chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a female patient (age not reported) who was vaccinated (date not reported) subcutaneously with the first 0.5ml dose of PNEUMOVAX (lot # 658074/0961U).  Subsequently, the patient developed cellulitis.  The patient had an office visit and received medical treatment with unspecified antibiotics and anti-inflammatories.  At the time of this report the outcome was unknown.  The pharmacist requested a lot check for PNEUMOVAX (lot# 658074/0961U).  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  This is one of several reports from the same source.  Additional information has been requested.
Severe arm pain at injection site night of.  At 5:15 AM the following morning (1/14/21) I experienced lightheadedness and fainted off the toilet hitting my face on the wall/radiator in front of me.  My husband (who witnessed the fainting episode) stated I began convulsing and my eyes were rolled to the back of my head for 5-10 seconds. Upon regaining consciousness I was covered in sweat. After being assisted back to bed, I had nausea and headache with continued severe pain at injection site. I went to the ER around 6:45 AM since my severe headache, dizziness and nausea continued and to examine if I broke my nose in the fall. While in triage at the ER I experienced severe nausea and a second episode of fainting.
Headache, NauseaVomiting, FIRST 3 DAYS PAIN AT INJECTION SITE. SECOND AND THIRD DAY N/V, BODY ACHES, HA, CHILLS, FATIGUE Narrative:
Information has been received froma physician's office concerning a female patient who on on 05/05/02 was vaccinated with rubella virus vaccine live (second generation). It was reported that the patient developed a rash all over her body. Unspecified medical attention was sought. Additional information has been requested.
fever for about 4 weeks (98-100.6); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for about 4 weeks (98-100.6)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 606M20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Breast cancer + bone metastasis) since 29-Nov-2017, Hypertension, Sulfonamide allergy, Drug allergy (Dilaudid) and Tetanus (Tetanus toxoid). Concomitant products included DENOSUMAB (XGEVA) for Bone cancer metastatic, LETROZOLE for Cancer, APIXABAN (ELIQUIS) for DVT, TIMOLOL MALEATE and BRIMONIDINE TARTRATE (ALPHAGAN) for Glaucoma, CARVEDILOL (COREG) for Heart disorder, FULVESTRANT (FASLODEX) for Hormone therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MAGNESIUM for Neuropathy, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3) for Osteopenia, PANTOPRAZOLE for Reflux gastritis, VITAMINS NOS, VITAMIN D3, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 12-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021 at 12:00 PM, the patient experienced PYREXIA (fever for about 4 weeks (98-100.6)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 20-Apr-2021, PYREXIA (fever for about 4 weeks (98-100.6)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included hormone injection once a month, cancer pill orally, heart pill for blood pressure and blood thinner, vitamins, Refresh advanced drops and refresh celluvisc gel for Cogan's syndrome. Cozaar-Losartan K (25 mg) used for BP.  Treatment products included Tylenol and Advil.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: ADR form --second dose update-- concomitant meds update-Report not scheduled for Follow up as initial report is pending for submission
Child received vaccines approximately 3:30 PM 9/16/03. Did fine that day. Awoke approximately 8:40 AM 9/17/03 with diffuse urticaria. Minimal eye swelling. Improved with Benadryl. Never had trouble breathing.
Arm pain - two days Body aches - 36 hours Fatigue - ongoing  Headache - ongoing Swollen/sore glands - 40 hours
Chest pain and hypertension,  ER visit, cardiac cath showed clotted vessle off the LAD that was stented.  Symptoms resolved without elevation in Cardiac enzymes
Being hospitalized with pancreatitis has nothing to do with the vaccine.  I've been dealing with this issue off and on for a long time, before getting the first dose of the vaccine.; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 19Mar2021 at single dose for COVID-19 immunization. The patient's medical history included pancreatitis. Concomitant medications were not reported. It was reported that patient had gotten home from being hospitalized for the last week with pancreatitis on an unknown date and fear that I may have to go back again. The patient wanted to get her second dose of the vaccine before I go back in and need to reschedule the appointment. It was reported that being hospitalized with pancreatitis has nothing to do with the vaccine. The patient was dealing with this issue off and on for a long time, before getting the first dose of the vaccine and stated that she need to get the second dose before going back to hospital. Outcome of event was unknown  Information on the lot/batch number has been requested.
Pt. devel inject site rxn w/redness & swelling. This is 1 of 8 employees of this facility to devel inject site rxn with lot# 4978139
Soreness at the site noted immediately after and continued to be present for 72 hours. Large red mark around injection site noted around 0800 and at 72 hours, went away on day 4.
I woke up in the middle of night to use the bathroom and I don't remember what I was feeling, but I kept telling my self to just finish peeing and I woke up on the ground, I was pretty out of it, it took a couple minutes to get out of it I had a couple of buries, I felt stages of light headed for a few days it felt like I was giving blood.  The next day I felt off, I didn't think I was safe to drive, I did feel better but still off and on Tuesday I felt drained.
Developed Shingles virus 2.5 weeks after getting first shot.  Began taking antiviral valacyclovir on 4/28/21.  Will monitor symptoms over next few weeks.  Concerned about getting my second dose which is scheduled for 5/4/21.
