chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the administrator referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 26-APR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot# M000442, expiration date 31- MAR-2018 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1705USA013001: US-009507513-1705USA012999: US-009507513-1705USA012998: US-009507513-1705USA012997: US-009507513-1705USA012995: US-009507513-1705USA012985: US-009507513-1705USA013000:
Had chest pain on and off for 5 days (started Thursday 3/25),  which I thought was related to acid reflux. On Tuesday 3/30 when it became worse and was no longer managed with ibuprofen I went to patient 1st. I was given an ekg which was abnormal and then sent to ER. There it was determined that I had a blood clot and 100% blockage in my right coronary artery. That night I had surgery and they placed a stent.
Patient received FLUVIRIN and PNEUMOVAX 23 on 9/16. She reported a swollen arm (softball size) around injection site. She was treated at ER and then released.
Pt. was in for her 1 year well check clinician ordered for her to receive MMR, Varicella and ACTHIB rather than the PREVNAR 13. Nothing adversely happened to the patient. She has now received all appropriate vaccines.
Tinnitus in both ears, although louder in the left ear. Occasional ear pain.
Mom stated pt had rash after last vaccines in 01/06/2005. Had at that time Prevnar, MMR, Varivax. We instructed mom to wait 20 minutes after vaccines given today. After 15 minutes red raised rash started only around injection site. 2 inches by 2 inches.
This case was reported by a nurse and described an adult female between the ages of 18 to 25 years old who did not respond to the hep B vaccine (Unk manf). The pt's medical history, concurrent conditions, and concurrent medications were not reported. The nurse reported that the pt had received her vaccination series prior to 1999. At an unspecified date in 2003, a hep B surface antibody titer
his arm feels like it has a knife/tries to pick up something, move his arm, or do something he gets a sharp, sharp pain was reported as worsened; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 03Jan2021 (Lot number: EK4176) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Jan2021, outcome "not recovered", described as "his arm feels like it has a knife/tries to pick up something, move his arm, or do something he gets a sharp, sharp pain was reported as worsened". The event "his arm feels like it has a knife/tries to pick up something, move his arm, or do something he gets a sharp, sharp pain was reported as worsened" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity. Additional Information: He was glad to say that he was healthy as a horse he had got all good numbers for his blood results (taken on unknown date). The patient said that he had his first Pfizer COVID vaccine on 03Jan2021 about 1100 or 1200. On 04Jan2021, his arm felt like it has a knife in it. He can push on the arm in the muscle from the outside and it doesn't hurt but when he tries to pick up something, move his arm, or do something he got a sharp pain. He has tried warm water in the shower and that made it feel better. He also tried an ice pack (over-the-counter ice pack that he kept in the freezer) last night, and his arm seized up when he used it. He then used a heating pad and it worked itself out. The patient also has taken both Ibuprofen and acetaminophen (Tylenol) and they helped a little bit but not much. The Ibuprofen worked better than the acetaminophen worked. The patient stated everything else was fine, he had no issues with the COVID vaccine. He had a physical (unknown results) 2 weeks ago (in 2021), and his provider checked him out and poked at his arm. The provider mentioned that either they hit a muscle or a nerve. The events continued until his second dose of the COVID vaccine on 31Jan2021 (lot# EN5318) on the right arm and it continued up to right now. The patient has no vaccination within 4 weeks prior to COVID-19 vaccine and has no medical history including any illness at time of vaccination and family medical history relevant to the adverse event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021267918 similar report from same reporter
Initial report was received from a healthcare professional on 12 July 2013. This case is linked with the mother case number 2012-07526. An infant (age, gender and date of birth not reported) was exposed in utero to ADACEL, lot number U43938A, on 09 August 2012. The patient's birth outcome was not normal with a unilateral clubbed foot. Outcome was not reported. Documents held by sender: None.
