chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when I got this shot, the mental pain left me/my acid reflux left me/pain in my back left me/I feel better/I haven't thought about suicide/Right after the 1st dose I started to feel better; I still have depression; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (when I got this shot, the mental pain left me/my acid reflux left me/pain in my back left me/I feel better/I haven't thought about suicide/Right after the 1st dose I started to feel better) and DEPRESSION (I still have depression) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Back pain. Concurrent medical conditions included Depression, Anxiety and Hypertension. Concomitant products included LORAZEPAM for Anxiety, AMLODIPINE for Blood pressure high, BUPROPION and DESVENLAFAXINE for Depression.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (when I got this shot, the mental pain left me/my acid reflux left me/pain in my back left me/I feel better/I haven't thought about suicide/Right after the 1st dose I started to feel better) and DEPRESSION (I still have depression). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (when I got this shot, the mental pain left me/my acid reflux left me/pain in my back left me/I feel better/I haven't thought about suicide/Right after the 1st dose I started to feel better) and DEPRESSION (I still have depression) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient takes medications routinely for her depression and anxiety, but not for the pain in her back. There were five people in her family and two killed themselves. She has suffered with depression all her life. She would take the anxiety medication and go outside and feel better, but after waking up from sleep in the morning, the mental pain would come back. She had visited a psychiatrist, but she doesn't go to that psychiatrist anymore. Her primary care physician prescribed her with depression medications.  No treatment information was reported.
RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 46 year old female of unspecified 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 vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of administration was not reported, batch number: and expiry: Unknown) dose was not reported, start therapy date were not reported, for prophylactic vaccination. No adverse events were reported following vaccination (dose number in series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, lot number: was 211A21A (also reported as 1822809) expiry: Unknown) dose was not reported, administered on 27-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On 27-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient received half dose for her booster dose (captured: Vaccine underdose) and off label use (dose number in series 2). As described by reporter, HCP (health care provider) (from public health dept) stated that there were 33 patients who received half doses (0.25ml (milliliter)) for their booster or 3rd dose a few days ago. Most of them were patients. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP did not think it had been reported yet through agency. HCP thought that the vendor will file the report with agency, not health department. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. HCP consented to being contacted, but stated that she may not be the best person to contact. If she had an alternate contact she would provide it to whomever reached out to her. The reporter went on to report that HCP stated that Spartan is the vendor. At the time of the discussion they were both teaming up together to gather information and they may have called to report these events as well, so HCP warned to be mindful of possible duplicate reports. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211201082, 20211201228, 20211201168, 20211200752, 20211201450, 20211200994, 20211201351, 20211201362, 20211202199, 20211202469, 20211201286, 20211204104, 20211202379, 20211201179, 20211201443, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211220129, 20211219871, 20211220152 and 20211201963.
Received VZV vaccine on 9-15-2011, came into office on 9-20-11 with pain in left arm, left mid-upper arm measures 16 inches, right mid-upper arm measures 15 1/4 inches, c/o pain with arm movement, but is able to move arm.  20 mm area of dark pink, firm, induration at the VZV injection site with large area of erythema surrounding injection site.  Pt applied ice and took Motrin and swelling decreased a "little".   Diagnosed with cellulitis to continue to apply ice to site and if not improved in 24 hours to start Cephalexin 500, one qid.
Eye swelled up by about 11 am the morning following dose. Swelling resolved by the next day.
In less than 24 hours the following happened 104 fever, seizures, body and mind numbness, unconsciousness,
Patient reports AM after vaccine given - injection site burned while in shower.  Approximately 2 days later site swollen red, with a blister.  No purulent drainage.  Arm not swollen.  Experienced nasal congestion, nasal drainage, raw throat 1-2 days after vaccine without cough or body ache.  Temperature 98.7  as compared to patient's normal 97.6.
Acute disseminated encephalomycelitis. Weakness left side. Personality and speech change.
Gradual to sudden onset shortness of breath with chest pain, diaphoresis and pallor.
