chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have no antibodies/SARS-COV-2-SPIKE AB, Semi-Quant, S showed value negative because it was below 0.40; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 12Jan2021 (Lot Number: EL1283; Expiration Date: Apr2021) as a single dose; and dose 2 via an unspecified route of administration on 02Feb2021 (Lot Number: EL3246; Expiration Date: Apr2021) as a single dose for covid-19 immunisation. Medical history included bilateral lung transplant patient. Concomitant medication included transplant drugs like to suppress her immunity, not totally but just to have a balance so that so her immune systems does not recognize the foreign body and start attacking. The patient reported that she received the two doses of Pfizer Covid-19 vaccine in Jan2021 and early Fe2021 of this year. She recently went to the clinic because she was transplant patient and she have work done in nice doing study on antibodies for transplant patient, so she got the permission to test for the antibodies which is the SARS-covid-19 spike antibody test, the specific and showed that she has no antibodies and it's been over 2 months since she completed, the whole series of covid-19 vaccine. The patient mentioned that since she doesn't know, because she is a transplant patient or maybe, she knows with the covid vaccine is has to be frozen. Any of the hands and the stuff could have compromised the efficacy of the vaccine. She inquired on the information about how the vaccine properly handled because she received the vaccine at the doctor's office, they called me, she went there and they gave her the first dose, the nurse did and the second dose, the doctor herself gave her the second dose. She mentioned that a clinic in a state was doing a study on antibodies for the people who receive the vaccine for the transplant patient. So, what she did was that she gave her blood. She already provided the blood for test to do as her regular routine test, so she gave permission to test for the antibodies. She thought she was the new in after getting the two doses but when they did the test, they called her and told her that her test shows that the antibodies are undetected. It is the below 0.4 u, whatever and the range is 0.80 or something. The specific test that they did, she double checked just to make sure it is correct, and test is the SARS-COVID-19 SPIKE AB test. She called a clinic to find out what else she needs to do because the other clinic suggested that it could be a late response, or she need a booster. So, she right now does not have immunity according to the test. She inquired if she should get a different vaccine. The outcome of the events was unknown.
Developed runny nose, cough, vomiting & diarrhea within 48 hours of administration. Pt evaluated by MD on 5/18. Dx: URI, Intestinal infection, enteritis - viral. Directed to push fluids. Call if symptoms worsen.
Staff member administrated the "Pink cap Moderna, 0.2ml"  The child was due to receive "Blue cap Moderna, 0.25ml"
Migrating Joint pain and swelling, started on left side. It started when he was at home, he was seen by his doctor and got blood labs drawn and some RF factor was coming up on his bloodwork. It sounds like from patient's wife they are not sure if it was caused by flu shot or not.
PATIENT RECEIVED A SUBCUTANEOUS INJECTION TO HER RIGHT ARM. NO ADVERSE EVENTS OCCURRED . PATIENT WAS  UNABLE TO RECEIVE AN INTRADERMAL INJECTION, THEREFORE THE VACCINE WAS ADMINISTERED SUBCUTANEOUSLY.
Woke up sweating; Feeling hot but my body felt cool. Felt like I had icy hot all over my body.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 13:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to latex and iodine. Prior to the vaccination, the patient was not diagnosed with COVID-19.Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 04:00, the patient woke up sweating, felt hot but her body felt cool. The patient felt like she had icy hot all over her body. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events woke up sweating, felt hot but her body felt cool and felt like she had icy hot all over her body was unknown at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt woke up and stated her arm was sore, she then looked and noticed it was swollen. Pt called in and was told to take Benadryl and put ice on and mark the swollen area of arm. As the day went on swelling went out of the marked outline.
Arm started swelling around 10hrs after vaccination but not like my partners or son. It was a one inch band around 3 inches long. The pain was severe. Couldn't sleep, touch roll over on that side, skin was raised and welted up in that band around my arm. My second vaccination in my left arm was sore, but a 2/3 on the pain scale which resolved in 3 days. This one got worse and peaked around the week mark and then held at that pain(8/9 on pain scale) I started losing mobility in my shoulder to raise my arm above my head, twisting, and reaching behind myself. At 3-4 weeks pain started to decrease. When I got to my 2nd vaccination the swollen red band had finally decreased to about 1/2 inch to 1 inch in diameter and the pain was around a 6/7 as long as I didn't reach up, behind, or bend my elbow(think like a arm behond head for a sit up). The swelling was gone by week 6-8 and now I am just left with the pain. Months later and still no improvement, Ibprofen helps more than prescription pain meds. The pain wakes me up every morning, and I am still losing more mobility.
