chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a very bad thing on body and not ok; suffering in pain; Did not sleep; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (a very bad thing on body and not ok), PAIN (suffering in pain) and INSOMNIA (Did not sleep) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced IMMUNISATION REACTION (a very bad thing on body and not ok), PAIN (suffering in pain) and INSOMNIA (Did not sleep). At the time of the report, IMMUNISATION REACTION (a very bad thing on body and not ok), PAIN (suffering in pain) and INSOMNIA (Did not sleep) outcome was unknown.            No concomitant medications were reported.  Patient received the bivalent booster dose on 26-Oct-2022 and reported to had very bad thing on body and not ok. Patient did not sleep also had suffered in pain.  No treatment information was reported.
I developed a sore throat, runny nose, cough and muscle aches on 07/07/2022.  I tested positive on 7/7 and reach out to my doctor the same day and received Paxlovid.  I finished the 5 day dosage of medication.  I started feeling better by day 4 of the medication.
Fever of 101.5 Soreness in arm Slept throughout day Had trouble standing. Slid off couch and couldn?t get up. Had to get help getting up. Happened only once.. Was incontinent many times.
pt recv vax 22MAR97 for scheduled exam & vaccines;DTP given in rt deltoid & PPD in rt forearm area;mom brought pt back to clinic Monday, 24MAR97 @ approx 545PM to read PPD & f/u apparent rxn from DTP on rt deltoid;t102, redness, heat, pain;
Information has been received from a physician concerning an 18 month old male who in August 2010, was vaccinated with the first dose of RECOMBIVAX HB (Lot number not reported). In August 2010, after receiving the first dose of RECOMBIVAX HB, the patient developed a rash on his back. It was not reported whether the patient sought medical attention. The patient's physician had not decided whether the series would be continued. No treatment was given for this event. The event improved after stopping therapy. On an unspecified date, the patient recovered. No further information is available.
patient experienced a breakthrough covid infection; patient experienced a breakthrough covid infection; swollen lymph node in her arm pit; This is a spontaneous report from a contactable consumer. A consumer reported for 37-year-old female that: A Non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 intramuscular, administered in Arm Left on 05May2021 17:15 (Batch/Lot Number: EW0176) as DOSE 2, SINGLE for Covid-19 Immunization. The patient medical history included Historical vaccine BNT162B2 on 11Apr2021 12:45 for Covid-19-Immunization with Lot number ER2613 via intramuscular route on Left arm. Concomitant medication(s) included Escitalopram Oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient experienced a breakthrough Covid infection on Aug2021, Swollen lymph node in her arm pit on 05May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Aug2021 Nasal Swab, Sars-cov-2 test: negative on Aug2021 Unknown, Sars-cov-2 test: positive on Aug2021 Unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient received treatment for the events. The clinical outcome for all the events was Unknown.   Follow-up attempts are completed. No further information is expected.
Suspected vaccination failure; Severe case of Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient was the reporter's sister. The age at vaccination was not reported. After receiving both the doses of Shingles vaccine, the patient was suffering from severe case of shingles at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation were not provided.
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: Employee reported experiencing symptoms of injection site pain, headaches, joint pain, body aches, fatigue, and nausea, which reportedly began about 20minutes after receipt of vaccine. Reports use of Tylenol (no dose/duration/frequency provided) and peppermint (no indication to formulation) for relief of symptoms. NO further information provided.
approx 26hr p/vax pt noticed rt arm very sore;that noc pt noticed swelling @ inj site, redness & extreme soreness;pt called hlth dept next AM to report problems;seen by MD; inj site sl swollen, some redness;
-Expired Hepatitis B vaccine given to patient (lot # 237PJ - Expiration 5/21/16 name brand ENGERIX-B). - Expired Poliovirus vaccine given to patient (Lot # K13291- - Expiration Jun18, 16 - name brand IPOL.  No adverse reaction reported.
