chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL0140), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL0140), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: Jun2014. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. The patient received Paxlovid as treatment of COVID-19 as other medication in 2weeks. The treatment start date was reported as 15May2022 and stop date was 20May2022. The patient also took Sertraline as Antidepressant as other medication in 2weeks product.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Pt. reported tingling in hand, lasting 2-3 days. Then he noted painful swelling in index & middle finger on 11/1 that persists.
During post vaccination observation period  c/o lightheadedness and "tingling flushed sensation" BP 165/79. Transported to ED, vital signs and lab work within normal limits. Symptoms had resolved by the time she arrived in ED, discharged to home
Pain in Left shoulder severe at first and tapering but still present at 3 weeks post dose.
Fatigue, chills, slight fever, loss of appetite, redness heat and swelling at injection site
Tinnitus  in both ears which had not been present before shot.  The noise has continued unabated for 11 days.
pt recvd vax; chest tightness, chills & fever lasted 24 hrs; very sore arm for 203 days;
arthralgia, myalgias, fatigue, dyspnea, arm (local site) swelling, itching, redness, nausea, fever
Did not receive the full dose; Vaccine leaked on arm; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive the full dose and vaccine leaked on arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot #025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Dec 2020, during vaccine administration, the pharmacist reported that the vaccine leaked on the patient's arm and that the patient did not receive the full dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The events, did not receive the full dose and vaccine leaked on arm, were considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient of unreported age and sex. The subject medical history is not provided. The patient experienced an unexpected event of not receiving the full dose and vaccine leaked on arm.  The event occurred on 23 Dec 2020 during administration of the first dose of the  mRNA-1273 (Lot #025J20-2A). The event is considered not related to mRNA-1273.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/5/2021 and 3/25/2021. Presented to ED on 1/17/2022 with SOB x3 days. Diagnosed with Covid19 PNA. D/c'd 1/26/2022. Presented back to ED 1/28/2022 from dialysis center with report of hypoxia. Admitted for sepsis with acute hypoxemic resp failure without septic shock, acute metabolic encephalopathy and Covid19.  Blood cultures: 2 of 2 bottles positive for cryptococcus neoformans and started on fluconazole. Coded on 2/2/2022 and expired.
Headache, soreness at injection site, extreme muscle aches and fatigue lasting from 12/25 to 12/30.
This spontaneous report has been received from a pharmacist via company representative referring to a three patients of unknown age and gender. Information regarding the patients' concurrent conditions, medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with PNEUMOVAX 23,(strength, dose, dose number, frequency, lot#, expiration date, and route of administration were unknown by the reporter) for pneumonia prevention. On an unknown date, the patients experienced a "swollen arm" around the injection site area (Injection site swelling) and the patients were hospitalized for unknown duration and at unknown hospitals. It was unknown by the reporter if the patients received treatment, laboratory diagnostics studies were performed and if the patients sought medical attention. A product quality complaint was not involved. At the time of reporting the outcome of the injection site swelling was unknown. The relatedness between the injection site swelling and PNEUMOVAX 23 was not provided. This is one of two cases from received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA004315.
After I received the vaccine exp nausea at 2:30 pm continued to 1 am. The following day I continued nausea and took Zofran. On 12/17 I left work due to nausea and around evening nausea stopped.
Initially after first dose I had only sore arm, two days later I was awaken with loud ringing in my ears.
Painful tongue issues; This is a spontaneous case, reported by other non-health professional (consumer) to Agency [reference number: SEQ19-06050] and initially received on 01-Nov-2019, concerning a 63-year-old, female patient.  The patient's relevant medical history included Crohn's disease, gluten intolerance, non-specific arthritis, sleep apnoea, acid reflux, breast cancer, diverticulosis, diverticulitis, polyps in colon (precancerous) and allergic rhinitis-seasonal. The patient's concomitant medications included Aprisi (as reported), Nexium (esomeprazole magnesium), duloxetine, vitamin D chewable, Vitamin B (vitamin B complex) liquid sublingual, Nasicortin nasal spray (dexamethasone tebutate, oxymetazoline hydrochloride), amitriptiline, Tylenol (paracetamol) and hydrocodone.  On 25-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiration date: not reported] for influenza prophylaxis.  On 26-Oct-2019, one day after vaccination, the patient experienced painful tongue issues. The patient stated that the sore was kind a white and painful when she was eating, and it started to progress. The patient was treated with Tylenol (paracetamol) and Paradox mouthwash. The patient stopped using vitamin B complex and chewable vitamin D and brushed her tongue which seemed to help.  At the time of initial reporting, the patient had not recovered from the event.  The case was assessed as non-serious.  The reporter did not provide causality assessment.  Non-significant follow up received from Agency [reference number: SEQ19-06742] on 12-Dec-2019: Additional reference number added. No changes in narrative.  Company comment: The patient experienced glossodynia one day after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. Medical history of Crohn's disease, acid reflux and allergic rhinitis may provide more plausible alternative aetiology for the event. Causality was also confounded by therapy with multiple concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as unlikely related.; Sender's Comments: The patient experienced glossodynia one day after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. Medical history of Crohn's disease, acid reflux and allergic rhinitis may provide more plausible alternative aetiology for the event. Causality was also confounded by therapy with multiple concomitant medications. Considering all the above mentioned, causality between suspect product and the events is assessed as unlikely related.
