chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 23APR96 & 10JAN97 pt exp itchy chicken pox rash w/more than 50 lesions on face, back, & neck;dx of chickenpox was made during an office visit on 13JAN97;
Information has been received from a certified medical assistant concerning a 60 year old female who on 14-NOV-2007 was vaccinated IM into the right deltoid with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658673/0990U). On 16-NOV-2007 the patient came into the office with hot, painful, large swelling at the injection site and she felt dizzy. It was also reported that the patient was improving. The patient sought medical attention. The physician requested a lot check. A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Mild throat tightness and discomfort beginning within 15 minutes after vaccine and lasting at least a week. Rash covering torso, arms, and legs the day after and lasting two days. Lip tingling beginning an hour after vaccine and lasting two days.  The day after vaccine, visited immediate care center and emergency room. They prescribed Benadryl. No change when taking benadryl. Throat discomfort persisted so saw doctor at employee health center a few days later. They prescribed Montelukast which provided some relief from throat discomfort and tightness. Throat still not back to normal.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: About 2-3 minutes after administration of flu vaccine and tubersol patient reported not feeling well.  Was laying down as has had history in past of vagal response with vaccination.  First BP was 74/50 with HR of 51.  Patient pale, no loss of consciousness.  Checked again with patient laying flat after drank some water and BP increased to 92/50 with HR of 56 a few minutes later was 110/70 laying flat.  Took about  10-15 minutes to recover.  BP at discharge was 109/92 HR 63
Patient returned to pharmacy 10/5/15 with large baseball sized contusion at site of injection with second bruise the size of golf ball 3" distal. Complained of severe pain immediately upon injection. Received medical care and antibiotic from ARNP on 10/4/15.
This spontaneous report as received from a registered nurse refers to a 45 year old male patient with diabetes. The patient's medical history included cellulitis. There were no other drug reactions/allergies. On 10-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (lot# reported as J015860), 0.5 ml, intramuscular in the left arm. Concomitant therapies included FLUZONE and insulin. It was reported that the patient developed a fever, redness, swelling, and warmth of the left arm on 11-OCT-2014. The patient was evaluated at an unspecified urgent care facility on 13-OCT-2014. He was diagnosed with cellulitis and was prescribed LEVOQUIN. The outcome of cellulitis was reported as not recovered/not resolved. The patient sought medical attention by urgent care facility. Additional information has been requested.
She has had reactions to other vaccines, such as the Pneumococcal vaccine.; This spontaneous report was received from a 74 year old female patient with bronchiectasis and atypical mycobacterial infection.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.    On an unknown date, the patient experienced vaccine reaction (vaccination complication).  At the time of the report, the outcome of vaccination complication was unknown.        The patient did not mention the causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)vacciantion.; Sender's Comments:  US-009507513-2106USA003286:
This case was reported by a consumer and described the occurrence of swelling injection site in a 45-year-old female subject who was inadvertently vaccinated with Boostrix for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject had no adverse events following receipt of prior immunizations. Concurrent medications included Fosamax. On 23 August 2006 at 5:00 p.m., the subject inadvertently received unspecified dose of Boostrix in the left arm rather than the intended administration of "meningitis immunization." Boostrix is recommended for immunizing individuals 110 through 18 years of age. On 23 August 2006 the subject also received hepatitis B vaccine. On 24 August 2006, 1 day after vaccination with Boostrix, the subject experienced swelling injection site and bruise injection site. On 26 August 2006, 3 days after vaccination with Boostrix, the subject experienced diarrhea. The subject was seen at a physician's office. The swelling and bruising at the injection site resolved on 28 August 2006. The subject reported that she, "had to have a colonoscopy to see why (she) was feeling so badly.". The diarrhea resolved on 26 October 2006.
