chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client brought in by stepmother-states child complained of itching in left arm at injection site.  Left deltoid noted to be very red, swollen and warm to touch.  Redness measured 93mm verical & 90mm horizontal.  Child denies pain.  Stepmother called doctor and nurse advised ice packs to area and Tylenol every 4 hours or motrin every 6 hours.  05/27/2003:  Talked with stepmother today.  She states arm looks better.  It is still red but is half the size.  Not hot.
Her fingers were so tight and inflamed; both of her hands and wrists started to get swollen.; both of her hands and wrists started to get swollen.; Her fingers were so tight and inflamed; very sore at the injection site for 2-3 days.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (both of her hands and wrists started to get swollen.), JOINT SWELLING (both of her hands and wrists started to get swollen.), MUSCULOSKELETAL STIFFNESS (Her fingers were so tight and inflamed), INFLAMMATION (Her fingers were so tight and inflamed) and VACCINATION SITE PAIN (very sore at the injection site for 2-3 days.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (very sore at the injection site for 2-3 days.). On 24-Feb-2021, the patient experienced PERIPHERAL SWELLING (both of her hands and wrists started to get swollen.), JOINT SWELLING (both of her hands and wrists started to get swollen.) and MUSCULOSKELETAL STIFFNESS (Her fingers were so tight and inflamed). On an unknown date, the patient experienced INFLAMMATION (Her fingers were so tight and inflamed). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 13-Feb-2021, VACCINATION SITE PAIN (very sore at the injection site for 2-3 days.) had resolved. At the time of the report, PERIPHERAL SWELLING (both of her hands and wrists started to get swollen.), JOINT SWELLING (both of her hands and wrists started to get swollen.), MUSCULOSKELETAL STIFFNESS (Her fingers were so tight and inflamed) and INFLAMMATION (Her fingers were so tight and inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient instructed to wait 30 min post vaccine administration. After 30 min patient reported feeling flush and cheeks were slightly red. O2 sats 98%, HR 62 bpm, denies shortness of breath. Notified Dr. who gave a telephone order for Benadryl 25mg PO now. Instructed patient to stay 30 additional for observation post Benadryl administration.
pt recv vax 15JAN96 & 23SEP96 pt exp a varicella-like rash;
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. In July 2015 the patient was vaccinated a booster dose of VAQTA, 4 months after the first dose of VAQTA that was administered in March 2015 (dose, route and lot# were unspecified). No adverse effect was reported. Additional information is not expected because there was no consent for contact.
I experienced fatigue and a cough originally. The cough was consistent throughout for about a month. I am still trying to recover from the fatigue. I was sneezing and had congestion but the cough was the worst symptom. I tested myself for COVID-19 on July 19, 2022. I went to the emergency room on the first day. After waiting for 5 hours I left and was not treated. My general practitioner was out of the country at the time that I had the breakthrough case. I received some advice from the doctor that was covering for her afterwards and I spoke to 2 separate doctors over the phone that prescribed the medication for me. I was treated with albuterol, a cough syrup and benzonatate 100 mg capsules. The albuterol was not helpful but the cough syrup was. I did have a chest x-ray which was clear. I tested negative on August 05th, 2022. I have recovered from COVID 19 after 3 weeks. I am still recovering from fatigue and mobility issues. I am in physical therapy in an attempt to get back to where I was.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with a first dose of GARDASIL (lot number, expiry date and dose were not reported)series intramuscular on 10-NOV-2011 and the second dose of GARDASIL (lot number, expiry date and dose were not reported) series intramuscular on 29-NOV-2012. No adverse effect reported. Additional information has been requested.
Pt fainted post vaccine, had LOC for approx. 3 to 5 secs...
Swelling and pain at injection site that evening  Fever, chills and body aches the next morning
Moderna COVID-19 Vaccine EUA Chills and fatigue began at 11:45 pm.  Chills ended at 2:30 am.  Fatigue most of 02/17/2021
Patient came into the pharmacy to report that he had severe pains, swelling, redness and soreness around injection site (Left upper arm -Deltoid area) about one week after receiving immunization. This pain lasted for almost a week and caused his blood pressure and heart rate to go up. He said the pain resolved after 1 week but he is worried about possible long term issues with reaction.
