chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experienced pain when the medicine goes in; experienced burning feeling when the medicine goes in; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, immediately after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site pain and injection site warmth. On an unknown date, the outcome of the injection site pain and injection site warmth were unknown.   It was unknown if the reporter considered the injection site pain and injection site warmth to be related to FluLaval Tetra 2020-2021 season and Flulaval 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 information was provided as follows: The pharmacist wanted to report that in 3 different facilities 70-100 patients who received Flulaval experienced pain and burning feeling when the medicine goes in. All of these patients had the same reactions regarding the injection site. It hurt worse than last year. She also confirmed that these patients received the vaccine in other facilities thats why she didn't have demographic details to provide regarding those patients The reporter did not consent to follow-up. The case has been linked with US2021AMR206679, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206679:same reporter
The patient received the influenza vaccine in error.  He was not supposed to receive it. According to his father, Pt's arm was sore following the vaccination.  He had no other side effects or negative outcomes.
Pt was given vaccine on 6/14/16-reportedly had a seizure on 6/15/16 and went to ER. Pt was not seizing when seen, did have a fever of 38.7- was released as improved.
Information has been received from a medical assistant concerning a female pt with unknown medical history who on 9/19/02 was vaccianted with pneumococcal vaccine 23 polyvalent (642719/0376M) and developed shortness of breath, welts, redness, and pain around the injection site. It was reported the events continued for three days. No intervention data was provided. The pt did not seek medical attention. The medical assistant reported another pt also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES0209USA02877). Additional info has been requested.
No additional AE/PQC; An expired dose of PNEUMOVAX-23 vial was administered/Vaccine expired on 10-AUG-2023; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-AUG-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number W007356 has been verified to be a valid lot number for vial formulation, expiration date reported and validated as 10-AUG-2023), administered intramuscularly (IM) as prophylaxis (strength, vaccination scheme and anatomical location were not provided). The product did not have any previous temperature excursions and the patient reported no symptoms.
Patient with hx of chronic UTIs and L hemiparesis developed a sacral decubitius ulcer requiring multiple debridements. Patient admitted with bleeding pressure ulcer to be seen by plastic surgery. Routine pre-op testing found COVID+; pt reports some nausea after eating, but otherwise has no respiratory symptoms of COVID.
Varicella vaccine administered at 12 months of age.  No history of Varicella in friends or family.  Herpes Zoster diagnosed 10/09/04 on chest/back.
LESS THAN FIVE MINUTES AFTER VARIVAX WAS ADMINISTERED BEGAN TO ITCH; LOCALIZED HIVE AT SITE. NO RESP SX OBSERVED FOR FIFTEEN MORE MIN. AND GIVEN BY MOUTH ANTIHISTAMINE.
No adverse events no treatment. Patient received DTaP #4 3 months apart from DTaP #3. Nurse should have wait 6 months from #3.
Swelling, redness at injection site. Swelling 3.25" x 2.5".
Low platelets, body rash, flat red splotches, unexplained bruises and black scabs/ blister on lips
extreme dizziness during the night; drop in blood pressure--Mon., 3/1, 7 a.m.  73/45  (67); 3/9, dizziness, 10 a.m. 79/44(74). This is very unusual for me.  Until I was dizzy & checked my blood pressure on March 1, I didn't attribute the drop in Bp to the vaccine.  But then I recalled the dizziness I experienced the night following the vaccine.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains patient details added
I experienced after the vaccine, I got super sick for one to two weeks as if I had Covid again, had a terrible headache that has not gone away. Also have horrible vertigo, feel like  I am spinning all the time and it has not gone away.  I also had SOB and my heart was pounding for one week. My PCP told me that I should wait it out that it was probably my body revolving against the vaccine and I was prescribed a medication for my headache and vertigo. My ear were also checked with an ENT and I have no inner ear problems. I can say that my symptoms came from the J&J vaccine.
A LITTLE AMOUNT OF INFLAMMATION IN ARMPIT ON SIDE OF JAB TAKEN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: cervical neck issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a little amount of inflammation in armpit on side of jab taken. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little amount of inflammation in armpit on side of jab taken was not reported. This report was non-serious.
This spontaneous report was received from a nurse and refers to a 11 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patient was vaccinated with GARDASIL 9)for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced injection site swelling, fever and lethargy. The outcome of the events injection site swelling, fever and lethargy and the causal relationship between all aforementioned events and therapy with GARDASIL 9 were not reported.
