chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel like crud; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of malaise (received 1st dose of Shingles vaccine on an unknown date and felt unwell, refer case US2021AMR198034).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles vaccine which made him/her feel like crud for about 2 days. The case is linked with the case US2021AMR198034, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198034:same reporter
SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious.
EC visit and subsequent admission for pain with breathing, cough, vomiting. Diagnosed with  sub-segmental pulmonary emboli
Moderate flu-like reaction to the first doze: extreme pain in left arm (unable to lift), severe flu like symptoms with 100-101 fever for 3 days, severe chills and body aches for 6 days, was in bed.  Was unable to sit more than few minutes due to weakness.  Headache, fatigue, weakeness continues on and off after 12 days since first doze.   I have to take several naps in between working just to get thru the day. I don't feel like my  normal self
I had a fever, felt nausea, hot and cold body chills, shakes, ache pain in body and a shooting pain in my legs. I could not stand for long period of time. I had to immediately lie down and struggle to drink water to help alleviate my pain and discomfort.  As a result of this I called out of work as a worker working from home.
Will not be receiving the 2nd dose; hands shake; shaky and internal shake; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (shaky and internal shake), TREMOR (hands shake) and INTENTIONAL DOSE OMISSION (Will not be receiving the 2nd dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.  No Medical History information was reported.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced TREMOR (hands shake). On 13-Mar-2021, the patient experienced NERVOUSNESS (shaky and internal shake). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Will not be receiving the 2nd dose). At the time of the report, NERVOUSNESS (shaky and internal shake) and TREMOR (hands shake) outcome was unknown and INTENTIONAL DOSE OMISSION (Will not be receiving the 2nd dose) had resolved. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-MAY-2021 and contains non significant information.
Several minutes after receiving 1st dose of Moderna patient fainted and slid from chair onto floor.  He was unresponsive for approximately 15-20 seconds and then regained consciousness.  Pharmacist immediately took his blood pressure and it was 112/56.  Patient stated that he was ok and had no trouble breathing.  His grandmother accompanied him and they did not wish to call EMS.  Patient was monitored for another 45 minutes and blood pressure was checked every 15 minutes where is was 122/64, 106/72, 107/78.  After 45 minutes patient said he felt fine and wished to leave.  Pharmacist accompanied  patient to his car and grandmother drove him home.
Fever of 104F,  arthralgia, nausea and vomiting, extreme fatigue.  N&V last ~24h and other symptoms lasted three days
pt recvd vax; chills, fever to 102, sore rt arm w/ redness,emesis x 2-3; fever resolved w/ acetaminophen; well by 19-mar-95
Large urticarial rash on site of injection within 2-4 hours, post vax. Given Benadryl po and resolved rash within 2 days.
RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 70 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL (both events dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3 ml) and off label use was not reported. This report was non-serious.  This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210112, 20211209679, 20211209706, 20211209740, 20211209782, 20211209816, 20211209843, 20211209880, 20211209912, 20211209921, 20211210019, 20211210106, 20211210107, 20211210141, 20211210143, 20211210165, 20211210180, 20211210350, 20211210385, 20211210585, 20211210588, 20211210590, 20211210610, 20211210662 and 20211210824.
This spontaneous report was received from a certified medical assistant, and refers to 2 patients of unknown age and gender. The medical history, concurrent conditions and drug reactions/allergies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, digital data logger reported as yes, lot # reported as L00456 with expiration date of 07-AUG-2016 (dose and frequency were not reported). No concomitant medications and no adverse symptoms were reported for any patient. No product quality complaint was involved. Additional information about the temperature excursion described that it was not less than 0 degree C for 80 hours. Even though, no previous temperature excursion was reported. Additional information has been requested.
About thirty hours after getting the vaccine I had some itching in my hand followed by a swollen lip the next day. Four days after the shot I had a shrimp dinner, and my tongue was swelling. I have never had any food allergies. I went to the ER where they gave me two doses of Epinephrine and I was admitted to the ICU with epinephrine drip. I was discharged the next day with a prescription of prednisone. I had been given 40mg of Solumedrol I tried not to take the prednisone as advised by the doctor. I started to get hives the following day. I was later prescribed multiple antihistamines and stayed on all of those since then. I am taking Zyrtec Twice daily Singulair once daily and Ranitidine since then and I have not had a reoccurrence of the hives. The doctor advised getting the Johnson & Johnson instead of the second Moderna. I was unable to get a Johnson & Johnson so now I am waiting again.
Within 5 minutes of receiving the vaccine (Friday 7/9/21), started feeling dizziness, whoozy, flushed, scratchiness in throat, pulse 49; stable after 30 min; pharmacist brought out the EpiPen, just in case. Within 2-3 hrs., tingling, numbness, fullness of lips, scratchy throat and raspy voice, tipsy sensation, general overall "weird" feeling; during the same timeframe, felt a numb, tingling, cold sensation of my left ring finger. By late evening, I started feeling a "zapping" sensation that occurred randomly throughout my body, like small, low voltage zaps or static charges. By late morning the following day (Saturday), started to feel a "bubble" sensation in my chest and throat, which continued intermittently. By evening time, lips finally normal, but throat was very dry/raspy; zapping sensations continued. By mid-day the next day (Sunday), central chest pressure persisted and became more noticeable; went to the ER, had a full workup for chest pain, which was all normal. By Monday, all symptoms had resolved.
