chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PM injection given into upper shoulder - needle stuck & was manipulated, but unable to inject vaccine. Needle removed with some resistance. Pain aching & shoot. Radiates moderate to severe pain with movement.
This case was reported by a consumer via out of hour services and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 2nd dose of SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced fever, muscle pain, weakness and headache. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the muscle pain, weakness and headache were unknown. It was unknown if the reporter considered the fever, muscle pain, weakness and headache to be related to SHINGRIX. Additional details were reported as follows: The patient reported that, the fever was went as high as 103.5 degrees F.
Difficult to move Left arm, can move hand. No fever, not hot, no redness, small hard spot where given.
330PM 10JAN06 pt recvd vax;6PM sx fussiness,eye itching & swelling,congestion;bumps on hands only
On 5/18/09 given VARIVAX, developed erythema with 3 mm central papule vesicle seen on 5/21/09.
Fever  Coughing lethergy The next morning no appetite and vomiting X 3 later. Fever x 4 days
TIA (transient ischemic attack) Aphasia Dysarthria Dizziness
pt recv vax 26JAN96 & 23MAY97 pt devel a varicella-like rash that was reported as mild;
The morning after patient had his vaccines he developed what they believe to be an exacerbation of his MS. He had been seen earlier in the month by his neurologist for an exacerbation of his symptoms- vision changes and gait instability. He got 3 days of Solumedrol 9/27-9/29. and he improved significantly. His symptoms were improved until the morning after the vaccines- Shingrix and Influenza were given. when he developed vision changes, double vision, difficulty with ambulation (unsteady, dragging feet), changes in speech (difficulty enunciating, garbled speech once again and even more..
central corneal opacity of the right eye; herpes simplex virus stromal keratitis; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 14-NOV-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) injection (lot number, dosage, vaccination site and route of administration were not provided) as recommended for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered blurry vision in the right eye (OD) and was diagnosed with central corneal opacity of the right eye and herpes simplex virus stromal keratitis. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.   Upon internal review, the events of central corneal opacity of the right eye and herpes simplex virus stromal keratitis were determined to be medically significant. The events of central corneal opacity of the right eye and herpes simplex virus stromal keratitis were considered to be disabling.
Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with cases 2018SA248595 for 4 years old patient, same reporter. This case involves a 20 years old patient (gender was not reported) who received vaccine IPV (VERO) [IPOL] (lot number N1J451M, expiry date not reported) via intramuscular route in arm not specified on 09-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was also reported that there was temperature excursion with Ipol 11.2C 1hr 12 mins. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
sore throat; feel sick; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ILLNESS (feel sick) and HEADACHE (headache) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), ILLNESS (feel sick) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), ILLNESS (feel sick) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that need to get tested to get back to work so they inquire if the test result may be affected by the vaccine    Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Updated reporter's Qualification and contains suspect product start date for booster shot 17-Dec-2021
Left vetribral artery dissection (Spontaneous) higher than where they normally occur. This occured in the area protected by the skull. No known trauma to the area. Sweating, vomiting, temporary loss of vision in one eye.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt called and said her arm was bruised (black and blue) at the injection site, also redness.
Pfizer second booster recd 11/2/22. Following 3 days had severe chills, headache, was weak and balance issues.
Pt rec'd IM injection and she c/o severe pain with injection; instructed to apply ice pack and return with any further c/o-12:00 noon pt returned still c/o severe pain at injection site-no redness or swelling noted, instructed to call-f/u with PCP.
pt recv vax 16JUN98 & c/o very irritable-cranky-local swelling to rt thigh site of IPOL-HIB/HEP B;to MD checked by MD given DPH;advised measure temp;
19th weekend stomach cramps and pain, severe, and severe nausea. Taking Promethazine for the nausea (I have that on hand as needed when I get migraines as I do get them. So now I'm just taking more of it). I have a GI consult coming up for persisting nausea that I'm experiencing.  No longer getting cramps and pain in stomach. Was getting an OMT session; as I was having that, I told my doctor what was going on and he ordered the Ultrasound, but a week after I ate a big meal and I stood up and felt pull and tug in my sternum area; it was a little bulge in between my breasts. She thought it was a hernia. Ultrasound, it's not a hernia. It doesn't hurt. I still have the bulge.
