chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix administered to a 10 month old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The health care professional called on the day of reporting to report Kinrix was administered to a 10 months old patient. The outside phone number for GlaxoSmithKline medical information given for future reference and transfer provided. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Mild rashes at injection site; small rash on the torso; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a elderly female patient who received Herpes zoster (Shingrix) (batch number 72F23, expiry date 31st March 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and rash. On an unknown date, the outcome of the injection site rash and rash were unknown.   It was unknown if the reporter considered the injection site rash and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced mild rashes at injection site and small rash in the torso after 1st dose of Shingrix. The healthcare professional (HCP) was not sure if it was the first dose. The reporter consented to follow up. This case has been linked with the case US2020042786, reported by the same reporter.
rec High dose flu. 4 hours later started feeling ill. throat feeling like its about to close,swelling and lump in throat on right side. Tachycardia sever stomach pains. Called HCP and they stated they would give her a call back in 24 hours. Will be contacting CDC info for additional medical advice.
Patient c/o dizziness at 11:53 am -  vs :BP 112/64 HR 62 SAT 97 12:13 -Patient felt better and requesting to go home patient wants to stay in his  patient left for home
Side effects started with in  7 hours starting with tiredness. Headache within 8 hours.  Muscle aches, fever and small bouts of nausea within 11 hours. All  side effects lasted about 24 hours after injection of the vaccine.
This spontaneous report as received from a healthcare professional refers to an unknown number of patients (age and genders were not reported). On unknown dates, the patients were vaccinated with PROQUAD (Merck) (doses, routes of administration and lot numbers were not reported), that had been improperly stored. No adverse effect reported. A phonecall was placed to the healthcare worker on 16-JUN-2015. A message was left with the receptionist requesting that the healthcare worker return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain a follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Consistent symptoms for one week after vaccine, including migraines, body aches, chills, nausea, fatigue,
I was coughing the day before I had cataract surgery. I was concerned about my eyes due to the movement that coughing was causing. After a virtual visit, I became more sick with a horrible headache, almost like a migraine. I had no appetite. I developed a horrible cough and couldn't stop coughing.
First Dose 3/26/21: Severe migraine, tinnitus, brain fog, dizziness. Tinnitus Remains. Second Dose 4/25/21: Accelerated heart rate. Normal BPM=45-50, current BPM=77-85. Visited emergency room. Was instructed to see cardiologist if symptoms persist.
headache; fatigue; coughing; tightness in chest; This is a spontaneous report from a contactable consumer or other non healthcare professional. This report was received via a sales representative. A 53 year old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation  .  Medical history included covid-19 from 2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced headache, fatigue, coughing and tightness in chest causing chest discomfort on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Palpitations, dizziness, and sensation of throat swelling.   Physical examination reveals mild uvular edema but is otherwise unremarkable.   The patient received 50 mg of diphenhydramine and 20 mg of famotidine and was discharged home after 1 hour of observation.
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received SHINGRIX for prophylaxis. On 18th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash, general body pain, joint pain, fever, chills and urine coloring orange. In July 2018, the outcome of the injection site rash, general body pain, joint pain, fever and chills were recovered/resolved. On an unknown date, the outcome of the urine coloring orange was unknown. It was unknown if the reporter considered the injection site rash, general body pain, joint pain, fever, chills and urine coloring orange to be related to SHINGRIX. Additional information was received as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter was scheduled for 1st SHINGRIX vaccine but then asked a question for a friend (patient). The patient experienced rash at site, body or joint aches, fever, chills for 4 days. The patient's urine was sometimes a bright yellow and orange. The reporter asked, whether that was a side effect of SHINGRIX.
Starting around 8:00pm started to experience muscle and joint pain in lower back and hips and headache. Left arm became warm to touch and felt slightly swollen. Chills and fever started to set in. Chills lasted for about 3 hours. Fever with a high of 101.7 degrees F noted around 2am. Took tylenol, which brought fever down, and reduced headache and muscle aaches. Fever remained between 99 and 100 degrees F for most of the following day. Took another tylenol in the late afternoon. Fever finally broke by the evening on 4/10/2021. Still fatigued for all of 4/10/2021. Woke up on 4/11/2021 with out any other adverse effects. Fever, headache, and muscle aches passed. Still a little tired, but felt more energized.
Recipient is newly onboarded clinic staff and selected her vaccine out of the fridge. She selected the children's formulation instead of the adult formulation. The medical assistant who administered the vaccine did not notice the discrepancy prior to administration.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 11-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L017140, expiration date 13-NOV-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
2nd dose of Rabies Imovax given IM on 3/25/01 at 10:15. Pt called nurse at home on 3/26/01 and stated he developed itching, redness, edema and blisters on feet, Sunday night 3/25/01. Also having a dull chest pain that increased with a deep breath. States all symptoms have improved but not completely resolved. RN consulted MD, who recommended changing vaccine manufacturer, which pt received on 3/29/01 without any known problems.
