chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unable to obtain more information from parent. Late evening, 3 days following vaccines, patient broke out in rash all over body. Rash looked like hives or small welts. Mother took patient to hospital. Says he was given BENADRYL.
Client said she got red bumps at the site where she received chicken pox shot and 1 bump also in her mouth. Client said she took Advil and stayed home until the area went away. Client said this lasted for about 10 days and also stated she didn't seek medical attention.
21May90 pt vax;  30May90 mom reported that pt had fever, cough, & lump in the groin.  Exam revealed inguinal adenopathy above the inject site, & distant adenopathy affecting neck; chest was clear.  101-102F fever lasted 48 hrs & resolved.
Very ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL tablet, extended release for Pulmonary arterial hypertension and TREPROSTINIL DIOLAMIN (ORENITRAM) tablet, extended release for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included APIXABAN (ELIQUIS), MACITENTAN (OPSUMIT) and RIOCIGUAT (ADEMPAS) for an unknown indication.   On 14-Oct-2021, the patient started TREPROSTINIL (Oral) 1.375 mg every eight hours and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) .25 mg every eight hours. On 14-Oct-2021, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 1 mg every eight hours and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .125 mg every eight hours. On 01-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ILLNESS (Very ill). At the time of the report, ILLNESS (Very ill) outcome was unknown. Not Provided          No treatment medication reported by reporter.  Patient was participating in a patient support program via Accredo specialty pharmacy and began therapy with Orenitram (treprostinil diethanolamine), on 14 Oct 2021 for primary pulmonary arterial hypertension. The patient was supplied with Orenitram 0.25 mg, 1 mg and 0.125 mg and the current dose was reported as 1.375 mg, oral (PO), every eight hours (q8h).  And on 01-Jan-2022, patient received Moderna booster shot.  The patient reported that he was very ill and it was touch and go for a while after the COVID booster shot.
diarrhea; first dose been over 42 days; cold and flu symptoms; low grade fever 99F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose been over 42 days), ILLNESS (cold and flu symptoms) and PYREXIA (low grade fever 99F) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Lymphedema (Patient is known to have lymphedema in the left arm.) and Autoimmune disorder. Concomitant products included PHENYTOIN SODIUM (DILANTIN [PHENYTOIN SODIUM]), MINOCYCLINE, METFORMIN and GLIMEPIRIDE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIARRHOEA (diarrhea), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose been over 42 days), ILLNESS (cold and flu symptoms) and PYREXIA (low grade fever 99F). The patient was treated with ZINC for Adverse event, at an unspecified dose and frequency. On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose been over 42 days) had resolved. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown and ILLNESS (cold and flu symptoms) and PYREXIA (low grade fever 99F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99 (High) 99F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication also included Cold and flu medicine (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received and reporter information updated.
Client here complaining of left arm pain which continues since she received her influenza vaccine on 10/16/02. Client states that immediately at the time of the shot, she felt a strong pressure all the way down her arm to her wrist. The pressure quickly started leaving, but the pain continued at the site, radiating down to her wrist. Client discussed it with doctor on Thursday, while in the office for a routine visit. He advised client to apply hot compresses to the site, but to continue to use the arm like normal. Client states she discontinued using hot compresses after 2 days, but the pain continued to radiate down to the wrist for 2 weeks. At present, client states that she still has stabbing pain at the injection site, which radiates down to her elbow, when she raises her left arm or moves it into certain positions. The pain no longer extends to the wrist. Client indicates a spot on her left, uppar arm, about 2 fingerbreadths below the acromion process as the still painful, injection site. No redness, bruising or swelling noted at this time. Advised client to follow up with her family doctor if pain continues.
This case was reported by a nurse via call center representative and described the occurrence of chills in a 56-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date unknown) for prophylaxis. On 25th May 2018, the patient received SHINGRIX (intramuscular). On 26th May 2018, 1 days after receiving SHINGRIX, the patient experienced chills, general body pain, stomach cramps and fever. On an unknown date, the outcome of the chills, general body pain, stomach cramps and fever were recovered/resolved. The reporter considered the chills, general body pain, stomach cramps and fever to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare provider (HCP) reported that, the patient developed chills, fever, body aches, and stomach cramps after receiving the SHINGRIX vaccine. The patient stated that, she "felt like she was hit by a truck" for 48 hours starting the day after receiving the vaccine. The healthcare provider did not have the expiration date.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL. Subsequently the patient fainted after receiving GARDASIL. On an unspecified date the patient recovered. No product quality complaint was involved. No further information is available.
Patient experienced a syncope episode immediately following his vaccination. Patient was laid flat on a gurney with his feet up, and patient did not lose consciousness, but shook a little. Had a blood draw earlier and ate only a pop-tart for breakfast.
