chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue-slept most of the day; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:ER8772) via an unspecified route of administration in the left arm on 28Mar2021 at 11.45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included early heart disease. The patient had no allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 07Mar2021 at 16:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On28Mar2021 at 12.00, the patient experienced fatigue and body ache. The patient slept most of the day after and took a 3hr nap on the second day. The patient experienced body aches off and on lasting for 3days. Therapeutic measure was taken as a result of the events which included treatment with tylenol. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event body ache and fatigue was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Complained of sore arm within a couple hours of vaccination. By early morning hours had chills, body aches and warm/swollen sore left Deltoid. Took Ibuprofen for above symptoms. About 30-45 minutes later became nauseated with projectile vomiting. Continued throughout the day with body aches, chills, flushed skin and sore arm. Able to keep liquids down by noon.
stinging post inj (2hr later) 24hr: erythema, redness, swollen hard diameter 3 inches sx persisted for 4 days;tenderness & pain (mild) for 7+ days;
Severe headache, vertigo, nausea, chills, feverish, weak, sore throat
Redness and complaints of pain to injection site (left upper arm). Applied ice pack for 10 minutes and held patient in clinic for 20 minute observation to rule out possible adverse reaction.
vaccine given 8/22/21, chest pain/pressure started 8/23 night, chest pressure continued into 8/24. no other sx and pt stable. parent monitoring at home.
This spontaneous report as received from a pharmacist (also reported as pharmacy manager) via company representative refers to 19 patients of unknown demographics. The patients medical history and current conditions were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot # not reported) dose 1. As the nineteen vials of ZOSTAVAX could not be reconstituted to the full, 0.65 ml dose amount, on an unspecified dates nineteen anonymous patients received incorrect doses of ZOSTAVAX between 0.5 ml and 0.6 ml. product quality complaint was filed. No adverse reactions were reported. Also reported that on an unspecified date an unspecified number of patients reported experiencing more pain when receiving any kind of unspecified reconstituted vaccine dose (vaccine, dosages, and manufacturers not specified) in which needle used during product reconstitution was also used for administering the injection. The outcome of the event was unknown. Additional information has been requested.
Patient received second vaccine outside the recommended window of 21-42 days from the first vaccine. 1st: 4/11/21 2nd: 10/7/21
VACCINE WAS GIVEN 2 DAYS PAST BY USE DATE. BY USE DATE WAS 5/23/2023, GIVEN 5/25/2023
FEVER; BODY ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and body aches. This report was non-serious.
It was reported that an 82 year old female patient received a Fluzone SV vaccination on 11/14/2000. Reportedly later that day the patient's face and tongue were swollen, no respiratory distress. Further information is requested. From correspondence received on 02/02/2001 it was reported that the patient recovered from this experience. Additional patient, vaccine and the responsible physician and vaccine administator information were also provided.
2 hrs. after receiving vaccine he got very achy joints all over and nausea. He had a slight headache and felt like he had a fever but he didn't check his temp. He also said he couldn't think clearly.
Constant hot flashes; sweating; missed period for 3 months; Endometrial polyp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:00 (Lot number: FJ8762) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Prev dose brand unknown=False, Prev dose lot unknown=False), administration date: 19Apr2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Prev dose brand unknown=False, Prev dose lot unknown=False), administration date: 27Mar2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: HOT FLUSH (non-serious) with onset 06Dec2021, outcome "unknown", described as "Constant hot flashes"; HYPERHIDROSIS (non-serious) with onset 06Dec2021, outcome "unknown", described as "sweating"; AMENORRHOEA (non-serious) with onset 06Dec2021, outcome "unknown", described as "missed period for 3 months"; UTERINE POLYP (non-serious) with onset 06Dec2021, outcome "unknown", described as "Endometrial polyp". The events "constant hot flashes", "sweating", "missed period for 3 months" and "endometrial polyp" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hot flush, hyperhidrosis, amenorrhoea, uterine polyp.  Additional information:The events were treated with blood tests, ultrasound and hysteroscopy. The patient did not have COVID prior vaccination but on 22Jan2022 the patient was tested positive for Covid test (Nasal Swab) post vaccination.   No follow-up attempts are possible. No further information is expected.
might have had a low grade fever night 1; Soreness; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events might have had a low grade fever night 1, soreness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) might have had a low grade fever night 1, soreness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), might have had a low grade fever night 1, soreness was unknown.
positive side effect; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (positive side effect) in a male patient of an unknown age 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 THERAPEUTIC RESPONSE UNEXPECTED (positive side effect). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (positive side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
Patient called the pharmacy to report that she was having leg cramps/aches, no bowel movement since vaccine yesterday, is very tired, and generally "feels bad". Advised her to stay hydrated and make sure she is eating to keep strength up. Get plenty of rest and contact us if any further or worsening symptoms develop.
