chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Devel h/a, stomachache 21JUL91 approx 730; 22JUL91 c/o feeling different, no other sx; 23JUL91 devel vomiting @ 4PM ;
Information has been received from a registered nurse concerning a female, who was vaccinated with the second dose of GARDASIL, IM in upper deltoid, single dose vial. Subsequently the patient experienced an injection site reaction which included a lump and soreness about 4-5 days after receiving the vaccine. The patient sought medical attention. Additional information has been requested.
swelling, inflammation in tongue; lowered cognitive ability; sense of calm; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSITIS (swelling, inflammation in tongue), COGNITIVE DISORDER (lowered cognitive ability) and FEELING OF RELAXATION (sense of calm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced GLOSSITIS (swelling, inflammation in tongue), COGNITIVE DISORDER (lowered cognitive ability) and FEELING OF RELAXATION (sense of calm). On 01-Feb-2021, GLOSSITIS (swelling, inflammation in tongue) had resolved. At the time of the report, COGNITIVE DISORDER (lowered cognitive ability) had not resolved and FEELING OF RELAXATION (sense of calm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Initially sore arm, followed by fever (99.8 degrees), fatigue, abdominal pain, nausea, and body and joint aches. Around 36 hours later, chest pains, shortness of breath, and heart palpitations.
No adverse Event; patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD) 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 EXPIRED PRODUCT ADMINISTERED (patient got vaccinated after BUD).    Patient registry ID was reported.  No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Multiple deep  skin ulcers appearing approximately 2 weeks later.  Ulcers last about 1 month. Start as small red itchy bumps and progress to large open, weeping soars. Tested negative for Monkey Pox, MRSA, staph.  Two on left chest/axillary area, one on left buttock, one on bottom of right foot.
several episodes high pitched screaming started 6PM 27JAN through 29JAN; getting less freq & shorter duration not eating evening of shot & next day; pale-evening of shot & next day;
Mentruation stuff; Sore arm; Bit tiredness; rough night afterwards with shivers; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Mentruation stuff), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Bit tiredness) and CHILLS (rough night afterwards with shivers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and 2), PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and 2) and PFIZER BIONTECH COVID-19 VACCINE (Dose 1 and 2). Past adverse reactions to the above products included Headache with PFIZER BIONTECH COVID-19 VACCINE; Menstrual disorder NOS with PFIZER BIONTECH COVID-19 VACCINE; Pain in arm with PFIZER BIONTECH COVID-19 VACCINE; and Tiredness with PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Mentruation stuff), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), FATIGUE (Bit tiredness) and CHILLS (rough night afterwards with shivers). At the time of the report, MENSTRUAL DISORDER (Mentruation stuff), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Bit tiredness) outcome was unknown and HEADACHE (Headache) and CHILLS (rough night afterwards with shivers) had resolved.            With moderna patient also had rough night afterwards, with shivers and headache. Was really just for one night though. No information on concomitant medication were reported. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Patient experienced chest tightness, palpitations, tongue swelling. No shortness of breath. The nurse confirmed vitals were good, and that the patient was able to eat/drink/swallow. Nurse administered 25mg of Benadryl. BP was 110/70 and HR was 64.  The patient noted he had a similar reaction to the first dose. Doctor spoke with the vaccinator and the patient. Patient is the school principal. The patient was discharged at 11:45am to the school nurse.
Immediate reaction - extremes dizziness and profusely sweating, nauseous and felt I was going to pass out. This happened about 5 minutes after I received the shot.
The one dose (Janssen) Covid vaccine has been administered on 4/1/2021.  on 5/26/2021 spotting started and converted to heavy bleeding from 5/31/2021 and lasted till 6/16/2021. This has pushed the patient in to anemia and had to visit Ob/Gyn to make sure there are no other abnormalities.  The boosted dose (Pfizer) vaccine has been administered on 1/3/2022 . On 2/21/2022 , spotting has started and converted to abnormal bleeding on 2/25/2022.  The patient did not have any menstrual cycles in between and vaccine had pushed the patient to have abnormal cycles to due to vaccine induced estrogen.  it seems patient is in the phase if transforming into mesopause, due to vaccine there was clear abnormal bleeding and patient became anemia. Hope this information helps to build the research data to investigate more.  Thanks!
Cellulitis of anterior left thigh involving nearly entire thigh from 4-5cm below inguinal line to knee with erythema, induration, and warmth.
Patient received high dose influenza vaccine at age of 64. No report of side effects since 1 hour after administration.
Redness, swelling, tenderness, warmth, itchy over deltoid. Reaction started 1.5 days after vaccine. BENADRYL given. Due to swelling dexamethasone given. Resolved after 3 days.
