chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At site of HIBERIX after shot, see a small needle size black dot. No treatment. No sign of infection.
SOB; Heart palpations; arm hurt; headache; hurt all over; Had trouble doing my regular exercise class this morning; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Expiration date: Not reported, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in Arm Left on 29Jul2021 16:30 (Age at vaccination 64-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included pneumococcal vaccine (PNEUMONIA SHOT) taken for pneumococcal immunisation from 23Jul2021 to 23Jul2021. Prior to vaccination, was the patient diagnosed with COVID-19 was No. On 29Jul2021 the patient experienced SoB, Heart palpations, arm hurt, headache, hurt all over. Had trouble doing my regular exercise class this morning. Since the vaccination, has the patient been tested for COVID-19 was No. Treatment received was no for all events. Outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received my vaccine at 1615 down in our hospitals clinic, I work as a floor nurse, I returned back to my unit to resume work, I walked in to talk to my charge nurse and felt completely fine within a minute or to (approximately 15 minutes since the vaccine was given) my legs felt like very weak, they became tingly and extremely heavy, my face and chest felt warm and I had to sit down to drink water. The nurses working with me that day took my vital signs, my blood pressure was 157/101, heart rate 80-90s and temp was 97.5F. I notified the pharmacist working on our floor about my symptoms and he directed me toward the infection control line, the pharmacst on the phone directed me to go to the emergency department. When I was admitted to the emergency department via wheelchair, the pharmacist met me there along with the Emergency medicine MD, a neurological exam was done and general assessment. While I was in the ER my heart was monitored, my CBC with diff, Mag and BMP was monitored all of which were normal. I was given a 1L bolus of IV LR through an IV in my left antecubital. Gradually the tingling  wore off over a few hours in my legs bilaterally however they still felt very heavy.   I was admitted from approximately 1645 until approximately 1900 and returned home.
Pt devel swelling & warmth @ lt distal thigh, inflammation of joints @ lt thigh; pt was admitted to Hosp; Pt is still in Hosp according to report;
Pt recieve flu mist at providers office - recieved cutaneous rash to face and body - hives.
This spontaneous report has been received a currently 70 year old male pharmacist (was also the patient) concerning himself via a company representative. Information about concomitant medication and medical history was unknown. On unspecified date in November 2011, when the patient was 64 years old, he received ZOSTAVAX (dose, route, lot # and expiration date were unknown) which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, route, lot # and expiration date were unknown) for prophylaxis. On an unspecified date, the patient developed ''shingles band in torso area". On an unknown date, the patient went to his primary care physician who prescribed antiviral Acyclovir, topical ointment capsaicin (ZOSTRIX), and at night time diphenhydramine hydrochloride (BENADRYL) for itching. The outcome of the events was recovered. The causality between the events and ZOSTAVAX was not reported.
Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of breath and my blood pressure has gone up.   The doctor has put me on anxiety medication but I still feel no difference.  I have not been able to work for the past 3 weeks.
Initial unsolicited report received from non-healthcare professional (family friend) on 21-Mar-2017. This case involves an 11-year-female patient who was vaccinated with a first dose of ADACEL (Batch number, expiry date, dose, and dose in series, route and site of administration were not reported) on an unknown date in allergist office. Patient's illness at time of vaccination was reported as none. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included milk allergy. Concomitant medications were not reported. It was unknown if the patient was vaccinated with any other vaccine within four weeks. On an unknown date, after vaccination, patient was anaphylactic. The patient was required ER/doctor visit. Laboratory investigations were reported as none. Corrective treatments were not reported. Patient was recovered from the event. Upon internal review the company decided to consider the case serious because of important medical event anaphylactic reaction. List of documents held by sender: none. Sender's Comments: Anaphylactic reaction is listed with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Although the patient is allergic to milk and from this is poorly documented case it is difficult to assess the role of the vaccine. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight was 225 pounds, and height was 67 inches. The patient's pre-existing medical conditions included patient does not consumed alcohol and non-smoke  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the patient underwent to laboratory test for antibody detection which was negative (confirmed immunological vaccine failure). The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210532314-COVID-19 VACCINE AD26.COV2.S-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
12 hours after receiving the second vaccine I developed a temp of 103 that lasted approximately 36 hours. I also developed a rash on my forearms 24 hours after the vaccine which lasted approximately 24 hours
About after 5 minutes, sense a strange smell and taste in the nose and throat,  than about 10 minutes felt a rush of warmth sensation over body, and felt tingling and itching of throat, lay down on gurney and try to do deep breathing and relaxing as instructed by staff.  About 40 minutes, felt light headed when walking back to car, about 1 hour later felt like a little mild asthma attack with tingling/itching of throat and had coughing spell.  About 4 hours later started to feel more pain at injection site,  sore, tight, limited movement, cannot raise arm, felt feverish , then headache, nausea, itching on left arm and chest and increased itching in the throat,, noticed mild swelling in both hands and joint tenderness, feels tight to breathe.  after 24 hours, itching and throat tightness subsided.  Still has persistent headache and nausea, itching of  throat, light headed, hard to focus.
