chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from doctor of pharmacy concerning a female patient in her late 70s or early 60s who on 27OCT2003 was vaccinated with a dose of pneumococcal 23v polysaccharide. Subsequently, on approximately 27OCT2003, the patient developed a severe local reaction. Unspecified medical attention was sought and treatment was required. The patient was "recovering with sequalea" at the time of the report.  A product quality complaint was not involved. The reporter also mentioned a second patient who had a local reaction post vaccination with pneumococcal 23v polysaccharide. Additional  information has been requested.
Started 12/23/2020: Body Aches, Sore Arm, Fatigue, Cold Chills, Elevated Temp from normal.
very tired; slept for 2 days after getting her vaccination; This is a spontaneous report received from a contactable consumer from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "very tired"; HYPERSOMNIA (non-serious), outcome "unknown", described as "slept for 2 days after getting her vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness; swelling; pain to the touch; fever; felt lethargic; This case was reported by a consumer and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced erythema, swelling, tenderness, fever and lethargy. On an unknown date, the outcome of the erythema, swelling, tenderness, fever and lethargy were unknown.   It was unknown if the reporter considered the erythema, swelling, tenderness, fever and lethargy to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. On Tuesday, the patient received Shingrix and experienced redness, swelling and pain to the touch, tenderness, fever and lethargy. This is 1 of the 3 linked cases, reported by the same reporter.
On 7-8-2022, I started noticing an occasional cough and runny nose. I took a home Covid19 test and it showed negative results. On 7-9-2022, I tested positive for Covid19 using a home test. I went to the clinic on 7-10 and was tested for Covid19 again with positive results. The pharmacist gave me a prescription for Paxlovid. I am doing very well now and recovered. I am reporting my breakthru case of Covid19.
Initial and follow up information has been received from a registered nurse and a health care provider, concerning a 12 year old female patient who on 21-NOV-2006 (previously reported as within the last 3 months) was vaccinated intramuscularly in the right deltoid, with an 0.5 mL dose of GARDASIL vaccine (Lot #653937/0637F), and on 06-FEB-2007, was vaccinated IM in the left deltoid with an additiional 0.5 mL dose of GARDASIl vaccine (Lot # 653937/0637F). After receiving the dose on 06-FEB-2007. Subsequently the patient experienced dizziness to the point of losing consciousness. The event lasted for a matter of seconds. The patient was well enough to leave in a few minutes. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. Follow up information from the health care provider who administered the vaccine, stated that on 06-FEB-2007 after the vaccination, the patient "was really cold, she got tunnel vision and began to lose her balance." The patient rested for 15 minutes, and was sent home after evaluation by the nurse. The patient was considered to have recovered on the same day. No further information is expected.
pt. recvd. 2nd vax & exp. dizziness,insomnia,& sensations of warmth.
suspected vaccination failure; got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter knew the patient who got shingles even though he/she received Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This case had been linked with case US2021AMR188188, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188188:same reporter
4 hrs after shot: chills, joints in hands, fingers, wrists, and neck - all painful. General aches. Eyes whites red and irritated. "Felt like sand in my eyes".
Patient was given a Moderna COVID-19 vaccine before his 18th birthday.  Patient did not have any adverse effects.
Information has been received from a consumer concerning her 18 year old daughter who in June 2007, was vaccinated with a first dose of Gardasil.  On 16-AUG-2007, the patient was vaccinated with intramuscularly with a 0.5 mL dose of Gardasil.  Concomitant therapy included SYNTHROID, ALLEGRA, DORYX, and YAZ.  On 16-AUG-2007, post vaccination, the patient felt dizzy and fainted.  The patient sought unspecified medical attention.  Subsequently, the patient recovered on 16-AUG-2007.  The patient's mother also reported that the patient "couldn't calm down after vaccination with MMR II (Enders Edmonston, Jeryl Lynn, Wistar RA 27/3) (manufacturer unknown) or DTP as a baby." (WAES 0709USA01120).  Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 10:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 10:43 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 31.85.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 24-May-2021, Excursion time was 08 AM and 09 AM, temperature was 35 at both the times, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18-May-2021, vial was moved to clinic on 24-May-2021. 03 vials were sent to clinic. Vaccine BUD date was 17-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Patient describes painful right forearm starting at elbow (pt claims shot was given in elbow?).
