chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, fatigue, nausea, dizziness, increased body aches, that started early the next day, at. 04:00 am . Rt arm soreness on day of injection. Pain, progressed, and on Tues- Apr 6, Arm became red, hot to touch, swollen, and hard around injection site ( rt deltoid). Extra Strength Tylenol, 2 tabs taken after oral  temp 99.5 recorded, on Apr 6, at 8:30am. Tingling, itching and pain continued at the injection site. Ice pack applied for 20 min. Temporary relief. Clear liquids and rest on Tues- Apr 6. Red swollen/ hard area measures approx 10-12 cm. Continuing with Tylenol and cool compresses. Rt arm has tingling, and pain to touch at present. All other general symptoms have subsided.
Bell's palsy; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old adult male patient 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 an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization.  Medical history included patient himself had never experienced Bell's palsy before, but a son had. The patient's concomitant medications were not reported.. About 3 days after vaccination on an unspecified date, the patient started experiencing symptoms of Bell's palsy. It was at the worst about 5 days after the first dose. He called telehealth and was given steroids and an antiviral and advised to postpone the 2nd dose. He received the 2nd dose approximately 6 weeks after the first, 2 weeks after stopping steroids. About 4 months later now, he has mostly recovered but has very mild lingering effects. Event took place after use of product. The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a certified family nurse practitioner (CFNP) concerning a 30 year old female clinic employee who in August 2006 was vaccinated with first dose of Gardasil (lot # not reported). In October 2006, the patient was vaccinated with second dose of Gardasil (lot # not reported). In February 2007, the patient was vaccinated with third dose of Gardasil (lot # not reported). In October 2006, the patient experienced stinging and sore arm after the second vaccination. The patient recovered after three days. In February 2007, the patient again experienced stinging and sore arm after the third vaccination. The patient recovered after three days. Additional information was received from the CFNP via telephone. The sore arm lasted about 3 days. There was no reaction with the first dose which came from a pre-loaded syringe. The second and third doses of vaccine were from a vial. No additional information has been requested.
Extreme fatigue in day following vaccine. Patient slept for 6 hours during day. Symptoms resolved following day.
After both shots, around 10 hours later I started to experience shivering but I was also sweating. I took my temperature and did not have a fever. I felt very nauseous during this time too but threw up only after the first dose. My whole body was sore and even the slightest touch was painful.
Patient stated 3-4 times that she did not like needles. I administered a MENACTRA in her right deltoid, then a BEXSERO in her left deltoid, then a GARDASIL 9 in her left deltoid. Around 30 seconds after the GARDASIL 9 patient said she "felt funny". Her eyes rolled back and she slumped in her chair. I put my arms around her to hold her steady just before she fainted. After 30 seconds or so, her limbs spasmed and she woke up. She was pale. I had her bend and put her head by her knees and take deep breaths. Then I had her sit up and breathe deeply. The color returned to her face. When she stood w/o dizziness, I escorted her to the waiting room and had her sit for a while before she left. I did suggest to her mother to call her MD.
1 week after BOTH of my vaccines I started to have an extremely severe case of hives. First they started without any visible signs - my skin simply itched so badly it felt like someone dipped my entire body in itching powder. It was and is so bad that I cannot sleep because the itch is so strong. I've never in my life been allergic to anything or experienced hives like this. The first round and second round vaccine have had the exact same effect on me to the point I wanted to go to the ER for treament but held off and waited for a Dr appointment. I put off my second dose because the hives were so horrible with the first dose. Ultimately i went back for the second because every Dr. says that the side effects aren't as bad as covid.
dizziness; Headache; nausea; cough; swelling above her eyelid and some underneath the eye; elevated blood pressure; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), COUGH (cough) and PERIORBITAL SWELLING (swelling above her eyelid and some underneath the eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), COUGH (cough), PERIORBITAL SWELLING (swelling above her eyelid and some underneath the eye) and BLOOD PRESSURE INCREASED (elevated blood pressure). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HEADACHE (Headache), NAUSEA (nausea), COUGH (cough), PERIORBITAL SWELLING (swelling above her eyelid and some underneath the eye) and BLOOD PRESSURE INCREASED (elevated blood pressure) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment: SoluMedrol, Tylenol, Benadryl, Pepcid   This case was linked to US-MODERNATX, INC.-MOD-2021-010122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-010122:Second patient as per SD
Moderna booster was accidentally administered to 13 year old when not approved for this age. At time of booster, Pfizer is only vaccine currently approved for child's age.  Side effects so far (as of 30 hrs after shot) include: increased resting heart rate (ranging from 105-138 at times), moment of chest tightness, headache, fever, arm pain, acheyness, & dizziness.
