chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; loss of appetite; constipation; nausea; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 46 years of age), dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, primary sclerosing cholangitis, prior NAFLD (nonalcoholic fatty liver disease); and had allergies to medications, food, or other products, all from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced allergy and DILI (Drug induced liver injury) in Dec2019. Concomitant medication included mesalazine (LIALDA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19 prior vaccination and was not tested since vaccination. It was reported that the patient got first COVID vaccine (Pfizer) on 16Jan2021 with second dose on 06Feb2021. He mentioned that he works in healthcare and as testing weekly for COVID as part of his job and has been negative. On 26Jan2021, 10 days after first dose, he developed fatigue, loss of appetite, constipation and nausea, all with outcome of recovering. The events are reported non-serious. No treatment received for the events.  Information on the lot/batch number has been requested.
15 out of 75 pts did not have high enough titers when tested p/completing series of 3 vax of Engerix-B; plan to give booster;
abdominal pain; dehydration; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain), DEHYDRATION (dehydration), PYREXIA (fever) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-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 ABDOMINAL PAIN (abdominal pain), DEHYDRATION (dehydration), PYREXIA (fever) and HEADACHE (headache). At the time of the report, ABDOMINAL PAIN (abdominal pain), DEHYDRATION (dehydration), PYREXIA (fever) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter. Treatment included fluids for dehydration.   Reporter did not allow further contact
Cold using many blankets, a sweater, and heating pad starting around 9PM on 9/22/ 2022 lasting about 12 hours. Then dark orange urine on 9/23 and 9/24. Stools brown, not pale. Orange urine gone on 9/25/2022, stools brown and diarrhea.
2-3 times slower healing of any cuts or wounds that started showing one month after the vaccine was taken.
43 year old male presents to clinic on 3/10/03 with c/o of tender supraclavicular lymphadenopathy. Has a headache and fatigue. Prior to Smallpox vaccination about 10 years ago, pt received recent Smallpox immunization on 3/7/03 in left arm with vesicle and surrounding erythema.
side effects; dose of Shingrix subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse drug reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, the patient received dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The patient experienced some side effects after shingrix administration. The reporter did not consent to follow up.
injected left arm Pt moved no vaccine administered .wasted the vaccine administered the new vaccine on the right arm.
p/vax pt devel circular reddened raised area @ vax site. rash on abd & diaper area
rash started Friday on head & neck, spread to arms, chest, back & upper buttocks; large red, bumps on back; itchy; has gotten worse each day; no fever or SOB; loss appetite;
On Sat./Sun Nov 6,7th -both hands were itching badly.  I took a Zyertec.   On Monday, Nov 8th , I did not feel good all day. On Thursday, Nov 11th by 8:30am, My mouth felt numb on the left side and strange all the way up to my left eye,  L-eye was twitching.  I went to my primary care, Dr. and she indicated it may be a reaction to the vaccine and should be reported.  If worsens come back and she would prescribe medication.
Pt presented with SOB and cough. Images shown infiltrates in the chest image. Pt received supplemental O2, remdesivir, and steroids
at aprox 9:40am child began c/o severe itching inside both ears and stuffy nose. Noted swelling of lips, nose and eyes. Gave Benadryl 25 mg at 9:45 am. Vital signs were stable and no hives noted on body. EMs was activated and transported chile to ER at 10:  am.
No known adverse effects; Patient received a dose of Vaqta on 05/003/2019 and on 10/24/2019; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not disclosed.  On 03-MAY-2019, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot number and expiration date were unknown by the reporter); afterwards, on 24-OCT-2019, the patient received another dose of hepatitis a vaccine, inactivated (VAQTA) (lot number S007770, expiration date 24-JUL-2020). Both doses were received as prophylaxis (strength, route of administration, anatomical injection site and indication were not reported for either dose) (inappropriate schedule of product administration). No adverse effects were reported.
Swelling, red, hot rash. VERY painful, went to ER Sat afternoon as it was extensive. Given IV infusion therapy/prophylaxis/Dx, ordered blood culture, CBC, Rx Bactrim and Vicodin.
Pt received MenA lyophilized conjugate component with plain sterile diluent instead of the men CYW-135 liquid conjugate component. Pt. had soreness at injection site. She will return for the complete vaccine.
pt recvd vax & w/in 24 hrs pt devel red welt, pain, bruising, & warmth @ the inj site;
Developed generalized rash and fever.  Visited ER with diagnosis or urticaria made, dipher and prelone given.
Injection was given and burned on insertion.  That evening and proceeding into next day I experienced loss of Range of motion in Left upper extremity, pain up to neck and down left arm, and back behind shoulder blade.
fever, chills, exhaustion. heavy coughing which lasted weeks.  Swollen, red, hot arm..  Started a period and bleed thru clothing, bedding  for 2 days before it slowed down.  Bleeding lasted about 5 days which is NOT normal for me.
