chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; Pap smear abnormal; 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): 22K-163-4309910-00.  A 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19"; SMEAR CERVIX ABNORMAL (non-serious), outcome "recovered", described as "Pap smear abnormal". The patient underwent the following laboratory tests and procedures: smear cervix: unknown results. The action taken for adalimumab was unknown.  Clinical course: Solicited report by a consumer of an adult female with events of non-serious Covid and Abnormal pap smear but it was not cancerous with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced COVID and Abnormal pap smear but it was not cancerous. On unknown dates, Covid and Abnormal pap smear but it was not cancerous resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Covid and Abnormal pap smear but it was not cancerous with Humira (Adalimumab) was a reasonable possibility.  Causality for Pfizer biontech covid-19 vaccine(tozinameran): The reporter's causality for the events of Covid was related and Abnormal pap smear was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, the reported event of pap smear abnormal is assessed as unrelated to vaccine ,due to known pathophysiology on the medical condition. 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.
shaking, chills, strong headache, nausea, cardiac colic, sweating profusely, lower leg's viens increased in size
6 month old patient  inadvertently received the Fluzone HD, no adverse event; 6 month old patient  inadvertently received the Fluzone HD, no adverse event; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 6 month old male patient who was vaccinated with a 0.5 ml first dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ288AB and expiration date 02-Jun-2020) via an intramuscular route in the right thigh on 20-Feb-2020 for prophylactic vaccination.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) received on 20-Feb-2020 for prophylactic vaccination.  Medical history and concomitant medications were not reported.  It was an actual medication error case due inappropriate age at vaccine administration and overdose.  No adverse event was 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.
They intended to use FLUBLOK but instead gave the High Dose to someone that was 60  with no reported adverse event; They intended to use FLUBLOK but instead gave the High Dose to someone that was 60  with no reported adverse event; Initial information received on 22-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 60 years old and unknown gender patient and reporter reported they intended to use Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv]  but instead gave the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] to someone that was 60  with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine (with an unknown strength,formulation, expiry date and lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the reporter reported they intended to use Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv]  but instead gave the Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] to someone that was 60  with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day).  It was reported, Good afternoon, I was calling to report a (unintelligible) incident. I had a customer reach out to me about giving the wrong flu product to a customer. They intended to use FLUBLOK but instead gave the High Dose to someone that was 60 and I was just calling to report that. I am the staff on the account. Feel free to give me a call back if you have any questions. I believe the physician called in to report it as well. I think it should already be in the system but just wanted to get this reported. Please let me know if you need anything else.   Action taken: not applicable.  Outcome: Unknown for the reported events  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.
extreme headache lasting for 5 days.  Felt immense pressure  in whole head area.  Headache not completely resolved with ibuprofen or acetminophen at maximum recommended doses .  Headache did finally resolve after the 5th day.
Tinnitus starting ~ 2 hours after the vaccination was giving. I've had this non-stop since the onset. I have an appointment with an ENT in the next week
This spontaneous report as received from a 77 years old female patient refers to herself (140 lbs, 62 inch) with high blood pressure, allergy to penicillin and allergy to LIPITOR. The patient's medical history included heart attack in 2002. The patient was vaccinated under the skin of the left arm with a dose of ZOSTAVAX (lot # not reported) on 09-MAR-2012. Concomitant medications included LIPITOR, generic atorvastatin calcium and unspecified blood pressure medicine. It was reported that after the patient got ZOSTAVAX on 15-MAR-2012 she had had an incident of burning and itching all around her neck. The patient also stated that she had gotten an ultrasound this same time (in March of 2012) that produced a horrible burn around her neck. However she said this came and gone. She said she also took LIPITOR and stopped taking it for 3 days and the pain and itching stopped. She took the LIPITOR again this Sunday and today she had the itching and burning had come back. She called her cardiologist today and he advised her to discontinue the LIPITOR. She said she had been using LIPITOR for about a year, but switch to the generic version (atorvastatin Calcium) in 13-MAR-2012. Unspecified treatment was given for the adverse events. On 11-SEP-2012 echocardiogram was performed and the result was not reported. The patient was not pregnant. The outcome of the adverse events was unknown. Additional information is not expected.
On or about April 7, 2021, I started to have soreness in my tendon between my left elbow and left wrist.   This pain has intensified and is present today.  On or about April 7, 2021, I started to have pain in my cervical spine.  Some time previously, I had a herniated disk, which continues until today.  The pain in my back (spine) intensified over a few days time, requiring pain medication (Hydrocodone).   Also, I have numbness in my index, middle finger and thumb.   Also, I  have pain in my right arm, presumably due to the herniated disk pressing on a nerve. Today, I continue to have these symptoms.   I believe that the nerve pain in my back started, or was aggravated, by the Pfizer vaccine.  The pain continues.
