chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1AM Sat. March 6:   Woke up shivering, lasted on and off throughout the day) Also had a Severe migraine, severe nausea, lower leg cramps, and vomited 5 times until nearly 5PM ( last 3 times was water that was sipped but "heaved") mild diarrhea.  Family offered to take me to hospital at since I had trouble "holding down" sips of  water. Dozed off about 11PM and woke up at 1AM feeling better. Nausea and headache had subsided greatly, Congestion lasted until Sat. Took a 24 hour non drowsy Sudafed on Thursday and Friday. Rested Sunday and ate very light (toast; applesauce).
p/vax pt exp lt elbow to shoulder pain & swelling of the area to twice the nl size;pt also exp lt eye swelling & tongue & airway swelled;pt refused to go to ER;tx w/ DPH & albuterol opened airway; pt recovered
Severe diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and mixed connective tissue disease. Concomitant medication was not reported. Prior to 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 COVID-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 23Mar2021, the patient experienced severe diarrhea. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the event severe diarrhea was resolving at the time of this report.   No follow-up attempts are possible; information about lot or batch number cannot be obtained.
Patient complained of feeling a dry mouth and blurry vision. She felt that this was a sign of an allergic reaction. EPI pen was administered and patient was brought to the emergency room.
Pain in upper left arm permeating down to elbow.  Very sore at top of left arm.  Definitely sore to the touch.  Trouble sleeping, lifting arm over head and during stretching movements.
patient vomited up a first dose of ROTATEQ then was administered another.; patient vomited up a first dose of ROTATEQ then was administered another.; patient vomited up a first dose of ROTATEQ then was administered another.; This spontaneous report was received from Other Health Professional and refers to a 4-month-old female. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 22-NOV-2022, the was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid at a dose of 2ml orally (vaccination scheme frequency was not provided; valid lot number U026661 with expiration date of 22-JAN-2022). The patient vomited up the first dose of the vaccine (vomiting of medication, accidental underdose); therefore, she was administered another dose rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid at a dose of 2ml orally (valid lot number U026661 with expiration date of 22-JAN-2022) (extra dose administered). Both doses were administered as prophylaxis.  The outcome of the event of vomiting of medication and the causal relationship between the event and the suspect therapy were not reported.
Mother of adolescent PT came back to the pharmacy with her daughter to receive daughters 2nd dose and reported her son had chest pain the day after receiving the pfizer vaccine. PT received the Pfizer vaccine on 5/30/21. The mom reported taking PT to ER on 5/31/21 where he was then referred to the PCP who then referred them to a cardiologist. At the ER PT was reported to have elevated blood pressure. Mom reported the physicians told her the chest pain was most likely due to administration of the Pfizer vaccine. Mom was advised to monitor PT's BP. Since seeing the cardiologist he no longer has chest pain. They have also been monitoring his BP since ER visit at home and reported today 6/20/21 he no longer has elevated BP.
Double Vision; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double Vision) 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 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced DIPLOPIA (Double Vision). At the time of the report, DIPLOPIA (Double Vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Follow up received on 02 Jun 2021 contains non-significant information
Concussion and subsequent post concussion syndrome.  Occurred 8/25/21 treatment is ongoing with neurologist.  Have received Physical and Occupational Therapy.  Physical Therapy is ongoing.  Have not returned to full physical activity (workouts) or a full work schedule since day of accident.  Symptoms are throbbing, dizziness, neck pain and stiffness, fatigue, vision problems, and problems sleeping and concentrating.  The vision problems and acute pain and dizziness are mostly resolved.
Patient reported severe pain and muscle stiffness across entire body. Difficulty moving and getting out of bed for 3 days. Baseball sized red spot and tenderness at injection site. All side effects resolved after 3 to 5 days. Patient did not seek out any medical advice or treatment. Self-treated with pain medication (Percocet) and muscle relaxer that she already had on hand.
Pt was vaccinated in 1995. Post vax, the pt developed a mild case of chickenpox. It was reported that the pts sibling had chickenpox at the same time as the pt.
