chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight fever; body aches; soreness of the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever), MYALGIA (body aches) and INJECTION SITE PAIN (soreness of the arm of the injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Non-Hodgkin's lymphoma (spleen and gallbladder removed in 2000), Chemotherapy, Monoclonal antibody unconjugated therapy, Nerve injury (Patient also has a pudendal nerve injury that causes them a lot of pain specially when sitting) and Kidney stones (that need to be removed every few years).   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced PYREXIA (slight fever), MYALGIA (body aches) and INJECTION SITE PAIN (soreness of the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PYREXIA (slight fever), MYALGIA (body aches) and INJECTION SITE PAIN (soreness of the arm of the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medication information was not provided.
I had the typical flu like symptoms starting the following day. I had that on injection two as well. Towards the end of the second day and increasing through the third day I developed moderate abdominal pain and distention, mostly on the right side. I haven't gone to be examined yet. I'm waiting to see if it starts to get better or continues to worsen.
In error: Administered 0.1 ml Td ID instead of PPD. Left forearm 50 mm 30 mm erythema with 10 mm induration. No reported pain.
experience rash on the arm; experience  itchiness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (experience rash on the arm) and VACCINATION SITE PRURITUS (experience  itchiness on the arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (experience rash on the arm) and VACCINATION SITE PRURITUS (experience  itchiness on the arm). The patient was treated with CORTISONE at a dose of unknown. At the time of the report, VACCINATION SITE RASH (experience rash on the arm) and VACCINATION SITE PRURITUS (experience  itchiness on the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
10 minutes after receiving vaccine felt jaw pain and tightening to the point patient could not open her mouth.  At that time,  patient took liquid Benadryl, one teaspoon .  Slowly symptoms began to subside.  Patient began to manually open and close her jaw.
my hole body was aching; having like nauseas; headache; had a lot of fatigue; started shaking; fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (started shaking), PYREXIA (fever), MYALGIA (my hole body was aching), NAUSEA (having like nauseas) and HEADACHE (headache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced TREMOR (started shaking) and PYREXIA (fever). On 12-May-2021, the patient experienced MYALGIA (my hole body was aching), NAUSEA (having like nauseas), HEADACHE (headache) and FATIGUE (had a lot of fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 13-May-2021, TREMOR (started shaking), PYREXIA (fever), MYALGIA (my hole body was aching), NAUSEA (having like nauseas), HEADACHE (headache) and FATIGUE (had a lot of fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Vitamin supplements for an unknown indication. Patient reported that he felt like when he had COVID.
I had a headache all day during the day after the vaccination.  Nothing too horrible, maybe a 5 out of 10 at the most.  I took 3 extra strength Tylenol about every 4 hours to help.
developed "flu-like" symptom."fo. u few days post vaccination; sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The age at vaccination was not reported. A year before the time of reporting, the patient received a dose of Shingrix. The patient experienced sore arm and in addition he developed flu like symptoms for a few days post vaccination. The reporter declined to provide the physician demographics. No additional adverse event information was given. This case has been linked to US2019AMR222413 (wife's case), reported by the same reporter.
high blood pressure; light headache; redness at the injection site; Knees hurt badly; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), HEADACHE (light headache), VACCINATION SITE ERYTHEMA (redness at the injection site) and ARTHRALGIA (Knees hurt badly) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Very bad arthritis), Fibromyalgia, Sulfonamide allergy, Iodine allergy, Latex allergy and Shellfish allergy. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced HYPERTENSION (high blood pressure), HEADACHE (light headache), VACCINATION SITE ERYTHEMA (redness at the injection site) and ARTHRALGIA (Knees hurt badly). At the time of the report, HYPERTENSION (high blood pressure), HEADACHE (light headache), VACCINATION SITE ERYTHEMA (redness at the injection site) and ARTHRALGIA (Knees hurt badly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient also experienced "positive " side effects. 1 to 2 days after the first and second doses, patient noticed that her arthritis got better. Her hands were 25-35% less swollen, less crampy and less painful. She said that her hands are usually twisted up and she can barely use them. Her nose is less stuffy as well. No treatment medications were reported   This case was linked to MOD21-072837 (E2B Linked Report). This case was linked to MOD-2021-092797 (Patient Link).; Sender's Comments:  MOD21-072837:Crosse linked
Information has been received from a licensed practical nurse concerning a 5 year old black male who on 05-MAR-2003 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 643586/0802M). On 08-MAR-2007 the patient experienced varicella. On 13-MAR-2007, the patient recovered from varicella. No further information is available.
