chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse. This nurse reported for a patient of unknown age, gender and race who received a single dose of PREVNAR 13 on unknown date. The patient experience allergic reaction with rash and significant swelling of leg on unknown date. It was also reported that it blanches with pressure. There was no clear indication that the reported events occurred after 4th or 5th administration of PREVNAR 13. The outcome of the events was unknown at the time of this report. Follow-up (05SEP2012) Follow-up attempts completed. No further information expected.
PATIENT HAD A ABSENCE SEIZURE IN HOME ON 01/27/2008.  PATIENT HAS HISTORY OF SEIZURES DIS-ORDER.  NO RECENT ILLNESS OR FEVERS.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Patient stated that he received the shingles vaccine  (Shingrix) in his left arm on Friday and presented to the emergency department with right arm swelling, redness and pain.  Ultrasound of the arm was done in the emergency department which confirmed a DVT in the right arm  as a possible ADR from the vaccine that he received on Friday.
pt recv vax;pt's leg swollen & red rt leg;inconsolable crying for 2 hr;PC to mom, states stopped crying,sleeping & eating well;mom to call back if further problems;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2020 as dose 1, single (Batch/Lot number: unknown), in right arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm, in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and in Aug2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Augmentin, reaction(s): "Known allergies: augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details indicated that COVID 19 Treatment was given from 22Dec2022 to 27Dec2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine use by date was 6/23/21, patient received the vaccine 1 day past the use by date. No adverse reactions experienced by the patient known
Left arm pain in deltoid, then significant increase in burning pain in whole upper arm with increased sensitivity to touch to whole upper arm. Left forearm/hand numbness/tingling. Right upper arm pain.
small knot noted at injection site. Pt reported area became red, firm and itchy next day and nodule increased in size.
Patient stated she felt dizzy and faint and then passed out for about 5 seconds. Appeared pale, but quickly was alert and oriented. BP's 108/68 and 102/70. HR 68, pulse ox 98%
ON 1/1/21, DEVELOPED SWELLING ON UNDERSIDE OF LEFT ARM. DISCOMFORT IN THE AREA AND PAIN RADIATING TO HER LEFT BREAST. ON 1/4/21, STATES THAT THE SWELLING IS RESOLVED AND THE PAIN IS IMPROVING, BUT STILL PRESENT IN THE LEFT BREAST.
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-JAN-2016, the patient was vaccinated with PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 344 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
nasau; diarrhea; Soreness then pain in the left arm; Later during the night, severe chills; Later sweats; This is a spontaneous report from a contactable consumer (patient) reported himself. A 61-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot Number: ER8727), via an unknown route of administration in left arm on 23Mar2021 at 16:00 (at the age of 61-years-old) as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient's medical history included allergies, high cholesterol, acid reflux, prostate cancer and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Yes, other medications in two weeks. Other vaccine same date was none. On 23Mar2021 at 22:00, the patient experienced soreness then pain in the left arm. Later during the night, severe chills and Later sweats. Next day, same thing with nausea and diarrhoea. Event resulted to visit emergency room/department or urgent care. No COVID tested post vaccination. Received fluids, medicine for nausea and pain as treatment and blood work was unknown. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
After patient's second dose of Pfizer vaccine, he developed chest pain, consistent with myocarditis. Got his second vaccine on 6/2 and then developed symptoms on 6/3 and 6/4 which prompted ER visit on 6/5. He has been on Ibuprofen ATC.
LUMP, AND ITCHING AT INJECTION SITE,  TOOK A COUPLE OF DOSES OF BENADRYL, RESOLVED IN 2 DAYS
Pt recv vax on 11/10/98; on same day pt exp swollen/ red vax site
The patient was given his 2 injections in the R Deltoid and then went to collect a urine sample. Subsequently he became flushed and light-headed. He was given some fluid and shortly felt somewhat better. Next, as he was leaving the facility, he became disoriented and pre-syncopal. He was guided back to the exam table where he proceeded to lose consciousness. He maintained this altered sensorium for roughly 2 hours before gradually returning to a normal level of consciousness. A Code Blue was called in the office. He was taken to our Emergency facility with stable vital signs but still poorly responsive roughly 1 hour after the initial event. Labs were all unremarkable with the exception of a positive urine screen for THC. He was admitted for observation.
vasculopathy; she developed ulcerations; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prothrombin clotting disorder" (unspecified if ongoing), notes: a clotting disorder for decades; "She had 6 live births" (unspecified if ongoing), notes: She had 6 live births; "1 miscarriage in her life" (unspecified if ongoing), notes: 1 miscarriage in her life. The patient's concomitant medications were not reported. The following information was reported: BEHCET'S SYNDROME (medically significant), outcome "unknown", described as "vasculopathy"; ULCER (non-serious), outcome "unknown", described as "she developed ulcerations". Clinical course: Patient with prothrombin clotting disorder developed vasculopathy and ulcerations on her feet after receiving the Pfizer COVID 19 vaccine. The woman had a clotting disorder for decades, but without symptom manifestation. She had 6 live births, 1 miscarriage in her life. Her entire family developed COVID 19. So to protect herself she got the COVID 19 shot. After receiving the shot she developed ulcerations and vasculopathy that had been unmanageable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021.
