chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to an approximately 20-year-old female patient (reported as 'in her 20s'). Patient had a history of being immunocompromised. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date and route not reported) in the arm. No concomitant medications were reported. On an unknown date the patient developed swelling the size of a tennis ball on her arm after receiving a dose of PNEUMOVAX23. The patient's reaction was diagnosed as a cellulitis and was treated with an unspecified antibiotic. The outcome of cellulitis was reported as recovering/resolving. Patient sought medical attention for the event. It was unspecified whether laboratory studies were performed. Causality was not reported. Additional information has been requested.
Muscle soreness , unable to lift left arm . It's been almost 2 weeks . Taking over the counter pain meds , benadryl . heating pad .
Severe joint inflammation. Could hardly get dressed or walk.  This lasted for about 2 1/2 months before it started to ease up.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a elderly female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intravenous). In September 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. On an unknown date, the patient experienced swelling arm and pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the swelling arm and pain in arm were recovering/resolving and the outcome of the vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that in the beginning of September 2018, she received SHINGRIX vaccine on left arm in the vein where you bend the arm, which led to vaccine administered at inappropriate site and inappropriate route of vaccination. Less than a year after receiving SHINGRIX, the patient experienced swollen and painful arm. The pain was on and off the day. The swelling and pain has decreased from before. The patient had to take two Tylenol at night for the pain. The patient visited her doctor once, and she had another visit scheduled next week from the reporting date. The reporter did not consent to follow up. The referred patient to health care provider. No further details were provided. This case was an accidental medication error associated with an adverse event.
Allergic reaction.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer who is the mother of a 12 month old male pt with no relevant medical history who on 06/10/04 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included MMRII. On 06/17/04, "within 1 week" the child started to develop blisters on the eyes. There was no diagnostic lab data performed. It was noted that treatment was required. The mother of the child has consulted with her pediatrician and an opthamologist. Unspecified medical attention was sought. There was no product complaint involved. The pt had not recovered. Upon internal review blisters in the eyes was considered an other important medical event (OMIC).  Additional information has been requested. This is an amended report. The adverse event of retinal disorder has been changed to eye disorder. The report is corrected as amended.
Child administered vaccines 10/14/03. On 10/24/03 developed fever (not taken with thermometer) and red, "splotchy" rash on face which progressed to rest of body and limbs. Child was inconsolable with decreased appetite. Parent gave Tylenol, applied calamine and gave Aveeno oatmeal bath which helped. Rash, irritability started to resolve 10/26/03.
pt c/o hot, painful, swollen area around inj site;size of swelling 12x8cm;tx w/DPH;
The vial used for this vaccination was opened for the first time on Thursday May 27th around 5 PM with an expiration time set for 6 hours after opening (11 PM on Thursday May 27th). The vial was accidentally not discarded at store closure and was placed back into the refrigerator. The next day Friday, May 28th the patient was administered a vaccine from the expired vial. The manufacturer was called for a recommendation. They stated administering the vaccination at the time period it was given was not studied and for the pharmacist to use their best clinical judgment. After consulting other pharmacists it was determined to not re-administer the dose, but to contact the patient and monitor for infection. The patient
Rash left arm, ill defined borders, started opposite of deltoid . Rash is red, raised, warm, tender to palpation, slight irritation/burning,  rarely itches. Slowly progressing towards site of injection .   1/1/20 - two Aleve and applied Hydrocortisone 2.5 % lotion x 1 1/2/20 - No significant change except it seems to be slightly clearing in center with red raised borders.
FEVER; PAIN IN LEGS; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to dogs and cats, pollen allergy, some raw fruits allergy, and vegetables allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 11:00 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021 20:00, the subject experienced fever. On 07-MAR-2021 20:00, the subject experienced pain in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and pain in legs. This report was non-serious.
administered improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 4 year old patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 12-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S032355, expiration date 14-OCT-2021, subcutaneous (dose and frequency were not provided), for prophylaxis reconstituted with properly stored sterile diluent.  Temperature/Time frame: 6°F to 14°F (l3.6F) 12 hours (multiple excursions); 15°F to 46°F (16.0F) 30 minutes Previous temperature excursion? no Was call because ofa "data logger''? yes
Hallucinating, pain in lower right back, buttocks, and legs; massage by daughter at bedside.
Initial report received from a health care professional on 06 April 2011. A 40-year-old female patient received on 22 March 2011 at right deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number C3661 and sanofi pasteur Inc. lot number U3554CA. The patient has no medical history and no concomitant medications. The patient had no illness at the time of vaccination. On 23 March 2011, the patient developed peeling and red lips "like when a child is licking his lips and they peel". She had no other complaints. The patient was to see her physician. The outcome was reported as not recovered. Documents held by sender: None.
Instant bruising. Very tired followed by elevated temperature. Very sore arm where shot was given and then later on  6/16/21 my arm swelled became very hot to touch, red and itchy. This lasted for over a week. As of today I feel usually irritable  constantly and very tired. Patient still has general malaise.