Months after shot two I developed severe night sweats. I have been tested for just about everything and there have been no answers. I had a rotator cuff surgery on August 13th and the thought was that the night sweats were due to an infection. This is likely the case and I am currently on IV antibiotics but after over three weeks of antibiotics the night sweats have not subsided. My guess is that this is not vaccine related but I want to check if others have reported anything similar to make sure.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-year-old patient of unknown gender. On 07-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Several minutes after receiving  vaccine patient vomited.  Monitored patient  and he was fine after 15 minutes
I have been receiving flu shots for years. I received a pneumonia shot about 1991. I haven't had any reaction to either type, on any of those occasions. This 11/22/02, I was advised by those offering innoculations at the senior center that now, all those that had pneumonia shots before they were 65 if 5 or more years have passed, they should have a second shot. On 11/22/03 at about 2:30PM, I was given both the flu shot and the pneumonia shot in the shoulder of my left arm. I was told that both shots were given in the same arm with no problem. About 4PM, first symptoms: increasing pain in the area of where the shots were given. About 5 to 6PM, increased pain and couldn't lift my arm; upper arm hard at touch and white. About 7:30PM increase in pain in arm and shoulder, headache and sick to my stomach. Was very cold and couldn't get warm even with additional clothes. At 9PM, went to bed in a lot of pain. 10PM couldn't put any weight on arm. Shivering constantly even under multiple blankets; temperature of 101 and couldn't move arm. Very sick all night and fever continued, but was too ill to bother taking temperature and go to the hospital. Just wanted to stay in bed. 11/23 AM brought relief from fever, somewhat; arm hard and now red from shoulder to inner elbow; still extremely painful.  Called CDC and couldn't get to talk to anyone. Was in pain all weekend and Monday called CDC again and was told to call VAERS. I was told that I should fill out a form to report the experience and it would be mailed to me, which I received a few weeks later. I went to the visiting nurse association to get the vaccine information requested on the form sent to me, but had to wait until after the director came back from days off. I am still having weakness and at times pain and soreness in upper arm and shoulder. I am concerned now as to if I should continue to receive either of these types of innoculations, as I have no idea which vaccine was the problem. Nurse follow up on 06/08/044 states: swelling.
Patient's face started to get red and hot and then she found it harder to breathe. Her granddaughter convinced her to go to the emergency room on Friday morning (5/26/17) where they gave her cetirizine 10mg daily for 7 days, as well as did chest xrays and drew blood as well as monitored her BP. Patient states that this is the same reaction she had to a liquid calcium supplement, which they determined to be an allergy to beeswax.
Vaccine was expose to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HBV (Engerix B) (batch number K329E, expiry date 24th April 2023) for prophylaxis.   On 4th August 2021, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that new born baby received a dose of Engerix B after a temperature excursion where the vaccine was expose to freezing temperatures, which led to incorrect storage of drug. The Engerix B was exposed to temperature minus 1.4 degree Celsius for 1 hours and temperature minus 26.4 degree Celsius for 4 hours. The doctor and mother have authorized to vaccinate this baby. The patient received a new Engerix-B vaccine on 5th August 2021. The reporter consented to follow up. ; Sender's Comments:  PR-GLAXOSMITHKLINE-PR2021167740:Deleted (incorrect Argus ID)
Phone call received from clients grandmothers stating client arose w/fever and abdominal pain today (5.28.14). Temp of 101.7 F cotrolled by TYLENOL. Grand mother denied client c/o pain, redness, inflammation at injection site. State client c/o headache intially but not any longer.
Pt reported redness, warmth and pain at injection site. Pt reported this to MD and was told to call back if it doesn't get better. Pt called back and received a course of antibiotic, which pt finished and completely recovered.
Patient reports arm pain at injection site and malaise for about a day or two following receipt of vaccine.
Bell's Palsy. Right sided. first time. occurred 9d post 2nd shot
Pt left voicemail stating that right after the vaccine, she had a rash w/ blisters at injection site of her right deltoid. Dr. spoke to her on the phone, and she described the rash on neck and shoulder, close to clavicle and painful to touch. She sent photos to Dr., and he suspected highly suggestive of shingles. He sent a prescription of valacyclovir 1000mg 1 tab PO TID for 7 days to her pharmacy and advised she do a viral culture test on vesicle fluid, cells at base of vesicle. He stated that it is very unusual to have zoster after both the live virus vaccine (patient had ZOSTAVAX on 4/2/2013) and the first dose of SHINGRIX.
Initial unsolicited report received from physician on 01-May-2018. This case involves female patient (age not reported) who was vaccinated with dose FLUZONE HIGH DOSE (batch number- UI869AB; expiration date, dose, dose series were not reported) on an unknown date. Medical history and concomitant medications were not reported. On an unknown date following vaccination patient had pain, swelling on left arm and itching on left arm. Lab data and corrective treatment were not reported. Outcome of the events not reported. 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 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. List of documents held by sender: none.