SYNCOPAL EPISODE AFTER TAKING BANDAID OFF OF LEGS WHERE SHOTS WERE GIVEN. SEEN IN ER AND DIAGNOSED WITH UTI AND VASOVAGAL SYNCOPE.
Fever, chills, loss of appetite, lethargy, headache, body ache, swollen lymph nodes (right underarm), loss of appetite, rash
2 weeks and 2 days following the vaccine I started having heart palpitations,  chest pain, fatigue, and shortness of breath.   I went to the ER where I was found to have an abnormal EKG.  I?ve been followed by a cardiologist and am taking metoprolol.  He did an echocardiogram and a holter monitor and told me that I have myocarditis.
Per Mom, immediately after vaccine he began experiencing headache. On Monday he began experiencing right sided facial drooping that has progressed over last 2 days to abnormal/ drooping smile, inability to close right eyelid. Pt denies any pain. Speech and vision WNL. Pt states he is numb in certain spots on face. Denies fever/chills, URI symptoms, N/V/D, abdominal pain, rash, decreased urination, paralysis of upper/lower extremities. This has never happened to pt before. No known sick contacts. No known tick bites.
Covid 19 positive 08/25/21 with 08/24/21 onset
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with PNEUMOVAX23 (lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient had an allergic reaction to PNEUMOVAX23. The outcome of adverse event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
positive Covid test; positive Covid test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-month-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 03Sep2021 as dose 3 (booster), single (Lot number: Fc3184) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: other medical history: Lupus; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure; "obese" (unspecified if ongoing), notes: other medical history:obese. The patient's concomitant medications were not reported. Past drug history included: Known allergies: codeine (iv), reaction(s): "Known allergies: Codeine (IV)", notes: Known allergies: Codeine (IV). The following information was reported: VACCINATION FAILURE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovering" and all described as "positive Covid test". Serious: No, Seriousness criteria-results in death: No, Seriousness criteria-life threatening: No, Seriousness criteria- caused/prolonged hospitalization: No, Seriousness criteria- disabling/incapacitating: No, Seriousness criteria-congenital anomaly/birth defect: No, Other medication in 2 weeks was reported as Yes. Other medication details: Other medication in 2 weeks product=Metoprolol Tartrate, Valsartan, Methotrexate, Hydroxychloroquine, Folic Acid, Pantoprazole, Montelukast, Alloporinal, D-3, B-12. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow up attempts are possible. No further information is expected.
At work on 12/31/04, raspy voice. Then tongue swelling then starting to go down. Could not breathe. Recurred in ER. ER doctor gave epinephrine. Started having hives over my entire body. Came home from hospital. 2 more ER visits. Doctoring with family doctor. I still have hives. I'm not working. Follow up 03/01/05: The patient had an acute reaction the day after vaccination; angioedema, shortness of breath, dysphagia and anxiety. She wa treated with Benadryl, Epinepherin, Tagament and Solumedrol. An allergist diagnosed as systemic anaphylaxis to an unknown substance. Patient had no known allergies prior to vaccination. Discharge summarty information states drooling. Medical Record received on 3/08/2005 states dysphagia.
swelling around eyes; redness around eyes; eye red; This case was reported by a consumer and described the occurrence of periocular swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 3 days after receiving Shingrix, the patient experienced periocular swelling, erythema periorbital and eye red. On an unknown date, the outcome of the periocular swelling, erythema periorbital and eye red were not recovered/not resolved.   It was unknown if the reporter considered the periocular swelling, erythema periorbital and eye red to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient went to primary care doctor, Ears, nose and throat doctor, eye doctor and allergist and none of the them know why this occurred three days after the patient had the Shingnx shingles shot.
