chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HPI:  The patient is a very pleasant healthy 21 y/o male with no sig PMH, he received the second dose of Pfizer's vaccine on the 15 th, he had some retrosternal sharp chest pain which was worse with breathing about 2 days ago which got better, but last night he started having more chest pain radiating to his lower jaw, he presented to the ER where his troponin came elevated, he has no fever chills no SOB no other complaints. His chest pain resolved with no recurrence, his EKG was normal. No h/o heart issues or chest pain in the past.
Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination.; Headache; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination.), HEADACHE (Headache) and FATIGUE (Extreme fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043LZ0A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020, Frontal headache and Fatigue (They both had Covid in October of 2020 had a minor case but a long stretch of frontal headache and fatigue, which were similar symptoms they experienced with the vaccine).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination.), HEADACHE (Headache) and FATIGUE (Extreme fatigue). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Soreness on the left side from his neck to the base of his skull within 4 hours of the vaccination.), HEADACHE (Headache) and FATIGUE (Extreme fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The symptoms lasted for 36-40 hours.
pt recvd & p/dose 2 exp fatigue, nausea, aches & h/a which lasted 3-4 wks;
pt devel allergic rxn w/swelling of face, eyelids-wheals p/3rd day of vax;seen in clinic epi given-also recv prelone/atarax;
Nurse administered adult dose meant for sibling that was 12 y.o. to this patient who is 5 y.o.  Child had no symptoms.
Swelling of right arm from elbow up no redness/ pain. Symptoms currently being relieved w/ice.
01/10/22: COUGH, MUSCLE PAIN, HA, LOSS OF APPETITE
Patient received 2nd dose too soon. Initial dose was administered on April 17, 2021. Scheduling staff scheduled patient 2 weeks later, rather than 4 weeks later. Vaccine administrator did not notice the date written on his card prior to administration. Error discovered at the time of documentation as part of a vaccine clinic.
pt recv vax; felt n; passed out while taking bath; became pale & v; ice cold towel to forehead; BP 88/68 p/ 10 min;
Bad headache, fever, over all body ache, waking up very hour from 2am head hurts more when lying down.
He presented to emergency room with weakness and fatigue related to COVID-19 infection.  Comes from assisted living, fully vaccinated with Moderna and this is unfortunately his second COVID-19 infection.o 3-day course remdesivir o Dexamethasone o Supplemental oxygen as needed o PT/OT o Robitussin as needed for cough o CRP 93.8, will trend
25 minutes after vaccination started to have sensation of difficulty breathing. No wheeze. Reported lips felt tingly. No swelling.  Vital signs monitored for 1 hour. Breathing normalized. Lip tingling resolved. Vital signs normal. WIll follow up with PCP if necessary.  When left clinic site at 14:11: BP 138/82 Pulse: 62 Resp: 16 O2 Sat 99% on room air, lungs clear oropharynx normal
Initial report was received from a consumer, who was also the patient, on 03 April 2013. A female patient had received an intramuscular injection in the left deltoid of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (manufacturer and lot number not reported) on 20 January 2012 and an unspecified amount of time following vaccination the patient experienced loss of vision, saw flashes, had red eyes, body aches over whole body and muscle aches. The patient was still being treated for vision problems and was originally diagnosed with panuveitis from immune response. The patient received the Tdap vaccine for "non-blood borne needle stick". The patient's muscle aches resolved but vision problems are ongoing although she has had treatment. The patient had no illness at the time of vaccination and no known allergies. Outcome was not recovered. Documents held by sender: None.
Seemingly random stomach cramping every couple of days. The patient diagnosed with IBS, but usually have symptoms under control, and diet has not changed recently was not resolved at the time of this report; Seemingly random stomach cramping every couple of days. The patient diagnosed with IBS, but usually have symptoms under control, and diet has not changed recently was not resolved at the time of this report.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 27Apr2021 at 11:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 01May2021, the patient experienced seemingly random stomach cramping which occurred every couple of days. The patient was diagnosed with IBS, but usually her symptoms under control, and diet was not changed recently. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event seemingly random stomach cramping every couple of days. The patient diagnosed with IBS, but usually have symptoms under control, and diet has not changed recently was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Flu; This is a spontaneous case initially received from a physician (case ID: SEQ19-02028) on 26-Aug-2019, concerning a patient of unspecified age and gender.   The patient's concomitant medications included hydroxyzine pamoate (25 mg Capsule, 1-2 capsules, orally, every 4-6 hours as needed) for muscle spasm and Lyrica (pregabalin) (150 mg Capsule, 2 capsules in morning, 1 capsule in afternoon and 2 capsules at bedtime, orally, everyday) for unknown indication. The patient's drug allergies included Cymbalta (duloxetine), Depakote (divalproex) and gabapentin.  On an unspecified date, the patient was administered with Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route, batch number and expiration date: not reported] for unknown indication.   On an unspecified date, after vaccination, the patient developed flu from the vaccine.   At the time of reporting, the outcome of flu was not reported.  The reporter assessed the event as related to Flucelvax Quadrivalent.  Company comment: A patient of unspecified age and gender has experienced Influenza associated with Flucelvax QIV. Chronology needs more clarification. The patient's concomitant drug - pregabalin provides alternative aetiology for the event. With information provided, causality is assessed as not related to the product.; Reporter's Comments: A patient of unspecified age and gender has experienced Influenza associated with Flucelvax QIV. Chronology needs more clarification. The patient's concomitant drug - pregabalin provides alternative aetiology for the event. With information provided, causality is assessed as not related to the product.
