chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days post PNEUMOVAZ 23 entire top of arm is red, swollen, hot, sore. Decrease function of arm/hand (left). Complaining of chest pain on and off since vaccination. I recommend pt go to ER.
It began with being light-headed and difficulty walking on March 25th. On April 14 I had my first "seizure like" event as I was going to teach school. I had Upper arm tremors and difficulty speaking and walking. Sent by ambulance to the emergency room. Released later that day and given meds for UTI which was later deemed a misdiagnosis by Dr.  Didn't go to work as I continued to  have difficulty walking and had headaches and overall weakness. Saw Dr. on April 20th.  Had to use wheelchair to attend the office visit and was given blood tests to see what was causing my condition. Had high blood pressure.  She also advised me to see a neurologist and heart doctor. ON April 20th had to go back to ER as I had the smae seizure like event!On April 22nd I visited Dr. office (heart doctor). Blood pressure was off on this day as well and I stayed at clinic until it was better. Was given a heart monitor to wear for 24 hours. Heart was fine after wearing the monitor. Visited Neurologist and was given EEG and CT CTA tests. All came back fine.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 12-JUN-2013, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Severe pain and swelling at the site.  Chills and fever.  Diarhea. Fatigue for two days after the injection.
Difficulty breathing, HA, feels like throat is constricting, took 2 puffs of her albuterol, no resolution, took another 2 puffs, feels better. Evaluated by EMS-refused transport.
Pt received vax on 04/24/2000. He came to the office on 05/01/2000 with about 300 lesions.
Patient developed a fever starting at 7pm that went up to 101.3 degrees F at 9pm. She also experienced a slight headache the following day.
Painful, golf ball size swollen right axillary lymph node; Painful, golf ball size swollen right axillary lymph node; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), intramuscular on 21Jan2021 - 02:00 pm at a single dose on the right arm for COVID-19 immunization. The vaccine was administered at a hospital. She did not receive other vaccines in four weeks prior to receiving bnt162b2. It was unknown if patient had covid prior to vaccination. Medical history included known allergies: latex and other chronic allergies. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), naproxen (NAPROXEN), colecalciferol (VITAMIN D), and melatonin (MELATONIN). The patient previously received the first dose of bnt162b2 (BNT162B2), intramuscular on 30Dec2020 - 11:00 pm at a single dose on the left arm for COVID-19 immunization (age at the time of vaccination: 38-year-old). On 23Jan2021 10:00 pm, the patient had a painful, golf ball size swollen right axillary lymph node. The patient was not tested for covid post vaccination. No treatment was received in response to the events. Outcome of the events was recovering.   Information about Lot/Batch number is requested.
Received covid 19 booster shot Moderna and then seconds later Flu vaccine(quad preserve free)  Within seconds felt faint, dizzy and then layed back. Nurse called for help. Patient found in what appears to be in tonic clonic seizure state, with muscle contractions and LOC. Around 30 seconds to a minutes she regained consciousness and was able to converse again with staff. She remembers the events prior to the vaccines. She does show signs of biting her tongue on the left side. Vitally stable after event. No vomiting.    Denies any history of seizures or family history of seizures. No prior reactions to past vaccines, has received two moderna vaccines and flu vaccine in the past
dose given after manufacturer expiration date of 09/30, but manufacturer stability data supports stability  of product through 10/19
Neasous and vomiting and fever lasted 5 hours  tylenol and zofran helped with symptoms
Patient received vaccine and began to feel lightheaded upon leaving vaccination room. Patient slowly started to sit down on the ground while mother was holding him up. Patient was then assisted to lay down in vaccination room and had vitals monitored while receiving oral liquids (water/juice). Initial blood pressure was 88/58 and heart rate 57. Approximately after 15 minutes of observation patient reported feeling normal with blood pressure of 108/67 and heart rate of 80.
just the adjuvant portion; received just the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment:  Office reported that a patient received just the adjuvant portion of Shingrix. The vaccine administration facility was the same as primary reporter. HCP could not read lot number for the Shingrix. Consented to follow up via email. Additional supportive information: As patient received only the adjuvant portion of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Massive, severe gout attack (greater than any previously experienced) that lasted for over two months.
