chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu-like aches; Fatigue; Nausea; Flu-like chills; Injection site still red 3 weeks later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 19:30 (Lot number: En6206) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cats" (unspecified if ongoing), notes: Cats; "Seasonal allergy" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "polycystic ovarian syndrome (PCOS)" (unspecified if ongoing), notes: PCOS; "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 13Mar2021 07:00, outcome "recovered" (15Mar2021), described as "Flu-like aches"; FATIGUE (non-serious) with onset 13Mar2021 07:00, outcome "recovered" (15Mar2021), described as "Fatigue"; NAUSEA (non-serious) with onset 13Mar2021 07:00, outcome "recovered" (15Mar2021), described as "Nausea"; CHILLS (non-serious) with onset 13Mar2021 07:00, outcome "recovered" (15Mar2021), described as "Flu-like chills"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Mar2021 07:00, outcome "recovered with sequelae" (2021), described as "Injection site still red 3 weeks later". Therapeutic measures were not taken as a result of influenza like illness, fatigue, nausea, chills, vaccination site erythema.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a licensed practical nurse concerning a 65-year-old female patient with an allergy to Penicillin, who on 09-SEP-2005 at 09:15 am, was vaccinated subcutaneously with a second dose of pneumococcal 23v polysaccharide vaccine (649694/0386P).  It was noted that at the time of vaccination the patient had weight loss and abdominal pain.  The licensed practical nurse reported that on 09-SEP-2005, the patient developed an injection site reaction which included redness, pain, local heat and swelling and was reported as a cellulitis.  She sought medical attention and the cellulitis was treated with antibiotics.  The patient fully recovered.  There was no product quality complaint reported.  Additional information been requested.
POST VACCINE EVALUATION BY RN, MOTHER REPORTED BY PHONE ON 06/14/2017 THAT PATIENT HAD FEVER OF 102.1 AT 11:00 PM, GAVE IBUPROFEN LIQUID 3 TEASPOON AT 11:30 PM. RN ADVISED MOTHER TO DO COOLONG MEASURES,INCREASE FLUID INTAKE AND REST, TO GO TO ER IF SYMPTOMS WORSEN. AT 08:45 AM PATIENT FEELS BETTER, TEMPERATURE WAS 99.1. AT 10:00 AM MOTHER REPORTED PATIENT IS DOING FINE AND WENT TO DAYCAMP.
Patient reported erythema, warmth, the day after, at the injection site measuring 1 1/2" x 3" patient reported this at 7-11-14 visit with dr.
Tenderness, rash, itching, inflammation and redness of skin at injection site beginning 8 days after injection
dizzy, nausea knot in throat becoming hot almost immdiatley; SOB went to ER; a cold;
pt recvd vax on 21APR93 & @ check up 23APR93 became very fussy & dysconjugate gaze noted, acute exotropia w/sl inc pupil size;
PATIENT CALLED TO SAY THAT THERE WAS SIGNIFICANT REDDISH CIRCLE APPROX THE SIZE OF HER PALM AT THE INJECTION SITE.  IT WAS ALSO WARM TO THE TOUCH.  SHE DID NOT TAKE ANYTHING TO TRY TO REMEDY THE SYMPTOMS AND SAID SHE WAS AWARE THAT SOME HYPERREACTION COULD OCCUR BUT THIS SEEMED 'SIGNIFICANT'.  I RECOMMENDED SHE SEE URGENT CARE TO RULE OUT CELLULITIS NEEDING ANTIBIOTICS.  I CALLED TO FOLLOW UP WITH HER THAT EVENING AND SHE STATED IT APPEARS TO BE RESOLVING A LITTLE BIT.  I RECOMMENDED SHE TAKE IBUPROFEN AND MAYBE BENADRYL IF SHE HAD SOME HANDY AND TO BE SEEN IF NOT RESOLVED OR GETS WORSE IN THE NEXT 24 HOURS.  SHE STATED SHE IS A NURSE AND MOSTLY JUST WANTED THE ADVERSE EVENT REPORTED.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted, but was still awake and responsive, just lightheaded. Patient left on own accord after interaction with paramedics
In less than 24 hours I became violently ill, sore throat with lesions on my throat, lightheadedness, dizziness, feeling of having a stroke like numbness but on both sides of the body. I developed pertussis within 3 days of receiving the vaccine. The pertussis lasted about 4 weeks in total. I had massive headache. I also now have a severe soy allergy and wheat/gluten allergy among many other milder food allergies because of this shot.
