chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the Vaccine Coordinator referring to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
Upper left arm at injection site is: swollen, hot to the touch, itchy and feels kinda hard, slightly painful to the touch. Happened 8 days after injection.
that night got a 102.7 fever / Trouble breathing  / very bad chest pains . My wife  called 911 , went to hospital next morning at 6:30 am , came home that  afternoon then 8:30 pm that night called 911 again , was in 3 different hospitals for next 19 days . lost 30 pounds in hospitals, been home now
5 days following my first Covid vaccine I developed pronounced  olecronon bursitis for the first time. The swelling was not resolved for weeks - - but once I took a continuous course of anti-inflammatory for over a week it did resolve. My doctor suggested that I should include this experience here as a potential consequence of the vaccine. The elbow does look changed, following the inflammation process - - there appears to be some remodelling/shape change.
C/O dizziness, nausea and sensation of throat closing. Speech clear, A/Ox4, able to drink fluids. Denies chest pain or shortness of breath. States hadn't eaten today and very little oral intake of fluids since yesterday. Medics on scene, care assumed.
headache; fever / experiences episodes of fever here and there; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever / experiences episodes of fever here and there) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and albuterol spray for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, 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 experienced HEADACHE (headache) and PYREXIA (fever / experiences episodes of fever here and there). At the time of the report, HEADACHE (headache) and PYREXIA (fever / experiences episodes of fever here and there) outcome was unknown. Not Provided          The concomitant medication was high blood pressure medicine. The treatment information was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up Added and contains Non Significant Information
Lightheaded, cough, mild wheeze that responded to albuterol Dizziness
This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a healthcare provider concerning her 20 year old daughter who was a student with a penicillin allergy who on 29-JAN-2007, at 08:10, was vaccinated intramuscularly into the left deltoid with a second dose of GARDASIL (Lot # 655617/1447F). Concomitant therapy included Ortho Tri Cyclen, albuterol and Advair. On 29-JAN-2007 at 13:00 ("later in the day") the patient was driving and developed dizziness ("very dizzy") and nausea which lasted about 4 hours. She could no longer drive so the passenger took over driving. No laboratory diagnostic studies were performed. On 29-JAN-2007 the patient recovered. A first dose of GARDASIL was given IM on 22-NOV-2006. Additional information is not expected.
Patient received ADACEL on 2-9-16. Red area, swollen, painful and warm to touch, low grade fever.
Pt reported dizziness following injection. Pt brought to Med Obs 1 at 11:03. Pt reported not eating breakfast but consuming an energy drink. Vital signs taken. BP elevated but all other VSS. Following administration of oral fluids and crackers, pt reported no more dizziness with standing and ready to go home. Repeat VSS, BP at 160/97. Pt escorted to exit and encouraged to follow up with PCP about BP.
This spontaneous report as received from a pharmacist via MedWatch form (MK25772) refers to a 65 year old female patient. Patient had no previous allergies. On 21-MAR-2013 the patient was vaccinated with ZOSTAVAX lot # J000433 exp date 10-APR-2014, subcutaneous for shingles. The patient did not receive any live vaccines within the last 28 prior to receiving ZOSTAVAX. There was no concomitant medication and it was unknown if there was any relevant past drug history. On 21-MAR-2013, the patient experienced red flare around the site of the injection. It was unknown if there was any relevant laboratory data. The outcome of red flare around the site of the injection was unknown. The relatedness for red flare around the site of the injection was not reported for ZOSTAVAX. Additional information is not expected. This case was linked to MedWatch form MK25773 (same reporter).
his hands just started shaking really bad; This is a spontaneous report from a contactable consumer (Parent) . A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# EW0151), via an unspecified route of administration on 10Apr2021 (at the age of 16-years) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021 (one week after vaccination), patient hands just started shaking really bad. Patient experienced it again during an exam making it hard for him to write. Reported parent asked if this was normal and a common side effect or something she should be concerned about. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
inadvertently received a dose ofBoostrix instead of a DTaP on 24-APR-2023/wrong vaccine administered; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 24-APR-2023, the patient received Boostrix. On 24-APR-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: inadvertently received a dose ofBoostrix instead of a DTaP on 24-APR-2023/wrong vaccine administered) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK recipt date: 10-NOV-2023 The reporter reported that a 3 year old patient inadvertently received a dose of Boostrix instead of a DTaP, which led to wrong vaccine administered and inappropriate age at vaccine administration. The caller declined to provide date of birth or initials. The reporter consented to follow up via email would be okay.
