chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 14-JUN-2016, the patient was vaccinated with an expired dose of M-M-R II (lot # J009382, expiration date 08-AUG-2015, albumin status HSA), 0.5 ml, subcutaneous, anatomical location was unspecified. No concomitant medications were specified. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
PER MOTHERS REPORT THIS AM INFANT STARTED WITH LIGHT JERKING OF RIGHT ARM. LATER ON IN THE MORNING SHE NOTICED SOME JERKING TO RIGHT LEG. THROUGHOUT THE DAY INFANT STILL CONTINUES WITH JERKING MOTIONS OF ARM AND LEG. MOTHER ALSO REPORTS LARGE KNOT TO RIGHT LEG WHERE VACCINE WAS ADMINISTRATED. F/U APPT WAS MADE FOR CHILD IN AM AND MOTHER WAS NOTIFIED TO MONITOR CHILD AND TO TAKE TO ER IF JERKING GOT WORSE OR APPEARED TO HAVE SEIZURE LIKE ACTIVITY.
TIRED AT NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tired at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired at night was not reported. This report was non-serious.
Audible wheeze, chest and throat tightness that lasted about 24 hours. Took Zyrtec. Some lessening of symptoms.  Pt is a Nurse Practitioner.
Pfizer BioNTech COVID-19 Vaccine EUA: Bell's Palsy Patient received Pfizer COVID-19 Vaccine on 7/15/2021. Patient presented to the ED on 7/29/2021 at 1248 with a right-sided facial droop. Physical exam: PERRL. EOMI without nystagmus. Facial sensation intact in V1-V3 distributions. Uvula and palate raise is symmetrical. Tongue protrusion is midline. Normal shoulder shrug bilaterally.  Patient with right-sided facial droop. Decreased right-sided eyebrow raise. Patient treated with prednisone and Lacri-lube.
Headache, Myalgia, Arthralgia, NauseaVomiting, CHILLS/BODY ACHES/FATIGUE Narrative:
pt devel a gen rash described as small red spots under the skin, 14 days p/vax;reporter indicated 6-8pt exp this event;however, they are not presently identifiable;
ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 1/14/2023 & 1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
patient got COVID-19; patient is tired all the time; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (patient got COVID-19) and FATIGUE (patient is tired all the time) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     It was reported that patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Hypertension and Overweight. Concomitant products included LOSARTAN, CHARCOAL, ACTIVATED (CARBOTURAL), HYDROCHLOROTHIAZIDE, AMLODIPINE and POTASSIUM for an unknown indication.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced COVID-19 (patient got COVID-19) and FATIGUE (patient is tired all the time). In December 2022, COVID-19 (patient got COVID-19) had resolved with sequelae. At the time of the report, FATIGUE (patient is tired all the time) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received first dose of Moderna COVID-19 Vaccine on 22-Feb-2021 batch number 001A21A, second dose on 22-Mar-2021 batch number 047A21A, first booster on 25-Oct-2021 batch number 012521D  and second booster on 30-Mar-2022 batch number 0B6L21A. It was reported that patient experienced headache and nausea during 24 hours after dose 2. On 25-Nov-2022 patient got COVID-19 even after getting the Moderna shots, and it lasted approximately for 16 days till Dec 2022 and patient was currently tired all the time. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712228 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712228:Bivalent case
Patient began to cry in her sleep and was inconsolable.  She had a fever of 100.5.  After an hour or so of crying we finally got her to take a bottle.  She continued to cry afterwards until around 1am (10/14/10) when she threw up.  She continued to be fussy and cry off and on throughout the night.  On 10/14 she ate smaller amounts than usual but at normal intervals.  On 10/15 I received a call from daycare stating that she was refusing bottles and hadn't eaten in approximately 8 hours. She slept for 13 hours (much longer than usual for her) the night of 10/15 into 10/16.  On the morning of 10/16 I took her to urgent care to have her checked out.  They found nothing wrong with her, and she did not have a fever at the time.  They said it might be a virus or that she could still be exhibiting "fussiness from her vaccinations".  On 10/16 she continued to cry off and on all day for no reason and to be much more tired than usual.  She also refused bottles at several points throughout the day.  She had a fever of 101.2 on the evening of 10/16.  After giving Tylenol the fever lowered and she slept for 11.5 hours.  On 10/17 she continues to cry when awake and to stare and be generally fussy and cranky - not at all her normal personality.  She has cried more during this last week than she has in her entire combined.  She is generally a very easy going, happy baby.