Pt recvd Engerix-B vax 14OCT91 but did not seroconvert p/5th dose; SGOT was elevated & white blood count was low; dx fatty liver; liver function tests (LFTS) remain elevated;
Patient came in 10-16-13 she said she had a rash in a different spots arms and legs with a blister in the center she said red and itchy. She was seeing her PCP the next day. PCP said it was from Flu shot. Pt called me on 10/17/13 to let me know this.
Tiredness; Muscle pain/muscles are so sore from her neck to her feet; Joint pain; Feeling unwell/not feeling well; doesn't have any energy; she has been down; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, muscle pain, joint pain, feeling unwell, doesn't have any energy and she has been down. Course of events: The patient had the first dose of the Pfizer Covid 19 vaccine. The patient was feeling tired and has gone downhill, she usually walks and goes to the gym and then she started not feeling well, she just doesn't have any energy. The caller has been going downhill a little bit each day, her muscles are so sore from her neck to her feet. The patient has been unable to do anything, it has been brewing since she had the shot. When the caller woke up this morning every muscle in her body is killing her. The patient wanted to know how does she get some kind of relief? The patient was looking at the side effects of the vaccine and checked off tiredness, muscle pain, joint pain, feeling unwell. Feeling unwell and tiredness started first, the caller can't go to the gym and it's not like her to say she can't do something. She knows that why she has been down is because of the shot because it is all new. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Pt here after dizziness and palpitations with flushing.  Symptoms occurred immediately after receiving her 2nd dose of the Moderna COVID vaccine .  Patient's symptoms were persisting and was brought to Ed for evaluation
10APR95 tc from mom stated pt devel rash on back, stomach & back of neck, irritable; adv to consult PMD; 11APR95 appt w/MD whose ofc reports morbilliform exanthum (measles like rash); dx as MMR react; adv APAP & DPH;rash flat & patchy;
Hypotension tachycardia numb arms and hands loss of function of arm and hand TIA severe cold and shaking rigors extreme muscle aches resulting in being bedridden for 24 hours color of hands change to white with painful cold confusion and inability to focus or concentrate lethargic and inability to move
DIZZINESS, PALE, DIAPHORETIC, BLURRED VISION, LAUGHING AND CRYING AT SAME TIME. ICE PACK APPLIED AND PT WAS FEELING FINE AFTER SOMETIME.
Approximately 1 hour post vaccination tingling in mouth / throat, isolated mainly to tongue. used antihistamine and subsided over the next hour. No further reaction or concern after that. 3 days post vaccination multiple blood spots under skin on right arm. No pain, darkened over day 1 and as of today they have mostly subsided. Will continue to monitor the site and rest of body for re-occurrence or new events
swelling at the injection site; pain, tenderness /at the injection site / ongoing and low level of pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site swelling and injection site tenderness. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the injection site tenderness was recovering/resolving.   It was unknown if the reporter considered the injection site swelling and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the upper, left arm and experienced pain, tenderness and swelling at injection site. The patient reported the tenderness and swelling have subsided. Informed Pain intensity had decreased and low level pain at injection site. Reporter consented to follow up.
The following day of the 1st vaccine, I noticed feeling shortness of breath, chest discomfort and feeling emotional, feeling like something is wrong/feelings of doom. I felt that way all that day on 8/24/21 & 8/25/21. On 8/26/21 it started to ease a little in the afternoon and by day 8/27/21, I felt better and shortness of breath was pretty much gone. I didn't realize that this may be an adverse side effect until my daughter (who works for a hospital) told me to get a hold of my doctor and let her know. I found the paperwork and read the normal possible side effects and more serious symptoms. I was a week away from getting my 2nd vaccine so I called my physician. She advised me that the shortness of breath was an adverse event and recommended that I don't get the 2nd vaccine and to report it to CDC. I did use my Albuterol during the time I had shortness of breath and chest discomfort. I was going to go to the ER or call my physician if I felt worse but I started feeling better by 4th day. I usually try to ride thru things and not go to the ER or doctor unless it's serious. I didn't realize what I was experiencing was not part of "normal" side effects.
