chrisvoncsefalvay/vaers-outcomes huggingface dataset:
abdominal pain/pain level was 10 and now it was down to a 2 on a scale of 1 to 10; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 09Aug2021 17:00 (batch/lot number EW0196 and expiry date 30Sep2021) at 42 years of age as dose 1, single for covid-19 immunization in a hospital facility. The patient has no medical history including any illness at time of vaccination. Concomitant medications were not reported. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect, has no additional vaccines administered on same date of the Pfizer suspect. The patient informed that his first dose of the Pfizer Covid-19 vaccine was on 09Aug2021 and today (10Aug2021), he was experiencing severe abdominal pain that has lasted for 3 hours, it was ongoing and improving. The patient informed that the pain started around 9:00 am, it got better and it improved around 12 pm. The patient's pain level was 10 and now it was down to a 2 on a scale of 1 to 10. The patient informed that he went to the hospital, thought it was the best thing to do. The patient went to the emergency room at 9:30. The patient had to wait so so long, the pain went down and by the time he was ready to be seen his pain level had gone down and he left. The outcome of the events was recovering.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe
pt recv vax & exp anaphylactoid rxn & sought medical attention;MD felt that there was an association between the anaphylactoid rxn & hep b vax is other medical event;
swollen lymph nodes; tingling in my left facial trigeminal area; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes and tingling. On an unknown date, the outcome of the enlargement of lymph nodes and tingling were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine on Monday and on Thursday he/she had two swollen lymph nodes at the collar bone on the same side of the injection (left).  No other symptoms of disease to explain this reaction. The patient stated that as the next nodes swelled he/she felt tingling in his/her left facial trigeminal area.
expired ADACEL was given with no reported adverse event; Initial information was received on 29-Oct-2021 regarding an unsolicited valid non-serious case from consumer and pharmacist via Medical Information (MI) (reference number- 00834465) and live follow-up dated 29-Oct-2021 (MI reference number- 00834904) both processed together.  This case involves a 56 years old male patient who reported expired adacel was given with no reported adverse event (expired product administered) while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine (Adacel).  The patient's medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On 28-Oct-2021, the patient received at 0.5 ml dose of suspect suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (frequency: once) (batch number C5666BA and expiry date: 17-Sep-2021) via an intramuscular route in the deltoid for prophylactic vaccination.  It was of actual medication error due to expired vaccine used (latency: same day).  It was reported "Pharmacist states that yesterday, (10/28/2021), a 56 year-old patient, received an ADACEL vaccine that was later noted to have expired. No adverse effects reported, vaccine will be repeated."  At the time of reporting, no adverse event 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 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.  No further information reported.
Hot flashes; fever 102; nausea; Vein discoloration; aches; bone pain; tongue swelling; noticeable arm swelling/armpit swelling; itchiness (arm); elevated heart rate; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 36-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185, expiry date: unknown) via an unspecified route of administration, in right arm on 17May2021 05:30 PM (at the age of 36-year-old) as dose 2, single for covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0161, expiry date: unknown) via an unspecified route of administration, administered in right arm on 26Apr2021 05:30 PM (at the age of 36-year-old) as dose 1, single for covid-19 immunization. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patients medical history included known allergies with colligene, pork, gluten, penicillin and pituitary tumor, arthritis, polycystic ovarian syndrome (PCOS). Concomitant medications received within 2 weeks of vaccination included dulaglutide (TRULICITY), Metformin and Vitamins for an unspecified indication. She was not diagnosed with COVID-19 prior to vaccination and patient has not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. Patient experienced hot flashes, fever 102, nausea, vein discoloration, aches, bone pain, tongue swelling, noticeable arm swelling, armpit swelling, itchiness (arm), and elevated heart rate, all on 18May2021 at 03:00 AM, she had not received any treatment for the events reported. Outcome of all events was not recovered.  Follow-up attempts completed. No further information is expected  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 completed. No further information is expected
From initial information received on 11//11/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 56 year old female patient received a dose of Fluzone SV '2003-2004' USP, lot number U1139AA, administered intra-muscularly in the left deltoid on 11/11/2003 at 10:00AM.  One hour and 15 minutes later, the patient developed local tenderness and swelling at the site, which measured approximately 7 to 10 cm in diameter.  The site was very warm.  The patient also complained of dizziness.  She denied shortness of breath initially after receiving the vaccine, but complained of it three hours later.  The patient used an inhaler, which relieved the symptoms.  At the time of this report the patient had not recovered.
This is a spontaneous report from a Pfizer Colleague who reported on behalf of contactable consumer (friend) reporting for a patient (friend's daughter). A 19-year-old female patient received TRUMENBA (lot# 09203, exp date Jun2016), via an unspecified route of administration on 08Feb2015, at single dose, as she had case of meningitis at her college. Relevant medical history was not reported. Concomitant medication included SYNTHROID from 2013 and ongoing. On an unspecified date the patient experienced nostril flared with outcome of unknown. Follow-up (17Mar2015): new information received from a contactable consumer includes: TRUMENBA details, concomitant medication. Follow-up attempts completed. No further information expected. Follow-up (15MAY-2015): Follow-up attempts completed. No further information expected.
