chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hands and feet cold with a sensation of numbness all day; hands and feet cold with a sensation of numbness all day; bruising on the legs/bruises changed its color from violet to brown; pain on the legs; headaches; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising on the legs/bruises changed its color from violet to brown), PAIN IN EXTREMITY (pain on the legs), PERIPHERAL COLDNESS (hands and feet cold with a sensation of numbness all day), HYPOAESTHESIA (hands and feet cold with a sensation of numbness all day) and HEADACHE (headaches) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced HEADACHE (headaches). On 23-May-2021, the patient experienced CONTUSION (bruising on the legs/bruises changed its color from violet to brown) and PAIN IN EXTREMITY (pain on the legs). On 24-May-2021, the patient experienced PERIPHERAL COLDNESS (hands and feet cold with a sensation of numbness all day) and HYPOAESTHESIA (hands and feet cold with a sensation of numbness all day). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CONTUSION (bruising on the legs/bruises changed its color from violet to brown), PAIN IN EXTREMITY (pain on the legs), PERIPHERAL COLDNESS (hands and feet cold with a sensation of numbness all day), HYPOAESTHESIA (hands and feet cold with a sensation of numbness all day) and HEADACHE (headaches) had not resolved.             No concomitant medications were reported.
about an hour and a half after my shot  Wednesday 12/30/20, I became extremely dizzy, it hit me suddenly.  Lasted for a few hours. 12/31/20 when I woke up, I was still light headed and slightly dizzy and I still feel the same 1/1/20 dizziness is not nearly as bad as the first day.
28DEC90 HBs Ag - negative; 27NOV90 Anti-HBs - negative; 28DEC90  ANti HBs positive; Given 5 doses vax 5OCT88, 2NOV88, 21APR89, 30NOV90, 3JAN91 fr lot#s 1893P, 1880R, 1238S, 1st & 2nd dose not recorded;
Severe Headache for 14 hours unrelieved with Aleve and Aspirin followed by intense itching of scalp and body relieved with Benadryl.
This spontaneous report was received from a pharmacist referring to a currently 61 year old female patient. The patient's pertinent medical history, drug reactions and allergies included: "histamine reactions" to other injections of unspecified medications, "Season Allergies" and other unspecified environmental allergies. The patient received "Allergy shots" on both arms on 09-OCT-2016 and received ZOSTAVAX (lot # M024698, expiration date 27-JUN-2016) subcutaneously, eighteen (18) hours later on 10-OCT-2016. Other concomitant therapies included vitamin D and SINGULAIR. On an unspecified date in October 2016, the patient had 3 inches of redness, warmth to the touch, and swelling around the ZOSTAVAX injection and unspecified redness around the allergy shot injection site on the same arm. The opposite arm did not have a reaction. The patient was also feeling flushed. The symptoms have not improved as of 11-OCT-2016 (not recovered). It was also reported that the patient did not receive treatment for the adverse events, that no laboratory diagnostic studies were performed, that she did not seek for medical attention nor was hospitalized, that no laboratory diagnostic studies were performed, that she did not seek for medical attention nor was hospitalized, that no intervention to prevent serious criteria was necessary and that the adverse events were not significant disability nor life threatening. The causality between the adverse events and ZOSTAVAX was not assessed. Additional information has been requested.
COPD  She was a resident at the Senior Living facility.  My mother received the vaccine on Tuesday, May 18, 2021 at approximately 11:00 a.m.  She was left by herself and called around at 11:32 to say she got the vaccine and she was having a hard time breathing.  Around 1:40, the nursing home called to let me know CPR was being performed.  My sister rushed to the site and  she was pronounced dead around 2:10. p.m.
Bilateral leg edema was observed on Sunday evening 5/23/2021 at approximately 6:30PM and still present at this time of filling.
I experienced diarrhea and headaches on the third day. I also experienced cold sweats and I also had a bad taste in my mouth approximately 3 days.
Moderate itching of forehead, eyebrows, and scalp.  Took a Benadryl before bed and all is well today.  I'm just reporting this because it may be an additional side-effect, but it's not serious.
Mom called and stated child's leg became red, hot and swollen.  She was taken to urgent care by her parents and patient was put on Zithromax.
