chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 3hrs (after injection) my eyes & ears began to burn, the injection site also began to have a lot of pain & inflamed (as expected/warned about). 10 hours after injection I began to havefever like feeling(checked my temp & it was at 99.7F) then a couple hours later suddenly had very rapid/fast rotating chills then fever-like (I checked again & it was at 100.7F), then after I took 2 tylenol-like pills it wasn't as "fast" (decreasing temp also) but still sweating for hours. 24 hours after the shot I had a sore throat with weak back & fatigue which continued for at least 6 more hours. I wasn't able to eat much if anything because I was so weak & hadn't been able to sleep more than 2 or 3 hours/day in past week. 48 hours after the (2nd/full) injection the inflammation of the injection site was finally starting to decrease along with the pain around it & on my arm, but I might get nausea if I start eating "normally" already, gladly no stomach problems yet. Treatment was "Moderna COVID-19 Vaccine EUA"
Vaccine received at 10:10. Mild pruritus occurred at vaccination site at 10:25. Quickly progressed to upper body widespread hives and itching/  Received 0.3mg epi in Right thigh at 10:35 and 25 mg Benadryl.  All hives resolved by 10:40 and itching resolved by 11:00
Patient had pneumovax on 01/26/05. That evening, she had left arm pain, swelling and sensation that her throat was closing. She went to the emergency room and was treated with prednisone.
Information has been received from a consumer concerning her 18 year old daughter with Nail-patella syndrome who in 2008 was vaccinated with the first and second doses of GARDASIL. On 23-FEB-2009 when she was 7 weeks pregnant, the patient was vaccinated with the third dose of GARDASIL. Concomitant medication included birth control pills for one week. Her EED was 26-OCT-2009. This was her first pregnancy. It was reported that the patient was "pretty sick and kind of weak". No further information is available.
neuropathic symptom concerns; Shingles; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 29-OCT-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date not provided) for routine health maintenance and for the intended purpose: the prevention of shingles (herpes zoster). On 17-DEC-2013, the pt presented to the doctor with a painful rash on his body. The pt returned to the doctor several more times, for help with neuropathic symptom concerns, reporting on several occasions that he felt the shingles again. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt suffered and incurred damages, including medical expense and other economic and non-economic damages. All damage proximately caused by the characteristics of the zoster vaccine live (ZOSTAVAX) product that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the pt.  The reporter considered the events to be disabling.
"37 year old female usually healthy and without significant medical history presents for pain and swelling after covid booster.  She received her vaccine booster 01/04/2022 and experienced some pain with redness to the local area of her left deltoid that evening.  She does not like taking medications and so did not take any OTC analgesics.  The next day she awoke with increased pain and noted palpable swelling to her upper arm/shoulder area extending to her left anterior and lateral neck.  No dysphagia, no hoarseness, no difficulty swallowing, no shortness of breath.  No overlying redness. No fever.  The pain continues 01/06/2022 worse with even light palpation over the area as well as rotation of her head and neck."  "Left upper extremity deltoid area contiguous with the top of her shoulder and supraclavicular region indurated without overlying erythema, no fluctuance, tender to palpation.  No axillary lymphadenopathy"  "This is likely a noninfectious inflammation secondary to her Covid vaccine..."
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient who on 26-OCT-2011, was vaccinated IM with a 0.5 ml dose of GARDASIL (Lot #668262/0841AA, expiration date: 08-APR-2013). The patient did not know that she was pregnant at the time of vaccination. No adverse effect was known. The patient visited doctor's office. At the time of the report, the patient's outcome was unknown. The patient's last menstrual period was 30-SEP-2011 and estimated delivery date would be 06-JUL-2012. Follow up information was received from a physician concerning an 18 year old female patient with a history of one pregnancy and 0 full term deliveries who on 26-OCT-2011, was vaccinated IM with the second 0.5 ml dose of GARDASIL (Lot # 668262/0841AA, expiration date: 08-APR-2013). On 20-JAN-2012, ultrasound was performed - result reported as 14617 - consistent with dates. At the time of the report, the patient's outcome was unknown. Follow-up information was received regarding the patient who on 19-JUL-2012 at 41.5 weeks gave birth to a full term female (7 lbs., 9oz) infant. Apgar scores were 7 and 8. It was reported that the patient experienced failure to progress/occiput posterior. The infant was reported as being normal with no congenital anomalies, abnormalities or other complications. It was also reported that the patient did not use any other medications during her pregnancy. Obstetric information included a negative/normal QUAD screen on 03-FEB-2012. Additional information has been requested.
hot all over her face, followed by itchiness on her face, tongue and throat. denies any shortness of breath or chest pain.  She denies any difficulty speaking or swallowing
Patient presented to emergency room on 9/21/2021 with mild confusion, weakness and fatigue. he also had a cough and increased shortness of breath. He was found to be COVID-19 positive and admitted for further management. Patient's condition did not improve and was transferred to the intensive care unit on 10/4/2021 and intubated on 10/4/2021. Patient was placed comfort measure due to worsening of condition on ***. Patient expired on 10/6/2021 from multi-system organ failure.
