chrisvoncsefalvay/vaers-outcomes huggingface dataset:
37 Patients were administered vials that were in the fridge for 34 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (37 Patients were administered vials that were in the fridge for 34 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (37 Patients were administered vials that were in the fridge for 34 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (37 Patients were administered vials that were in the fridge for 34 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information were reported.
Moderna COVID19 vaccine EUA:  Significant right arm pain improved with Tylenol and ibuprofen. Almost resolved  in 2 days.  Hives and itching started the morning after the injection and worsened throughout the day. Hives started on right arm and spread to whole body. Improved with Benadryl and anti-itch cream. Not completely resolved but greatly improved over night.
tingling/pain in my left leg; tingling/pain in my left leg; This is a spontaneous report from a contactable consumer. The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 16:00 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma. Concomitant medication(s) included: LAMICTAL; BUSPAR. The following information was reported: PARAESTHESIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 12Mar2021 23:30, outcome "not recovered" and all described as "tingling/pain in my left leg". The event "tingling/pain in my left leg" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, pain in extremity.  Additional information: No other vaccine received in four weeks. Other medications in two weeks: Lamictal and buspar. Patient tested post vaccination. Tingling and numbness in patients left thigh. It started after the first shot and got worse after the second. It's causing serious discomfort.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills; Fever; Felt like crap; Body aches; Eyes hurt when she moves them; Pains in her back; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received first dose bnt162b2 (Solution for injection, Batch/Lot Number: ER2613; Expiration Date: Jul2021), dose 1 via an unspecified route of administration, administered in Arm Right on 29Mar2021 16:00 (at the age of 56 years) as dose 1, single for COVID-19 immunization. Medical history included exposure to sars-cov-2 from 27Mar2021 to an unknown date she was also exposed to her niece and grandchildren last Saturday who are COVID-19 positive, covid-19 from an unknown date and unknown if ongoing Her niece and grandchildren last Saturday who are COVID-19 positive. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 the patient experienced chills, fever. on 29Mar2021 body aches, eyes hurt when she moves them. on 30Mar2021 felt like crap, pains in her back on Mar2021.The outcome of the events was chills, fever, felt like crap recovered. Body aches recovering, Eyes hurt when she moves them not recovered, Pains in her back was unknown.  No follow-up attempts are needed. No further information is expected.
Retroperitoneal hematoma. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Patient is a 83 Y male who presents to the Emergency Department for fall, vomiting, hypoxia.  Diagnosed 5 days ago with Covid.  Was given Regen-COV in the ED.  Was seen on the next day for nausea and vomiting and has continued to have issues with that.  Tonight he had a ground-level fall.  Has brown emesis and very coarse breath sounds with sats in the 70s for EMS.  Satting 99 on 10 L nasal cannula.  Denies head injury or loss of consciousness.  Denies abdominal pain. 1 day of patient reporting that he needed to urinate every 10 minutes.  This morning patient declined to eat breakfast which is abnormal for him.  He also developed nonproductive cough today.  The rest the family has had a small cold but is otherwise felt okay.  One child tested negative for Covid.  No fevers, vomiting, diarrhea, abdominal pain, headaches.
Patient reported feeling dizzy, lightheaded, and feeling warm sensation Patient seen by medical team and vitals were stable Patient stated symptoms improved with water Patient refused medical transport and signed ama form and driven home by parent
autoimmune with serious issues; heart issues; shortness of breath; bad reaction rash all over diagnosed eczema; itch; Rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced autoimmune disorder (Verbatim: autoimmune with serious issues) (serious criteria GSK medically significant), heart disorder (Verbatim: heart issues), shortness of breath (Verbatim: shortness of breath), eczema (Verbatim: bad reaction rash all over diagnosed eczema), pruritus (Verbatim: itch) and rash (Verbatim: Rash). The patient was treated with hydroxyzine. The outcome of the autoimmune disorder, heart disorder, shortness of breath, eczema, pruritus and rash were not reported.   It was unknown if the reporter considered the autoimmune disorder, heart disorder, shortness of breath, eczema, pruritus and rash to be related to Shingles vaccine.     It was unknown if the company considered the autoimmune disorder, heart disorder, shortness of breath, eczema, pruritus and rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-Mar-2023 The case was received from the patient via interactive digital media. The patient had bad reaction to the first shot.  The patient also had rash all over, later diagnosed as eczema.  The patient now autoimmune with serious issues. The patient had Steroid pills and Hydroxyzine for itch caused heart issues now and shortness of breath.  The patient stated that beware if you have any allergies, he/she did not thought he/she had allergies.  The follow-up could not be possible as no contact details were available.