Redness. Swelling. Pain at administration site. Inj. done at HD - lot/location unknown unavailable.
First I had the normal head ache, tiredness, rash, pain, and swelling around injection site on my shoulder. Within 48 hours, everything was back to normal. Until Monday night. My arm was bothering me, so I looked at it and the rash/spot was back along with the pain and swelling. It is very itchy and warm to touch. For the first reaction of the site, I wasn't concerned. But it went away completely and came back 5 days later. Now it is itchy and war to touch, so this isn't normal. I've been good about keeping my hands busy with work or cooking to prevent me from focusing on scratching the itch, and if it is unbearable I have used ice to help stop it.
blanched patch @ inject site; raised 1/4cm x 1/2 cm x 1cm; No redness, warmth, pain or induration; almost looks like a small pox scar; edges are not smooth; 9OCT92 f/u recovered w/sl red area less than 1/4";
Red area about 2 1/2 inch diam lasted at least 3 days. Took BENADRYL and used calamine. Arm hurt. Also hard area at inj site.
no additional AEs; administration of an expired vaccine; Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 29-JUN-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, (1 time dose, lot# S005856, expiry date 03-DEC-2020; strength and route of administration were not reported) (Expired product administered). No other adverse event involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S005856; expirationdate: 03-DEC-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Pain Lt subcranial 2nd since flu shot - clinically looks like subcranial bursitis.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a pharmacist concerned a 60 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 14-JUN-2021) dose was not reported,  frequency once total, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced suspected immunological vaccine failure.  The test done was SARS COV2an (IGg spike) - Semi Quant. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test negative (NR: not provided) Negative antibody. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210449920-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Left sided TIA, completed labs, completed ekg, completed Echo, complete CTA all negative. .
the person who administeredthe 2nd shot vaccine toher lifted the skin of her arms while injecting.; This is a spontaneous report from a contactable consumer (Patient reported for self). A 75-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number were not reported; Expiry Date: Unknown), via an unknown route of administration, administered in the arm on 27Jan2021, as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had earlier received first dose of BNT162B2 for COVID-19 immunisation on 06Jan2021. The patient had already had her 1st and 2nd dose, 06Jan2021 and 27Jan2021, respectively. Patient mentioned that the person who administered the 2nd shot vaccine to her lifted the skin of her arms while injecting. According to patient, she read on the internet that this shouldn't be the right way to administer a vaccine, so she's kind of worried if she still got 100 percent efficacy from the vaccine administration. The patient stated that when they administered it (first dose), they just gave it to her in her arm. However, she states that when she went for her second dose, she noticed that the vaccination provider "pulled up the skin" on her arm and then injected the vaccine. She states she could feel it "go through my arm" that time. She says yesterday she read online that the skin should not be lifted prior to injecting the vaccine and would like to know if this makes her second dose less effective. The patient stated that Nurse lifted fatty part of her arm and gave the vaccine it was not the way supposed to give the vaccine and should be directly into the deltoid muscle. The patient reported she does not know if that was the deltoid muscle that she used or not or if that was correct, but they said it needs to be done the other way, the patient reported. Patient was kind of worried if she still got 100 percent efficacy from the vaccine administration. When probed for vaccine LOT#, consumer stated, "I do not know, I have no idea." As consumer was not willing to proceed the call. Product details pharmacy details and further probing could not be done. Limited information available over the call. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Dizziness-vertigo: 7 days after vaccine. Lasting 2 days Red rash- itchy, swollen. At site of injection 10 days after vaccine
lt arm red & sl indurated 16mm in length, 12mm in width;no fever c/o pain;
felt horrible; bended over; Vaccination site pain; fever; side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt horrible), POSTURE ABNORMAL (bended over), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION COMPLICATION (side effect) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced POSTURE ABNORMAL (bended over), VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (fever). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt horrible) and VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (felt horrible), POSTURE ABNORMAL (bended over), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION COMPLICATION (side effect) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up was received New AE Side effect was added Duration was added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.
Within 24 hours of receiving the injection, I had extreme fatigue, then aches, then cough, then diarhia, then fever/chills.  Intense pain.
Fever, aching left arm, redness, swelling and mild headache started 2nd day after flu vaccine given. Seen at ED, fever to 101.1, given ibuprofen 400 mg once in ED, another dose at home.  Fully recovered within 24 hours.
