chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu-like thing; stomach cramps; diarrhea; swollen arm; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu-like thing), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), PERIPHERAL SWELLING (swollen arm) and PYREXIA (fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (sulfa). Concomitant products included COLLAGEN and VITAMIN B NOS for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INFLUENZA (flu-like thing), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), PERIPHERAL SWELLING (swollen arm), PYREXIA (fever) and NAUSEA (nausea). On 25-Apr-2021, INFLUENZA (flu-like thing), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Patient had not taken anything to relieve reactions, patient said just wanted to sleep.
Patient was administered DTap/IPV/Flu vaccine within 5 minutes or less after vaccines given, patient developed generalized flushing and urticaria and swelling of lips noted, anaphylaxis.  Patient given Epinephrine SC and Decadron IM with with good response.
Information has been received from a pharmacist concerning a six year old female patient, who on 10/15/99, at the age of 13 months, was vaccinated with a dose of varicella virus vaccine live. The pharmacist reported that the patient is a pre-intestinal transplant patient, who underwent standard laboratory tests prior to transplant and she did not show seroconversion or symptoms after a recent titer. At the time of the report in April 1005, it was noted that the patient was hospitalized as a transplant patient. The pharmacist reported that the patient was revaccinated with varicella virus vaccine live due to the recent negative titer. The reporter also mentioned that the patient's serious underlying GI condition requiring intestinal transplantation was in no way related to varicella virus vaccine live. No other information regarding the adverse event or the patient's outcome was available. There was no product quality complaint reported. Additional information has been requested.
Pt received Varicella dose and Proquad dose, pt was to have MMR.  Pt had no reactions, no rashes.
GI problems- steatorrhea, nausea, vomiting, weight loss, headaches, low grade fevers, heart throbbing, discoloration to vaccine site (vitiligo).  Tested positive for Covid 19 2 days after my vaccine. I am questioning if I received the correct vaccine. I have received flu vaccines for the past 10 years with no side effects. I called to ask the manufacturer and they were unable to tell me. I?m wondering if I received the COVID-19 vaccine instead of the flu vaccine.
Patient had seizure like activity 5 days after vaccines. Has had these same vaccine in the past with fever to 100.  Patient is a 6 m.o. male. History provided by father and mother. He is a very active baby. Mom feels like he has been advanced compared to his sibs. When he was 3 months old, mom noted that he moved his hand and feet more than any other kids she know. Sometimes he will stiffen his feet for no reason. Over the past few weeks he has been moving his hands (twisting, shaking) and a week ago he had some shaking along with it. Mom was holding him and he had some arm shaking and hand movement. On Tuesday he had an episode while he was in the car seat, mom noted that he was staring in to space and he had arm shaking. (He had recently had his 6 month vaccines and he has had a fever with previous shots although he did not note fever that day). On Wed he looked more tired than expected then he tilted to one side and mom could not get his attention. His mouth was open and his feet were pointed.
On 07Mar2021: he received the first dose of the vaccine. Last Monday, he came down with COVID-19; he came down with COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), via an unspecified route of administration on 07Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The report stated as, on 07Mar2021: he received the first dose of the vaccine. Last Monday, he came down with COVID-19, which he says he has recovered from now. His second dose is scheduled on 28Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test and tested positive on 22Mar2021. Outcome for the event he came down with COVID-19 was recovered on an unspecified date and remaining event was unknown.  Information on the lot/batch number has been requested.
Information has been received from the mother of a 21 year old female with penicillin allergy who in 2006 was vaccinated with HPV vaccine. There was no concomitant medication. The patient's mother stated that following vaccination, her daughter was sick. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No further information is expected.
approx 2 days following vax pt exp upper resp sx, bad gastrointestinal problems a few hrs prior to having tonic clonic sz while asleep; also has had partial sz episodes;
BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included mild covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and headache. This report was non-serious. This case, from the same reporter is linked to 20210359766.
Pt developed fever and chills, leading to restless night and malaise and body aches the following day. Pt received TYLENOLl for fever.
