chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2023) Positive; (11Aug2023) Negative; (13Aug2023) Positive; (14Aug2023) Positive; (15Aug2023) Positive; (16Aug2023) Positive; (17Aug2023) Positive; (18Aug2023) Positive; (19Aug2023) Positive; (20Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 03Aug2023 to 08Aug2023.  Clinical course: Tested positive for Covid on 03Aug. Started taking Paxlovid the same day. Got a negative test result on 11Aug23. Got a scratchy throat the following day and tested positive again on 13Aug. Tested positive for a full 7 more days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Paralyzed face; Felt like something was poking face; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced kind of a paralyzed face/ facial paralysis and like something was poking the face/ facial discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date, prior to the onset of the events, the patient received his dose of mRNA-1273(Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, patient experienced a paralyzed face and like something was poking the face. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, kind of a paralyzed face and like something was poking the face was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient stated that he felt "faint", a "head rush", nauseous, and dizzy immediately after his vaccination. No shortness of breath, itching, or swelling of throat or face. Vitals signs stable. Symptoms consistent with vasovagal response. Symptoms resolved after about an hour.
On the next day of the vaccine on 1/5/2021 I had sore arm, mental fog, a little bit of chills, & a rash on the injection site. The rash started 1 week later after the vaccine it was about 2in diameter it lasted about 2 weeks. Mental fog lasted for about  weeks & the chills only a couple of days. I did see my doctor on 1/14/2021 she recommended me to use a steroid cream.
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021.  Based on the information learned, Health took the following steps: ? Contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information:  o ?The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  ? Contacted a county medical director and based on this information from Moderna, no re-vaccination is needed.
Runny nose; Burning sensation on my throat; Cold; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0177), via an unspecified route of administration on 18May2021 as 2ND DOSE, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On May2021 the patient experienced runny nose, burning sensation on my throat and cold. The outcome of event was unknown. Follow-up activities closed. No further information is expected.
About 4 hours after receiving my first shot my hands and feet started tingling.  It then progressed to feelings of needles sticking my hands and feet.  The next day if felt better so I thought nothing of it.  But by the day following my hands were beginning to tingle again and my toes felt tingly/numb when I would walk.  I finally decided to contact my doctor's office. They suggested I come in to see my Doctor.  My doctor said they have been seeing this at times.  She suggested I double up on my Zyrtec and start taking B complex.  She said it my take a few weeks to subside.  Luckily by day seven all tingling and needle pricking sensation was gone.  She told me I should still get my 2nd shot, which I will receive on April 5.  She also told me to report my reaction to the CDC.
Patient had COVID symptoms after vaccination.  Symptoms included sore throat, chills, body aches, cough, headache, loss of taste/smell, and congestion.  Positive PCR for COVID.
Expired vaccine was stored in refrigerator on 04 Apr 2022 and administered on 19-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 04 Apr 2022 and administered on 19-Apr-2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 04 Apr 2022 and administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 04 Apr 2022 and administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022. On 04-Apr-2022, the vial was initially stored in the refrigerator. Reportedly, the vial didn't undergo any temperature excursions.  No treatment information was reported.
Patient recieved a Pfizer Bivalent Booster as 1st dose in her primary series of COVID vaccination.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 12-year-old female with no pertinent medical history or allergies who on 17-MAR-1999 was vaccinated subcutaneously with one dose of Varivax (lot# 628694/1663H). There was no concomitant medication. On 10-OCT-2006 the patient broke out in a chickenpox-like rash. She was seen in the physician's office on 12-OCT-2006 and it was noted that she had scattered vesicular lesions on her face, neck, ear, trunk and extremities and also had 2 lesions in her throat. No laboratory or diagnostic tests were performed. The patient was recommended baths and oral BENADRYL. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Child passed away 10/18/06. Patient was chronically ill with pontocerebellar atrophy, had shortened life expectancy 1/11/07 Received medical records from hospital which reveal patient admitted 10/13/06 secondary to cardiopulmonary arrest.  Apparently had been in usual state of health & was riding in car w/parent when suddenly became pale with circumoral cyanosis & stopped breathing.  Parent initiated rescue breathing & called EMS who then initiated CPR, intubated & gave epi during transport to outlying hospital before transfer to this Hospital. Made DNR & expired on 10/18/06.  PMH: undefined degenerative neurologic disorder, feeding tube, salivary gland removal.  Hx of previous arrest from respiratory secretions.  Had otitis media 10 days prior to admit tx w/antibiotics.   Birth HX: Adopted.  Normal development till 9 mos of age when lost milestones.  Currently, eyes open spontaneously, non verbal, sits only with support. unable to grasp.  Joint contractures of all extremities. LABS: MRI revealed hypoxic/ischemic event to putamen/caudate (some new), cerebral atrophy & cerebellar degenerative changes.  Trach c/s grew pan susceptible pseudomonas.  Blood & urine c/s all neg.  WBC 12.8 on admit, max of 26.8 on 10/16.  CXR showed LLL density due to atelectasis & collapse. FINAL DX:  None provided. 4/6/07 Received Death Certificate which reveals COD as upper airway obstruction; hypoxic ischemic encephalopathy; cerebral atrophy; and neuromuscular disease (unspecified).
