chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient who received the first dose of the Pfizer BioNTech COVID-19 vaccine about 3 months ago and then  developed the COVID-19 infection 2 weeks later; a patient who received the first dose of the Pfizer BioNTech COVID-19 vaccine about 3 months ago and then  developed the COVID-19 infection 2 weeks later; This is a spontaneous report from a contactable other Healthcare professional. This other HCP reported for a female consumer (patient) via medical information team.  A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed the Covid 19 virus about 2 weeks after receiving the first Covid 19 vaccine. The patient received About 2 weeks after receiving the first Covid 19 vaccine she developed the Covid 19 virus and she missed her second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. About 2 weeks after receiving the first Covid 19 vaccine she developed the Covid 19 virus. The patient wanted to know the information regarding repeating the first dose or is it ok to receive the second dose. The outcome of the events were unknown.  Follow-up: This is a spontaneous report from a Pfizer sponsored program. A contactable other HCP reported for a female consumer (patient).   Information on Lot/Batch information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
On Friday 09/20/2013 I began experiencing dizzy episode while moving head lying in a prone position. Several time Friday Sat and Sunday. On Sunday I experienced a dizzy spell while driving and feel that I am putting myself at risk as well as others and don't think I should drive.
pt recv vax;exp erythema  & arm pain w/in 24 hrs of injection;devel a dry cough,T 101 & extreme lethargy 48 hrs post inject;he claims the sx lasted for 8 hrs;
Starting about 10:00, I experienced what seemed like every nerve firing in my body at the same time. This included toothache, headache and general body ache. This lasted for about five hours and then dissipated by about 3:00 in the morning.
A case of pertussis disease in a three year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3278AA received on 05 May 2009, dose two lot number C3292AA received on 01 July 2009 and dose three lot number C3431AA received on 01 September 2009 and one dose of TRIPEDIA, lot number U3009AA on 03 January 2011 (routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 17 June 2012, approximately 17 months after the last dose. On 17 June 2012, the subject developed a cough and paroxysmal cough on 01 July 2012 with a whoop. Laboratory testing included positive PCR on 28 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 June 2012 for five days. The subject was not hospitalized. At the time of final contact on 01 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
prolonged unconsolable high pitched cry all noc p/vax;mom reported this to MD 12JUN96;
Chills, body aches, cold sweats, headache, dizziness, fatigue, sore arm
A patient experience sore arm after her first Moderna Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (A patient experience sore arm after her first Moderna Covid-19 vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MYALGIA (A patient experience sore arm after her first Moderna Covid-19 vaccine).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Pt recvd Td vax & devel fever, chills, & redness w/swelling (2.5 to 3 inches of the lt arm);
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 102 doses were given from LOT 026C21A. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non significant follow up. No new clinically significant information received.
severe pain at times in my left leg and top of left foot (veins), ongoing since the vaccination. sharp pain - still experiencing; constant ticking in my right ear (now subsided); heart palpitations and dizziness on and off (now subsided)
Second Pfizer Shot was given on right arm, broke out in mild shingles on my left upper arm. Cleared up by the following week.
Immediately after vaccine, burning in chest (esophagus or lungs?), lightheaded, flushed, sweaty, red face.  7 days after vaccine (yesterday), 2 x 3 inch swollen knot in arm, red, itchy and hot.
Tingliny tongue within 10 minutes of vaccine.  Allegra given. Felt better after approx 20 minutes.
Significant facial swelling less than 24 hours after vaccine given. Tx with epinephrine 1:1000/ml 0/4 ml. Prednisone 30 mg po and ZYRTEC 10mg po. Transferred to ER.
Had a Menveo at 11 then again at 12; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (unknown dose received at age of 11 years).   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: Had a Menveo at 11 then again at 12).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter reported that the patient received Menveo at 11 years and then again at 12 years, which led to extra dose administered. The reporter wanted to know how we proceed.  The reporter stated that there was no information available regarding patient. The reporter consented to follow up.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot number of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information has been received from the registered nurse who provided patients' details. The report refers to a 9 weeks old infant patient of unknown gender. On 20-JUN-2014, the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial was initially stored in the refrigerator on 14-Mar-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.
Pain in the opposite arm that was vaccinated.  The pain worsened the week after the shot and now the pain is severe in the opposite shoulder.  In a resting position, it feels like shoulder muscles are detaching.  I have a crackling and popping sound in the shoulder.
