chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 12 year old daughter who on an unspecified date was vaccinated with her first dose of GARDASIL (LOT# was not reported). Approximately one week after vaccination, the patient started bleeding. It was reported that the patient had not started or gotten her menstrual cycle quite yet but the reporter thought that bleeding could be her actual cycle since her daughter is 12 year old. No other adverse event was reported. Additional information is not expected.
Healthy 12 month old well visit, received schedule 12 month vaccine of varicella with diluent on 08/29/2018 without incident. Mom called office and states child woke up with "hives" all over his body and was cranky. Pt seen in office that am and appears well other than the hives. Was treated with BENADRYL.
Redness and swelling around injection site 3/27 left upper arm from pt of shoulder to mid-arm, blotchy erythema, scratch marks, warm to touch.  No significant nodes.
I experienced extreme SOB 10/02/2021. I went to hospital (Unknown Hospital), had multiple pulmonary emboli in my lungs. I never had history of that before. I was hospitalized form 10/02/2021 to 10/04/2021 and I am now on blood thinner medication. I had a chest CT scan. I am in the process of recovering.
Dysphasia I have had many Dr's appointments with ENT, Gastrointerology, Speech Pathologists and went to urgent care/ ED several times. No one can figure out what is wrong. This is still an ongoing event.
Information has been received from a physician concerning a 12 year old female, who on 16-FEB-2008 was vaccinated with a first dose of Gardasil.  Concomitant vaccinations included tetanus toxoid and meningococcal vaccine (unspecified).  Over the weekend, within 24 hours post vaccination the patient experienced several episodes of dizziness, and one syncopal episode where she actually fainted.  The patient returned to the office and the physician did not see any signs of dizziness at that point.  It was reported that the patient did not require any emergency or prolonged health assistance.  The patient recovered on an unspecified date.  Additional information has been requested.
Soldier complained of localized moderate edema to (unknown left or right) deltoid injection site and headache
Patient  states symptoms started walking to the car after receipt of the vaccine. He states about two hours after receipt he experienced pressure in his neck. He could not lie flat due to exacerbation. He felt progressive worsening of symptoms to include head pressure, dizziness, dyspnea, productive cough with clear mucus and left sided chest pressure he attributed to his lungs. He finally sought ER care at about 1 week. Findings included positive troponins and heart failure and was admitted.
Mouth watering, throat started feeling tight, legs got extremely weak  all within 15 minutes of shot. Blood pressure up to 150+ for roughly 3 days.  I carry my own meds (Benadryl/Epi/pen), nurse had me take Benadryl and wait longer to see how I felt. It really took me until sat 4/3 in the afternoon at work to start thinking clearly and get my legs back under me.
Dose 1 COVID Pfizer on 5/12/21, dose 2 COVID Pfizer on 6/2/21, and patient was admitted with COVID resp. failure on 11/14/21, and remains hospitalized at this time(11/16/21)
INNOCULATED ON 10/14/2006,11:AM WITH PNEUMOCOCCAL VACCINE(1ST INNOCULATION 1999) AND ANNUAL INFLUENZA VACCINE.  PAIN, SWELLING, AND FEVER BEGAN AT SITE OF PNEUMOCOCCAL INNOCULATION AT 1:00PM.  2:00PM PAIN IN UPPER ARM BECAME INTENSE.  3:OOPM NAUSEA BEGAN.  INGESTED AT 9AM, 220MG OF NAPROXEN.  5OOMG OF ACETAMINOPHEN INGESTED AT 9AM & 1PM.  PATIENT BECAME FEARFUL OF ADVERSE REACTION BEING LIFE THREATENING BECAUSE OF PRE-EXISTING CONDITIONS OF ASTHMA, HYPERTENSION, & OBESITY.  TRIP TO EMERGENCY ROOM AT 4PM.  DECIDED NOT TO WAIT TO SEE PHYSICIAN. NO TREATMENT RECEIVED. RETURNED HOME. VOMITING BEGAN AT 5PM.  PHONED THE PHYSICIAN ON CALL.  SHE PRESCRIBED 25MG PROMETHAZINE SUPPOSITORY TAKEN AT 5:30PM.  VOMITING CEASED WITH MODERATE NAUSEA REMAINING FOR THE NEXT 8 HRS. MOIST HEAT APPLIED TO SHOULDER WHICH HELPED EASE PAIN SLIGHTLY.  400MG OF IBUPROFEN TAKEN ORALLY AT 6:30PM, 11PM, AND 5AM.  INTENSE PAIN LASTED FOR 16HRS.  UPPER ARM REMAINED SWOLLEN, FEVERISH, AND IMMOBILE FOR 4 DAYS.  LEFT ARM STILL HAS LIMITED ROTATION AND MILD PAIN AROUND SHOULDER JOINT. PUBLIC SHOULD BE ALERTED TO EXPECT A MORE SEVERE REACTION WITH A SECOND PNEUMOCOCCAL INNOCULATION.  NO ADVERSE REACTION WAS DISPLAYED WITH THE 1ST INNOCULATION IN 1999 AND NO REACTIONS FROM ANY INFLUENZA VACCINATIONS.