This case was reported by a pharmacist and described the occurrence of diarrhea in a 50-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 10 October 2013 the subject received a dose of FLULAVAL (unknown details). On 10 October 2013, within hours of vaccination with FLULAVAL, the subject experienced diarrhea. In October 2013, within a week of vaccination with FLULAVAL, the subject experienced injection site warmth, injection site inflammation and injection site swollen. The subject "received a FLULAVAL vaccination at the same time as her boyfriend. They went out to dinner afterwards and when they got home they started experiencing diarrhea." See case A1047929A for details on the male subject. At the time of reporting the outcome of the events injection site warmth, injection site inflammation, and injection site swollen were unspecified. At the time of reporting, the outcome of the event of diarrhea was unresolved. Per the pharmacist, the subject is "still experiencing diarrhea" "after 6-7 days." Per the pharmacist, the subject was "advised to seek medical attention but she has not yet seen a doctor" at the time of reporting. The pharmacist reported other cases with FLULAVAL, see A1047929A and A1046504A for details on the other cases.
This spontaneous report as received from a male pharmacist of unknown age refers to himself. On an unknown date, the patient was vaccinated with a dose of Hep B vaccine (manufacturer unknown) (lot#, expiry date, dose, strength, route and indication not reported). On an unknown date, the patient was vaccinated with the second dose of Hep B vaccine (manufacturer unknown), Intramuscular, (lot#, expiry date, dose and strength not reported), possibly greater than 6 months after the first dose, and had not received the third dose as of today (18-MAR-2014). No adverse effect reported. Additional information has been requested.
there was some swelling; right arm started itching; developed a slight rash on her right arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (there was some swelling), INJECTION SITE PRURITUS (right arm started itching) and VACCINATION SITE RASH (developed a slight rash on her right arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Clot blood (blood clots in her legs and lungs) since 23-Jan-2021. Concomitant products included RIVAROXABAN (XARELTO), LOVASTATIN, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), VITAMIN D [VITAMIN D NOS] and IRON for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INJECTION SITE PRURITUS (right arm started itching) and VACCINATION SITE RASH (developed a slight rash on her right arm). On an unknown date, the patient experienced SWELLING (there was some swelling). At the time of the report, SWELLING (there was some swelling), INJECTION SITE PRURITUS (right arm started itching) and VACCINATION SITE RASH (developed a slight rash on her right arm) had resolved.            Treatment medication included  over the counter benadryl cream.  The symptoms started 3 days after the vaccine and lasted about 1-2 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant Follow- up received-the event swelling  added, duration of event  and outcome was updated.
Patient stated that they always get sick to their stomach when getting vaccines and did vomit receiving after vaccine. Patient stated that this happens all of the time and felt much better after some water and waited 20 minutes before leaving the store.
7 days after vaccination  I developed very itchy rash on arm near injection site. Rash is approximately 3 inches long and 2 inches wide.
7 m old breast fed baby developed 104 degree fever 6 days post mom getting vaccinated. Fever unable to be reduced by tylenol/motrin for 2 days. Fever started subsiding on day 5. No other symptoms expect for red/pink right eye when having high temperature. Negative for cough, ear infection,  uti, etc.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical history was provided.     On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 26-Nov-2020 and the estimated date of delivery was 02-Sep-2021. On 28-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 28-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
12 hours after vaccine, patient awoke with severe shortness of breath and cough.  Over the ensuing 12 hours it worsened considerably and she went to an ED.  There she had a high fever, hypoxia, hypotension, and tachycardia.  She was treated with BiPAP and admitted to the ICU.  CXR looked like fluid overload vs infiltrate.  She was treated with IV antibiotics.  She recovered over the course of 3 days and was sent home 9/10/19.
pt recvd vax & exp arm ache & arm numbness; No further details are available; This case is considered to be invalid;
Information has been received from a health professional concerning a patient who on unknown dates was vaccinated with PNEUMOVAX (lot #660685/0619X). The patient experienced pain, swelling and unable to lift arm after getting the vaccine. Unspecified medical attention was sought. The outcomes of the events were not reported. This is one of several reports received from the same source. Additional information has been requested.
