chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an unspecified reporter via online media refers to a female patient of unknown age. The patient's current conditions, medical history and concomitant medications were not reported.On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown) (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. On an unknown date, the patient became seriously ill after receiving the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(manufacturer unknown). The outcome of the event 'seriously ill' was unknown. The causality assessment was not provided by the reporter. The reporter considered the event 'seriously ill' to be medically significant. This is one of the two reports received from same reporter.; Sender's Comments: US-009507513-1711USA000471:
I tested positive for a breakthrough infection of COVID-19; I tested positive for a breakthrough infection of COVID-19; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0185), via an unspecified route of administration on arm right on 16May2021(age at vaccination: 28 Years) as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0171), via an unspecified route of administration on arm right on 25Apr2021 as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient Concomitant medications were not reported. On 16Aug2021, the patient tested positive for a breakthrough infection of COVID-19. The event resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has tested for COVID-19. Treatment received was reported as no. The lab test included SARS-CoV-2 test(Nasal Swab): positive on 17Aug2021.The outcome of event was resolving.  No follow up attempts are possible. No further information is expected.
General side effects: Fatigue, headache, muscle pain, joint pain, chills and nausea.  Treatment: Ibuprofen 800 mg and rest. Course: Approx 18 hours
Itchiness of torso, given Benadryl 25 mg PO. BP 152/101 (pulse 68), 125/90. O2 sat 99%.
fever 102.8, diarrhea, vomiting, chills, tachycardia, arm red and swollen where shot was given.
PATIENT HAD REDNESS AND SWELLING AROUND THE INJECTION SITE INITIALLY AND LATER A SKIN INFECTION APPEARED. PATIENT SEES A PRIMARY CARE PHYSICIAN 28 DAYS AFTER VACCINATION AND WAS DIAGNOSED WITH SOFT TISSUE CELLULITIS. PATIENT WAS PRESCRIBED KEFLEX 500MG ONE CAPSULE THREE TIMES DAILY FOR TEN DAYS.
About seven months after receiving the third dose of Pfizer, I experienced spells of feeling dizzy. I went to the doctor when the dizzy spells became more frequent. After checking my blood pressure, he noticed that the diastolic number was very high. I have been on HCTZ since September 2022. The medication has been helping and my blood pressure is back to normal now.
Dizziness/ Lightheadedness; Nausea; Vomiting; This is a spontaneous report received from a non-contactable healthcare professional. A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 17Mar2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 17Mar2021, after 15 minutes of vaccination, the patient experienced light-headedness, dizziness, nausea and vomiting. The patient received water and was treated with ZOFRAN, PEPCID and ZYRTEC and also applied ice pack. The response to treatment was good and the patient was discharged in a stable condition and was advised to follow up with primary care physician. The clinical outcome of the events light-headedness, nausea and vomiting were recovering.  No follow-up attempts are needed. No further information is expected.
Patient fainted post vaccine and was out for about 10 seconds, and then came to. After waiting 15 minutes, drinking some water, and eating a light snack, patient was fine.
Day 5 - intense itch began, duration 3 weeks Day6- pain, redness, swelling began  duration 3 weeks+ As of 10-21-2021 the patient was still reporting  pain in the shoulder/arm/neck region.  She reports numbness (ache) and a loss of strength.  She reports a reduction in range of motion.  She says the injection site is still very sore and if it is touched or pushed, the intense pain increases and shoots down into her fingers.
chest pain. Chest Pain since 0900, started while at rest, radiating across chest lasting a couple minutes, describes as aching, deep breath makes it worse, reports feeling warm; reports CP at this time; alleve taken around 0915.
