chrisvoncsefalvay/vaers-outcomes huggingface dataset:
less than a year old patient received Havrix adult dose; less than a year old patient received Havrix adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old female patient who received HAV (Havrix adult) (batch number 4CY9H, expiry date 28th April 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received the 1st dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-Aug-2022. Reporter's Comments: The nurse reported that a patient who was less than a year old received an adult dose of Havrix. The reporter consented to follow up via email.  Additional Supportive Information: The patient who was less than a year old received an adult dose of Havrix, which led to overdose and adult product administered to child.
Patient received their second Pfizer vaccine.  They were walking in front of the pharmacy and I noticed the gentleman helping her  walk toward me in the pharmacy.  She fainted and he helped her to the ground where she was sitting.  I went out to help her to a chair.  We gave the patient something to drink and waited with her until she felt better.  There were no injuries noted.  The patient said she was extremely nervous and felt she had a panic attack which led to her fainting.
Initial non-serious report received from a health care professional on 04 November 2008. A 32 year-old female patient developed runny nose, itching and upset stomach one hour after receiving an intramuscular deltoid of FLUZONE. The symptoms lasted for four days. No additional details were provided. The reporter of this case is the same as cases 2008-03431 and 2008-03433. Documents held by sender: None.
Redness, itching at vaccine site 3" in diameter, (L) thigh.
My lip felt sore and swollen. I looked in the mirror and it?s moderately swollen. I had filler in my lips 2 years ago.
Flu-like symptoms.  Aches, fever, chills.  Began the morning after the shot.  Ended the following morning.
Patient had Pediarix, Hib and Prevnar on January 5, 2004.  Tylenol was give for the first 8 hours.  On the evening of the 6th, the baby was more fussy than usual but was not febrile according to the parents.  Tylenol was given anyway.  The morning of Jan 7, the baby's temp was 102.  Tylenol was given.  Baby awoke from a nap on 1/7/2004 at 18:45 and have a temp to 101.7.  Tylenol was given at 19:00.  At 22:30, temp was 105 rectally by digital thermometer.  Baby was mottled, having chills and had blue lips per these parents.  I saw the baby shortly after that and he was well appearing and his temp was 100.3.  Because of his age and the history, I did a sepsis work up.  Cath urine was neg with a neg urine culture.  Blood culture was negative.  Spinal fluid was normal and cultures were negative.  Peripheral WBC was 9.2 with 73.8% polys, 16.4% lymps, 9.3% monos.  The remarkable things were his lytes.  Na 130, C)2 15 and glucose 166. After observation, baby was discharged and followed up the next day.  In the office, temp was 100.5 and had a normal exam.
Shivering, severe headache, shooting joint pain in hips, fingers, knees, toes, jaw. Severe weakness, nausea, burning skin and nerves (like I had a bad sunburn), sweats. Started about 8 hrs after shot, continued for 12+ hours. Headache, weakness and sweats lingering.
pt recv vax & exp a rash from head to foot;tx w/unspecified antihistamine & rash resolved;
pt brought to ED via EMS from nursing home with increasing SOB; was positive for COVID day before coming to ED; worsening mental status; acute on chronic hypoxic respiratory failure secondary; and type II non-STEMI; COVID pneumonia; pt became unresponsive, pulseless; asystole; code blue x 15 mins; pt passed away in ED
I started to have a psychotic break to were the police and fire department were called. I was delusional and I was put in a psych ward. I wasn't in reality anymore. This has never happened to me before. It took me from 06/09/2022-06/21/2022 to become back sane. They prescribed me medication that I must take for life.
On Friday 4/9 I experienced chills, fever and body aches.  I called the on call doctor and he informed me my symptoms would be better in 24 hours and to call back if my symptoms worsened.  On Saturday 4/10 I started having problems breathing and pain in my chest which lasted all day.  Sunday 4/11 I went to the emergency room of which I was admitted and was told I had Pulmonary Embolism.  I am currently being treated with Eliquis.
Raised rash on legs, arms, stomach, and cheeks. No fever, no itching, no pain. Vaccines given on 6/29/10. Rash started on 7/4/10.
