chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PETECHIAE ( Pin point size bruises) Lower legs plus half part upper legs No itching  Flat to the touch No color change if pressed Gone after a week
HOSPITALIZED BREAKTHROUGH CASE VACCINATED WITH MODERNA ON 1-12-21 AND 2-9-21. SYMPTOMS-HYPOXIA EXPOSURES-WIFE ALSO TESTED POSITIVE FOR COVID ON 12-31-21  HE WAS TAKEN TO THE ER AFTER A FALL AT HOME.  HE HAD FRACTURED RIBS AND A PNEUMOTHORAX. AFTER HIS OXYGEN LEVELS DROPPED, HE WAS TESTED FO COVID AND FOUND TO BE POSITIVE.
Chest pain. Right side breast through to the back shoulder blade. Hurts to breathe and cough. Laying down seems to make it worse. Began about 1 day after recieving Pfizer vaccine  dose 2. Today is day 2 after and I feel the pain is intensifying.
Very late menstrual period after second shot, about one month late.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product: COVID 19, lot unknown: True, lot unknown reason: Misplaced/discarded, dose number: 1), for COVID-19 immunization, reaction(s): "Menstrual disorder". The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "unknown", described as "Very late menstrual period after second shot, about one month late.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation delayed.  Additional information: The patient received no other vaccine in four weeks. The patient received no covid prior vaccination. The patient had been covid tested post vaccination. Adverse event: Early menstrual period after 1st shot, at least a week early. Very late menstrual period after second shot, about one month late. The patient underwent lab tests and procedures on an unspecified date which included: sars-cov-2 test: negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tenderness in the arm; Vaccine leaked during injection, patient not sure if full dose was received; Vaccine leaked during injection, patient not sure if full dose was received; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in the arm), UNDERDOSE (Vaccine leaked during injection, patient not sure if full dose was received) and DEVICE CONNECTION ISSUE (Vaccine leaked during injection, patient not sure if full dose was received) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 939902) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HCTZ, LOSARTAN, POTASSIUM and VITAMIN D3 for an unknown indication.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced UNDERDOSE (Vaccine leaked during injection, patient not sure if full dose was received) and DEVICE CONNECTION ISSUE (Vaccine leaked during injection, patient not sure if full dose was received). On an unknown date, the patient experienced TENDERNESS (Tenderness in the arm). On 13-Jul-2021, UNDERDOSE (Vaccine leaked during injection, patient not sure if full dose was received) and DEVICE CONNECTION ISSUE (Vaccine leaked during injection, patient not sure if full dose was received) had resolved. At the time of the report, TENDERNESS (Tenderness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medications No treatment medications were provided.   This case was linked to MOD-2021-321449 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant FU ADR form includes indications of concomitants and 2nd dose events, batch number, its outcome, treatment which were added in the 2nd dose case.
RASH ON LEGS, ARM, FACE- OCCURRED 8 DAYS POST INJECTION
Information has been received from a county health nurse practitioner concerning a 12-month-old female who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 655346/1324F). Immediately post vaccination the patient developed wheal at the injection site. The patient was seen at the emergency room but was released without treatment. Nurse stated "she has never seen such a reaction before." Subsequently, the patient recovered. Lot check has been requested. Follow-up information has been received from a registered nurse concerning a 4-year old female (previously reported as 12-month-old) who on 27-JUL-2007 at 12:00 hours was vaccinated subcutaneous in the left arm with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 654153/0951F) (previously reported as lot # 655346/1324F). Concomitant vaccines administered on 27-JUL-2007 at 12:00 hours intramuscularly in the left vastus lateralis included fifth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a fourth dose of poliovirus vaccine inactivated (Vero) (IPOL). On 27-JUL-2007, at 12:00 hours the patient developed a 1 1/2 cm X 2 cm reddened and raised area immediately following injection (wheal at injection site). It was reported the child was kept in the office 30 minutes for observation. No further symptoms developed. Later that day the patient was seen by a family doctor. On 27-JUL-2007, the red/raised area resolved without treatment. This is one of several reports from the same source. The records of testing prior to release of lot 655346/1324F have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information is not expected.