States that she received FLUZONE in arm, by bedtime, (L) deltoid was red, warm to touch, swollen and painful. Infection preventionist brought her to us on Thurs. 10-12-17. She had just been to ER so PA could look at area. No treatment done. Area measured. 54 mm x 61 mm redness. Saw patient on Tues 10-17-17 - everything gone.
Patient came to MD office for administration of HPV #2; Tolerated vaccine well and waited while sib had an injection, then walked to front desk to check out and without warning fell to floor. See attached
Patient received J&J vaccine in April.  No detail on the exact date and lot number is available in system.  Patient reported developing bilateral ulnar numbness and swelling at night.
Red and burning after shower tod, Red 2" x 1.5" (hot), highest temperature 101F, complaint of being fatigued.
Subsequent to receiving varicella virus vaccine live pt failed to seroconvert and the pt developed leukemia.
On last Wednesday (8/26/15), went to pharmacy and got a flu shot as well as a Prevnar. The flu shot hurt.  Area throbbed.  Took ibuprofen and iced it.  Could not sleep. Her daughter said she was slurring her words after taking some Benadryl.  Refused to come in 8/27/15. Vicodin helped with her pain.  Took it every four hours.  Then took T3 from her son the doctor.  Vomited once on Saturday after taking the T3.  In total, she has taken about seven of them as two last about 24 hours.  Now she feels "lousy."  Her arm hurt this morning before she took the T3.  The area of the shot is slowly getting better, but she feels nauseated and doesn't feel like eating. Left shoulder deltoid area -  23 by 12 cm erythematous area with a large blebs of fluid under the skin.  Central bruise  is mild - ? from the injection site. Reaction after flu shot  - this is quite a response to the flu shot.  Possible cellulitis.  Will treat with keflex 500 mg tid x 5 days.  Discontinue T3, as it may be causing the nausea.  Go back to Vicodin 5/325 if absolutely needs an opiate at all.  Aim for 1/2 tab as rarely as possible.  Ice the area.  I will see her back on Friday, 9/4/15, unless it is completely resolved.  She will call me if the area of redness extends beyond the line I drew on her shoulder.
Pt given .5cc Infuenza vax in L deltoid. Sm amt of bleeding occurred at site. Immediately, raised, reddened are appeared approx 1" dia. Applied cold compress. No respiratory problems noted.
Case previously recorded as MA2009-4593. Initial case report received from a physician, on 17 NOV 2009. A patient (gender unknown) under 3 year-old was vaccinated with FLUVIRIN 2009/2010 (batch no. unknown) i.m., on 13 NOV 2009. No adverse event was reported. Reference no: NA09-008308.
Arm stayed swollen for 3 months, still swollen around injection, knot still in injection spot, arm hurts around area. Hurts to move arm in the area. Pain in arm regular wake me up at night use pain pads.
Had arm/shoulder  pain/swelling/redness for 7 days; At day 5 left hand was painful in joints and swollen and reddened. Right hand became painful and reddened after 3 more days. She saw her primary physician and received a course of Cephalexin 500 TID x7 days starting 12/19/18. Hands were still somewhat swollen and pink (not red) after 7 day course completed. Pain is reduced after Abx course.
The flu shot was painless and easy.   The side effects started in the next day or two.  Flu like symptoms, feeling low energy and sick.  Developed a bad toothache that persisted for some days, and a pain in the arm where the vaccine was administered.   The other syptoms subsided after about a week, but the pain in the arm persisted day after day, week after week, month after month, and is still present today, 2/12/2020,  In addition, the pain has increased lately and is worse now than it was initially.
Moderna COVID-19 Vaccine EUA "Covid arm" : itchy, red knot at injection site followed by a large round rash/red area for about 36 hours
EPSDT visit age 7 wks, immunizations given 1-19-05.  Parent notified clinic via telephone, child L thigh red, swollen 1-25-05.  Advised to bring child to clinic immediately.  Mom had no transportation.  Advised to go to nearest ER.  Parent presents c child 1-26-05 - sent to ER - cellulitis post vaccine.  Admitted to hospital 1/26/05.
