chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic to the flu vaccine; left shoulder swells up and the swelling went down into her heart; left shoulder swells up and the swelling went down into her heart; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer from a patient support program.  This case involves a 50 years old female patient who experienced allergy to vaccine, joint swelling and cardiac discomfort while receiving vaccine influenza vaccine and while treated with treprostinil sodium.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included sildenafil citrate; and rivaroxaban (Xarelto).  On 19-Jul-2022, the patient started taking treprostinil sodium Inhalation Gas at a dosage of 18 ug (3 breaths), four times a day (QID) via inhalation route (lot - 2102185, expiry date: 31-Oct-2023) for Pulmonary arterial hypertension.  On an unknown date, the patient received an unspecified dose of suspect influenza vaccine produced by unknown manufacturer (formulation and strength not reported; lot 2102185) via unknown route in unknown administration site for influenza immunization.  On an unknown date in 2022, the patient developed non-serious events of allergic to the flu vaccine (allergy to vaccine) and left shoulder swells up and the swelling went down into her heart (joint swelling) and (cardiac discomfort) (unknown latency) following the first dose intake of treprostinil sodium and (unknown latency) following the administration of influenza vaccine.  It was reported that the patient was allergic to the flu vaccine (allergy to vaccine), left shoulder swells up and the swelling went down into her heart (joint swelling and cardiac discomfort).   Action taken was unknown with treprostinil sodium and not applicable with influenza vaccine.  It was not reported if the patient received a corrective treatment for the events (allergy to vaccine, joint swelling, cardiac discomfort).  At time of reporting, the outcome was Unknown for all the events.
Patient passed out and hit his head following vaccines.  Patient responsive almost immediately following incident.  Within moments pt became unresponsive with facial and forearm muscle twitching.  Pulse slow and thready.  Paramedics arrived on site and transported.  Patient conscious and alert at time of transport.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 26-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as L0404865 with expiration date 02-DEC-2017). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Pt developed numbness of the jaw, felt as if something was struck in throat, shortness of breath, felt syncopal while driving home from the vaccine clinic.
issue with autoimmune disease; This spontaneous report was received from a consumer concerning a female patient of unknown age. No information about the current condition, medical history or concomitant therapy was reported.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route and lot# were not reported) for prophylaxis.  On an unknown date, the patient felt that ever since then she had issues with autoimmune disease (autoimmune disorder). The outcome of the event was not reported. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not applicable.   The causality between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported. Upon internal review, the event of autoimmune disorder was considered as medically significant.
02-01-2021 patient syncope x 2 with loss of consciousness. Chest heaviness, dizziness, lightheaded, increasing fatigue. Went to ED - diagnosed with new onset Right Bundle Branch Block and hypophosphatemia. Elevated D-Dimer.
itching all over body; A spontaneous report was received from a consumer who is an unidentified patient who experienced itching all over the body.     The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31-Dec-2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient began itching all over the body.  Patient denied breathing issues or the need to call for emergency help.   Treatment included Benadryl.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, itching all over, was recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Extremely high fever 106.1 degrees the night of receiving the injection 5/1/2021. Fever controlled with Tylenol but never went below 100 degrees until day 2 (5/3/2021). On 5/3/2021 my arm, armpit, (lymph node area) started tingling. I checked the injection site and notice major swelling and patchy red areas.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 03-JUN-2011, the patient received improperly stored VARIVAX dose 2, from lot # 669223/1564Z, expiry date 11-NOV-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
The pt received the vaccine at 14:00 and at 14:30 she complained of feeling flushed and heart rate was increased. She denied any respiratory problems. She stated that she returned to unit and started to feel funny. Her BP was 132/80, HR-112, lungs were clear. No rash was noted. Some redness noted on upper chest wall. Returned at 14:45. Noticed redness on arms but no respiratory problems. She does have hot flashes.
pt recv vax & exp fever from infect;it was reported that the second dose of vax will be given later than 8wk p/the first;
10/14: at 22:00, experienced headache, not feeling well.   10/15: 02:00, experienced nausea, dry heaves abdominal cramps.  Also experienced insomnia, decreased appetite, weakness.  Off work 10/15-16, gradually improving headache gone.  No treatment.
