chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Swelling at Injection Site-Mild, Additional Details: patient had a blood clot on 01/12/2023
Severe aches; Pain; Nausea; vomiting; headache; cognitive impairment/difficulties-not answering questions; confusion; not making sense, blank stare on my face; not making sense, blank stare on my face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Oct2023 at 16:45 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for immunisation; for immunisation; bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 16:45 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering"; PAIN (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering"; PAIN (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering", described as "Severe aches"; COGNITIVE DISORDER (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering", described as "cognitive impairment/difficulties-not answering questions"; CONFUSIONAL STATE (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering", described as "confusion"; HEADACHE (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering"; INCOHERENT (non-serious), STARING (non-serious) all with onset 11Oct2023 at 13:00, outcome "recovering" and all described as "not making sense, blank stare on my face"; VOMITING (non-serious) with onset 11Oct2023 at 13:00, outcome "recovering". Therapeutic measures were not taken as a result of pain, pain, nausea, vomiting, headache, cognitive disorder, confusional state, incoherent, staring.  Additional information: Severe aches, pain, nausea, vomiting and headache were noted. This wss noted as starting at approximately 1 pm on 13Oct. The patients daughter noticed that she had cognitive impairment/difficulties. She was not answering questions, confusion, not making sense, blank stare on the face were noted.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v , bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pain at injection site, stomach pain similar to deep hunger pain, severe back pain from shoulder blades to waist, headache
AFTER 12 HRS AFTER VACCINATION I STARTED TO HAVE  A FEVER OF 104 OR HIGHER, VIOLENT COLD CHILLS, MUCLES ACHES, FATIGUE, LASTING FOR AROUND 24 HOURS
On Jan 18 ,2021 I experienced severe anxiety and heart palpitations that have continued on and off since that date. Heart rate varies from 35-120 and I can feel the palpitations .
received lot number involved in the Recall; received lot number involved in the Recall; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pediatric office receptionist reported that between 18th July and 25th August 2021, the patient received recall Engerix-B lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. This case was 1 of 20 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226422:same reporter
Developed infectious lymphangitis a few days later to b/l axilla. Tx with Bactrim DS
Inadvertedley administrated an expired dose of the vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HBV (Engerix B) (batch number 9p9b5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 14th February 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: The reporter stated that, the patient was inadvertedley administrated an expired dose of the vaccine, which led to expired vaccine used. No further events were reported. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up. Note: The vaccination date in the structured field was reported as 4th March 2022 (future date), however was captured as 14th February 2022 as per the narrative.
Nausea; vomiting; diarrhea; exhaustion; cold sweats; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 14:00(at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history was not included. The patient did not have any allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN,18mg) from unknown date for unknown indication, ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, ergocalciferol, iron, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopheryl acetate (CENTRUM) from unknown date for unknown indication and collagen vi (MANUFACTURER UNKNOWN) from unknown date for unknown indication and multivitamin(MANUFACTURER UNKNOWN)from unknown date for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in right arm on 09Mar2021 at 14:00, as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 31Mar2021, at 16:00 the patient experienced nausea, vomiting, diarrhea, exhaustion and cold sweats for several hours. The patient did not receive any treatment for the reported events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, vomiting, diarrhea, exhaustion and cold sweats were not resolved at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
low grade fever; body aches; This is a spontaneous report from a contactable consumer (patients friend).   A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history included unspecified autoimmune disorder. The patient's historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, (Batch/Lot number was not reported), dose 1 for COVID-19 immunisation on unspecified date. Patient was not on Keytruda. Patient reported that she heard more reaction occur with the second dose of the Covid vaccine. The patient experienced low grade fever and body aches on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given injection 10-15-10. She reports that arm is still very sore and has trouble lifting arm. I advised patient to consult with physician.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 29-Oct-2021, the vial was placed in the refrigerator. The vial did not undergo any temperature excursion and the patient had no adverse event.  No treatment information was provided.   This case was linked to MOD-2022-491837.
Patient experienced blisters, itchy areas, and a rash which developed around his ankles starting 2 weeks after receiving ZOSTAVAX. The rash spread to the upper arm and lower legs. Patient was still experiencing the rash as of 1/30/2017. The rash goes away when steroids are used for a COPD exacerbation, and then returns when the course of therapy is completed. Skin rash, rash, urticaria pruritus and blisters, swelling, pain, burning sensation. Fludrocortisone 0.1 mg every day, triamcinolone apply sparingly to AA on shin, clobetasol AAA bid to extremities, torso.
jaw tenderness; soreness on her arm; This is a spontaneous report from a contactable nurse. This female nurse (patient) reported that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number/Expiry date: Unknown) via an unspecified route of administration as a single dose for COVID-19 immunization on 10Feb2021. The patient's medical history and concomitant medications were not reported. On 10Feb2021, she had only soreness on her arm where she got the vaccine and on 11Feb2021 (reported as now this morning), she is having jaw tenderness when she opens her mouth. She says she would like to know if this is a known side effect or something else. She says that it is slight, so it could be something else. Investigation Assessment was Not Provided. The clinical outcome for the events was unknown.   No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.
