chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 2 patients (Husband and wife). This is 1st of 2 reports. A 93-year-old male patient received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history included immunocompromised. The concomitant medications were not reported. The patient experienced cancer on an unspecified date with outcome of unknown.  The reporter wanted to know the patients should receive a second dose of PREVNAR 13, since  immunocompromised. Information on the batch number has been requested.; Sender's Comments: Cancer is not related to the vaccination with PREVNAR 13 representing an intercurrent malignancy.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2018423295 same reporter/product/event, different patient.
Adverse reaction began 20 minutes of receiving injection. Began with a rash on throat and neck. Followed by swelling of throat, trouble breathing, O2 levels dropped, itching began, selling in face, watery eyes, and other.
My daughter has never had anything remotely close to this happening before and is generally very healthy.  My most healthy child. After the vaccines, she turned pale, then green, and as I stepped out to get her juice (no one else in the room) she passed out head first, landed on her head. We rolled her over, her eyes were rolled back into her head and she went into convulsions. She has no recollection of this. She convulsed for several seconds before she came out of it.
The area feels hot; Injection site reaction of pain and swelling; Injection site reaction of pain and swelling; This spontaneous report was received from a pharmacist referring to an elderly reported as "over 65 years old" male patient. Information regarding the patient's medical history,  drug allergies, or reactions was reported as none. Patient historical vaccines included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVENAR) and concomitant vaccines, an unspecified influenza virus vaccine inactivated.       On 29-SEP-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23), 0.5 milligrams once, intramuscularly in the deltoid for prophylaxis (strength, lot number and expiration date were not provided).    On 30-SEP-2020, the patient experienced vaccination site pain and vaccination site swelling. The patient was told to take acetaminophen (TYLENOL) and used iced.  On 01-OCT-2020, the patient was contacted, and he reported that the swelling was extended down to the elbow, and the area feels hot (vaccination site warmth) in addition to being painful. The patient was advised to contact the physician.    The outcome of vaccination site pain, vaccination site warmth, and vaccination site swelling was reported as not resolved.     The reporter did not assess the causal relationship between the events and  pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23 ). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Fatigue: I had Covid last summer and experienced fatigue for several months.  I felt better by the Fall but fatigue returned after my 2nd dose of the vaccine. Unable to work for normal 8-9 hours/day.  This has been for the past two months. Symptoms seem to be getting better slowly. Tinnitus:  I had mild tinnitus prior to the vaccine but it has increased. No change in the past two months.
pt recvd vax & was cranky, pulling @ ears, teething, sl fever; mom states lightly bumped head; then turned white, eyes were open & fixed & for 2-4minutes stayed that way; not responsive to efforts to get him to cry or move; ear infect;
I received a ZOSTAVAX Shingles Vaccine from my local pharmacy. Within 1/2 hour I had numbness in my left arm and extreme pain in my left shoulder and shooting up into my head. It lasted about a week and then calmed down. But it reoccurs frequently (not numbness, but pain) and has made my life miserable. It even hurts to wear my glasses over my left ear. I refused to have the second shot for fear of an even worse reaction. The date I listed was a guess, but I know I had it in February.
Small rash, first on palm of right hand, then on back of left hand on an old scar; This is a spontaneous report from a contactable consumer, the patient. A 41-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 12Mar2021 at 16:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history, and did not have any known allergies. The patients concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date (at an unknown age) 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. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 06:00, the patient experienced small rash, first on palm of right hand, then on back of left hand on an old scar. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event small rash was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
My symptoms were swelling, pain, and stiffness on and around my right ankle. I had not knowingly strained or physically injured my ankle recently before or after receiving the vaccination. The symptoms began suddenly while I was just sitting down. Because of the severe pain, I was unable to walk or stand on my right ankle for several days. I contacted my primary care physician the morning after I received the vaccine and informed him of my symptoms and he advised taking 800 mg of ibuprofen every 8 hours. I followed his advice for a week while resting, elevating, and icing my ankle. Symptoms subsided after a week.
