chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; COVID-19, Pneumonia in Left Lung Then Entered Right; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4327066-00 (AbbVie).  A 64-year-old male patient received BNT162b2, on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), on 18May2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Feb2022, outcome "recovered" (2022) and all described as "COVID-19"; COVID-19 PNEUMONIA (medically significant) with onset 14Feb2022, outcome "recovered" (2022), described as "COVID-19, Pneumonia in Left Lung Then Entered Right". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2022) Positive. The action taken for adalimumab was unknown. Clinical course: Solicited report from the RA by a consumer of a 64-year-old male with events of non-serious COVID-19, Pneumonia in Left Lung Then Entered Right and Pain/Still Hurt Everywhere with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced pain/still hurt everywhere. In 2021, the patient experienced COVID-19. On 14Feb2022, the patient experienced COVID-19 and pneumonia in left lung then entered right. In 2022, the COVID-19 and pneumonia in left lung then entered right resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 26Apr2022, received updates to event information, reporter opinion of causality, concomitant drug information and narrative description. On 29Jun2022, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. "Pain/Still Hurt Everywhere" was added. The reporter's causality for the event(s) of COVID-19 onset 14Feb2022 and Pneumonia in Left Lung Then Entered Right with Humira (Adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of "covid-19" and "covid-19, pneumonia in left lung then entered right" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Patient experienced pain on injection site for four days, myalgia and shivering 2 days after injection was given.
Patient called pharmacy describing tender red arm and fever of about 101. stated she generally wasn't feeling well. Instructed patient to take some ibuprofen or acetaminophen for the fever and to continue to monitor the injection site.
Reddened, hot, swollen area around injection site about 4 x 4 in size.
Inadvertently gave a 3rd dose of Varicella Vacc. Thought pt had only received 1 dose, but he had received 2. No adverse reaction occurred.
Leg she had a small itchy rash which has since spread to her arms, torso and both legs; Swelling; Skin was tender; Skin allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Leg she had a small itchy rash which has since spread to her arms, torso and both legs), SWELLING (Swelling), PAIN OF SKIN (Skin was tender) and HYPERSENSITIVITY (Skin allergic reaction) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced RASH PRURITIC (Leg she had a small itchy rash which has since spread to her arms, torso and both legs), SWELLING (Swelling), PAIN OF SKIN (Skin was tender) and HYPERSENSITIVITY (Skin allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Leg she had a small itchy rash which has since spread to her arms, torso and both legs) and PAIN OF SKIN (Skin was tender) had not resolved and SWELLING (Swelling) and HYPERSENSITIVITY (Skin allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was mentioned.
HPI: patient is a 30 y.o. female with various medical conditions and various allergies who presents to the emergency department secondary to an allergic reaction following her first COVID-19 vaccination.   This morning patient went to have her first Moderna COVID-19 vaccination.  She was accidentally given and 3 mL instead of 0.5 mL of this vaccine.  She was monitored following administration of this vaccine.  Patient apparently did well and she went home.  Then around 1030 she started having diffuse body itching and felt that her throat was tight.  She has an epinephrine pen at home and administer this medication to herself over concerns of potential anaphylaxis.  She contacted EMS who transported her to the ER.  EMS gave her 25 mg of Benadryl in route.   On arrival patient reports that she still feels itchy but she is no longer having any tightness in her throat.  She reports that she is feeling better.   Patient denies any lip swelling, tongue swelling, throat tightness, difficulty breathing, difficulty swallowing, and other related symptoms not mentioned above.
Mother and patient report pain, swelling at injection site, hives all over body with HPV #1 and #2. Also bruising 2x2 inches with #1 and #2. #3 not given.
Patient started having unilateral shoulder pain 2 weeks following dose 1 of Pfizer injection, then progressed to bilateral hip pain. Received 2nd dose and the following day had severe pain in arm, extensive lymphadenopathy. Pain in shoulders and hips increased, having difficulty with bending and ambulating, sciatic pain, cannot lift left arm at all at this time, difficulty sleeping due to pain and increased heartrate at night. Suspect development of autoimmune reaction post vaccination. Encapsulated shoulder requiring surgical intervention.
