chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received shot  Weds @ 1400. Within  2 hrs I had a low grade temp. Within 4 hrs I became achy and sluggish, with a small HA. Next morning I felt ok, just achy. By 1400 I?m sluggish, very achy, and a migraine. Sat was a repeat of Fri. Today, same thing. All I do is sleep and hurt all over, including a migraine.
got the flu after it; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 31-Oct-2020.  This case was linked to cases 2020SA307606, 2020SA307607, 2020SA307608, 2020SA307609, 2020SA307610, 2020SA307611, 2020SA307612, 2020SA307613, 2020SA307614 and 2020SA307599 (same reporter).  This case involved a patient with unknown demographics who got the flu (influenza) after the patient received INFLUENZA VACCINE.  The patient's past vaccination(s) included flu vaccine. Always got the flu after it. Been without 40 something years. Relevant medical history, past medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There would be no information available on batch number for this case.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
On 5-3-12 8:00 pm mother noticed rash on face, abdomen, legs and back, felt warm to touch, no fever. Mother gave 75 mg of Ibu and called us to report symptoms on 5-4-12 when rash not resolved. Dr. treated pt. with BENADRYL and to follow up prn.
7 days after the shot my arm became itchy, painful , swollen and warm. My doctor said to use moist hot compresses and tylenol. I also used benedryl. The compresses helped within 20 minutes. All symptoms were better by morning and gone in 3 days.
is a 35 y.o. female who presents ambulatory to the emergency department.  She states last evening she began having chills, body aches, headache, difficulty taking a deep breath, nausea.  Patient denies any tongue swelling or throat swelling but states when she was eating she felt nauseous.  She did get her second maternal COVID-19 vaccine yesterday.  States she took ibuprofen last evening but has not taken anything today.  Patient does have a history of asthma.  She does take two maintenance inhalers on a daily basis.  She does take albuterol as needed.  Has not had to use her albuterol inhaler.  Patient denies any fever.   She denies any vision changes, hearing changes, neck pain or stiffness.  She denies any chest pain, abdominal pain, nausea, vomiting, diarrhea.
Patient reports headache 7/10 not relieved by motrin. Onset of the headache was upon awakening at 0500 on 12/17. She denies visual changes, nausea, and vomiting. She also reports that her back is sore. She has a history of migraine headaches and has not taken her migraine medication for this headache. She says she gets headaches "all the time" and this headache is different for her in that she didn't experience the visual aura she usually gets with her migraines.
pt says she had headache, nausea, joint pain.  She said the left side of her face was swollen from the neck to the bottom of her ear.  Her left side of her lips are numb like she had Novocain. The left and top side of mouth are inflamed with swelling and pain in the mouth.  She has an appt with her dentist on 4/26/2021.  She has been taking Benadryl for her symptoms.  On 4/23/21 she has swelling around her left ankle.   She is making an appt w/ PCP today.
Pt had begun the Moderna primary vaccine series(6mo-5y dose)  on 7/27/22 but was inadvertently given the Pfizer vaccine (6mo-4y dose) on day of clinic visit.
Sore Arm; Achy body; Headache; Neck pain; Back pain; Chills; Fever; Dry mouth; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 13:15 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medication. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 13:15 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 14:00, the patient experienced sore arm, headache, neck pain, back pain, chills, dry mouth, nausea, achy body and fever. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of sore arm, headache, neck pain, back pain, chills, dry mouth, nausea, achy body and fever was recovering at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected
Information has been received from a physician concerning a 10 year old male patient who on unspecified date in "end of January", was vaccinated with a dose of PNEUMOVAX 23 (lot # 664535/0060Z). Subsequently, the patient experienced a severe injection site reaction. No treatment was given for the adverse event. On an unspecified date, MRI of the left arm was performed (results not reported). The patient sought unspecified medical attention. The patient recovered on an unspecified date. Follow up information has been received from a physician concerning a 10 year old male student with amoxicillin allergy who on 13-JAN-2011 was vaccinated with the first dose of PNEUMOVAX 23, intramuscularly in left deltoid (lot number: 667712/1211Z) (dose not reported). On 14-JAN-2011, the patient experienced severe localized inflammation reaction, pain, low grade fever and unable to use arm (results not showed). The patient had Sinusitis at the time of the vaccination. MRI on left arm was performed. On 20-FEB-2011, the patient recovered from severe injection site reaction, pain, low grade fever and unable to use arm. Follow up information has been received from a registered nurse who stated that the patient's arm was swollen, red and hard. The patient was unable to move his arm. The registered nurse felt this was disabling for the patient. The patient had recovered (date unspecified). Arm was swollen, red, hard, and unable to move his arm were considered disabling by the nurse. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 12 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 21-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Positive PCR Covid test on 7/1/2021. Covid symptons. Itchy hives on 6/15/2021.
