chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported swelling that lasted approximately 1 week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): GL-101921-24790 (Agency).  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid Disease" (unspecified if ongoing), notes: Taking levothyroxine for 10 years. Concomitant medication(s) included: RESTYLANE, start date: Jul2021, stop date: Jul2021; LEVOTHYROXINE taken for thyroid disorder. The following information was reported: SWELLING (non-serious) with onset 2021, outcome "recovered" (2021), described as "Patient reported swelling that lasted approximately 1 week". Additional information: Reported Adverse Event Per consumer: Patient was injected in July2021 with approximately 1/2 a syringe of Restylane Kysse (lot and exp. unknown) into the upper and lower lips. Patient reported swelling that lasted approximately 1 week, after swelling went down she noticed she had no results. She contacted the injecting provider who treated her with the other 1/2 syringe of Restylane Kysse and she reported again after 1 week when swelling went down there were no results. She reported that she contacted the injectors office and was told she would have to wait 3 months before trying any more treatments. She reported that she was seen on 08Oct2021 and did not receive another treatment, Injector advised her to call Withheld. Event not resolved. Reported she has had fillers and toxins for 3-4 years. No allergies. Has had the shingles vaccine in May2021. No illnesses in the month prior to treatment. No dental procedures in the last 6-12 months. Follow-up (06Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
She was waiting for an email to be able to use the vaccine and she got an email but she's not sure if that's the email she's been waiting for. Product had been administered to a patient.; This case has been considered invalid as no adverse event. Reason for nullification: F/UP Nullification- No AE.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: NO ADVERSE EVENT (non-serious), outcome "unknown", described as "She was waiting for an email to be able to use the vaccine and she got an email but she's not sure if that's the email she's been waiting for. Product had been administered to a patient."  Additional information: Incoming attempted transfer from [Name withheld] [Withheld] with agency providing #. Caller is a Pharmacist. Calling in regards to the Pfizer BioNtech Covid Vaccine Grey Cap Bivalent.  She had gotten a call from Pfizer, the individuals name was [Name], it was in regards to their data logger, asking them to quarantine vaccine until Pfizer tells them it is okay to use. She then got an email saying it was okay to use. They had already given 1 dose prior to that email. Agent clarified that she was actually not sure if second email said it was okay to use. Caller disconnected prior to completion of transfer. Agent also states that when she was trying to transfer this caller she did try to get out of the transfer saying that she didn't know much about the situation. Agent states that she will submit verbatim what the caller said.   The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.  Follow-up (31Oct2023): This case is being deleted from the database for the following reason: F/UP Nullification  No AE.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Chills, HA, body aches, back pain, upset stomach, fatigue, burning sensation in throat as he breathes in
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-FEB-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route not reported) that was reconstituted with cyanocobalamin (manufacturer unspecified) instead of the supplied diluent. No adverse effects reported. Additional information has been requested.
The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM; dose administered past manufactures expiration date/ Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient had no known allergy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 03-May-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 3:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM).    No concomitant product reported by reporter.  It was unknown if patient had the ever been diagnosed with Covid-19. It was unknown if patient had acute illness or chronic health conditions at the time of vaccination . It was unknown if patient experienced similar adverse event in the past. Vaccine did not undergone any temperature excursion issue. Vaccine was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM. Dose administered after 30 day Use By Date or after manufacturer date of expiry.  No treatment medication reported by reporter.
Pt received Prevnar 13 vaccine on 9/17, around 2pm. Later that evening she noticed a large bruise develop. She became concerned and consulted with her MD who confirmed it was a hematoma. The hematoma measure about 3-4 inches long and 2 inches wide. Spoke to pt on 9/22 and provided evidence to pharmacist on 9/24 confirming hematoma. Rph tried to follow up with patient on 9/29, but no response.
Almost immediate fatigue that lasted about 5 hours.  Slight headache.  Later that night while sleeping I woke up and could not breathe and my chest hurt.  It lasted about 15-20 minutes.  I would like to know if it is safe for me to take the second dose as I have heard from friends that it was a little bit more difficult if you had side effects.
