chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received ENGERIX B (batch number ahbvc253aa, expiry date unknown. On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: From 11 October 2013 to 18 November 2013, ENGERIX B was stored at temperature as low as 27F. Vaccine was administered to an unknown number of patients.
lightheaded; pale; very fatigued; At the sit of injection, it was the size of a baseball and hot to the touch; At the sit of injection, it was the size of a baseball and hot to the touch; This is a spontaneous report from a contactable Nurse.  A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Patient previously received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced lightheaded; pale; very fatigued; at the sit of injection, it was the size of a baseball and hot to the touch. It was stated that the event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Client received vaccine in right deltoid.  Experienced swelling at injection site with tenderness.  Client states enlarged axillary lymph nodes right side.  Client instructed to take pain reliever and apply warm compresses to area.
UTI; fever; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age (age: 73, unit: unknown) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a reaction to the vaccine, a fever, the next day, 13Jan2021.  He stated that the  fever lasts 8 days and was "predictable" (started normal temperature in morning, then would increase as the day progressed). It was also reported that he was diagnosed with UTI on an unspecified date and was being treated for UTI and the fever subsided. The patient is scheduled to get the second dose on 02Feb2021 but was reluctant to have this dose if he had this reaction to the first one. He stated that he understands the reaction to booster is more significant to original. The outcome of the event fever was recovering while the outcome of the event UTI was unknown.   Information on the lot/batch number has been requested.
There was a mix up with expired vaccine and recently reconstituted vaccine. The patient may have received a vaccine that was outside the recommended syringe storage time of 6 hours.  After consultation with Pfizer, the CDC and our vaccine experts it was determined that microbial contamination was primary concern and revaccination was not necessary. We made daily attempts to reach out to patient and notify but they do not answer phone or return calls. We are going to discuss at next dose. Unknown if patient had any increase incidence of fever or site reaction.
First vaccine dose received 12/18/2020 @ 1844. Symptoms appeared 1 days later.  Flu like symptoms without fever, upset stomach, nausea, cough, chills, headache and general malaise. Improved with Theraflu and Tylenol .Symptoms worsened on 12/24/2020 around 1800. Runny nose, cough, headache, chills, body ache but still no fever.
Patient came in for his 2nd Moderna Dose Covid Vaccine 2/9/2022, however before being vaccinated client disclosed that he received previous dose of Janssen COVID Vaccine (LOT #: 1821282) on 6/17/2021 in (Privacy). Client did not disclose the dose of Janssen COVID Vaccine when he presented to clinic on 1/12/2022 and received a full dose of Moderna COVID vaccine (LOT #: 084J21A). RN educated the client that he received a full dose of Moderna COVID vaccine on 1/12/2022 when he should have received a booster dose of Moderna COVID Vaccine and he was not eligible for 2nd dose of Moderna COVID vaccine. Client voiced understanding of this information. RN submitted dose of Janssen COVID vaccine to the  Immunization Registry to update immunization record.
Approx 1 hr after injection pt c/o "not feeling well". Found to be tachycardic, Left ear felt plugged, swollen cervical lymph nodes, difficulty swallowing, Sent to ED and treated. Had Hx of heart transplant 11 years ago.10/26/2009 records from ED visit 9/30/2009. Patient presents with sx of feeling off balance, weakness, feeling flushed, and vision being '''weird". PE was normal. Tx: F/up with PCP 10/1/2009. DX: ? TIA abnormal presentation.
Arm hurt at the injection site starting a few hours after injection and lasted around 2 days. Mild nausea and dizziness occurred around 30 hours after injection and lasted intermittently for around 1 day. Around 7 days after injection, I noticed a small red circle (approx. 2 inch diameter) around the injection site. It was not painful or itchy.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 10-JAN-2008, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) which was administered by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-FEB-2016, the patient was treated by (unspecified healthcare professional) at the community medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Initial report received from a non-healthcare professional on 10-Oct-2013. A 67-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number and route was not reported) on 30-Sep-2013. On 09/30 at 1:30 pm patient received vaccine at a pharmacy, 3 hours after the injection, strange feeling in arm developed and excruciating pain in arm. Patient called pharmacist, at 5:30pm. Pharmacist told her to put some ice on it, take some ADVIL or bufferin. Two hours later the pain got worse, intolerable. She had worst pain. She went to physical therapist, three times a week. Saw the doctor 3 days after the vaccine. Started in the injection area, down to hand, up to shoulder and then up to the shoulder and neck. Patient was not capable of doing anything with right hand. Patient was unable to do things with her hand and arm. List of documents held by sender: none.
