chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 minutes after administration of Pneumovax 23 patient noticed itching, redness, and a hive at the sight of injection.  As the evening progressed, the itching became unbearably worse.  Patient had to take Benadryl and use Hydrocortisone cream to relieve itching.  When she woke up, her arm is extremely swollen and there is an erythema that extends from her shoulder to slightly past elbow and covers most of the width of the outside and some of the inside of the arm.
Swollenness/soreness in thigh; Swollenness/soreness in thigh; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Swollenness/soreness in thigh) and INJECTION SITE SWELLING (Swollenness/soreness in thigh) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (Swollenness/soreness in thigh) and INJECTION SITE SWELLING (Swollenness/soreness in thigh). At the time of the report, INJECTION SITE PAIN (Swollenness/soreness in thigh) and INJECTION SITE SWELLING (Swollenness/soreness in thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported by reporter. Case level outcome was reported as unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Pt recvd immun on 23JUL91 & broke out in hives & whelps late last evening; c/o moderate amount of itching; No c/o difficulty in breathing; Taking DPH once last night & this AM;
?Janssen COVID-19 Vaccine EUA? i Headache muscle aches and chills began at 2200 on day of vaccine, by midnight fever was brought down to 100.5 after taking 800mg ibuprofen.  Slept ok, next day temp was 100.2 and headache, muscle aches, nausea continued throughout the day despite rest.  Today Tuesday fever and headache are  gone, mild muscle aches persist.  Vaccine site is very sore.
Patient complained of dizziness and hands tingling.  B/P- 150/94, P-101, R-22, O2 sat-99% on room air.  Denies any other signs and symptoms.  Patient left with daughter.
nausea; dizziness; headache; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on 20Dec2020 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that about 2 weeks after the vaccine the patient experienced nausea, dizziness and headache.The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
01/23/2021 to present: bilateral arthralgias of the hands, wrists, elbows, shoulders, knees, ankles, feet. No joint swelling noted.
PATIENT CAME IN ON SUNDAY 11/17 STATING THAT SHOT WAS GIVEN ON LEFT ARM ON TUESDAY 11/12 AROUND 7PM. SHE HAS HAD A SORE ARM EXTENDING FROM THE TOP OF HER SHOULDER TO HER ELBOW. SHE STATES IT HURTS TO ELEVATE THE ARM, DRIVE COMFORTABLY, LIFT ANY WEIGHTS
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; The vaccines were initially placed in the refrigerator on 19Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (The vaccines were initially placed in the refrigerator on 19Jan2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 026b21a and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (The vaccines were initially placed in the refrigerator on 19Jan2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (The vaccines were initially placed in the refrigerator on 19Jan2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vial was initially stored in the refrigerator on 19 Jan 2022 and vaccine was administered between 22Feb2022-03Mar2022. No temperature excursions were reported.  No treatment medications were provided.
I felt tired, weak, short of breath, and had chills for most of the afternoon into the evening.   This resolved by the next morning 3/19.  However morning of 3/19 a large lump about the size of my fist formed at the injection site.  It was red and slightly raised.  It remained until at least 3/25, and resolved shortly after this date.
11/19/21 4:30pm Pfizer booster given 11/20/21 9:00am mild fever (99.5) that reduced to normal after an hour. Muscle aches in knees and back 11/20/21 8:00 pm chills and elevated fever (100.7) 11/20/21 11:00 pm muscle aches returned and elevated fever (101.3) 11/21/21 1:00am elevated temperature (102.7) with nausea 11/21/21 11:00 am temperature returned to normal, pressure headache that is continued to this time (currently 9:20 pm) 11/21/21 4:00 pm intermittent chest tightness   lethargy throughout time from 11/20 to present time at 11/21/21.
Had flu shot 10/20/2003 during day. Went to ER that night for itching, redness, urticaria (generalized). Received Solu Medrol and Benadryl. Returned to ER on 10/22 for return of red rash, itching, hives. No resp. problems. Received Solu Medrol 125mg IM, Phenergan 50mg IM, Tramerlone cream 0.625.