Patient was vaccinated with TDap and MENACTRA. After about 5 minutes post vaccination he felt dizzy, passed out. He recovered immediatly about 1 minute after passing out. He was dizzy for about 30 minutes and completely recovered after that.
This was my second shingrix vaccine. For both, I experienced chills, headache, fever, severe body aches, flushing of the face, dizziness, stomach upset. I am not a hypochondriac, but I can easily say this is the worst I have felt in a very long time.  I almost didn?t get the second vaccine because it was so bad the first time, but I figured I would just muscle through.
Became very fussy and inconsolable later in the day. Per parents, would cry uncontrollably and not be able to be soothed by usual methods. Sleeping patterns changed and was very drowsy the following day. Would fall asleep on one of the stairs in the house which is not her typical behavior. Also would repeat the same statements (ex: the beetle got the spider) over and over.  Did develop a fever 48 hours later which subsequently resolved. Over the weekend, was noted to have periods of alternating crying and laughing.
Site is itchy; Became so very very tired; Had chills; Had an upset stomach; No appetite at all; Right arm was sore; Booster; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the right arm on 16Oct2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and Diabetes 2. The patient had no known allergies. Concomitant medications included unspecified regular medications from unknown dates for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine (flu high dose) (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 28Sep2021 for immunization within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 73-years-old) as a single dose and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 16Oct2021, on the day of vaccination, nothing happened to the patient. On 17Oct2021, the next day of vaccination, the patient became so very very tired, had chills, had an upset stomach, had no appetite at all and also the patient's right arm was sore. That was all on 17Oct2021 (Sunday). On 18Oct2021, the patient's arm was still slightly sore but the site was itchy with no redness or swelling and the patient was still tired. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events became so very very tired, had chills, had an upset stomach, no appetite at all, right arm was sore and site was itchy was resolving at the time of the report.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. In January 2017, from 20-JAN-2017 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of with VARIVAX (anatomical route of vaccinations was not provided) for prophylaxis. Involved lot # were M025867 with expiration date on 24-MAY-2018, lot # M017292 with expiration date on 07-APR-2018, lot # M033904 with expiration date on 20-JUL-2018, lot # M025864 with expiration date on 24-MAy-2018, lot # M035141 with expiration date on 03-AUG-2018 and lot # M006157 with expiration date on 05-FEB-2018. It was reported, that, VARIVAX was exposed to a temperature excursion of >5°F but < 14°F (> -15°C but < -10°C), on a time frame of 40 minutes. It was also reported, the the vaccine was not exposed to a previous temperature excursion. Data logger was involved. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001011:
hospitalized 9/19/21, SARS-CoV-2 positive prior to admission.  Complaints of generalized weakness, myalgias, mild cough, and subjective fever and chills.  PMH morbid obesity.
Myself and my husband got the vaccine from the same vial; however, both shot caused adverse events to me. Constipation for about two weeks, nausea, extreme severe muscle and joint pains to my entire body. Muscle weakness, extremely fatigue, loss of appetite. Legs felt tired and burning nerve pain to my left leg from thigh to ankle, also on about 8 days later, the opposite hand became very painful requiring a sling. Nothing happened to my husband. The second dose gave me a temperature of 101.9 to 104.7 and extremely painful joints.
Peripheral neuropathy, paralysis from neck down. Tingling, numbness. Abscess infections. Severe pain and burning and numbness in legs and feet. IVIG treatment. Jan of 2009 to present.
then a few days later you test positive; then a few days later you test positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. 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), outcome "unknown" and all described as "then a few days later you test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nine days after vaccination, developed redness, inflammation, and itchiness at vaccine site. Only previous side effects were fatigue and soreness at vaccine site in the 24 hours after vaccination.