Patient experienced syncope about 5 minutes after recieving vaccine.  he fainted fell to the floor bumped his head then got up immediately later and reported to pharmacist around 7:40.  Patient was asked to sit down, given water and powerade for fluids and electrolytes.  after 20-30 minutes patient vomited.  911 was called immediately after.  first responders came in 10 minutes around 8pm and took vital signs and questioned patient.  patient refused to go with them stating he felt better.  patient left pharmacy around 8:30 pm 5/12
Sudden onset nausea and vomiting, throughout the afternoon and evening I received the vaccine.
Patient developed raised, itchy almost weeping rash on the inside elbow of the arm opposite the injection site. Still very itchy, no other symptoms.
Information has been received from a nurse practitioner concerning a 21 year old female with allergic reaction to CECLOR who on 26-Mar-2008 was vaccinated with the first dose of GARDASIL (lot#659655/1486U). Concomitant therapy included LOESTRIN. On 02-Jun-2008. the patient was vaccinated with a second dose of GARDASIL(lot#660387/1967U. It was reported that after the patient's second dose (date not provided), the patient developed severe and prolonged diarrhea after each meal, with no abdominal pain. Subsequently, the patient recovered on Sep-2008. It was reported that the event was mentioned at the patient's next office visit. The reporter also indicate that the patient "may have experienced diarrhea after her first dose" of GARDASIL . No laboratory diagnostic studies were preformed. Additional information has been requested.
pain in his left thigh area; Tingling sensation in thigh; This case was reported by a consumer via call center representative and described the occurrence of pain in thigh in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2020, the patient received the 1st dose of Shingrix. On 31st January 2020, 1 days after receiving Shingrix, the patient experienced pain in thigh and tingling of extremity. On an unknown date, the outcome of the pain in thigh and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the pain in thigh and tingling of extremity to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient started to experienced pain in his left thigh area with some tingling sensation. The patient stated that he had gone for massages and chiropractic manipulations and this pain did not resolved. The patient was stating that the pain get worsen with extended standing. The reporter consented to follow up.
Information has been received from a physician concerning a 19 month old white male who on 29-DEC-2004 was vaccinated SC in the right thigh with the first dose of varicella virus vaccine live (Lot#645819/1055N). Concomitant therapy included budesonide (PULMICORT), albuterol and cetirizine HCl (ZYRTEC). The physician reported that on 21-JUL-2005 at 08:00, the patient developed a rash and diarrhea consistent with breakthrough varicella. At the time of this report, the outcome was unknown. Additional information has been requested.
pt recvd vax 330PM; @ about 6AM eyes turned red & area around eyes started swelling; took daughter to ER approx 830 that noc;
i had an accident after 30 minutes of the vaccination and i don't remember anything. The officers kept asking me about the accident but i don't remember anything. I think it's because of the vaccination cuz my blood sugar was normal.
Janssen COVID vaccine was given to this patient when she is 17 years old.  Her year date of birth was 2003 and it was not realized that she had not yet turned 18 because her birthday is in December.
Immediately following injection, patient stated that she felt dizzy, lightheaded, and hard of hearing as if she was "underwater". She was pale and clammy. The RPh tried to take her pulse and HR but automated reader came back as "error"
arm was killing her; has bleed so much from the shot; when she wipped the site, there were blood clots on her napkin; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was killing her), VACCINATION SITE HAEMORRHAGE (has bleed so much from the shot) and VACCINATION COMPLICATION (when she wipped the site, there were blood clots on her napkin) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was killing her), VACCINATION SITE HAEMORRHAGE (has bleed so much from the shot) and VACCINATION COMPLICATION (when she wipped the site, there were blood clots on her napkin). At the time of the report, PAIN IN EXTREMITY (arm was killing her), VACCINATION SITE HAEMORRHAGE (has bleed so much from the shot) and VACCINATION COMPLICATION (when she wipped the site, there were blood clots on her napkin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported. Treatment details were not provided.
Swollen and pain in left arm from shoulder to elbow. Red welts in long zig zag pattern
Same day after getting shot pt. started c/o headache, nausea, hurting all over; no energy, dizziness at times. C/o redness/soreness rt. arm- 4 inch diameter- hurt when moves, can't hold anything heavy- Continues to be sore.
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to experience whole body chills, teeth chattering, and extreme fatigue. I took Ibuprofen and went to sleep. I experienced chills until approx 3 AM. My watch alerted my heart rate rose above 120 bpm three separate times during the night in the 1, 2 and 3:00 hours. Upon review of the summary it appears to have been sustained at just over 120 for that entire time. I awoke at noon, with a temp of approx 99.5 F, I felt extreme fatigue and a sense of cold but body was warm to touch and I was very sweaty this entire time. I slept most of the day and at 5 pm awoke with a temp of 102.4F. I contacted my physician who directed me to use tylenol and Benadryl. I took a dose at 5 pm, anther at 9 PM. Upon waking the next morning I was afebrile. At that time I felt slightly dizzy and lightheaded but also dehydrated. Forcing fluids relieved symptoms. I experienced a very mild headache and very mild queasiness as well.