Vertigo/dizziness with nystagmus  Abdominal pain & diarrhea  Fatigue, muscle and joint aches Fever
The first shot was little to no pain at all. The second shot gave me a low grade fever of 100.6. There was pain from my shoulder down to my finger tips and occasionally travel across the sides and back of my neck. My entire body ached. Ckuldnt eat for a day and a half. I felt extremely nauseous. I couldnt sleep due to the pain and could barely move. Even now my arm is in an unbarable amount of pain but not as much as when the pain started.y fingertips no longer have a burning pain and my elbow is no longer aching but i can barely move my shoulder around.
Felt really, really awful; felt like I was going to die; Suffering from the effects of many discomforts; 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 VACCINATION COMPLICATION (Felt really, really awful; felt like I was going to die) and DISCOMFORT (Suffering from the effects of many discomforts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome (Active lupus).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Felt really, really awful; felt like I was going to die) and DISCOMFORT (Suffering from the effects of many discomforts). At the time of the report, VACCINATION COMPLICATION (Felt really, really awful; felt like I was going to die) and DISCOMFORT (Suffering from the effects of many discomforts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Translation received on 17-MAY-2021 contains significant information: Added medical history and adverse events.
tiredness, fever 98.9 in the morning, 99 to 100.2 in the evening since March 12th, the day after vaccination
Her daughter tested positive both on the rapid and RT-PCR Test for COVID-19. Her daughter is asymptomatic; Her daughter tested positive both on the rapid and RT-PCR Test for COVID-19. Her daughter is asymptomatic; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer sponsored program. This consumer reported for 20-Year-old female patient that received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date was not reported), via an unspecified route of administration on 01Jul2021 dose 1 single as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, the reporter's son tested positive for COVID-19, so they all went out to get checked and her daughter tested positive both on the rapid and RT-PCR Test for COVID-19 on an unspecified date Jul2021. Her daughter was asymptomatic. Patient was scheduled to take her 2nd shot of the Pfizer vaccine on 22Jul2021. Reporter wanted to know if her daughter could still get the 2nd dose of the Pfizer COVID Vaccine on 22Jul2021. The outcome of each event was unknown. Information about batch/lot number has been requested.
Patient via phone describes swelling size of golf ball at site of injection with itch. Swelling same day of vaccination. Patient did report a fever which was resolved with Tylenol however swelling and itchiness is unresolved.
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 33 year old male. 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 not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210959581, 20210958425, 20210959620, 20210959351, 20210958518, 20210958348, 20210958371, 20210958525, 20210958566, 20210958806 and 20210958977. This case, from the Others is linked to 20210958423.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 at 13:00 as dose 1, single (Lot number: EN6199), in left arm, on 25Mar2021 at 15:00 as dose 2, single (Lot number: EP6955), in left arm, on 10Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 07Apr2022 at 04:00 as dose 4 (booster), single (Lot number: F63527) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course included No other medications in two weeks. No known allergies. Treatment for Covid-19 included Paxlovid.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot(s) EN6199, EP6955, FC3183 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot(s) EN6199, EP6955, FC3183 fill lot(s) EN5331, EP6954, EY0555 and the formulated drug product lot(s) EN5320, EP6953, EP8657. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9264), in right arm, on 16Feb2021 as dose 2, single (Lot number: EL9266), in right arm and on 28Sep2021 as dose 3 (booster) single (Lot number: FF2389) at the age of 77 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies; penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ROSUVASTATIN; EZETIMIBE; TAMSULOSIN; ASPIRIN; VITAMIN D3; FISH OIL; GLUCOSAMINE. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "not recovered" and all described as "Indication Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: From 05May2022 to 10May2022 the patient received Paxlovid for Covid-19 treatment. On 19May2022, 9 days after finishing the Paxlovid, patient had new Covid symptoms and tested positive again for Covid on a rapid at-home test. Patient was previously symptom-free for 11 days.
Information has been received from a registered nurse concerning an approximately 81 year old male with sulfonamide allergy and history of cardiovascular disorder who on 10-NOV-2008, was vaccinated with a 0.5 ml dose of PNEUMOVAX (LOT# 661577/1161X). Concomitant therapy included COUMADIN. On 10-NOV-2008 the patient experienced redness and swelling at the injection site. The registered nurse reported that 5 years ago the patient received PNEUMOVAX vaccine and experienced an unspecified adverse event. Also on an unspecified date a Doppler Reading Diagnostic test was performed with unknown result. The patient sought unspecified medical attention. At the time of the report the patient has not recovered. Additional information has been requested.