high fever  extreme headache extreme body ache throwing up extreme weakness  stabbing pains in organs    lasting about 5 hours then stayed in bed for 2 days  each morning i woke up with a different sym.  felt like i had been run over... at the in set for 5 hours I could not raise my head off my pillow.  it has it has been  weeks now and i am still feeling weakness and body aches.  this was the worse sickness i had ever had,.. if i had been in my right mind at the time I would have called 911
4? diameter rash: red, itchy, hot, hard spot at injection site on posterior deltoid. Appeared 10 days after injection.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was administered an improperly stored ROTATEQ, oral liquid, orally, lot # M016238 with an expiration date of 07-DEC-2017 (dose was not reported). Administered vaccine underwent the temperature excursion of 52.8 degrees Fahrenheit (F) for 40 minutes which was detected by a data logger. The previous temperature excursion was not reported. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25May2022, 1 day after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8 days after injection, injection arm became red, slightly swollen and itches.  Now on day 10 and it still persists
Extremely cold with chills, face lost color, lips purple, extreme body aches.  Headache.  Went to doctor at 11:15.  103 fever, change in vision, chills, aches, cold.  Sent to outpatient for blood work.
extreme vertigo ongoing, nausea for 72 hours, arm pain, chills, fever, shortness of breath, chest tightness, extreme fatigue
8 Days after my vaccination I woke up and noticed warm itchy red splotches on my arm below the vaccination spot.  Throughout the day it has progressed into a spot roughly the size of my palm.  Raised, red, warm, and itchy.  My arm is somewhat achey.
Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (dose, unit and route not reported, Lot# K015993 and Exp. date 23-SEP-2016). The vaccines were exposed to 6.65 F for 14 hours 15 minutes. There was previous temperature excursion reported, vaccines had been exposed to 17 F for 1 hour and 6.05 F for 14 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
I have had a prolonged illness ever since 3-4 days after my second Moderna Vaccination on April 9th.    Fevers, chills, elevated heart rate (104-115), copious amounts of phlegm from my sinuses making it even harder to breath, coughing from deep in my lungs trying to clear the phlegm, much went in my stomach making me nauseous. Lethargy!   I took some over-the-counter meds to keep the mucus levels to a point I could breath.  but not many nor very often  as I knew those led to elevated heart rate, and I already had that.  Headaches became common, more like icepicks driven into my head.   My GP thought I must have a sinus infection and started me on one type of antibiotics, then switched to Amoxicillin when that didn't work.  Antibiotics did nothing.  My best relief - 2 ibuprofen & a Benadryl taken sparingly so I could sleep.  I coughed up lots of mucus!  1st trip to the Hospital ER on 05/10/2021 came when my temp reached over 100.4  & my heart rate was at 114.  their conclusion:  I was having a bad reaction to the vaccination.  Take Afrin for 3 days & be glad I was vaccinated.  Through multiple freeze then fever sessions starting this past week,  I have started to feel somewhat better.  my sinuses cleared,  most of the coughing has subsided, the headaches are less frequent and intense.  today, 05/18/2021, my heart rate finally dropped below 100 and my Oxygen level is now mid-90's .
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 18-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007011:
Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient states she has not been able to move her arm since vaccine was given- she says she has seen a doctor and will need to go to physcial therapy with a copay of 60 dollars everytime she goes
No additional AE; Patient was administered Improperly Stored ROTATEQ; This spontaneous report was received from a licensed practical nurse, referring to a 6-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 29-OCT-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number 1660998, which have been verified to be valid, expiration date reported and validated as 03-MAY-2021) as prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion above of 9 degrees Celsius (C) (9.7 degrees C) for 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.; Sender's Comments:  US-009507513-2010USA012044:
No adverse effects reported; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S012246, expiry date 10-FEB-2021) (exact dose, frequency and route of administration were not reported) for prophylaxis.  On 30-SEP-2019, the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) experienced a storage error. The storage temperature was 68 Fahrenheit degrees during the time frame of 8 hours. Previous temperature excursion was 57 Fahrenheit degrees for 2 hours. A digital data logger was involved.  No adverse effects were reported. The outcome of the event was unknown.
approx 36hr p/vax mom noticed a difference in arm size when holding child;when checked lt upper arm was swollen, warm tot ouch w/dark reddish coloring from inj site to elbow approx 3-4:;
Developed left upper arm swelling at injection (VARIVAX) site less than 18 hrs after receiving immunization; warm, firm, swollen and red: Benadryl and MOTRIN prn; ice/cool compresses to site as tolerated.
