chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The pharmacist stated that other pharmacists had told her patient's had gotten a rash after getting a Shingrix vaccination. The pharmacist was unable to provide further details at time of reporting.
Rash developed over bil anterior thighs after 4mo shots: Pediarix, Hib (Rt) and PCV (Lt). Mom reported same rash after 2 mo shots but was not seen at clinic for it.
sore throat for 24 hours.     Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: pt complained of dizziness. lied down w/ feet elevated + used ice packs. stated this has not happened before. BP very high on 1 reading (233/108) and decided to call EMS out of precaution. begain shaking after a few minutes of ice packs but stopped after a few minutes of removal. EMS evaluated, sat pt up, and once pt was sitting up began shaking again and they decided to take to hospital to get checked out.
Pt recvd 3 doses of Engerix-B, 3rd dose given 20NOV90 7PM; 4th given 7MAY @ 430PM;
arm hurts quite a bit - left arm; Swelling in arm; Flu like symptoms; Body aches; Injection site has hard spot / injection site has knot on it; Low grade fevers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts quite a bit - left arm), PERIPHERAL SWELLING (Swelling in arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches) and VACCINATION SITE INDURATION (Injection site has hard spot / injection site has knot on it) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurts quite a bit - left arm), PERIPHERAL SWELLING (Swelling in arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches) and VACCINATION SITE INDURATION (Injection site has hard spot / injection site has knot on it). 21-Apr-2021, the patient experienced PYREXIA (Low grade fevers). At the time of the report, PAIN IN EXTREMITY (arm hurts quite a bit - left arm), PERIPHERAL SWELLING (Swelling in arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), VACCINATION SITE INDURATION (Injection site has hard spot / injection site has knot on it) and PYREXIA (Low grade fevers) outcome was unknown.            No concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-083276, MOD-2021-083116 (E2B Linked Report).; Sender's Comments:  MOD-2021-083276:Husband's case MOD-2021-083116:Husband's case
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 10-MAY-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot # K009876 with expiration date of 19-MAR-2016, dose and route unknown. No symptoms were reported. Additional information has been requested.
Pt did not disclose had already received 1st dose of vaccine on 1/20/2021 at Medical center
Screaming and crying for more than 3 hours. Within 24 hours of receiving vaccines. Also noted redness at the injection site, right thigh.
Positive for covid after covid vaccines; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for covid after covid vaccines) in an 87-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Patient had no other medical conditions.     On 12-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-May-2023, the patient experienced COVID-19 (Positive for covid after covid vaccines). At the time of the report, COVID-19 (Positive for covid after covid vaccines) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2023, SARS-CoV-2 test: Positive.         No concomitant medication information was provided.   It was reported that all of the vaccines the patient received were the Moderna covid vaccines. Patient received first dose on 03-Feb-2021, second dose on 03-Mar-2021 and first Moderna booster on 03-Feb-2022. Patient further stated at the time of report, patient was covid positive but had not yet started the Paxlovid treatment. Patient was prescribed 100mg of Paxlovid with 3 doses in the morning and 3 in the evening and to take six a day for 5 days. Patient stated that she had not felt anything, had not had any testing or treatment and had not done anything except for the covid testing positive.   This case was linked to US-MODERNATX, INC.-MOD-2023-725637 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2023: Follow-up received contains non-significant information. On 24-May-2023: Product quality complaint number was added in the case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725637:husband case
Hives anywhere clothing touches skin to where I scratch. Affected areas raise and burn for about 10 minutes and then subside in that spot but itch is constant.
Patient erroneously given DTaP instead of Tdap. Patient was notified of the error and he said he had no problems. No reactions.