Patient developed the immediate onset within 1-2 hours of  severe coughing, shortness of breath, wheezing, increased intestinal gas, sore joints, throat pain and low grade fever of 99.8. Coughing and shortness of breath continued to worsen over the day and evening and persisted for several days requiring treatment with prednisone. There were no other apparent causes for these symptoms except for the COVID-19 vaccination.
Experienced itchy rash on torso and back (quarter sized circles) within a day or two of receiving second dose of vaccine; This is a Marketing Program spontaneous report from a non-contactable consumer or other non hcp (Patient) via a sales representative. A 21-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced Itchy rash on torso and back (quarter sized circles) within a day or two of receiving second dose of vaccine. The clinical outcome for the event was unknown. Reporter does not wish to be contacted for follow-up.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
lower lip swelling; treated with Prednisone 40mg every day for 5 days and Zyrtec 10mg twice a day for 7 days; diagnosis of lip angioedema; mild pain with  swelling and 2 oral mucosal ulcers on inner lower lip.
while drawing it out the pressure squirted the vaccine in their eye; while drawing it out the pressure squirted the vaccine in their eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 25-year-old female patient who received Herpes zoster (Shingrix) (batch number 7l777, expiry date 22-AUG-2025) for prophylaxis.   On 01-NOV-2023, the patient received Shingrix. On 01-NOV-2023, an unknown time after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: while drawing it out the pressure squirted the vaccine in their eye) and exposure via eye contact (Verbatim: while drawing it out the pressure squirted the vaccine in their eye). The outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 Pharmacist reported that a student was mixing Shingrix and while drawing it out the pressure squirted the vaccine in their eye, and they already washed their eye, which led to exposure via eye contact and occupational exposure while preparing product for administration. The pharmacist inquired any information available, what were the next steps, any side effects/problems that might occur from this. The reporter did not consent to contact.
Chest pain, spreading across chest and then into arm.  Tightness in neck.  occured 3 days after vaccine given, progressed. she went to the ER
About 14 hours after dose was given, patient experiences labored breathing and sweating for four hours.
This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to ENGERIX. Additional details were provided as follows: The other healthcare professional reported that the patient might have had an allergic reaction after vaccination with ENGERIX B. No further information or clarification was obtained.
chicken pox like rash noted under arm and near site as well as rib cage; very itchy
This spontaneous prospective pregnancy report was received from a certified registered nurse practitioner, concerning a 32 year old female patient. The patient had not medical history, drug allergies, previously drug reactions and concurrent conditions reported, and her concomitant medication included PRENATAL PLUS, as prenatal vitamins. The Last Menstrual Period date (LMP), date of conception and estimated delivery date (EDD) were not reported. On 03-OCT-2017, when she was 27 weeks of gestation, the patient was vaccinated with a dose of GARDASIL 9 in the left deltoid, lot number N017542 with expiration date in 21-NOV-2019 (strength and route of administration were not provided) instead of TDAP, for prophylaxis. The reporter confirmed that this event was not a result of product confusion but a result of human error, no treatment was given to the patient and no laboratory diagnostics or studies were performed. At the time of the report, the pregnancy outcome was pending and the fetal outcome was unknown. No adverse effect was reported.
This case was received from a health professional on 02 October 2007. A 69-year-old female patient with a history of osteoarthritis, diverticulitis, and osteopenia received a left arm injection of YF-VAX (lot number UF102AA) on 26 September 2007. The patient was taking estradiol concomitantly, and was not ill at the time of vaccination. Within 48 hours of receiving the vaccine, the patient experienced dizziness, nausea, and "extreme lethargy." The events recovered spontaneously within 24 hours, and then returned in another 72 hours. Following the second occurrence, the events resolved within "4-5 hours." According to the reporter, the patient had recovered. Follow-up information received on 11 January 2008 from a health care professional. Per the reporter, the last symptoms experienced by the patient were nausea, dizziness, mild aches, a sleepy feeling, and feeling cold which appeared on 02 October 2007 and only lasted a few hours. There were no further symptoms. All symptoms resolved without treatment on 02 October 2007.
joint pains (both hips and knees)/her hips hurt/her knees hurt/such bad joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pains (both hips and knees)/her hips hurt/her knees hurt/such bad joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (joint pains (both hips and knees)/her hips hurt/her knees hurt/such bad joint pain). On 21-Apr-2021, ARTHRALGIA (joint pains (both hips and knees)/her hips hurt/her knees hurt/such bad joint pain) had resolved. Not Provided          Treatment information was provided by the patient who stated that she used Mobid and Alleve. She stated that the pain began to decrease starting on 09-APR-2021. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Followup received on 21-Apr-2021, patient race and ethnicity updated, event outcome updated to recovered.
