chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a swollen area under his left armpit which is assumed to be a lymph node/swollen area under left arm pit; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 63-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9266, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 20Feb2021 13:15 (age at vaccination was 63 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9264, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 30Jan2021 (age at vaccination was 63 years) as dose 1, single for COVID-19 immunization. On 21Feb2021, after second dose the patient experienced a swollen area under his left armpit which is assumed to be a lymph node/swollen area under left arm pit. He described it as being noticeable, pushing outward, significantly wide as compared to the body, and very very very tender but not painful or sore. Patient says that he has had both injections in his left arm, the last one on saturday in the early afternoon. He days on Sunday night under his arm pit area where lymph nodes are he noticed that there was a palm sized area that was wide and not sticking out, and it was still there. He says he would like to know if this was a normal reaction or if he has to run to a doctor or something. He says that the area was tender to touch, but is not horrible pain, and doesn't have any redness. He says he saw that swollen lymph nodes were listed on the paperwork that was given to him on his first visit, he was just a little concerned about if this was normal or an issue. Patient says he got his first dose of the Pfizer COVID-19 vaccine on 30Jan2021 between 01:30PM and 01:40PM, closer to 01:30PM, and it was LOT EL9264. He says he got the second dose 20Feb2021 at 01:15PM, and it was LOT EL9266. He mentioned that he needed his glasses to read handwritten vaccine card, and they did not provide NDC/EXP on it. patient says he has done no treatment to the swollen area, and if it has gone down it has been very minimal. He says tonight will have been two full days of it. He says it is not painful, it is just a wide area under his armpit going down his torso. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
This case was reported by a non-health professional via interactive digital media and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included cancer (11 years ago) and immune system disorder. Previously administered products included SHINGRIX (1st dose, refer case US2018GSK135835). In April 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain and headache. On an unknown date, the outcome of the pain and headache were recovered/resolved. It was unknown if the reporter considered the pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient might had the bad reaction from reduced immune system from cancer 11 years ago. The patient had 1st dose of SHINGRIX 2 months ago. The patient commented on 26th April 2018 about having a 2nd dose 2 days ago. The patient had a bad reaction of aches and headaches after vaccination both doses.
This spontaneous report was received from a physician referring to a 9 month old female patient. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot# N014945, expiration date 31-AUG-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 24-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768.
We are not aware of any adverse events at this time.  This is to report an error in administration.  The patient was supposed to receive 0.5 mL of the Bivalent Moderna Covid-19 booster.  However, she received 0.5 mL of the original Moderna vaccine (essentially the patient received another primary series dose).
CHILLS; HORRIBLE HEADACHE; RIGHT ARM IS SORE; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, attention deficit disorder, non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse and illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced horrible headache. On 11-MAR-2021, the subject experienced right arm is sore. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 12-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fever, horrible headache, and right arm is sore. This report was non-serious.
This is a spontaneous report from a contactable nurse. This nurse reported similar events for 15 patients. This is the 7th of 15 reports.  A patient of unspecified gender, age and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/product/event, different patient.
I received vaccine at 12:15 pm on 4/7/21.   That evening  I experienced severe chest pain /pressure a  few times.   Had headache next two days, fatigue and feel somewhat short of breath.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history, drug reactions and allergies were not reported. On 05-OCT-2014, the patient was vaccinated with the first dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot number was not reported). On 06-OCT-2014, the patient was vaccinated with a second dose of ZOSTAVX, 0.65 ml, subcutaneous (lot number was not provided). No adverse effects reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Immediately post vax, the pt experienced severe pain at injection site and muscle weakness in left arm.
Saturday the 28th, very tired with a headache. Went to bed Saturday night and woke up at 3AM Sunday with severe sore throat. Headache and sore throat. Sunday morning I took a home test and it was positive. At that point, sore throat and headache continued. I went to clinic and confirmed the positive. I was prescribed Paxlovid. Sunday I was shaking, fever 101. Typical fever symptoms. Monday I woke up at 5AM drenched in sweat. And fever was gone. Then Monday- today, a lot of fatigue. Today a really bad headache and a cough.
