chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse and refers to unspecified number patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M022400, expiration date 01-NOV-2017 (dose and route of administration were not reported) for prophylaxis. The PROQUAD was reconstituted with properly stored diluent (lot number and expiration date were unknown). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions of 7.7 degrees Fahrenheit for 1 hour and 30 minutes, 9.9 degreees Fahrenheit for 1 hour and 30 minutes, 8.2 degrees Fahrenheit for 30 minutes, 13.3 degrees Fahrenheit for 1 hour and 30 minutes, 7.7 degrees Fahrenheit for 1 hour and 8.8 Fahrenheit degrees for 1 hour. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. Additional information has been requested. ; Sender's Comments: US-009513507-1703USA013690: US-009513507-1703USA013738:
pt recvd vax; titers drawn on 16jun95 neg; 29aug95 exp sore throat, body aches, fever & five lesions;30aug95 # of lesions inc;
Pt developed generalized pruritus for 3 weeks, papular rash in intercostal areas, followed by intermittent achy, pin prick dysesthesias and tender lymph nodes that exacerbated in 2/00. Papular erythema, pain in both hands, chronic illness. Annual follow - up states the pt occassionally experiences papulo-pustular lesions and also a papular rash. A follow up report received 6/12/2000 adds: Pt reports info given in box 18 was in error. The generalized pruritis occurred on 11/14/1999 and lasted approx 3 weeks. He was given Varivax "as a precaution" after exposure to a pt with sore throat and "weird type" lymph nodes who later developed chicken pox-like rash. "There was no time to do a titer" so Varivax given to this physician. A "few days" after the Varivax both the pt and his wife, an ICU nurse, developed "weird rashes". The rash abated, but in February he developed pain in left arm and 2 weeks later itching. A "lymphatic cord" was noted in left arm and mild "chickenpox lesions". In late February he developed a rash on his hands and peeling goes to the present. Intermittent appearance of papular rash on his back and aches and pains in medial aspect of arms (lsp left) and thighs. Aches and pains temporarily relieved with aspirin. Also has tried acyclovir x 2 which "helped rash temporarily". The "cord" in left arm was diagnosed as ulnar entrapment neuropathy" and is "probably coincidental". Pt consulted with a doctor at CDC who stated there some similar reports. He also spoke with Merck who offered to biopsy lesions, but none are vesicular at present. Pt will fax and mail a complete progress note and lab test results currently available.
1/7/22 37-year-old male presents the ICC complaining of headache, nasal congestion, occasional cough, and scratchy throat. Patient states that he had his booster this past Sunday and started feeling bad the following day.  He thought he was having symptoms related to the booster. Symptoms persisted and he checked a home test which was positive for Covid. Patient denies any speech difficulty, no focal weakness, no chest pain, no shortness of breath, no abdominal pain, no nausea, and no vomiting. Patient has been vaccinated including booster. He is here with family members who have similar symptoms. Review of Systems: Constitutional: Negative for fever. HENT: Positive for congestion and rhinorrhea. 1/7/22- Scratchy throat; Respiratory: Negative for shortness of breath. Occasional cough. Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Neurological: Positive for headaches. Negative for speech difficulty, weakness and numbness
Patient awoke 1 day post vaccine with severe headache, malaise, dizziness, lightheadedness, and paleness. Patient was seen at clinic with pallor, fatigue and lightheadedness.
lower back pain; Diarrhea not liquid but with stools that don't have color; Diarrhea not liquid but with stools that don't have color; This is a spontaneous report from a contactable consumer.    A female patient of an unspecified age (Age:71; Unit:Unknown) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 15Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, The patient experienced lower back pain and diarrhea not liquid but with stools that don't have color. Outcome of events were reported as unknown.   Information about lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a healthcare worker and refers to a male patient, who is currently 61 years old. The patient did not have any pertinent medical history or drug reactions/allergies. On 28-OCT-2014, the patient received his first dose of RECOMBIVAX HB (which had a lot # of K010238 and an expiration date of 14-APR-2016; however, dose, route and anatomical site were not reported). Subsequently, he received the second and third dose on 26-DEC-2014 and 29-MAY-2015 respectively, both of which had the same lot number and expiration date. The patient did not have any concomitant medications. It was reported that, after the three dose series, the patient did not seroconvert and his titer was negative (laboratory test performed on an unknown date). It was reported that the patient visited the physician's office on an unknown date, nevertheless, no treatment was given for the reported event. No Product quality complain (PQC) was involved. At the time of reporting, the patient did not recover from the event. The reporter did not provide a causality assessment between the reported event and the suspect vaccine. Additional information has been requested.