Since Zostavax was administered in the R deltoid area, Ms. Cubelic has had intermittent intense itching in the right arm distal to the injection site.  This happens 3 to 4 times a week and lasts up to 15 minutes. Resolves spontaneously. No associated rash, hives or systemic symptoms.  Please note that this vaccine was administered at a local pharmacy due to Medicare payment issues.
I tested positive for Covid 19 after receiving 3 doses.; I tested positive for Covid 19 after receiving 3 doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Oct2021 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 14Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: VACCINATION FAILURE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 03Feb2022 04:00, outcome "recovering" and all described as "I tested positive for Covid 19 after receiving 3 doses.". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (03Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, sars-cov-2 test positive. Clinical course:If other vaccine in fourweeks: No,Other medications in twoweeks: Advil.I tested positive for Covid 19 after receiving 3 doses. Tested positive on 03Feb2021.If covid prior vaccination: No.If covid tested post vaccination: Yes.Covid test type post vaccination; Nasal Swab.Covid test name post vaccination: PCR.Known allergies: no. Other medical history: no.  The lot number for bnt162b2 was not provided and will be requested during follow up.
T101.7 10min prior to sz episode;sz activity 7-8min;fever cont 99.4R-101 w/motrin a/afeb p/sz;tonic/clonic activity;OM;limp;tympanic membranes;oxygen;
3 cm oval area over injection site that was warm, erythematous, minimally indurated. c/o burning pain at injection site. Tx: ibuprofen. Symptoms lasted 5 days.
site where she got the vaccine injection showed hives; site where she got the vaccine injection showed hives and the area was warm/red for a few days; site where she got the vaccine injection showed hives and the area was warm/red for a few days; Facial swelling; Lip swelling; drowsy; exacerbations of her asthma; wheezing; fell asleep; Throat tightness; trouble breathing / gasping for air; This case was reported by a other health professional and described the occurrence of injection site hives in a 33-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced injection site hives, injection site erythema, injection site warmth, facial swelling, lip swelling, drowsiness, asthma aggravated, wheezing, difficulty sleeping, throat tightness and difficulty breathing. On an unknown date, the outcome of the injection site hives, injection site erythema, injection site warmth, facial swelling, lip swelling, drowsiness, asthma aggravated, wheezing, difficulty sleeping, throat tightness and difficulty breathing were unknown.   It was unknown if the reporter considered the injection site hives, injection site erythema, injection site warmth, facial swelling, lip swelling, drowsiness, asthma aggravated, wheezing, difficulty sleeping, throat tightness and difficulty breathing to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-Oct-2022 Reporter's comment: The reporter reported an adverse event that was brought to his/her attention. The reporter got a call from an allergy clinic customer who had a patient came in, had been given their Engerix-B for Hepatitis B vaccine, and was not sure if the reaction she had was due to their vaccine. They were referred this patient from a family practice clinic to see if they could test for it. The information reporter was given was, after being given the Hepatitis-B vaccine, she developed facial and lip swelling/throat tightness hours later. She took Benadryl and it caused her to be drowsy, so she fell asleep. She woke up later and had exacerbations of her asthma, trouble breathing, wheezing, gasping for air. She took her asthma inhaler and more Benadryl. The site where she got the vaccine injection showed hives and the area was warm/red for a few days. The patient received Engerix-B for Hepatitis-B. This was the only vaccine the patient received. The manufacturer was not reported, and the call was made on 31st October 2022. Additional supportive information: Concomitant medication BENADRYL was only retained in narrative, as the ingredient was "NOS" which leads to report failure. Follow-up would not be possible as no contact details were available.
pt recvd vax & went home midly fussy & 4 to 6 hrs later p/feeding & being laid supine was found limp/pale/apnic; irritable, cry, pale, unresponsive, not breathing
arm hurt; couldnt sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and INSOMNIA (couldnt sleep) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Blood sugar abnormal and High cholesterol.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt) and INSOMNIA (couldnt sleep). At the time of the report, PAIN IN EXTREMITY (arm hurt) and INSOMNIA (couldnt sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medications for  the management of high blood pressure, blood sugar, high cholesterol.  Treatment information was not provided.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported   This case was linked to MOD21-138908, MOD21-138909 (Patient Link).