AFTER RECEIVING 2ND DOSE OF MODERNA COVID-19 VACCINE, PATIENT TOLD PERSON SHE WAS WITH THAT SHE FEELS LIKE SHE IS GOING TO PASS OUT AND SHE DID.  PATIENT EXPIERENCED DIZZINESS, WARM FEELING, NAUSEOUS, TINGLY IN HANDS AND FEET.  AFTER CALLING FOR HELP I IMMEDIATELY WENT OUT TO CHECK PATIENT AND SHE WAS ALREADY AWAKE, ALERT AND TALKING.  SHE PASSED OUT AND WAS CAUGHT BY THE PERSON SHE WAS WITH BEFORE SHE HIT THE GROUND.  WE TOOK HER BP AND PULSE, 112/69, PULSE 68.  WE THEN HAD HER DRINK A BOTTLE OF WATER AND SHE LAID DOWN.  SHE ALSO ATE A SNICKERS BAR.  AFTER LAYING DOWN AND SITTING FOR 35 MINUTES AFTER PASSING OUT SHE WAS FEELING MUCH BETTER.  SHE STOOF UP AND WALKED AROUND BEFORE SHE LEFT.  SHE REFUSED EMS WHEN OFFERED AND SAID SHE FELT FINE.  SHE HAD SYMPTOMS OF VASOVAGAL SYNCOPE? PATIENT LEFT FEELING OK.
paralyzed; felt like a stroke; fell on floor; could not take pants down; bowels emptied; woozy; sweating profusely; she had some soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (paralyzed), TRANSIENT ISCHAEMIC ATTACK (felt like a stroke), FALL (fell on floor) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take pants down) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 030L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken ankle.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021 at 2:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced PARALYSIS (paralyzed) (seriousness criterion medically significant), TRANSIENT ISCHAEMIC ATTACK (felt like a stroke) (seriousness criterion medically significant), FALL (fell on floor) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take pants down) (seriousness criterion medically significant), ANAL INCONTINENCE (bowels emptied), DIZZINESS (woozy), HYPERHIDROSIS (sweating profusely) and PAIN IN EXTREMITY (she had some soreness in her arm). At the time of the report, PARALYSIS (paralyzed), TRANSIENT ISCHAEMIC ATTACK (felt like a stroke), FALL (fell on floor), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take pants down), ANAL INCONTINENCE (bowels emptied), DIZZINESS (woozy), HYPERHIDROSIS (sweating profusely) and PAIN IN EXTREMITY (she had some soreness in her arm) outcome was unknown.            Patient had her first Moderna vaccine on 27Jan2021 with no side effects. Patient experienced a low grade fever and a slight headache that lasted about 7 hours. Patient had a broken ankle and was on a scooter in the night she got on her scooter to go to the bathroom and urinate. Patient had never experienced anything like this before.  Her cognitive function was fine and so was her speech. Patient gave consent to be contacted by email or phone.  No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-298153 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
104 degree fever starting approximately 22 hours after the second shot. The fever lasted 2.5 days.  Tightness in breathing, heaviness in chest, and a general weak feeling after excise (i.e., when heart rate increases) following the 2nd shot. Still ongoing today (6/24/21)
Intense symptoms including: Fever 102+ for three days; Severe shakes (could not hold cup of water without spilling) 3 days; Stomach pain (most intense ever experienced "like on fire") 2days; Nights sweats (necessitating full change of bed linens) 8/29 and 30/2018 2 nights; Headache 3days; Dizziness 2days.
Within two hours of the shot I started getting flu like symptoms which progressed from headache to body aches to fever to a week long severe upper respiratory infection.  One week later I am still feverish and am still experiencing flu like symptoms.  My husband and children who have been very close to me since the time of the shot have no symptoms at all.
Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 07-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that the recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1209USA006055,  1209USA006056, 1209USA006058, 1209USA006059, 1209USA006060,1209USA006061, 1209USA006062, 1209USA006063, 1209USA006064, 1209USA006065, 1209USA006066, 1209USA006067, 1209USA006068, 1209USA006069, 1209USA006070, 1209USA006071, 1209USA006072, 1209USA006073, 1209USA006074. Additional information is not expected.
Patient states got flu shot on 10-4-08. Stated shot hurt when recieved, but not issues immediately following shot. Patient said about 14 hours later pain woke her up with stiffness on her right side. Patient said went all the way down her right side, including hand, hip, and knee. Patient denied any tingling associated with stiffness. Patient denies any other problem with the shot. Patient stated last a "couple of hours" and has no residual pain and/or stiffness today.
