chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; body aches; nausea; restless sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 at 12:30 as dose 4 (booster), single (Lot number: GJ3275) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE; OSTEO BI-FLEX [ASCORBIC ACID;BOSWELLIA SERRATA RESIN;CHONDROITIN SULFATE;COLLAGEN;GLUCOSAMINE HYDROCHLORIDE;HYALURONIC ACID;MANGANESE SULFATE;METHYLSULFONYLMETHANE;SODIUM;SODIUM BORATE]; CALCIUM; CETIRIZINE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: ER9231; Anatomical location: Left arm), administration date: 06Jan2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9261; Anatomical location: Left arm), administration date: 27Jan2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot Number: 330258D; Anatomical location: Left arm), administration date: 26Dec2021, when the patient was 55-year-old, for COVID-19 Immunization; flucelvax pfs (Anatomical location: Arm Left), administration date: 05Nov2022, when the patient was 55-year-old, for Immunization. The following information was reported: NAUSEA (non-serious) with onset 27Nov2022 at 22:00, outcome "recovered" (Nov2022); POOR QUALITY SLEEP (non-serious) with onset 27Nov2022 at 22:00, outcome "recovered" (Nov2022), described as "restless sleep"; PAIN (non-serious) with onset 28Nov2022 at 08:00, outcome "recovered" (Nov2022), described as "body aches"; PYREXIA (non-serious) with onset 28Nov2022 at 08:00, outcome "recovered" (Nov2022), described as "fever". Therapeutic measures were taken as a result of nausea, poor quality sleep, pyrexia, pain.  Additional information: Began with nausea at 10 pm that night, restless sleep with continued nausea, by 8 am fever and body aches. Slept all day took Advil and Zofran, less nausea by 5p, still with a fever and aching. All symptoms improved and resolved by 8 am the next morning. The patient had no known allergies. The patient received other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201346629 Same reporter/drug, different event/patient.;
This spontaneous report was received from a physician via a company representative and refers to a non-pregnant female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with a first dose GARDASIL (route of administration, lot number, expiry date were not reported) and after vaccination she fainted while still in physician's office. The therapy with GARDASIL was continued. The outcome of the event was reported as recovered/resolved. The relationship between the event and GARDASIL was not reported. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # L045117, expiry date 06-OCt-2018; lot # L004754, expiry date 10-NOV-2016; lot # L020157, expiry date 12-MAR-2018; lot # L001626, expiry date 06-OCT-2016; lot # K023863, expiry date 03 APR-2016 (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of five reports received from the same reporter. Additional information has been requested.
7/24/10 - vaccinated - 7/26/10 c/o rash pinpoint vesicular rash arms & pruritic BENADRYL.
patient had the 2nd dose but received a NON- Moderna COVID-19 vaccine instead of Moderna.; Patient received the second dose more than 42 days after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient had the 2nd dose but received a NON- Moderna COVID-19 vaccine instead of Moderna.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 42 days after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 01-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient had the 2nd dose but received a NON- Moderna COVID-19 vaccine instead of Moderna.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 42 days after the first dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient had the 2nd dose but received a NON- Moderna COVID-19 vaccine instead of Moderna.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 42 days after the first dose) had resolved.        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.   Concomitant Medications was not provided.
patient reports severe shortness of breath. pt was advised by provider to go to the hospital. she states that SOB was severe enough to limit daily activity. further advised patient to follow provider initial advice to be seen
Patient developed acute onset of gastroenteritis type symptoms (persistent non-bilious emesis and diarrhea) necessitating evaluation by the emergency department.
Severe Bil groin pain following 2nd Maderna vac left side resolved after 24/48 hrs. Right side cont. 3 months diag severe OA right hip. 6 months MRI severe OA requires THA.
