chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gastro pains; diarrhea; felt like someone was sticking needles in my heart; couldn't get out the bed; no appetite; lost about 7 pounds; very tired; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (gastro pains), DIARRHOEA (diarrhea), CARDIAC DISORDER (felt like someone was sticking needles in my heart), BEDRIDDEN (couldn't get out the bed) and DECREASED APPETITE (no appetite) in a 90-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.     The patient's past medical history included Breast cancer.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced GASTROINTESTINAL PAIN (gastro pains), DIARRHOEA (diarrhea), CARDIAC DISORDER (felt like someone was sticking needles in my heart), BEDRIDDEN (couldn't get out the bed), DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost about 7 pounds) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, BEDRIDDEN (couldn't get out the bed) had resolved. On 01-Mar-2021, GASTROINTESTINAL PAIN (gastro pains), DIARRHOEA (diarrhea) and CARDIAC DISORDER (felt like someone was sticking needles in my heart) had resolved. At the time of the report, DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost about 7 pounds) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-067748 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067748:Original Case : MOD-2021-067715
Feel like I have the flu; Very sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingles vaccine. On 04-MAR-2023, 1 days after receiving Shingles vaccine, the patient experienced influenza (Verbatim: Feel like I have the flu). In MAR-2023, the patient experienced pain in arm (Verbatim: Very sore arm).  The outcome of the pain in arm and influenza were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and influenza to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and influenza to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported the patient via interactive digital media. The patient received first shot of vaccine day before reporting. The patient arm was very sore and the patient felt like flu on the day of reporting. The patient was hopefully that the patient would feel better tomorrow.  The follow-up could not be possible as no contact details were available.
Approx. 5 inch x 4 inch red, firm, swollen area on right upper arm in the area of the injection. This area is warm and painful. I also have some pain and tenderness on the underside of my arm and in my armpit area. These symptoms were worse on the 6th day after the injection. I have also been a bit dizzy all week long since the injection.
C/O redness, swelling, itching, pain at injection site, difficulty sleeping, and nervousness. Ice pack applied to injection site.
This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spot in his arm), PERIPHERAL SWELLING (Arm swelled up and was half-dollar size, Swelling was down his whole arm) and DYSPNOEA (Shortness of breath/Difficulty breathing) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Shortness of breath, Stent placement in 2013 and Angiogram (patient has allergy to the dye for angiogram). Concurrent medical conditions included Diabetes. On 28-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Red spot in his arm), PERIPHERAL SWELLING (Arm swelled up and was half-dollar size, Swelling was down his whole arm) and DYSPNOEA (Shortness of breath/Difficulty breathing). At the time of the report, RASH MACULAR (Red spot in his arm), PERIPHERAL SWELLING (Arm swelled up and was half-dollar size, Swelling was down his whole arm) and DYSPNOEA (Shortness of breath/Difficulty breathing) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that patient was allergic to dye for angiogram and stated that patient did not have a positive COVID test or diagnosis. Concomitant medications include unspecified blood thinner and antibiotics before the 1st dose. After receiving the shot, the patient subsequently had a red spot in his arm, and everything was fine per the caller except the arm swelled up and was half-dollar size. The swelling was down his whole arm but did not have pain after the shot. The caller reported shortness of breath before the shot when he goes out in cold weather but had difficulty breathing when sleeping and shortness of breath over the course of the week after the shot. No treatment was provided by the reporter.
Expired Engerix-B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 68-year-old male patient who received HBV (Engerix B) (batch number T2S4Z, expiry date 20th November 2022) for prophylaxis.   On 29th November 2022, the patient received Engerix B. On 29th November 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-NOV-2022 Reporter's comment: The reporter reported that administered expired Engerix-B to adult patient on 29th November 2022. The vaccine dose expired on 20th November 2022.  Dose from vial- batch number T2S4Z verified.  The reporter was consented to follow up. Additional Supportive Information: The Engerix-B vaccine was already expired and was administered to the patient, which led to expired vaccine used.