Patient developed itching all over and hives within minutes of administration of vaccines. Oral administration of BENADRYL 25 mg was ordered within minutes of reporting symptoms and exam by physician of airway and skin reaction. Symptoms subsided within minutes.
pt recv vax & 4AM high pitched cry, felt warm but temp not taken-dose of APAP given minutes later pt staring, drooling, grand mal sz (mom is RN) lasting 2min;pt sleepy for 15-20min p/nl behavior;t103
Moderna COVID-19 Vaccine EUA Chills, 4/15 10 pm to 4/16 5 am Difficulty sleeping, 4/15 10 pm to 4/16 5 am Headache, 4/16 12 am to 5 am Nausea, 4/16 3 am to 5 am Body aches, 4/16 all day Fatigue, 4/16 and 4/17 all day  Tylenol was taken on 4/16 at 5 am. Advil and Tylenol was cycled all day 4/16 Returned to normal on 4/18  ***Had COVID-19 in June 2020
WARM SENSATION FROM FEET TO HEAD   Narrative:  Patient received 2nd dose of Pfizer COVID vaccine and experienced warm sensation from feet to head twice a few minutes later. No SOB, hives or other symptoms. BP 144/91, P 58, PO2 98% NAD remained stable and improved. Released with instructions to seek medical care if symptoms return.
One day post vax, the pt experienced a reddened, sore, and warm injection site. Treated with Advil.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt was 75 years old with past medical history of A.Fib, Hyperlipidemia, COPD, Ocular Hypertension, Sleep Apnea, Chronic ischemic heart disease, Chronic pain, History of malignant neoplasm of bladder, Arteriosclerosis of nonautologous coronary artery bypass graft. Last few notes says patient had vascular surgery and was discharged to short term rehab in 3.21. There weren't notes on cause of death. Pt was deceased on 4.8.21.
I never had a fever. I had a headache, and I was totally exhausted. It was hard to think clearly. I had a really bad cough which caused bruising on my ribs from the constant coughing.
REDNESS, LARGE BRUISING UNDER THE INJECTION SITE THE FOLLOWING MORNING.
Patient reported feeling ''weird''/lightheaded and seeing green dots. Patient was placed in a wheelchair and brought to a private observation area. On arrival patient was unresponsive and drooling. EMS was notified. Upon EMS arrival patient became arousable and was talking without difficulty. Vitals and telemetry wnl.  Patient reported a similar syncopal episode with blood draw in the past. Patient was stable AAO x3. Patient agreed to have a friend drive her home, f/u with PCM if recurrent symptoms, and ER if new or worsening symptoms.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Over 35 days since patient's 1st dose in Mid April) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 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 PRODUCT DOSE OMISSION ISSUE (Over 35 days since patient's 1st dose in Mid April). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Over 35 days since patient's 1st dose in Mid April) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Received flu shot on Saturday 9/27 and noticed under left arm 2 different places that were swollen and red. Area is where the arm meets the shoulder. He noticed that area changed on 9/28 and says it is slightly worse today. Advised to keep an eye on it for worsening symptoms and to contact doctor.
Reported muscle weakness, fatigue, severe soreness at site of injection. Out of work for 4 days. Course of adverse event 4 days.
Patient got first dose of Moderna on 4/24 at a different pharmacy and  on 5/21 got Pfizer as a second dose instead of Moderna, as patient didn't have Agency card at the time of vaccine administration.