I am itching after a day of receiving the shot; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (I am itching after a day of receiving the shot) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PRURITUS (I am itching after a day of receiving the shot). At the time of the report, PRURITUS (I am itching after a day of receiving the shot) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The patient experienced itching after a day of receiving the shot. There was no swelling, and it didn't happen right away. It was also reported that the patient might call back if nothing comes out of the test scheduled (unspecified). Treatment medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2023: Live non-significant follow up received included reference IDs and reporter details. On 21-Nov-2023: Live significant follow-up received and updated patient details, reporter details and reference IDs.
(8/11/2021) Mini Stroke, had numb arm and could not verbalize. ER visit and was given MRI & CAT scans. Removed Plavix and issued Lipitor, advised to wait a week before taking aspirin. Cleared by that evening but was kept for observation. Also, memory issues lasted about a week.
I ran a 103.5 fever for over two hours. I am still running a 100 fever. I have maxed out on my dosage of ibuprofen and tylenol.
Myocarditis with cardiac cath with normal coronary arteries.  + troponin.  Symptoms of chest pain onset 2 days post vaccine.
Heart attack; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 as a Dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that, came to know a man who walked outside of the center and died right after the Covid vaccine from a heart attack. The reporter was unsure if it was Pfizer. People were there to help the patient right away and he still died. The reporter can't find much information about this event on the internet because of censorship. On 08Feb2021, the patient collapsed and later died after leaving the vaccination site. The patient died 25 mins after receiving the vaccine. First responders got to the man in seconds, and he passed away in the hospital. It was not reported if an autopsy was performed or not.  Information on the lot/batch number had been requested.; Reported Cause(s) of Death: Heart attack
No additional AE reported; temperature excursion and administered to patient; This spontaneous report was received from a medical assistant referring to a 12-month-old male patient. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 07-FEB-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# W006412, expiration date upon internal review was established as 23-FEB-2024, dose and strength were not reported) intramuscularly in right thigh for prophylaxis at a private doctor's office/hospital, after a temperature excursion. Total time in the range of -14 degree Celsius to -10 degree Celsius was 1 hour. Total combined excursion time was 1 hour (product storage error). This adverse event was previously reported to manufacturer. No additional adverse events were provided (no adverse event).  This is one of several reports reported by the same reporter.; Sender's Comments:  US-009507513-2304USA007931: US-009507513-2303USA002114:
Dizziness, Headache, Arthralgia, Diarrhea, NauseaVomiting, pain+itching at site, fatigue, chills, weakness Narrative:
Macular rash seen by mother in diaper area which extends to the entire body about 60-70%. No fever, fussiness, vomiting or diarrhea.
Chills, Fatigue, Nausea, Headache, Very Sore Arm.
Site of vaccine has no pain, unlike previous 3 Pfizer; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction: "Site of vaccine has no pain, unlike previous 3 Pfizer". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Site of vaccine has no pain, unlike previous 3 Pfizer".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201182250 same patient/product, different dose/events;US-PFIZER INC-202201182347 same patient/product/event, different dose;US-PFIZER INC-202201182345 same patient/product/event, different dose;
Migraine came on within first 15 minutes; subsided within six hours; extreme chills started around 7 p.m. throughout night; extreme arm pain (expected); very low blood sugar in morning (45) - normally 89.
I did not know what was going on, but I had problems with my memory. I lost your balance, I three bad falls that I had to go the emergency room. The first one I hit my head and elbow; the second time I felt while I was gardening, my left leg was numbed; the third time I was dressing putting my pajamas to go to bed and I hit my shoulder area. When I went to the ER the doctor gave me steroids shots. I have to go to the doctor again for a checkup. When I close my eyes, I don't have balance at all. I am having spasm on the right side of my face, on the right eye.
NOTED RIGHT UPPER ARM SWOLLEN AND SLIGHTLY WARM TO TOUCH, REDNESS DOWN ARM AND PUFFY IN BACK OF ARM ALMOST TO ELBOW, NO C/O ITCHING, PAIN AT THIS TIME. NO SHORTNESS OF BREATH, LUNGS CHECKS FOR BREATHING, TEMP. 96.1 MEASURED 13 1/2" CIRCUMFERENCE afebrile a+o amb non focal  redness ; swelling ; warmth ; intact skin Rt UE deltoid area at site of of  pneumococcal injection down to elbow ant > post area  pulses radial wnl  sensation intact  motor 5/5  no ax adenopathy chest cta no rrw  cor rrr  pv no edema   allergic reaction rt UE re to pneumococcal vaccine 08/15/06   Swelling resolved by 8/23/06
C/O sudden onset of high fever/chills/fatigue. Injection site painful and swollen. 05/23/07-records received C/O fever with chills. Temp in ED 99.4-BP 95/45. C/O pain over left deltoid area where he was given an injection. Some swelling present. Headache diffuse with no visual changes. No nausea or vomiting. Assessment:most likely allergic reaction to tetanus injection. Too soon for cellulitis. PE: Pain and tenderness over left deltoid area.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6206), on Mar 9, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache, and myalgia/muscle pain, with outcome of unknown. Additional information: The patient asked if it was okay to have the Hepatitis B vaccine shot today (Mar 29, 2021), since she took the first dose of BNT162B2 on Mar 9, 2021. The second dose was scheduled Mar 30, 2021. No follow-up attempts possible. No further information expected.
