chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a patient who on an unknown date, was vaccinated with VARIVAX (Merck) (dose and route not reported) (lot number 666856/0164Z). The pharmacist reported that a physician stated that the patient who received VARIVAX went into complete renal failure on an unknown date. It is unknown if the patient sought medical attention. At the time of the report the patient's status was unknown. Upon internal review the complete renal failure was determined to be an other important medical event. Additional information has been requested.
Case number PHEH2012US008746 is an initial spontaneous report received from a health care professional on 19 Apr 2012 with a follow up report received on 01 May 2012. This report refers to an 11-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 17 Apr 2012 she received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X10132) intramuscularly and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported. Follow up received on 01 May 2012: Patient demographics updated (age, height and weight).
Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-month-old female patient who received Hib (Hiberix) (batch number EK5Y2, expiry date 25-MAY-2023) for prophylaxis.   On 02-JUN-2023, the patient received the 3rd dose of Hiberix. On 02-JUN-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 02-JUN-2023 The reporter was a medical assistant. The reporter wished to know how to proceed.  The information about patient, vaccine and event was provided. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The patient accidentally received an expired dose of Hiberix, which led to expired vaccine used.
Patient observed post COVID-19 immunization for just a few minutes before she had dizziness and nausea. She proceeded to pass out and urinate while being attended to by the nursing staff. This was very brief as she began responding to supine positioning. Pulse was 55 and regular by auscultation. She needed to vomit (which she never did). Her legs were raised. She responded within a minute saying she felt better. Vitals at this point (1:59 pm) P-89, BP 98/60, pO2 100%. She was moved by wheelchair to a lobby couch where she chose to remain sitting and drink water. She felt almost back to normal. She conversed easily. After 25 min observation, Mom (present the whole time) was sent to get car and patient was taken to the vehicle. She appeared well at discharge. Patient's mom was aware of post admin emergencies having had 2 other children vaccinated: Difficulty breathing, swelling of face and throat, a fast heartbeat, a bad rash all over body, dizziness and weakness. Vasovagal reaction to injection, now resolved. Plan: Allow next observation for dose 2 to be in supine position after admin. Pfizer lot #FK5127 R deltoid.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; vaccination date will be the start date of the event.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (vaccination date will be the start date of the event.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccination date will be the start date of the event.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (vaccination date will be the start date of the event.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
The day after I received the second dose, I woke up and felt like I had the flu. I called to make an appointment with my family doctor and I couldn't get in to see someone until March 25th, 2021. I saw his PA. The reason I didn't go to the doctor right away is because the pain lasted about 2 full days and then it was gone. The PA thought that I may have had a 24 hour flu.
Vaccination at 11:45am. 4:30pm, patient's wife reported chills and nausea and asked if it is a possible side effect of the vaccination and asked for a refill of his omeprazole. 5:00pm, spoke with the patient and he said the needed the omeprazole for gas feeling. The feeling occurs every now and then and is relieved by omeprazole. Per wife: The chills and diarrhea progressively worsened until 2am. Wednesday 8th when was too weak to get up and 911 was called. Patient was taken to the hospital and admitted until Monday 13th. Note: Patient's wife indicated to the pharmacy that the hospital said he was "messed up by the shingles vaccine". The patient's wife said no treatment was given at home and the patient did not drink any or much water.
Felt tired, then chills and fever. Took 2 ibuprofen,  went to bed. Lasted 1 hour
This spontaneous report as received from nurse referring to an 81 year old male patient with muscular dystrophy, hypertension and atrial fibrillation, who on 25-FEB-2013, was vaccinated with a dose of ZOSTAVAX (lot # H021292, expiration date, 28-FEB-2014, dose and route not reported). The nurse reported that the patient developed shingles on 12-MAR-2013. He had a moderate case of shingles with papules on his ribs. The patient was treated with acyclovir. At the time of this report the patient had not recovered from shingles with papules on his ribs. The patient sought medical attention, contacted the physician. Additional information has been requested.