13 x 18 area of erythema and induration; mother noted 42 hours after immunization with Hep A #2 and DTaP #4. C/O leg pain and fever the night before and had some limp. Seen 48 hours after immunizations and dx with cellulitis and given cephalexin and ibuprofen and will f/u tomorrow.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6207), on 12Apr2021 as dose 2, single (Lot number: ER8734) and on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "eczema" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Known allergies: Pennicillan" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ASTELIN [AZELASTINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]; MONTELUKAST; QVAR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (11Aug2022) Negative; (15Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral treatment included nirmatrelvir/ritonavir (PAXLOVID) from 04Aug2022 to 09Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hyporesponsive collapse, 7 hr p/shot; brief (<3min); hosp overnoc w/monitor w/o sequelae;
Varicella Information has been received from a physician and a school nurse concerning an 10 year old male who on 09-JUL-1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was also noted that the patient was vaccinated with a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 16-NOV-1995 and 02-FEB-2000. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesion. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. No additional information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
05/25/2022 I started having a sore throat, body aches and chills, which probably was with a fever. I tested positive for COVID. On 5/26/2022 and 5/27/2022 I had a very heavy nasal drip in the back of my throat, nothing I could blow. I was very tired, chills, fever and not much appetite. 05/28/2022 It got worse and the nasal drip moved to the front. If I took a deep breath I would cough but did not cough that much. I slept for 20 hours, could not move. I had no appetite. My body basically shut down for those 20 hours. I had dinner and went back to bed and slept. On 5/29/2022 I felt better had stopped blowing my nose and could take a deep breath without coughing. I lost my taste. On 5/30/2022 I felt much better. Today I had the strongest COVID positive test even though I feel a little better. I still have a pressure between my ears, but not behind my eyes. It feels like my head is in a vice. I have a feeling of being very depressed. I am treated for depression, but this is how I feel in my head when I am really depressed. My taste today is better, but not 100%.
here for well visit;given injections without incident. Enroute home,mom called-child became itchy. Now with hives on back and legs;no resp distress. Advised to go to ER. Dr. spoke with ER-no actual hives;few red areas. Given benadryl. will need to wait 30 min. after next Hep A given.
Moderna COVID-19 Vaccine EUA:  Rash on right side of stomach ~5 inches in diameter, started about 2 days after first shot,  on 6th day after shot still present.
Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient who received half dose of vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Mar-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA via intramuscular route in the other. It was an actual medication error due to vaccine underdose and syringe issue. The nurse drew the DAPTACEL up into a syringe from the single dose vial, the needle fell off of the syringe during administration and most of the dose was lost. It was unknown whether adverse event was experienced. 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.
4/11/21 - first Pfizer covid vaccine received.  4/22/21 - my breastfed infant (4 mos at the time) has a mild allergic reaction with hives on neck, armpits and face. Relieved with hydrocortisone cream 5/2/21 - second Pfizer covid vaccine received  5/15/21 - my breastfed infant (now 6 mos) has another allergic reaction with more severe hives all over body and facial swelling. Relieved with hydrocortisone cream and benadryl
Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.) had resolved.        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 relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow- up received : contains No new information
felt ill; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and she felt ill after receiving the vaccine. The reporter was not sure if this event occurred after dose 1 or 2 and was not sure how many doses of Shingrix the patient had received.  The reporter did not wish to provide any additional information regarding this patient or event and requested for no follow up regarding this event.
Numbness in shot arm immediately Comes and goes now. Next day pain in both knees Painful to walk and constipation. Eye irritation  beginning on the 11/06/2021. Neck and shoulder pain beginning on 11/08/2021. Burning sensation from knees down to toes beginning on 11/11/2021 Comes and goes now.
Triggered Asthma Attack at 12:30pm on 2/6/2021, Caused throat to become hoarse, raspy and sob. Extreme pain in left arm and swelling of arm and fingers. By 4:30pm on 2/6/2021 Hands Swollen, L Arm Extremely Swollen, Swelling of Lymph Nodes in Throat and L Armpit. Hands, Feet and Face Swollen. Extreme Fatigue and Body Aches, Extreme Headache, Fever 100-101 for 4 days, Vertigo, Dizzy Spells, Nausea, Joint Pain, Teeth Pain, Heart Rate and Blood Pressure Increased. Took albuterol nebs, antihistamine and napoxen, increased fluids, reported to director of pharmacy at work/vaccine site and was on bed rest for 4 days. Broke fever on 2/9/2021 in the evening, fatigue, joint pain, lupus symptoms, migraine, swelling in hands and vertigo/nausea still present as of 2/11/2021. Doctor Appt already scheduled with neurologist on 2/11/2021 at 11:30am, family physician notified but out of the office.