Mom reports positive red area and felt warm on 4/1/08.  On 4/3/08 for separate issues follow-up mom requested check of leg.  Left leg with 8 cm area of erythema and 4.75 cm area of induration.  NT, no temperature.
pt recv vax 25NOV98 & raised red rash mostly on trunk, splotchy, a few on face & a few on trunk;rash disappeared in about 3 days;mom fearful will have worse rxn next time;
within 2 hours extreme fatigue; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; headache; fever; This is a spontaneous report from a contactable healthcare professional (patient herself). A 53-year-old female patient received the second dose of bnt162b2 (BNT162B2, Pfizer, lot number was not reported), via an unspecified route of administration on the left arm on 11Jan2021 15:00 at a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included metformin, atorvastatin calcium (ATORVASTIN), vortioxetine hydrobromide (TRINTELLIX) and insulin glargine, lixisenatide (SOLIQUA). The patient previously took the first dose of BNT162B2 (Pfizer, lot number was not reported) on 23Dec2020 on the left arm and experienced tingly lips; and previously took codeine and experienced allergies. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. On 11Jan2021 18:00, the patient experienced within 2 hours extreme fatigue, lots more muscle soreness than the first. This soreness went across the back and to the other shoulder then down the back. The patient slept from 6 pm to 8 am and would wake to take ibuprofen and TYLENOL. Ran some fever. Had a headache since 6 pm. She had extreme fatigue and stayed in bed all day. The patient did not receive treatment for "within 2 hours extreme fatigue" and "more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back". The patient has not recovered from the events.   Information about lot/batch number has been requested.
No adverse reaction. Resident received additional dose of booster d/t no documentation from clinic on administration into database of dose given on 4/6/22 while at clinic appointment. Resident when asked wanted to get an additional booster. Facility medical record showed  resident received one booster in facility on 11/10/21. Then was dx with covid on 4/22/22 so resident was not set up for booster clinic. Clinic did not upload in database that vaccination was given on 4/6/22 while resident was there for clinic appt. So it appeared resident could have additional booster. Booster was administered and it was then found out the resident had a previous booster on 4/6/22 at clinic appt. Resident had no ill or adverse side effects.
Patient recived 0.5mL of Booster dose instaed of 0.25 mL; started hearing ringing/buzzing in ear / the ringing is there all the time/ ringing in the ears all the time is an annoyance; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (started hearing ringing/buzzing in ear / the ringing is there all the time/ ringing in the ears all the time is an annoyance) and OVERDOSE (Patient recived 0.5mL of Booster dose instaed of 0.25 mL) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 013M20A and 026L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In August 2021, the patient experienced TINNITUS (started hearing ringing/buzzing in ear / the ringing is there all the time/ ringing in the ears all the time is an annoyance). On 18-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Patient recived 0.5mL of Booster dose instaed of 0.25 mL). At the time of the report, TINNITUS (started hearing ringing/buzzing in ear / the ringing is there all the time/ ringing in the ears all the time is an annoyance) had not resolved and OVERDOSE (Patient recived 0.5mL of Booster dose instaed of 0.25 mL) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: Test results were normal. On an unknown date, Magnetic resonance imaging: Test results were normal.         No concomitant medication was reported. Patient stated After about 2.5 - 3 weeks of receiving the vaccine, she started experiencing buzzing/ringing in her ears. She was not sure what was going on so she decided to see an ENT to get her ears checked out. Her ENT doctor suggested that it could be an inflammatory response to the vaccine which may or may not resolve. She said that the ringing was always there but with the tv on, for example, patient did not noticed it as much. Patient noticed it more when there was silence in the room, like at night, then she can definitely noticed that something was going on. Patient said that she did not get any other side effects from the vaccine, but having that ringing in the ears all the time was an annoyance.   On an unknown date, MRA of the brain done, all test results were normal.  Treatment information provided that, patient also tried to go through acupuncture but it did not resolve the ringing in ears.   This case was linked to MOD-2022-645242 (Patient Link).