Pt received varicella vaccine from our office on 10/20/2007.  Pt diagnosed with chickenpox by Reading Hospital ER physician in October 2007.
Posterior Lt arm pea size nodule with erythema surrounding by a 5x10cm erythematous area.  Treated with KEFLEX for 10 days.
Patient received vaccine on 6/18/19. On 6/19/19 patient developed headache, tiredness, weakness and arm pain at vaccination site. On 4/22 patient developed some redness at vaccination site after being out in the sun.
Widespread fasciculations that began two weeks after second dose and persist to current date (11/16/2021)
Pt received flu vaccination on 10/28/16 at approx. 1700.  Next day he had a syncopal episode and was advised to hydrate with water and  Gatorade, and after reported feeling okay.  Later on at home, he noted he had a fever of 105, and did not seek medical advice or treatment, but did not report his fever until Sunday pm when further asked about the events of the previous day.  Pt required to go to ER for further eval.
Patient was given H1N1 Flu Mist on 10-15-09 after receiving Seasonal Flu Mist on 9-22-09.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date, the patient was vaccinated with improperly stored (temperature 44.2 F and time frame 75 hours) doses of VARIVAX (Merck) (lot # L021211, exp. 10-JUN-2017 and lot # L029467, exp. 06-AUG-2017) (dose and route of administration not provided). No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
pt on 8/5/99 pt began tremors, inc heart rate; seen in clinic 1pm, inc heart rate gone
Pt received diphtheria/tetanus booster and developed a reaction that was red and painful, mor than a usual reaction at injection site.
Narrative:  Patient came to ED for supervised vaccine after developing itching within 12 minutes after first dose which was administered at local pharmacy on 9/14/21. Patient received Pfizer dose #2 10/18/2021 and developed itching but no rash or evidence of anaphylaxis. She was given PRN Vistaril and it was noted she had an epi-pen at home.
while standing up became lightheaded. No chest pain, SOB, diaphoretic, abdominal pain. no tingling at vaccine site
No adverse effect; adult patient was inadverently administered a pediatric dose of recombivax; This spontaneous report was received from a nurse regarding an adult patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On an unknown date in 2019 (last week), the patient was inadvertently vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dose, route, lot# and expiry date) for prophylaxis (incorrect dose administered). No adverse effects reported (no adverse event). Product quality complaint was not involved.
11/14/23 11pm Rash on Left Heel worse on Left & Right Heel And Started to Reduce Red Bumps & Burns Responded to Hydrocortisone Cream
Patient reported having redness and swelling from injection site radiating down to her elbow starting roughly 5 hours after vaccine administration. Reported a fever and pain. Went to ER and received an antibiotic and pain medication
Pt said immediately felt pain and sick. Pt states had 103 fever and vomiting soon after vaccine for days.
