chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Individual described feeling gassy after receiving the 2nd dose of the Pfizer Covid 19 vaccine; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to milk. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient received any medications within two weeks of vaccination. It was unknown if patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, after receiving the second dose of the Pfizer COVID-19 vaccine, the patient felt gassy. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination the patient not been tested for COVID-19. The clinical outcome of the event felt gassy was recovered on unknown date of Apr2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse practitioner concerning a 11 week old patient who on 28-DEC-2008 was vaccinated with the first dose of hepatitis B virus vaccine.  On 16-MAR-2009, the patient was vaccinated with a dose of ROTATEQ and the second dose of hepatitis B virus vaccine (MSD, WAES # 0904USA01908).  Vaccine received at the same day including, PREVNAR, IPOL, ACTHIB and TRIPEDIA.  On 26-MAR-2009 the patient was again inadvertently vaccinated with a dose of ROTATEQ and the third dose of hepatitis B virus vaccine.  Vaccine received at the same day including PREVNAR, IPOL, ACTHIB and TRIPEDIA.  No symptoms reported.  Additional information has been requested.
PATIENT VISIT HOSPITAL THREE TIMES DUE TO DIFFERENT TYPES OF ALLERGIES, SEVERE ALLERGIES. HOSPITAL STAFF INDICATED IT MUST BE DUE TO COVID VACCINE SINCE BEFORE ADMINISTRATION PATIENTS WAS NOT ALLERGIC TO ANYTHING,
Red eczematous rash on back flared since getting shots mostly on right thigh where PT -> HIB were given
Client received the 1st COVID vaccine of Moderna lot # 046A21A on 03/21/2021 at 11:09am. At 14:30pm on 4/18/2021 Site Manager caught that underage client received Moderna at check in when checking ID card. Reported to Lead RN via walkie talkie. At 14:35 Lead RN consulted with Client and her mother in the upstairs lobby of building where Client was returning for second dose of Moderna today.  Lead RN educated both Client and her mother regarding Moderna's suggested application to 18 years and older only. Lead RN assessed Client for tolerance after first dose, and Client denied any adverse reactions or side effects.  Client and her mother denied any significant Medical history, current medications, supplements, or allergies.  Client along with mother were also educated by Lead RN about the CDC's interim clinical considerations for COVID Moderna unauthorized age group. Client and her mother verbalized understanding and expressed a desire to proceed with vaccination.  Lead RN reinforced Client and her mother to please stay for the full 15 minutes in the observation area, and explained the VAERS and VERP reports would both be submitted for the incident. Client received Moderna vaccination #2 lot# 046A21A from RN at 14:45pm.  Lead RN checked on Client in the observation room at 15:00pm where Client denied all side effects and left the observation room at that time with her mother.
Within three hours of injection of HVP vaccine to left deltoid my daughter started experiencing "stabbing" pain (6/10) in her left wrist (palmer side) that was unrelieved with Ibuprofen, ice or heat. (She denied injury or changes, etc. since office visit) Upon waking up the next morning (0600) she reported bilateral "aching feet", 7/10 on pain scale. Upon examining her feet-she appeared to have a light red/un-raised rash/discoloration over the top of her feet-she denies any itching, burning, etc.-Just that the bottoms of both feet and the tops in some places ached. She was given Ibuprofen- a couple hours later the light red/pink rash was gone but the aching to both feet remain. Upon waking this morning (02/02/18) she said that throughout the night her bilateral hands "tingled" for "a couple of minutes"- she reports she is still experiencing "aching" pain in her bilateral feet, 3/10 this morning. I administered another dose of IBU and sent a message to PCP that pain continues and that we need to follow up. I contacted the CDC yesterday morning and they suggested I take her to her PCP-He had no available office or after hours appointments and suggested I take her to ER. ER attending and NP, reported the could not find a reason for the pain and did not think it was related to the HPV vaccine but "could not be 100%" suggesting that she have second vaccine in six months. NP stated that she didn't know what the VAERS reporting system was and that she had never done it. She refused to provide vaccine information until I requested to see hospital administrator.
Pt completed 2 covid vaccine morderna doses Feb 18, 2021. Pt with increasing weakness and short of breath for 3 days PTA on 3/6/2021.
Patient had generalized itching of entire body.  No visible signs or rash, hives, or redness at injection site
LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 350 pounds, and height was 75 inches. The patient's concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious
Patient received the zoster vaccine at the VA clinic 2/5/09.  At his f/u visit 3/3/09 he reported he'd developed a shingles rash approx 10 days after the vaccine.  An exam noted a rash on the right mid-back and on the anterior right chest at approximately the T3 dermatome - consistent with a shingles rash.  Patient reported mild pain (pins and needles type) and itching.
