chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom reported pt had shots 10JUN91 AM, started w/irritability around 2PM also temp, given APAP but temp did not come down; Became worried 13JUN91 pt taken to clinic for eval;
02/14/2005 - 5 year old male child given 3 vaccines - DTAP right deltoid intramuscular, IVP - left arm subcutaneous, MMR - right arm subcutaneous.   02/17/2005 child presented with redness, swollen area 1x1.5 inches with warmth, complained of itching "but not so bad today" said child.
ADVERSE EVENT NOS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced adverse event nos. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from adverse event nos. This report was non-serious.
Undergoing COVID-19 vaccinations and developed acute hypoxemic respiratory failure with bilateral palm infiltrates.  Work up inconclusive for infectious etiology.  Treated preemptively for pneumonia with antibiotics and glucocorticoids.  Remains on oxygen but improving.
My throat started to close. I was itchy and had a difficult time breathing until I was given an epi pen.
Fever, chills, muscle aches that lasted for 36 hours. Soreness at injection site, swollen axillary lymph node on side of injection.
pt recv vax & w/in 12-24 hrs devel an inj site rxn characterized as red,raised,warm & 3 inches in circumference
potential not to get the second shot; headache; neck ache; fever; throwing up; This is a spontaneous report from a contactable consumer (grandparent). This consumer reported for a 12-year-old male patient (grandson).   A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jul2021 11:30 (At the age of 12 year old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller called on behalf of his grandson (12-year-old) who received the first dose of the Pfizer Biontech COVID-19 vaccine and on the same day he got the shot, he experienced headache, neck ache, fever, and throwing up on 07Jul2021. Stated that the headache gets better and comes better. Stated that it was tolerable and comes back. Stated that the fever comes and goes. Started throwing up 2-3 days ago. She wanted to know if those side effects were related to the COVID19 vaccine and if she needed to go to the doctor and if he could get the second dose. Caller also stated that the side effects outweigh the COVID shot, I do not want my grandchild to suffer like that. Vaccines were supposed to make you feel better, not sick. Caller asked if the vaccine was tested on children and if they had side effects. Wanted to know if she needed to go the doctor because he cannot live throwing up all the time. Stated that he had never been sick before. Stated that he was only 12 years old. Does not think that vaccine was adequate for children. Therapeutic measures included Ibuprofen for his headache and fever. Stated that he had cold compresses for the neckache. Stated that he had ginger ale and Pepto Bismol for throwing up. Outcome of the event headache and throwing up was reported as not recovered at this time of the time. Outcome of the event neck ache was reported as recovered on 11Jul2021. Outcome of the event fever was reported as recovering and outcome of the event potential not to get the second shot was reported as Unknown.   Information about the lot/batch number has been requested.
Patient rec. FLUZONE HD 12/7/16 4 to 5 hours later Pt report "felt throat closing" vomited and dry heaving did not access medical assistance all symptoms resolved by next day.
Office visit 5/24/05. Lesions on face, chest, back. Lesion of left upper eyelid. Referred to ophthalmology.
Patient had significant swelling of right arm where the vaccine was given, and pain. swelling started the night after receiving the vaccine and continued to get worse.  2 days after receiving the vaccine, he was seen at an urgent care clinic, and was diagnosed with a staph infection, and placed on antibiotics.  He began to improve that evening, and was recovered in several days.
Total loss of appetite/ I couldn't eat or drink anything; Loss of taste; I was felling very sick; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Total loss of appetite/ I couldn't eat or drink anything), AGEUSIA (Loss of taste) and MALAISE (I was felling very sick) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DECREASED APPETITE (Total loss of appetite/ I couldn't eat or drink anything), AGEUSIA (Loss of taste) and MALAISE (I was felling very sick). On 01-Jun-2021, DECREASED APPETITE (Total loss of appetite/ I couldn't eat or drink anything), AGEUSIA (Loss of taste) and MALAISE (I was felling very sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant product use was reported No treatment information was provided
Developed severe upper respiratory systems, nodules on the skin, had a tumor removed, bone fractures, gall bladder removal, chest pains, swollen liver, swollen spleen, chronic pancreatitis.