SKIN PAIN; DIZZY; ARM HURTS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced skin pain. On 2021, the subject experienced dizzy. On 2021, the subject experienced arm hurts. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and skin pain, and the outcome of arm hurts and dizzy was not reported. This report was non-serious.
Initial and follow up information has been received from a registered nurse via a company representative concerning a 54 year old female patient with an unknown medical history how on 7/6/05 at 8:30am was vaccinated in the left deltoid with a dose of Pneumococcal 23v polysaccharide vaccine lot 650457/0973P. On 7/6/05 previously reported as 7/7/05, at 9:00pm, the patient developed a bad pain in the shoulder/arm and chills. It was reported that the reaction was red and swollen and was pronounced in the arm where the injection was given (from the elbow to the shoulder). Follow up information from the nurse confirmed that the patient had a large local reaction to the injection that was painful at the site with chills. The patient was directed to put ice on the arm and take ibuprofen by the nurse who saw her on the follow up visit. It was also reported that the patient recovered on an unspecified date in July 2005. Follow up information from the nurse also indicated that the pt had a previous vaccination with Pneumococcal 23v polysaccharide vaccine on 3/7/05 and noted that the one given on 7/6/05 was given in error, thus the reaction. There was no product quality complaint involved. Additional information is not expected.
Itchy face that lasted 2 mins; tightness in the throat lasted about 2 minutes; complete facial numbness; pressure behind right eye.; sore throat possibly swollen lymph nodes; sore throat possibly swollen lymph nodes; This is a spontaneous report from a contactable other health professional (patient). A 35-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), intramuscularly on 22Dec2020 13:00 at single dose on left arm for COVID-19 immunization in hospital. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient known allergy included hydrocodone. The patient experienced itchy face that lasted 2 mins followed by tightness in the throat lasted about 2 minutes, 10 minutes of no other reactions then complete facial numbness and pressure behind right eye, slight pressure still and sore throat possibly swollen lymph nodes. Adverse event started from 22Dec2020 13:30. No treatment received for the adverse events. The outcome of events itchy face and tightness in the throat was recovered on 22Dec2020, of the other events was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
nausea, vomiting, fever, chills, sweats, body aches, headache, sore arm.  I got my shot at 3:30pm and the symptoms started at 1am that night. 2 days later they have mostly subsided but I am still very tired and occasionally sweating.
been sick since I recieved the 1st dose nausa, worst migranes, blacking out, have more sick days then not
Dizziness or lightheadedness after taking a shower.  Was not very severe and I was able to drive to work.  The dizziness lasted most of the morning and became less noticeable as the day went on.  By 5:00 pm it was hardly noticeable at all.  The morning of day 2 there was a slight dizziness still present.  As of today I think I am fine, but still feel some dizziness at odd times. The one other event worth noting is that during the vaccination, when extracting the needle from my arm there was a significant amount of blood that came out of the injection site as if the needle had penetrated a blood vessel during administration.
Headache; body aches; Chills; This is a spontaneous report from a non contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously 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 18Feb2021 at 12:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. On 10Mar2021 at 22:00, the patient experienced headache, body aches and chills. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event headache, body aches and chills was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke in the morning with left arm numbness and tingling, pressure in right upper chest.
Three months after dose 5, was exposed to family with COVID-19, then the next day I started coughing really bad. Went to urgent care and given a COVID-19 test and was positive. Given PAXLOVID and started feeling better about 2 weeks later. Since I had COVID-19 I've been smelling cigarette smoke at night every night, and still do. Isn't around anyone who smokes and but continues to smell it.
After receiving vaccine, c/o being lightheaded, dizzy, headache, left arm pain with fingers tingling, sore throat and chest tightness.
I had chills, body ache, headache, and lost of smell. I also lost some weight as well. I went the ER on Sept 26th. They did a COVID-19 test, which came back positive. My symptoms lasted about a week. About a week later, I had an infection shot. I been having pain on my left side of my stomach.
Severe chills, fatigue, muscle soreness, nausea, muscle tension, for approximately 36 hours.