Got my vaccine on Tuesday evening, by Wednesday evening i had a quarter size red rash around the injection site, by Thursday morning that had more than doubled in size. it is swollen and tender and feels like a knot in it. it was very hot when you touch it. i started taking Benadryl on Wednesday night but size is not changing. taking Tylenol 2x a day as well.
Patient got COVID few days after she got the shot; Patient got COVID few days after she got the shot; Patient end up having well from the very beginning; Not being able to breathe; One of Patient artery is blocked 90% which was not blocked at all a year and half ago; This is a spontaneous report from a non-contactable consumer (reported for herself). A female patient of an unspecified age received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer stated that, "The reason the patient was calling is because quite a while back I wrote Pfizer and fill whole bunch of forms because she got COVID few days after she got the shot so with my husband and with few other people that were in my doctors office (Further not clarified, split not made). And now, what happened is the patient had to be in home because of COVID and had ended up having well from the very beginning not being able to breathe or whatever and her doctor gave her catheterization and found out one of her artery was blocked 90% which was not blocked at all a year and half ago very unusual for not reclogged that quickly that much and in less than a year and half, so, the patient wanted to know whether it was possible that the shot had caused the clogged artery". The events COVID-19 and drug ineffective was assessed as serious (medically significant). The patient underwent lab tests and procedures which included arterial catheterisation: found out one of the artery was blocked 90% and sars-cov-2 test: positive on an unspecified date (Patient got COVID few days after she got the shot). The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
vomiting; lethargic; sweating; Was breastfed yesterday after his mother received Covid Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 month-old male patient was exposed to bnt162b2 (BNT162B2), transmammary, administration date 15Sep2021 20:30 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious) with onset 15Sep2021, outcome "unknown", described as "Was breastfed yesterday after his mother received Covid Vaccine"; INFANTILE VOMITING (non-serious) with onset 16Sep2021, outcome "unknown", described as "vomiting"; LETHARGY (non-serious) with onset 16Sep2021, outcome "unknown", described as "lethargic"; HYPERHIDROSIS (non-serious) with onset 16Sep2021, outcome "unknown", described as "sweating".  Additional information: Patent stated that she was calling about the Pfizer Product: Covid Vaccine. She had a concern. she got the vaccine yesterday around 20.30. Around 03:00 this morning her baby started throwing up. She had breastfed him after receiving her vaccine last night. She was concerned, could he have side effects and not her. Parent stated that her son had no symptoms prior to this. States he was a healthy 14 month old who has never been sick or thrown up in his life. Now, he was throwing up, sweating, and lethargic. Stated that her and her husband are concerned if it could be from her vaccine.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101218317 Same reporter/drug, different patient/event (mother/baby case)
-Severe Migraine- extreme sensitivity to light, extreme pain -Body tremors that traveled around my body for prolonged period of time over 3 days -Resting pulse rate over 100BPM for 3 days w/o relief   Bed bound at home waiting for symptoms to subside, after day 3 of the same reaction listed above + extreme pain, I called dr. on 10/02/21 and was advised to seek immediate attention at closest Emergency Dept. The Dr. urged me to call an ambulance. Emergency Dept. at closest hospital discharged me with migraine medicine and advised I see my own Dr. asap.   I called neurologist who provided me with guidance for my Rx migraine meds to alleviate the pain and he advised I see GP asap.
PATIENT STATES: WITHIN FIVE MINUTES OF INJECTION MY FACE BEGAN TINGLING ON THE LEFT SIDE STARTING IN MY CHIN AND MOVING UPT O INCLUDE MY ENTIRE MOUTH, LIPS, UNDER MY LEFT EYE AND THE ENTIRE LEFT SIDE OF MY FACE AND HEAD.  THE TINGLING BECAME NUMBNESS AND VISION ISSUES IN MY LEFT EYE.  I STARTED EXPERIENCING HEART ARRHYTHMIAS DIZZINESS AND VERTIGO.  I THINK IT WAS CAUSING ME SOME STRESS, WHICH CAUSED ME TO BE HYPERSENSITIVE TO EVERTHING.  I WAS SITTING IN MY CAR FOR THEREQUIRED 15 MINUTES AND AT THAT TIME I WENT INTO THE PHARMACY TO REPORT IT BUT THERE WERE SO BUSY THAT I COULD NOT GET ANYONE'S ATTENTION TO ALERT THEM SO MY WIFE AND I LEFT.  WE WENT TO A COFFEE SHOP, I HAD SOME CAFFEINE AND I FELT OK TO DRIVE BACK HOME TO REST.