Information has been received from a physician concerning a 14 year old white female with mild asthma who on 09 OCT 2001 (also reported as 10 OCT 2001) was vaccinated with a seventh dose of pneumococcal vaccine 23 polyvalent (lot # 479567, invalid) IM in the right arm and influenza virus vaccine in the left arm. Concomitant therapy included fluticasone propionate, salmeterol xinafoate, and albuterol. On 09 OCT 2001 (also reported as in the evening of 11 OCT 2001), the patient developed extreme tenderness and a blotchy, erythematous rash around the injection site of the pneumococcal vaccine. By the morning of 12 OCT 2001, the patient's right arm was so sore that hte patient could not use that arm. The physician reported that the patient subsequently recovered on 19 OCT 2001. No additional information is expected.
Fever, rash 2 days after immunization MMR, Varicella- 4/21/04 Benadryl 1ml Cold given today.
Didnt feel so good; Arm was hot; Swollen; Itchy; Arm was black and blue; Rash; Fatigue; Sweatiness; Pain in the arm; Fever 99.5-101.2; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweatiness), PAIN IN EXTREMITY (Pain in the arm), MALAISE (Didnt feel so good), FEELING HOT (Arm was hot) and SWELLING (Swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HYPERHIDROSIS (Sweatiness), PAIN IN EXTREMITY (Pain in the arm) and PYREXIA (Fever 99.5-101.2). On an unknown date, the patient experienced MALAISE (Didnt feel so good), FEELING HOT (Arm was hot), SWELLING (Swollen), PRURITUS (Itchy), SKIN DISCOLOURATION (Arm was black and blue), RASH (Rash) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweatiness), PAIN IN EXTREMITY (Pain in the arm), MALAISE (Didnt feel so good), FEELING HOT (Arm was hot), SWELLING (Swollen), PRURITUS (Itchy), SKIN DISCOLOURATION (Arm was black and blue), RASH (Rash), PYREXIA (Fever 99.5-101.2) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
feeling arm soreness; This is a spontaneous report from a non-contactable physician.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced feeling arm soreness in Dec2020. No other symptoms were reported.  The outcome of feeling arm soreness was recovered in Dec2020.    No follow-up attempts are possible. information about lot/batch number cannot be obtained.
ON 4/7 PATIENT RECEIVED A JANSSEN COVID VACCINE AT OUR PHARMACY. THURSDAY AND FRIDAY HE HAD NORMAL REACTIONS TO A VACCINE (LOW GRADE FEVER, SORE ARM, HEADACHE).  BY SATURDAY HE HAD A HIGHER FEVER AND WAS NAUSEATED. ON MONDAY HE STARTED WITH VOMITING AND SEVERE CHEST PAIN. PT WAS ADMITTED TO HOSPITAL ON TUESDAY WITH HIGH TROPONIN AND FLUID ON THE LUNGS. THEY ARE RUNNIGN MORE TESTS TODAY (WEDNESDAY). MOM CALLED ME TO REPORT.
Pain during injection ("a jab, I jumped, then another jab"), followed by diffused pain @ chest for a week after which prompted pt to see PCP.  Exam shows well healing ecchymosis @ R chest wall & R breast.
pt recv vax 3NOV98 & that evening pt devel an inj site rxn characterized by a big wheal & knot;
given ACTHIB vaccine that was diluted with a different diluent with no reported adverse event; Initial information was received on 08-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.   This case involves a 12 months old female patient who experienced given acthib vaccine that was diluted with a different diluent with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 08-Jun-2022, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine (lot UJ635AAA, expiry-17-Nov-22) (dose, formulation, and strength: unknown) via intramuscular route in left thigh for immunisation.   On 08-Jun-2022, the patient developed a non-serious given acthib vaccine that was diluted with a different diluent with no reported adverse event (product preparation error) (latency same day) following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event given acthib vaccine that was diluted with a different diluent with no reported 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 the 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.
