chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: While sitting in waiting area after vaccine: client became weak, and walked towards assistance saying he did not feel well and could not see well. Responded yes to question about sensation in the lips, tounge or throat so 1 epipen was administered. He reported feeling better within 1-2  mnutes. He sat for observation for 30 more minutes and left asymtomatic.
3 1/2 hrs p/DTP given pt had brief cyanotic, limp spell; did have t102 @ time; seen in ER & felt to have nl exam;
pt took 2nd capsule on 4SEP & had dinner & had diarrhea then 6SEP woke up @ 4AM; had diarrhea & vomited; diarrhea cont every hr & still took 3rd capsule that noc;
A student received a Hep B vaccine at school on 10/28/1999. Broke out in hives that evening. Mother took to MD who said that the pt should no longer receive vaccines.
Dizziness - no focal weakness, numbness, headache, visual changes, chest pain, SOB, rash or pruritus. No abdominal pain History of asthma denies taking any medications. Reports she did not eat today VS: 120/79, HR 77 bpm, O2 Sat 95%, PERRL,  heart and lungs clear to auscultation. Oropharyngeal clear with no swelling Pt resolved completely with rest and leg elevation. Pt was advised to seek immediate re-evaluation if symptoms return
The pt experienced swelling of the big toe and loss of power of right foot. The left foot became bad. Can not run or exercise. The pt has has a reaction to all four injections.     27 Febuary 2003  I reported a negative event in April 27 2001 with my Anthrax series. i was activated in the navy on Dec 13, 2001 and have been doing well with my side effects since then, the side effects from 2001 were swelling of my big toes and loss of feeling in my feet. I receive a booster Anthrax shot in Feb 2003. i was apperhensive of my bad experience. For 3 days after the shot, the bottom of my feet felt normal, I could feel things and did not experience any usual pain. After 3 days the bottom of my feet went back to not having feeling and always having some pain. Have any of the other people who have received Anthrax shots had the same reaction? Is there any cure?  Follow up on 12/28/2000: "Patient partially recovered from adverse event.  Toes on both feet are numb.  No power in toes, gets worse with exercise."
This spontaneous report as received from a 75 year old female patient regarding herself. The patient had her thyroid removed.  The patient had no drug allergies or reactions. On an unknown date in 2008 or 2009 (reported as 4 or 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). Concomitant medications included unspecified blood pressure pill and thyroid pill. On 01-SEP-2013, the patient developed shingles in an unspecified unusual location of her body after having had an unspecified shingles vaccine that may be ZOSTAVAX. The patient was treated with hydrocodone, acyclovir, lidocaine oral topical solution. There was no lab tests performed. The outcome of shingles was reported as not recovered. The patient sought medical attention. Additional information has been requested.
tested positive for COVID; tested positive for COVID; loss of smell; This is a spontaneous report from a contactable other hcp. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), via intramuscular on 18Feb2021 (age at the time of vaccination was 50-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), via intramuscular on 28Jan2021 (age at the time of vaccination was 50-year-old) as dose 1, single for COVID-19 immunisation. On 05Oct2021, the patient experience loss of smell. On 07Oct2021, patient tested positive for COVID. The patient underwent lab tests and procedures which included nasal swab Covid test resulted positive on 05Oct2021. It was unknown if patient received treatment for the event. The clinical outcome was recovering for the events.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event s drug ineffective and covid19 cannot be totally excluded.
