chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 15 min after vaccine 1145 asked patient how feeling he said he felt normal but had hesitation when stated. After asking again who he was feeling stated he was "woozy". Wife states he gets dizzy after eating breakfast & had eaten prior to getting to the home.  Pt denies other sx. Checked bp 200/80 left arm manual  98F  59 P. Pt alert oreinted, no distress noted.  At 1147 pt reports feeling better  bp  165/65 P 59 denies dizziness.  1158 pt states feeling slight sob, had mask on & had remove mask. Called EMS  for evaluation at 1158. Pt alert oriented x 4, normal even respiration, color normal for race. prior to EMS arrival pt ambulatory with walker to bathroom deneis dizzy.  EMS arrived at 1205 Paramedics along with EMT evaluated patient  EMS vitals 189/69  100%RA pt states feeling better & refused transport to hospital.
2 wks after shots, patient developed 100.9 temp and was inconsolable. Since it was after  hours, our doctor told us we had to go to the ER. Checked for RSV & cath'd for a UTI. They sent us home with no answers. I had to call back days later for them to tell me it was an unspecified virus. Of course, she had just been injected/given 19 viruses exactly 2 wks prior, but no one asked about recent vaccinations or mentioned checking her for any of those viruses. No treatment given other than Tylenol. Fever lasted for 2 days. Patient would go on to develop eczema and slight reaction to peanut butter many months later. TERRIBLE sleeper, only sleeping for 7 minutes at a time. She started daycare a couple weeks later and they would let us know if she slept for 30 minutes the entire day. Most days, she didn't. Has some sensory issues that remain.
Patient had vaccine 1130a, 1135a patient developed chest tightness, with intermittent sharp chest pain, midsternal, with dizziness, lightheadedness, and felt cold/clammy reported by patient. 1145a patient in observation on stretcher, with bp 120/88, rr 18, sao2 99% on ra. 1150a, patient denies sob and midtsternal sharp cp, but chest tightness remains, bp 104/66, rr 18, sao2 100% on ra. Discussed with patient pmh and ems transporting to ed for cardiac workup to roll out complications, patient in agreeance as chest tightness unrelieved. 12p ems arrived to location, bp 117/71, rr 16, sao2 99% on ra, chest tightness remains but all other s/s resolved, departed with ems after report given in stable condition, transported to hospital. spouse notified by patient.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 13-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number  S002506 and expiration date 04-APR-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
smell and taste sensation is lost; smell and taste sensation is lost; cold; little cold and congestion; No side effects from vaccine, just soreness on injection area.; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (smell and taste sensation is lost), AGEUSIA (smell and taste sensation is lost), NASOPHARYNGITIS (cold), NASAL CONGESTION (little cold and congestion) and INJECTION SITE PAIN (No side effects from vaccine, just soreness on injection area.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE PAIN (No side effects from vaccine, just soreness on injection area.). On 13-Mar-2021, the patient experienced NASOPHARYNGITIS (cold). 13-Mar-2021, the patient experienced NASAL CONGESTION (little cold and congestion). On 14-Mar-2021, the patient experienced ANOSMIA (smell and taste sensation is lost) and AGEUSIA (smell and taste sensation is lost). At the time of the report, ANOSMIA (smell and taste sensation is lost), AGEUSIA (smell and taste sensation is lost), NASOPHARYNGITIS (cold), NASAL CONGESTION (little cold and congestion) and INJECTION SITE PAIN (No side effects from vaccine, just soreness on injection area.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
On 4/22/2021 after my second dose of the moderna vaccine, I started menstruating for a period of over 30 days. Resolved with tranexemic acid. On 12/4/2021 I received the moderna booster. I have now been menstruating for over 14 days. This is abnormal as I usually do not menstruate due to nexplanon.
huge inflammation, comparable to a golf ball on her collarbone; This is a spontaneous report from a non-contactable consumer (patient friend) reporting for a female patient.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient also mentioned that one of her friends who took the Pfizer Covid vaccine had left her with side effects. On an unspecified date patient experienced a huge inflammation, comparable to a golf ball on her collarbone She even had pictures. However, her friend's doctor did not give her any indication for treatment and said to let the body assume the effects and the natural antibody production after receiving the vaccine. The adverse event did not result in Life Threatening, Disabling Incapacitating, Intervention Medically Important, Congenital Anomaly Birth Defect, Death, Hospitalization Required and Hospitalization Prolonged. Product Complaint: There was no product complaint associated with this case. The outcome of event was unknown.   No follow up attempts are needed, No further information is expected.
Information has been received from a pharmacist concerning a patient who in September 2006 was vaccinated with a dose of Varivax instead of a dose of Zostavax. The patient had no symptoms. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
5cm area erythema, swelling, heat, hardness possible cord. No vesicles.
6 days after ZOSTAVAX administration, patient called to report symptoms of chickenpox; her doctor agreed and prescribed acyclovir to treat.