I started noticing my right ankle was swollen it was big. Then in the night I got charlie horses in my right calf several times at night. I went to see my PCP who wants me to have the veins in my legs scanned. Since I saw him I only now having the pain in the day, it hurts.
After receiving vaccine patient felt nauseous and faint. She started fainting & mom guided her down to floor. Store manager called 911, mom refused medical treatment. We got patient a chair, water & oranje juice and she started to feel better and they went home
My shoulder has remained sore since the flu vaccine was given. It seems to be getting better but is still sore. I had never had a reaction to any flu vaccine I received.
082404 MOM NOTICED EDEMA, INFLAMMATION, TENDERNESS & HOT TO TOUCH AREA LEFT ARM @ INJECTION SITE APPROX 4"X3". ADVISED WARM COMPRESSES TO AFFECTED AREA, TYLENOL Q4-6 HOURS PRN & OTC ANTIBIOTIC TO AFFECTED AREA PRN
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 21-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Started with a headache, about an hour later progressed to intense body chills, fatigue and fever. Took over 16 hours and tons of sleep for symptoms to subside.
Patient experienced pain and swelling after administration RPH recommended IBU. Patient took it, did not work/relief pain or swelling. Patient advised to speak to MD and take additional IBU and add BENADRYL.
break out in hives all over her body; some dizziness; soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (break out in hives all over her body), DIZZINESS (some dizziness) and VACCINATION SITE PAIN (soreness in the injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Sulfonamide allergy (allergy to products containing sulfa).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIZZINESS (some dizziness) and VACCINATION SITE PAIN (soreness in the injection site). On 25-Jan-2021, the patient experienced URTICARIA (break out in hives all over her body). The patient was treated with PREDNISONE for Hives, at a dose of UNK dosage form and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (break out in hives all over her body) had not resolved and DIZZINESS (some dizziness) and VACCINATION SITE PAIN (soreness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient fully vaccinated with Pfizer Covid-19 vaccine, seen in clinic and test results show positive for Covid on 7-21-2021
Swelling, itching, soreness, fatigue, muscle pain injection sight. Body ache, chills, fever, headache.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. Found it difficult to get out of bed due to arthritic bone and joint pain. His experience with the anthrax vaccine is well documented. His post vaccination blood work showed seroconversion to the auto-immune marker, ANA. (OMIC)
patient forgot they needed a 2nd dose of Shingrix, had first dose on 7Jan2020 and never got a 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient forgot they needed a 2nd dose of Shingrix, had first dose on 7Jan2020 and never got a 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist reported a patient forgot they needed a 2nd dose of Shingrix, had 1st dose and never got a 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up via email
Information has been received from a physician concerning a 20 year old female patient who on 04-DEC-2008 was vaccinated intramuscularly with the second dose of GARDASIL (Lot # no reported). Concomitant therapy included NUVARING. On 04-DEC-2008 the patient experienced red spots, swollen hands and achy joints. Also, she experienced cramps while on NUVARING. The physician reported that on 08-DEC-2008 the patient visited the hospital but was not hospitalized. At the time of the report, therapy with GARDASIL was discontinued. The outcome of the patient was no reported. Follow-up information was received from a physician concerning a 20 year old female patient who on 04-DEC-2008 was vaccinated intramuscularly with the second dose of GARDASIL (Lot # 0947X) in the left arm. On 08-DEC-2008 (previously reported as 04-DEC-2008) the patient was seen in ER, and experienced swollen hands, joint aches and red splotches. The patient recovered from these events. No further information is available.
