chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rotarix was reconstituted with sterile diluent and administered orally to patient. Pentacel was not reconstituted and patient only received HIB portion of the vaccine intramuscularly. No adverse reaction reported by patient's guardian. Patient is being brought back in clinic to be revaccinated for both rotarix and pentacel per manufacturer recommendations.
About 15-20 minutes after receiving the vaccine clients right side of tongue and lips started swelling.  Client immediately given  Benadryl and symptoms began decreasing.   Client states she has a history of allergic reactions and she will plan on taking the Benadryl on the regular schedule for the next several days.
Fever (102F); Sore Arm; Fatigue; Headache; Body ache; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 46-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 06Dec2021 at 09:15 (Lot number: FF8839) at the age of 46 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EN6203, Anatomical location: Right arm, Administration time: 11:00, Route of administration: Intramuscular), administration date: 23Mar2021, when the patient was 45 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6203, Anatomical location: Right arm), administration date: 01Mar2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 at 09:15, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Fever (102F)"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Sore Arm"; FATIGUE (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Fatigue"; HEADACHE (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 07Dec2021 at 01:00, outcome "recovering", described as "Body ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, fatigue, headache and pain. Additional Information: The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
lump at infection site; Redness; swelling; fatigue; full body aches/pain; joint pain; This non-serious case was reported by a consumer and described the occurrence of injection site lump in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 579F4, expiry date 23-JAN-2025) for prophylaxis.   On 23-SEP-2023, the patient received Arexvy. On 24-SEP-2023, 1 days after receiving Arexvy, the patient experienced injection site lump (Verbatim: lump at infection site), erythema (Verbatim: Redness), swelling (Verbatim: swelling), fatigue (Verbatim: fatigue), general body pain (Verbatim: full body aches/pain) and joint pain (Verbatim: joint pain).  On 29-SEP-2023, the outcome of the injection site lump, swelling, fatigue, general body pain and joint pain were resolved (duration 5 days) and the outcome of the erythema was resolving (duration 5 days).   It was unknown if the reporter considered the injection site lump, erythema, swelling, fatigue, general body pain and joint pain to be related to Arexvy.     It was unknown if the company considered the injection site lump, erythema, swelling, fatigue, general body pain and joint pain to be related to Arexvy.   Additional Information: GSK Receipt date: 14-SEP-2023 The patient self-reported this case. The patient experienced redness, swelling, pain, lump at infection site; fatigue, full body aches, joint pain. The symptoms were not treated. The reporter agreed to follow up.
2nd day started feeling nauseous and begin more and more..by middle of night voimitting and diarehha 3rd day Wed. sick in bed could not do anything but only diareahha today Thursday still have red patch on arm and its warm but doesnt hurt feel cloudy and yuk feeling very dizzy still
Initial unsolicited report received from nurse on 11 October 2016. This case involves female patient (age not reported) who was vaccinated with dose of Fluzone (Batch number, expiration date, dose, site and route of administration were not reported) on an unspecified date. Patient medical history and concomitant medication were not reported. It was reported that on an unspecified date the patient was hospitalized for cellulitis (date unspecified) following getting a flu vaccine about 5 years ago. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none. Sender's Comments: Patient had cellulitis following INFLUENZA QUADRIVAL A-B VACCINE 5 years ago. Time to onset is unknown, detail medical history, allergic history, site of cellulitis, past vaccination history are needed to further assess the case.
Diarrhea on/off  for 8-9 days following vaccine. began the evening of the vaccine along with malaise, fatigue. Diarrhea has resolved but continues to have " unsettled feeling"
School nurse reports pt has 1", 1/4" raised cyst like lump on wrist. Pt states occurred after IPV injection. No redness or tenderness.
loss taste; loss of smell; Runny nose and slight congestion; runny nose; Sore arm day of injection; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old  patient of unknown gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) via an unspecified route of administration in the arm right on 18Mar2021 at 14:45 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive medication within two weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab test on 26Mar2021 which included nasal swab test, blood test, PCR, rapid COVID test and COVID antibody test and all the test result was negative. On 18Mar2021 the patient experienced sore arm, on 23Mar2021 the patient experienced runny nose and congestion and on 26Mar2021 the patient experienced loss taste and loss of smell. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events sore arm, runny nose and congestion, loss taste and loss of smell was recovering.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received PREVNAR 13, (Lot number and expiration date were not reported), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, both the patient's forearms broke out in rashes. The outcome of the event, 'both the patient's forearms broke out in rashes', was unknown. No follow-up attempts are possible. No further information is expected.
Hives and red rash started on right leg where the injection site was.  About 10:00 AM the hives spread to other leg.  Benadryl was given.  About 3:00 P.M., the hives spread to back and face.  Patient also started to cough.  He was then taken to the ER.
15 minutes post-vaccination patient complained of itching all over her body.  Rash in some areas was also visible.  BP was taken at that time and was 150/72 and Pulse was 100.  Ambulance was called to transport patient to the ED.  Patient denied ever having any difficulty breathing.
