chrisvoncsefalvay/vaers-outcomes huggingface dataset:
quite uncomfortable; headache; chills; tiredness; She slept most of the evening in the daytime; I was quite sick; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 87-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose number unknown , 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: COVID-19 (non-serious) with onset 25Sep2023, outcome "unknown", described as "COVID"; MALAISE (non-serious), outcome "unknown", described as "quite uncomfortable"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; SOMNOLENCE (non-serious), outcome "unknown", described as "She slept most of the evening in the daytime"; ILLNESS (non-serious), outcome "unknown", described as " I was quite sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Caller asking if her COVID that she now is testing positive for covered by the Comirnaty vaccine that she received? Is comirnaty vaccine for covid. she received it last friday and the next day she day terrible headache tiredness and slept most of the evening. 87 year old female stated, 'I received the Pfizer COVID vaccine Comirnaty for 12 years of age and older on Friday and the next day, I was quite sick. I was quite uncomfortable with a headache and chills, and tiredness for about a day and a half. Today (25Sep2023), I was diagnosed with COVID.  So I'm on Paxlovid now. I'm wondering if the vaccine caused that reaction or if I already had COVID at that point.'  The caller had the Pfizer COVID shot last Friday, and she experienced a lot of difficulty that evening, and the next day she had a terrific headache and tiredness. She slept most of the evening in the daytime. She would like to know if there are usually reactions to that. She is asking the Comirnaty vaccine for Covid-19. She mentioned that she experienced a lot of difficulty that evening, and the next day she had a terrific headache and tiredness. She slept most of the evening in the daytime.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311116 same patient, different Vaccine dose/event ;
Injection site had a little blood at the site that I noticed the day after when I took off the bandage. After showering it was all gone and has not returned. The evening after the vaccine, I started to experience a little pain in the left arm, especially the shoulder joint area. It did not prevent me from sleeping but did wake me when I rolled onto my left side. The pain was more severe the next morning but started to decrease after lunch. At 8 pm the day after it is just a dull ache now.
Fever of 104.3.   Legs heavy.  Occasional cold chills until 10:00 PM.  Drank fluids.  Covered up with blanket
Hives larger than silver dollar, redness, itching. Symptoms worsened over 24 hours. Pediatrician diagnosed allergic reaction mid-morning on 10/11/2010. approx. 48 hours after vaccine, pimply red rash developed and lasted approx. 2 weeks.
Information has been received from a physician concerning a male pt who on approximately 8/5/02 was vaccinated with a dose of MMR II. On 8/22/02 the pt developed a reticular rash on his face spreading down ward to his arms and legs. Unspecified medical attention was sought. Additional info has been requested.
Soreness of arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Soreness of arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness of arm). At the time of the report, VACCINATION SITE PAIN (Soreness of arm) 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.   Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Pt noted light headedness about 2 min after immunizations, pt's color redness from face, became diaphoretic, passed out. Pulse oximetry applied & feet elevated. VS stable, ammonia smelling salts provided. Pt responsive within 1 min. Moved to supine position & monitored for 20 mins. Pt noted feeling better. Color back in face. No nausea or vomiting vs stable
8 hours post injections unable to move arms, joints aching. In bed next 2 days, felt like "tin woods man", fever 101 with nausea following day. Took ibuprophen, alka selzer. Called Health dept. to report reaction. Right arm continued aching, unable to pull up blankets at night etc. Right wrist began aching, loss of strength, then left wrist, then jaw, ankles, knees. Am now being treated for arthritis, on Relefen. Aching joints, loss of hand strength continues 5 months later.  05/17/2007 Several office notes received from PCP.  OV 12/30/06 for c/o longstanding wrist pain 2' to wrist fx in 1990's and cough with increasing chest tightness and thickened sputum. Assessment:  Chronic bronchitis with thisckened sputum.  Right wrist pain.  OV 2/26/07 for c/o pain in multiple joints. Assessment:  Likely osteoarthritis.  Wrist pain exacerbated by previous fx.   OV 4/19/07 F/U Osteoarthritis improved.  Insomnia improved.  Assessment:  Osteoarthritis, insomnia, allergic rhinitis all improved.  06/11/2007 MR received for single visit for tendinitis of the R wrist.  Hx of fx of Rwrist 20 years ago and 2 recent minor incidents. ROM is limited. Tenderness noted with palpation around the radius and ulnar side of the wrist. DX: Tendinitis of the R wrist.
I have experienced a gradual increased amount of itching, swelling of eyelids, rash around eyes which started approximately early February. I actually never thought it was from the vaccine, just maybe allergies. With each month passing, it has become severe, where I have been to an eye doctor twice and a dermatologist four times. Currently, I have extremely swollen eyelids (both top and bottom), slight red rash to them and always very itchy. The lower lids have been  "drooped" since maybe mid-April. I am awaiting to see a allergist to do a "broad spectrum " test on my skin but no even sure if that will help.
One week a day later I woke up with itchiness on the site were the vaccine was given and started developing a hot to the touch, welty rash.
