chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose schedualed >36 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedualed >36 days after first dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedualed >36 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedualed >36 days after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
cannot eat or drink water since her throat is irritated; cannot eat or drink water since her throat is irritated; feels that her foot  fracture that  not healing as well; progressively getting worse; sore arm, painful foot; coughing which is getting horrible; painful throat; whole body inflammation from inside out but not  visible; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm, painful foot), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful throat), INFLAMMATION (whole body inflammation from inside out but not  visible) and THROAT IRRITATION (cannot eat or drink water since her throat is irritated) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Foot fracture and Allergy to animal (Singular for cat allergy). Concomitant products included GABAPENTIN and VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm, painful foot), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful throat), INFLAMMATION (whole body inflammation from inside out but not  visible) and CONDITION AGGRAVATED (progressively getting worse). On an unknown date, the patient experienced THROAT IRRITATION (cannot eat or drink water since her throat is irritated), FEEDING DISORDER (cannot eat or drink water since her throat is irritated) and IMPAIRED HEALING (feels that her foot  fracture that  not healing as well). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) ongoing since an unknown date for Allergy to animal, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm, painful foot), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful throat), INFLAMMATION (whole body inflammation from inside out but not  visible) and CONDITION AGGRAVATED (progressively getting worse) had not resolved and THROAT IRRITATION (cannot eat or drink water since her throat is irritated), FEEDING DISORDER (cannot eat or drink water since her throat is irritated) and IMPAIRED HEALING (feels that her foot  fracture that  not healing as well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         No treatment medication was reported.   This case was linked to MOD-2021-004244 (Patient Link).
EXPIRED PPSV23 ADMINISTERED TO PATIENT.  VACCINE EXPIRED ON 10/31/2023. NO REACTION OCCURED. NO SIDE EFFECTS.
cough, runny nose, fussiness-unconsolable for 7 days;no temp;APAP for fussiness-self resolved;
Hives on arm, legs and back; Burning tongue and chest; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on arm, legs and back), BURNING SENSATION (Burning tongue and chest) and HYPERSENSITIVITY (Allergic reaction) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMOXIFEN for Hormone therapy, HYDROXYZINE for Itching, TRAMADOL for Pain, APIXABAN (ELIQUIS) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced URTICARIA (Hives on arm, legs and back), BURNING SENSATION (Burning tongue and chest) and HYPERSENSITIVITY (Allergic reaction). At the time of the report, URTICARIA (Hives on arm, legs and back), BURNING SENSATION (Burning tongue and chest) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter.
No appetite, Metallic or strange taste in my mouth, Very sore at injection site, Fatigue, Sweats, Temperature of 100 degrees. Symptoms appeared in the above order and began about one hour after injection and got progressively worse throughout the night. Took one TYLENOL which brought the fever down. Felt weak and shaky today but symptoms seem to be subsiding. With regard to the type of shingles vaccine, Part 1 was SHINGRIX so I am assuming that Part II (which is what I was taking) was also SHINGRIX but you would need to confirm with doctor.
9/4 Pt had various symptoms last week prior to ED visit, Nausea, no vomiting, cough for last 4-5 days, generally felt poorly and weak for the last two to three weeks.  Pt had exposure to family member who was COVID positive about 3 days prior .  She was fully COVID vaccinated.  Denies SOB and was not hypoxic.
Pt came back today & had localized reaction to IMZ. She had redness & swelling across arm area. No bruising at injection site. She told me after the injection that she had been having therapy on her right arm & I asked her why she didn't tell us that previously & we would of done IMZ in her other arm & she said because she had injected her insulin in her left arm & we discussed why she was giving that in her arm & not her thigh or abdomen. I told her to be sure to let Dr know she had IMZ when she went back to therapy. She tensed up when getting IMZ & said it hurt. And I told her she may have soreness or bruising due to that. When she presented with the reaction today I instructed her to apply ice packs & got her some Benadryl to take every 4 to 6 hours as needed. I called her back tonight to check on her & she said it was still swollen some but she was able to rest with no problem.
Pt devel fever 104.8 & given APAP; crying unconsolably about 3PM to between 7-8PM; began again around 9PM; MD was called; pt seen by MD 1130PM & MD gave med; advised to report as rxn; pt ok 24 hrs later;
Immediately after the injection (less than a minute), she was lightheaded & dizzy, very pale/grey, had ringing in the ears. She said she didn't feel good, then fainted/passed out. She began twitching. She was very clammy to the touch and she was shivering cold. The doctor was notified right away and I (her mother) was able to wake her, by then the doctor was in the room. The doctor had my daughter lay on her back with her knees to her chest for a few minutes. After a few minutes, her well child visit was able to be completed. After the exam, my daughter moved from the exam table to a chair to begin putting her clothing back on. She was able to get her pants on before she just sat there feeling nauseous along with lightheaded, dizzy, pale/grey, ringing in the ears for a second time. I was able to get her back to the exam table to lay down just before she again fainted. She again felt cold and clammy, she was shivering. The nurse happened to pop her head back in and quickly spoke to the doctor who advised my daughter to have a Popsicle. That was actually very helpful. My daughter had eaten breakfast, but that was about four hours prior to the vaccine. After all of this, she is mentally and physically exhausted. She is moving very slowly and deliberately. Every time she stands, it takes effort because of the dizziness/lightheaded feeling. It will be a few days before I can fully say that she's okay. As a parent, this is very traumatic. I made the choice to give her this vaccine, but will not be finishing the dosing.