The day of vaccine pt came down with pink eye likely viral.  However the parents describe that the 10 days following the vaccine pt was very much less active that usual.  Indeed in the office pt actively level was quite low.  howevere the night of the 11/16/07 although sent home, from office spiked and fever and became quite dehydrated,  essential a partical septic work-up was done and some viral cultures were drwan and all were negative.  the CRP did get as high as 6.3, but pt was treated with IV hydration and released without antibiotic (was given a dose of rocephin in the ED) .  Was followed the next,following release, day in clinic and was doing well and activity was back to normal. 12/10/07-records received for DOS 11/17-11/18/07-DC DX: Fever, dehydration, tonsillitis. Seen in ED temp 102.3, history of fever times 2 days. Decreased oral intake, decreased urine output,  Cough, nasal congestion.PE: pharyngeal erythema, right and left sided tonsillar erythema, swelling and hypertropy.
Her arm hurt a little; 11 days after the dose she has redness, itchiness, and it is hot at the injection site; 11 days after the dose she has redness, itchiness, and it is hot at the injection site; 11 days after the dose she has redness, itchiness, and it is hot at the injection site; Swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 07May2021 (Lot number: EW0167) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "Her arm hurt a little"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset May2021, outcome "unknown" and all described as "11 days after the dose she has redness, itchiness, and it is hot at the injection site"; VACCINATION SITE SWELLING (non-serious) with onset May2021, outcome "unknown", described as "Swollen".  Additional information: Patient stated that after first dose of vaccination with no reaction other than her arm hurt a little, now 11 days after the dose she has redness, itchiness, and it is hot at the injection site. She would like to know if this is common and did not know that this is a normal side effect because it says that it usually happen that in the first couple of hours not 10 days later. Patient stated that her arm is red and itchy and hot and swollen.  No follow-up attempts are possible. No further information is expected.
Patient developed a raised red bump at injection site that eventually lead to being pus filled.  He reported that he used peroxide and it was infected for 4-5 days and remained raised for 2 weeks.  The raised bump is still slightly observed at 2nd injection clinic.  We gave his second injection in his Left arm this time. Patient did not contact his PCP during the time his arm was infected. No sign of infection at 2nd dose clinic at initial injection site.
pt recv vax MAY97 & exp a warm sensation in the upper body;event lasted approx 4-5hr;
COVID Breakthrough. COVID+ 2/22/22 but also positive on 12/15/21. Asymptomatic test positive on 2/22/22.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The patient received both a dose of VAQTA and a dose of RECOMBIVAX HB on 14-DEC-2015 and on 14-MAR-2016 (lot # and dose unknown) intramuscularly (inappropriate schedule of vaccine administered). No known adverse effects were reported. It was unknown if any medical attention was sought. Additional information has been requested.
Severe diarrhea started on March  30.  Fever, headache, sore throat started on April 1.  Took about Covid home test on 4/02/21.  It was positive.  Loss of taste and smell. Extreme weakness.
Given that this was one of the last vaccines I had received in 2013 before being diagnosed with Miller Fisher Variant Gullian Barre Syndrome in 2015. During 2014, late July, I started experiencing the lost of my voice. I thought it was sore throat, but after going weeks with no signs of getting better, I started going to different docotrs trying to find out what was wrong with me. I've made repeated trips t the ENT were I was getting a camera down my nose almost every time I went. They found nothing. It wasn't until I was recommended to go see a neurologist who after running a couple of in office test, told me to admit myself in the hospital when I've finally been diagnosed. After more being ran, spinal taps, speech pathologist, and blood transfusions all they could tell me was that what I had closely resembles Miller Fisher Variant Gullian Barre Syndrome. I can no longer speak normally, I speak with a whisper and it is harder for me to swallow food without choking. Swimming has also become more difficult for me since the back of my throat/ vocal chords are  partially paralyzed its harder for me to hold my breathe under water.
This spontaneous medically confirmed report concerns a 76 year old male patient. On 25-SEP-2014, the patient received one time dose of intravenous influenza virus vaccine (manufacturer and batch number not reported) at 0.5 ml (inappropriate route of vaccine administration). The outcome was not reported.
2004 tuberculosis; 2009 neuro cardiovascular genic syncope; 2009 PTSD; 2009-current multiple TBI's; 2010 anxiety and stress disorder; 2010 arthritis in spine; 2010 degenerative disk disease; 2010 eroded duodenum; 2010 IBS; 2010 3in part of muscle /tendons pulled off spine; 2010 extremely low testosterone still ongoing; 2010 has a large pocket in intestines; 2010-current low immune system; 2009 clinically mutated foot; 2010 unexplained hives.
Site: Itching at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: the patient started with hives and rash on 9/21/21 and progressed to difficulty breathing where she went to er.  She is picking up benadryl. difficulty breathing is resolving on its own slowly
rash on the arm and side of my body where the injection was given.   i took some Benadryl    on 01/14/2021 the rash came back and the injection spot became really warm and harden. i took Benadryl again it went away. the rash came back 01/16/2021 and i took more Benadryl and the itcing stop. isaw a few red spots on my arm today bot no itching.
