chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 79 years old male patient with no drug reactions/allergies. The patient was vaccinated with a dose of live ZOSTAVAX (lot# 669634/0752AA, exp 20-FEB-2012) subsequently on 03-FEB-2012. No other co-suspects were reported. No concomitant medications were reported. On approximately 10-FEB-2012 the patient experienced shooting pain at the injection site which lasted for 2 or 3 days. This shooting pain outcome of shooting pain at the injection site was reported as not recovered. The relatedness for shooting pain at the injection site was unknown for live ZOSTAVAX. The patient had called the pharmacy for medical attention. Additional information is not expected.
5-6 Covid symptoms; 5-6 Covid symptoms; This is the spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 18Mar2021 for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient received first dose of Pfizer BioNTech Covid 19 vaccine. Then on this past Sunday (04Apr2021), she started having 5-6 Covid symptoms, but was feeling somewhat better today. She was having headaches, stomach cramping, chills, body temperature 100.4F, muscle aches, fatigue and diarrhea. She was due to receive her second dose on Thursday and was awaiting Covid test results. Patient asked if she should hold off on receiving the second dose, and how long side effects could start happening. The outcome of events was resolving.   The information about lot/batch number has been requested.
Employee reports having fever of 101F, chills, and body aches later that night. Employee states fever and chills resolved by morning but the body aches continue until the next day.
Developed an echo in left ear that had become increasingly louder and the sound is at a slightlyhigher pitch than actual sound; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG 206) via an unspecified route of administration in the arm left on 11Mar2021 at 09:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, arthritis and obesity. It was unknown if the patient had any known allergies. The patient received other medications within two weeks of vaccination, names were unspecified. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021, the patient experienced an echo in left ear that had become increasingly louder. The sound was at a slightly higher pitch than actual sound. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event an echo in left ear that had become increasingly louder, the sound was at a slightly higher pitch than actual sound was not recovered.  No follow-up attempts are needed. No further information is expected.
muscle cramps; swollen lymph nodes under left armpit; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle cramps), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under left armpit), HEADACHE (headache) and CHILLS (chills) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCLE SPASMS (muscle cramps), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under left armpit), HEADACHE (headache) and CHILLS (chills). On 21-Mar-2021, MUSCLE SPASMS (muscle cramps), HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under left armpit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.  All symptoms resolved after about a week they have started.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Start date of all the events are updated. Outcome of the event [VACCINATION SITE LYMPHADENOPATHY] has been updated to recovered from unknown.
Symptoms: Tightness of chest, fast heart rate, facial and scalp itching  Outcomes: Given benadryl at 12:30, consulted with MD, 2nd dose given at 12:45. Stable VS throughout. Patient advised to get ride home.
miscommunication with patient who did not mention she wanted the hep b vaccine, but instead received a dose of COVID shot. later learned that this was her 3rd dose as she completed 2nd shot a month ago. Incident report was created and PCP was notified
This case was reported by a healthcare professional and described the occurrence of vomiting in a 4-month-old male subject (reported as less than 20 weeks of age) who was vaccinated with ROTARIX (GlaxoSmithKline).  There were no known concomitant medications.  On 27 August 2009 at 17:30 the subject received unspecified dose of ROTARIX (oral).  On 27 August 2009, immediately after vaccination with ROTARIX, the subject experienced vomiting.  The subject vomited after the dose of ROTARIX and per reporter, majority of the dose was vomited.  The reporter requested to know if a ROTARIX dose can be repeated.  The subject was still in the office at the time of reporting and no other adverse events were noted.  At the time of reporting the outcome of the event was was unspecified.
Trouble breathing, vertigo, brain fog , severe headache , Big red swollen whelps  all over my body , that itches severely,  swelling of eyes, throat , joints ,  Feeling like I was going to die .
August 17, 2005 Vaccinations given. @ 3:30 pm August 22, 2005 102.5 fever - crabby August 23, 2005 103.0 fever - crabby September 3, 2005 102.0 fever September 4, 103.5 fever, vomiting, very lethargic and distraught. September 5, 2005 104.5 fever, very lethargic and withdrawn September 6, 105.2 fever.  Took her into the doctor and he said it's a reaction to the vaccines, more specifically the MMR.  Her ears where perfect, lungs = perfect, glands = perfect.  Said to wait another day or two and see if the fever goes away, if it DOES, it's the vaccines.  If not, we'll test for a UTI.  The fevers went away the next day.  She returned to her happy, playful self.  * Treatment for fevers: Ibuprofen and Tylenol alternating and that didn't even bring the fever down.
Site: Pain at Injection Site-Medium, Systemic: has a hard time lifting/extending arm-Medium
Injection was given 12/18/2020.  On 1/14/2021 at the sight, a pea-sized lump appeared which is painful to the touch and with movement.
Strong shaking, tremors. Starting with jaw, then whole body, then the legs. Lasted a few minutes.
