chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 24 hours after the shot I experienced muscle aches, and pain at the injection site. A general feeling of lethargy became progressively worse throughout the day. from morning to noon i felt off but thought i was just psyching myself out. My noon I realized i was experiencing side effects. Around 2pm i began to experience mild chills. While cooking dinner at around 5pm I felt like my muscle aches in my back were on the threshold of feeling likes spasms. around 8-9pm before going to bed the symptoms were at there worst and comparable to a moderate illness. By the next morning I felt about 80% better but got headaches between my eyes whenever i stood up or moved too fast. As of today I feel about 95% better but still somewhat lethargic.
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case is linked to case 2018SA250328 (same reporter). This case involves a 34 years old patient (gender not reported) who received 0.5 ml expired dose of FLUZONE QUADRIVALENT (frequency once, lot number UI852AD, expiry date and route of administration were not reported) in the right deltoid on 04 Sep 2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. Patient had not reported any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Additional Details: Patient fainted about 10 minutes after injection. She had not eaten prior to receiving the vaccine. Had her prop her feet up on chair while laying on ground to return blood flow to her head. Recovered without further incident.
booster; had a horrible Aura migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 08Dec2021 (Lot number: FH8027) at the age of 28 years as dose 3 (booster), single , single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: "I have Asthma. I am taking albuterol as emergency inhaler, (unclear voice) and Singulair."; "Migraine" (unspecified if ongoing), notes: I usually get them once every couple years. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma; SINGULAIR taken for asthma. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "booster"; MIGRAINE WITH AURA (non-serious) with onset 08Dec2021, outcome "unknown", described as "had a horrible Aura migraine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine with aura.  Additional info- Patient did not receive any vaccination within 4 weeks prior to vaccination. It was reported that patient need to know if I need to go a doctor for some sort of like cardiovascular issue (Further not clarified) or it's a normal side effect to get a migraine afterwards .Therapeutic measure were taken as AE and treatment was taken with 200 milligrams pills of Ibuprofen but no it usually doesn't, it helps a little bit but not enough.  No follow-up attempts are possible. No further information is expected.
On 2/24/21, approximately 8 or 9 days after vaccination, left arm, in area of injection, began to itch. No redness or edema was noted. Approximately 2 days later, area was still itchy an became erythematous. still no edema noted. Hydrocortisone Cream 1% relieves the itch temporarily. As of 2/27/21 little improvement noted.
Bilateral ear pain lasting only 5-10 min at 2.5 hours after vaccine. High pitched noise in right ear (no pain) 8 hours after vaccine
Janssen booster shot, severe body pain, fever, chills, nausea. Not able to sleep, at all.   This only last about 4-6 hours and I was still able to make it to work , by 8am.  I thought maybe all vaccine side effects should be reported, I had no problems, except insomnia, with the first Janssen vaccine.
Pt presents to the clinic with swelling of the (L) arm and redness and warmth around injection site of PNEUMOVAX that he received yesterday. Pt reports achiness of the (L) arm and fatigue. Pt denies any difficulty breathing or feeling of throat swelling. Pt is given DEPO-MEDROL 80mg IM today and advised to take BENADRYL 50mg Q 4 hours throughout the day today. Pt is advised to contact clinic if no improvement tomorrow a.m.
Fever around 100 degrees; Body aches; Chills.; Still feel more lethargic at night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever around 100 degrees), MYALGIA (Body aches), CHILLS (Chills.) and LETHARGY (Still feel more lethargic at night) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No medical history reported).    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever around 100 degrees), MYALGIA (Body aches), CHILLS (Chills.) and LETHARGY (Still feel more lethargic at night). At the time of the report, PYREXIA (Fever around 100 degrees), MYALGIA (Body aches), CHILLS (Chills.) and LETHARGY (Still feel more lethargic at night) outcome was unknown. Not Provided
SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lung cancer ( the middle lobe of her lung removed), and concurrent conditions included: crohn's disease (her small and large intestines removed), chemo neuropathy, osteoarthritis, and allerigic to nsaids, and other pre-existing medical conditions included: The patient was on oxygen therapy at the time of vaccination. The patient experienced drug allergy when treated with gabapentin, and oxycodone hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213O21A, and expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for neuropathy, tramadol for neuropathy, ergocalciferol, metoprolol, and pyridoxine hydrochloride. On an unspecified date, the patient experienced sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache. This report was non-serious.