I had pain and huge swelling on my left side of the body. I contacted my doctor and he sent me for diagnosis and did the CT scan and it flared up but it went away after 6 weeks.
Fever 100 degrees F., aches and pains, insomnia for the next 3 nights, fatigue, malaise, anorexia, dehydration, weakness.
Pt reported burning and pain when vaccine given.  following days reported sore arm that eventually lead to decrease range in motion.  Patient reports taking NSAIDs to help with pain, but not improving.  Vaccine was given on 9/30/21,  Adverse event reported on 11/9/21, and symptoms still present and persist.
Patient died suddenly at approximately 6AM on the following morning  of 9/28/2021 after receiving the vaccine on 9/27/2021.  Pt became acutely SOB and family called 911 for an ambulance but patient died before help could arrive.  Pt's wife unable to give much further history.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 75-year-old male patient who received SHINGRIX. The patient's past medical history included hip replacement. On 16th May 2018 10:00, the patient received the 1st dose of SHINGRIX. On 16th May 2018, several hours after receiving SHINGRIX, the patient experienced pain, fever, pain in hip, chills and muscle pain. On an unknown date, the outcome of the pain, fever, chills and muscle pain were recovered/resolved and the outcome of the pain in hip was not recovered/not resolved. The reporter considered the pain, fever, chills and muscle pain to be related to SHINGRIX. The reporter considered the pain in hip to be possibly related to SHINGRIX. Additional details were provided as follows: Concomitant products included gout medications, statins and vitamins. All symptoms were presented the evening on the day the patient was received SHINGRIX but they intensified the next day. All the symptoms were begun to resolve the following day except the hip pain which was still present, at the time of reporting. The other symptoms were almost gone by the 4th day and completely resolved by the 5th day. The patient had denied permission to contact their physician and he was not sure if the hip pain was due to the shot or a 6 hour hike he took the day of the vaccination. The patient also had a fall which he described as a bouncing fall on that hike. That same hip had also been replaced.
13Aug96 pt recv 1 dose vax. 20Feb98 pt devel chickenpox of 12-16 vesicles on hand,trunk & scalp. Pt recovered 25Feb98. This reported as "possible vaccine failure".
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FC3181) at the age of 68 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown Results; Blood test: Unknown Results; Electrocardiogram: Unknown Results; SARS-CoV-2 test: Unknown Results. The report was not related to a study or programme. The patient said that with her first shot there was no reaction. The patient went to Pharmacy for both vaccines and she would not have known.  The patient wanted to know whether the first and second vaccines had different ingredients or the vaccines were different. The reporter was reading information from her vaccine card. The patient had Covid-19 in Jan2022. No additional vaccines were administered on same date of the Pfizer suspect.
Pt states that after receiving H1N1/Seasonal flu (22degrees) she developed a localized raised rash from shoulder to elbow that was hot to touch & swollen. Denied any respiratory issues at that time.
Patient reports history of seafood allergy; within 10 minutes of administration of vaccine, began to develop dryness in throat leading to persistent coughing, was closely monitored and began to develop some difficulty breathing. Was given 50mg of Benadryl at first, coughing became more severe, epinephrine injection was administered on right thigh and paramedics were contacted as administration took place.   As a result, patient was still responsive but continued to show symptoms of anaphylaxis, paramedics arrived and escorted patient to the nearest hospital in which patient complied. Paramedics were also provided with information of what to place and what was given to the patient as a result of the anaphylactic episode.
Approximately 10 min after admin pt felt "woozy" and head was swirly and needed to sit down. Pharmacist called and CMS pt refused transfer and was assisted to her car
MY SON OF 17 RECEIVED THE  FIRST DOSE; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (MY SON OF 17 RECEIVED THE  FIRST DOSE) in a 17-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (MY SON OF 17 RECEIVED THE  FIRST DOSE). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (MY SON OF 17 RECEIVED THE  FIRST DOSE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatments were provided
Swelling, redness, itching of left arm approx an inch and one-half above elbow. Patient to take BENADRYL and ibuprofen to see if improves pt will let us know if no improvement.
Employee reported by bedtime of 12/28/2020 which was the date she received her 1st dose of the COVID-19 vaccine  she had the following symptoms:  Arm was sore as a boil and she had upper respiratory symptoms similar to a cold, drainage, nasopharyngeal irritation and cough lasting a good while.
Rash to face and left orbital area. Treated with hydrocortisone cream 1%.
p/vax pt blood test showed elevated liver enzymes;apparently was being denied a preferential rate for insurance;A physical & blood work done the prev month was fine;
Injection site pain Injection site swelling  Diarrhea  Arm pain Swollen lymph nodes
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In June 2016, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (route, lot # and expiration date were not reported). On 07-MAR-2017, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX for prophylaxis (route, lot # and expiration date were not reported). It was stated that the health worker was unaware that the patient was already administered the ZOSTAVAX. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.