Patient reported having increased SOB requiring O2 all day rather than just at night, feeling ill, fatigued, generalized weakness for 1 week. Was fully vaccinated with Moderna COVID-19 vaccination in  02/26 and 03/26/2021. Today 10/05/2021 diagnosed with breakthrough COVID-19 infection.
pt recvd vax; brief stiffening of body w/ clonic movements of lower extremities; fever 102 R;
URINATION DIFFICULTY; DIFFICULTY HAVING BOWEL MOVEMENTS; NIGHT SWEATS; ACHES AND PAIN IN JOINTS; ACHES AND PAIN IN LEGS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight was 170 pounds, and height was 60 inches. The patient's concurrent conditions included smokes marijuana, alcohol use, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 04-APR-2021, the subject experienced night sweats. On 04-APR-2021, the subject experienced aches and pain in joints. On 04-APR-2021, the subject experienced aches and pain in legs. On 04-APR-2021, the subject experienced severe headache. On 05-APR-2021, the subject experienced urination difficulty. On 05-APR-2021, the subject experienced difficulty having bowel movements. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats on 10-APR-2021, and severe headache on 09-APR-2021, and had not recovered from aches and pain in legs, difficulty having bowel movements, urination difficulty, and aches and pain in joints. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
couldn't get out of bed in morning due to pain-all over body weakness (extreme)-not in joints-just muscles; lt leg & ankle started to swell 2 to 3 wks, rt hand swelled a little; had cont pain in muscles;
11/27/21 presents to ED for "low pulse ox" "short of breath, weak". PMHx of "HTN, HLD, CAD w/ stent"
1st dose 30Apr2021; no 2nd dose; Sleeping the whole time; Congested; Trouble breathing; Low grade fever; 16 years old administered with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping the whole time), NASAL CONGESTION (Congested), DYSPNOEA (Trouble breathing), PYREXIA (Low grade fever) and PRODUCT DOSE OMISSION ISSUE (1st dose 30Apr2021; no 2nd dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21N) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old administered with the vaccine). On 01-May-2021, the patient experienced SOMNOLENCE (Sleeping the whole time), NASAL CONGESTION (Congested), DYSPNOEA (Trouble breathing) and PYREXIA (Low grade fever). On 17-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 30Apr2021; no 2nd dose). On 30-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old administered with the vaccine) had resolved. On 01-May-2021, SOMNOLENCE (Sleeping the whole time), NASAL CONGESTION (Congested), DYSPNOEA (Trouble breathing) and PYREXIA (Low grade fever) had resolved. On 17-Aug-2021, PRODUCT DOSE OMISSION ISSUE (1st dose 30Apr2021; no 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Took Pfizer-BioNTech COVID-19 Vaccine EUA on 20th April, 2021 at around 1:30 PM. After couple of days, lost the sense of smell while having food. I was not able to smell the aroma of the cooked food. I also had no sense of taste while having food. E.g. I tried raw red chillies / onions with food. But neither I did feel any reaction to my taste buds nor any smell. I can smell perfume, garlic from a close distance. However I did not feel any taste while having oranges. I informed my doctor about this who ordered a covid test for me. The result is negative. I am not taking any medicine / treatment for this. I am just waiting and hoping that the sense of taste will be back within few days. I am not sure if it has any connection with the vaccine. I just thought I will mention it to the concerned people.
Initial rash on trunk: not raised, pink, no drainage, skin intact. Temp 1/11/07: 101.0
1:45 pm January 5, next day I was pretty good but started running a fever. 99.5 and stayed at that temp until 12th - went up to 101.3 and I was very dizzy. Dizziness was just for 24 hours. January 14th - at 6:00 pm - my temperature 100.9 and it started going down after that. It fluctuated to 99.5 to normal up and down - evening when temperature would come back up. I took 1 acetaminophen (phone call to dr told me to take it) to get temperature down when it was 101 but all the rest of the time I just counted on the aspirin that I take at night to help. Have to call the doctor to get the Lot numbers for the dose. Feb2 - was when I was took second dose and I was recovered from 1st dose.
injection site redness; swelling size of softball; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number E3Z7E, expiry date unknown) for prophylaxis.   On 12th February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and extensive swelling of vaccinated limb. On an unknown date, the outcome of the injection site erythema and extensive swelling of vaccinated limb were unknown.   It was unknown if the reporter considered the injection site erythema and extensive swelling of vaccinated limb to be related to Shingrix.  Additional details were provded as follows: The patient experienced redness at injection site and had swelling of the size of softball after receiving Shingrix vaccine.