Swelling and redness noted at area of injection after 24 hr. After 72 hr pt c/o itching at site. Pt fully recovered.
several hr p/vax pt devel redness & swelling @ site of vax;the next morning swelling had extended to involve the entire upper arm;area nearly purple & hot to touch;pt also cold & clammy;tx w/APAP & ice seen by MD who recommended tx w/DPH;
Fever on Saturday 7/7/2012 only rash of red small bumps on chest, back, face and legs. Patients mother discussed with triage nurse - home care measures reviewed.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. The nurse reported that, on 23-JUL-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case). Previous temperature excursion: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case). The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005376.
BENIGN CYST ON PITUITARY GLAND; HEADACHE; FLU LIKE SYMPTOMS; PRESSURE IN SINUSES NOSE/EYE AREA; PAIN BEHIND EYES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus issues, glaucoma/ocular hypertension, migraine headaches, hypothyroidism, and chronic sinusitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, (Dose number in series was 1), administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced flu like symptoms, pressure in sinuses nose/eye area, and pain behind eyes. On 13-APR-2021, the patient experienced headache. On 23-JUN-2021, the patient experienced benign cyst on pituitary gland (Dose number in series was 1),. Laboratory data included: CT scan (NR: not provided) cyst on pituitary gland. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Everything came back normal, and MRI (NR: not provided) no sinus obstruction/disorder. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 07-APR-2021, was recovering from pain behind eyes, and headache, had not recovered from pressure in sinuses nose/eye area, and the outcome of benign cyst on pituitary gland was not reported. This report was non-serious. This case, involving the same patient is linked to 20211238514 (Dose number in series 2).
Localized swelling  and redness at injection site, measured 40x30 mm.
redness came back; it was really hot; swelling the size of the golf ball; arm was hurting; arm was swollen; arm was red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting), SWELLING (arm was swollen), ERYTHEMA (arm was red), ERYTHEMA (redness came back) and FEELING HOT (it was really hot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting), SWELLING (arm was swollen) and ERYTHEMA (arm was red). On 16-Apr-2021, the patient experienced ERYTHEMA (redness came back), FEELING HOT (it was really hot) and SWELLING (swelling the size of the golf ball). The patient was treated with CORTISONE ACETATE (CORTISONE [CORTISONE ACETATE]) at an unspecified dose and frequency. On 10-Apr-2021, PAIN IN EXTREMITY (arm was hurting), SWELLING (arm was swollen) and ERYTHEMA (arm was red) had resolved. At the time of the report, ERYTHEMA (redness came back), FEELING HOT (it was really hot) and SWELLING (swelling the size of the golf ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient into clinic on 1/18/07 for appointment. Patient not asked if she could be pregnant. Given varicella vaccine. Patient returned on 2/15/07 for another appointment. Discovered in appointment that patient is pregnant. Attending doctor noted at previous visit that patient had received varicella vaccine. Patient's est. GA  is about 24-25 weeks and has had no prenatal care. Dr. advised patient on theorictal risk, counselled about medicine labels for pregnancy precautions. Referral to prenatal clinic
She states shortness of breath fast & severe & resolved .  Upper & lower extremity weakness after injection.
Mixed series (Pfizer as 1st dose and Moderna as 2nd dose); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series (Pfizer as 1st dose and Moderna as 2nd dose)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 59H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER. Past adverse reactions to the above products included No adverse event with PFIZER.    On 07-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series (Pfizer as 1st dose and Moderna as 2nd dose)). On 07-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series (Pfizer as 1st dose and Moderna as 2nd dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
pt recvd vax; exp pain in the arm of inject described as "internal pain";persisted x 3 days;MD replied that was unaware of any side effects in this pt;
Woke on morning of 09/29/2018 with right arm pain, swelling, redness and warmth to skin. Also had body aches, fever and chills. Symptoms improved at time of report, but slight redness, swelling and warmth noted to right arm.
Vaccine administered 9/16, pt came back into pharmacy 9/29. Pt presented with a raised red area at injection site. Pt stated it felt like it was full of fluid the previous night. Rph contact pts PCP and agreed it was an injection site reaction. No treatment necessary.
Large bald spot on head by hairline appeared, hair has not regrown, diagnosed as Alopecia. Generalised urticaria when cold outside, perioral dermatitis, dermatitis on arm that comes and goes, burning sensation on lips when eating eggs. The alopecia and dermatitis we noticed after about a month. The urticaria we noticed in the early winter when the cold weather came, maybe November 2016. All these symptoms have been diagnosed by a dermatologist February 15, 2017.  Dr Dermatology, Dr said there are few treatments for these conditions/autoimmune disorders.