Continuous muscle pain, stiffness, swelling in legs, primarily the lower half; intermittent muscle pain in left arm near armpit
No adverse event; 2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 patients received expired 2nd dose Monovalent Moderna COVID-19 vaccine).    This case contains the information of male patient.  Concomitant medications were not reported.  Nurse was calling to report that 2 patients (Male 5 and female 4 -year-old) received expired 2nd dose Monovalent Moderna COVID-19 vaccine.  Monovalent 6M-5Y was administered to the patients.  Individual vials or intact cartons : 1 vial inside open cartons.  Vial size was reported as 0.4 mL, 2.5 mL or 5.5 mL*: 2.5 ml.  The date vial was initially stored in the refrigerator was 14-FEB-2023. The vial did not undergone any temperature excursions.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-710745 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710745:Female case
two days after injection had significant discomfort bilateral arms, bilateral axilla and back this persisteded for 10 days following the injuection
Patient received Afluria on 9/16/23. On 9/25/23 patient contacted the pharmacy complaining of arm soreness and mild shooting pain when exercising. Contacted her PCP Dr. to inform office about the arm soreness and pain and spoke with representative. Patient has not tried any treatments.
Red, swollen area around inj site after imms. Afebrile left thigh.
"feeling like a building fell on me, cold and chills, but no fever, inability to sleep"
Flu Vaccine 9/26/2016 at 11:00am; TDAP vaccine 9/26/2016 at 8:00 pm. Headache and nausea started 9/27/2016 at 9:00 am. Uncontrollable chills and fever (102.3) started at noon on 9/27/2016.
friends that got shingles after the shot/Suspected Vaccination failure; friends that got shingles after the shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and friends that got shingles. The reporter reported that no guarantee that you will not get them again. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Chills first then high fever (103 F) overnight, 101-102 next day and down to 99 tonight, 2 days later.  Nausea and diarrhea and bad headache throughout this time but getting better now.  The lot number was not written clearly.  The "B" might be a O, 0, or D.  First character could be 0 or O.
Broke out in lesions on face and torso which Dr feels is related to receiving Varivax vaccine.
Information has been received from a physician concerning a 4 year old female who, "on her 12 month visit", in approximately 2002, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Recently", in 2005, the patient experienced breakthrough varicella of about fifty lesions or less with no fever. Subsequently, the patient recovered. No treatment was given. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
COVID Arm large red rash with inflammation started on day 2 post 2nd dose  below injection site. Started with slight itching on day 4.
Pt was hospitalized at for COVID-19 from 07/13/2021-08/05/2021. Updated symptoms and pre-existing medical conditions per medical records. Pt experienced shortness of breath, fever and cough. Pt has hypertension, dyslipidemia, COPD, hypothyroidism, and dementia. Per medical records, family found out that one of the pt's visiting granddaughters was found to be positive for COVID-19, so the family brought the pt to the hospital for further management. Per medical records, pt was seen and examined on day of discharge in stable condition and transferred to Hospital.
Throat tightness, hair loss, left breast pain persisting since vaccine.  Started about 1 hour after vaccine and has persistent since then.  Went to the ER but did not want to wait so she was never evaluated.
injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever - for 2 days 101-102 degrees; injection site swelling; nausea; feeling unwell; dry cough; This is a spontaneous report from a contactable Consumer. This 67-year-old Female Consumer reported for herself that:  A 67-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Not available/provided to reporter at the time of report completion) via an unspecified route of administration in arm left on 25Feb2021 11:00 as single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing if covid prior vaccination Yes. Concomitant medications included levocetirizine (LEVOCETIRIZINE), metoprolol succinate (TOPROL), pantoprazole (PANTOPRAZOLE) all taken for an unspecified indication, start and stop date were not reported and have other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 26Feb2021 at 12:00 patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever - for 2 days 101-102 degrees, dry cough, injection site swelling, nausea, feeling unwell. Patient didn't received treatment for adverse event. The clinical outcome of the event was recovering.    No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Right anterior thigh edematous with hyperemia involving entire thigh front and back with mildly increased tone, no drainage, no abscess. Ambulates well without difficulty. Normal popliteal and pedal pulse. Continue compresses and observations.
patient had dizziness about 5 minutes after the vaccination, patient felt like she needed oxygen and so we decided to contact ems once she stated she was having feelings of passing out. patient was seen by ems an ekg was run, blood pressure was 200/100 and the ems advised her that this may be a panic attack related to getting the vaccine that the increase in blood pressure was not a hypertensive emergency. patient then chose to stay and wait for her daughter to come pick her up. her blood sugar was also taken and it was 99 within normal range.