Initial report was received on 19 August 2011 which consisted of a cluster of two patients who experienced adverse events after receiving TYPHIM VI, lot number E0549. This case represents one of the two patients. The other patient has been captured in case number 2011-07268. A 21-year-old male patient who had no concurrent illness and no known allergies had received an intramuscular injection of TYPHIM VI, lot number E0549 on 12 August 2011 and six days later, he wasn't feeling well. He was hospitalized and was diagnosed with bacterial meningitis. Outcome was not recovered. No additional information was provided at the time of the report. The reporter for this case is the same as case number 2011-07268.
BEGGED NOT TO TAKE VACCINE...MANDATED AS HEALTHCARE WORKER OR WOULD LOSE MY JOB.  I HAVE A FAMILY!!! I AMOST HEMMORAGED TO DEATH D/T URINE FIBROIDS AFTER VAX  25 years an RN....had known uterine fibroids finally under control for the last several months.  (Privacy) is now starting studies of effects on menstrual cycle and increased bleeding.  INFORMED CONSENT MEANS I SHOULD HAVE HAD THE RIGHT TO OUTCOME OF STUDIES BEFORE TAKING VAX.    10/11/21 I took the vaccine.  The bleeding started 3 days post and continued for 3 solid weeks.  1 week off and November cycle worse.  December was even worse; meds changed.  Put me on double dose of birth control and Lysteda...now at risk for blood clot.   January I full blown hemorrhaged and was admitted to the hospital for 2 blood transfusions and IV IRON.  My H/H normally runs 8/43 and it dropped to 6/24.   I felt like I was dying.    No MD would write me a note.   I very specifically was concerned about increased bleeding due to vaccine.  This is documented PRIOR TO VAX and I have proof....a whole chart of proof WITH SERIAL BLOOD WORK  I should have been able to wait for those studies by (privacy)...this is what INFORMED CONSENT IS.  NO ONE believed me.  NO MD would write a note; as I 'm told the MDs were threatened THEY WOULD HAVE LICENSE REMOVED IF THEY WROTE A NOTE.   My religious exemption was denied.   The worst part....all unnecessary since I have DOCUMENTED NATURAL IMMUNITY X16MONTHS....I HAVE THIS DOCUMENTATION AS WELL.   25 YEARS AN RN AND I HAVE NO SAY OR CONTROL OVER MY OWN HEALTH DECISIONS.  I ALMOST DIED.   THIS MANDATE NEEDS TO STOP!!!!   GET THE VACCINE IF YOU WANT RESPECT THOSE THAT CAN NOT.
received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine).   On 21-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD21-093500, MOD21-093559, MOD21-093561, MOD21-093562, MOD21-093563, US-MODERNATX, INC.-MOD-2021-162156, US-MODERNATX, INC.-MOD-2021-162267, US-MODERNATX, INC.-MOD-2021-162303 (E2B Linked Report).; Sender's Comments:  MOD21-093500: MOD21-093559: MOD21-093561: MOD21-093562: MOD21-093563: US-MODERNATX, INC.-MOD-2021-162156: US-MODERNATX, INC.-MOD-2021-162267: US-MODERNATX, INC.-MOD-2021-162303:
Moderate to severe pain in left arm for 4 days. Large rash appeared at injection site 10 days later. Took ibuprofen for the pain.
Pt fainted at car in clinic parking lot. Mother & sister walked her back into the clinic. We kept her on exam table where she was A & O - VSS. Offered juice. She was taken to ER via w/c d/t c/o (R) arm weakness & sluggish pupils bilat.