A non-serious report of "six patients received expired FLUMIST" was received from a nurse concerning a five-year-old patient (gender unknown).  The patient's medical history and concomitant medications were not available.  On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008).  The product was expired by 10 days.  There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu resulting in some medication errors that occurred  shortly after the product expired.  Follow-up information was received on 09-Apr-2009 that included the following:  Product Complaint Investigation results.
Information has been received from a registered nurse concerning a 9 year old white female who on 21-JAN-1999 was vaccinated subcutaneously into the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 628694/1663H). Concomitant therapy that same day included a first dose of measles-mumps-rubella vaccine (Lot # 628706/1540H) administered subcutaneously into the left thigh. There was no illness at the time of vaccination. There are no known pre-existing allergies or medical conditions. There was no concomitant medication. On 07-MAY-2007 the patient's mother called to report that her daughter developed 60 lesions all over her body, including her vaginal area. At the time of reporting the patient had recovered from 60 lesions all over her body. There were no lab diagnostic studies performed. Additional information is not expected.
No adverse effects reported; dose of Rotateq was administered to 2 week old unspecified patient; This spontaneous report was received from a registered nurse and refers to a 2-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-MAR-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose, orally for prophylaxis (lot # and expiration date were not reported.) It was reported, that there was no product confusion. No adverse effects were reported.
Skin itching began at under chin, then spread to neck and arms and back. Itching turned to burning(heat) and itching.
Headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN IN EXTREMITY (Sore Arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included TOPIRAMATE (TOPAMAX), ALPRAZOLAM (XANAX) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced HEADACHE (Headache) and PAIN IN EXTREMITY (Sore Arm). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Pain in arm, at an unspecified dose and frequency. On 17-Feb-2021, HEADACHE (Headache) and PAIN IN EXTREMITY (Sore Arm) had resolved.        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.   Patient feels better now.   This case was linked to MOD21-063341 (E2B Linked Report).; Sender's Comments:  MOD21-063341:MOD-2021-059668 -2nd Dose of Vaccine
MMR vaccine administered on 01/23/2020.  Patient contacted office on 02/04/2020 stating she was feeling "achy" and her lymph nodes in the back of her neck and behind her ears were feeling swollen.  Patient stated she had an appointment to see her primary care provider on 02/05/2020.  Patient called office on 02/11/2020 stating that her face, neck and trunk were covered in a rash.  Rash started on 02/09/2020.  She states she was not seen by her primary care provider on 02/05/2020 as her appointment time was wrong.  Is being evaluated at Urgent Care on 02/11/2020.
seasonal allergies; This is a spontaneous report from a contactable consumer reporting for herself. This female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had her 1st vaccine and had seasonal allergies since an unknown date. The patient wanted to know if it was ok to take a Benadryl. Event outcome was unknown. Information on the lot/batch number has been requested.
The day after he had shot, he started vomiting 5 times a day. Then, he started having staring spells; 1 or 2 a day. In February, he started having multiple ones. He ended up in a hospital for 4 days and 3 nights. Per review of hospital d/c summary: final diagnoses of partial complex seizures and respiratory syncytial virus bronchiolitis. Per annual report-We haven't given him the second dose of the medication.  We are afraid he might react again.  So, that is unknown.
Site: Pain at Injection Site-Medium, Additional Details: She said it felt weird when the shot was going in her arm. She has had pain in the injection site since she received the injection and sometimes it keeps her up at night. She told her doctor and they said to report it to us. She is still experiencing the same pain. She does not have any mobility limitation in her shoulder.
By the next morning had painful quarter size knot, red and hot to the touch. Throbbing pain radiating down right arm from knot. Fatigue, headache.
