chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My daughter fainted immediately after administration of the vaccine.  Her eyes rolled back, and her body had mild convulsing, followed by fainting.  I have just found out about your reporting system, therefore the delay in reporting.  My daughter has had 2 shots of the HPV Vaccine, and fainted following both.  She has had all other childhood vaccines and many travel vaccines and never fainted.  I believe both HPV vaccines were Gardasil, but this should be confirmed with physician.  The first HPV vaccine 12/06 was administered with an additional DTap vaccine; HPV Vaccine #2 was administered alone and again produced faintness.  Both times injection was given in upper arm-- can't recall which side.
Patient got the Pfizer vaccine and today she got moderna vaccine as second dose; Patient got the Pfizer vaccine as first dose /today she got moderna vaccine as second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient got the Pfizer vaccine and today she got moderna vaccine as second dose) and INTERCHANGE OF VACCINE PRODUCTS (Patient got the Pfizer vaccine as first dose /today she got moderna vaccine as second dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient got the Pfizer vaccine and today she got moderna vaccine as second dose) and INTERCHANGE OF VACCINE PRODUCTS (Patient got the Pfizer vaccine as first dose /today she got moderna vaccine as second dose). On 25-May-2021, PRODUCT ADMINISTRATION ERROR (Patient got the Pfizer vaccine and today she got moderna vaccine as second dose) and INTERCHANGE OF VACCINE PRODUCTS (Patient got the Pfizer vaccine as first dose /today she got moderna vaccine as second dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information on received on 25 MAY 2021 and does not contain any new information.
Patient had the vaccine on 3/5/21.  She then had major abdominal surgery which included abdominal reconstruction, hernia repair and excess skin removal on 3/19/21.  She was released from the hospital on 3/22/21.  She was readmitted on 4/4/21 for blood clots.
vaccine that was reconstituted with a mispaired diluent; vaccine that was reconstituted with a mispaired diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number DC439, expiry date unknown) and (batch number 5393G, expiry date 1st April 2023) for prophylaxis.   On 22nd November 2021, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 22nd November 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   The reporter considered the inappropriate dose of vaccine administered to be unrelated to Shingrix.  Additional details were provided as follows: The reporter stated that, a male patient received Shingrix vaccine that was reconstituted with a mispaired diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The boxes had different lot numbers DC439 and 5393G. The reporter consented to follow up.
Severe neck and left arm pain (vaccine administered in left arm), associated with low-grade fever (99.9), neck stiffness, and syncopal episode.
dizziness; severe headache; Excessive tiredness.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (severe headache) and FATIGUE (Excessive tiredness.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 048A21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Jan-2021. Concurrent medical conditions included Breast cancer since 01-Nov-2014.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (severe headache) and FATIGUE (Excessive tiredness.). On 14-Nov-2021, DIZZINESS (dizziness), HEADACHE (severe headache) and FATIGUE (Excessive tiredness.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was given by reporter. No treatment medication was given by reporter.  Events started on 13-Nov-2021 at 02:30 pm.   This case was linked to MOD-2021-388786 .   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Followup received,  Medical History , information on 1st and 2nd dose information of suspect vaccine , Event onset date and outcome of the event updated.
Seen at next care on 10/01/06 DX'd with erysipelas, given Rocephin inject 850mg. RX Keflex 250 mg 5ml U tsp O QID x 7 days.
Patient started feeling lightheaded and felt like he was going to faint.  Dr assessed the patient and stated it was a vasovagal episode.
Patient received Tdap 5/3/07 PM in left deltoid. 5/4/07 she was awakened by nausea with vomiting, "horrible" headache, shaking chills, and fever to 102. She slept all day 5/4/07, and by 5/5/07 the fever was gone, but the left arm at injection site had "ballooned",and the entire arm was swollen such that she removed her rings for fear of not being able to get them off her swollen fingers. Patient took Tylenol, Aleve and Beadryl.  She felt better by 5/6/07 and the swelling appeared to be receding.  Then 5/8/07 evening the injection site got redder and more painful, extending from the top of the left deltoid to the distal one third of the upper arm laterally and posteriorly. Patient saw a surgeon friend who opined that she had either an abscess or a hematoma, and gave her doxycycline 100mg BID which she started 5/9/07. During this time, patient continued to take Aleve (?)4 tablets a day and Tylenol (?)twice a day.  On my examination, 5/10/07, there was greenish blue discoloration at injection site, mild induration, but no fluctuance.  Faint macular erythema extended over posterolateral deltoid to just below the deltoid tendon.  Tenderness spread from the puncture site to encompass most of the lateral aspect of the deltoid. There was no cervical or axillary adenopathy. No fever. Findings did not really look like cellulitis resolving after only two doses of doxycycline, but patient was told to finish at least 7 days of doxycycline and cont Aleve and Tylenol as needed for pain.
