chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of pain localized in a 59-year-old male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020). On 8th May 2018 09:15, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the dose was an unknown dose. On 8th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain localized, body temperature increased and headache. On 9th May 2018, the patient experienced fatigue and tenderness. In May 2018, the patient experienced myalgia. In May 2018, the outcome of the body temperature increased, fatigue and headache were recovered/resolved. On an unknown date, the outcome of the pain localized, myalgia and tenderness were recovering/resolving. The reporter considered the pain localized, myalgia, body temperature increased, fatigue, headache and tenderness to be probably related to SHINGRIX. Additional information was received as follows: The reporter himself was the patient. The patient received the vaccine in the left deltoid. The SHINGRIX adjuvant vial had lot number A4X57 and expiry date 13th July 2020. The patient had 10% localized pain, 10% myalgia and 30% tenderness pain on pressure. The patient noticed a slight rise in his temperature but he did not take his temperature for confirmation. At the reporting time, the patient felt good and he was happy. The patient had no unusual side effects. The reporter stated that nurse practitioner administered the SHINGRIX to him. No further details was provided.
Rash; itchy near injection area; spread to the elbow with redness; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash), VACCINATION SITE PRURITUS (itchy near injection area) and VACCINATION SITE ERYTHEMA (spread to the elbow with redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (Rash), VACCINATION SITE PRURITUS (itchy near injection area) and VACCINATION SITE ERYTHEMA (spread to the elbow with redness). On 25-Feb-2021, RASH (Rash), VACCINATION SITE PRURITUS (itchy near injection area) and VACCINATION SITE ERYTHEMA (spread to the elbow with redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.   This case was linked to MOD-2021-081754 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: The follow up received on 11-JUN-2021 and contains no new information
Pt. Became pale, said throat felt "funny". Within 1 minute of HPV, Influenza vaccine. Given 0.3mg epinephrine and all symptoms improved within 1 minute. EMT called but back to normal by time the arrived. 5 min
Patient receive 0.3 ml of undiluted PEDS pfizer bivalent instead of the intended adult bivlatent pfizer
I know it was the quad vaccine, but I am not sure which manufacturer/brand. Overnight I work up with severe pain in the upper left shoulder/back, near the base of the neck. Starting Wednesday night I notice shortness of breath. My lungs feel clear, but I feel some resistance when I try to breathe in deeply. I notice maybe some slight soreness in the abdomen and right lung. So I suddenly get very winded if I try to jog even a short distance, and I've even noticed it while walking fast. I get the flu shot annually without exception and have never experienced any of these symptoms in the past.
Information has been received from a licensed practical nurse concerning a 5 year old male who on 21 Aug 2001 was vaccinated with a dose of Varivax (lot # 637667/1606K). Concomitant vaccination included a dose of MMR II. On 04 Apr 2006 it was reported that "within the last 1-2 weeks" the patient experienced breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Followup information from the nurse indicated that all the information on the varicella vaccine and the chicken pox was submitted. No further information is available.
p/vax pt having spasms on lt arm;up in the middle of noc w/spasm;described as tightness throughout lt arm;pain & soreness w/spasm;dx local rxn & med prescribed;
Varicella vaccine was given in left arm between 400-415 pm.  Shortly thereafter he began wiping his nose and rubbing his eyes.  He said he had a cold.  It became apparent it was not a cold and he was given 25 mg Benadryl at 430 pm.  His eyes swelled more & he was given 26 mg epi 1:1000 or 440 ppm.  Fire rescue was called & he was taken to hospital.  He left ER after 9 hrs.  He did not need more epi.  He was given albuterol via neb after he started wheezing when he fell asleep.  He received IV fluids.
09/20/2005 Twinrix, TD given intramuscularly, oral Typhoid started 09/26/2005.  Complaint of rash on face, upper chest/back area 10/03/2005.  Started Benadryl several days later due to increase intensity of rash 10/13/2005.  With no relief and eyes now swollen spoke to a pharmacy who recommended topical cream, antihistamine and see PMD.  Saw a physicians assistant at walk in clinic on 10/26/2005 who recommended steroids - client refused.  Advised to see PMD - stated she would.
Extremely sore at injection site, continuing at least 48 hours. Muscle aches, sore throat, low grade fever, malaise.