extreme fatigue, nausea, dry heaving, headache, dizziness (all similar but milder than my covid19 symptoms from April); arm soreness, tender to touch (both expected), large knot in upper arm/injection area
The patient stated that she vaccine made her "life into tailspin"; This spontaneous report has been received from a female consumer of unknown age referring to herself. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis.         The patient reported that she experienced unspecified adverse events after getting zoster vaccine live (ZOSTAVAX) in the past. It's reported that the vaccine made her "life into tailspin" and the patient did not explain what she meant by "life into tailspin". The outcome of the event was unknown.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
From initial information received on 10/06/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 48 year old female patient received her first does of Influenza Virus Vaccine, lot number U1260AA, administered intra-muscularly in the right arm on 10/03/03.The following day, the patient developed redness and edema at injection site, itching, pain and swelling in joints, as well as fever, aching, and nausea. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302256 and 200302257.
This is an estimate of the date. Patient took bus and developed cramps in calf muscles. Went to ER -- negative DVT. Pain then generalized. Now with generalized muscle achiness/pain (more in extremities), twitching, popping sensation in joints, now also shooting pains in chest.
Chills starting at 5 pm day 1; severe chills and shaking for 10 minutes on preparing for bed at 8 pm, fever 98.9, which resolved upon lying down under warm blankets; fever 101.1 at 11 pm day 1, 102.0 at 5 am day 2, 100.7 at noon,  101.8 at 5 pm on day 2,  with muscle ache and headache throughout day 2;100.5 at 2:30 am on day 3.  Fever went down to 100.0 at 5 am and was normal thereafter, mild headache through daytime of day 3.  No symptoms since.
reddish type of rash on the back and front of his body, the upper arms and a little on his neck/rash all on the front and sides of his body; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 74-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0183, Expiry date: Unknown) via an unspecified route of administration on 28Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10May2021 the patient experienced yesterday, he developed a reddish type of rash on the back and front of his body, the upper arms and a little on his neck/rash all on the front and sides of his body. The outcome of events was unknown.   Information about batch/Lot number has been requested.
Red swelling, itching, hot raised patch around the injection site, sensitive, patient took Benadryl and it helped with the itching.
Information has been received from a registered nurse concerning a 14 year old female with no fever, otitis (diagnosed on 22-DEC-2006), mild sore throat, congestion, runny nose, amoxicillin and erythromycin allergy who on 22-DEC-2006 was vaccinated with the first dose of GARDASIL (lot # 653938/0954F), IM. Concomitant therapy included the first dose of MENACTRA (lot # U2141AA), IM.  On 22-DEC-2006 after the vaccine while at the check out window, the patient stated that she felt hot, felt her vision was fading and felt faint.  The registered nurse held her arm and walked with her back to an exam room where she had her lay down and elevated her legs on two pillows for 15 minutes.  The patient's feeling passed. When the patient first returned to the exam room the physician checked her and then checked her when she felt better. After 15 minutes of lying down, the patient then sat up for 5 minutes. Her blood pressure was taken and was normal 98/60. Subsequently, the patient recovered from the events that same day.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. It was reported that there was no diagnostic work-up performed, the patient was not hospitalized nor was an outpatient and the patient fully recovered before she left the physician's office. On 21-FEB2007, the patient was vaccinated with the second dose of GARDASIL and had no side effects. Additional information is not expected.
I started having the normal side effects. I had body aches, chills, fever, swelling and soreness in the arm. I took some Tylenol and it did not get any better. I started being delirious and having seizures. I went to go for my transcranial magnetic stimulation treatment. The doctor told me to go to urgent care because Tylenol did not make my fever go away. They called it an uncontrolled fever. I had to go get a shot of Toradol. They took my temperature and swabbed my nose for some research project and took my blood and vitals. They said I had a 99.7 temperature which they call low grade but I could not get rid of it and it was causing my seizures. My throat felt swollen and I felt pressure in my ears too. Every vaccine makes me sicker than they said it will. But this is the first time the COVID vaccine has made me this ill. I do not think is the vaccine, I think it is me. I still feel like I have a mild cold.
R upper lateral thigh area redness noted approx. 2 inches in diameter around injection site. Area slightly warm, firm. No pain with palpation/pressure. Mom states redness started 7/31 is les today. Child ambulating with no noted problems, active, playful. No fever. Instructed on warm compresses. Tylenol for pain. Two follow-up calls, no response from mom.