Sometime in May 2021, I started having bilateral lower leg pain. I have often had leg pain and anemia and thought my symptoms were related to it. In July 2021, I had a hysterectomy and the pain got better. In Sept 2021, I started working on my feet all day long and noticed swelling to both of my feet. Sometime in September 2021, I went to a hospital ER and they referred me to podiatry due to my foot swelling. I went to the podiatry clinic in Oct 2021. He had me do an MRI in Oct 2021 and Conduction Nerve Study done in Jan 2022. I went to a vascular doctor for vein studies who asked me to wear compression socks and made an appointment for ultrasound to be done on August 19, 2022.
Employee reports noticing s/s (redness, pain, swelling and tenderness) on the 10/28/21 approximately around 07:00 PM. Employee refuse medical care at work and denies receiving any outside care. Employee was recommended to apply cold compresses and look for medical care if symptoms worsen.
Mom in with the child to show the nurse her left arm where she had reddened area of induration about 3 inches wide and 3 inches long. Denies any fever, nausea, pain, red streaks and the child has been eating and playing as usual. Mom to apply warm compress to child's arm and to seek care of MD or Er if needed and comfort measures discussed.
My symptoms are swollen right supraclavicular  lymph nodes, non-tender, pea size and movable
Mild injection site pain initially, next day increased injection site pain; Headache; Malaise; Low grade fever; This is a spontaneous report from a contactable pharmacist. This pharmacist (Patient) reported that the 29-year-old male patient received first dose of bnt162b2 (BNT162B2, Pfizer COVID-19, Batch/lot number: EL1284), via an unspecified route of administration on 04Jan2021 02:30 PM at single dose on Left arm for covid-19 immunisation. Medical history included covid prior vaccination. No Known Allergies to medications, food, or other products. Facility type vaccine was hospital. No other vaccine in four weeks. No other medications in two weeks. The patient experienced Mild injection site pain initially, next day increased injection site pain, malaise, low grade fever, and headache from 04Jan2021 03:00 PM. No covid tested post vaccination. The event was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered in Jan2021.
2 weeks after vaccine had mild headache. 4 weeks after vaccine had cramping in R hamstring. 4-6 weeks after vaccine started having balance issues, difficulty swallowing, weakness. LP as below which showed albuminocytologic dissociation. Clinical picture was concerning for Guillain-Barre syndrome. Patient started on IVIG.
Mother states that after shots/vaccines administered she took the baby to day care, fed the baby, and then left work. Then, within 1 hour, received call that baby was having a seizure - mom took baby to MD listed above.  12/21/07 Reviewed vax record which confirms lot #s as reported. Reviewed hospital medical records which reveal patient experienced runny nose & low grade fever on 10/30/07 day of vax.  Patient had apparent seizure while at daycare later in morning of 10/30/07 w/blank staring spell & inability to respond to stimuli then started shaking violently.  Alert after shaking stopped.  No further seizure activity noted.  Taken to pcp who sent to ER.  Very sleepy in pcp office & in ER. Admitted 10/30-10/31/2007. FINAL DX: no d/c summary available.  Epilepsy.
Fever and tiredness evolving into serious joint pain in shoulders and hips which is painful enough to affect sleeping.  Continuing fever and low energy.
My father got vaccination on 1/26/2020 in the evening and got high temperature and body ache next morning on 1/27/2020 Vaccination was made by pharmacist. My father is also himself PhD Internal Medicine doctor presently practices
swelling; redness; soreness; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced swelling, erythema and pain. On an unknown date, the outcome of the swelling, erythema and pain were unknown.   It was unknown if the reporter considered the swelling, erythema and pain to be related to Shingrix.  Additional details were provided as follows: On 20th July 2019 Saturday, the patient received 1st dose of Shringrix and experienced swelling, redness and soreness. The patient was asked how long should the swelling, redness and soreness last. The patient was provided with the guidance of Shingrix package insert.
Lightheadedness, followed by severe headache and photophobia.  Seen at Urgent Care (diagnosis migraine-like; ER 02/12 after vomiting and no relief from headache/nausea.  After spinal tap diagnosed with meningitis.  Week of 02/17 still slight headache with high blood pressure and sore throat/chest cough not yet resolved.