Rash noticed approx. above time, diagnosed on 01/21/2010 as  Shingles. Physician prescribed  Valtrex 1 GM
Pulsatile tinnitus in left ear after first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: ER8733) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "Pulsatile tinnitus in left ear after first dose". The event "pulsatile tinnitus in left ear after first dose" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
8/29/206 patient walked in with mom and brother, complains of left deltoid red, hot and swollen.  Temperature 100.2
The patient came to the counter and complained that her "throat is tighter than normal."  I instructed her to remain an additional 15 minutes (30 min. total).  I provided her with water and 25mg diphenhydramine.  At the end of her 30 minute wait, she stated her throat was still feeling tight, but there was no additional swelling or difficulty breathing.  She stated she was going to the Urgent Care across the street to get checked out.
Currently 9weeks pregnant with expected due date Aug 21 21.  OB office was contacted about reaction and they will continue to monitor during my pregnancy but as of now no signs of harm.  Adverse reaction started with minor muscle aches  then about 12hr after I started with a fever/ chills that got very severe during the night. Finally around 1am/2am the fever started to break.  I took Tyenol 500mg every 4 to 6 hours x 5 doses in the 24hr period.
Information has been received from a nurse referring to multiple unspecified patients. No medical history, concurrent condition or concomitant medication was provided. On multiple unspecified dates, the patients was vaccinated with improperly stored doses of VARIVAX (lot# was reported as M023324 (invalid), expiration 15-MAY-2018) or (lot# M028553), expiration date 09-JUN-2018) (dose and route unspecified). The vaccines were stored in 3.2 Celsius for 1 hour and 37 minutes. There was no previous temperature excursion. Data logger was involved. Additional information has been requested.
15 month pt was seen here 01/15/04.  Had DTAP and HIB/HEP B immunizations.  Per father, approximately 20 minutes after leaving our office, while he was holding pt, he suddenly passed out.  He awoke after a few seconds of shaking.  He passed out, fell asleep suddenly awoke about a half hour later in moms arms.  He was sleepy and difficult to wake.  No jerking, no vomiting.  No further problems, no crying before episode.  Riding with parents in car both times.
Patient experienced S/S of epileptic episode immediately after administration of Pfizer COVID-19 vaccine.  Disclosed history of SA and Rx Methadone for cessation therapy.  Undisclosed history of epilepsy and non-compliance with Rx KEPPRA.  According to field reports and verbal debrief, patient had: brief unresponsiveness + nystagmus + upper extremity contraction.  During episode, patient's partner disclosed to nurses her PMHx epilepsy and non-compliance with KEPPRA.  After a minute or so, S/S ceased and patient was AOX4.  No concern by RN after VS measurement and monitoring.  Paramedics summoned for second-eye assessment.  No concern by paramedics.  Patient verbalized feeling OK.  Released after a further 30minute observation.
No adverse event; The patient received improperly stored VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   07-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# S028926, expiration date 16-SEP-2021, for prophylaxis (strength, dose, route and frequency were not reported), reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot# S002624 and expiration date reported as 05-NOV-2021).  The temperature excursion was of 15 Fahrenheit degrees (°F) to 46°F (9°C to 8°C) 21.5°F, during 25 minutes. However, a previous temperature excursion of 6°F to 14°F (-14°C to -10°C) 6.6°F for 5 minutes were also reported. A digital data logger was involved. No adverse effects were reported.
Body Aches; Tiredness; been having to take many naps during the day; headache; This case was reported by a consumer and described the occurrence of general body pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on an unknown date and experience headache and fatigue,for the tolerance of 1st dose refer the case US2021AMR095072). Concomitant products included COVID 19 VACCINE.   On 13th April 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th April 2021, less than a day after receiving Shingrix, the patient experienced general body pain, tiredness and daytime sleepiness. In April 2021, the patient experienced headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, tiredness and headache were not recovered/not resolved and the outcome of the daytime sleepiness was unknown.   The reporter considered the general body pain and tiredness to be related to Shingrix. It was unknown if the reporter considered the daytime sleepiness and headache to be related to Shingrix.   Additional details were provided as follows: The case was reported by the patient's wife and by the patient's Physician. After vaccination, later that same day, the patient experienced body aches and tiredness.  He had been taking many naps during the day since the vaccination.  These symptoms were ongoing and had not yet resolved. The reporter consented to follow up with their health care provider and provided phone number.  The patient's physician reported that, the patient experienced headache and fatigue after receiving Shingrix. The HCP did not have lot number or expiration date of doses of Shingrix. The HCP described the headache and fatigue had not gotten any better or worse since they began. The HCP noted 14 days before dose two of Shingrix, the patient received Covid vaccine.  No additional information was reported. The reporter did not consented to follow up. This is 1 of the 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094721:same reporter US-GLAXOSMITHKLINE-US2021094725:same reporter