Patient had syncope, dizziness, flushing/sweating, seizure, urinary incontinence. BP 119/79 -- > 103/53 -- > 108/50, HR 47 -- > 38 -- > 37 -- > 64 -- > 62, RR 16, O2 100%, Temp 97.3F. EMS called at 17:06, arrived at 17:13.
13 MONTH OLD RECEIVED 0.5 ML OF FLUCELVAX (INDICATED 4 YEARS OLD AND OLDER). NO ADVERSE REACTIONS OR EVENTS WERE REPORTED AND PER VERBAL FOLLOW UP WITH PATIENT'S PARENTS ON 10/13/2018 AT 1:12 PM; MOTHER WAS ADVISED THAT THERE SHOULD BE NO TOXICITY PER POISON CONTROL AND TO GO TO ED OR RETURN TO CLINIC IN THE EVENT THAT AN ADVERSE REACTION OR EVENT OCCURS.
Presented to ED 10/5/2021 c/o SOB. Admitted w/acute hypoxic respiratory failure. Cardiology and nephrology consulted early d/t need for diuresis, hx of CKD. Started on dexamethasone and heparin. Heparin d/c 10/8 and switched to Eliquis. Hemodialysis initiated 10/8. IV abx w/superimposed bacterial pneumonia. L foot osteomyelitis so started on remdesivir. Resp status worsened requiring BiPAP then weaned to bubble NC. Progressive anemia so IV Fe w/EPO. Intermitten episides of epistaxis. Pt stable w/sudden agitation then arrest. No recovery depsite multiple roudsn during code. After family consulte changed to DNR/DNI and expired 10/19/21
I woke up in the middle of the night and was off balance. I was dizzy and felt that I was not walking straight. It was similar to what I would think vertigo was like.
Patient states that Sunday 1/24/10 in afternoon started w/itching and progressively got worse Sunday night and into Monday AM. Called Dr. Monday since still itching and blotchy red skin on arms, abdomen, neck, face, and legs-instructed to take BENADRYL. Tuesday still itchy and skin blotchy, so seen by Dr. and gave him shot and prescription for medication for itching prn.
fever; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced fever and nausea. On an unknown date, the outcome of the fever and nausea were recovered/resolved.   It was unknown if the reporter considered the fever and nausea to be related to Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by patient for herself. The age at vaccination was not reported. The patient received Fluarix vaccine about a year ago and developed fever and nausea. The patient had nothing else to report. The reporter refused to provide additional information because she already reported adverse event to her doctor last year.
on the 8 day swollen at site and warm to touch, rash on both arms, itch
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 01-JUL-2015 the patient was vaccinated with oral, ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K016314 with expiration date: 05-JUN-2016) which was improperly stored. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt has a history of tic disorder in January 2009-exacerbation of tics. Parent concerned - poss. R/T GARDASIL administration. Persistent exacerbation with ER visit - X 1 hosp.  3/25/09 MR received for o/n admission for eval of increased tics, weakness, back pain and dizziness x 2-3 months in a pt with known Tourette's syndrome. Pt had been able to control tics until ~ 2-3 months ago.  Pt received 3rd Gardasil 3 months ago. PE (+) for jerking of trunk and upper extremity approx every 15-30 seconds.  Upper extremity DTRs hyperreflexive. Neuro consult with non-focal exam. Will try Haldol tx as out pt. Follow-up: Pt has Hx tic disorder with exacerbation after vaccine - ? related to.
"Patient was ten years and three months when she started her first menses and it occurred ten days from the time of her first COVID-19 vaccination.  Her biological half sisters were all 12 or older when they experienced their first menses. I think it is worth considering if the vaccine could have triggered her first menses.  I am requesting that this be reported to the Vaccine Adverse Event Reporting System (VAERS) and that be noted in Patient's chart."
I have a temperature 100.2 right now; I have little weird feeling this morning like heavy headache; I have little weird feeling this morning like heavy headache; burning over my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 21Sep2021 (Lot number: EW0191) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had COVID" (unspecified if ongoing), notes: I had COVID (further clarification unknown) in March I know I have the antibodies. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "I have a temperature 100.2 right now"; FEELING ABNORMAL (non-serious), HEADACHE (non-serious) all with onset 22Sep2021, outcome "unknown" and all described as "I have little weird feeling this morning like heavy headache"; EYE IRRITATION (non-serious) with onset Sep2021, outcome "unknown", described as "burning over my eyes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, feeling abnormal, headache, eye irritation. No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after 3 vaccines Pfizer 1/14/21 Lot# EL3249;  Pfizer 2/4/21 Lot# EM9810;  Pfizer 10/12/21 Lot# FC3183
pt recvd vax; on 29jul95 devel fever w/ no oth sxs;4aug95 epstein barr virus titer drawn & results suggestive of a current epstein barr virus infect
This case was reported by a physician via sales rep and described the occurrence of injection site reaction in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site reaction and dermatitis. On an unknown date, the outcome of the injection site reaction and dermatitis were unknown. It was unknown if the reporter considered the injection site reaction and dermatitis to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that she had a patient that had reaction to BEXSERO at the injection site and all over the face. The doctor believed it may had been related to BEXSERO.