Same day post 2nd dose of vax, the pt developed a fever and a maculopapular rash. Myalgia and lymphadenitis also developed the following day. Symptoms consistent with serum sickness due to rabies vax.
PATIENT REPORTED ON 3/27/23 THAT SHE IS STILL EXPERIENCING  LIMITED RANGE OF MOTION IN HER LEFT ARM FROM THE BOOSTRIX VACCINE THAT WAS ADMINISTERED ON 3/10/23. AS A RESULT, PATIENT STATES SHE HAS DIFFICULTY COMBING HER HAIR AND PUTTING ON SHIRTS.  ALSO, SHE MENTIONED THAT SHE CAN NOT EXTEND HER ARM WITHOUT PAIN. SHE STATES IF SHE PRESSES THE INJECT SITE HARD ENOUGH SHE CAN FILL A KNOT. SHE STATES SHE HAS TAKEN IBUPROFEN AND APPLIED ICE PACKS AND NEITHER HAS HELPED WITH DECREASING LIMITED RANGE OF MOTION.  IT WAS RECOMMENDED FOR PATIENT TO SEEK MEDICAL ATTENTION.
APPROX 3-4 MIN AFTER ADMINISTRATION PT STATED SHE WAS DIZZY THEN SLUMPED OVER HER CHAIR FOR 5-10 SEC. SAT BACK UP AND ASKED IF SHE BLACKED OUT. RPH ASKED HOW SHE FELT, (IF SOB, ITCHING) SHE SAID NO BUT FELT WIERD AND HER EARS WERE RINGING. TOLD HER TAKE A FEW DEEP BREATHS. ABOUT 1 MIN LATER SHE SLUMPED OVER HER CHAIR AGAIN AND ARMS JERKED SLIGHTLY. CONSCIOUS AGAIN IN ABOUT 10 SEC. APPEARED VERY PALE. EMS ARRIVED AND TOOK HER TO HOSPITAL.  MOTHER CONTACTED PHARMACY SEVERAL HRS LATER AND REPORTED HER DAUGHTER WAS FINE THAT IT WAS AN ANXIETY ATTACK.
By later afternoon of the day the vax was recvd pt was lethargic & had high pitched crying; did not report to MD until 5MAR94 when pt went for a check-up (routine); lethargy lasted about 1 1/2 days; crying was sporadic lasting 1 1/2 days
vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for Covid-19 immunization.  The following information was reported: VERTIGO (non-serious), outcome "unknown".  Additional information: Caller stated she just got the 4th dose of the Pfizer Covid 19 vaccine the other day went to bed and woke up the next morning experiencing vertigo for a week now. Caller was asking if this was normal.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Abdominal Pain-Severe, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: 3-5 minutes after receiving vaccine, pt experienced severe abdominal pain, hypotension (BP 75/58, HR 86), vomiting. Called 911, emergency services arrived and administered IV fluids. Pt was taken to ER. Followed up with mother of patient via phone and he was discharged from ER about 3 hours after arrival feeling better but still tired.
Right upper arm where injection was given underneath was very red, swollen, red, very painful. The arm stayed this way for 6 days before the swelling went down. There is still a hard bump in the patient's arm where the injection was placed at.
Persistent tendonitis supraspiratous tendon, 3 months after injection; not caused by needle but by TD.
Gave her energy and kept her up; Paining very bad; Pain in her shoulder; Chills all over her back and arms, chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (Gave her energy and kept her up), PAIN (Paining very bad), ARTHRALGIA (Pain in her shoulder) and CHILLS (Chills all over her back and arms, chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENERGY INCREASED (Gave her energy and kept her up), PAIN (Paining very bad), ARTHRALGIA (Pain in her shoulder) and CHILLS (Chills all over her back and arms, chills). At the time of the report, ENERGY INCREASED (Gave her energy and kept her up), PAIN (Paining very bad), ARTHRALGIA (Pain in her shoulder) and CHILLS (Chills all over her back and arms, chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided. Treatment medication not provided   This case was linked to MOD-2021-071464 (E2B Linked Report).; Sender's Comments:  MOD-2021-071464:
DEVELOPED RIGHT ARM AND SHOULDER PAIN WITH DIFFICULTY RAISING ARM. PAI 7 OUT 10 ON PAIN SCALE
Could not bear weight with the arm that was vaccinated in for 15 days. Pain began in the left deltoid the evening of the exam & for the next 15 days. There was no warmth or erythema.
Pfizer-BioNTech COVID-19 Vaccine EUA: six days after vaccination patient reports persistent fatigue, light headedness, feeling jittery, and headache.  All vital signs within normal ranges. Left cervical lymph nodes noted to be swollen. Patient denies respiratory, cardiac, and gastrointestinal symptoms. Patient advised rest and home care: discharged from urgent care medically stable.
I took the vaccine at 2:10pm on 4/8/21 and 20 minutes later at 2:30pm on 4/8/21 my cycle started a whole week early, which is very abnormal for me. I am bleeding clots of blood for 5 days now with weakness and pains. My normal cycle is very regular and lasts 3 days, the first day is heavy then moderate, then light on the third day i barely need a liner. This has been heavy bleeding with sizable blood clots.