Didn't feel well after his 2nd dose; This spontaneous case was reported by an other and describes the occurrence of VACCINATION COMPLICATION (Didn't feel well after his 2nd dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Didn't feel well after his 2nd dose). At the time of the report, VACCINATION COMPLICATION (Didn't feel well after his 2nd dose) outcome was unknown.            No treatment information was reported. Concomitant medication was not provided.   This case was linked to MOD-2021-006025 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates in 2018, the patient was vaccinated with two doses of GARDASIL 9 injection (exact dose, route, site of administration, lot# and expiry date were not reported) for prophylaxis. On an unknown date in 2018 (reported as "sometime after receipt of the vaccines"), the patient was diagnosed with Guillain-Barre Syndrome. The outcome of the event was not recovered (reported as "ongoing"). Causality between the event and the suspect vaccine was not provided. Upon internal review, the event of Guillain-Barre Syndrome was considered to be medically significant.
Arm swelled below shot site, large red circle developed, intense itching, some pain. Three weeks later, some swelling and redness still present but itching and pain has stopped. I used Benadryl cream and Tylenol.
No additional adverse event or product quality complaint were reported; Inadvertently gave an employee a dose of  PROQUAD instead of MMRII; Inadvertently gave an employee a dose of  PROQUAD instead of MMRII at the age of 56 years old; This spontaneous report was received from a License practical nurse referring to a 56-year-old patient.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 04-FEB-2021, the patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported) for prophylaxis.     On 05-MAR-2021, the patient was vaccinated inadvertently vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live(PROQUAD) at a dose of 0.5 milliliters, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered).  The second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) had been not administered yet.   No additional adverse events or product quality complaints were reported.
a drastic change in my health/experienced health related issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jul2021, for COVID-19 Immunization, reaction(s): "a drastic change in my health/experienced health related issues". The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset Aug2021, outcome "unknown", described as "a drastic change in my health/experienced health related issues".  Additional Information: It was reported that the patient noticed a drastic change in health in Aug2021 when 2nd dose COVID vaccine was received. The patient also experienced health related issues and knew that they were directly connected to the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300101458 Same patient, Same reporter, Same product, Different dose, Same event;
pt recvd vax & 24 hrs p/vax exp dizziness & poss eye problems which resolved; 30 days dose 2 pt exp lt & rt forearm pain, weakness & demyelination; these sx are unresolved; MS was r/o;
This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received TRUMENBA, (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling of arm and fever both on an unspecified date. The outcome of the events was unknown. The following information on the batch number has been requested.
injection site redness; injection site swollen; injection site soreness; Body temperature increased; This case was reported by a consumer via other manufacturer and described the occurrence of injection site erythema in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included eculizumab (Soliris) for myasthenia gravis.   On 10th June 2019, the patient received Bexsero. On 11th June 2019, the patient started Soliris (intrvenous push) 10 mg/ml at an unknown frequency. In June 2019, less than a week after receiving Bexsero, the patient experienced injection site erythema, injection site swelling, injection site pain and body temperature increased. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were not recovered/not resolved and the outcome of the body temperature increased was unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and body temperature increased to be related to Bexsero.  Additional details were received as follows: The age vaccination was not reported. The patient stated that the area around where received the vaccine was red, sore ans swollen. The patient body temperature was 99 something but the patient had not considered it as fever. Treatment was not reported. At the time of reporting the action taken with soliris was not reported. No additional information has been requested since the reporter did not consent for follow up. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and body temperature increased to be related to soliris as well.      Lab Comments: On an unknown date body temperature was recorded.
4MAY04 1500: skin lesions on face that aren't healing. Since start of July bilateral puffy eyes and open lesion on right side of nose bridge.
Patient was given an expired adult covid vaccine. Unware that the vaccine was expired at the time that the vaccine was given to patient.  Saw a co worker vaccine draw vaccine and thought that it was okay to draw and started drawing also explain to supervisor that i was unsure of how many dose were in vial due to the person who took out not drawing all doses. The supervisor stated to draw the remaining and that would tell us how many doses. Vaccine then was given.  Pt was notified of the error and verbalized understanding.
Nausea. Vomiting. Cold sweat. Fever. Chills. Muscle aches.
Mother reports afternoon fever of 102 in the afternoon before he had an hour long seizure with dropping oxygenation level.
PLEURISY; PINS FEELING IN CHEST; COLD SYMPTOMS; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. The patient's past medical history included: heart murmur as baby, and jaundice. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the patient experienced cold symptoms. On 01-JUN-2021, the patient experienced pleurisy. On 01-JUN-2021, the patient experienced pins feeling in chest. On 04-JUN-2021, Laboratory data included: Lab test (NR: not provided) diagnosed as pleurisy. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Normal, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms on 23-MAY-2021, and had not recovered from pins feeling in chest, and pleurisy. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
day of vaccine went to bed and had chills, woke up 3:00 in morning had fever 101.6 took Tylenol and it went down but keeps going back up to 101.6  and arm is really sore and hard for me to move it.