Reported Symptoms:  10037844:RASH; Narrative:  A 76yrs old male was reported with Pfizer Covid - 19 vaccine induced pruritic rash on December 12, 2022 by a PCC attending physician.  It was reported as an observed mild pruritic rash on arm.  Per the attending physician's Assessment /Plan note  The patient had
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES; DOES NOT FEEL BETTER AFTER RESTING/ NOT FEELING WELL; ENERGY LEVEL DOES LIMIT DAILY ACTIVITIES (ASTHENIA); FATIGUE/ SYMPTOMS OF FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. 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, the patient experienced loss of personal independence in daily activities, does not feel better after resting/ not feeling well, energy level does limit daily activities (asthenia), and fatigue/ symptoms of fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the energy level does limit daily activities (asthenia), fatigue/ symptoms of fatigue, does not feel better after resting/ not feeling well and loss of personal independence in daily activities was not reported. This report was non-serious.
So far, the 1st COVID shot was received on Tuesday and Day 5 I'm still feeling the following effects:  Alternated between chills and hot flashes; splitting headache turned into shooting pain on right side of neck and head; swollen lymph nodes on right side; achy body; loss of appetite; light-headedness; queezy stomach; extreme tiredness.
pt recvd vax at 2pm; at 6:30pm suddenly became SOB,started coughing,had chills;fever 100;rt arm swollen hot & had great difficulty moving it; aspirin given then slept;pt better;still cough & lusky voice;3" diam red swollen on rt arm at site
Slight cold symptoms 13Apr2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 64 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 13Mar2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 22Feb2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 13Apr2022, outcome "unknown", described as "Slight cold symptoms 13Apr2022". It was unknown if therapeutic measures were taken as a result of nasopharyngitis.  Additional information: It was reported that COVID was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Redness, swelling, severe itching, hot to the touch,      symptoms are ongoing 5 plus days
tongue was swollen; This is a spontaneous report from a Pfizer sponsored program  via non-contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tongue was swollen. It was reported that patient tongue was swollen after first dose and the second dose of vaccine was coming up. Reporter wonders if patient should get 2nd dose. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
arm soreness; puffiness around the eyes; light headedness; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; PERIORBITAL OEDEMA (non-serious), outcome "unknown", described as "puffiness around the eyes"; DIZZINESS (non-serious), outcome "unknown", described as "light headedness"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: Patient had history of reaction, mild reactions to medications. Reporter seriousness for puffiness around the eyes, light headedness, nausea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
severe fatigue for a week, large bruises on lower limbs, such weakness in my legs that it felt like I was paralyzed. If I stood up I would collapse immediately. neuropathy exaggerated beyond my medicine's capacity (Gabapentin)
no additional AEs; patients received doses of VARIVAX vaccine on 8/9/22 while improperly stored outside recommended storage temperature range; This spontaneous report has been received from a registered nurse regarding a 3 years-old patient of unknown gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 03-AUG-2022, varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to -14 Fahrenheit (F) up to 46 F (14F) for 4 hours (h) 15 minutes (min). On 09-AUG-2022, the vaccine was exposed to 14 F up to 46 F (45F) for 4 h 45 min. On the same day, the patient was vaccinated with one dose of a stored outside the recommended storage temperature range of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, on the left deltoid at a dose of 0.5 milliliters (ml), once (lot number: W011626, which was verified to be valid, with an expiration date: 06-APR-2024; strength was not reported) (product storage error). The reporter called for an evaluation of vaccine temperature stability. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of several reports from the same reporter.
Crying for 4-5 hour spells within the 24 hrs following immunizations on 3/22/03.
1: the day after my first covid shot, in the evening, my heart rate jumped from around 70 to around 130 instantly when walking up the stairs in my house. This happened twice that evening and has never happened before. My pulse was pounding in my head and it took about 1-2 minutes of slow breathing to calm my heart rate again. I wore my heart rate monitor the rest of the evening and overnight, with no other adverse effects. Stairs had no impact on me the next day. I had also exercised that morning, and while my heart rate was higher than normal with that type of workout, I didn?t think anything of it at the time and didn?t have the pounding head issue.  Due to this issue, I?m a bit nervous about the second shot in the series.   2: I started my period the morning I got the shot; day 4 and 5 of my period were significantly heavier flow than normal. Day 4 also included cramps and nausea throughout the entire day, which is not normal for me.
LMP: 01/11/21 EDD: 11/14/21 Fetal demise at 14 weeks 5 days (by ultrasound) Delivery: 06/10/21 Birthweight: 1oz Low progesterone through out pregnancy, progesterone supplements were prescribed
Developed erythematous, vesicles rash along T6 dermatome 2 days after injection. Treating with Valtrex. This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a licensed practical nurse concerning a 68 year old female with no known allergies, and history of hypertension and osteoporosis, who on 16-FEB-2007 at 13:15 was vaccinated intramuscularly into the left deltoid with a first dose of ZOSTAVAX (Merck) (Lot # 656606/003U). There was no illness at the time of vaccination. On 17-FEB-2007 the patient didn't feel well. On 18-FEB-2007 "during church" the patient developed an erythematous, vesicular rash along T6 dermatome two days after the injection. The patient also experienced pain on that same day. On 20-FEB-2007 the patient was seen by the physician and presented with shingles. At that time there was a rash on the left side and under the left breast. The patient was treated with VALTREX. As of 21-FEB-2007 the patient was "fine" and was not in the hospital. On an unspecified date, a viral culture, rapid, varicella was obtained, which was positive. There was no product quality complaint involved. At the time of reporting the final outcome was unknown. Additional information is not expected.