My arm has been aching since the 1st one. I let the RN giving me the 2nd shot aware and he said that?s weird.  I just happened to have the same person injecting both times. Never reported or had me speak with anyone at that time. He said I could get it in the left, but I denied due to I didn?t want the pain in both arms. When he gave me the 2nd shot I felt it so much more than the first shot that I blurted out that hurts and a felt a twinge in my arm, as if it hit something other than the muscle. My arm 2 mos later is not let up the pain. I can only raise it so high. I cannot sleep on either side w/o pain. Same days are worse than others. The pain is right at the injection site. This is the only thing I have had done to my arm so I know it has something to do with the vaccine. I alternate ice and heat along with ibuprofen and it does not touch the pain/aches. It is a constant ache in my arm. I did contact my employee health at work and she advised me to fill out report on this website and in the Hospital safety report.
Vaccine at 10:45 am.  At 2 am patient awoke with severe chest, left arm, back of the head, neck, stomach and shoulder pain and was breathing heavily, in a panic attack.  Said he feared he was having a heart attack.  I gave him an extra strength tylenol, rubbed his neck, back of head, shoulders and suggested he was having a vaccine reaction.  After about an hour, he fell asleep. He awoke around 8:30 am with a slight headache but otherwise feeling fine.
had post menopausal bleeding for a few days after first booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization.  The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 21Jun2022, outcome "unknown", described as "had post menopausal bleeding for a few days after first booster".  Clinical course: I had post menopausal bleeding for a few days after first booster. I'm worried about getting second booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received the varicella vaccine on 10/31/06.  She was seen on 7/10/08 for chicken pox.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received the 1st dose of SHINGRIX. On 9th August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site lump and injection site pain. On 11th August 2018, the patient experienced nausea and fever. On 12th August 2018, the outcome of the nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, nausea, fever, injection site lump and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The following day after vaccination, the patient experienced soreness, redness and swelling in the form of a big lump on the injections site. Those symptoms were resolved after 3 days. On Saturday, the patient felt slightly nauseous and feverish. Those symptoms were resolved after 24 hours. The reporter had given consent for follow up. The patient's girlfriend also experienced all of the same symptoms but less severe (refer case US2018GSK212697).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date in November 2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot number and route not provided) and the patient received a possible second dose of PNEUMOVAX 23 (0.5ml, lot number unknown, intramuscularly) on 15-SEP-2014. No adverse effect reported. There was no product quality issue involved. Additional information has been requested.
The day of I was ok. The next morning I woke up on the bathroom floor unconscious. I fell and hit my head bruising my face and a minor cut. I've been experiencing lost of memory.
Erythema, cellulitis the next day requiring emergency room visit, intramuscular antibiotics followed by oral antibiotics.
Woke with a migraine, dizziness, and slight nausea. I took Excedrin which usually takes care of my migraines. It knocked it back to pressure and a slight headache, but did not get rid of it entirely. I continued to be sensitive to light all day. When the pain increased that afternoon/ early evening i took another dose of Excedrin.  This continued for the next two days, the second of which I added musinex and an antihistamine in the morning because it felt like it could be sinus pressure.  These did not help and seemed to make the dizziness and nausea worse. I woke up on day 3 with a migraine and ear pain the next day and was still sensitive to light, which continued all day. I woke up on day 4 with a headache and ear pain to the point that I thought I might have an ear infection.  This time I did not take any medication. I woke up on day 5 with a headache but no other issues.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Approximately on an unknown date in May 2013 (reported as throughout May and June), an unspecified number of patients were vaccinated with an unspecified number of unsupported doses of GARDASIL (lot number and expiry date reported as H020910 and 18-JUN-2015 respectively, dose and route unspecified) which was exposed to as low as minus 1 degress Celsius (C) for approximately 13 hours. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
After a week, I started to feel itching and swelling in the arm where the vaccine was applied.
