chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; fever of 104; inject site react & axillary lymph node enlargement;rx steroids,atbs,dph,apap
Woke middle of night (04/06/21 at 3:30am) w/extreme chills.  Took 1000mg acetaminophen.  Woke back up 7am w/sweats & soaked clothing.  Felt tired w/flu like achy symptoms rest of the day.
first dose of Shingrix on 12/7/21 / the second dose on 1/11/22.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3AA9T, expiry date 20th April 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 11th January 2022, the patient received the 2nd dose of Shingrix. On 11th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose on 7th December 2021, batch number 3BD9E  and expiry date 6th April 2023. The patient received 2nd dose on 11th January 2022, early than the recommended time interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Adverse effect of other vaccines and biological substances, initial encounter on 2023-03-09.
On 12/20/2019, 1 day following vaccination, patient had a 30 second episode of closing eyes and rapidly shaking arms and legs with generalized muscle tension and toes curled downward.  Also would not open eyes to parent's voice during episode.  Appeared sleepy after episode for 20 minutes and then took a nap.
A report was received form a health care professional in 07/22/2002, concerning a 77 year old female patient who experienced a large red firm area at injection site after receiving Fluvirin on 10/09/2001. On 10/09/2001, the patient received Fluvirin, after which the patient experienced a red firm area at injection sit. The patient recovered in  approximately 3 days without treatment or intervention. At the time of reporting no further information was available. Update: A follow up report was received form a health care professional on 10/02/2002 concerning the 77 year old female patient who experienced redness, warmth and swelling  at injection site which lasted for 3-5 days. The patient did not need medical intervention and fully recovered. The reporter has assessed the relationship of Fluvirin to the event as probable. Update 10/14/2002: A follow up report was received on 10/14/2002 confirmed that the patient had received Fluvirin.
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On an unknown date the patient was vaccinated with PROQUAD lot # M018638 for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD.
Pt recvd vax & devel knotty bruise & arthritis-like pain;
Headache and "Not feel well"  2/3/21 4:20AM  Nausea, weak, tired, diarrhea 2/3/21 9:56AM Vomited and "almost" diarrhea 2/3/21 2:04PM Loose BM and nausea 7:10PM 2/3/21 7:10PM
Developed severe photosensitivity to sunlight with visual disturbances of acuity. Lasted 24 hours and seemed to resolve ( but could be because there was an absence of sun light) UNTIL  2/19/21 and then was unable to go outside because of the sunlight could not keep eyes open or leave house.  Mild problem with computer/iphone but No problem with LED, home lighting or TV  light
After the 2 days or so of injection sore pain and bump, the pain went away and then began to hurt at the left shoulder -Rotator cuff area.  This happened to Right Arm after dose 1, but less significant.  Pain and inflammation lead to poor mobility and arm movement, poor sleeping and pain at sleeping in left shoulder.  Both shoulders hurt and became inflamed after about 2-3 days post vaccine-but left shoulder really inhibits daily function.  Right to a lesser degree
Fever, chills, sweats, redness around vaccine site that extended about 3-4 inches all around injection site and was drowsy and nauseous and fainted morning after vaccine.
Information has been received from a physician concerning a 66 year old female who on 13-Sep-2007 was vaccinated with Zostavax (Lot #658207/0883U).  Concomitant therapy included "TDAP".  On 15-Sep-2007 the patient experienced an 11 x 14 cm red, inflamed area at the injection site after receiving zoster vaccine.  Within that area was a 3 x 5 raised blister.  The patient also experienced flu symptoms, achiness, and a fever just less than 102 degrees.  Follow-up information has been received from a registered nurse indicating that the 66 year old retired white female with hypertension and no allergies who on 13-Sep-2007 was vaccinated with an SC dose of Zostavax (lot #658207/0883U) in the right arm.  There was no illness at the time of vaccination.  On 15-Sep-2007 (also reported as 01-Oct-2007) the patient developed a large erythematous welt with a central blister at the injection site.  The patient sought medical attention through a doctor visit.  No labs or diagnostic studies were performed.  The patient was "recovered after 1 week."  Additional information has been requested.