Lump under the armpit of the vaccinated arm (left); Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 02:30 (Lot number: 33030817) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: PRISTIQ; CLIMARA PRO; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 28Mar2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 18Mar2021, when the patient was 44 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE MASS (non-serious) with onset 23Nov2021 20:30, outcome "not recovered", described as "Lump under the armpit of the vaccinated arm (left)". Therapeutic measures were not taken as a result of vaccination site mass.  Additional Information: Prior vaccination within 4 weeks was reported as none. The patient had no known allergies. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 79 years old patient and reported that patient's arm became painful, swollen and a rash developed, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 13-Nov-2018, the patient received a dose of 0.5 ml suspect FLUZONE HIGH DOSE (lot number: UJ042AB and expiry date: 19-May-2019) via unknown route in the left deltoid. On an unknown date, following the vaccination the patient experienced swollen arm, rash and painful arm. Lab data not reported. Final diagnosis was the patient's arm became painful, swollen and a rash. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.
Patient came into pharmacy on 3/10/19 to report pain at injection site. She said she got the chills and weakness on day 1 after the vaccine was given. She had a large, red spot on her arm. She said it had gotten better over the last day or so.  I explained to help with the swelling she can take APAP or ibuprofen if necessary and to alternate icing/heating the arm.
13th of January received first Moderna shot. 18-19th began to have headaches 22nd headaches worsened 25th at the doctor's (tested negative nose swab) home till 28th (28th tested positive for corona after having her first shot at Advent) stroke symptoms at school 28th Advent did CT scan MRI venous thrombosis diagnosis, from front to back, hemorrage in the northern hemisphere 29th blood thinner administered to attempt to drain clot, seizures 31st passed away
03/16/2023 I had a cough, chills and a sore throat My symptoms got progressively worse overnight. On  03/17/2023 I had diarrhea, feeling faint and generally unwell.I took a home COVID-19 test and was positive. I contact my Dr. via a telehealth appointment amd was prescribed Prednisone, Doxycycline and  Moluprivar x 5 days I am currently on blood thinners and was not a candidate for Paxlovid.Symptoms lasted for 12 days.  I still have a lingering cough but I am feeling better.
Received second dose above on  1/8/21.  Developed a blood clot in left leg  early February, Went to doctor after a week or so on February 8.   Bad Swelling in left calf
2.5 cm nodule at right anterior upper leg at immunization site, some overlying erythema.  No red streaks, no fluctuation.
Ringing in ears; 1st dose on 3/22/2021 and second dose on 4/12/2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 3/22/2021 and second dose on 4/12/2021) and TINNITUS (Ringing in ears) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Family history included Hypertension since an unknown date, Aneurysm cerebral, Thyroid cancer since an unknown date, Ovarian cancer since an unknown date and Cervical cancer since an unknown date. Concurrent medical conditions included Aortic aneurysm since 2009.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 3/22/2021 and second dose on 4/12/2021). On an unknown date, the patient experienced TINNITUS (Ringing in ears). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 3/22/2021 and second dose on 4/12/2021) and TINNITUS (Ringing in ears) outcome was unknown.            No concomitant medications were reported. It was reported that after 2 hrs of shot patient experienced ringing in ears. It was worse. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On unspecified dates the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L040458 and expiry date 04-FEB-2018) (lot # M000442 and expiry date 31-MAR-2018) (dosing regimen and route of administration were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Had vaccinations on 1/23/07 and started complaining to mom on 1/25/07. Presents 1/26 with left deltoid warm and swollen. Recommended visit with doctor.
Patient reports shooting pain in right arm and limited range of motion x 4 days. And shooting pain.
Headache, sore throat, fatigue, low grade fever, small rash on face.
Rash on left arm and left side of rib cage.  Rash was persistent for over 2 months until treated my perscription
Patient described to me that she received the 1st dose on 1/4/21. She noticed a reaction about 10 days later, and it presented as a red rash on her body. This rash did get worse after the 2nd dose of the Covid vaccine on 2/1/21. The rash is red and raised and does itch. It is all on 4 extremities, her abdomen, and her back. It is on her face, and on her scalp. She did a telehealth visit with an MD who prescribed her steroid cream. This did not help, and she has a dermatology appt on 3/30/21.   I wish there was a way I could upload pictures because what I am describing does not do it justice. Her entire body is covered with this rash, and it is causing her a lot of discomfort. She did state the red, raised areas bleed if she scratches them, which she avoids trying to do.