Circular redness at injection site, swelling, pain - persisted for ~ 3 days.
She had gone to the doctor as she was having issues with hives.  The doctor asked her if she had the Shingles vaccine, and she told her no and she administered the vaccine without permission that she is aware of.  She told her that she did not want the vaccine, and that she was there for treatment of the hives and she thought she was getting a steroid shot to help her with her present symptoms.  She feels now that she was some sort of experiment now.    She got the vaccine and within 2 weeks she started having  loosing her hair to the point that she lost it all, it's now about 1" long.  She had not cut her hair in over 4 years.  She started getting blisters all of her body and her body started turning red.  She lost all her nails on her hands and her feet, very very painful.  She couldn't touch anything, could not walk to the bathroom and had to get a bedside commode and for 3 months she had to wear diapers as she did not have the strength to get out of bed.  She is down to 176# right now ,but weighed 210# at the time of the vaccine.   She has to moisturize her skin every 2-3 hours as she had scales and the dryness was so bad that her skin was cracking and she could see her under skin.  She could not shower as the pressure of the water felt like she was being cut in half.   She went back to the doctor at that time and she refused to help her and told her that the vaccine could not have done that to her, but she had not had any reaction like that before the vaccine.     She has had skin problems her entire life but never had a reaction like this until the vaccine.    She would have to fill the tub with more cold than hot and used aloe vera shampoo and body wash mixed and sit in it and try to run water over her body and it would cause her skin to fall off.   She would have to shower with the lowest setting, and then moisturize again.  She could not bear the feeling of the wind on her skin as it would start to scale and had to have a blanket at all times due to chills.  She still gets blisters a little but moisturizes to make sure that it stays under control.   She is in a lot of pain due to this reaction.  She has gotten to a new doctor who is treating her with Benadryl and steroids, which finally after 5 months has started to help her and improve.    Her skin continued to scale off and if she does not moisturize for 6 hours then she will start to react the same way.    Due to this she has lost her job, which she worked her entire life, and was evicted from her home due to not able to pay rent due to loss of income.  They increased in November without any notice, no repairs to her apartment, no heat or central air, never late on her rent, but the apartments were under new management and increased the rent $300.00 more.
Since having my first shot, I have had chronic hives. I have to be on an antihistimine all of the time. I went and got allergy testing and am now highly allergic to several things that I was only mildly allergic to before. When not on antihistimnses, even brushing up against something causes hives.
Approx. 5-6 hrs later felt palpatations. Lasted 4 hrs.
5/30/12 Mother notes child is getting rash starting on face and spreading on body. 5/30/12 Parent calls asking for child to be seen for rash to body. Seen by ARNP. Diagnosed with diffuse rash with suspect vaccine reaction. Treatment: Orapred 15mg/5ml. 1ml po Q8 hr x 5 days. Supportive Care. To ER if swelling around mounth or respiratory distress. Patient starting a new HMO tomorrow. Instructed parents to follow up with HMO provider. 6/1/12 Seen by ARNP. Diagnosis: Rash resloved. Treatment: Finish Oraped. Follow up when able for referral to allergist. No vaccines prior to referral.
Covid arm started 1 week after injection.... red rash in a circle around the injection site. Slightly warm to touch, itchy, slightly raised bumps. Applied cool wash cloth. Not severe. Next day slightly less noticeable.
I started feeling COVID-19 symptoms on 12/04/2022 I had a fever; cough; sore throat. I took OTC ADVIL for symptoms. Additionally I have tested positive for the last 10 days however the positive result is faint.
Developed erythematous, macular rash with tan center 3 days after vaccine. 6x12cm left thigh, 16x18cm right thigh. Given Benadryl 12.5mg, 5cc 1 1/4 tsp per mouth ever 6 hours.