This pediatric patient was immunized with 0.2ml of pediatric vaccine that was not reconstituted.  There were no immediate adverse effects, and the parents were contacted and informed about the event, and instructed to look out for local or systemic signs or symptoms of adverse effects.
3/11/03 - Onset of chest pain 1200; pain scale = 8 3/13/03 - Seen at Dental Surg appt and sent to ER, BP 150/100, Temp 101.5.  Administered IV Flos, 25 L nitro transfer to Cardiology service
Pain at time of injection.  By the evening I could not raise my arm.  I had to lift my left arm with my right to roll over in bed.  I have had difficulty putiing on clothing, putting on my seatbelt,cannot lay on my left side, and simply raising or twiting my arm.  I have tried oral anitinflammatory OTC,, oral cortisone, and had one cortisone injection in November.  The cortisone gave some temporary relief, but pain is back and increasing.
My daughter got chickenpox vaccine and Measles mumps & rubella vaccines several days ago, 1 day after shot, she felt low fever, 8 days after shot, she had lots of proteins and red blood cells in her urine, she was diagnosesed as  Nephrotic syndrome. i want to know did you found some case similliar with her? How can i do for the furture immunization. Thanks
1/4 left shoulder pain, rigors, joints pain and pain between shoulder blades, fever 100.8,  fatigue, took tylenol100mg and  Advil 400mg  1/5 shoulder pain subsided a little
Woke up at 3:30 am day after the vaccine with slight Head ache, body rash, severe itching, feeling hot.
heart arrhythmia, lasted 10 weeks then symptions got to be less still acting up now and then  shingles, I had the shingles vaccine and got shingle after the covid booster, lasted  10 weeks strong headaches for 10 weeks general lack of energy and not felling well
After my second Pfizer vaccine I was fine and went to bed.  In the middle of the night I must have tried to get out of bed and fell on the floor.  My legs did not work at all and I slept on the floor.  I felt that I was severally drunk.  I did have one normal drink prior to bed.  I also had severe chills.   I woke up the next day and I was tired and that is it.  On  Oct 26th I had my phizer booster shot and I woke up on the floor again with the exact same issues as before with my 2nd dose.  This time I did not have any alcohol.    I will end up taking the next booster if it is needed in the future.
This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 2-month-old male patient who received HIBERIX (batch number 5FC3Z, expiry date 20th January 2018). Co-suspect products included HIBERIX (batch number 2S27K, expiry date 17th September 2017) and HIBERIX (batch number 4294M, expiry date 20th January 2018). On 9th December 2016, the patient received the 1st dose of HIBERIX. On 15th February 2017, the patient received the 2nd dose of HIBERIX. On an unknown date, the patient received the 3rd dose of HIBERIX. On an unknown date, less than a year after receiving HIBERIX and not applicable after receiving HIBERIX and HIBERIX, the patient experienced injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. On an unknown date, the outcome of the injection site hyperpigmentation and injection site hyperpigmentation were recovered/resolved and the outcome of the injection site hyperpigmentation was not recovered/not resolved. It was unknown if the reporter considered the injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation to be related to HIBERIX, HIBERIX and HIBERIX. Additional details were reported as follows: Health care provider was called back with additional patient details regarding an adverse event he reported on 13th June 2017. He stated that the patients developed a hyperpigmented dark spot at the site of the injection of HIBERIX that was not resolved. It occurred with all three doses of HIBERIX which the patient received. The batch number reported for HIBERIX (25K27K) did not exist and was updated to 2S27K, as per sales database. This case was 1 of 3 cases, reported by same reporter.
my heart rate has been accelerated ever since my second dose. It has been a month later after my second dose and my heart is still beating 130 per minute and I'm sitting down.
chills; stomach aches; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer-sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID19-immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach aches"; HEADACHE (non-serious), outcome "unknown", described as "headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: The patient got symptoms after the second dose. she started getting chills, stomach aches, and headache about 20 days after the second dose. "Interpreter is no longer on the call" message played while mid-way isi. tried getting another interpreter, but caller hung up. faxed ae. CoVax US Support CEP 159558.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
There was 9 x 8 inch area of induration, erythema and warmth extending from (R) shoulder to just above elbow. Tx with BENADRYL and KEFLEX.
A nurse reported that a male received ROTASHIELD, ACEL-IMUNE, COMVAX (Merck) and IPV (PMC) vaccines on 18-NOV-1998. On 30-NOV-1998, he developed diarrhea which lasted several days. The patient recovered. Copies of this report have been forwarded to Merck and PMC, manufacturers of the concomitantly administered vaccine. Manufacturer's comment: The lot number for ROTASHIELD was reported as 48016; however, this is not a ROTASHIELD lot number. This is 1 of 2 patients from this facility who had an adverse experience following receipt of ROTASHIELD or the concomitantly administered vaccines.
