chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX (batch number G72ZD, expiry date unknown) for prophylaxis. On 31st January 2019, the patient received the 1st dose of SHINGRIX. On 31st January 2019, 1 day after receiving SHINGRIX, the patient experienced injection site pain, shoulder pain, fever, injection site rash, itchy rash and injection site discharge. On an unknown date, the outcome of the injection site pain, shoulder pain, fever, injection site rash, itchy rash and injection site discharge were unknown. It was unknown if the reporter considered the injection site pain, shoulder pain, fever, injection site rash, itchy rash and injection site discharge to be related to SHINGRIX. Additional details were provided as follows: The case was reported via chat. The patient subsequently experienced pain at the injection site, shoulder pain, low grade fever, and lesions around the injection site. It was reported that per conversation with patient, the symptoms developed about 24 hours after injection. The lesions started as itchy bumps and as on the reporting date a few have opened with a small clearish discharge. The lesions only surrounded the injection site. The reporter only expected the patient to experience the pain at the injection site, shoulder pain, and low grade fever. The patient received vaccine at the patient's pharmacy and not at the clinic where the reporter worked.
About 2 weeks I started experiencing sudden headaches, and I realized it was probably due to high blood pressure. My usual dosage was not sufficient, and my blood pressure refused to go down. The doctor prescribed higher dosages of my blood pressure medicine and my blood pressure has stabilized.
After receiving the Janssen COVID-19 vaccine, the client became dizzy and nauseous while in observation.  Our clinical staff helped the client to the ground and placed her in supine position with legs elevated.  Patient recovered quickly and was helped to a wheelchair where she was given water and Gatorade.  Client was monitored for an additional 30 minutes before she was able to leave with her family under her own power.  Patient stated that needles made her anxious.
Information has been received from a 27 year old female through a pregnancy registry who on 7/18/01 was vaccinated with varicella virus vaccine live. The pt reported that she had "just" developed shingles (12/01). The pt reported that she believed she might be pregnant. She stated that the date of her last menstrual period was 11/22/01. At the time of this report, the pt did not have OB physician. Her estimated delivery date was determined to be 8/29/02. Additional information has been requested.
Swelling and redness at site of injection and all around upper arm. Onset, next day, post vax, and lasting until the 3rd day afterwards.
2/8/15: 4 in. band of ecchymosis around arm at injection site. 2/13/15: hair loss on arms/legs/back of neck/torso. Psoriasis hx on ankles, but new areas of exacerbation on toes, knuckles, elbows, knees.
5/22/08 Pt. seen well visit received Hep A/varicella/MMR.  About 12 hrs after vaccines pt dvpd redness of face and arms swelling of eyelids, puffy face and hands when he awoke in the morning.  No difficulty breathing.  Mom gave a dose of BENADRYL with decreased swelling of eyelids.
Pregnancy loss: estimated due date was September 22, 2021. The only symptoms I experienced were pelvic cramping and chills. I did not have a fever. I received both doses during pregnancy. There is no explanation for the loss of the pregnancy. The baby showed as healthy and normal with a strong heartbeat on Feb 5 and the baby stopped growing and the heart stopped beating on Feb 6.
patient returned to the pharmacy 1 week after receiving rsv vaccine and reports having an approximately 3 inch diameter red raised blotchy area surrounding the injection site. patient reports no itching/pain/sensations in the area other than cosmetic redness and area is slightly raised
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: Patient felt dizziness while sitting for observation after vaccine (third shot, booster)
Sporadic, lower left side uncontrollable facial twitching for approximately 12 hours
Fever of 99.9 to 100.3 for 2+ days Mild headache Stomach ache Joint stiffness Soreness around injection site Redness around injection site Injection site hot to the touch Low stamina
Brought to ER on 3/6/05 by parents c/o generalized rash x 1 wk. Fever and decreased appetite x 2 days. Mom states is taking PO fluids well. States received imm 2/23/05. Pt did receive Hib #3, MMR #1, Varicella and PCV #4. Lung tab. Pt playful, smiling and interacting well with staff and parents. Parents deny child pulling at ears, vomiting, other sx. Scattered papules, vesicles, pustules on trunk and ext. Parents deny child itching lesions.
