chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. states approx. 20min. after vaccine given she felt burning and itching on lt. arm. About 1 hr. she felt chills but felt warm on her back, legs, and arms. Later she developed a rash all over. "goose like bumps." Upper back felt tight. Had "tightness"in chest and "hard to get her breath." At 5:00pm she went to urgent care facility. Was given IV Benadryl and Pepcid. Sent home with directions for Benadryl & Pepcid to take orally.
6/28/04 11:30 AM Seizure very sudden; no fever and no apparent illness. 8:45 PM Had second seizure in hospital. First worst; rigid and eyes rolled back. 6/29/04 10:30 AM Dismissed. 6/30/04 12:35 PM Third seizure lasting 30 seconds; less rigid. Information from annual follow-up report states: Mom reports child was involved in MVA after receiving vaccines and she believes car accident and resulting head injury cause of seizures, not vaccines, PMD, neurologist agrees.  Nurse follow up on 7/20/04 states: "Complete."
Ate breakfast, mostly milk and just a few bites of bread. Played normally, vomited suddenly about 45 minutes after drinking milk. BM was foul smelling and loose. Slept more than usual during the day and vomited again after supper, mostly milk.
Pt started with soreness in jaw and neck, back and body aches, fever (102), headaches less than 24 hours after vaccine. C/o chest tightness and rib pain a couple of days later. visited physician. Dx pneumonia. 11/18 and 11/24/2009 PCP records for 11/2 and 11/9/2009. Dx pneumonia  Patient with c/o's fever and chills. CXR noted RML infiltrates. Tx: Tamiflu, Z-pak Repeat CXR noted RML infiltrate improved
Pharmacist pulled vaccine from package with an expired beyond-use-date. Vaccine administered to the patient 3 days past beyond-use-date of 7/29/2022 batch/lot# 016B22A; expiry date 11/13/2022; beyond-use-date 07/29/2022.
Chills; fever; This is a spontaneous report from a contactable nurse (patient).  A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date unknown) via an unspecified route of administration in the right arm on 07Jan2021 at 8:30 AM at a single dose for for COVID-19 immunization.  The patient medical history was not reported. The patient has not had COVID prior to vaccination. Concomitant medications included doxycycline, lisinopril, thyroid, ubidecarenone (COQ10 [UBIDECARENONE]) on unspecified dates for unspecified indications.  The patient previously took EES (erythromycin ethylsuccinate)  and experienced allergies, and previously received the first dose of BNT162B2 on 17Dec2020 for COVID-19 immunization. The patient had no other vaccines in four weeks. 07Jan2021 at 20:00, the patient experienced chills and fever. It was reported that patient missed three days of work. It was unknown if treatment was received for the adverse events. The outcome of events was recovered on unspecified date in Jan2021.
Severe nausea, moderate vomiting, upper sternum pain, mild diarrhea first 24 hours only.  Nausea and pain continued for duration of week through Friday, August 9, when patient was taken to emergency room due to pain intensity.  Patient unable to hold down solid food for medication during most severe symptoms.    Patient was place in observation status from 1200 PM Friday, 10/9 and then discharged back to hospice care on Monday, 10/12.  Patient is currently still recovering, but pain and nausea have been remediated.
This case was reported by a healthcare professional and described the occurrence of intussusception in a 9-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (Sanofi), PEDIARIX (GlaxoSmithKline) and PREVENAR (Lederle) all given on 3 October 2008. There were no concurrent medications. On 3 October 2008 at 12:00 the subject received 1st dose of ROTARIX (oral). On 26 October 2008, 23 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised and the healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with unknown (Unknown treatment). On 6 November 2008, the event was resolved. The healthcare professional considered the event was probably related to vaccination with ROTARIX.  12/01/2008 MR received for DOS 10/26-30/2008 with D/C DX: Intussusception. Pt presented with 4 day hx of fussiness, intermittent emesis, tarry stool and poor po intake. IS noted on Abd US with attempted air enema reduction which was unsuccessful x 3.  Taken to OR for an open reduction of IS, appendectomy and repair of serosal tears. initially NPO with PCA pain mgmt. Transitioned to oral diet and pain meds and d/c on POD#3.
At first my eyes , mouth, and throat started to burn, then I started to shake uncontrollably for several hours. I went straight to the ER when it started. Every day since then I have had several shaking episodes lasting in length from 30min to 2 hours. After I get a horrible headache and feel exhausted.
