chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lips burn and  mouth swelled Benadryl 25 mg 1 every 8 hours starting on 01/08/2021 @ 7:00pm x 4 doses; and then took another one at 10:30am on 01/11/2021 after her mouth started swelling again
Feel extremely dizzy; Tired; Arm was very sore; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, herniated disc and regular headaches. The patient did not have allergies to medications, food, or other products. Concomitant medications included ethinylestradiol; norgestimate (SPRINTEC), vitamin d nos (VITAMIN D), fish oil (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN), all medications received on unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 14:45 after 45 minutes of vaccination, the patient experienced extremely dizzy and tired. The patient also experienced sore arm on the same day. It was also reported that she had started to feel extremely dizzy and tired which lasted for 2 to 3 hours, after which the dizziness went away but she still felt really tired and her arm was very sore for the two days following the injection. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcome of events feel extremely dizzy was resolved on 31Mar2021 and arm was very sore was resolved on 02Apr2021, while that of tired was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a health professional concerning a 17 year old white female who on 26-NOV-2007 was vaccinated with Gardasil (lot# 659437/1266U).  Subsequently the patient fainted after the vaccination.  Unknown medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  This is one of the multiple reports from the same source.  Additional information has been requested.
C/O nausea, vomiting, neck stiffness, fever and red swollen arm. A follow up report received 10/22/2003 adds: left arm involved, cough. No temp. Vitals WNL. No intervention.
Swollen tongue, throat pain, discoloration to throat and palate (white patches)lesions/painful sores on both sides of tongue, difficulty swallowing, burning tongue, white discoloration of tongue, jaw pain mostly right sided, frontal head pressure, numbness and tingling from forehead down both sides of face down jawline.
flublok being administered to pediatric patient with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to cases 2022SA402510(CLUSTER), 2022SA402530(CLUSTER), 2022SA402436(CLUSTER), 2022SA402500(CLUSTER), 2022SA402514(CLUSTER) and 2022SA402505(CLUSTER).  This case involves a 16-year-old female patient to whom Influenza Quadrivalent Recombinant Vaccine [Flublok] being administered to pediatric patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Sep-2022, the patient received 0.5ml total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE strength: standard (formulation: unknown); Duration of Drug Administration 1 day, (lot number: UJ887AA and expiry date: 09-Jun-2023) via intramuscular route in Left Deltoid for Immunization and it was being administered to pediatric patient with no reported adverse event (product use issue) (latency: unknown).  It was reported, this situation is reported as a medication error.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  At time of reporting, the outcome was Unknown.  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 Regulatory Authority. 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.
Muscle aches; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 12:45 (Batch/Lot Number: EL3247),  age at vaccination of 40-years-old, as single dose, for covid-19 immunisation.  Medical history was none; patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 12:45 (Batch/Lot Number: EL3247) for covid-19 immunisation. There were no concomitant medications. The patient had not received other vaccine in four weeks. The patient experienced muscle aches and fatigue on 13Feb2021 at 05:45 AM (around 16 hours after injection of the second dose). No treatment was administered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Feb2021. The patient was not tested for covid prior vaccination. Muscle aches started to feel better as the day progressed. The patient was considered to be recovering from the events.
MONOVALENT VACCINE GIVEN WHEN BIVALENT SHOULD OF BEEN GIVEN PATIENT HAD NO SX
After 2 days of predicted discomfort associated with the vaccine, On the night of 1/30/2019, I suddenly developed severe chest pains only in a very localized area under my upper sternum. On 1/31/2019 I went to my doctor's office to get checked out. After receiving an EKG, I was taken to Hospital and given a heart catherization, which showed no blockages or other serious abnormalities with my heart. However, I was diagnosed with a condition called pericarditis. I was told this pericarditis was caused by an unknown virus that resulted in an inflammation around my heart.
Patient told pharmacy she wanted flu and Shingrix. Before administration the pharmacist confirmed with the patient which vaccines she was getting.  During administration the patient stated she said Moderna and Shingrix (not Flu). The flu vaccine had already been administered by this time. This is the second Flu shot she recieved this season.  First one on 9/18/22
Information has been received from a pharmacist concerning an 81 year old female who on 21-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  On 21-JAN-2008 the patient experienced an injection site reaction with swelling and redness at the injection site.  The patient's injection site reaction persisted.  Unspecified medical attention was sought through the pharmacist.  No product quality complaint.  Additional information has been requested.
