chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program. A 23-year-old female patient (her daughter) received first dose of TRUMENBA on 04Mar2015 and the second dose on 13May2015 both at 0.5ml single dose intramuscular in the left deltoid. The third dose vaccine was due in Oct2015, but her physician did not carry the TRUMENBA, so administered meningococcal vaccine (ZAXSERO or BEXSERO) intramuscular on left arm at 1 DF single dose on 05Nov2015. Concomitant medications included  NECON for hot flashes and acne but it wasn't helping with her hot flashes and acne and AVIANE. Medical history included ongoing lactose intolerance, ongoing hormone level abnormal, ongoing hot flush and ongoing menstrual disorder. After both doses of vaccine the patient experienced arm sore. She noticed the soreness immediately after getting vaccinations. The soreness lasted almost a week after the TRUMENBA vaccines. The outcome of the event was recovered. Follow-up (31DEC2015): Follow-up attempts completed. No further information expected.
After 30 minutes of having first covid vaccine I had hives, nausea and migraine not sure if I need to gwt 2nd dose on Feb. 18th
pt recv vax;w/in 24 hr devel fine papular itchy reddish rash w/ circumoral pallor;cheeks were "really red"to MD who thought was fifth disease;tx w/ diphenhydramine & baking soda baths;tests:HBsAg & anti-HBs nonreactive;recv 2nd dose;fine
patient took vaccine went over to post vaccination area and fainted. Patient immediately woke up in cold sweats. Sat for 30 minutes and felt better.
Headache- day 9th; fever; chills; diarrhea; nausea; muscle and joint pain; muscle and joint pain; injection site pain; exhaustion; feeling unwell; rash on my neck; This is a spontaneous report from a non-contactable consumer (patient) reported herself. A 43-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: ER 8829), via an unknown route of administration in left arm on 10Apr2021 (at the age of 43-years-old) as dose 2, single for Covid-19 immunisation at hospital. The patient's medical history included seasonal allergies and hazelnuts allergy. Concomitant medications included cetirizine hydrochloride [ZYRTEC (CETIRIZINE HYDROCHLORIDE)], bupropion (BUPROPION), phentermine (PHENTERMINE); were taken for an unknown indication from an unknown date. The patient previously received first dose of BNT162B2 as historical vaccine (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: ER 8727), via an unknown route of administration in left arm on 20Mar2021 at 08:00 (at the age of 43-years-old) as dose 1, single for Covid-19 immunisation. No other vaccine in four weeks. On 11Apr2021 at 01:00, the patient experienced headache- day 9th (For first 3 days, headache), fever, chills, diarrhea, nausea, muscle and joint pain, injection site pain, exhaustion, feeling unwell, rash on my neck. Event resulted in visit to doctor or other healthcare professional office/clinic. No covid prior vaccination. No covid tested post vaccination. Migraine pills received as treatment. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
1700- Pt c/o itching throat.  Given cool water.  Pt stated felt better 1710- Pt c/o slight itchingon arms.  On checking with Pharmacisit, gave 25 mg Benadryl PO.  Requested to have someone drive her home.  Confirmed she has a ride home.   1715 - Pt feels beter- less itching.  No throat issues
The pt experienced 3 seizures, the first one a few seconds duration, the 2nd one 45 minutes in duration. The 3rd one stopped with Valium or Ativan in ER.  Also diagnosed with viral gastroenteritis.  Follow up on 09/18/2001: "The awake recording shows a 6-8 Hz moderate voltage occipital dominant rhythem that blocks with eye opening, large amounts of low voltage 14-20 Hz activity, frontal dominant, small amounts of moderate to low voltage scattered 3-5 Hz activity.  Photic stimulation produced a moderate driving response.  Hyperventilation was not performed. Sleep was acheived.  K complexes, vertex sharp waves and symmetrical sleep spindles were noted.  IMPRESSION: Normal EEG."