Approx 10 minutes post vaccine patient reported she felt a c " cold rush" through her whole body, felt like she was shaking, developed hand tremors and then bilateral feet and calf numbness
SARS-CoV-2 Infection; SARS-CoV-2 Infection; VACCINE RESPONSIVENESS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA  This is a non-interventional study report received from a contactable reporter(s) (Other HCP).  A subject (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The subject's relevant medical history included: "Chronic lymphocytic leukemia" (ongoing). The subject's concomitant medications were not reported. Vaccination history included: Pvc13, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "SARS-CoV-2 Infection". Clinical course: With a median follow-up of 263 days (interquartile range, 241-280) from first SARS-CoV-2 vaccine, 3 subjects developed SARS-CoV-2 infection, and all subjects are alive upplemental). Two subjects (1 previously treated and 1 active BTKi) required hospitalization and received dexamethasone (n 5 2), remdesivir (n 5 2) 6 casirivimab/imdevimab (n 5 1). Both hospitalized subjects were initially vaccinated with Ad26.COV2.S with undetectable postvaccine titers (,0.04 U/mL) and received an additional dose of mRNA vaccine on study (subsequent titers of ,0.04 and 1.39 U/mL). The subject underwent the following laboratory tests and procedures: Antibody test: unknown result; Blood immunoglobulin G: unknown result; CD4 lymphocytes: unknown result; Absolute CD3+ T-cell count: unknown result; unknown result; Lymphocyte count: unknown result; SARS-CoV-2 antibody test: less than 0.04; 1.39 IU/ml, notes: after additional dose.  The reporter considered "sars-cov-2 infection" related to COVID-19 Vaccine - Manufacturer Unknown. 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 information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.,Linked Report(s) : US-PFIZER_INC-202200582227 same article/ suspect/event but different patient.;US-PFIZER_INC-202200582229 same article/ suspect/event but different patient.
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 days old male patient who received expired dose of vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE 13V for Immunization; HEPATITIS A VACCINE for Immunization; MMR for Immunization; and VARIVAX II for Immunization. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI799AAB expiry date: 01-Jul-2018 via unknown route in the left thigh. It was a case of actual medication error due to Expired vaccine used. It was also reported that expired dose not valid so re-vaccination recommended. It was also a case of Inappropriate age at vaccine administration. It was not reported that any adverse event occurred or not. 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. List of documents held by sender: none.
Right shoulder weakness and pain.  Joint pain shooting all the way to my elbow.  Trouble rotating arm without pain.  Not getting better
Red, slightly swollen, itchy area roughly 2 to 2.5 inches below the injection site. Roughly 2 inches in diameter.
Intense nausea approx 12 hours after immunization and dry-heaving for about 8-9 hours after.
Aching joints, muscle aches, hot flashes, shivering, migraines, no appetite, weak, tired, continuing thru Friday morning.
Next morning, after 2d dose, flu like feeling, mild aches etc.   Late morning, noon, rested, fell asleep for about 2 hours, woke refreshed. Arm still a bit sore but feeling great.
This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that an infant patient of unspecified gender received PREVNAR 13 for immunization at single dose at the age of 2 and 4 months, date unspecified. The patient received also penicillin. Concomitant medications and medical history were not reported. The patient's mother said that the patient had local reactions at 2 and 4 months old with bumps. It was also mentioned that after unspecified 4-month vaccines, the patient got bumps on his backs. Outcome was not reported.
This spontaneous report as received from a physician refers to a 15 month old male patient. In February 2015, reported as "last week", the patient was vaccinated with a dose of M-M-R II (dose, route, lot number and expiration date were not reported). In February 2015, after receiving M-M-R II, the patient experienced measles-like rash and fever spike. No treatment was given for the events. The patient's mom sough medical attention: she called the clinic. At the time of the report, the patient was recovering. Relatedness between the events and vaccination with M-M-R II was not reported. Additional information has been requested.
10AM began with difficulty breathing then chills and achiness. Trouble deep breathing and coughing forcefully. Hands/fingers cold and white. Nail beds turned purple. Eyes red and bloodshot, vision cloudy.
Started to have shortness of breath 4/20/2021, began using albuterol inhaler after primary care visit on 4/23/2021, went to ER 4/26/2021 due to still being short of breath and was given prednisone and breathing treatment then was sent home saying it was an asthma exacerbation. Followed up with primary doctor on 4/28/2021 with continuing and worsening symptoms now including chest pain as well as shortness of breath and was sent back to ER for more testing for pulmonary embolisms.
Patient developed dizziness and lightheadedness 5 minutes after receiving the vaccine. Clinic nurse practitioner took over and took her vitals, her blood pressure was low and heart rate was low as well. She drank some orange juice and we called paramedics to follow her further.
More than a week after receiving the vaccine I am now having a very large rash at the injection site that is sore, itchy and raised
Patient received Pfizer COVID vaccine on May 11. On May 12 Patient called patient response center reporting low grade fever, headache, and mild tachycardia (104 bpm) - patient did not report similar ADRs following first vaccine and ADRs resolved by subsequent PCP appointment (no mention in PCP documentation)
Delayed cutaneous hypersensitivity a week after first dose. Red, swollen, sore and itchy, hot to touch.
I started having a sore throat and coughing I took a home COVID 19 test on March 27, 2022 but it came back negative. I was still feeling unwell on April 1, 2022 and took another Home COVID 19 test, this time it came back positive. Once it came positive I went to the emergency room and they confirmed my test my taking a Rapid PCR COVID 19 test that also came back positive. I was prescribed PAXLOVID. I am feeling much better now.