This spontaneous report as received from a healthcare worker refers to a number of unspecified patients (demographics unknown). On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (dose, route and lot number were not reported). Concomitant medication was not reported. The doses of GARDASIL were exposed to a lowest temperature of 24.2 for "42 minutes". The healthcare worker will confirm the actual time that the vaccines were below 36F, since it was unlikely that the total time below 36 F was only 1 hour. No adverse effect was reported. This case is linked to MARRS# 1401USA003227 and 1401USA003228 by the same reporter. Additional information has been requested.
Body stiffness to the point where other people have noticed it. Knee pain. Sleep disturbance problems. Tingling sensation on my back. I will be seeing a doctor soon regarding these issues.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 11Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 15Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Recurrence of positive test and minor COVID symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergy.  No follow-up attempts are possible. No further information is expected.
Heavy menses April, May, July 2021; increase in estradiol levels per blood lab results.; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533), via an unspecified route of administration in Arm Left on 30Mar2021 at 16:45 (at 55 years) for covid-19 immunisation. Medical history included hypothyroidism, breast cancer and asthma. No known allergy.No covid prior vaccination and no covid tested post vaccination. Concomitant medications included thyroid (ARMOUR THYROID), tamoxifen and montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported.  Previously the patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6208), via an unspecified route of administration in Arm Left for covid-19 immunisation . The patient had heavy menses on 05Apr2021 (also reported as Apr2021), May2021 and Jul2021 with increase in estradiol levels per blood lab results. No treatment given and outcome of the events was unknown.
Patient states that within 24 hours of receiving the vaccine, she became tired and lethargic, fell asleep during the afternoon and when she awoke, the side of her face that she had been sleeping on was swollen and numb.  Patient states that the swelling has since reduced, but some swelling remains 72 hours after the vaccine.
headache; abnormally amout of bleeding; vomiting; almost passing out; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: ew0158, expiration date unknown) via an unspecified route of administration in the arm left on 17Jun2021 at age of 33-year-old for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history included anxiety. Patient had no known allergy. There was no COVID-19 prior vaccination. COVID was not tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications received within 2 weeks of vaccination included sertraline. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received 1st single dose of BNT162B2 (Batch/lot number: EW0153) via an unspecified route of administration in the arm left on 27May2021 at age of 33-year-old for COVID-19 immunisation and the first menstrual cycle following the vaccine was much heavier than previous ones. It was reported that the first menstrual cycle following the vaccine was much heavier than previous ones. Each month since, the amount of bleeding during patient's cycles has increased from the previous month. Patient had also been getting really bad headaches during her cycles since the second dose. She had brought it up to her doctor and he said he hadn't heard of the vaccines affecting cycles nor amount of bleeding and brushed her off. Not until recently did she start finding others who were experiencing similar symptoms since the vaccine and decided to report it as her doctor would not. Her most recent cycle had an abnormally amout of bleeding specifically one day 24Aug2021, vomiting, and almost passing out. Patient reported she should have probably went to the ER but she was not thinking right nor did she knew this be from the vaccine and could be a sign of something more serious. Patient has dr appointments set up and if she experience this again, she will be going to the hospital as she cannot see how it can get worse than it did last cycle and she still live. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. No treatment received for the events.  Follow-up attempts are completed. No further information is expected.
Nausea, fatigue, muscle and joint pain, stiffness in thumb, and headaches.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient got normal soreness at injection site following the vaccine.  After a few days the normal pain went away replaced by a lump, swelling, and soreness.  I suggested the patient see a doctor if these symptoms persist or worsen.\r\n
Patient has been having severe neck pain (b/l right below ears) and severe bilateral shoulder pain since 04/12/21 (the day after his Johnson and Johnson COVID vaccine). Patient has been unable to sleep due to the severe pain. Patient was given some PO pain medication from his PCP and has not been able to get any relief.
Itchy spot; Red Spot; Painful spot; A spontaneous report was received from a consumer concerning a 75 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Itchy spot /pruritus, red spot /erythema, painful spot /vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, approximately 2 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Not given) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) Itchy spot, red spot, painful spot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), Itchy spot, red spot, painful spot was unknown.