Woke up the next day with pain and a lump at injection site.  As the day progressed, it was hard to lift my arm to get in and out of my coat.  At about 1pm,  began with deep muscle aches, mostly back and hips, fatigue, weakness and headache.  By 4pm, fever to 102.7.  Pain and swelling in left arm (injection site) and unable to lay on it or lift it.  Took Advil to bring down fever and relieve symptoms. Fever of 100.8 following day, arm pain.  Took Advil to relieve symptoms.  Fever of 99.0 the next day, less severe arm pain.  Took Advil to relieve symptoms.  By day 4, mostly back to normal, but still some pain in arm.  Now 3/21/2014, mild discomfort on touch of lower left deltoid.
Fine morbilliform rash - resolving by the time patient was seen on 7/25/07. (Also has a h/o eczema)
Headache, body ache hurts to move eyes.  Fever hot, then cold, cold sweats joints hurt, muscles hurt.  Had same type reaction 9 years ago after Typhoid.
BODY ACHES; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, body aches, and fatigue. This report was non-serious.
Fast Heart Beat, Dizziness, (200 beats a minute Blood Pressure 95/65
Full body aches, swollen right armpit, naseau, vomiting, restlessness, inability to sleep, chills, presumed fever, increased resting heart rate (up by 40+ bpm compared to normal), shortness of breath, anxiety
Patient received the GARDASIL 9 vaccine as well as MENVEO in the left deltoid muscle on 6/27/2017. The day after the vaccines, the left upper arm became edematous erythematous, mildly tender to touch. She was evaluated in the office for this 6/29/2017
This spontaneous report as received from a medical assistant that inquired on behalf of the physician, if ZOSTAVAX could cause vertigo. The medical assistant did not know if there was a patient involved but due to the nature of the question asked, there might have been a patient who experienced vertigo after receiving ZOSTAVAX. The outcome of possible vertigo was unknown. The relatedness possible vertigo was unknown for ZOSTAVAX. Additional information is not expected.
This spontaneous report as received from a healthcare worker and nurse refers to unspecified patients. Medical history and concomitant medications were unknown. The nurse reported that improperly stored doses of ROTATEQ were given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. The case is also related to 1506USA009859, 1507USA001114 and 1507USA001115 (same reporter link). Additional information has been requested.
pt c/o of low back pain 4MAY93; pt passed out & was unconscious for about 10 mins; felt numb & then had pain; dx polyneuritis;
Pt received flu vaccine with the proper technique and was fine after but called next day (according to Rph on duty) saying she had some tenderness in the area, a common side affect, however they followed up and pt felt better the day after.
Pain at injection site, muscle/body aches, chills, prickly skin, headache, nausea & fatigue.
Felling dizzy; Fever; She has not slept all night; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Mar2021 10:45 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, she has not slept all night on 21Mar2021, felling dizzy on 22Mar2021. Reported as, reporter and his wife both had a Pfizer shot yesterday (21Mar2021) around 10:45 in the morning and she came down with fever last night 10:30-11:00 o clock and she has not slept all night and she has a fever all night and also she was dizzy this morning. Still has a fever, fever was 102 degree. she have a reaction to a shot. The patient underwent lab tests and procedures which included body temperature: 102 degree on 22Mar2021. Outcome of the event fever was not resolved and unknown for other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After receiving the 3 vaccination. Patient said she felt dizzy. She fainted for about 2 minutes. Patient also said she fainted once at doctor's office when getting a PCN shot. She refused medical attention when ambulance arrived.
Patient got vaccine administered at job interview on April 1, 2022. She states she received Pfizer shot number 1 in right deltoid. Hours after the vaccine was given she experience fatigue and sore right arm. She noticed the next day she had "hard, red lump" to right deltoid area where the vaccine was given. She has been putting warm compresses on the site and taking tylenol/motrin to help with pain. She also reports fatigue and feels "foggy" with thinking.