Giavanna was brought in today by her mother because of a rash and redness at the site of the MMRV vaccination that she received on November 30, 2006. The mother said that 2 days after she received the vaccine she started having erythema at the site in her left lateral arm. It has gradually increased in size over the last 24 hours and became itchy and warm. She has no vesicular lesions. She has no other lesions on her body. Her review of systems is negative for fever or any other complaints. Physical examination:Vital Signs: Her weight is 31.25 kg or 68 3/4 pounds. Temperature 97.7 through the ear. Genera: Appearance: Comfortable in no acute distress. Skin: Exam reveals a 5x7 cm erythematous well-circumscribed warm slightly raised lesion over the lateral aspect of the left arm at the site of the previous vaccination on November 30, 2006. There are no vesicular lesions. There are no other rashes on the body. The rest of her physical exam is completely normal. Impression: Possible reaction to the MMRV vaccine. Possible superimposed secondary infection. Plan:1.  Report to vaccine adverse events reporting system. 2. Course of  Keflex (250 mg in 5 ml) 7.5 ml q 6 hours for 7-10 days, 300 ml given no refills. 3. Follow up with us if symptoms worsen or are not improving within 24 or 48 hours or any other concern or spreading of the rash or high-grade fever.
Recent hospitalization at Hospital from 8/18 through 9/4 for treatment of Covid 19 and acute renal failure. The patient is currently maintaining an excellent O2 sat breathing room air. Note findings on the CXR and on cuts through the lung bases on CT abdomen/pelvis, but suspect these are residual from her recent Covid pneumonia. While the possibility of secondary bacterial pneumonia exists, this would seem unlikely based on her lack of any new pulmonary symptomatology, lack of fever, good 02 sat breathing room air, and a normal procalcitonin level. Will DC dexamethasone and ceftriaxone Monitor clinical course closely for any evidence of evolving secondary bacterial pneumonia.
Mother of patient came in office on 07/17/2008 stated that she notice a large circular wheal on the arm in area where Varicella vaccine was administered on 07/16/2008. The wheal was noticed this morning and mom brought patient into the office.
allergic skin response with swelling and redness at the injection site and down the upper arm.  fever, chills
A large node began swelling on the exterior of my anus at about 11:00 PM. The swelling of my anus was accompanied by the swelling of the lymph nodes on the right side of my body. The node on my anus swelled to about the size of my thumb that night, and burst the next day in the morning. The node regrew the next day and burst again; this process repeated for about a month, until I began applying Preparation H. The swelling in my lymph nodes subsided in about 3 days. The node continues to swell on my anus now, about a year later, and bursts if I don't regularly apply Preparation H. The last time it burst or bled was about a month ago.  I was recommended by the nurse who administered my shot to report my symptoms when I went in for my second shot a month later. I did not because I was ashamed and embarrassed.
Flu shot given in upper left arm.  After the shot left arm has been very sore and now has an impingement that has caused limited range of motion and severe stabbing pains.  Went to my doctor who diagnosed the impingement and referred to Physical Therapy.  Have been going to Physical Therapy for 13 weeks and my arm has not gotten better.
Pt got her vaccination on Sunday evening, 11/7.  On Thursday evening, 11/11 she complained of an itchy arm as she was getting ready for bed.  We looked, and her left arm, and it was lumpy and red 1-2 inches away from her injection site. The lumps didn't exactly look like hives (which she sometimes gets), and it was not symmetrical around the injection site. I called a friend who is doctor and a infectious disease specialist, who asked if pt was having trouble breathing.  She was not.  My friend said she could have some Benadryl or Claritin or whatever we usually would offer her if she was itchy or having hives.  So we gave her 5 mL of Benadryl. Pt has complained of some itchiness since (and we have given Benadryl another evening one time), the redness has decreased but some of the lumps are still there, if reduced.