PATIENT WAS GIVEN INCORRECT VACCINE FOR HER BOOSTER DOSE.  SHOULD HAVE RECIEVED MODERNA BIVALENT FOR BOOSTER, HOWEVER THERE WAS NO MODERNA BIVALENT BOOSTER DOSES IN STOCK AT THE CLINIC. AEMT PROCEEDED TO VACCINATE PATIENT.   PATIENT HAS NOT HAD ANY ADVERSE EVENT. SHE IS NOT EXPIERENCING ANY SIDE EFFECTS TO THE VACCINATION.
Intense arm pain; Aches; Possible fever, not confirmed; Felt lousy; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID vaccine with an associated reaction of pain in extremity (experienced a sore arm when she had gotten a Covid vaccine).   On 15th June 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, pain, fever and feeling bad. On an unknown date, the outcome of the pain in arm, pain, fever and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm, pain, fever and feeling bad to be related to Shingles vaccine.     Linked case(s) involving the same patient: US2023AMR018960   Additional Information: GSK Receipt Date: 03-FEB-2023 and 06-FEB-2023 Reporter's Comments: The case was self reported by the patient. The reporter reported that shingles did not run in her family. The patient received first dose of Shingles vaccine an experienced significant side effects as intense arm pain, aches and a possible fever. The patient asked did the presence of virtually identical side effects indicate that there was a good chance the second shot was effective. The patient asked was it toll late to take another shot, was it safe to take a third shot, if she were to take it could she expect better, same or worse side effects. The patient indicated that her Shingrix side effects were bad, but not horrible. The patient had been warned that Shingrix could cause side effects and said that she never took her temperature to confirm if she had a fever, but she just felt lousy. The patient reported that the arm pain from Shingrix was not big deal. Additional Supportive Information: For tolerance of 2nd dose, refer case US2023AMR018960. This case was linked with US2023018204 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR018960:Same reporter US-GSK-US2023018204:Same reporter
muscle ache; fatigue; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID:   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 11Aug2022 as dose number unknown, single (Lot number: FK9894, Expiration Date: 15Jun2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 11Aug2022, outcome "unknown" and all described as "The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired."; MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; FATIGUE (non-serious), outcome "unknown".  Additional information: Caller was asking about the gray cap vaccine. The vaccine was expired and was administered to 5 patients. Caller mentioned that she was going to report this to VAERS and wants to check on what to do next. She said that this vaccine has an expiration date of 15Jun2022. Caller said at least that helps with one patient and all the patients were similar. 3 patient did report they had several days of side effects- so they thought event though expired that the vaccine had some effect on their sometimes muscle ache, fatigue.  Follow-up (18Aug2022): This is a spontaneous follow-up report received from a contactable other HCP. Program ID:  Updated information included: Reporter information, lot number and expiry date, therapy start and stop date, and event onset date.  Follow-up attempts are completed. No further information is expected.  Follow-up (26Sep2022): This is a spontaneous follow-up report received from same contactable Other-HCP. This Other-HCP reported in response to HCP letter sent in cross reference case that included:  Updated information included: Reporter details, new events and additional information added.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201070713 Same reporter/drug/event, different patient; PFIZER INC-202201093830 Same reporter/drug/even, different patient; PFIZER INC-202201070271 Same reporter/drug/even, different patient;
red/warm to touch @ injection site at time of injection went away and returned on 1/31
Aug 12 2021: Received Johnson and Johnson Vaccine Aug 16: Her husband was diagnosed with  COVID, she did not develop symptoms and was not tested for COVID Late Aug/Early Sep: began to develop dizzy/lightheaded that was a real change for her  10/18/21: Progressive chest fullness when returning from trip to lake with family and friends, presented to ER, diagnosed with pericarditis, begun on colchicine and ASA 650 BID 10/20/21: Progressive epigastric abd discomfort, poor appetite, called our office, recommended to down titrate ASA dose to 325, which she did 10/20-10/25/21: Progressive chest fullness, epigastric discomfort, poor appetite, emesis, difficulty being flat in bed   10/24-25 CT C/A/P and ECG: Pericardial effusion Atrial flutter/fibrillation is newly diagnosed
right arm pit was tender; right arm pit was swelling; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non health-care professional.  This case is linked to case 2020SA229160 (same reporter).  This case involves a 14 years old male patient who experienced right armpit was tender and   swelling (tenderness, swelling), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 14-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6638AA) via an unknown route in the right deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-seriousright armpit was tender and swelling (tenderness, swelling), unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.