On 10/22/2021, at approximately 8 a.m., I went to the Emergency Room because I was dizzy, constipated, and could not urinate. I was diagnosed with renal failure and Acute Kidney Injury and given IV fluids and admitted for overnight observation. It was decided that the problem had been a reaction to the clindamycin that I was taking for an abscessed tooth.
slight tingling in her lips; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Single, (Lot # not provided)), for Covid-19 Vaccination, reaction(s): "slight headache". The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 31Mar2021, outcome "unknown", described as "slight tingling in her lips". Additional Information: The patient's age was reported as 48 (units unknown). The patient had her second Pfizer COVID Vaccine about one hour ago and was having slight tingling in her lips and wanted to know if it was okay to take Benadryl. She received the first COVID Vaccine and had no problems other than a slight headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021365939 same patient, same drug(different dose), different event
her arm is red and swollen; her arm is red and swollen; arm feels warm not hot but warm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "her arm is red and swollen"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "arm feels warm not hot but warm".  Additional Information: The patient wanted to know if she should put ice or heat on the injection site.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was found in the bathroom , urinating , walked to the wheelchair complaining of numbness over his whole right side  denies any chest pain  no tingling no trauma no incontinenc
Missed to take last dose on scheduled day; Spontaneous report received on 21MAY2020.  A pharmacist reported that a female consumer "missed to take last dose on scheduled day" (PT: Product dose omission) following immunization with Vivotif. On 12MAY2020, the consumer started taking Vivotif. It was reported that the patient took three doses of Vivotif correctly but, missed the last dose which was scheduled on 18MAY2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed to take last dose of Vivotif on scheduled day (missed dose). Vivotif should be taken every other day, and the causality of product dose omission is assessed as not applicable due to the nature of the event.; Sender's Comments: A consumer missed to take last dose of Vivotif on scheduled day (missed dose). Vivotif should be taken every other day, and the causality of product dose omission is assessed as not applicable due to the nature of the event.
This is a 73-year-old male resident of healthcare who was transferred from his dialysis session with a report that he was different from baseline.  He arrived alert but was not answering questions or following commands.  He was noted to have a cough.  His past medical history is significant for vascular dementia, anemia, BPH, bleeding hemorrhoids, ESRD on dialysis (Tuesday, Thursday and Saturday sessions), GERD, GI bleed, XRT for prostate cancer, hypertension.  He was reportedly in his usual state of health and alert and responsive.  Staff at dialysis noted he was not responding or speaking is normal. He was able to complete his dialysis session. Then sent to ER for evaluation. Started zosyn for possible pneumonia but This was later discontinued as he had no clinical signs of pneumonia and his imaging results were reviewed.  COVID-19 was positive. He remained afebrile throughout his stay and had no clinical signs of pneumonia and chest was clear. He was retested for Covid on 8/8 which resulted negative.  Discharged on 8/11/21.
61 y.o. M w/ PMH of RA HTN and HL presented to primary care with c/o purpuric rash on body since he received the Flu vaccine at the Flu Clinic on 10/13/09. Pt reported the rash started on his left thigh 3 days after receiving the vaccination. Adverse event was entered in pt chart. Pt has previous allergies listed to Methatrexate, Gold and Azathioprine.
Information has been received from a physician concerning a 16 year old female with oesophageal acid reflux, heartburn and peanut allergy and a history of parvovirus infection who on 01-MAY-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included naproxen and PREVACID. On 14-JUN-2007 the patient received her second dose of Gardasil. On approximately 11-JUL-2007 "around the second week of July 2007", the patient experienced a febrile illness. She had diffuse arthralgia, elevations in her liver function tests "(70's and 90's)", elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST). On 26-JUL-2007 laboratory tests showed AST 97 and ALT 97. On 26-OCT-2007 AST was 237, ALT 257, and gamma-glutamyl transferase (GGTP) was 97. On 07-NOV-2007 the AST was 218, ALT was 227 and GGTP was 28. An abdominal ultrasound was performed, results not reported. The outcome for febrile illness was not reported. The elevation in liver enzymes AST and ALT was not recovered. Diffuse arthralgia was improved. Unspecified medical attention was sought with "a few doctors/specialists" that included a gastroenterologist. Additional information has been requested.
A report has been received from a Pharmacist concerning a 7 year old, Female subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on 14-Jan-2014. The pharmacist reported that the patient had received expired FLUMIST which started on 14-Jan-2014. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious.
