chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX. On 21st March 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 21st March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anyone. This case was reported by the patient. The patient received SHINGRIX vaccine on the left arm subcutaneously rather than intramuscular route, which led to incorrect route of vaccine administration. The patient's arm had a sore spot approximately the size of a silver dollar where the vaccine was administered, just above the elbow on back side of the left arm. This case was linked to case US2018049217, reported by the same reporter.
Hives, Swelling of the tongue, diarrhea - delayed reaction perhaps due to the fomatidine
On 1/4/21 Client had what appeared to be a seizure and went unresponsive. He foamed from the mouth and turned blue. O2 Sat was in the 60's, O2 was applied previous to paramedics arrival. BP was high. Unresponsive for 30 minutes. When he woke he did not recognize anyone, did not know where he was at or what day of the week it was.  He was transported to the Hospital. Multiple tests were ran and nothing out of the ordinary was found. Started seizure medication.
This spontaneous report as received from a physician refers to a patient of unknown age who in approximately 2013, was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (route and lot number not reported). The physician reported that within the past week in approximately July 2013, the patient presented with pneumonia and bacteremia after receiving PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. The relatedness for pneumonia and bacteremia and PNEUMOVAX 23 was unknown. Additional information has been requested.
Very bad pain in the left arm, shoulder and upper back, sudden chills, sweating all night while sleeping, raised red welt extending from the armpit to the elbow with a clear outline around the edge. The welt lasted 3 days and all other symptoms were gone by morning except for some normal soreness. The welt did not itch or hurt.
p/vax pt devel itch; rash size 6''x5''; pt states had rash; itching;
had flu like reaction but not strong ones; soreness on injection site; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu like reaction but not strong ones), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (feeling tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (had flu like reaction but not strong ones), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (feeling tired). On 12-Feb-2021, INFLUENZA LIKE ILLNESS (had flu like reaction but not strong ones), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (feeling tired) had resolved.        Concomitant medications was not reported. Treatment history was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-032269, US-MODERNATX, INC.-MOD-2021-065557 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-032269:Wife case US-MODERNATX, INC.-MOD-2021-065557:wife case
After dose 4 and 5 I experienced body pains especially in my shoulders they hurt so much that I couldn't lift them. I also had severe joint pain and fatigue for 2 to 3 days after the vaccine and felt better afterwards. In August is when I had a major anti inflammatory flare up my mouth was blistered and raw, body pains, pain in my knees and hands. My lips were swollen and I was getting cold sweats. These episodes lasted from August through December. I started feeling better in December.
Information was received from an office administrator concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. It was reported that on 02-AUG-2016, the patient was vaccinated with VAQTA (dosage, lot number, and route of administration not provided), and on 01-NOV-2016 was inadvertently vaccinated with VAQTA injection "25/0.5", lot# M027879, expiration date 24-JAN-2018 (dosage and route of administration not provided). No adverse effects reported. Additional information has been requested.
Had Covid, diagnosed September 4, 2022, Had bivalent booster on 10/30/2022. Developed swollen lymph nodes, swollen eyes and tested positive for Mono EBV , end of November of 2022.  I still have swollen glands, eyes and fatigue currently as of today. The symptoms are not improving.  I had Mono at the age of 11, 54 years ago. I am unsure if this reaction was a result of the vaccine or the  covid, or both, however I thought it was important to report.  I was hopeful there would be some sort of treatment.  It has been approx 4 months experiencing these symptoms and they are not improving.
Body rash on entire torso.  After the second injection, on 3-25-21, the rash became more significant. The rash began in Feb as a few red bumps at my waist.  Within a day, it had moved up my torso including the top of my inner thighs.  The rash was almost gone by the second inject. However, after the second injection, the rash doubled in size and appeared the following day.
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 29-JUN-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA002267: US-009507513-1907USA012223:
pt recv vax 23AUG96 & 14SEP96 pt was hosp & dx w/viral meningitis;addtl details will be requested;
Mother reported no adverse reaction after immunization. Being investigated as a SIDS death.  Nurse follow up on 11/03/04 states: "No new information."  10/21/04 ER records received which revealed patient was in cardiac arrest on arrival & was unable to be resuscitated.  ER called coroner.
Patient is a 9 month old male that was given Meningococcal B (Trumemba) instead of Hepatitis B vaccine. That same night of vaccination had fever and irritability.
Pt was given TD intradermally 0.5ml, pt developed red raised bump size of quarter 2 days post vaccination. No other symptoms that pt reported.
Having consistent drowsiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Aug2021 11:30 (Lot number: FC3180) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: 10Aug2021, Lot: FC3180, NDC: Unknown , Expiration: Unknown , Route of administration: Right shoulder, Time the Vaccination Was Given: First dose: 11:30), administration date: 10Aug2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset 31Aug2021, outcome "not recovered", described as "Having consistent drowsiness".  Additional information: The caller states she received her first dose Pfizer Covid Vaccine on 10Aug2021 and the first day of drowsiness was on 11Aug2021. The caller states the drowsiness is persistent and continued after receiving the second dose Pfizer Covid Vaccine on 31Aug2021. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  No follow-up attempts are possible. No further information is expected.