No additional AE/PQC.; inadvertent administration of MMR-II and PROQUAD to a patient.; Patient was scheduled to receive their second dose of MMR-II and VARIVAX on 10/05/2023 but instead inadvertently received MMR-II and PROQUAD.; This spontaneous report was received from  a medical assistant and refers to a 5-year-old patient. The patient's medical history, concurrent conditions and concomitant  therapies were not reported.  On 05-OCT-2023, the patient was inadvertent vaccinated  with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, both  administered for prophylaxis (strengths, doses description, lot #s, expiry dates, anatomical locations, and routes of administration were not provided) (accidental overdose). It was stated that the patient was schedule to received  varicella virus vaccine live (oka/merck) (VARIVAX) injection, for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  (Wrong vaccine administered). No additional adverse event was reported.
Child developed high fever of 103.8 and extreme irritability. Fever and irritability persisted for 6 days in addition to trouble sleeping, lack of appetite, and loose stools. Rash developed day 12 after shot and lack of appetite, difficulty sleeping, irritability, and loose stools persisted as well. Child was seen by physician day 19 after shot and was diagnosed with measles due to MMR vaccine. Today is day 19 after shot.
FLUZONE 0.5ml was administered to 12 month old instead of age-appropriate 0.25ml dose - no ill effects reported, MD notified.
CONTACTED MOM ON 02/25/2022 AND  AS AS OF YET PATIENT HAS NOT HAD ANY ADVERSE REACTION (S).
Pt states that the vaccination was administered too high in the deltoid and "hit bone and nerves" and has caused significant amount of pain.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Headache, Myalgia, NauseaVomiting, runny nose Narrative: Received vaccine on 1/26/21 woke up on 1/27/21 with, HA, nausea, vomiting, runny nose, body aches. Patient notified that these are normal side effects to vaccine and should resolve in 2-3 days. If becomes worse notify employee health.
pain at the injection sire; CHILLS; body aches for a day; A spontaneous report  was received from a Healthcare Professional concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at the injection sire, chills, body aches for a day.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: UNKNOWN) for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced the events pain at the injection sire. chills, body aches for a day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 22 Jan 2021 the outcome of events pain at the injection sire was resolved.On 22 Jan 2021 the outcome of events chills was resolved.On 22 Jan 2021 the outcome of events body aches for a day was resolved. .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
This spontaneous report was received from a student nurse practitioner concerning a 65 years old female patient. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patient was vaccinated with the third dose of GARDASIL (strength, lot# and expiration date were unknown) for prophylaxis and completed the 3 vaccination series. It was unknown when the first and second doses were administered to the patient. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Strong, prolonged and persistent headache. Pain and upset stomach, inappetence. Generalized pain in bones and joints. Fever. Pain and swelling in the armpit of the arm where I was vaccinated.
Fever, SkinRash,  rash to injection site arm(left arm) below injection site one week later after receiving shot, low grade fever day after receiving shot for 12 hours Narrative:  reports low grade fever for 12 hours on the day after receiving  1st shot and rash to left upper arm below injection site 1 week later after receiving shot. Both are resolved at this time
NOTIFIED PHYSICIAN OF AGE INAPPROPRIATE VACCINE FIRST, THEN LEFT A VOICEMAIL FOR MOTHER WITH NO RESPONSE
Dry heaves, chills, fever, sleepiness.  Soreness at site since vaccine given.
3/20/21 @ around 10:15AM: Immediately upon getting shot, goosebumps developed on both arms and legs and hair on back of neck stood up. 3/20/21 @ around 6:00PM: Sudden and severe cold chills began and continued through all day 3/21/21.  3/20/21 @ around 8:30PM: Severe cold chills followed by continuous/intermittent fever that lasted until about 10:30AM on 3/21/21. Temperature was taken both via forehead and ear. Temperature of fever began increasing every hour, and the longest period being spent between 103 and 104.