was 5 years old and was given the 6mo-4yr old dose.  On 2/10/23 he was given the correct age appropriate vaccine the 5y-11yr old formulation
Period started significantly early. It started 1 day after vaccine, 15 days after last cycle began. Patient has significant past medical history of oligomenorrhea and has never had before had an early cycle in the 13 years since menstruation began.
No adverse effects after the first or after the second injection on 02/28/2021 at the same place.  2nd injection  lot #013A21A March 11 in the morning I noted that my left hand was swollen. The swelling went away during the day, but returned the next morning. There have not been any changes to this. At times the swelling is more severe than on other days. There is no numbness in  my fingers.
Information has been received from a registered nurse concerning a female child who was vaccinated PO with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source.
not feeling well after 2nd dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well after 2nd dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (Lot # K011801 with expiration date 21-AUG-2016, Lot # L002215 with expiration date 21-JAN-2017, Lot # L020003 with expiration date 02-JUN-2017, dose and route not reported). Information regarding concomitant medications was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional
Pt experienced dizziness, nausea, vomiting, cramps and diarrhea until he went to bed last night. Symptoms began.
Patient stated that arm started to become warm that evening of the injection, then on the following day, there was a rash and inflammation from site to elbow. She came in on Saturday (9/23) and pharmacist told her to take some APAP and to put ice on the area through out the day. Husband had no adverse reaction from his shot given the same day.
Extreme aching body, body aches; No energy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme aching body, body aches), ASTHENIA (No energy) and PYREXIA (Fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced PAIN (Extreme aching body, body aches), ASTHENIA (No energy) and PYREXIA (Fever). At the time of the report, PAIN (Extreme aching body, body aches), ASTHENIA (No energy) and PYREXIA (Fever) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided. The patient height was 175.26 cm.
A MMRV WAS ADMINISTERED INSTEAD OF A MMR WHICH RESULTED IN THE PT RECEIVING TWO VARIVAX DOSES; A MMRV WAS ADMINISTERED INSTEAD OF A MMR WHICH RESULTED IN THE PT RECEIVING TWO VARIVAX DOSES; This case was retrieves during monitoring on 12-APR-2023 with the following Primary ID 2601724-1. The original narrative from the sender is as follows:  A MMRV was administered instead of a MMR which resulted in the PT receiving two VARIVAX doses.  Due to the nature of the events, the causal relationship between Vaxelis and the event "A MMRV was administered instead of a MMR which resulted in the PT receiving two VARIVAX doses" was not applicable.  No further information is expected. Notes: Based on the available information, the events were not related to Vaxelis but to Varivax and MMR vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved and information was kept as reported in the form.
Pain and inflammation in left knee starting at about 7:30pm on 2/22/2021.   Chills starting at 11:30pm on 2/22/2021  Knee was bright red by 12:00am 2/23/2021.   Hydrocodone 5mg-acetaminophen taken at 8:30 pm.  No relief.   Oxycodone-Acet. 5mg taken at 11:30 pm pain worse, no relief.  By 2:30am considering ER.  2:30am took  2 Prednisone 10mg tablets, and 1 Ketrolac 10mg.  Pain relief within 20 minutes.  By 8:00am 2/23/2021 knee pain was  gone.  Did notice burning urination at that time, but none since.  by 12:00pm 2/23/2021  mild fatigue but no pain or inflammation.
Blood work was done as a routine physical one year after vaccine was distributed and the patients blood platelet count was at a low of 90 (normal range 140-400) Primary physician suggested that patient see a hemotologist, over the last year 2008-2009 patient has undergone routine bloodwork 01-09, 03-09, 05-09, and platelet count was still low, then Hemotologist had patient do a bone marrow biopsy to see if maybe her marrow wasnt producing enough platelets, biopsy showed that marrow was producing a healthy count of platelets, so after much blood work and evaluation, patient now has an auto-immune disease called ITP where her immune system is killing off her platelets leaving her with a low range of platelets, prior to the vaccination blood work shows normal range of platelet counts.
Tacchycardia at 110 bpm with no other symptoms 2 hours after vaccine. Continued through the night to include fever, aches, chills. Increased to 125-150 bpm the next morning and it became increasingly difficulty to breathe, was lightheaded, had chest pain, slowness of speech/thought. Went to ER. No fever, blood pressure 115/79. Chest x ray, CAT scan, bloodwork, 3 bags saline therapy, Tylenol. After 13 hours, breathing, lightheaded, slowness, and chest pain resolved but heart rate was still above 120. Discharged to recover at home with high heart rate, soreness, and a swollen lymph node in my left underarm/chest. Heart rate slowly declined over the following 48 hours as other side effects resolved.
10 days p/vax pt did not act sick, but had a t105; had no other sx; was given APAP-did not work; finally pediatric Ibuprofen worked;
MOTHER OF CHILD INFORMED PHARMACIST PT EXPERIENCED A RED ITCHY RASH ALLOVER HER TORSO AFTER RECEIVING VACCINE. RASH SPREAD TO LEGS AND LEFT SIDE OF FACE. SHE ALSO HAS A LOW GRADE FEVER.
Systemic: Allergic: Rash Generalized-Mild, Systemic: Fever-Medium, Additional Details: had a high temperature of 102/103 an hour after the vaccination followed by a non-itchy reddish rash covering whole body
immed swelling & redness of lt arm;IM DPH given immed;redness & swelling subsided w/in 15min;discharged w/DPH;
Shot tore my arm up; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was unknown.   The reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient had shot tore his/her arm up. The follow-up would not possible as no contact details were available.