ER dx 12MAY96 mild lt arm allergic rxn;lt deltoid hyperemic mildly tender reused 5cm wheal;11MAY96 AM arm red-swelling&itching worse 12MAY96 so to ER:DPH given;
the mRNA vaccines do not work very well for the patient; the mRNA vaccines do not work very well for the patient; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000004143.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "It was reported the patient is a liver transplant recipient" (unspecified if ongoing), notes: It was reported the patient is a liver transplant recipient. The patient's 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 "the mRNA vaccines do not work very well for the patient". Clinical course: On 06Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose (booster) for COVID-19 immunisation. It was reported the patient was a liver transplant recipient and the mRNA vaccines did not work very well for the patient because of the medications he takes.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
redness, rash, itching on both arms.  Steroid injection at Urgent Care and Medrol dose pack rx'd for treatment.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient with none medical history and none drug allergies. On 23-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J004747, exp 20-JUL-2013). There was none concomitant medication. Pharmacist reported that the patient experienced an injection site reaction hours after receiving the PNEUMOVAX23. Pharmacist stated that the patient experienced itchiness and swelling at the injection site which spread on the arm. There was no lab diagnostic studies performed. The patient was treated with Ice, unspecified antihistamine. Pharmacist stated that patient reported that the area was much better as of 26-SEP-2013. The outcome of the adverse events was reported as recovering/resolving. Additional information has been requested.
Extreme fatigue; Uncontrollable chills for 3 hours; Flu like symptoms; Generalized muscle soreness; Stuffy nose and ears; Stuffy nose and ears; Short of breath; Loss of appetite; Headache; Headache; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 08Jan2021 07:15 at right arm, at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 28Dec2020 at right arm, at single dose for covid-19 immunization, and experienced mild headache and mild arm soreness. The patient received the second dose, and experienced extreme fatigue, uncontrollable chills for 3 hours, flu-like symptoms (headache, generalized muscle soreness, stuffy nose and ears), short of breath, loss of appetite, all at 08Jan2021 13:00. The outcome of the events was recovering. No treatment was received for all events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Headache / Nausea / Vomiting / Fever / Numb tingly feeling on face
Left arm swelling and redness after Pneumococcal vaccine 23 valent. No report of SOB or fever. Given Prednisone 20 mg tab, 1 tablet daily x 3 days & Loratadine 10 mg tab, 1 tab daily Dispense #30 with no refill. Use cool packs on affected areas & return for worsening symptoms to reevaluate promptly.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. On unknown dates the patient were vaccinated with improperly stored ROTATEQ lot # L008031, expiration date: 03-AUG-2016; lot # L008574, expiration date: 22-NOV-2016, orally (dose, dose # and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; LISINOPRIL. Past drug history included: Rituximab, start date: Mar2022, for RA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Aug2022, outcome "unknown" and all described as "Tested positive for Covid using rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: positive for Covid using rapid test on 01Aug2022. Therapeutic measures were taken as a result of covid-19. Clinical course: The patient tested positive for Covid using rapid test on 01Aug2022. She started Paxlovid with evening dose on 02Aug2022. Took final dose of med on 07Aug2022 morning. Tested positive for Covid on 08Aug2022 so not a rebound case. Waiting to see if symptoms return. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness and swelling started morning after, along with some tenderness. Taking ibuprofen and BENADRYL to help.
Armpit pain, slight neck stiffness, and felt like I had a mild sunburn all over my body. Any material that touched my skin hurt and water while taking a shower stung my skin. I took Tylenol and slept. I still continue to have armpit tenderness.
PATIENT CAME IN FOR VACCINE WITH HER MOTHER.  SHE WAS ADVISED TO STAY IN THE STORE FOR 15 MINUTES AND HYDRATE AFTER RECEIVING THE VACCINE.  THE PATIENT AND HER MOTHER CHOSE TO LEAVE THE STORE IMMEDIATELY AFTER RECEIVING THE VACCINE.  THE PATIENT STARTED TO FEEL LIGHT-HEADED IN THE PARKING LOT.  SHE FAINTED.  HER MOTHER CAUGHT HER.  SHE DID NOT HIT HER HEAD.  I WAS INFORMED SHE FAINTED.  WHEN I WENT OUTSIDE TO CHECK ON HER, HER MOTHER STATED SHE THAT PATIENT HAD NOT EATEN THAT MORNING AND WAS VERY NERVOUS.  THE MANAGER ON DUTY CALLED 911.  I RAN BACK IN AND GRABBED A BOTTLE OF WATER FOR HER AND A BOTTLE OF ORANGE JUICE.  THE PATIENT WAS SITTING UP AND CONSCIOUS. MANAGER STAYED WITH HER UNTIL 911 ARRIVED.  THE PARAMEDICS EXAMINED THE PATIENT AND THE PATIENT WAS RELEASED TO LEAVE WITH HER MOTHER.  I CALLED THE PATIENT'S MOTHER SEVERAL HOURS LATER.  THE PATIENT WAS FEELING MUCH BETTER AFTER EATING SOMETHING.  I ADVISED THE FAMILY TO CALL US WITH ANY FURTHER QUESTIONS OR CONCERNS.