Tingling in my right ring and pinky fingers; Tingling in the right jaw that started near the ear, the front of the mouth, including the tip of the tongue; Numbness in the right jaw started near the ear progressed down my teeth toward the front of my mouth; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6201), via an unspecified route of administration in the right arm on 06Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history and known allergies were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient  received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks of vaccination. On 06Mar2021 at 11:00, after about 20 minutes of receiving the first COVID-19 vaccine dose, the patient experienced tingling in her right ring and pinky fingers. Then quickly the patient experienced tingling and numbing in her right jaw that started near the ear and progressed down her teeth toward the front of her mouth including the tip of her tongue. The patient felt like she received a novacaine shot from the dentist. The tingling and numbness continued through out the day into the evening. When the patient retired to sleep, just a bit of numbness on the tongue had remained. Following day the patient experienced additional tingling in that right hand in the ring and pinky fingers. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events tingling in right ring and pinky fingers, tingling in the right jaw that started near the ear, the front of the mouth, including the tip of the tongue, numbness in the right jaw started near the ear progressing down the teeth toward the front of mouth were recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
the patient stated when they took the bandage off 9/26 am they had a mark and red area (approximately 3" size) where the vaccine was given. She went to the doctor and was told it was irritation due to the vaccine solution but they expect it to heal on its arm and didn't prescribe any treatment.
Redness and itching at site of vaccination. Question if SQ approach taken. No fever or rash.
<1 hr after Varivax given eyelid swelling and chest pain; no hives or wheezing better after Benadryl 1; 1 dos oral Prednisone also given for treatment.
Pt recv vax on 12/4/95; on 12/7/95 P/ midnight pt woke screaming unconsolably w/ hysteria, Later in morning, pt could not talk and could not comprehend anything.  Extensive testing done, dx: Autism.  Continues in this state today.
Extreme body ache night of injection, Tylenol remedied,. Fatigue and lethargy for approximately 24 hours after day of injection
received a shot of the "Johnson&Johnson" vaccine and one dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap) one week before she got COVID-19; received a shot of the "Johnson&Johnson" vaccine and one dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap) one week before she got COVID-19; This is a spontaneous report received from a contactable reporter consumer or other non HCP from medical information team.  An 80 year-old female patient (aunt) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; JANSSEN COVID-19 VACCINE, administration date Mar2021 (batch/lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", COVID-19 (medically significant), outcome "not recovered" and all described as "received a shot of the "Johnson&Johnson" vaccine and one dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap) one week before she got COVID-19". Therapeutic measures were taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
side effects were more intense after the booster dose when compared to after receiving the 1st or 2nd doses of vaccine.; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (side effects were more intense after the booster dose when compared to after receiving the 1st or 2nd doses of vaccine.) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 VACCINATION COMPLICATION (side effects were more intense after the booster dose when compared to after receiving the 1st or 2nd doses of vaccine.). At the time of the report, VACCINATION COMPLICATION (side effects were more intense after the booster dose when compared to after receiving the 1st or 2nd doses of vaccine.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-406419, MOD-2021-406421 (Patient Link).
Information has been received from a licensed practical nurse (L.P.N.) for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with stomach cramps and no drug reactions or allergies, who on 28-JUN-2010 received the first dose of GARDASIL and the second dose on 14-OCT-2011. The nurse reported that the patient came to their office because she had her period for 3 weeks. While at the office on 28-JAN-2011 she received her third dose of GARDASIL (Lot # 0787). After receiving the dose a urine pregnancy test was found to be positive. The patient's date of last menstrual period and her estimated date of delivery were unknown. Follow up information has been received from a nurse practitioner via pregnancy questionnaire concerning the patient with Gastrooesophageal reflux disease, tobacco user, anemia and a history of 2 prior spontaneous abortions (date unspecified) who on 28-JAN-2011 experienced a vaginal bleeding spontaneous abortion, 6 weeks from last menstrual period by receiving vaccine. Upon internal review vaginal bleeding SAB by receiving vaccine was determined to be an other important medical event. The products of conception were not examined. It was unknown if the fetus was normal. No further information is available.
