chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was administered on 3/9/10.  At primary care follow up on 9/30/10 the patient reported that it made his arm "swell like a softball".
Hard red bump 2 in diameter on injection site appeared after 8 days post vaccine (I had no reaction  whatsoever prior to that). Looks like a large insect bite, red, hard and tender to the touch.
Generalized weakness, fatigue and sleeping all day, no appetite with severely limited p.o. intake, dry cough,.
1st dose 3 years ago, never received 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose of Shingrix three years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's Comments: The reporter stated that patient who got his 1st dose of Shingrix three years ago and never received the 2nd dose. The reporter did not had any additional information and demographics.  The reporter did not have a record of vaccine because it was given at a different location. The reporter did not provided consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Myalgia, Diarrhea, LEFT deltoid, soreness redness and lump RESOLVED 12/28. periorbital edema/upper eyelids, diarrhea, myalgia and fatigue 12/25 all resolved 12/28. upper eyelids conts Narrative:
This is a spontaneous report from a contactable nurse. This nurse reported similar events for 15 patients. This is the 15th of 15 reports.  A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunization.  The patient medical history and concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter, product, event, different patient.
A non-serious spontaneous report of inadvertent administration to an eight month old was received from a health professional concerning an eight-month-old female. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient inadvertently received FLUMIST on 13-Oct-2011. There was no adverse event associated with this medication error; therefore, treatment and sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Not sure exact date started. Thought maybe due to Hand Sanitizer, so used Cortizone cream and tried anti fungal without relief.  Small bumps on some inner fingers and dry, rough with some peeling on both insides of fingers and some on right palm. Not on fronts or backs of fingers.  Had doctors appointment with my new PMD on 3/9. She prescribed Triamcinolone Acetonide Cream, 0.1%. No more rash, dryness persists but less.  Have also used Acquaphor Oint some nights during sleep.  At least 3 weeks not completely resolved, but getting there.
On the 3 rd day after pt received her first shot. She started getting symptoms of Bells Palsy on the Right side of her face. Eye and mouth drooping. On 4/25/2021 she still has some drooping and her Right hand eye is blurry.
Developed swelling of the eyes, tightness in her throat and chest with associated wheezing and raspy feeling in chest. Advised to go to ER and pt received BENADRYL 50 mg IM.
10/07/2022 After I received my vaccine that afternoon, my arm got red, was tingling, felt like it had fever and itched. I waited and it kept getting bigger. On 10/9/22 I went to the doctor and he prescribed antibiotics.  I had diarrhea for 21 days as a result of the antibiotics.  Once I started the antibiotics, the swelling and rash almost automatically disappeared. By 10/11/22 I was feeling excellent.
Information has been received from a registered nurse concerning a female patient who was vaccinated with Hepatitis B vaccine recombinant. Approximately one month post-vaccination, the patient experienced pain and swelling on one side of the face. No further information is available.
Huge delayed rash one week after - about 8 to 10 long and ten inches wide. Itchy and raised. Day four of rash, has gotten slightly bigger. No fever.
9/30 got vaccination, light chest pain blood pressure elevated. 11/13/22 went to ER. Contracted Covid 12/02/2022.
Significant pain, swelling, and redness at the injection site. Symptoms of fatigue and body aches. 48 hours after the vaccine was administered, the injection site is still extremely swollen and red.
Swelling at the injection site; Stomach ache; felt severe fatigue; Flu like symptoms; Diarrhea; Fever; Fatigue; Dull headache; Pain in arm; A spontaneous/solicited report was received from a consumer concerning a 88 years old, female patient who developed fatigue , dull head ache , pain in arm ,felt severe fatigue , flue like symptoms ,diarrhea , fever , stomach ache ,swelling at injection site  The patient's medical history included [HISTORICAL CONDITION] diagnosed with irritable bowel syndrome.Concomitant product use was not provided/unknown by the reporter.  On 22-JAN-2021 ,prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:[032L20A] intramuscularly in the unknown site for prophylaxis of COVID-19 infection.  On 19-FEB-2021 ,prior to onset of events ,the  .patient received second of two planned doses of mRNA (Batch number:013M20A)intramuscularly in the unknown site for prophylaxis of COVID-19 infection  On 22-JAN-2021 ,the patient experienced event(s) fatigue , dull head ache ,pain in arm. On 19-FEB-2021,the patient experienced events felt severe fatigue ,flue like symptoms ,diarrhea ,fever. On 21-FEB-2021 ,experienced event stomach ache. On 22 FEB-2021 ,patient experienced event swelling at the site of infection.   Treatment details included NONE.  Action taken with response to events were unknown.  On 23-JAN-2021 ,the outcome of events developed fatigue ,dull head ache ,pain in arm were recovered. On an unknown date the outcome of events felt severe fatigue, flue like symptoms ,diarrhea ,fever , stomach ache swelling at the injection site was not reported.