The patient's first dose of Rotateq was inadvertently administered last week on 3/21/07, patient was 17 weeks of age. Parent is. At the time of this report, attempts to contact parent by telephone have been successful. We will mail an appointment card for catchup immunizations next month and notify her of this administration error recommendation to complete the Rotavirus vaccination series per schedule. Please see attached email correspondence.
Injection site 2 X 1 inch area that is very red; Injection site irritated; Hot like it has a fever in that area; Arm Sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUL-2023, the patient received the 2nd dose of Shingrix (right arm). On 04-JUL-2023, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Injection site 2 X 1 inch area that is very red), injection site irritation (Verbatim: Injection site irritated) and injection site warmth (Verbatim: Hot like it has a fever in that area). In JUL-2023, the patient experienced pain in arm (Verbatim: Arm Sore). The outcome of the injection site erythema, injection site irritation and injection site warmth were not resolved and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the injection site erythema, injection site irritation, injection site warmth and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site irritation, injection site warmth and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUL-2023 The patient self-reported this case. The patient reported that her arm was sore within 12 hours of receiving the vaccine but did not hurt on the day of reporting. The patient also reported that the next day of vaccination, just around the injection site there was a 2 X 1 inch area that was very red, irritated and hot like it had a fever in that area which was still all there on the day of reporting.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up with healthcare professional.
I got my vaccine on 3/19 at 10am. My 6:30 pm on 3/19 my face got dark red, almost purple and started to swell. I went to and urgent care where they gave me a 50 mg shot of Benadryl. AFter about 20 minutes the reaction was getting better so they released me to go home. They told me to continue taking the Benadryl every 4-6 hours for the next 2-3 days. I did as directed for through the night and the next day. Around 6:30 pm on 3/20 I started feeling very tired, shaky, and dazed. My about 9:00 that evening I began to feel swelling in  my throat/tongue. I then went to the emergency room and where they gave me another 50 mg shot of Benadryl and a 6 mg shot of Decadron. They monitored me for a couple hours and the swelling in my mouth had gone down and the rash that had also reappeared had gone down. They sent me home with a prescription for Prednisone 10mg 4 pills a day for 4 days and told me to continue the Benadryl. I took the Prednisone and Benadryl for all day 3/21 and was feeling better. When I woke up on 3/22, my chest and arms had a rash on them. I took a Benadryl around 7:30 and Prednisone around 8:30. I went to work and around 10:30 my face started getting red and swelling again. I contacted my dermatologist who did skin patch testing and got an appoint for 3/22 at 1:45. She extended the Prednisone out to 12 days and told me to switch to Zytrec during the day and I will follow up on three weeks.
arm sore during day-not @ noc;fever & chills-noc of vax & next day until 5PM 8/18/99;nausea & dizziness next day until Friday 8/20/99;fatigue from noc of vax until 8/19/99;
Patient administered Covid vaccination that had been punctured greater than 12 hours prior, past the acceptable timeframe in which it is to be used.
16 hours after vaccine administration I noticed  muscle aches. Over the next 4 hours the muscle aches worsened and I developed intense chills, headache, nasal congestion, joint pain and fatigue. I had one episode of dizziness associated with standing in the afternoon (approx. 25 hours post dose). My highest oral temperature recorded was 101.8 F. These symptoms continued until approx. 35 hours post vaccine. At that point the fever abated and the next day I felt somewhat better but was still achy, congested and significantly fatigued. On the third day after vaccination I felt much better.
Itchy rash developed on her neck/chin within 48 hours that was treated with over the counter medications.  Day 5 she had full blown hives from her neck to her calves. Complained of sore throat and nausea. Treated with albuterol, Zyrtec, Benadryl, and zofran.
No adverse event; administered a Moderna regular vaccine instead of the omicron; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered a Moderna regular vaccine instead of the omicron) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 05-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (administered a Moderna regular vaccine instead of the omicron). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered a Moderna regular vaccine instead of the omicron) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (administered a Moderna regular vaccine instead of the omicron).    No concomitant medications were provided by the reporter. The pharmacist enquired whether there were any recommendations when the patient could receive the omicron booster. No treatment medications were provided by the reporter.
JOINT AND ARM PAIN (LEFT ARM) DIFICULTY SWALLOWING PROLONGUED COUGH
I had a sore arm and I felt achy for about a day. I tested positive for COVID-19 on 09/2021. Second time tested positive for COVID-19 on 1/19/2023. I had a really bad headache and elevated heart rate with COVID-19 in 09/2021. Recently I had shortness of breath in 02/2023 and I went to the emergency room. I was given a breathing treatment and I was told that the treatment did help me. I was tested again for COVID-19, but it was negative. I have been advised to continue to use the inhaler.