chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fully vaccinated patient admitted through ED for diarrhea that was reported by patient as black.  No respiratory symptoms, however, tested positive for COVID during admission testing.  Provider note below:  "90 yo male with history of CAD w/ MI s/p CABG, dilated cardiomyopathy s/p pacemaker in situ, Atrial fibrillation on warfarin, aortic stenosis. Reported to Medical Center walk in with 4 day history of diarrhea, He states he has been having 10-15 loose stools a day. They are coffee ground and black in nature. He states anytime he eats something it goes directly out. The stool is described as loose and watery in nature. He does not take any PPI. No epigastric pain. No hematochezia or hematemesis. No recent hx of travel or abx. Besides these symptoms, he is also complaining of significant weakness. He states he hasn't eaten/drank anything for about the 4 days due to this diarrhea. He initially went to walk in clinic but was told to come to the ER.  In the ER, he was found to be COVID +. But not hypoxic or short of breath. Labs were significant for AKI. CT AP did not show any significant pathology. He was given fluids, AKI improved with fluid.  Pt's HBG is around 12.5, no sign of hematochezia and active bleeding. He has no BM during the stay, cannot confirm with melena.  GI was consulted: recommended po PPI for 8 weeks, and restarts warfarin's and ASA, don't recommended GI follow up at this time.  Pt has no sign of active bleeding and no BM. Pt is stable upon discharge. "
pts left arm got extremely sore and painful after taking the vax.  The pain radiates from the shoulder to his finger tips.  Pt had appt w/ PCP on  4/7/21.  He was prescribed Ibuprofen for his pain which did not help.  He had another appt on 4/19/21.  He was prescribed Tylenol w/ codeine for his pain which did not help. He was sent to have an US to rule out blood clots.  No blood clots were found.  On 4/26/21  he was given Tramadol which did not help.  He had a tele-visit on 5/4/21. He was given hydrocodone-acetaminophen-7-325 for pain.  No medicine he has helped with his arm pain.  He had a tele-visit on 5/10/21 and a nerve conduction test.  Evidence of radiculopathy was found.  He was prescribed prednisone.  He is scheduled for an Acute neurologic eval on 5/25/2021.
SWELLING OF LEFT ARM POST VACCINATION. NO FEVER, SWELLING, PAIN, OR DECREASED USE OF ARM WHEN SEEN IN CLINIC 6/11/19 AT 1345.  OBS FOR NOW.
vomiting, headache, high fever, rash, burning sensation all over body, fatigue, weakness, weight loss, dehydration, had to get IV fluids on 3 separate occasions.
Injection site localized pain started approximately 10 hours post injection. I used an ice pack on the site and took 400 mg of ibuprofen. Before the injection I had no pain, fever, muscle soreness, or joint pain. I took one 500 mg extra strength TYLENOL before bed. I awoke from sleep in my bed at 2 AM feeling chilled with severe arm pain at site of injection. I did nothing and tried to go back to sleep feeling this was normal. At 6 AM on the 20th of April I awoke and while getting out of bed felt arm soreness, feverish, headache, muscle pain in my upper back and neck and joint pain in both hips, both knees and both ankles. I took my temperature orally and it was 101.4 degrees F. I ate breakfast even though slightly nauseated, so I could take one 600 mg ibuprofen tablet. Continued ice pack applications and bed rest seem to be helping. As a pharmacist I understand how important reporting ADR's are for documentation.
numbness in her right arm; exposure during breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in her right arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (exposure during breastfeeding) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in her right arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (exposure during breastfeeding). At the time of the report, HYPOAESTHESIA (numbness in her right arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (exposure during breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.
Patient reported feeling dizzy shortly after the vaccine. Symptoms resolved after she laid down and we got her a drink.
Patient has had 1 dose previously for MMR and varicella.  Patient was given Proquad as a second dose instead of separating.
Fall - ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Mom states child had nonstop crying for 45 min around 8 PM on 9/15/01. She couldn't do anything that would stop her from crying. Child arched her back and acted as if in severe pain. Took child to ER in DeSmet. Child seen by Radish, PA. No fever, or other symptoms or signs. Mom states child relaxed and settled down down as they approached DeSmet City limits.
