chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; chills; body aches; headache; This is a spontaneous report from a contactable nurse.  A 49-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Ej1686), in a hospital intramuscularly in the left arm on 18Jan2021 at 09:00 at 49-years-old at a single dose for COVID-19 immunization.  Medical history included type 2 diabetes mellitus (Dm2 controlled) from an unknown date and unknown if ongoing.  Concomitant medications included venlafaxine hydrochloride (EFFEXOR), levothyroxine (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), Pro tonic (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose -Lot Number: Ek9231, intramuscularly in the left arm) on 28Dec2020 at 49-years-old. On 18Jan2021 at 16:00, the patient experienced fatigue (non-serious), chills (non-serious), body aches (non-serious), headache (non-serious); with no treatment received.  The clinical outcome of the events was not recovered. The patient did not receive any other vaccine in four weeks prior to the COVID-19 vaccine. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination..
Pain - that PM fever - swelling, redness, site hot to the touch, alternating fever and chills.
Right arm redness and swelling,itchy, hot to touch. Hot pack if swelling persists. start Keflux 500t/d. increased swelling started antibiotic
Patient was present to get their 2nd Pfizer shot for COVID 19.  Patient was accidentally given a Pediatric Pfizer shot when they should have gotten the adult dose.  Will be speaking with mother with a Spanish translator of the situation and will be advising the patient to report any adverse events.  We will also be contacting them the next few days.
This spontaneous report received from a patient concerned an 8 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 23-AUG-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced feeling dizzy, headache, and numbness on both sides of face from cheeks down to jaw line. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling dizzy, and had not recovered from headache, and numbness on both sides of face from cheeks down to jaw line. This report was non-serious.
Received vaccine on 3/16/21 at 10am- arround 10pm started hot and cold flashes with arm soreness.  3/17/21- still arm pain and having hot and cold flashes still.  3/18/21- woke up at 5:30am with burping , nausea, and abdominal pain. 3/18/21- hospitalized with Appendicitis.
Left armpit pain, started 5 days after the shot.  Swollen Lymph Nodes
Pt reported that the vaccination was administered by the pharmacist on duty that day right above his elbow. This means that the pt may have received the vaccine Subq.  The patient had a tingling sensation in his hands and feet the night of receiving the vaccination. The pt was sluggish for 2 days and reported some swelling  at the injection region. Pt has since recovered and feels fine.
afib; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ATRIAL FIBRILLATION (afib) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, ATRIAL FIBRILLATION (afib), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Reporter stated that her husband has AFib and he was on a blood thinner. Reporter also stated she read something about being on a blood thinner. when she was speaking about receiving the Moderna COVID19 vaccine.  Company comment- This is a spontaneous case concerning a 74-year-old male patient with no medical history reported, who experienced the serious (medically significant) unexpected AESI atrial fibrillation. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as a booster dose of COVID-19 vaccination schedule, was administered. Onset date of the event and vaccination date were not provided hence latency cannot be assessed. Patient also received a dose of TOZINAMERAN vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine products). Reporter stated that patient had atrial fibrillation and he was on a blood thinner. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact
(R) upper arm swollen. Approximately 6 inch x 4 inch area. Ice to area. Itches. TYLENOL, BENADRYL. Notified employer on 10-31-11.
Information has been received from a case in litigation for WAES # 0902USA01678 from a consumer who reported "her daughter's anemia became worse after received a dose of GARDASIL."  Additional information has been requested.
Loss of vision in left eye.; This is a spontaneous report from a contactable consumer.  A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), via an unspecified route of administration, administered in right arm on 13Apr2021, at  10:00 as single dose for covid-19 immunisation.  Medical history included Lupus, Hashimotos, chronic obstructive pulmonary disease, asthma, non- alcoholic fatty liver disease, and allergy from unknown dates. The patient experienced loss of vision in left eye on 13Apr2021, at 10:00.  The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent other tests and magnetic resonance imaging in Apr2021 with unknown results. Therapeutic measures were taken as result of the event. No COVID prior to vaccination was noted. No  COVID test was performed post vaccination. The outcome of loss of vision in left eye was not recovered.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
5 min after the shot was administered, I broke out into a rash  on my face neck and chest, was put on pulse oximeter to monitor O2 levels  and was given oxygen. Left hospital drive through site 1 hour later. Saturday 4/10  around 9 pm  started to feel tingling and slight pain on right side of the back of my arm and woke up with a Shingles about 10inches long.
On 8/31, the EUA changed for Moderna and Pfizer monovalent vaccines to no longer include boosters.  The press release was announced around 10am.  Our organization has been asked to report the number of monovalent vaccines that were given in error on 8/31 due to this change.  The Pharmacy administered 130 monovalent boosters on 8/31 while the recommendation was changing.