Pfizer vaccine in fridge beyond 30 days at time of administration. Pharmacist did not know until after administration. Discussed with patient, and he reported a sore arm. I advised to repeat vaccination.
Acute Lymphoblastic Leukemia; appetite reduced; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 14:00 as dose 2, single (Lot number: Fl8094) at the age of 5 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, lot number FI8092, dose administration time 3:00 PM, vaccine location Left arm), administration date: 19Apr2022, when the patient was 5-year-old, for COVID-19 Immunization. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The following information was reported: ACUTE LYMPHOCYTIC LEUKAEMIA (hospitalization, life threatening) with onset 12May2022, outcome "unknown", described as "Acute Lymphoblastic Leukemia"; DECREASED APPETITE (hospitalization, life threatening) with onset 12May2022, outcome "unknown", described as "appetite reduced". The events "acute lymphoblastic leukemia" and "appetite reduced" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (Oct2021) growth are all normal, notes: Child was 100% healthy and previous blood reports Oct2021. Therapeutic measures were taken as a result of acute lymphocytic leukaemia included Chemotherapy. After receiving COVID vaccine, kids appetite reduced and after a month kid diagnosed "Acute Lymphoblastic Leukemia".
Breakthrough Covid-19 infection, symptoms June 9, confirmed by antigen test following day, low fever, chest congestion, fatigue, all mild. Treated with 5 day course of Paxlovid.
Pt was here for a WCC visit. Vaccines were administrated at 10:20am.  Not long after, pt fainted for about 10-15 seconds.  Medical assistant picked baby off the table and patted her back.  Patient then became alert and started crying.  Juice given to patient and provider was called. MD came to the patient and stated that he thinks she had a Vasovagal  syncope.  Noted large rash around both injection sites.  Patient was then monitored for about 15-20 min and left acting normal.  Mother was here with patient.  I have reported to VAERS
This spontaneous report as received from a Physician assistant refers to a 24 year old female patient. Medical history, drug allergies and concurrent conditions were unspecified. On an unknown dates the patient was vaccinated with GARDASIL (also reported as manufacturer unkonwn and could not be ruled out) 1st and 2nd dose (strength, dose, route and lot number were unspecified) for an unknown indication when she was in high school. On an unspecified date, the patient was seen at the medical office and stated that she tested positive for an HPV type, but she did not know which one. No treatment was given. No product quality complaint (PQC) was involved. The outcome of event was unknown. Reporter causality assessment was not provided. Additional information has been requested.
Patient is a 32 year old male with PMHx of chrohn's dz, IBS, PSHx of none and not a smoker, who presents to the UCEC for URI symptoms for the past 6 days. Pt reports initial onset with fever, ear pain bilaterally and sore throat on Monday and developed intermittent prod coughing that is brown on Wednesday and then developed SOB worse when lying down since last night. Pt reports associated symptoms of nausea only in the AM and intermittent diarrhea (but has Crohns and not currently on meds yet but saw GI 2 wks ago) Pt reports taking benzonatate and tylenol for the symptoms w/relief. Denies CP, HA, dizziness, vomiting, or any other symptoms at this time
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot#, strength, dosage, route unknown). On an unknown date the patient developed cellulitis. The outcome of cellulitis was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt returned approx. One and a half hours later, stating he was cold and shivering. Pt stated feeling light headed, dizzy, and a little nauseous. Pt was placed in imm office laying supine with feet elevated. Pt was given warm blankets and a nurse was notified.
On April 2, 2021, Offender presented for CoVID vaccine clinic, unbeknownst to staff, offender had received first CoVID vaccine on March 16, 2021.  Staff administered dose of vaccine to offender.  This was approximately 11 days too early to receive his second dose of vaccine.  Offender had no complaints or side effects from receiving vaccine early.