Raised heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Raised heart beat) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Raised heart beat). At the time of the report, HEART RATE INCREASED (Raised heart beat) had not resolved.            Reporter did not allow further contact
after Booster shot, experiencing increased levels of ANA, arthritis in fingers and toe joints.
Chief complaint of allergic reaction. Patient reported that she just received her first dose of the COVID vaccine. Approximately 15 minutes after that, she started experiencing diffuse itching and chest tightness. She denied shortness of breath but reported that it felt like she just finished running a race regarding her breathing. She denied rash at this time but has itching everywhere. When she informed the staff at the vaccine center, she was told to go to the emergency department for evaluation. She was not given any medication prior to coming here. The patient reported a history of 2 pulmonary embolisms and a cardiac stent placed. She reported that her chest tightness that is dissimilar from what she experienced with stent placement. She cannot remember the feeling when she had the pulmonary embolism. She has no other acute complaints. She denied chest pain, sensation of throat closing, facial swelling, lip or tongue swelling.
This spontaneous report as received from a consumer refers to a 65 year old female patient. On 07-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 dose 2 for prophylaxis. Other suspect therapies included PREVNAR 13. Concomitant therapies included vitamins (unspecified). On 2016 the patient experienced injection site pain and injection site warmth. On 07-AUG-2017 the patient experienced product name confusion. On 08-AUG-2017 the patient experienced swelling and erythema. The outcome of swelling and erythema was reported as recovering/resolving. The outcome of injection site pain and injection site warmth was reported as recovered/resolved. The outcome of product name confusion is unknown. The reporter considered product name confusion to be not related to PNEUMOVAX 23.
Fever or Chills  Cough  Shortness of Breath  Difficulty breathing  Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Sore throat  Congestion or running nose  Nausea or vomiting  Diarrhea  oTelephone Visit  10/20/2021  Internal Medicine -  MD Internal Medicine COVID-19  Dx   HPI: Patient is 68 y.o. female for whom I am doing a telephone visit discuss her current Covid infection.  She started with symptoms last Tuesday which is October 12 with chills and headaches and body ache followed by temperature ranging up to 100.4 °F.  This was followed by cough with clear to brownish phlegm along with nausea vomiting and diarrhea which has now resolved but she continues to have some cough and some shortness of breath on exertion.  She does not have any shortness of breath on rest.  She is overall feeling better compared to last week.  She has not checked her temperature this week at all.  She has not been checking her oxygen level because she does not have a pulse oximetry.  I discussed in length about the risk benefits of monoclonal antibody infusion and that she would be a candidate although she is nearly on day 9 of the 10-day window for the infusion.  She would not like to get that and would like to monitor and treat conservatively.  Did recommend to drink lots of fluids rest and monitoring the temperature and oxygen level.
pt recvd 1 dose of Engerix-B 8JUL92 following vax exp substernal pain lt arm/back/sternum, tingling in lt arm, pain on spine in middle of back, heaviness in chest, felt hot, perspiration, cardiac-type pain, & was lightheaded; seen in ER;
UPON WAKING UP, PATIENT HAD A 100.3 FEVER. HALF HOUR LATER, PATIENT FAINTED.
Headache, nausea and vomiting 42 hours past second dose- lasted for 7 hours.; Headache, nausea and vomiting 42 hours past second dose- lasted for 7 hours.; Headache, nausea and vomiting 42 hours past second dose- lasted for 7 hours.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Lot number: ER8727, EW0173) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=ER8727, EW0173,, lot unknown=False,, administration date=Apr/2021), administration date: Apr2021, when the patient was 51 years old, for COVID-19 immunisation, reaction(s): "lethargy", "soreness mild muscle aching". The following information was reported: HEADACHE (non-serious), NAUSEA (non-serious), VOMITING (non-serious) all with onset Apr2021, outcome "recovered" and all described as "Headache, nausea and vomiting 42 hours past second dose- lasted for 7 hours.". It was unknown if therapeutic measures were taken as a result of headache, nausea, vomiting.  No follow-up attempts are possible. No further information is expected.
