chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart palpitations; clouded ears; ringing in the ears; swollen feet; brain fog; weight gain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 1, single (Lot number: 33036BD) at the age of 39 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious) with onset 17Feb2022, outcome "not recovered", described as "brain fog"; INNER EAR DISORDER (non-serious) with onset 17Feb2022, outcome "not recovered", described as "clouded ears"; PALPITATIONS (non-serious) with onset 17Feb2022, outcome "not recovered", described as "heart palpitations"; TINNITUS (non-serious) with onset 17Feb2022, outcome "not recovered", described as "ringing in the ears"; PERIPHERAL SWELLING (non-serious) with onset 17Feb2022, outcome "not recovered", described as "swollen feet"; WEIGHT INCREASED (non-serious) with onset 17Feb2022, outcome "not recovered", described as "weight gain". The events "heart palpitations", "clouded ears", "ringing in the ears", "swollen feet", "brain fog" and "weight gain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, inner ear disorder, tinnitus, peripheral swelling, feeling abnormal, weight increased.  Additional information: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient received the first dose on 16Feb2022 and second dose on 16Mar2022 but after both doses she experienced clouded ears, ringing in the ears, heart palpitations, swollen feet, brain fog and weight gain. Still till this day in Sep2022 experiencing clouded ears where its hard for her to hear at times and periodically heart palpitations, brain fog, and increase weight gain. The events required Doctor or other healthcare professional office/clinic visit. The patient had covid prior vaccination. The patient was not covid tested post vaccination. The patient had no/none known allergies and no other medical history.   No follow-up attempts are possible. No further information is expected
Reaction began with pain and warmth at the injection site then pt noticed redness and swelling.
-Day after 1st  vaccine w/heavy menses x 16 days, on Nuvaring & typicaly has no menses...then another menses first week of May -May 21 Donated blood & noted to bleed excessively long though finger stick and IV site even 6 hours later -May 24 episode of easy bruising to thigh
Hives, breaking out, flush, chills, faintness/dizziness   Treatment was an injection of Benadryl and ice packs
Pt presented to the hospital on 7/26/21 with a complaint of shortness of breath, cough, loss of taste and smell, body aches and generalized weakness. Some symptoms started about 2 weeks prior to admission, but 2 days prior to admission had significant worsening of cough and SOB. 7/26/21 SARS-CoV-2 PCR Detected. Required 4L O2 on admission. Diagnosed with COVID-19 PNA. Started on Remdesivir and IV dexamethasone. On day 4 of admission pt was clinically improved, off O2 and discharged with prescription for PO dexamethasone to completed a 10 day course. Note: Patient was vaccinated with the Moderna COVID-19 vaccine (2/27/21, 3/27/21).
Case number PHEH2016US029397, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 23 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1619021) at a dose of 0.5 ml intramuscularly, on 07 Nov 2016. The nurse accidentally got FLUVIRIN in an employee's (patients) eye while administration. The nurse immediately flushed the eye with water. No adverse event was reported following this administration error (accidental exposure to product). The case was assessed as lost to follow up.
(5pm) after vaccines, pt experienced shaky/tremor, felt faint. Chest pain upon walking and at 9 PM slight slurred speech - pt went to ER.
MODERNA COVID-19 VACCINE EUA:  Individual presented to COVID-19 vaccination clinic sponsored by Health Department being held for Healthcare Providers.  Individual marked on Vaccination Consent form that she was a Medical Assistant at her father's  medical practice. After administration of vaccine it was discovered that she is 17 years old. This vaccine is not for individuals < 18 years old.  Call made to CDC who advised us to call Moderna.  Called Moderna and awaiting guidance/advice from Moderna Medical Information division.
The patient came in to the pharmacy today with her husband and wanted to let us know that she had been having a reaction to the flu shot she received here on 1-14-2019. She is a retired nurse and said she always gets the flu shot every year, but this year had some problems. After she received the shot the area (she pointed to the area under the deltoid muscle from under the deltoid to near her elbow, not the deltoid) was red and quite tender. There was no swelling, but the area is still sore when she moves her arm, and sometimes wakes her up at night if she is sleeping on that arm. She said the shot was given in the right place (center of deltoid) and she had no known drug allergies. I told her it may be nerve pain and she could try tylenol (she hadn't taken anything for it yet). I told her I would fill out a report and took her phone number.