Barely able to speak; So much Pain; Chills; Headache; Stomach ache; Bedridden; was not able to eat; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2022, the patient received the 1st dose of Shingrix. On 8th October 2022, 2 days after receiving Shingrix, the patient experienced chills, headache and stomach pain. On 12th October 2022, the patient experienced pain. In October 2022, the patient experienced bedridden and unable to eat. On an unknown date, the patient experienced aphasia. On 10th October 2022, the outcome of the unable to eat was recovered/resolved. On an unknown date, the outcome of the chills, pain and aphasia were not recovered/not resolved and the outcome of the headache and stomach pain were recovering/resolving and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the chills, headache, stomach pain, bedridden, unable to eat, pain and aphasia to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter was a wife of the patient. The reporter reported that the patient received Shingrix vaccine. On 8th October 2022 after 2 days of received Shingrix vaccine the patient experienced chills, headache and a stomach ache. The reporter stated that the patient was bedridden until the Monday (10th October 2022), when the symptoms seemed to resolved. The reporter stated that the patient was not able to eat anything after received vaccine until Monday, 10th October 2022. The reporter reported that the patient felt well enough to complete some yardwork on Tuesday (11th October 2022). On 11th October 2022 the patient went out on the road as they are truck driver and on 12th October 2022 the patient was again experienced chills and pain the reporter stated that the patient had so much pain they were required to pull off of the road to lie down. The reporter reported that the patient was barely able to speak. The reporter did not provide the patient's demographics as they were attending to the emergency. The reporter did not consent to follow up.
First J&J vaccine was on 4/4/2021. Booster was on 12/9/21 Diagnosed with Invasive Ductal Carcinoma, Grade 3, 2.7 x 2.4 x 3.1 cm ER & PgR Negative,  HER2 Positive (Score 3+) Right Breast, Stage 2b No history of breast cancer in my family.  Very healthy before this diagnosis. Treatment - (6 cycles) Neoadjuvant Chemotherapy: Trastuzumab, Pertuzumab, DOCEtaxel, CARBOplatin 1st on 4/8/22, last was on 7/22/22. Currently on Trastuzumab every 3 weeks for 14 cycles. Lumpectomy Surgery, Right Breast and Right Sentinal Lymph Node Biopsy - 8/25/22 Radiation Treatment - 20 treatments to begin on 10/5/22 for 4 weeks
Vaccine received Sunday at 3:30 p.m.  Monday:  Muscle pain, some shortness of breath, lethargy, redness in face and some mild swelling of face, loss of appetite.  Tuesday, some improvement, but lethargy, loss of appetite, and anxiety and general bad feeling continued.  Went to Urgent Care Tueday pm, about 48 hours after admin of vaccine.  Advised to take benadryl at bedtime, Zyrtec in the morning,  Wednesday morning still lethargic, some muscle pain, anxiety.
At midnight on 1/28/21 I had 101 degree fever, chills, sweats, migraine headache, nausea that lasted until I could take 2 Ibuprofen around 8:00 AM.  The fever returned after the ibuprofen wore off.   Today is 1/29/21 and I am still experiencing a 99 degree fever, sweats, chills, light headache, and diarrhea.   Two days of work missed.
After vaccination, patient was light headed and complained of nausea. Patient denied any itching or sob at this time. After half hour of observation patient states that she "feels better" and wasn't light headed anymore. Pt requested to take her own Tylenol as she felt a headache. pt did take that from her own purse.
