chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Mild swelling at injection site without erythema present.  Mild swelling of soft tissue of the lower axillary  area of the left upper arm.  Pain in the axillary area on lifting of the arm.  Mild tenderness on palpation of the swollen lower axillary area.
On Friday I was really sleepy dint hurt, my arm was sore. Then on 3/22 started running chills went Monday night to get Covid test (results positive).
Extreme nausea, tiredness, dizziness, injection site pain. Took a Tylenol 500mg and Meclizine HCL 25mg.
wound up getting the stomach virus (virus) between the 3rd and 6th week after the 1st dose; wound up getting the stomach virus between the 3rd and 6th week after the 1st dose; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 60-year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NOROVIRUS INFECTION (non-serious), WOUND (non-serious), outcome "unknown" and all described as "wound up getting the stomach virus (NORA virus) between the 3rd and 6th week after the 1st dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 20 year old female who on approximately 25-FEB-2007 was vaccinated with Gardasil. On approximately 25-FEB-2007 the patient experienced numbness, headache, dizziness and muscle tenderness. After one week, the patient recovered. On 24-APR-2007 the second vaccination with Gardasil was given. Additional information has been requested.
Patient received a pediatric dose of the Pfizer vaccine0 .2ml (10mcg) instead of the .3ml dose designated for age of 13
pt recvd vax & at 12:03 was clammy, pale, gray, ashen,12:04 ems called; 12:05 BP 70/32; 12:06 O2 per mask; 12:10 P68; BP 100/70; 12:14 P 60; Bp 130/64; 12:19 ems arrived; 12:22 pt sat up c/o jitteriness & dec nausea;
non-immunocompromised receiving full dose as third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (non-immunocompromised receiving full dose as third dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE [PREDNISOLONE SODIUM PHOSPHATE]) for Rheumatoid arthritis.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (non-immunocompromised receiving full dose as third dose). At the time of the report, ACCIDENTAL OVERDOSE (non-immunocompromised receiving full dose as third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has taken prednisolone 7mg everyday for long time, greater than 3 months for rheumatoid arthritis.   No treatment medications were reported.
hypertension- 166/85 tachycardic-106 Profound HA- 8 out of 10 pain scale weak, dizzy mouth very dry
Chills, shaking, teeth chattering, fever 102.5, massive body pain and searing pain at site, swollen neck...fever 12 hours later remains at 100.5 with severe body pain
13 hours post vaccine: muscle body aches all over. About 16 hour mark: feverish, chills. Lasting throughout the night. Took 2 ibuprofen 200 mg 25 hours after. Vomited once.
Vial of Pfizer Bivalent Covid vaccine had been opened for more than the recommended 12 hours after opening, and a dose was administered 2/1/23. Notified immunization supervisor, awaiting further recommendations from immunizations coordinator from our State Authorities.
Severe headache and temperature ranging from 101 - 103 for 5 days.
1ST DOSE MODERNA 1/26/2021 LOT# 071220A ; 2ND DOSE PFIZER 2/22/2021 LOT# EN6198.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 2:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 2:42 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 71.13.  Concomitant products were not provided.  Temperature Excursion at 9 AM, 10 AM, 11 AM, the temperature was 29, 35, 35 respectively. Total doses given for the day was 55, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 12-Feb-2021. 3 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
PATIENT EXPERIENCED FEVER OF 103F, CHILLS, MUSCLE ACHES, NAUSEA, AND VOMITING LASTING 48 HOURS
Upon patient shopping with mom after waiting 15 minutes for monitoring, the patient became nauseous and vomited in the store. My pharmacy manager, and I both came right away after being notified. We questioned the patient who stated that she immediately felt better, but just that her stomach had been hurting. She did not feel light headed or nauseous after.
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for small bowel obstruction with perforated cecum and peritonitis/Ventilator-dependent respiratory failure. Vaccination took place 1/31/2008. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-SEP-2016, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-SEP-2017, the patient was treated by a physician for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
5/25/04- Vaccines given, later that evening pt began to run fever 102.2 was given Motrin and came down. Child woke up 3:30 am 5/25 crying a lot and gasping for air- Temp 104.3 given Motrin & tepid bath, temp came down. 5/24/04 7:00 am Temp = 98.9 no complaints since other than being less active than usual. Parent called to office 5/25/04 at 11:30.
NO ADVERSE EFFECTS GIVEN AN EXTRA DOSE AS A BOOSTER BY MISTAKE, LAST DOSE NOVEMBER 2021
Pt. develop outbreak of hives about 5 hours after receiving pneumonia immunization. Started on arms last 6/1/11, went away after 24H, now had hives on ankles & left side of body, small areas, no shortness of breath, no wheezing, itchy. ZYRTEC once daily x 1 week, BENADRYL 25mg q 6 hrs. Breakthrough itching.
Patient died from Covid 19 complications after being fully vaccinated. Also tested for Influenza A.
hives, constriction in throat, SOB, bloating 48 hrs p/vax; sx persisting intermittently last 3 months;
Client received Pfizer on 11/03/21 as first vaccine in primary series. Client requested Moderna on 12/03/21 as second dose in primary series. Client completed 15 minute monitoring period. No adverse reactions occurred.
