chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported.; HCP called to report a TE with PNEUMOVAX 23 PFS. The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F).  The excursion was discovered upon looking at the data logs.  Data logger recorded a 46.7F temp on Marc; This spontaneous report was received from a consumer and refers to a 71-year-old patient of unspecified gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated with an improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 ml, lot #W027449, (expiration date: 25-SEP-2024), administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of 46.7F (47F) for 72 hours 0 minutes 0 seconds discovered upon looking at the data logs (product storage error). Data logger did not record again until logging a 43F temperature on 06-MAR-2023, worst case scenario of 46.7F was used for the full 72 hours of the weekend per health care professional direction. No additional adverse event was reported (no adverse event).  This is one from several cases from the same reporter. ; Sender's Comments:  US-009507513-2304USA002650: US-009507513-2304USA002667: US-009507513-2304USA002696: US-009507513-2304USA002675: US-009507513-2304USA002696: US-009507513-2304USA002759: US-009507513-2304USA002776: US-009507513-2304USA002932: US-009507513-2304USA002750: US-009507513-2304USA002696:
Death. Patient lived alone, was found dead at 11:04 the morning following his second dose of vaccine. Actual time of death is unknown. Time of vaccine administration the previous day is estimated.
One week post Pfizer covid booster developed severe proximal muscle weakness in the legs, followed by severe covid infection one week later.
Patient complaining of body aches, fever, 1000mg of Tylenol given to control fever.  Everyday after vaccination had 102 degree temperature, neck and back aches and dizziness.  Had tightness when breathing, no runny nose.  On 4th day (Thurs) had temperature of 103.9 and seen by doctor who ruled out an ear infection and concluded vaccine was culprit.  Patient was fine by Sunday.
11 year old patient receiving Flublok instead of Fluzone Quadrivalent / no AE; patient received Flublok vaccine instead of Fluzone Quadrivalent vaccine/No AE; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA006402. (Same reporter)  This case involves a 11 years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  it was reported that 11 year old patient receiving  FLUBLOK QIV (Product administered to patient of inappropriate age)   It was a case of actual medication error wrong vaccine administered and Inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient presented with severely swollen, red upper right arm. Symptoms started the evening of vaccination and had not improved by morning when presented to pharmacy the following day
Initially irritation to vaccination site to Left deltoid, then mild swelling on 5/24, worsened by 5/25 pm.  Presented 5/26 with moderate swelling, 40% larger diameter left upper arm with redness, warmth and swelling.  Patient neurovascularly intact.  Treated with iv Solumedrol and clindamycin.  Redness and swelling decreased by 60% after iv Solumedrol.
Injection site pain, redness, swelling Enlarged lymph nodes in Right axillary region Fatigue, headache,  muscle pain/body aches, joint pain, chills, sweats, nausea, vomiting, fever Took Tylenol every 4 hours for 12 hours, rested All symptoms gone after 15 hours
I started having very dark and heavy vaginal bleeding that lasted for 3 days. I bled through 5 super tampons within 4 hours. I wasn?t due for my period for 2 1/2 more weeks. My period never comes early and is never that heavy. There were dark blood clots in the vaginal bleeding.  I bled through several pairs of pants at work. I also was having very bad abdominal pain. It got to the point (on the second day) where i had to leave my work unit (I work in a hospital) and go to my hospital?s ER. They ran blood work and did a vaginal ultrasound.
The pt experienced screaming and crying for over 3 hours and was uncomfortable. The pt also experienced a fever and swollen glands at the base of neck.
3rd dose Moderna Covid Vaccine given 4/14/22, #065K21A;  8/31/22 pt admitted to hospital with AHRF secondary to aspiration pneumonia and COVID infection; pt had positive test for COVID; advance directive stating DNR/DNI; comfort care; transitioned to hospice where pt passed away
This case was reported by a consumer, who is also a pharmacist and described the occurrence of pain in a 46-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject thought the vaccine was manufactured by GlaxoSmithKline. On 5 October 2007 at 14:00, the subject received unspecified dose of Influenza vaccine (.5 ml, unknown, left arm). On 6 October 2007, 1 day after vaccination with Influenza vaccine, the subject experienced pain, which radiated from her shoulder down to her hand. The pain in her hand was intermediate, but the frequency had increased. In November 2007, the subject experienced numbness and tingling in her arm, leg, and lip on left side. The subject reported she had not slept in three days. The subject considered the events jeopardizing and required intervention at the doctor's office. The subject was treated with ibuprofen and aspirin. At the time of reporting, the events were worse.
Burning and clamp like sensation in feet and legs. Both hands are numb with weakness. Tremors throughout body. Lower back pain, neck pain, headaches, ED. All symptoms within 30 days of vaccination. I am under neuro care. Gabapentin and Nortriptyline as treatment.
At 10hrs I started having severe chills. 30 min-1hr later I had severe diarrhea and vomiting 1 time. Joint pain followed in ankles, knees, hips, elbows. Next day I had a severe headache with neck and mouth pain. Next day I was terribly weak.
Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   This case contains information about patient 04 out of 04 patients. No concomitant medication was provided by reporter. Four adult patient was impact due to Moderna COVID-19 Vaccine for Illness. Reporter assumed patient get sick because of the vaccine. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-737834 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737834:Patient 1
She developed a scattering of 2-3 mm raised, red macules on her arms, approximately 12, and popliteal area/approximately 10. Patient seen on 10/5/18 for fever (102 degrees) and redness at injection site.
Pt presented at pharmacy for vaccine and was give a pfizer vocid 19 Vaccine , but wanted a High dose Flu vaccine. Pt  had received their 3rd pfizer shot 09/27/2021 and was not due another. They received Fluzone HD today. I told the patient I would file a report and to let me know if they suffered any ill effects.
still have a round red circle and a black and blue mark where she got the injection/Round circle on arm/ Black and blue mark on arm; sneeze; scratchy throat; runny nose; still have a round red circle and a black and blue mark where she got the injection; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received first dose bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Right on 29Mar2021 09:15 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had her first shot on 29Mar2021 and experienced around circle on her arm and scratchy throat. The patient still had the circle on her arm and it had already been 8 days and patient was not sure how long it was supposed to last. scratchy throat was about the same or a little bit better. Over the weekend, Patient started to sneeze a lot and had a runny nose. Patient did not know if these were side effects because she was totally fine last week and prior to the shot. The sneezing started last week or early weekend. Patient confirmed that she was not sneezing a lot as of now. As of yesterday, the sneezing had not been as severe the sneezing was not all day long. The outcome of still have a round red circle and a black and blue mark where she got the injection was not recovered, recovering from vaccination site bruising, Otcome of the events scratchy throat and runny nose and sneeze was unknown.  Follow up (06April2021): This is a follow up spontaneous report received from a contactable consumer included: Age, additional events, event onset date and narrative information were updated.  Follow-up attempts are completed. No further information is expected.
frequent urination; ketoacidosis; diagnosed as a late onset type one diabetic; vitiligo spread one month after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 17:30 (Lot number: ER8731) at the age of 41 years as dose 2, single for covid-19 immunisation. Facility type vaccine: Pharmacy or Drug Store. Relevant medical history included: "Vitiligo was dormant for 15 years prior to vaccine" (not ongoing). No Known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Vaccination history included: Bnt162b2 (1st dose, lot number= EP6955), administration date: 02Apr2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "vitiligo". No covid prior vaccination. No covid tested post vaccination.  The following information was reported: POLLAKIURIA (hospitalization, disability, life threatening) with onset May2021, outcome "not recovered", described as "frequent urination"; KETOACIDOSIS (hospitalization, disability, life threatening) with onset May2021, outcome "not recovered", described as "ketoacidosis"; TYPE 1 DIABETES MELLITUS (hospitalization, disability, life threatening) with onset May2021, outcome "not recovered", described as "diagnosed as a late onset type one diabetic"; VITILIGO (hospitalization, disability, life threatening) with onset May2021, outcome "not recovered", described as "vitiligo spread one month after the first dose". The patient was hospitalized for pollakiuria, ketoacidosis, type 1 diabetes mellitus, vitiligo (hospitalization duration: 3 day(s)). The events "frequent urination", "ketoacidosis", "diagnosed as a late onset type one diabetic" and "vitiligo spread one month after the first dose" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pollakiuria, ketoacidosis, type 1 diabetes mellitus, vitiligo. Treatment for DKA and lifelong insulin injections.  The patient reported that he started to have frequent urination and vitiligo spread one month after the first dose. After months of the frequent urination he was admitted into the ICU with ketoacidosis. He was know diagnosed as a late onset type one diabetic, triggered by the vaccine.
pt recv vax 19JUN97 & was seen on 25JUN97 because of fine, sl itchy bumps @ the vax site starting 2-3 days a/visit;on exam 1cm patch of follicles was seen @ Td site;rest of arm had keratosis piloris lesions;negative redness, tenderness;
dizzy about 5 mins; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy about 5 mins) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Medications unknown). Concomitant products included LETROZOLE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (dizzy about 5 mins). On 03-Feb-2021, DIZZINESS (dizzy about 5 mins) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.
gave flu; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious case received from consumer (patient) via social media.  This case involves a patient of unknown demographic who developed flu (Influenza), when the patient received INFLUENZA VACCINE.  At the time of the event, the patient had ongoing allergy to flu shot (allergy to vaccine).  Patient's concomitant medication, past medical treatment and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency) the patient developed non-serious flu (Influenza) following administration of INFLUENZA VACCINE.  No laboratory data provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the event outcome was unknown  There will be no information available on the batch number for this case.
