chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OBSTRUCTIVE SLEEP APNEA ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF RIGHT FEMORAL VEIN ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I am a pharmacist, and I administered a Covid vaccine to a patient around 6:12pm.  After administering, I pulled back the syringe and needle from the patient's arm and accidentally stuck myself with the needle into the right fingertip of my index finger.
presented w/a hx of fever & rash-septic work up was done;pt started on med on adm which was discontinued p/72hr;pt cont to have fever spikes otherwise eating well;
Moderate (RA) pain flared in multiple joins approximately 6-7 hours after injection (given on 6/3).  This is unusual because I typically do not get pain in a lot of joints at one time.  Individual knuckles on fingers, wrists, hip, neck, shoulder, knees and ankles. Morning after injection (approx. 16 hours): joint and muscle aches, low grade fever (99; I typically am at 97.4-97.8), moderate malaise and fatigue.  Headache, eyes ached, mild nausea, stomach upset and diarrhea.  Could not stay awake.   Symptoms subsided greatly 30-32 hours after vaccination.  Fatigue persists, but is minor; goes away with short rest.
Dad called on 9/5/13 to inform us that he had taken child to the ER on 9/4/13 at 11:00 PM for a possible side effect to the IVP given on left arm on 9/3/13. Stated his son's physical symptoms were a large  red rash with hard area to left upper arm.
Patients eyes rolled back into head and began seizure, then fell backward from table and hit her head on the wall.  Took about 45 minutes to get back to her feet.  We went directly to her personal physician to report.
I received my first dose of the Moderna vaccine on Tuesday, January 5th at 9:00 AM. I felt fine immediately following the vaccine but quickly felt worse throughout the day. I developed a fever of 101.4F with medicine, chills, muscle aches, fatigue, and general malaise. I know these are all common symptoms, so I didn't worry too much. However, my fever has persisted. I stayed home from work Wednesday, Thursday, and Friday due to not feeling well and still having a fever. Thursday, I also developed pain in my armpit with movement and palpation. I am guessing that pain in related to swollen lymph nodes. Friday, the pain in my armpit seemed to spread into my arm. Most of my armpit and the upper inside of my bicep is extremely tender to movement and touch. Today, I still have some tenderness in my arm and my fever is still present. Throughout this week, my fever has remained around 100F, even with Tylenol and ibuprofen.   I contacted my PCP yesterday about my concern for my persistent fever and arm pain. They believe that because I tested positive for COVID-19 in October 2020, that I am reacting to the first dose of the vaccine as if I am receiving the second dose of the vaccine. They advised me to continue taking ibuprofen and Tylenol. I am worried that if I receive the second dose of the vaccine, I will be sick for longer.
I have severe noise and ringing in my ears that has not gone away, my Dr office really had no solution.
prescription for Shingrix  that was written for a 44 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 44-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated they just received the prescription for Shingrix that was written for a 44-year age of patient and physician confirmed the prescription was due to prior Shingles, which led to intercepted drug prescribing error. The health care professional stated, the written prescription for Shingrix however no confirmation if the health care professional administered the vaccine during reporting. The reporter did not consent to follow-up.
rash one hour later along with headaches for 3 days assoated with feeling dizzy
Rash on the left side of face, neck, and chest; intermittently itchy.
so tired; some body aches; chills; 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 female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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 covid-19 vaccine), administration date: Apr2021, for Covid-19 immunization, reaction(s): "Chills", "really tired", "some body aches", "golf ball sized" bubble or lump appear on her arm". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "so tired"; PAIN (non-serious), outcome "unknown", described as "some body aches"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional information: The caller proceeded with her second dose and this type of reaction did not occur. The caller states that she did have some systemic reaction to the first dose and described it as, "I was really tired, like too tired to play with my kids because I did not even want to get out of the chair. The tiredness started that afternoon and lasted through the next day." She also endorsed systemic type side effects with her second dose which were more intense than the first dose and described those side effects as, "I just went to bed because I was so tired. I had some body aches and chills as well. It was much more than I had with the first dose." Caller asks if she should get tested for antibodies to assess whether or not she is protected from COVID after receiving the primary vaccine series.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & 1mo later devel a pruritic rash;tx w/daily hot showers;
Patient sharing that they received a full dose instead of the half dose for both of their Moderna Monovalent booster doses.1st booster: unknown date2nd booster; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (Patient sharing that they received a full dose instead of the half dose for both of their Moderna Monovalent booster doses.1st booster: unknown date2nd booster) and NO ADVERSE EVENT (no adverse event) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Johnson & Johnson one shot). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.   On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient sharing that they received a full dose instead of the half dose for both of their Moderna Monovalent booster doses.1st booster: unknown date2nd booster) and NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Patient sharing that they received a full dose instead of the half dose for both of their Moderna Monovalent booster doses.1st booster: unknown date2nd booster) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant product use was reported.  The patient said they did a little bit of reading about a months ago, the information they learned was that the Moderna booster was a half dose. When they went to the pharmacy, they asked them to give them a full dose and the pharmacy did that for them for both boosters. Also reported that they are due for another booster, and they know there was a new booster we have. Patient asked the pharmacy if they would provide them with a full dose booster when they come in and they said they would but it's already a full dose.  No treatment information was provided.   Reporter did not allow further contact