Moderna Covid vaccine EUA. I believe the vaccine effects my menstrual cycle. It is normally 27-30 days. I have never ever experienced any cycle shorter than 27 days before. However, this cycle lasted only 20 days. I had bad dizzy and could not stand  on my feet right when the period blood came out. I laid down and had some candies. The dizziness went away after 15 mins.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 26Sep2021 at 10:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "food allergies" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jun2022) Negative; (29Jun2022) Positive, notes: home test x 2; (29Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
papular pruritic rash developed same day as vaccination, spread to chest arms, face by day 3
No adverse side effects were reported with the administration of the vaccine.; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes); This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. The patient's concurrent conditions, pertinent medical history,  drug reactions or allergies, and concomitant therapies were not reported.  On 19-JUN-2023, the patient was vaccinated with improperly stored pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 ml once via injection in right thigh, lot #W039033, expiration date 01-OCT-2024, for prophylaxis (route of administration was not provided). It was reported that the vaccine underwent a current temperature excursion at 49.1 degree Fahrenheit (F) for 34 minutes, and also underwent two previous temperature excursions at 35.9F for 2 minutes and again at 35.9F for 2 minutes. The user of the device was a health care professional (HCP) and product was not available to obtain. No adverse side effects were reported with the administration of the vaccine. No additional AE information was provided and no PQC.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2307USA004472
Cold started 7 days ago with chills, cough, upper airway congestion, no fever. Progressed to sinus infection and eye infection.  Within one day of receiving the booster, I experienced heart palpitations with elevated heart rate (110 range) and feelings of exhaustion that lasted approximately one week with no medical intervention.
This spontaneous report was received from a 84 year old female patient reporting on herself. On 15-DEC-2010 (also reported as two weeks ago) the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) oral. Concomitant therapies included VICODIN. On approximately 11-SEP-2013 (two weeks ago) the patient advised of pain from middle of chest, middle of back and rash. She stated it was very painful especially in the mornings. The pain eases later in the day. Her rash was not itchy. Her doctor prescribed VICODIN for the pain but it made her feel sick to her stomach. He also prescribed prednisone (manufacturer unknown) but she was not itchy and VALTREX for the shingles virus. Her pain has not eased since she first got it two weeks ago. She also had a bladder infection when she had the Doctor appointment (on unspecified date in September 2013) but no medication was prescribed just a urine test (for bladder infection, results not provided). The outcomes of the events were reported as not recovered. Additional information has been requested.
Lower back pain just to the right of the fusion of my L4, 5.  I've taken 2 tylonel extra strength to ease the pain.  The pain started soon after the injection and increased in intensity culminating the morning after the injection.  The Tylenol has eased the pain somewhat, but it's still problematic.
Ringing in the ears, headaches, throat hurts when I breath in (swollen glands), shortness of breath, fevers, sweats, chills, jaw pain, sore body
Night sweats; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Nov2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes, androgenic alopecia, hashimotos, sulfonamide allergy and COVID-19 diagnosed, prior to the vaccination. The patient received other medicines (unspecified) within two weeks prior to vaccination. On 04Nov2021 at 02:00, the patient experienced night sweats. The patient received the vaccine on tuesday and for the past two nights from the time of reporting  he had been waking up in a pool of sweat. Further reported that hopefully it would not continue. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event night sweats was unknown at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
Patient presented to facility with fever, currently on Chemo for Breast Cancer.  Admit for neutropenia.
Chest pain, weak extremities, tingling  through arms, nausea Has occurred frequently since 3/27/21 2nd dose of vaccine received at same location on 4/20/21, Moderna, Lot #038B21A
right palm pain felt like it had a hot poker in it, rating 8-9; reports pain down her right arm; itchy rash; started to have a rash, smooth, reasonably hard, very itchy, and grew; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (started to have a rash, smooth, reasonably hard, very itchy, and grew), SKIN BURNING SENSATION (right palm pain felt like it had a hot poker in it, rating 8-9), PAIN IN EXTREMITY (reports pain down her right arm) and VACCINATION SITE RASH (itchy rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (started to have a rash, smooth, reasonably hard, very itchy, and grew) and VACCINATION SITE RASH (itchy rash). On an unknown date, the patient experienced SKIN BURNING SENSATION (right palm pain felt like it had a hot poker in it, rating 8-9) and PAIN IN EXTREMITY (reports pain down her right arm). At the time of the report, VACCINATION SITE RASH (started to have a rash, smooth, reasonably hard, very itchy, and grew), PAIN IN EXTREMITY (reports pain down her right arm) and VACCINATION SITE RASH (itchy rash) outcome was unknown and SKIN BURNING SENSATION (right palm pain felt like it had a hot poker in it, rating 8-9) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
COVID PCR positive on 7/28/21.   patient with runny nose and fatigue
This spontaneous report was received from a pharmacist concerning to a female patient of unknown age with sulfa allergy. On 31-JUL-2013, the patient received a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unspecified date after the vaccination, on approximately 01-AUG-2013, the patient developed a knot under the skin and redness at the site of ZOSTAVAX injection. The patient did not receive any treatment for the events and sought medical attention by calling the pharmacist. No laboratory test was performed. At the time of the report, the patient was recovering from the events. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Patient cannot move arm around especially in the morning.  This started right after reaction on the injection site.  Patient uses left arm where he got the pneumovax, to play golf.  It has affected his golfing.