She heard media urge all at-risk to get the booster (before they changed their stance later).  She immediately went out and got it, her 3rd Moderna.  It was a big reaction for her.  I became aware after she called me to tell me how bad she felt.  Several days of feeling very beaten down, fatigued and ill. She kept hydrated, though, and was able to start eating, and seemed to be getting better. Day 9 I talked with her, she was tired by up and about, and thought she was getting better.  Morning of day 10, my wife got the alert call, rushed over, confirmed to them that it was a 911 for real.  I rushed over and held her upright while ambulance was enroute. She was having trouble breathing, couldn't get enough (couldn't get enough) air in her lungs. She said to me: "This could be it. I've had a good life."  But she was on the road to being a centenarian, riding her exercise bike regularly, an iron-clad diet to keep her diabetes in check, etc.  She had multiple cardiac arrests enroute and in the emergency room.  While stabilized with extreme blood thinners, (suspected Pulmonary embolism confirmed by ultrasound), they took her for a scan, where they found MULTIPLE pulmonary embolisms in BOTH lungs.  She died less than an hour later, even on the breathing machine with a team of attendants.  She wanted to not be a burden on the medical resources and I checked with them during this event and they said they had the capacity and that she was the sickest person in the hospital by far,  'we have the resources now'.   I signed the DNR after the (I think) 4th cardiac arrest to stop them from shattering more bones in her torso, about an hour before she died.  She was intubated the whole time in the hospital.
Severe headache, body aches/pain, diarrhea, nauseated/dry heaves, extreme tiredness
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported a similar event for 2 patients (wife and husband). This is the 2nd of 2 reports, referred to the husband. This 81 year-old male patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, in 2016 at an unspecified age, at single dose, for immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient got pneumonia which caused hospitalization. The outcome of the event was unknown. 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. Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment. Linked Report(s): US-PFIZER INC-2017242084 Same reporter/product/event, different patient.
woke up with a non stop runny nose; cannot stop sneezing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (woke up with a non stop runny nose) and SNEEZING (cannot stop sneezing) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No history provided by Reporter.  The patient's past medical history included Chemotherapy.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced RHINORRHOEA (woke up with a non stop runny nose) and SNEEZING (cannot stop sneezing). At the time of the report, RHINORRHOEA (woke up with a non stop runny nose) and SNEEZING (cannot stop sneezing) had resolved. Not Provided          Concomitant medications included some chemo treatment and antibodies for cancer. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: patient doing fine
On 1/23/17 patient was given a second dose of PROQUAD. The family was contacted and advised to watch for symptoms and to return in 1 month for KINRIX.
During the administration, there was a failure of the syringe/needle. The vaccine leaked out at the junction where the needle screws into the syringe. I don't believe the pt. received much if any of the dose so I administered a new full dose of the vaccine. No other adverse events occured.
Symptoms began after 20 minutes from receiving vaccination to left deltoid. Pain from site radiated through arm, towards armpit and left chest. I was told to take ibuprofen if needed for pain when I left the facility. A few hours later I began to have SOB, even at resting positions. Pain had now spread to back shoulder, and left side of my neck. SOB became very apparent at night while laying down, having extreme pressure on entire chest but more present at center to left of chest. Tingling and loss of sensation occurred off and on to left arm down to fingertips. Pain was 100/10 from site to chest, left shoulder, back and left side of neck. Headache began on frontal area, and left side of face became slightly numb to touch at times. Piercing headache moved to left temple radiating through the forntal, temporal area of head, to behind the ear and jaw.  Contacted the Nurse Advice line, in audible distress, labored breathing. Was placed on hold to contact a Dr. and was asked if I had Aspirin available to take. Possibly Nitro as well. They stated if I needed to head to ER to do so, but I no longer had coverage, and was also told an urgent message would be sent to a DR. to schedule and appointment the following day. I never received a call. Until a few days later my primary stated she needed to schedule a appt to see me for heart palpitations which was never a symptom I mentioned with the adverse reaction.
Patient is 32 weeks pregnant. Thus far an uneventful pregnancy. Beginning at 10pm, cold symptoms began, including stuffy nose. This rapidly turned into skin tingling, violent shivers and shaking throughout the body followed by burning hot fever. Once this passed, at about 2:00am, nausea began and mild vomiting. After that, exhaustion set in and loss of appetite. The exhaustion and lack of appetite lasted until about 8pm on Saturday - about 28 hours post-vaccine. However, vomiting occurred again at midnight that night as well about 34 hours post-vaccine.
10/6/12 - Advised ice and ibuprofen. 10/7/12 - ER visit to f/u with PCP.