Hives 4 hours post-vaccine. Improved with diphenhydramine. Resolved by the following day
Within 1 hour of receiving the injection, the patient complained of painful arm.  Within a few hours, the arm was swollen, more painful and patient complained of sinus congestion, then slurred speech.  Mom gave patient BENADRYL, went to ER for a "sense of her throat swelling".
PT HAD REDNESS AND SWELLING AT INJECTION SITE FOLLOWED BY A GENERALIZED MACULOPAPULAR RASH.
At approximately 7pm, June began screaming and crying unconsolably, which is unlike her. It was noticed that she was favoring her leg by, when bending her legs while screaming, she would very quickly correct her left leg and straighten it back out while keeping her right leg (unvaccinated leg) bent. Upon removal of her pants, her entire leg was extremely red and swollen, all the way down to her foot. We had to take her sock off as it was cutting into her leg. The screaming and crying went on for over an hour before she finally calmed down and her leg was back to normal within 2 hours.
The employee was vaccinated with her first dose on 12/29/20 in the am. By the evening she had a headache. By Wednesday(12/30/20) morning, the headache was severe and lasted until Saturday(1/2/21) morning. Friday(1/1/21) the headache was so severe she almost went to the emergency room. She also reported that Friday she vomited frequently. That Saturday, she noticed the whole right side of her face was numb and tingling, was uncomfortable but not painful, "like when your foot falls asleep." As of Sunday(1/3/21) morning, all the symptoms had resolved all together she believes.
Sore arm for two days after injection.  Then ok.  Days later itchy rash and lump appeared at injection site.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received TWINRIX for prophylaxis. Concurrent medical conditions included allergy (gluten and wheat). On an unknown date, the patient received TWINRIX at an unknown dose. On an unknown date, unknown after receiving TWINRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to TWINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received TWINRIX vaccine away from home. The patient experienced bad reaction. Due to the patient's reaction, he thought the vaccine might include some gluten or wheat to which he was intolerant. The patient did not wish to provide additional information. The phone number to GSK (GlaxoSmithKline) was provided.
01/15/23 presents to ED for "SOB". PMHx of "CKD stage III, PE on Eliquis (December 2022), chronic hypoxic respiratory failure status post RSV with superimposed MRSA pneumonia (November 2022), asthma, bronchiectasis, IgA deficiency, CVA with PFO, HFpEF, COVID-19 pneumonia"
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date in November 2015, the patient was vaccinated with first dose of GARDASIL (dose, frequency and route were not reported) and the second dose was vaccinated on an unknown date in June 2015 (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
2/21/18 Went to enter vaccination into data system after it had been given earlier (2/19/18) and realized an expired dose (1/30/18) had been given to resident by LPN. Resident has shown no S/S of an adverse reaction to having received the expired vaccine. Both the CDC and Sanofi (manufacturer) stated that he wouldn't have any more of a reaction to the expired dose than one that would be non-expired; but that this dose would be considered - not effective and would need to be repeated later on. Dr. (campus PCP) does not want him vaccinated at this point. Will review his chart within the year, to determine when to re-vaccinate patient. Resident had the flu 2/4/18 and was treated w/TAMIFLU, SUDAFED and TYLENOL x 5 days. He was symptom free at time of vaccination when his yearly physical was completed on 2/13/2018.
Abdominal cramp/diarrhea on day of injection and 2 days later 4/17/21, 4/18/21, 4/19/21 Headache and feeling of weakness and foggy head day after injection 41/18/21 subsided by third morning 4/19/21.