Patient is fully vaccinated. COVID positive on 3/20/2022.  74y.o. female with history of sleep apnea, hypothyroidism, DM, HTN, depression and anxiety who presents with a complaint of A.fib with RVR.Denies any history of prior arrhythmias or MI. Notes intermittent episodes of SOB not relater exertion with associated lightheadedness/dizzyness over the last 1 month. Labs show hypokalemia and elevated troponin.  Treated with cardizem and heparin. Cardioversion.  Heparin changed to Eliquis. Discharged home.
15 minutes after receiving the vaccine, she experienced an episode of syncope.  She turned gray and had white lips.  She lost her hearing and partial conciousness.  The RN who administerd the vaccine and I carried her back to the examining table and had her lie down and put her legs up.  After about 15 minutes of lying down her hearing returned as did her color and level of conciousness.  MD was informed.
pt devel 6 chickenpox lesions on back & both legs;no temp, not ill;
MCV 4 dose #2 given to Pt too early. Pt and his mother notified of incident on 08/12/22. Pt has no apparent adverse effects.
Patients husband came in today, approx 24 hours after the injection. He said his wife started experiencing pain last night. The pain was in her right shoulder, with swelling, redness, tenderness. She also started getting body aches/pains and was nauseaus. I suggested they try massaging the injection site, and try TYLENOL. I told him to call us and/or her dD if the symptoms got worse.
The patient received the vaccine, proceeded to the observation chair to wait for 15 minutes. The wife informed us: "He is having a reaction" we immediately went over to assess the situation. The patient was shallow breathing, unresponsive, low blood pressure, and very pale. The patient was slumped in the chair and then brought to the ground. An EpiPen was administered and 911 was called. The EMTs then came and did an assessment as the patient was able to then sit up. They took him to the hospital for further observation.
woke up feeling hot; had a fever of 99.8 F; A spontaneous report was received from a consumer concerning, a 70-year-old female patient, who received Moderna (mRNA-1273) vaccine and woke up feeling hot and had a fever of 99.8 F.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 27 Jan 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 043L20A) in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021 at 10:30 PM, the patient went to bed and slept until 3 AM and woke up feeling hot. The patient had a fever of 99.8 F. The patient went back to sleep and when woke up the fever was gone. The patient stayed up for 2 hours and then slept until 2 PM. The reporter stated that the patient had the best sleep they had in a long time.   Treatment information was not provided by the reporter.    Action taken with mRNA-1273 in response to the event(s) was Not Applicable.  On 28 Jan 2021, the outcome of the events, woke up feeling hot and had a fever of 99.8 F were considered resolved.
Chills, nausea, vomiting, headache, neck pain. Improving.
losing her voice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 78 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: current medical condition. Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. The following information was reported: APHONIA (non-serious), outcome "unknown", described as "losing her voice".  Additional information: The patient stated that she was exposed to COVID (Coronavirus Disease) and has been vaccinated but that she did seem to be losing her voice. She had reached out to her HCP (health care professional) and had not heard back yet.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 DAYS AFTER THE VACCINE, SHE STATES SHE FEELS SOMETHING UNDERNEATH  HER BREAST ( L) , SHE STATES IT FEELS LIKE A LUMP, THE SIZE OF A CHERRY TOMATOE, it is painless. SHE STATES THE LUMP WAS NOT PRESENT PRIOR TO VACCINE, THERE WAS ALSO PAIN IN HER ARM ( L) AT THE SITE. SHE WAS TAKING IBUPROFEN FOR THE PAIN 600MG X 4 TABS PER DAY. SHE NO LONGER HAS THE PAIN.RN RECOMMENDATION - MAKE AN APPT.  WITH HER PCP FOR FURTHER INVESTGATION OF HER LUMP, I ALSO SUGGESTED SHE DISCONTINUE USE OF THE IBUPROFEN, DUE TO HER BEING PAINFREE. Pt was agreeable.  5/1-/u call made; no answer
No adverse event; 4 year old patient received a dose of the Moderna COVID-19 Vaccine Bivalent for 6 years and older (0.25 mL) instead of the 2nd dose of the primary series.; Patient received dose 1 on 26Sep2022 and dose 2 on 16Dec2022; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 year old patient received a dose of the Moderna COVID-19 Vaccine Bivalent for 6 years and older (0.25 mL) instead of the 2nd dose of the primary series.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26Sep2022 and dose 2 on 16Dec2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 16-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (4 year old patient received a dose of the Moderna COVID-19 Vaccine Bivalent for 6 years and older (0.25 mL) instead of the 2nd dose of the primary series.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26Sep2022 and dose 2 on 16Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 year old patient received a dose of the Moderna COVID-19 Vaccine Bivalent for 6 years and older (0.25 mL) instead of the 2nd dose of the primary series.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26Sep2022 and dose 2 on 16Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (4 year old patient received a dose of the Moderna COVID-19 Vaccine Bivalent for 6 years and older (0.25 mL) instead of the 2nd dose of the primary series.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26Sep2022 and dose 2 on 16Dec2022).    No concomitant drug information was provided.  Patient had received dose 1 of Moderna COVID-19 vaccine (monovalent) on 26Sep2022.  Patient had not experienced any adverse events. No treatment drug information was provided.