pt recv vax 26JUL96 & 31JUL96 pt c/o soreness redness & warmth observed @ site;pt given ATB by MD;pt returned in 1wk & sx had dissipated;
She called 3 days after vaccine administration and said she had a quarter sized bump, a little raised, a little red and not black or blue.  Tender to touch.  She said she had the same thing as her second dose of Pfizer.
arm was sort of swollen, red, hot to the touch and it was warm; arm was sort of swollen, red, hot to the touch and it was warm; arm was sort of swollen, red, hot to the touch and it was warm; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age receive pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13, lot number X13847, expiration date Jul2020), via an unspecified route of administration from an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm was sort of swollen, red, hot to touch and it was warm after the vaccine was administered a couple of days ago, on an unspecified date. The outcome of the event was unknown.
About 3 days after receiving an H1N1 injection to (L) deltoid, pt. noticed a pain radiating up to her neck (L) side and down to finger tips (L) side. Pain numbness persisting through today.
This spontaneous report was received from a physician reffering to a patient of unknown age and gender. There was no information about the patient's concurrent conditions and medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously lot# R006753, expiration date 06-MAR-2020 or dose of VARIVAX subcutaneously lot # N026999, expiration date 28-SEP-2019  (also reported as 20-SEP-2019), for prophylaxis. It was unspecified which lots of VARIVAX was given to the patient. The sterile diluent used to reconstitute the vaccine was properly stored. There was no adverse effect reported. Administered doses of vaccine were exposed to the temperature excursion of -14 degrees Celsius to -10 degrees (-13.7 degrees Celsius) Celsius for 2 hours 6 minutes. Data logger was involved. There were no previous temperature excursions. This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA004533: US-009507513-1808USA004633.
inadvertently administered Menveo Diluent only; inadvertently administered Menveo Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered menveo diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was unable to provide any patient or vaccines details. The reporter also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 11 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170620:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter
Pfizer vaccine. Around 6pm the following day, left eye swelling noted. Did not decrease in swelling until next day (after 4 doses of antihistamines).
This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. It was reported that on unknown dates, doses of PEDVAXHIB (lot number M032148, expiration date 18-APR-2019) which were exposed to temperatures outside of the recommended range, were administered orally to the patients. No adverse experience had been reported. Temperature and time frame were: 1.3 degrees Celsius (C) for 1 hour and 57 minutes; 1.4C for 2 hours and 15 minutes; 0.9C for 36 minutes; 1.3C for 21 minutes (duration: 309 min). There were no previous temperature excursions. This was reported because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA009624: US-009507513-1611USA009625: US-009507513-1611USA009623: US-009507513-1611USA008904.
After physical, pt went to beach was wearing SPF 60 sunscreen and mom reports shielding his body from the sun with hers. A friend noticed his left side was red. After a dip in the cool water he was less red. Pt acted fine. Was seen in office L leg to foot light red, but clinically happy and playful. Mom instructed to give Benadryl. Monitor legs, walking etc. DX sun VS flushing reaction.
8 hrs after vaccine admin., sudden onset of weakness bilateral arms & legs.  Difficulty with speech, swallowing & ineffective cough.  Overall sensation of feeling "wet" and "burning" flesh pain & paralysis.  Not recovered but some improvements seen.  2/8/08 Reviewed hospital medical records which reveal patient experienced arm & leg pain, slurred speech & right facial droop.  Admitted 12/13-12/29/2007.  Progressed to paresthesias & then paralysis.  Swallowing & urination compromised.  Neuro consult done & felt non reversible.  Transferred to hospice. FINAL DX: cervical cord compression 2nd to severe spinal stenosis; neuropathic pain in upper & lower extremities 2nd to cord compression. Annual Follow-up Information 18-FEB-2009: There was partial paralysis of the lower extremities that remained - unable to rehab pt. after receiving vaccine. Pt died approx 5 weeks ago (Jan 16) Sepsis due to bladder infection, being bedridden at nursing home and advanced age.  Pt. passed away 35 days after receiving this vaccine (Jan 16th 09). His residual symptoms were lower extremity (partial) paralysis. The upper extremity paralysis. Resolved shortly after initial onset but unable to rehab the lower lungs. Spots from bilateral infection had to hi.sdeath
Migrainesfor 2 days, hives, rash, tiredness, injection site red and swollen, fever and chills for 2 Days. Itching and rash continued to day 8.
15 minutes after injection. Patient suffered muscle paralysis from the waist down. She was unable to walk out of the pharmacy and was transported to her car on a motorized scooter. The paralysis lasted 1 hour. She reported chills and fatigue over the next 24 hours. After than, for an additional 24 hours, she felt fatigued. Patient refused to be seen by a provider and recovered.
Pt states that she has itchiness and redness all over her front trunk area starting since 01/05/12 night.