Flu vaccine clinic provided injections for numerous participants.  51 participants inadvertently received the wrong dose.  Dose required was .5 ml and 1 ml was administered.  All 51 participants were contacted immediately upon learning of the mistake.   Out of 51 participants only 1 participant had increased side effects which resolved within 24 hours.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 12-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes an d18.2 f for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Ever since May of second vaccine I have had horrible menorrhagia. Horrible. I just read on social media how many women are still complaining. I had no idea and did indeed check that there are lots of publications on this adverse effect. My doctor tested by ferritin level and it was 4!!! This is severe. I wish I never had the vaccine. I was started on a  form of progesterone which is not working and now having to schedule a uterine ablation.
Patient received Shingrix and TDAP (boostrix) vaccine on 01/24/2022 and later developed pain, redness and tenderness up into her shoulder/trapezoid and behind her right scapula. Patient visit urgent care due to the adverse reaction stated above. Patient stated at urgent care and later at follow up appointment with PCP that the reaction was due to receiving the Shingrix vaccine, but per clinic records it was TDAP that was given on the right not Shingrix. Shingrix was given incorrectly to patient through Subcutaneous route instead of intermuscular. Glaxo Medical Information line was contacted due to vaccination mistake and per CDC/Glaxo studies the Shingrix vaccine will not need to be repeated due to a study that showed the same immunity response whether vaccine was given subcutaneous or intermuscular. Information was emailed to clinic and event report created accordingly
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 11-APR-2014 the patient was inadvertently vaccinated with ROTATEQ (lot # H017721) (Dose: 2 ml) orally which was expired on 01-APR-2014. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Urticaria/rash to body on Aug 21, 2006. Vaccine given on 8/18/06. Went to ER on 8/21/06. Rx for Prednisone given . Seen 8/21/06 for rash continuing.
Visited Provider appx 500 pm 1.14.2021   DVT - left calf  -  2 clots via ultrasound    on Eliquis now
Redness at injection site w/in a few hours of injection increasing over the next 24 hours. 1/2 of (R) upper arm red, hot and indurated; low grade fever.
Received vaccine on 1-10-11, signs & symptoms: "red whelping rash" "arm locked up" x "2 days" "intense itching" on assessment of patient red whelps noted on (R) forearm and upper (R) arm. Patient has been seen on following dates for above problems. 1-25-11, 2-7-11, 2-14-11, 2-22-11, 2-23-11.
A report has been received from a Health Professional concerning, Male subject, who had been receiving Nasal FLUMIST, Unknown MENACTRA and Unknown Varicella. FLUMIST started on 25-Feb-2013, MENACTRA started on an unknown date and Varicella virus vaccine started on an unknown date. The reporter stated that dose of expired FLUMIST was administered which started on 25-Feb-2013 and syncope. The outcome of the event of syncope and administered a dose of expired FLUMIST is unknown. The report was considered to be non-serious.
Acute ischemic stroke on 02Jan2021; This is a spontaneous report from a contactable Healthcare Professional. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose for COVID-19 immunisation at the age of 78-year-old. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccination. Patient had Acute ischemic stroke on 02Jan2021; the patient was hospitalized, and she was treated for the event. On 01Feb2021, nasal swab resulted negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was recovering from the event. Patient has not tested positive for COVID-19 since having the vaccine. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information there is no evidence or argument to suggest a causal relationship between the reported event of ischemic stroke and BNT162B2 administration. Event occurred prior to vaccination.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 56-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 24-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter US-GSK-US2023AMR060652:Original Case : US2023AMR056407
Sometime overnight last night which would be 3/27 into 3/28 my smart watch, which I?ve been wearing for four years, the breath rate graph  went substantially below my normal range down to 10. I?m curious if this is a common side effect of the Moderna vaccine and I?m concerned because I live alone.
pt recv vax 23FEB98 & on 3MAR98 pt devel a erythematous papular rash w/approx 50 lesions on the trunk, scalp & lower extremities;
diarrhea; fatigue; sore arm; This is a spontaneous report from a contactable consumer (patient wife). A 50 years old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 Immunization. The patient (husband) experienced diarrhea, fatigue, sore arm in Apr2021.  Outcome of event was unknown. It was reported reporter's son (16 years old) also received 2nd dose of the Pfizer covid vaccine on Sat 10Apr2021 and experienced fatigue, insomnia, chills, slight temp (99.7 F).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in an 87-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Parent reported this am that within 4 hours of receiving vaccines on 10/6/17, developed 101.8 degree oral temperature, headache, dizziness, nausea, no vomiting, and weakness. this continued for almost 48 hours. Fever gone since 10/8/17 but other symptoms remain.