low grade fever; body aches (right arm and back/neck); headache; painful swollen lymph node; painful swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP6955, patient was 48-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 30Mar2021 at 11:15 AM as DOSE 2, SINGLE for covid-19 immunisation. Medical history included chronic migraines, sarcoidosis. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EF3247), via an unspecified route of administration, administered in Arm Right on 09Mar2021 at 11:15 AM as DOSE 1, SINGLE for covid-19 immunisation. No known allergies to medications, food, or other products reported, the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine, no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was not tested for COVID-19. On 30Mar2021 at 04:30 PM, the patient experienced low grade fever, body aches (right arm and back/neck), headache, painful swollen lymph node. The outcomes of events were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Chin, lips and tongue began in tingle; Slight bitter to bad taste formed in the back of throat; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 13Apr2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included fluticasone propionate (FLONASE), zinc (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D), pantothenic acid (MANUFACTURER UNKNOWN), antihistamine (MANUFACTURER UNKNOWN), yinviv ease tonic (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took naproxen (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 48-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 13Apr2021 at 13:30, the patient experienced chin and lips and tongue began in tingle and a slight bitter and bad taste formed in the back of throat. 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 events. The clinical outcome of the events chin and lips and tongue began in tingle and a slight bitter and bad taste formed in the back of throat was recovering.   No follow-up attempts are needed. No further information is expected.
RN      4/26/21 9:28 AM Note    Positive Screen   Wheezing when she coughs and feeling faint.  First covid shot on the 2nd of April - second shot the 23 of April.  Symptoms started the day before her second covid shot.  Speaking fine and breathing fine.  Thick phlegm.  Should be seen in two hours.  Please call to schedule:  Wheezing most troublesome in the morning and the evening.  Patient would like a prescription.     ED Discharged  5/2/2021 - 5/3/2021 (2 hours) Hospital ED  MD Last attending ? Treatment team COVID-19 +1 more Clinical impression Shortness of Breath Chief complaint ED Provider Notes DO (Resident) ? ? Emergency Medicine Cosigned by: MD at 5/11/2021  3:19 PM Expand AllCollapse All        ED RESIDENT NOTE        Attending: Dr.         Medical Decision Making     This is a 68-year-old female presenting to Hospital emergency department with history as documented below.  Patient mostly concerned because her pulse ox was read 94% at home.  Patient's pulse ox here has not dropped below 94% with ambulation.  I did discuss her results with her including her chest x-ray and basic labs which were within normal limits.  Patient should follow-up with her PCP and continue checking her pulse ox at home.  I did state if her pulse ox drops below 90%, that she should come to emergency department for further evaluation and management.
pt recv vax 22MAY97 & 27SEP97 pt devel a rash & then devel an extreme case of chickenpox;
past the recommended window; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past the recommended window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Mar-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 PRODUCT DOSE OMISSION ISSUE (past the recommended window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past the recommended window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Initial case received on 21 January 2010 from the parent of the patient. A 4 year old male patient received an injection (route and site not reported) of DT ADS PED USP (th.) (lot number U2105AA). The patient has a history of autism. He had no illness at the time of vaccination. Numerous unspecified supplements were taken by the patient. On an unspecified date post vaccination the patient experienced a headache. One and half weeks after the vaccination, a "high lead level" was noted during routine periodic blood work for lead levels. The outcome of the adverse events is unknown. Documents held by sender: None.
From telephone contact with the reported it was stated that an adult patient (1 of 2) received a Tetanus Toxoid Adult vaccination. The patient developed a local reaction and vomiting. No specifics were provided. Further information is requested. Correspondence received on 6/4/01 stated that the patient received the Tetanus Toxoid vaccination on 4/16/01. He complained of vomiting, fever, arm pain, redness and swelling at the injection site after receipt of vaccine (duration not specified). The patient recovered from this experience. No further information is anticipated for this report. From additional correspondence received on 9/5/01 it was reported, "8/28/01 patient has not been seen since this incident was reported. Has not contact our office to report any further problems. No additional information at this time." This case is closed.
Herpes Zoster diagnosis on 11/4/2014 in two-dose varicella vaccine recipient. Seen by her PCP. Painful rash in one dermatome, blisters on right shoulder and arm.
Lethargic, clammy, migraine type headaches that lasted for 2wks, continued fatigue, trouble sleeping, headaches
An expired covid vaccine vial (exp 10/24/22) was drawn (1 syringe) and administered to the pt. As soon as this error was caught, RN notified NP  RN called pfizer to address this error. Pfizer pharmacist explained to RN that it is outside of the recommendation but it is still safe and effective to use and administer the vial 2 days post expiration date. Pharmacist also stated CDC recommends to continue series even with this error (next dose will be dose 2 in 3 weeks). Pharmacist reports no safety concerns. Documentation sent to RN from Pfizer. RN called pharmacy back to inform about the findings. Pharmacy verbalized understanding and agreed to continue with the vaccination series. RN messaged supervisor and pharmacy to report the error and findings from the call with Pfizer.