Pt recvd vax then exp low grade fever 1-2 days p/immun; On 25MAY91 while standing, pt appeared to stare & became stiff w/shaking of all body lasting 10-15seconds; Same day had another similar episode standing & quivered for a few secs;
Pain at the injection site / injection site is still sensitive when touched; Redness / at injection site; Arm soreness; unable to do daily walk due to fatigue; Right shoulder was big and puffy; Fatigue; severe itching /injection site; swelling/ injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2021, the patient received the 1st dose of Shingrix. In July 2021, 1 day after receiving Shingrix, the patient experienced injection site itching, injection site swelling, injection site joint inflammation, fatigue and walking difficulty. On 27th July 2021, the patient experienced injection site pain, injection site erythema and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovering/resolving and the outcome of the injection site erythema, injection site itching, injection site swelling and fatigue were recovered/resolved and the outcome of the injection site joint inflammation and walking difficulty were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site itching, injection site swelling, injection site joint inflammation, fatigue, pain in arm and walking difficulty to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received Shingrix and experienced pain, swelling, severe itching and redness at the injection site.  The patient experienced fatigue and arm soreness. The pain at injection site and arm soreness began immediately and had greatly subsided. However, the right arm at injection site was still sensitive when touched or massaged.  The swelling began on the second day after receiving dose and was at its worst by day 2 to day 4 after receiving vaccine and resolved after a week. Right shoulder was big and puffy. The itching began on the second day after receiving vaccine and lasted for 3 weeks.  The redness at injection site began immediately and was resolved.  The patient was unsure how and when the redness had resolved.  Fatigue began the day after receiving vaccine and lasted between 5 and 7 days. The patient was unable to do her usual, daily walk due to fatigue. The patient stated that she received the dose at a special station set up at the main office, due to COVID restrictions. The reporter consented to follow up.
I have noticed extreme shortness of breath and stamina lately, and that I cannot function physically anywhere near my recent past without getting chest pains and exhaustion.
pt recvd pneumococcal vax on 2DEC91 & devel a local reaction w/pain, warmth, erythema, induration & edema from the inject site to the elbow; pt was seen by MD 4DEC91 & later recovered; No further details were provided;
In the 2 menstrual cycles since the vaccine: heavier period, more painful period, period that lasts longer than any previous one
This spontaneous report as received from a pharmacy technician concerning a currently 1 year old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 04-APR-2014, the patient was vaccinated with VARIVAX lot#J009165; expiration date: 24-JUK-2015, (dose, strength and route not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reported. Additional information has been requested.
Patient called the pharmacy at 1:10pm on 10/8/2020, approximately 24 hours after receiving her Flublok immunization, that she had an oblong, orange-sized red area surrounding the injection site that was also slightly raised and rough. When asked, the patient reported soreness on the level of a normal intramuscular vaccination and the are being only slightly warmer to the touch. No reported itching or systemic reactions.
Vaccine at 9 am 1-15-21, by 7 pm experiencing fatigue, chills, sweats for the next 24 hours.  1-17-21 at 2am woken up by itching, covered in rash/hives from head to toe, took benadryl.  Severe headaches began and continued until around the 25th, treated with tylenol and ibuprofen with little relief.  Morning of 1-18-21 developed thrush and treated with nystatin.  Noted increased fluid retention and swelling, rash still present.  From the 17th to 21st noted a 10lb weight gain due to fluid, rash present until 21st, swelling continued to increase.  Noted increased SOB, and chest pressure, went to ER at 9pm 1-23-21 when at #28lb weight gain was noted.  Sx began to subside over the next few days with weight slowly coming off.
Flu-like symptoms; Sick; felt like she was going to die; spent the entire day in bed; Not been able to take the second dose; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received Herpes zoster (Shingrix) (batch number 2CP9B, expiry date 30th April 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, sickness, feeling lifeless, activities of daily living impaired and social problem. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved and the outcome of the feeling lifeless, activities of daily living impaired and social problem were unknown.   It was unknown if the reporter considered the influenza-like symptoms, sickness, feeling lifeless and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix shot a little over six months ago and became sick with flu-like symptoms and felt like she was going to die. The patient spent the entire day in bed the day after receiving the vaccine. The consumer also reported that she had not been able to take the second dose of Shingrix due to the Covid 19 epidemic which lead to social problem. The report did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020089531:same reporter
gout flare-up that existed prior to vaccine #1 and was not fully resolved.  After vaccine dose 1, one day following is why pain was exacerbated.  After a tapered dosage of prednisone and combination with colchicine, the flare never fully went away prior to vaccine dose 2.  Again, a day following the vaccine, pain was exacerbated to a point where I could not even walk and had to take the day off from work.  I have stated another dosage of prednisone and pain level is manageable.  There is no coincidence that the flare never went away and that it got worse both times a day following the the vaccines.  It does not appear to trigger new flares, but if a flare existed prior to taking the vaccine, it causes some pretty serious inflammatory response.