Only the adjuvant / was given to patient; Only the adjuvant / was given to patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number PN2L3, expiry date 7th November 2022) for prophylaxis.   On 21st May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 21st May 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The case was reported by the pharmacy student. The patient received only the adjuvant part of Shingrix, without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No signs and symptoms were reported and limited information was obtained.   The pharmacy also requested a replacement dose.  The reported batch number PH2L3, was not found in sales data sheet, hence was updated to PN2L3.
Significant increase in arthritis pain in knee and hip; Significant increase in arthritis pain in knee and hip; Tingling in toes; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the left arm on 20Mar2021 at 13:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and high blood pressure. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), oxybutynin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN), all taken from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6205) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 13:00, the patient experienced significant increase in arthritis pain in knee and hip and tingling in toes. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events significant increase in arthritis pain in knee and hip and tingling in toes were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) 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 relevant concomitant medications were reported. No treatment information was provided. The patient is not immunocompromised.   This case was linked to MOD-2021-363403, MOD-2021-363338 (Patient Link).
pt recvd vax; generalized body itching; eye lids swollen; blisters under eyes; n; tiredness; DPH given; hx of blisters forming around eyes in response to oth allergy;
Five days following the first dose of the Moderna COVID-19 vaccine, the patient developed diffuse body pain, beginning in the right shoulder (for which she received a steroid injection), but then spreading to the entire body. This pain became so severe that she presented to the hospital via EMS, and was found to have a platelet count of 41 (9 days following the vaccine). No baseline platelet count is available prior to the vaccine (most recent was from 2019). Immune-mediated thrombocytopenia is being considered, and the patient has been placed on IVIG and steroids. It is now 4 days into the patient's admission, and platelets continue to fall (currently 26). Hemoglobin appears normal at the time and there is no sign of active bleeding. Of note, the patient also has positive blood cultures, so thrombocytopenia as a result of sepsis is also a possibility.
This spontaneous report as received from a Doctor of pharmacy refers to a currently 62 year old female patient with many allergies. The patient was vaccinated with lot # (672608/1715AA) expiration date 02-FEB-2013, 0.65 ml ZOSTAVAX subcutaneously in the left arm on 04-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that the patient was vaccinated with ZOSTAVAX and developed an adverse reaction. The pharmacist reported that the patient went into the pharmacy with warm, itchy red rash, (about 8 inches) at the injection site of the left arm. The patient was treated with BENADRYL (OTC) and cold compress laboratory and diagnostics were not performed. At the time of the report, the patient had not recovered from warm, itchy red rash, (about 8 inches) at the injection site of the left arm. Additional information has been requested.
103 degree fever and severe body aches (all over) - 9 hours after vaccine. Treated initially with ice pack and Ibuprofen at night on 7/13. Treated with Ibuprofen and Acetaminophen & fluids on 7/14, 7/15, 7/16. Fever 103 degrees on 7/13, 101 degrees on 7/14, 100 degrees on 7/15 and 99 degrees on 7/16. Fever & body aches gone on 7/17.
Trouble breathing the next day, progressively getting worse each day.  Muscle cramps and stomach/bowel problems.  The 3rd day after i was ok (except the above) and then around 3pm i started a fever, chills, total body aches and being tired.   Fever progressed each hour and hit a high of 102 degrees around 10pm.  Started taking Tylenol around 8pm.   About 2am fever hit it's hjigh and i began sweating a lot and was sick to my stomach.  Lasted about 30 minutes.  Fell asleep until 7am.  Fever gone, felt much better and just tired.
Tired; Soreness of the arm; This is a spontaneous report received from a contactable consumer reporting on husband. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at single dose for COVID-19 immunization. Medical history included severe allergies. concomitant medications were not reported. Caller's husband received his first dose of Pfizer Covid Vaccine on 15Apr2021. He is scheduled for second dose of Pfizer Covid Vaccine on 06May2021. Caller asked, they are scheduled for the 6th and are leaving on the 7th back on the 11th. Asked if there was anyway to get the second dose that week of the 13th when they return home. Her husband has severe allergies and has an Epi pen and god forbid problem should occur, he would have an anaphylactic reaction. After he received his first dose of Pfizer Covid Vaccine, they kept him after longer to monitor him. The only side effect her husband experienced was that he was tired and had soreness of the arm. Caller clarified she did not call to report about her husband, she called to ask the question about the second dose, with them traveling and it being Mother's Day. Caller mentioned that everyone she has spoken to that has had the Pfizer vaccine or Moderna has had problems with the second dose, not the first. Caller and Spouse received the 1st vaccine on 15Apr2021 and are scheduled to receive the 2nd dose on 05May2021, stated that they will be out of town and would the 2nd dose be able to be given on another day after they return. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial information has been received from a pediatrician in the form of medical records concerning a 27 day female normal infant who on 5-DEC-2007 the was vaccinated with PREVNAR, ROTATEQ, PEDIARIX and PEDVAXHIB. On 18-DEC-2007, the approximately one month old patient was accompanied by her mother and presented with a chief complaint of yeast infection on buttocks, thrush concerns. Additional comments were: mother recently treated for mastitis, no fever, no vomiting or diarrhea, no changes in appetite or sleep. The infant was diagnosed with candidiasis urogenital and it was recommended for treatment CLOTRIMAZOLE cream, twice a day for seven days. The pain score assessment was 0. Physical examination revealed an awake and alert female infant with mild yeast diaper rash, normocephalic atraumatic, with normal tone and normal movements of all extremities. The baby's extremities were pink, warm, brisk capillary refill. On 26-MAR-2008, the four old female infant had a healthy appearing, the patient had breast formula feeding and may be able to start cereals and baby's "first food", no more than two new foods per week. Physician reported that the patient was also vaccinated with second dose of PREVNAR, ROTATEQ, and PEDIARIX. On 28-MAY-2008 the approximately 6 month infant weighted 22.35 pounds, her height was 27.5 inches, and her pulse rate was 132 and respiration 36. Additional information has been requested.