Patient received only the powder vial of this two part vaccine.  It was inadvertently diluted with sterile water diluent instead of the included part two liquid vial.  This dose was deemed invalid and was repeated on 11/29/2021  The root cause of this error is due to the packaging by manufacturer.  Unlike all other vaccines, this two part vaccine must be mixed together in order to be effective.  It is not a sterile water diluent like our other vaccines.   Other vaccines packaged this way come as 10 vials in a box = 10 doses.  Menveo is 5 vials each of the liquid and powder therefore only 5 doses.  The two vials do not come "attached" in any way.  GSK knows this is an issue and therefore has created bands that we can pair the vials to each other after opening.  In a busy clinic, or new staff when the box is opened its easy for staff to pull just one vial - if its the powdered vial - reconstituting with sterile water diluent like other powedered vaccines is a common error.  If the liquid vial is pulled, its easy to administer just this liquid without mixing.    When this happens, its difficult to trace to one patient therefore often the entire 5 doses need to be tracked and revaccinated since its difficult to know who may have received the correct dose vs incorrect.   In this instance an inexperienced MA administered the powder only, diluted with water to a total of 4 patients before the error was discovered.      Recommended packaging change so that it is very clear that its a two part vaccine , perhaps a peel pack with the two vials together or apply the band before packaging instead of having the end user apply the band.  Better yet. similar to solumedrol vials - its one vial with two chambers, that when the lid is pushed down, it pushes the rubber stopper and the two parts mix together.  This would also prevent unnecessary access to the vial with needles to remove and inject into the other.
Erythema, swelling and mild tendernaess around vaccination site approxiamtely 10 cm in diameter
Initial unsolicited report received from a nurse via other company (Merck) on 02-Dec-2016. This case involves a four-year-old female patient who was vaccinated with a dose of Fluzone Quadrivalent (Batch number, expiration date, dose, dose in series, route and site of administration were not reported), a dose of KINRIX (manufacturer: other, batch number, expiration date, dose, dose in series, route and site of administration were not reported), and 0.5 ml single dose of PROQUAD (Batch number: L045676, expiration date: 09-May-2017, dose in series and site of administration were not reported) subcutaneously all on 10-Nov-2016 (reported as given on the same office visit). The patient's pertinent (relevant) medical history and allergies were reported as none. The patient was receiving unspecified pediatric multivitamin with fluoride as concomitant medication. On 18-Nov-2016, eight days following vaccination the patient's mother reported that patient experienced dark urine that was 'sinking to the bottom of the toilet'. The patient was seen in the office by physician assistant on 21-Nov-2016. Laboratory investigations included urinalysis done on 21-Nov-2016 which revealed brown turbid urine with positive results for blood (positive 1), bilirubin (positive 1), protein (positive 3) in urine along with traces of leucocytes. The patient was to return for blood tests and ultrasound on the same day. The patient did not receive any corrective medication. The outcome of the event was not reported. List of documents held by the sender: None.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Pt passed out but recovered and felt fine after
On 1/6/2021 Patient noticed itching at injection site.  On the next day 1/7/2021, Patient  stated that the injection site was red, swollen, warm to touch and sore to touch. Patient followed up with her health care provider.  Health care provider recommended that Patient take ibuprofen for the swelling and also prescribed an antibiotic, but Patient was told to wait to take the antibiotic for 2-3 days to see if it resolves without taking the antibiotic.    Patient stated that she originally had pain at the injection site on the evening of the injection (12/29/2020) and the next day (12/30/2020,  but it resolved after that.
This spontaneous report was received from a pharmacist reporting on a female patient of unknown age. There were no patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. In April 2016 (reported as "1 year ago"), the patient was vaccinated with one unspecified dose of PREVNAR, for prophylaxis. On 27-APR-2017, the patient came to the pharmacy to receive a dose of PNEUMOVAX 23 (lot#, expiration date, route of administration were not reported), for prophylaxis. The patient received a second dose of PREVNAR instead, because she told the pharmacist she was due for a dose of that vaccine, and realized she was actually supposed to get PNEUMOVAX 23 only after the pharmacist gave her the second dose of PREVNAR. The pharmacist did not report any adverse effects. Additional information has been requested.
Overt symptoms and a diagnosis of Lupus erythematosus developed in an otherwise healthy woman within 2 months of the two done vaccine
Developed swollen (L) axillary node, tender. Day after Meningitis B vaccine which was administered - (L) deltoid; Treated with oral antibiotics.