I am experiencing what I saw online as "COVID arm". After the vaccination, the pain lasted for about 2-3 days and it was gone. Then after another 2 days, I realized that I had a huge red rash mark right under where I got the shot. It was a huge red patch of crazy itchiness and a little bit of dull pain, but it was extremely hot and swelled up. So that has been on going for a few days now.
parent claims child devel T101.5 10APR99;arm was red, swollen, hot to touch & sore;
numbness & weakness lt side of face & upper extremities in early 8JAN94;pt had hep vax 20DEC93;p/CT's, heart monitors which were essentially neg it was felt  these sx could be d/t vax & pt advised not to recv any addtl hep b;
On 04/10 at approx 7pm the pt complained of pain and swelling at injection site. Upper arm was hot and swollen. Pt called the physician and was instructed to put ice pack on site and give Benadryl and Tylenol. On 04/11/2002 continued symptoms with no improvement.
received COVID vaccine on 01/06 and on 01/07 in AM low grade temp of 99 muscle aches and headache Friday temp 101 better on Saturday  Had infection of COVID in the past.
thumb, index finger, middle finger, and fatty part of my palm started tingling as if it was going to fall asleep; my left hand asleep, particular thumb index finger, middle finger, and fatty part of palm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 17:00 (at the age of 31-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 31-years-old); both as a single dose for COVID-19 immunisation. Medical history included genital herpes and rosacea. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aciyclovir (ACYCLOVIR) for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 08:00, after patient got vaccine, patient had frequent occurrence in the mornings with left hand asleep, particular thumb, index finger, middle finger, and fatty part of palm. It happened when lying on back and hands were laying on stomach or holding up sheets. The patient slept with one pillow under head. It happened to both hands, but primarily left. This sleeping position was often used by patient (along with sleeping on side or stomach) and never had this happened as frequently as it did post vaccine. On unknown date in Jul2021, went on a hike, mowed the lawn, tidied up, then picked up some dinner. I was tired and very hungry, probably a little dehydrated too, While I was waiting in line, patient's thumb, index finger, middle finger, and fatty part of palm started tingling as if it was going to fall asleep. This was concerning as it typically only happened when patient was waking up in bed. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient underwent COVID-19 Source NP (nasal swab) and tested negative. The clinical outcome of the event left hand asleep, particular thumb, index finger, middle finger and started tingling was not recovered at the time of this report.
Experienced redness in left eye for more than 24 hours. Patient said he would seek medical attention.
I suffered from COVID Symptoms from 10/4-13.   Fever or chills Cough Fatigue Muscle or body aches Headache Sore throat Congestion  Nausea Diarrhea   I went to the Emergency Room on 10/7 due to the development of: Shortness of breath or difficulty breathing
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Felt sharp pain and burning in (R) deltoid injection site which continues when she attempts to lift arm above shoulder level or to back. No prior tx. until saw M.D. on 1/11/12. She recommended TYLENOL, ice/heat, ROM.
Subsequently post vax, the pt developed an injection site abscess. The abscess was drained.
STARTED WITH FEVER AND THEN LYMP NODES ENLARGED ON L ARM PIT ,2 DAYS LATER MOVED TO R ARM PIT  AFTER  A WEEK R LEG SWOLLEN BELOW THE KNEE AND MOVED TO THE LOWER LEG. WITH LOTS OF PAIN AT THE KNEE
86 yo male w/ PMH of CAD, vertigo, and vocal cord CA 2012 s/p resection, recent possible reoccurrence and recently treated w/ zpack for bronchitis who p/w weakness, falls and prolonged time on floor which started yesterday. According to pt and family, he visited his wife in hospital yesterday and she felt he was not looking himself- so he went home around 5pm and sat in chair for a couple hours. When he tried to get up around 745p he couldn't and eventually fell on the floor. He denies any LOC or injury at that time. He pulled and crawled around floor for what sound like several hours. Eventually he pulled himself up and "dragged himself " upsatirs. He fell again in bathroom, again unknown down time but eventually got hhimself in bed. In the morning he spoke w daughter and eventually 911 was called. He denies CP, SOB, N/V/D or any other focal symptoms. No known sick contacts.