Woke up one morning w/pain/ache in left lower jaw/back teeth, especially w/opening my mouth.  Chewing on back molars hurt.  As time went on pain worsened and radiated into my cheek, left eye and left ear.  ~ One week later, I saw a dentist; he couldn't say whether it was TMJ or tooth problem, so sent me home w/quick splint to separate my top & bottom teeth at night and some exercises.  These didn't help, so ~ a week after that, he gave  me antibiotic.  No improvement in symptoms until ~ a week after that.  I saw pcp, as it felt like something was crawling inside my left ear.  Ears were fine; she agreed w/inconclusive answer of dentist - at this point, there was some improvement in my symptoms.  She suggested prescription-strength Naproxen for 10 days, which I did.  the pain/ache has been mostly gone since completing the Naproxen.  For last few weeks, I've been back to normal - no ache/pain/strange sensations in ear at all.
blood clot on the lungs; This is a spontaneous report from a Pfizer sponsored program. Received from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient already got the 1st dose of the vaccine and have a 2nd dose schedule tomorrow. They wanted to reschedule the 2nd dose because the patient was in the hospital and might have a blood clot on the lungs. Treatment was received. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Patient was given both the FLUARIX and the PNEUMOVAX shot in the right arm on 10/5/18 at 06:45pm. Patient presented to the store the following day (10/06/18) with swelling at the injection site and up towards the clavicle. There was no fever, rash, or redness just pain and swelling. I advised patient to take ibuprofen and will follow up with patient next day to see if symptoms improve.
Pain in arm; Kind of allergy you know like sneezing a lot, the whole day I have been sneezing; Kind of allergy you know like sneezing a lot, the whole day I have been sneezing; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Consumer stated, "I have a question about, I just had Pfizer on last Friday so I didn't have any symptom anything, the next day on 19Dec2020 I have like my arm pain, not swollen just pain and then I have kind of allergy you know like sneezing a lot, it is  the whole day I have been sneezing and just like the whole day. Is it allergy to the Pfizer or should I just have another like second shot should I have it or is it the allergic reaction or what is that? It is the COVID the one COVID I had from Pfizer (COVID Vaccine). Because of I am afraid to have second shot if I have like more allergy or." The outcome of the events unknown.   Information on the Batch/Lot number has been requested.
This spontaneous report was received from a licensed practical nurse concerning an unspecified amount of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients was vaccinated with doses of improperly stored VARIVAX (dose, frequency, route and indication not reported, lot # M046924 with expiration date 28-NOV-2018) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature that the vaccines exposed to was 6 F to 14 F with time frame 1 hour. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. ; Sender's Comments: US-009507513-1708USA012061:
he got shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (he got shingles) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HERPES ZOSTER (he got shingles). At the time of the report, HERPES ZOSTER (he got shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Urgent care doctor  prescribed an antiviral for treatment of shingles.  No concomitant medications was reported   This case was linked to MOD-2021-350352 (Patient Link).
A serious spontaneous report of meningitis has been received from a non-health professional concerning a five-year-old female, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. On 01-Nov-2010, patient received FLUMIST. On 15-Dec-2010, patient experienced meningitis. As per the reporter, it was because of FLUMIST. The outcome of the event was unknown. The reporter assessed the event of meningitis as related to FLUMIST.
Received Pneumovax 23 in Right deltoid. No symptoms until ~2AM. Pt reports arm (shoulder) doubled in size and pounding and hot to touch. Put ice on shoulder and took ibuprofen. Reports nausea. No fever. Went to an urgent care in morning and received antihistamines and ibuprofen. Arm feeling better.