Moderna vaccine was administered outside of facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------ ACUTE PULMONARY EMBOLISM 8/3/2021 SICKLE CELL ANEMIA
About a month after my Pfizer booster shot on December 13, 2021, I woke up severe pain one morning.  It was excruciating pain, overwhelming pain in the back legs to the knee. neck and shoulders and arms to elbow had the same pain.  Also, there was overwhelming tiredness.  We were in another state for the winter and did not know what doctor to go to because we have our doctors.  I talked to pharmacists to get more over the counter meds.  We arrived home on April 12 still undiagnosed.  I researched my symptoms and came up with Polymyalgia Rheumatic.  I had a doctor appointment on April 21.  After examination, Dr arrived at my conclusion.  He put me on 15 mg of prednisone.  That is the only med that helps with this disease.  It is only after hearing and reading about other people getting PMR from vaccines and boosters that I have concluded that the booster caused/triggered PMR in my case.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On an unkonwn date the patient was vaccinated with M-M-R II injection, dose 1 and dose (dose, route and lot # unspecified). No concomitant medications were reported. On an unknown date the patient experienced seroconversion test negative. Pharmacist confirms after two doses of M-M-R II, the patient, in the military, failed to seroconvert to mumps and rubella. Antibody blood test was drawn, unspecified when. No adverse effects reported. Pharmacist states she does not have any other information since patient was vaccinated elsewhere. The outcome of seroconversion test negative was unknown. Causality assessment was not reported. Additional information is not expected. Pharmacist does not want to be contacted about this report.
Went to ER based on advice with on-call nurse. Urine was red. With one kidney and having the Muir-Torre syndrome, this was a reason to panic. Life without a working kidney could be very difficult.
pt recvd vax &  devel generalized rash; t inc; pt had febrile sz 20jul94; went to hosp; released /p T stabilized; sz activity ceased;
Cellulitis of left upper arm in shich TDAP was given.  Some pus was drained.  Chills, nausea.  Treatment:  clindamycin and heparin injection and vancomycin IV overnight.
On March 12th 2021, I received my first Moderna vaccine for COVID-19. The morning of March 18th, I woke up with a hoarse voice. I went to an ear, nose and throat doctor on April 20th, since the hoarseness did not go away. I had a flexible laryngoscopy that day. He determined I have a paralyzed left vocal cord.
The very next day I had menstrual spotting but it was gone the next day as if it was never there. I talked to my doctor and they said that this was happening to a lot people that it was not just me that was going through this.
Horrible flu; This spontaneous case retrieved on 24-Nov-2020 from Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 885811-1), reported by other non-health professional (consumer) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for prophylaxis. The batch number was not reported.  On an unknown date, less than a year after receiving influenza virus vaccine polyvalent, the patient got a horrible flu.  The outcome of the event was unknown.  The reporter did not provide a causality assessment influenza virus vaccine polyvalent.  The event of 'flu' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment:The patient developed influenza unknown amount of time after receiving the suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Due to lack of information regarding temporal relationship, causal relationship is assessed as unassessable.; Sender's Comments: The patient developed influenza unknown amount of time after receiving the suspect product, influenza virus vaccine polyvalent. Chronology is unclear. The patient's medical history and concomitant medications were not reported. Due to lack of information regarding temporal relationship, causal relationship is assessed as unassessable.
Myalgia, Fever, inj site sore and inflammed, fatigue, unable to focus, irritable Narrative:
Patient sent message to her Provider that she had 3 days with joint pain, swelling lips  skin rash after the vaccine administration.
Wheezing; Shortness of breath,She cannot walk much without getting shortness of breath; Dizziness; Asthma got worse; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), DYSPNOEA (Shortness of breath,She cannot walk much without getting shortness of breath), DIZZINESS (Dizziness) and ASTHMA (Asthma got worse) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WHEEZING (Wheezing), DYSPNOEA (Shortness of breath,She cannot walk much without getting shortness of breath), DIZZINESS (Dizziness) and ASTHMA (Asthma got worse). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, WHEEZING (Wheezing), DYSPNOEA (Shortness of breath,She cannot walk much without getting shortness of breath), DIZZINESS (Dizziness) and ASTHMA (Asthma got worse) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up document received and patient email details had been updated. Nonsignificant information
Patient had chief complaint of red eye right after receiving the vaccine and it lasted for a couple of days afterwards.
Pt developed erythema and swelling at the injection site. When seen 3 days after the immunization there was a reticular pink rash on arm and shoulder and significant arm edema.
Rash. Received COVID-19 vaccine X 2 and then Shingrex X 1 on 6/23/2021.  Surgical pathology report of 9/9/2021 was consistent with lichen planus, an autoimmune disorder of unknown etiology. Treatment is Betamethasone Dipropionate Cream, USP, 0.05%. Rash has no subsided; this is second month.
Received Janssen vaccine on 4/27/21 COVID-19 positive by PCR on  1/10/22 admitted to hospital on 1/10/22 d/t generalized weakness, falls; found to be COVID positive on admit.