Getting vaccine but got shingles from it / got shingles again 3 yrs later; None of the other cases were as bad as the Ramsey Hunt; Getting vaccine but got shingles from it / got shingles again 3 yrs later; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included systemic lupus erythematosus.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ramsay-hunt syndrome (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ramsay-hunt syndrome and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient recovered fully, which was a miracle since the patient had systemic lupus erythematous (SLE) and stated many people with an autoimmune disease do not ever completely heal.  The patient waited 6 months before getting vaccine but got shingles from it and then got shingles again 3 years later. The patient stated none of the other cases were as bad as the Ramsey Hunt. This case was considered as suspected vaccination failure as details regarding complete vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 16-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
reported on 8/28, l arm where received an immunization had become inflamed, itching and swelling generalized in the upper arm from 3"above the elbow to shoulder.  Duration approximately one week.  Saw PMD who advised continue benedryl until well.
PATIENT RECEIVED VACCINATION AT 4:20PM. AT 4:23PM PATIENT COMPLAINED HE WAS THIRSTY AND FEELING BAD. CLINICIAN ATTENDED AND NOTICES PATIENT WAS FLUSH. CLINICIAN GAVE HIM WATER AND HAD HIM LAY DOWN ON THE FLOOR.  PATIENT SEEM TO START RECOVERING. AS A PRECAUTION CLINICIAN CALLED EMT. EMT ARRIVED AT 4:30PM AND ATTENDED TO PATIENT. PATIENT RECOVERED. EMT PERSONNEL OFFERED TO TRANSPORT TO HOSPITAL FOR FURTHER EVALUATION  BUT PATIENT DECLINED
Was due for his second dose on 21-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was due for his second dose on 21-May-2021) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was due for his second dose on 21-May-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was due for his second dose on 21-May-2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Covid booster given 09/29/2022. On 10/01/2022, presents with acute pancreatitis. A pleasant 63-year-old female patient with past medical history of hypertension, obstructive sleep apnea on CPAP at night, GERD, history of asthma who presents patient was referred from Medical Center for acute pancreatitis. Patient reported epigastric abdominal pain that started around 1 PM today. She described her pain as dull aching and pressure-like with intensity of 10 out of 10 and radiating to the back. She reported associated nausea and vomiting of ingested matter. She denies fever or chills. She denies diarrhea. She denies chest pain or chest tightness. She denies urinary symptoms. She denies alcohol use. Vitals are stable. Her lab work from MC revealed WBC of 13.8, hemoglobin 14.1, platelet 247, creatinine 0.89, potassium 4.2, AST 164, ALT 151, alk phos 79, total bilirubin 0.7, lipase greater than 30,000, triglyceride 141. Initial troponin 0.7. CTA chest showed no PE. 8 mm nodule in the right middle lobe. CT abdomen/pelvis showed moderate peripancreatic inflammatory changes suggestive of acute pancreatitis. No pseudocyst or abscess collection. Hepatic steatosis. Minimal coronary calcification. RUQ US showed distended gallbladder with multiple stones. No peripancreatic fluid or gallbladder wall thickening. CBD measures 4 mm. GI consulted prior to transfer [no indication for ERCP/MRCP for now, surgical consultation in the morning recommended]. She has received normal saline bolus, Dilaudid, aspirin 324 mg prior to transfer.
After patient received this vaccine dose, it was discovered that the vial had been stored outside of the recommended temperature range calling into question its efficacy  After conferring with immunization experts it was determined that this dose needs to be repeated.  Patient was contacted by the person completing this form and made aware of this information.  The patient has agreed to repeat this vaccine dose and has scheduled to return on 24 April 2021.
Patient was in the office on 3/19/21 for her first dose of Moderna COVID vaccine. 15 minutes after administration of vaccine, patient expressed she was feeling hypertensive and her hands were feeling cold. Patient was taken to an exam room for evaluation with assistance of language interpreter and RN. BP of 220/120 with symptoms of headache and blurry vision. No chest pain. No signs of anaphylaxis. Patient stated she was feeling slightly better after 3 minutes. Repeat vitals of BP 180/94, pulse 80, RR 32, O2 sat 98%. Patient did take BP meds as prescribed. Plan to go to the ED was communicated to patient and her brother in law to which they agreed. Patient requested that her brother-in-law drive her to the ED instead of activated EMS. Report was called to the hospital ED recieving provider by myself with diagnosis of hypertensive emergency.