This spontaneous report as retrieved from webpage refers to a 12 year old patient of unknown gender who was reporting on themselves. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date in 2011, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot number and expiration date were not reported). On an unknown date in approximately 2011, the patient experienced indescribable pain. It was also reported that it was a desperate and terrible time for the patient because they were unable to do anything, being blamed for being sick and no help was in sight. According to the reporter, 6 months into their sickness, they went to a homeopathic doctor (natural medicine) and were given unspecified remedies which slowly cured them (date unspecified). The relatedness between the events and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
She got home and after 3 hours she started seeing things, and talking nonsense. Every bone in her body was hurting. It was early in the morning and she thought it was in the middle of the night.  Her husband had to help her to walk with the walker, and was out of her head. She has not been able to walk since Monday afternoon about 4:00. She is now just today able to get to the bathroom. She has taken Extra Strength Tylenol, Trazedone and Klonopin so she could sleep as she has not been able to. She has never experienced anything like this in her life due to the pain. She is a little better today, she gets dizzy when she gets up but still in the bed. She called the doctor yesterday and spoke to the nurse who told her to go to the ER but did not as her husband cannot help her much as he has prostate cancer.
Patient, who is a pharmacy intern, completed screening form and checked "No" to the question ?Have you ever received a COVID-19 vaccine?  If so, when and type/manufacturer.?  Based on this, he received the Moderna Vaccine and stated he would return for his second dose in 28 days.  Upon entering the vaccination into IMMTRAC, it was found that he in fact had a Pfizer Covid-19 Vaccine on 03/05/2021.  He was contacted and at that time admitted he did receive the vaccine on 03/05/2021 from a different manufacturer.  He stated that he felt fine and was not having any issues when asked by the Pharmacy Director.
A large, red, basically round, itchy welt emanating from the injection site the next day. It's approximately 2" across, itches, and is painful to the touch. It also hurts when I lift that arm. (If useful, the receipt also stated.
Patient broke out in a rash to bilateral upper thighs on 8-10-16. Pt brought in by parents on 8-11-16 and noted rash to bilateral upper thighs where vaccines were administered.
This spontaneous report was received from a pharmacist concerning a 26 year old female patient with heartburn, smoker, naproxen (reported as naproxyn) allergy and acetaminophen, EXCEDRIN allergy. The patient was a post-partum patient, after delivering an infant on 29-JAN-2014. On 31-JAN-2014 the patient was vaccinated with PNEUMOVAX 23 (Lot # J013345; Expiration date: 11-JAN-2015), 0.5 ml, intramuscular in the left deltoid for prevention of pneumonia. Concomitant therapies included acetaminophen, NORCO. On 31-JAN-2014, the patient experienced fever 100.4, sharp pain shooting down to hand, numbness, and swelling from the injection site to the hand and mildly elevated white blood count after receiving PNEUMOVAX 23. The patient was treated with BENADRYL and ice pack to arm. The patient was discharged to home on 31-JAN-2014. The patient's outcome was unknown. Pharmacist requested lot check. This is one of several reports from the same source. Additional information has been requested.
Since then she has been experiencing side effects; Hot fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Since then she has been experiencing side effects) and PYREXIA (Hot fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced VACCINATION COMPLICATION (Since then she has been experiencing side effects). On an unknown date, the patient experienced PYREXIA (Hot fever). At the time of the report, VACCINATION COMPLICATION (Since then she has been experiencing side effects) outcome was unknown and PYREXIA (Hot fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.
Post vax, the pt developed a high fever up to 106.5F (tympanic) for 2 days per parents. The pt was not brought in by parents until after the fever resolved. Pt was without fever when brought in.
2/19/2021 Sore arm, achey, dizzy.  2nd day after 2nd shot.  7/30/2021  I caught a cold. After about 5 days started using my nebulizer along with other meds like expectorant. Was achey, coughing, wheezy, tired, trouble breathing. . By August 8, had to go to Med. Having trouble breathing and earaches.  I was put on Arithromiacin for infection and a graduated  prednisone pack. Also, continued to use my nebulizer for treatments. I had a follow-up appt with the pulmonology Nurse Practitioner on August 23. I am supposed to keep using my asthma meds, my rescue inhaler in mornings and evenings in calm down the inflammation.  I am still coughing and get short of breath.
7 yo patient received 0.2ml of undiluted vaccine,  remaining quantity of vial was destroyed
He got where he could barely walk, has trouble shallowing, eating, super sensitive hearing and sensitivity to light,  he has been to the hospital appr. 8-12 times, had MRI, ct scans, he's on Cymbalta, valuim, several other meds for anxiety.
24 hours of muscle soreness all over patient's body; chillsb and headaches.
Patient recently vacationed and presented to the emergency department with mild, non-productive cough, nausea, recurrent vomiting, and mild upper abdominal discomfort x 1 day, and few loose stools. She tested positive for COVID19. She was afebrile, O2 saturation was good on room air, and hypertensive. CXR without pneumonia. She was treated with IV labetalol for hypertension and also received 1 liter of fluids and anti-nausea medications. She was not hypoxic throughout her admission. She received supportive management (acetaminophen, ondansetron) with good effect) and was discharged in asymptomatic condition on 8/13/21.
