chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the Shingrix adjuvant only instead of the reconstituted vaccine; Received the Shingrix adjuvant only instead of the reconstituted vaccine; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 2nd dose of Shingrix. On 9th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-Jun-2022 Reporter's Comments: The patient self-reported this case. The patient received the Shingrix adjuvant only instead of the reconstituted vaccine. The reporter had nothing else to report. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received the Shingrix adjuvant only instead of the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Fever 100.2, marked swelling, redness, induration right thigh.  Seen in ER given antibiotics.
Pt developed large facial blisters one day post vax. Had previously denied adverse response to #1 and 2 Hep B, but now feels that the flu like illness following those injections may have been related. Fever of 101-102 with the first two doses.
She got her vaccine, was okay when she left and felt real tired when she got home, went to bed.  This morning she had a really bad headache ,dizziness and her nose feels like it's all stuffed up and has to breathe through her mouth.  The dizziness worries her.  Did take her BP medicine and her diabetes medicine and checked her sugar and that was OK.
3/19/09 T/C to reporter who states patient experienced redness & pain at anthrax site right arm & had limited mobility w/right arm, using left arm to lift right.  Seen in clinic yesterday & improving slowly.
Pt. developed soreness at injection site following day. Said the pain continued. He is experiencing needle like pain in whole arm. Can not lift right arm as much as he can do on left arm. Fingers show weakness.
I'm not diabetic and it raised my sugar dramatically to 289 for numerous days; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jul2021 (Batch/Lot Number: FA6780) at age of 42-years-old as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Patient was not diabetic and it raised her sugar dramatically to 289 for numerous days on 15Jul2021 with outcome of recovering. Treatment received included Insulin. No COVID prior vaccination. No COVID tested post vaccination.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of blood sugar increased cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product 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.
I received the vaccine Friday morning, 09:15 AM, (EST)  I was woken up at 04:23 AM (EST) by a very loud hissing noise, I thought it was outside, however I soon realized it was in my ears.  I was not able to go back to sleep.  I realized it was Tendinitis, as I have had systems of Tendinitis, over the years, but it just came and went, and was not loud enough or lasted long enough to be anything but a minor annoyance .   In this case while it is not loud, it is loud enough to be annoying, and it still did not go away. (time is now -01:13 PM 2/16, I am hoping it is just the vaccine working its way through my system.   I notified my primary care doctor at the VA, as well as audio dept.
We recently had COVID Again; We recently had COVID Again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Suspected COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "We recently had COVID Again". Clinical course: The patient had received all shots for Covid, had Covid again.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300110818 same reporter/drug and different patient/events.;
Vaccine received during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine received during pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 24-Sep-2021. On 10-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine received during pregnancy). On 10-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine received during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "hypertensive" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergy: amoxicillin, reaction(s): "Known allergy: Amoxicillin", notes: Known allergy: Amoxicillin.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Dec2022) Positive, notes: tested positive 3 days after Paxlovid course; (Dec2022) Negative, notes: negatives right after course completed. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid treatment start from 26Nov2022 to 30Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt presented to clinic requesting seasonal influenza vaccine.  Patient give Sanofi Pasteur Flu Quad Recomb Lot # UJ724AA per public health nurse.  Pt returned to clinic approx 2 hours later and c/o redness and swelling to injection site on right deltoid.
Initial onset of soreness and minor swelling at injection site, subsided within 24 hours. Within 8 hours gradual onset of body aches, fever up to 101.0 F, chills, rigors, and fatigue. Symptoms initially improved over a few days, but now worsening again x 1 week.
The evening after receiving my vaccine, I didn't feel well. I work up the next morning with vertigo. I had to sit up in the bed for a few minutes before standing. It was very difficult to walk. About two days later, I went to see my doctor and she prescribed an antihistamine. I took one dose and it helped. I haven't had vertigo since then.
Approximately 1 1/2 hours after receiving HPV vaccine developed headache. Next morning had fever, continued headache and neck pain. On 8/22 began vomiting, double vision. Has also been camping prior with bug bites.