Information has been received from a physician's administrator, a registered nurse, a medical assistant and a consumer concerning her 17 year old daughter with seasonal allergies and allergy to BENADRYL and BACTRIM who on 14-MAR-2007 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot No. 655618/0186U) administered in her left arm. On 09-JUL-2007 the patient received a second dose of GARDASIL (Lot No. 654272/0319U) administered in her right arm and on 09-JAN-2008 received a third dose of GARDASIL (Lot No. 657872/0515U) administered on her left arm. Concomitant medication included NUVARING. On 26-MAR-2008 the patient developed a "bump" on her thigh. In June 2008 the patient developed a MRSA infection, confirmed on 29-SEP-2008. On 02-JUL-2008 the patient experienced bowel movement issues. The patient's mother mentioned that the patient is in constant pain which she described as 6 on a scale of 1-10. She also had periodic paralysis of her lower extremities and her "muscles go numb and she falls all the time". She had abdominal pain and nausea and had developed ovarian cysts. The patient saw a pediatric surgeon for her ovarian cysts. The physician's administrator indicated that the condition had "nothing to do" with GARDASIL. The mother mentioned that the patient was almost completely bedbound. It was reported that the patient's boyfriend had a breakout of MRSA on 17-FEB-2009. The medical assistant stated that in March 2009 the patient was seen for the last time after a "well check-up". The patient was hospitalized twice in the summer of 2009 for an unknown reason (length of stay unspecified). The patient had been to the neurologist and had tests done on her muscles and her bones and no one could "figure out what's wrong with her". The medical assistant did not have any information surrounding the patient's paralysis, ovarian cysts, or hospitalizations. Bone scan, colonoscopy, CT scans and MRI tests were performed with no results provided. On 18-NOV-2009 the patient was seen by a neurologist. An EMG was done along with a physical exam. The patient was stable and no neurological symptoms were noted. At the time of the report, the patient had not recovered. Additional information has been requested.
The patient subsequent to the vaccine developed a severe hypertensive reaction despite years of stable blood pressure and blood pressure medications.  This is temporally related.  She has had a primary vaccine series and now 3 boosters in addition to having had covid illness.  Suspect vascular dysfunction from repetitive and unnecessary inflammatory stimuli.
Patient had a seizure lasting approximately 2 minutes.  Pt. has a history of seizures the last one 1 week prior.  RN and EMT on site to evaluate the patient.  Pt. was stable the mother refused to EMS transfer.
Hives; Itching; This is a spontaneous report from a contactable consumer or non-hcp (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in arm left on 03Feb2021 at 13:50 (at the age of 74-years) as single dose for COVID-19 immunization. Medical history included, thyroid disorder from an unknown date and unknown if ongoing, cardiac disorder from an unknown date and unknown if ongoing. Patient's Medical History (including any illness at time of vaccination) included Allergy to Amoxicillin. She has been diagnosed with that for a long time. She doesn't have the product to provide NDC, lot, and expiry. She hasn't had Amoxicillin since the first time when it made her sick. Concomitant medication(s) included levothyroxine taken for thyroid disorder from an unspecified start date and ongoing; metoprolol taken for cardiac disorder from an unspecified start date and ongoing (started taking it probably three years ago. She was not sure if Metoprolol was for her blood pressure. Her heart was beating very fast and this pill regulates it); alendronate sodium taken for bone health from an unspecified start date and ongoing; aspirin was taken for an unspecified indication from an unspecified start date and ongoing; Vitamin d was taken for an unspecified indication from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced itching on 04Feb2021 at 18:00 and hives on 05Feb2021 at 04:00. Course of events as follows: She broke out in hives bad. She still has them. She got the shot on 03Feb2021 and still has hives. On the fourth her hands started itching. On Friday the fifth she broke out a little and still had the itch. Then on the sixth it got worst. Then on the seventh she couldn't stand it anymore and went to the outpatient clinic. She was still broken out and was going to the doctor that afternoon. The hives are still there and expanding. She did get Prednisone at the outpatient clinic. It is the fifth day of taking it and it hasn't helped. It is 20mg and she takes two tablets a day. Prednisone is in a pharmacy vial. She doesn't have NDC, lot, or expiry to provide. She has misplaced the vaccine card. She doesn't have NDC, lot, or expiry to provide for the vaccine. The outcome of events  were not recovered.  Description of Product Complaint: Description of complaint: While providing adverse event for COVID19 Vaccine caller the hives are still there and expanding. She got Prednisone (20mg, count size: 10 pills) at the outpatient clinic. It was the fifth day of taking it and it hasn't helped. It was 20mg and she takes two tablets a day. Prednisone was in a pharmacy vial. She doesn't have NDC, lot, or expiry to provide. She was about to take last pill and won't have any left to send. Packaging was sealed and intact  Information about lot/batch number has been requested.