Client c/o "feel like I can't breathe".  V/S stable, no c/o nausea, no fainting. Client laid down on cot. VS monitored q5m for 15 min 0844: 164/89, 88/min, 100%RA 0850: 143/91, 84/min, 100% RA 0853: 137/97, 85/min, 99%RA  Client sat up, stated feeling better. Given water, client exited clinic stable and without incident.
After 1st RABAVERT pt c/o HA q d but has increased since 8p last night. Armpit pain (when arm down only) started at 8pm last night-has elevated-ice only increased pain. Pt. feels hot but has not taken temp.-face not red. Under arm has sharp pain and sl. swelling. Recommend PCP FU today.
Pt received Typhim vi, Yellow fever and Hepatitis A vaccines on 03/15/2005. On 03/19/2005, she erupted in hives and overall body rash, 1/2 hour after eating a salad and shrimp in int, She previously wasn't know ti have any food allergy. Hives and rash progressed through 03/22/2005 and she called her PCP who Rx [rodmospme.40 mgx b5 days. She will see her PCP on 03/24/2005.
Information has been received from a registered nurse concerning a child who was vaccinated with Varivax. The child broke out in a rash 7 days post vaccination. Unspecified medical was sought. Additional information has been requested.
had a mild flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 (Lot number: EN6201) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "aorta valve transplant", start date: 2018 (unspecified if ongoing), notes: 3 years ago, everything seems to be fine. There were no concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "had a mild flu like symptoms". Therapeutic measures were taken as a result of influenza like illness.  Additional Information: Because of the event, the patient rested that day.  No follow-up attempts are possible. No further information is expected.
The next morning when she woke up, she had a headache; Four hours later, she had chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 18Mar2021 07:00 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 18Mar2021 11:00, outcome "unknown", described as "Four hours later, she had chills"; HEADACHE (non-serious) with onset 19Mar2021, outcome "recovered" (21Mar2021), described as "The next morning when she woke up, she had a headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
he was tested positive 9 days later; he was tested positive 9 days later; This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect. A non-contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient got his 1st dose of Covid-19 Vaccine last 22Dec2020. He said that he has tested positive 9 days later which was on 31Dec2020. He was asking if he could get the 2nd dose of vaccine tomorrow or should he wait for the scheduled vaccine which was 3 weeks later, since he mentioned that it has been 12 days since he was tested positive. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Warmth, erythema and tenderness at site of injection, spreading to ~5cm diameter
Pt complained of numbness in left arm starting around 2 hours after immunization. Still painful more than 1 week later causing loss of sleep.
vaccinated 3/31/2021 w/o any problem.   on 4/8/2021 about 6 pm she had ?allergic reaction? with sudden severe bilat eyelid swelling and swelling both external ears with "weeping" (transudate) and bilat ear pain.   no swelling  lips/tongue, no wheeze, no SOB, no hives. Seen at a Urgent care on 4/9/2021 diagnosed with bilat otitis media, bilat otitis externa, started on Augmentin and ciprofolxacin drops.  seen by me 4/15/2021 with ear pain, congestion, hearing loss.  exam shows bilat suppurative otitis media.  I switched her to DS Septra and have asked her to follow up with ENT if not improving.  she has never had an ear infection nor allergic reaction like this before.
On day eight I developed a hard knot at the injection site.  It has since started to feel warm and itch.  There's a small red area at the site as well.
Pain, swelling and "red streak" of the left calf  beginning 2 days after 2nd dose of Pfizer Covid vaccination.  Venous duplex ultrasound of the left lower extremity revealed a thrombosis of the greater saphenous vein.  Patient has been treated with the anticoagulant apixaban.
Patient has been experiencing excruciating pain in her arm since the influenza vaccine was administered on 1/1/20.  She also has limited range of motion in her arm.  Patient has been taking  ibuprofen over the counter but she is still having pain.  Patient has not seen a doctor regarding the adverse reaction yet.
Febrile Seizure, Rash, Pneumonia, Viral Exantham
Donor received immunization on 09/26/16. The day following on 09/27/16 donor noticed left arm was tender, reddened, and raised. Donor in facility today, left arm is reddened, raised, warm to touch and localized tenderness noted. Reddened area surrounding injection site measures 3.5 x 3.0 in.
INJECTION SITE REACTION (SWELLING, HOT TO TOUCH, PAIN, HARD BUMP UNDER SKIN) APPEARED THE DAY FOLLOWING INJECTING AND PERSISTS AT DAY 6. SEVERE FATIGUE FOR 2 DAYS FOLLOWING VACCINATION.