Started feeling extremely fatigued/exhausted on 4/19/21 (approx. 3 weeks after 2nd Pfizer COVID vaccine dose). Onset of exhaustion was acute and lasted for 3-4 weeks. Felt exhausted after full nights of 8-10 hours of sleep. Just walking up or down a single flight of stairs made me feel ?spent,? although I had been comfortably running 8-12 miles prior to the onset of symptoms on 4/19. Could not complete a full day of work (at my computer) for 2 weeks after symptom onset, due to physical and mental exhaustion. ?Brain fog? symptom lasted for 2 weeks only and then went away abruptly (I just woke up feeling clear-headed), but the physical exhaustion lasted over 3 weeks from symptom onset. Never experienced chest tightness, but just needed to catch breath after/during activity during this period of physical exhaustion. Also missed my menses after receiving 2nd dose of vaccine and was not pregnant.  Received 2 negative COVID tests 10-12 days after symptom onset, and after having had extremely limited exposure to anyone outside of my home.  Visited my PCP 3 times while symptoms lasted and also got a special appointment for an echocardiogram. I received no diagnosis during these visits.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Left upper arm red, swollen, hot touch. Given BENADRYL oral and cool compress.
The connection of the syringe and safety needle was not tightened prior to vaccination. There was vaccine leakage from the connection when administered.
pfizer 5-11 year old dose was given. patient just turned 12 and 1st dose was given was adult dose. 2nd dose we accidentally gave kids dose.
episodic blurred vision (lasts about 1 -2 hours and has occurred a couple times bilateral eye pain and eye redness
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       CC: This is a regulatory case concerning a 56-year-old female patient with no reported medical history, who experienced the  non serious event Sore arm,  after receiving the first dose of mRNA-1273.  Events seriousness captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report. No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-403769 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 56-year-old female patient with no reported medical history, who experienced the non serious event Sore arm,  after receiving the first dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Case number PHEH2013US024756, is an initial spontaneous report received from a pharmacist on 22 NOV 2013. This report refers to a 21-year-old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X12025), without being reconstituted with Men A lyophilized conjugate vaccine component on 19 NOV 2013. No adverse event was reported following this administration error.
I received the COVID vaccine while pregnant. My baby's head size changed to a diagnosis of prenatal microcephaly following the COVID vaccine.
Information has been received from a Register Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 22-APR-2014, the patient received first dose of M-M-R II (route of administration, lot number, expiration date, and anatomical location were unknown) for prophylaxis, reconstituted with sterile diluent (MRK) (lot number and expiration date were unknown); later on 22-APR-2014 received a second dose of M-M-R II with lot number H017435 and expiration date 20-SEP-2014 (route of administration and anatomical location were unknown) for prophylaxis, reconstituted with sterile diluent (MRK) with lot number J002745 (expiration date was unknown). There were no adverse effects reported. Lot number J002745 is an invalid lot number for sterile diluent (MRK). There was not Product quality complaint involved. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-FEB-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 mL (lot # H017304, expiration date 05-DEC-2015, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion once. The total cumulative excursion time was 72 hours. The lowest recorded temperature was 32 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Persistent headaches and numbness in left arm, fingers, chest and leg starting after HPV #1(7/8/08), which were annoying but tolerable. Now experiencing persistent intolerable painful tingling and numbness with headaches over past 2 weeks after receiving HPV#2 (1/22/09). These symptoms are interfering with her ability to sleep and participate in college activities.  2/11/09 MR received for ER visit 2/7/09 with DX: Left Arm/Leg Pain. Numbness. Pt presented with 6 month hx of intermittent, worsening numbness and tingling which began in the chest and L arm, now involving bilateral upper and lower extremities.  Happening now several times/day and lasting hours at a time. Currently with chest and arm pain. Sleeping more. HPV vax in July 2008 and January 2009.  PE WNL. W/U (-). D/C.
mom states took pt to clinic because t104 & had sz; stayed in hosp overnoc; had LP; also found to have ear infect & cutting teeth; had no sx of ear infect;
Torso rash / hives on both chest and back.  Lasted about a week.
None. Patient had previously received PPSV-23 on 7/14/16. System was down and did not return online until after patient visit. He received PCV-13 today (7/19/16). No reaction.
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 52-year-old female patient received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 1 day and as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications within in 2weeks after vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". On 02Jul2022, the patient had experienced bitter taste. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 02Jul2022 to 06Jul2022 for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, warmth, itching swelling that started 8 days after receiving the vaccine.