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 46-year-old female patient who received BOOSTRIX (batch number B4G4G, expiry date 5th NOVEMBER 2017). On an unknown date, the patient received BOOSTRIX, .5ml. On an unknown date, an unknown time after receiving BOOSTIRX, the patient experienced nausea/headache, fever, joint pain and allergic reaction. The patient was treated with naproxen. On an unknown date, the outcome of the nausea, headache, fever, joint pain and allergic reaction were unknown. The reporter considered the nausea, headache, fever, joint pain and allergic reaction to be related to BOOSTRIX. Additional details were provided as follows: The reporter stated that the patient experienced adverse events (nausea, headache, fever, allergic reaction and joint ache) associated with BOOSTRIX vaccination. The reporter called Center for Disease Control and Prevention and the reporter was told that, the patient was experiencing allergic reaction and asked to treat the patient with Naproxen. It is unknown if the side effects resolved. The reporter would like to be contacted regardless if there were similar reported adverse events associated with this specified lot number or not. The reporter was nervous because she used to buy BOOSTRIX in bulk. This case has been linked with case US201610943, reported by the same reporter.
day p/vax pt devel swelling in left arm area to above elbow w/discomfort and no fever
Dizziness, Chills, Nausea. Lasted about an hour then went away. I had to go to bed, then symtoms went away. I felt fine the next day.
first dose of Engerix-B on 18-Mar-2020 and the second dose on 05-Aug-2020 as could not get them on time due to pandemic situation.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 68-year-old male patient who received HBV (Engerix B) (batch number H2T35, expiry date 29th May 2020) and (batch number B79CS, expiry date 20th May 2022) for prophylaxis.   Previously administered products included Engerix B (received 1st dose in 18th March 2020 (batch number: B79CS, expiry date 20th May 2022)).   On 5th August 2020, the patient received the 2nd dose of Engerix B. On 18th March 2020, the dose was an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination is not applicable. The patient received the first dose of Engerix-B on 18th March 2020 and the second dose on 5th August 2020 as could not get them on time due to pandemic situation. The reporter consented to follow up.
I had a regular routine blood work check up in May 2021, and I found out that my blood platelets were low.  The doctor sent me to an oncologist. The oncologist told me to wait 3 months to do some more bloodwork. I waited the 3 months then went back to the doctor, and my blood platelets were still low. The oncologist said that they weren't normal but it could be a early sign of bone marrow dysplasia. She said maybe in a year or five years depending if the blood platelets continue to drop, then I would possibly have to be a patient for bone marrow dysplasia . She told me to exercise and be on a good diet. She said she doesn't think it was connected to covid vaccine. My blood platelets is currently at 114,000. She said I need to watch it to make sure my blood platelets doesn't go down to 50,000.  As of now I am feeling fine and well.
Had blood clots and a stroke on 6/14/2021. Was good health leading up to the stroke.
The patient presented to receive 4 vaccines- HPV, Influenza, Meningococcal ACWY, and TDAP. During the administration of the 4th vaccine (HPV), the patient had a syncopal episode. He lost consciousness and hit head on the counter in the exam room. He immediately regained consciousness and was slightly disoriented upon awakening. At this time, the patient was put back on exam room table and laid flat. He was given an ice pack for his head and juice. Patient reported feeling better within minutes of episode. He was examined by several other RNs and one MD immediately following the episode. He was released home after 10 minutes of monitoring.
Pt was seen three days post vaccine. Had a 7 x 9cm of swelling at injection site. Benadryl was given and eventually got better.
pain in left shoulder; hard time lifting her shoulder; pain in her left deltoid injection site; 28 weeks & 3 days pregnant exposed to Adacel vaccine; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA036161, 2020SA036186 and 2020SA036190.  This case involves a 34 years old female patient who experienced pain in her left deltoid injection site (injection site pain), hard time lifting her shoulder (injected limb mobility decreased) and pain in left shoulder (musculoskeletal pain), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The events occurred at 28 Weeks of pregnancy.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment, vaccination and family history were not provided.  The patient previous pregnancy/ies details not reported.   No concomitants reported.   On 31-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6602AA and expiry date: 25-Feb-2022) via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious pain in her left deltoid injection site (injection site pain), hard time lifting her shoulder (injected limb mobility decreased) and pain in left shoulder (musculoskeletal pain) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of vaccine exposure during pregnancy.  Other relevant tests were not reported.  Final diagnosis were injected limb mobility decreased, injection site pain and musculoskeletal pain.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient outcome was reported as unknown for all events.  Pregnancy outcome was unknown at the time of report.
Dizziness and lightheaded.   VS wnl except BP- 179/109 Pt was given Clonidine 0.1 mg and BP was checked 20 min later- BP 157/84.    Pt stated sxs had resolved after 10 min. Pt was observed for 45 min and was allowed to go home with ER precautions. Husband accompanied pt.