Ping pong size knot at vaccine site; Site warm to touch; Always itchy; This is a spontaneous report from a contactable consumer or other non hcp. A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration in the left arm on 20May2021 at 15:30 (age at vaccination 48-year-old, Pregnant at Time of Vaccination: No) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and obesity, all from an unknown date and unknown if ongoing. The patient did not receive any concomitant medication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 09:00, the patient experienced ping pong size knot still at vaccine site 2 weeks after vaccinated, site still warm to touch and always itchy at the time of reporting. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events ping pong size knot at vaccine site, site warm to touch and always itchy was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Case number PHHY2011US37915 is an initial spontaneous report received from a health care professional on 03 May 2011 which combined an internal review on 13 May 2011 of the data received on 02 May 2011. The MRD of the initial report was wrongly reported as 03 May 2011 instead of 02 May 2011. This report refers to an adult male patient. He was given the lyophilized Men A component of MENVEO vaccine (batch number A100034) reconstituted with sterile water instead of the MenCYW conjugate component, intramuscularly on 28 Apr 2011. No other adverse reaction was reported. Following internal review on 13 May 2011 the MRD of the initial case was corrected.
About 3 AM, chills, dizziness, weakness shortness of breath. Normal breathing restored after 40 minutes followed by fever and extreme exhaustion. Episode began to end about11:00 AM same day.
This spontaneous report was received from a registered nurse referring to a 46 year old male patient. The patient's concurrent conditions included multiple sclerosis, erectile dysfunction and arthritis. The patient had no drug allergies or reactions. On 17-AUG-2015, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, (dosage, route, lot number and expiration date were not provided). On 30-SEP-2015, patient had titers drawn which exhibited that the patient did not seroconvert (seroconversion test negative). On 05-NOV-2015, the patient was administered with a second dose of (Oka/Merck) VARIVAX (dosage, route, lot number K026387, expiration date 15-DEC-2016) and patient was tested again for titer on an unspecified recent date. Titers exhibited that the patient did not seroconvert (seroconversion test negative). Concomitant therapies included TYLENOL, amitriptyline hydrochloride, CIALIS and RAPAFLO. It was unknown if the patient finally seroconvert. Additional information has been requested.
Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No relevant concomitant medications were reported.   On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccines were administered.   No treatment medication reported.   This case is of patient 13 out of 26 patients.
pt recv vax & immed post vax pt was inconsolable for 3hr & cried for addtl 2;always has high pitched cry;
After patient left store, experienced hives that covered entire body. Patient took a BENADRYL which did not aleve symptoms. Seeked medical attention, Dr. who prescribed oral and topical steroids. Next day, saw allergist who prescribed SINGULAIR and ZYRTEC. Symptoms lasted 5-7 days.
Storage and handling excursion- Patient was given a dose of pfizer vaccine past BUD time of 6 hours- with labeled expiration time of 3:00PM of 8/11/2021 dose was given at 3:45PM .
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was provided as follows: The patient's demographic details were unknown. The age at vaccination was not reported. The reporter stated that the patient received SHINGRIX at a pharmacy. The patient complained of arm being so painful that it was useless for 24 hours then the pain slowly faded away. The reporter did not agree to follow up. This case was linked with US2018GSK054705, reported by the same reporter.
Immediate pain "felt like burning" in her arm as soon as the vaccine was administered.       She noted swollen nodes in her L axilla and leg aches after this time and the symptoms have persisted. Hurts to touch her thighs. Still sore in the L upper chest/breast area. No palpable breast mass. Movement provokes her current pain.    Evaluated on 4/15/21 and suspect rhabdomyolysis and reaction from COVID 19 vaccine.
Dizziness; Shortness of breath when exerted at all; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 10:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/norethisterone acetate (JUNEL) taken for birth control from an unknown date and unknown if ongoing. The patient previously received measles vaccine/mumps vaccine/rubella vaccine on an unknown date for an unknown indication and experienced allergy to vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 12:00, 36 hours after vaccination, the patient experienced dizziness and shortness of breath when exerted at all. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and shortness of breath when exerted at all were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I got the pneumonia shot in my left upper arm about 2 hrs. later my arm began to hurt and about 2 to 3 hrs later it was sore and swollen - red - feverish and hot to the touch by 9 PM it was swollen so big and red all around my arm from top of shoulder to my elbow. I had a bad time at night - couldn't sleep. I got the shot on 1-27-2018 on Saturday - It was very sore all over my arm. So swollen it didn't look like my other arm. It was sore and swollen. I could hardly move my arm, it hurt so bad. Sunday and Monday it began to get better, the swelling began to go down and the fever was better, by Tuesday it was a lot better. It I'd known all the pain and fever and discomfort I had endured a pneumonia shot, I wouldn't have gotten it. This adverse reaction was the direct cause of the pneumonia shot. There's no doubt in my mind what so ever. Shot ingredient name - Pneumococcal Polysaccharide Vaccine (23-valent). I am 72 yrs. old - I've gotten the flu shot every year for the past 35 yrs - and I've never had any problem except a little swelling at injection site and a little pain. Last year 1-26-2017 I got the pneumonia shot and it barely hurt later.