pt recvd 1 dose of Engerix-B & the same day broke out w/a rash covering all of body;
Immediate allergic reaction. Itching face first then spread, coughing, wheeze, tight chest, hoarseness.  Extreme pain in vaccinated arm. Severe weakness in both arms, legs, feet, hands. Dragging right foot  ( hx of clonus), excruciating neck pain and back pain, increased numbness and tingling in hands and feet. Lost ability to stand or walk the few steps I could walk before vaccine.
No appetite, malaise, Fever 102.3 starting at 12AM. Chills, very painful L arm.
Received flu vaccine 9/22 pm c/o pain swelling down arm 2-3 hours later with pain & swelling to wrist.
Severe Rash that started from the first dose and got worst with the second dose.   Prescribed using Hydroxyzine HCI 25.
Sore arm for two days. Not a problem.  Stuffy nose and headache after 3 days. Continued for two days.
pt recv vax 8MAR96 & 19APR97 pt devel a chickenpox rash consisting of greater than fifty lesions disseminated on trunk & face;pt also exp a low grade fever of moderate severity;
During monitoring period post Pfizer initial COVID-19 vaccine, pt experienced sweating, flushing, chills, lightheadedness, nausea. VS: 135/83, P 53, R 19, O2 95%. IM Benadryl administered per patient request, blanket and water provided.  VS: 143/85, R 21, P 59, O2 100%, orange juice given. Repeat VS in opposite arm: VS 152/90, P 60, R 10, O2 100%. 12:41 VS: 140/75, R 20, P 60, O2 100%. o Patient was discharged to home in care of parent.
This spontaneous report was received from a nurse and a healthcare worker and refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 03-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
The day following her vaccine slight fever and malaise was noted. Within 2 days of receiving  the vaccine the child broke out in hives and a red itchy rash  that did not resolve for 6 months. The child also experience daily vomiting. Allergy testing was completed, no allergies found. Multiple OTC and prescription ointments and lotions where used with little change. Barium sallow showed slight delayed gastric emptying. In May of 2019 skin rash and symptoms began to resolve with no correlation with any particular cream/ointment/or lotion.
per pt's wife, pt was seen at an urgent care after a fall at home on 9/9/21; xray showed no acute findings; urgent care did a COVID test and pt found out it was positive on 9/10/21; pt received monoclonal antibody infusion on 9/12; was brought to ED 9/14/21 with altered mental status and increased lethargy, fever, cough, and decrease in urine output; O2 sats 98% on RA; positive COVID tests on 9/14/21 and 9/21/21; through the course of his stay, his condition worsened; pneumonia; ARF; wife made pt a DNR; he slowly declined and transitioned to comfort care; he experienced cardiac arrest and passed away in the hospital
Patient had a an allergic reaction to the vaccine on the (R) upper arm which radiates down the entire arm.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored VAQTA (lot # R018935, expiration date 05-SEP-2019; dose was unknown) intramuscularly for prophylaxis. The storage temperature of the vaccine was reported as 0.4 degrees Celsius for a time frame of 40 minutes. There was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. The call was due to a data logger.
rash developed at injection site hours after injection and spread on right side of body.  mother is physician assistant and handled treatment,  symptoms diminishing at time of phone call to pharmacy.
