chrisvoncsefalvay/vaers-outcomes huggingface dataset:
legs were not working after the Covid-19 vaccine shot; This is a spontaneous report from a contactable consumer. A 91-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261, expiration date 31May2021), intramuscular on her left arm on 23Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's legs were not working after the Covid-19 vaccine shot on 24Jan2021. She got the shot on Saturday afternoon. The patient seems to be ok today. The outcome of the event was recovered in 25Jan2021.
Patient called clinic the day of receiving COVID19 vaccine to report she is having numbness and tingling that goes down her arm and into her fingers that hasn't gone away. Took ibuprofen 800mg at 1045 the morning of injection. Injection was in left arm. Reports injection site looks fine, no signs of erythema, ecchymosis, or swelling. Can palpate radial pulse. Normal ROM in arm, hand, and fingers. Reports normal cap refill in fingers.
Severe diarrhea for several days, lump on arm that was hot to the touch, bruising, headache, fatigue.
Missed period month of April  Period began month of May (May 4th), lasted 3 days, then returned in 2 days for 4 days, then returned again. very heavy. From May 4th to 18th a total of 14 days.    I have not had a period since and do not know how to log if for month of May. This has never happened before  I have been severely tired; I sleep for many hours awake only to go back to sleep again
ErythemaMultiform, UrticariaPruritus, Injection site pain, heat, ulceration Narrative:
sore in her r arm; chills; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore in her r arm), CHILLS (chills) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore in her r arm), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore in her r arm), CHILLS (chills) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and chills are consistent with the known safety profile of mRNA-1273   Reporter did not allow further contact; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and chills are consistent with the known safety profile of mRNA-1273
Severe balance issues.  Sometimes unable to get up and extreme difficultly in walking and standing.  Have had to use a cane on occasions.  Have to hold on to people or things to walk.  Some days are good and others bad.  It is very unpredictable still to this day.  I can feel fine one minute and then the next I am unable to walk.
The patient reported to the pharmacy counter after her 1st dose of the COVID19 (Pfizer-Biotech) vaccination within 5 minutes stating "Guys, I don't feel good." One of the pharmacists grabbed her chair and moved it to our check out window and sat down with her to ask her what she was experiencing. I grabbed the blood pressure cuff and returned to the patient. The other pharmacist reported to me that she felt light-headed, dizzy, and that her throat was itchy. We administered 25mg of diphenhydramine (oral tablet) and gave the patient some water. We then checked her BP and it was 68/40, which prompted us to call 911 for assistance. The other pharmacist stayed with her until the paramedics arrived (~15 minutes). About 5 minutes later we rechecked her BP and it jumped to 144/90. I tried to assess the patient's coherence, which began to diminish as she was very confused and could not understand the questions we were asking her. About 1 minute before they arrived, the patient said her throat was feeling worse and swelling, so we went to grab an epinephrine pen. EMT's arrived right as the dose was about to be administered, so we stopped to let them take over.
Call to patient after receiving my chart message with picture included or round raised lesion and blistering at site of vaccination. Reports swelling started Tuesday evening after vaccination was given. The area is tender to the touch but not painful without touching it. She does not feel it has increased in size since Wednesday evening. Denies: facial swelling, breathing issues, drainage of the blisters, fever, hives over body, illness in the past month. Reviewed VAERS form data.  Patient is not taking any prescription medications, herbal or vitamin supplements.  She took some otc tylenol yesterday. No known allergy to egg or medications. No chronic health conditions.  No recent illness in the past month.
expired PENTACEL vaccine was given with no reported adverse event; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves an unknown age and gender patient who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 29-Jul-2021, the patient received a dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number-UJ349AA, expiry date-22-Jun-2022) via an unknown route in unknown administration site for prophylactic vaccination (expired product administered).  It was reported that, "Caller stated that a 2-month-old patient was given the Ipol and dtap portion of product and not the Acthib. Caller wanted to know if the ActHIB can be given separately. She also wanted to know if there was any concerns of not given the product with Act-Hib".  It was a case of actual medication error due to expired vaccine used (latency-same day).  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.
pt recvd vax 15JUL95 & 8AUG95 pt devel 10-15 pox-like lesions w/no fever;the lesions were bigger 9about 2mm?) than a nl chicken pox & were located on scalp (one) & the rest of body w/itching;pt tx DPH;
itchy rash; reddish; superficial vein in leg; tender to touch; bruise; A spontaneous report was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced superficial vein in leg, tender to touch, bruise, itchy rash, reddish.  The patient's medical history was not provided. Concomitant medications reported were Advil for drug use for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced superficial vein in leg, tender to touch (tenderness), bruise (contusion). and On 12 Feb 2021, the patient experienced itchy rash (injection site pruritus) and was reddish (injection site erythema).  Treatment details included that patient had applied a compress many times a day in the leg and applied a cream in the injection site.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Flu A and B; arm hurt so bad; felt bad; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) who had flu A and B (influenza), arm was badly hurt (pain in extremity) and felt bad (feeling abnormal) when received vaccine INFLUENZA VACCINE.  The past vaccination(s) included INFLUENZA VACCINE (the patient had been taking it for years).  Past medical treatment(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu A and B (influenza) and about died. Last year, the patient's arm was badly hurt (pain in extremity) and felt bad (feeling abnormal) for a week, following the administration of INFLUENZA VACCINE.  The patient was not willing to take flu shot anymore.   All events assessed as non-serious and latency was unknown for all.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the events was unknown.  There will be no information available on the batch number for this case.
