chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles outbreaks from the vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles outbreaks from the vaccine). At the time of the report, HERPES ZOSTER (Shingles outbreaks from the vaccine.) outcome was unknown. Not Provided, The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment medication were reported. This case was linked to MOD-2022-478940 (Patient Link).
pain at injection site joint pain in bilateral hips, knees and wrists fatigue onset within 2 hours of vaccine, treated with otc naproxen 220 mg q12 hours prn  pain continued next day, continued otc naproxen 220 mg 2 12 hours
MMR given 25APR95 pt felt warm & was given APAP 29APR95 pt unable to lift head, unable to swallow neck & glands swollen; t102-103; MD stated to give more APAP; 4MAY95 pt still has rash; gland, throat still swollen; t100 today;
Information has been received from an investigator concerning a 6 month old pt who on 1/20/99 was vaccinated with haemophilus b conjugate vaccine (-) hepatitis b vaccine recombinant (yeast). This report was part of a post-marketing surveillance program. Concomitant therapy included inactivated poliovirus vaccine and diphtheria toxoid/pertussis/tetanus vaccine. On 1/24/99, the pt experienced a 30 second tonic-clonic seizure followed by a post-ictal state, "then was happy". The pt was seen in the ER and dx'd with a 1st afebrile seizure. No treatment was given, and the pt was sent home. The pt recovered. The pt will follow possibly related to study therapy. The 1st afebrile seizure was considered to be an "Other Medical Event". No further information is available.
Sore arm; Transient ischemic attack, symptoms of tia; A spontaneous report was received from a consumer concerning a 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced symptoms of transient ischaemic attack (TIA), transient ischemic attack/transient ischaemic attack and sore arm/pain in extremity.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date patient had sore arm like from a flu vaccine. On 24 Jan 2021, the patient went to emergency room thinking patient had a TIA (transient ischemic attack). TIA was not detected at that time but found one later which is considered as medically significant event. Patient had all the symptoms of TIA to the point where patient could not talk, right leg was numb, and eyes went grey. It is unknown whether the patient had history of TIA.   The patient had a brain scan, heart tests, and an MRI whose results were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Pulmonary function test revealed significant decrease in pulmonary function as compared to six months ago.; difficulty breathing at rest and particularly with activity.; increased wheezing; Symptoms improved however worsened after the second vaccine and have continued to be worse than prior to first vaccination.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Oct2021 17:00 (Lot number: FF2593) at the age of 14 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: FF8839, Dose administration time : 04:00 PM, Vaccine location: Left arm), administration date: 30Sep2021, when the patient was 14 years old, for Covid-19 immunization, reaction(s): "increased wheezing", "difficulty breathing at rest and particularly with activity". The following information was reported: DYSPNOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "difficulty breathing at rest and particularly with activity."; WHEEZING (non-serious) with onset Oct2021, outcome "not recovered", described as "increased wheezing"; CONDITION AGGRAVATED (non-serious) with onset Oct2021, outcome "not recovered", described as "Symptoms improved however worsened after the second vaccine and have continued to be worse than prior to first vaccination."; PULMONARY FUNCTION TEST DECREASED (non-serious), outcome "not recovered", described as "Pulmonary function test revealed significant decrease in pulmonary function as compared to six months ago.". The events "difficulty breathing at rest and particularly with activity.", "increased wheezing", "symptoms improved however worsened after the second vaccine and have continued to be worse than prior to first vaccination." and "pulmonary function test revealed significant decrease in pulmonary function as compared to six months ago." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea, wheezing, condition aggravated, pulmonary function test decreased.  Additional information: No other vaccine received in four weeks. Facility type vaccine was pharmacy or drug Store. No Covid prior vaccination. No Covid tested post vaccination. Clinical course: Medications received in two weeks was albuterol inhaler. patient was asthmatic and well controlled with medications. Due to worsening symptoms, she went on prednisone and was taking increased medication. AE treatment was oral prednisone and symbicort. Albuterol. AE resulted in doctor or other healthcare professional office/clinic visit.  Follow-up attempts are completed. No further information is expected.
