chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Medical Information Team (159558). The reporter is the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in left arm, administration date 01Mar2021 (Lot number: EN6205) at the age of 43 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing); "non hodgkins lymphomas" (unspecified if ongoing); "Had some surgeries" (unspecified if ongoing); "Chemo" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shot, reaction(s): "diarrhea", "headaches", "nausea", "arm swells up"; Anthrax. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Mar2021, outcome "recovering", described as "a bit of pain in her arm/her arm got sore at injection site". Additional information: The patient reported she stayed for 45 minutes after the vaccination due to her medical history and felt fine when she walked. Patient added she has had no fever, has not been tired, none of the usual side effects that she would normally feel with a shot. No follow-up attempts are possible. No further information is expected.
Information has been received from a  registered nurse concerning an 18 (also reported as 16) year old female with a history in 2003 of Valley Fever who on 25-JUL-2007 was vaccinated in the left upper arm with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot #657879/0652U). Additional suspect vaccination included a first dose of hepatitis A virus vaccine inactivated (MSD) (lot # 656497/1213F) given in the right deltoid, a first dose of hepatitis B virus vaccine rHBsAg (yeast) (MSD) (lot # 650890/0144R) given in the left deltoid, and a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (MSD) (lot # 655620/0171U) given in the right deltoid. Concomitant therapy included a first dose of poliovirus vaccine inactivated (Vero) (IPOL) (lot # 20001-2) given in the right upper arm and a first dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (Lot#AC52B03AA) given in the left deltoid. There was no illness at the time of vaccination. No symptoms were reported. There was no product quality complaint involved. Follow up information was received from the nurse who noted that the patient was an un-immunized teen, and she "glitched" and gave her the measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) without thinking about the patient's age. She received six vaccinations that day. The nurse added that the patient was fine afterwards. Additional follow-up information from the registered nurse indicated that the patient had some slight soreness in her arms from the multiple shots. It was noted that the right deltoid HPV rL1 6 11 16 18 VLP vaccine (yeast) (MSD) (lot # 655620/0171U) injection site was sore for 3-4 days. On 21-SEP-2007 specimens were collected, the patient's measles IgG antibody, mumps IgG antibody and rubella IgG antibody were all positive. The patient's varicella zoster IgG antibody was negative. There were no other problems and on an unspecicifed date the patient recovered. The patient had no adverse events following prior vaccination.  Additional information is not expected.
11/8/23 @ 22:15 resident was administered routine dose of pain medication 11/9/23 @ 06:22 Resident noted to be without heart tones and pulse. No signs of life present. Resident pronounced deceased  Death unexpected/unanticipated
Muscle pain; Headache; Chills; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, thyroid disorder, high cholesterol and COVID-19 all from unknown date. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), vitamin d2 (MANUFACTURER UNKNOWN) and telmisartan (MANUFACTURER UNKNOWN) all for unknown indication and from unknown date. The patient previously received codeine and experienced allergy.  Prior to the vaccination, the patient was 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 COVID-19 vaccine.  On 01Apr2021 (day after vaccination) at 04:00 the patient experienced muscle pain, headache, chills, joint pain, nausea and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event chills, muscle pain, headache, joint pain, nausea and feeling unwell was not recovered at the time of this report   No follow-up attempts are needed. No further information is expected.
MOM CALLED ON 7-23-2008 STATING THE DAY AFTER CHILD RECEIVED VACCINES, SHE NOTED SWELLING ON THE BACK SIDE OF CHILD'S LEFT ARM.  MOM STATES SWELLING HAS INCREASED TODAY (2 DAYS AFTER VACCINES).  MOM DENIES USING COOL COMPRESSES.  MOM INSTRUCTED TO USE COOL COMPRESSES AND IF SHE FELT CHILD NEEDED MEDICAL ATTENTION TO TAKE CHILD TO HEALTH CENTER, SINCE CHILD DOESN'T HAVE A PRIMARY MD.
needle had broken when drawing the dose, resulting in the skin exposure to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (needle had broken when drawing the dose, resulting in the skin exposure to vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (needle had broken when drawing the dose, resulting in the skin exposure to vaccine). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 28-Mar-2021, DEVICE CONNECTION ISSUE (needle had broken when drawing the dose, resulting in the skin exposure to vaccine) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment medication include ibuprofen     This case was linked to US-MODERNATX, INC.-MOD-2021-081345 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081345:1st dose
Sore arm, fatigue, general not feeling well SINCE vaccine was given. Patient reported on 10/7/18 that she has felt awful since the immunization. She has not reported to or looked for medical care.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe
Redness, warm, indurated, 4x5cm, nontender, no fluctuance, no red streaks, no adenopathy.