Mild exacerbation of asthma, flu-like symptoms, most likely related to pneumovax. Asthma (now) 2/22/01 stable, left arm redness and stable 2/22/01 as pt taking Benadryl. Mild urticaria.
Systemic: Body Aches Generalized-Mild, Systemic: Fever-Medium, Systemic: Tachycardia-Mild
IN OCTOBER 2021 I STARTED HAVING A LOT OF PAIN IN MY LEFT BREAST AND ARMPIT. IN NOVEMBER 2021 I FELT LIKE I HAD INFLAMATION IN MY ENTIRE BODY. PAIN IN MY ABDOMEN AND RIBCAGE AREA BEGAN IN DECEMBER. END OF DECEMBER, BEGINNING OF JANUARY 2022 I WAS DIAGNOSED WITH AN ENLARGED LIVER AND NON-ALCOHOLIC FATTY LIVER DISEASE. WHILE I DON'T BELIEVE THIS VACCINE CAUSED FATTY LIVER, I THINK IT MIGHT HAVE CAUSED THE PAIN IN MY LEFT BREAST AND ARMPIT AND AGGRAVATED THE LIVER TO START THE PAIN AND INFLAMATION IN THE LIVER AND SURROUNDING AREAS.
THE AREA AROUND INJECTION SITE BECAME RED, RAISED, HOT TO THE TOUCH AND CAUSE THE PATIENT TO HAVE DIFFICULTIES LIFTING ARM WITHIN 24 HOURS OF INJECTION. THE PATIENT TRIED TO TREAT WITH TYLENOL DAILY FOR A WEEK BEFORE COMING TO THE PHARMACY. THE PHARMACIST REFERRED THE PATIENT TO AN URGENT CARE CENTER. THE PATIENT WAS PRESCRIBED TYLENOL 325MG; HYDROCORTISONE 2.5%; FEXOFENADINE 180MG; AND BACTRIM DS.
-severe arrhythmia for up to 3 days. Couldn?t be controlled with normal medication (metoprolol)  -shingles blister-like rash within 1 week after both doses 1 and 2; on buttocks. Never had this type of outbreak before.
Localized erythema, no edema, mild firmness to right upper arm; some occasional itching symptoms began 12/8/13. Provider gave advice regarding treatment for itching and instructed to return if experiencing trouble breathing. Patient came in on 12/9/13 for a doctor visit.
Acute on chronic congestive heart failure, unspecified heart failure type; Cough; ESRD (end stage renal disease); Hypertension, unspecified type; SOB (shortness of breath); Shortness of breath
Per patient's mom. Patient begin a fever around 7pm after receiving the shot at 11:15 am. His mom gave him took 2 TYLENOL tablets. Then about 2:20 am patient started feeling worse. He had 101 temp and his heart rate was up to 170 according to his watch. His parents them took him to the ER. They gave him fluids and ran a variety of test EKG, urine test, blood work and could not find anything. They kept him in the ER until they released him at 9:30 am. His mom stated that the ER doctor was treating him as if he had the flu and gave him an RX for TAMIFLU. His heart rate was down to 120 by the time he left and that if in a few days his heart rate was not lower he would need to see a cardiologist. Mom stated when she came in to pick up his TAMIFLU rx his heart rate was down to 100.
Patient broke out in a chicken pox-like rash on 3/25/2010. She had received VARIVAX on 3/19/10.
29 y.o. male w/possible reax to Smallpox vax. Erythema with itching noted to both left and right arms. Swelling at vax site. Meds: Benadryl.
Swelling of left thigh the night after vaccination. Called into office and was given appointment 1/7/03. Left thigh swelled and indurated around site of injection. Was given instruction for cool compress and Benadryl every 4-6 hours PM.
Information has been received from a physician concerning a 15 year old female who on approximately 29-MAY-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). Post vaccination the patient mentioned that she "felt like someone was pulling on her bone" and stated that she felt a little dizzy. The nurse administering the vaccine had the patient lay down for 5 minutes and then stated that the patient was fine. Additional information has been requested.
Reported to facility with chest pain, AMS, shortness of breath, elevated Ddimer. Suspected PE, given antithrombolytics, transferred to higher level of care