6/14/2017-6/17/2017:  Swollen, puffy neck and jaw; headache; significant jaw and eye pain; sore throat; fever 100-101 degrees. 6/19/2017-6/22/2017:  Measels rash of red, itchy bumps on torso; on day 2 his rash spread to his face, arms, hands and groin. 7/17/2018-8/14/2018:  Hospital admission for Epstein Barr Virus that turned to mono; severe sore throat with inability to swallow or eat, serious headache for two weeks. 9/15/2018-11/2/2018: Erythema nodosum with severe bruise-like lumps on legs from EBV; significant sore throat, and joint pain in his elbows  and knees. Another rash developed after a few weeks similar to the  chicken pox rash.
Woke up screaming and was inconsolable for a while. Unusual increased lack of appetite and slept longer than usual. Also started having breath holding spells at about 10 months old. Very textbook: triggered by getting very worked up, passing out and then coming "to" again after about 20 seconds. Onset of these followed her 9 mo. shots. Not sure if there is a coorelation, but it is worth mentioning. It is also worth mentioning that her older sister Adisen had a reaction to her shots. Both shots were given on the same day at the same time by the same provider and within 12 hours, both girls developed a reaction that lasted for approximately 20 hours post vaccination.
pt sought medical treatment 31OCT94 4PM lt deltoid red, warm to touch, painful treated lt arm elevated, hot packs & ATB Keflec-10 days;
(L) arm became swollen & red from elbow to (L) deltoid then increased to swelling (L) clavicle & (L) side of face - took to MD - MD recommends no further DTPs.
Patient states "hit ulnar nerve" with needle after administering flu shot. Now using brace.
Pt. got the first shot of Covid 19 Moderna Vaccine. Pt was seated in the post vaccination area. After 5 min pt. fainted. Pt suffers of vasovagal syncope. Pt. had pulse and was breathing all the time. Pt. came back in less than 1 min. Pt was laid on the floor with her legs up. Pt. asked for alcohol swabs, I provided it. Pt. was feeling dizzy and throwed up after 15 min of being laid on the floor. Pt. asked for water, I provided. Pt. 's mom was next to her all time. Pt. stayed in the area of the event for one hour until she was ready to leave. Pt.'s mom drove her back home.
Heavy menstrual bleeding/Bleeding non stop; Cramps in the thigh; Pulp in uterus; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding/Bleeding non stop), MUSCLE SPASMS (Cramps in the thigh) and UTERINE POLYP (Pulp in uterus) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 24-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 HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding/Bleeding non stop), MUSCLE SPASMS (Cramps in the thigh) and UTERINE POLYP (Pulp in uterus). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding/Bleeding non stop), MUSCLE SPASMS (Cramps in the thigh) and UTERINE POLYP (Pulp in uterus) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concurrent medical conditions included Blood Pressure.  Concomitant medications includes Blood pressure and Diabetes medications. No treatment information was provided.  Patient stated that she took 2nd dose on 24-Apr-2021, Lot number 009C21A.
Shot did not hurt. Started feeling sore at night. Went to bed at 12, was sore, and warm, slightly red, size of silver dollar. At 2:30am wore up very hot temp was 102. Arm was quite red in a much larger area. By 5:30am temp was 97.4.  Started itching the next morning , 8-9am. Redness stayed for a week, itching. Soreness went away after the forth day. Redness faded about 8 days later.
Swelling and reddness at injection site for 2 wks, motrin PRN.  5 days s/p immunization pt awoke with subconjunctival hemorage of L. eye.  1 month s/p vaccine pt had URI that cause "reactivation" of swelling and discomfort at injection site that lasted for 2 wks.
Patient received vaccine. Complained of pain in arm. Went out to car to get water and came back into the clinic, sat down in a chair and became unresponsive. Patient recovered consciousness about 10 seconds later. States he remembers feeling lightheaded and felt a "headrush." Patient remembers waking back up in chair. He was laid down on the floor with feet up and give a cookie and water.
