chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT DOSED FROM A VIAL OPENED THE PREVIOUS DAY; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAY-2021, the subject experienced subject dosed from a vial opened the previous day. The action taken with covid-19 vaccine was not applicable. The outcome of patient dosed from a vial opened the previous day was not reported. This report was non-serious.
Patient c/o numbness and tingling of tongue after receiving Pfizer vaccine. Patient stated she felt like she had a coating on her tongue. Patient c/o throat being dry. Patient was monitored for 45 minutes after receiving vaccine and seen by a  provider. Followed up with patient on 1/7/2022 via telephone. Patient reported she felt like she has something in her throat after leaving  until approx 11:00pm. Patient reported all symptoms have resolved at time of call.
Daughter got rash from hottub on top of foot; had gotten a bacterial infection from a hot tub; This is a spontaneous report from a Pfizer sponsored program COVAX US support via a contactable consumer reported for her daughter. A female patient of unspecified age received the first dose of BNT162B2 (Pfizer COVID-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was due for second dose on 21Apr2021. Patient got rash from hot tub on top of foot and would be taking antibiotics. Reporter was asking if rash/antibiotics would render second dose useless. Patient had gotten a bacterial infection from a hot tub. She was on antibiotics and wanted to know how long she had to wait to get the second dose. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mom reports that a rash appeared on his buttocks approx 2 hrs. after vaccinations. Rash has progressed to being papular & pustular. It is diffuse in location, on lower extremities & diaper area & is red in color.
Low grade fever to 100.8, left axilla swelling (3 inches by 7 inches) Left breast swelling, redness, and hot to touch. Area approx 5 inches by 9 inches from collar bone to lower breast. Fatigue, headache and body aches.
The patient is a 31 year old kidney transplant recipient who had been in his usual state of health and feeling well over the past months. On May 7, he received the first dose of COVID vaccine and experienced intense myalgias at that time. He recovered, but then around May 17 noted the onset of pain in the R thigh and lower R back and subsequently developed a vesicular rash in this area. He saw his primary care physician who prescribed gabapentin. However his pain worsened and the rash extended and he presented for admission. He was diagnosed with disseminated zoster, was hospitalized from 5/24/21 - 5/29/21 and was treated with IV acyclovir  followed by oral valacyclovir.
6/1/16 Parent calls to report a localized reaction day after vaccination to (L) deltoid of swelling and discomfort. Counseled to use cool pack/ibuprofen. 6/2/16 Swelling, involved "entire" deltoid area. Pain/swelling improved.
No additional adverse effect reported; Caller reported that VAQTA and ROTATEQ that underwent temperature excursions; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-NOV-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, lot # 1821791, expiration date 26-JUL-2022 (dose and anatomical location were not reported) for prophylaxis. Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000818: US-009507513-2112USA000819: US-009507513-2112USA000713: US-009507513-2112USA000820: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000825:
Arm was red (the size of a silver dollar about 2); Injection site was itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Arm was red (the size of a silver dollar about 2)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itching). On 14-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm was red (the size of a silver dollar about 2)). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Arm was red (the size of a silver dollar about 2)) 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 information was provided.  No concomitant medication was provided.
Information has been received from a pharmacist concerning an adult female who was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R). It was noted that the pt received her first dose prior to age 65. Subsequently, the pt's arm had redness, and warm, and was tender. It was noted to be band like. Unspecified medical attention was sought and the pt was instructed to use ice packs for comfort. The pt was recovering. A product quality complaint was not involved. Additional information has been requested.
5x8 cm - local reaction erythematous raised border. 2x3 cm purplish central area.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine on or about 26-JUL-2013 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). It is alleged that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-OCT-2015, the patient was treated by a physician for a painful rash that was diagnosed as shingles. The patient was prescribed acyclovir and ibuprofen (MOTRIN) for management of her severe symptoms. As a direct and proximate result of these malfunctions, 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 shingles is unknown. Additional information has been requested.
(Starting at about 12 hours post vaccine) at Midnight woke up with fever 100.7, severe chills, joint and muscle aches and an intense migraine. By 3 am was up again vomiting. That lasted a few hours. Temp hovered around 101-102 all day (alternating Tylenol 1000mg and Motrin 600 mg q 3 -4 hours). Could not get out of bed all day.  It was pretty intense. By evening the N/V subsided but the other symptoms remained. Temp broke by 10 pm.  The next morning temp was normal, chills were gone, still had the migraine (which migraines are not unusual).  Felt fatigue and body aches, but was functional. By the evening joints hurt so bad could barely walk again. Cont. next page....
Sore throat 3 days after shot; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes mellitus and hypertension. The patient was allergic to strawberries and penicillin. Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), atorvastatin (MANUFACTURER UNKNOWN) and chloramphenicol (CHLO); all for unknown indications from an unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccination. On 04Apr2021 at 05:45, 3 days after the vaccination, the patient experienced sore throat. The patient did not receive any treatment for the reported adverse event. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event sore throat was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After the first vaccine: flu-like symptoms (headache, achy joints, lack of energy) starting approximately 12 hours after vaccination and lasting  for about 20 hours.  After the second vaccine:  severe flu-like symptoms (headache, achy joints, lack of energy, chills, mild fever, uncontrollable shaking) starting approximately 4 hours after vaccination and lasting for about 30 hours.