Moderna COVID-19 Vaccine EUA  Palpable 5cmx6cm lump/erythema/edema/soreness just inferior to injection site  on R middle deltoid. Onset of sx was approx 5 hrs after injection.  Localized moderate mm soreness began approx 3 hours after.  Approx 1 day after vaccine, experienced chills, fever, generalized body aches, muscle soreness which has continued through Day 2 (today).  Then came onset of grumpiness when I realized ...
Patient received her 4 month vaccines on approximately 4/12/09 of this year (2 injections, 1 to the R thigh and 1 to the L thigh presumably pentacel and prevnar).  4 days after receiving vaccines, she developed redness, tenderness and swelling around the injection site on her R thigh.  This progressed and she was admitted to Hospital on 4/23 for cellulitis at a vaccination site on iv clindamycin.  She was discharged home on 4/24 on po clindamycin.  7/24/09 Hospital records received 4/23/09 to 4/24/09. Assessment: Cellulitis, fever. Patient presents with redness, swelling, right thigh at site of Prevnar vaccination. Fever, fussiness, increased sleeping. Erythema, tender indurated area.
Burning sharp pain in the left breast and chest area that subsided into a tightness and dull pain in left chest. Visited my pcp and he ruled it as Costochondritis in the left rib.
Patient is an immunocompromised individual (transplant patient) who received the Janssen COVID 19 vaccination as their primary vaccination series. She came in for a Moderna booster dose, and was given a full 0.5mL Moderna dose instead of the recommended half dose (0.25mL).
Red hot swollen at site, tender, disoriented, fever. Lump on upper middle thigh/mid abdomen (didn't have before shot). Went to ER. Put on Antibiotics.
Vaccine administered on 11/12/2021, expiration date was 11/7/202.  Mistook expiration date to be 11/17/2021.  No adverse event or outcome to recipient.
This spontaneous report as received from a registered nurse refers to unspecified multiple patients.     There was no information about the patients' concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unknown date, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB lot # M035487 with expiration date of 23-FEB-2019, lot# M044031 with expiration date of 01-FEB-2019, lot# N009802 with expiration date of 19-DEC-2019 and lot# M036156 with expiration date of 23-FEB-2019; for prophylaxis (dose, route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 0°C to 1°C degrees for 4 hours and 20 minutes. Data logger was not involved. There were previous excursions of 0°C to 1°C for 51 hours (6 cycles). No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA009564: US-009507513-1709USA009566: US-009507513-1709USA009276:
Information has been received from a LPN concerning a 32 month old female who on 12/02/2002 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included amoxicillin for UTI prophylaxis. Subsequently  the pt  developed lesions. The pt's mother asked a resident to look at her daughters lesions. The resident reported lesions on her trunk and a few  on her face looked like a breakthrough varicella. A physicain then saw the pt and said that it maybe a breakthrough case and it may not be. The pt's lesions were crusty, dry and healing, and the pt was afebrile. It was reported that the nurse and the pediatrician never saw the pt. Subsequently, she recovered. There was no product quality complaint involved. Additonal information has been requested.
Per mom on 10/08/2003, left arm was swollen and red and patient had hives and wheezing (he is an asthmatic).  Symptoms persisted/progressed on 10/08/2003 and treatment sought at medical center on 10/08/2003.  Treated with Benadryl and inhaler.
Pt recvd vax & devel a systemic reaction of an unspecified nature;
Pt recvd vax in 1992 & pt exp rt upper quad pain & elevation of liver enzymes; pt's MD felt that pt exp was not directly related to the vax; No further details were provided;
cranky, swelling @ inj site-x 2 days later a rash around inj site spreading away from site & along the thigh;no sleeping well, remains cranky;
Confusion, Headache, Myalgia, Arthralgia, Diarrhea & NauseaVomiting Narrative:
PATIENT HAD SEIZURE ACTIVITY LASTING APPROXIMATELY 20  MINUTES WITH TWO DIFFERENT EPISODES OF SEIZURES WITHIN THAT TIME FRAME LASTING APPROXIMATELY 5 MINUTES
Very tired, sore arm for several days, periodic  shooting chest/heart pains, light headed, nausea after eating.   None of these symptoms were present before vaccine.
Patient was given vaccines 13 days too early. Pt should not have received them until 3/13.
Pronounced angioedema, swelling, pain, redness, hardness and fever at the injection site >10 cm diameter, from 2 hours post injection, worsening at 12 hours post injection and gradually improving to 72 hours post injection, with rash still visible.