Patient sat outside of pharmacy in a chair for approximately 5 minutes. He started to look not so well. Went to bring him back into consultation room and he passed out. He laid down on the floor for 10 minutes or so. Gave him some water and animal crackers.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) lot # H006462; expiry date 08-MAR-2014 dose unknown. No concomitant medications were reported. It was reported that VARIVAX (Merck) lot # H006462 was exposed to -2.5C for 252 hours and as was administered to unspecified number of patients. No adverse effects were reported. This case is linked to case # 1312USA011848 and 1401USA000286 (same reporter link). Additional information has been requested.
symptoms happened shortly after getting the immunization  included rash, fever, shaking, incontinence, jaw movements, muscle weakness of the legs and he could not stand up by himself. Today he is a little better  but still having symptoms  and cannot stand up.
Patient received vaccine in the morning and by the time the patient went to bed she reports feeling almost like she was paralyzed/ heavy feeling in her limbs, trouble standing and walking, and feeling very lethargic. She called her son the next morning and he contacted the pharmacy to report her symptoms.   The pharmacist suggested she seek medical attention from urgent care or emergency department for further evaluation. Result/follow through unknown at this time.
Felt left finger nerve pain with back stiffness. Sciatic pain in both feet.  Didn't see Dr. Tried to relieve pain with exercise.
My arm was in extreme pain immediately after the shot that lasted for 7 days. I was barely able to lift my arm up and any kind of touch would be very painful. I was also extremely fatigued and had a low grade fever of 101 degrees for day. I also have been having a lulling headache that has been going on and off. My doctor told me to take Tylenol and ice my arm.
Rash on both thighs, hypersensitivity to touch, burning pain when walking and thighs touching, chills of feeling like getting sick
My nose started running as soon as I received the nasal vaccine spray.  Later on that day my sinus got blocked and my head started hurting.  I have taken sinus medicine, Nyquil and Dayquil but do not feel any better.
This spontaneous report as received from a physician via a company representative refers to a 4 year old patient of unknown gender. Information regarding concurrent conditions and pertinent medical history was not provided. On 12-SEP-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (injection, lot # K003423, expiry date 06-MAR-2016, 1 shot in the right thigh, route unspecified). Concomitant therapies included Immune Therapeutic Vaccine (ITV), which was vaccinated with at the same time. On an unspecified date, in approximately September 2014, the patient developed a varicella-like blister at injection site after receiving VARIVAX (Merck). The reaction was reported to the office on 17-SEP-2014. The patient did not seek medical attention. No treatment was given for the adverse event. No lab diagnostics study was performed. The outcome of the event was reported as recovered on an unspecified date of 2014. Additional information has been requested.
First day- arm pain  body ache Second day-Fever spiking to 100.2f full body aches, fatigue, arm pain, lethargic,  Third day- fever broke early morning,  fatigue and aches all over Treatment included Nyquil, Tylenol, DayQuil, lots of rest and fluids
Patient is 37 w 3 d pregnant, Doctor ordered vaccine to be given and this nurse went and got vaccine from immunization room and went into exam room and verified patient's name and vaccine was given in the Right deltoid, this nurse went into give vaccine and while charting saw that patient had been given a dose the month prior, immediately went and informed Dr.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: RASH (non-serious), outcome "unknown", described as "I had experienced a rash on both arms". Additional information: Patient was unable to get a second dose of vaccine (Pfizer COVID-19 Vaccine); and stated did not get the shot, 21 days apart. Patient got first dose but it would be 26 days today. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I woke up Friday morning (8:23) with a severe, burning itching all over. It was horrible and did not react to any antihistamine or topical medicines. I finally took some oral steroids I had left over in a desperate attempt to stop this reaction. I was crying and itching, putting ice bags alternating places on my body and even thought death might be better than this experience. The itching finally calmed down but it returned Friday evening and was even more horrible. It finally calmed down again for a while, but occurred again during the night, multiple times. I got no sleep at all and had to get a friend to take me to the ER at 8:30 AM Saturday. The ER doc ran bloodwork to rule out liver issue. Prescribed steroids, ATARAX, and EPIPEN. It did not occur to me that the shot could have caused the reaction so I didn't even tell the ER doc about the SHINGRIX. I thought the itching was related to another topical allergic reaction that I thought had been solved and was over but these episodes made me think the allergic reactions had suddenly gotten much worse and that I had not identified the medication that caused the symptoms (amlodipine - which I had stopped and the symptoms had gone away). After getting my prescriptions filled, and the pharmacist actually asked if they were caused by the vaccine I read about the shot at home and was livid that I was not warned that the vaccine had not been tested on people with Autoimmune diseases and that Lupus in particular was a real concern!