Developed 3 smaller bumps resembling hives; This case was reported by a other health professional via interactive digital media and described the occurrence of papular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received Shingrix. In August 2019, less than 3 weeks after receiving Shingrix, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was unknown.   It was unknown if the reporter considered the papular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced 3 smaller bumps resembling hives. The patient asked could this be a side effect and is it safe to be around my pregnant daughter-in-law.
location reaction on day 9-10; Itching at the site; Swelling at the site; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PRURITUS (Itching at the site), INJECTION SITE SWELLING (Swelling at the site) and INJECTION SITE REACTION (location reaction on day 9-10) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itching at the site) and INJECTION SITE SWELLING (Swelling at the site). On an unknown date, the patient experienced INJECTION SITE REACTION (location reaction on day 9-10). At the time of the report, INJECTION SITE PRURITUS (Itching at the site), INJECTION SITE SWELLING (Swelling at the site) and INJECTION SITE REACTION (location reaction on day 9-10) outcome was unknown.        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 was received no concomitant medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: No specific follow-up information recorded.
Left Side of Head and Face Hurt Teeth, Head, Ear, Sinus, Neck Pain
get sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 23-Dec-2020.  This case is linked to case 2020SA300682.  This case involves a patient of unknown demographics who developed get sick (Illness), while he/she received vaccine Influenza Vaccine.   The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiration date unknown) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date (latency unknown) after the administration of suspect the patient got sick (illness).  It was not reported if the patient received a corrective treatment.  The outcome was unknown for illness.  There will be no information available on the batch number for this case.
After the first vaccine I noticed low vision. Now after two shots and a booster - my left eye is worse. Right eye has low vision. I am legally blind in 8 months.
congestive heart failure; 48 hours migraine; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose number unknown via an unspecified route of administration on an unspecified date (at an unspecified age of vaccination) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history was not reported. There were no concomitant medications.  The patient experienced congestive heart failure (medically significant) in 2021 with outcome of unknown, 48 hours migraine (medically significant) in 2021 with outcome of unknown. The patient underwent lab tests and procedures which included; cardiac stress test: 30% on 2021 down from 65%.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Mom states she took the child to the ER on 5/5/99 with a fever of 104, shaking as though she was falling. Mom states child received reducer and antibiotics by mouth and also seizure medication. Child has recovered and mom states no more seizures since this time.
Breakthrough case admission after 2 vaccines Pfizer 4/15/21 Lot# Ew0158;  Pfizer 5/6/21 Lot# Ew0179
Patient developed vice-like headache approx 3 hours after Trumenba administration. the next day she also developed body aches. Denies fever, swelling, difficulty breathing, vomiting, rash. History of similar reaction after first dose of Trumenba resulting in ER visit. So far at the completion of this form, she has not sought care for this reaction but her mother called the office and I advised taking benadryl with ibuprofen at onset of headache and advised she could alternate the ibuprofen with tylenol every 4 hours prn. If no improvement with this, patient was instructed to go to ER for migraine cocktail, as this improved her symptoms last time.
Information has been received from a physician concerning a female (demographics not reported) with hyperlipidaemia, diabetes, urinary tract infection, sinus infection and drug hypersensitivity to prochlorperazine maleate and a history of immunoglobin g decreased. On 29-MAR-2007 was vaccinated intramuscularly with Pneumovax 23 (Lot#655290/0959F). On 31-MAR-2007 the patient experienced injection site redness, injection site swelling, injection site pain and cellulitis at injection site. The patient was seen by the physician and treated with prednisone and Keflex. At the time of this report the patient was recovering from the events. Additional information has been requested.  07/30/2008 This is in follow-up to report(s) previously submitted on 7/30/2007. Initial and follow up information has been received from a physician concerning a 54 year old female with oesophageal acid reflux, hyperlipidemia, decreased immunoglobulin g, diabetes, urinary tract infection, sinus infection and a drug hypersensitivity to prochlorperazine maleate. On 29-MAR-2007 at 10 am was vaccinated intramuscularly with PNEUMOVAX (Lot#655290/0959F). Concomitant therpies included NEXIUM, VYTORIN, AVANDIA, DIOVAN, HUMALOG and GLUCOPHAGE. On 29-MAR-2007 at 10 amthe patient developed a large local reaction "the size of a softball". On 31-MAR-2007 the patient experienced injection site redness, injection site swelling, injection site pain and cellulitis at injection site. The patient was seen by the physician and treated with prednisone and KEFLEX. At the time of this report the patient had not recovered from the large local reaction and was recovering from the injection site redness, swelling, pain and cellulitis. The physician reported that the patient had been referred for allergy testing (NOS). Additional information has been requested.