Temp started on 10/23. at 0730 on 10/24/2020 child "squealed, started shaking and spasming and turned very pale"; EMS was called. Rectal temp was 102.5. Child was sleepy and lethargic since that time. Was seen in office.
pt recv vax; w/in 2 min, a vasovagal response occurred change in LOC to obtunded, skin clammy, diaphoretic; pallor;BP 80/60;persistent weak pulse;O2 per face mask;
This spontaneous report as received from a pharmacist via a company representative refers to an approximately 73 year old male patient. In October 2012 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. The pharmacist informed field representative that the patient (no patient contact details provided) who had reported that he had experienced an outbreak of shingles three (3) times since receiving ZOSTAVAX. The outcome of he had experienced an outbreak of shingles three times since receiving ZOSTAVAX is unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Light headed following vaccine with noted elevated Blood Pressure of 162/110 .  Client alert and oriented with mild slurring of speech.  Client reported she was "speech delayed"  since childhood.  EMS and Dr  on site.  At 13.10 blood pressure 168/111 and at 13.15pn 158/106.  Released by EMS and advised to seek medical attention for elevated blood pressure .
cold,; body aches; really sick,; Warmth and hardness at the injection site.; Warmth and hardness at the injection site.; experienced chills; fever,; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold,), PAIN (body aches), ILLNESS (really sick,), VACCINATION SITE WARMTH (Warmth and hardness at the injection site.) and VACCINATION SITE INDURATION (Warmth and hardness at the injection site.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced NASOPHARYNGITIS (cold,), PAIN (body aches), ILLNESS (really sick,), VACCINATION SITE WARMTH (Warmth and hardness at the injection site.), VACCINATION SITE INDURATION (Warmth and hardness at the injection site.), CHILLS (experienced chills), PYREXIA (fever,) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold,), PAIN (body aches), ILLNESS (really sick,), VACCINATION SITE WARMTH (Warmth and hardness at the injection site.), VACCINATION SITE INDURATION (Warmth and hardness at the injection site.), CHILLS (experienced chills), PYREXIA (fever,) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter.   This case was linked to NO-MODERNATX, INC.-MOD-2021-060168 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021. No new information added.; Sender's Comments:  NO-MODERNATX, INC.-MOD-2021-060168:cross link
Not back to his normal self; stomach started feeling upset maybe from talking about it; Legs got heavy; WEAK; Dizzy; tired; blood pressure shot up; pulse went up to 114 beats per minute; WEAKNESS; Feeling weak; Headache; Painful arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Legs got heavy), FEELING ABNORMAL (Not back to his normal self), ASTHENIA (Feeling weak), HEADACHE (Headache) and PAIN IN EXTREMITY (Painful arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ASTHENIA (Feeling weak), HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm), BLOOD PRESSURE MEASUREMENT (blood pressure shot up), HEART RATE INCREASED (pulse went up to 114 beats per minute) and ASTHENIA (WEAKNESS). On 23-Feb-2021, the patient experienced DIZZINESS (Dizzy), FATIGUE (tired) and ASTHENIA (WEAK). On 01-Mar-2021, the patient experienced LIMB DISCOMFORT (Legs got heavy). On 11-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach started feeling upset maybe from talking about it). On an unknown date, the patient experienced FEELING ABNORMAL (Not back to his normal self). The patient was treated with IBUPROFEN (oral) at a dose of 1 dosage form. On 22-Jan-2021, ASTHENIA (Feeling weak), BLOOD PRESSURE MEASUREMENT (blood pressure shot up) and HEART RATE INCREASED (pulse went up to 114 beats per minute) had resolved. On 25-Jan-2021, HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm) and ASTHENIA (WEAKNESS) had resolved. At the time of the report, LIMB DISCOMFORT (Legs got heavy), FEELING ABNORMAL (Not back to his normal self), DIZZINESS (Dizzy), FATIGUE (tired), ASTHENIA (WEAK) and ABDOMINAL DISCOMFORT (stomach started feeling upset maybe from talking about it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Heart rate: 114 (Inconclusive) beats per minute.         This case was linked to MOD-2021-223803 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: No NewInformation
The woman received injectable H1N1 vaccine at approx 1330 on 11/19 at the Health Dept. She states that this evening she began 'feeling really weird.' She has received seasonal influenza vaccinations in the past without incident. The woman is a 44 year old female, she complains of lightheadedness, dizzy and 'almost passed out'. She states that she feels anxious, has tremors and a dry mouth. She states that her 'heart is racing'. Also complained of 'a little bit' of nausea without vomiting. Denies shortness of breath (no more than usual SOB related to chronic bronchitis), denies chest pain or pressure or discomfort. Denies pain, or pressure or discomfort to neck, jaw, back or arms.  Not currently taking any medications. Allergic to PCN. Caller has an occasional cough. Denies alcohol and recreational drug use. She states that she had one cup of coffee this morning. States that she ate breakfast but has not eaten since approx noon. She states that she is drinking water right now. She is currently at her place of business (pool hall). The woman was evaluated in emergency room on  the evening of 11/19. Physician diagnosis: CO Toxicity, CO HGB 9.5% at time of initial ABG. Caller states that she 'had my head in the woodstove' earlier in the day, 'obviously for too long.'