Spouse described patient having muscle pain and tightness radiating from the arm into the right side of the neck. Patient visited ER on 12/20 and was prescribed Naproxen 500mg and baclofen 10mg.
I received my second Moderna vaccine on 3/8/21. On 3/10/21 I started spotting (bleeding: a menstrual period). This was 12 days ahead of my normal cycle. Today, 3/15/21 I am still experiencing mensuration bleeding. The blood is mostly brown, but also red, and has small clots. It comes and goes throughout the day unlike my normal period.
On Wednesday I started with some sore. On Friday it increased with Tightness, numbness, tenderness some pain, knobs coming from shoulder to where they injection was done a week after shot. Today morning it?s a lot worst. My doctors office is close this Saturday.
Information has been received from a foreign Health Authority (Ref no: IMB 038170) concerning a 5 year old female who on 19-SEP-2007 was vaccinated with MMR, route, site, batch number not reported. Concomitant vaccination on 19-SEP-2007 included TETRAVAC, route, site and batch number not reported. There was no concomitant therapy. On 19-SEP-2007, the same day as the vaccination, the patient experienced a tonic-clonic fit, syncope and vomiting. The events lasted for six minutes. The patient received treatment with unspecified first aid and the next day telephone advice. Subsequently the patient recovered from tonic-clonic convulsion, syncope and vomiting without sequellae. Both the reporter and the agency considered this to be a serious reaction due to other important medical event. Other business partner numbers include E2007-06794. No further information is available.
Before giving vaccine answered questions regarding vaccines,  Mom and patient agreed to be monitored for 15 minutes after administration of vaccine and VIS was given to patient.  Gave vaccine and mom stayed with patient in the room.  Timer started and immunization documented. Ten minutes after giving vaccine Mother of patient- came out of room and asked for water.   MA  immediately got water and when giving water to mother , mom reported that the patient had fainted backwards on the exam table but immediately came to.   MA went into exam with mom and laid patient down on the exam table.  Other MA  retrieved  ice pack and nurse.  MA stayed in room with patient and mom until nurse came into room. Nurse stayed in room with patient to continue monitoring. Patient rest in exam room for 15 minutes and then she sat up and stayed for another 5 minutes. Patient was alert and oriented during the entire monitoring time.  No injury to patient. Provider notified of event and nurse rechecked/monitored  patient. Patient observed and symptoms completely resolved. Able to walk out office on own will. Mother and patient made aware to call if any further concerns. Flag added to chart that patient should be monitored after any vaccine or blood draw..
Pt seen at ER on 01/22/04 for fever, crying.  Uncertain whether it was "required" or not.  Mom called at 2 month old daughter who received 2 month immunizations on 01/21/04.  Yesterday pt had 102F greater then 3 hours of inconsolable crying, high pitched cry (+) vomiting.  Pt taken to ER and given Tylenol for fever.  Pt improved today appetite good, (-) vomiting, temperature 100F.  Sleeping increased but mom particularly concerned that pt clenching fists and holding them to sides of face.  RN suggested that was simply a return to fetal position d/t discomfort.  Recommendation Tylenol for fever and comfort, continue to watch closely call with any further questions.  Next time we can space out immunizations to try to prevent similar response.
given an expired Dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 25th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called and informed that, on 25th February 2022, the patient was given an expired dose of Twinrix. No details from patient available. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
unexpected reaction; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient had unexpected reaction after receiving Shingrix vaccine. The reporter did not consent to follow up. The medical assistant denied she was reporting any adverse event, and refused to provide further details regarding patient, product or event. This case linked with US2019170906, reported by same reporter.
Patient received first dose of covid vaccine on 2/26/21 with Pfizer manufacturer.  At visit for second dose on 3/22/2021 patient received Moderna manufacturer as her second dose in error. No adverse reaction was reported from the vaccine, only reporting incorrect manufacturer received.
Left arm was sore and ached evening of 10/31/05. Morning of 11/01, left triceps red, sore for about 1 week.
This spontaneous report as received from a physician refers to a 6 months old patient. On 05-MAY-2014 the patient was inadvertently vaccinated with  GARDASIL (lot# not reported), 0.5 ml, intramuscularly. No adverse effect reported. Additional information has been requested.
Big, round red spot at the site of injection and its still there after 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Big, round red spot at the site of injection and its still there after 3 weeks) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big, round red spot at the site of injection and its still there after 3 weeks). At the time of the report, VACCINATION SITE ERYTHEMA (Big, round red spot at the site of injection and its still there after 3 weeks) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Mom reports child woke up with red spots the morning of 02-20-2018. Reports child has a few red spots on her forehead, around her neck, back and tummy area. Mom reports red spots ranging in size from the tip of a pen to a pencil eraser. Spots are raised, not fluid filled. Denies child scratching at these areas. Mom reports on 02-17-2018 child ran a low grad fever of 99.0 F and was winy all day. Reports child is eating good, having good wet diapers, regular bowel movements and sleeping normally. Mom reports child is also teething, giving TYLENOL as needed.
