chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Dose 5, 4 (Moderna)/ Dose 3, 2 and 1 (Pfizer); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 11Apr2021 as dose 2, single (Lot number: ER8729) and on 12Nov2021 as dose 3 (booster), single (Lot number: Pg3527) at the age of 33 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Lot number: 006a22a), in right arm and on 12Sep2022 at 15:45 as dose 5 (booster), single (Lot number: 19811), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: MUCINEX, start date: 05Dec2022, stop date: 10Dec2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "unknown", described as "Dose 5, 4 (Moderna)/ Dose 3, 2 and 1 (Pfizer)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received other medications in 2 weeks. Paxlovid used for COVID 19 Treatment.
SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Got vaccine in my car and parked. Had a little extra bleeding at the time of injection. Once parked, I had immediate and intense nausea. Very dizzy and light-headed. My hearing went away. I closed my eyes for a second and passed out. I awoke about ten minutes later covered in sweat. Felt better at this point and it was my time to leave, so I felt well enough to drive home at that moment. I should have reported the adverse event at the site.
dizziness, lightheadedness, palpitations, diaphoresis about 5-10 minutes after
Fever above 105 degrees for 5 days; Enlarged lymph nodes on left side of neck; tremors; causing difficulties breathing; pushing on esophagus; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was unknown and expiry was not reported), via an unspecified route of administration, in Left arm on 04Apr2021 at 13:00 (at the age of 27-years-old) at 1st dose single for COVID-19 immunization. Medical history included environmental allergies and Hashimoto's. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) in two weeks of vaccination. The patient previously took Ceclor and experienced allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The patient had fever, above 105 degrees for 5 days and unable to reduce with Tylenol, causing tremors; had enlarged lymph nodes on left side of neck causing difficulties breathing and pushing on esophagus as per ER physician on 05Apr2021 at 12:00 after the first dose. The events resulted in emergency room/department or urgent care (2 visits to ER needed in first 5 days following vaccine). Residual issues remained. Treatment was given for the events. The outcome of the event fever was recovered with sequel on 10Apr2021 while the other events (enlarged lymph nodes on left side of neck causing difficulties breathing and pushing on esophagus) was recovered with sequel in Apr2021. The event tremor was recovered in Apr2021.     No follow-up attempts are possible; information about lot/batch number cannot be obtained
Had a little headache afterwards/ Next day about 24 hours later had headache.; This is a spontaneous report from a contactable consumer or other non hcp (Patient) from a Pfizer-sponsored program.   A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that Received first dose of covid vaccine Wednesday. Had a little headache afterwards. Next day about 24 hours later had headache. Had taken 2 Advil and Benadryl. Then was reading you should not take anything before vaccine. Does not want to mess vaccine up. Wondering what we say about taking anything after vaccine. Therapeutic measures were taken as a result of event with 2 Advil and Benadryl. The outcome for the events was reported as unknown at the time of this report.  Information on the lot/batch number has been requested.  Follow-up (31Mar2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUL-2015, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX; lot number L001335 and expiration date 13-JAN-2017 (15 administered), lot number K0296385 and expiration date 15-DEC-2016 (4 administered) lot number L006385 and expiration date 25-FEB-2017 (13 administered) (dose and route of administration not reported). Concomitant therapy was not reported. No adverse experiences had been reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient developed redness, swelling, and pain over lateral aspect of left arm on the afternoon of 11/4/11, which has worsened through 11/7/11 and measures approx. 8cm x 5cm on 11/7/11 with warmth and erythema, no drainage or fluctuance. Developed fever on 11/4/11 pm, peaked at 103.6 degrees F PO on 11/5/11, 38.1 degrees C PO on 11/7/11. Complaining of arm pain, stomach pain. Treatment with MOTRIN, BENADRYL, and cool compresses.
high fever 103-105;sz;unusually fussy & discontent for over 1wk;crying & irritable (this is not like  the content, happy baby;
pain in leg; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced pain in leg. The outcome of event was unknown.  Information about lot/batch number has been requested.
Vaccine administered 10:30 AM 7/7/08 R deltoid.  Approx. 5 pm to pain w/ movement.  By L/S, pain impacting sleep.  By am 7/8/08 redness, swelling at site, feverish and fatigue, SOB w/ minimal exertion.
Information has been received from a licensed practical nurse referring to a 13 years and 6 months old patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 08-OCT-2014, the patient received first dose intramuscularly of GARDASIL for prophylaxis (dosage, Lot Number, expiration date and anatomical location were not reported) later, on 27-OCT-2015 the patient received a dose of GARDASIL 9 (intramuscularly, lot number L025737 Expiration date 28-JUL-2017; dosage, anatomical location were unknown). No adverse effect was reported. There was not product quality complaints involved. Additional information has been requested.