she has received the Moderna vaccine and she has experienced side effects that have lasted longer than two months; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (she has received the Moderna vaccine and she has experienced side effects that have lasted longer than two months) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 IMMUNISATION REACTION (she has received the Moderna vaccine and she has experienced side effects that have lasted longer than two months). At the time of the report, IMMUNISATION REACTION (she has received the Moderna vaccine and she has experienced side effects that have lasted longer than two months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Felt jittery; sore left arm; This spontaneous case was reported by a nurse and describes the occurrence of FEELING JITTERY (Felt jittery) and PAIN IN EXTREMITY (sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included ESTRADIOL (ESTROGEL) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING JITTERY (Felt jittery) and PAIN IN EXTREMITY (sore left arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 28-Feb-2021 for Pain in extremity, at an unspecified dose and frequency. At the time of the report, FEELING JITTERY (Felt jittery) and PAIN IN EXTREMITY (sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   .   This case was linked to MOD21-041846, MOD21-041948 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-MAY-2021 contains non-significant information.; Sender's Comments:  MOD21-041846:same reporter MOD21-041948:same reporter
c/o  swelling of lt upper arm (lymph node);pt spoke w/MD & said it might be related;pt got better as the day went on;
Dizzy, nauseated, developed axillary lymphadenopathy on side with Menactra inoculation.
Patient  delivered by NSVD without complication on 6/4/2021 and was stable post delivery.  She had a 7# 15oz, female. Hospital admission within 6 weeks of receiving the COVID vaccine.
Patient was vaccinated with PCV13 on 5/1/18 and again with PCV13 on 6/26/18. Patient has been notified of error and warned of the increased risk of side effects including arthrus reaction.
Fully vaccinated patient admitted through ED for COVID-19. Provider D/C note below:  "81-year-old male patient with past medical history of obesity, hypertension, diabetes mellitus type 2   Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)   Treated  For covid 19    Started on Eliquis for AFib  Eliquis stopped on the advice of Cardiology, also she stopped remdesivir due to bradycardia   Acute hypoxic respiratory failure due to COVID-19 infection /pneumonia CTA has ruled out PE, on remdesivir and steroids   Atrial fibrillaton -was found to be in AFib on the night of 11/8, converted back to sinus rhythm, echo showed LVEF of 60%, grade 2 diastolic dysfunction,  started on anticoagulation ChDVASC of 4   was on Eliquis, 11/1.  On the advice of Cardiology cause of isolated event of AFib   Bradycardia-with episodes most likely related to remdesivir, which has been discontinued  11/12 continues to be bradycardic often in 40s his, asymptomatic Planned discharge was  Postponed, , after discussing with cardiologist since heart is improved patient was discharged Cellulitis of the right leg- on Ancef from 11/8, improving "
The pt states in approx. 2005 while working on the postpartum ward as an RN she received a FLUMIST vaccination. Initially, the pt reported that she had received Influenza IM but has since recalled that it was FLUMIST. The pt states she immediately had burning in her sinuses. At the end of the shift (7PM) the pt noted that she was fatigued, had a headache, felt feverish and had nasal congestion. The next day the pt went to work and was so fatigued that she fell asleep at the nurse's station so she went home. The symptoms continued and additionally she developed a productive cough and chest discomfort when she coughed. The pt treated herself with OTC medications. The fatigue, fever, headache, nasal congestion lasted 3-4 days. The cough lasted 3-4 weeks. The pt did not seek medical attention. At the time there were no other sick family members and no co-workers who were ill with similar symptoms. Symptoms: Pain, Fatigue, Malaise >60 Days, Fever, Headache, general, Cough productive.
Feeling cold and hot at night. Body feels cold to touch and feeling freezing but sweating as well.  Having symptoms like thyroid disorder. Fatigued and brain fogginess noticably. I have a lump(benign cyst)  in the back side of neck and it started having pain after the vaccination which never bothered me for more than 5years.
Approximately 26 hours after injection pt experienced chills and fever of 101.5, painful swelling at site with 13 x 20 cm induration and 10 x 15 cm erythema. Tx with ice. Rechecked by MD several times. Complete resolution.
Confusion, Myalgia, Fever, Nausea Vomiting & DELIRIUM
Vaccine expired on 04/06/2022, vaccine was given on 04/06/2022. Moderna was contacted once we were made aware that the vaccine was expired. Moderna concluded that the vaccine had maintained viability and no reimmunization was needed.
other zoster related injuries; herpes zoster; varicella type rash; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 59 years old. No information was reported about the pt's medical history, concurrent conditions or concomitant medications. On or about 18-APR-2014, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a physician for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by physicians and other healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: herpes zoster, varicella type rash, and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatments were provided. HCP has provided demographics for all the patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021). For this patient, the number of days that have passed were 4   This case was linked to MOD-2021-278394 (Patient Link).