My arm hurt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm hurt at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (My arm hurt at the injection site) (seriousness criterion hospitalization). At the time of the report, VACCINATION SITE PAIN (My arm hurt at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. Treatment information not provided.  Second dose was taken on 1-Feb-2021 and patient was diagnosed with breast cancer on 15-Mar-2021, undergone lumpectomy on 7-Apr-2021. Patient also had had radiation treatment the 1st 3 weeks in May 2021. Booster dose was taken on 1-Sep-2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-305899, MOD-2021-305900 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The zoster vaccine was administered on 10/30/2013.  On November 25th, the patient reported to a pharmacist on duty that she was experiencing pain and inquired if this was a normal side effect.  On November 26th, I spoke with the patient and she reported that a few days after getting the shot she was feeling what she described as "shocks" in that arm.  She mentioned that it started more near her shoulder, traveling towards her elbow.  She reports that it is not a constant pain, just intermittent "shocks".  She reports that it has gotten better over time and that she is currently experiencing it 1-2 times per day and more towards her elbow.  She also reports that she is having trouble with both arms with putting her jacket on.  Since the vaccine she had been her physician and did not mention the "shock" pains and only mentioned the problems with both arms putting on a jacket.  I spoke with the physician to report the symptoms the patient reported to us.  I also recommended patient call the office to discuss with her MD.
Severe respiratory  distress on day 3 after vaccine administration. Pain in upper respiratory tract when breathing. Lasted 2 days with still some lingering pain with deep breaths.
This spontaneous report was received from a 78 year old female patient reporting on herself. The patient's medical history included shingles from which she recovered from in 2010 and stroke. The patient had an allergy to penicillin. On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX injection, subcutaneously, 1 shot (exact dose, lot #, expiration date and anatomical location were not reported). The patient had no concomitant medications. On an unspecified date in 2015, the patient experienced a second case of shingles. On an unknown date in December 2015, the patient experienced a stroke and was hospitalized for 5 days in the intensive care unit (ICU) and 10 days in rehabilitation. The patient sought medical attention and received six unspecified medications including one painkiller, as a treatment. On an unknown date, sonogram of liver and kidneys was performed (details and results were not reported). The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not provided. The reporter considered stroke to be disabling. Upon internal review, stroke was considered to be medically significant. Additional information has been requested.
This spontaneous report as received from a pharmacist via a publicist representative refers to a female patient of unknown age. Information about concurrent conditions and medical history was not provided. On 07-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, lot, batch # and expiration date not reported) subcutaneously. Therapy reason for use reported as vaccination. Co-suspect and concomitant therapies were not reported. On 10-NOV-2014 the patient called the pharmacist and stated that she had redness and swelling in the same arm in which she received a dose of ZOSTAVAX although it was not around the injection site. As a treatment for the event  were applied warm compress. Lab diagnostics studies were not performed. The patient sought medical attention by calling the pharmacist. The outcome of the events was unknown. Additional information has been requested.
HEADACHE; DIZZINESS; PYREXIA; NECK PAIN; MOBILITY DECREASED; PAIN NOS. Information has been received from a registered nurse and a physician concerning a 14 year old male student with a history of Lyme disease (1998 currently resolved) who on 08-jan-2003 at 15:00 was vaccinated in the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 643757/0781M). There was no illness at the time of vaccination and there were no adverse events following prior vaccinations. On 11-Jan-2003, the patient developed a severe headache, severe neck pain, body aches, a fever to 103 F dizziness and he "couldn't get out of bed". No local reaction was noted and the "arm site was fine". The patient sought medical attention and was treated with acetaminophen (TYLENOL) or ibuprofen (ADVIL). It was noted that the patient was not brought into the office. No other laboratory tests were performed. The symptoms lasted approximately 3 days. Subsequently, the symptoms resolved and the patient recovered. It was noted that a product quality complaint was not involved.
extreme shortness of breath (can barely make it to the bathroom even with oxygen tank); feet swollen; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (extreme shortness of breath (can barely make it to the bathroom even with oxygen tank)) and PERIPHERAL SWELLING (feet swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 038K204) for COVID-19 vaccination.     Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]), VITAMIN D3 and VITAMIN E NOS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced DYSPNOEA (extreme shortness of breath (can barely make it to the bathroom even with oxygen tank)) and PERIPHERAL SWELLING (feet swollen). At the time of the report, DYSPNOEA (extreme shortness of breath (can barely make it to the bathroom even with oxygen tank)) and PERIPHERAL SWELLING (feet swollen) outcome was unknown.            No Treatment medication reported. Patient advised that she had other medicines that caused her to have shortness of breath and she used an oxygen tank. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant Follow-up received on 08-JUL-2021, reporter information like address ,fax, name and AE contact information was updated On 29-Jul-2021: Non Significant follow-up
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: EW0198) at the age of 59 years 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: "Overweight" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Coartem, reaction(s): "known allergies: Coartem (a malaria treatement)", notes: (a malaria treatement). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Product: COVID 19 Treatment. treatment start date: 16May2022. treatment stop date: 21May2022. Indication: Treatment of COVID-19. On the 5th and final day of the Paxlovid treatment she developed an itchy rash. Main patches were on the upper thighs, but small, more isolated spots were found on the chest, neck, back, lower legs and arms. The rash and itch were still active 48 hours after the final Paxlovid dose.