Moderna COVID-19 Vaccine EUA.   I had vaccine on 01/26/2021, did not feel shot.  Starting around 4pm on the 27th, I started feeling achy and fatigued.  During the night, early 01/28/2021, I got up and had horrible cold chills that actually hurt.  I have never felt anything like this terrible feeling.  I took Ibuprofen and drank lots of water and returned to bed.  I was drenched with sweat when I awoke for the day.  I felt fair the 28th when I went to work and by that afternoon, my temperature raised a degree up to 100.3 with feelings of general malaise.  I continued to take Ibuprofen.  I took Ibuprofen during the night on the 29th and again had broke a fever; the neck of my pajamas were soaked.  My left deltoid is still very painful as of the 29th as I type this.  Swollen, hard with red area in the center.
Chills, shivers, elevated pulse rate.  Started about 12 hours after vaccination, lasted about three hours.
I developed an erythematous rash over the injection site that  and itchy, odd that it would happen over a week after the injection.    The erythema measures 12 X 10 cm, almost like an urticarial plaque.  I am not an itchy person.
1) Showing Pfizer COVID vaccine in records when Novavax was given 2) Novavax was outdated on 4-30-23
PATIENT IMMUNIZED WITH MODERNA AT AGE 17. WAS NOT CAUGHT UNTIL PATIENT FINISHED THE SERIES.
A few minutes after injection into left arm, said arm began to feel tingly and heavy. Staff checked on me and suggest I recline, which I did. A few moments later my lips, tongue, lower arms, and lower legs began to tingle and I began to feel light headed. Nurse came to transfer me to ER. While in transit, breathing became a bit erratic, but no sensation of lacking air. By the time I was put in a wheelchair to bring me from the parking lot into the hospital I began to experience tremors throughout the body. Then came nausea and dizziness. Nausea decreased once out of wheelchair.  Trembling violently and tingling continued for approximately an hour, after which all symptoms but mild nausea and mild lightheaded sensation subsided.  After an additional hour all symptoms subsided. Released from observation at 12:15pm. Tingling in face and lips returning at about 7pm the same evening.
Fever, Chills, Nausea.  Fever spiked late night and had delusions.  Tried to walk, legs collapsed.  Onset of symptoms were 10.5 hours after shot, so went to bed.  Woke feeling nauseated, bed linens drenched with sweat.  Had a family member (sister in law who is a nurse)  come to the house in the morning.  Took Tylenol and an anti-nausea medication around 10am.  Slept another 10 hours straight.  Fever did not break until 7am this morning (43 hours after inoculation).  Thought to report my reaction as I have not heard of others my age having the same.
Pt reported local rash with redness, swelling induration about 3 x 2.5 cm
Early morning cough, and night cough. Cough sporadic throughout the day. No signs of post nasal drip or allergies.  Allergy medicine does not assist with relief, inhaler and prescribed Benozotate does provide temporary relief.  Pre COVID 19 shot no signs or symptoms until roughly 2-3 weeks after shot. Cough has been president since early/mid June.
I got a mild skin rash on my chest, but it wasn't really itchy; my arm swelled a little and was very tender; Chills; headache; body aches/pains; extreme fatigue; had limited range of motion; shoulder and arm pain; shoulder and arm pain; shooting pain; This is a spontaneous report from a contactable consumer or other non hcp.   A 47-years-old female non Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8731), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 11:30 as 2nd dose, single for covid-19 immunisation. Medical history included ongoing Multiple sclerosis. Concomitant medication(s) included natalizumab (TYSABRI); melatonin (MELATONIN); zolpidem tartrate (AMBIEN. The patient previously took bnt162b2 for covid-19 immunisation, tetracycline. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID It was Reported that, on 11 Apr2021 07:00 evening after she received the vaccine, my arm swelled a little and was very tender.The next morning, woke up and felt minor chills, headache, body aches/pains and extreme fatigue. This continued for two days. Two days after the vaccine got a mild skin rash on my chest, but it wasn't really itchy.It went away less than 24 hours later.  By the third day after was only fatigued. Day 4 or 5 I was back to normal, had limited range of motion, shoulder and arm pain, shooting pain when I move it in certain directions. The outcome of the event was not recovered. The patient underwent lab tests and procedures which included sars-cov-1 test negative: negative on 14Apr2021. Therapeutic measures were taken as a result of Physical Therapy, had limited range of motion (joint range of motion decreased), shoulder and arm pain (arthralgia), shoulder and arm pain (pain in extremity), shooting pain (pain).  Follow-Up (08Jul2021): Follow-up attempts are completed. No further information is expected.