In the evening p/vax pt had fever of 103 & was unresponsive; mom stated had a little bit of shaking & snoring respirations; episode lasted a minute or so; no recurrence;
Red, warm to touch, mildly painful area of induration 25 mm diameter at site of VARIVAX vaccination, (L) upper arm SQ.
This spontaneous report was received from a Registered Nurse (R.N.) referring to an identified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N035176 expiring on 09-JUN-2019, for prophylaxis (dosage schedule and route of administration were not reported). Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) properly stored. The administered dose of the vaccine experienced a temperature excursion of 6°F to 14°F for 3 hours and of 15°F to 46°F (21°F) for another 2 hours , as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same source.; Sender's Comments: US-009507513-1805USA015000: Original Case : 1805USA015000.
''I'' have felt dizzy ever since; On day 3 after the second vaccine, ''I'' woke up with the room spinning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 10:00 (Lot number: EN6250) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIVALO. Past drug history included: Parafon forte for Muscle relaxant, reaction(s): "Hives", notes: Known allergies: Parafon forte (old muscle relaxant). Hives. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EN6200, Anatomical site: Left arm), administration date: 23Feb2021, when the patient was 62 years old, for COVID-19 immunisation. The following information was reported: VERTIGO (non-serious) with onset 19Mar2021 07:00, outcome "recovered" (21Mar2021), described as "On day 3 after the second vaccine, ''I'' woke up with the room spinning"; DIZZINESS (non-serious) with onset 21Mar2021, outcome "not recovered", described as "''I'' have felt dizzy ever since". The events "on day 3 after the second vaccine, ''i'' woke up with the room spinning" and "''i'' have felt dizzy ever since" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, dizziness.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Steroid as the treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (dose and route not reported, lot# K022265, expiration date: 22-OCT-2016, lot# J007299, expiration date: 03-FEB-2016). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.
3-5 minutes after MMR and VARIVAX administration, pt. developed hive-like rash on (L) check and (L) thigh around injection site. Gave 1/2 tsp. BENADRYL and MOTRIN in office.
Sleep disturbed by Night Terrors and sleep walking started11/22/21 and have continued almost every night since vaccine. Night Terrors were more severe the first week after vaccine. He would eventually wake up and then not be able to return to sleep. The second week episodes last from 15 minutes to just 2 minutes, and he is able to return to sleep. Patient has never had this problem before the vaccine. I messaged patient's Pediatrician who recommends not getting the second dose and also recommended I report patient's symptoms as an adverse reaction.
received second shot early; A spontaneous report was received from a Reporter like a nurse concerning a 63 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  event inappropriate schedule of vaccine administered.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the anatomical location for prophylaxis of COVID-19 infection.  The patient is scheduled to receive his second shot on 19-FEB-2021, but received the vaccine (early) on, 09-FEB-2021.   Action taken with mRNA-1273 in response to the events was not reported.   On 09-feb-2021, the outcome of the events was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Patient took flu and pneumonia shot 10/03/02. Patient developed temperature of 104, malaise, and flu type symptoms. She was hospitalized at hospital on Saturday/Sunday and did not return to work until Wednesday 10/09/02 by MD release.
Symptoms: Dizziness, nausea, vomiting, extremely elevated heart rate, near fainting, chills and shaking, profuse sweating, muscle pain and stiffness, tingling in extremities, flushing in face Treatment: IV Benadryl and methylprednisone administered in the ER, reaction resolved
This case was reported by a nurse via call center representative and described the occurrence of headache in a 50-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced headache, nausea, injection site pain, fever, fatigue and myalgia. On an unknown date, the outcome of the headache, nausea, injection site pain, fever, fatigue and myalgia were unknown. It was unknown if the reporter considered the headache, nausea, injection site pain, fever, fatigue and myalgia to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on left deltoid. The patient came into the doctor's office on 22nd August 2018, 11 am and reports common reactions such as, local pain at injection site. No additional information provided. The healthcare professional called representative (MI), and would like to know if the patient should receive the 2nd dose. The representative escalated the call to medical expert (MES).
The patient began to experience numbness; Tingling in the left arm; Aching in left hand; This is a spontaneous report from a non-contactable health care professional. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration on 22Mar2021 (at the age of 39-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had previously received PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation. During his 15-minutes waiting period after the injection, the patient experienced numbness and tingling in the left arm and aching in left hand on 22Mar2021. He denied rash, hives, difficulty breathing, wheezing and light headedness. The patient had no daily prescription medications for numbness and tingling of left arm/hand. The patient did not receive any treatment for events. Follow up response to treatment was good (as reported). The patient was discharged to home as stable. The outcome of the events numbness and tingling in the left arm and aching in left hand were resolved in Mar2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Historical vaccine details (39 years added as age/units) and leading sentence updated to a non-contactable health care professional.