hx of szs;had medical clearance 27SEP95 mom states pt looked funny earlier in evening; had sz-taken to hosp T103; adm overnoc;rash next day-spinal tap-OK 3OCT95 pt OK
Started stuttering.  No stuttering prior to vaccine.  Stuttering occurred on the first word of every sentence.  Repeating the first word 15-20 times.  Stuttering stopped @11/11/2009.  Speech is back to where it was prior to the Influenza vaccine.
Flu like symptoms, tingling/numbness in left arm where shot was administered, swollen lymph nodes under armpit and in my neck on the left side.
pt recvd vax;later on same day, exp facial flushing,facial rash & tightness in the throat;
pt was dc'd from hospital to home (one day prior to this hospital admission) for infected wound (pseudomonas) ulcer Achilles tendon and dry gangrene of left great toe; back to hospital with increasing generalized weakness and change in mental status; family not able to care for pt at home; positive COVID test on admission; treated with ABX; pt's condition worsened and he experienced cardiac arrest and died in the hospital
Vaccination clinic held on 30 October, 2021. Documentation of Moderna administered doses, wasted doses and remaining doses was off by 2 doses. In investigating the discrepancy, it is possible a vial(s) was punctured more than 20 times. We were unable to confirm this is actually what happened. There were no immediate seen or reported adverse reactions by any of the clinic participants and as of this morning, there are still no reports of any.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 13:00 as dose 1, single (Lot number: EN6204), in right arm, on 30Mar2021 at 13:00 as dose 2, single (Lot number: EN6198), in right arm, on 28Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 16May2022 at 13:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 60 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient reported Known allergies: No, other medical history: None.
His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.; His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 80--old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for covid on home tests.  Clinical course: The caller said he's calling on behalf of his friend who has traveled with his family. His friend was 80 years old and his wife was 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests. The 80-year-old wife was now in hospital. Everybody involved has been vaccinated and boosted. Caller wants to know where they can get Paxlovid or if they can send them the medication Paxlovid. Sending as precautionary AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
a missed dose AE for GARDASIL. The caller stated that she was given two doses of GARDASIL on an unspecified date when she was 15; No additional AE reported; caller stated that she is now 31 and received a dose of GARDASIL 9 on 03/16/2022; This spontaneous report as received from a a 31-year-old female patient, concerning herself. The patient's concurrent conditions, medical history, or concomitant therapies were not provided.   On an unknown date (reported when she was 15 years old), the patient was vaccinated with two doses  quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, dose, route, lot number, expiration date were not provided) for prophylaxis . At the time of this report, she was now 31 years old and  on 16-MAR-2022, she was vaccinated with a dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot number, expiration date were not provided) for prophylaxis. No adverse events were reported.
Headaches 8/10 lasted 76 hours with no relief. Due date January 2, 2021.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 10:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:34 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.26    Concomitant products were not provided.  On 28-Mar-2021 Excursion time was reported at 10 am with temperature as 35 degrees Fahrenheit respectively , total doses given for the day was 150 , condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021  On 28-Feb-2021 Excursion time was reported at 09 am and 01 pm with temperature as 27 and 26 degrees Fahrenheit respectively , total doses given for the day was 152 , condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar -2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient received Pfizer bivalent vaccine for first dose instead of Pfizer monovalent.
Friday 2/5/2021 day after vaccination developed fatigue and headache, Friday evening 2/5/2021 developed sweats, chills, diarrhea, and body aches.