This spontaneous report as received from a physician refers to a 15 year old female patient. The patient was vaccinated with the first 0.5 ml dose of GARDASIL (route and lot # not reported) on an unspecified date, and second 0.5 ml dose of GARDASIL (Lot # 670048/0963AA expiration date 09-NOV-2013) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The physician stated that on an unspecified date, the patient felt faint after the first dose of GARDASIL. The outcome of felt faint was unknown. The physician reported that on an unspecified date, the patient was getting her second dose of GARDASIL and she started to feel light headed and dizzy and she became sweaty. The doctor had her lay down for a few minutes, and when she stood back up she experienced seizure like movements and her limbs were jerking. This lasted about 6 seconds and then the patient woke up. The doctor asked her questions to be sure she was not disoriented and then let her leave. The patient did not receive treatment for the adverse events. The patient recovered on the same day the adverse events occurred. Upon internal review seizure like movements were considered medically significant. The relatedness for seizure like movements, became sweaty, dizzy, limbs were jerking and felt faint was unknown for GARDASIL. Additional information has been requested.
EXCESSIVE POST NASEL DRIP WITH COUGH AND WORSENED GERD
she can't even move; weak; she feels exhausted; shoulder pain; the chill all over; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (she can't even move), ASTHENIA (weak), FATIGUE (she feels exhausted), ARTHRALGIA (shoulder pain) and CHILLS (the chill all over) 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 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 MOBILITY DECREASED (she can't even move), ASTHENIA (weak), FATIGUE (she feels exhausted), ARTHRALGIA (shoulder pain) and CHILLS (the chill all over). At the time of the report, MOBILITY DECREASED (she can't even move), ASTHENIA (weak), FATIGUE (she feels exhausted), ARTHRALGIA (shoulder pain) and CHILLS (the chill all over) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided by the reporter.
Eating breakfast and very nauseous. Couldn?t finish eating. Lasted few hours. Now I?m tired, slight headache, fatigue. Day after vaccine, injection site hurt and slightly swollen. Still tender today.
Has no energy; Is very sick; Can hardly move; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Has no energy), ILLNESS (Is very sick) and HYPOKINESIA (Can hardly move) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced ASTHENIA (Has no energy), ILLNESS (Is very sick) and HYPOKINESIA (Can hardly move). At the time of the report, ASTHENIA (Has no energy), ILLNESS (Is very sick) and HYPOKINESIA (Can hardly move) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient only wanted to report the adverse events and did not want to provide further information. Patient did mention something regarding cancer treatment, but did not state specifics.  No concomitant medications reported.
Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the side effects.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in right arm, single dose, for COVID-19 immunisation. Medical history included Moyamoya disease (unspecified if ongoing), epilepsy (unspecified if ongoing), and migraines (unspecified if ongoing). Concomitant medication included low-dose Aspirin taken for migraine. The patient had pain in extremity/sore arm (non-serious), with outcome of not recovered. Therapeutic measures were taken as a result of pain in extremity. No follow-up attempts possible. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021366857 same reporter/drug/similar event, different patients.
18JAN adm acellular DTP/OPV/MMR 19JAN pt began to shake & became stiff-bodied (dad picked up) & arched back & became limp; eyes rolled back for approx 15-30 sec; t101;
Patient received Pfizer COVID vaccine on 3/10/21 (lot # EN6208), 4/7/21 (lot # EP7533), and Moderna COVID vaccine on 12/1/21 (lot # 065F21A). Patient was diagnosed with COVID infection on 10/4/22 (symptom onset 9/30/22). On 10/9/22, patient was intubated and admitted to CCU with acute hypoxic respiratory failure secondary to COVID pneumonia, and ARDS. Patient was extubated on 10/11/22 and transferred from CCU to med/surg unit on 10/12/22. As of today (10/18/22), patient is still admitted in the med/surg unit.
fever to 106.2 R w/in 48 hrs p/vax; +fussiness; fevers resolved by 48hrs; no further problems;
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (route, dose, lot number and expiration date were unknown). There were no reports of adverse effects. This is one of the three reports received from the same source. Additional information is not expected as there is no consent to contact the reporter.
No booster received yet.  Repeat of reaction after first Moderna shot.  Full body skin burning/itching & chills that lasted about 24 hours.  I never had this reaction before the Modernat Vaccine.  No unusual food was consumed prior to reaction.