New hire employee received 1st varicella vaccine on 6/6/19.  Stated she was fine initially and the day after.  However, two days after receiving the vaccine she stated she noted swelling, induration, warmth, redness, and itching to vaccine site.  Treated with icing.  By the third day after receiving vaccine, symptoms started to subside, noted decreased swelling, warmth and redness.  Denies fever, chills, or night sweats.  Stated she has become increasingly allergic or sensitive to various antigens within the last decade such eating chicken, any medications containing epinephrine, etc.  Plan to re-check immunity titer to varicella one month after vaccine.
This case was reported by a nurse via sales rep and described the occurrence of meningitis in a patient who received BEXSERO (batch number 16G201, expiry date unknown) for prophylaxis. This case was associated with a product complaint. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO and MENACTRA at an unknown dose. On an unknown date, less than a day after receiving BEXSERO and unknown after receiving MENACTRA, the patient experienced meningitis (serious criteria GSK medically significant), general body pain, fever and pharmaceutical product complaint. On an unknown date, the outcome of the meningitis, general body pain, fever and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the meningitis, general body pain and fever to be related to BEXSERO. Additional details were provided as follows: The licensed practical nurse (LPN) reported this case. The age at vaccination was not reported. The reporter states that they noticed a trend of administering BEXSERO and patients returning within the same day complaining of adverse events (3 adverse events in 1 week). The patient experienced symptoms of meningitis and body ache. The patient had to be transported to the emergency department (ED) via ambulance. The reporter believed the co-administration issue with MENACTRA and BEXSERO. The reporter stated since administering BEXSERO only and no other vaccines at the visit, they had not seen any other additional incidents. Once they stopped co-administering BEXSERO with MCV4, the adverse event trend stopped. This case has been linked to US2018GSK13439, reporter by same reporter for unspecified number of patients.
14 cm x 11 cm right thigh pink, blanchly, increase warmth area, tender.  7 cm x 6 cm left thigh pink, blanchly, increase warmth area ( but less pink than right and not warm). Same in clinic 2 days after vaccine administered than immunitization clinic. No fever, no limp
Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.
Information has been received from a medical assistant concerning a 60 year old patient who "about 9 months ago" (approximately May 2007), was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) rather than zoster vaccine live (Oka/Merck). There was no reported adverse experience related to this event. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
COVID-19. I started getting sick on June 21st and on the 25th I was really sick. I didn't realize that I had COVID. It started with sinus issues and I kind of ignored the symptoms due to my other issues. By the 25th I moved away from the house I was sitting at and I realized that I was a lot sicker than just the fragrance sensitives I thought I was having. At the 10 day mark I still couldn't go back to work. And after COVID I then got a sinus infection that I'm still sick from. I got steroids and cough syrup. I found out Oct 2020 until March 2022 the home I was in was moldy.
"Rash appeared on lower abdomen and upper buttocks appearing impetiginous. Lesions had a central grey fluid filled vesicle. Rash erupted 27 days post vaccination."
PATIENT RECEIVED MMRV INSTEAD OF MMR AND VARICELLA SEPERATELY
BLOOD CLOT IN BRAIN; This spontaneous report received from a consumer via a social media and by a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient ended up dying (Death) for a blood clot in brain. It was unknown if an autopsy was performed. It was reported that "My sister got the J&J vaccine ended up dying for a blood clot in brain". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221135799.; Sender's Comments: V0: 20221135762-blood clot in brain. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT IN BRAIN
staff member received his first injection in the left arm. As staff was waiting for his time of observation, he stated he could feel his blood pressure rising. When assessed, his blood pressure was 196/119. Staff member stated to the MD he takes medications for hypertension but was unable to state what that medication was. He says he just takes what he was given. Staff member stated he was having a hard time breathing due to his blood pressure and was given supplemental oxygen at 3L per nasal cannula. O2 was 98% throughout. 911 was called to assist staff member to ED for evaluation of symptoms. While taking staff member to meet the ambulance, via wheelchair, he stated he believes he forgot to take his medication for the day. Ambulance took staff to ED with no noted complications.
Injection site turned red and warm, then started to peel like a sunburn.; Injection site turned red and warm, then started to peel like a sunburn.; Injection site turned red and warm, then started to peel like a sunburn.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE EXFOLIATION (Injection site turned red and warm, then started to peel like a sunburn.), INJECTION SITE WARMTH (Injection site turned red and warm, then started to peel like a sunburn.) and INJECTION SITE ERYTHEMA (Injection site turned red and warm, then started to peel like a sunburn.) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE EXFOLIATION (Injection site turned red and warm, then started to peel like a sunburn.), INJECTION SITE WARMTH (Injection site turned red and warm, then started to peel like a sunburn.) and INJECTION SITE ERYTHEMA (Injection site turned red and warm, then started to peel like a sunburn.). At the time of the report, INJECTION SITE EXFOLIATION (Injection site turned red and warm, then started to peel like a sunburn.), INJECTION SITE WARMTH (Injection site turned red and warm, then started to peel like a sunburn.) and INJECTION SITE ERYTHEMA (Injection site turned red and warm, then started to peel like a sunburn.) was resolving.            Not concomitant therapy information was provided.  No treatment information was provided.