Rt Arm - Proquad Red bump/lump (local) Lt Deltoid - Kinrix Red swelling travled
All-over body ache with chills that lasted about ten hours the night of the shot.  Then 4 days later I got what I can only describe as a weird headache, like no other, that took me out for half a day.  Then 2 days after that I got a weird vision impairment in which I couldn't see right in front of me, a big spot of my vision was gone, and around that spot was kind of see-thru and wavy, and soon after it lead to another headache.
R deltoid is swollen around injection site and skin is blotchy.  No open areas.   Pt notes arm is painful especially when she tries to raise arm.
Information has been received from a 69 year old female with no drug reactions, fibromyalgia, restless legs syndrome, cholesterol high and a history of cardiac pacemaker insertion who at the end of April 2008, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included DIOVAN, LIPITOR, and DIAZEPAN. The patient reported that she had fibromyalgia where her muscle pain on the scale from one to ten is usually around a three or a four, but after receiving the ZOSTERVAX vaccine (Oka/Merck) her muscle pain intensified to about an eight or a nine in the beginning of May 2008. Since the muscle pain intensified, the patient had been resting more and had been taking a muscle relaxer name and manufacturer of muscle relaxer unspecified by reporter). The patient reported that as of 08-JUN-2008 her pain had subsided a little bit. The patient did not seek medical attention. No product quality complaint was involved. No further information is available.
Pt notes s/p PNA vaccination (unsure of type), on Monday 7/29/19, on awakening Tues 7/30/19 local erythema and blister.  Increasing in area since. Nothing other than intermittent Tylenol, presents to UCC for evaluation on 8/3/19 with concern for allergic reaction.  All other systems neg. Left deltoid and upper arm with 11x16 cm area of erythema, induration and 1+ local edema. Central blistered area to 2x3cm area. Marked with skin marker, no streaking, no local lymph. 2+ radial pulses, distal perfusion and sensation intact. Skin otherwise c/d/i, no other areas of concern. good capillary refill in nail beds,no clubbing, cyanosis, or edema. Lung CTA no stridor, no drooling and GI WNL.  Tx allergic reaction: Benadryl, Medrol pk, Pepcid. Delayed Keflex for cellulitis coverage if worsening. To follow up with vaccinating provider Mon. ER care reviewed at length.
On evening of 5/28/01 pt noticed redness, pain, and swelling at injection site L deltoid, redness was about size of a baseball. Over the evening hours she began to have pain in her neck and bad headache during the overnight hours. Pt states she awoke  6 or 7 times because of aching in joints, especially in hips and ankles. Presented at clinic at 17:00 on 5/29 - aching in joints had decreased but headache neck pain weakness continued.
Fever the day after receiving 2nd dose on 4/29/21. Then intense stomach pain and discomfort began 4-5 days after the 2nd dose.  Facial, leg, and feet swelling began 4-5 days after vaccine was given.
Redness swelling, extremely hot,  Dr put on Bactrim 800 mg 2 xd daily and Zyrtec started these mess on 01/22/2021.If not cleared up in 7 days to come back.
Client here for Moderna booster one day early of 6 months. Moderna first dose on 5/19/2021, Moderna second dose on 6/16/2021. Client denies any severe allergic reaction to primary Moderna doses.  Moderna booster dose approvedfor today by medical team.
Bexsero to complete the MenB dose that started with Trumemba.; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number AVXA87AV, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 28th July 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received TRUMENBA. On 28th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Patient received a dose of Bexsero to complete the MenB dose that started with Trumemba, which led to interchange of vaccine products.  The reporter did not consent to follow up. The vaccine administration facility was the same as primary reporter. Lot number and expiration date not were confirmed since health care professional did not had that information handy.
In  November pt. received booster dose of 0.25ml (booster dose) instead of 0.5ml (additional dose). In December it was advised to give other half of additional dose so received another 0.25ml. According to CDC Covid-19 administration errors and deviations (2-22-2022), lower-than- authorized dose volume should be repeated so pt. was given 0.5ml dose on 4/8/22 and completing VAERS for 12/2/21 dose of 0.25ml
Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, fever, headache, nausea and 1 episode vomiting, myalgia throughout body, dizzy/lightheaded ness and extreme fatigue. The next day Jan 16 had diarrhea all morning