Patient complaint of soreness on the right arm, where ADACEL and AFLURIA vaccines was administered and swollen glands on both underarms.
First week just mild soreness because of bruise at injection site.  On 1/15 started itching and swelling at injection site about 11AM.  By 5PM swollen red patch and itching. On 1/16 til now 1/18 PM still swollen, red patch, hot and sore to the touch.
10/2/06 seen.  Diagnosed with Varicella Had Varicella vaccine 5/10/06.
7 days after initial injection, I started experiencing itching at the injection site.  The next day, my arm was swollen, red & itchy.  The swelling went down within 4 days, but it is still red & itchy one week after the reaction.  I have been putting hydrocortisone cream on the affected arm, twice a day.
Patient c/o SOB, pale and diaphoretic. Administered 02 2L/NC, NS 0.9 200 ml given, Benadryl 50mg IVP and Solu Medrol 125mg IVP given. called 911. Pt verbalized  he feels better after medication administered but still want to go ER.  Patient send to hospital via ambulance. Doctor notified.
Intense burning on left side of chest for a couple of minutes. The next morning, headache(2 days), sore throat(1 day), fatigue(continuing) and brain fog(continuing though not as severe).
During a review, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Left arm slightly swollen and pink. Her arm was very sore and the pink area was from the deltoid to the elbow. Arm doesn't appear infected, just irritated. Client has seen her PCP x 3 and started steroids for inflammation. Nurse called to check on client 2/3/12. Client feeling some better.
01/02/04: Grandmother reports rash around immunization site.  01/05/04: Grandmother reports "better today." Rash about the size of 50 cent coin.
5 minutes after having vaccine I felt lightheaded. Paramedics checked vitals 30 minutes after vaccine and felt it was anxiety. This is day 5 after having vaccine and every day I feel lightheadedness and feel as if I am going to faint. I have called my primary doctor to report this daily and went to Urgent care once. Vitals at urgent care was fine. Not sure why I keep being lightheaded 5 days after first Pfizer dose. This happens once per twice each day and lingers for about 10 minutes.
Developmental delays (speech-gross motor delayed). Follow up on 12/05/2002: "At 4 months well child visits infant was unable to flip over, disliked being on her feet, sat poorly, did not push up with arms.  Evaluated by neurologist at 15 months.  Still unable to crawl.  Has speech delay and poor fine and gross motor skills.  Follow up on 02/07/2003, Per MD: "This week chromosome studies confirmed that her hypotonia is the result of Angelman Syndrome.  I therefore do not believe that any vaccines were the cause of this patients developmental problems". Follow-up received on 2/12/03: "This week's chromosome studies verified Asperger syndrome as the cause of hypotonia and developmental delay. The annual follow up received on 12/23/03 states 12/11/03 symptoms were not related to vaccines. Pt diagnosed with angel syndrome.
This is a spontaneous report from a contactable nurse, who reported for her mother. An 88-year-old female patient of an unspecified ethnicity received PREVNAR13, via an unspecified route of administration on 06OCT2014 in an arm at a single dose. Medical history included ongoing type 2 diabetes mellitus for the past 10 years. Concomitant medications included JANUVIA, glipizide, and SYNTHROID. During the night of 07OCT2014, the patient experienced blood sugar was elevated at 160. This did not settle for 3 days. The clinical outcome of the event, blood sugar was elevated at 160 was recovered on 09OCT2014. The nurse also mentioned that she received her regular flu shot in the other arm;  however, the day of this vaccination was not mentioned. Follow-up (09JAN2015): Follow up attempts completed. No further information expected.
Vaccinia reaction: dermal rash, non pustule/vesicle initially cheeks, face, arms, torso, legs, forming lack after smallpox vaccine administered. Lasted 1.5 weeks, disappearing in order of appearance. Neg for malaise, fever, resp sx, or headaches. pos itching.