November 7th at 11:00 pm symptoms were itching on trunk of body,. Patient took oral Benadryl. November 8th at 8:00 am saw Dr. (unrelated consult) noticed hives on patient's stomach, back, buttocks, breast, lower abdomen, inner thighs.  Dr. told her to take 2 Benadryl every 4-8 hours.  Patient went home.  On November 9th, symptoms worsened.  Patient called primary MD on November 9th. Patient saw PA at 1:00 pm that day. Hydroxyzine HCL  50 mg tabs 1-2 tabs three times per day for rash. This medicine did help the rash and itching. On November 10th and 11th, patient developed sore throat and body aches. On the 10th, itching and hives returned. On the 12th, the itching and hives stopped.  On November 12th, lower abdominal pain started. Dr. (GYN) was seen on November 14th. Pelvic was done on patient as she had hysterectomy on 10/26.  Hives and itching returned associated with the abdominal pain in th evening of the 14th. Pelvic ultrasound (internal and external) on November 15th due to abdominal pain. Ultrasound was normal. On November 16th got stomach flu with nausea, poor appetitie, sharp abdominal pain. Diarrhea started on the 16th pm to early 17th am. On November 18th am went to Divine Savior ER, saw Dr., due to dehydration. Urine C/S and CBC were fine. One liter of IV fluids were administered and she went home. On November 18th pm, returned to ER because symtoms did not improve. Dr. saw patient. Two IV liters were given, Phenergan for nausea, Dilantin for the pain. Patient sent home on clear liquid diet. Prochlorperazine 5 mg for nausea was given previously for gastric bypass and MD approved continued use. On November 20th, feeling somewhat better, went to church. On November 22nd, still on liquids as solids upset stomach. Patient still has diarrhea with upset stomach.
Information has been received from a 27 year old female consumer with nausea, no drug reactions or allergies and no pertinent medical history who refers to herself, for GARDASIL, a Pregnancy Registry Product, who on 13-FEB-2012, was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The consumer stated that she was administered GARDASIL on 13-FEB-2012, (dose in vaccination schedule was unknown) and it was subsequently determined on 15-FEB-2012, that she was six weeks pregnant. Her last menstrual period was on approximately 04-JAN-2012. Her estimated delivery date was approximately 10-OCT-2012. Urine test was performed at physician's office to determine pregnancy. The patient sought medical attention in physician's office. Follow up information received. Three attempts was made at follow up with no response. The case is lost to follow up. The pregnancy outcome is unknown. Additional information is not expected.
Low grade fever (99.6 F); Body aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received unknown dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 04Mar2021 at 17:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Allergies to medications, food, or other products was reported as none. Concomitant medications included VITAMIN D3 and VITAMIN C, both for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced low grade fever (99.6 F), body aches and chills. The patient did not receive treatment for the reported events. The clinical outcome of the low grade fever, body aches and chills was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient developed progressively worsening delirium that progressed to requiring hospitalization.  Patient was incoherent, unsteady gait and incredibly agitated on presentation to dialysis unit.  12/29/09 DC summary and consult notes received for DOS 08/11/09-08/20/09. DX: Altered mental status sec to uremia from ESRD.  Pt presented with altered mental status s/p HD, V/N, fatigue, inability ADL, lethargic, hallucinations, low BP, peripheral edema. Neurology consult: metabolic encephalopathy s/p HD. tx continued: HD for ESRD. Pt discharged home in stable condition.
Headache, Nausea w/o vomiting, slight dizziness, fatigue.  Resolved itself in approximately 6 hours.  Injection site soreness remains.
Pt had been taking Fasenra for asthma and stated that it seemed like he had an asthma flare-up after receiving both vaccines and was put on a Medrol dosepak for symptoms.
This spontaneous report as received from a licensed practical nurse refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with the dose of GARDASIL (lot # K014191; expiration date, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Resident developed fever or 101.9 and unresponsive. Was sent to Hospital and admitted.
Patient states she feels pain, itchiness, warmth to the touch, and a lump underneath the site of injection. There is redness that's about 1.5 inch diameter on her right arm. Advised patient to take BENADRYL, use a cold compress, and contact her PCP.
Information has been received from a registered nurse concerning a 22 year old male who was vaccinated, at his place of employment, on an unspecified date, with a dose of MMR II. Subsequently the patient experienced anaphylactic shock and was sent to the hospital, where he stayed in the critical care unit for two days. The reporter was unsure of what treatments the patient received at the hospital. It was reported that the patient recovered. Additional information is not expected.