Has been acting deranged and very angry/having a deranged behavior and angry after getting the shot; Has been acting deranged/ having a deranged behavior; noticed a change in her attitude; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 90 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Manic depression" (unspecified if ongoing), notes: manic depression/manic depressive. The patient's concomitant medications were not reported. The following information was reported: ANGER (non-serious), outcome "unknown", described as "Has been acting deranged and very angry/having a deranged behavior and angry after getting the shot"; ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "Has been acting deranged/ having a deranged behavior"; PERSONALITY CHANGE (non-serious), outcome "unknown", described as "noticed a change in her attitude".  Additional information: Reporter stated she was calling regarding her step-mother who has a history of manic depression/manic depressive. After getting the COVID vaccine she has been acting deranged, she is a very angry person and has not stopped. She stated she wants us to do a study to see how this vaccine effects people, especially people who are older. Her step mother is in her 80s. She has manic depression and we need to know these details. She has been having a deranged behavior and angry after getting the shot. She will be calling the CDC next. She wants us to take a closer look at manic people. Her step mom normally has a good attitude, but since she got the shot she has been acting deranged and really angry which is not her. She is normally a loving, dancing person. The family has all noticed a change in her attitude. She just wants to do more research and find out who the vaccine is good for and not good for. She stated it is unknown apparently how long these events will last for the patient.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with brain fog, unable to focus, fatigue, chills and body aches.  Continued to progress to temp 101.8, shaking chills, EXTREME arm pain, upper back pain, chest pain, wheezing, SEVERE headache, nausea, vomiting, diarrhea, EXTREMELY swollen axillary lymph nodes enlargement.  Symptoms started approx 2 hours after injection and proceeded for 6 days then started to slowly improved then resolve.
On 09/28/2021 I had congestion, chills, fever, headache consent, diarrhea, nausea. Still having headache and nausea to the present date 10/13/2021.
Mom states Friday night after vaccine there was some puffiness at the site. Sunday it was red and hot at the site. this morning the redness has spread down his arm. Mom tried some Tylenol yesterday with no effect. Walk in treatment advised
Report is being submitted as a vaccine error as pt received a second booster for covid vaccine which was not indicated as pt was under the age of 50 and did not qualify as being immunocompromised.  Vaccine error was noted the following day on 7/7/22 when pt called the office and discussed if booster had been needed.  Pt. reported that she had come in to office to request and receive the booster due to increased prevalence of covid cases in the workplace.  Pt. denied any adverse reaction to receiving the vaccine.  There is no adverse event to report and no medical tests performed.
A thrid dose of Rotarix was given to child.  First 2 doses were given at 2 months and then 4 months of age - which is recommended per vaccine  guidelines- 3rd dose however was inadvertently given.     No adverse event was reported by parent or guardian.  As vaccine was given outside of label instructions, it is being reported today.
Patient returned to room about 15 minutes after vaccines administered. Noted red raised lump on (L) thigh. Patient did not have any difficulty breathing.
I woke up the next morning with bad muscle and joint pain, chills, nausea, threw up and had fever. This was worse than when I had covid.
no adverse event; expired ROTATEQ inadvertently adminsitered to a child; ROTATEQ administered to a child; ROTATEQ 0.5 ml was administered; This spontaneous report was received from an unspecified reporter (provider) referring to a child patient. The patient's pertinent medical history, concomitant therapies, drug reactions/allergies were not reported.  In the morning of 06-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (0.5 ml, once, lot # 1660666 has been verified to be a valid lot number and expiration date was 22-MAR-2021), taken orally for prophylaxis (expired product administered, inappropriate age at vaccine administration, and underdose). The dose never had a temperature excursion and was supported per the post-expiry memo. No product quality complaints or additional adverse events were reported, and no further information was provided.
Information has been received from a pharmacist concerning a pt who on approximately 10/21/02 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Post vaccination the pt developed swelling of the left arm. Unspecified medial attention was sought. Additional info has been requested.
COVID BREAKTHROUGH - 58 year old female. She is Admitted to Medical Med/Tele for COVID19, Neutropenic Fever, Abdominal Pain, UTI, Metastatic Lung Cancer to Spine and Brain on Chemotherapy,and Elevated LFT's. First covid dose 4/19/21. She has recieved the booster shot on 12/7/21.