severe allergic reaction; Hives and itching throughout body; Hives and itching throughout body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), URTICARIA (Hives and itching throughout body) and PRURITUS (Hives and itching throughout body) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction), URTICARIA (Hives and itching throughout body) and PRURITUS (Hives and itching throughout body). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (severe allergic reaction), URTICARIA (Hives and itching throughout body) and PRURITUS (Hives and itching throughout body) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
POUNDING HEADACHE; CONVULSION; BODYACHES; WEAKNESS; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, Crohn's disease, and migraine. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total dose, administered on 31-MAR-2021 (Wednesday) on left arm for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021 on Wednesday, the patient experienced severe chills to the extent of teeth chattering ,body shaking and convulsion, due to which her husband kept covering with blankets. At 19:00, she developed pounding headache. She experienced body aches. As per her doctor, fibromyalgia might exacerbate the body aches due to which she stayed in bed for 2 days. She also experience weakness and nausea. On 02-Apr-2021 (Friday), she was finally able to cook. She was still experiencing weakness, nausea and excruciating headache for which she was not sure if it was due to vaccine or from migraine that she had. The patient also informed that she underwent unknown test for six times on unknown dates and the test result was found to be negative. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, convulsion and had not recovered from weakness, nausea, and pounding headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409019 -COVID-19 VACCINE AD26.COV2.S- convulsion. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Fever 101.7 Chills started around 5:00 PM or about 32 hours after injection.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 27Jul2021 as dose 1, single (Lot number: fa7485), on 17Aug2021 as dose 2, single (Lot number: fc3183), on 19Jan2022 as dose 3 (booster), single (Lot number: fk5618) and on 13Jul2022 as dose 4 (booster), single (Lot number: fm0173) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Esophageal Cancer" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE; FAMOTIDINE; LOSARTAN POTASSIUM; OPDIVO; PANTOPRAZOLE; MULTIVITAMINS. Known allergies: nka. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive; (02Aug2022) Negative; (06Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   No follow-up attempts are possible. No further information is expected.
Large red mark on arm extending most of upper arm - lasted several weeks and one month later still around vaccine site. No itching, pain, or raised welt.
Neckache; little dots on and around injection site 2-4 inches around; Aches; A spontaneous report was received from a Consumer concerning a 23-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events little dots on and around injection site 2-4 inches around(Injection site reaction), neckache(neck pain), aches(pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events little dots on and around injection site 2-4 inches around . On an unknown date, the patient experienced the events neckache . On an unknown date, the patient experienced the events aches.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, little dots on and around injection site 2-4 inches around, neckache, aches was not reported.
A non-serious spontaneous report of accidental exposure, influenza, fever exhaustion, coughing, headache and sneezing was received from a female adult consumer, who is a nurse, subsequent to FLUMIST. The patient administered FLUMIST "years ago". The reporter stated that, "twice I gave FLUMIST years ago and twice I contracted influenza. The reporter stated she was in bed for one week with exhaustion, a fever of 104, sneezing coughing and severe headache. The outcome of the events was not reported.  All follow up attemps completed.  Information not available 11-11-2009.
ARM HURT FOR TWO DAYS; HEADACHE THE SECOND DAY AFTER VACCINATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm hurt for two days, and headache the second day after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt for two days, and the outcome of headache the second day after vaccination was not reported. This report was non-serious.
patient had hives and tightness of throat, went to ER twice. will follow up with allergist
This is a spontaneous report from a Pfizer-sponsored program. A 68-year-old female contactable consumer (the patient) of unspecified ethnicity received PREVNAR 13 at 0.5 ml single and influenza vaccine, both via an unspecified route of administration on an unknown date in Dec2009 for immunization. The patient was a smoker. Concomitant medications were not reported. The patient received the vaccine and she got pneumococcal infection in Dec2009 (2 to 3 weeks after vaccination). The event required hospitalization in Dec2009 for 10 days. Therapeutic measures, breathing treatments, were taken in response to the event which resolved on an unknown date. The patient stated that the only good thing that came from this was that she quit smoking and had not had a cigarette since Dec2009. She also had not had a flu shot or pneumonia shot since that time and has been relatedly health. The consumer didn't know whether the suspect product was actually Prevnar and not Prevnar 13 (considering that administration date was reported as Dec2009, while Prevnar 13 was launched only on 31Mar2010). Follow-up (08Aug2016): New information from the same contactable consumer includes: medical history, suspect vaccination partial date, concomitant vaccine, updated event outcome, seriousness criterion of hospitalization provided, treatment received information. Follow-up (27Sep2016): New information reported from a contactable consumer included: SAE onset date; hospitalization date; course of events; unknown if Prevnar or Prevnar 13.