I had a dry cough on the that Tuesday, the 14th of March. I felt weak and a little off. I was tired and that night I started getting a cough. In the middle of the night, it was just coughing. The next day on 15th I tested positive at home. The cough was worsening through that day. Primarily that was the symptom. It was just a little bit of ache and pains, but that was all. I called my doctor and was sent to the clinic; I was tested again and the prescribed PAXLOVID. By the 16th and 17th, the cough was better, and I did get a runny and stuffy nose somewhere in there. It felt like a common cold. I recovered fully that following week.
Tiredness; Headache; Muscle and Joint aches; Muscle and Joint aches; Chills; Administration date 10Nov2021 at 10:15, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 10Nov2021 at 10:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical dystonia, wheat intolerance, allergies to casein and coffee, latex and adhesive sensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR), losartan (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 56-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021, the patient experienced tiredness, headache, muscle and joint aches and chills. The events tiredness, headache, muscle and joint aches and chills did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events tiredness, headache, muscle and joint aches and chills. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, headache, muscle and joint aches and chills was resolved on an unknown date in Nov2021.
12hrs after shot: vomiting, 103? fever, chills, muscle pain, extreme perspiration, dizziness. 24hrs later dizziness worsened  To where I couldn?t walk unassisted. Vomiting continued for 3 days.subsided after given Zofran  prescription.   Fever subsided after 48hrs. Chills, body aches and diarrhea lasted for 4 days.   Had a visit virtually with Dr who suggested I needed an IV to fight hydration and Zofran to stop the vomiting
Pt fell to floor post GARDASIL vaccine #2, 10 minutes post vaccine. Alert, responsive, pale. BP 70/50 - 78/60 - 86/60 - 92/70 - 98/70 - (Bumped L head.) WNL. Ice packs to head.
nosebleed/ reaction to the vaccine; This case was reported by a pharmacist via sales rep and described the occurrence of epistaxis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced epistaxis. On an unknown date, the outcome of the epistaxis was recovered/resolved.   It was unknown if the reporter considered the epistaxis to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's Comments: The reporter stated that within 24 hours of receiving Shingrix, patient had a nosebleed that lasted three days. Patient asked if this was a reaction to the vaccine and if it was common.  The patient would be following up with their primary care and reported the incident to VARS.
vagal response post vaccination while seating in post vaccine observation area. Fainted with loss of consciouness approximately 10 seconds then arousable but foggy mentation that progressively cleared. She did not eat breakfast this morning. Vital signs stable, oxygen stauration 98-99% on room air. Brought from Vaccine Clinic to Emergency Department via stretcher. Examined, recovered, able to eat discharged to home.
20JAN sx vomiting, diarrhea, fever, abd pain, cough (productive) was told pneumonia present, viral in origin;4hr ER visit for rehydration required;
For the first 36 hours: Fatigue, nausea, localized pain, localized swelling, muscle aches, profuse sweating, headache, migraine.  For 3-4 days following the administration of the vaccine: Fatigue, mental fogginess, headache, sluggishness, localized pain. For weeks following the administration of the vaccine (until May 4th, 2021): increased frequency of migraines. Before I received the vaccine I experienced migraines about once a month, sometimes twice a month. Until May 4th, I experienced at least one migraine per week.
Pt. states she passed out when she got home after vaccine, and had shakes and muscle spasms, and very sore arm (the arm she received PNEUMOVAX in).
knot on injection site not go down with ice pack. still knot on arm at infection site after one week. it is also still sore.