18 days post injection I had severe pain in right shoulder and under scapular. pain level 9. This continued for a few days. Made appointment with my MD. Day 4 of pain a large painful rash appeared on my R upper back, under the arm and upper chest. ( Quite sure it was shingles. Started on Famciclovir  500mg. and tramadol 50mg. Had severe case of shingles with fatigue and excruiciating pain.  My MD stated he has seen a number of patients post vaccine with shingles.  Was scheduled for second vaccine on February 16th. The pharmacist at the vaccine center would not approve booster, stating my immune system is already stressed. My primary also recommeded no booster at this time.
Pt came on Saturday explaining that she developed rash on face, right arm, back, and leg on Friday evening after administration. She also experienced heart palpitations. I advised her to take Benadryl and to see a doctor if symptoms worsen.
Severe pain in the joint area and at the back of the left arm along with trouble breathing approx. 15 hours after receiving the vaccine .
severe nausea; vomiting; pain around the injection site; stinging sensation; dizzy; fatigued; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 13:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included generalised anxiety disorder, smoker (Vaping), overweight, COVID-19 and shellfish allergy. Concomitant medications included escitalopram oxalate (LEXAPRO), and oral contraceptive nos (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was 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 12Apr2021 at 10:00, the patient experienced several unpleasant side effects, most of which were said to be normal. The worst symptom was very severe nausea, as well as vomiting. Also experienced quite a bit of pain around the injection site with a sort of stinging sensation, dizzy and fatigued. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very severe nausea, vomiting, pain around the injection site with a sort of stinging sensation, dizzy and fatigued was not recovered.  No follow-up attempts are needed. No further information is expected.
Shaking chills, fever, sore throat, headache. All symptoms relieved by ibuprofen.
Information has been received from a registered nurse concerning a 12 months old female with diarrhoea and with no adverse events following prior vaccination who on 24-SEP-2010 was vaccinated SC in right thigh with the first dose of VARIVAX (Merck) (lot# 662575/0045Y). On the same day, the patient concomitantly was vaccinated with the first dose of MMR II (MSD) (lot#665976/0155Z, SC in left thigh), the first dose of VAQTA (lot# 667859/0569Z, IM in left thigh) (MSD) and the first dose of FLUZONE (lot# UT3562BA, IM in right thigh). On 02-OCT-2010, the patient experienced rash status post vaccines within 11 days on chest, back and legs, blanching 3 mm red macules and papules, not vesicular. There were approximately 50 lesions. The outcome of the patient was not reported. Additional information has been requested.
Patient is 17 years of age and vaccine inadvertently administered. The error was noted on entry of the vaccination later at the clinic. Follow up on 4/1/21 with the father reports that although did not feel well in the AM of 3/31/21, is not having any complaints at this time.
Eyes burning; Extreme sensitivity to light; Eyes hurt; Extreme shivering; Body burning in various areas; Flu like symptoms; This is a spontaneous report received from a contactable consumer. A 66 years old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID 19 MRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration, administered left arm, on 17Mar2021(at age of 66 years old) at 10:30 as a single dose for COVID 19 immunisation. The patient was allergic to drugs nitrofurantoin, pseudoephedrine and iodine and had high blood pressure. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 MRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration on unknown anatomical location, on 24Feb2021 at 10:15am (at age of 66 years old) as a single dose for COVID 19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient concomitant medications included Atenolol (MANUFACTURER UNKNOWN), KLONOPIN and Loratidine (MANUFACTURER UNKNOWN) from unknown dates for unknown indication. On 17Mar2021 at 12:00, the patient experienced eyes burning, extreme sensitivity to light, eyes hurt (cant turn them without pain), headache, extreme shivering for two hours or so, about 12 hours after vaccine, body burning in various areas (not all area) flu like symptoms and eyes were still hurting at the time of report. The clinical outcome of the event eyes burning, photosensitivity, eyes pain, headache, chills, extreme feeling hot of and influenza like symptoms was not recovered. No follow up attempts are possible; information about lot number cannot be obtained.