Patient admitted for COVID pneumonia on 2/27/21. Patient received first Moderna shot 2/20/21. Patient hospitalized until 4/9/21. Patient presented to the hospital with dyspnea. She was found to be COVID positive. She had rapid development of respiratory failure and required intubation. She had a prolong ICU stay. She as successfully extubated to oxygen. Her oxygenation improved. She did have some urinary retention prior to discharge but this improved. She was discharged on minimal oxygen to rehab.
Nov. 11th woke up with tingling sensation in feet and hands with bad backpain and weakness. Dec 21 Had EMG with Dr. Dec 30 Had Lumbar puncture at Hospital.
NONE.  Nurse follow up on 09/23/04 states: "cardiac arrest, pulmonary arrest."  Nurse follow up on 10/05/04 states: "none, awaiting autopsy report."
Mom reports vomited several times on 8-2-14. States baby was getting diaper change and vomited. States baby went limp. CPR started and ambulance was sent.
Initial unsolicited report received from a nurse on 11-Jun-2018. This case involves a patient (age and gender not reported) who was vaccinated with a dose of ACT-HIB (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong solution used in drug reconstitution and it was reported that patient received dose reconstituted with sterile water instead of supplied diluent. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
2-in rash left arm (itchy, red), (Day 3) Headaches Chills Fever
Patient had already had 2 doses of TDAP, last one was in 2011. Patient received another TDAP on 6/6/14. After discussing the MA involved, she stated "doctor told me to".
Upper right arm swollen, warm and very hard. Red from top of arm to mid upper arm and around back of arm to just above elbow.
admitted to hospital within days of receiving Gardasll 9; they only had a 48 hour window for a Bone Marrow Transplant; the bone marrow donor was a sibling; breast tumor; Gardasll HPV vaccine was found to INCREASE the risk of Cancer by 44.6% In pooplo who had alroady boon oxposod to tho HPV virus.; elevated interferon; Is returning for more surgery for additional tumors; This spontaneous report was received from unspecified reporter and refers to an unknown number of patients (included 17 year old female and male of unknown age).  The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  It was reported that the Gardasll HPV vaccine was found to increase the risk of cancer by 44.6% In people who had already been exposed to the HPV virus (vaccination failure). Ono vaccinated 17 yr old teen developed a breast tumor after receiving the GARDASIL HPV Vaccine, and had It removed at age 16. She Is now 17, and was returning for more surgery for additional tumors. A male Gardasil HPV Vaccine recipient was recently admitted to hospital within days of receiving Gardasll 9. After a week of observation, doctors at a notified his parents that they only had a 48 hour window for a Bone Marrow Transplant. It appears that the Gardasll9 caused elevated Interferon, and severely elevated Interferon can affect bone marrow and Interfere with platelet production. Because the bone marrow donor was a sibling with active CMV, the survival of the patient was questionable because CMV can thrive if transplant anti-rejection suppressants are administered. Onset date of the events and outcome were unknown.   The reporter considered elevated interferon to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The causal relationship between additional tumors, hospitalization, breast tumor and bone marrow disorder and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  The reporter considered elevated interferon to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The causal relationship between additional tumors, hospitalization, breast tumor and bone marrow disorder and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). was unknown.  Causality between vaccination failure and suspect therapies was assessed as related.  Upon internal review, the event bone marrow disorder was determined to be medically significant.
p/3 doses of oral typhoid devel severe urticaria; treated w/Antihistamines & pred;
7 days p/vax pt had 5 days of T105, lethargy, inability to eat & play;3 1/2wk p/vax temp pt had cerebral ataxia-unable to walk or lift head for 3 1/2wk;
On Monday May 10, itching started on the back. My daughter checked me and saw red spot. The next day more hives and itching appeared on her neck. In the following days the hives spread all over the back and right leg.