Immediately post vax, the pt experienced pain in his left shoulder, Havrix had been injected into the left deltoid. The pt reported that the pain persisted as of 11/21/2000. The physician reported that the pain resolved without treatment, on 02/15/2000. The physician considered the injection site pain to be related to Havrix administration.
This spontaneous report was received from a 43 year old male consumer, as part of a marketing research program conducted by MSW Research, referring to himself. Information about the patient's medical history and concurrent conditions was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided). Concomitant medications was not reported. It is reported that the patient had the vaccine once and got the disease (pneumococcal infection). At the time of reporting, the outcome of pneumococcal infection was unknown. The reporter did not assess the relatedness between pneumococcal infection and pneumococcal vaccine (manufacturer unknown). Additional information is not expected as no reporter details were provided.
FEELING ACHY; FEELING WEAK; HEAD HURTING; FEELING SICK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperkalemia, congestive heart failure, diabetes ii, neuropathy, osteoarthritis, and chronic obstructive pulmonary disease.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included magnesium chloride for drug used for unknown indication. On APR-2021, the subject experienced feeling weak. On APR-2021, the subject experienced head hurting. On APR-2021, the subject experienced feeling sick. On 06-APR-2021, the subject experienced feeling achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, and feeling weak, and the outcome of head hurting and feeling achy was not reported. This report was non-serious.
Patient with fever, diffuse myalgias, neck pain and sore throat with robust take of smallpox vaccination.  Symptoms of fatigue and achiness began 3-4 days after vaccination, but significantly worse over the past 24 hours.
Morbilliform rash at trunk and extrimities. Papulovesicular rash on back.
Pt recv vax on unspecified date; on unspecified date pt exp rxn of injection site of erythema,pain,pruritus,warmth &swelling from shoulder to elbow.  Pt tx=antihistamine &warm compresses.
sick; my body goes crazy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 43 years as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "my body goes crazy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
14DEC91 started w/cold sx & backache & severe h/a & malaise following x 11days; fever of 102 x 5 days; hospitalized 23DEC91; 25DEC91 due to dehydration; no antibiotics administered; viral infection recuperating; no h/a, fever;
Pt recvd DTP/OPV/HIB several hrs later devel high pitched crying & fever ranging from 103.5 ax to 104 R;
Patient received Moderna COVID vaccine on 3/3/21 and 3/31/21. On 8/20/21,  she started having weakness, fatigue, body aches as well as shortness of breath with hypoxia, fever, and some loss of smell/taste. Patient presented to our Medical Center and was admitted on 8/26/21 for acute hypoxic respiratory failure due to COVID-19 pneumonia as well as AE of COPD exacerbation and small right-sided pulmonary embolism (likely secondary to COVID-19). As of today (8/31/21), patient is still admitted in the inpatient med/surg setting.
she felt restless like she had drank a bunch of coffee. Felt "racy".; anxious; difficulty sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for hypersensitivity; BENADRYL taken for hypersensitivity.  The following information was reported: RESTLESSNESS (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "she felt restless like she had drank a bunch of coffee. Felt "racy"."; ANXIETY (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "anxious"; INSOMNIA (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "difficulty sleeping". The patient had the Pfizer shot and everything was fine maybe about 8, 10 hours later she started feeling very restless like she had 10 cups of coffee, kept awake a little bit. Felt "racy".  It wasn't noticeable during the day so much as it was at night.  It lasted two nights in a row, difficulty sleeping. She was restless and anxious maybe about first 48 hours then she laid down.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Thyroiditis 01/29/2008 resolved, alopecia areata 5/2008 resolved.
Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, malaise
Erythematous rash left deltoid area with mild induration. Lasted 4-5 days.
No other AE; Caller reported an AE for MMRII. The caller said the product was administered on 7/13/2023 after the labeled expiration date. Confirmed with caller no other AE occurred. Confirmed no temperature excursion occurred prior to administration. AE letter s; This spontaneous report has been received from an office manager, concerning to a 12-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 13-JUL-2023, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, dose number, route of administration, anatomical location were not provided) (lot#: U011993, expiration date: 15-APR-2023) (albumin status: rHA) (expired product administered). No other adverse event occurred and there was no temperature excursion prior to the administration. No further information was provided.
Swelling, redness of whole upper left arm down to elbow, very sore & warm.
Pt came in after weekend complain of joint and muscle pain after anthrax vaccine on 7/7/2017. Pt stated he was unable to move or hardly function over the weekend. The pt said the muscle fatigue is gone it just joint pain in both arms and knees. Pt had no redness, swelling, or tightness at injection area.
Vaccine expired on 13 Oct 2021 and was kept in refrigerator on 18 Oct 2021 and administered on 27-Oct-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and was kept in refrigerator on 18 Oct 2021 and administered on 27-Oct-2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and was kept in refrigerator on 18 Oct 2021 and administered on 27-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and was kept in refrigerator on 18 Oct 2021 and administered on 27-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment medication information provided.  Patient administered booster dose. It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  Vaccine did not undergo any temperature excursion. No adverse events were reported.