chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 4 year old male at 41 pounds weight and 41.5 inches with no medical history or drugs allergies, who on 08-FEB-2006 was vaccinated in the left with a first dose of VARIVAX (Merck) (646539/0551R).  The same day the patient was vaccinated in the right with a dose of MMR II (lot # 649805/0465R, HSA) and in the left with a dose of DTAP (manufacturer unspecified).  The patient received a second dose of VARIVAX (Merck) (lot # 659433/1919U) on 13-OCT-2008.  Concomitant therapy included montelukast sodium (MSD).  The patient developed chickenpox.  The symptoms presented as a "rash all over" on 24-JUL-2009.  The patient was seen in the office on 28-JUL-2009.  The patient was advised to use oatmeal bath, CALAMINE lotion), BENADRYL and not to attend school.  No laboratories studies performed.  On 18-AUG-2009 the patient was completely recovered at the check up.  Follow up information was received from the nurse stated that the patient did not return for follow up in one week as recommended but did come in 08-AUG-2009 fully recovered (previously reported as 18-AUG-2009).  This is the third of four cases for this reporter.  No further information is available.
Reaction following Dtap-Fever 102F, Nausea, Chills, Malaise, Joint Aches, Dizziness, Headache, Fatigue. Treated with APAP 325mg q 6 hours for 24 hours.
Injection site became increasing more tender and red. By afternoon injection site had doubled in size and very painful to touch. Began running fever pm 1/16/2015, and over next day pain in entire upper arm with site now quadrupled in size. Went to ER and was admitted with cellulitis of L arm. Was admitted to the hospital with IVs and put on 3 different IV antibiotics, and the cellulitis grew to cover the entire upper left arm and about 4 inches past the elbow. Continued running fever and arm very painful for entire 6 days in hospital even though was on the 3 IV antibiotics. Discharged on 7th day and was put on oral antibiotic for 3 more weeks.
This happened with my first shot and my booster shot (but not my second shot): When I woke up the morning after my injection and got out of bed, I immediately became nauseas, lightheaded, short of breath and started sweating profusely.  The first time I fainted (only time I have fainted in my life). I did not faint with the booster, but thought I was going to and my husband helped me stay upright. After about 10 minutes, the symptoms subsided.  Immediately after the most recent episode (the booster), my husband took my blood pressure and the reading was 103/50. My normal blood pressure is 115/75. About 10 minutes after the first reading, my blood pressure readings were normal.  I am otherwise very healthy and active. I believe the vaccine causes me to experience an extreme drop in blood pressure the following morning.  I thought the first time was a fluke; after the booster I know it was not.
Pregnant patient, unknown EDD, inadvertently give Pfizer COVID Bivalent Booster for her second dose of Primary series. No Adverse reactions noted
GUILLAIN-BARRE SYNDROME; This spontaneous report received from a health care professional via social media via company representative concerned a male patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the subject experienced Guillain-Barre syndrome. The reporter had a patient last week who now had this syndrome four weeks after taking the vaccine and can barely walk or 'hold in anything" This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This spontaneous report received via social media post concerns a male patient of unspecified age and ethnicity who had Guillain-Barre syndrome 4 weeks after receiving the Janssen Covid-19 vaccine.  The patient was reported as "can barely walk" or hold in anything".  No other pertinent details reported.  The information available precludes a complete and meaningful assessment.  Based on the information available, and the occurrence of GBS could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.
On the morning of 01/10/22 the patient experienced rapid heart rate, mild chest pain, and mild shortness of breath, in addition to a sore arm, fatigue, and mild headaches. On 01/11/22 the patient still had chest tightness, but all other symptoms had subsided. The chest tightness lasted through 01/13/22, with the patient experiencing no further side effects on or after 01/14/22. No treatment was administered and patient appears normal, but no tests have been performed to determine any long-term effects.
Within minutes of giving vaccines, patient became pale, diaphoretic and c/o being "UNM". Noted patient to be close to fainting. Cool cloth applied, use of ammonia inhalant used. States she ate before coming. Mother present. Water given to patient. Mother reports pt. has history of fainting and Dr is aware. No further issues.