Awakened from sleep Fri. night with fever, chills, muscle spasms of jaw and feet, dizziness, nausea. Only able to doze off and on rest of the night d/t symptoms. Foot muscle spasms occurred approximately every 2 hours and lasted 5-10 minutes each time. Muscle spasms of jaw only occurred initially and lasted approximately 5 minutes. Spent Saturday going from couch to bed as symptoms continued along with feeling unable to function mentally & extreme fatigue. Tried to drink fluids, took Tylenol, ate only 6 crackers all day. Fever broke the following night and other symptoms gradually dissapated by Sunday evening. Still felt fatigued for 4 more days. Noted cellulitis on left arm 2 inches below injection site on Monday which lasted 1 week (redness approximately 3 x 4 inches with hardened area approximately 1/2-3/4 inch with itching/soreness).
mom contacted on 3FEB93; requested to see MD because pt was not taking formula, water or pedialyte; mom stated pt not doing well since recvd vax; mom informed MD not available & pt need to be evaluated by MD; pt taken to ER;
GASTRO PROBLEMS; SEVERE ABDOMINAL PAIN; BODY ACHE; WATER/SLUDGE/BILE DIARRHEA; FEVER; HEADACHE; INJECTION SITE PAIN; LITTLE RED DOTS AROUND THE INJECTION AREA; NO ENERGY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included congested heart failure, and concurrent conditions included blood clot problem, and diabetes.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced gastro problems, severe abdominal pain, body ache, water/sludge/bile diarrhea, fever, headache, injection site pain, little red dots around the injection area, and no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from little red dots around the injection area, and the outcome of gastro problems, fever, headache, severe abdominal pain, water/sludge/bile diarrhea, body ache, no energy and injection site pain was not reported. This report was non-serious.
ATE FOOD 10 MINUTES AFTER TAKING VIVOTIF; DID NOT TAKE VIVOTIF ACCORDING TO SCHEDULE; This spontaneous case report (PVX2019-1964) was received from a nurse on 30-Jul-2019. It described a female consumer who "did not take Vivotif according to schedule" (PT: Inappropriate schedule of product administration) and also "ate food 10 minutes after taking Vivotif" (PT: Product administration error). The consumer was receiving oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer did not take Vivotif according to schedule and ate food 10 minutes after taking the fourth dose of Vivotif. The doses were taken on 22-Jul-2019, 24-Jul-2019, 27-Jul-2019 and 30-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not take Vivotif according to schedule" and also "ate food 10 minutes after taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take Vivotif according to schedule" and also "ate food 10 minutes after taking Vivotif" was considered as not applicable.
At approx. 1057 pt received first dose of Pfizer COVID vaccine, pt has known hx of anxiety with blood draw or vaccines, subsequently she was asked to wait x15 min sitting in the lobby, per nursing staff pt ambulated to lobby with no abnormal gait noted and sat down in a chair.  At approx. 1108 pt started to c/o inability to breathe, dizziness and presented syncope.  Pt was triaged by Doctor, VS obtained T: 97.7 P: 65 R:17 B/P: 100/67 O2: 97%..  Pt recovered  consciousness approx. 2-3 minutes and was transferred to a private room. Pt was alert, answered Doctor questions while in supine positiion.  Pt was assisted to a fowler's position with c/o slight dizziness.  Doctor proceeded to further assess pt by completing a neurological and strength test to which pt followed directions and completed test fairly well. EKG completed per Doctor, process explained to pt prior to conducting EKG, all metal was removed, with 2 more set of vitals completed:1120 T: 97.6 P: 85 R: 18 B/P: 103/72 and 11:49 T: 97.8 P: 68 R: 16 B/P: 101/70.  Post last set of vitals pt was asked to stand and ambulate around the room.  Per pt she felt better and was able to ambulate with no assistance required. Pt A&O x3, with Mother driving her back home.