I had my annual mammogram and they said it looked abnormal. My doctor ordered me a diagnostic mammogram. They said their calcifications. I also had a biopsy 03/28/2023 and the results were benign.
Hive started on hand.  The hives went to left toes.   She took 2 Benadryl at home on her own.   10 years ago she had a food reaction where she needed to take Benadryl.  She might get hives when there is an extreme environmental change.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THE CLINIC ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
stroke; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-FEB-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a pharmacy (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was hospitalized and treated by a healthcare provider for stroke (cerebrovascular accident). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continued suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of cerebrovascular accident was unknown. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, cerebrovascular accident was determined to be a medically significant event.
Difficulty breathing; Dizzy; Weak; Headache; Clogged ears; Just not feeling well but not sick; Tired; Some chest pain left side; Injection site pain; Muscle pain; Joint pain; Swelling; Nausea; Diarrhea; Arm pain; Awful smell; Awful smell and taste in nose/mouth; This is a spontaneous report from a contactable Other HCP (patient). A non-pregnant 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number: not reported, expiration date: not reported, Age at vaccination: 59-year-old), via an unspecified route of administration in arm left on 20Jul2021 17:00 as dose number unknown, single for COVID-19 immunization. Medical history included allergies from Pan, erythro, tetra, Prozac, and 150 foods/elements/airborne and 3x cancer survivor, complex partial seizures, vocal cords not functioning properly, migraines, broken bones, myofascial spasms, Hpylori, IBS, spondylitis, sciatica, osteoarthritis, hyperthyroidism, gerd. Concomitant medications were not reported. On 21Jul2021 06:00 AM, patient experienced difficulty breathing, dizzy, weak, headache, clogged ears, spacey, tired, some chest pain left side, injection site pain, muscle pain, joint pain, swelling, nausea, diarrhea, arm pain, just not feeling well but not sick, awful smell and taste in nose/mouth. Facility type vaccine was pharmacy or Drug Store. No other vaccine in four weeks. 11 prescriptions in two weeks were. No treatment present for adverse event. Covid was not present prior vaccination. Covid was not tested post vaccination. The outcome of events was not recovered.   The lot number for [BNT162B2], was not provided and will be requested during follow up' Vs ''information on batch/lot number has been requested.
she felt dizzy; This is a spontaneous report from a contactable Nurse (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on unknown date via unknown route of administration at unknown dose for unknown indication. Medical history and concomitant medications were not reported. Patient received the COVID vaccine. Later in the day she felt dizzy. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient called on 4/10 to report that he experienced knee pain, swollen leg, and pain on both shoulders. I advised patient to seek medical care for those symptoms.
diagnosed with an enlarged heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose:1), administration date: 13Mar2021, for COVID-19 Immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 14Oct2021, outcome "unknown", described as "diagnosed with an enlarged heart". Additional information: The patient mentioned that she took her first dose of the vaccine last 13Mar2021 and her second dose on 3Apr2021, her booster dose last 17Dec2021. She also mentioned that she was diagnosed with an enlarged heart on 14Oct2021, for which she blamed Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt claims she started to experience pain around October 10/2/2019. Pt received vaccine 8/17/2019 right arm.
Yes and got the flu anyway; Initial information received on 06-Dec-2022 regarding an unsolicited valid social media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who experienced yes and got the flu anyway after receiving vaccine INFLUENZA VACCINE.  It was  unknown if the patient experienced any additional symptoms/events .  It was unknown if the patient had any medical history, concomitant disease or risk factor  On an unknown date, the patient received a suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination  .  On an unknown date the patient developed a non-serious event yes and got the flu anyway (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available  Action Taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (Yes and got the flu anyway).  At time of reporting, the outcome was Unknown for the event yes and got the flu anyway.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history or concurrent condition were not provided. On 17-FEB-2016 the patient was vaccinated with an expired dose of MMR II (batch/lot # K001997, expired date as 10-FEB-2016, rHA (recombinant human albumin), dose and route were unspecified). No adverse effect was reported. Additional information has been requested.
L deltoid with 1mm clear vesicle @ injection site with surrounding 3X4cm oval induration with mild pain.