Pt reported for 2nd dose Pfizer on 8/5/21.  At the time of registration, pt guardian noted that the pt DOB was incorrect and the DOB was corrected on file.  It was noted that this change meant that the pt received 1st dose at age 11yrs and 11mo.  Pt guardian stated that they were unaware of the situation d/t different guardian bringing pt in for 1st dose.  Pt/pt guardian reported no adverse event from first dose.
child w/fever, vomiting beginning 4OCT;seen in ER on 5OCT by MD;mom report's child dx w/UTI but told could still be a rxn to immun @ least in part as fits time frame;T103 @ hosp, 2hr p/baby motrin;
Soreness in upper arm started at 6 PM. Warm rush of feeling starting from arm to neck and rising to the head.  Not uncomfortable just notably not usual for me. Left ear started ringing and lasted for 10 minutes and just went away.  The left side of my face feels slightly numb but OK.  The strangest thing was I thought someone was just standing next to me and sticking something in my ear as a joke.  I only live with my mother of 87 so this idea is preposterous but the feeling of something swimming and moving and going inside my ear was so strong I actually used a Q Tip to make sure there wasn't a bug going in there.  it stopped after 5 minutes but it was the weirdest thing ever.  It reminded me of when you get your ears cleaned and the doc puts something (cleanser - peroxide for instance) in it.  GOD I'm glad it stopped because there is NO WAY I would be able to sleep with that. Now its fine.  I hope it never comes back.
Patient is a 76 y.o. female patient of MD with history of vertigo, sleep apnea, hyperlipidemia, obesity, hypertension, depression, GERD presented to Hospital with chief complaint of headache and weakness   Acute on chronic respiratory failure with hypoxia  Covid-19 PNA Date of onset of symptoms: 3/21/23 Symptoms present on admission: Fever, shortness of breath, fatigue, cough Date of covid positive test: 3/23/2023 Oxygen requirements on admission: 3 L Current oxygen requirements: RA Medical therapy: remdesivir, steroids, Anticipated special isolation end date: 4/1  Home oxygen eval was done on discharge. Patient did not qualify for one    Ecoli UTI Macrobid for 3 days     Essential hypertension Continue amlodipine   Tobacco abuse 62-pack-year history Advised cessation   Obesity  BMI 31   OSA cpap
Muscle tightening, soreness, red knot moving down muscle of arm, 3 1/2 to 4 inch diameter red spot on skin shoulder soreness, muscle soreness, unable to use arm for 72 hours.
Fever 102.9 3-8-12 at 1400 (TYLENOL 650mg PO, IV antibiotics, IV fluids). Altered mental status (CT of brain). (Fever came down to 101.7 degrees then 98.2 at 1900; PO fluids encouraged; IV fluids - antibiotics initiated; mentation remains altered though pt appears to be improving).
Rash approximately 6 inches by 5 inches at immunization site reported Oct 16, 2015.
second shot will be past day 35; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot will be past day 35) 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot will be past day 35). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot will be past day 35) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported   Reporter did not allow further contact
Point tenderness immediately following injection into left deltoid region. Approximately 2 weeks later a left bursitis with decreased range of motion and pain.
SORE GLAND ON NECK/ GLAND SORE TO TOUCH; SORE NECK; TENDERNESS/ INFLAMMED GLAND ON  LEFT SIDE OF NECK; FLU LIKE SYMPTOMS; NOT FEELING WELL; SORE ARM; This spontaneous report received from a patient concerned a 64-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies and minor asthma. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered for prophylactic vaccination on 13-MAR-2021. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: Unknown) dose was not reported, 1 total administered at left arm (left shoulder) on 26-OCT-2021 for prophylactic vaccination (Booster dose). Concomitant medications included losartan for blood pressure, montelukast sodium for minor asthma, and loratadine/ pseudoephedrine for seasonal allergies.  On 26-OCT-2021, the patient experienced sore arm. On 28-Oct-2021, after the booster dose minor flu like symptoms started without fever, body chills, and was not feeling well. The event lasted 18-24 hours. On 28-Oct-2021, the patient experienced sore gland in neck (Sore Neck), while had no issues with breathing or swallowing, was sore to touch inflamed (tenderness/ inflamed gland on left side of neck). The patient was little concerned but it resolved after 3 -4 days. All events resumed to normal and the patient mentioned it was an immune system reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore gland on neck/ gland sore to touch, sore neck, and tenderness/ inflamed gland on left side of neck on 02-NOV-2021, flu like symptoms and not feeling well on 29-OCT-2021, and sore arm on 27-OCT-2021. This report was non-serious.
Case number PHEH2014US011545, is an initial spontaneous report received form a nurse on 05 Jun 2014. This report refers to an unknown age and gender patient. Past medical history and concomitant medications were not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported), without being reconstituted with Men A lyophilized conjugate vaccine component on an unknown date and few days later received full dose of MENVEO. No adverse event was reported following this administration error.