No additional AE; administered MMR-II following the temperature excursion; This spontaneous report was received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided.  On 13-JUN-2023, the patient received improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 0.5 milliliter once (strength and dose not reported, lot # W035040, expiration date: 10-MAY-2024) for prophylaxis (product storage error). The vaccine was exposed to 48.8 degrees Fahrenheit for 0 hours 40 minutes 0 seconds. No additional adverse events were reported.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2306USA008250:
had a weird feeling in body; unpleasant medicinal taste that also was accompanied by a similar smell; unpleasant medicinal taste that also was accompanied by a similar smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 IMMUNISATION. The following information was reported: FEELING ABNORMAL (non-serious) with onset 20Feb2021, outcome "unknown", described as "had a weird feeling in body"; DYSGEUSIA (non-serious), PAROSMIA (non-serious) all with onset 20Feb2021, outcome "not recovered" and all described as "unpleasant medicinal taste that also was accompanied by a similar smell".  Additional information: On 20Feb2021, it was reported that patient received the 2nd COVID-19 vaccination and within 20 mins., had a weird feeling in body and the forward portion of tongue had a unpleasant medicinal taste that also was accompanied by a similar smell. Both these subsided in a few hours. Then, on 01Mar2021 it was back and has been with the patient (to varying degrees) up to this moment. The sensation was especially aggravated by toothpaste, cleaning product vapors and chewing tobacco, but was always lingering in the background.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within a couple of hours, I started have body aches and feeling feverish.  I missed two days of work.  Stayed in bed over 24-hours straight at one point.  Now, after 50+hours, I am just starting to feel better, but, am probably a day or so away from feeling "normal" again.
Patient had PFIZER COVID-19 vaccine, Dose 1 date: 01/7/2021, Dose 2 date: 01/28/2021, AND TESTED POSITIVE TO COVID
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Vomiting-Medium
Patient started itching and rash on neck, arm and head and moving towards torso the evening  of the shot and reported to me the following day.  She had already taken a zyrtec and was advised to take benadryl and pepcid and contact dr.  Patient was prescribed a medrol dose pak and changed 2 days later to prednisone as symptoms were still aggravated.  Symptoms are doing better, 1 week later
My daughter received 4 vaccines: DTaP, Hep B, pneumococcal, and polio. She ran a temperature around 100.4 for the first couple days. The morning of the reaction her fever started getting higher. I continued to give tylenol all day. By 7pm, I checked it and it was above 104. I gave more tylenol and within 5 minutes the siezure started. It lasted around 5 minutes. We called 911 and an ambulance was discharged to our home. She was taken to the hospital for tests. When we arrived they took her temperature at 104.4 and that was almost an hour after taking the tylenol.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored and administered beyond 30 days use by date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Anatomical location for vaccination given to patient was reported as deltoid. No concomitant medication information provided. Vaccine was stored in fridge longer than 30 days prior to administration. Date the vial was initially stored in refrigerator was 27-May-2022. The vial did not undergo any temperature excursion. Upon follow-up it was stated that reporter was still investigating exactly what happened, but after talking to the pharmacist at the clinic that day it sounds like the vaccine was placed in the refrigerator on 26-May-2022. Further it was reported that reporter was still trying to determine if any patients received a dose after the 30 days, but 30-Jun-2022 is the latest it could have happened. No treatment information provided. This case was linked to US-MODERNATX, INC.-MOD-2022-613777, US-MODERNATX, INC.-MOD-2022-613606, US-MODERNATX, INC.-MOD-2022-613604, US-MODERNATX, INC.-MOD-2022-613607, US-MODERNATX, INC.-MOD-2022-613782. Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2022: Follow up contains significant information: I-narrative updated. On 11-Jul-2022: Follow-up document received includes no new information was added. On 25-Jul-2022: Significant follow-up received: Patient details added, dosage details added, event onset date updated. Narrative supplement updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-613777:Master case US-MODERNATX, INC.-MOD-2022-613606:Master case US-MODERNATX, INC.-MOD-2022-613782:Master Case US-MODERNATX, INC.-MOD-2022-613607:Master case US-MODERNATX, INC.-MOD-2022-613604:Master Case
A couple of days later around 3/13/2021 I noticed that I was starting to scratch a lot my skin was so itchy. It was in different parts of my body. Then a couple days later around 3/20/2021 I started to break out it looked almost like pimples & it was at the places where I was always itchy. On 03/26/2021 I went to see my doctor by then my skin was already irritated from all the scratching. My doctor prescribed me Zyrtec. Till this day 04/14/2021 it has not gone away.