1 hour after vaccine felt lightheaded. chest tightness. symptoms intermittent for an hour
It was a very painful injection. Arm hurt. The next day it was more painful. primarily shoulder joint/elbow/base of head in those muscles and those joints. It feels bone deep. I have a limited range of motion on my arm and neck. I cannot turn my head left like i should be able to. It always aches but certain movements can send shooting pain.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-MAY-2016, the patient was vaccinated with VAQTA "10Pk 25U/0.5 ml SD LLok w Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 384 hours and at -0.5 Celsius Degrees for 72 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
No aditional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 19-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S003872 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: (Positive) COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided
pt recvd vax;3 days later devel flu-like sxs,t 102,aches,rhinorrhea,& dizziness;exp sinus congestion,h/a,nervousness,lack of sleep,altered sense of smell;tx apap & ceclor;sxs resolved 5dec x/ exacerbated sinus congest & altered sense smell;
Pt received immunizations (FLUMIST, HepA/B, Meningococcal, MMR, Pneumococcal) on 2/18/09. Per the pt he received these vaccinations on 2/19 or 2/20/09 (he arrived at Boot Camp on 2/18/09). On 2/27/09 the pt noted a dry cough. On 3/2/09 the pt reported sick. Call with a productive cough and rhinnorhhea. He denied sore throat, earache, fever, N,V, diarrhea, headache or decreased appetite. He was treated with SUDAFED, MOTRIN and MUCINEX. Also, noted at the visit was paronychia middle finger/bilateral which was treated with KEFLEX. On 3/4/09 the pt noted numbness of his right forearm which progressed to his right hand/fingers then to his right shoulder by 3/6/09. He had minimal weakness of his UE. By 3/6/09 he also noted numbness of his left arm/hand/fingers/shoulder and "weakness in his lower legs. On 3/7/09 the pt also noted numbness from his anterior neck to his chest and his feet felt "cold and tingly". The numbness radiated to his back on 3/8. By 3/9/09 the pt was barely able to move his legs, he had problems with balance and his arms were weak. He was seen in Sick Call and diagnosed with and treated for dehydration. By 3/12/09 the pt was worse; he was having hard time walking independently; his UE were weak; he hands and feet were completely numb. The pt states he was sent to the ER and admitted to hospital on 3/13/09. Tx with IVIG for 3days and PT. Discharged on 3/20/09. 4/3/09 residual numbness on bilateral great toes.   4/15/09 Received medical records of 3/16-3/31/2009. FINAL DX: Guillain-Barre syndrome Records reveal patient experienced dry cough on 2/27/09, then developed productive cough & rhinnorhea, seen in clinic, dx w/URI & tx symptomatically.  Also had paronychia & tx w/oral antibiotics.  Patient noted numbness UEs beginning 3/4/09 & progressing to include LBP, weakness & tingling of LEs.  By 3/9 barely able to move legs.  Seen in clinic & dx w/dehydration.  By 3/12 had difficulty walking, balance disturbance & hand/feet were completely numb.  Seen in ER & admitted 3/13-3/20/09.  Tx w/IVIG x 3.  D/C to home w/PT & Neuro clinic f/u.
received a dose of Shingrix on 20January2022 and records indicate that he received a dose in September 2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose received on an unknown date in September 2020).   On 20th January 2022, the patient received the 2nd dose of Shingrix. On 20th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter stated that the patient received a dose of Shingrix late which led to lengthening of vaccination schedule. The reporter stated that the patient told, he had not received a dose in September 2020 and wanted another dose. The reporter stated that the records indicate that patient had received a dose in September 2020. The reporter was not having the lot at the time of report. The reporter consented to follow up via email.
Rash with itchiness  in the  face, neck, arms, groin, shaft of the penis, scrotum, swelling of the upper and lower eyelid and face.  Denied any neurologic symptoms, cardiovascular or respiratory symptoms. the itchiness and the rash is intense. the rash  can be notice from  distance. Consulted the primary care Dr. and was prescribed a course of prednisone of 10 day taper  starting at 50 PO mg/day.
left sided Bell's palsy.  10/26/09:  Primary Care Records received for date of service 10/17/09 to 10.21.09.  Dx:  Bell's Palsy. Assessment:  Presented with L side of face paralysis. Sensation of tingling in cheek.  L eye watery.  Had mild pain behind L ear that lasted half an hour.  Feeling of weakness.  Slight improvement noted with sense of taste. No nystagmus, decreased movement and L eye only closes about 90%, normal Romberg, normal heel walk and toe walk on exam.  No antecedent for infection. Case discussed with neurology.  Prescribed prednisone and Valtrex.  Discharged to home.  Bell's Palsy was resolving by appt. on 10/21/09.
After 6 hours after I experienced shortness of breath and I lost my voice. I could not talk for about 3 weeks and my right arm swelled up. I also had an upper respiratory type infection after my vaccine. I still continue with some SOB today. I do not have lot# to provide.