body aches/ intense Pain; nausea; This is a spontaneous report from a contactable consumer.  A 60-years-old non-pregnant female patient that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number) via an unspecified route of administration, administered on unspecified date in 2021 as Dose 1, single for and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number unknown) via an unspecified route of administration, administered on unspecified date as Dose 2, single (age at vaccination was 60-years-old) for covid-19 immunisation. The patient received most recent COVID-19 vaccine was administered. The patient had unknown allergies. The patient medical history include fibromyalgia and heart disease. Concomitant medication was not reported. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient received other medications within 2 weeks of vaccination was unknown. On 23Jul2021, patient experienced body aches, intense pain, nausea. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose 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 (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 33-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Vaccination occurred at 08:27, advised to wait 30 mins for observation. At 08:47 pt stated feeling "tightness in chest" Pt.'s SpO2 was 100% and HR 60 and had clear breath sounds upon auscultation. Advised pt. to wait longer for observation. Around 0905, pt. stated that it was "becoming harder to swallow" and "the feeling traveled up to my throat." Vitals were SpO2 100%, HR 57, RR 18, BP 124/80 on right arm, and skin WNL. Pt. did not appear to be in any respiratory distress. Advised pt. to seek emergency care if the  feeling got worse or continued. Pt. stated that he was comfortable having his friend who was present drive him to the Pt. departed clinic around 0913, headed to
mom stated on 10FEB96 pt was pulling arms over head, eyes open wide & sl crossed;mainly occurs p/pt awakens from nap but would do this up to 10 times a day;seeing ped neuro who confirmed that the pt is having infantile spasms;sz persist
SM unaware that she was pregnant at the time she received her MMR inoculation. This is not a follow-up to the previously submitted VAERS report 332837. This is actually a second, repeat episode of inadvertent receipt of MMr on 03/05/2010, early in her second pregnancy. Once again, the SM states she did not know she was pregnant when she received a second dose of MMR on (03/05/10). Her current pregnancy was confirmed by a positive serum HCG test on 03/25/2010. The SM denies any sequelae or adverse event following the first episode of inadvertent receipt of the MMR (08/18/2008), during her 1st pregnancy. She delivered a normal, healthy infant at 38 weeks gestation in April of 2009. Her labor was induced due to low amniotic fluid. She currently denies any spotting, bleeding, pelvic pain or contractions with her second pregnancy. She is currently at 7 weeks gestatio. Her LMP was 01/29/2010 and her estimated date of delivery (EDD) is 11/05/2010. Her primary care manager is aware of the SM's second episode of inadvertent MMR immunization during early gestation.
run low grade temp-broke out all over body-face w/rash;instructed take APAP;it pt got worse take to MD or ER;
Seizure lasting about 10 to 15 minutes. Ambulance arrived. Blood sugar of patient was 60 and given oral glucose once conscious. Patient left on his own and drove home after about 30 minutes.
I woke up one day about four weeks after the vaccine with a rash. It was all over my right lower quadrant in big blotches. It is not itchy or hot and I have been given some Antifungal cream and it has not helped. They were not all circular and after three weeks it has become more diffuse but it is still there. The whole area is about the size of my hand. I did not have any other symptoms but I don't normally get rashes. After the first dose I had a lot of intestinal distress. My stomach was doing flip flops. I had pain in my arms and it radiated down my arms. It lasted for about two weeks.
Had a fever over 102.6 degrees F that started a day after the injection and has been waxing and waning ever since (starts mild in the AM and gets worse over the day). Has been treating with rest and acetaminophen. Patient will contact provider on Monday if not improving. Patient says she has reacted poorly to other vaccines in the past "due to Lyme Disease."
First shot - No symptoms, only slight bruise pain at injection site; First shot - No symptoms, only slight bruise pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 08:00 (Lot number: el8982) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ACCUTANE. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset Jan2021, outcome "unknown" and all described as "First shot - No symptoms, only slight bruise pain at injection site".  Additional Information: The patient did not have covid prior vaccination The patient was not tested for covid post vaccination.The patient's other medical history was reported as none  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101796094 similar report from same reporter
Swelling at injection site, hot and red. Also red bump on child body and one in childs mouth.
MA that pended the order had pentcel which we don't have in our office. I attempted to fix this, however I did not pay attention to the System.
Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The physician stated that she had a patient go to the pharmacy for a Shingrix vaccine and the patient claimed they got shingles after the fact from the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter agreed to follow up from GlaxoSmithKline.
I get migraines and I get continuous treatment for migraine headaches, so I don't know if I would have as  many if I had not received the vaccine.   The first reaction was a sore arm at the injection site.  The second continues to be a rash at the injection site, which started 6 days after the injection and has not subsided.  It changes in visual characteristic but itches fairly consistently.  I have taken acetaminophen for the discomfort, and some migraine specific medication (rizatriptan) for the headaches.
It is 3 weeks past date of Tdap booster in left arm. Experiencing sharp pain, inability to raise left arm above head or cross over chest or push left elbow backward. Getting dressed/undressed is painful. Cannot sleep on left side.