Client reported shortness of breath with gradual onset within 30 minutes  of vaccination. Monitored by paramedics and symptoms resolved without treatment.
Patient presented to ED on 18Oct21 c/o severe headache and back pain after receiving her first Pfizer COVID19 vaccine on 15Oct21. After getting the shot, she reports having immediate severe headache lasting 2 days. Pain migrated to her midline lumbar spine region and radiated to both LE's so she came to the ER.  There was a small consolidation in the lungs so was treated for pneumonia. Initial exam below:  "Gen: patient is writhing on the bed c/o excruciating pain in midline lumbar region + headache HEENT: Atraumatic, PERRL, no nasal discharge, airway patent, voice wnl Neck: Full ROM, no meningismus CV: RRR, no m/r/g, strong peripheral pulses Pulm: BL CTA, no increased WOB Abd: Soft, non-distended, non-tender w/o guarding Back: No injury, tenderness MSK: + midline TTP lumbar spine region Neuro: AAOx3, moving all extremities, normal speech, normal gait Skin: Warm, dry, no rash Psych: Normal mood, affect" Patient was admitted but developed progressive altered mental status and was intubated and transferred to a high level of care at another hospital on 20Oct21.  Unclear follow-up from other Hospital. Though patient is being transferred to yet another hospital facility. Suspected diagnosis is Guillain barre with Miller Fisher variant.
Dry mouth and throat; Dry mouth and throat; This is a spontaneous report from a non-contactable consumer, the patient.  An adult female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number Gl5730), via an unspecified route of administration in the left arm on an unspecified date as a single dose for COVID-19 immunization.  Medical history and concomitant medication was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Dec2020 the patient experienced dry mouth and throat. The events were reported as non-serious. The patient did not receive any treatment for the dry mouth and throat. The clinical outcome of dry mouth and throat was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Swelling, redness and irritation at vaccine site in addition to minor left axillary swelling that started approximately 12 hours prior to vaccine site reaction noticed.
Chills, fever up to 102.5, and aches. Alternating ibuprofen and Tylenol lowered the fever to 100 but weren?t able to break the fever for over 12 hours. Temperature is continuing to drop back to normal range now.
testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 2nd of 14 reports.   An elderly patient (more than 65 years) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021 with outcome of unknown. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab. The event resulted in doctor or other healthcare professional office/clinic visit.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient.
after second (day 3) dose ran a fever for about 24 hours then again after third (day 7) dose ran a high fever; 104 Fahrenheit fever for 24 hours; Initial information was received on 16-Apr-2021 regarding an unsolicited valid  non-serious case from a physician.  This case involves a four-year-old female patient who experienced after second (day 3) dose ran a fever for about 24 hours then again after third (day 7) dose ran a high fever; 104 Fahrenheit fever for 24 hours  (pyrexia), after receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's medical history included Animal scratch. The patient's past medical treatment(s), vaccination(s) and family history were not provided. List concomitant -no other vaccines.  On 07-Apr-2021, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via intramuscular route in the left leg. She also received second and third dose of the same vaccine on 09-Apr-2021 and 13-Apr-2021 respectively, (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in APR-2021, the patient developed non-serious after second (day 3) dose ran a fever for about 24 hours then again after third (day 7) dose ran a high fever; 104 Fahrenheit fever for 24 hours (pyrexia) (unknown latency) following the administration of RABIES (HDC) VACCINE.  It was reported that, the child received the first dose without problem. Her fourth (day 14) dose is due on Wednesday, 07-Apr-2021, and her parents are concerned regarding the elevated fever.  Relevant laboratory test results included: Body temperature - On an unknown date: 104 Fahrenheit.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown for the event.  There will be no information available on the lot number for the two doses in this case.
At around 1 pm I started feeling fatigued. Around 2 pm I started feeling warm. I took my temperature around 2 pm and I had a fever of 101.4.  After that I started having chills, so I took my temperature again and it was 101.6. I decided to lay down for a while. Around 6:30 pm I got up and took my temperature and it was 103.1.  At that time I took 2 500 mg Tylenol. Around 8:30 pm I took my temperature and it was 99.0
Side effects are rash on legs and Arms & itching on back On the 3rd day swelling a little bit on foot
This spontaneous retrospective pregnancy report as received from the Nurse Practitioner,, for GARDASIL, a Pregnancy Registry product, refers to a 26 year old female patient. The patient received her third dose of GARDASIL (lot # was 1696AA; exp. date was 12-SEP-2014) 0.5ml, intramuscularly on 26-JUL-2012. The patient had no concomitant medication. There is no medical history and no drug reaction or allergy. At the time of the third dose, the patient was "one week to ten days pregnant". The last menstrual period was approximately on 16-JUL-2012 and the estimated delivery date was on 22-APR-2013. The fetus was followed throughout the pregnancy and monitored for "fetal pyelectasis which the nurse described as a "congenital abnormality of the kidneys" with unspecified diagnostic testing. The mother was induced as a result of low amniotic fluid, and the baby was delivered on 24-MAR-2013. The baby was diagnosed with the kidney abnormality "mentioned above with unspecified diagnostic testing, and the Nurse practitioner stated it had not resolved by her check up appointment in January. The outcome of the event was unknown. The baby's report was captured in Marrs # 1304USA014310. Additional information has been requested.