injection site soreness and swelling. Pain under breast states its breast tissue pain  Narrative:   Other Relevant History:
Flu shot given to me on 10/14/2003 by the nurse. My arm turned red and puffy. I called in and was told it would be fine. I also told them I was having severe pain and she stated it was my fibromyalgia acting up. So then I told her again later about it getting worse and she said to tell the doctor about it when I seen her. Doctor said that I should go back because she didn't specialize in it. So the doctor did ordered an xray at my request. It was normal. So she referred me. He stated it was fluid on my shoulder and gave me bextra to take for ten days and suggested therapy. I went to therapy and the lady said she couldn't do much to help me. I then told the doctor it was getting worse and she referred me to another doctor who stated it was tendonitis and brusitis and gave me a shot and told me to continue therapy. But yet the therapist contacted the rehab clinic to get a script for therapy and he never replied and or never sent them one either. So our insurance changed at the first of the year so I went to a new doctor. He said I have a frozen shoulder and sent me to another clinic. One doctor is the bone doctor. He told me to do therapy for eight weeks. That was it. The lady that does my therapy said she didn't know what he expected her to do. I went twice and then the neurologist said to do my therapy at home and gave me some pills for nerve damage and said he is sure the flu shot caused the problems. The pain management doctor gave me Daypro for the swelling and a tens unit. The daypro made some of the swelling go down but the tens unit made it worse. So she told me she is sure the flu shot caused the problem and that I needed to get me another opinion from a bone doctor. So I went to another doctor. Finally someone that could help with the pain. I am now having to pay for therapy three times a week, a membership for a gym, medicine and doctor bills all from getting a flu shot. And the worst of it all is I have only been getting an hour or two of sleep and I am left handed and she gave me the shot in my left arm. I had been looking for work and have had to turn down several jobs because of my arm not working and the severe pain I live with day in and day out. Ratterman did give me some pills for the pain and a shot to help. I finally got some sleep last night. Before today I couldn't even type.  Medical Record received on 4/7/2004 includes tenderness, shoulder capsulitis, and impingment syndrome.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 74-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL9266), in right arm, on Feb 18, 2021, at 11:30, single dose, for COVID-19 immunisation. Medical history included unspecified allergies (unspecified if ongoing). The patient took concomitant medications. The patient had fatigue/very tired, and somnolence (slept for about 10-12 hours each day), onset Feb 18, 2021, with outcome of recovered (Feb 23, 2021). No therapeutic measures taken as a result of fatigue and somnolence. No follow-up attempts possible. No further information expected.
Swelling in the back of the throat; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling in the back of the throat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHARYNGEAL SWELLING (Swelling in the back of the throat). On 02-Mar-2021, PHARYNGEAL SWELLING (Swelling in the back of the throat) had resolved.            Patient took couple of concomitant medications but did not provide names. No treatment medications were provided. Patient stated that symptoms were a 3 on scale of 1 to 10 and was able to drink water and stayed there and symptoms dissipated in less than half hour. Patient experienced reaction and asked whether to get booster dose considering the reaction.
Unable to lift arm within 10 hours. In 18hrs was shaking and extremely cold. Had temp of 100.9. That lasted for 6 hours and transitioned to burning up. During this time I had severe pain in all joints from my neck to my hips. My fingers swelled as well. My legs felt fine and no headache. Tylenol and ibuprofen helped my fever but did not alleviate my pain symptoms. My shot was Friday evening. By sunday afternoon my fever was gone as well as the pain in all but my arm. But is was down to manageable.
Received the 1st dose > 35 Days and is determined not to get the 2nd one.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the 1st dose > 35 Days and is determined not to get the 2nd one.) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the 1st dose > 35 Days and is determined not to get the 2nd one.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the 1st dose > 35 Days and is determined not to get the 2nd one.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Second Covid Shot: sick; Second Covid Shot: fever of 101; Second Covid Shot: threw him off for like a half day; Second Covid Shot: uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Second Covid Shot: sick"; PYREXIA (non-serious), outcome "unknown", described as "Second Covid Shot: fever of 101"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Second Covid Shot: threw him off for like a half day"; DISCOMFORT (non-serious), outcome "unknown", described as "Second Covid Shot: uncomfortable". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The prior Covid Shot he had before the booster shot, the second Covid Shot, he got sick with as expected, had fever of 101, threw him off for like a half day, uncomfortable, but no big deal.  The lot number for bnt162b2 was not provided and will be requested during follow up.