No additional AE reported; PNEUMOV AX 23 expired on 12/22/2020 and was administered; This spontaneous report was received from a Nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies were not provided.      On 22-SEP-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5mL, with lot # S003872 and expiration date on 22-DEC-2020 (dose and route were not reported) for prophylaxis (expired product administered).  No additional adverse events were reported. No additional information provided.
This spontaneous report as received from a healthcare worker (also reported as a nurse) refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of oral, ROTATEQ were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. This is one of several reprots from the same reporter. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that, on 03-APR-2015, the patient of unknown age and gender was vaccinated with improperly stored oral, ROTATEQ (Lot number: K010219, expiry date: 02-JUN-2015). Additional information has been requested.
Beginning the day after the shot I started with vaginal swelling which wasn?t terrible that day but by the second day (Thursday) it was severe. I worked that entire day not realizing just how bad it was but by the end of the day I could barely walk out to my car. I was in so much pain and so swollen that by the next day I could not do anything. I went to my GYN first thing that morning (Friday) where they swabbed to send for various tests which have all come back negative so far.  I had to return for a re-culture that had come back inconclusive and we are still waiting on those results. I have been given an antibiotic and prednisone which still have not resolved the swelling. I am about 50% resolved and almost 2 weeks later at this point but there is still significant internal swelling which is uncomfortable but not hindering me from working. I was out of work for an entire week and not able to do anything for that entire timeframe.
Sleepless night, back pain, fever, headache, neck, stiffness, and arm pain.
p/vax pt exp approx 40 lesions;the reporting MD reported on follow up that the pt did not exp varicella;pt exp an allergic rash;
Administered expired vaccine to the patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021.  No treatment details were reported.     Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included no new information.
Pain at the injection site radiated down the arm.  It has been ongoing since 10/22/15.  The shooting pain is intermittent. No redness, no pus, and not swollen.
Area of erythema and induration over deltoid area of upper left arm measuring 8 1/2 cm by 11 cm 48 hours after administration of IPV vaccine
This gentleman returned to the pharmacy 1 hour after administration of the vaccine.  His lips were very swollen and he said he felt terrible.  His face was also getting red and blotchy.  He also told us that he was having trouble seeing.  We asked him to sit down so we could call 911 but he insisted on returning to his car to be with his wife.  He was sweaty and confused.  911 arrived and took over the situation.
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: FOLLOWING VACCINATION, PATIENT WAS IN OBSERVATION AREA SEATED WITH CAREGIVER. PATIENT STARTED SHOWING SIGN OF FAINTING, SWEATING, AND LIGHTHEADEDNESS. PATIENT WAS OFFERED BOTTLE OF WATER. CALLED AMBULANCE, EMT ARRIVED AND EXAMINED PATIENT. PATIENT DENIED TO GO TO HOSPTIAL. STATED HE HAS STARTED FEELING BETTER.
Received flu shot yesterday c/o increase fever >104 degrees F. headache, sore throat. Flu test shown (+) A & B
Information has been received from a consumer concerning her 78 year old husband with "cholesterol" and no allergies who on 15-MAY-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included simvastatin and ezetimibe. On approximately 15-MAY-2007, after vaccination the patient experienced hearing loss in the right ear. No medical attention was sought and no diagnostic laboratory tests were performed. At the time of report, the patient was not recovered. A product quality complaint was not involved. Additional information has been requested.
Hives. (VAERS form faxed to ER doctor with request to complete and submit).
51 year old female patient received first dose Moderna at 5:28pm is waiting 15 minutes in the observation area and when she was in pharmacy she felt chest pain and went back to the vaccination Center so the EMT checked her vitals. When the patient was waiting in the observations area she reports her last meal was a protein bar and 4oz of juice at 10am. Vitals at 6pm 160/100 B/P, 98% of SPO2 and 70-80 pulse. At 6:48pm her vital signs were checked again: 180/98 B/P of 100-70, 90-60 pulse. Patient is transported to medical center.