Next day patient developed fever and her injection site turned red and itchy. Urgent care MD suggested that it could be skin infection so he gave her Doxycycline100mg bid for 10days, hydrocortisone 1% and zyrtec10mg. a few days later patient developed a reaction to the doxycycline that was classified by her primary care MD as an allergic reaction. Her Arm has improved by then and The primary care MD told her to continue hydrocortisone cream and zyrtec and no need for a different antibiotic to replace doxycycline for the suspected skin infection. Patient said that her arm continued to improve without antibiotics until it fully cleared.
pt received vaccine at 1137 in left deltoid IM, started having acute right gluteal pain approximately 3-4 hours later after getting undressed.  pain to put pressure on the buttocks, hurts to bear weight/transition from sit to stand.  did not have this pain prior to the vaccine, did not do activity today to aggravate the gluteus, does not have a hx of this type of pain.
patient received vaccine 1330at Bakers 300 , 30 minutes later arm numbness 1400 1800 severe itching, 1900 altered mental status  given Bendaryl 50 mg and Solumedrol 125 mg IV PTA by EMS squad 1925 arrived ED stroke alert activated - per neurology no stroke  2010 Compazine 5mg , ativan 0.5 mg and LR 1000mL IV r/o migraine
This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. The patient's pertinent medical history, drug allergies and concomitant medications were unknown. On an unknown date the patient was vaccinated with VARIVAX, lot#, expiry date, dose and route were unknown when she was "5 weeks and 2 days" pregnant. The last menstrual period (LMP) and expected delivery of date (EDD) were not known. The pregnancy outcome was pending. The fetal outcome was unknown. No adverse effects were reported. Additional information has been requested.
Red discolouration; Swelling at vaccination site .; Black and blue discoloration; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 11Mar2021 at 00:00 (at the age of 70-year-old), for COVID-19 immunisation. The patient had unspecified medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received other unspecified medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested positive for COVID-19. The patient had unspecified allergies to medications, food, or other products. On 11Mar2021 at 00:00, the patient experienced swelling at vaccination site with red black and blue discoloration. Therapeutic measures were not taken for any of the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling at vaccination site with red black and blue discoloration was not resolved (same after 12 days) at the time of the event.  Information about lot/batch number cannot be obtained. No further information expected.
6/2/23: Lump 3 inches from the injection site and 2 inches in diameter, swollen, tender, warm, 2 days after shot; took ibuprofen. 6/3/23: Redness increased in size approximately 1 inch the day after, with the addition of moderate itching; no treatment. 6/4/23: Improvement of same size but less red, less warm, less itchy; no treatment.
I received my fourth dose of the COVID vaccine (Pfizer) in April 2022 and I tested positive for COVID-19 in July 2022. The symptoms I had was about 24 hours of intense general symptoms. It seems to have lasted for about 4 days. I did receive PAXLOVID which seemed to assist with helping me feel better.
too many people I know have come down with covid even after being fully vaccinated, including myself; too many people I know have come down with covid even after being fully vaccinated, including myself; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "too many people I know have come down with covid even after being fully vaccinated, including myself".  Clinical Course: Reported that the patient was thinking of the advertising he just saw saying, 'please enter anything you felt, thought, or were reminded of while viewing it. Everything was acceptable. There are no right or wrong answers, no silly or dumb feelings. Don't worry about spelling, punctuation, or grammar'. He understood the idea of getting vaccinated, since he was fully vaccinated and had the additional booster. When it was said that, it fully protects from covid, he disagree, too many people he knew had come down with covid even after being fully vaccinated, including himself. Inquired if it was not better just to say it minimizes the effects of covid. Patient had no side effects from the Pfizer/BioNTech vaccine, while with moderna he did. This way he thought Pfizer-BioNTech COVID-19 vaccine unique and different from other COVID-19 vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201174283 Same reporter/ drug/ event for different patients;
enlarged and tender deep cervical lymph nodes on the left side. Symptoms started on day 5 after vaccination.  Sore left arm.  I experienced sore left arm and general malaise on the day of vaccination and the day after then I was symptom free till Day 5 after vaccination.
On an unspecified date, the vaccine received her second injection of Infanrix. "Days later", a knot appeared at the injection site. On 12/12/01, the vaccinee received her third injection of Infanrix. On the same day, in the right leg, she received injections of Prevnar and Recombivax-HB. Within 12 hours post-vaccination, approximately 0.5 inch from the Infanrix injection, a knot appeared. The area was red, it was not swollen, painful to the touch or fluid-filled. A home visit by a registered nurse was required. As of 12/11/01, the outcome of the events were unknown.