Pain deep in arm at injection site, continuing since 10/4/99, date of injection, left arm.
Pain at injection site and further down arm towards elbow and also into armpit starting by 9 PM.  Woke up with acute pain in sites described at 3 AM on 31st and also profuse sweating and chills.  Headache started by 4 AM and persisted for 12 hours.  The sweating and chills came and went until 4Pm.  Lack of appetite and  tiredness kept me in bed until 4PM on the 31st.    Also had a minor occasional cough that was accompanied by sharp pain in right lung similar to pain from pneumonia.  Appetite restored by 6 Pm, but even though I'd slept most of the day, went to bed by 10:30 and slept through night.  As of 7:30 on the 1st only symptom remaining is pain at injection site and surrounding area.
Within one hour of receiving the shot I became nauseous.  Three hours later my ears were bright red, hot, and swollen.  My heart rate was extremely high, and I started to have tremors.  Sharp pains went through all parts of my body.  I had to be wheeled to Urgent Care because I could not safely walk.  My blood pressure was 165/111 and I had chest pains.  I took Benadryl for several days, a steroid, and an anti-nausea pill.  Over the course of the next several days I had a stiff neck, arm pain, shortness of breath, malaise, chills, fever, muscle weakness, numbness and tingling in my left arm and hand and right leg and foot, bruising on my left foot and lower leg, night sweats, insomnia, abdominal cramping, diarrhea, headaches, back pain, laryngitis, a taste of metal in my mouth, swollen lymph nodes, swollen face, congestion, shoulder pain, vomiting, and constant ringing in my ears.     Since I got the vaccine, nearly 11 weeks (about 2 and a half months) later, I still have severe tinnitus and have missed the past two menstrual cycles (not pregnant) so now I have amenorrhea.
This case was reported by a healthcare professional and described the occurrence of injection site warmth in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline. on an unspecified date the subject received 1st dose of BOOSTRIX (unknown, right arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site warmth, injection site redness and injection site reaction. At the time of reporting the injections site warmth, injection site redness and injection site reaction were resolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. A total of four subjects were report to have had an injection site reaction for the other three cases see A0911825A, A0911826A and A0911827A.
Fever, chills, severe malaise, nausea, diarrhea,  confined to bed With permission of physician, took ibuprofen at 1:pm that day. Symptoms eased  General malaise continued for 2 more days
Approximately 10 minutes after second dose injection client experienced weakness in both arms and light headed in the 30 minute monitoring lot. The EMT on site was summoned to car:  B/P 189/86, HR 80, SPo2 100%. Client reported to EMT, tingling hands, and chest pressure. No respiratory symptoms reported. Client was transferred to local hospital to monitor for symptom. No medications were administered in ambulance nor at the  hospital ER per client report
At the time of my first vaccine injection on 3/14/21 I was approximately 6 weeks pregnant. I suffered a missed miscarriage somewhere between then and 4/9/21, my first prenatal checkup and ultrasound.
Weird feeling with itchy throat, back of tongue swelling, warm and flushed feeling, difficulty swallowing
Swelling at the injection site and upper arm; Body aches / could not get out of the bed; Swelling at the injection site and upper arm, red and warm to touch; Swelling at the injection site and upper arm, red; could not get out of the bed; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site swelling, general body pain, skin warm, injection site erythema and activities of daily living impaired. On an unknown date, the outcome of the injection site swelling, general body pain, skin warm, injection site erythema and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, general body pain, skin warm, injection site erythema and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 1 year ago and experienced body aches, could not get out of the bed for days.  The patient experienced swelling at the injection site and upper arm, red and warm to touch 2 to 3 days.  The swelling proceeded longer, unsure when the HCP did not feel comfortable to provide any additional information and said patient was in her 60's. The reporter did not consent to follow up.
Upon receiving the GARDASIL (#2) vaccination my daughter became diaphoretic and began twitching (arms and shoulders). She recovered within 10 minutes but started to complain of nausea the morning after. She vomited twice that day. She continued with nausea x 3 weeks regardless of whether or not she had food in her stomach. We have seen her pediatrician who referred us to a GI ((-) H pylori, (-) Abd ultrasound, (-) occult stool). Nausea continues (it's been 3 mths!).
Developed measles rash, high temperatures, vomiting, lethargic, sick for two weeks. Now he has anxiety. He gets sick all the time.