Sore shoulder- Left; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder- Left) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder- Left). At the time of the report, ARTHRALGIA (Sore shoulder- Left) outcome was unknown.        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 information was provided. No treatment medication were provided.   This case was linked to MOD-2021-058103 (Patient Link).
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a retrospective which refers to a 19 year old female patient with no drug reactions or allergies. The patient's medical history included irregular heart beat (2010). The patient was vaccinated with dose 1, lot # (662724/0313Y; exp date 28-MAY-2011) of GARDASIL (dose and route not reported) on 24-FEB-2010, with dose 2, lot # (666118/1539Y; exp date 10-AUG-2012) of GARDASIL (dose and route not reported) on 26-APR-2010 and with dose 3 of GARDASIL (lot #, dose and route not reported) on 10-SEP-2010. No other co-suspects were reported. There were no concomitant medications. The nurse practitioner reported that the patient had thyroid cancer on an unspecified date. The nurse also reported that the patient was pregnant in 2012 and had the baby recently on an unspecified date (in 2012). The patient went to the office on 13-MAR-2012 as a referral by the patient's unspecified obstetrician due to a thyroid mass found. The patient was received treatment with iodine. At the time of the report the outcome of thyroid cancer was reported as recovered (approximately in 2012). The nurse practitioner did not feel the thyroid cancer was related to the patient getting GARDASIL. The nurse practitioner considered thyroid cancer to be life threatening and medically significant as cancer treatment intervention was needed to prevent serious criteria. Additional information is not expected.
I felt a tingling in my middle, ring and pinky fingers of my left hand. This began about 30 minutes after. Approximately 24 hours after, I am noticing that my left hand is slightly tingling, as well.
101 fever, sore throat, severe body aches, chills, sleeplessness, huge swollen lymph node
Outbreak of Shingles 24 hours post vaccination; This case was reported by a physician via sales rep and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had outbreak of shingles. the reporter asked Outbreak of Shingles 24 hours post vaccination was related. The reporter did not know the date exactly of occurrence.
This spontaneous report was received from a medical assistant regarding a 10 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 29-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
I had a sore arm for about two days after receiving the vaccine. I had the vaccine one week prior to going on a trip. I started feeling symptoms in the evening of 05/17/2023 after returning home. I tested positive for COVID-19 on 05/19/2023. I had a low-grade fever, cough, congestion, and a horrible sore throat. I contacted my doctor and got a prescription for Paxlovid. I tolerated the medication without any complications. As of today, I still have some congestion.
This case was reported by a nurse via sales rep and described the occurrence of myalgia in a 58-year-old female a patient who received SHINGRIX (batch number ZY3X4, expiry date unknown). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia, fever, injection site erythema and immunization reaction. On an unknown date, the outcome of the myalgia, fever, injection site erythema and immunization reaction were unknown. It was unknown if the reporter considered the myalgia, fever, injection site erythema and immunization reaction to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a large immune reaction complete with myalgia low grade fevers and an 8 cm erythematous area over the injection site. The nurse was agreeing to follow up from safety department.
Rash broke out on bottom front of neck, birght red, itchy, some swelling.  I have used Benadryl  cream  and have taken Benadryk orally for the itching.   It is slowly ckearing up.
My left arm, where I received the shot, began hurting after a few hours. Approximately 12 hours after receiving the shot, fatigue began. Approximately two hours later, I was unable to walk, I collapsed on the floor, my heart was racing, I was sweating, my entire body went numb, and there was ringing and static in my ears. After about 20 minutes on the floor, I got back into bed. My fingers and hands wanted to curl up and not open and that lasted throughout the night. My arms and legs stayed numb all night long.  At around 24 hours post vaccine, the numbness started to subside, I could open my fingers and hands, and regular flu symptoms were present (fatigue, body aches, low grade fever). I could not work the day after receiving the shot. I slept all day. I was not able to drive until around 5PM the day after receiving the shot. The second night and throughout the following day (so 36-48+ hours post shot), I had cold sweats. It is now 3 days later and I still feel terrible. I am worried about getting the second Moderna shot.
This spontaneous case, initially received from other non-health professional on 21-Feb-2018, concerns a 23-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2015, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date in 2015, the patient had malaise and myalgia. At the time of the report, the outcome of the events (malaise and myalgia) was not reported. The reporter assessed the case as non-serious. Non-significant case correction received with the IRD 21-Feb-2018: The case comment corrected accordingly.
pt recvd vax 3JUN93 & on 10JUN93 seen by MD for inject site react of erythema 6x4 cm; treated w/hot packs; area devel into abscess on 14SEP93; abscess drained by MD-purulent fluid; tx unk