Pt developed hypotension after administration of the influenza vaccine. Pt was taken to the ER from the primary care clinic and later admitted for observation. Symptoms: Symptoms: 1. Palpitations, 2. Hypotension, 3. Syncope, 4. Sweating.
loss of sense of taste; Headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of sense of taste) and HEADACHE (Headache) in a female 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 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 07-Mar-2021, the patient experienced AGEUSIA (loss of sense of taste) and HEADACHE (Headache). At the time of the report, AGEUSIA (loss of sense of taste) and HEADACHE (Headache) had resolved.      No Concomitant  information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Updated event outcome.
Information has been received from a nurse practitioner concerning a female who was vaccinated with GARDASIL. Subsequently the patient went completely bald after getting GARDASIL. The patient's outcome was unknown. This is one of several report's received from the same source. Attempts are being made to verify the existence of an identifiable patient.
Pt complained  of throat tightness about 12 mins into observation, initial O2 Sat at 84% RA. Given Epipen 0.3mg on right thigh. O2 on 4L via NC given. 911 activated. Pt states some relief after 4-5 mins. BP=111/71, HR=81, O2 sat=100% at 4L/NC. Pt transferred to ED via EMS.
We have some past expiration administrations that have surfaced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). On 05-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
The night of receiving vax, pt developed erythema and swelling at injection site. The following day, pt had fever and induration. The swelling subsided slightly with cold compresses. Pt was seen 10/26/01 and treated with oral antibiotics.
A few drops of the vaccine leaked out; A few drops of the vaccine leaked out; A spontaneous report  was received from a nurse concerning a patient of unknown age and gender, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and a few drops of the vaccine leaked out   The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection and a few drops of the vaccine leaked out (accidental underdose).  No AEs were reported, and no treatment medications were reported.  Action taken with mRNA-1273 was not reported.  The outcome of the event was considered recovered.; Reporter's Comments: This report refers to a case of accidental underdose and vaccination site discharge for mRNA-1273 (lot # unknown) with no associated AEs reported.
On Day 8 diagnose by medical professional skin infection  (swollen arm, redness, itchiness)
Chills, fever, congestion, cough, shortness of breath and positive COVID-19 test.
Red bumpy rash on left leg and right leg. More rash on the left leg than the right. Does not itch.
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) on 05-Apr-2021 for Fever, at an unspecified dose and frequency. On 06-Apr-2021, PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Arm/injection site started itching 4 days after, became red and warm to touch. Red area around injection site 4" x 3.5" No respiratory symptoms, hive resolving.
30 min after shot, my tongue started to tingle, but went away within the hour. I did have headaches almost daily, got the first week or 2.
BP  130/83               pt complained of "dusty throat"  HR    94                   given  25 mg diphenhydramine RR    16                   1st dose  6/2/21 no symptoms                                observed additional 30 mins
demyelinating disorders onset/relapse after vaccine exposure/Multiple Sclerosis Relapse; demyelinating disorders onset/relapse after vaccine exposure; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant), outcome "unknown", described as "demyelinating disorders onset/relapse after vaccine exposure/Multiple Sclerosis Relapse"; DEMYELINATION (medically significant), outcome "unknown", described as "demyelinating disorders onset/relapse after vaccine exposure".; Sender's Comments: Based on the information in the case report, a possible causal relationship between the Multiple sclerosis relapse, Demyelination and suspect product BNT162b2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
9 days, post vax, pt developed rash on thigh and buttocks and foot.
Very cold, very strong pain in the whole body, hives all over the body from the chest to practically the feet on the front and after two days it started on the back part, lasting approximately 5 days totally invaded and it is already disappearing
Chills Headache  Muscle aches Joint aches Nausea  All worse during the night
On 02/09/22 at approximately 1310 I administered a 4th dose of 0.5mL instead of 0.25mL of Moderna vaccine into the left deltoid of an employee. I was distracted due to assisting another employee with inputting the staff members information into database. I did not look at the vaccine card prior to administering the vaccine. The employee was monitored for 15 minutes and released with no negative effects noted. Education was provided about what to do if anaphylaxis develops. The employee stated they understood.
Vomiting, fever of 109, body aches, headache ache, fogginess, shoulder and throat hurts. Adverse reactions have lasted a week. Very fatigued.
Systemic: Lymph Node Swelling-Medium, Additional Details: pt visited clinic on sunday and they told her it was a side effect. she states around 7:30pm 12-20-21 that she is feeling better and just wants the side effect reported.