A nurse reported the occurrence of an injection site reaction in a 5 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 2/26/03, the subject received his fifth injection of Infanrix (lot DTPA567A2). On that date, he also received injections of inactivated poliomyelitis virus vaccine and MMR vaccine. Later that day, he developed an injection site reaction at the site of Infanrix administration. On 2/27/03, the subject presented to the physician, who observed an 11cm by 14cm area of redness and warmth. On 2/28 03, the affected area measured 20cm by 16cm. The reporting nurse considered the injection site reaction to be related to Infanrix administration. The injection site reaction resolved after an unspecified period of time.
Patient received Meningococcal vaccine on 6/2/23. Mom states that patient has had headache and still next x3days (since 6/11/23). She reached out to her pediatrician, who stated that the discomfort may be from an ear infection. As of 6/14/23, the symptoms are continuing and mom fears the vaccine is the problem. Mother has been advised to reach back out to her pediatrician for further evaluation of her son.
pt. phoned to clinic, reporting rt. upper arm red and swollen, fever to touch. and bruising to site, Taking motrin and tylenol
Patient felt poorly for the two days following the vaccine.  Severe abdominal pain developed by about day #3 after first dose of the vaccine.
1) Sore arm at injection site 2) My period was due April 15, 2021 (the date of first vaccination dose), but ended up being delayed until April 23, 2021.  My cycle is very regular normally. Visited my OBGYN doctor on April 23, 2021 and received pelvic exam (normal), pregnancy test (negative), and TSH check (normal).  3) Rheumatoid arthritis symptoms returned temporarily after being in remission since 2016. Contacted my primary care doctor about it and he advised I should wait to get the second dose.
mild fever, chills - 12-24 hours after shot, lasting 24 hours hard, sore, swollen arm - 2 hours after shot. lasting 4 days patchy rash on chest - 12-24 hours after shot. 14 days and still active
Intital report received from a patient in the USA on 04 January 2007. A 35 year old, female patient experienced fatigue, nausea and couldn't lift her arm 4 days after she received Decavac (lot number U1786DA, route of administration not reported) in the left deltoid on 14 December 2006. She had a haematoma at the site of injection. She called the doctor and was told to use an ice pack and heat alternately and use an antiinflamatory. In the morning (AM) and night, she can't lift her left arm - it is sore. At the time of the report, she had not recovered. She did not have any illness at the time of injection. Her last Decavac injection was in 1995.
Bloody nose (nasal mist vaccine was used); occurred during school day around mid-morning.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 16-year-old male patient who received BEXSERO (batch number 165401A, expiry date 31st March 2018). Concomitant products included ibuprofen, ZYRTEC and MENACTRA. On 10th March 2016, the patient receive BEXSERO (intramuscular). On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unchanged. The reporter considered the pain in arm to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on left deltoid and MENACTRA on right deltoid. After receiving BEXSERO, the patient experienced pain in left arm which was lasted for 3 weeks. The patient required emergency room visit.
chills, fever, throwing up, joint pain, teeth pain, head ache, extreme fatigue, night sweats, duration- 6 days- still fatigued 14 days later
Patient described missing work due to being ill several days after vaccines given, then developing a knot in the arm where administered. The knot did not resolve, and required an ultrasound at a hospital.
raised red rash-on abd & back w/hives responding to DPH; No other known poss causes of hives
Patient received ZOSTAVAX on 5/13/13. Patient presented to pharmacy on 5/19/13 complaining of a 2" long erythematic line at the site of injection. Area feels lumpy to patient. No itching, no fever, area not warm to touch, not painful.
Myalgia, Arthralgia, injection site pain, chills and sweating Narrative:
I started feeling sick on September. My migraines got intensified, uncontrollable cough to the point where it was extremely painful. I kept coughing a weird greyish phlegm, body aches, I was cold and weak. On 09/21/2021, I got tested for COVID-19 and it came back positive. They did not give me any medication since I am already on pain killers. I still feel weak. I could not work during that time. I had to go to the emergency room several times. They tested me for other things, check my vitals, and blood work. They came back normal. I am still extremely drained which is frustrating.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concomitant medications, concurrent conditions or drug reactions and allergies was provided. On 17-NOV-2016, the patient was vaccinated with a dose of unspecified pneumococcal vaccine (dose, route, lot # and expiry date were not reported) for prophylaxis. The reporting pharmacist did not know if the pneumococcal vaccine was PREVNAR 13 or PNEUMOVAX23. On the next day, the patient was vaccinated with a dose of ZOSTAVAX (dose was not reported) lot # M013377, expiry date 25-MAY-2017, subcutaneously for prophylaxis. Concomitantly, on the same day, the patient was vaccinated with a dose of FLUZONE (dose, route, lot # and expiry date were not reported). No adverse effects were reported. Additional information has been requested.