Patient developed acute new neuropathic pain and then a few days later weakness.  Hospitalized with dx made of Guillan Barre Syndrome (GBS) after exclusion of other causes and based on abnormal lumbar puncture.  Protracted course in hospital and rehab.
Class 3 severe obesity with body mass index (BMI) of 45.0 to 49.9 in adult (CMS/HCC)  Fibroid uterus  Blood type, Rh positive  Tetrahydrocannabinol (THC) use disorder, mild, abuse  Rubella immune  SVD (spontaneous vaginal delivery)  High risk HPV infection  Obesity affecting pregnancy in second trimester   Please see the prenatal record and admission history and physical for details.   Labor Analgesics: Epidural     OB Complications:  Pre-eclampsia    Cervical Ripening Type: Misoprostol  Cervical Ripening Comment:      Induction: AROM;Cervical Ripening   Induction Indications: Chronic Hypertension    Augmentation: Oxytocin    Delivery Date: 1/17/2022  Delivery Time: 7:53 AM  Gestational Age(weeks days/7): 39 2/7      Method of Delivery: Vaginal, Spontaneous     Birth Weight: 3.098 kg (6 lb 13.3 oz)   Sex: male   Apgar Score (1 min): 9   Apgar Score (5 min): 9     Laceration  Episiotomy: None   Laceration Type: 2nd   Perineal Laceration:      Quantified Blood Loss (ml):    Est Blood Loss      For further details of the delivery see the delivery summary.    Her post partum course was complicated by:  None     Patient with uncomplicated post-partum recovery.  On the day of discharge pain was well controlled with oral pain meds, she was ambulating and voiding without difficulty, and was tolerating diet without nausea/vomiting.  Patient was requesting discharge home.  Following complete examination and review of recovery course, patient was deemed stable for discharge. Patient will need a blood pressure check in 3 days.     Procedures performed: SVD with repair of second degree and right periurethral    Discharge       All Hospital Problems (Other diagnoses): Active Hospital Problems   Diagnosis ? Principal Problem: SVD (spontaneous vaginal delivery) [O80] ? Chronic hypertension with superimposed pre-eclampsia [O11.9] ? Rubella immune [Z78.9] ? Class 3 severe obesity with body mass index (BMI) of 45.0 to 49.9 in adult (CMS/HCC) [E66.01, Z68.42] ? Blood type, Rh positive [Z67.90] ? Fibroid uterus [D25.9]   Resolved Hospital Problems No resolved problems to display.
This case was reported by a lawyer and described the occurrence of peripheral neuropathy in a 51 year old male patinent who receieved LYME disease vaccine for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receieving LYMErix, the patient experience "rheumatologic and neurologic complaints including peripheral neuropathy" Time to onset, treatment and outcome were not reported.
Passed out; Foggy; Dull headache; Achy; Very tired; Nausea; A spontaneous report was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced foggy, passed out, dull headache, achy, very tired, nausea.   The patient's medical history was not provided. Concomitant medications reported included insulin, pravastatin, enalapril maleate.  On an unspecified date, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route  and site for prophylaxis of COVID-19 infection. On 11 Mar 2021, approximately 7 hours prior to the event, the patient received her second dose of mRNA-1273 (Lot number: unknown) intramuscular in right arm deltoid for prophylaxis of COVID-19 infection  On 11 Mar 2021, the patient experienced foggy, passed out, dull headache, achy, very tired, nausea. . Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events is not applicable.   The events, dull headache, achy, foggy, passed out, very tired, nausea were considered recovered after week and half.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever, nausea, dizziness, body ache headache, stomachache.  Lasted 24-36 hours
Myalgia, Fever, CoughWheeze, Syncope, Fever, pain, chills at nighttime , extreme fatigue , dry cough. body aches Narrative:
Pt. arrived at the clinic for final dose of Hep B.  Preparation and administration of vaccine was normal.  Few hours after administration, pt. voiced concerns about rash at the site of administration.  Pt. had a follow up appointment with provider.