Crying for over an hour the evening after the vaccine, along with apparent leg pain and mild swelling at the site of the DTaP/IPV/Hib vaccine
Eye infection after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (Eye infection after receiving the vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 11-Mar-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 EYE INFECTION (Eye infection after receiving the vaccine). The patient was treated with DOXYCYCLINE HYDROCHLORIDE (DOXICYCLINE [DOXYCYCLINE HYDROCHLORIDE]) for Eye infection, at an unspecified dose and frequency. At the time of the report, EYE INFECTION (Eye infection after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included mepathor.   Reporter did not allow further contact
PATIENT IS AN 11 YEAR OLD AND WAS ADMINISTERED AN ADULT PFIZER DOSE. PATIENT WAITED THE 15 MINUTE WAITING PERIOD AND HAD NO REACTION.
How long after contracting covid until I can get my booster? This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (How long after contracting covid until I can get my booster?) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (How long after contracting covid until I can get my booster?). At the time of the report, COVID-19 (How long after contracting covid until I can get my booster?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a patient  of unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), after receiving unspecified dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No Concomitant Drug details were reported.  No Treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a patient  of unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), after receiving unspecified dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
patient sitting in post-vaccination area has a witnessed seizure at 1525,  patient had twitching, LOC and eye rolling.  EMT and RN  were there and observed. Patient returned to consciousness, and moved behind curtin. Patient had another witnessed seizure @  1532 lasting 10 seconds, with LOC, twitching, eyerolling and vomiting. Patient came to and placed on floor, alert and awake, able to answer questions but feeling foggy. EMS was called during 1st seizure. EMS arrived and took patient to hospital @ 1558.
Patient is a 58 y.o. female  who presents to Hospital with a several day history of upper respiratory infection in which she thought she was having ?allergies.  She took several days of antihistamines with no improvement and drove straight from State back to State arriving early yesterday morning.  Patient contacted her pulmonologist and nursing staff they were instructed her to take her Aldactone and Lasix as directed.  In addition she was instructed to go to the urgent care or emergency room and patient stated that she would go to ER.  Patient complains of worsening lower extremity edema and swelling left greater than right as well as exertional dyspnea and fatigue.  On arrival to the ER she tested positive for COVID-19.   On arrival to the med surge unit this evening patient again is refusing to take her Lasix and Aldactone.  We will contact her pulmonologist in the morning for further recommendations.  All other pulmonary hypertension meds which are listed below or not on formulary and not available nor is there appropriate alternative substitutes.  Patient states that she does wear oxygen at night at home 2 L per nasal cannula and does have sleep apnea but does not wear CPAP.   Patient had transient mild systolic pressure is 88-99 but not tachycardic and no worsening shortness of breath.  Patient does have a BNP of 1400. I do not recommend giving her significant IV fluids at this time.  We will continue to monitor her blood pressure, additionally with a low-potassium restarting her Aldactone she will have to have supplemental potassium increased.     Additionally patient was concerned about pulmonology knowing she was here therefore letters were e-mail to her pulmonology team this evening, as well as her PCP and copied to Doctor.
Local swelling, tenderness, some warmth beginning the evening of shot. Swelling was quite significant.
Pt received 2nd COVID Vx on 8/2/22. On 8/4/22, she developed fever, chills, fatigue, rhinitis & rhinorrhea, tachycardia, wheezing. Her mother brought her in to urgent care 8/6 for evaluation (ill-appearing, febrile with shaking chills; T 102.7F, pulse 160, RR 26, 97% O2). Pt was given Tylenol in clinic. She immediately vomited. Replacement dose was given. Pt tested negative for COVID, flu, and Strep. Pt was discharged with Orapred Rx with instructions to monitor closely for worsening. Mother was advised to follow up with PCP and to take her to ER if any worsening.
Pt recv vax on 1/20/97; on 1/22/97 pt exp pain in LA to shoulder.