12/16/22 I got up that morning. I had a cough and congestion which seemed like cold symptoms. I took a Covid test and it was negative. The next morning, I felt much worse. My congestion kept me up so much the night before, my ears were filled up with fluid which made it hard to hear. I had severe head congestion. I took another COVID test on 12/17/22 which was positive. I called my PCP at 8:00AM and he said he thought it was the latest version of COVID and unless things get worse, to let him know. I asked about PAXLOVID, and he prescribed PAXLOVID. On 11/18/22, I started the PAXLOVID. I also took an antihistamine. After 5 days, I began feeling better. I took another COVID test on 11/22/22 and it came back negative. I am almost fully recovered. The congestion is almost gone, the cough is just about gone and at the rate it is going, in another few days, I will be at 100%.
No AEs reported.; Moderna COVID-19 Vaccine after more than 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No AEs reported.) in a 79-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine after more than 30-day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No AEs reported.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No AEs reported.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No AEs reported.) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine after more than 30-day use by date).    No concomitant medications were reported.   Healthcare professional reported that they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date. No AEs reported. Patient identifiers for patient number 11 are documented in this case.  No treatment details were reported.
This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered an unspecified number of improperly stored doses of ROTATEQ orally (lot # L027076, expiration date 25-MAY-2017; lot # L029934, expiration date 01-MAY-2017; lot # L029617, expiration date 19-MAY-2017; lot # M004890, expiration date 10-NOV-2017) (dose was not reported). The administered doses experienced a temperature excursion of 32 F for 2 hours and 8 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine admin. approx. 10:40 in am, at 3:30pm parent called that pt vomited x 1, was lethargic and pale. Advised to come to office; limp, pale, easily aroused decreased tone, brief periods of apnea hypotonic reaction prob 2 hours to pertussis. Admitted to hospital. Hypotonic reaction.  Follow up: becomes serious care.  after discharge from hospital.
Humming/buzz in my ear - kind of like tinnitus - becoming more dominant now; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Humming/buzz in my ear - kind of like tinnitus - becoming more dominant now) and ARTHRALGIA (Joint pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dental implant user (Patient stated that she had dental implants after she received the vaccine).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Humming/buzz in my ear - kind of like tinnitus - becoming more dominant now) and ARTHRALGIA (Joint pain). At the time of the report, TINNITUS (Humming/buzz in my ear - kind of like tinnitus - becoming more dominant now) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.  No relevant concomitant medications were reported.   Patient thought the humming sound was due to the dental implant but her oral surgeon told her it was due to vaccine, a rare side effect.  Treatment information was not provided.
This spontaneous report as received from a registered nurse (R.N) refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot # not reported) on an unspecified date in September 2011 and the second dose of GARDASIL (lot # not reported) on 02-AUG-2012. No adverse effect reported. Whether the patient sought medical attention was not reported. The outcome was unknown. Additional information has been requested.
Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in January 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter stated that the patient never received her second dose and asked Should she just get one more or the entire 2-shot series. The VAERS details was reported for 1st dose. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up via postal.
Patient was given influenza vaccine on 11/22/22. After administration, it was discovered that patient had already received the influenza vaccine on 10/4/22.
Nausea, burning sensation "all over"; chest tightness but not short of breath, tingling "all over".
no other adverse events; temperature excursion; This spontaneous report was received from a physician referring to a 11 month old patient of unspecified gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.    On 20-MAY-2021, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature excursion that lasted 84 hours, at a temperature of 43.7 degrees Fahrenheit (product storage error); no previous temperature excursions had occurred. On 24-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot number T037957, expiration date 09-MAY-2022, 1 dosage form (dose/frequency reported as "1 time dose") as prophylaxis (strength, route of administration and anatomical location were not provided). Digital data logger was involved. No signs, symptoms or adverse events were reported.        The outcome of product storage error was unknown.
Goose egg on arm at injection site, redness, soreness followed by chills, severe muscle aches and fever between 100-101. Visited Dr. at Urgent care clinic 09/01/2016, Hydrocodon-Homatropin 5-1 .5mg/5 SYR and Azithromycin 250mg tab (6 count).  As of today, 09/01/2016, all symptoms still present except swelling of injection site has subsided.
Information has been received from a health professional concerning a female who was vaccinated with the second dose of GARDASIL. Subsequently the patient experienced erythema, edema and tenderness over that "took up her whole deltoid region". The reporter felt that erythema, edema and tenderness over that  took up her whole deltoid region were not related to therapy with GARDASIL. Per the reporter, the patient also had this experience with the first dose of GARDASIL. The patient will not receive the third dose. No further information was provided. Additional information has been requested.
Itching of right palm of hand & wrist, became  red & hot to touch--- right hand swelled up unable to bend fingers --- slight itching & swelling on left hand also. Went to  urgent care was prescribed steroid which got rid of swelling & itching.