Erythematous rash on left deltoid <15 min. after administration. Later, developed erythematous rash and swelling of (R) arm and extension of rash to below her elbow on the (L) arm.
felt faint, increased heart rage to 180 near syncope.  systemic rash.   Pt reports a hx of food allergies and carries an epi pen
Then 10 days later, her arm developed redness (the size of a quarter); 10 days later, her arm developed redness (the size of a quarter) and itchiness; Sore arm at injection site; Mild itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site), VACCINATION SITE PRURITUS (Mild itchiness at injection site), ERYTHEMA (Then 10 days later, her arm developed redness (the size of a quarter)) and PRURITUS (10 days later, her arm developed redness (the size of a quarter) and itchiness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site) and VACCINATION SITE PRURITUS (Mild itchiness at injection site). On 28-Jul-2021, the patient experienced ERYTHEMA (Then 10 days later, her arm developed redness (the size of a quarter)) and PRURITUS (10 days later, her arm developed redness (the size of a quarter) and itchiness). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site), VACCINATION SITE PRURITUS (Mild itchiness at injection site), ERYTHEMA (Then 10 days later, her arm developed redness (the size of a quarter)) and PRURITUS (10 days later, her arm developed redness (the size of a quarter) and itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by reporter  Treatment information was not provided by reporter   Reporter did not allow further contact
I got very sick; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (patient received 1st dose on an unknown date and experienced sickness, refer case US2021AMR205339).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported.  The patient saw his/her mother had shingles 2 times and hence decided to take the vaccine and got very sick but thought that it was worth it.   The patient stated that having shingles was worse than the effects of the vaccine. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205339:Same reporter, same patient, same suspect, different dose US-GLAXOSMITHKLINE-US2021AMR205339:Same patient, same reporter, same suspect, different dose
Around an hour after receiving the injection my heart started racing and that lasted for about 1 hour. When my heart started racing I become fatigued and developed a headache. My heart has not been affected since then but I am still experiencing fatigue and headache.
Given 8/27/03. Resulted in localized area of erythema, swelling at both deltoids as soon as vaccination given. Mom treated with warm compresses and right deltoid resolved but left deltoid remained as above. No increase in reaction. No itching/fever/malaise/vomiting.
felt heart was racing, comes and goes. clammy hands, anxious. HR 92 BP 136/82
The next after taking the vaccine his right arm started to hurt bad and the pain has radiated throughout his whole body. Restless and muscle pain also his head has started hurting real bad.
feeling off all day; knee pain and swelling; knee pain and swelling; hip joint pain; tired; fall asleep just sitting down; Headache; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 15:40 (at the age of 68-year-old) as dose 1, single for COVID-19 immunisation. Medical history included thyroid from an unknown date and ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid disorder from 2000 and ongoing. It was reported that from Nov2020 dose for Synthroid increased (150mcg; take once daily by mouth). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient family medical history was reported as none. Patient stated that she is scheduled for the second dose on 30Mar2021. On 09Mar2021 the patient experienced headache. On 10Mar2021 the patient experienced feeling off all day, knee pain and swelling, hip joint pain, tired, fall asleep just sitting down. It was reported that " she had her first dose of the Pfizer COVID 19 vaccine 09Mar2021 at 15:40PM in the left arm. Tuesday night she had a slight headache and she took Ibuprofen before she went to bed because the nurse said she could take it. Wednesday morning she had a slight headache again and was feeling off all day; then that afternoon all the sudden her knee buckled and she noticed the pain in her knee with swelling and hip joint muscle pain. She thought it would go away but she still has it. Adds the knee swelling in the left knee is the worst in the morning; the knee is so swollen she can't put weight on it or it buckles. She did not have this before. Mentions it is all on the left side, the left knee and the left hip. Her right side is fine. Adds she is also so tired she falls asleep just sitting down. Mentions she used to be a medic. She is scheduled for the second dose on 30Mar2021. Mentions she had read all her stuff but didn't look at the part with the risks until she just felt awful". Patient received treatment for the event headache with Ibuprofen. Outcome of the events knee pain and swelling was not recovered and other events was recovering.  No follow-up attempts are possible. No further information is expected.
Red, itchy, welt appeared a week post vaccination at the injection site. The welt is hot to touch and the spot is hard and painful.
pt recvd vax 3:15pm; approx 5pm started w/ bad ha;at 6:30pm had difficulty swallowing,breathing,throat swelling;called family MD;to er;recvd IV,steroids & DPH;
Severe arm pain starting a day after the flu shot, persisting now 2 weeks, with movement of shoulder, upper arm.