Lymerix was given on 3/9/99. Had flu-like symptoms that lasted 3-4 days. The 2nd Lymerix was given on 4/13/99 and was unable to get out of bed for 2 weeks. The 3rd Lymerix was given on 6/9/99 and had pain every day in joints, bones and muscles.
First shot I broke out with eczima on my palms, very bad blisters had to go to emergency for treatment,  treatment help the painful swelling.  Then on the second shot 11 days after I had a mild stroke.  I know it was the shots because I am healthy no health issues,  very active,  strong for my age.  Never again will I take another shot.
Tinnitus, frequent dizziness (dizzy spells lasting for 10-15 minutes, to where I had to sit down)
After receiving vaccinations patient returned home and started amoxicillin (~2 doses before bed) patient starting having fever and chills right before bed then experience nausea/vomiting the next day after taking ~2 more doses of amoxicillin. Patient suffered from fall around noon the next day. Seems to be suffering from dehydration. Advised to rehydrate and discontinue amoxicillin (inform PCP ASAP), if condition continues to visit urgent care/ER.
I had a headache, muscle aches, the normal side effects of a vaccine. One day I felt so bad I was unable to perform at work. There were a few days that I was unable to drive. I went to see my doctor and was told that it was arthritis. I am unable to walk normally or run. I have to be very careful when performing task like getting in and out of the car.
Information has been received from an 85 year old male consumer with no known allergies and a history of shingles and kidney infection who on 03-JAN-2008 was vaccinated with a first dose of zoster vaccine live (Oka/Merck) in the arm. The patient was on unspecified concomitant therapy. "14 days post vaccination", on 17-Jan-2008, the patient developed shingles. Unspecified medical attention was sought and the patient was treated with medication (specifics were not known) from his Physician. The patient also noted "constant misery." There were no lab studies performed. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Complaints of redness at back of neck and itching. Employee sent to emergency room by manager.
Tennis ball size reaction 2 inches below the injection site that was reddened and warm; Tennis ball size reaction 2 inches below the injection site that was reddened and warm; This is a spontaneous case, initially received from other health professional via Agency (reference number: SEQ19-04292) on 09-Oct-2019, concerning a 43-year-old, female patient.   The patient's relevant medical history and concomitant medications were not reported.  On 08-Oct-2019, the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route: intramuscular, anatomical location: left deltoid, batch number: 259808, and expiration date: 31-May-2020] for influenza prophylaxis.  On the same date, six hours after vaccination, the patient developed a tennis ball size reaction 2 inches below the injection site that was red and warm.  On an unspecified date in Oct-2019, the patient recovered from the events. The events were resolved within 24 hours, as reported.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax Quadrivalent .  This case is linked to cases 201905128 and 201905129 (the same reporter).  Follow up was received from other health professional on 11-Nov-2019: Stop dates and updated outcomes for the events were provided. The narrative was amended accordingly.  Company Comment: The patient experienced vaccination site warmth and injection site erythema six hours after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible.  No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as related for both events.; Sender's Comments: The patient experienced vaccination site warmth and injection site erythema six hours after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible.  No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as related for both events.
Itching and mild rash starting 4-5 after, persitent to today, 3/27/2021. In left shoulder, 8 inch diameter circle
This is a spontaneous report from a contactable physician . A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3249) intramuscular in Right arm on 20Jan2021 at 10:45 at single dose for covid-19 immunisation .  Medical history included attention deficit hyperactivity disorder (ADD) and hypertension (HTN). Patient had iodine allergy. Patient was not pregnant.Concomitant medication included methylphenidate hydrochloride (CONCERTA); amlodipine; calcium/vitamin D NOS ; omeprazole (PROTONIX); meloxicam and medroxyprogesterone acetate (DEPO-PROVERA). The patient previously on 30Dec2020 at 10:45 took the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE;lot EK9231) intramuscular in Right arm for covid-19 immunisation.  On 22Jan2021 at 09:00 the patient experienced joint pain, malaise, R axillary lymphadenopathy, enlarged and tender spleen, tender liver, all non serious.No treatment given for the adverse events.The final outcome of the events was reported as not recovered
Red swollen and getting bigger by the day, been three day and I called pharmacy today (saturday). They told me to call my doctor and he is not in tody.