14 years old who received a shingrix dose.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patientreceived dose of Shingrix at the age of 14 years old, which led to inappropriate age at vaccine administration. The pharmacist clarified that she was reporting the case, but the administration provides from  a clinic. So, the health care professional did not have more information about the patient or the vaccine. The reporter did not consent to follow up.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Elderly patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. It was a case of actual medication error due to improper product storage. The shipment had been flagged as having been too long in shipping transit. 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.
Patient has a history of seizure disorder, shortly after receiving 2nd covid vaccine she had 2 seizures one lasting 1 minute and the other lasting 2 minutes, patient has no memory of the events.  She had myalgias and muscle pains in her lower extremities as well as mild headache, which is normal post seizure for her.  After 1st dose she felt funny like she was going to have a seizure but did not have a full seizure.
The patient's mom reported the event the following day. Patient complained of itching, redness and warmth of the injection site, on right arm. Patient's mom advised to give Tylenol / Motrin and cool press to site.
Significant arm pain, headache, joint paint, lethargy, sleep disruption (due to pain)
This spontaneous report as received from a health care worker refers to a approximately 70 year old female patient with no drug allergies. The patient's medical history was none. On 20-MAY-2014 the patient was vaccinated with ZOSTAVAX. Concomitant medications were none. On an unknown date in May 2014 the patient experienced itching and swelling. Lab diagnostic tests performed were none. The patient sought treatment at an unspecified immediate care center prior to 28-MAY-2014 and treatment medications were unspecified. The outcome of itching and swelling was reported as recovered with no continuing issues. The causality of itching and swelling was not reported. This case is linked to 1406USA004741 (same reporter link). Additional information has been requested.
I got my dose 2 and all  I had was a sore arm in 6 hrs. At the 28 hr mark, I had tachycardia that stayed continuious. It was at 133 when I went to the doctor's office. My arm at the site was hot without brusing and redness. I am currently wearing a  Holter Monitor for 2 weeks.
Pt presented from a nursing home due to AMS. Was found to be COVID positive post vaccination. Pt was diagnosed with COVID pneumonia.
Pt experienced redness, soreness, hot to the touch and a lump at the injection site of the PNEUMOVAX 23.
PATIENT STATES THAT ABOUT 5 HOURS AFTER ADMINISTRATION OF VACCINE SHE BROKE OUT IN HIVES ALL OVER BODY.
Narrative:  Patient reported ADR following second dose of Moderna COVID vaccine. Patient has significant hx of chronic pain syndrome, PTSD, headache, and spastic paraparesis. Patient reported "Also, I had my second COVID-19 vaccine shot and had an extremely bad reaction. Had a fever of 102.6 and my neurological symptoms were worse than I've ever felt in my life. I couldn't walk without assistance, couldn't turn my head, had a terrible headache, and experienced clonus far worse and for a longer period of time than usual. Didn't get much sleep at all. I'm doing MUCH better now. Just feel drained and tired. I don't think it was an allergic reaction, rather the vaccine exacerbated the symptoms of my neurological condition FAR beyond what I'm used to." Per available documentation, appears patient did not actively treat reaction with any medications. Did not seek medical attention or require any further intervention following resolution of symptoms.
Sxs of fever, chills, disorientation, headache.  Sxs started approximately 4days after vaccine administration.  Went to ER, admitted to hospital for observation. 10/27/08-records received for DOS 5/13-5/18/08-DC DX: Neck pain and headache likely viral syndrome with post lumbar puncture headache with possible adverse reaction of headache and fever secondary to immunizations. Presented with intractable headache and neck pain and fever. Temperature 101. Arthralgias, fevers chills and mild confusion 4-5 days prior to admission. One day of discharge C/O tunneling vision, blurry vision increased confusion with position changes. Transferred. 12/19/08-records received for DOS 5/18-5/20/08-DC DX: Headache. Possibly post LP. Febrile illness post immunization. Intractable headache times 1 week exacerbated following LP times 2 at outside hospital. Chills and fever. Anxiety and stress may have contributed to persisting headache.
Flu shot administered at 4:PM. Nausea started at 10:PM, lasted all night, and terminated in vomiting at 5:AM.