1 week after receiving the first dose,  I developed a hive (2-3 inches across)  at the injection site that was itchy,  raised,  red, and hot. It's 3 days later now and mostly gone,  but still a bit itchy.
pain in bladder area with low grade fever... approx. 3 weeks after shots.. occurred with both shots
My arm feels like numb like when your arm falls asleep when somebody lays on it; I have that on my entire arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was unknown), via an unspecified route of administration on an unspecified date in 2021 as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. As per verbatim, consumer stated, I got my first Covid shot on Thursday (on an unspecified date in 2021). On an unknown date in 2021, the patient's arm feels like numb like when your arm falls asleep when somebody lays on it, that feeling and patient have that on entire arm and wanted to known is that normal. The patient wanted to know, if the normal side effects can be told to them or not. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Patient was administered a Janssen COVID vaccine lot # 043A21A at approximately 10:33 on 4/10/2021. Patient expressed no history of difficulty with shots or vaccinations. Patient gave no indication he was not feeling well or any indication he was experiencing difficulties. Shortly after administration of the vaccine, approximately 3 minutes and while handing Patient his paperwork, he became unresponsive. Patient was lowered to the floor where he exhibited what could be described as minor convulsions that were very short lived. His feet were elevated and he regained consciousness after approximately 2-3 minutes. His vitals were taken and recorded. Patient reported that he has no remarkable medical.
Patient verbally reported that this was her first covid vaccination to the manager and provider. Upon entering the vaccine in to the Registry of Immunization Transactions and Services. Clinic staff found patient received the second dose of her Moderna Covid Panel 4 months prior. Patient did not report any adverse reactions.
No adverse effect. Patient received the monovalent instead of the prescribed bivalent.  Pharmacist dispensed the incorrect vaccine.
This spontaneous report as received from a pharmacist via a company representative refers to a 66 year old male patient. Medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (concentration, dose, frequency and lot number were not reported). No concomitant therapy was reported. On an unknown date, the patient experienced unusually large injection site rashes 10 days after receiving ZOSTAVAX. The ras was extremely swollen, hot and red. The patient did not sought medical attention. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Pt presented to physician with red swollen right arm, physician diagnosed cellulitis from injection, prescribed cephalexin 500mg 4x per day x 7 days.
A non-serious spontaneous report of administered of expired FLUMIST was received from a  physician concerning a 58-month-old male.  who received FLUMIST. The patient's medical history and concomitant medications were reported. On 06-Jan-2009, the child inadvertently received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medicatin errors that occurred shortly after the product expired. Additional information was received on 01-Apr-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 02-Apr-2009: Product Complaint Investigation results.
Moderna vaccine was thawed on 5/17 and administered on 6/23/23 (7 days past the 30-day stability date). When outreaching Moderna for extended stability data, a lot assessment was conducted and it was determined the lot was active against COVID-19 at this time interval. Patient has not reported any adverse effects to date.
Patient received the wrong BRAND of the vaccine. Instead of Pfizer pt received Moderna. No reaction or adverse events occured.
About an hour after the injection, my left arm from site down has gone ice cold. Have not had swelling or soreness as of yet.  The left arm is ice cold and white compared to my right arm. Did not experience this with the first COVID-19 shot or any other vaccine I have received prior.
I had a small fever the next day, but that went away. I had upper lobe of my right lung removed in 1987. Not long after my second dose, I had a pain in my right upper quadrant of my abdomen and it keeps getting worse and worse. I went to my gastroenterologist and he did an endoscopy and it came back negative. We are unsure what is going on with it. When I went to Dr., he recommended a CT scan of the chest and I got the scan and it came back pleural thickening with associated fibrosis and parenchymal scarring.
In bed x 3days pt reports weakness, dizziness, sl chills, h/a, flu-like severe sx;
NO ADVERSE EVENTS, PATIENT GIVEN EXPIRED VACCINE (TDAP) EXPIRED 12/2012.
pain and pressure in the left ear; right arm swelling; chills; fever; hard area at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (right arm swelling), CHILLS (chills), PYREXIA (fever), VACCINATION SITE INDURATION (hard area at injection site) and EAR PAIN (pain and pressure in the left ear) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE SWELLING (right arm swelling), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE INDURATION (hard area at injection site). On 08-Mar-2021, the patient experienced EAR PAIN (pain and pressure in the left ear). At the time of the report, VACCINATION SITE SWELLING (right arm swelling), CHILLS (chills), PYREXIA (fever), VACCINATION SITE INDURATION (hard area at injection site) and EAR PAIN (pain and pressure in the left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication taken Nyquil.