This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0151; Expiration date was not reported) on the left arm on 06Apr2021 (15:00) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included neuroendocrine lung cancer, asthma, and allergies to shellfish and IV contrast dye. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7534; Expiration date was not reported) on 15Mar2021 (when the patient was 50 years old) for COVID-19 immunization. On 11Apr2021 (03:00), the patient had rectal bleeding, stomach cramps and diarrhea. The events were assessed as serious (medically significant), and had resulted into an emergency room/department or urgent care. The patient had received unspecified intravenous (IV) fluids as treatment for the reported events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.
on 4-10-03 8 pm temp 101-102 given tylenol alternate with motrin.  11:30 pm temp 105.3, to ER no tx sent home (fever down 101) temp continued between 100 & 103.8. on 04-13-03 red rash over body with face puffy. To ER. Diag with pneumonia and middle ear infection. Began on zithromax for 3 days and ceflex for 10 days. 4-16-03 to personal doctor no pneumonia. 4-15-03 rash worse low grade temp. 04-16-03 no fever and rash fading.
Right arm swollen, red only at injection site, bruised below deltoid in curved shade, arm also warm to touch 2-3 weeks.
pt recvd vax 3oct & devel swelling & erythema in genitals & welts on lt dorsal hand, larger one on RT biceps; tx w/ benadryl;
Swelling and popping of joints, primarily knees. Full body weakness. Beginning 6 days after vaccine and continuing.
Vaccine given 5/22/15. 5/24/15 pt given Rx BACTRIM secondary to allergic reaction vs. cellulitis. In office 5/26/15 improved symptoms noted. Advised complete BACTRIM, BENADRYL, OTC.
Extreme soreness at injection site/upper left arm x 48 hrs; Heart racing; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female (not pregnant) patient received BNT162B2 (lot number: EK5730) first dose on 21Dec2020 05:30 PM on left arm at single dose for COVID-19 immunization. Medical history included allergies to PCN. Concomitant medications in two weeks: sertraline hydrochloride (ZOLOFT), meloxicam (MOBIL) and calcium supplements. No other vaccine in four weeks was No. Facility type vaccine was Hospital. Patient experienced Heart racing on 21Dec2020 05:45 PM. Patient had Extreme soreness at injection site/upper left arm x 48 hrs on 21Dec2020 06:30 PM. No covid prior vaccination and no covid tested post vaccination. No treatment received for the events. The outcome of event Heart racing was recovered. The outcome of the event Extreme soreness at injection site/upper left arm x 48 hrs was recovering. The seriousness was reported as no.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided          No Concomitant medications were provided No Treatment information provided
Fever; Chills; Flu like symptoms; weakness; I fell on the floor and could not get up for 15 minutes today.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weakness) and FALL (I fell on the floor and could not get up for 15 minutes today.) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FALL (I fell on the floor and could not get up for 15 minutes today.). On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ASTHENIA (weakness). At the time of the report, PYREXIA (Fever), CHILLS (Chills), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weakness) and FALL (I fell on the floor and could not get up for 15 minutes today.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
SEE ER NOTES; Lightheaded/vomiting this AM. Now raised hives/rash x 1 hour on chest/back/arms. Shortness of breath. Tetanus/Meningococcal shots on Friday.
Pt recv vax on 2/26/99; on 2/28/99 pt exp cutaneous, pruritic rash; tx=Benadryl
The patient was given the Pfizer Bivalent vaccine instead of the 1st dose in the primary series of COVID-19 vaccination. The dose given was appropriate for patient's age. There has not been an adverse reaction to the vaccine.
Case number PHEH2015US002913, is an initial spontaneous report from a health care professional received on 06 Feb 2015. This report refers to a 70-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with a dose of FLUVIRIN (batch number: 1412801) at a dose of 0.5 ml intramuscularly on 12 Jan 2015. It was reported that the FLUVIRIN MDV dose administered to the patient reached temperature to 34 Fahrenheit for 15 hours. No adverse events were reported following the maladministration.
This spontaneous report as received from a non-healthcare professional via Pfizer (Manufacturer Report Number: 2018116255) refers to a female patient of unknown age. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosing information was not provided) for prophylaxis. According to the reporter, the vaccine which was advertised to help avoid cervical cancer in women, but was having devastating side effects. His son was dating a girl who had the vaccine, and now had all kinds of health issues- heart arhythmia, fainting, shortness of breath and really a mess. No reversal/cure (The outcome of the events was not recovered and patient did not receive any treatment). He reported that it was getting worse and they tried to talk all the kids into it these days. The reporter considered the causality for events to be related with GARDASIL. Upon internal review, arhythmia was determined to be medically significant. This is one of the two reports from same reporter.
Patient noticed mild swelling to upper lip around 0630 am.  Several hours later, the patient developed swelling to left upper eyelid and left cheek/jaw.  She reports slight irritation to her throat, with no evidence of tongue or throat swelling.  Denies cough, difficulties breathing, or shortness of breath.  Also having nasal congestion/runny nose, which has been intermittent for the past week.  The facial swelling had already improved upon my evaluation of the patient.  She did not take any medications for the symptoms prior to her arrival.  She was given a prescription for Zyrtec 10 mg daily and Pepcid 20 mg BID x 10-14 days with strict return precautions for any signs of worsening.