On November 11, I became dizzy and my pulse raced very fast. I was transported to the Hospital emergency room by ambulance. Tests done included a head CT, blood work, and urinalysis. The diagnosis was dehydration and a urinary tract infection. Antibiotics were prescribed and taken as directed. I also saw my primary care physician, who determined that the UTI was still present. He added a second antibiotic, which was taken as directed. The UTI was resolved but some episodes of dizziness continued unpredictably. Please see Item 19 for more information.
BREAKTHROUGH COVID: PT who presents with weakness, fatigue, soft stools, SOB and cough for the past several weeks. He states his last usual state of health was almost 1 month ago, but has gotten worse. FIRST DOSE 6/17/21.
Dime size bruise at injection site, muscle was hot to the touch, arm was swollen and blotchy. Pt was instructed to take BENADRYL and apply an ice pack 15 minutes at a time and to see medical attention of symptoms worsen.
Left knee (side of injection site) felt hot. Similar to an MRI contrast. Not hot to the touch, but felt hot "inside". Lasted intermittently that day and the following 5 days. The "hotness moved from my knee to right above the knee. I started wearing compression socks on Saturday. Haven't felt the heat today (May 3, 2021).
pt. vax'd w/ 1st dose of hepatitis B vac. & developed T of 102,muscle aches,headache,& chills.
During the day of the vaccine, experienced 6 hours of a racing heart.  He could feel his heartbeat.  He has not seen his doctor for over a year and did not call them (or the pharmacy).  He has high blood pressure.  He  laid down and slept all night and the next day and was well.  Additionally, he experienced a covid  infection 11/2020 and could hardly breathe and could not sleep.  We discussed the risks and benefits and the patient decided to get the second shot because his employer required it.  He was strongly urged to call his doctor or go to the ER urgent care if he experiences severe symptoms of pounding heart or increased blood pressure. He may need to adjust his meds and could be at risk for a vascular event.
Nausea and dizziness and slight headache started 10 minutes after getting shot T hour after shot still feeling dizzy and nausea: sipping water, resting. Pulse 80 Response 24.
This is a spontaneous report received from a contactable consumer or other non hcp. A 50-years-old female patient received bnt162b2 (COMIRNATY,Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on Mar2021 as DOSE 1, SINGLE for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced later that evening she had shortness of breath (dyspnoea) , after one hour, she had severe dizziness, slept for one hour and when patient woke up she had abdominal cramps that lasted about an hour (abdominal pain) on 26Mar2021.The outcome of the events was recovered.The patient didn't received any other vaccine within 4 weeks after covid vaccine. The patient was not admitted to hospital as the case was not serious.
Chronic muscle aching mid-deltoid, moderate weakness and reduced range of motion in upper arm, dull ache affecting sleep due to pain in upper arm and elbow. Treatment in PT three times a week, beginning Jan 4, 2016 and continuing to date.
Patient has the vaccine and then got dizzy and started to put self on floor, passed out and hit face on the floor. Patient has a red bruise on his forehead and nose. Patient was advise that he should go to ER to get checked out because he passed out and hit his head. Patient refused and went home with girlfriend. They were advised as to what signs to look out for and then if the patient gets these symptoms to take him to the ER to get evaluated
Gave the bivalent booster based on the nurse's instructions at the assisted living. Later found out she had not completed the original series. Based on information on database she only had one dose of moderna
Within 4 hours, fever (up to 101 deg. F) headache, bodyaches, redness and soreness at site. Bodyaches, fever and headache intermittent for 2 1/2 more days following injection.
Information has been received from a county health registered nurse concerning a 6 year old male who on 10-AUG-2004 was vaccinated with varicella virus vaccine live (Oka/Merck). On 26-MAR-2007, the patient developed varicella < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the country health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is on of 28 reports received from the same source. No further information is available.
ADMINISTERED A DOSE OF VACCINE THAT WAS OPENED FOR 18 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced administered a dose of vaccine that was opened for 18 hours. On 29-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered a dose of vaccine that was opened for 18 hours and incorrect product storage was not reported. This report was non-serious.
I am approximately four years post menopausal and had some spotting/bleeding about 2 weeks following my Moderna booster. I have an appointment on 12/15/2021 regarding this most recent bleeding following my booster shot, however I had this same reaction following my 2nd dose of Moderna.  I did not report it at the time as I did not realize the two could be related.  At that time I saw my doctor who performed a hysteroscopy to confirm the cause of bleeding was not due to cancer.
Local reaction Information has been received from a registered nurse concerning a 44 year old female with hypothyroidism and type 2 diabetes mellitus and a history of obesity who in November 2005 was vaccinated subcutaneously with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot #649697/1038P). In November 2005, the patient developed a local reaction after receiving her first dose of pneumococcal 23v polysaccharide vaccine. The patient sought unspecified medical attention. At the time of the report the patient was recovering. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 21 year old female with no pertinent medical history and no known drug allergies who on 21-AUG-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 659054/0311Y). There was no concomitant medication. The nurse reported that the patient experienced an increase in heart rate and collapsed 1 minute after administration of GARDASIL. The patient regained consciousness and her symptoms were resolved on 21-AUG-2009. No lab diagnostics study was performed. The patient sought unspecified medical attention. Additional information has been requested.