Extreme bilat eye redness and swelling with purulent drainage. Asthma attack, coughing, trouble swallowing.
arrhythmias; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ARRHYTHMIA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "arrhythmias". Patient reported that after she received the second dose of Comirnaty she was hospitalized due to arrhythmias. This was early 2021 and she just told the story today. Event took place after use of product.  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 information provided in the case, considering the temporal association that the patient was hospitalized due to the event "arrhythmias" after the second dose of BNT162b2, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported event "arrhythmias". 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. This case will be reassessed once additional information is available.
Patient was administered Tdap instead of Dtap and is 6 years old. Patient did not have any adverse reaction.
Currently pregnant due 9/3/2021. I had a low grade fever, chills, body aches, headache, dizziness, extreme heartburn and vomiting. I medicated with Tylenol.
Every day my son is getting the fever with 100 to 103.5 after vaccination these 3 weeks; This is a spontaneous report from a contactable consumer. This consumer reported for male consumer (reporter's son) that,  A 13-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0185) (at the age of 13 years old), via an unspecified route of administration, administered in arm left on 16May2021 18:00 as dose number unknown, single for covid-19 immunisation. Medical history included blood iron decreased from an unknown date and unknown if ongoing and no known allergies. Concomitant medication(s) included paracetamol (TYNELOL) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported. It was reported that on 17May2021 every day patient was getting the fever with 100 to 103.5 after vaccination these three weeks. They had been conducted blood work for viral and Covid everything which was negative. But fever was not controlling. No treatment was received for event. Patient did not have covid prior to vaccination. The patient was visited, doctor or other healthcare professional office/clinic visit. Patient was not tested for covid post vaccination. The outcome for the event was not recovered.  Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Pt recvd MMR vax on 21SEP91 & 5 hrs p/vax pt devel a pruritic rash on face & bax; pt taken to ER;
Patient presented to ED with itchiness to scalp and feeling hot in face and ears after receiving the second dose of the Moderna COVID vaccine. Patient reported symptoms similar to when she had an allergic reaction to Amoxicillin. Admitted. Patient was given Benadryl, Pepcid, and Claritin. Symptoms appeared to be improving and patient discharged as requested.
Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  stiffness to left arm/hand/back of neck, dizzy, tingling to left arm.   Assessment : Time of assessment 1551. Alert and oriented   Actions taken:  EMS on site, patient taken to triage area. 1455:BP 146/83, P 92, 98% O2 saturation; 1500: tingling gone to left arm, stiffness still present; 1502: 141/75, P 88. Reports feeling better, stiffness still present. 1508-EMS recommends home and to call 911 if symptoms get worse.   Medications administered: No medication administered.   Disposition:Home, instructed to call 911 if symptoms worsen, follow up with PCP. Ambulatory out with husband.
My sinus infection has come back; This is a spontaneous report from a Pfizer-sponsored program, from a contactable Other Health Professional (nurse reporting for herself). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 01Oct2021 as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) 125 micrograms, everyday; gabapentin (GABAPENTIN) 1000 milligrams, twice a day; sertraline hydrochloride (ZOLOFT); buspirone (BUSPIRONE) 15 milligrams twice a day; cranberry (CRANBERRY); calcium (CALCIUM); colecalciferol (VITAMINE D); mometasone furoate (MOMETASONE [MOMETASONE FUROATE])- all taken for unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613), via an unspecified route of administration as dose1, single and dose2, single for COVID-19 immunisation. The patient reported that 'my sinus infection has come back' on an unspecified date. No Investigation assessment reported. Nurse stated that she had a sinus infection. So, she was on prednisone from 08Sep2021 to 15Sep2021 and she had her last dose on 15Sep2021 and then she got her Pfizer third booster shot early on 01Oct2021 because she was a healthcare professional. So, her sinus infection has come back and her ear, nose and throat doctor put me on a product Augmentin and she wanted to know if she want to take the prednisone. She stated, LOT 301558A (further not clarified). Prior vaccinations (within 4 weeks): Nurse stated, "I think I had an allergy shot (further not clarified hence, captured as Unspecified Shot), last Wednesday" (further clarifications unknown). Therapeutic measures were taken as a result of sinus infection. Treatment: Nurse stated she took a Augmentin from 08Sep2021 to 15Sep2021. She took 875 milligrams of Augmentin for a week, twice a day with the prednisone 40 milligrams (voice not clear). The end is on15Sep2021 and then they just gave her a prescription to start Augmentin again 875 milligrams to start tonight 875 milligrams, twice a day for 10 days. Outcome of event was unknown.
pt devel herpes zoster (lt T5 dermatome) on 6AUG98, almost 3 yr p/vax;reporter states their is no complete data regarding the effectiveness of varivax @ protecting child from shingles;
Patient received the vaccine on 05-Apr-2022 which had got expired on 24-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 05-Apr-2022 which had got expired on 24-Mar-2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 05-Apr-2022 which had got expired on 24-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 05-Apr-2022 which had got expired on 24-Mar-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the second booster dose.  Patient received the vaccine on 05-Apr-2022 which had got expired on 24-Mar-2022.  Concomitant drugs were not reported.  Treatment details were not given.