chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergy to PEG in Covid vaccine; This is a spontaneous report from a contactable consumer via medical information team . This consumer reported similar events for two patients (including himself). This is second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as dose number unknown, single for covid-19 immunization.  This vaccine contains Polyethylene Glycol (PEG). The patient medical history and concomitant medications were not reported. The patient experienced allergy to PEG in covid vaccine on an unspecified date. Treatment for the event was not reported. The outcome for the event was unknown.  The lot number for the BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101096598 same reporter, drug, event/ different patient
I had a fever of 101.4 that lasted for about 24 hours, aches, chills, and fatigue that lasted for about 48 hours. My headache lasted for about 72 hours.   Estimated date of deliver is 03/24/2021
Information has been received from the nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL (dose and route unknown) on 24-MAY-2013, lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
COVID Vaccine  I got my #2 Pfizer last Tuesday Apr 6....no problem at all with #1.  The vaccination was in my LEFT arm, and the 1st day or so I didn't really have anything but tiredness.  But the last few days have been very painful.  I developed swelling on the RIGHT side of my face starting at the temple. That progressed down to the ear area the next few days and was quite painful.   Since Saturday  my tongue, lips, gums became swollen resulting in barely being able to swallow. Also rash developed and is getting worse.  Additionally I ache all over and feel like a very bad case of the flu.  I tried Tylenol Extra Strength in the beginning, but that seemed to only ease the pain for about an hour.  Now I'm  using  Advil, which helps for several hours.  Is there anything I can do to get relief.  This is the 8th day....and it seems to be getting worse instead of better.
Felt faint in the shower; Very tired after first vaccine; Injection site left arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt faint in the shower), FATIGUE (Very tired after first vaccine) and VACCINATION SITE PAIN (Injection site left arm was sore) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DIZZINESS (Felt faint in the shower), FATIGUE (Very tired after first vaccine) and VACCINATION SITE PAIN (Injection site left arm was sore). At the time of the report, DIZZINESS (Felt faint in the shower), FATIGUE (Very tired after first vaccine) and VACCINATION SITE PAIN (Injection site left arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
Incorrect dose as administered.  Patient was to receive 0.25 mL/25 ug but patient received 0.2 mL/10 ug.  Patient's caregiver has been instructed to restart the series.
Information has been received from a nurse practitioner concerning a 15 year old female with asthma and allergy to amoxicillin, who on 22-MAY-2008 was vaccinated intramuscularly with her second 0.5ml dose of GARDASIL (lot # 659964/1978U). Shortly after being vaccinated, the patient developed tingling in her arm, swelling and redness at the injection site, low fever (101.8 F), chills, shakiness, nausea and dizziness. It was reported that the patient was seen the next day in office and the symptoms seemed to be improving. At the time of this report, the patient was still recovering. No other information was available. Additional information has been requested.
C/O LEFT LEG RED AND SWOLLEN/ QUICKLY INCREASE SWELLING WITH WARMTH/ ABLE TO BEAR WEIGHT BUT STIFF LEG WITH WALKING/ LEFT ANT. THIGH WITH 5X6 CIRCULAR WARM ERYTH. AROUND VACCINE SITE WITH CENTRAL AREA INDURATION 24 CM AND TENDER
Patient received first dose of Pfizer vaccine without incident. Patient waited 15 minutes and left. He  reported getting in his car, driving a few blocks and started to feel dizzy and lightheaded. Patient returned to clinic pale and hyperventilating. Patient laid down. Vitals were stable. He drank water and juice and reported feeling better. Patient sat for 15 more minutes then requested an ambulance be called as he was still not feeling well and wanted to go to the hospital to be evaluated. Ambulance was called and patient walked out of clinic and climbed into the ambulance himself.
Cellulitis of left arm extending from injection site to elbow. Treated with Keflex.