Constant pain in shoulder (where vaccine was administered) and surrounding areas from second dose of Hepatitis A vaccine. First one given in April 2012 with no adverse reaction. So far pain has lasted 5 month.
Pt recvd vax 10/21/97. Approx Dec pt donated blood; RPR test was positive. Seen by MD 01/22/98; FTA test & RPR both negative.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted while sitting on bench
High fever 102 degrees from 12 hours after injection for 2 days off and on   High blood pressure - my BP is typically 104/70 ... it was 148/105 for 6 days   Extremely high heart rate between 122 and 135 bpm for 8 days   Loss of clear vision innleft eye - went from 20/15 vision to 20/80 - still blurry and unresolved   Extreme headache for 8 days   Tinnitus in both ears from day2 to present - still have tinnitus almost 2 weeks later   Extreme fatigue / lethargy/ inability to stay awake  Extreme body aches / chills / muscle pain   Difficulty grasping and holding things   Foggy memory
Experienced mild headache the first day snd mild chills the second day. Sharp chest pains on the left side, the pain comes and goes. Still experiencing this pain.
Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with a dose of MERUVAX II.  Subsequently the patient experienced allergic reaction and was hospitalized (name, address and phone number unspecified).  At the time of the report, the patient's outcome was unknown.  This is one of several reports from the same source.  No further information is available.
Chemo brain is taking some of the thinking away.; With chemo her weight has fluctuation; but her platelets and neutrophils were low, so they extended it to every four weeks to give her body more time to rebound; but her platelets and neutrophils were low, so they extended it to every four weeks to give her body more time to rebound; her cancer antigen test, called CA125, had started to rise; She is having a recurrence of cancer, which was originally diagnosed in 2020 and was in chemo during her first two shots, so now she is having a recurrence; PET scan showed still had one or two active spots; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 08Jun2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A 71-year-old female patient received carboplatin (CARBOPLATIN), first regimen since 03Nov2020 and second regimen since 02Mar2023 for fallopian tube cancer, ovarian cancer; paclitaxel (PACLITAXEL), first regimen since 03Nov2020 and second regimen since 02Mar2023 for fallopian tube cancer, ovarian cancer; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 70 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL8982), on 03Mar2021 as dose 2, single (Lot number: EN6202), on 20Aug2021 as dose 3 (booster), single (Lot number: EW0167) and on 20May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AVASTIN [ATORVASTATIN CALCIUM]. The following information was reported: POSITRON EMISSION TOMOGRAM ABNORMAL (non-serious) with onset 07Feb2023, outcome "unknown", described as "PET scan showed still had one or two active spots"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "Chemo brain is taking some of the thinking away."; WEIGHT FLUCTUATION (non-serious), outcome "unknown", described as "With chemo her weight has fluctuation"; PLATELET COUNT DECREASED (non-serious), NEUTROPHIL COUNT DECREASED (non-serious), outcome "unknown" and all described as "but her platelets and neutrophils were low, so they extended it to every four weeks to give her body more time to rebound"; CARBOHYDRATE ANTIGEN 125 INCREASED (non-serious), outcome "unknown", described as "her cancer antigen test, called CA125, had started to rise"; NEOPLASM RECURRENCE (non-serious), outcome "unknown", described as "She is having a recurrence of cancer, which was originally diagnosed in 2020 and was in chemo during her first two shots, so now she is having a recurrence". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for carboplatin and paclitaxel was unknown.
103 TEMERATURE - 24 HOURS. 101 TEMERATURE - 2ND 24 HOURS. 99-100 TEMPERATURE - 3RD 24 HOURS. RUNNY NOSE. VISIBLE SWOLLEN NODES ON NECK. RASH ON FACE. RUBBING EARS DURING 3RD 24 HOUR PERIOD. RUBBING FOREHEAD DURING 3RD 24 HOUR PERIOD AND CONTINUES. RUBBING EYES DURING 3RD 24 HOUR PERIOD ON CONTINUES. SLEEPS ONLY 2 HOURS AT A TIME WAKES UP SCREAMING SINCE ONSET OF REACTION. LACK OF INTEREST FOR EATING FIRST 96 HOURS. VERY FUSSY FOR FIRST 96 HOURS
arm soreness; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 88 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jul2021 10:30 (Lot number: ER8736) at the age of 88 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: METHIMAZOLE taken for hyperthyroidism (ongoing); METOPROLOL taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE (ongoing). Vaccination history included: Flu shot, reaction(s): "Fever". The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm soreness"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "low grade fever".  Additional Information: Reporter stated with first dose of the Pfizer covid vaccine she and her mother had similar reaction like arm soreness and low fever then it went away, after the second dose she had body aches, which went away but for her mother its not going away. No Prior Vaccinations (within 4 weeks). The patient had a fever with the flu shot a couple of years ago. Reporter had no product or information and does not know NDC, lot or expiration date.  Follow-up attempts are completed. No further information is expected.