PATIENT IS EXPERIENCING PAIN, SWELLING, REDNESS AND ITCHING OF THE RIGHT ARM BETWEEN THE ELBOW AND SHOULDER.  SYMPTOMS ARE PREVALENT ON THE UNDERSIDE OF THE ARM (FATTY AREA OF TRICEP) AND DELTOID. PATIENT ALSO COMPLAINS OF SLIGHT FEVER ON 10/9/08.  PT WAS GIVEN 50 MG OF DIPHENHYDRAMINE ELIXIR AROUND 3:00 PM ON 10/8/08 AND ADVISED TO USE COLD COMPRESS ON AREA. PT DID NOT WANT TO TAKE DIPHENHYDRAMINE EARLIER WHILE WORKING.
p/vax devel itchy hives all over body;pt made MD appt was given cortisone shot & cortisone cream;pt reports still have some itchy hives & feel sl off but expects to return to work on 6/24/99;afeb throughout;
dizziness, tingling in left lower leg/foot, tingling in hands from approximately 10 minutes after the vaccination to approximately 15 minutes after.
extreme fatigue and headache, body aches, 102 fever , and site soreness... and first dosage gave me 10 days of morning vertigo.  I?m hoping this shot doesn?t do the vertigo again.  Fever broke after 24 hours, now just a bad headache and body aches.
No additional AE; HCP reporting an improperly stored vaccine was administered to a patient; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 30-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliters (lot number: W007371, which has been verified to be a valid lot number with an expiration date: 13-JUL-2023; strength, vaccination scheme, route of administration and anatomical site of application were not provided) administered for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion at 34.5 fahrenheit (F) for 1 hour 7 minutes 0 seconds. Also, was reported a previous temperature excursion of 66.7 fahrenheit (F) for 13 hours 52 minutes 0 seconds. No additional adverse event reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-2210USA005917: US-009507513-2210USA005916: US-009507513-2210USA005929: US-009507513-2210USA005624: US-009507513-2210USA005942: US-009507513-2210USA005994: US-009507513-2210USA005979: US-009507513-2210USA005937: US-009507513-2210USA006007: US-009507513-2210USA005936:
The LPN drew up and administered 0.3 milliliters instead of 0.5 milliliters.
Arm (L) started hurting immediately after shot; felt like needle went to the bone; continues to be sore; went to the doctor - anti-inflammatory prescribed and referred to ortho doctor.
Nausia, chills, fever, and taste modification.  Modification in tongue sinsitivity. Soreness in arm of injection  Taste and toungue sensitivity lingers.  Fever and chills lasted one day .
On 7/9/2021, a patient presented to pharmacy requesting COVID 19 immunization and she was given the first dose of Moderna by the pharmacist. Patient seemed fine and after fifteen minutes she left. After about 30 minutes patient came back to the pharmacy stating that she felt nauseous so her supervisor sent her to the pharmacy so that she could report side effect to us. The administering pharmacist requested that she remained seated for 30 minutes in front of the pharmacy for observation and provided her with water. The pharmacist mentioned this immunization adverse event with another pharmacist, before leaving for the day since her shift had ended.  Before leaving the pharmacist also spoke with patient to notify her that she was leaving but if she didn't see any improvement to speak to the other pharmacist. After the designated time, the patient left the observation area without mentioning her departure to the pharmacy team member. The pharmacist contacted this patient in the evening for follow-up observation at approximately 7 p.m. on the same day. The patient said that her forehead felt hot, she was still nauseous without any improvement, and she was also dizzy.  Also, she was taking her body temperature periodically throughout the day.  I recommended to her that if her adverse reactions continue to be an issue, she needs to seek medical care immediately. Then pharmacist called again, the next morning to follow-up. Patient said that she felt much better after sleeeping and that he symptoms had resolved.
No additional AE reported; dose of PNEUMOVAX 23 expired on 9/13/2022 and was administered on 11/3/2022; This spontaneous report has been received from a pharmacist concerning a patient of unreported age and gender. The patient's medical's history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 03-NOV-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # U002528, expiration date 13-SEP-2022 (route of administration and anatomical location were not provided) as prophylaxis (expired product administered). It was reported that no temperature excursions occurred previously. No additional events were reported (no adverse event).