Tested positive for COVID, Slight fever treated with Tylenol, Cough & Congestion treated with expectorant & liquids
CoughWheeze, Fatigue, Itchy throat, Short of Breath, Cough, Anxiety Narrative:
patient reported  facial swelling and L sided droop starting after the 2nd Moderna vaccine he received on Friday 4/23. Noted initially a headache, not localized to any area, and about 8-10 hours after noticed facial swelling bilaterally on eyes, lips, and down to his throat. His L side of the face was also noted to be drooping, the next day, including inability to raise his eyebrow on L, difficulty closing L eye, and a L sided mouth droop. Reports the swelling started to get better just prior to arrival in ED, however is still persistent and includes the lips and throat, says it feels like the inside is swollen. Was able to tolerate liquids but noted some difficulty. Denies any difficulty breathing. Also denies any extremity weakness, vision changes, balance issues, speech deficits other than what's related to lip swelling and mouth droop
20 minutes after receiving vaccine patient walked up to pick up counter to tell someone she did not feel well- sweating and headache.  Patient could not speak and passed out.  EMS was called and responded.  Vitals checked out ok. Patient was not transported.  Patient's  mom was called and came to pharmacy. Patient rode home with mom.
9 month-old child was supposed to receive a Pentacel vaccine, but the CMA administered only the DTaP/IPV portion, without reconstituting the Hib with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a health care professional on 15-Dec-2020.  This case involves a 9 month-old child who was supposed to receive a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL) vaccine, but the CMA administered only the DTaP/IPV portion, without reconstituting the Hib (medication error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar).  On an unknown date, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 mL daily via intramuscular route right thigh (lot number: UJ390AA; Expiration date: 10-Dec-2021) for prophylactic vaccination.  On an unknown date, it was reported that the 9 month-old child was supposed to receive a Pentacel vaccine, but the CMA administered only the DTaP/IPV portion, without reconstituting the Hib (medication error) (non-serious event) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No laboratory tests were reported.  It was not reported if the patient received a corrective treatment. At the time of report, the outcome was not applicable for the event.  Disclaimer: 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 2001/83/ec and module VI of the good pharmacovigilance 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.
Warfarin (Coumadin). Office/Lab visit within 6 weeks of receiving COVID vaccine.
right shoulder and left knee are experiencing moderate pain; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left on 24Mar2021 02:15 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Not allergies reported. The patient experienced right shoulder and left knee are experiencing moderate pain on 25Mar2021 08:00. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Swelling of arm (tricep area), redness, hot to the touch, hanging skin. Started Friday 6/9/17. No treatment. Called doctor who said prednisone was not necessary.
About two weeks ago, I started to notice my legs were itching more than normal. Then, this Monday (4/26),  the skin on my legs started burning. On Tuesday (4/27),  I woke up not feeling the burning, but as I started my day, my skin on my legs started to feel like there were pin pricks all over. This then transitioned to the burning that I felt on Monday. Since Tuesday, I wake up and my legs feel fine, but as I go about my day, my skin starts to burn, with the burning sensation increasing in intensity until the afternoon.   Given my history of Hodgkin's lymphoma, I saw my oncologist today. My blood work was all normal and he said the symptoms do not indicate lymphoma. He did some simple neurologic tests, but nothing is out of the ordinary. I mentioned that I had received the COVID vaccine two weeks ago. He said my symptoms did not sound like Guillain Barre, but recommended that I contact someone who might be better positioned to know for sure - like the CDC. He also suggested that I confer with an expert before I get my second COVID dose.   If possible, I would appreciate speaking with an expert who could advise on next steps, as well as to let me describe the symptoms in more detail  - if warranted. I want to get my second COVID vaccine dose, but I also recognize the concerns re: Guillain Barre.  Thank you.
Noticed some itching on my left arm at injection site and there was 3 large sized welts/hives on that area of my arm. They were itching, red, raised and slightly warm. Seen by CNP 1/4/21 Advised to take benedryl. Took some that night . This morning still have the 3 welts and still red but, the itching is not as bad as yesterday.
