chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 at 12:00 as dose 1, single (Lot number: EL9267), in left arm, on 08Mar2021 at 12:00 as dose 2, single (Lot number: EN6198), in left arm and on 10Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Mar2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN, stop date: 05May2022; AMLODIPINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 14May2022 at 22:00, outcome "unknown", COVID-19 (medically significant) with onset 14May2022 at 22:00, outcome "not recovered" and all described as "COVID 19 Treatment". Rebound from paxlovid. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: I tested negative on day 6; Positive, notes: Symptoms reoccurred on day 10 and tested positive for covid on day 11. Therapeutic measures were taken as a result of vaccination failure, covid-19. Antiviral details: Product- COVID 19 Treatment, brand: paxlovid, treatment start date: 05May2022, treatment stop date: 09May2022.  No follow-up attempts are possible. No further information is expected.
Pt stated is experiencing hair loss 4 to 6weeks after 2nd vaccination. N/A other symptoms
Arrhythmia - burst of a-fib, pain in joints, weakness, chills, inability to sleep continued for 3-4 days. After consultation with cardiologist returned to normal activities over the course of the following week. Recommended not receiving second dose.
Expired vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. It was reported that some patients had reported flu like symptoms after receiving the vaccination but did not have details on that. Date the vial was initially stored in the refrigerator on 01 Dec 2021.
0911: 20 minutes post-vaccination patient reported feeling "short of breath" ,  "throat starting to swell" and "chest heaviness".  Upon assessment patient is pale, tachypneic, wheezes  noted  in bilateral upper lobes, alert and oriented x3,  No visual rash or angioedema. BP 160/100, O2 98% RA, HR 91.  Patient reported history of anaphylaxis to "allergy shot at age 17" but has since had vaccines with no reactions.  0912: 911 called for ambulance/medical transport  0915:  50 mg Benadryl administered IM left deltoid  9:20: 0.5mg Epinephrine administered IM left deltoid 9:22: patient transported via ambulance to St.Marys Healthcare Emergency Department Amsterdam NY.
Started running a T and felt very ill and weak. Arm turned red, hot, hard and painful past elbow. 1:30 AM T (102.7) taken w/ digital thermometer. I was ill for 4 days and slowly got better. I did have inflamed sinus on (L) at the time and post nasal drip. T that high unusual for me.
patient did not receive the full dose of Menquadfi/ only got 1/4 of a dose with no reported adverse event; Initial information was received on 22-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 11-year-old female patient who did not received the full dose of 0.5 ml MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]/ only got 1/4 of a dose (oral solution, lot U6935AA, expiry date 26-May-2023) via oral route for prophylactic vaccination (underdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of an actual medication error due to vaccine underdose (latency- same day).  At the time of report, no adverse event was reported.  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 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.
Around 10-11 PM child had red splotches, no fever. Mom gave BENADRYL. I talked to the mom 4/18/18 9:00 AM she says the splotches are fading, and again at 4:00 says he is better still can see the splotches. I just spoke to her she says he is much better.  This child's brother had shots at the same time but not the same shots and he had a more severe effects after his shots. The mom works at a doctors office and one of her friends is a nurse practitioner that looked at the child but did not see him as a patient. She advised mom to report his reaction to the place that gave him the shots.
Pt recvd MMR vax w/in few minutes had blotchy pink rash about 2" x 2" surrounding site; no itching; resp-WNL, lungs -clear; 23OCT91 pt doing well; blotchy rxn gone few hrs p/immun recvd; no problems;
Initial report received from a healthcare professional on 04 September 2013. A female patient, whose age, medical history and concomitant medications were not reported, had received an intramuscular dose of ADACE (lot number, dose in series and site of administration were not reported) on 04 September 2013. The patient's last menstrual period date was unknown and the expected date of delivery was reported as 20 October 2013. The patient was healthy at the time of vaccination. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: none.
Fever, loss of response to environment, acting as if deaf, loss of speech development, behavioral impairment, resulting in diagnosis of autism on Jan. 2001. 60 day letter states pt has not recovered. Pervasive developmental disorder-NOS-which later deteriorated into autism, obsessive, compulsive disorder, anxiety disorder. Annual follow up on 03/10/04: "Pt did not recover from adverse events. Child became withdrawn, acted deaf, lost speech, lost normal play routines, started losing developmentally appropriate milestones and eventually was diagnosed PPD-NOS then autistic with OCD, Anxiety disorder, malabsorption, dysbiosis and heavy metal toxicity."