On 11/21/2001 the patient's temperature was 100.3 with erythema and induration at the injection site. On 11/22/2001 the erythema and induration increased to the size of a nickel. On 11/23/2001 the erythema and induration was 2.6cm x 1.5cm.
This spontaneous report was received from a medical assistant and refers to a 1-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 15-OCT-2018, the patient was vaccinated once with a 0.5 ml dose of GARDASIL 9 intramuscularly, lot# R001263, expiration date: 10-NOV-2020 for prophylaxis. No adverse effects were reported.
About 8 days after the second vaccine, I suddenly got achilles tendinitis in the heels of both feet.  No injury of any kind to either foot.  Family history of Guillan Barre after flu vaccine.  As a result, I never took flu shots.  While this is not Guillan Barre, it seems to me like a similar type of situation where my body reacted to the vaccine by attacking both of my achilles tendons.  My left heel first and within a few hours it started in my right heel also.  Still have heel pain in both heels after 4 months.  I have never had anything like this problem in any part of my body.  Even if I am the only person to report this problem, I think it needs to be documented.
Breakthrough case of COVID Started on 04/30/2022 with a headache, nasal congestion, a dry cough and general malaise, fatigue, like a cold. Tested with a home test on 05/01/2022 which came back positive.  Paxlovid started on 05/02/2022. The headache went away fast with 12 hours. Other sx persisted progressively getting less and less. I tested negative on 05/16/2022.
devel high pitch cry for more than 3 hrs assoc w/apnea x  2; pt was pale & listless w/dec HR;
However 8 days later after completing the dosing series. he went to urgent care and tested positive for the COVID19 virus using the rapid test; However 8 days later after completing the dosing series. he went to urgent care and tested positive for the COVID19 virus using the rapid test; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization.The patient medical history and concomitant medication were not reported.On an unknown date, 8 days after completing the dosing series, the patient tested positive for Covid19 virus. It was reported that reporter's son was exposed to someone last week who was positive for Covid 19 and became symptomatic on Wednesday and son tested positive for Covid 19 on Thursday, however reporter and his wife tested negative for the Covid19 virus. The patient had his 2nd dose of the Pfizer Biontech Covid-19 Vaccine, at that time he was negative for the Covid19 virus, however 8 days later after completing the dosing series, he went to urgent care and tested positive for the Covid19 virus using the rapid test. The patient underwent lab tests which included sars-cov-2 test: negative on an unspecified date and 8 days after 2nd dose patient had lab test for sars-cov-2 test: positive on an unspecified date. The patient mentioned that his HCP told him that as long as he was negative, he can get vaccinated but if he is positive, he would have to wait out 90 days before getting the shot. He also mentioned previously that he called us before and talk to safety department and asked if he can take the second shot post exposure to someone who tested positive for the virus. He wanted to know if the second dose was as effective if he was infected or does he have to be revaccinated again, because he read somewhere that the vaccine may cause false positive result for the tests. Outcome of the events were unknown.  Information on the Lot/Batch number has been requested.
Right heel pain.  On-going since vaccine. Taking Ibuprofen and wearing shoes at all times when up.  I feel this is a reportable event and hope it passes in time.
Fever of 101.8 for 2 days; when given Tylenol fever would reduce and then creep back up to 101.8 after 4 hours.
Pt. received the 1st dose of Influenza *undetermined 10/11/2021, started experiencing symptoms that evening of eye pain (pressure on the eyes *both). Current examination @ Clinic no visible injuries. Still continuing to experience symptoms.
Patient admitted day after vaccination for mild fever and cough (however states cough was present prior to vaccination). Also notes some mild pain at injection site. CT chest showing possible right lower lobe pneumonia however present in previous imagining as well, potentially concerning for community pneumonia exacerbated by vaccination.
muscle pains in all extremities, sinus pressure, headache, sensitivity to light, nausea, tiredness, chills, fever of 100.7 degrees Fahrenheit, sweating, shakes.
moved while injection was going into her left deltoid due to burning feeling. given advise to ice arm  throughout day and night. Left arm is much better no longer have as much swelling or pain to touch
Welt size of a 1/2 dollar.  Thick, itchy and warm to touch. Very painful. Painful to the touch and hard to move arm.
fluzone high dose quadrivalent being administered post excursion with no reported adverse event; Initial information received on 30-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 80 years old male patient who had vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] high dose quadrivalent being administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Dec-2022, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ924AC and expiry date: 06-Jun-2023) via intramuscular route in left deltoid for immunisation.  On 28-Dec-2022 the patient developed a non-serious fluzone high dose quadrivalent being administered post excursion with no reported adverse event (poor quality product administered)(latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable.  Outcome: Unknown.  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.
Chills, weakness, exhaustion, lack of appetite, dizziness, shortness of breath, pain and hot at injection site.
pt recvd 1 dose of Engerix-B & is being followed for poss MS;
Inflammation , pain at injection site and surrounding area: prescribed Prednisone 20mg x 2 days  -10 mg x 2days
No adverse reaction; wrong formulation given to the patient. Pt is 4 months old.