I received the vaccine on January 8th, with no adverse events beside arm pain which subsided after 2 days. On January 16th, I noticed that my arm began to ache again. Then on January 17th, I developed redness, warmth, and swelling, which has continued to expand down my arm. I reported this to employee health, who recommended I report to this site, was not allowing me to self report.
sore right arm; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers (including the patient) reported that an 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176, expiration date: Mar2021) intramuscular on the right arm on 21Jan2021 14:00 at 0.3 mL, single for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. She had the first shot. She was going for the second shot on Thursday. She had a sore right arm on Jan2021, so she took ibuprofen (ADVIL) and she was hoping she did not ruin the fact that she had the first shot. The Advil took the soreness away and she has not had any problems since. The soreness started late in the evening when she went to bed around 11:30 or 12 and that was when she took Advil. The sore arm recovered the next day. She heard rumors from people that people should not take Advil or Tylenol after receiving the shot. She asks if this was true. She is asking if she can take Advil for her second dose. The events did not require a visit to physician office or Emergency Room. The facility where the vaccine was administered was in a convention center. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event was recovered on an unspecified date in Jan2021.
Nausea and vomiting  the next day after receiving the vaccine.   N/V lasting for 1 day only.
She fell twice. The second time was due to a blood clot on the brain that led to multiple bleeds under dura and the brain. She needed an emergency craniotomy and is now undergoing acute rehab for speech, PT and OT.
Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage; Used two vials from the freezer after 30 days to administer them; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) and EXPIRED PRODUCT ADMINISTERED (Used two vials from the freezer after 30 days to administer them) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used two vials from the freezer after 30 days to administer them). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage). At the time of the report, PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) and EXPIRED PRODUCT ADMINISTERED (Used two vials from the freezer after 30 days to administer them) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Reporter stated that it was notified to them that their upright freezer (two separate doors for freezer and fridge) was not good to use after 30 days. They normally pull the vials out before the 30 days to thaw. Reporter further stated that they wanted to have a standalone freezer because of an automatic defrost cycle on some two door freezer/fridge combinations. The vial was initially stored in the refrigerator on 17-May-2022 (1 vial) and 19-May-2022 (1 vial). The temperature had not gone out of range at all, no temperature excursion happened. The patient received booster dose. Reporter further stated that the patients had not contacted them about any problems.  Treatment information was not reported.
A pretty significant mass raised and warm to touch/ it was a localized reaction; Initial information was received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA229573 (same reporter).  This case involves a 30 years old female patient who had a pretty significant mass raised and warm to touch, it was a localized reaction (inflammation), while she received vaccine  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not pr ovided.  The patient did not receive any concomitant vaccinations.   On 24-Aug-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ432AB, expiry date 30-Jun-2021, form: prefilled syringe) once via intramuscular route in the right deltoid for prophylactic vaccination.  On 24-Aug-2020, the patient developed a non-serious pretty significant mass raised and warm to touch, (inflammation) on same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was evaluated in office by an Obstetrics/gynaecologist who said his impression was it was a localized reaction.  No laboratory data was provided.  The patient did not receive any corrective treatment.  At the time of report, the outcome of event was recovering (reported as The reaction had improved following day).
7 doses mixed with non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number BA975, expiry date 16th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The medical assistant reported staff discovered that 7 doses of Hiberix were potentially mixed with non-supplied diluent when they were reconstituted for administration.  It was believed the doses were reconstituted with sterile water diluent from Merck that was used for reconstituting proquad vaccines. The reporter did not have patient details at the time of call.  The reporter did not know dates of administration. The reporter had consent to follow up. Additional supportive information: Hiberix was reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. This was one of the 7 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR136348:Same reporter. US-GSK-US2022AMR136361:Same reporter. US-GSK-US2022AMR136360:Same reporter. US-GSK-US2022AMR136363:Same reporter. US-GSK-US2022AMR136364:Same reporter. US-GSK-US2022AMR136365:Same reporter.
Chills, "covid-arm" (huge red welt), fatigue (in bed for two days)
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 2:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 2:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 35.66.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 28-Apr-2021, the excursion time on initial supply was 09 am, temperature was 33. Total 150 doses were administered for that day, condition of vaccine prior to vaccination was not frozen. Vaccine moved to fridge on 19-Apr-2021 and moved to clinic on 28-Apr-2021. 04 vials were moved to the clinic. Vaccine BUD date was 19-May-2021.  On 28-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41 and 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Joint pain 8 hours after administration - took 400 mg Ibuprofen "knocked edge off", swollen lymphnode above right clavical day 2 - to present (day 10). Joint pain stopped Monday (Day 6).