Patient was vaccinated at 9:45am with 0.3mL of Moderna Bivalent instead of the usual dose of 0.5mL. At time of conversation patient was alert and showing no ill effects. Patient was notified of dosing error and it was communicated a medical consultation was in progress. Patient stayed 15 minutes for observation. Patient had other plans and needed to leave before a resolution was reached. A call later at 1150 am advised the patient of the resolution to revaccinated. Patient at the time reported no ill effects.
pt recvd vax 3JUN95 & 5JUN05 pt devel croup & was treated for 3 days;pt's brother was also vaxed & devel croup & a rash
Fever (102.2), body aches, fatigue, headache - SX lasted > 24 hours
1st dose 3 years ago and did not receive second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 94-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years before the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: This case was reported by the patient. The patient received his first dose of Shingrix 3 years ago and did not receive second dose. The patient was planning to receive second dose as soon as possible. The consent to follow up was given. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
began to experience dizziness/vertigo 2 weeks after 1st dose of pfizer vaccine.  For the first 5 days symptoms were intermittent, occurring 0-2 times per day, for several hours at a time.  Intensity was mild to medium.  Symptoms were worse when moving around, or with more head or eye movement.  Eating could also make symptoms worse.  On the sixth day the symptoms went from intermittent to constant, except when lying down. Symptoms remain constant on day 8.  Intensity still varies from mild to medium throughout the day.  I have not sought medical treatment at this point, mostly due to other people with the same symptoms reporting that Drs/ENTs were unable to find anything wrong or help them.
Patient came down with shingles after receiving SHINGRIX Vaccine/Suspected vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Patient came down with shingles after receiving SHINGRIX Vaccine/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUN-2023 The physician reported that the patient came down with shingles after receiving Shingrix vaccine. Limited information was provided. It was unknown of the gender, age, name of patient. It was unknown after which dose (first or second) the patient came down with shingles. According to the GlaxoSmithKline agent, the reporter had a lengthy conversation about the events. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This is 1 of 2 patients case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR088322:Same reporter, Report for 2 patient
Information has been received from a registered nurse concerning a 27 week old infant who was vaccinated on 05-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Severe large lump approximately 3 inches in full 360 circle on the arm. Red in color and raised approximately 1 inch. Tender to touch but very lumpy. I still to this day have a ball in the injection area. It hurts. I had hives for a few days but I took benadryl. two weeks later I called the doctor and she wanted to see me.
Pfizer-BioNTech COVID-19 Vaccine At approximately 4 pm on December 23 (day of vaccine) I experienced sudden onset of fatigue. I also had a low-grade temperature of 99.0 F with chills. By 5:30 pm, I was also bringing to experience lightheadedness and dizziness. That night at approximately 10 pm I had a temperature of 99.1. On December 24, I experienced lightheadedness and dizziness the entire day, from waking up to going to bed later that night. My eyes were glassy and I would feel an impulse of dizziness go distinctly from the right side of my head to the left, and then feel more dizzy after that. It was constant throughout the entire day and would occur while I was sitting, standing, or moving around. On December 25, I was tired but the dizziness had gone away.
Mother reported over 1 month later that patient had initial swelling LUE "whole arm" (wrist to shoulder) but it resolved on its own in 24-48 hours.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked with case 2018SA285692, from same reporter. This case involves a 55 years old female patient who experienced swelling at the site about 10-15 cm in size with redness, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 11-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On unknown date, the patient developed a non-serious swelling at the site about 10-15 cm in size with redness (extensive swelling of vaccinated limb) (erythema) and (vaccination site reaction) with Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not provided. Final diagnosis was swelling at the site about 10-15 cm in size with redness. As a corrective treatment to apply ice and alcohol compress was adviced. The patient outcome is reported as Unknown for swelling at the site about 10-15 cm in size with redness. List of documents held by sender- none.
at 8pm on 3/12, started with chills, cold sweats. Approx 12AM, started with fever 100.8, then around 2AM, fever was at 102.6. Also had body aches, and chills. very fatigued
7 days p/vax pt's eyes rolled back, jerking episode-stopped by gently shaking pt; mom notified MD whom did not think pt had sz & did not relate episode to vax;
Information has been received from a registered nurse concerning a 5th grade elementary school student who on 08/01/1995 was vaccinated with a dose of varicella virus vaccine live.  In mid December 2004 the student developed chickenpox.  According to the school nurse, 58 other students in the school developed chickenpox in mid December 2004 and 34 of them had previously been vaccinated with a dose of varicella virus vaccine live.  Unspecified medical attention was sought.  There was no information regarding the present status of the 5th grade student.  No product quality complaint was involved.  Additional information has been requested.
Large welt 1 and a half incest at injection site discomfort and then redness 3 inches round.
Left thigh marked redness and swelling, area of swelling 16" x 17" extending to knee. Placed on Omnicef 250/5 1 90 x 3 days and Benadryl PO q 6h.
a rash around my main torso on my back and underarms/ itchy rash; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient stated that, since getting the Shingrix vaccine, he or she had been breaking out in a rash around his or her main torso, on back and underarms. The patient also mentioned that, the rash seemed to clear up some and then break out again. There were no blisters, just fine but very itchy rash. The patient was asking if this was normal. No further information was provided.  Note- as per the nature of event (rash), TTO is kept unknown even if reported as since getting shingrix vaccine. Also no dates were provided.
Pt rcv'd varicella vax, at age 4. 12/2 (age 7) pt devel fever and didn't feel well. 12/27 had multiple pox marks. Sx subsiding by 12/29.