Initial and follow up information has been received via the Merck pregnancy registry, from a physician's assistant (PA), concerning a female patient (birthdate invalid; age previously reported as age 11), with a drug hypersensitivity to DEPAKOTE and no previous pregnancies, who had her LMP on 19-JUN-2007, and on 23-JUL-2007 was vaccinated IM with the first dose, 0.5 ml, of Gardasil (Lot # 654885/1424F). Concomitant therapy included ORTHO TRI-CYCLEN. Following the vaccination (date not specified) the patient had a positive urine pregnancy test confirming that she was pregnant (estimated date of delivery was 25-MAR-2008). Follow up information received from the PA reported that on approximately 13-NOV-2007 ("21 weeks from LMP"), the patient experienced the death/stillbirth of her fetus (details not provided). It was unknown if the fetus was normal, or if the products of conception were examined. The sex of the fetus was not reported. The PA noted that the patient had a blood type of Rh negative (type A-), and the paternal blood type was Rh positive. No further details were provided. The PA added that the patient had married and moved (address not provided). The patient sought unspecified medical attention. Additional information is not expected.
Patient informed pharmacy that she has not been taking the increased dose of HIZENTRA as prescribed by prescriber because the prescriber did not let her know that she has to increase her dose. 6/28/2018 Symptoms of malaise, GI upset. Fever 101 degree F, and inflammation at injection site within 24hrs of SHINGRIX #2, injection approximately 3 month after 1st injection. Both injections (L) deltoid.
Pain in arm where shot was given and in muscle. It hurt to lift arm. Chills, mild fever, tiredness, headache & sore joints.
This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 51-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced bronchitis. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with antibiotics, prednisone and Corticosteroids For Inhalation. On an unknown date, the outcome of the bronchitis and incomplete course of vaccination were unknown. It was unknown if the reporter considered the bronchitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it can be 50 or 51 years. The patient received SHINGRIX on left arm. The patient experienced bronchitis about 14 days before reporting. His pharmacy had the vaccine in stock, and he wants to know if it was safe for him to go ahead and get the vaccine. Till the time of reporting patient did not report the 2nd dose, which led to Incomplete course of vaccination. The reporter gave medical disclaimer referred to his HCP (healthcare professional). Emergency room visit Required. The reporter gave consent to follow up.
Patient had vaccine on 12/17/14. Reports on 12/18/14 her arm felt sore, slight swelling. Normal side effects. On 12/19/14 reports hard lump redness and warmth not at site of injection but about 3 inches below site all the way around arm.
Severe headache on left side, same side as vaccine. Pain in arm, shoulder, down back and leg on left side. All progressing in the couple days following vaccine. Getting better but still feel some tightness and pain.
After my 2nd vaccine of Moderna, I had a 102 fever and my entire left side of my body was in pain, so much so that I could not sleep on my left side.  The booster (information above) I also had a fever of 101 and pain at the point of entry. I was also lethargic for two days. My brother and my nephew also had similar symptoms, even from the 2nd initial vaccine of Moderna.  I have progressively noticed a loud ringing in my right ear, which seems to ring up to the crown of my head. It's quite noticeable especially when I am not engaged in any activity. It must mention that my mother had Johnson Steven's Syndrome.
On 3/1/01, the infant received her 3rd injection of Infanrix. On that date, she also received her 3rd injections of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs) and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). On 3/1/01, 3 hours, post vax, she developed a fever as high as 103.2F (rectally), irritability, decreased appetite and increased sleep. On 3/5/01, the 5th day of fever, the infant developed a rash. The fever abated, 1 day following the appearance of the rash. The infant was hospitalized for sepsis evaluation. Blood, urine, and CSF cultures were negative. She was treated with unspecified IV antibiotics, for 2 days. She was discharged from the hospital after a total of 3 days. On 3/13/2001, she was seen by her physician, who noted "a healthy child without sequelae."
patient received the vaccines ( shingles and flu) around 11: 20 am, After the pharmacist advised her to stay for 15 minutes for monitoring her (since she id doing shingles for first time , But she had the flu shoot in the past many times) , she left the pharmacy after these 15 minutes ,then she came back in an hour later stating that : she had broken in hives ,the pharmacist  checked her physically and notice she had a slight rash all over her body with no swelling or breathing problem  .The Pharmacist sat her down for monitoring ,checked her blood pressure which was 134/93 . And administer her Benadryl tablet from the emergency kit .the pharmacist monitor the pt for another 30 minutes  , when she said (and the pharmacist notice the rash got less) ,PT left the pharmacy and advised to visit the ER if the symptoms get worse.A phone call by the Pharmacist made and hour later to chek on the patient ,and she stated she is improving.
I have put a ice pack on it , I have massaged it and rubbed with bio freeze.