Mom states child developed hives on back, arms, hands, and feet. States he also had a lump on each arm the size of 1/2 a golf ball. States she did not take his temperature, but she stated he only felt slightly warm, so she stated if he had a fever it was not a high one. Mother also stated child gets hives frequently from different things. Did have a similar reaction to a vaccine when he was younger. Mother gave child BENADRYL, but she states it has not helped. Encouraged her to contact child's doctor.
The morning after vaccination, the patient had a high fever with severe pain and large local swelling on her arm at the injection site. The vaccine shot was given -2.5-3 inches below the lip of her shoulder, middle of deltoid muscle. She could not work and move for the next 4 days. She had tingling/numbness in all her fingers, palm, and arms. She called the clinic where she got the flu vaccine they suggested that she contact the ER. The ER prescribed Thuja, Tylenol, Lomatium, Byonia, Alba. As of 01/04/2010, she still does not feel well and could not being working again and or moving about.
very bad reaction/ she was swollen, hot, lymph nodes enlarged, and she hurt; hurt; she was swollen; she was hot/ doctor put cold packs on it; very bad reaction; she didn't mix the vaccine and feels like it wasn't mixed correctly; 0.5 ml; This spontaneous report was received from a currently 71-year-old nurse who is also a female patient and she refers to herself. There was no information about the patient's concurrent conditions or medical history provided. Her concomitant therapies included possibly blood pressure medication. She had drug hypersensitivity to doxycycline and penicillin, she had rubber (latex) sensitivity, and she was allergic to bee stings. On an unknown date, approximately in 2011 (reported as 10 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection in dose 0.5 (units not reported) for shingles (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported). On an unknown date, approximately in 2011 (reported as 10 years ago), the patient had a very bad reaction when she was vaccinated. She stated, she was swollen, hot, lymph nodes were enlarged, and she was hurt. It got worse 48 hours later. The patient did see the doctor and put cold packs on it as she was taking anti-inflammatories. Caller stated that she didn't mix the vaccine and it felt like it wasn't mixed correctly. She had never had a reaction like that before and it seemed uncommon. The patient recovered from all the events on an unknown date. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was not provided.
Slight pain day of shot.  Then all good  8days later woke to a rash warm itcy patch at place where shot was given
Neck tightening (immediate but was most likely the lymph nodes reacting and not allergy), 35 minutes after receiving the vaccine, tingling tongue and lips, tongue swelling with difficulty speaking. These went away as soon as I got close to the hospital so I did not seek medical treatment. 45 minutes after receiving vaccine, headache and lymph node swelling. 30 hours after receiving the vaccine rashon arm that started out as small hives and then grew to a rash 4 inches side and 2 inches tall and this lasted for 5 days. The rash was so inflamed that an ice pack could not cool the skin. Dizziness for 2 days.  Hives on left foot the 3rd day that went away quickly and hives on right food on the 4th day after receiving the vaccine that went away quickly. Excessive thirst the first 2 days and dry mouth. Bleeding/spotting for 5 days even though my period had ended 2 days prior to receiving the vaccine.
Heart palpitations, shortness of breath, rapid resting heart rate,  dizziness, nausea.
Pt. has no temp, area not reddened, not irritated, not warm to touch. There is a small area where the needle was inserted, that has a grey to silver particle that is just under the skin. Area is not raised. Dad/mom has not noticed area. Area of infection was left upper vastus  lateralis.
Discharge Diagnosis:  Acute renal failure, E.coli cystitis, COVID 19, Dm2, Acute metabolic encephalopathy.    Hospital Course:  The patient was admitted with the above. He did not have sx from C19 and was not on oxygne so only supportive tx was given. E.coli grew in the urine. He was initally on rocephin but was changed to vantin to complete a 5 day course. His acute metabolic encephalopathy was felt to be due to the prior two dignoses and was improved at D/C. He was asked to follow up outpatinet.   Consults to:  Nephrology.    Significant Diagnostic Studies:  CT abdomen and npelvis.    Procedure(s): none.    Disposition:  SNF   Discharge Condition:  fair
2 day post administration of vaccine patient developed induration, redness, and swelling on the left arm.
Fever and chills noted day after administration. Fever of 101.2 on 12/23 at 14:25 and returned to baseline at 12/23 19:03.
Pneumonia vaccine adult administered 7.2.13 pt called 7-3-13 c/o redness chest, arms associated with itching. Advised patient to take BENADRYL. Redness fading-itching gone.
This spontaneous report as received from a physician via a Company Representative concerning a 61 year old male patient without pertinent medical history. Drug reactions/allergies were not reported. In June 2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot number and expiration date were not reported) as directed. Secondary therapies were not reported. Concomitant therapies included unspecified statin medication which was discontinued and the problem persisted. Reporter explained that in June 2012, the patient developed a localized pain bilaterally down his arm accompanied by numbness and tingling in his hands following administration with ZOSTAVAX. The outcome of the events was reported as not recovered. Additional information has been requested.
adm to hosp 22SEP97 for fever ? OM;d/c & transferred to Iowa city 24SEP97;