Pain, redness at site, pain with movement - shoulder to neck, swollen node (R) side of base of neck. No fever, no axillary node enlargement.
Flu shot was administered into the superior most aspect of the right deltoid muscle just distal to the acromion and was incidentally injected into the sub acromial bursa vs rotator cuff tendon. On exam with PCP (myself) had notable bruising at the injection site, which was superior to where IM arm injections should occur. I attempted to contact Pharmacy for further information, but unfortunately all of their phones were down.
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus and acellular pertussis vaccine ;manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ;manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "Flumist" and administered intranasally. There were no other adverse events other than "bad taste."
1st dose 14Mar2021, 2nd 9Sep2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on 14th March 2022 from lot number CN3J5 and expiry date 19th November 2023).   On 9th September 2022, the patient received the 2nd dose of Havrix. On 9th September 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received first dose of Havrix on 14th March 2022 and second dose on 09th September 2022 which was 5 days earlier than recommended schedule. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received 2nd dose of Havrix early than recommended time frame, which led to shortening of vaccinations schedule.
This spontaneous report has been received from a licensed practical nurse referring to a different nurse of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On an unknown date, the nurse got some M-M-R II (strength, dose detail, batch/lot # and expiration date were not reported) in the eyes while preparing the dose of M-M-R II (exposure via eye contact, inadvertent exposure to vaccine and occupational exposure while preparing product for administration). No known adverse effects were reported.
Felt really bad; had fever/Running a fever; Kinda tired; Headache; Chilling (chills); knees hurt (when he does not have knee pain normall); felt sick to stomach and still does; Congestion in throat; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (felt sick to stomach and still does), THROAT TIGHTNESS (Congestion in throat), FEELING ABNORMAL (Felt really bad), ARTHRALGIA (knees hurt (when he does not have knee pain normall)) and PYREXIA (had fever/Running a fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced FATIGUE (Kinda tired). On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Felt really bad) and PYREXIA (had fever/Running a fever). In September 2021, the patient experienced ABDOMINAL DISCOMFORT (felt sick to stomach and still does), THROAT TIGHTNESS (Congestion in throat), ARTHRALGIA (knees hurt (when he does not have knee pain normall)), HEADACHE (Headache) and CHILLS (Chilling (chills)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, ABDOMINAL DISCOMFORT (felt sick to stomach and still does) had not resolved and THROAT TIGHTNESS (Congestion in throat), FEELING ABNORMAL (Felt really bad), ARTHRALGIA (knees hurt (when he does not have knee pain normall)), PYREXIA (had fever/Running a fever), FATIGUE (Kinda tired), HEADACHE (Headache) and CHILLS (Chilling (chills)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Body temperature: 101.8 (High) 101.8.     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.   No relevant concomitant medications were reported.
On 04/29/2023, patient received first dose of Pfizer 12 year +, patient should have received Pfizer 5year to 11 year dose.  Incident was discovered on 05/02.2023.  No adverse reactions were reported.