Information has been received from a physician concerning a 20 year old female with no known allergies who on 09-JAN-2008 was vaccinated with Gardasil. There was no concomitant medication. On 09-JAN-2008, 10 minutes after receiving her first dose of the vaccine, the patient experienced anaphylactic reaction. She had a burning feeling in her stomach and head, her tongue started to swell, and she had difficulty breathing. The patient sought unspecified medical attention. The outcome of the patient was not provided. Additional information has been requested.
A couple days after the vaccine I was working and developed a fever and chills which lasted about 2 days and went away on its own. During that time I had real bad fatigued just wanting to sleep. Since the vaccine my body has had trouble fighting off infections and now when I shave my legs I get bumps that turns into ingrown hairs and get really infected and turns into staph infections. I have been on antibiotics 3 different times now for the same issue. I have had 2 sinus infections since the vaccine that clears up with antibiotics but comes right back after the antibiotics are done. 2 toe nails have randomly developed ingrown nails and now the nail on my left big toe has an infection from the ingrown nail that has to be surgically removed.
This spontaneous report received from a patient concerned a 41 year old male.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: 1808780 expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-JAN-2022, the patient experienced sore throat, cough, runny nose, and body aches. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from sore throat, cough, runny nose, and body aches.This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), in Sep2020 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: The patient did not receive any other medications in two weeks. The patient received treatment with Paxlovid from 17Jul2022 to 21Jul2022 for COVID-19. COVID rebound after negative test result the days after completing 5 day course of Paxlovid. positive test came on day 4 after completion of 5 day course of Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 02 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Rash is diffuse in location, reddish and fine papular, no skin thickening, induration or subcutaneous nodules , noted after the vaccines were given.
1300 vaccine received 1310 pt reported feeling dizzy. VS 97.6, BP 134/83, HR 68 O2 99% room air. 1315- persistent dizziness, first responder called and patient transferred to bed. 1318: VS O2 100% room air, HR 85, BP 165/89, temp 97.1 1319: First responder team arrived. Patient denied needing to be seen in the ED. 1320-1330 patient continued to lay supine. At 1330, patient was able to sit and dangle with no dizziness. Shortly after, patient ambulated and felt fine. Patient discharged from clinic and told to report to Employee Health or ED if symptoms return, or new symptoms occur.
103 degrees Temperature on Saturday, 99 degrees on Monday redness in the left arm; left arm pain; treatment: Tylenol, Benadryl, and Claritin PRN
This spontaneous report was received from a physician via company representative refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. On an unknown date, the patient reported that the arm "really swelled up". The physician sent the patient to an allergist after the swelling that was experienced. Treatment information was not reported. The outcome of the event was unknown. Additional information has been requested.
I miss read vaccine records and thought she had not had her Meningococcal. Age of patient at time of event: 11 years 4 months. Type of Event: Wrong timing/interval.
When our facility received the Covid - 19 vaccine, I spoke at Dept of Health and was told that the exp. date for the vaccine was 9 months from the mfg. date on the box. Which made the exp. date 5/31/22. On 5/20/22 the Dept of Health Contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 4/29/22. Thus, we unknowingly gave exp vaccine to patient.   Patient tolerated vaccine well, no adverse effects have been reported.
Patient received the original Moderna shot for her 5th dose instead of the indicated Moderna bivalent dose. No adverse event reported.
Patient had sudden onset of tachycardia - heart rate 120s - 140s. Felt lightheaded.
3 hours after injection my right thumb started involuntary movements, which I never ever had before in my life. Went to doctor. Tested my electrolytes, magnesium good, vitamin D 46 but my nitrates were not supposed to be over 19 and were 24. Never ever had that on my test that high, probably due to the shot.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-JUN-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster.  On or about 25-MAY-2016, the patient was treated by a Registered Nurse and diagnosed with herpes zoster, or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.