I received my shot at 11:15am and at 4pm I developed a horrible headache, was dizzy & nauseous.  I am now on day 8 of a headache.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted but recovered immediately, we helped him up and elevated his feet and at the same time we call 911 for help and everything was taken care of by the medic. The patient is fine.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J009990, exp date: 12-AUG-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
two hours after injection I started elevated heart ratej-irregular and strong.  After one hour it was  97 BPM, still sirone and a bit strong and a bit irregular. after another half hour it return to a regular beat and soft  like normal and has been fine ever since.
Hair loss, frequent headaches, body aches, went from regular periods to no periods for 5 months and then extremely painful and heavy menstrual periods lasting anywhere from 3 weeks to 7.5 weeks, Felt internally hot to where I had to lay with ices packs all over my body just to get some relief, shortness of breath, Heart palpitations, increased anxiety and panic attacks, random fevers no higher than 102), Nausea, diarrhea
Heplisav-B stored at -8°C for 38 hours.; Initial Report Received on 26-Sep-2022  This is a spontaneous report, received from a pharmacist regarding a female patient, aged 54 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 20-Sep-2022, dose 1 of HEPLISAV B (Lot #39TZ2, expiration date 07-SEP-2023, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.   The vaccine administered was reported as being stored at -8° C for 38 hours.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Fever, chills, headache, dizziness, stabbing roving body pain, nausea
Information has been received from a medical assistant concerning a 12 month old male with soybeans and milk allergies, and a history of eczema who on 01-JUL-2010 was vaccinated with VARIVAX (Merck). Subsequently the patient developed red splotches on his arm, leg and hands after administration. The patient was seen by a allergist who did not believe it was due to VARIVAX (Merck). The patient was recovering. No further information is available.
Pt reported weakness, dizziness approx. 15-20 min post injection. BP/pulse normal (138/78, 65 bpm). Pt continued to rest for 40 additional minutes. Declined EMS service. No EMS called. Symptoms subsided. Pt left pharmacy without incident. RPH unable to reach pt for follow up.
Information has been received from a health professional concerning a female patient with a history of smoking, who on 03-Oct-2007, was vaccinated with 0.5 ml second dose of pneumococcal 23v polysaccharide vaccine. Subsequently the patient experienced fever and lymphadenopathy which lasted for about 3 days. Unknown medical attention was sought. Subsequently the patient recovered from fever and lymphadenopathy. No product quality complaint was involved. This is one of the multiple patients report from the same source. Additional information has been requested.
I was fine the first 24 hours but then became very weak and ill, starting 24 hours after the vaccine I vomitted for 48 hours, had a sever headache and was incredibly weak for for about 72 hours.
pt recv vax 7AUG98 & same day exp a tingly & strange feeling in head & loss of sensation in head;balance was off when walking;over the period of the next day 8AUG98 pt felt fine;10AUG98 pt awoke extremely dizzy & nauseated & stayed in bed;
Immunization provider screened and vaccinated the patient (sitting down) for Flu and instructed the patient after vaccination to wait in front lobby for 15-20 mins in case of adverse reaction. the patient was waiting in the lobby and was ''on one knee/ sweating profusely stating he felt lightheaded". The patient was escorted to Dr's office down the hall for evaluation
2/26/07 6pm - Hives over arms and legs and Temp 102 ax. Resolved mid after next day.
Patient received shot & got bruising on arm as well as pooling of blood under the skin. She said the redness was getting bigger.
1/6/2021 day of vaccine pink, swollen injection site at bedtime. 1/7/2021 0200-Both eyes, lips and face very swollen with moderately swollen hands. Sore arm.  0815-Temp 99.9 scan. Swelling continued, coworker noticed my eyelids and under eyes swollen (rest of face was masked) 0845 1 gm tylenol and 600 mg ibuprofen. Drank lots of fluids. 1100 98.0 scan 1300 99.0 perspiring, malaise. Eyes still swollen, hands still swollen. Lips and cheeks normal. 1600 chills, fatigue. Drank lots of fluids. 1gm tylenol. Swelling of face resolved. 2000 went to bed early, tired, malaise. Hands mildly swollen. 1/8/2021 0815am 98.3 scan. No swelling. Moderate headache, malaise. Took 1 gm tylenol and 400mg ibuprofen. Noon- felt better, but very tired. 1600-arm mildly sore, no other symptoms. 2000- no return of symptoms  2345- no return of symptoms
PATIENT HAD RASH AT THE SITE THAT LATER DEVELOPED INTO RASH OVER THE BODY
Intense chills; Body aches; Muscle soreness; Stiffness; Weakness; Joint pain in lower body; Severe vertigo; Dizziness; Loss of appetite; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 30Apr2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The medical history included obesity, anemia, childhood thyroid disorder, severe childhood bronchitis and recent abortion. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications included sertraline hydrochloride (ZOLOFT) and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER0734) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 03:00, the patient experienced intense chills, body aches, muscle soreness, stiffness, weakness, joint pain in lower body, severe vertigo, dizziness and loss of appetite. It was also reported that survey was taken 24 hours after the second shot. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense chills, body aches, muscle soreness, stiffness, weakness, joint pain in lower body, severe vertigo, dizziness and loss of appetite were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.