COVID 19 - extreme sore throat, productive and persistent cough, stuffy & runny nose, chills, fatigue
Within 24 hours of receiving his 2nd vaccination, my son began complaining about heart pain. He described them as sporadic, and mild in nature - mostly an annoyance. The pain was not associated with increased heart rate or increased/labored breathing.  He has never experienced anything similar in the past and is in exceptionally good health (He runs long distance cross country and track for his high school). Three days from his vaccination, I took him to his primary care physician where the performed and ECG which the doctor interpreted as "normal", and most likely not Myocarditis. He recommended Advil (3 tablets up to 4 times a day) for a few days, to reduce any potential inflammation, which he began immediately.   Once he began the Advil regiment, his conditions ceased to come back and he has not experienced any further episodes even after he stopped taking Advil. Is is now exactly 7 days after his 2nd vaccine.
After receiving both the Pfizer Bivalent and Flu vaccines, client became dizzy and had a headache.  Client was placed supine on the ground and vitals were taken.  It was discovered that the client was hypertensive with BP 170/120.  Client was placed in a seated position and monitored for approximately 1 hour.  BP after 1 hour measured 152/96, client felt well enough to walk.  Client was advised to follow up with their health care provider about her hypertension and walked to her car with a nurse.  Family drove client home.
No issues day of vaccine. Next day (Monday) started to have racing heartbeat. Tuesday his blood pressure shot up (he did not say what it went up to). Wednesday he broke out into a full body itchy rash with large welts.
pain on her elbows, knee, back, legs and clavicle; pain on her elbows, knee, back, legs and clavicle; pain on her elbows, knee, back, legs and clavicle; pain on her elbows, knee, back, legs and clavicle; feeling very tired; can't hardly walk; it feels like she was hit by a truck; This is a spontaneous report from a contactable consumer (patient) via a  sponsored program  Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER2613 and expiration date: not reported), via an unspecified route of administration, on 22Mar2021, as DOSE 1, SINGLE for covid-19 immunization. Medical history included fibromyalgia from 10Jan2000 to Jul2015, spinal operation on Mar2015: Fused and spacers, spinal operation on Jul2018: Spacers removed, spinal operation on Sep2019: Fused and pins. The patient had no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 23Mar2021, the patient experienced pain on her elbows, knee, back, legs and clavicle, feeling very tired, can't hardly walk, and it felt like she was hit by a truck.  Therapeutic measures were taken as a result of events included Aspirin. The outcome of the events was recovered in 28Mar2021.  No follow-up attempts are possible. No further information is expected.
a patient received an expired dose of FLUZONE HIGH-DOSE QUADRIVALENT vaccine/ No AE; Initial information received on 03-Dec-2021 regarding an unsolicited valid non-serious case from a consumer (patient) via phone via regulatory agency number: 00884333.  This case is linked to case 2021SA411813 (husband case).  This case involves a female patient of an unknown age who received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 14-OCT-2021, the patient received a 0.7 ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ500AB, expiry date: 30-JUN-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Patient states that she was told by the facility where she and her husband received their FLUZONE HIGH-DOSE QUADRIVALENT vaccines on 14-OCT-2021 that the product had expired on 30-JUN-2021. Caller wanted to know what was contained in the 2020-2021 FLUZONE HIGH-DOSE QUADRIVALENT vaccine and asked for a strain comparison between 2020 and 2021. Patient states that she does not know how long the vaccine that she received on 14-OCT-2021 will remain in her body and is unsure if she should be revaccinated at this time. Caller states that she will reach out to the facility to determine if they have reported this to Safety first."  At the time of reporting, no adverse event was reported.   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 the guidelines. 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.
mom described rash as a rough sandpaper type bumps over the chest & neck area-lasting 2 wks;
Whole body flushed skin, feels like hot, prickly, uncomfortable heat rash. 4" Welt at injection site that is hot, painful, red/purple, extremely hard/dense, skin is shiny it has stretched out so much. Concerned this is an allergic reaction.  Articles on  "covid arm" discuss occurrence a week after vaccine.  Both my first dose and second dose this happened within hours of vaccine.  Welt is worse after second dose.  Vaccine was administered in different arm for dose 2.  Fever of 102.  Advil brings fever down to upper 99s. Body/bones are achy. Dizzy.  Over feel completely lousy.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 17-MAR-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Itchy, red, hard bump on arm about 7 days after my first dose. I know it is normal and known but wanted it documented for stats and my account also. In terms of treatment I?m just using lotion and ice to keep the swelling down. It is not affecting anything else other than more fatigue in the last week.