Flu shot and still got the flu / Suspected vaccination failure; Got the flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the flu shot and still got the flu. This case was considered as suspected vaccination failure as details regarding full vaccination schedule, laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The follow up was not required.
Patient received vaccine FLUVIRIN lot #97846P2A around 11am on 9/22/09. Around 10:30pm the patient was admitted to the hospital with a blood pressure of 80/50. Stayed about 24 hours then was released.   10/30/09 ICD9 codes and  Medical records received for DOS 9/23.  Ed visit DX: acute hypoxia, sever dyspnea, sinus tachycardia, hypokalemia, renal insufficiency, elevated D-dimer, r/o PE.  Patient developed weakness, nausea, vomiting x1, chills and joint pain s/p flu vaccine. Ibuprofen resolved. Later developed SOB and took nitro tab. BP dropped. 911 activated.  Presented w/pulse 119, BP 114/55. O2 sat 94% on room air and dropped to high 80's. Increased to 90 and 96 on O2. Accucheck 163.  Hypokalemia, renal insufficiency. Doppler results- thrombus L greater saphenous vein.  ICD9 Codes: 276.51, 458.9, 278.8, 401.9, 272.4, 530.81, 250.0, 799.02, 427.89, 593.9.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE PERIPHERAL NEUROPATHY 9/19/2022 --  RECURRENCE OF SAME SYMPTOMS
Extreme deltoid muscle pain front and rear deltoid muscle of injected left arm after painful injection.  Unknown if permanent injury at this time.  Limited arm mobility, pain at deltoid, to trapezius, front & back of neck, and tingling of arm to fingers identified to date.  Constant pain; interrupted sleep.
Blistering rash is present in the arms, back and neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (Blistering rash is present in the arms, back and neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized in December for a week before receiving 1 shot of the Moderna vaccine) in December 2020. Concurrent medical conditions included Fibromyalgia, Hypertension and Sleep disorder.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH VESICULAR (Blistering rash is present in the arms, back and neck). At the time of the report, RASH VESICULAR (Blistering rash is present in the arms, back and neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: higher (High) Higher.         Patient experienced blistering rash that she mentioned to be similar but of greater intensity as she experienced whit the first shoot of the vaccine.  No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.   This case was linked to MOD-2021-295770, MOD-2021-295772 (Patient Link).
Approximately 4 hours after vaccine administration, I developed hives on my right arm. Afterward my eyes began to itch. The inner corners of both eyes swelled, along with upper and lower eyelids.
States began having malaise, neck pain, feverish feeling. Symptoms continued 2 days later. States onset of symptoms was about 2-4 hrs after vaccine administered.
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) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported. On 21-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. concomitant medication of the patient was not reported. The vaccine was placed in refrigerator on 21-Sep-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. The patient did not experience any adverse event. No treatment information was provided by the reporter. This case was linked to MOD-2022-491837 (Patient Link).
Received flu shot on 9/16/2010. About 2 weeks later he reported his arm began to hurt right at the injection site and he started to have pain thru out the day and at nite. He went to doctor in Feb. Still has pain but seems to be getting better.
Patient came in for second dose of Pfizer Covid vaccine. Received Janssen Covid vaccine.
Information has been received from a nurse practitioner concerning a 25 year old female who in the summer of 2007, was vaccinated with a first dose of GARDASIL vaccine (lot number, injection site and route not reported). On 20-MAR-2008, the patient was vaccinated with a second dose of GARDASIL vaccine (lot number, injection site and route not reported). After receiving the 2 doses of vaccine, the patient developed a abnormal PAP smear. Unspecified medical attention was sought. Additional information has been requested.
Client had Nausea and dizziness for 3-4 days: then on the 3rd or  4th day client blacked out.  Client informed by her Physician that she had a concussion.  On 3-16-2021  on  a follow-up call it was reported by her son that she is now fine.
Erythemia Multiform Minor, etiology unclear but may be related to MMR and VARIVAX 2/10/2009.
Got flu shot and still got the flu a month later; Initial information received on 05-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves patient of unknown demographics who got flu shot (influenza vaccine) and still got the flu a month later.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient got flu shot and still got the flu a month later (influenza)  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local authorization. Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got flu shot and still got the flu a month later).  At time of reporting, the outcome was Unknown for the event
TC from mother stating that client has a large, red, hard area between the sites of the vaccines on (L) arm. Client has called PCP and awaiting call back. Cold compresses applied. Started 7/7/14 pm. Attempted 2 TC no responses.