This spontaneous report was received from a female patient in her 50s reporting on herself, via company representative. She had diabetes, asthma, clostridium difficile infection and pneumonia. She did not present drug reactions/allergies. On 12-JAN-2016, the patient was vaccinated with ZOSTAVAX PREFERIGERATED vial 19400 plaque-forming units (PFU), 1 shot (dose, route and lot number were not reported). No concomitant medications were reported. On 13-JAN-2016, 2 days after onset of therapy the patient experienced injection site swelling, hot and shooting pain. She also reported injection site tenderness, chilling, flush and headache. The patient sought medical attention and contacted a physician. The physician told the patient to take ibuprofen, BENADRYL and to place ice on the swelling area. At the time of report, the outcome of flushing and chilling was reported as recovered. For the rest of the adverse events, the outcome was recovering. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Rash - (urticarial & papular) in 10 cm + 6 cm area around injection site.  Began 3 days after shot -> still there at day 5.
Car accident; Broke left wrist; Humerus bone; Achiness; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4200465-00.  A 57 year-old patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 57 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ROAD TRAFFIC ACCIDENT (medically significant), outcome "recovering", described as "Car accident"; WRIST FRACTURE (medically significant), outcome "recovering", described as "Broke left wrist"; HUMERUS FRACTURE (medically significant), outcome "recovering", described as "Humerus bone"; PAIN (non-serious), outcome "recovered", described as "Achiness". The action taken for adalimumab was unknown.  Causality for Humira : The reporter's causality for the event(s) of broke left wrist and humerus bone unknown onset, broke left wrist and humerus bone unknown onset, achiness for day due to vaccination and car accident with humira(adalimumab) was no reasonable possibility. opinion is that there is no reasonable possibility that the events of broke left wrist and humerus bone unknown onset, broke left wrist and humerus bone unknown onset, achiness for day due to vaccination and car accident are related to humira(adalimumab).  Causality for BNT162B2: The reporter's assessment of the causal relationship of the events with the BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events wrist fracture, humerus fracture, pain and road traffic accident cannot be excluded, However co-suspect humira, is the confounding factor for causality assessment that seems to be more likely explanation for causing the events.  The case will be reassessed if additional information becomes available. 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.
Pt was given ADACEL 11/15/10 then it was discovered that pt had already been given ADACEL 4/08.
Diarrhea  9/25/2021 - 12/18/2021 (12 weeks)
Violent case of diarrhea; Cold hands feet; Mild Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild Soreness), DIARRHOEA (Violent case of diarrhea) and PERIPHERAL COLDNESS (Cold hands feet) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN (Mild Soreness). On 31-Jan-2021, the patient experienced DIARRHOEA (Violent case of diarrhea) and PERIPHERAL COLDNESS (Cold hands feet). At the time of the report, PAIN (Mild Soreness) and PERIPHERAL COLDNESS (Cold hands feet) outcome was unknown and DIARRHOEA (Violent case of diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Client stated she had an extremely painful right arm. It had started shortly after the vaccine was given and has continued until she called us on 10/27/2010. She stated it was difficult to raise her arm.  Client was advised to see her family doctor.  She was called 11/04/2010 and has not been seen yet. She has an appointment in two weeks.  Her arm feels slightly better.