Area about the size of a softball was red, not swollen, warm to the touch and painful.
Initial unsolicited report received from a pharmacist via other company (Merck) (case number: 00181567) on 14-Sep-2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus Toxoid Adsorbed) (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient had an unspecified allergic reaction. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
15 hrs post vax/Wednesday  AM: woke with notable chills, migraine, fever, severe body aches, extreme lethargy, nausea, painful vax arm Last until 28 hours post vax with migraine lingering but treatable with Tylenol.  39 hrs post vax/Thurs AM : woke with extremely itchy upper arm at site of vax. Skin was hot to touch and red rash starting around vax sit spread up over shoulder and down towards elbow quickly after itchiness began. Had to treat with benAdryl and cold compress. Rash was visibly shocking to see. Shot site was still sore and painful. Rash/severe itchiness resolved on it own over next 24 hours.  fri and Sat (18th-19th) arm mildly sore, rash clear but still has random itching at vax site.
feel chest tightness/pressure/pain intermittently, worse on evening of 4th day post vaccine; feel chest tightness/pressure/pain intermittently, worse on evening of 4th day post vaccine; This is a spontaneous report from a contactable consumer (patient himself). A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 17:30 (at the age of 58-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Other vaccine received in four weeks was none. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient reported that, 2 days post vaccine started to feel chest tightness/pressure/pain intermittently, worse on evening of 4th day post vaccine on 05Mar2021 at 19:00 (as reported). Patient did not receive any treatment for the event. Outcome of all the events were recovering.  No follow-up attempts are possible no further information expected.
Chills; Fever; body aches; headache; muscle aches; joint pain; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot. FC3181) on 21Aug2021, at 03:45 PM, in the left arm, at single dose, for COVID-19 immunisation. Relevant medical history included Penicillin allergy. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 21Aug2021, at 07:45 PM, the patient experienced chills, fever, body aches, headache, muscle aches and joint pain. No treatment was received. Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Headache, nausea, chills, feverish, body aches, diarrhea, joint pain
Patient stated that after getting her second dose on 3/19/21, she experienced bloody diarrhea shortly after that. Pt thought it was normal and expected side effect so didn't inform us until 3/31. Till that date, she was still having bloody diarrhea with dizziness as well so advised her to go ER or if your physician can see you right away then try to contact them as well. Also told her to keep the fluids up
arm hurt for three days; This 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.   In February 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, 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 Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR056428   Additional Information: GSK Receipt Date: 25-MAR-2022 Reporter's Comment: The patient received dose of Shingles vaccine last month and experienced arm hurt for three days. The patient stated that the Shingles shot was not too much worse than a flu shot. The patient also stated that he/she was not interested in finding out how shingles felt. Getting on face or eye could be very serious. Additional supportive information: The patient self-reported this case via interactive digital media. The follow-up would not possible, as no contact details were available. This case has been linked to the case US2022AMR056428 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR056428:same reporter
Patient received the Pfizer COVID vaccination for the 1st dose on 07/16/2021. When he returned to the pharmacy on 08/06/2021  he was given Moderna COVID vaccination in error.  Patient has not had any reaction or adverse events after completing the vaccination today, 8/6/21.
Shortness of breath, chest pain; with the symptoms patient tried antihistamine medication and they are relieved in 3 days.
Redness, swelling right upper arm noticed evening after >24 hours after immunization given. Redness and mild induration, increased warmth 12 x 15cm diameters no fever.
macular rash 2 wk post MMR; myalgias; polyarthralgias; rt knee effusion 15th day past MMR;
has not received the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th September 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments: The case was reported by patient. The patient received the 1st dose of SHIGNRIX but had not received the 2nd dose as she was not aware she had to have the 2nd dose month 2 to 6. The reporter inquired if she would need to restart the vaccine schedule and what was the efficacy of SHINGRIX. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination.