Is it common to run a fever of 100 after the second vaccine shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Is it common to run a fever of 100 after the second vaccine shot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Is it common to run a fever of 100 after the second vaccine shot). At the time of the report, PYREXIA (Is it common to run a fever of 100 after the second vaccine shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) fever of 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.   Reporter did not allow further contact
Admitted to hospital with positive COVID PCR 8/31/22.  Has received 3 doses of vaccine.
Subsequent to receiving one dose of varicella virus vaccine live the pt presented to the physicians office with a fever of 103F and approximately 50 lesions and was diagnosed with chickenpox.
Feb 20, 2021 = 24 hours post-vaccine left deltoid presented 6 inch diameter slightly inflamed patchy area. Feb 27, 2021 = 8 days post-vaccine front of both thighs and back of both legs (mid-calf to mid-thigh) presented an inflamed red, itchy, swollen rash. Mar 01, 2021 = 10 days post-vaccine Primary Care Physician diagnosed the likelihood of the rash being a delayed reaction to the Moderna vaccine. PCP recommended and I'm following her advice to: 1) apply hydrocortisone 1% creme 3 times daily 2) take Xyzal 5mg daily 3) take Benadryl 25mg at bedtime
My dad had the first shot of the covid vaccine and less then 24 hours later he went into cardiac arrest. He spent 10 days in ICU and we had to remove him from life support and he survived another 6 days suffering until he past in April 3rd
Right after I received dose 4, I felt soreness on my arm. That night I had chills and aching in my whole body. The next day I had the same symptoms and had a low-grade fever of about 99. In August 2022 I felt tingling and numbness in my right hand. I gradually started feeling pain in my elbows and then both hands. I now have joint pain in my knees. I noticed I had a rash in mid-September 2022. The rash is on my thigh, back of leg, lower abdomen, my neck, and my ear. The rash is bumpy, red and it itches. I met with a doctor, and she ran a couple of tests to eliminate arthritis. I was diagnosed neuropathy.
Client received first HPV9 on 6/18/21. On 7/10/21, patient described soreness, redness, mild fatigue, and swelling at the vaccine site. The pain "peaked on 7/14." Patient also reported small hard lump at the vaccine site. Patient received second Pfizer vaccine in the same arm on 5/3/2021.
Discomfort at site few hours after rcv'd vax. Headaches, started several hrs later. 5 days later had nausea.
within 15 minutes of receiving the vaccine patient reports nausea, dizziness and stated her tongue "felt weird"
Subsequent to receiving first and second doses of varicella virus vaccine live, the pts laboratory evaluation revealed a lack of response (0.24) for varicella antibody test.
3 days after vaccines developed hyprexia. Went to local ER. Test unk 1 pos meng. 1 - meng. Air vac to hospital. Discharge summary states fever, hyponatremia, bronchiolitis, dehydration.
No additional AE reported; An expired dose of M-M-R-II was administered to the patient; This spontaneous report was received from a physician concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 19-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter, for prophylaxis (lot number S025155, has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 13-AUG-2021) (strength, route of administration and anatomical location were not provided).   No adverse event reported.
03/28/2022 case experienced severe abdominal pain, was taken to ER and had surgery for appendicitis.
Headache, Myalgia, tired, weak, could not look at her computer, pain at the injection site Narrative:  Did not feel that needs to see the doctor today. Could not look at her computer at work. Left work today, felt the need to lay down and rest.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with a dose of improperly stored PEDVAXHIB (dose and route unknown, lot # M025193, expiration date: 21-MAR-2019; lot # L009649 expiration date: 29-NOV-2017). The vaccines were exposed to high temperature excursion of 47 degrees Fahrenheit for 30 minutes and low temperature excursion of 35 degrees Fahrenheit for 8 hours (7 cycles). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had a rash on face, arm, lips swollen, tired, body aches and back aches with fever, flu-like symptoms, brain fog and loss of weight.
Woke up in the night with a horrific headache; A spontaneous report was received from a nurse, concerning a 61-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced horrific headaches and currently in bed.  The patient's medical history was not provided. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A, expiry: 5-JAN-2021) intramuscularly in the left arm (deltoid) for prophylaxis of COVID-19 infection.   On the night of 05 Jan 2021, the patient experienced horrific headaches which she described as someone squeezing her head. The patient also reported that she's currently in bed. No treatment was administered.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, horrific headaches and currently in bed was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
COVID-19 symptoms started on 06/10/2022; tested positive on 06/11/2022 but the official date I was diagnosed, since I was on a cruise ship, was on 06/13/2022. Symptoms started with common sinus conditions like runny nose and stuffy nose and then ear blockage and congestion. Eventually I had sore throat and that went into chest from coughing. Symptoms lasted until the 13th or 14th because I was put on a drug treatment and was negative on the 17th, 5 days probably from first onset. Medication was Molnupiravir. I have lingering effects which include a productive cough, fatigue, and sometimes shortness of breath upon exertion but other than that I'm good and get tired easily.
Hives on both arms within 5 minutes. Resolved with BENADRYL.