A report has been received from a Health Professional concerning a, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST, (intranasal) started on an unknown date. The reporter reported that they inadvertently gave expired FLUMIST (last years vaccine) which started on 16-Sep-2013. The outcome of the event inadvertently gave expired FLUMIST (last years vaccine) is unknown. The report was considered to be non-serious.
This case was reported by a other health professional via call center representative and described the occurrence of injection site vesicles in an unspecified number of patients who received KINRIX. On an unknown date, the patients received KINRIX .5 ml. On an unknown date, less than a day after receiving KINRIX the patients experienced injection site vesicles. On an unknown date, the outcome of the injection site vesicles was unknown. It was unknown if the reporter considered the injection site vesicles to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the reporter read on web site that some children were reported to develop vesicles after receiving KINRIX immunization. One of the patients of the reporter developed vesicles after vaccination with KINIRX. The reporter was inquiring about any special advice to give to the parents or any need to apply local antibiotic at the site to prevent bacterial infection. This was an ICC pop request. The reporter did not answer for additional adverse event information.
I had a response to the vaccine approximately 16 hours after the injection of chills, myalgias and headache, however 24 hours after injection my clavicular  lymph nodes became enlarged and tender.
This spontaneous report as received from a 65 year old female patient refers to herself. The patient's medical history included "cold which tends to develop into bronchitis because of asthma". The patient was allergic to ragweed, mold, dust, dill, cat dander and grass. On an unknown date in December 2015 (reported as about a week ago) the patient was vaccinated with PNEUMOVAX 23, 25/0.5 ml/one shot (lot number not provided). No concomitant medications were reported. On the same evening, on an unknown date in December 2015, the patient noticed that her shoulder felt sore and "was hot to the touch". The patient mentioned the arm she received the vaccination in also "felt hard" and appeared red around the injection site area. The patient had a huge bruise that was 3 to 4 inches in diameter and she recalls that the vaccine "shot hurt" when she first got it. The patient did not seek medical attention and no treatment was given for the adverse events. No laboratory diagnostics were performed. No product quality complaint was involved. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
sick; Patient couldn't drink; head hurt so bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-153964, 115262.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), administration date: Apr2021, for Covid-19 immunization. The following information was reported: ILLNESS (non-serious) with onset May2021, outcome "recovered" (May2021), described as "sick"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset May2021, outcome "recovered" (May2021), described as "Patient couldn't drink"; HEADACHE (non-serious) with onset May2021, outcome "recovered" (May2021), described as "head hurt so bad". Additional information:Patient got first shot in Apr and second shot in May for the Pfizer vaccine. Patient said that she was sick for a day after second dose. Patient couldn't drink, her head hurt so bad. This lasted for 24-48 hours, and then she was fine. Patient didn't have the vaccination card to provide full info on the shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
covid-19; covid-19; This is a literature report for the following literature source(s): .  A 75-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "coronary artery disease" (ongoing); "chronic obstructive pulmonary disease" (ongoing); "diabetes mellitus" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: Computerised tomogram thorax: mild ground-glass and 8 reticular opacities, notes: mild ground-glass and 8 reticular opacities consistent with COVID-19 pneumonia; Nasopharyngeal swab: Positive, notes: after testing positive for SARS-CoV-2 by nasopharyngeal PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid 19 cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-PV202200012045 Same patient;