Information has been received from a health professional concerning a 14 year old female who on 18-OCT-2007 was vaccinated with her first dose of Gardasil vaccine. Concomitant therapy included vaccination with hepatitis A vaccine (inactive) (manufacturer unspecified). On 18-OCT-2007, the patient experienced dizziness. The patient sought unspecified medical treatment by calling the nurse practitioner. The patient's dizziness persisted. Lot number was not available. No further information provided. Additional information has been requested.
Heart/chest pressure, tightness Heart palpitations, fluttering, racing Heart/chest pain GERD, burping, heart burn Vertigo Nausea Tired, weak Anxiety Cramps (back, knees, shoulders, neck, jaw) Headache On and off tinnitus Lymph node under arm sore Injection site sore Runny nose Sore throat Sneezing Wheezing
Moderate reaction to first dose; Some loss of muscular coordination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderate reaction to first dose) and COORDINATION ABNORMAL (Some loss of muscular coordination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (Moderate reaction to first dose) and COORDINATION ABNORMAL (Some loss of muscular coordination). At the time of the report, VACCINATION COMPLICATION (Moderate reaction to first dose) and COORDINATION ABNORMAL (Some loss of muscular coordination) had resolved.            No concomitant medications were reported  Treatment information was not provided. The patient had to stay at the vaccination location for about 2 hours while her symptoms abated.
Patient developed a red mark surrounding injection site, tender to touch, warm, swollen. 5.5 x 6 centimeters on (L) deltoid - urticarial welt.
The patient who is currently 4 years old received the first dose of RECOMBIVAX in 2019 and did not receive the second dose yet.; No additional AEs were reported; This spontaneous report was received from a medical assistant and refers to a 4-years-old patient of an unknown or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2019, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and the patient did not receive the second dose yet (Inappropriate schedule of vaccine administered). No additional adverse event were reported.
5AUG93 6 hrs p/vax were given pt began having sz lasting 20 mins; there was a 3-5 min rest interval & sz restarted; pt taken to ER;
the plunger was not going in the patient's arm; the spraying out came from the dispensing point due to the hard push and there was no defect noticed on the syringe; no additional AE was reported; This spontaneous report was received from a pharmacy intern and refers to a 77-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications and drug allergies/reactions were unknown by the reporter.  On 27-OCT-2020, the reporter tried to administer pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), in the left arm, (lot # T021485 and expiry date 15-MAR-2022; strength, dose, route of administration were unknown) to the patient for prophylaxis.   During the administration, the plunger was not going in the patient's arm. The pharmacy intern then took the syringe out of the patient's arm and pushed it harder this time. The medication then sprayed out. When asked if the spraying medication came from dispensing point due to hard push or was there any other defect noticed on syringe, she stated the spraying out came from the dispensing point due to the hard push and there was no defect noticed on the syringe. She disposed this syringe and used a new syringe from the box. The new syringe worked fine and the patient got her dose. No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; operatorofdevice: Other; operatorofdeviceother: Pharmacy Intern; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient received MMR, varicella, PREVNAR and Hepatiti A vaccines on 6/19/12. On 6/20/12 in the morning pt noted to have hives all over body. Grandmother called our office. We called in BENADRYL. Before pt ever had dose of BENADRYL grandfather called back and said rash was worse. Nurse spoke to the doctor and doctor advised pt go to Emergency Room for evaluation. Grandparents took pt to an urgent care center and pt was given prescription for oral steroids and BENADRYL. Nurse spoke to grandmother on 6/21/12 evening and rash is resolving. There was never any lip/eye swelling or breathing difficulties.
Body ache; Feels like a horrible flu; Arm hurts; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), INFLUENZA LIKE ILLNESS (Feels like a horrible flu), PAIN IN EXTREMITY (Arm hurts), HEADACHE (Headache) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (Body ache), INFLUENZA LIKE ILLNESS (Feels like a horrible flu), PAIN IN EXTREMITY (Arm hurts), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN (Body ache), INFLUENZA LIKE ILLNESS (Feels like a horrible flu), HEADACHE (Headache) and CHILLS (Chills) had not resolved and PAIN IN EXTREMITY (Arm hurts) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications include paracetamol (Tylenol), thyroid medication and blood pressure medication.  Treatment medications were not provided.
Fever (100.4 degrees F), body aches, chills, fatigue, rapid pulse rate 101.
Urticaria, bronchiospasm, swelling around eyes, cough, difficulty breathing, no severe distress.  Benadryl given, Albuterol breathing treatment administered.  Orapred given, observed for 1 hour.