Pt recvd a series of 3 Engerix-B vax on 16AUG90, 27SEP90, & 19FEB91; post vax indicated that pt was a non-responder; On 09MAY91 pt recvd booster dose for post exposure prophylaxis;
she administered the Orange cap Covid-19 vaccine that expired a day before it was administered.; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "she administered the Orange cap Covid-19 vaccine that expired a day before it was administered."  Additional information: The patient received orange cap Covid-19 vaccine that expired a day before it was administered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a physician and a mother referring to her 16 year old son. The pt received second "arm" dose of Lymerix in mid-September, 1999. One week, post vax, the pt experienced lower leg pain (inner calf and shin area) which was considered to be probable stress fractures. Lymerix was discontinued. The results of the bone scan show a local area of increased uptake in the right mid-shaft tibia, consistent with a healing stress fracture and a more diffuse pattern in the left tibia, consistent with medial tibial stress syndrome of shin splints. Dx is probable healed stress fracture right mid-shaft tibia. Physician stated that he was not sure that Lymerix had anything to do with the shin splints or stress fracture. He thought that this was more coincidental than causative. The most recent information, received on 10/25/99, reports the condition of the pt is unknown.
I got vaccinated at my work on 001-21-2021. I started to develop fever, chills, body aches, fatigue and also experienced shortness of breath two days after my first dose Pfizer vaccine. I went to ER where I got tested for Covid. My results came back and I was positive for Covid. Due to Covid I was out of work for one month. I can say today that my breathing is not the same as before, a bit shallow and I get fatigued easily. For my second dose, I developed headaches and fever which only lasted two days and then my symptoms went away.
Whole body all 4 extremities & head stiffening followed by relaxing every 6-15 sec for 15min episodes intervals w/o episodes lasting 10-40 min began at 9:30pm - 12am observed at home & in ER, Pt then fell asleep at home. Has slept all day until 3pm, refusing food, falls asleep with bottle.
Developed radiating pain from shoulder, up side of my neck causing pain in my teeth and jaw.  Pain started at 1700hrs Wednesday and worsened throughout the day Thursday.   Headache, painful joints and fever started Thursday.  Fever spiked Thursday evening around 1700hrs to 101.4.  I had the chills and diarrhea.  Sometime between Thursday and Friday the fever broke.  As of Friday at 1000hrs, I no longer have a fever or radiating pain into my jaw and teeth .  As of Friday at 2120hrs, my joints still ache (especially my knees), I have a slight headache and diarrhea.
Temperature 101.1 degrees Fahrenheit on 1/18/2021 @ 1:28pm. Tylenol 650mg administered. Orders obtained to admnister one liter of normal saline via intravenous route due to resident's poor oral intake. IV fluids initiated. Temperature 98.9 degrees Fahrenheit on 1/18/2021 @ 4:35. Temperature  101.0 degrees Fahrenheit on 1/18/2021 @ 11:54pm. Cold compresses applied. Temperature 98.8 degrees Fahrenheit on 1/19/2021 @ 12:52am.
Shingles to Left side, treated with 7 days TID ValcyclOVIR
Patient received Hepatitis A and B vaccine on 5/6/2013 had received a prior Hepatitis B as first dose years ago. Pt noted a rash below the vaccination that resolved had chills no fever. Since that c/o bilateral shoulder L>R and neck pain. No injury to area no admitted straining. Patient attributes pain directly to injection.
I took the Pfizer Covid-19 vaccine (March 27, 2021) and booster (April 17, 2021). I have been struggling with sever tinnitus, daily, all of the day, and I have suffered hearing loss. I'm making an appointment to see a doctor after reading possible links to the vaccine and tinnitus as that triggered my thinking and realized I never had these issue until after the vaccine.
Patient presents with 7 day history of shortness of breath.  Ct angiogram showed multiple pulmonary emoblism with ventricular strain.  Patient required EKOS procedure for clot dissolution and bridging from Lovenox to warfarin.
TWO VACCINE ADMINISTERED FOR COVID-19; This spontaneous report received from a consumer concerned a male 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 not reported, batch number: unknown) dose was not reported, left arm administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 21-MAR-2021, the subject experienced two vaccine administered for covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two vaccine administered for covid-19 was not reported. This report was non-serious.
PATIENT BEGAN TO COMPLAIN OF LOCALIZED TENDERNESS AT INJECTION SITE WITHIN 6 HOURS OF ADMINISTRATION.  LOCALIZED TENDERNESS, REDNESS, WARMTH, AND EDEMA INCREASED TO AN AREA 3" IN DIAMETER AT SITE OF INJECTION UNTIL COMMENCING TO SUBSIDE ON 3RD DAY AFTER VACCINE ADMINISTRATION.