Covid-19 I tested positive on July 15th  i experienced congestion, coughing, scratchy throat, and fatigue that was the first day and the second day i was prescribed paxlovid around 11am and while taking paxlovid i started to feel better and symptoms started to subside.
Administered vaccine per usual route. Upon documentation of vaccine discovered that vaccine was 3 days expired.  Immediately contacted manufacturer GSK. GSK forwarded recommendation  was up to provider discretion. Discussed with Dr. who determined that no additional vaccination was required and no adverse effects of the vaccine would be noted. Patient will be able to receive the 2nd dose of the vaccine per cdc guidelines.
Pt vax w/ 2nd hepta B on 04Dec90; Later pt exp aching all over, h/a, neck ache. 9 hrs later pt exp vomiting.  Sx resolved w/in 24 hrs.  No 3rd dose given.
This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (runny nose), AXILLARY PAIN (arm pain) and FATIGUE (fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. No Medical History was provided by the reporter.  On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced COUGH (Cough), RHINORRHOEA (runny nose), AXILLARY PAIN (arm pain) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), RHINORRHOEA (runny nose), AXILLARY PAIN (arm pain) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported.
sore arm/soreness for a short while at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm/soreness for a short while at the injection site) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and COPD.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm/soreness for a short while at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm/soreness for a short while at the injection site) had resolved.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2022-472076, MOD-2022-473800 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2022: Follow up received: Updated outcome from unknown to recovered.
Red, itchy, hot, irregularly shaped patch around injection site. Aporox size 1.5? x 2.5?.
Upon awakening 9/11/2000, noticed a rash on chest stomach back and under arms, was red itchy it raised. She took Benadryl, symptoms a little better in am. Took no more Benadryl as had school. She saw MD and was started on Zantac, uses Benadryl PRN. She states hair is gone around injection site.
Injection arm soreness (vaccine 1 and 2) Vaccine 2: Headache Fever (100.8, 99.9) Exhaustion/Tired Nausea Constipation Loss of appetite Severe chest pain (6 hours on and off 04/09/2021 6pm to midnight)
Chills, body aches, fever, systemic internal itching (felt like all my organs were itchy), headache, red itchy and throbbing welt at injection site. Just passed the time and also took my usual dosage of Zyrtec D.  Fever gone within 12 hours. Circled itchy welt which spread throughout arm for 6 days.
After my first Covid Vaccine, I developed diarrhea, which lasted for 3+ months, when I was diagnosed with microscopic colitis and started treatment
Rash and swelling in hands; Rash and swelling in hands; Blisters; This is a spontaneous report from a contactable healthcare professional (patient). An adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 13Jan2021 (12:00) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient did not have relevant medical history and concomitant medications. On 15Jan2021, the patient had rash and swelling in hands; and blisters. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had received valacyclovir as treatment for the reported events. The outcome of the events, 'rash and swelling in hands' and 'blisters', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
arm was all red and tender and swollen/clinic said it was cellulitis; Red arm; Tender arm; Swollen arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE CELLULITIS (arm was all red and tender and swollen/clinic said it was cellulitis), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PAIN (Tender arm) and VACCINATION SITE SWELLING (Swollen arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Asthma. Concomitant products included LOSARTAN for an unknown indication, SECNIDAZOLE (SENEX).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (arm was all red and tender and swollen/clinic said it was cellulitis), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PAIN (Tender arm) and VACCINATION SITE SWELLING (Swollen arm). The patient was treated with CEFATRIZINE PROPYLENEGLYCOLATE (CEFTIN [CEFATRIZINE PROPYLENEGLYCOLATE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CELLULITIS (arm was all red and tender and swollen/clinic said it was cellulitis) had not resolved and VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE PAIN (Tender arm) and VACCINATION SITE SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient reported 2 issues developed since her first dose of the Pfizer COVID-19 vaccine. The first issue is a very sore arm. She stated it began hurting with the first dose and became even more sore after the second dose she received 3 weeks later. She reported worsening pain, weakness and limited range of motion. The second issue is a change in her menstrual cycle. She stated since receiving her first dose of this vaccine, her periods have increased in frequency. She has a much heavier flow and is now having very large clots.
Disorient -Loss of memory light headed loss of balance - could not retain thoughts forgetful- on going current today.