Presents for cough, body aches, BLE weakness; COVID + 1wk PTA. Found to be hypoxic in ER. Admit for COVID & respiratory distress. Tx: O2 (intubated for emergent surgical procedure but extubated on hospital day 2 to high flow O2), abx, steroids, vit c, vit d, zinc, remdesivir, barcitinib. Elevated d-dimer & CTA shows acute aortic occlusion; emergent thrombectomy performed on hospital day 1. For the COVID pneumonia she was treated with IV steroids remdesivir and barcitinib. and blood thinners restarted after hemoglobin stable. For the COVID pneumonia she was treated with IV steroids remdesivir and barcitinib. weaned off oxygen down to 2 L. DC'd to Home w/ Home Health.
Patient received a booster dose of Pfizer 20 days too early. 2nd dose was given on 9/22/21, booster was administered 2/2/2022. No adverse events occurred while at the clinic.
arm got real red and sore; arm got real red and sore; there was a little bruise where the shot was given; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunization. Patient had historical vaccine, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced arm got real red and sore, there was a little bruise where the shot was given. Patient stated had both Pfizer vaccines and the second on was on 03Feb. She had no side effects until a week later (10Feb) when her arm got real red and sore and there was a little bruise where the shot was given. It lasted a day and today it is better and she feels fine. She is was surprised to have no other symptoms. The outcome of event was recovering.  Information on the batch/lot number has been requested.
Information and follow up information has been received from a bachelor of science in nursing and a registered nurse concerning a 25 year old female patient (109 pounds, 59 inches) with dexamethasone allergy, none known birth defects or medical conditions, none known illness at the time of vaccination and none adverse event following prior vaccination, who on 05-JUN-2009 was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly. On 11-JUL-2009, the patient was vaccinated in the left deltoid with the second dose of GARDASIL (lot# 663451/0216Y). There was no concomitant medication. The patient was fine when she left the office but later the evening of 31-JUL-2009 (also reported as 11-AUG-2009) the patient started to experience back aches, leg pains, chills and flu like symptoms. Then the next day the patient started to feel a little better and went to work. The patient recovered from back aches, leg pains, chills and flu like symptoms. The patient sought unspecified medical attention. Follow up information was received from the registered nurse who stated that the patient received the second dose of GARDASIL on 31-AUG-2009 (previously reported as 11-JUL-2009) at 7 pm. The nurse reported that the same day the patient's father called at 8:05 pm stating that the patient was having an "allergic reaction" with complaints of chills, lower back pain and leg pain. "Per doctor the patient was to take TYLENOL and BENADRYL. If reaction worsened the patient was to go to the Emergency Room". On 01-SEP-2009 the nurse called patient who was feeling better per her mother. No laboratory diagnostics tests were performed. Additional information is not expected.
Vaccines were given Thursday pm, wok up Friday feeling nauseated and her (L) arm started swelling, itching and was red where she had the vaccine. Redness and swelling spread to 5" x 3" by Saturday along with occipital headache, dizziness, and fatigue. Pt called provider on Saturday evening and then was seen in office 1/23/17. With normal PE, besides 3x5" fading erythema of (L) upper arm.
reports four PTs caught COVID after vaccine; reports four PTs caught COVID after vaccine; This is a spontaneous report from a non-contactable other healthcare professional. This other healthcare professional reported similar events for four patients. This is the second of four reports. An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Jan2021 (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that the patient was vaccinated in Jan2021 and already had COVID. The reporter stated that they don't think they have, they are associating to it at the hospital, but patient was symptomatic. 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.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events Drug ineffective, Covid19  and the administration of the vaccine cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101392305 different patient, same event and dose;US-PFIZER INC-202101392306 different patient, same event and dose;US-PFIZER INC-202101392297 different patient, same event and dose
Started day or 2 after administration of vaccine with headache and sore throat.  Symptoms continued and 1-1 1/2 wks later developed low grade fever along with headache and sore throat.  Also developed trouble breathing at that time and was given an inhaler.  Tested negative for flu.  Was given Bactrim.