chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash/hives over entire body within 60 min of injection. Patient returned to office; was given 125mg IM of Solumedrol and prescription for Clarinex. This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a nurse, concerning a male who on sometime last week (approximately 18-AUG-2008) was vaccinated with ZOSTAVAX (Merck). The patient sought medical attention. There was no product quality complaint. Follow-up information has been received from a registered nurse, concerning a 60 year old male patient with hyperlipidemia, hypertension, depression, anxiety, rash while on therapy with LEVAQUIN and allergy to grass, pollen and wheat, who on 18-AUG-2008 was vaccinated with 1 vial/ single dose of ZOSTAVAX (Merck) (Lot #658084/0888U) in left arm. Concomitant therapies included CYMBALTA, ADVICOR, UNIVASC, vitamins (unspecified) and chondroitin sulfate sodium (+) glucosamine sulfate. On 18-AUG-2008, the patient experienced generalized rash, hives entire body and general malaise. The patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. Additional information is expected.
Mild headache, tired, itchy eyes and face, sneezing, congestion, heart racing
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Pt describes painless itchless rash that "moves around" arm and has appeared and disappeared in multiple locations.  one rash appeared on torso with mild itching.  unresolved 7 days post vaccine.  counseled to seek provider care if rash lasts for two weeks from vaccination or gets worse, and seek PCP advice on receiving second shingrix vaccination.  No breathing or facial swelling issues.
Information has been received from a registered nurse concerning a female patient who on 27-MAY-2011 was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). The registered nurse reported that on 27-MAY-2011 the patient experienced fainting and seizures after receiving GARDASIL immunization. At the time of the report, the patient's outcome was unknown. Upon internal review, seizures were considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Facial redness without hives, dyspnea or dysphasia 15 minutes after vaccination.  Treated with OTC antihistamines.
Patient claims that 48 hrs after flu shot she began to experience vertigo-like symptoms. Dizziness, light-headedness, ringing in ears, loss of balance. No treatment mentioned in phone conversation. Said symptoms are worsening.
Cough and severe nasal congestion, Ear canal congestion, Chest congestion 2 days later. Coughing was deeper as the day pass, (7/27/2021, 8/4/2021, 8/17/2021) altitude dizziness w/BP drop, Inhaler Albuterol, Breztri, and Benzonatate.
1)Pain, redness, swelling at injection site. 2)Dermatomal rash on L supraclavicular area and L axilla, originating from midline/neck. 3)Flu-like symptoms x 3 days.
Extremely cold, headache, nausea and vomiting, diarrhea, weakness all through the night, took temp several times was in 96 range, chills, called Urgent Care but did not seek treatment, symptoms continued to Monday and then felt weakness and had loose stools for a week ending 11/10/14.
Headache, congestion and cough that was diagnosed as COVID. It has been ongoing for more than two weeks.
pt recv vax 1996 & titers drawn 6mo p/vax were negative for Heaptitis A antibodies;this situation is still being eval & further vax has not been discontinued;
Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 62 year old patient, who on 25-APR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot # 670551/0738AA, Expiration date 17-MAY-2013) (dose and route not reported), rather than ZOSTAVAX (Merck). No adverse effects reported. Follow-up has been received from a Licensed Practical Nurse (L.P.N.) provided the patient's gender as female. Reported did not remember the patient's name or date of birth. Also she stated that the patient did not receive any other vaccinations at the same time as VARIVAX (Merck). The L.P.N. reported that the patient was fine and there was no adverse event. She mentioned that she previously contacted the company to inquire whether the patient should receive the ZOSTAVAX (Merck) in addition to the VARIVAX (Merck). Additional information is not expected.
This Pfizer shot was my booster, after receiving the Janssen vaccine in March 2021.  I had no adverse reactions to Jansseen but with this booster my left underarm has swollen, it is somewhat painful (not extreme) but very tender to touch. Basically, I have a small ball under my left arm. The injection site is a little tender but the real reaction seems to be underneath the arm/armpit. My entire left arm - at times, not consistently -feels a little numb. I received the booster shot two days ago and the symptoms are still with me.
Pain in my arm, nausea, vomiting, and diarrhea. The diarrhea will not go away. I have a UTI and I have never had one before and it was bloody.  I was at the hospital with my sister who was having surgery and waiting for her to get out. I kept having to go to the bathroom. I have had a hysterectomy and I saw I'm bleeding and it is increasing to quite a bit of bleeding. I called my Primary Care Physician and they told me to go to Urgent Care.  I couldn't leave right away. I have night sweats and chills (have been freezing the whole time) and that is still occurring. Today is the first time I could leave the house and drive. I ate solid food yesterday, but I haven't eaten - just been drinking electrolytes. I have not been able to eat today though - vomited it up. I tried crackers but I couldn't.  I have had abdominal pain and stomach cramping. I am having leg spasms and my joints were hurting - that seems minor compared to everything else. It just felt like my whole body seemed to be shutting down on me. I still have diarrhea and I still have sweats and vomiting it up too. Was prescribed Macrobid and Peridium.  I had a flu shot at the same time and in the same arm. I don't know the exact brand of it.