Typical side effect of very sore arm occurred 6 hours post-injection. Four hours later (10 p.m.) I spiked a fever of 102.5 and started having violent chills. I alternated Tylonol and Ibuprofen every six hours but the high fever lasted for 72 straight hours.  I could not get our of bed until the fourth day when I woke up with no fever (my clothes and bed were dripping wet).   Two weeks later I contracted a non-COVID respiratory infection that I could not seem to get rid of. Over the course of four weeks I took two antibiotics  and a steroid course and I eventually recovered by the end of March. I was tested twice for COVID during that time The results were negative both times.
Allergic rxn to vax, Rt arm was tender, sore & inflammed in several areas, T 97.6, symptoms lasted 1 wk.
46 individuals were given a dose of the Moderna vaccine, 9 days post the recommended storage of 30 days in the refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (46 individuals were given a dose of the Moderna vaccine, 9 days post the recommended storage of 30 days in the refrigerator) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) 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 PRODUCT STORAGE ERROR (46 individuals were given a dose of the Moderna vaccine, 9 days post the recommended storage of 30 days in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (46 individuals were given a dose of the Moderna vaccine, 9 days post the recommended storage of 30 days in the refrigerator) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Patient report breaking out in a rash.  Very itchy, very painful, large red blotchy area on her right trunk. This occured a few days after the vaccine. It became drier and then flared up again.  Came to see Dr. on 6/23/2020. Dr. recommended report adverse reaction. Started patient on an anti viral med valtrex.
Site pain remains sending pain to shoulder and neck. Pain was 7 on a scale of 1-10; Site pain remains sending pain to shoulder and neck. Pain was 7 on a scale of 1-10; Site pain remains sending pain to shoulder and neck. Pain was 7 on a scale of 1-10; Neck movements limited in Turing to left; This is a spontaneous report from a contactable consumer (patient himself). A 54-years-old male patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207; Expiration Date: unknown, at age of vaccination 54 years) via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:45 as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus. Patient was allergic to dye. Concomitant medication included dulaglutide (TRULICITY) taken for an unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 the patient experienced site pain remains sending pain to shoulder and neck. pain was 7 on a scale of 1-10, neck movements limited in turning to left. Therapeutic measures were taken as a result of adverse events as patient received Motrin, Tylenol and Aleve. Motrin or Tylenol nor Aleve work to alleviate pain. Since the vaccination, the patient was not tested for COVID-19. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected
Information has been received from an RN concerning a 5 year old female with no known allergies and who recently has a physical for special education on 8/28/01 was vaccinated with a dose of MMRII. Concomitant therapy included multi-vitamins and supplements. On 8/29/01, the pt's mother reported that her "child broke out in rash on her chest". There were no other symptoms reported (no fever, no cough, no lethargy and no swelling). The pt sought unspecified medical attention. Follow-up information from the reporter stated that the adverse event was unlikely vaccine related. The reporter spoke with the mother again and the child was improving. It was reported that the pt recovered. No further information in expected.
Whole side hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole side hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Whole side hurts). At the time of the report, PAIN (Whole side hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
"Huge Massive" bumps on legs below both knees-3 on left side, 2 on right side, hard to walk. Pt had treatment at a hospital-not student health. Bumps still present. Dx "erythema nodosum."
Large dark spots (2x1in, and 1x1in) similar to bruising but no tenderness to touch. Tiny abrasion on smaller bruise.
This literature marketed report has been received from authors of a published article, referring to 23 adolescent patients of unknown gender. The patients' medical history, concurrent condition and concomitant therapy were unknown. The purpose of this longitudinal study was to identify individual and interpersonal factors associated with human papillomavirus (HPV) vaccine series completion in a sample of low-income adolescent girls and boys. On an unknown date patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose, frequency, route, batch/lot number and expiration date were not provided) for prophylaxis (product origin unknown). Within 1 year of initiation, the patients received only the initial dose or two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). On an unknown date, patients experienced side effects of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). The outcome of the event was unknown. The event was considered to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown). Findings highlight important opportunities for improving completion of the HPV vaccine series among adolescents. Intervention efforts should involve health care providers and parent-adolescent dyads and prioritize evidence-based strategies for reducing missed opportunities for series completion. This is one of three reports regarding the same literature (linked case# 1903USA008996 and 1903USA008997). Sender's Comments: US-009507513-1903USA008996: US-009507513-1903USA008997.
On 12/09/2000 the patient developed chicken pox with approximately 12 pox. On 12/14/2000 the patient developed a cough. The patient was seen in the office with a cough, pharyngitis and viral syndrome. Subsequently, the patient recovered. Additional information has been requested.
I got itchy throat, dry cough, swollen lymph nodes. Lasted about 5 days and is now just a cough and congestion
Pt recvd vax & exp local tenderness & swelling @ the site; The same day as vax exp tingling arm, malaise lymphaddenopathy  & insomnia which resolved p/3 days;