Insomnia, shortness of breath, sleep apnea, rash, palpitations, exercise intolerance, weight loss, off/on tingling in hands and feet.
EXPIRED VACCINE (EXPIRED 9 DAYS PRIOR) 08/31/2022
Vaccinee "did not convert" following a series w/Engerix-B (dosing schedule 0, 1, 6);
Information has been received from a registered nurse referring to 10 patients of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017, dose, dose# and route unknown). No adverse symptoms were reported. No product quality complaint was involved. Additional information has been requested.
At approximately 10:30pm Sunday 2-24-08 patient felt overwhelmed as if there was a huge weight on her shoulders and she cried. Lasted about 30 min. at approximately 1:00 am, felt overwhelmed, trapped and alone. Cried. Lasted 15 min.  Again at 3:00 am for about 10 min. felt alone and cried. In AM 2-25-08, crying for no reason.
Severe abdominal pain with intermittent periods of nausea. Severe headache with periods of diaphoresis.
This spontaneous report as received from a pharmacist refers to a 66 years old female patient with drug induced lupus, anxiety and hypertension. The patient's medical history included muscle spasms. The patient had none drug allergies. On 03-OCT-2012 the patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # reported as H01132, expiration date reported as 08-SEP-2013). The pharmacist stated that the patient was taking prednisone, PLAQUENIL, and IMURAN, when she received ZOSTAVAX, and may also have been taking VALTREX at that time. The pharmacist reported that he received a call on 12-OCT-2012, from the patient who reported that she was "not feeling well" and felt like she might be getting a cold or the flu. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was reported as not recovered. Additional information has been requested.
rash on bilateral arms near the crest by his elbows & bilateral legs near the crest on the back on 16Feb2021; headache; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266) intramuscularly in upper left arm on Sunday, 14Feb2021 at noon (at the age of 67-year-old) as single dose for COVID-19 immunization. Medical history included Polycythemia vera, excess red blood cells. Patient had no family history. Concomitant medication included dabigatran etexilate mesilate [PRADAXA] 150mg twice a day taken for Polycythemia vera, has excess red blood cells. Patient was a medic in the Air Force 30 years ago and was in respiratory therapist school. Patient previously received all the Hepatitis shots and had the shingles shot last year, had regular Flu shot a month and a half to two months ago and had no adverse events following prior vaccinations. Patient did not administer any other vaccine on same date of suspect or within four weeks. On 14Feb2021, patient experienced headache at night and on 16Feb2021, yesterday evening patient started breaking out in a rash on his bilateral arms near the crest by his elbows and bilateral legs above the knees and in the crease in the back of his knees. Relevant tests included: blood work done at VA a month ago on an unspecified date in 2021. Outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
3 patients received a booster dose after the vial was already punctured 20 times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (3 patients received a booster dose after the vial was already punctured 20 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (3 patients received a booster dose after the vial was already punctured 20 times). At the time of the report, PRODUCT ADMINISTRATION ERROR (3 patients received a booster dose after the vial was already punctured 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
I got my period the same day I got my first dose of the Pfizer vaccine; it was 10 days early. I have tracked my period religiously for 5 years, and I?ve never had my period come more than 3-4 days early.   I started experiencing debilitating headaches on the right side of my head. I stopped being able to fall asleep and stay asleep. I would get extremely nauseous throughout the day. I had painful earaches on the right side of my head. All doctors said my ears, nose, and throat were fine. All of my imaging came back normal. I had no injuries or accidents anywhere around this time or at all in my history. I?ve continued to have neurological problems with pain radiating through my neck, back, and arms. I?ve seen over 8 doctors and had over 30 doctors appointments, and none can see any reason why I would be experiencing the pain that I am now constantly in. I have been injected with a nerve block, been prescribed a plethora of pain medications, muscle relaxers, and sleep aids with no lasting or promising  relief.
Dizzy, nausea, extreme tiredness (slept for 6 hours after returning home).  Tiredness lasted for over a day.  The best I can explain this is "internal shaking".  I was so weak that when I tried to get up and move, my body would shake internally.  Hard to explain.  When I first woke up after sleeping 6 straight hours, I was sweating but I don't know if I had a fever.