chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 15:00 as dose 4 (booster), single (Lot number: GJ6739) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Jan2021 at 09:00 as dose 1, single (Lot number: EL3246), on 03Feb2021 at 09:00 as dose 2, single (Lot number: EL9265), in left arm and on 21Jan2022 at 15:00 as dose 3 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "allergic to contrast dye when getting MRI" (unspecified if ongoing). There were no concomitant medications. The patient started feeling ill on Saturday, 05Nov2020. She had chills, sore throat, body aches, fatigue, and fever of 102.3 (fever was normal when taking Tylenol) then tested positive for Covid-19 on Monday, 07Nov2022. The patient took Paxlovid that evening. She took every dose as prescribed and tested negative on Friday, 11Nov2022. The patient took the last dose of Paxlovid on Saturday, 12Nov2022 and got a new sore throat, runny nose, congestion, fatigue on Saturday, 18Nov2022. The patient tested positive for Covid again on Monday, 21Nov2022. Outcome of the events was unknown.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 , BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), o the Vaccination failure and covid 19 cannot be ruled out.
Nausea; Fatigue; vomited for 8 hours; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting, nausea and fatigue. On an unknown date, the outcome of the vomiting, nausea and fatigue were recovered/resolved.   It was unknown if the reporter considered the vomiting, nausea and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after receiving the first dose of the shingrix vaccine, he vomited for 8 hours. After the vomiting resolved, patient reported nausea and fatigue that did not resolve for 10 days. All symptoms had resolved without intervention from health care professional.  The patient declined to provide any other information. The reporter did not consent to follow-up.
This is a spontaneous report from a contactable consumer reported for herself. A 71-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL9262), at the age of 71, via unknown route, in left arm, on Feb 19, 2021, at 08:15, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications reported as none. Prior vaccinations (within 4 weeks): Patient did not receive other vaccines. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL3246), at the age of 71, via unknown route, in left arm, on Jan 29, 2021, single dose, for COVID-19 immunisation. On Feb 19, 2021, patient experienced soreness in arm. On Feb 20, 2021, patient had chills, body aches and headache (which was gone now). On Feb 21, 2021, patient had dizziness, still having body aches and soreness in arm. The patient did not visit the emergency room or physician office due to the events and not hospitalized. No relevant test was performed. The patient received treatment for the events with Tylenol. The outcome of soreness in arm and headache resolved on Feb 21, 2021; and of the other events: not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Purpuric rash A 12 year old male patient with a history of environmental allergies had received an intramuscular left deltoid injection of Menactra, lot number U1995AA on 24/MAR/2006. Four days later, the patient developed a purpuric rash over his left should and upper arm around the site of vaccination. Per the reported, tests included the following, "CBC, diff, platelets, PT/PTT-normal". At the time of this report the patient had recovered. Follow-up information received on 05/May/2006 from a health care provider. The patient was examined by the physician on 31Mar/2006 and 10/Apr/2006. Per the reported "CBC, platelets, and PT/PTT performed on 31/Mar/2006 were all normal". The patient had no respiratory or GI illness at the time of vaccination or within the weeks preceding and following the vaccination. The case was reviewed by the reporter and no additional information was available.
Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy.  The patient's medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021.  On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient's last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021.  On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events was considered recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with an Adverse event  of Spontaneous abortion  for this 41-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.
HPV given 11/20/07 - In clinic 11/25/07 with 5 days of cough, hoarseness, fever.  Non-productive cough - sore throat, stiff neck - hurting to take deep breath.