2APR91 began w/ inc temp (unk degree) & crankiness; 8APR91 red, raised rash over trunk & face w/continued fever; 9APR91 taken to pvt MD for sx; 10APR back to school feel better;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. On 21-NOV-2016 the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (dose, route, anatomical location, lot # and expiration date were not reported). Subsequently, on 30-JAN-2018, she received a second dose of ZOSTAVAX 19400 PFU, subcutaneously, lot # N020852, expiration date 31-JUL-2018 (dose and anatomical location were not reported). Both doses were given for prophylaxis, and the second dose was reconstituted with sterile diluent (MERCK). No adverse effect reported.
Patient said her arm became swollen, red and itchy from shoulder to elbow.  She was able to treat with ice and decrease swelling.  Resolved.
Elevated heart rate, can feel it beating and rate is up to 188 while playing tennis.  Also on 12/4 did not want to come down from 135 after stopping play.  Still had a heart rate of 185 on Thursday 1/13.  This happened after my second shot also, but I do believe it had resolved in 6 weeks or so.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea were unknown. It was unknown if the reporter considered the general body pain, headache, appetite lost, chills, pain in arm, neck pain, loss of energy, feeling bad, influenza-like symptoms, throat pain, swollen glands, fever, injection site swelling, injection site pain and nausea to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. At late afternoon, the patient had the second shingle vaccine. The patient had bad body aches, headache, loss of appetite, chills, the patient's arm was awaken and painful in the area. The patient had neck pain too and she had taken 2-225 mg Aleve. The patient was running out of fuel, feeling really really bad like she had the flu. The patient's throat was hurting, her glands were swollen. She had a temperature of 100 degrees F. She had swelling and pain at the injection site. The patient said she took Aleve 225 mg but it had not helped her headache. She also mentioned she was experiencing nausea and loss of appetite.
A rash on my inner forearm near my wrists. It looked like tiny pinprick sized blood dots at first. Now it looks more like a traditional rash. Also a little swollen. I felt a wave of dizziness. That has passed.
Employee  reported these signs with in 12 hours of injection: redness; extreme soreness; fir, swollen area; hot skin; "vesicles" "flu like symptoms" "fever for a couple of days" (employee is an R.N.) Employee has multiple allergies.
This spontaneous report was received from a nurse and refers to an approximately 10 months old female patient. No medical history, concurrent conditions and concomitant therapies were reported. On an unknown date in 2014, the patient was vaccinated with the first dose of LIQUID PEDVAXHIB dose 0.5 ml, intramuscularly for baby vaccination (lot #, expiration date and anatomical location were not reported), on 16-SEP-2014, the patient was vaccinated with the second dose of LIQUID PEDVAXHIB dose 0.5 ml, intramuscularly for baby vaccination (lot #, expiration date and anatomical location were not reported) LIQUID PEDVAXHIB dose 0.5 ml, intramuscularly for baby vaccination (lot #, expiration date and anatomical location were not reported) and on 22-APR-2015, the patient was vaccinated with third dose of LIQUID PEDVAXHIB lot # reported as K015465, expiration date 07-SEP-2017, dose 0.5 ml, intramuscularly in thigh for baby vaccination. The patient received an unspecified second vaccine in alternate thigh at the time of third dose of LIQUID PEDVAXHIB. On 21-JUL-2015, the patient was seen in office for check up. Patient's mother reported to the nurse that approximately in May 2015 (reported as "one month later, after the third dose"), a pustule developed at injection site, like a skin abscess. The patient's mother applied warm compresses to the site and site healed over time. The nurse stated, that the last LIQUID PEDVAXHIB injection site was dark purple and had a 1 cm lump which was firm, palpable, not tender. There was no fever or rash. The outcome of the events was reported as recovering. The relatedness between the events and LIQUID PEDVAXHIB was not reported. Lot number K015465 has been verified to be a not valid lot number for LIQUID PEDVAXHIB. Additional information has been requested.
Morning after vaccine patient reported muscle pain and flat red rash that spread down to elbow over 48 hr period, then started to improve. Was itchy but not painful. Muscle pain gone after 4 days.
Under-dosage was given. Administered .05mL of Fluvirin instead of 0.5mL.
Symptoms started around 8:00 p.m.  They were:   Headache,   Body aches,  very tired.   Went to bed by 9:00 p.m.,   Slept all night,   Slept through the next day and night with just a few times awake to go to the bathroom.  Monday not as tired, but still headache and body aches.   Tuesday feeling a bit better.