chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Area 2 inches below the injection site started itching. Then became red, swelled and hardened. Was put on doxycycline for cellulitis.
The pt experienced shortness of breath, sounds congested, eyes were red, was jittery, felt dizzy. BP 110/80, P 124. Benadryl given.
Vaccine was given 1:20 pm on 10/10/2014. Pt came back after 1 hr with symptoms of nausea and vomiting. Pt was taken to nearby hospital.
Swelling in armpit lymphnode that started Sunday morning, 1/31 and continued to grow through Wednesday, 2/3. Started as lymph node about as big as a golf ball and continued to softball size.  Swelling in clavicle lymph node that started Tuesday night, 2/2, and continued to grow through Wednesday 2/3. Swelling started about the size of a quarter, has grown to about a golf-ball
Varicella - Information has been received from a registered nurse concerning a 4 year old female patient with allergies and who was exposed to varicell a who on 10 Mar 2000 was vaccinated with varicella virus vaccine live.  Concomitant therapy included loratadline (claritin).  On 21 Mar 2000 the patient developed a rash that consisted of red slightly raised lesions about the size of a pencil erasure.  There was no blistering and no fever.  The patient sought unspecified medical attention.  Follow up information from a registered nurse indicated that on 24 Mar 2000 was diagnosed with a case of breakthrough chickenpox that consisted of a red raised area on the torso, neck, and legs without blistering.  she had new spots every day for four days.  The nurse did not consider this a reaction to varicella virus vaccine live, but rather contracted a modified case of varicella due to disease exposure prior to her having had the vaccine.  Additional information has been requested.
Pt became very lightheaded & faint on administration of vaccine. Injection site red and inflamed for few days after admin. and bruising at site of injection continues at this time.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 years old male patient who received a dose of FLUBLOK QIV (batch number: QSAA1811, Expiry date: 30-Jun-2020) rather than FLUZONE (batch number and expiry date was not reported) (dose, dose in series, route and site of administration were not reported for both the vaccines) on 16-Nov-2018. The patient's past medical history included Food allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as He did not receive any other vaccines that day. It was a case of actual medication error due to inappropriate age at vaccine administration and Wrong vaccine administered. No adverse event was experienced. 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 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. List of documents held by sender: none.
I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.
Pain at injection site, swelling/redness 6 cm, fever/malaise, muscle and joint pain.
About an hour after receiving the first dose of the vaccine I began having ringing/hissing noise in both ears.  It has not gone away.  A week after it started, I saw my primary care physician.   There is not much to be done.  Suggested taking allergy meds.  It has not cleared up. - two weeks after the first dose.    It is difficult to sleep as it seems to be worse at night.
Two hours after the injection my tongue started swelling and pain increased throughout the day to the point where I could not eat.  The next morning (Dec. 23rd) I had painful white lesions under and on the sides of my tongue. This worsened over the next day and I was seen at an urgent care clinic who took culture swaps for lab test.  (eventually negative for oral herpes).  Pain and lesions continued to worse and I was admitted to the ER on December 26th.  Breathing, heart rate, and blood work all normal.  Diagnosed with Herpangina/Coxsackie Virus.
Ipsilateral Shoulder pain, occurring within 24 hours and persisting now > 5 months.  X ray-unrevealing. MRI pending
At a mobile vaccine event at a school we vaccinated a ?just turned? 12 year old student with the Peds (5 ? 11 yr) dose of the Covid vaccine.  The parent had attested on the paper consent form that the age of their child was between 5 and 11 years old, even though the child turned 12 a few days before the first dose.  No adverse effects have occurred. The parents were notified when this error was discovered.  They are communicating with the child's regular PCP to determine what they would like to do as far as getting a repeat dose of the adult Pfizer vaccine due to the under dosing per CDC guidelines (patient did recieve both doses of primary series with pediatric formulation (5-11) instead of adult).