Right Arm,  Tingling from injection site and below,  Still sore at injection site if pressed,  Has  hx ruptured bicep of right arm.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-MAY-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ 2ml, 10 unit dose tube, lot # J010140; expiration date 26-APR-2016 (dose and dose number were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the ROTATEQ had 6 temperature excursions of 392, 8, 336, 1172, 80 and 24 hours. The lowest recorded temperature was -3 Celsius and the highest recorded temperature was 59F (15 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a 16 year old female consumer with no previous medical history, and an allergy to penicillin, who was vaccinated at an unknown date, with the first dose of Gardasil. There was no concomitant medication. The patient reported that she did not know that she was one week pregnant at the time of vaccination. On 25-May-2007 she found out that she was pregnant. It was reported that on 25-Jul-2007 the patient had a miscarriage. Unknown medical attention was sought. The patient was recovered. No product quality complaint was involved. Upon internal review miscarriage considered to be an other important medical event. Additional information has been requested.
Information gathered from physician documentation is as follows:  Within hours of injection, patient developed diffuse chest pressure that waxed and waned in intensity. She also had some discomfort in her back and sitting upright provided relief. She had a mild dry cough and labored breathing with minimal exertion. Her symptoms progressed the following morning. Her husband (a retired physician) found her to be tachycardic with profound dizziness and that was the point at which she was brought into the hospital.  She was diagnosed with acute cardiac tamponade and hemorrhagic pericarditis which required an urgent pericardiocentesis with drain placement. Multiple physicians believed  this was secondary to COVID vaccine induced pericarditis. Patient was also started on colchicine and indomethacin on day of arrival.
pain she is having in her left shoulder/Joint pain; states the pain radiates from her back of neck and shoulder from part of her back.; since she had the vaccine she has had a pain in her left arm and it subsided today and it has gotten worse; states the pain radiates from her back of neck and shoulder from part of her back/and she can barely move her arm up; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation : solution for injection, Batch/Lot number : unknown, expiry date: not reported), via an unspecified route of administration, administered in the right arm on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On an unspecified date, the patient experienced pain in her left shoulder, states since she had the vaccine she had a pain in her left arm and it subsided today and it has gotten worse and she can barely move her arm up; states the pain radiates from her back of neck and shoulder from part of her back, joint pain. Caller states that she was having joint pain and wanted to know if that is one of the listed side effects. Caller asked how long the report would take because she was in pain. Caller declined to complete the full report at this time and states she would like to ask how she should handle this or if she should go to the emergency room but was unable to provide treatment recommendations or medical advice and she was referred to her HCP. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
muscle pain; joint pain; severe chills; headache; nausea; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old male patient received bnt162b2 (lot number: EL1284), via an unspecified route of administration at left arm, first dose on 24Dec2020 11:15, at single dose, for COVID-19 immunization. No relevant Medical history. No known allergies to medications, food, or other products. No concomitant medication was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Age at vaccination was 37 years old. The patient experienced muscle pain, joint pain, severe chills, headache, nausea on 28Dec2020 14:00. No treatment was received for the adverse event. The events were reported as non-serious. Outcome of the events was recovering.
Information has been received from a health professional concerning a 17 month old white female with no known allergies who on 4/25/01, at 14:40, was vaccinated, IM, in the left arm with a 1st dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot 639075/1826K). There was no concomitant medication. There was no illness at the time of vaccination. On 4/26/01, the pt developed a 2" by 3" red, firm and somewhat tender lump surrounded by 1" of redness. On an unknown date the pt recovered. No further information is expected.
Patient received expire Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expire Moderna Covid-19 vaccine) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expire Moderna Covid-19 vaccine). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expire Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Patient ID was reported as 7597754. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications was reported. No treatment medications was reported.
DVT of the right leg. Diagnosed on 7/12/21. Symptoms of swelling and pain started on 7/10/21
several months p/vax got hair cut & thought barber cut a plug out of hair but was able to cover over w/other hair;spot size of ASA-then penny-larger over next several months;located on back of head went to MD dx w/alopecia;
Quadracel was given out of indication by accident to a two year old child, with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] was given out of indication by accident to a two year old child, with no reported adverse event.  The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 09-Dec-2022, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine suspension for injection (strength, batch number and expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination, which was given out of indication by accident to a two year old child, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It is unknown if there were lab data/results available.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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.