Burning when shot was given. Later a blister formed at the site of injection and fluid drained from the site. Client developed a rash over her arm and stomach. Private doctor treated patient for allergic reaction to flu shot and recommended no flu shots in the future.
Idiopathic thrombocytopenia  Onset Jan 27;  platelets dropped to <3000. Good response to decadron with rise to 100,000 by feb 1.  No significant bleeding
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 11:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 11:03 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 81.28.  No concomitant medications were reported.  Batch number 022M20A administered on 17-Feb-2021 with temperature 22 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 11-Feb-2021 and beyond use date for the vial was reported as 13-Mar-2021. Product moved to clinic on 17-Feb-2021. Excursion time was 9am.  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. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
"PENTACEL - 3 hours of inconsolable crying" went to sleep about 1400 - woke up 15 minutes later & started crying. F/U appt in office same day. Ibuprofen given 10mg/kg & observed in office for 20 min after. "Hold" on future DTAPs.
Body aches, fever (100.7), very tired partly because it started in the middle of the night so I didn't sleep. Took TYLENOL, drinking fluids. Symptoms eased significantly, no fever by noon.
The main symptoms and signs were severe acute pericarditis and bilateral pulmonary pleuritis with pericardial and bilateral thoracic effusions, fever, dyspnea, painful inspiration, dyspnea, hypoxia, severe headache, photophobia, thoracic and lumbar spine pain, migratory myalgias.  Treatment consisted of aspirin, colchicine, bed rest
This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 50-year-old, adult male patient. The patient's medical history and concomitant medications were not reported. It was reported that FLUCELVAX QIV underwent temperature excursion for about 30 minutes and lowest temperature was 34.7-degrees F (out of the recommended range) (explicitly coded as incorrect product storage). On 29-Nov-2017, the patient was administered with FLUCELVAX QIV which underwent temperature excursion (batch number: 195226, expiry date: 30-Apr-2018, dose, route of administration and anatomical location: not reported) (explicitly coded as drug administration error). The reporter assessed the events as non-serious. Case correction received 07-Dec-2017: Added classification as "special case with no AE" in the general tab. Updated expiry date of suspect vaccine as 30-Apr-2018 (in the product tab). The narrative was amended accordingly.
Patient reported he got up last night, walked to the door and "everything got dark" He said, "I may have blacked-out." Glucose level checked and blood sugar fine. He reported he ate breakfast and lunch today. Complained of mild flu-like symptoms. Denied any further episodes of changes in LOC.
crying almost continuously since 2PM yesterday had shots yesterday 24JUL morning quiets only for few mins @ a time; t104; giving APAP; giving sponge baths; gradually improved until back to nl evening of 26JUl;
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with GARDASIL (dose, route not reported, lot# K023432 with expiration date 18-JUN-2016) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 12/21/99, the pt experienced a papular rash over her whole body, low grade fever, crying and was not sleeping well. Follow-up information reported that the pt was treated with hydroxyzine dihydrochloride and subsequently recovered. No further information is expected.
Four month old become unresponsive immediately following vaccines, arms flexed straight out from her body like Frankenstein. Remained unconscious and unresponsive for eight hours when she had previously never slept for more than one to two, followed by severe high pitched screaming. Doctor mentioned the word encephalitis when we explained the episode.
Patient has experienced deep pain near the injection site since injection was given. Cannot sleep on left side as a result. Patient has past medical history of CLL. Pain was worse right away and has subsided somewhat but still cannot sleep on left side.
Headache, Myalgia, Arthralgia & Nausea Vomiting