Right after injection  my arm was sore and fine for a number of days and on the 7th day, i had pain and itchiness, injection site was red and swollen.
Urticaria 708.9, vomiting, rash. Treatment diphenhydramine 25 mg every 6 hours.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQc0 involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Headach, Nasal congestion /bleeding, Sore throat, Burning sensation in lungs and eyes. Coldlike symptoms. Started the day after receiving Flu Vaccination. One other coworker here received the vaccination with me, experienced same symptoms. None of the other 12 people here currently sick and none of them received the flu shot.
Fever up to 101.5 Headache Chills Sore at injection site Achy  Vomiting Diarrhea (All but the diarrhea has subsided)
More than 42 days for administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days for administration of second dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days for administration of second dose). On 01-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 42 days for administration of second dose) had resolved.            Concomitant medications were not reported. Treatment medications were not reported.
CHILD UNDERAGE FOR VACCINE.  DOB REPORTED AS 09/03/2008 ON CONSENT. CORRECT DOB IS 09/03/2009.  RECEIVED SECOND PFIZER DOSE ON 08/06/2021 (LOT# EW0183)
Couldn't walk; Couldn't feed herself; Couldn't talk; Disoriented; Shaking; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (Couldn't walk), FEEDING DISORDER (Couldn't feed herself), SPEECH DISORDER (Couldn't talk), DISORIENTATION (Disoriented) and TREMOR (Shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025AZ1A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 pneumonia (hospitalized) in December 2020.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced GAIT DISTURBANCE (Couldn't walk), FEEDING DISORDER (Couldn't feed herself), SPEECH DISORDER (Couldn't talk), DISORIENTATION (Disoriented) and TREMOR (Shaking). At the time of the report, GAIT DISTURBANCE (Couldn't walk), FEEDING DISORDER (Couldn't feed herself), SPEECH DISORDER (Couldn't talk), DISORIENTATION (Disoriented) and TREMOR (Shaking) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Patient acquired a fever. Instructions from doctor was to take MOTRIN. Patient also had body aches.
On 27 July 09 child received 3rd HPV vaccine in left arm. On 28 July 09 a lump was seen over injection area. Was seen on 29 July for a check up again on 31 July 09 the lump was slightly smaller. No treatment received or required.
Patient had Moderna booster and developed a hive type delayed reaction.  No other stimulus . Rash is red raised and itching, Patient notes in head, armpits, around belt line. Vaccine administered approximately 10 days ago, rash started.
Knot to left arm at injection site, followed by burning, itching, redness that continues to get larger everyday, fever. Marked the area to verify it is getting larger. Contemplating a dr office visit.
Fainted briefly, EMS contacted and vitals were ok.  He drove himself back to college
1 Week after MMR patient had a 20 minute seizure. No fever. Was treated with Diastate and in emergency room was postictal and had brief left arm paralysis. Recovered over 2 days then back to normal.
Vomited 4 times; nausea; severe abdominal pain; diarrhea; extremely drowsy; This is a spontaneous report received from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 20Mar2021 at 8:00 (at the age of 33-years) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks. On 20Mar2021 at 12:00, the patient was extremely drowsy. On 21Mar2021, the patient experienced abdominal pain and diarrhea. On 22Mar2021, the patient vomited 4 times overnight and continued to have sharp abdominal pain, diarrhea and nausea. The adverse events resulted in doctor or other healthcare professional office/clinic visit/ emergency visit. It was unknown if therapeutic measures were taken as a result of the events. The clinical outcome of the events extremely drowsy, abdominal pain, diarrhea, vomiting and nausea was not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information expected.
Injection was given too high, infiltrating the bursa sack around the shoulder joint of the left arm.  Resulting in bursitis,  a very painful joint and restricted movement of the arm/shoulder.  The patient was given 40 mg of Prenisone for 7 days and 10 mg of Toradol every 6 hours as needed for 5 days.  This was resolved in 48 hours. The patient also experienced vomiting twice, on the third day after the administration of the vaccine. She also experienced a headache four days after the administration. This patient tested positive for COVID in mid November.  She had severe, nausea, vomiting, fatigue, headaches during her acute phase.
Case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2020, the patient received Shingrix. On 9th October 2020, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles 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 was selected as adult as per vaccine indication. The patient had a case of shingles that broke out 2 days ago from the day of reporting.
Information has been received from a consumer concerning her approximately 25 year old female friend who was vaccinated with the series of GARDASIL. Subsequently, the patient then became pregnant, and delivered a still born baby. The patient sought unspecified medical attention. The reporter indicated that the patient is now fine and the reporter does not want to provide any further information. No product quality complaint was involved. Upon internal review, still born was considered to be an other important medical event. No further information is available.