This spontaneous report received from the physician referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The physician reported that on an unknown date, an unspecified patient was administered a dose of VARIVAX (lot and expiry date not reported) subcutaneously on an unspecified date, that had been reconstituted using an unspecified brand of Sterile Water (product preparation error). No adverse effects reported. Additional information is not possible as consent to be contact is not provided.
Patient was given Prevnar vaccine to patient, patient was not yet due for vaccine. Patient's mom was notified by Nurse immediately after. Patient parent was called 01/26/2023 to follow-up on child, received no response. Left Voicemail for Call back. Provider determined there is no danger to child. Patient just received an invalid vaccine.
Temp of 95 at midnight first night. Aches, chills, and fatigue through second night. Incessant itching of scalp and upper facial region, particularly 36+ hours after vaccine.
Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves male patient who was vaccinated with 0.5 ml TYPHIM VI on an unknown date (batch number, expiry date route and site of administration was unknown). It was reported that, patient had received Typhoid dose 6 month prior in JUL2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to extra dose administered as again after giving the typhoid vaccine noted that he last had one in July of 2018 6 months before. It was unknown whether the patient had any adverse event. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Patient might have received an empty syringe; This spontaneous case was reported by a health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient might have received an empty syringe) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Patient might have received an empty syringe). On 11-Mar-2021, INCORRECT DOSE ADMINISTERED (Patient might have received an empty syringe) had resolved.        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 medication and treatment information was provided by the reporter. No events was mentioned as due to vaccine not administered due to syringe issue.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: the follow-up case received on 22-JUN-2021 with no new information; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 030M20A with no associated AEs.
info on dosing interval (beyond 6 months between the first and second dose); This case was reported by a other health professional and described the occurrence of drug dose administration interval too long in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The dosing interval between the first and second dose beyond 6 months. The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of vaccination schedule. It was stated need more information on dosing interval.
We were under the impression we were administering the Pfizer Bivalent COVID vaccine but we administered the Pfizer Monovalent COVID vaccine in error. Patient was made aware and offered CDC guidance on how proceed.
pt recv vax & w/in 5min post vax, pt exp syncope, inc BP, & inc pulse;sx resolved
I got diagnosed with Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient got diagnosed with covid on 19Mar2021. He stated, "Do I need to keep my appointment since I got diagnosed with Covid last Friday (19Mar2021)? I am due for my second dose 29Mar2021". Outcome of the event was unknown.   Information on the lot/Batch number has been requested.
I received the shot on March 18th, and had no problems on that day at all. I woke up on March 19th and my arm was very sore, swollen and red. the pain and swelling subsided by the following day March 20 and the redness was gone by March 21. Then on March 25th my are started itching really bad and swelling and got a little red. When I woke up on March 26th my are was again itching, swollen more are the redness spread. I called  Dr. office and was told to do ice and Tylenol or Motrin and it should be better in a few days.
Canker type sores in mouth still present. Complained of sore throat,achy,abdominal pain, general malaise the past couple of days but feeling better yesterday.  Important to note is that she has a boyfriend who may have been infected with HG (herpes gladitorium)-his wrestling team had "ringworm" and "staph" and now area wrestlers are showing up with HG which is said to be confused often times with staph skin infections.  Cold sores are common with HG and are contagious of course, so it might be possible that she contracted the sores by kissing her boyfriend who may have been infected with HG?? Not sure and can't prove that he was infected.