pt recv vax & 2wk later pt devel a rash consisting of approx 50 lesions;
12:37 PM: PATIENT ARM SWELLED UP WITHIN MINUTE AFTER INJECTION (APPROX. 1 IN. WIDE BY 2 IN. LONG & RAISED 1/4 IN). I APPLIED ICE PACK ON THE SITE APPROX. FOR 15 MINS., THE SWELLING WENT DOWN. PATIENT WAS FEELING FINE NO PAIN. AFTER 15 MINS. THE INJECTION SITE SWELLED UP AGAIN, THE PATIENT WAS FEELING FINE (NORMAL). I DID COUNSEL REGARDING GIVING BENADRYL INJECTION IF SHE EXPERIENCING ANY SYMPTOMS. PATIENT REFUSED BENADRYL INJECTION. AFTER MORE THAN AN HOUR THE INJECTION SITE LOOK MUCH BETTER. I COUNSELED AND GAVE BENADRYL TABLETS AND WATER TO PATIENT AT 1:37 PM, PATIENT SAID SHE WILL TAKE THE BENADRYL IN THE CAR WHILE HER HUSBAND DROVE HER HOME. SHE MENTIONED THAT SHE NORMALLY TAKE 1/4-1/2 TABLET OF BENADRYL BECAUSE SHE DOES NOT LIKE TO BE KNOCK OUT. I COUNSELED HER TO TAKE WHOLE TABLET TO HELP WITH ALLERGIC REACTION. I CALLED HER AT 8:05 PM, SHE SAID IS FINE, NO MORE SWELLEN, NO PAIN. I AM NOT SURE IF THE PATIENT TOOK THE BENADRYL OR NOT CAUSE SHE WAS NOT 100% SURE IF SHE TOOK IT. 10/13/23 1:20 PM: PATIENT IS FINE.
Side effects due to the Moderna vaccine; Couldnt breathe. It was pretty severe and almost passed out, had to put her legs in the air to let the oxygen get back to the brain; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects due to the Moderna vaccine), INFLUENZA LIKE ILLNESS (Flu like symptoms) and DYSPNOEA (Couldnt breathe. It was pretty severe and almost passed out, had to put her legs in the air to let the oxygen get back to the brain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 08-Feb-2021, the patient experienced DYSPNOEA (Couldnt breathe. It was pretty severe and almost passed out, had to put her legs in the air to let the oxygen get back to the brain). On an unknown date, the patient experienced ADVERSE EVENT (Side effects due to the Moderna vaccine). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. On 07-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. On 08-Feb-2021, DYSPNOEA (Couldnt breathe. It was pretty severe and almost passed out, had to put her legs in the air to let the oxygen get back to the brain) had resolved. At the time of the report, ADVERSE EVENT (Side effects due to the Moderna vaccine) outcome was unknown. Not Provided          This case was linked to MOD-2021-031127 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Follow-up information includes concomitant ,treatment and events were added. On 06-Jul-2021: Follow-up information includes contact information were updated.
Myalgia, Fever up to 101, Chills.  Treat with Tylenol or Motrin, Bath/Ice Packs, Pushe fluids.
On 03/18/21 at approximately 0:930am patient presented to be vaccinated with the Moderna vaccine, against the Covid 19 virus. Upon arrival at my station, patient had passed through our registration process and advanced to the vaccination station. Upon arrival at my station, I reviewed his chart and concluded that, based on his responses that he met the criteria to be vaccinated. I vaccinated patient and upon escorting him to our observation area I discovered that his age was not sufficient in order to qualify for the vaccination. I immediately reported this error to our clinician who was entering the data. I was later contacted by our supervisor of the error and that I needed to vett every
This is my second shot and I have a very bad rash on my breast, under my breast, and my groin. I have had it since last month of May and it keeps me up at night along with a fever at times now.  I need to know what I should do?
Patient noticed later in the evening after receiving her vaccines that her left arm was red, swollen and hot to the touch. The redness had spread down to her elbow by the time she called the pharmacy on 10/5/22. I recommended that she call her physician to determine if she needs an antibiotic for potential cellulitis.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (31Jan2023) Positive, notes: tested positive 31Jan2023; (09Feb2023) Negative, notes: Tested negative 09Feb2023 and 10Feb2023 and had no symptoms; (10Feb2023) Negative, notes: Tested negative 09Feb2023 and 10Feb2023 and had no symptoms; (11Feb2023) Positive, notes: Symptoms restarted on 11Feb2023 and I got a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No known allergies. product was COVID 19 Treatment, brand was paxlovid,, treatment start date at 01Feb2023, treatment stop date at 05Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19".
pt recv vax 5MAY97 & 9JUN97 pt devel lesions over the face, eyelids, & abd;