This is a spontaneous report from a Pfizer colleague reporting for her daughter. A 17-year-old female patient of an unspecified ethnicity received third dose of TRUMENBA, via an unspecified route of administration on an unspecified date at 0,5ml single dose. The patient medical history and the patient's concomitant medications were not reported. About 45 minutes or so after the dose administered the patient experienced dizzy, vision became darken and started to shake. The patient previously had received the first and second dose of the same vaccine on unknown date. The mother, a non-practicing nurse sat her down, covered her with a blanket and got her some OJ and protein. The outcome of the events was unknown. Follow-up (11AUG2016): Follow-up attempts are completed. No further information is expected.
Redness and dime size wheal above injection site in left arm. Denied itching. Dr examined. Cold pack applied to site and BENADRYL given.
I woke up not feeling well. I was pale in color and felt nauseous, light headed and my ears were ringing. I took my blood pressure and the reading was 120/71 with a pulse of 54 which is really low. I went to the Dr. to be evaluated. Dr. felt it was a vasovagal response. I will continue to monitor myself and if it continues, I will see a cardiologist.
About 30 hrs after vaccine I had fever of 99.8, cramps, diarrhea, nausea and chills.  Had vaccine 6/5/2021 and still have fever varying from 99 to 100.4 at 9:35 pm 6/7/2021. Body aches and chills.
Pt received TDAP on 4/18/06. Received phone call from mother of pt on 4/20/06. States pt started complaining 4/19/06 at 21:00 PM of a burning, stinging, quick shooting pains under R shoulder blade and going down his back. Pt had worked in flower garden digging up hard clay and moving dirt with wheel barrows and had gotten sunburned after receiving TDAP. States back itched but hurt worse when he scratched it. Pain relieved some with a cold shower. Advised mom to take child to MD and report receiving TDAP and events that took place afterwards also.
3 periods in 2 months. Abnormal menstruation. Then no period for 40 days.
Information has been received from the doctor's nurse concerning a 61 year old female who on 01-MAY-2009 was vaccinated subcutaneous injection, 0.65 ml, with ZOSTAVAX (Merck). Over the weekend the patient thought was running a fever, but didn't take her temperature. There was also a raised red spot at the injection site about 3-5 inches in diameter. The patient sought unspecified medical attention and was feeling "fine", but the spot was still there. The patient was recovering. Additional information has been requested.
Approx 4 hours after receiving PNEUMOVAX her (R) arm became tender, red and swollen-proximal (R) arm. Also developed nosebleed. (R) proximal anterior arm is erythematous with increased warmth and mild/mod edema. Tender. Cold application, BENADRYL and TYLENOL given.
an expired dose of Pentacel was inadvertently administered/No AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves patient of an unknown demographics who received expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot C5543AA) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error as an expired dose of Pentacel was inadvertently administered.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Admit 5/17. Vaccine 2/10. CHief complaint in ED lower back pain. Hx of Leukemia, degenerative disc disease. Developed high feveral. Admit COVID PNA. Elavated LFT, inflammatory markers. Neg CXR, CT shows lower lobe PNA. Treated w/antibiotics, steroid. Remained asymptomatic respiratory wise, stable on RA. DCd to home
57 y/o with past medical history of HTN who presents with dizziness and diaphoresis post vaccination. Patient states that this is the first dose in the two-dose series. Patient states that vaccination was received to the right arm. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. Patient evaluated by the NP and Paramedics. Patient placed in Trendelenburg position. Patient initial vitals all within normal limits (118/81 BP, 86 HR, 96% O2 RA and 12 Resp). Within 5 mins of Trendelenburg position patient states feeling better. Patient states that the reaction is probably due to fearing needles. Patient placed in sitting up position and water provided. Patient vitals remained within normal limits. Patient discharged in stable condition.
Redness and induration in right thigh 2 days after administration, measuring 3.5 x 3.0 cms. No tenderness. Patient c/o some itching. BENADRYL has prescribed on 7/6/09.
A report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres (frequency not reported). FLUMIST QUADRIVALENT started on 10-Mar-2016. It was reported that patient had been received expired dose. The outcome of the event of pt received expired dose is unknown. The report was considered to be non-serious.