In for Decavac (DT) and received DTAP,  CDC called for information, watch for local reaction, do not revaccinate.  Reported information to parent. Follow up information dated 8/6/05 states site assessed at 1400 on 7/26/05 no reaction at injection site.
11/17 - Severe chills & couldn't get warm 230 am. 11/17 - Headache, backache (lumbar) fatigue, continued chills, fever 100.8 degrees developed as day progressed.
Received vaccine on 02/04/2021 and on 02/05/21 started with left droopy eye lid and ringing in the right ear.  Continues with both symptoms today.
seizures started  June 23rd, resulting in asthmatic emergencies as well.  Have resulted in two life flights, approximate ten ER visits in five different hospitals. As of Evening of 27th Tourette like Tics have began. Verbal, facial, and Movements
Localized right arm erythema, edema, mild cellulitis and c/o nausea. Little local discomfort ( area 4x4") below deltoid area. Cephalexin 500mg PO x 5 D. Clarinex 5mg PO Q 24 H x 5 D.
Local redness and soreness, triaged over the telephone, told to ice and take NSAID's.  Two hours later pt reported to ED with chest tightness.
Pt has a little fever after vaccine. 4 days after vaccine pt has red rash. Dr. gave CIPRO 500mg twice x 10 days.
Patient was registered for a Covid 19 vaccine. Flublok was inadvertently administered. He did not experience any adverse effects.
Patient received vaccines, sat for a few minutes but then jumped up and skipped towards the door and then lost balance, passed out and fell onto the floor in the waiting room.  Called to check out patient and patient cleared to leave with friend
On January 26th I was seeing double images one and above the other. The next day seen doctor  Dr. PA thought I was experiencing Cranium Nerve 4 Palsy.  Since then I have been Diagnosed in August by Dr. as having Myasthenia Gravis (MG). My Head Droops I am Unable to hold it up. I have difficulty swallowing like there is a lump in my throat.  Now I am confined  to my house and unable to care for myself. I'm  receiving a IVIG treatment that is not helping very much.
Arm pain (4 days), migraine,/chills/fever (day after), swelling (golfball size bump), large bruise (4 days)
feeling unwell; his right arm where he got the shot is feeling pretty heavy; Chills; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 13:05 (Lot number: L3247) at the age of 19 years as dose 2 , single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, LOT EL3247), administration date: 18Feb2021, when the patient was 19 years old, for COVID-19 immunisation.  The following information was reported: CHILLS (non-serious) with onset 12Mar2021 01:00, outcome "unknown", described as "Chills"; FATIGUE (non-serious) with onset 12Mar2021 01:00, outcome "unknown", described as "Tiredness"; MALAISE (non-serious) with onset 12Mar2021 05:00, outcome "unknown", described as "feeling unwell"; VACCINATION SITE DISCOMFORT (non-serious) with onset 12Mar2021 05:00, outcome "unknown", described as "his right arm where he got the shot is feeling pretty heavy". Therapeutic measures were not taken as a result of chills, fatigue, malaise, vaccination site discomfort.  Additional information: The patient stated that, through out the day he was exhausted. He stated that it was not too serious, he had got a health care professional that told him it would probably be gone in 48 hours.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. Since 04-FEB-2015, an unspecifed number of patients were vaccianted with a dose of RECOMBIVAX HB, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were incorrect stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional infromation has been requested.
This spontaneous report as received from a consumer refers to a 12 month old patient of unknown gender. On unspecified date, the patient was vaccinated with a dose of VARIVAX (Merck) (strength, dose number, dose unit, route, lot # and expiry date not reported) and a dose of PROQUAD (strength, dose number, dose unit, route, lot # and expiry date not reported) at the same time. No further information was provided. It was unspecified if the patient sought medical attention. This is one of several report received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a female patient between "14 and 16 years old" who in February 2007, was vaccinated into the left arm with a first dose of Gardasil. Concomitant therapy included an unknown vaccination into the right arm. Subsequently, the patient fainted after receiving the vaccinations. It was reported that the patient was fine after sitting for a bit. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Additonal information is not expected.