MODERNA VACCINE GIVEN TO UNAUTHORIZED AGE GROUP (16 Y/O AT TIME OF VACCINATION).  WE DID NOT REALIZE UNTIL AFTER VACCINE WAS ADMINISTERED.  PT AND GUARDIAN WERE CONTACTED AND PT HAD NO ADVERSE EFFECTS.  PT WILL RECEIVE 2ND DOSE 28 DAYS AFTER 1ST DOSE AS PER CDC GUIDANCE AND PER PT AND GUARDIAN WISHES.  PT DID NOT FILL OUT ONLINE SCREENER WHEN SHE REGISTERED THAT CONFIRMED THAT SHE WAS CORRECT AGE TO RECEIVE THE VACCINE.  WE HAVE NEW STORE POLICIES IN PLACE TO PREVENT THIS FROM HAPPENING AGAIN (CHECKING ID'S AND MATCHING WITH DOB ON INTAKE FORMS)
felt weaker; difficulty breathing while sleeping; could not walk at my normal pace; pulse was 102; Pulse irregular; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse was 102), ASTHENIA (felt weaker), NOCTURNAL DYSPNOEA (difficulty breathing while sleeping), DECREASED GAIT VELOCITY (could not walk at my normal pace) and HEART RATE IRREGULAR (Pulse irregular) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement in 2013. Concurrent medical conditions included AFib in 1980. Concomitant products included METOPROLOL SUCCINATE for Atrial fibrillation, FUROSEMIDE from 15-Feb-2021 to an unknown date for an unknown indication.    On 18-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEART RATE IRREGULAR (Pulse irregular). On 31-Jan-2021, the patient experienced HEART RATE INCREASED (pulse was 102). On an unknown date, the patient experienced ASTHENIA (felt weaker), NOCTURNAL DYSPNOEA (difficulty breathing while sleeping) and DECREASED GAIT VELOCITY (could not walk at my normal pace). On 23-Jan-2021, HEART RATE IRREGULAR (Pulse irregular) had resolved. At the time of the report, HEART RATE INCREASED (pulse was 102) and ASTHENIA (felt weaker) had not resolved and NOCTURNAL DYSPNOEA (difficulty breathing while sleeping) and DECREASED GAIT VELOCITY (could not walk at my normal pace) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood pressure measurement: 500 (High) I made over 500 blood pressure.. On 07-Jan-2021, Heart rate: 67 (Low) Low. On 31-Jan-2021, Blood pressure measurement: 144/93 (High) High. On 31-Jan-2021, Heart rate: 102 (High) High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported his normal resting pulse rate was in the 60s. The patient took pulse readings on 23JAN2021 which were 93, 70, 63, 77, 72, and 50. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-114911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: follow up information received Contains significant information, Added  patient's demographic information, batch/lot no., concomitant drug information updated.
The shot was administered very high on my arm and hurt very much on entry, unlike previous vaccinations where I felt the needle and stinging but not real pain. By that evening my arm hurt so intensely I couldn't raise it and my husband had to cut up my food so I could eat dinner. I took acetaminophen before going to bed and it did nothing to reduce the pain. The pain in my shoulder was intense when I tried to lie down. That night and the next I could only get comfortable by sitting up, so I had to doze while sitting up instead of going to bed. My range of motion remains restricted. I am a side sleeper but have to sleep on my back now or I feel pain in my arm. I began taking Ibuprofen on Oct. 27.
received first dose of vaccine and slept for two days straight; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  It was reported that the patient slept for two days straight on an unspecified date. The outcome of the event was unknown.
Fever, chills, horrible headache, overall pain, faint, but then 2 hours of awful heartburn. It went away on day 2 and some heart pain returned on day 3 and hasn't returned.
This is to report vaccine administration error. The 2 nd dose of Hepatitis A was administered earlier than a 6 month recommended interval. The first dose was given on 5/1/2023 and the second dose was administered on 6/14/2023.
Myocarditis, pericarditis, pericardial effusion, pulmonary effusion