This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. This 84-year-old, female patient of an unknown ethnicity was injected PREVNAR 13 vaccine 0.5 ml (one syringe) on 10Nov2015 in the right arm (deltoid region). The lot number was reported as M20639, expiration date was Apr2017 and NDC number was 00005-1971-05. The frequency and route of administration were unknown. The relevant medical history included diabetes, allergic reaction to iodine and penicillin on an unknown date. The concomitant medication and past drug history were unknown. On 10Nov2015, the patient experienced cellulitis in the right arm. The relevant lab data was unknown. The action taken with PREVNAR 13 in response to the event was unknown. Therapeutic measures taken were unknown. As of 22Dec2015, the clinical outcome of the event cellulitis in the right arm was unknown.
Slight/ minor chest pain in the area of the heart, rapid heart rate/ pulse on occasion and ringing in left ear.  Minor chest pain is constant, rapid heart rate comes and goes throughout the day and evening. Ear ringing is constant.
QUARTER SIZE KNOT AT INJECTION SITE WITH SEVERE PAIN.  UNABLE TO RAISE ARM DUE TO PAIN X 48 HOURS. KNOT AT INJECTION SITE LASTED FOR 7 DAYS. PAIN HAS DECREASED TO CURRENTLY ABOUT A 2.
Pt received J+J as their first vaccination. Came in to get the moderna booster. According CDC guidelines pt is to get 0.25ml booster, instead he was given full 0.5ml booster.
11 days post ROTATEQ mucous stools, sl. blood tinged.  12/12/2008 Spoke with MD who stated blood streaks had resolved.  Still having diarrhea.  Other family members having similar sx.  Likely GI bug, not AE
Gave adult dose HAVRIX to 18 year old patient. No adverse events were reported.
Experiencing severe vertigo; Eyes feel like they are flying back and forth; She feels off balanced/ When she's up and moving around is when she feels the worst; feels the worst,head feels weird; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Experiencing severe vertigo) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D48F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced VERTIGO (Experiencing severe vertigo) (seriousness criterion disability), OCULAR DISCOMFORT (Eyes feel like they are flying back and forth), BALANCE DISORDER (She feels off balanced/ When she's up and moving around is when she feels the worst) and FEELING ABNORMAL (feels the worst,head feels weird). At the time of the report, VERTIGO (Experiencing severe vertigo), OCULAR DISCOMFORT (Eyes feel like they are flying back and forth), BALANCE DISORDER (She feels off balanced/ When she's up and moving around is when she feels the worst) and FEELING ABNORMAL (feels the worst,head feels weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information were provided.  No treatment information were provided.  Company comment: This case concerns a  42-year-old, female patient with no relevant medical history, who experienced the unexpected events of Vertigo, Ocular discomfort, Balance disorder, and feeling abnormal. The events occurred approximately 6 days after the first dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown as the events occurred after the first dose and no information about second dose is available.The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. The event Vertigo was considered Serious as the source document described the event resulted in a Disabling/Incapacitating outcome.; Sender's Comments: This case concerns a  42-year-old, female patient with no relevant medical history, who experienced the unexpected events of Vertigo, Ocular discomfort, Balance disorder, and feeling abnormal. The events occurred approximately 6 days after the first dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown as the events occurred after the first dose and no information about second dose is available.The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. The event Vertigo was considered Serious as the source document described the event resulted in a Disabling/Incapacitating outcome.
Myalgia, Arthralgia, NauseaVomiting, FATIGUE, ARM PAIN, CHILLS Narrative.
Urticaria and pruritus of both hands and wrists.  Denies dyspnea, chest pain, rhinorrhea, nausea, and dizziness.
Within 24 hours of vax, pt developed a "severe" injection site reaction characterized by swelling, redness and tenderness. No further info was available at date of this report. Manufacturer's Comment: The reporter indicated that 5 pts experienced this event; howeer, they are not presently identifiable. Addtl reports will be generated when identifying info is provided.