Fever A spontaneous non-serious report of fever of less than 101 has been received from a physician in the USA concerning a child of unknown age and gender. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. On an unknown date, the patient received a dose of FLUMIST. The physician reported the event of fever of less than 101 three days after FLUMIST. Per the reporter, the patient was a young child: no demographics were available at the time of this report. The child had no other significant symptoms. Outcome for the events was not provided by the reporter.
Case number PHEH2014US019579 is an initial spontaneous report received from a pharmacist on 29 SEP 2014 and a follow up report from the pharmacist received on 06 NOV 2014. This report refers to a 46 year old female patient. Her medical history included metabolic disorders. Her previous vaccinations were tolerated. She was vaccinated with FLUCELVAX 2014/2016 (batch number: 013031A) at a dose of 0.5 ml intramuscularly on left side (unspecified whether arm or leg) on 26 SEP 2014 (at 2:05 PM). On 27 SEP 2014, after vaccination she experienced increased muscle pain and tenderness and arm tenderness. The pain started to decree from 27 SEP 2014 to 29 SEP 2014. The patient reported to the immunologist that she had increased pain at site of injection on 29 SEP 2014. The events recovered on 30 SEP 2014. On 01 NOV 2014, the patient stated that she had no other issues. The seriousness and causality of the events were not reported.  Follow up report from the pharmacist received on 06 NOV 2014. Added event pain at site of injection and medical history. Updated vaccination date, onset event dates and recovery date and final outcome.
Narrative:  Pt was an 84 YO male with PMH significant for dementia, CKD, and gout. Pt was in a severe MVA in May and after discharge from STR pt was transferred to home hospice, where he passed away.
Information has been received from a health professional concerning an adult male pt who was vaccinated with a dose of varicella virus vaccine live. Three years after receiving the vaccine, the man's child received varicella virus vaccine live and then the man experienced chickenpox. Medical attention was sought and he was treated with an antiviral agent. He recovered on an unk date. No product quality complaint was involved. The pt's experience was considered an other important medical event by the reporter (OMIC). Additional information has been requested.
This spontaneous report was received from the registered nurse regarding a 13 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 07-NOV-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
I have had significant changes to my menstrual cycle since the first menstruation following the 2nd dose of the vaccine.  All other reasons like perimenopause, hormone changes, inflammatory illness, thyroid, pregnancy etc have been ruled out via blood work by my doctor December of 2021 that were all normal.  My usually very regular cycle has been very inconsistent and even skipped since the vaccine.  I have also had very painful periods with a very heavy clotted flow since the vaccine.  All of this continues to be happening to date. I have also had generalized extreme fatigue, new onset acne, mood changes, weight gain, inflammation in my body, increased asthma episodes, GI bloating that also continue to date.
Patient received two doses of Moderna COVID-19 vaccines on 3/1/2021 and 3/29/2021, respectively; and was subsequently admitted to our hospital on 11/25/2021 and diagnosed with COVID-19 on 11/24/2021
51 y.o. male from a group home who presents with complaints of a cough for the last 1 week.  Patient states that he had a fever of 102 on Friday and 99.9 on Saturday morning with 97.7 on Saturday afternoon.  Patient states that he got Tylenol on Saturday which did help him feel better.  Patient states his cough was not getting any better therefore came into the ER for further evaluation where he was found to be COVID positive.  He has had one dose of J&J vaccine.  He was febrile to 102.2 in the ED.  He was also hypoxic and requiring 2 L of oxygen to keep his sats above 90%.  He had labs drawn in the ED.   In the ED his labs were relatively reassuring.  Patient admitted inpatient for treatment of COVID with supplemenoxygen, IV remdesivir, and dexamethasone.
The following morning after the flu injection I had severe pain to the bottom of my feet causing major difficulty in walking. The pain became progressively worse that day and had to stop walking several times that day. The pain was better by the evening and progressively improved by 9pm.  Still have tolerable mild pain but able to function.