June 4: Vaccine received June 6 (AM): felt arm pain and mild chest pain not affected by breathing or moving. Continues on and off, but was relieved by ibuprofen. June 7: 1PM- chest pain became persistent, not relieved by ibuprofen. Describes as "squeezing" with palpitations. Accompanied by feeling clammy, weak, pale, subjective fever. Brought to ED and transferred to ICU 6/7 at 18:44 for labs and imaging consistent with myopericarditis.  Started treatment on scheduled Ibuprofen (600 mg q8 hours). Chest pain improving, but serial troponin continued to rise.  6/9: NSAID changed to Toradol for continued chest pain with colchicine
Patient thought he was supposed to receive his 2nd dose on the 28th of August instead of in 28 days.  He got his 2nd dose 10 days sooner; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient thought he was supposed to receive his 2nd dose on the 28th of August instead of in 28 days.  He got his 2nd dose 10 days sooner) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Prediabetes (Borderline Pre-Diabets).   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient thought he was supposed to receive his 2nd dose on the 28th of August instead of in 28 days.  He got his 2nd dose 10 days sooner). On 28-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient thought he was supposed to receive his 2nd dose on the 28th of August instead of in 28 days.  He got his 2nd dose 10 days sooner) had resolved.            The patient weight reported as 200 with unknown units  Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up information include patient demographics, relevant medical history and vaccine facility information were added.
Cellulitis to RUE to include erythema and edema 15cmx9cm. Warm to touch and pain. SXS started last night. Pt tx'd IV Abx and PO Abx.
SKIN ON ARMS HURT. MOREE SO ON LEFT ARM (VACCINE SITE). FELT WARM FOR UNKNOWN AMOUNT OF TIME. NO FEVER.
The day after my shot, my body felt as it did when I had covid. My muscles felt unable to function. The next day I work up with a sore arm . The next day, my neck was so tight. It was been so tight and in pain since.
Swelling, redness, urticaria around the site; Swelling, redness, urticaria around the site; Swelling, redness, urticaria around the site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE URTICARIA (Swelling, redness, urticaria around the site), VACCINATION SITE SWELLING (Swelling, redness, urticaria around the site) and VACCINATION SITE ERYTHEMA (Swelling, redness, urticaria around the site) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Swelling, redness, urticaria around the site), VACCINATION SITE SWELLING (Swelling, redness, urticaria around the site) and VACCINATION SITE ERYTHEMA (Swelling, redness, urticaria around the site). At the time of the report, VACCINATION SITE URTICARIA (Swelling, redness, urticaria around the site), VACCINATION SITE SWELLING (Swelling, redness, urticaria around the site) and VACCINATION SITE ERYTHEMA (Swelling, redness, urticaria around the site) 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.   Concomitant medication was not reported. Treatment medication was not reported.  It was first thought as cellulitis, but it was a local reaction.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021 as the outcome of all events has been updated as recovered.
Patient didn?t feel well the day after his COVID vaccine. He was extremely tired and he had body aches. This continued until his 1st visit to the hospital on July 1st. He was jaundice and weak. They diagnosed cirrhosis, high blood pressure and low blood platelets. He stayed in the hospital for 3-4 days and was released. 4-5 days later we went to the hospital again with the same symptoms. This time they told him he had hepatitis B along with the other things already diagnosed, again he was released from the hospital after a few days. 5-6 days later he had a doctors appointment, she told him he needed to go back to the hospital. This stay was for 16 days. He needed platelets and was then diagnosed with an aggressive form of lymphoma, received treatment and was released on July 30. That evening he started with a cough and felt progressively worse. August 3rd he was scheduled for more blood platelets, arrived to the hospital and was again admitted. They then diagnosed him with an ecoli infection which was to much for his weakened state and he passed away on August 10
Full body rash and hives, a plt count of 1, RHO(D) Immune Glob given via IV.
9/1-  cramping on the top of her stomach, 9/2 and 9/3 the cramping intensified and began to spread throughout her body. On 9/3 she took an antacid and immediately vomited, whole body was cramping, she was unable to bend her fingers and the left side of her face was drooping.   hospitalization 9/3- 9/6. Employee stated that her doctor shared that he believed it was a negative reaction to the 2nd vaccination. However, the discharge paperwork states hypertension, hand-tingling and stroke-like symptoms.