2/12 pm- start of sore arm and slight headache approaching at bedtime.  2/13- swollen lymph node in left axilla with pain, painful left arm and swelling at injection site, headache, fever over 101 degrees F, body aches, on/off nausea  2/14- on/off nausea 2/15- severe headache all day, on/off nausea, sensitivity to smells, light sensitivity, eye pain 2/16- slight nausea  2/17- slight nausea
Patient complained of swelling to right breast and right axilla three days after receiving the varicella vaccine.  Patient states she also developed lumps to her right breast with an aching sensation.  Patient states she also had some swelling to left breast with lumps.
After I received the vaccine went home rested temp went up one time 99.0. The next day woke up heart was pounding check my BP 150/80 laid back down. I woke up around 5pm my BP had elevated to 160 (don't remember diastolic reading) pulse rate normal limits. I informed my spouse of what was happening called 911. At the hospital checked vitals, EKG, CT Scan, Chest X-ray, Blood work and  Potassium was low took 2 Potassium pills. I went back home on 12/31 returned to work did fine that day. On New Years day everything started back again discomfort went back to ER. I felt like force in my chest the doctor collected my information and I was placed on a low dose BP medication until I return to my PCP, cardiologist(stress test). I followed up with PCP via Telehealth about my BP concerns, my dosage was increased to 25 mg and due to my symptoms I was placed on leave from work 2 wks. I also have a appointment scheduled with Neurologist.
Pt. at 9:05 am at observation line was having difficulty breathing, throat tickling sensation.  Paramedic assessed pt. once symptoms subsided they released the pt. to leave.
Problem: Patient was given the incorrect dose of 0.5 mL for Moderna Booster in Drive-thru Vaccine Clinic. Nurse was given the incorrect dose dispensed by the pharmacist. This inadvertent incident happened due to a lack of communication in training given to the Nursing staff from the Pharmacy team.     Corrective Action: Nursing and Pharmacy has since been given a vaccine dose chart with correct dosing amounts listed for Moderna, Pfizer and Johnson & Johnson vaccines. Second, trays have been given to both teams to separate vaccine doses to prevent future error events.  Lastly, Pharmacy is only preparing the Pfizer vaccine since it is standardized to 0.3 mL presently. Going forward, Pharmacy and Nursing will continue to work together to maintain open communication.  Patient was notified of the incorrect dosing and given an opportunity to be seen in clinic by a provider if they remained concerned.
Originally - headache, sore arm, chills, body aches everywhere, sneezing, coughing  For the past 5 days - extreme headache that will not go away along with a feeling of dizziness or nauseousness.
beyond use date of somelot numbers for moderna that were administered to patients; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (beyond use date of somelot numbers for moderna that were administered to patients) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (beyond use date of somelot numbers for moderna that were administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (beyond use date of somelot numbers for moderna that were administered to patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 51 years 1 month. Concomitant products were not provided.  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions.  It was reported that patient had no adverse reactions after the administration of vaccine. Patient got Moderna.   Treatment medications were not reported.
Dizziness, nausea, diarrhea, severe stomach pain after standing up from sitting
Information has been received from a physician concerning a daughter of a nurse who was vaccinated with a first dose of Gardasil. Patient experienced "nausea" within 24 hours after she received the first dose of Gardasil. It was not known if patient sought medical attention. The patient's outcome was unknown. The physician reported that two other patient experienced nausea after receiving the first dose of Gardasil. Additional information has been requested.
First I started having severe pain over the entire shoulder, lasting 72 hours at this time. Next event, was fever of 102 and chills, then the next event was the enlargement of the lymph nodes in the arm pit- left. With irritation of the nerve, with tingling and irritation of the hand. Pain, enlargement of lymph nodes, fever and chills. The pain was out of portion of what I have ever received. The enlarged lymph node was very painful and irritated the nerve. I did not seek any medical care for it.
breakthrough covid + 9.29.2021, requiring hospitalization 10.6.2021, cough, SOB, HA, fevers, congestion, O2 requirements.
started with slight rash  from my waist to knees. I used cortizone for the itch. Then rash spread to my whole body. At this point I am using calamine lotion and benydryl tablets.  Today is Sat. Monday I am calling my Dr for a steriod for the itching. This is terrible!
Arm soreness, then I started feeling like I was drugged, that's lasted now for 2 weeks. I have been unable to get around, I get lost, I forget to do the simplest tasks. It feels like it's progressing.
The pt received her first and second doses of vax in February and March, 1999, respectively. In June 1999, she was found to have Lyme disease with flu-like symptoms. Two blood tests confirmed diagnosis. She was treated with Ceftin, and antibiotics (not specified). The most recent information, received 07/20/99, reported the condition of the pt is ongoing.
Headache, Myalgia, NauseaVomiting, freezing cold, left arm hurting, no appetite Narrative:
Patient admitted on 15L of O2 and placed on BiPAP at 100%.  Shortness of breath with dry cough.  Hypoxic on room air
30 minutes after vaccine started feeling bad, headache, tingling in the head, heart was racing and diarrhea.  Symptoms lasted all day.  Arm hurt for 2 days.