Woke up Saturday (7/23/11) & injection sites were red with knots, by Sunday her anterior thighs were completely red with big knots. The highest her temp. got was less than 101 degrees. Mom took her to urgent care center & pt. seen by a dr. & said she got an allergic reaction. Red swollen sites were (L) upper thigh PREVNAR, (L) lower thigh Hep A, (R) upper thigh DTaP.
BLOOD CLOT; This spontaneous report received from a consumer via media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot. The reporter stated that, "I finally know of someone who died of a blood clot from the vaccine". It was unspecified if an autopsy was performed. On an unspecified date, the patient died from blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20220547817-covid-19 vaccine ad26.cov2.s-Blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
Increased heart rate of 150 beats per minute started at 8:30 pm the night of vaccine dose 1.
SEVERE UNCONTROLLABLE DIARRHEA; A spontaneous case report was received from a nurse on 11-Nov-2019 for two consumer. Additional information was received on 13-Nov-2019.  Based on the information obtained from the nurse, two individual case safety report PVX201911-000856 (PVX2019-2787; female) and PVX201911-000857 (PVX2019-2788; male) were created and cross-linked in the database.  The case report (PVX2019-2787) described a 65-year-old elderly female consumer who developed severe uncontrollable diarrhea (PT: Diarrhoea), while being on oral Vivotif (took one capsule every other day) for typhoid fever prophylaxis.   Case report: The consumer took Vivotif doses on 16-Oct-2019, 18-Oct-2019, 20-Oct-2019, and 22-Oct-2019. It was reported that the consumer was still complaining severe uncontrollable diarrhea. As of 11-nov-2019, the event was ongoing which was interfering with her daily life.  Consumer's medical history included celiac disease.  Past medication included Yellow fever vaccine and a Tetanus vaccine, which were taken on 09-Oct-2019.  Action taken with Vivotif with respect to reported event was unknown.  The consumer had not recovered from the reported event.  Company's Comment: In this case, it was reported that a female consumer developed sever uncontrollable diarrhea following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The consumer's medical history of celiac disease is a significant confounding factor in the case.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer developed sever uncontrollable diarrhea following administration of  of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The consumer's medical history of celiac disease is a significant confounding factor in the case. US-PaxVax Berna GmbH-PVX201911-000857:
heart Attack symptoms - chest pain, loss of feeling in arm and severe pain running through arm EKG revelaled alleged heart attack  though  Cardiac catheterization (at emergency room) checked for heart attack revealing unobstructed arteries Misshapen heart, high troponin levels, loss of ventricle function diagnosed as Taskotsubo Cardiomyopathy
Rash at posterior neck, hairline, arms, legs, torso; started approx 6 hrs after received vaccine and slowly worsened overnight; when seen in office next morning was given Kenalog 40 mg IM and advised to start Zyrtec qd.
Face, hand, feet swelling, face and chest color reddish flushed, diarrhea, nausea, mild dizziness and a spacey feeling. No issues breathing though.  Started about 35 minutes after vaccination I was over come with diarrhea on drive home from vaccine facility so stopped used restroom, continued drive home. Didnt notice how swollen I was until I arrived home total time about an hour later. At initial injection time felt heat rise across chest and into face. No symptoms progressed further just new ones such as fatigue, night sweats the first night, feeling pain at injection site a couple days later. Blood pressure and oxygen levels normal, pulse raised to 125 after injection then subsided by next day.
Pt developed a fever to T maximum rectally to 104.2 approx 15 hrs S/P Prevnar injection. Fever self-resolved after 2 days.
He had a local reaction 7.5 cm x 6  cm with severe induration, pain , no generalized reaction
Patient presents to pharmacy with complaint of rash where Prevnar 13 immunization was administered. Rash is not itchy, but is red and warm to the touch. Rash is approximately palm-sized. I advise the patient to take Benadryl tablets to help stop the allergic reaction and to seek immediate medical attention if she experiences trouble breathing or facial swelling.