Red, swollen knot at injection sight that was warm to touch.  Sore arm at injection site. Symptoms started 4/10/2021 , the day after shot, and lasted 3 days through 4/12/2021.
myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (PRIVATE). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown".  Clinical course : Caller said that he just got the Pfizer vaccine and is experiencing myocarditis. He was wondering why we were doing that to our vaccines. Created manual AE form since the caller had myocarditis after taking the covid 19 vaccine. Caller also stated that he wanted to talk to someone in (city name). Resolution: - The call was transferred from our location (Name and number withheld) - While reading the opening spiel, caller hang-up - No action was made - Submitted manual AE form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
husband who is positive for Covid-19; husband who is positive for Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "husband who is positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: He already administered with the 1st and 2nd dose of the vaccine and also for the booster shot. She wanted to know how to get the prescription PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presents to deployed medical clinic complainig of swelling at smallpox vaccine site, multiple papular lesions on R forearm and bil lower extremities. No lymphadenopathy, no fever, + pruritis, otherwise asymptomatic. Treated with Naproxen and Benadryl.
This spontaneous report was received from a physician who refers to a female patient in her mid-70's. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, and lot# not reported). The physician reported that on an unknown date the patient ended up with a light rash and then full blown shingles pain and then post herpetic neuralgia (PHN) lingering after. The patient sought medical attention. The patient received LYRICA for adverse events treatment. None lab diagnostic tests were performed. At the time of the report patient's medical status was reported as not recovered. Additional information has been requested.
Started developing chronic acid reflux around Jan 10. No history of ever having this before the vaccine.
Information has been received from a nurse practitioner concerning an adult pt (age and gender not reported) with an unk medical history and unk allergies who on 27Oct05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot651524/0605R). Subsequently, the pt developed an injection site reaction which included swelling, redness, pain and local heat. The pt was treated with antibiotics (unspecified). The pt was reported as recovering. There was no product quality complaint involved. Additional information has been requested.
Upper arm extremely red with extreme swelling around injection site.   Pt also had headache.  Per pt redness & swelling has diminished but still bothersome.
I noticed that I was having a hard time keeping my balance. One day when I was outside feeding the dogs, I noticed my nephew was approaching tried to walk towards him I had to grab a tree. I went to bed started sweating and got back in the bed. Around 12:00AM got up to urinate. I could barely walk my wife was asking me," what's wrong." My wife took me to hospital on April 27, 2021, I was informed I had a stroke two weeks earlier. I was admitted to the hospital for 9 days. I'm still going to doctors for my stroke.
The patient medical history and concomitant medications were not reported. Patient was asked that, "I got my first vaccine on March 26th and then the following, on April 6th I tested positive for Covid. my second dose was supposed to be on April 16th but I was still positive. I was positive through April 23rd. I am no longer positive, What do I do with the second shot". The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 9 week old male who "at the beginning of the year" in approximately January 2007, was vaccinated with Rotateq (Lot# not provided). Immediately post vaccination, the infant "went limp" and broke out in a rash. The infant was monitored at the office for approximately 45 minutes and recovered with no treatment. Additional information has been requested.
Acute pain radiating up the neck on the same side as the injection, beginning 30 minutes after jab and continuing.  It has now been almost 9 hours. Soreness where the injection was administered beginning 6 hours after the jab.
Immediately after injection,  my arm was numb for more than 15 minutes. I waited 30 minutes before leaving.  After that, all seemed good.  In early April, my legs seemed heavy for a day.  The next morning, I would barely walk.  After visiting an orthopedic surgeon, I was sent to have an EMG and nerve conduction study which showed demylinatization in my legs and somewhat in my arms, especially my right arm.  I visited a neurologist who completed extensive blood work and a lumbar puncture.  The EMG, nerve conduction study, and very elevated protein in my spinal fluid confirmed Guillian Barre.  I had to undergo IVIG treatments, which helped.  I continue to suffer from effects today (July 2021), but am now able to walk better.    I support the vaccine still. It appears to be saving millions.  I just "hate" that I was adversely impacted by the vaccine personally.
Approximately 10 to 15 minutes post injection she started feeling hot, then patient began to become flushed . I gave her oral  benadryl 50 mg and 40 mg of famotidine oral. The difficulty in breathing did not lessen. She began to use her accessory muscles. Her O2 sats were 99%  via finger pulse oximeter. Breathing became increasingly labored. An Epi pen 0.3 mg was administered. An ambulance was called. Her breathing became less labored, she was transported to the hospital  via ambulance to be checked out.
I received the Covid-19 vaccine on May 19th, 2021 and 2 weeks after started having uncontrollable amp and leg movements that would last for 10-15 minutes 3-4 times a day. I continue to have daily uncontrollable arm and leg movements and have now started having episodes of confusion after the uncontrollable movements. Those episodes of confusion last for 10-15 minutes and I do not know where I am/who my family is or anything in that nature. I have had 3 of those episodes in the last 2 weeks. I have also been having migraines headaches since the start of the uncontrollable movements with no relief from over the counter migraine medicines.