Patient was born at 37 weeks considered a preemie. He had COVID-19 at 2 months old and tested positive on 1/6 in the ER. The virus lasted for about 4 weeks. He fought hard and guaranteed he had lingering Covid in his system when he passed on 4/28. He received his first round of shots on 2/9 (DTaP/ Hep B/ IPV, HiB, Pneumococcal Conjugate (PCV-13), and Rotavirus Pentavalent). Later that week he developed a cough/ temperature of 100. He did not feel well which I have documented on video. He had the 2nd dose of the same vaccinations listed above on 4/19.  I have photos of a rash that showed up on Friday 4/22 and continued throughout the weekend. He was clammy, weak, fussy, irritable and not himself after the second round of shots.   The vaccinations played a role in my son losing lack of oxygen and not being able to cry out or get his head up when I found him on 4/25. I believe he had a delayed reaction VERY possible considering his circumstances. Patient is not going to be framed as a SIDS baby; there are reasons behind his death and the truth needs to be addressed. I want justice for my son and the head of the Health Department to own up to the pressures they push on doctors when all babies are not the same.   Babies are not a number or a medical study. There needs to be FDA guidelines for vaccinations for babies who are preemies or have experienced COVID-19 or any sickness for that matter.  No reason why we couldn?t have spread his shots. He was only 5 months way TOO much for a baby to handle. Where is the common sense in all this??? I had questioned the doctor and trusted the medical field. Now I am left with a dead son. No one else is suffering the pain my husband and I get to face everyday. If we had waited longer he would still be here today. There should be compensation from the vaccination companies to my husband and I. They need to be held accountable and so does the board of immunizations.   Looking forward to a response with truthful answers. This is my son?s life, not some political cover up or pay out.
Ache; Injection site leaking; COVID-19; Diabetes; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4087377-00 (COMPANY). A 68 year old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), intramuscular, administration date 03Dec2021 at the age of 68 years as dose 1, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as citrate free and subcutaneous (Batch/Lot number: unknown) as citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 23Aug2021, outcome "recovered" (2021), described as "COVID-19"; DIABETES MELLITUS (medically significant) with onset 2021, outcome "recovering", described as "Diabetes"; INJECTION SITE EXTRAVASATION (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "Injection site leaking"; PAIN (non-serious), outcome "recovering", described as "Ache". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB)  The reporter's causality for the event(s) of COVID-19, medication ooze back out from shot site and aching with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of diabetes was not provided.    The lot number for (BNT162B2) was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Had significant pain in arm 1st few days after vaccine administered. Pain continues like "dull tooth ache deep down to bone" intermittently and when present affects ability to raise arm (right). She was instructed to see MD
This is a spontaneous report from a contactable physician via a sales representative. An 8- year-old patient of an unspecified gender received 4 doses of PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient was hospitalized for pneumonia for 8 days on an unspecified date. The patient underwent lab tests included ran strep pneumonia antibody serotypes test: some of the serotypes were below protective levels. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13- valent conjugate vaccine in this patient cannot be completely excluded.
Patient complained of swelling on the inside of his throat that caused difficulty breathing at 4-5 am on 1-18-08 after receiving Hepatitis A/Hepatitis B vaccine on morning of 1-17-08.  The condition got progressively less troublesome after drinking water frequently for several hours and was resolved by 12 noon on 1-18-08.  Did not seek medical evaluation until today.  Complained of urinary pain that began at the same time 1-17-08 4-5 pm which has persisted.  Referred for evaluation.
I felt warm but no fever, really bad headache, fatigue and flu like symptoms with joint pain, sore throat.
5 minutes after vaccination, patient experienced a vaso-vagal syncope episode, lasting 5-6 minutes. Pt. was placed in prone position, lower extremities elevated. VS WNL @ 110/73-99 RR 18 SpO2 98% @ 0945; 112/81-88 RR 14 SpO2 99% @ 0950; 119/83-80 RR 12 SpO2 99% @ 1004. No medications were administered/needed. Apple juice given as patient had not had anything PO prior to appointment.
Information has been received from a health professional concerning a 71 year old female with shingles who was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  It was reported that the patient's shingles got worse.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Sore left arm around 9pm on June 24, 2021. Around 10:30pm on June 24, 2021 chills, 100 degree fever, and aches. Continued through the night and continuing as of June 25, 2021.
Large, local reaction of thigh; urticaria both feet; arthritis contralateral ankle.
5 mins post administration of J and J vaccine, patient complained of flushing nausea and light headedness.  Vital signs obtained  98% room air, post rate of 72,  blood pressure 138/72 temp 97.1.  Patient provided water and 1  cooling pack and observed for 10 mins. 2nd vital signs were obtained which was 98% room air 72 heart rate 130/70 and 98.1.  Patient was observed until symptoms resolved.  final vital signs showed 98 room air, 74 heart rate 126/78 BP 98.1 temp. Patient was safely discharge without further incident.
@ 24hr p/vax pt got urticaria lower extremities then generalized;resolved in 3 days;
Swelling in l deltoid. States painful with numbness and tingling down arm and pain to back.