Vaccination site pain; SORE ARM AND HIP; SORE ARM AND HIP; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (SORE ARM AND HIP) and ARTHRALGIA (SORE ARM AND HIP) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.  The patient's past medical history included Polycystic ovarian syndrome.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In February 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (SORE ARM AND HIP) and ARTHRALGIA (SORE ARM AND HIP). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (SORE ARM AND HIP) and ARTHRALGIA (SORE ARM AND HIP) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: Elevated.         No concomitant medications were reported No treatment medications were reported. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624427 (Patient Link).
Pt experienced swelling and redness at the injection site and anaphylaxis with fever, throat closing, wheezing and respiratory distress.  Pt was treated with Benadryl. The pt's symptoms persisted at the time of the report. The anaphylaxis was considered an "other medical event". No further information is available.
Arm pain within 2 hours, extreme fatigue, malaise, vivid dreams, headache lasting 10 hours
sid effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (sid effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (sid effects). At the time of the report, VACCINATION COMPLICATION (sid effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation; propranolol hydrochloride (BETALOL [PROPRANOLOL HYDROCHLORIDE]) (Batch/Lot number: unknown) for blood pressure measurement. Relevant medical history included: "Blood pressure measurement" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BRONCHITIS (non-serious) with onset Aug2021, outcome "unknown", described as "Bronchitis". Therapeutic measures were taken as a result of bronchitis.  Additional information: Patient got bronchitis 2 weeks later of vaccination and given antibiotics (Treatment).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The evening of the vaccine I only had about 3 hours of generalize achiness; slight generalized joint discomfort and slight burning sensation; This is a spontaneous report from a contactable nurse (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient reported that: "the evening of the vaccine I only had about 3 hours of generalize achiness (18Dec2020) and was back to normal after that. About 3 days after the vaccine I have slight generalized joint discomfort and slight burning sensation. This is not limiting my activity". The patient outcome of generalized achiness was recovered, the outcome of slight generalized joint discomfort and slight burning sensation was unknown.   Information on the batch/lot number has been requested.
Father called 8/11/03 indicating 3 1/2 inch rash (circular) on right upper arm noted on 8/7/03 which progressed to around lip area of face. Fever up to 101 degrees F orally. Reported symptoms resolving as of 8/11/03 and did not feel evaluation by PCP necessary, although recommended.
rapid heartbeat; my heart like aches and sometimes there is shooting pain; my heart like aches and sometimes there is shooting pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, batch/lot number: not reported, expiration date: unknown) via an unspecified route of administration 12Mar2021 as dose number unknown, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Mar2021, 2 hours after vaccination, the patient started having like a really rapid heartbeat and then the patient went home and still had a rapid heartbeat and ever since then there was something like the patient's heart like aches and sometimes there was shooting pain and the patient still have a rapid heartbeat currently. So, the patient just wanted to report that in case Pfizer had any side effects reported like that or what to do from here." The patient had provided limited information over the call. The outcome of the event rapid heartbeat was not recovered, and the outcome of other events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Child & Grandparent presented on 10-16-09 at 4:30pm. Grandma noticed swelling on 10-10-09, and child held arm still. Grandma reported to Fm. Dr. on 10-16-09 and stated Dr instructed her to go back to the Health Dept. on observation on 10-16-09 child's upper deltoid was swollen with dark warm discoloration.
chills, severe muscle aches, body aches, fatigue  We did not administer this vaccine, the reaction was reported to us by a family member
Pain in neck, back, and back of arm on injection site side (left).  A little trouble breathing, for a short time as well.  She said she is feeling a lot better now (9-16-2016 2:38pm EDT) and just a little bit of residual pain in the left arm, but it's going away.  I recommend she talk to her doctor as well.
Patient received covid vaccine at 12:56pm on March 31, 2021.  At 1:00pm he sat down on the floor.  He remained conscious but complained of feeling dizzy.  HR was 40.  Staff was able to assist pt into a wheelchair and escort him into a private side room.  Pt was assisted onto a cot and his legs were elevated.  At 1:05 his BP was 130/75 and HR 60's.  Patient's skin at 1:06pm appeared pink and WNL.  1:13pm = BP 115/75 and HR 67.  1:23pm = 130/75 HR 68.  Patient denied shortness of breath/chest pain throughout the entire episode and did not lose consciousness.  At 1:23 patient stated he no longer feels faint, just a bit weak.  At 1:24pm patient dangled on cot.  1:27pm = 130/80, HR 70.  1:33pm = left facility in the care of his mother who is driving.  He stated he feels a little weak, but not faint or dizzy.  He left ambulatory.  He refused transport or the need for additional medical care.  Follow up call was placed to pt on Friday, 4/2/21.  Pt denied any residual effects and stated he is at baseline.