Pt recv vax on 1/4/99; on 1/13/99 pt exp rash on abdomen & back, face; tx=Benadryl
Smell cigarette smoke and burning smell constantly  Some foods taste rancid, metallic, gasoline taste and the food items with this taste also have the same smell.  I have not been treated for this.  This has been going on for about 1 week as of 3/31/2021 at 11:44am.  Hoping it goes away soon.
Severe arm pain; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non- pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 03May2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history included. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 05Apr2021 at 13:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination.  On 03May2021 at 15:30, the patient experienced severe arm pain and headache. Therapeutic measures were taken as a result of severe arm pain and headache and included treatment with ADVIL twice on 2nd day after shot to an unknown stop date. The clinical outcomes of the events severe arm pain and headache were recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Patient was diagnosed with otitis media on 12/27/07 and treated with amoxicillin after 2 days of temperature to 100 F, decreased appetite and slight increase in the number of bowel movements.  She returned 4 days later for a regularly scheduled checkup for delayed immunizations and had been without fever since the prior visit and ears were improving.  On 12/31/07, she received DTaP3, Hib3, IPV3, PCV3.  In the evening on 1/3/08, she began developing a red, raised rash and possible swollen knee (L).  She also reported eating shrimp near (but probably after) the rash appeared.  The rash was seen by me on 1/4 and was red, raised, with target lesions and some with purple centers.  There were no mouth lesions.  CBC was unremarkable, ESR was elevated.  The rash became worse and she was seen in the ER at Hospital on 1/4 and 1/5 as the swelling of the lower extremities and rash spread.  It was felt to be erythema multiforme.  Amoxicillin was stopped on 1/3/08 and patient's rash resolved spontaneously by 1/7/08.
Began with left arm itching in the early morning approximately one week after the shot.  Progressed to a rash approximately 5 inches in length and 3 inches in width.  Continues to remain slightly red, warm to the touch, and itchy.  I have been applying an anti itch cream with relieves the itching.  Today is day number 5. On the day of the injection, February 2, 2021 my left arm began hurting about 10 hours after the shot.  I could not lift my arm above my shoulder without experiencing pain.  This lasted until the evening of February 3, 2021.
Information has been received from a registered nurse concerning her 4 year old daughter with no known drug allergies and no pertinent medical history who on 16-AUG-2010 was vaccinated with a dose of PROQUAD (Merck upgrade process), SQ, 0.5 ml in the left upper arm.  There was no concomitant medication. On 17-AUG-2010 the patient developed fever as well as redness, induration, and swelling at the injection site. The nurse contacted the physician's office by phone and was suggested to use warm compresses and ibuprofen. There was no lab or diagnostic test performed. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
C/o shortness of breath and "racing heart." BP: 160/90 P: 120; Benadryl 50mg pm at 11:41. Repeat c/o at 12:05- color good, no SOB vitals monitored until 2 pm when she visited her doctor.
Sick  Large red  hard spot at injection sight   Pain in neck and headache  Repeat of  large hard red spot a weed later
Patient called the pharmacy to let us know her arm got a rash and was itchy and she went to her doctor. The doctor stated she had cellulitis and the patient was prescribed antibiotics.  The rash has since cleared up and patient has no residual effects from the vaccine.
MUSCLE SPASMS; UNCONTROLLABLE SHAKING; HOT FLASHES; SWEATY; DISAPPEARANCE OF PREVIOUS TINNITUS; CHILLS; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included tinnitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUNE-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced muscle spasms. On 10-APR-2021, the subject experienced uncontrollable shaking. On 10-APR-2021, the subject experienced hot flashes. On 10-APR-2021, the subject experienced sweaty. On 10-APR-2021, the subject experienced disappearance of previous tinnitus. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasms on 10-APR-2021, and uncontrollable shaking, hot flashes, and sweaty on 11-APR-2021, had not recovered from disappearance of previous tinnitus, and the outcome of chills was not reported. This report was non-serious.
Started having shortness of breath in March (or possibly earlier than March) 2022, had heart cath in April 2022 which was normal. April 2022 had shortness of breath, extreme fatigue, swelling in lower extremities and abdomen, nausea, vomiting. Diagnosed in May 2022 with blood clots in legs and lung, had saddle embolism in lung, hemoglobin would drop due to bleeding ulcers in GI tract, was having to have paracentesis weekly due to fluid in abdomen from non alcoholic cirrhosis of her liver. 5 hospitalizations in less that 2 months. Died on June 11, 2022. These were all new medical issues within 3 months of having the Covid booster.