We tended to younger brother after shot, he was pale and nauseous, but likely due to 'fear' of shot. We sat and waited a good 15 minutes for him to feel better and then a nearby friend's son felt ill - his throat. We stayed to sit with them to see if they needed our help, so then my son, patient came up and indicated his arm was tingly. And then within a few minutes he came up and passed out in my arms. I laid him to the floor and called for paramedics. The lady with me is a school nurse and she indicated that she thought he had a seizure, biting his lips, eyes were strange. After going to the floor he was out perhaps 30-60 seconds and then work up screaming at me - Mom, I'm fine, let me go, Mom, I don't know how I got here! We got him calm down and his eyes were very dialated. The paramedic took his blood pressure and was 70/40. After 15-20 more minutes, he became more aware and vitals were better. We sat him up and he was dizzy, laid him back down and called ambulance. When they arrived they stood him up and indicated perhaps he didn't need to go to the hospital. Today is he fine.
Spouse called stating that she has been tired feeling with headache not able to perform activities of daily living. Also, stated that both sites were very sore and hot feeling.
Initially no symptoms, however the next day I had a terrible headache and warped vision. On day 2, I felt sluggish in the morning and by the afternoon I was nauseous and had a fever.  The fever continued for several days from 99.5 to 102.9. On day 3, I began vomiting and was unable to keep down water. On day 4, I reported to the ER where I was treated for dehydration. The ER department also ran extensive lab and it showed I had high liver enzymes. They did a sonogram to check my gall bladder and determined my liver was enlarged. M y temperature was 98.5 upon leaving the ER. After leaving the hospital, I began having diarrhea. At this point, I had not eaten for almost 2 days. I went on a liquid only diet to help keep hydrated and stop the diarrhea. On day 5, I woke up with very red and hot hands and feet. They were painful to the touch. Also on this day, my fever returned to 100.2 and began fluctuating until the evening of day 6. The diarrhea continued on day 6, probably because of the medicine at the hospital for acid reflux and indigestion. They hydrated me with 2.5 IV bags in less than 9 hours. On day 7, I had my first 'real' meal and notice the redness and pain were replaced with a measles like rash on my hands. Which caused constipation. On day 6 and the 2 days following, I didn't have a fever, my hands and feet had returned to normal, but itched, and I didn't have many symptoms, but felt very sluggish and fatigued. On 5/29/2021, more than 2 weeks after the 2nd shot, I noticed blisters on my fingers. I have made no changes to any health and beauty products or done any work to cause this. The blistering has continued today, 6/1/2021. I'm also having reactions to food I could once eat so it seems I've developed food allergies. I don't know what is causing stomach pain and nausea eating foods I've never had a problem with. I'm also still feeling very fatigued. I have to take frequent breaks when completing simple tasks.
Abnormal Pap smear with mild dysplasia and HPV present on smear.
Patient reported feeling dizzy, anxiety, trembling hands, and a mild headache. Patient was hypertensive, tachycardic, and afebrile. Blood glucose within goal.
Pt had prevnar 13 on 10/2/18.  Pneumovax 23 was last vaccine to give.  Patient stated the next morning he felt like his arm was swollen, warm to touch below injection site.  The pharmacist yesterday instructed him to ice and use an anti-inflammatory.  Patient came in today around 3:16pm stating his arm was still swollen and red, but the redness had moved down his arm.  The swelling was above and below elbow.  Contacted the patient's pcp Dr. and left a message.  Instructed the patient to go to the urgent care next door, but he said he would ice it and take Naproxen.  We had him mark his arm, and I instructed him if the redness expands or is still warm to touch seek medical treatment.
I received the first dose of the Pfizer COVID19 vaccine on 03/14/2022 at approximately 2:00 PM. By the next morning at 8:00 AM, I began to have a horrible headach, fever, and facial pain/sensitivity. By midday, I began to notice vesicles appearing on my nose and left forehead. On 03/16/2022, I was diagnosed with facial shingles by my PCP. I then started Valtrex orally. As of today, 03/23/2022, I still have vesicles but it has started to heal.