My period lasts for 5 WEEKS now.  It's been late and long for the first cycle after each vaccine.  However it was weeks longer after the third and now I'm on my second cycle and I've been bleeding for 4 weeks.
Felling the same symptoms; Fever; Diarrhea; Bellyache; Feeling bad; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 21-May-2021.    This spontaneous case was reported by an other and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Bellyache), PYREXIA (Fever), FEELING ABNORMAL (Feeling bad) and CONDITION AGGRAVATED (Felling the same symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Bellyache), PYREXIA (Fever) and FEELING ABNORMAL (Feeling bad). On 20-May-2021, the patient experienced CONDITION AGGRAVATED (Felling the same symptoms). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Bellyache), PYREXIA (Fever), FEELING ABNORMAL (Feeling bad) and CONDITION AGGRAVATED (Felling the same symptoms) outcome was unknown.
The pt experienced warmth, redness and itching at injection site. Redness was 3-4 inches across. Swelling that lasted 2 days.
Pt is a 55 yo F with no previously documented encounters. On 04/07/21, pt presented to clinic for immunization. At 0819, pt was administered COVID-19 J&J (Janssen) Vaccine 0.5 mL in left deltoid (Lot #043A21A; exp: 6/21/2021; NDC #59676-580-15). After injection, pt became lightheaded and reported throat soreness and a "feeling like her vision was closing in." Vitals assessed with BP: 61/39. Pt was placed in reclined position and feet were elevated. On exam, pt denied any itching or hives, denied any previous allergic reactions or anaphylactic reactions, but reported having lightheadedness after a prior injection. Pt reported feeling well prior to arrival, but acknowledged not eating much and anxiety about injection. Pt was monitored for 45 minutes with BP recovering to 124/82. Pt was discharged in stable condition and escorted to her vehicle by staff.
This spontaneous report as received from a certified medical assistant refers to two patients of unknown age and gender. On 29-MAY-2014, the patients were vaccinated with PROQUAD (Merck) lot # H020851, expiration date 26-MAY-2014, intramuscular. On 29-MAY-2014, 2 patients received PROQUAD (Merck) via the intramuscular route. There were no known adverse effects. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Follow-up received from the other health professional, provided information about 52 months female patient, who on 29-MAY-2014 at approximately 04:00PM was vaccinated with the first dose of PROQUAD (Merck) lot # H020851 in the left arm. None other concomitant medications was reported. This is one of several reports received from the same source. Additional information is not expected, questionnaire was received.
Information has been received from a registered nurse concerning a 41 year old female with allergies to diazepam and furosemide who on 25-OCT-2006 was vaccinated intramuscularly in the right deltoid with a dose of Pneumovax 23 (lot 651321/1036F). The patient was concomitantly vaccinated with influenza virus vaccine (unspecified) in the left deltoid. On 26-OCT-2006, the patient's arm was sore at site. The arm swelled in deltoid area, became red in deltoid area and under arm into the breast area. The area throbbed with pain for one week. The patient reported that it felt like a brick on her chest. Her eyes were watering and crusty for 3 days, and her nose ran. The patient was treated with diphenhydramine HCl. Subsequently, the patient recovered in one week. Additional information is not expected.
7/23: Swollen, red, itches, shoulder-softball size, not all the way around arm, warm to touch. 7/22: fever <101, told to use ibuprofen.
Experienced chills and tactile fever 16 hours after injection and fatigue x 24 hours.
itching at the injection site; swelling that is a bit raised at the injection site; redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included DEXTROAMPHETAMINE SULFATE for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site) was resolving. Not Provided      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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Itchy rash on chest and stomach, spreads to arms turning a purplish color.
Patient states she felt really dizzy and light-headed and felt a sharp pain in her lower back. We sat her down on a chair and gave her some water. We then checked her blood pressure and it was a normal reading. After a few minutes (about 5 or so minutes), patient states she felt better, not as dizzy and her back pain had subsided. She did not want us to call anyone for her. We called patient at her home about 30 minutes later and she said she felt better but her head still felt a little foggy and light headed.
