chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; Took an antigen test and it was positive again.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 19Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V" (unspecified if ongoing); "protein C deficiency" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "DVT" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 15Jul2022, outcome "unknown", described as "Took an antigen test and it was positive again."; COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. It was reported patient receive Paxlovid for covid-19 treatment. Three days following Paxlovid course patient had recurring symptoms of aching eyes, severe sinus symptoms. Took an antigen test and it was positive again.
Information has been received from a consumer concerning a 15 year old female with asthma and an allergy to BACTRIM who on 01-JUN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included montelukast sodium (MSD) and ZYRTEC. The patient developed hives after getting the vaccine. Medical attention was sought. On an unspecified date, she recovered. She was yet to receive her second shot. No further information is available.
patients experience "more of a burning effect" in the arm; This spontaneous report was received from a nurse referring to an unspecified number of male patients aged from 11 to 14 years old. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown. The patients' concurrent conditions were not provided.  On unknown dates (reported as in the last few months), the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration unknown) (dose, frequency, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccination).  The nurse reported in the last few months, she had noticed when hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringes were administered to patients, the patients were increasing complaining of a severe burning sensation in the arm when receiving the vaccine from prefilled syringe than when she used the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vials. It was unknown if treatment was given for the event. The outcome of the event was unknown at the reporting time. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1908USA002987:
Large, 2 inches, red blotchy patch  injection site; hot to touch, itchy; lasted about a week.
2:30 patient received immunizations and dad and child checked out.  At the check out desk the child got very dizzy and felt like she was going to pass out.  Everything looked blurry and then started getting black.  Sat her down in a chair and called the RN.  We applied cool compresses to her face and forehead.  Gave her juice and peanut butter and crackers and observed her for 30 min.  BP taken.  She was escorted downstairs by RN and dad picked her up in car.  She left with dad.
Tinnitus in both ears.  It was there before, but this shot may have increased it 4 fold.
received 1st dose on 21Jul2019, it is unclear if a 2nd dose was administered.; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st July 2019, batch number 5JX9Z, ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The medical assistant did not have record of the expiration date of vaccine. The second dose was not administered at same facility and it was unclear if a second dose was ever administered.  The patient might have received shingrix out of state, records had been requested and were pending. The reporter consented to follow up.. This case was linked with case US2021238418, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021238418:same reporter
Pt arrived to the ED due to her fall at her adult foster care home.  She had tested positive for COVID there today.  Pt denies any COVID symptoms.
Patient developed a welt 2x3inches with raised injection sites approximately 5 minutes after injection was administered.  Patient was given 5ml of childrens Benadryl and the welt reduced in size. Injection site was still slightly red but not raised.
Irritability, crying, appearance of intestinal distress - intense grunting with fists clenched, face getting red.
Headache, Myalgia, Arthralgia, SkinRash, right arm swelling redness calor Narrative:
Approximately 2 weeks after my 2nd shot in the Pfizer 2-shot initial vaccine series, I developed intense fatigue, orthostatic hypotension, GI distress (low abdominal pain and diarrhea), tremor. If I stop for more than a minute, I developed tachycardia, profuse sweating, weakness /feeling like I was going to faint.  This persisted  in a severe state for 6 months, at which point I slowly became better. During this time, I was non-functional. Oddly, I also developed tiny stinging skin bumps on my torso and arms. At this time, I continue to have abnormal exertional fatigue, tremor, and if standing for long, tachycardia, increased tremor, followed in 30 - 60 min. by GI distress. I am MUCH better than I was, but my functioning continues to be impaired.
NO ADVERSE EVENT REPORTED BY PATIENT HOWEVER, VACCINE ADMINISTERED WAS OUTSIDE THE "GUIDELINES PROTOCOL OF ONLY 6 HOURS AFTER DRAW FROM VIAL"-- UPON CALL WITH PFIZER--PHARMACIST WAS INFORMED THAT "OFF-LABEL STABILITY STUDIES SHOW THAT AS LONG AS DRAWN DOSES ARE KEPT IN REFRIGERATION ARE STABLE FOR UP TO 24 HOURS", HENCE PHARMACIST DECIDED NOT TO REPEAT THE 2ND DOSE.
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had resolved.            Concomitant information was not provided by the Reporter. Treatment information was not provided by the Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received. Updated Event outcome to recovered.
18April97 & 18Jan98 pt recv 1 & 2nd dose of vax. 22Jan98 lab eval revealed failure to seroconvert.
Pneumovax administered 9/5/06 pt developed swelling at site, head and erythema, It increased.