Patient received dose on 04/25/21, started experiencing itching and redness on the evening of 05/03/2021. She used neosporin pain formulation to treat itching because it was available at home. Next morning (05/04/21) patient says area turned a deeper shade of red with intense itching. She states it is also warm and somewhat hard to the touch. Patient showed this upon presenting to the pharmacy, it is a large area, about 2in by 2in of redness. Pt states no other symptoms or distress. Patient is going to treat with benadryl and hydrocortisone cream
BlurredVision, Dizziness, Palpitations & HYPOtension Narrative:
Patient reported chest tightness (at 8:00 pm) shortly after receiving the above immunizations (at 7:45 and 7:50 pm). Her blood pressures were 134/77, 128/76, and 117/77. Her skin did not change color. She was able to speak to us as usual. When calling paramedic, it was advised that we give her 2 tablets of aspirin 325 mg and we did. Paramedic arrived very quick. They checked her blood pressure, heart rate and oxygen level. All came back normal per paramedic. Upon questioning, she stated that she experienced similar chest tightness before and was diagnosed with depression. However, she just picked her bupropion XL 150 mg and had not take it yet. She refused to go to the hospital with the paramedic. At 8:40 pm, she decided to front end to purchase Q-tip and will go home with her daughter.
Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment medications was not provided; Sender'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.
Patient came back in 5 days after injection. At this point his arm was still quite red -probably 6 inches in diameter - and sore. He said his arm had also been swollen and he had experienced feverish, flu like symptoms. Upon questioning, the symptoms were clearly resolving and no longer requiring treatment.  He said he had insisted on getting both vaccines in the same arm and "would never do that again".
Case number PHEH2015US020296, is an initial spontaneous report received from a nurse on 08 Oct 2015. This report refers to a 56 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly on 07 Oct 2015 that was out of temperature range at 47 Fahrenheit. No adverse event was reported following this medication error.
I had vaginal bleeding for almost 4 months. My ob/gyn Dr diagnosed me with endometrial hyperplasia. Bleeding stopped on Nov 28,2021.
I start around probably around 1:30, 1:15 something rash like, I am scratching and I am getting all red; It looks like I am getting a side effect of rash; I am not comfortable; I start around probably around 1:30, 1:15 something rash like, I am scratching and I am getting all red; It looks like I am getting a side effect of rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Nov2021 (Lot number: FF2593, Expiration Date: 19Nov2021) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 Immunization; Bnt162b2 (Second Dose), for covid-19 immunization. The following information was reported: PRURITUS (non-serious), RASH ERYTHEMATOUS (non-serious) all with onset 2021, outcome "recovering" and all described as "I start around probably around 1:30, 1:15 something rash like, I am scratching and I am getting all red; It looks like I am getting a side effect of rash"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovering", described as "I am not comfortable".  Additional information: The patient stated, "Right now I am very concerned very, very because my two shots before this one and I never have this experience. I am very concerned because is the rash I am having and it's like a side effect from the three vaccine that I have for Covid. So it looks like that I". NDC and UPC number of Covid-19 Vaccine was Unknown.  No follow-up attempts are possible. No further information is expected.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Large leg bruising. Purple , black and blue in color. Leg bruising occurred after both shots. The bruising appeared on my leg within one hour of second dose of Moderna. Bruises took 3 weeks to go away after each shot. I have had high blood pressure at every doctors visit since vaccine. I did not have high blood pressure during gynecologist visit in august of 2021 before vaccine.
Patient stated fear of needles/shots prior to getting the shot. After getting the second Pfizer shot, patient was instructed to go sit in the waiting area for 15 minutes. During that time, the patient decided to go get a water bottle from a cooler by the front registers of the store. Shortly after, security camera shows patient sitting down on the ground, then falling back on elbows, and then passing out momentarily before regaining consciousness right after. Patient and patient's mother state that this has happened in the past though not in some time. Patient was assessed for injury however none was found so that patient was escorted back to the waiting area to wait out the remainder of his time under close watch. Several hours after the patient and his mother left, I called to check in on patient and the mother stated he was doing fine.
Developed papulosquamous rash on trunk several days after vaccines administered and persisted for 2 weeks.
She got her COVID vaccine on 1/15/21 and the rash started 1.5 weeks after her COVID vaccine. She got the COVID vaccine on right arm, contralateral to the rash. The rash is on her left neck underneath her hairline and on her left ear. It is itchy. She had shingles a year ago in her leg. She tried hydrocortisone cream for a couple days, she put it on once per day. The rash has started in one spot and has started spreading.