chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Off label use: Vial given more than 6 hours after initially punctured; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use: Vial given more than 6 hours after initially punctured) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced OFF LABEL USE (Off label use: Vial given more than 6 hours after initially punctured). On 14-Mar-2021, OFF LABEL USE (Off label use: Vial given more than 6 hours after initially punctured) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist made error in writing the correct date. The vaccine that was administered to the patient was not expired and had not been punctured.  No concomitant medication use was provided by the reporter. Treatment of events was not reported.
I had the PNEUMOVAX 23 vaccine administered to me despite the fact that it is recommended for ages <2 or >50. I now suffer extreme pain and debilitating results, including severe trauma. The following are listed symptoms of the said vaccination: a decreased appetite a slightly raised temperature irritability redness and swelling at the site of the injection feeling sleepy or not sleeping well Serious side effects of the PCV vaccine are rare, and include: a high temperature, possibly leading to convulsions (febrile seizures) allergic reactions, such as an itchy skin rash. I have experienced all of these symptoms to a severe degree since having the vaccination administered to me against my own knowledge. I have never had pneumococcal disease so why this vaccine shows in my health records as administered to me is yet another example of how I have been the victim of EXTREME MALPRACTICE. I expect that this will be reviewed and corrected, along with ALL OTHER VACCINES BEING ADMINISTERED TO THE HUMAN BEINGS THAT MAKE UP OUR COUNTRY AND UNITED NATIONS. THIS IS AN EXTREME ABUSE OF POWER AND OBVIOUS DISCRIMINATION AS WELL AS AN ATTEMPT TO MASS GENOCIDE MINORITIES.
4 months after I received the J&J vaccine, I was diagnosed with a DVT in my left calf.
This spontaneous case was initially received on 02-OCT-2015. This case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 01-OCT-2015 - 01-OCT-2015, Batch no: not provided, Route of administration not provided, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-OCT-2015, after starting / treatment with AFLURIA the patient received a 1 ml dose of AFLURIA instead of 0.5 ml/Overdose (non serious, outcome: Unknown). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The reporter stated that all the patients seemed fine, and confirmed that none of the patients were pregnant. The 1 ml dose was due to clinical error, which did not confirm the dosage.
During my next menstrual cycle following the first shot, I had heavy bleeding and cramping which had still not stopped after starting my new pack of oral contraceptives. I usually do not bleed at all on my birth control.
PATIENT RECEIVED VACCINE AT APROX 12:30PM, LEFT THE IMMUNIZATION ROOM AND SAT DOWN IN THE WAITING ROOM. AROUND 12:38PM, THE PATIENT STARTED TO FEEL HOT, DIZZY, AND SOME TIGHTNESS. WE CHECKED ON PATIENT EVERY FEW MINUTES TO MAKE SURE SHE WAS OK, PROVIDED A COLD COMPRESS. CALLED EMS AROUND 12:53PM WHEN SHE STARTED TO LOSE RESPONSIVENESS. HUSBAND WAS WITH PATIENT DURING THE ENTIRE VISIT. EMS ARRIVED AND TOOK PATIENT TO THE HOSPITAL.
Weeping rash on face, erupts, doesn't heal , continues to break open . Started about 1 week after vaccine
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: elevated (High) ELEVATED.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO Concomitant medication was reported   This case was linked to MOD-2021-339433 (Patient Link).
aseptic meningitis - headaches, stiff neck, fatigue, right ear pain, dizzy
Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 20 years old female patient who experienced broke out in hives, had red welts that had increased on her back and were spreading up to her face, itching while she received vaccine ADACEL. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported broke out in hives, had red welts that had increased on her back and were spreading up to her face, itching and a pregnant female received the ADACEL vaccine occurred at unknown gestation period and the patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 30 weeks and 2 days of pregnancy, during third pregnancy trimester for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The date of last menstrual period was reported as 20-Aug-2018. The estimated due date is 27-May-2019. The patient had no previous pregnancy. On 28-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6128AA, expiration date: 20-Nov-2020) via intramuscular in the right deltoid. On an unknown date, the patient developed a non-serious broke out in hives, had red welts that had increased on her back and were spreading up to her face, itching 2 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was also a case of exposure during pregnancy. Other relevant tests included No Lab data was reported. Final diagnosis was a pregnant female received the ADACEL vaccine, itching and broke out in hives, had red welts that had increased on her back and were spreading up to her face. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for broke out in hives, had red welts that had increased on her back and for itching. Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as Unknown and fetal outcome was reported as Unknown. Documents held by the sender: none.
Approximately 8-10 hours after vaccine given, patient became ill: nausea/vomiting/diarrhea - duration 24 hours. Unsure if vaccine related or just unrelated illness.
sore arm, fever 100.5 degrees, fatigue.  Took Tylenol.  Symptoms gone after second day
1MAR98 pt came to office w/rash on arms, back & legs;also c/o h/a;dx varicella;
Pt was given flu shot in (R) deltoid, and immediately his muscles became tense and he felt he could barely breathe, he denies any seizure activity. He has had previous flu shots without any problems. Pt taken to Emergency Room. VS = BP 132/100 - P=132 - R=20 - T=99; HT=70"; WT=222; O2 sat=98%.