Patient didn't have an adverse event. Patient was given Janssen COVID-19 Vaccine March, 2021. On 08/12/21 patient was vaccinated with Moderna COVID Vaccine. Patient is AA&OX3, no noted distress, denies any discomfort. Patient vital signs WNL will continue to monitor.
Right deltoid pain after flu and Menactra vaccines 2/9/15; red and swollen area 10cm by 6cm developed 2/10/15.
shivering; flu like symptoms; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for an unknown indication.   On 15th April 2020, the patient received the 2nd dose of Shingles vaccine. In April 2020, less than a day after receiving Shingles vaccine, the patient experienced injection site pain. On 16th April 2020, the patient experienced shivering and influenza-like symptoms. On an unknown date, the outcome of the injection site pain, shivering and influenza-like symptoms were unknown.   It was unknown if the reporter considered the injection site pain, shivering and influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received Shingrix vaccine in the evening and experienced pain at injection site. On the day of reporting at 11 am, the patient experienced shivering, the patient asked if was truly a side effect or perhaps the onset of flu-like symptom associated with Covid-19
Information has been received from a consumer concerning a 4 year old male with penicillin allergy, autism and decreased immune system who on 05-MAY-2005 was vaccinated with a dose of MMR II. Suspect therapy included PEDVAX HIB. On approximately 08-MAY-2005 the patient experienced high fever of 105.7 reading and was hospitalized. The patients mother stated that the high fever started "3 days after receiving vaccinations. The patient was brought to the hospital on 10-May-2008 and was admitted for 2 days. Per reporter, "if the patient gets fever sometimes it goes as high as 104. Reporter noted that the patient has not had any fever recently. Unspecified blood work was performed. It was noted that the patient was recovering at the time of the report. Unspecified medical attention was sought. No product quality complaint. No further information is available.
Expired vaccine administered to 26 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 26 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022. No Treatment medication reported.
pt recv vax & exp heaviness in arm like muscles are numb;reporter noted that the numbness in the arm was d/t the nurse hitting the nerve during administration of the vax;
11/5/21  Symptoms include fatigue, myalgia, post nasal drip, non-productive cough and sore throat. Denies fever, anosmia, dysgeusia, nausea and vomiting.    Sick contacts: COVID exposure    SARS-CoV-2 immunity status: fully vaccinated    Patient reports history of: seasonal or environmental allergies    Patient has taken acetaminophen for symptoms with no effect Symptoms include fatigue, myalgia, post nasal drip, non-productive cough and sore throat. Denies fever, anosmia, dysgeusia, nausea and vomiting.    Physical Exam    Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is not ill-appearing. 11/5/21  Cont Review of systems:    Right Ear: Tympanic membrane, ear canal and external ear normal.     Left Ear: Tympanic membrane, ear canal and external ear normal.     Nose: No congestion or rhinorrhea.     Right Sinus: No maxillary sinus tenderness or frontal sinus tenderness.     Left Sinus: No maxillary sinus tenderness or frontal sinus tenderness.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Posterior oropharyngeal erythema present. No oropharyngeal exudate.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds. No murmur heard.
Red firm area 2.5 inch by 1.5 inch. Firm, warm to the touch. Mild pain and itchiness associated with the area. Developed 7 days after vaccine administration. Symptoms ongoing.
p/ being vax the pt subsequently exp shingles. Information has been received from a physician concerning a 1 year old male patient who on 14-MAR-1998 was vaccinated with the first dose of VARIVAX vaccine. Subsequently the patient experienced shingles. No further information is available. It was reported that the patient's sibling had a similar expereince (WAES#98031678). This is in follow-up to report (s) previously submitted on 05/14/1999. Information has been received from a physician concerning a 1 year old male patient who on 14-MAR-1998 at 10:30 am was vaccinated with the first dose of VARIVAX vaccine (lot# 623134/0708E). Subsequently the patient experienced shingles. No further information is available. It was reported that other family members (WAES# 01060054) and the patient'svaccinated brother (WAES# 98031678) had similar experiences. No further information is available.
Fever, Fatigue, Naseua, Vomitting, Body aches. Started 3/7/21 thru 3/13/21.
Extreme fatigue, joint and muscle pain, headache, diarrhea, weakness, loss of appetite,