Order was given by FNP-BC I gave the immunization per protocol. It was double checked by RN.I and FNP-BC were unaware that this vaccine was not to be given over the age of 13 years or older. This was reported to the Dept of health, CDC guidelines states it was given off label and her immunization does count. No Need to re vaccinate.
On May 26, 2021, I started having a dry sore throat and green nasal discharge. I took sudafed but didn't help any symptoms. I never had a fever. I decided finally 6/1/21 to see a doctor since symptoms had not improved and did not want to be spreading any infections. They didn't think from my symptoms that it was covid. They prescribed Antibiotics for me which I took for 3 days after, I did not take all of the pills provided.
The RN accidentally administered a Tdap on 12/02/2022 despite the patient already having Tdap on 05/2022. Right after the incident, the RN notified the incident to the patient. She didn't have any symptoms at the time and left her home. The RN sent a secure message to the patient three days later; she opened the message but did not respond.
Increased heart rate; Feeling very dehydrated; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization and lisinopril, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for hypertension. Medical history included patient was prediabetic. The patient's concomitant medications were not reported. On an unspecified date in 2021, patient was having a little bit of concern, she just had side effects that were a little scary. She have had like an increased heart rate and now, feeling very dehydrated. The action taken in response to the events for lisinopril was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Red swollen area on spot where shot occurred on arm. 4? plus diameter and inflamed skin. Hot to touch and very sensitive and painful at times. Treated with topical Benidryal and ice therapy and ibuprofen.
Severe shoulder and neck pain in the arm (right) where injection was given.  Too painful to even sleep during the night (neck and shoulder spasms). Assumed it was side effect from flu vaccination, so on 10/23/2014 I took 2 Motrin (200mg) within a half hour both pain and spasm began to subside.  Felt 98% better later that morning.  Just thought it was something I should report.
PER PT WHEN RECEIVING THE VACCINE- INSTANTLY HAD PAIN WHEN BEING INJECTED AND AFTERWARDS. DENIED ANY REDNESS OR WARMTH AT INJECTION SITE. PT CONTINUES TO HAVE PAIN PRESENT TO RIGHT DELTOID AREA.  PT WAS SEEN ON 4/27/2022 AND COMPLAINED OF PAIN AND THEN AGAIN ON 6/20/2022.
2 days after shots (both same arm), pt started experiencing swelling on shoulder. By end of day, swelled "larger than a softball." Pt instructed to ice and monitor and be seen if feels need at any time to but could start by seeing how icing does and then if worse or not getting better to be seen. Said is sensitive/painful to raise arm.
Very heavy periods, bright red and going through super plus tampon every 10 minutes along with a super pad; extreme abdominal cramping
This spontaneous report as received from a nurse refers to patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with VAQTA stored for many days' at 28F, lot # H010437 expiry date not reported and lot # H012669 expiry date 17-APR-2015 (dose and route not reported). Concomitant medication was not reported. No adverse effects reported. The reporter stated that 10 unidentified patients received unspecified frozen or refrigerated vaccine doses that were improperly stored. This is one of several reports from the same source. Additional information is not expected.
Resident was to receive Pfizer Bivalent Vaccine and was inadvertently given Pfizer Monovalent.
Within one minute of receiving the shot, my 18 year old son fainted and has a slight seizure. After he regained consciousness, his vitals were checked. Within 5 minutes, he fainted again and this time had a much worse seizure. His vitals were again check, including his blood sugar levels were good.
Narrative: Pt received Moderna covid vaccine #1 on 2/2/21. On 2/5/21, his wife called his primary care clinic with reports of a rash to his arms and legs. She had given him diphenhydramine x 1 dose and used OTC hydrocortisone cream. His PCP then prescribed famotidine and cetirizine. On 3/1/21, he was admitted to the ICU for treatment for pneumonia and UTI. He passed away in that facility on 3/4/21. There were 30 days from date of vaccine to date of death. No autopsy report available.
Child reported to a clinic with local reaction in (R) deltoid. Red/swollen at the injection site. The doctor at the clinic called and reported reaction to our clinic.