Bleeding every2-3 weeks and would last over a week. Lasted until July when birth control dose was increased
14:00 (approx): Patient attempted to stand approx. 1-2 minutes after receiving TDAP, MCV, and HPV vaccines and having a fingerstick hgb (patient was with mother in exam room, unwitnessed by staff) and "almost fell over"- mother caught her and helped lay her on the exam table. Patient did not lose consciousness but felt "woozy". Staff was called to room immediately (this examiner and MA). Patient was somewhat pale and mildly disoriented initially, but awake and able to respond to staff. She was positioned on exam table with feet slightly elevated and a cool compress placed on forehead. Vitals were checked and were as follows: BP 87/52, HR 106, SpO2 98%. Patient was responsive to staff and answered yes/no questions. She was able to drink some apple juice. By 14:10, patient reported feeling better with mild headache only. Pulse was rechecked and was 90. Patient continued to rest lying down until approx. 14:15, at which point mother stated patient felt better and wanted to go home, also mother needed to pick up another child from school. Patient was able to independently get up from exam table and walk out of clinic unassisted. The declined repeat vitals before leaving clinic.
eye and mouth swelling; eye and mouth swelling; injection site pain; unable to think straight; low energy; sweats; mild diarrhea; Chills; headache; bodyache; cough; dry throat; This is a spontaneous report from a non-contactable Other HCP reported that an adult patient receives first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot/Batch Number and Expiration Date unknown) intramuscularly on 25Dec2020 at single dose for covid-19 immunization. The patient's medical history included allergies to Pollen/dust, extreme weather. The concomitant medications were not reported.  The patient experienced Chills, sweats, headache, bodyache, cough, dry throat, eye and mouth swelling (after 24 hours), injection site pain, unable to think straight, low energy, mild diarrhea. Adverse event start date: 25Dec2020.  The patient been tested for COVID-19 and no COVID-19 prior vaccination. There is other vaccine in four weeks. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient discharged after (2) day inpatient stay 11/12-11/14/2021 Patient is a 62 y.o. female with past medical history significant for essential hypertension, type 2 diabetes mellitus, non-insulin dependent and hyperlipidemia who presented to the ED with right sided chest pain, nausea, vomiting, diarrhea and dry cough. In the ED, she was hemodynamically stable, afebrile and non-hypoxic on room air. Covid 19 PCR was positive. CXR obtained and negative for acute cardiopulmonary process. Lab work revealed hyponatremia with Na 121. Troponin x2 was 7 -> 8 and EKG without acute ischemic changes. While in the ED, the patient received 1L IV fluid with improvement in sodium level to 126. She was admitted for further management.   Hyponatremia felt likely hypovolemic secondary to vomiting and diarrhea in setting of Covid 19 infection. Home hctz was held and she was given gentle IV fluids. Her sodium levels slowly improved over the next 48 hours. She was without dyspnea, had no further chest pain and remained on room air. She felt much improved and felt stable for discharge. She was instructed to stay hydrated, continue to hold hctz and follow up with her PCP within one week for repeat lab work and follow up. She was discharged home with her husband in stable condition.
Headache, Myalgia, FATIGUE Narrative: PT REPORTED HEADACHE, MYALGIS & FATIGUE AFTER 2ND DOSE OF COVID VACCINE. PT TREATED WITH TYLENOL & MOTRIN.
Lt leg red, hot to touch, 6 x 10 cm area, swelling, induration, tender; Will walk w/encouragement;
Shaking, muscle spasms, muscle pain. 7/9/2016- Injection side swelled to size of a nickel. 101 degree fever. Flu-like symptoms. Chills. Nausea. Injection site rash spreading, raise, hot, burning. Rash from shoulder to elbow. Extremely limited arm movement. 7/10/16- Injection sit rash spread further. Blotchy. Raised, hot. Fever continues 100 degrees. Extremely limited arm movement. 7/11/16- Injection site rash spread to bicep. Blotchy, raised, burning. No fever. Body aches.