received a booster dose of Pfizer Covid vaccine on 04Nov2021 but he received it subcutaneously; received a booster dose of Pfizer Covid vaccine on 04Nov2021 but he received it subcutaneously; The only side effect was he had was tenderness at the shot but not deep pain like with the other shots.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 41-year-old male patient received bnt162b2 (BNT162B2), subcutaneous, administered in deltoid left, administration date 04Nov2021 (Lot number: FE3590) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, start date: 2021, stop date: 2021. Vaccination history included: Covid-19 vaccine (First dose, Given at an unknown time in the left shoulder, Lot: EW0150.), administration date: 08Apr2021, for COVID-19 immunization, reaction(s): "he had was tenderness at the shot but not deep pain like with the other shots"; Covid-19 vaccine (Second dose, Given at an unknown time in the left shoulder, Lot: EW1067.), administration date: 29Apr2021, for COVID-19 immunization, reaction(s): "the first 2 shots he declines saying it was the normal pain after a shot". The following information was reported: IMMUNISATION (non-serious), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) all with onset 04Nov2021, outcome "unknown" and all described as "received a booster dose of Pfizer Covid vaccine on 04Nov2021 but he received it subcutaneously"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "The only side effect was he had was tenderness at the shot but not deep pain like with the other shots."  Additional information: The patient received booster dose on 04Nov2021 and it was later determined he received it subcutaneously. Prior Vaccinations (within 4 weeks):  The patient stated that he got Flu shot before the booster, probably a few weeks the booster shot but the date was unknown. The patient does not know the flu shot name. It was stated the patient had no negative reaction to the shot it was just administered incorrectly. The only side effect he had was tenderness at the shot but not deep pain like with the other shots. He wanted to know if it was possible to get another shot. The patient observed when the dose was administered, that it was given more under the skin and wondered if he should get another shot, if it would be effective.   No follow-up attempts are possible. No further information is expected.
About 6 hours later flu like symptoms, body aches, fever.  The next day having tinnitus type symptoms and sensitivity to sounds.  That lasted about another day and seemed to go away.  Then the same hearing symptoms came back on April 5.  I went to my Ear, nose and throat doctor and they said I had moderate sudden hearing loss in my left ear.  I have gone before and they had a baseline test to compare it to.  They have prescribed a steroid, prednisone to try to help. They said there is a possibility the hearing loss could be permanent.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypertension-Mild, Systemic: Tachycardia-Mild
He believes that he has contracted a rash on his back from the Pfizer covid vaccine, less painful now; less painful now, but is itching more.; Then it actually started to peel, like a bad sunburn; It started out as a red spot; irritating his back; heat rash; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 17Mar2021 at 13:30 (Lot Number: EN6208; Expiration Date: 30Jun2021) as SINGLE DOSE for COVID-19 immunization. The patient did not have any medical history. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for cholesterol from an unspecified start date and ongoing; metformin (METFORMIN) taken for pre-diabetes, start and stop date were not reported. The patient previous received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left shoulder on 24Feb2021 at 14:30 (Lot Number: EN6200; Expiration Date: unknown) as SINGLE DOSE for COVID-19 immunization. No other vaccine was administered on the same day of Pfizer COVID vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date of 2021, about two weeks ago, the patient started noticing the rash on a hot day, because it was irritating his back. He was thinking that it might have been a heat rash. After a while, it started peeling like sunburn. The patient believed that he had contracted a rash on his back from the Pfizer COVID vaccine. It started out as a red spot and was closer to the middle of his back. Then it started to peel, like a bad sunburn. It was moving a little over to the right and reported that It was less painful but was itching more. The outcome was reported as not recovered for the reported events.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 47 year old female with no pertinent medical history and no known allergies, who on 30-MAY-2007 was vaccinated with the third dose Gardasil (lot # 657737/0522U). The patient reported that following the vaccination, "all the fluid leaked out along with some blood". The patient informed the nurse that she knew how to administer vaccines. The nurse stated that medical assistant at the office who administers vaccines refuted the patient's claim. The nurse confirmed the patient's age. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
constant ringing in ears since vaccine, softer and high pitched, it is constant at a softer level and then increases to higher and louder.  no dizziness, lightheadedness, nausea, visual disturbances, numbness or tingling - it is just the ringing.