5 days after shot developed numb/tingling in lip. It has persisted for a week. I have HSV-1 but no cold sores present, just lip tingling for a week now.; 5 days after shot developed numb/tingling in lip. It has persisted for a week. I have HSV-1 but no cold sores present, just lip tingling for a week now.; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 19:45 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "no just HSV-1" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; CELEXA [CELECOXIB]. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 09Apr2021, when the patient was 27 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Mar2021, when the patient was 27 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 19:45, outcome "unknown", described as "booster"; HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 26Nov2021 06:00, outcome "not recovered" and all described as "5 days after shot developed numb/tingling in lip. It has persisted for a week. I have HSV-1 but no cold sores present, just lip tingling for a week now.". The event "5 days after shot developed numb/tingling in lip. it has persisted for a week. i have hsv-1 but no cold sores present, just lip tingling for a week now." and "5 days after shot developed numb/tingling in lip. it has persisted for a week. i have hsv-1 but no cold sores present, just lip tingling for a week now." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of hypoesthesia oral, paraesthesia oral.  Additional information: This case assessed as non-serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Redness swelling, itchy at injection site Fatigue Severe stomach pain beginning day 7 and ongoing  Thickening of vaginal Mucus No urgent care where I live. If symptoms continue until Monday (8/30) I will call my doctor for an appointment
Headache, Myalgia, Arthralgia, severe abdominal cramping, fatigue. Narrative: Three hours after began having severe abdominal cramping, has IBS so he too his prescribed medication for it. Later in the evening, began having muscle pain/aches, went to work anyway, then yesterday evening had a lot of muscle/joint pain, had to take Motrin, also having headaches, and fatigue. Took the day off to sleep off the side effects as the only thing lingering is a headache.
On 02/24/2000 pt presented in the clinic with hives on his face, head, neck and ears. He was alert and did not appear to be in any distress. He was sent to physician's office immediately. He was treated with 1/4 tsp Benadryl as needed.
Information has been received from a physician assistant student concerning a 16 year old female who on 06-JAN-2009 was vaccinated with first dose of GARDASIL.  There was no concomitant medication.  On 25-FEB-2009 she was seen in the physician's office and was found to have genital warts.  She and had two small warts in the inferior anus, lesions intravaginally and the entire area of perineal area covered with warts.  The patient was asymptomatic.  The patient admitted to having unprotected intercourse in mid December 2008.  The patient had not recovered from the event at the time of the report.  Lab studies performed included Papanicolaou test (results not reported).  Additional information has been requested.
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) 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.    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 HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication details were reported.   This case was linked to MOD-2021-423287 (Patient Link).
Given vaccination on 6May10 and on 8May10 mother brought child to Hospital ER for evaul.  Was admitted with cellulitis and d/c from hospital on 10May10.
he became very ill last night.; Throwing up; very nauseous; Thinks he had fever, he felt really really hot; Thinks he had fever, he felt really really hot; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 19Mar2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that the patient received his second vaccination on 19Mar2021, and it was quite a while ago actually, but he became very ill a day before reporting on 28Mar2021 in the night, he was throwing up, very nauseous and he thought he had fever, he felt really hot. The reporter wondered if that was normal, or this could be reaction to the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician refers to a 26 year old female patient. On an unspecified date in January 2012 the patient may have been vaccinated with GARDASIL (date, route, dose and lot number unknown) dose 2. No other suspect therapy or concomitant medication was reported. On an unspecified date in January 2012 the patient may have received a second dose of GARDASIL after she turned 26 years of age. No adverse effects reported. No patient contact details available. Additional information has been requested.
A report has been received from a Medical Rep concerning a subject of unknown gender, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported tat 20 patients test positive for influenza. The outcome of the event of 20 patients test positive for influenza was unknown. The report was considered to be non-serious.