SUBJECTIVE: The patient is a 36 yo female who is here today for a flu vaccine.  The Pt. denied any allergies except Latex and Ibuprofen.   She received Fluarix  Quadrivalent, ZZ772  Exp. 6/30/20 given in right deltoid at 8:42 AM.  Five min. after the vaccine the Pt. started C/O itching on her back.   She denied any lip tingling/swelling or trouble breathing.   She didn't disclose any other allergies until after the vaccine had been given.  Once she started feeling itchy she admitted that she had been allergy tested and was very sensitive to Balsam of Peru and slightly sensitive to polysorbate 80.  OBJECTIVE. Red flat 20 plus blotches appeared on the back of her neck and mid scapular area 5 min after injection. One, three cm sized hive on her right arm 3 inches from the injection site after injection.   No redness or swelling or itching around the injection site at 10 min after injection. Palpable fine rash and redness noted on left shoulder 10 min. after the injection. Palpable fine ash on right side of face 10 min after injection.  VITALS: Pulse 80 Respirations 14 Airway patent and lungs clear BP not taken (We do not have a BP cuff large enough)  Denies being pregnant - on OCPS LMP: 10/19   ASSESSMENT:  Possible allergic reaction to Fluviarx (contains polysorbate - 80)  PLAN. 1.  Diphenhydramine  25 mg given PO STAT.  Epi pen was on hand. 2.  Manager notified by the Pt. that she was having an allergic reaction to the flu vaccine. 3.  Pt. was observed for one hour after given 25 milligrams of diphenhydramine po. 4.  Pt. advised she could RTW after an hour of observation but if the itching started again that she should go      straight to the ED. 5.  Pt. advised should let her PCP and allergist know about today's allergic reaction. 6.  Pt. was given a list of all the flu vaccines and what each one contains and advised to share with her       physicians.   7.  Pt.  was advised to clarify with her allergist if she can have the Fluzone Quadrivalent vaccine in the future as it       is polysorbate - 80 free.  The Fluvarix Quadravalent that the patient received did contain polysorbate - 80. 8.  Redness and itching started to resolve 15 min after administration of Diphenhydramine but still pink rash at 1 hour after meds. 9.  Pt.  states she understands and agrees with the plan of care.  FOLLOW - UP DONE: The Pt. was called an two hours after the allergic reaction and 6 hours after the reaction for f/u.  She stated she no longer felt itchy and the hive and rashes were still improving.
The evening the vaccine was given, he developed pain, erythema, swelling and induration to the anterior Right thigh.  Pain has improved and he has remained afebrile, is walking on the leg without difficulty.  He had the exact same reaction in 2019 after the flu vaccine was given in the Left thigh (2019 Flu vaccine: Fluzone quadrivalent, Lot UJ257AC given in the Left thigh on 11/06/2019) Both times treated with cephalexin for possible cellulitis.  Currently pending referral to allergist
Patient was injected with Shingrix intramuscularly. Patient suffered reaction (cellulitis) which was diagnosed on 7/12/19 at Urgent Care
Headache; Fatigue; Fever; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 07-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever). On 08-Mar-2021, HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment information was provided. no concomitant medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional Info: Possible NNI
hives; rash on the left side of the body including at the injection site; pain on the left side of the body; This case was reported by a consumer via call center representative and described the occurrence of hives in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced hives, rash and pain. On an unknown date, the outcome of the hives, rash and pain were resolved with sequelae.   It was unknown if the reporter considered the hives, rash and pain to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The age at vaccination was not reported but could be 65 or 66 years. The reporter stated that the patient received the 1st dose of Shingrix and developed a rash on the left side of her body including at the injection site. The patient developed pain on the left side of her body and used a topical botanical gel for the pain as recommended by a pharmacist and the pain lasted approximately 7 to 10 days before going away. The patient also developed hives on her body. The reporter did not consent to follow up. This case has been linked to US2020017550, reported by the same reporter.
Raised itchy, circular rash, approx. 3" diameter, on right upper arm, about 1" below actual vaccination site.
High fever up to 104.9 lasting for 3-days. Then again on 03/08/2016 red spots appeared randomly all over her body.  They resemble a bug bite but after a doctor visit, it cannot be confirmed that it isn't related to the vaccines.
10/02/2006 received Fluzone and Pneumovax. 10/03/06 left arm turned red, swollen, 10/04 visit to MD, 10/04 or 5 went to ER, 10/05 went to ER again and was admitted, 10/06 discharged with RX for Clindamycin 300mg and Bactrim DS.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 31-AUG-2016 , the patient was vaccinated with a dose of improperly stored PROQUAD lot # M012987 with expiration date 12-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
Gradually enlarging red, non-tender but warm induration on Left arm (7x4cm) with clear center at site of DTaP/IPV injection given 3 days earlier.