Experienced swelling at the injection site; experienced redness at the injection site; experienced tenderness, and pain at the injection site; Her arm was very tense; Felt itchy; itchy at the site; A large red hive appeared; discomfort; This is a spontaneous report from a contactable consumer (patient's husband).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose (dose 1, arm) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient is a physician who received the shot at work. Reporter stated patient had a localized reaction to the COVID-19 Vaccine. On the first day after receiving the vaccine, she experienced swelling, redness, tenderness, and pain at the injection site for 24 to 48 hours, and her arm was very tense. After 3 days, the discomfort disappeared but her arm was still tight. 8 days after the injection patient felt itchy and itchy at the site and a large red hive appeared, the injection site was again tender and swollen, the next day the hive was gone but patient's arm was still tight and swollen at the site of the injection. 13 days after the vaccination she returned to normal. Reporter wanted to know if the only contraindication to not receiving the second dose of the vaccine is if someone experienced anaphylaxis after the first dose.  Information on the Batch/Lot number has been requested.
One day after vaccination, patient had a localized reaction about one inch below injection site. The site was red, slightly raised and tender to the touch.
almost immed p/inject in anterior thigh, site became erythematous, then swelling of the foot to the point of almost cyanotic; resolved w/in 2 hrs w/o treatment;
Injection site pain Tiredness Headache Muscle pain Chills Joint pain Fever Nausea Feeling unwell
J96.00 ACUTE RESPIRATORY FAILURE 1/12/2022 OPEN WOUND OF RIGHT LOWER LEG, INIT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/6/2022 OPEN WOUND OF RIGHT LOWER LEG, INIT J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/20/2022 OPEN WOUND OF RIGHT LOWER LEG, INIT J96.00 ACUTE RESPIRATORY FAILURE 1/12/2022 ACUTE RENAL FAILURE, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/6/2022 ACUTE RENAL FAILURE, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/20/2022 ACUTE RENAL FAILURE, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 1/12/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/6/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/20/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 1/12/2022 SECONDARY HYPERPARATHYROIDISM, RENAL ORIGIN J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/6/2022 SECONDARY HYPERPARATHYROIDISM, RENAL ORIGIN J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/20/2022 SECONDARY HYPERPARATHYROIDISM, RENAL ORIGIN
Patient inadvertently received vaccine after published expiration date.  MOderna Company analyzed vaccine and advised lot 007B21A maintained activity needed to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
She broke out in a rash that appears as if to be chicken pox. Blistering and pruritic. This occurred despite verifying previous infection with a titer.
Dizziness, Redness in face, Intense pain in back muscles, Shortness of breath with immediate onset.  Patient requested to lay on floor, Epi-pen was administered with patients approval. 911 was called.  Epi-pen worked well and patient was complaining of less back pain and shortness of breath.  Patient was released to go home.
Information has been received from a physician concerning a female who on 30, Jan 2007, was vaccinated with GARDASIL. Subsequently, the patient developed a large lump on her neck and swelling to her thigh at injection site after immunization with GARDASIL. Unspecified medical attention was sought. As of 03, Mar 2007, the patient's large lump on her neck and swelling to her thigh at injection site persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007.  Initial and follow up information has been received from a physician, concerning a 37 year old female patient, who at 1:30pm on 01-FEB-2007 (previously reported as 30-JAN-2007) was vaccinated in the left deltoid (previously reported as the thigh) with the second dose of GARDASIL vaccine (Lot #655617/1447F). On approximately 01-MAR-2007 ("onset at one month"), the patient developed a large lump on her neck and complained of pain in her neck and left arm (previously reported as swelling on the thigh). On 06-MAR-2007, the patient revisited the office, still complaining of pain, and was diagnosed with neck and left arm pain. The physician confirmed that the patient had recovered from the events on 10-MAR-2007. No further information is expected.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 1, single (Lot number: FL0007), in left arm and on 07Jan2022 as dose 2, single (Batch/Lot number: unknown) at the age of 11 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Bactrum, reaction(s): "Known allergies: Bactrum", notes: Known allergies: Bactrum. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 15May2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: COVID test type post vaccination: Nasal Swab; (17May2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of covid-19, vaccination failure. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Children's multivitamin, unsure of anything else. On 17May2022, tested positive for COVID-19 on 2 different home tests. Sore throat first began on the evening on Sunday, 15May2022. On Monday, 16May2022 he didn't go to school due to feeling under the weather (sore throat and nasal congestion). Treatment received for the adverse event was cold medicine so far ongoing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
inadvertently received two doses of Menactra; patient inadvertently received two doses of Menactra who was supposed to receive MMR vaccine not Menactra on 29-May-2019; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 55 years old male patient who experienced inadvertently received two doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site on 22-May-2019 and 29-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to extra dose administered and wrong vaccine administered. It was reported that the patient inadvertently received two doses of Menactra who was supposed to receive MMR vaccine not Menactra on 29-May-2019.  It was not reported whether the patient had any adverse event or not.  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 and Module VI of the 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.  Information on batch number was requested.  List of documents held by sender: none.
Lethargy, Exhaustion, Inability to Walk, Heart Attack and Death from Acute Cardiac Arrest