This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (reported as in past six months), the patients was vaccinated with ZOSTAVAX (unknown route and dose) in left arm. Concomitant medications were not reported. The patients had come to pharmacy to complain of injection site adverse events post vaccination with ZOSTAVAX. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Patient(pt) received the first dose of Pfizer vaccine around 15:30pm. Pt had symptoms of weakness, dizziness, and lightheadedness right after the vaccination.  Pt's father, coordinator, and I assisted pt to sit down on the closest chair. I checked pt's blood pressure (BP) immediately with reading of 71/33 mmHg, HR 50. 8 ounces of water was given to pt. Patient declined to lie down. put another chair to have pt leaned on. Pt was alert and oriented during the observation. About 10 minutes later, pt stated he felt a little better and started to drink water and eat candy bar, Pt finished 8 ounces of water and one candy bar. Second bottle of 8 ounces of water given to pt. BP checked again with reading of 113/73mmHg, HR 71, O2 Sat 98%. No nausea, vomiting, accessory muscle use, labor breathing, facial edema, edematous lips, or rash noticed. Pt was alert and oriented with clear speech. Pt finished the second bottle of 8 ounces water. 20 minutes after receiving Pfizer covid vaccine, pt was able to ambulate without assistance. Re-checked pt's BP with reading of 95/59 mmHg, HR 70, O2 Sat 98%. Pt's father denied that pt has any type of allergy to medications or vaccines but stated patient is always afraid of needles, and he fainted last time with his mother after receiving vaccine. Patient stated he wanted to go home. ER precautions given to pt's father. Side effects and allergy reactions of Pfizer covid vaccine discussed with pt's father and educated pt's father to give pt Tylenol for fever, body aches, or arm pain as needed, increase water intake, have enough rest, and avoid NSAIDs use. Pt's father verbalized understanding. Patient ambulated with steady gait to their car. Pt and his father left at 15:53pm.
Unconsolability x 3 days, high-pitched shrieking cry; restlessness.
This spontaneous report as received from a physician via a company representative on 21-JUL-2015 refers to a 17 year old male patient. The patient's medical history and concurrent conditions were unspecified. On an unknown date in July 2015 (reported as last week) the patient was vaccinated with the first dose of GARDASIL (Strength, dose and lot number not reported) intramuscularly. The concomitant medication included unspecified Hepatitis A vaccine (manufacturer unknown) and unspecified Meningococcal vaccine. The physician reported that the patient passed out (syncope) and fell within 15 minutes of administration of GARDASIL and required stitches in the eye area. The event occurred within the physician's office. It was unspecified, if any lab test/diagnostic studies was performed. On an unspecified date of July 2015, the patient recovered from the events. Causality assessment for the event was not provided by the reporter. No further information was provided. Additional information has been requested.
This spontaneous report was received from a licensed vocation nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-OCT-2015, the patient was vaccinated with a dose of VARIVAX (Merck), lot # L021214 and expiration date 10-JUN-2017 as reported (dose, route of administration and anatomical location were not provided). There were no concomitant medications reported. No adverse effect was reported. No product quality issue was involved. This sis one of several cases from the same reporter. Additional information has been requested.
pt had a positive COVID test on 8/1/22; was admitted to hospital with AHRF secondary to COVID 19 infection; dc'd  on 8/14/22 with home O2; 8/20/22 pt became acutely SOB and became pulseless; CPR started at home; EMS transported pt to ED; required CPR and medications before ROSC achieved; Dx with bilateral pulmonary emoblism; administered tPA; thrombectomy of right pulmonary artery embolus and plaed IVC filter; transferred to CCU; intubated; vasopressors; suppered cardiac arrest; CPR not successful; pt passed away in the hospital
pt recv vax & 2wk later suffered a gen rash over limbs & eyelids were swollen;pt was vaccinated one facility & treated for the AE's in another;pt recvd DPH & the events resolved;
Unknown reason for blood in urine.  Had catscan of abdomen.  Everything looked normal.
Patient received Pfizer vaccine 08/24/2021) for primary Covid-19 vaccine. On 09/17/2021 patient possible received Moderna vaccination instead of Pfizer for second dose. Moderna check on immunization form - lot appears to be Pfizer on form FC3184 - and patient believes received Pfizer.