Patient developed swelling right thigh less than 24 hours after Varivax given to area. In soft tissue cellulitis.
I developed a DVT. I have never experienced blood clots until receiving the Covid vaccines. The first blood clot was 4/13/21 after receiving the second dose.
Fatigue, fever, loss of appetite, and nausea. Fever treated with Tylenol and Motrin. Vomiting at 10:30 pm, 12:30 am, and 8:00 am.
Pt. soon after receiving vaccine developed chest tightness and hives to the forehead and face. No difficulty in swallowing
About 1 week after receiving Covid-19 Moderna vaccine, on  04/03/2021 presented to ED  with new onset headache,  "She returned to the ER on 04/05/2021. Initial blood work was essentially unremarkable except for elevated CRP and CSF. A CT head was performed which showed a hyperdense pituitary. MRI of the pituitary was obtained on 04/06/2021 demonstrating numerous increased signal flare within the cerebral white matter. Lumbar puncture was done in the ER showing elevated RBCs consistent with traumatic tap but lymphocytic pleocytosis with normal glucose, normal protein and negative meningitis/encephalitis panel. She was admitted with a diagnosis of aseptic meningitis. Neurology was consulted who elected to defer high-dose steroids since she was clinically improving without any intervention. Autoimmune encephalitis panel as well as inflammatory labs were added. Her headache spontaneously improved with rehydration during the hospitalization. " Follow up MRI one month later revealed resolution of abnormalities seen initially. Continues with + MOG antibodies.
pt crying, c/o h/a, rubbing eyes; resp regular & unlabored, skin dry and cool to touch, BP 120/70, heartbeat regular, eyes red not swollen, both sites flat & smooth; rt eye began to appear swollen p/15mins; referred to ER
Patient given 0.25 ml fluviron vaccine for >4 yrs.  Marked on box.  Not marked on actual vial.  Patient had no reaction.
pt became unsettled, crying, c/o stomach pain. exp loss of appetite, weakness,vomit;MD suspected acute appendicitis but not confirmed;slow reactions, short term LOC;Acute Pancreatitis was dx; 12dec97 encephalitis symptoms, short term LOC;
Patient presented to the ED on 5/4/21 with chest pain.  Patient received initial dose of of COVID vaccine on 4/2/21 and stated he received his second dose on 4/30/21.
Pt given COVID vaccine Bivalent booster at 2045. After 5-7 minutes after vaccine given pt stated she was "not feeling great." Stated her tongue and throat were tingling. Pt taken to treatment room to lie down, vital taken, Benadryl given - 25 mg total. Pt was constantly monitored by team: LVN, RN, NP, and MD.  Epi-pen at bedside but no s/s anaphylaxis so not used. 911 called after pt continued to fill ill and c/o throat and tongue tingling. Pt taken to ED in ambulance, accompanied by NP
New hypertension 165/105 detected on Monday 11/29/21.  Had preceding intermittent headaches headaches that improved with ibuprofen or naproxen.  Then started feeling dizzy/brain fuzzy on 11/27/21, improved with lying down to sleep, but recurred intermittently through the daytime, but became more persistent Monday morning.  Elevated blood pressure detected around noon time by clinic nurse, and BPs remained elevated through the rest of the evening ,though the ED visit.   Blood pressure improved to ~147/97 by later that evening.   Saw PCP on Wed 12/1, and started on Losartan 25 mg daily.   BPs have improved since then.
Injection site felt like "Bee Sting" while driving home. Upper arm was tingly, warm to touch. Red, swollen and itchy 15 minutes after injection. Eventually redness went from shoulder  to elbow. Seen at hospital and given prednisone and Atarax at 9:30 am
CHILD UNDERAGED. DOB REPORTED ON CONSENT. CORRECT DOB IS DIFFERNT DATE. CONSENT CLAIMS THAT CHILD RECEIVED FIRST DOSE OF PFIZER VACCINE BUT NO DATE IS INDICATED.