Max/Low Temperature reached: 54.3 degrees Fahrenheit Duration out of recommended range: 2 hours and 45 minutes/ received a dose since the excursion occurred with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA409280(CLUSTER) and 2022SA410650(CLUSTER).  This case involves a 22 years old female patient and reporter states that max/low temperature reached: 54.3 degrees fahrenheit duration out of recommended range: 2 hours and 45 minutes/ received a dose since the excursion occurred with no reported adverse event involving vaccine IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On 30-Sep-2022, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection at a dose of 0.1 mL in Left lower forearm intradermal (strength, formulation was unknown, lot - C5928A, 01-Mar-2024) for Skin test. On an unknown date, the patient received an unknown dose of suspect IPV (VERO)(strength, formulation, frequency, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 30-Sep-2022 the patient developed a non-serious event of max/low temperature reached: 54.3 degrees fahrenheit duration out of recommended range: 2 hours and 45 minutes/ received a dose since the excursion occurred with no reported adverse event (poor quality product administered) (Latency: same day) following the first dose intake of TUBERCULIN TEST and (Latency: unknown) following the administration of IPV (VERO). Extended stability data cover the excursion. This situation was reported as a medication error due to administration post temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Light headed, dizziness, fatigue, word finding problems, confusion, "brain fog", headache, head pressure, tingling
Although I felt super tired the day I got the shot, I experienced few other side effects until a month later. I've just had one of the worst periods of my life - the headache was unbearable and the cramps were near crippling. My period was a week late. Although these are not life-threatening side effects, they did handicap me for an entire day to the point where all I could do was sit on the couch; this is highly unusual for my menstrual cycle, so I thought I'd report it.   I realize that women's cycles are hard to analyze because of stress, diet, and other irregularities that make it difficult to pinpoint sudden changes; but my cycles have been mostly predictable to the point where this is memorable in a long line of unmemorable periods. I was not going through any extra stress (physical or emotional) in the weeks before my period, had not eaten anything strange, met new people, or even had sex in the month prior to my period.   The first three days of my 7-day cycle (which is now complete) were utterly devastating. The headache started as a migraine, which is not unusual for me, but it progressed to my ENTIRE HEAD and down to the top of my shoulders (double-sided migraine, which I've never had before). My cramps were powerful, relentless, and left me gasping for breath. My flow was extra heavy and lasted. much longer than normal.
Patient is an 84-year-old female with history of intermittent atrial fibrillation, hyperlipidemia, COPD who does not normally require oxygen presenting to the emergency department as nursing staff noted her blood pressure to be low.  Per EMS, nursing staff stated her pressure was 60/40.  Upon EMS arrival, patient's blood pressure was normal, however patient had a significant cough and wanted to come to the ER for evaluation.  She denies any fever or chills, denies nausea, vomiting or diarrhea.  Associated Symptoms: cough, fatigue, shortness of breath, wheezing
Warm rash at injection spot and down my arm Itchy Pain in arm  Swelling in lymph nodes Tired
I lost consciousness and collapsed for five mintues. I was sweating so much my close was covered in water.
patient had massive intracerebral hemorrhage 3 days after vaccination.  family claims patient was doing well until vaccination.  there is a suspicion that patient might have had sinus venous thrombosis that lead to the the ICH.
This spontaneous report as received from a other health professional refers to an 81 year old female patient. The patient's medical history included herpes zoster. On an unknown date in 2016, the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent. In June 2017, the patient experienced herpes zoster and pain. The outcome of herpes zoster and pain is unknown. Causality assessment was not provided. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1707USA009909.
I tested positive for COVID; I tested positive for COVID; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 55-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EN5318) and on 17Feb2021 as dose 2, single (Lot number: EN5318) at the age of 53 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jun2022, outcome "recovering" and all described as "I tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
RIGHT ARM SWOLLEN AROUND THE SHOULDER. ARM HURTS TO MOVE UPWARD, AND TO TOUCH ON THE SITE OF THE INJECTION. NO FEVER, DUE TO RECEIVE MOTRIN EVERY SIX HOURS AFTER SHOTS GIVEN.