This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a 59-year-old male patient who received SHINGRIX. On 12th March 2018, the patient received SHINGRIX. On 12th March 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty thinking (serious criteria GSK medically significant), injection site pain, tiredness and weakness. On 17th March 2018, the patient experienced generalized pruritus and general body pain. The patient was treated with BENADRYL and TYLENOL. On an unknown date, the outcome of the difficulty thinking, injection site pain, tiredness, weakness, generalized pruritus and general body pain were recovering/resolving. The reporter considered the difficulty thinking, injection site pain, tiredness, weakness, generalized pruritus and general body pain to be possibly related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. This case was reported by the registered pharmacist. The patient experienced soreness at the injection site. The reporter did not know which arm the patient had the injection. That  evening, the patient reported he felt tired and weak. The patient reports that he could not think clearly. On Saturday 17th March 2018, the patient experienced itching all over his body and pain all over his body. On Sunday 18th March 2018, the patient took BENADRYL and TYLENOL. When the patient contacted the pharmacy today on 20th March 2018, all of the events were improved, but there was still some itching present.
pt recvd vax & 1 hr p/vax exp 4 cm redness & swelling @ the inject site, malaise, & nausea;
This spontaneous report as received from a non-healthcare professional via social media regarding a 14-year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot, expiry date, dose, strength were not reported) for prophylaxis. On an unknown date, the patient experienced seizure and epilepsy. On an unknown date, the patient died due to unknown cause (medically significant). It was unknown if autopsy was performed. Outcome of seizure and epilepsy was unknown. Causality for the events was not reported. Upon internal review, the events seizure and epilepsy were determined to be medically significant. This is one of the three reports from the same reporter. Reported Cause(s) of Death: unknown cause of death.
Approximately 10 minutes after employee was given immunization she states she was feeling dizzy. She laid down on exam bed for approx. 5 min. and then sat in chair with no change in dizziness. Denied any other symptoms.
developed raised rash, back of arms, back of legs, sides of hips (just above where my hand rest on legs)
Case number PHEH2015US021049, is an initial spontaneous report received from a pharmacist on 16 Oct 2015. This report refers to a 3 years old male patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173988) intramuscularly at a dose of 0.5 ml o 14 Oct 2015. The case was reported as non-serious. No adverse event was reported following the maladministration.
1 hr p/recvd flu vax pt exp local pain/adenopathy @ inject site lt deltoid; paresthesia to the fingers was also noted; pt required ER/MD visit; recovery occurred w/in 48 hrs;
I've had a moderate case of SIRVA for the past month. Shoulder pain that is still persisting. I believe this was caused by the nurse administering the vaccine too high on my arm - the  shot was very close to my acromion.
chills in AM; fever about 530PM 102 x 2 days then 99.8 x 2 days then 102 x 2 days;12OCT95 saw MD;13OCT95 temp 104;14OCT95 & cont 100;APAP decreases fever some nausea;
Patient returned to the pharmacy 12/28/2019 and showed me his left arm complaining of itching and redness. I took a look at his arm and it there was a large area which was pink and very warm to the touch. The patient said it was not painful at all, just very thcing and he has noticed the pink area has spread in the last 2 days is worsening. He did not do anything to treat it, but asked for an over the counter remedy before he goes into his doctor  I recommended Benadryl for the possible allergic reacton and hydrocortisone cream topically. I recommended he go to his MD since it is spreading and warm to touch and there may be an infection beginning.
Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given.  She also felt dizzy for about 30 seconds but this resolved on its own. Pt reported to staff.  Vital signs were taken Temp 97.9, heart rate 84, BP 124/85.  Pulse was regular.  Pt denied any ongoing dizziness or other symptoms.  She was given apple juice and monitored for another 15 minutes with no further symptoms
pt recv vax;2 days later,devel gen,morbilliform erythematous rash,predominantly on lower half of body
Rash and hot and swollen injection site. On 8/25/13 developed severe strep throat, on 08/28/13 developed rt upper lobe pneumonia, then on 09/5 treated for sinus and on the 9/25 for another sinus then on 10/15/13 pharyngitis and sinus.
I noticed an intense itching on my chest. It looked like a rash that was going up over my shoulder and down my arms. It was like hives. It was very intense. A couple days later I went to my PCP. The doctor gave me some prescription to help. It didn't make the itching go away immediately, but it make it bearable until it went away. It left scars. It finally stopped itching after 2 weeks. I think they did some test but I have no clue what they were.
pt devel fever 3-4 days later then noticed having myoclonic sz then 2 wks later devel a rash all over body & the sz got severe & more frequent then went to MD & was diagnosed;