began day 7 after injection with itching on back on scapula under bra on one side; day 8 itched on back under bra both sides;day 9 woke at 1:00 am with SEVERE itching and inflammation over both shoulders and upper back and took 2 Benedryl .  At 8:50 called GP for help who prescribed 1 Zyrtec twice a day + 2 Benedryl per 4 hours + Cortisone 10 mg cream 3 times/day.  At 4:40pm  such intense itching and pain  doctor prescribed Methylprednisolone pack which I started at 6pm.   Rash progressed Jan 31, Feb 1,2,3 to cover whole body.  Worst in armpits with swelling.  Slept with numerous cold gel packs.  Inflammation began subsiding day 6, taking just Zyrtec + cream today day 7.
This spontaneous report was received from a pharmacist refers to 2 unspecified patients of unknown age and gender. Pharmacist reported that she had two separate occasions where she was only able to withdraw up 0.6mL and 0.61mL from each sterile water diluent, and so she also used an additional sterile water diluent for each under filled via to draw out at least a total volume of 0.7mL, and used this amount of diluent from these vials to reconstitute the ZOSTAVAX vials and administered these doses to two unspecified patients a few months ago on unspecified dates. PQC filed. No adverse effect reported. PQC filed. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 34 years 04 months.  Concomitant medication of the patient was not reported. It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.   The patient did not experience any adverse reactions after the administration of vaccine.  No treatment information was provided by the reporter.
STARTED WITH A HEADACHE ABOUT 12:30 I TOOK A NAP AND AWOKE AROUND 4:30. INJECTION SITE WAS SWOLLEN AND RED WITH MUSCLE ACHES, AND VOMITING CONTINUING TILL 11/1/09 AT 09:00 PM. PERSISTANT HEADACHE EVER SINCE TAKEN TYLENOL, ADVIL, IBUPROPHEN, ALEVE, BENADRYL, CLARITIN, ICE PACKS, PLENTY OF WATER, DARK AND SILENCE WITH NO SIGNS OF HEADACHE RELIEF.
no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 29-JUL-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038700 (expiration date: 01-DEC-2021) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010128:Original Case : 2008USA010000 US-009507513-2008USA010124:Original Case : 2008USA010000 US-009507513-2008USA010125:Original Case : 2008USA010000 US-009507513-2008USA010126:Original Case : 2008USA010000 US-009507513-2008USA010127:Original Case : 2008USA010000 US-009507513-2008USA010122:Original Case : 2008USA010000 US-009507513-2008USA010000:Original Case : 2008USA010000 US-009507513-2008USA010123:Original Case : 2008USA010000 US-009507513-2008USA010134: US-009507513-2008USA010135: US-009507513-2008USA010136: US-009507513-2008USA010137:
At 7:30 p.m. on 1/21/21 I developed a really bad headache and muscle aches.  I took Tylenol.  At 2:00 a.m. I developed a fever and really bad chills still with a headache.  I took more Tylenol.  Throughout the day on 1/22/21 I took Tylenol to relieve the symptoms.  On 1/23/21 at 5:00 a.m. I had 3 small white bumps around my right wrist.  I put Benadryl on them and went back to bed.  When woke at 8:00 a.m. the three white bumps were very red, raised and was completely around my arm.  I understand that the vaccine I received wasn't active, but the rash I have really resembles shingles.  I have seen shingles before.   I know this is how my immune system is dealing with the vaccine and vaccines can affect people very differently.  I believe a rash should be noted on the literature a patient is given about this vaccine as a "side effect".  A rash isn't listed as a side effect.  Thank you.
No additional AE/PQC.; Merck Employee called to report HCP administered GARDASIL 9 to an 8 year old patient because the HCP states the mother passed on HPV to patient at birth and HCP was using the GARDASIL 9 as a method of treatment.  HCP did confirm permission to contact; This spontaneous report was received from Company Representative and refers to an 8-year-old of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-JUL-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 25-JUL-2023, Merck Employee called to report HCP administered GARDASIL 9 to an 8 year old patient because the HCP states the mother passed on HPV to patient at birth and HCP was using the GARDASIL 9 as a method of treatment. HCP did confirm permission to contact, but not by phone or email. No additional AE/PQC.
This spontaneous report as received from a Registered Nurse regarding a 10 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 30-JAN-2019, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
Side effects Post first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects Post first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects Post first dose). At the time of the report, VACCINATION COMPLICATION (Side effects Post first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Reporter's Comments: unspecified adverse event as reported