Patient is a 65 y.o. male with history of  who presents with left sided headache and right hemibody sensory change. The patient went to bed at his baseline at 2130 pm on 9/22/2021 and awoke at 0100 on 9/23/2021 with left sided, primarily retro-orbital pain and noticed with movement that his right hemibody felt abnormal. He initially described numbness but then reported paresthesias. He presented to the ED. Upon arrival, vitals were BP 136/82, pulse 75, temperature 36.5 °C, temperature source Oral, resp. rate 16, SpO2 98 %. Initial NIHSS 0. Labs were glucose 142. EKG showed sinus rhythm with first-degree AV block. Noncontrast head CT was negative for acute intracranial pathology. CTA head & neck showed no significant stenosis, dissection, aneurysm or large vessel occlusion. CT head venogram showed no evidence of venous sinus thrombosis. The patient was ultimately not deemed a candidate for thrombolysis given outside the time window or endovascular given no evidence of large vessel occlusion.
Pt presented to the hospital with a fall, confusion, and weakness. Found to be Covid +. Received Bebtelovimab
Information has been received from a registered nurse concerning her 20 year old granddaughter with asthma, cyst in breast and no known drug allergies who in 03-JUN-2009, was vaccinated with the first dose of GARDASIL (Lot number unspecified). On 03-SEP-2009 the patient received another dose of GARDASIL. Concomitant therapy included oral contraceptives. Subsequently the patient experienced repeated yeast infections (at least 4 times) since receiving one dose of GARDASIL. The patient was examined by her physician on 17-NOV-2009 for her most recent yeast infection. The reporter was not aware of any other issues. The patient's reported yeast infections persisted. Additional information has been requested.
Swelling of left clavicle, both sides of neck, and left armpit glands appearing 2 days after shot. Fatigue apparent 1 day after shot.
Fevers to 102, erythema, pain at site within 24 hours.  Treated with BENADRYL & MOTRIN.
This spontaneous report was received from a physician regarding a 19 years old female patient. The patient's medical history included hidradenitis suppurativa diagnosed on 02-FEB-2017, and herpes type II positive definite. Concomitant medication included valacyclovir hydrochloride (VALTREX) and concurrent conditions were not reported. She did not have drug reactions or allergies. On 16-MAR-2017, the patient was vaccinated with the first dose of GARDASIL 9 in the left deltoid, lot # reported as M04373 with expiration date 26-APR-2019, (route of administration was not reported) for vaccination, 20 years old at risk (prophylaxis). On the same date, the patient complained of a cold described as "lasted for up to a month after receiving the dose". She did not seek medical attention and no treatment was given for the event. The second dose was never received. At the reporting time, the patient recovered from the cold. The causality assessment was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA012316: US-009507513-1804USA012254:
Received COVID vaccine 12/28/2021.  Later that day had COVID exposure at home.  +PCR for COVID but no symptoms.
On Friday 3-19 she had a swollen lip. It went down and she had her first dose of COVID vaccine.  Saturday she was well and had a fever on Sunday. Fever went away and she felt better until Tuesday when she had a high fever on Tuesday night.  Wednesday she had swollen puffy eyes but they were never red in her conjunctivae.  Thursday seen by Dr. Labs showed mild increase in LFTs and Cr. She had lymphocytosis and atypical lymphs consistent with a viral infection. She was negatvie for EBV and had a negative COVID swab. She does not have history of exposure to COVID a month ago. She is careful at school. They are tested frequently and no one has been sick, however one of her roommates had mono. Friday and Saturday fevers continued. Saturday repeat labs showed higher LFTs and negative CMV. ESR and CRP and ferritin are elevated. She has no rashes, cough or congestion. She is mentally clear and not light headed. She has a headache when her fever is high but otherwise is okay. No conjunctivitis, No sores in mouth or lips, and no swollen LNs.
Sore arm; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Body Aches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Body Aches). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
8 x 5 cm erythematous injection site reaction  ice pack applied 10 min periods x 2
Lips, tongue, face, hands went numb/tingling. Hands sweating. 2 doses of Benadryl. Went to hospital. Hospital gave me steroids.4-6-2021 Still having some reactions - continue taking Benadryl
Patient fainted while walking away after flu shot, immediately regained consciousness, was helped to bench where he passed out again about 1 minute after first incident. Patient was unconscious for about 15 seconds second time, even with physical jostling/stimulus & talking loudly to him. Patient urinated himself then woke up. Once patient was unconscious second time, pharmacy called 911 who instructed us to keep patient here with no foods or liquids. We talked to patient and kept him on bench- patient said he had passed out before during other vaccinations but didn't tell us since the "flu shot is not as serious". Paramedics arrived within 5 minutes and pharmacy staff reported what happened then gave them privacy. Patient refused service to hospital but paramedics recommended he go and get checked out on own still. Paramedics say patient passed out third time while they were here. Patient was with girlfriend who drove him home.  Pharmacy will follow up with patient next day.
pt recv vax 22OCT96 or 23OCT96 & pt devel n/v & diarrhea w/o fever 48hr p/inj;pharmacist  related there were other pt that exp vomiting & diarrhea who did not recv flu vax;this is one of 25 cases reported by pharmacist;
Fever, chills, nausea, muscle pain, injection site soreness, headache, fatigue.