Fever with in 24 hours of 103.7, severe body aches arthralgia, headache, dizziness, chest pain, lymphadenopathy, injection site pain.  Fever ended after 24 hours but remained with bone pain in long bones and chest pains and severe lymphadenopathy.   Took Motrin and Tylenol for discomfort.  After 6 days and still having chest pain went to Emergency room for eval.  +D-dimer and chest cat scan done.  No pulmonary embolus.  Negative troponin, chest pain unresolved but not really any explanation given.
stroke (cerebrovascular accident); Initial information was received on 07-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional.  This case involves a female patient (age unspecified) who had a stroke (cerebrovascular accident), after she received INFLUENZA VACCINE.  Medical history, concomitant medications, past vaccinations and family history were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious stroke (cerebrovascular accident) in less than a month following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It is unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  The information on batch number was requested; Sender's Comments: This case concerns a female patient (age unspecified) who experienced cerebrovascular accident in less than a month after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. Information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Patient had a positive covid test on 10/12/2021 despite having received 2 covid vaccines on 2/12/2021 and 3/12.2021
Information has been received from a health professional concerning a 5 year old male who was vaccinated with a dose of Zostavax. No adverse reactions were reported. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the health professional who stated that the patient was supposed to receive a dose of Varivax instead of a dose of Zostavax. The error occurred because both vaccines were stored in the same location and a wrong vaccine was grabbed. The child was reported to be "fine". It was reported that now both vaccines are being kept in different containers and are clearly labeled. Additional information has been requested.
I have a patient here that received his 1st dose of the Moderna Covid-19 vaccine on 28Oct2021.; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I have a patient here that received his 1st dose of the Moderna Covid-19 vaccine on 28Oct2021.) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I have a patient here that received his 1st dose of the Moderna Covid-19 vaccine on 28Oct2021.). On 28-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I have a patient here that received his 1st dose of the Moderna Covid-19 vaccine on 28Oct2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "latex" (unspecified if ongoing); "CAD" (unspecified if ongoing). Concomitant medication(s) included: TOPROL oral, start date: 24Jun2022, stop date: 28Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive, notes: PCR CT values at 22. Therapeutic measures were taken as a result of drug ineffective, covid-19.The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical course: Patient received vaccine and also she was on other medication in 2 weeks.Patient was on Anti-viral treatment with Paxlovid. Treatment start date was 24Jun2022 and stop date was 8Jun2022 with indication COVID 19 treatment, Oral. Patient completed full course of treatment. felt better, tested negative on antigen. 2 days after finishing course and testing negative, developed fever, cough. Tested positive on antigen and PCR CT values at 22.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
PATIENT STARTED OIUT FUSSY AND SORE, OVER NEXT FEW DAYS WAS SICK, IRRITABLE, VOMITING, FAST HEARTBEAT, DIFFICULTY BREATHING, CONSTIPATION.
Had chest noises, wheezes & spit blood. Throat swelling a lot when lying down at night. Sit in recliner, legs & feet swelled still.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 72-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Four days after injection, patient noticed redness - about 3 to 4 inches around injection site, was itchy and she thought her temp was elevated (8=98.9). I recommended Benadryl. She saw doctor next day - no temp. Dr told her take Benadryl and watch for any signs of infection - outlined circumference of red area.
About 1 week after receiving the booster shot, I was driving at night and noticed extreme glare from oncoming headlights. I had never experienced this before and I was concerned about driving any longer. I called my optometrist who did a full eye exam and they referred me to  saw me and said I needed cataract surgery on both eyes. So far, I have had cataract surgery on the left eye (01/25/2022) and plan to have surgery on the right eye on (02/10/2022).
Chills, fever, exhaustion, nausea, headache   Delay in period (no period since the vaccine), over a week late. Hot flashes and sweat night appears for over a week (2 weeks after the vaccine). I was regular before the vaccine and never experienced hot flashes before.
Patient was seen in COVID vaccine clinic for first dose of Pfizer vaccine. Patient has a history of vasovagel episodes related to anxiety and past healthcare appointments.  Per mother patient has "White Coat Syndrome", and has been 2 years since previous episode. Given history patient laid supine on examination table for vaccine. Immediately following vaccine patient complained of lightheadedness and lost consciousness for approx 30 seconds. Patient woke up to stimulation but continued to complain of "fuzziness". Initial vitals HR 45, BP 100/51, MAP 73, RR 14, and sats 99% with bounding pulses.
Had influenza symptoms (fever, cough) and positive NP swab for influenza despite adequate immunization.  1/6/06, 2/6/06, 12/5/06, 11/21/07.
Small Burning rash on neck 24 hours after injection. Went away after 3 days.