02/10/21 received the shot in right arm - pain at site of injection, developed headache; 02/11/21 woke up with nausea, tiredness, headache, pain in arm - symptoms continued 4 days; 02/14/21 developed itching all over body- itching lasted one day, severe joint pain in right shoulder continued 4 days; 02/18/21 mild joint pain in right shoulder, mild pain started again in right shoulder, itching and rash developed at injection site; 02/19/21 woke up in night due to pain in chest and back when breathing in, this continued through the day so contacted doctor's office was was told to go to ER to get checked, went to ER 3:30 pm - Diagnosis chest pain, unspecified, pleurisy; 02/21/21 pain in chest with breathes continues
5/07/2021 I had the shot and immediately I got dizzy when I stood up. That night I encountered fatigue, fever, muscle ache and sore throat. Fever lasted 2 days and fever lasted for 5 days. 5/10 the arm was sore and there was a 6x6? huge rash. 5/24- 5/26 I had a rash that I kept under control with Benadryl. 5/29 my saliva glands began to swell and that?s why I went to the Doctor. The Dr sent me to an ENT and Rheumatologist.
I experienced fatigue upon waking up along with frequent heart  palpitations. Heart was racing and then would come and go in fits.
Tingling and swelling of lips, upper and lower started approximately 22 mins post injection lasting approximately 90 minutes.  Pharmacist (vaccinator) notified and Benadryl 25mg taken with effect.  Primary care physician consulted by patient
The symptoms were just a scratchy throat. It lasted a day. I continued to test positive for 12 days. My doctor called in a prescription for PAXLOVID. It was primarily to keep any infection from spreading to my heart.
Received Pfizer vaccines on  1/29/21, 3/1/21, 9/16/21 COVID-19 positive by PCR on  3/16/22 admitted to hospital on 3/16/22 d/t cough w/ progressive SOB, fatigue, RUL Consolidative pulmonary process Underlying CLL, lupus Also had h/o COVID in 1/2022 treated w/ 2 courses of remdesivir and convalescent plasma.
Patient received Rotateq PO then three injections (Pediarix, HIB and Prevnar).  Within several minutes (2-4), he developed redness and swelling around his eyes; hives and wheezing.  Dr. was immediately called to examine the baby, he ordered Benadryl PO and Albuterol.  Patient was observed, symptoms resolved and he was discharged.
Within 24 hr. arm swelled like a red apple at site of vaccine. Following this I had arm and leg cramps. My legs felt all tingling - weak - this lasted for at least 6 month. Orthopedic MD said it was probably a neuritis.
Contracted Covid 19 September 4, 2021. Fever of 102.4 F. for 5 days with inflamed trachea, achy, and loss of appetite.  Felt fine after fever broke. Prescribed Medrol dose pack and albuterol inhaler. Received monoclonal antibodies on 9/11/21. Cough lasted about 3 weeks. Lost taste and smell, which returned within 2 weeks. Taste has changed with some foods.
Post vax, the patient developed a fever, fatigue, myalgia, nausea, loose stools and chills.
severe lower extremity weakness.  on 4/13/2021 experienced myalgias and generalized weakness/malaise,  which have persisted.  on 4/21/2021 the patient was able to walk using her walker however extremely slowly.  At baseline she is able to walk around the house with a walker relatively briskly.  on 4/22/2021 the patient was unable to transfer from a sitting to standing position, and was no longer able to ambulate with her walker.
refrigerator containing Fluzone went down to 29.1F. the vaccine was given to the patient inspite of being compromised / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038352, 2020SA038466, 2020SA038467, 2020SA038468, 2020SA038469, 2020SA038470, 2020SA038471, 2020SA038472, 2020SA038473, 2020SA038474,  and 2020SA038467.  This case involves a 9 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the right arm for prophylactic vaccination on 15-Jan-2020, which was exposed to the temperature of 29.1F (incorrect product storage).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient inspite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
given only the liquid componen; given only the liquid componen; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA731A, expiry date 30th September 2023) for prophylaxis.   On 21st September 2022, the patient received Menveo. On 21st September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's comment: The reporter asked if a patient was given only the liquid component of Menveo, how long did they need to wait to administer this vaccine correctly. HCP (Health Care Professional) declined to provide initials. The reporter consented to follow-up via postal. Additional Supportive Information: The patient was given only the liquid component of Menveo, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Flu-Like Symptoms, Muscle Aches, Earaches in both ears, not ringing, but earaches for two days.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # N003536 with expiration date of 02-NOV-2019 (doses and route of administration were not reported). On 04-AUG-2017, the administered doses of vaccine underwent a temperature excursion of 48.79 degrees Fahrenheit for 38 minutes which was detected by a digital data logger. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005778: US-009507513-1708USA005890: US-009507513-1708USA005827.
pt recv vax 3AUG98 & 9AUG98 pt exp inj site redness & tenderness;the following day pt presented w/fever of 101;11AUG98 pt treated w/Cefadroxil;a/ cefadroxil pt devel an itchy rash on arms & legs;