03/21/19 at 7 am: arm pain and nausea, 03/21/19 11 am: achy all over, headache and nausea, 03/21/19 3 pm: slept until 6:30 pm, restless, achy, 03/21/19 7:30 back to bed same symptoms, 03/22/19 8:00 to 6:00 all the same symptoms, 03/22/19 7:00 pm: showered and noticed a red circle on her left arm that was not near the injection site, it hurt to touch. 03/23/19: Morning: felt nauseous, tired, no energy, 03/23/19 03:30 pm nausea is gone, red circle is still present on arm but the pain is almost gone. The red circle only hurts when she presses on it. 03/23/19: 6pm more energy, able to make supper. 03/24/19: 9:13 am not sore, all symptoms are gone except red circle is still there but not painful unless it is pressed on (2 to 3 pain scale).
hypoxemia, urinary retention Narrative: Transferred from facility to ED with 1 day of fevers, hypotension, and c/f new oxygen requirement and admitted to acute care ward on 1/14/21. Tachycardia resolved w/ fluids. Patient was ruled out for PE and infectious workup negative. Fevers, hypoxia resolved overnight. Medicine Team felt symptoms were side effects from COVID vaccine (2nd dose received 1/13). He was treated for possible cellulitis at L shin wound (warm and tender to touch with mild erythema, without fluctuation) with 14-day cephalexin course, however cellulitis not deemed severe and unlikely contributing. Regarding urinary retention, the Discharge Summary stated, "Urinary retention seemed new in the last day. Pt on condom cath during admission, urinating well." Discharged 1/15/21 and returned to facility.
administered expired daptacel with no reported adverse event; Initial information received on 05-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA206010.  This case involves a 1 years old female patient who was administered expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A Vaccine) for Prophylactic vaccination; and Hepatitis B Vaccine (Hepatitis B Vaccine) for Prophylactic vaccination.  On 23-Jun-2023, the patient received 0.5 ml (1X) (Dose 4) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C5893AA; Expiry date: 21-Jun-2023) (With an unknown strength) via unknown route in the right thigh for Immunization  On 23-Jun-2023, the patient was administered expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine with no reported adverse event (expired product administered) (Latency: same day)  It was reported, Caller says that vaccine that had expired June 21,2023 was accidentally administered to 5 patients. Caller would like to get information on next steps. The doses were all administered by medical assistants. It was not the same medical assistant who gave the expired doses to the five patients. Patient was administered expired Daptacel on 23Jun2023 for her fourth dose in the series. The dose was administered by a medical assistant in the right thigh. The patient received concomitant vaccination against hepatitis A and hepatitis B that day.   Action taken: not applicable.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA206192:01679504 US-SA-2023SA206192:01679483 US-SA-2023SA206192:01679488
On 1/22/13 I received the flu shot - FLUZONE - extra dose for age 65. In 2 days I had a terrible headache, sore throat w/a tickle in my throat, runny nose, sinus infection, cough-hoarseness. This lasted 1 wk or more. I believe it was due to the shot & was all side effects. I very seldom have a cold and all the above I believe was due to the shot. Also, when I went to receive the shot at pharmacy the person who gave it to me never asked me what medication I was currently on, if I was allergic to anything, etc. All she asked was which arm I wanted the shot in. Isn't it amazing that as far as we are in the technical world that humans are treated like this. To the government we are just a number and I never plan on getting this shot again.
Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration; Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigrator on same day of administration) outcome was unknown. Not provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 180 Concomitant medications were not reported. Patient had received 2nd booster dose. Patient had reported no adverse events.28 patients may have received the expired Moderna COVID-19 vaccine The vials were thawed the same day of administration. The vials did not undergo any temperature excursions Treatment information was not reported.
Temporary memory loss; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMNESIA (non-serious), outcome "unknown", described as "Temporary memory loss".  Additional Information: The reporter classified the event as not serious. The patient was recently vaccinated with the Pfizer COVID-19 vaccine and everything went well, but he suffered from temporary memory loss due to the medication he was taking and he could not find his vaccination card. He was asking if he can have a copy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a licensed practical nurse concerning her 74 year old mother with contrast dye allergy and a history of varicose veins and spinal fracture who on 27-FEB-2009 was vaccinated with ZOSTAVAX (Merck) (lot # not reported) in her left arm. Concomitant therapy included FOSAMAX, LASIX and potassium (unspecified). It was reported that on 01-MAR-2009, 2 days after the patient was vaccinated she started presenting with a headache. On 04-MAR-2009, within 5 days post vaccination the patient started experiencing numbness in her legs and her left arm where received the vaccine and she went to see her primary physician. On 05-MAR-2009 the patient went to the ER and was admitted to the hospital and released on 08-MAR-2009. The patient was diagnosed with transient ischaemic attack that affected the left motor nerve of her left arm. The patient was placed on PLAVIX and aspirin. Laboratory test performed on unspecified dates included Doppler, CT scan, MRI and Echo-cardiogram (results not reported). At the time of reporting, the patient was recovering. Additional information has been requested.