9APR91 felt hot, temp not measured, abscess formation, cellulitis seen by MD;
soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got the first shot and it caused a little soreness.  The patient said, he/she would not get shingles. For the tolerance of the 2nd dose, refer case US2021AMR196276, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196276:same reporter
Client reported chills, fever, aches, tenderness at site of MCV4 injection.  Temp 103 degrees 7/2/08.  Temp 101 degrees (ax) 7/3/08.  Parent contacted Dr. - advised to medicate with ibuprofen-up to 60mg q 4-6 hrs if needed.  Recovered well-regular activities by 7-4-08 per mother.
When she received the shot she said it burned. The next day the area was really sore and by the day after that pt had difficulty lifting her arm. About 4 days after the shot her arm hurt so bad she could not put her arm into gear. Pt went to the dr on 10/22 and the dr told her it was a side effect and prescribed her tramadol for the pain.
BODY ACHES; HEADACHE; This spontaneous report received from a consumer concerned a 37 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and headache. This report was non-serious.
On 9/23, pt developed palpitations and chest tightness while watching TV. Ambulance called, but symptoms resolved quickly and did not require treatment. Later that evening, he presented to ED after symptoms he developed. Troponin, BNP, D-dimer, and TSH were all within normal limits.  Presents to ED on 9/26 with continuation of palpitations, later admitted to PICU for post vaccine myocarditis workup vs panic attack, all labs negative (serial troponin 19->30->32), normal BNP, and normal bedside ECHO. Started on Ibuprofen 400mg Q6h.
Rotator cuff inflammation and pain starting immediately after vaccines administered and progressively worsened over two days. Then patient sought emergency room attention.
Patients received a dose vial an expired vial, a vial which had been punctured on 30Jan2022 (more than 12 hours).; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received a dose vial an expired vial, a vial which had been punctured on 30Jan2022 (more than 12 hours).) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received a dose vial an expired vial, a vial which had been punctured on 30Jan2022 (more than 12 hours).). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patients received a dose vial an expired vial, a vial which had been punctured on 30Jan2022 (more than 12 hours).) had resolved.        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.   No concomitant medications were reported. No treatment medications were reported.  It was reported by practice administrator that on 01-Feb-2022 three female patients received a dose vial an expired vial, a vial which had been punctured on 30-Jan-2022 (more than 12 hours).   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow-up received includes no new information.
Complains of pain on her left arm where the injection site is. No redness or swelling noted, pain rated as 5/10. she woke up this  morning 02/26/2021 and feels that her R eye is droopy. Slight swelling on her R eyelid noted. Denies numbness on that side.  Instructed her to contact PCP or visit urgent care as soon as  possible.
Patient received 0.5mL of vaccine instead of 0.3ml. Patient had no reaction to vaccine dosage administered.
Information has been received from a mother, and Occupational Therapist, concerning her eight year-old son, who at the age of one year was vaccinated with a dose of varicella virus vaccine live. The mother reported that her son was diagnosed with chicken pox on 11-Dec-2003. She also reported that her son was afebrile, had 15 lesions on his body and 10 on his head. I was noted the patient had been taking diphenhydramine hydrochloride (Benadryl) and had been using "lotion" to decrease the itching. No additional information was available. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
It was reported that a male pt, age unknown, received a tetanus toxoid vaccination, on an unspecified date. An unspecified time later, a nurse reported that the employee experienced "coma" after receiving the immunization and was hospitalized. It was reported that the "MD may not be contacted." The pt recovered from this event. No additional info was provided. A 15-day follow up report received 12/11/2003 adds: From additional info received on 12/03/2003 from a telephone conversation with the reporter. The reporting RN called the pt for info prior to administering a Hepatitis B vaccination. The pt relayed some past childhood info regarding a reactin after receiving a Tetanus vaccine. The pt described a "coma" state and was hospitalized. The pt received a Hepatitis B vaccination on 09/16/2003 and did not have any reaction. The pt is healthy. The pt has no pre-existing conditions or allergies at the present time. The pt's initials and date of birth were also provided.
Patient was given 5 ml's of the vaccine instead of .5mls.  Poison control was called.   The parent was called and instructed to watch child closely.  Give Tylenol as directed.  Take child to ER for any adverse effects.
(Before vaccines given, patient had left eye with itching/redness). Patient here for 5 year old check up and received the four vaccines listed below. Within 5 minutes, patient complained of nausea/vomiting, chest pain, and abdominal pain. Patient encouraged to lay down and sip on juice and rest. Patient still in exam 20 minutes later when Dad came out and told nurse patient's left eye was swollen. Examined by doctor, VS taken. Benadryl 12.5mg PO given at 4 PM and 0.13 mg Epi SQ left arm at 4:10 PM. Left eye with decreased edema and patient perky 5 minutes after Epi. RA SATS 98-100%. Discharge summary states anaphylaxis.  Medical records state hives. msv
Rash on bilateral hands, Right foot, and bilateral inner arms. BENADRYL 25 mg, TYLENOL 650 mg, and triamcinolone to rash.