got vaccinated / got internal shingles 3 weeks later; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got Shingles vaccine and 3 weeks later got shingles which lasted for 3 months. The follow-up would not possible as no contact details were available.
tested + for covid on     1-19-22 and 1-25-22     and deceased on 2-23-22;  I have no other information other than he did have covid sx of  muscle aches , sorethroat and headache
Patient was complaining of dizziness and tingling in the arm that she received her vaccine. EMT on site took a heart rate and pulse ox. Complained of tightness in chest, described it as "pain beneath my sternum." Pain was not radiating and centrally located. Increased wait time, patient described feeling better and  left by self.
Patient reported severe right breast infection including streaking 2 days after vaccination with the Shingrix vaccine.
HCP calling to report a child was inadvertently administered a third dose of MMRII and a third dose of VARIVAX. The patient has had no side effects. No further information provided. No additional AE/PQC.; HCP calling to report a child was inadvertently administered a third dose of MMRII and a third dose of VARIVAX. The patient has had no side effects. No further information provided. No additional AE/PQC.; This spontaneous report was received from a registered nurse referring to 17-year-old male patient. The patient's concurrent condition, and medical history were not provided. Concomitant medication included sterile diluent.  On 31-MAY-2023, the patient was inadvertently administered a third dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection 0.5 mL (route of administration and anatomical location not provided; lot# U022983, expiry date: 22-JUL-2023) and a third dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection 0.5 mL (route of administration and anatomical location not provided; lot# U029621, expiry date: 22-SEP-2023) as prophylaxis (extra dose administered). The patient had no side effects and there was no additional adverse event (AE) (no adverse event).
Within 30 minutes I had severe jaw pain, tingling in tongue and gums, and headache.
suspected vaccination failure; Second time; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient did have a shingles shot for Shingles but it didn't help. This was a very painful disease. The patient experienced shingles 2nd case in second time, while surgery on ankle. The patient kept it quiet. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. For 1st and 3rd occurrence of shingles, refer cases US2021AMR187315 and US2021AMR187330 respectively, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187330:same reporter US-GLAXOSMITHKLINE-US2021AMR187315:same reporter
Two extremely itchy, circular welts begin growing on the side on my face; Two extremely itchy, circular welts begin growing on the side on my face; This is a spontaneous report from a contactable other nurse (patient herself).  A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3246, Expiration date: unknown), intramuscularly, administered in left arm on 13Jan2021 10:30 AM as 2nd Dose, single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL5730), intramuscularly, administered in left arm on Dec2020 11:00 AM as 1st Dose, single dose for covid-19 immunisation. The patient's medical history included known allergies to Mastisol. The patient's concomitant medications included Levothyroxine within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 08:00 AM, the patient experienced two extremely itchy, circular welts begin growing on the side on my face. They continued to grow. Since the vaccination, the patient had not been tested for COVID-19. These adverse events led patient to visit doctor or other healthcare professional office/clinic visit. The patient had received antibiotics, steroids, multiple creams and now she was on Dupixent injections every two weeks as a treatment medication for resulted events. The seriousness of the event was assessed as non-serious by nurse. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of Urticaria and Pruritis  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency as appropriate.
Pt describes tingling sensation - swelling of arm she had her flu shot in. Pt visited doctor - he prescribed MOTRIN.
Inappropriate refrigeration of vaccine; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Inappropriate refrigeration of vaccine) and VACCINATION SITE PAIN (Pain at the injection site) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Inappropriate refrigeration of vaccine). On 01-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Inappropriate refrigeration of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  Treatment medication was not provided
left eye lid swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (left eye lid swollen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 93909) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced SWELLING OF EYELID (left eye lid swollen). At the time of the report, SWELLING OF EYELID (left eye lid swollen) outcome was unknown.            No concomitant medication information was provided.  No treatment medication information was given.   This case was linked to MOD-2021-395554 (Patient Link).
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.