LADA (latent autoimmune diabetes in adults)  First symptom was increased thirst, followed by a yeast infection that didn't respond to treatment. A routine health screening at work in early March 2022 showed elevated fasting glucose and HgA1C. Nurse at health screening advised me to see primary care physician ASAP.  Saw PCP on 3/14/22 who referred me to an endocrinologist for diagnosis and treatment. Saw endocrinologist on 6/20/22 and she prescribed Metformin and long-acting insulin along with a diet low in carbohydrates and regular exercise. She also ordered lab tests to determine if I had type 1 or type 2 diabetes.
Developed Type 1 diabetes mellitus-diagnosis 6/8/15 3 wks after vaccination.
This case was reported by a consumer and described the occurrence of hives in a 12 month old female pt who received Pediarix. The reporter is the mother of the pt. A physician or other health care professional has not verified this report. On 3/10/05, the pt received the 1st dose of Pediarix. Approximately 5 days , post/vax, on 3/15/05, the pt experienced hives. The pt was seen at a physician's office and was treated with prednisone. The hives resolved on 3/16/05. The immunization series with Pediarix was discontinued.
rash underneath the injection site; cold but not as cold as after the 1st dose; more sore; Headache; Body ache; This spontaneous case was reported by a nurse and describes the occurrence of FEELING COLD (cold but not as cold as after the 1st dose), PAIN (more sore), VACCINATION SITE RASH (rash underneath the injection site), HEADACHE (Headache) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Mar-2021, the patient experienced FEELING COLD (cold but not as cold as after the 1st dose) and PAIN (more sore). On 04-Mar-2021, the patient experienced VACCINATION SITE RASH (rash underneath the injection site). In March 2021, the patient experienced HEADACHE (Headache) and MYALGIA (Body ache). In 2021, VACCINATION SITE RASH (rash underneath the injection site) had resolved. At the time of the report, FEELING COLD (cold but not as cold as after the 1st dose), PAIN (more sore), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. The night (02-Mar-2021), patient was cold but not as cold as after the 1st dose was able to go to sleep but felt more sore. The patient had a rash underneath the injection site 2 days after and that lasted for a week. The patient also had a headache and body ache.   This case was linked to MOD-2021-377089, MOD-2021-377122 (Patient Link).
38y.o. G2P0010 at 37w0d presents to Triage with elevated BP. Cesarean Section, delivered baby girl. 5/15 Pt stable and discharged.
Headache, Myalgia, Arthralgia, NauseaVomiting, chills, fatigue Narrative:  onset of s/s within first 24 hours post injection
01 Dec 09 after vaccinated stated he had chest discomfort x 1 day followed with swollen and tender lymphnodes under left arm 7 days post vaccine administration.
Dry heaving. Decreased appetite. Insomnia. Fever (99.6 degrees). Pt. is increasing fluids as tolerated.
After 2nd dose for 2-3 weeks after , irregular heartbeat, no medical care because I had this before until 2AUG2021. It was pronounced heartbeat on 4AUG201 and diagnose with Afib. Cardiologist normally rhythm and PAC for another two and since 9sep2021. In 2018 nomavax vaccine and had this reaction. Resting normal heartrate 52, mine was 3aug2021 Doctor 4AUg2021
In 24hrs - sore arm, tired, queasy. In 48hrs - severe diarrhea, continued tiredness.
Redness swelling and warmth to upper Left deltoid around where immunization was given. Also soreness reported.
localized erythema & swelling. 10x7 cm & 3x7 cm treated with cephalexin.
Information has been received from a physician concerning her 4 year old daughter with no pertinent medical history and no allergies who in Feb 2002, at age 1, was vaccinated in the left arm with a dose of VARIVAX. Concomitant vaccination, also given at age 1, include a dose of MMR II. It was reported that the child had never been exposed to varicella. On 3/29/2005 (also reported as 3/31/2005) she developed quite a few zoster in the same dermatome that she was vaccinated in, left arm left deltoid. Unspecified medical attention was sought, no treatment was required. It was reported to be varicella zoster. The physician reported that the duration of the incident was 6-7 days and recovered on approximately 4/5/2005. It was also noted that the varicella zoster was resolved before the paperwork was received to obtain samples for cultures. No product quality complaint was involved. Additional information has been requested.
pt with left deltoid erythema 11x10 cm.  Also with HA, chills, myalgias, double vision.  Symptomatic treatment.