Within a few hours the patient developed soreness, erythema, edema and tenderness at the injection site, which was the left deltoid muscle. On the evening of the day of the injection the patient was aware of chills and a feverish feeling.  The temperature has been normal and the feverish feeling/chills resolved in less the 18 hours.  The soreness, tenderness and erythema have improved approx. 75 % at this point (less than 48 hours). Subsequent to the VAERS report filed, utilizing the Web-form, the patient recalled that she had received on influenza immunization at approximately the same site on the same arm, on approximately October 7.She did not state who administered that injection and she was not an established patient at this office at the time. She does not recall having an adverse reactionof any sort after the influenza immunization.
This spontaneous report as received from a physician refers to a 61 year old female patient with Igg deficiency. The patient had no pertinent medical history or drug reactions/allergies. On 13-SEP-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. The physician reported about a case of possible encephalitis after administration of ZOSTAVAX. On 18-SEP-2013, the patient developed diplopia. On 19-SEP-2013, the diplopia worsened and the patient had difficulty swallowing. She was admitted to the Hospital on 19-SEP-2013. She was transferred to the Intensive Care Unit (ICU) on 20-SEP-2013. Two Magnetic resonance imaging (MRI) of the brain have been normal. A provisional diagnosis of Myasthenia Gravis was made and the patient was started on plasma exchange. Since admission to the ICU, the patient has developed a neuropathic occipital headache radiating down her spine. The physician states that at the moment of the report, the patient was undergoing testing for possible encephalitis. Upon internal review Myasthenia Gravis was considered to be medically significant. Reporter considered the events caused significant disability or incapacity, and life threatening. The outcome of myasthenia gravis, neuropathic occipital headache radiating down her spine and plasma exchange was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, body aches, skin sensitivity, headache, chest tightness and burning on inspiration, runny nose, unproductive cough, just felt horrible with all of this for two days fever ran between 99.7 and 100.6.   Symptoms began to resolve and no fever by day three. Every day after continued to improve but joint pain, weakness with a general malaise through Thursday.  It is now the following  Friday and I am still experiencing fatigue and just a general feeling of not being quite 100%.
Numbness feeling on left side of body; sharp pain in jaw; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: En8201), dose 1 via an unspecified route of administration, administered on Arm Left on 25Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, on 25Feb2021, The patient experienced numbness feeling on left side of body, sharp pain in jaw. No treatment was received for the events. The outcome of events was "recovered".
Administration after 11:00.  Was ok until 3 PM and then started feeling tired. Nausea during supper and little food eaten. Continued to feel weak and tired.  Headache by 9:00 and nausea, chills and Temp 100.5.  Went to bed. Could not even sip water. Felt awful. At 2:00 AM woke up to urinate. Still feeling very nauseated. Could not get up and return to bed. My husband heard me in bathroom. Something like breathing difficulty, he found me sitting and he called my name but I did not respond. He put me on the floor and blew into my mouth 2 times. I remember looking up and saying " I just want to go to bed" I felt so nauseated and weak. B/P 117/77. Pulse 88. I was sweating all over, arms, legs. He used cool compresses on them. I slept  and awoke  7/28,  somewhat better overall. No appetite, some nausea and headache. Felt ill until Friday night. Started to eat and drink more.7/29
Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012Y20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away). At the time of the report, URTICARIA (Developed hives after the second dose and has been fighting them for about 4 months now that have not gone away) had not resolved.            Concomitant product use was not provided by the reporter.  The patient developed hives 3 1/2 months ago after the second dose.  Treatment information was not provided.
dizziness; shortness of breath; near fainting; This is a follow up-spontaneous report from a contactable Pharmacist.   A 46-year-old non-Pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: ER8735), via an Intramuscular route of administration on 24Apr2021 at 16:30 pm into Left arm as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Prior the vaccination, patient was not diagnosed with COVID. Post vaccination, Patient was not tested with COVID. Patient had no allergies. On an unknown date Apr2021 at 16:30 pm, the patient experienced dizziness, shortness of breath, near fainting. The patient received lay on floor with feet elevated as a treatment. The outcome of the events was recovered (In Apr2021)   No follow-up attempts are needed. No further information is expected.
About 6 afters after receiving the shot I started to feel body aches, which was followed by chills and then a fever of 102 and headache. I was mostly back to normal by the next morning, with just a minor headache and some fatigue. The next day I was back to normal.
Arm is sire where shot was given. But nothing bad. I have a dry cough, lots if drainage down my throat,  my nose is more stuffed up than before. I feel like I do when I get the onset of a chest cold.
Child sneezed a few times as they were leaving but mother not concerned.  Within 5-10 minutes, he was flushed with hives breaking out on hands, feet and extremities that itched.  Also started with a dry cough and throat tightness.  Mother immediately went to local ER for evaluation and treatment.
Swelling under arm (arm pit) same arm as injection site.  I have not seen my PCP for this issue.