Noticed a swelling at the site of injection, Left upper arm,  which gradually increased in size along with redness and then his whole upper arm and adjacent shoulder area was swollen, hot and firm to touch.
pt recv vax & lab results indicated pt failed to seroconvert;dates of titered info started in 1990 & then again in 1996, 1997, & 1998;
Pt c/o strong palpitations for approx one week. Went to ER on Sept 6th, 2005.
Severe swelling on injection site (gold ball size lump); painful crying inability to walk for a week.
The pt received the vax on 6/26/00, the pt woke up with a large red area around injection site that warm to the touch and itches.
temperature up to 104 which lasted for 12 hrs; reaction started w/in 2 hr of shot;
Patient was given pfizer covid 19 booster gray top inadvertently mixed with 1.8 ml sodium chloride
This spontaneous report as received from a registered nurse refers to unspecified number of patients. On unknown dates, the patients were vaccinated with VAQTA (lot #, dose, route not reported), which were exposed to 31.5F during a period of 4.7 days in a physician's office. The reporter stated that the physician's office has twice told her that no vaccines were administered, but then told her that there were, however, she had not specified patient information or dates of administration. No adverse effect was reported at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Vomiting and Diarreha, several times daily for each.  I have been treated with several courses of antibiotics, Steroids, and and now am on Viberzi.  None of the pervious treatments seemded tohelp, the Viberzi has helped a little but we are looking at consultation to the Clinic for a more indepth look.
neck pain has decreased since yesterday. Patient has taken Tylenol to relieve neck pain. Recommended to see primary provider if symptoms worsen.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid as treatment from 06Sep2023 to 02Oct2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. No medical history provided. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medications were provided. On an unknown date after the vaccination the patient experienced "CNS problems". The patient developed numbness and tingling in hands, confusion and headache. No outcome was reported. Additional information has been requested.
Arm/injection site pain within first 12 hours, then chills, followed by fever and severe headache, muscle aches and fatigue. Symptoms continued into 48hrs post injection.
expired vaccine administered with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who had expired vaccine administered with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (formulation, strength, dose, route and administration site not reported) (lot UT7325MA and expiry date: 30-Jun-2022) for prophylactic vaccination.  On 03-Oct-2022, (latency: same day) the patient had expired vaccine administered with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.; Sender's Comments:  2022SA409871:
pain after 1 st injection ; second injection patient experienced numbness down arm that received injection.  (this numbness was not a previous symptom of patient/ patient does have peripheral neuropathy in history; still numb almost 1 month after symptom started
No adverse events to record. Patient received the original moderna vaccine instead of the bivalent booster.
ASYMPTOMATIC COVID-19; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: The patient was quarantine for five days after the second time of corona. The patient had has underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 30-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-DEC-2021, the patient experienced asymptomatic covid-19. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious. This report was associated with product complaint number 90000210331
Headache, Myalgia, Fever, Palpitations, fatigue, SOB Narrative: Evaluated in ER and per employee dx severe inflammatory reaction to Covid vaccine. Symptoms resolved. except fatigue.
This spontaneous report as received from a Medical Assistant refers to multiple unspecified patients, of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored GARDASIL Lot # K006960, expiration date 19-FEB-2017 (dose and route were not reported). No adverse effects reported. No product quality complain (PQC) was reported. This is one of several report received from the same source. Additional information has been requested.
Lump in arm since flu shot and very painful. Right arm aches, hurts to lay on and throbbing. Shooting pains if she lifts something. Using ice and ibuprofen which is helpful. Topical diclofenac cream- not helpful. Physical Therapy not helpful