Dose 1 04/01/2021 Pfizer lot # EW0177
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath  1 day later: redness injection site, moderate swelling or arm,  mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
Red at site of vaccine, hard, tender to touch Ice for first 24 hours and nothing since Still red and tender 10 days after vaccine
This spontaneous report was received from a nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates in approximately 2017, the patients were vaccinated with PROQUAD lot # M006106 with an expiration date 01-AUG-2017 for prophylaxis (dose and route of administration were not reported). No adverse event was reported. Administered doses of PROQUAD experienced the temperature excursion of -13.3 degrees Celsius for 30 minutes on 30-JAN-2017, -14 degrees Celsius for 30 minutes on 31-JAN-2017, -13.1 degrees Celsius for 45 minutes on 01-FEB-2017, -13.8 degrees Celsius for 30 minutes on 02-FEB-2017, -13.3 degrees Celsius for 60 minutes on 03-FEB-2017, -13.1 degrees Celsius for 75 minutes on 04-FEB-2017, -13.8 degrees Celsius for 30 minutes on 05-FEB-2017, -13.6 degrees Celsius for 30 minutes on 05-FEB-2017, -13.6 degrees Celsius for 30 minutes on 06-FEB-2017,-13.3 degrees Celsius for 75 minutes on 10-FEB-2017, -14.9 degrees Celsius for 15 minutes on 10-FEB-2017, -13.3 degrees Celsius for 60 minutes on 10-FEB-2017, -13.2 degrees Celsius for 75 minutes on 11-FEB-2017, -13.2 degrees Celsius for 45 minutes on 12-FEB-2017, -13.2 degrees Celsius for 75 minutes on 11-FEB-2017, -14.9 degrees Celsius for 15 minutes on 11-FEB-2017, -13.2 degrees Celsius for 45 minutes on 12-FEB-2017. There was no previous temperature excursions. Data logger was involved. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006196:
Rash and swelling around injection site (covid arm), fever, chills, body aches, head ache, fatigue, swollen lymph nodes in armpit on arm that vaccine was given. All started about 30 hours after injection and lasted about 24 hours. The swollen lymph nodes are still swollen and painful.
On the night of the 15th when i received the vaccine my arm was sore and i was very tired. I woke up next day after a great sleep and arm was just a little sore but I was totally exhausted and napped through the day and went to sleep that night. Wednesday the 17th of march I woke up at 4:30 in morning with a screaming headache and my neck and shoulder muscles were extremely tight. I felt like my head was going to explode! I am not used to headaches but this one hurt pretty bad. I took Tylenol and used ice packs on head and neck and back shoulders. I used Electronic Muscle Stimulator Pads for 12 minutes on middle shoulder back area. That evening I was feeling a little better with small headache but when i was rubbing
Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 11Jun2021 16:30 (at age of 58 years old) as single dose for COVID-19 immunization. Medical history included mast cell activation syndrome, ehlers danlos syndrome, allergic to garlic, allergic to beef, known allergies: Narcotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included verapamil; pregabalin (LYRICA); famotidine; loratadine (CLARITINE); cromolyn sodium. The patient previously took omalizumab (XOLAIR), salbutamol (ALBUTEROL), Sorbitol, clindamycin, diclofenac diethylamine (VOLTAREN), sildenafil citrate (ZOLTAN), all had drug allergy. The patient had Anaphylaxis on 11Jun2021 03:30 PM. This case was Serious with Seriousness criteria-Life threatening. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event (epinephrin). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
2 days after receiving the vaccine patient reported redness, swelling, pain and fever. She then went to urgent care and was diagnosed with cellulitis. She was prescribed an antibiotic and is now feeling fine.
This case was reported by a pharmacist and described the occurrence of anaphylactic reaction in a male subject of unspecified age who was vaccinated with DTPa (with small D and P), manufacturer unspecified). On an unspecified date the subject received a dose of DTPa (with small D and P) (unknown details). The vaccination was administered "many years ago." Per the pharmacist, the subject was not sure if he received the BOOSTRIX or "it might have been similar vaccine from another manufacturer." At an unspecified time after vaccinations with DTPa (with small D and P), the subject experienced anaphylactic reaction and stopped breathing. The pharmacist reported that the subject "was probably hospitalized due to the anaphylactic reaction." This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. No additional details were provided.
Right arm swollen, red, sore at site of injection. Pt reports feeling weird, hadn't eaten yet, most likely unrelated.
c/o chills, weakness, light headedness in mid Pm p/inj;saw MD;dx w/kidney infect & fluid in ear;
The client father stated that the client developed a rash over his entire body the day after his vaccination. The clients father states that this happened previously after his sons last vaccination but he did not report it as it was a smaller rash.
Patient received Prevnar 13 but jerked away in the middle of administration. Received partial dose.
heavy nausea x 6 days; intermittent stomach cramping, cold sweats on & off; no fever; no diarrhea resolved 6 days p/onset; blood work pos;