4 LVNS recvd 3 doses of Engerix-B, dates of vax 1991-1992; titers were neg;
Felt dizzy after his HPV vaccine, put supine for 10 mins, walked to waiting room and still felt dizzy, had water and lollipops, BP taken=120/80, MD assessed pt before he left.
pt recv vax 1DEC97 & states 2DEC97 devel a rash-slept little that noc saw pvt MD 3DEC97 & was given med;T102.9;
Client became dizzy and briefly lost consciousness. Continued to feel dizzy and weak for 15 minutes or more
I as driving to work, and ended up in the middle of city, don't know how I got there. It was like a severe brain fog; I'm still feeling tired and run down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (I as driving to work, and ended up in the middle of city, don't know how I got there. It was like a severe brain fog) and FATIGUE (I'm still feeling tired and run down) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced FEELING ABNORMAL (I as driving to work, and ended up in the middle of city, don't know how I got there. It was like a severe brain fog) and FATIGUE (I'm still feeling tired and run down). On 20-May-2021, FEELING ABNORMAL (I as driving to work, and ended up in the middle of city, don't know how I got there. It was like a severe brain fog) had resolved. At the time of the report, FATIGUE (I'm still feeling tired and run down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment information was provided
Patient reports inflamed shoulder bursa.  Patient has been treating with rest, cold, and hot therapy.  Patient has continued limited range of motion.  Patient advised to seek follow up evaluation and care with primary care provider.
10/28/09 15 month old boy c/o possible reaction to vaccine. T-97.3 No fever, occ crys; mother's main concern of appearance ant left thigh 11x7 erythema, central mild vague increased induration ~ 3cm no fluctuant no pointing. Hadn't had any TYLENOL or MOTRIN. Vaccine reaction to DTaP. Doubt cellulitis. Precaution: TYLENOL or MOTRIN PRN pain check temp first. RTC 24 hours. Recheck. May return to preschool. Adverse Vaccine Report 10/29/2009 Doing better decreased erythema decreased tenderness no fever.
Fever, crying, fussy, clingy, sensitive to sounds, doesn't want to be set down. Acting completely out of character and this is still on going. Took her to the doctor and was told it was a secondary reaction to the vaccine MMR. Also her arm was red and raised.
incessant high pitched cry x 4 hrs; 101 fever; swollen red inject site; diarrhea;
No additional AE reported.; HCP reports patient was accidently administered an expired dose of MMR II on Apr 25, 2022.; Patient date of birth 06-FEB-1987/expired dose of MMR II on 25-APR-2022; This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions/ allergies was not provided.  On 25-APR-2022, the patient was accidently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, frequency, route of administration and lot number was not provided; expiration date was reported as 08-JAN-2022) for prophylaxis (expired product administered). The vaccine had no known temperature excursions. No further information was provided. No additional adverse event (AE) reported (no adverse event).  Follow up information has been received from pharmacist on 08-JUN-2022  Patient's information details were updated, the case was concerning a 35-year-old patient (product administered to patient of inappropriate age).  The patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) with lot number T000889, that was verified to be a valid number with an expiration date reported and established as 08-JUN-2022.   The outcome of the event was reported as recovered/resolved (conflicting information, assessed as unknown according to internal guidelines). It was reported that suspect vaccine was removed from inventory.  This case previous non-valid case was updated to valid as patient's identifiers were provided.
Sore throat; post-nasal drainage/rhinorrhea; post-nasal drainage/rhinorrhea; This is a spontaneous report from a contactable healthcare professional. This 46- year-old male patient received the first dose of BNT162B2 on 29Dec2020  6:30 PM (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL1284), via intramuscular route of administration, (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a Hospital and anatomically located on the left arm. Allergies to medications, food, or other products: Lactose intolerance.  The medical history included: Heart/Double Lung Tx, Bronchiolitis obliterans. Concomitant medications included: Tacrolimus, Sirolimus, Enalapril, Prednisone, Bactrim, Zithromax, Prenatal vit, Citrical +D. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021, he experienced Sore throat, post-nasal drainage, and rhinorrhea. The patient did not receive treatment for the events. The clinical outcome of the events Sore throat, post-nasal drainage, and rhinorrhea was not recovered without treatment. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient received second dose BNT162B2 on 19Jan2021 at 06:30 pm (lot number: EL8982),Intramuscular, anatomically located on the left arm.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. The information of concurrent conditions, medical history and concomitant medications was not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 injection (lot # L013429, expiration date 21-JUL-2017; lot # L09287, expiration date 14-SEP-2017; lot # L027282, expiration date 21-SEP-2017) (dose and route were not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a consumer refers to her 18 year old son (male patient) with no pertinent medical history and drug reactions/allergies. On 24-FEB-2013, the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). No concomitant medications were reported. Approximately on an unknown date in March 2013, the patient suffered severe stomach problems after the GARDASIL vaccine, was hospitalized and diagnosed with Crohn's disease. Approximately on 10-MAR-2013, the patient was hospitalized (reported as 2 weeks after his first dose of GARDASIL). Consumer stated that her son was in good health prior to receiving the GARDASIL vaccine. An unspecified treatment was rendered for the event. The patient was recovering from the event at the time of this report. No intervention was done to prevent the seriousness criteria. The consumer had further questions about the second injection of GARDASIL, she was advised to contact her physician. Causality was not reported. Additional information has been requested.