Pt states after receiving the vaccine she started to having hearing impairment.  It sounds like people are talking very light
Fever, Numbness of Right arm (one used for injection) and Numbness of Left leg.
Child is 7 years old and got DTAP (Regional shortage of TD and child with multiple recent cuts at work site of parent's home which is under construction). Child with integrated Sensory Deficit, thus increased pain tolerance. Mom noted a large lesion at injection site while child in warm bath this AM, 48 hours, post vax. Child decreased historian, denies pruritus or significant pain. Red, raised non-pruritic warm lesion right lateral thigh 6.2cm X 3.2cm (6.2mm X 32mm). Parents lived in Africa when child was 3 years old and had a severe pertussis at age 3.
Fatigue, headache and joint point on 10/26/21.  On 10/27. still have fatigue, headache and joint pain but also have a rash on neck/collar bone on both sides.
Itch/ the caller experienced itching on both arms; she had a sore arm; This is a spontaneous report received from contactable consumer (patient) via a Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 03Jun2021 as 1st dose single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received flu shot. It was reported that the patient received her first dose of Pfizer-BioNTech COVID-19 Vaccine on 03Jun2021 (Thursday), and her second dose was scheduled for 24Jun2021. The patient stated, she just wanted to check in because she did find had no real reaction, the shot was like a flu shot. On 05Jun2021, at first the patient experienced a sore arm and then that went away. The patient stated both her arms started to itch which was on Saturday 05Jun2021 (reported as two days later). Arm itching had stopped. The clinical outcome of the evets was recovered on an unknown date in Jun2021.  Information on the lot/batch number has been requested.
dizziness, flushing, swelling of tongue and lips tightness in chest, Face and arms turned red, nausea all within 30 minute observation period. All symptoms were completely relieved within 15 minutes after IM Diphenhydramine 50mg/ml given in the office. Patient refused to go to ER to be evaluated.
Horrible and sudden diarrhea.; Chills; Aches; Fever; Headache; Urinary incontentance; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administration in the right arm on 06Apr2021 at 12:15 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included thalassemia minor, hypothyroidism and known allergy to sulfa. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) ,vilazodone hydrochloride (VIIBRYD) and vitamins nos (DAILY VITAMINS); all for unspecified indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the right arm on 16Mar2021 at 12:15 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 13:30, the patient experienced chills, aches, fever, headache, urinary incontinence. On 08Apr2021, the patient experienced horrible and sudden diarrhea. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of chills, aches, fever, headache, urinary incontinence and horrible and sudden diarrhea were recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
Patient is a 70 y.o. female who was admitted with increasing SOB, fevers.  COVID 19 PNA with acute hypoxia  - stable now on RA. Cont steroid taper at home  - given Remdesivir. Inflammatory markers improved -  procalitonin nl,  abx discontinued
Patient sitting for about 20 minutes and feet felt hot/on fire; no shortness of breath. BP 118/84; pulse 84; p ox 99%. Has had same sensation when had allergic reaction to bactrim.  Monitored for another 15 -20 minutes; took gatorade. Wanting to go home and take liquid benadryl.
One week after 2nd Janssen vaccination, patient began having symptoms of mania. He would have increased agitation, stereotypy and severe insomnia. His awake periods would last up to 39 hours, then sleep the next night for about ten hours and then cycle repeated every other day. this pattern began one week after vaccination. This cycle continued for 14 days and did not subside without an increase in his nighttime clonazepam and Lithium dosing. His bipolar disorder had been stable for several years until this occurrence.
Bleeding breast; A spontaneous report was received from a consumer concerning a 63 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced breast bleeding.   The patient's medical history was not reported. No concomitant medications were reported.   On 05-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 10-Mar-2021 patient experienced some blood from breast. The patient's doctor recommended an emergency mammogram.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome events, breast bleeding, was considered unknown.; Reporter's Comments: This case concerns a 63 year-old, female patient, who experienced some blood from breast 6 days after the first dose of mRNA. The patient's doctor recommended an emergency mammogram. Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Since my visit in November I have experienced cramping, pain, and limited ROM at the site of my flu shot in the left lower deltoid. I have noticed it but became extremely apparent during a relaxation massage on 01/03/2018. I wrote my healthcare provider to let her know my concern and she instructed me to report it to the CDC. I have no redness but with activity or abduction have limited ROM, pain, and cramping. I use ice, heat, massage, and stretch to treat.