11/02/2021, the night of the vaccine, my ears were very hot and red, fatigue, and sore. The next morning 11/03/2021, at 04:00AM, I was getting ready to go to work. I had fatigue, sore ears that were red, and hot, light fever 100.2 degrees, body aches, all over my body-muscles and joints. Under my arm pit area, I had severe pain, like I had marbles under there. The doctor told me it was lymph nodes reacting to the vaccine. Every movement that I made hurt. Itchy on vaccine area and sore and red rash around the injection area. I did not feel nauseous, I had a stomachache, followed by cramping. My mouth had a sensation like I had was going to throw up, but not nausea. I had a headache, super fatigue and tired and wanting to go to sleep on the spot. I ended up going to work. I could not focus. I was having brain fog. 11/04/2021 I did not go to work. I could not have another day with the symptoms. I felt all the symptoms until 7:00PM. 11/05/2021 I felt fully full recovered.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277418 and 2018SA277420 (same reporter). This case involves a female patient (age unknown) who received vaccine INFLUENZA FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6301NA and expiry date: 30-Jun-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to underdose. It was reported that 3 of the 0.5 ml prefilled syringes leaked around the hub during administration. Two different nurses found that when they were going to give vaccine with needle already attached,it leaked from base of the hub with 3 different prefilled syringes and were unable to deliver full dose (syringe issue). It was unknown whether product technical complaint was registered or not for the syringes. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Developed wheals with itchiness 2 hours after administration of first dose of Pfizer COVID-19 Vaccine. Mother promptly gave benadryl with complete resolution of symptoms. Never had additional organ system involvement outside of skin rash. Since hives occurred shortly after vaccine, would hold off on second vaccine for now.
This spontaneous report was received from a Nurse via a company representative referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. In March 2014, the patient was vaccinated with a dose of GARDASIL (Dose, route, lot # and expiration date were not provided). In April 2014 (reported as a month later), the patient lost her ability to walk and play sports and was home-bound and could not go to school. In November 2015, the patient was diagnosed with coeliac disease. It was stated that the patient was placed on a "special diet" and that 2 weeks after she started the diet she was fine and back to normal. At the time of reporting, the outcome of abasia was unknown. The causality assessment between the events and GARDASIL was not provided. Upon internal review, coeliac disease was determined to be medically significant. Additionally, abasia was determined to be medically significant and disabling. Additional information has been requested.
Pain at previous hernia site. She was admitted for observation and was able to tolerate a diet, passed flatus and stool. On the date of discharge, 1/2/2022,  the patient was seen and examined, labs and vitals were reviewed and the patient was in stable condition.  Pain is controlled without narcotic medications, she is tolerating a low fiber diet diet, voiding, having bowel function, is mobilizing at baseline without assistance and she is neurologically  at baseline. she will follow up with Trauma/Surgery as scheduled and primary care. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Significant pain and swelling in the armpit under the vaccine administration site. Numbness in the hands began the next day and continues at night when she is laying down.
48 hours after the 2nd dose of the COVID-19 vaccine, he had generalized body aches that had worsened, chills, agitation/anxious, dizzy, and hyperventilating/ shortness of breath.  He went to the hospital with his wife on 3/1/2021.  He stated "I think I'm going to die".  Patient had been off Cymbalta  for 3 days completely- treating neuropathy (previous daily medication that his primary physician advised him with weaning down the dose).  The patient was manic and had tangential thoughts- from crying/angry to laughter.  It is believed that the agitation could be due to medication withdraw.
The pediatric nurse who administered the injection had been complaining (in conversation) of carpal tunnel and was wearing a wrist strap. When she gave the shot she did it overhand with no pinching of the deltoid muscle with the free left hand. She did the shot as if she were throwing a dart but with a sudden jabbing motion. The patient felt stiffness in her left arm on the same day that the injection had been administered. The following day she had limited mobility in the arm and could not raise it above her waist level; sleeping was extremely uncomfortable. We contacted the Dr and ADVIL was recommended. Three days after the injection had been given a prescription for prednisone was given. We did not give the prednisone to our child and continued with ADVIL and TYLENOL. Limited mobility continued for 2 weeks. We consulted a shoulder surgeon/specialist who said the injection had gone into the bursa sac instead of the deltoid and that our child had bursitis. Activity, stretching and cardio exercise was recommended to decrease the inflammation as well as 3 x 200 mg ADVIL plus 2 x 200 mg TYLENOL three times daily for 10 days. One month later, our daughter has more mobility in the arm but still has stiffness. This was an unfortunate occurrence because she is a high school athlete who is in the middle of being recruited by colleges.
weak; on the toilet with diarrhea; has not been to bed all night; hot flashes; toes were hot; stomach was bloated; in the bathroom every half hour during the night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (has not been to bed all night), HOT FLUSH (hot flashes), FEELING HOT (toes were hot), ABDOMINAL DISTENSION (stomach was bloated) and HYPERTONIC BLADDER (in the bathroom every half hour during the night) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INSOMNIA (has not been to bed all night), HOT FLUSH (hot flashes), FEELING HOT (toes were hot), ABDOMINAL DISTENSION (stomach was bloated) and HYPERTONIC BLADDER (in the bathroom every half hour during the night). On 25-Feb-2021, the patient experienced ASTHENIA (weak) and DIARRHOEA (on the toilet with diarrhea). At the time of the report, INSOMNIA (has not been to bed all night), HOT FLUSH (hot flashes), FEELING HOT (toes were hot), ABDOMINAL DISTENSION (stomach was bloated), HYPERTONIC BLADDER (in the bathroom every half hour during the night), ASTHENIA (weak) and DIARRHOEA (on the toilet with diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.