RPh accidentally gave JUST the adjuvant.  The powder vial had not been reconstituted.  Discovered after the shot was given in left arm,  when labels were pulled off vials, powder was still in the vial.  RPh notified patient asap,  a second adjuvant was then used to reconstitute the powder, the vaccine was then given in right arm.   No adverse rxn noted, patient stayed in store.  Patient said he felt fine.  MD will be notified via fax.
A report was received from a health professional on 11/1/01 concerning a 63 year old female patient who experienced cellulitis 2 days after receiving the Fluvirin vaccine on 10/30/01. Relevant medical history includes a hysterectomy, osteoarthritis, and hypertension on unknown dates. Co-medication taken by the patient included a topical Estrogen patch and Clindamycin. On 11/1/01, the patient experienced cellulitis of the entire right arm 2 days after receiving the Fluvirin vaccine. The Fluvirin administration was given in the right deltoid muscle. Therapeutic measures taken as a result of this event included Clindamycin and Diphenhydramine. The patient had not recovered at the time of report. The reporter assessed the relationship of the study medication to the event as possible. (OMIC)
The pt experienced intense screaming, fell instantly into a deep sleep and would not wake. For the next 3 weeks, he slept nearly all day and through the night. He did not sleep much prior to the shots. Sleepiness was replaced with intense sleeplessness until next set of shots.
she was having severe jaw pain and it lasted until today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (she was having severe jaw pain and it lasted until today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (1st dose - 10Mar2021 with lot number EN6199 2nd dose - 31Mar2021 with lot number ER8732) from 10-Mar-2021 to 31-Mar-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included TMJ syndrome (She has a condition called TMJ and was wondering if the vaccine can trigger jaw pain.).    On 29-Oct-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN JAW (she was having severe jaw pain and it lasted until today). On 02-Nov-2021, PAIN IN JAW (she was having severe jaw pain and it lasted until today) had resolved.            Concomitant information was not reported. Treatment information was not reported.
August 10, 2021 - Woke up and could not hear anything out of left ear August 12, 2021 - Appt with Primary Care Physician, who advised was a medical emergency and to see an ENT immediately August 13, 2021 - Appt with ENT Specialist, Confirmed diagnosis of Sudden Sensorineural Hearing Loss in Left Ear1.  Blood work and MRI were ordered for further testing; Prednisone was prescribed for 12 days.
Approximately 20-25 minutes after injection, dizziness, tingling in face, and throat tightness occurred, which resolved after about 15 minutes.  No shortness of breath experienced and symptoms were not severe enough to seek medical treatment.
2-230pm temp of 104. Went to 105. Tylenol would not work.   Stopped accepting food starting 2am-10am Very lethargic from 6am-9am when normally up  Shaking and convulsing
I received the first dose of my moderna vaccine on February 9th. for 48 hours I had a sore left arm, where the vaccine was administered.   On February 14th I started experiencing paresthesias of the bilateral soles of my feet. Over the next couple of days the paresthesias were worsening and moving proximally until they were in both my lower extremities. They remained in my bilateral lower extremities for several days without moving further.   On February 21st around 11 pm I felt the paresthesias move up my posterior legs into my buttocks, up my back, and down my bilateral arms. I went to sleep and woke up on February 22nd and felt rectal pressure and increased saddle paresthesias and became concerned. I went to Hospital ED on February 22nd around 9 am.
09/18/21-Vaccine L arm HD flu zone; 09/19--7 AM onset Myalgia Erythema L arm deltoid 6-8"-Resolved after 9 days 10/02/21-onset severe L arm shoulder pain-L Supra/infra spinatus into L deltoid;  Severe pain 10/03/21 thru 10/08/21 Pain worsened 10/03/21-pain 9/10-Started Acupuncture tid Pain stabilized and improved 10/08/21 to present pain 1-2/10 10/03/21 noticed L arm hand weakness which is persistent; Skin overlying Supra-infra spinatitis roughened and desquamated; Researched-Parsonage Turner syndrome-Visible Supra infraspinatis Atrophy L shoulder noted.fortunately no paralysis-Apparently not unusual after influenza and Covid*retrospect I experienced a milder similar reaction with Shingles vaccinations in 2020 and Covid vaccines in 2020 and 2021 (December/January)
a child under 18 years of age may have been received the Flublok Quadrivalent but she is not sure, no AE.; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a child who is under 18 years of age and may have been received the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number, expiration date and other dosing details not reported) on an unknown date but the reporter is not sure.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.  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'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.  Information on the batch number was requested.
Pt with what appears to be viral exanthem. Mom reported generalized rash, over trunk, back, arms, legs. Mild nasal congestion and diarrhea x 1 day (approx. 9 days after vaccine given).
school nurse noted small amount serous drainage in area of inj, broken skin1cm upper are 7 3cm lower area where vax given site was pink & some soreness noted on palpation;