Pt found in parents bed, face down, not breathing, unresponsive on 5/6/07 at 9am. Mom called office 5/4/07 pt had been having 1 episode diarrhea daily since 4/31/07. No vomiting, no fever, no other signs of illness.  5/15/07 Received vax records from provider which corrected Lot number of RO & & confirmed dose as number 1.  VAERS database updated.  6/25/07 SIDS per Proof of Death letter from ME (reported cosleeping w/parents in adult bed, found face down in pillow).  Manner of death undetermined.
Information has been received from a physician concerning a 7 year old female with no medical history who on 25NOV1996, at 0910, was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (lot 620620/1107D). There was no illness at the time of vaccination. The physician reported that on 25-MAR-2003, the patient began complaining of hip pain and then began breaking out with blisters, atypical, not crossing the midline similar to herpes zoster At an office visit on that same day, it was noted that the lesions progressed form the left lumbar region over the groin to the anterior region of the thigh, left knee and left ankle. There was apparent L5-S1 involvement. The patient also developed a low grade fever. The physician also reported that the the patient developed generalized lesions consistent with chickenpox. The physician felt that the patient had a combination of herpes zoster and chickenpox. The physician indicated that, for about a day or so, the patient could not extend her leg or hip and could not walk because the herpes zoster lesions extended under her feet. The patient's parents carried her because of this. It was also noted that some of the patient's lesions contained pus. No laboratory tests were performed. Calamine, diphenhydramine HCl (Benadryl) and Cephalexin (KEFLEX) were prescribed. As of 27MAR2003, the patient seemed to be getting better as she could extend her leg and the lesions appeared to be healing. On 07-APR-2003, the patient recovered. No further information is available.
Pt received FLUVIRIN 13-14, said arm was numb after, went to dr. He said we hit a nerve.
Inappropriate Schedule of Vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th April 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-Jul-2023 and 18-Jul-2023 The nurse stating that one of her residents (patient) did not receive his second Shingrix vaccination. The reporter asked that the guidance was for someone who did not receive a second dose of Shingrix or the series need to be restarted. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Pt presented at ED 01/11/2022 with  chief complaint of increased weakness and lethargy.  Presented with metabolic encephalopathy, likely secondary to acute UTI. Admitted for continued observation, antibiotic administration, follow-up of urine and blood cultures.
Child developed fussiness and vomiting within 24 hours of vaccine. Arrested en route to the ED for evaluation of listlessness on 7/26/19.  Child had CPR for 14 minutes with return of heart rate, however due to prolonged arrest had severe  hypoxic injury to the brain and developed autonomic instability. Support was withdrawn on 7/28 and patient died 7/28/19.
Parotitis - fever, for 3 days - WBC 19.1, Amylase 924 Keflex 250mg/ 5 ml - 6ml BID x 10 days. Tylenol/Motrin - fever negative - HIV, Coxsackie, CBC with diff improved after 2 days.
Painful right axillary; Lymphadenopathy; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second single dose of BNT162B2 (Pfizer, lot number: EL3246, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Jan2021 16:15  for COVID-19 immunization. Facility Type vaccine: Hospital. The patient medical history was not reported. The patient was not pregnant. The patient did not have covid prior vaccination. The patient had no other vaccine in four weeks. Other medications in two weeks included ascorbic acid (VIT C), and melatonin. The patient took the first dose of COVID19 vaccine (Pfizer, lot number: EK5730, exp date not reported) on 21Dec2020 19:45 (vaccine location: Left arm). The patient experienced painful right axillary lymphadenopathy on 12Jan2021 21:00. No treatment was provided for the AEs. Patient was not covid tested post vaccination. Outcome of the events was not recovered.
2/10 headache, patient feels like a sinus pressure headache. No other c/o pain or symptoms.
2/10: Fever, fatigue, tylenol 2/11 @ 1300: pt made DNR, hospice consulted 2/11 @ 1800 decreased LOC, increased RR, fever, chills - 1/5L NS bolus IV, rectal tylenol. Refusing to eat/drink, PO morphine 2/12 @ 16:30, deceased at facility **resident was not doing well prior to vaccination
inputted for bivalent moderna booster, however, the patient received the pediatric monovalent moderna vaccine
First dose January 11. Sore arm next two days. One week later injection site was warm, red and had a hard ball, chills that night. Then following Saturday started to have itching all over body and left arm had a red mark the size of my hand on it. Not warm to touch just there. Went to walk in clinic prescribed me hydroxine for itching. Itching went away. Following day had burning sensation all over left side of body. Was seen by primary care.