nausea; Felt like regurgitating; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diverticulosis. Previously administered products included Shingles vaccine (received previous shingles vaccine in 2016) and Shingrix with an associated reaction of abdominal pain lower (1st dose received on 2nd July 2020, refer case- US2020186285).   On 2nd September 2020, the patient received the 2nd dose of Shingrix. On 16th September 2020, 14 days after receiving Shingrix, the patient experienced nausea and regurgitation. On an unknown date, the outcome of the nausea and regurgitation were not recovered/not resolved.   It was unknown if the reporter considered the nausea and regurgitation to be related to Shingrix.  Additional information was provided as follows: The patient was feeling nauseous for the first time and felt like regurgitating on the day of reporting. The patient after the 1st dose of Shingrix experienced lower abdominal pain especially when she had a bowel movements and also as of 08/2020, she was stating that her stomach was swollen, large and firm to touch. The lower abdominal pain and swollen stomach was ongoing and had not resolved. She had felt a shiver one time when she heard two people take in anger, which she has not felt before. The patient was daignosed with diverticulosis and was not taking any medication for it. The reporter consented to follow up. The case was considered as medication error with harm. The case is linked with case-US2020186285, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020186285:1st dose
Injection to shoulder went in vein rather than muscle; bleeding. A week later left ankle swelling, turned worse, calf starting cramping and swelling. On next Monday went to Hospital for ultrasound. Diagnosis: 2-foot long blood clot, DVT.  CT Venogram taken February 11 no cause found. Went to hematologist did full blood panels.  No cause found. Diagnosis: only alternative cause: COVID-19  vaccine.
MUSCLE TWITCHES NEAR THE SHOT AREA; BACK ACHE; This spontaneous report received from a patient via a company representative 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced muscle twitches near the shot area, and back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle twitches near the shot area and back ache was not reported. This report was non-serious.
Information has been received concerning a 5 year old female who on 10-DEC-2001 was vaccinated with one dose of HIB. Concomitant vaccination included one dose of IPOL, one dose of Infanrix and one dose of Prevnar. On 10-DEC-2001, one hour post vaccination, the pt developed diarrhea. Later that evening, an unspecified time post vaccination, the pt developed a fever of 104.7 degrees F and would not respond to her mother. The pt was hospitalized from 10-DEC-2001 to 13-DEC-2001. The parent reported that "it was not determined what was wrong with her". As of 13-DEC-2001, the fever and diarrhea had resolved but the infant was still not acting normal. No further information is available.
This infant had localized erythema, swelling,and a papular rash. Treated with oral Benadryl.
This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis. On 29th December 2021 07:14, the patient received Shingrix. On 29th December 2021, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown. Additional details were provided as follows: The healthcare professional reported administration of Shingrix to the patient after reconstitution on 28th December 2021, stored in refrigerator overnight and accidentally administered at morning of reporting date, which led to wrong technique in product usage process. The reporter consented to follow up.
Varivax given 06/09/2005 in left thigh.  Patient came in on 06/24/2005 still had a red spot on left thigh was itchy and warm seems to be resolving no other symptoms, no fever.
Developed shingles in right supraorbital area. Severe pain associated with skin lesions. Associated with hyperesthesia over forehead and also R ear pain for several days and brief episode vertigo. Fortunately, pain resolved and no post-herpetic neuralgia.  Scar remains over right supraorbital area.
Fever...low grade...99.3 highest  Body aches...everywhere on my body. Very tired for several days. Nauseated.....on and off for 10 days Feet very hot....purple bruised like appearance under big toes, both toes ached for 11 days...thumb nails also had purple under the nails Blood vessels all over my body were larger then normal
Patient woke up in the night, walked downstairs to get water, walked back upstairs and became nauseous, laid down and became unresponsive. Eyes were open but not focused, breathing was irregular and snoring-like. this lasted less than a minute and he regained consciousness.
Local reaction of (L) arm with swelling, warmth, induration with blisters.
Headache, Myalgia, Fever, NauseaVomiting, CHILLS Narrative: STAYED HOME FROM WORK DUE TO SYMPTOMS
I fainted after receiving the vaccine.  However, I was still drowsy and dizzy after three hours.  I tried to drive home and could not.  I felt drunk and was burping.  I was admitted to the hospital's ER.  They told me I would not have to pay the bill, but still got a 5,000 bill.   I was tested for everything.    They told me I had orthostatic hypotension, so they could not let me go unless my blood pressure was normal.  They tested me for everything else.  I was given an IV.  My hypotension lasted for about seven hours, then I had a fever for three nights after that.  I was told in the ER that they don't recommend me getting the second dose.  I am not sure what to do.  The only other thing they found was that my potassium and calcium was low.