The nurse did not add enough diluent.  Max dose drawn was 5 doses.  The children received the vaccine and this error was noticed approximately 1 1/2 hours later.  The parents have reported no adverse reaction as of today 10/24/2022
microcephaly, cerebral palsy, sxs occurred 2 days p/vax-inconsolable crying, upper resp infect, ear infect;12MAR94 hospitalized for failure to thrive;dx w/microecephaly;15MAY94 dx w/cerebral palsy started PT & OT & speech therapy
ACUTE RESPIRATORY FAILURE 1/28/2023 B-CELL LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE HYPOXIA 1/15/2023 B-CELL LYMPHOMA UNSPECIFIED TYPE, UNSPECIFIED SITE ACUTE RESPIRATORY FAILURE 1/28/2023 DIASTOLIC HEART FAILURE, CHRONIC HYPOXIA 1/15/2023 DIASTOLIC HEART FAILURE, CHRONIC ACUTE RESPIRATORY FAILURE 1/28/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION HYPOXIA 1/15/2023 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
1740- Patient Reported to observation staff that she was feeling very dizzy "like I was gonna throw up" following 1st dose Pfizer. Assisted onto wheelchair to close obs with Safety Officer, assisted to supine position with legs up. BP taken. Client reports history of HTN and currently 32wks pregnant. Denies hx of fainting with injections or vasovagal. Does report feeling anxiety about vaccine prior to receiving it. Vitals: 1746: 150/80 -- p: 86 1754: 146/80 -- p: 85 1759 148/78 -- p: 82  1800 -- Reports nausea subsiding following taking Zofran 4mg sublingual.  1830 -- Told to notify MD as needed. Client's husband and children came inside to help as needed. Client able to ambulate off site independently with family.
When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke; When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 31Oct2023 as dose number unknown, single (Lot number: HF1068, Expiration Date: Aug2024) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEEDLE ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 31Oct2023 and all described as "When they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke".  Causality for "when they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off; it is the actual syringe that broke" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  Additional information: Reporter (Nurse) stated, they had experienced an issue with the Prevnar 13 (Later clarified and confirm as Prevnar 20) and was not sure if it was here the LOT number or what the end of the prefilled syringe when they were activating the safety needle feature like after they administered the vaccine it was breaking off. With all three of these after the vaccine was administered when they put the needle out of the patient and they went to activate the safety feature of the needle the tip just break off. Right but it was the actual syringe that broke. Vaccine was administered to any of the patient. There was not an issue to the patient. After the needle on all three occasion, it was after it was administered to the patient and they pull the needle out and then went to activate the safety needle feature that was when it broke. Reporter did not know which Pharmacy we got it from they just place an order with they organization or Pharmacy and they just send it to the reporter. There is a product complaint to report. UPC#: maybe PAA201729.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353292 Same reporter/drug/event for different patients.;US-PFIZER INC-202300353440 Same reporter/drug/event for different patients.;
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
10 minutes after receiving vaccine, felt fuzzy, lightheaded, dizzy, and fatigued. Rested under supervision, felt nauseous with no vomiting. No LOC, no SOB, no CP. Vitals monitored, requested ambulance transport, taken to ED
3/20/11 Left arm (at injection site) was warm to the touch, red & swollen. 3/21/11 seen in occupational medicine. MD ordered Z-PAK and MEDROL pack.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Treatment information was not provided.       Moderna booster vaccines were administered to patient around 490 to 500 people on the date last Oct 20.2021 to Nov 29, 2021, with lot numbers 006C21A (10-10-2021), 026B21A (09-17-2021),031B21A (9-22-2021).
Raised, red rash over face, chest, back, legs. Cool compresses to rash and BENADRYL for itch.
Neck hurts; Didn't feel well; Nauseated; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck hurts), MALAISE (Didn't feel well), NAUSEA (Nauseated) and FATIGUE (Fatigued) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. No concomitant medication reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck hurts), MALAISE (Didn't feel well), NAUSEA (Nauseated) and FATIGUE (Fatigued). At the time of the report, NECK PAIN (Neck hurts), MALAISE (Didn't feel well), NAUSEA (Nauseated) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
My left arm has been in extreme pain to the point at times I cant move it, and it hard to sleep at night.