Second Dose given too early on day 16. Interval should have  been 17-25 days.  Patient notified of error
2:15 BP 96/60, P82, pale, talkative, mom states pt has had stomach flu, onset eaten applesauce & crackers today;color returning given sucker to eat, dismissed to mom, told to eat;2:20 BP 98/70, P82;2;25 P84;2:35 BP 101/76;
chills; nauseous; slept all day; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), FATIGUE (felt tired), CHILLS (chills) and NAUSEA (nauseous) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced SOMNOLENCE (slept all day) and FATIGUE (felt tired). On 10-Apr-2021, the patient experienced CHILLS (chills) and NAUSEA (nauseous). The patient was treated with CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM BICARBONATE (GAVISCON [CALCIUM CARBONATE;SODIUM ALGINATE;SODIUM BICARBONATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (slept all day), FATIGUE (felt tired), CHILLS (chills) and NAUSEA (nauseous) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications were reported.
I administered HPV and HepB vaccines and approximately 5 minutes later, patient fainted. He recovered quickly with no additional issues and left facility approximately 20 minutes later.
Kidney issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "Kidney issue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient originally contacted Pfizer due to a kidney issue following patient second booster & starting with patient 1st COVID-19 Vaccine shot. Patient provided all that information to you. The latest results of testing from May to Sep show information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine given on 07/28/2008.  On 07/29/2008 temp of 102.  Treated with motrin.  Injection site red, swolen, hot to the touch & soreness.  On 07/30/2008 temp subsided.  Injection site still red, swolen, hot to the touch & soreness.
Bleeding down his arm afterward; He received a dose in his left arm, and noticed he was bleeding down his arm afterward/He had another dose given in his right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), first in the left arm and second dose in the right arm, both via an unspecified route of administration on 02Feb2021 at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received his first round of Pfizer-Biontech Covid19 vaccine yesterday 02Feb2021.  He received a dose in his left arm, and noticed he was bleeding down his arm afterward, which was out of character for him.  When he alerted his nurse who had administered the vaccine, she discussed it with a colleague who said "go ahead and give him another one".  He had another dose (second dose) given in his right arm on 02Feb2021.  Patient stated he's "feeling fine".  He wanted to know if he still needs to get the second dose in the series. It was also further reported as they gave him the shot in the left arm and he started to bleed.  He got a 2nd one in the right arm.  He was feeling fine. The nurse asked another nurs- and she said, "go ahead and give him another one". The outcome of the event bleeding down his arm afterward was unknown.   Information on the Batch/Lot number has been requested.
BLEEDING IN THE MOUTH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and light bleeding in mouth, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced bleeding in the mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding in the mouth. This report was non-serious.
I experienced a headache; a few hours later my face swelled up; This is a spontaneous report from a contactable consumer. This 23-year-old female consumer (patient) reported for herself that: A 23-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 25Feb2021 at 07:00 (at the age of 23-year-old) as single dose for covid-19 immunisation at Hospital. Patient was not pregnant at the time of vaccination. Medical history and concomitant medication reported as none. Patient had no known allergies. Patient not diagnosed with covid-19 prior to vaccination. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 04Feb2021 at 07:00 as single dose for covid-19 immunisation. Patient was not received any other vaccine four weeks prior vaccination and patient did not receive any medication two weeks prior vaccination. Patient reported I experienced a headache and then a few hours later my face swelled up on 25Feb2021 at 18:00. Since vaccination patient not tested for covid-19. Event resulted to visit Emergency room/department or urgent care. This case assessed as non-serious by the reporter. Therapeutic measures were taken as a result of the events with steroids shot. Outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021251542 similar report from same reporter
Hospitalized for COVID-19 infection/AHRF after COVID-19 immunization. Administered oxygen and dexamethasone and discharged to home medically stable.
Sore Throat; Chills; Muscle Ache; Sore Injection Site; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), MYALGIA (Muscle Ache) and VACCINATION SITE PAIN (Sore Injection Site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), MYALGIA (Muscle Ache) and VACCINATION SITE PAIN (Sore Injection Site). In February 2021, OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), MYALGIA (Muscle Ache) and VACCINATION SITE PAIN (Sore Injection Site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken to  mRNA-1273 (Moderna COVID-19 Vaccine) not applicable. Concomitant and treatment information were not provided.