04-25-2018: Pain, swelling, redness at injection site, muscle pain and limited mobility shoulder to elbow beginning at about 11:30 AM. 04-25-2018: MOTRIN, ice and heat modalities on left arm. 04-26-2018: Severe shakiness, and nausea, extreme tiredness, sleepiness, weakness, "spacey", loss of appetite, beginning at 4:00 AM. 04-27-2018: Appointment with MD at 1:00 PM.
Patient complained of severe redness, itching, and swelling in immunization arm which resolved after a few days. Patient complains of persistent eye discomfort and trouble seeing 12/19/14 and still persisting through 12/27/14.
Bouts of moderate dizziness/lightheadedness approx 3-4 times daily began approx 1 week after 2nd dose of Moderna vaccine received.  I noted it does not appear related to hunger/lack of food or missed medication dose (sertraline).  I have not reported this to my doctor yet.  Symptoms cause me to pause what I?m doing at the time until it passes (approx 10-15 seconds in duration).
Patient developed redness and itching ~10 minutes after administration of vaccine. After additional 10 minutes, patient complained of dizziness, headache, and difficulty breathing. Patient noted nausea after administration of rescue medications. Patient observed in emergency department and discharged in stable condition ~3 hours later. Patient noted generalized body aches the following day during follow-up call.
Expired vaccine used vial punctured before 24 hours of administration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used vial punctured before 24 hours of administration) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used vial punctured before 24 hours of administration). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used vial punctured before 24 hours of administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information reported. No treatment medication information reported.   This case was linked to MOD-2021-332841 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information was received include no new information.
PULMONARY EMBOLISM; BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned a 34 year old female of an unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in 2021, (2 years ago), the patient developed blood clots. On an unspecified date, the patient experienced pulmonary embolism. On 28-JUN-2023, the patient died from pulmonary embolism. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20230712979- pulmonary embolism, blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: PULMONARY EMBOLISM
he is feeling aches/feel body aches; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 23Dec2020 08:00 at a single dose as COVID-19 vaccine. The patient's medical history and concomitant medications were not reported. Patient would like to know if it's okay to visit with his family tonight since he was feeling aches after receiving the vaccine. Patient further reported that he received the COVID-19 vaccine yesterday, 23Dec2020 at 8:00AM. He stated he worked the graveyard shift (clarified as overnight shift) and came home and slept with no problem. He said he came home from work this morning, 24Dec2020, and he was starting to feel body aches. He said he read the information about the COVID-19 Vaccine side effects, and he knew that feeling body aches after receiving the vaccine is normal. He said he has a question, clarifying that he forgot to ask the question before receiving the COVID-19 vaccine. He asked if it is OK for him to have dinner with his parents after receiving the COVID-19 vaccine. He stated there would be 4 people total, clarifying he would be gathering with 3 people plus himself. The outcome of the event body aches was not recovered.   Information about lot/batch has been requested.
VACCINE KEPT AT ROOM TEMPERATURE FOR OVER 2 HOURS AFTER FIRST PUNCTURE; ADMINISTRATION OF IMPROPERLY STORED VACCINE; This spontaneous report received from a pharmacist 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  (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23/JUN/2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced administration of improperly stored vaccine. On an unspecified date, the subject experienced vaccine kept at room temperature for over 2 hours after first puncture. The action taken with covid-19 vaccine  was not applicable. The outcome of the administration of improperly stored vaccine and vaccine kept at room temperature for over 2 hours after first puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20210544367, 20210544466, 20210544591 and 20210544384.
The day after the vaccine shot the day after the vaccine shot, as she took off her adult diaper there was quite a bit of blood in the diaper, so we call the Dr. she also has Pessary and we needed to make sure that is not what was causing the bleeding, when we went to the Dr a few days later they stated that it was not because of the Pessary that was fine, they then had us do a vaginal internal and external ultrasound, and urine test and that come out normal or negative, We did the ultra sound and they found everything normal also, As I understand it the test was to make sure the lining of the uterus did not swell, it was like she was menstruating's, it did stop for a while but then a week ago she started bleeding again for a day, it was not as bad but she has been in menopauses and should not have been bleeding. My neighbor stated she knows of two other women that has the same problem because of the vaccine.
Fatigue for two months; worked half-time due to fatigue. Treatment for hyperthyroidism seemed to help.