The patient was inadvertently administered an expired dose of M-M-R II; This spontaneous report was received from an office manager, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (DILUENT MRK). The patient's medical history, historical drugs, concurrent conditions or drug reactions/allergies were not provided.   On 28-DEC-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(recombinant human albumin)(M-M-R II) lot # N032749, with expiration date 20-NOV-2019 for prophylaxis (strength, frequency, route, vaccination scheme and anatomical location were not provided).No temperature excursion was reported.
allergic reaction; couldn't hear; numbness around her mouth; Facial swelling; fingers were numb; tongue was swollen; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program, COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first vaccine on 12Mar2021 and then on 18Mar2021 she started having a numbness around her mouth, facial swelling, her fingers were numb, she couldn't hear, and her tongue was swollen. The patient took Benadryl every four hours. The following day the patient still had the swollen tongue and numb fingers. The patient thinks it was an allergic reaction. The patient wanted to know if it could be from the vaccine. The patient thought it was a spider bite, but the reaction didn't occur until 6 days after the vaccine. The patient has allergies that's why she didn't put it together. It was further reported that the patient had the vaccine on 12Mar2021 and started having an allergic reaction approximately 7 days later. The outcome of events swollen tongue and numb fingers was not recovered; the outcome of other events was unknown.  Information on the Batch/Lot number has been requested.
Information has been received from a consumer and a school nurse concerning 41 child pts who in approx 1995 were each vaccinated with a dose of varicella virus vaccine live. In approx 2003, the pts developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 pts were not previously vaccinated with a dose of varicella vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 7 year old pt who on 01NOV1996 was vaccinated with a dose of varicella virus vaccine live. On 11MAR2003, the pt developed chickenpox. The previously vaccinated pts. included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other pts that developed chickenpox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
After receiving the vaccination patient immedicatly stated her arm her.  after a minute or so she got extremely light headed.  we used ice on her neck and laid her on ground.  Her blood pressure fell to 73/40.  We recheck and it began to come back up.  Patient was fine about about 15 minutes.  Patient did mention numbess in fingers
PATIENT RECEIVED VACCINE ON THURSDAY 5/20/21 IN THE AM. SEEN IN OUR OFFICE ON 5/24/21 AND HE REPORTS SYMPTOMS OF RACING HEART, PALPITATIONS, LEFT CHEST TIGHTNESS, LOW FEVER, AND HEADACHE THAT STARTED THE EVENING OF 5/20/21, SAME DAY HE RECEIVED VACCINE. AT VISIT ON 5/24/21, HE REPORTS NEW LEFT ARM TINGLING IN ADDITION TO CONTINUED SYMPTOMS NAMED ABOVE.   EKG OF HEART PERFORMED IN OFFICE 5/24/21, WHICH SHOWED NO CHANGES COMPARED TO PREVIOUS EKG IN HIS RECORD FROM OCTOBER 2020.   LAB TESTS ORDERED ON 5/24/21 AND COMPLETED THE SAME DAY WERE WITHIN NORMAL LIMITS AND SHOWED NO CARDIAC CAUSE OF HIS SYMPTOMS. LABS ORDERED WERE: 1) COMPLETE BLOOD COUNT WITH PLATELETS AND AUTO DIFFERENTIAL 2) COMPREHENSIVE METABOLIC PANEL 3) HEMOGLOBIN A1C 4) TROPONIN I  ON 5/25/21, PATIENT CALLED OUR OFFICE TO REPORT NEW RASH ON ONE ARM AND HIS BACK. HE REPORTS RASH DOES NOT ITCH OR HURT.  ON 6/1/21, SPOKE WITH PATIENT AGAIN TO SEE HOW SYMPTOMS WERE DOING AND HE REPORTED THAT LOW FEVER, RASH, RACHING HEART, CHEST TIGHTNESS, AND LEFT AND RIGHT ARM TINGLING COMES AND GOES FROM DAY TO DAY, BUT HEADACHE HAS CONTINUED DAILY.
felt ill; out of balance; felt sick; sleep whole next day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt ill), BALANCE DISORDER (out of balance), ILLNESS (felt sick) and SOMNOLENCE (sleep whole next day) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MALAISE (felt ill), BALANCE DISORDER (out of balance), ILLNESS (felt sick) and SOMNOLENCE (sleep whole next day). On 25-Feb-2021, MALAISE (felt ill), BALANCE DISORDER (out of balance), ILLNESS (felt sick) and SOMNOLENCE (sleep whole next day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
PATIENT ACTED AS IF SHE WAS COMING IN FOR HER FIRST MODERNA DOSE.  WAS COUNSELED ON WHEN TO RETURN FOR SECOND DOSE. SHE ALSO ASKED ABOUT BOOSTER SHOTS AND WAS TOLD MODERNA BOOSTER WAS STILL PENDING. MEDICAL RECORDS WASNT PULLED UNTIL MINUTES AFTER VACCINE WAS ADMINISTERED. REALIZED PATIENT HAD ALREADY RECEIVED 2 DOSES  ON 2/8 AND  3/8. CALLED PATIENT IMMEDIATELY AND LEFT VOICEMAIL. PATIENT HAS YET TO CALL BACK AT THE TIME OF THIS REPORT