Grunting, flushed, fever, generally looking unwell. Seen in ER twice/ultimately admitted d/t persistent grunting. Blood cx neg, urine cx neg, abd U/S neg. Placed on Ceftriaxone while cx's pending. Discharged home in good health, sx resolved.
Mother called to report red area on right arm, "larger than your hand" and a "quarter" sized lump. C/o "itchy", denies fever, chills, nausea and vomiting.
Numbness on tongue that subsides in a few days, occurred following both doses Hepatitis B, eats bread without symptoms. Same symptoms after using Beano
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlated of protection against influenza following vaccination in older adults. The patients were vaccinated with INFLUENZA (manufacturer unknown, batch number unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient was exposed to a H3N2 LCI case and had acute respiratory illness. This patient had an antibody titer value of 40, 113, and 320 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. But the patient was not available for nasopharyngeal swab at the time of illness. The patient had 4-fold increase in titer value and tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as an LCI case of INFLUENZA A/JH3N2. The outcome was not reported.
pain in the injection site and arm/pain at injection site all the way to her elbow; pain in the injection site and arm/pain at injection site all the way to her elbow; felt like someone stuck a knife in her muscle; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number A3249 and expiry date unknown, via unspecified route of administration at the left arm on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included other medications. The patient had the first dose of the Pfizer vaccine on 21Jan2021 and the following day (22Jan2021), she experienced pain in the injection site and arm. The patient informed that it felt like someone stuck a knife in her muscle. The patient informed that the pain was improving and not sure if she wanted to get the second dose. The patient informed that she had a dental procedure done and was taking pain medication to help with that but it didn't help with her pain in her arm from the shot. The patient has been having pain at injection site all the way to her elbow. The patient informed that the first day they it was like she had a shot. The patient informed that it felt like a knife was being stuck in her muscle the second day (22Jan2021). The patient informed that today it felt like pressure. The patient informed that at night time that she sleeps perfect and when she gets up in the morning that it was bad pain. The patient informed that she was leery about getting her second shot. The patient informed that she had two teeth pulled on Friday (unspecified date) after she got the vaccine. The patient informed that they redid her partial for those teeth. The patient informed that they had prescribed 800 mg of ibuprofen for her teeth. The patient stated that she thought it would help the pain in her arm but it did not. The patient was told to keep taking it but she stopped. The patient informed that she has to take antibiotics for her teeth until they were all gone. Therapeutic measures was received by the patient due to the events. The outcome of the events was recovering.
Pt woke up with 102 temp and felt like he was trying to hyperventilate. Felt weak.
Severe pain in left arm now 48 hrs after shot. Fever on 2 consecutive nights - bedding and pillows soaking wet. No appetite - headaches.
extreme body pain especially in the upper part of his body; Chills; Fatigue; nurse administered 0.5ml of the vaccine as opposed to 0.3ml; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Apr2023 as dose 3 (booster), 0.5 ml single (Lot number: GJ6739, Expiration Date: 31Jul2023) at the age of 53 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization. The following information was reported: OVERDOSE (medically significant) with onset 14Apr2023, outcome "not recovered", described as "nurse administered 0.5ml of the vaccine as opposed to 0.3ml"; CHILLS (medically significant) with onset 15Apr2023, outcome "not recovered"; FATIGUE (medically significant) with onset 15Apr2023, outcome "not recovered"; PAIN (medically significant) with onset 15Apr2023, outcome "not recovered", described as "extreme body pain especially in the upper part of his body". Caller is a nurse practitioner calling about the Covid-19 Bivalent vaccine and reported that on the 14Apr2023, one of their nurse administered 0.5ml of the vaccine as opposed to 0.3ml. The patient initially felt fine, but 24 hours later, they complained about extreme body pain especially in the upper part of his body. Caller stated that they were body aches. The patient had no fever, but has chills and fatigue and is still experiencing all of this and reporting that it is the same or worse. Relatedness of drug to reaction(s)/event(s): Source of assessment: Method of assessment: Result of Assessment: Yes; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.