Had vaccine and got shingles/ suspected vaccination failure; mild shingles on head and forehead; So painful; Felt like sunburn; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, pain and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comments: Reporter's Comments: This case was received from consumer via interactive digital media. The patient had the vaccine and still got a mild form of shingles a few weeks back on his/her head and forehead. It was so painful and started like had a sunburn which he/she did not but felt that way. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
injection site redness; injection site hardness almost down to elbow; injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site induration and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site pain were recovered/resolved.   The reporter considered the injection site erythema, injection site induration and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the unknown deltoid. The patient stated that, 1st dose was given on 11th April 2019 or 12th April 2019, so entered as 11th April 2019. The patient stated that, within 24 hours of injection, the injection site became red, sore and hard almost down to her elbow. The patient stated that, the symptoms lasted over a week. The patient reported that, in the afternoon of the day of reporting, was scheduled for 2nd dose. There is discrepancy with time to onset as per narrative and reported field ,so considered least time to onset. The patient consented to follow up.
This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. The patient's medical history, concurrent condition and drug allergies were not reported. On 09-APR-2014 the patient was inadvertently vaccinated with VARIVAX (lot # H007700, expiration date 30-MAR-2014), 0.5 ml, subcutaneous, No adverse effects reported. Additional information has been requested.
About 15 min after getting FLUZONE the patient c/o of feeling hot, flushed, started sweating and c/o feeling a bit dizzy. She also c/o slight tightness in her chest. Her B/P was elevated.  We had her lie down in trendelenberg and her symptoms improved.  The reaction did not appear allergic but more vasovagal.  Over the next 20 min her symptoms continued to improve and she required no allergic intervention.
On 2/28/21 a used vial of Pfizer vaccine was reconstituted again with sodium chloride, they were reconstituted in error and patient received diluent only immunization. The immunization administered that day was not effective in providing protection against COVID.   Patient did not have any adverse reaction to the sodium chloride and returned on 3/6/21 to receive the correct dosage of Pfizer vaccine.
Caller asking the efficacy of the second Pfizer COVID 19 Booster during the time a patient actively has covid?; Caller asking the efficacy of the second Pfizer COVID 19 Booster during the time a patient actively has covid?; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller asking the efficacy of the second Pfizer COVID 19 Booster during the time a patient actively has covid?".  Additional information: Reporter voiced the vaccine was 95% effective throughout year. Now it's ran down with the first and second boosters. Reporter also voiced that she has encountered several people who have tested positive with covid even after the boosters.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Swelling arm; Vaccination site pruritus; Vaccination site rash; Vaccination site erythema; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Bull's eye maculopathy.   On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm). In March 2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). On 06-Mar-2021, PERIPHERAL SWELLING (Swelling arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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.   Concomitant drugs not reported. Treatment information was not reported.
No anaphylaxis. Pt developed fatigue the day after and sore arm. Pt developed a red non-bumpy rash on site of shot, about 3-4 inches in diameter, which continue to remained 2-3 weeks after the shot
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 11-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously, lot # R008393, expiration date 20-MAR-2020 (exact dose, frequency and site of administration were not reported) for prophylaxis. Vaccine was diluted with properly stored sterile diluent. Temperature excursion was detected by digital data logger. No details were provided. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA005350.
tinnitus in both ears, began 4  days after second shot as an extremely loud sound in R ear that faded after 20-30 seconds, turned into constant 24/7 high ringing tinnitus in both ears that has not abated at all, now have the extremely loud sounds on occasion in both ears that last 20-30 seconds as well
On or around June 4 or 5th I woke up with a swollen face. And some other itchy hives. I went to urgent care to be seen and got a steroid shot. Was feeling sick
Received Varicella on 7/13/12. Next day - mosquito bite lesion at site which enlarged to 3 in oval area of redness - no pain is clearing now. Need to know if she can receive 2nd dose.
This is to the best of my ability. I took notes, but they started after my symptoms were bad. This starts at about 12:40pm. It should also be noted that I have been feeling symptoms of either mono or IBD for over a year now (I got diagnosed around the same time and it's difficult to discern what is causing my feelings of general fatigue and headaches, however I haven't experienced muscle fatigue, per se).  0-3 hours: mildly sore arm at injection site only (happened immediately) 3-5 hours: headache, slight nausea, slight muscle fatigue 5+ hours: strong headache, severe muscle fatigue, nausea, chills, fever of 102.6   Started taking notes at the time they occurred, I will note when symptoms went away.  4:38am- 102.0 fever, chills stop (However, I was buried under blankets) 9:00am- 101.6 fever, loss of appetite... muscle fatigue and headache improve but are still present 7:56pm- 100.4 fever, other symptoms remain  Next day (in general) Muscle fatigue is virtually gone, fever is gone, headache is present, slight nausea (when eating anything other than small amounts of white rice) and loss of appetite still remain