mother states that child woke up on 3/23/22 with complaints of left arm hurting. When  mother looked at arm it was swollen, red and her skin was blotchy around it. She gave her Tylenol and Benadryl. Child continued to have side effects and was taken to PCP on 3/28/22. Advised by PCP was allergic reaction and to continue to give benadryl. Unable to decide which vaccine due to both shots administered in same arm
Pt recvd 3 doses of Engerix-B vax & titer checked JAN92 result neg;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:37 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 47.36 years. No concomitant medications were reported. Batch number 044B21A  underwent temperature excursion on 15-Apr-2021 with temperature 35 degrees Fahrenheit at 09:00 AM. The vial was initially moved to the fridge on 06-Apr-2021 and proposed beyond use date was 09-May-2021. Product moved to clinic on 12-Feb-2021. 18 vials were sent to clinic. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Received the  Vaccine on 1/21.  Injection site was sore,  red, and irritated the following 4 or 5 days, appeared to be getting smaller, then on 1/26 or 1/27 got larger, redder, more painful. Went to the doctor on  1/29 and was diagnosed with cellulitis at the injection site and given antibiotics
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid for treatment of COVID-19 from 06Nov2023 to 10Nov2023. Patient did not had any known allergies nor had medical history.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300377345 Same patient, different drug/events;
Pt reported numbness and tingling in lips/mouth area less than 5 minutes after she received the second dose of the moderna covid19 vaccine. Pt was given liquid Benadryl PO and recovered quickly with symptoms quickly resolving post Benadryl administration. EMS was onsite and offered their services which the patient denied. After approximately one hour, patient denied any s/s and was released. She desired to drive herself home. She was instructed to f/u promptly with her PCP.
Major pain throughout entire left arm, 7 on a 10 scale.  Injection site pain, 9.5 on a 10 scale High, prolonged fever Nausea Major headache beyond 72 hours after injection, lingering headache and nausea ongoing.  Minor paralysis in left leg.
On 04/25/2021 I began to have hip pain, sharp jabbing pain, itching. On 04/26/2021 itching with rash and bumps, fatigue, and body aches, joints hurt. All symptoms went away by May 5th, besides the joint and hip pain, it is still ongoing as of today.
On Feb. 5, 2021 (8 days after 1st vaccination), I woke up with a really terrible backache. I had not had a backache like that in probably 20 years.  I didn't feel well, nothing specific, just generally not well.  I took 600 mg. ibuprofen.  Backache lasted all day.  Feb. 6 terrible backache continued, and I had slight headache; again generally feeling unwell.  Continued taking ibuprofen - 600 mg 2 to 3 times/day. Feb. 7, backache was better, and I had non-stop minor headache all day.  My temp. is normally around 97; that day it was 98.3. Feb. 8 backache was better, minor headache continued throughout the day, and general feeling of not being well.  Feb. 9 I finally felt better, but 2 hours after getting up in the morning, I was overwhelmingly tired.  I laid down and slept for 3 hours.  When I got up I felt better, but was exhausted all day.  I went to bed at 10:30 pm and slept through the night until 7:00 the next morning, and felt fine.  I didn't think this was a reaction to the vaccination until a friend told me one of her coworkers had COVID and it started with a backache.
Dizziness directly after vaccine, although I thought it might be nerves. Dizziness subsided then within 4 hours was lightheaded and nauseous. By next day I had muscle spasms as well and occasional pins and needles in feet. By the following Tuesday, pins and needles are consistent and dizziness is still present.
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves male patient of an unknown age who was vaccinated with a first dose of vaccine ACT-HIB (lot: U6000BA, which was expired on 18-Feb-2019) in the left deltoid on 20-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired product administered. It was reported that nurse did not realize that the ACTHIB lypholized powder and the liquid diluent had different expiration dates - the diluent expired on 18-Feb-2019 and it was given on the 20-Feb-2019. Lypholized Powder vial: Lot: UI863AA, expiry date: 17-OCT-2019, Diluent vial: Lot: U6000BA expiry date: 18FEB2019 and Package: Lot: UI863AAA , expiry date: 18FEB2019. The patient had no adverse 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 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.
DROWSINESS, NAUSEA, DIAREA, FATIGUE, ARM PAIN.
Information was received from a physician via a company representative referring to a 16 years old male patient. The patient had a history of mental illness and unspecified drug use. On 13-JUL-2016 the patient received an injection of GARDASIL 9 intramuscularly (dose and frequency unknown). It was unspecified which dose within the series was received on 13-JUL-2016. Concomitant therapies included 3 unspecified injections on that day. On unknown dates, after receiving the injections, the patient developed an altered mental state (unspecified account of what actually took place) and went to the emergency room. It was unknown if the treatment was given for the event. The patient recovered from the event with no consequences on an unknown date in July 2016. Additional information has been requested.
It was reported that an 18 y.o. female PT received a Menomune A/C/Y/W-135 vax, administered SC in her left arm on 9/12/01 at 13:08. Reportedly on 9/14/01 the PT initially c/o'd of numbness of the left elbow lasting 15-20 mins. At approx 8 p.m. experienced tightness in neck radiating up to head. Temp 98.5 deg, glands w/in normal limits. As of 9/18/01 the tightness in her neck continues. The PT's recovery status is currently unknown.