1-year-old was vaccinated with GARDASIL 9 subcutaneously; 1-year-old was vaccinated with GARDASIL 9 subcutaneously; 1-year-old was vaccinated with GARDASIL 9 subcutaneously; This spontaneous report has been received from a physician and an office manager, concerning a 1-year-old male patient. The patient's concomitant vaccines were Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13). No information was provided regarding the patient's pertinent medical history, current conditions, previous drug reactions, or allergies.  On 28-FEB-2022, the patient was vaccinated mistakenly with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered subcutaneously (product administered to patient of inappropriate age, incorrect route of product administration) as prophylaxis (lot number T028583 has been verified to be a valid lot number, expiration date reported and established as 04-MAR-2023) (exact dose, route and anatomical location of administration were not reported). No other adverse events (AE) reported (no adverse event).
After giving the flu shot. The lady went up to the register and started feeling dizzy and then started to faint. She seemed to be going in and out of consciousness.  A person standing next to her grabbed a chair to set her down. After sitting down she continued to go into and out of consciousness when I went in the pharmacy and grabbed an epi pen then went back out to administer it to her. It seemed to work almost immediatley as the started to regain consciousness. We called 911 during the entire process.  After the paramedics came they took they took over the situation. She later was in hospital for further evaluation where she remained in stable condition.
3/19/21 got 1st vaccine> 3/27/21 hives appeared on my face and it was itchy and hot, but disappeared little later so did not go to any medical facility. 4/20/21 got 2nd vaccine > 4/25/21 hives appeared on my face, neck, arms and back. It was itchy and hot. I took benadryl got little better and disappeared. But few days later sames thing happened again few more time within few weeks, so this time i considered to go to urgent care, but finally did not go due to busy schedule and since it gets better everytime when i take a benadryl. 12/7/21 got 3rd vaccine > 12/16/21 started extreme itchiness and even can't focus on my daily activities. Even got bruised due to scratching too hard. 12/19/21 finally went to the urgent care and got steroid, cetirizine and famotidine. Not too itchy and able to do my daily activities as long as i take a medicine. But not taking medicine, can't focus anything......
This spontaneous report as received from a pharmacist refers to a 2 year old male patient. The patient's pertinent medical history and drug allergies or drug reactions were not reported. On 09-OCT-2013, the patient was vaccinated with a first dose of MMR II (lot number, expiry date and route not reported.\). On 17-OCT-2013, the patient was vaccinated with a second dose of MMR II, (lot number, expiry date and route not reported). On 17-OCT-2013, the patient experienced inner ear discomfort. The physician determined that the patient was probably developing a ear infection and prescribed amoxicillin. On 25-OCT-2013, the patient developed a rubella rash all over his body. The unspecified physician determined that the patient was not developing an ear infection on 17-OCT-2013 but the ear discomfort was from the rubella rash developing inside of his ears. The pharmacist stated that the patient was taken to an unspecified emergency room on an unknown date but was not admitted to the hospital. The patient was treated with unspecified steroids and unspecified antihistamines. However these treatments did not make the patients conditions improved. There was no lab tests performed. The outcome of the events were reported as not recovered. The patient sought medical attention. Additional information has been requested.
Patient experienced swelling, itching, tenderness at site of injection that encircled upper arm. Patient used cold compress, Ibuprofen, benadryl every few hours with no relief (now day 2). Patient saw NP at clinic that prescribed a steroid dose pack to use in case swelling worsens and advised to seek further medical attention if swelling does not lessen.
9pm- chills 11:30pm- fever, nausea, vomiting, tachycardia, diaphoresis Husband Called 911 2/24- all day fever, chills, headache, fatigue 2/25 last fever at 10:30am, still have chills, fatigue, headache
Strong Tinnitus, I can?t sleep, eat, work, I?m crazy, I have panic attacks because that .
Dizziness, states vertigo also Narrative: Pt stated at end of 15 min holding time that he felt like he had vertigo and that he was dizzy. Pt was placed on bed and VS obtained. VS were stable and Pt. left 15 minutes later at 3:10pm stating "I feel ok now".