The patient was administered one dose of Pfizer that had not been diluted.  So far she has not reported any adverse effects.
1 week after second dose I developed a blood clot behind my left knee, in hospital for 9 days; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 09:00 (Lot Number: EN6201) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, controlled from an unknown date and unknown if ongoing and penicillin allergy from an unknown date and unknown if ongoing. The patient previously had first dose of BNT162B2 in the left arm (lot number: EL3244) on 20Jan2021 for COVID-19 immunization. Concomitant medications included apixaban (ELIQUIS), metformin, caredevil and fish oil; all taken for an unspecified indication, start and stop date were not reported. On 24Feb2021 12:00 PM, it was reported that the patient 1 week after second dose, developed a blood clot behind left knee, in hospital for 9 days that also resulted in emergency room/department or urgent care. The event was treated with blood thinners. The patient had no COVID prior to vaccination and has not tested for COVID post vaccination. The outcome of the event was recovering.
I received my second Pfizer booster for COVID-19 on 5/2/2022. On the morning of 7/14/2022, I got up to do my morning walking routine. The temperature here has been in the triple digits, and I felt hot, but I sort of assumed it was because of my walking in the hot weather. When I got back home from walking, I took my temperature, which was 101. I just took some Tylenol and didn't think much about it, because I thought I was just overheated. A short time later, though, a friend of mine called to tell me that she had tested positive for COVID-19. I had seen her two days prior, so I began to wonder if I had COVID-19, also. I then took a home test for COVID-19, and the result was positive. Since my husband also took a test and got a negative result, I wondered if I had a false positive . Later that day, I took another home test and got another positive result. I called the telenurse number provided by my insurance company, and the nurse told me that I had COVID-19 and that I needed to contact my PCP and ask him about getting a prescription for an antiviral. She then gave me isolation guidelines. On 7/15/2022, I called my PCP and explained the situation. At that point, the only symptom I had had was a fever, and when I told them this, they said that it was probably too late to take an antiviral. They just advised me to take OTC pain reliever as needed and to stay isolated. If my symptoms worsened, I was to immediately call them. During my isolation, my only symptoms were fever and fatigue; overall, my symptoms were very mild and I didn't feel bad. I took another home test on 7/18/2022 and got another positive result. I continued isolating and took another test on 7/20/2022 and got a negative result. Even though I had finally gotten a negative result, I decided to isolate a couple of more days just to be sure I was safe. I then took another home test on 7/23/2022, and I got another negative result. After that, I felt that it was safe for me to leave my home if I wished.
This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency time 1 total was administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-AUG-2021, the patient had confirmed immunological vaccination failure. Laboratory data included: COVID-19 antibody test (NR: not provided) negative. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210843278. This report was associated with product quality complaint 90000190438.; Sender's Comments: V0: 20210853492-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
5 mins after her first dose of covid-19 vaccine pt began to experience shortness of breath, laid down, clinician notified and responded immediately, epi 0.3 , benadryl 25mg po qty 2, solumedrol 125mg im administered and 911 called. transported with 0 signs of distress, clear lungs.
-chest pain under left armpit immediately after shot 2. -elevated heart rate and BP after shot 1 proceeding to get quite high to present day (148/90 at some readings).  -pins and needles (tingling) in fingers starting around 6/11/2021 developing into full arm and leg tingling (hands and feet included) -chest pain under left armpit recurring as of 06/20/2021
Patient had pain upon having her injection placed, extreme soreness for the next 2 days, and then extreme pain with movement including internal and external rotation of her shoulder, abduction, flexion, extension. Some numbness and tingling in her 4 fingers not including her thumb.
This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (have no energy at all), FEELING ABNORMAL (I feel out of it/felt out of it all day), NAUSEA (nausea) and PYREXIA (a little fever) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 082B22A, 068H21A, 012M20A and 013L20A) for COVID-19 vaccination. It was unknown if the patient had any allergies to medications, food, and other products.  It was unknown if the patient ever had COVID positive test or diagnosis.  It was unknown if patient had medical history relating to mentioned Adverse event and both Acute and Chronic illnesses at the time of vaccination. It was unknown if any other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2022, the patient experienced ASTHENIA (have no energy at all), FEELING ABNORMAL (I feel out of it/felt out of it all day), NAUSEA (nausea) and PYREXIA (a little fever). At the time of the report, ASTHENIA (have no energy at all) outcome was unknown and FEELING ABNORMAL (I feel out of it/felt out of it all day), NAUSEA (nausea) and PYREXIA (a little fever) had not resolved. No concomitant medications were reported. On 05-Aug-2022 morning, the patient felt out of it and had felt out of it all day. The patient had no energy at all and had nausea and a little fever. It was reported that the patient didn't experience any side effects after first, second and first booster dose. It was unknown if the patient had experienced similar adverse events in the past. The adverse events didn't cause the patient to seek medical care. Reportedly, the symptoms after the second booster dose worsened. No treatment information was provided by the reporter.