Left arm numbness; hand tingling; left jaw pain; Left side of face and scalp began to burn; Internal tremor of the brain; dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 40-years-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: Er8730 and Expiration date was not reported), via an unspecified route of administration, in right arm (age at vaccination 40-year-old) as 2nd dose, single for covid-19 immunisation and patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,: solution for injection, Batch/Lot Number: En6208 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 19Mar2021 09:45 AM for covid-19 immunisation. Medical history included hypervitaminosis, migraines, and prior to vaccination, patient was diagnosed with COVID-19. The patient was allergic to Levaquin. Concomitant medications that patient received within 2 weeks of vaccination included ferrous citrate (IRON [FERROUS CITRATE]). Facility where the most recent COVID-19 vaccine was administered in hospital. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Prior to vaccination, patient became now not diagnosed with COVID-19. Patient underwent laboratory test which includes nasal Swab Pcr, covid test on 11May2021 and the result was pending. On 09Apr2021 10:00 the patient experienced left arm numbness 5 minutes after injection, hand tingling, left jaw pain. Left side of face and scalp began to burn one day after injection. Internal tremor of the brain and dizziness. Treatment was received for all event as medical supervision from hospital staff. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was not recovered.    No follow-up attempts are needed. No further information is expected.
Fell asleep during day; very sore arm; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Fell asleep during day), PAIN IN EXTREMITY (very sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced SOMNOLENCE (Fell asleep during day), PAIN IN EXTREMITY (very sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, SOMNOLENCE (Fell asleep during day), PAIN IN EXTREMITY (very sore arm), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
fever and abdominal pain day after vaccine rash to left arm - warm to touch - will start keflex
received the vaccine post excursion with no reported adverse event; Initial information received on 22-Dec-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case is linked to case 2022SA518461.  This case involves a 4 months old female patient who  received the vaccine post excursion with no reported adverse event after receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HIB VACCINE (HIB) for Immunization.  On 04-Oct-2022, the patient received a (series: 2nd dose) suspect IPV (VERO) (Batch/lot number -U1A451M)(Dose-0.5mL)(Frequency-Total/once )(Expiry date-20-FEB-2023)( Strength = standard)(Formulation- Suspension for injection) via intramuscular route in the right thigh for Immunization .  On 04-OCT-2022 the patient developed a non-serious event received the vaccine post excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).(Latency- same day)  It was reported The caller advised there were 3 patients that received the vaccine post excursion. Caller advised a couple months ago she called in reporting a temperature excursion at their facility where IPOL was concluded to no longer be viable.  Action Taken : not applicable.  At time of reporting, the outcome was Unknown for the event received the vaccine post excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  case number 01312315:
This spontaneous report as received from a certified medical assistant (healthcare worker) refers to a patient of unknown age and gender. It was reported that the patient received doses of GARDASIL on 25-SEP-2013 and 18-SEP-2014 (dose, route and lot numbers not reported). No adverse symptoms were reported. Additional information has been requested.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: patient had hives in arms, back and face. was given children's benadryl liquid. Patient's hives subsided to max extent and he said he felt okay. Parents are made aware to look out for signs of reaction and made aware if need be visit to ER
Rash has developed below injection site on left arm.  Rash the size of 3 quarters, warm to touch, itchy.  Bumpy/raised
Feeling something in her bones; migrating in the body in the lower back like a flu shot; Sore upper arm; This spontaneous case was reported by a patient and describes the occurrence of BONE DISORDER (Feeling something in her bones), SENSATION OF FOREIGN BODY (migrating in the body in the lower back like a flu shot) and PAIN IN EXTREMITY (Sore upper arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     The patient's past medical history included Sleepy (May be after third or second dose, patient felt sleepy and always soreness in the injection site) and Injection site pain (May be after third or second dose, patient felt sleepy and always soreness in the injection site). Previously administered products included for Product used for unknown indication: Pfizer (Lot number ER2630, Dose 1) on 19-Mar-2021, Pfizer (Lot number EW0158, Dose 2) on 09-Apr-2021, Pfizer (Lot number 32030BD and Dose 3) on 21-Oct-2021. Past adverse reactions to the above products included Vaccination complication with Pfizer, Pfizer and Pfizer.    On 02-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE DISORDER (Feeling something in her bones), SENSATION OF FOREIGN BODY (migrating in the body in the lower back like a flu shot) and PAIN IN EXTREMITY (Sore upper arm). At the time of the report, BONE DISORDER (Feeling something in her bones), SENSATION OF FOREIGN BODY (migrating in the body in the lower back like a flu shot) and PAIN IN EXTREMITY (Sore upper arm) outcome was unknown.            No concomitant product reported by reporter.  No treatment medication reported by reporter.   This case was linked to MOD-2023-694555 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Non significant live follow-up added.
within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches
It was reported that 3 hrs post vaccine the pt developed a fever 102.2F, the pt was taken to the emergency room.