Headache, Myalgia, Arthralgia, Fever, LOSS OF SMEEL/TASTE, FATIGUE, AND CHILLS  Narrative:  EMPLOYEE REPORTS SYMPTOMS BEGIN 12/31/20 (10 DAYS AFTER RECEIVING VACCINATION
17FEB98 reported pt became ill 3 days p/vax;s/s included parotid gland swelling bilat, sore throat, nasal congestion, laryngitis lasting 2wk, throat pain subsided p/2 days;swelling subsided p/ 5 days;
When my symptoms returned I tested positive using an at home antigen test.; When my symptoms returned I tested positive using an at home antigen test.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 at 13:30 as dose 1, single (Lot number: EI9264), in left arm, on 16Feb2021 as dose 2, single (Lot number: EI9266), in left arm and on 22Sep2021 at 13:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 05Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL / NORETHINDRONE ACETATE; ALEVE, start date: 01Apr2022; FLONASE [FLUTICASONE PROPIONATE], start date: 01Mar2020; LEVALBUTEROL TARTRATE HFA; FLOVENT HFA; BIOTIN; UBIQUINOL. Past drug history included: Torradol, reaction(s): "known allergies Torradol", notes: known allergies Torradol; Morphine, reaction(s): "known allergies Morphine", notes: known allergies Morphine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "When my symptoms returned I tested positive using an at home antigen test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: While on the Paxlovid I tested negative twice using an at home antigen test; (unspecified date) Negative, notes: While on the Paxlovid I tested negative twice using an at home antigen test; (May2022) Positive, notes: When my symptoms returned I tested positive using an at home antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Information: COVID 19 Treatment reported as Paxlovid, Treatment started on 18May2022 and stop date was 22May2022, Indication was reported as Treatment of COVID-19. Adverse event was reported as, 7 days after last dose of Paxlovid cough, runny nose, scratchy throat, slight nausea and general feeling of malaise returned. While on the Paxlovid patient tested negative twice using an at home antigen test. When symptoms returned patient tested positive using an at home antigen test.  No follow-up attempts are possible. No further information is expected.
Rheumatoid arthritis in left thumb started out mild with severe pain when I first woke up but lasted under a minute.  Since then it has progressed to pain in the left thumb all day and unable to use thumb to open jars or apply any pressure to that thumb.  Stiffness also starting in right hand but not to the extent experienced in the left hand and not the pain. Experienced severe reactions to all three Moderna shots lasting 2 to 3 days after shot.  Site reactions lasted 1 - 2 weeks.
L arm swollen, warm to touch, tender to touch. Mom treated pt with Tylenol and ice packs as advised and noted some relief, but presented to clinic post swelling cont despite OTC tx. Pt referred to PMD for evaluation.
Information has been received from a pharmacist referring to a 60 year old female patient. The patient had breast cancer on an unspecified date 3-4 years ago. She had no drug reactions/allergies. Concomitant therapies included ARIMIDEX and unspecified flu shot on 22-OCT-2016. On 22-OCT-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # M019646 with expiration date 18-JUL-2017, dose not reported, subcutaneous). On 26-OCT-2016, the patient called the pharmacist back to report that after receiving the vaccine, she developed warmth, itching and redness about 4 inches in diameter at the injection site  (unspecified date in October 2016). No treatment was given for the events and no lab diagnostics studies were performed. The patient reported to the pharmacist that the size of the affected area had "now" decreased to a 3-inch area as of 26-OCT-2016. The outcome of the events was reported as not recovered. The causality was not reported. Additional information has been requested.
This spontaneous report was received from a physician, refers to a 16 year old patient of unknown gender. On 20-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M043306, exp. date: 24-APR-2018, albumin status: rHa) (strength, dose and route unspecified) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (°C) to -10 °C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. A digital data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA001467: US-009507513-1709USA005542: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820: US-009507513-708USA001338.