mom states rt thigh began to swell & redden all over down to knee & was almost twice the size of lt thigh (front of thigh) located about 24 hrs; had no problems p/that no inc temp;
dizzy, fever, aches, nausea and vomiting, fatigue, headache, stomach ache, chills, sore throat
Moderna COVID-19 Vaccine EUA. At home, about an hour after getting the vaccine had extreme blood pressure spike, dizziness, heart palpations, ear ringing, dry mouth, weakness and trembly, visual aura with eyes closed of red ball in field of vision, some pain at temple as if migraine tho I only have had migraines in first trimesters of pregnancy, adolescence and at time of diagnosis of hyperthyroidism. Have had blood pressure brief spikes in past (possible tyramine sensitivity) but this persisted rather than momentary. Live alone and was at home so called Ambulance. Took over 12 minutes for ER to come after called when symptoms did not quickly resolve. Was still having symptoms though blood pressure had dropped to
From initial information received on 3/8/05 from another manufacturer (reference number WAES0501USA04558), initially reported by a nurse, regarding an adverse event, it was reported that a 30 year old male patient received his first dose of FLUZONE, lot number U1531AA, administered in the left deltoid (route of administration not reported), and his first dose of PNEUMOVAX 23, lot number 647724/0946N, administered IM in the left deltoid on 1/7/05 at 10:00 AM. Two days later, at 9:00 AM, the patient developed redness, swelling, tenderness, and pain at the site of injection, as well as, nausea, vomiting, and severe headache. The patient was seen in the emergency room that same day. Reportedly, the patient stated that it hurt to raise or move the arm. He was treated with Augmentin and IM Rocephin. On exam, the patient had a fever as well as arm redness, warmth, and swelling. On 1/10/05, per the nurse, the redness, pain, swelling and warmth at the site had increased with decreased range of motion in the arm. The patient was diagnosed with left arm cellulitis and was admitted to the hospital. Medical records indicated that the chief complaint at admission included weakness, nausea, vomiting, headache, and pain and redness in the left arm. During the hospital course, the patient was treated with IV fluids, Unasyn, Solu-Medrol, Reglan, Entex PSE, and Darvocet-N 100 as well as saline spray and amantadine hydrochloride. Influenza AB screen was presumptive negative for the influenza A or B antigen. The patient was discharged from the hospital and recovered on 1/24/05.
After going to the bathroom, I blacked out and fell backwards; After going to the bathroom, I blacked out and fell backwards; hurt my elbow; hurt the back of my head; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age (reported as Age: 74; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 from 05Jan2021 to an unknown date. Concomitant medications were not reported. Patient stated that on 02Apr2021 she had her first Pfizer vaccine. In the middle of the night she had a bad reaction. After going to the bathroom, she blacked out and fell backwards and hurt her elbow and hurt the back of her head. Patient wanted to know if she should get the second (2 nd) vaccine and If so, she wanted to know if she should get it on the three weeks interval or wait longer. Outcome of the events was unknown. Information on about lot/batch number has been requested.
COVID19 VACCINE : patient received the first dose on Wednesday, Feb 3 around 1 pm. Then, on Monday, Feb 8, at 2 pm, he started to feel a intense pain (pangs) on the left side of his neck and tingling scalp. He took Advil at night, which helped him to feel better next day. However, On Wednesday,  Feb 10, he started to feel the pangs again, but this time on his right ear. The tingling scalp decreased but it never vanished.
Approximately 11 days subsequent to receiving dose 2 of Engerix B, the pt experienced floaters in her left eye. No treatment was given. The most recent information received, reports that the condition of the pt is resolving.