Client received immunization in the morning and states she started feeling systemic symptoms by that evening. She mentioned her symptoms were headaches, elevated temperature of about 100F, muscle aches, malaise, loss of appetite, nausea. States all symptoms "hit all at once." Symptoms continued for 2 days and today she feels better. States symptoms felt worse in the evenings. States symptoms were not those that she usually has felt after vaccinations in the past where she "could go about [her] day," but were intense systemic symptoms. Describes as feeling "significantly sick." Client used anti-inflammatory medications for symptoms. Did not visit a provider.
Information has been received from an office manager refers to a 23 year old female patient. On 20-FEB-2015 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot# not reported). 06-MAR-2015 the patient was vaccinated with the second dose of GARDASIL (lot # K008931, dose and route not reported) which was only 2 weeks after she received her first dose. No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Benign positional vertigo and tinnitus that started the evening of  03/13/21.
Approximately 22 hrs after receiving shingles injection, I noticed a red rash developing on the right forehead above right eyebrow. After inspection of the area I noticed other small red pimple like spots on right temple and into hairline. I immediately got online and researched Zostra. It said to contact doctor immediately if rash was anywhere near the eyes. So I called Primary Care, Dr. wanted to see me immediately. I went in, she said yes its shingles that I was contagious, told me to stay away from work for one week. She prescribed Valtrex and said it was good that I came in so early. She also took blood and swabbed the rash site.
Sleepiness, Soreness and Achy, Covid Arm, Chills lasting five hours, nausea.
Fever Severe shoulder pain, limited mobility, arm weakness Both started once I woke up on Saturday. Could not sleep from the shoulder pain and it is still extremely painful
6/12/2014- 5:30 AM. Woke up to arm and shoulder soreness. Progressively got worse through out the day. Extreme painful to lift arm. 6/13/2014 - 5:30 AM. Woke up to same symptoms as above as well as swelling under the arm and upper arm to the elbow. Glands under the arm swollen and very painful. 6/13/2014 - 11:15 AM drs office returned call. Said normal reactions. Watch for severe redness which would indicate an infection and take ibuprofen.
"I" had very bad fever; "I" had very bad fever and body aches the next two days.; few weeks later "my" period came a week early; "I" had inflammation in lymph nodes on opposite side of shot.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Feb2021 at 15:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 10Feb2021, the patient had very bad fever and body aches the next two days. On an unknown date in 2021, a few weeks later the patient's period came a week early and had inflammation in lymph nodes on opposite side of shot. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very bad fever and body aches was resolved on an unknown date in Apr2021, while the clinical outcome of the events period came a week early and inflammation in lymph nodes on opposite side of shot was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Crummy; Listless; Discombabulated; fever blisters; Fuzzy headed/could not think straight; Bad headache; Fever (T100.8F); Hurt all over as if hit by a truck; Felt tired; Little sore at the injection site; Dizzy/head spinning/equilibrium problem; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/head spinning/equilibrium problem), FEELING ABNORMAL (Fuzzy headed/could not think straight), CONFUSIONAL STATE (Discombabulated), ORAL HERPES (fever blisters) and MALAISE (Crummy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizzy/head spinning/equilibrium problem) and VACCINATION SITE PAIN (Little sore at the injection site). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Fuzzy headed/could not think straight), HEADACHE (Bad headache), PYREXIA (Fever (T100.8F)), MYALGIA (Hurt all over as if hit by a truck) and FATIGUE (Felt tired). On 12-Mar-2021, the patient experienced ORAL HERPES (fever blisters). On 13-Mar-2021, the patient experienced CONFUSIONAL STATE (Discombabulated). On 16-Mar-2021, the patient experienced MALAISE (Crummy) and LISTLESS (Listless). On 12-Mar-2021, PYREXIA (Fever (T100.8F)) had resolved. On 22-Mar-2021, DIZZINESS (Dizzy/head spinning/equilibrium problem) had resolved. At the time of the report, FEELING ABNORMAL (Fuzzy headed/could not think straight), CONFUSIONAL STATE (Discombabulated), ORAL HERPES (fever blisters), MALAISE (Crummy), LISTLESS (Listless), MYALGIA (Hurt all over as if hit by a truck), FATIGUE (Felt tired) and VACCINATION SITE PAIN (Little sore at the injection site) outcome was unknown and HEADACHE (Bad headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 100.8 (High) degree F.         No relevant concomitant medications were reported. Treatment information included paracetamol. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-054451 (E2B Linked Report).; Sender's Comments:  MOD-2021-054451:First dose
This spontaneous report was received from a female patient of unknown age who is also a Registered Nurse. On 09-OCT-2013, the patient received an expired dose of MMR II with an expiration date of 26-AUG-2013 (lot# not reported). No adverse effect was reported. Additional information is not expected.