Swollen armpit; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high triglycerides" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; CYCLOBENZAPRINE; MELOXICAM; CHROMIUM PICOLINATE; CALCIUM; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]; ACIDOPHILUS; ZINC. Past drug history included: Aspirin, reaction(s): "known allergies;aspirin". Vaccination history included: BNT162b2 (Dose Number: 1, Lot Number: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Feb2021, for covid-19 immunisation; BNT162b2 (Dose Number: 2, Lot Number: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Mar2021, for covid-19 immunisation; BNT162b2 (Dose Number: 3, Lot Number: 30135BA, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 08Dec2021, for covid-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 23Sep2022 at 03:30, outcome "recovered" (25Sep2022 at 15:00), described as "Fever"; SWELLING (non-serious) with onset 23Sep2022 at 22:00, outcome "recovered" (26Sep2022 at 10:00), described as "Swollen armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, pyrexia. Additional Information: The lot number was reported as (6 or G) 72528. The patient did not receive vaccine in four weeks and took Centrum in two weeks. Fever started Friday, Sep23 at 3:30 AM and ran through Saturday, Sep25 at 3:00 PM. Highest temp: 100.1 F. Swollen armpit start Friday, Sept 23 at 10 PM and continued to Monday, Sep26 at 10 AM. The patient has not been diagnosed with covid prior vaccination and has tested negative covid post vaccination.  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.
I received my first COVID-19 vaccine shot through facility. There I received the Moderna vaccine on Feb 12, 2021. Since then that location is no longer scheduling appointments and refers me to another County. I also received confirmation from there, where I registered, so I made an appointment today and received the first Pfizer vaccine. The concern is that I now have two different vaccines. Should I receive a second of either Moderna or Pfizer, and if so, which one should I receive?
Patient developed a rash with itching at injection site approx 24 hours after injection. She reported the reaction 8 days afterwards, the rash was still present, measuring 12 inches up and down and 6 inches around her arm. No other symptoms were mentioned.
Soreness at site of injection; This is a spontaneous report received from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 17:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medications were none. The patient was not allergic to food, medications and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Mar2021 at 5:00, the patient experienced soreness at the site of injection. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the soreness at the site of injection was resolved on an unknown date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Diagnosed with Bells Palsy by same doctors office that administered vaccine. Symptoms started a little over three weeks after first dose. Facial paralysis on the right side of face. Cannot fully blink right eye and achieve full smile as the other side of the face.
On Thursday, 5/6/21, patient was to receive his second dose of Pfizer COVID vaccine (LOT #: EW0167, exp: 8/2021) at approximately 11:00 am. RN administered patient's second dose in his left deltoid. Client was observed in the Observation Area for 15 minutes with no adverse effects and left vaccination site with a steady gait at approximately 10:50am. RN finished administering his 6 doses around 11:45am and returned his Pod Participant Form for "Vial 24." RN 2 noticed a duplication in vial number 24 Pod forms. Upon further assessment, RN 3 recognized that she had reconstituted the same Pfizer vial, vial 24, twice with 1.8ml of Normal Saline. Issue was elevated immediately to Clinical Lead who advised to call client back to receive the proper full dose. Patient was called at 1:20 pm. RN 2 apologized and explained to client what happened. Patient was understanding and verbalized agreement to come back at 2:15 pm. Patient received his second dose of Pfizer COVID vaccine (LOT #: EW0179, exp: 8/2021) on opposite arm ( Right deltoid) at 2:27 pm. Patient denied history of severe allergic reactions. Patient was observed in Observation Area for 30 minutes. Patient was educated by RN 4 on signs and symptoms of adverse reactions and when to go to the ED/call MD. Patient was also encouraged to sign-up on v-safe. Patient left vaccination site with a steady gait at approximately 3:00 pm.
On April 1, 2021 @ 9:30 Pm, Started with nausea then cold sweats and then went into more intense nausea and sweating profusely.  Also began vomiting.  This went on until 6:30 AM April 2, 2021 and then the vomiting stopped.  Then cramping throughout body, hands, feet, legs all body.  Had temp 101.8.  Took Tylenol and was able to sleep a bit.  April 3, 2021 less body cramping and able to hold hold down clear liquids.  Also on April 2, 2021 Left Arm 2x3 inch site became red, swollen and itchy and this lasted until April 4, 2021.  As today April 7, 2021 is getting better but still recovering.
Headaches, Chills, worst nausea and abdominal pain I?ve ever had in my life, vomiting
approx 10 days p/vax pt exp 1/2 nickel size red, slight raised area.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 21-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N023828 (expiration date 25-JUN-2020) and VARIVAX lot number N021720 (expiration date 10-AUG-2019). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Return of symptoms and positive test 7 days after negative test; Positive, notes: Return of symptoms and positive test 7 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.