Headache, Myalgia, Arthralgia, EAR PAIN Narrative:
Viral infection; throat was red, swollen, and dry; throat was red, swollen, and dry; throat was red, swollen, and dry; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Viral infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VIRAL INFECTION (Viral infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced PHARYNGEAL ERYTHEMA (throat was red, swollen, and dry), PHARYNGEAL SWELLING (throat was red, swollen, and dry) and DRY THROAT (throat was red, swollen, and dry). The patient was hospitalized on 26-Mar-2021 due to VIRAL INFECTION. At the time of the report, PHARYNGEAL ERYTHEMA (throat was red, swollen, and dry), PHARYNGEAL SWELLING (throat was red, swollen, and dry), DRY THROAT (throat was red, swollen, and dry) and VIRAL INFECTION (Viral infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Vasovagal episode/Syncope  9:05 BP 112/67, HR 59, RR 12, O2 99, Blood Glucose 98 9:09 BP 112/67, HR 60, RR 12, O2 99 9:11 97/63, HR 63, RR 12, O2 97
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 12:00 (Lot number: FC3182) at the age of 33 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "I am currently breastfeeding", start date: 25Apr2021 (ongoing), notes: Had 2nd child on 25Apr2021 and, I am currently breastfeeding. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. Vaccination history included: Bnt162b2 (Product: COVID 19, brand: Pfizer, Lot number: EW0198, Lot unknown: False, Administration date: 09Aug2021, Administration time: 12:00 PM, Dose number: 1, Vaccine location=Left arm), administration date: 19Jan1988, when the patient was 33 years old, for COVID-19 immunization, reaction(s): "Headache". The following information was reported: DIZZINESS (non-serious) with onset 01Sep2021 07:30, outcome "not recovered", described as "Feelings of dizziness/vertigo in the morning hour"; VERTIGO (non-serious) with onset 01Sep2021 07:30, outcome "not recovered", described as "Feelings of dizziness/vertigo in the morning hours"; HEADACHE (non-serious) with onset 01Sep2021 07:30, outcome "not recovered", described as "Had a mild headache after receiving the 1st and 2nd dose of the vaccine". Therapeutic measures were not taken as a result of dizziness, vertigo, headache. Additional information: Patient did not received any other vaccine in four weeks. Patient was not tested for Covid post vaccination. It was unknown that if patient had Covid prior to vaccination. There were no known allergies. No follow-up attempts are possible. No further information is expected.
Extreme swelling of right upper arm from top of arm to elbow- extending to right breast tenderness.  Upper arm swelling fees hard and hot.  Skin dark red over area and resembles a sunburn.   Localized pain and burning.  Overall generalized fatigue and malaise.
Flushing of the face; This spontaneous case was reported by a physician and describes the occurrence of FLUSHING (Flushing of the face) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FLUSHING (Flushing of the face). On 14-Mar-2021, FLUSHING (Flushing of the face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant products usage were not reported by the reporter.  Treatment details were not included.  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.; 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.
Client was vaccinated with Moderna vaccines on February 4 and March 4, 2021 at a large public health clinic site.  Client tested rapid positive for Covid on 8/24 and had symptoms starting 8/22: low grade fever and myalgia.  Reported as a breakthrough Covid illness in a person who was fully vaccinated.
Less than an hour after the injection, (and I put ice pack on the injection site for 20 minutes every 2 hours) I became feverish, had severe bone, joint and soft tissue pain, could hardly walk. Finally took temp at 10 PM, and it was 102.5. I already knew the injection site would be painful for 2 weeks, but with 1st shot, I did not have these debilitating symptoms. I shivered all night and it all continues today! Have taken 2 ALEVE x2 in 24 hours, but if I had something stronger would have taken it, as body pain is 8/10. Severe headache, all of which caused me to stay in bed all day...and still feel the same. And of course, cannot even lay on right arm, as pain is 8/10.
My psoriasis became inflamed and spread all over my body with the exception of my face. It was itchy and burning and very very red and scaly, and extremely uncomfortable. It was amplified and enhanced beyond normal. After each dose there was a slight outbreak of it but that normally comes from food, but this dose was so intense that I needed to seek medical help. The doctor is sending me to an oncologist. He gave me some creams that are definitely helping. It's clearing up now, but its not fully gone.
Information has been received from a medical assistant referring to an unspecified number of patients with unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided.  On unknown dates, an unspecified number of improperly stored doses of ROTATEQ (lot# reported as L042217, expiration date 03-JUN-2017, oral, dose was unknown) might had been administered to the patients. No adverse effects were reported. The excursion temperature was 31 F with duration of 16 hours and 30 minutes. The call was due to date logger. There was no previous excursion. This is one of several reports from the same reporter. Additional information has been requested.
I did not have an adverse reaction to the vaccine. My throat was really sore, and I went to the clinic. I tasted positive for COVID-19 in 12/2022. I was given the prescription PAXLOVID and I tolerated it without any complications.
PATIENT RETURNED TO PHARMACY ON 10/1/2020 WITH INFLAMMATION AND BRUISING IN HER LEFT ARM BELOW THE INJECTION SITE. SHE SAID SHE NOTICED TO ISSUE ON THE MORNING OF 10/1/2020. WE RECOMMENDED THAT SHE FOLLOW UP WITH HER PCP