On June 3, 2021 tingling began in right buttocks. Within two hours tingling increased and began spreading up to right hip area and down right leg to right foot. Began having issues walking with a normal gait and right foot started to drag. Symptoms increasingly progressed within 6 hours and had to use a wall to brace walking in building. Outside walking gait was abnormal and struggled to move right leg and right foot. Went to clinic and was sent to get x-rays. Within 12 hours of onset of symptoms, began using crutches to get around.  Called clinic on June 4, June 5, June 7, and June 8, 2021 and clinic received x-rays but had not viewed x-rays yet. Went to the emergency room with assistance from co-worker as symptoms were still present and not improving. Over that weekend loss of bladder control started, and had not had a bowel movement since June 5, 2021. Was admitted to the hospital, received CT Scan of Head, T-Spine, and L-Spine on June 8, 2021. MRI done on June 8, 2021. Lumbar puncture attempted bedside on June 9, 2021 with no success. Sent to get Lumbar puncture done on June 10, 2021. Was given medication on June 10, to assist with bowel movement; no bowel movement since June 5, 2021. Loss of bladder control continued. Was given Steroids to assist with improving ability to walk starting on June 10, 2021. Was discharged on June 13, 2021 with plan to have in-home physical therapy. Began outpatient physical therapy at the hospital by the end of June 2021. Continued monitoring with MRI scans and Neurology.
pt recvd vax 13JUN95 & 23JUN95 pt devel low grade fever to 101.5 & 30 to 40 lesions of the face & trunk;MD noted that the lesions resembled papules, not vesicles;condition resolved by 26JUN95
Information has been received from a registered nurse concerning a 6 year old male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647634/0863N). Subsequently, the patient experienced cellulitis and was hospitalized. The patient was treated with an IV antibiotic and reportedly recovered. No product quality complaint was involved. The RN considered cellulitis to be an other important medical event (OMIC). Additional information is not expected.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 15 years old female patient without drug reaction. The patient's medical history included allergic conjunctivitis of the left eye (date of allergic conjunctivitis unspecified). The patient's history of previous pregnancies and live births was unknown. The patient was vaccinated the first, second and third dose of GARDASIL (lot number 665547/1318Y, 662518/0087Y, 672547/1745AA) on 08-MAY-2010, 06-NOV-2010 and 16-JUN-2012, respectively. No other co-suspects were reported. Concomitant medications included WESTCORT-CREAM, MOTRIN, PATANOL and ondansetron. Subsequently, the patient became pregnant. The nurse was not sure about the gestation or LMP, but provided that the expected delivery date was 07-NOV-2012. Initial exposure to GARDASIL was at 14 week(s). The patient was exposed to GARDASIL during trimester 2. Prenatal vitamins with iron were given as treatment. Urine pregnancy test was performed on 05-JUL-2012. The patient contacted office for seek medical attention. Additional information has been requested.
Subsequent to receiving varicella virus vaccine live, pt developed clinical varicella. Additional information has been requested.
This spontaneous report was received from a registered medical assistant refers to a 13 month old female patient. The patient's concurrent condition included dacryostenosis congenital, otitis media, viral upper respiratory tract infection. The patient had no medical history and no known drug allergies. The patient's concomitant medications included PEDVAXHIB and oral probiotics. On 05-MAR-2018, the patient was vaccinated with 3rd dose of RECOMBIVAX HB (dose, units and frequency not reported) (lot # M029233 and expiration date: 09-AUG-2018) which was improperly stored. On 13-OCT-2017, RECOMBIVAX HB had temperature excursion due to power outage. Alert has been sent and all vaccines transported to hospital for continued storage and returned after temperatures were verified to be in range. The administered dose of RECOMBIVAX HB was stored at a temperature from 9 degree Celsius (9 C) to 25 C (also reported as 10.7 C) for 1 hour 8 minutes as recorded by digital data logger. The administered RECOMBIVAX HB had previous temperature excursion from 9 C to 25 C for 2 hours and 17 minutes. No product quality complaint and no adverse effects reported.
D/T given 05/09/2003 with fruit size redness and swelling about 3-4 inches lasting less than 1 week. With still residential lump about size of pea on arm. She did not come in immediately.
Donor stated she had no peripheral vision in left eye, she is nauseous and dizzy. Left arm slightly swollen and sore to the touch. 09-05-08; Donor stated no treatment was necessary. 09/05/08