I experienced quick onset vertigo shortly after waking up that was extreme for 3 days then mellowed out over the next week. No signs since then.
2 days after taking 1st dose ofvaccine, patient woke up with a lumpunder his armpit in the arm that wasinjected; Pocket of fluid in the armpit that spread towards the breast area.; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the arm on 10Mar2021 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 12Mar2021 (2 days after taking the first dose of vaccine), the patient woke up with a lump under his armpit in the arm that was injected. There was also a pocket of fluid in the armpit that spread towards the breast area. The patient was concerned to take the 2nd dose. The patient did not receive any treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of axillary lump and axillary abscess were recovered with sequalae on an unspecified date in Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
Patient reports pain and soreness in the shoulder and arm 1 week after receiving the vaccination, which makes it difficult to sleep at night. Patient states that pain does seem to be improving on 8/17/2019. Patient states they have taken ibuprofen and aspirin in attempts to control the pain.
Itchy throat within hours. Still occurring 3 days post injection.; Sore left arm within hours of injection.; 3 days post injection the surrounding area of site is now itchy; 3 days post injection the surrounding area of site is now itchy with a red bumpy rash.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient's medical history reported was not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 16:00 the patient experienced itchy throat within hours, still occurring 3 days post injection, sore left arm within hours of injection, 3 days post injection the surrounding area of site was itchy with a red bumpy rash. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy throat within hours, still occurring 3 days post injection, sore left arm within hours of injection, 3 days post injection the surrounding area of site was itchy with a red bumpy rash was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt. describes feeling a lot of pain and swelling at site of injection. Next day, pt. felt worse to the point of going home early from work to see her physician. A rash spread from her arm to her face and neck. Her doctor recommended taking an antihistamine and an anti-inflammatory. Pt. was feeling better by 12/29/11.
noticed twitching of head the weekend p/vax given 2OCT92; mom was told per pt's teacher that pt been having twitching of head, stares in daze & won't sit still on 15OCT92; felt cool to touch like low body temp;
Patient came in for his second dose after 3 weeks and I asked him if he had any issues with his first dose.  He responded that his arm became numb after his first dose and it is still numb.
Rash and redness on arm at injection site l arm, welt 5 in ring around injection site has developed and warm  to touch, pain in arm pit ? this has resolved
Pt felt like her heart was going to explode. She also experienced abdominal pain and anorexia.
Patient had no adverse affects. She received J and J on 3/9/21 and Pfizer 10/27/21. She came to our booster clinic and was given a booster.
Sore arm and mild rash at location of injection for 2-3 days after receiving vaccine.
A week after the first injection was given my left arm had a large  perfectly round area that formed. It was itchy,  firm and warm to the touch.  It  stayed 8 days. The last two days the area looked like a bullseye. It was a red ring with a white center and was still itchy. I went to the Doctor 3 days before it faded away. No meds were given, we decided to watch it since I didn?t have a fever or any other issues.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-FEB-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 240 hours. The lowest recorded temperature was 34 F (1.111111111).  No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm 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: "Sulfa in antibiotics" (unspecified if ongoing). Concomitant medication(s) included: JUNEL FE 1.5/30 taken for contraception. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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 with Paxlovid. Clinical course: Patient received Paxlovid (lot number: GC0529) from 23Jun2022 for COVID-19 treatment and experienced nausea and vomiting and change of taste in mouth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
3 week after patient had what appeared to be a partial seizure lasting 5 minutes. Went to ER and she was given antibiotic. Not even sick. Than on 10/31/2006 she had another only it was Grand Mal lasting 45 min. Now on anti-seizure med after CPR was performed.