2.5 to 2 3/4 inch area of redness and swelling at injection site.  To take Tylenol, Benadryl and apply ice to site.
No adverse event reported.. Patient recieved the bivalent moderna booster without recieveing the 2 dose primary series.
1st dose - nerve twitching in nose lasting for about 3 hours after receiving.  2nd dose - nerve twitching in arms and legs lasting for several hours after receiving.
Case number PHEH2014US024345, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 65 year old male patient. Medical history and concomitant medication were not reported. He had tolerated vaccines (no further details provided) well in the past. He was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into right deltoid intramuscularly at a dose of 0.5 ml on 01 Dec 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (right deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
At 12 hours - chills and fever.  Extreme fatigue for next 24 hours (slept till 8am, up an hour back to sleep, up at noon up an hour back to sleep,  up at 6pm, bed at 11pm slept through)
"I" was injected in my left arm and starting the day after "I" noticed soreness in my arm pit, the soreness/tenderness has been mild,; Soreness on left clavicle/neck; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm left on 10Feb2021 at 16:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had reported sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), multivitamins (MANUFACTURER UNKNOWN), fish oil (OMEGA 3) and calcium, magnesium (CALCIUM; MAGNESIUM); all for unknown indication from an unknown date and unknown if ongoing. On 10Feb2021 at 22:00, the patient noticed soreness in arm pit, the soreness/tenderness has been mild, also soreness on left clavicle/neck- it was mild and has decreased but still there (on 04Mar2021) under armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "I" was injected in my left arm and starting the day after "I" noticed soreness in my arm pit, the soreness/tenderness has been mild and soreness on left clavicle/neck was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report has been received from a nurse via a company representative and refers to a 52-year-old female patient with no pertinent medical history. No information regarding the patient's drug reactions or allergies was provided. On 05-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, lot number and expiration date were not provided) for the prevention of pneumonia. There were no concomitant therapies reported. On 06-MAY-2017, reported as "the next day", the patient woke up with a sore arm. The reporter stated that, on an unspecified date in May 2017, the sore arm had progressed to 103 degree fever, headache, earache and bodyaches. The patient's upper arm had been red, hot and painful (unspecified date in May 2017, reported as "by the time she got in to the doctors office"). The patient sought medical attention by visiting a doctor's office. Treatment given for the adverse events included therapy with ketorolac tromethamine (TORADOL) and an unspecified prescription medication. The outcome of the adverse events experienced by the patient was not reported. No product quality complaint was involved. The relatedness between the adverse events experienced by the patient and PNEUMOVAX 23 was not reported. Additional information has been requested.
The day after I received my vaccine I had a fever, body aches, extremely fatigued. My fever got up to 105F, I took TYLENOL to get it to come down. I slept the whole day, as I did not feel like moving. I had decided that if I felt the same the next day, I would call my doctor to see what I should do. When I awoke the next day, I was feeling much better. They fever was gone, no fatigue, body aches were gone.
Blood pressure became elevated after 6-7 days and stayed high; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in arm right on 19Jan2021 at 09:00 as SINGLE DOSE for covid-19 immunization. Medical history included cardiac disorder, diabetes mellitus, hypertension. The patient previously took lisinopril and experienced drug hypersensitivity. On 25Jan2021, the patient experienced blood pressure became elevated after 6-7 days and stayed high. The patient underwent lab tests and procedures which included blood pressure measurement was elevated on 25Jan2021. The outcome of event was recovering.
pt recv vax 110PM & was seen by MD 2PM w/t102R, resp of 42, HR 164; unable to ausculate or palpate BP-poss D/T rapid HR; skin was pale, mottled, cold & clammy; duration of episode 3-4hr;shaking, vomited x4 & irritable; tx APAP & Motrin
I did not have an adverse reaction to the vaccine. I was exposed to COVID-19 during a vacation. On 03/25/2023, I tested positive for COVID-19. I contacted a provider and got a prescription for molnupiravir. I tolerated the medication without any complications. I'm not sure that it helped me. I was sick for two weeks. On 04/11/2023, I had an appendectomy. As of today, I do not have any lingering symptoms.
Starting approximately 48 hours after my first vaccine (3/7/21), I began experiencing a sudden onset of apraxia of speech. I found myself using words that I did not intend to say, distorting letter sounds and word endings. I was very conscience of the errors, but was unable to  stop myself. My speech, in terms of cadence and clarity was also affected.  These symptoms began to slowly subside by 3/11/21 and completely cleared by 3/13/21. I have never experienced anything like this in my life.