This spontaneous report as received from a consumer refers to a patient of unknown age, who is one of her grandchildren. It was reported that the patient may had received GARDASIL (lot # not reported) outside of the closing schedule. The reported was unaware of the dates when the patient received the GARDASIL injections. No adverse effect reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Fever 102.8 - lasted till afternoon of the 15th of November. No sequelae. No S/S of illness.
Mother states child started having the very next day green stool, rash (on left thigh), and fever of 101F. She spoke to her Pediatrician and advised to hold of on future doses of Rotateq. Mother and Pediatrician both believe it may have been Rotateq.
12-3 2-10 C/o Tingling in her her left fingers that started approximately 30 minutes after the injection. She head a sound in her nice like a swishing while she was getting the injection. She was instructed to move her hand and arm and use heat. She  was advised to follow up with the nurse if she did not feel any better. 12-6-2019 patient called the Rn to report that she had gone to the ER because of the tingling . The ER gave her a dosepack of Prednisone and released her to home with no restrictions . The diadnosis was Radicular Pain. Patient has is not on extern and not in school. She was told to follow up with the nurse at the clinic. .
Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016276718) on 01 June 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, site and route of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed allergic reaction. Lab data and corrective treatment were not reported. Outcome of the event was unknown. List of documents held by sender: none.
Body pains; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on Feb2021 at 03:00 PM as 2nd dose single for covid-19 immunization. Patient's age at vaccination was 52-year. The patient medical history and concomitant medications was not reported. No covid prior vaccination. No covid tested post vaccination. Historical vaccination of BNT162B2 for COVID-19 immunization as first dose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: workplace clinic. The patient experienced body pains on Feb2021. The seriousness of the event was non-serious. No treatment received for AE. The outcome of the event was recovered on Feb2021.   No follow-up attempts was possible; information about lot/batch number cannot be obtained.
After 1st shot patient experienced a "moderate" fever after the first dose and a "high" fever after the second dose.; This is a spontaneous report from a contactable consumer. An adolescent female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose, single dose and  via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as second dose, single dose for COVID-19 immunization. Medical history was reported as unknown. The patient's concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. It was also unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there's any other medications the patient received within 2 weeks of vaccination. It was reported that after first shot, patient experienced a "moderate" fever after the first dose and a "high" fever after the second dose. It was unknown if treatment was received for the adverse event.  The outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Immediately after giving the injection the patient said he felt like he was going to pass out. His head went back and his eyes rolled up in his head and it looked like he was having a seizure. It lasted for a few seconds and he looked pale. He put his head between his legs til he felt better. I called 911.
A few days after my second Shingrix injection I began to have tingling, numbness, and pain the my bilateral lower extremities.  I have seen several doctors, lab work, test, ER visit, scans etc with no accurate diagnosis.  Today is April 20, 2023 and I still have these severe symptoms which all began after my second Shingrix vaccine.
started feeling hot 6 dasy p/vax-7th day has redness around area w/swelling;having tenderness-swelling 16mm length redness w/approx same size in width;referred to MD p/soaks today;
This spontaneous report as received from a pharmacist refers to a 50 year old female patient who was physician. There were no medical history, no concomitant medication and no drug reactions or allergies. On 05-MAR-2015 the patient was vaccinated with ZOSTAVAX, lot # K020185, expiration date 27-JAN-2015, 0.65 ml, subcutaneous. On 06-MAR-2015, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. There was no labs diagnostics studies performed. The patient took AUGMENTIN as a treatment for adverse events. The patient sought medical attention via contacted with pharmacist. The outcome of injection site erythema, injection site pain, injection site warmth and injection site swelling was unknown. Relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617, 20211034734, 20211038269, 20211038411, 20211038664, 20211039749, 20211038614, 20211039732, 20211038269, 20211038442 and 20211040433.
Patient had a seizure lasting less than 1 minute. No treatment given, only monitoring of vital signs. Patient is alert and verbal.
Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 24-FEB-2016, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of severe herpes zoster. On or about 10-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed tramadol for management of her painful symptoms. 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. Additional information has been requested.
Complained of sore throat and difficulty breathing 12/16/2003.  On 12/19 face and tongue swollen.  Hives (rash) on face and buttocks 12/22/2003 recovery "feels better".
Dizziness, SkinRash, Palpitations, flushing of the hand and feet, sweating,  Narrative:
Patient fainted while sitting during his 15-minute observation period. Patient was sitting in a chair and fell to the ground and hit his head on the ground when he lost consciousness. He regained consciousness on his own within a minute of falling from the chair and was alert and oriented. Patient had a visible bruise on his head from the impact. Paramedics were called and arrived on scene to assess. Transport was then called, and the patient was taken to the ER/hospital for further tests to rule out a concussion or other underlying health issues. Patient was discharged the same day and the doctor concluded that loss of consciousness was likely just a side effect of the vaccine and concussion was ruled out.