8-10 hours, started 10 hours after vaccine administration: severe lightheadness and dizziness causing temporary vision loss, almost fainting 8-10 hours, started 10 hours after vaccine administration: severe nausea, no vomiting
Heart flutters; mimicking a pvc; This is a spontaneous report from a contactable consumer (patient). A female patient of 32-year-old age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), second dose on left arm via an unspecified route of administration on 09Apr2021, 09:00AM at unknown dose single for COVID-19 immunization. She was not pregnant at time of vaccination. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), on left arm via an unspecified route of administration on 19Mar2021, 09:00AM for COVID-19 immunization. Vaccine was administered in Doctor's office/urgent care. No medical history reported. Concomitant medication included Levothyroxine (received within 2 weeks of vaccination). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient had been tested positive for covid-19. Patient reported heart flutter and mimicking pvc on 17May2021 (21:00). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Jun2021 Nasal Swab , sars-cov-2 test: negative on 16Jul2020, sars-cov-2 test: negative on 28Oct2020. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of Events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 hrs later, severe bruising at injection site, very fatigued, slight headache, no fever. 48 hrs later - severe body aches - continued fatigue. 72 hrs later - body aches and fatigue.
I was forced to have a second Adacel injection by administration in health system because they could not locate the documents for the first injection I claimed to have in the same system 2 yrs ago. They assured me two years is an acceptable safe window have I had an undocumented injection in past. 10 hours after the injection I became violently sick which lasted for three days. My skin was mottled, I bounced between hours of painful chills, had to keep my jaw preventing shattering my teeth to fever of 102 and drenching sweats. I was confused and restless and with severe headache and body pain and very hypersensetive skin with dry cough and congested sinuses. The site of injection was extremly hard, warm to touch and erythematous and twice and swollen with spontaneous twitching of muscles all around it. I have never been sick with any vaccinations and I had multiple of them in near past. In case of doubt and facing undocumented vaccination I do not think the current recommendation of TWO years is a real safe and sound one for TD /Adacel injections.
rash on left arm, rash on right arm, rash on left leg. Given diphenhydramine 25mg PO and observed for 1 hour, no increase in reported symptoms.  No difficulty breathing / SOB/ wheeze / anaphylaxis noted.
Foot drop on right side. Leg numbness lasting about 2 weeks. Symptoms resolved but recurred after receiving a flu vaccine on 10/22/21
Heart Arritmia, dizziness, breath difficulty when the events occur. Tachycardia
This spontaneous report as received from a physician via company representative refers to a 13 year old female patient. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On approximately July 2015 (reported as sometime last week), the patient was vaccinated with a first dose of GARDASIL (lot number, Expiry date, dose and route were not reported). It was reported that the patient fainted after receiving GARDASIL. No other vaccines were administered. The patient was given apple juice and was fine. The relatedness between the event and GARDASIL was not reported. Additional information is not expected due to no consent for follow up.
Patient received Fluarix vaccine, which is not approved for children under age 18.  No adverse reactions reported by Mom.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
upon presentation to ER pt had fever, chilling & lethargic; pt mom state prior to the ER pt had blueness of hands & feet & blueness noted around the mouth (circumoral cyanosis)
breakthrough infection, positive for COVID 19; breakthrough infection, positive for COVID 19; This is a spontaneous report from a contactable nurse communicated through a Pfizer Sales Representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced breakthrough infection, positive for COVID 19 on an unspecified date. Outcome of the events was unknown.   Information on batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Drug ineffective and COVID-19 cannot be completely excluded.
11/06/21 presents to ED for "cc of BL LE extremity weakness". PMHx "GERD, dyslipidemia, HTN"
This spontaneous report as received from a healthcare worker regarding a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-MAY-2015, the patient was vaccinated with VARIVAX (Merck) (lot # K021487, expiry date 30-JAN-2016) which was exposed to temperature excursion of 25F for 41hours. No adverse effects were reported. This is one of the several reports from the same reporter Additional information has been requested.
Five episodes of vomiting within a 2-hour time period. Onset approx. 5 hours after vaccines given. No fever, no diarrhea; no concurrent illness. No treatment administered - self-limited episode.
Patient only took first dose on 2/13/15. Vomited on 2/15/15 dose 2 not taken.
Patient could not move arm soon after vaccination. Saw MD who told her to ice her shoulder and try to move arm. Patient will keep us updated on condition. Was advised to see MD again for further treatment.