About a week after receiving the shot a set of spots appeared on my ankles, and over the next week or so grew more numerous and spread to my feet, with numerous blisters appearing.  The area around the spots gets painful in the evenings.  After a doctor's visit, leading to blood tests and a biopsy, I was diagnosed with IgA vasculitis.   My understanding is that IgA vasculitis can be associated with a reaction to vaccines, although to my knowledge it has not yet been reported in connection with a COVID-19 vaccine.  My doctor advised, "IgA vasculitis has not been reported so far with the Covid vaccine that I could find in the literature.  It has been reported in association with Covid infection and some other vaccines though, so it stands to reason that it may be related."   The symptoms have not yet abated as I am still in the 14-day window after my second vaccination shot, and my doctors have advised to hold off on taking immunosuppressant steroids until that time period elapses.
pt stated that after her injection that she had fatigue.  On 2/14/2021 she said her nerves were tingling from her head to her feet.  On 2/15/2021 the nerves are tingling in her body and she is having a shaking sensation like she is having a neurological condition.  Pt contacted her PCP before getting the vax which confirmed with her Neurologist that she was good to get the vax since she has had these symptoms before after having viral infection. Pt contacted her PCP since getting the vax  since she is still having these symptoms.  She asked for a Xanax prescription to help relax her nervous condition since they didn't know how to treat her condition.  Stated she will FU w/ a Neurologist if her symptoms persist.
RAPID DECLINE IN HEALTH; LACK OF INTEREST IN LIVING; REQUESTED HOSPICE AT AGE 72  WITH NO MAJOR TERMINAL ILLNESS; STOPPED SOCIALIZING, INTERACTING WITH ANYONE; LACK OF APPETITE; VERY WEAK AND FRAIL;  DEATH FOLLOWING 2ND SHOT
Patient received COVID-19 vaccination dose 1 on 2/8/21 and dose 2 on 3/1/21 at outlying extended care facility.  Manufacturer and lot # of vaccinations are not available.  Patient presented to ED on 3/8 (7 days following 2nd vaccination) with chief complaint of progressive dyspnea for the last week and constipation.   Patient was diagnosed with acute on chronic congestive heart failure exacerbation with bilateral pleural effusions.    Patient has a history of recurrent pleural effusions requiring thoracentesis.   Patient then had a positive COVID-19 PCR test on 3/9/21.  Patient underwent thoracentesis on 3/10/21 and was treated with Lasix diuresis with  much improvement of respiratory status.  Respiratory status remained stable throughout hospitalization and required no treatment for COVID-19.  Patient was discharged back to his extended care facility on 3/18/21 after an 11 days hospitalization.
Fever of 100.1° at peak Extreme fatigue for 36 hours Severe headache unresponsive to Tylenol
No additional adverse effects were reported in the patient; patient received one dose each of PROQUAD and VARIVAX on 1/28/2020; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-JAN-2020, the patient received one dose each of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD), lot number S027467, expiration date 02-MAR-2021, and varicella virus vaccine live (oka/merck) (VARIVAX) lot number S025914, expiration date 20-AUG-2021, both for prophylaxis (exact dose, frequency and route of administration were not reported for either of vaccines). Concomitant medications included sterile diluent. No additional adverse effects were reported in the patient.
High fever (to to 103.2) over 3 days swelling both legs - still present on 5/14/06 (size of 2cm on right, left) very fussy, tearful on and off for 3 days, eyes swollen 1st - 2nd days.
After 1 week I got a red welt on my left arm.  It itches and is warm to the touch.  It is also hard.  It does not hurt and is similar to the reaction I had to the flu vaccine I received last year.   I am icing the location and taking advil and tylenol
I experienced extreme headaches in mid-August which happen when I bent over and at night. I went to see my PCP and she prescribed antibotics (took two different rounds of them since she thought it may be a sinus infection but the symptoms did not subside).  I'm currently experiencing the headaches. My PCP then she scheduled me for an MRI for 10/06/2021.
Fatigue, weakness, body aches ,nausea, vomiting ,chills, pain in left arm vaccination spot and shoulder. Adverse effects were present for 8 days . Fatigue, body aches and pain in left shoulder and arm still present.  Taking OTC medications for pain and Pedialyte for hydration due to vomiting.
Fever  chills diarrhea vomiting dizziness  weakness couldn't walk limbs felt heavy headache. Day after vaccine   went to emergency room. Treated with Zofran and iv fluids