fever off & on x 3 days;max recorded temp of 100.6 R;mom reports pt fussy, personality different x 3 days p/vax;
Fever and chills starting approx. 30 hrs after booster that lasted approx 8 hrs Cramps/Charlie horses in both feet and left leg 30 hrs after booster randomly for approx. 8-16 hours Swollen lymph node under left armpit after approx. 48 hrs after booster Lump on chest/neck area possibly Supraclavicular lymph node (left side) after approx. 72 hrs after booster.
finger pain; trigger finger returned; trigger finger returned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tracheostomy", start date: 1971 (unspecified if ongoing); "Closure of hole from Trach", start date: 1980 (unspecified if ongoing); "c section", start date: 2000 (unspecified if ongoing); "Asthma" (unspecified if ongoing); "c section", start date: 2002 (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing); MONTELUKAST (ongoing); FLUTICASONE + SALMETEROL (ongoing). Vaccination history included: BNT162b2 (DOSE 1, Anatomical Site of injection: Left arm, Batch/Lot : EW0161, Administration time: 10 Am), administration date: 28Apr2021, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "Tingling in finger tips", "Trigger finger"; BNT162b2 (DOSE 2, Anatomical Site of injection: Left arm, Batch/Lot : EW0182, Administration time: 10 Am), administration date: 19May2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "Trigger finger in middle finger after second vaccine". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jun2022, outcome "not recovered", described as "finger pain"; TRIGGER FINGER (non-serious), DISEASE RECURRENCE (non-serious) all with onset Jun2022, outcome "not recovered" and all described as "trigger finger returned".  Clinical course: Fingers were tingling-day or two after shot began trigger finger-middle finger left hand-got worse went to Dr in Dec and got cortisone injection helped, but finger pain and trigger finger retrieved Jun2022.
05/19/2003: After 24 hours left thigh swollen to knee.  No soreness or redness noted.  Leg measured 3in longer than right leg.  05/20/2002: thigh measured 1 in smaller, no pain.
Headache, Myalgia, Arthralgia, Fever, chills, tiredness-extreme Narrative:  referred to PCP/Urgent Care for sx
BAD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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 was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-JUL-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache. This report was non-serious.
Localized reaction: arm where injection was given became warm, red, felt hard, swollen to size of grapefruit.
Patient was unknowingly given 4th COVID vaccination as it was not known that she had already received a booster dose one month prior. No adverse reactions were seen at the time time, nor were any reported in the time since administration of the extra dose.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had a covid infection after being vaccinated) and DRUG INEFFECTIVE (drug ineffectiveness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced COVID-19 (I had a covid infection after being vaccinated) and DRUG INEFFECTIVE (drug ineffectiveness). On 20-Oct-2021, DRUG INEFFECTIVE (drug ineffectiveness) had resolved. At the time of the report, COVID-19 (I had a covid infection after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2021, SARS-CoV-2 antibody test: positive (Positive) positive. On an unknown date, SARS-CoV-2 antibody test: no antibodies (Negative) no antibodies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 71-year-old male  patient with no medical history reported, who experienced unexpected event of COVID-19; drug ineffective was considerer as an additional event. The events occurred approximately 8 months after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-114596, MOD-2021-114568 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 71-year-old male  patient with no medical history reported, who experienced unexpected event of COVID-19; drug ineffective was considerer as an additional event. The events occurred approximately 8 months after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I95.9 HYPOTENSION 1/26/2022 J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/26/2022 J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/16/2022
2+ edema to posterior left tricep.  skin erythemic, warm, and hard to touch.  Head ache x 24 hours post immunization.
Patient was here for 2nd dose of COVID-19 shot, I went over with patient whether there was any reaction after first shot she said no she was fine, I then administered the shot. After about 5 minutes of patient waiting in the post vaccination area she came to the window and stated that she felt faint and at that point I asked that she have a seat while I spoke with her and she stated that she now felt that her throat was itching. I offered her a bottle of water after her initial comment that she felt faint however when she stated that her throat was itching I gave her one dose of 5ml Benadryl and asked that she continue to wait in the post vaccination area. After another 10 minutes she stated that she no longer felt faint but her throat was still scratchy, I offered her another dose of Benadryl but she stated that she would buy some oral tablets and then she left.
Vaccine was within BUD; however, the EUA was revoked on 9/11/23 and vaccine was given 9/12/23.
Swelling of the arm. Swelling was a large red spot for 3 weeks. Spot hurt to touch (up to and past the 4-week mark).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 which included Paxlovid from 30Jun2022 to 05Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a company representative concerning a 12 month old male pt who on 6/7/00 was vaccinated with MMRII, varicella and a 4th dose of haemophilus b conjugate vaccine. On 6/26/00, the pt developed a rash on his arms and legs and itchy umbilicated papules on his upper body and extremities. The physician indicated that the rash was molluscum contagious. The pt was not hospitalized. It was reported that the pt subsequently recovered. Follow-up information from the health care facility received on 11/6/00, indicated that no other adverse reactions occurred. No further information is expected.