Breaking out with some rashes, little red rashes that itch like crazy; Still getting the rashes, they pop up here, pop up there and they itch like crazy; Breaking out with some rashes, little red rashes that itch like crazy; Still getting the rashes, they pop up here, pop up there and they itch like crazy; Breaking out with some rashes, little red rashes that itch like crazy; Still getting the rashes, they pop up here, pop up there and they itch like crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 76-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 (Lot number: FC3181) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: FA7485, Time: 10 AM) for Covid-19 Immunisation. The following information was reported: RASH PRURITIC (non-serious), RASH ERYTHEMATOUS (non-serious), RASH (non-serious) all with onset 19Aug2021, outcome "not recovered" and all described as "Breaking out with some rashes, little red rashes that itch like crazy, Still getting the rashes, they pop up here, pop up there and they itch like crazy". Therapeutic measures were not taken as a result of rash pruritic, rash erythematous, rash.  Additional details: Patient received the first dose around 10 o' clock. Patient reported that she got both doses before 12 o' clock and it was in the morning. Patient reported some of the rashes are big rashes marks. Patient did not receive any prior vaccinations (within 4 weeks). Patient reported other medical conditions and other medications as "No, just normal stuff" which was not clarified further. Patient still experienced the rashes and itching. Patient never had this experience before.  Follow-up (03Sep2021): Follow-up attempts are completed. No further information is expected.
mild joint pain & stiffness of fingers, wrists, knees & ankles; enlarged cervical glands; sx resolved by 3MAY94;
On 04/14/2021 I got covid arm & I also got shingles. I went to the urgent care on 04/18/2021. They prescribed me an antiviral for the shingles. I am 12 weeks pregnant my due date 11/04/2021 & everything is going well with my pregnancy.
Patient became pale, diaphoretic and loss of consciousness. Patient was coming in and out of consciousness. Patient's wife stated that "he gets this way when he gives blood." Patient's B/P was 90/60, Pulse 160, 02 @ 67% and increase to 81% on nasal cannula @ 12:33. Patient was given 0.3mg Epinephrine auto-injector IM to the right thigh. EMS arrived @ 12:33. Patient was transported to near hospital for evaluation.  Today I talked with Patient's wife and she sates , He was released from the hospital yesterday with no complications and he  is at home and doing fine with no complications.
I had Tightening of throat and Wheezing I did not consider it significant enough for ambulance so pharmacist recommended I call my family dr. who prescribed an epipen just in case. I never had to use the epipen, but I took 50mg of Benedryl at 3:30 and again at 7:30, which helped lessen the symptoms. Symptoms subsided overnight.
Incorrectly administered Pfizer primary series.  instead of Pfizer # 2 patient received PZR bivalent booster.
A nurse reported that an employee at a long-term facility received a dose of flu shield in November 2001. Within 24-48 hrs, the employee developed a "local reaction" characterized by inflammation, warmth, and itchiness at the site of flu shield administration. The symptoms resolved approx 48 hrs after onset. No further info was available at the date of this report.
p/vax pt devel rash all over body; swelled face; T99.3; rx: benadryl; tylenol; MD advise via telephone
7-7-18 ED; Left leg cellulitis. 7-9-18 UC; Allergic Reaction.
On Tuesday 9/14/21, She started complaining of weakness in the lower extremities progressed to difficulty ambulating and heavy feeling in the legs and poor balance. Around 4pm began to have numbness in the bilateral lower extremities, dizziness, headache on the right side of head, and nausea. Disorientated around 5pm with difficulty finding words. 5:30pm drove to valent of the hospital because could not find the ED and asked them to call the emergency room because I could not feel the gas pedal or brakes to drive home and my legs did not function.  Once triaged in the ED, struggled to go the bathroom ambulating, then to urinated it was difficult to start the urine stream and inability to empty the bladder. Once brought back to ED room around 7pm where MD evaluate for stroke. Findings were bilateral upper extremity weakness with tremors and LLE weakness was worse than RLE extremity with difficulty. She had to be ambulated with assistance to prevent falls because right was shaking and left leg drag on floor. Admitted to the hospital where a CTA was order and labs. admitted for full neuro work up and PT.