chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sensitivity to light; Inappropriate route of vaccination; Body aches; Headache; Chills; Fever; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Sensitivity to light), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Streptococcal infection (Tonsils and adenoids removed due to chronic strep throat.) in 2007, Tonsillectomy in 2007 and Tonsillectomy & Adenoidectomy in 2007.    On 28-May-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 28-May-2021, the patient experienced PHOTOPHOBIA (Sensitivity to light), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting). On 28-May-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, PHOTOPHOBIA (Sensitivity to light), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.            Concomitant medications were not provided. Treatment information was not reported.
Patient presented with fatigue, cough, and shortness of breath. Started on oxygen. Tested positive for COVID-19 on 8/22 and is fully vaccinated.
It was reported that a female pt received a TD Adult on 9/22/00. Reportedly, on 9/29/00, the pt complained of 10cm of redness, swelling and warmth to the touch at the site of injection. The pt had no previous booster.
Severe dizziness, vertigo, fatigue, lethargy  Unable to continue normal routine of activity
6-7-14 fever, very poor appetite, no energy, dazed, weak and lethargic, drowsiness.
On 12/12/2023 I started feeling tired, headache and a stuffy nose. On 12/13/2023 my symptoms continued I had body aches,chills and fatigue. I went to Urgent Care they noted that my HR was 108 and BP were extremely high. (154/103) and fever of 101.0. I was prescribed a full course of Paxlovid. I treated my body aches with pain killers and kept hydrated with Propel water with electrolytes. I have fully recovered at this time.
Information has been received from a physician concerning an 18 year old female who on approximately 11-JUN-2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 11-AUG-2007 the patient was seen and had purpura and platelets 80,000. Additional information has been requested. 10/16/07-received phone call from reporter-vaccination records were not completed, no lot# available. Reporter also indicated that the adverse event is not related to the vaccine and will not send additional information on the case. 01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow up information has been received from a physician concerning his 18 year old student daughter who on approximately 11-JUN-2007 was vaccinated into the deltoid with a first dose of GARDASIL. There was no illness at the time of vaccination. On 11-AUG-2007 (also reported as 15-AUG-2007) the patient was seen and had a purpuric rash on both calves and a CBC revealed platelets 83,000. Follow up the next day revealed platelets 175,000. The physician mentioned that the thrombocytopenia was not life threatening, disabling. Nor did his daughter require hospitalization. The physician reported this was a questionable lab error versus effect of the GARDASIL. The patient is not receiving the second or third dose of GARDASIL. Additional information is not expected.
Pt recvd 1st dose of Hep B vax; recvd 2 doses of Engerix-B exp no adverse exp however did not convert;
On 21FEB91 pt devel fever 104, eyes rolled back & shook for 10 sec; Sitter observed pt & brought to ER; Exam normal
randomly smelling cigarette smoke despite not being around it at all; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation . Medical history included COVID-19.Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination .Concomitant medications included sertraline hydrochloride (ZOLOFT) for an unknow indication from an unknown date. On 19Mar2021, the patient experienced randomly smelling cigarette smoke despite not being around it at all. The 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 events. The clinical outcome of the event smell alteration was not recovered at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 08:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Woke this morning with swelling of the face; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2374938-1. The original narrative from the sender is the following:  Patients mother called clinic and notified us that patient woke this morning, 7/20/2022, with swelling of the face, mother stated that she was acting fine and had no signs of dyspnea.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "woke this morning with swelling of the face".  No further information is expected.
Narrative:  Vitals taken. Water and snack given. Added additional 15 mins monitoring. Released after.
Possible allergic rxn to PREVNAR. 1 day after PREVNAR, red bump at site of shot followed by spreading rash from that site to rest of body. Went to ER and urticaria noted. Rx with IM Dexamethesone and it cleared the next day. No reaction at PENTACEL site.
Fever, headache, body ache, chest pain and nausea(I ended up vomiting.)
Uncontrollable twitching and jerking per Mom.  Was transported to hospital by EMS. Treated with Xanax and Zofran and released. Multiple ER visits since.  EEG 1/20/10.  Currently under the care of Neuro Dr.   MRI shows back right side of brain abnormalties per Mom. Appointment scheduled for 48 hour EEG on 03/03/10.  Currently taking Tinex 1/2 mg twice a day.  No shaking episodes since 02/16/10 per Mom.
At 11:00 o'clock on Wednesday, July 30 patient became ill with chills, fever, and nausea. She was carried to private medical doctor that pm. Later that night she developed a fine rash with itching, still having the same symptoms. Thursday 4:15 seen again by physician with added symptoms of stuffy nose and cough. At 2 am Friday she had temp of 105.4. Mother continued to alternate Motrin and Tylenol. Temp. started down again to 102. Seen at 9:30 by doctor again. She receive an injection of Rocephin, cough syrup, oral antibiotic, and urine test which had white cells. Negative for strep. Other cultures done. Mother will call us when she know the results. According to mother, doctor believed she had several things going on, infection, and reaction to "shots."
The patient developed a diffuse reaction/hives all over 5 days after the shot and had to go to the ER for treatment. She has received a DEPO-MEDROL 80mg shot and has been prescribed Prednisone.
Initial and follow up information has been received from a nurse practitioner concerning a 20 year old female who on an unspecified date was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown).  The nurse practitioner reported that the patient was told she was "allergic" to RECOMBIVAX HB (manufacturer unknown).  The nurse practitioner also reported that the patient's throat became swollen 2-3 days after her second dose of RECOMBIVAX HB (manufacturer unknown).  In follow up the nurse practitioner reported that she had no additional details as the vaccine was not administered at "our" site.  She reported that the patient stated the information in response to the question "have you ever had an adverse reaction to an immunization?" GARDASIL was not administered due to the answer.  Additional information is not expected.
After first injection on the 1st night has the chills all night. After the 2nd injection kidney pain with having to urinate at all hours of the night and day. Along with frequent urination and loss of bowel control.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received an expired 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 medication details were not provided. Treatment details were not provided.
Patient reports intermittent transient episodes beginning with witnessed event at work 6/2/21 of right sided weakness, confusion , difficulty speaking, memory loss and fatigue.  He was evaluated at ED 9/29/2021, ED 10/2/2021 and saw neurologistlogist 10/5/2021 who determined he was likely having ischemic events and put him on Plavix,  Atorvastatin and ordered MRI.  When he went for his Covid booster and mentioned this to the pharmacist, he was given Pfizer vaccine and told to follow up with his PCP to report adverse event.  He continues to have fatigue and memory loss.
Felt tingling in arm for first 10 minutes after shot. Arm extremely sore first 24 hours. Could not sleep on it.  Fatigued for first 24 hours as well.
PT STARTED TO HAVE COMPLICATIONS WITH ASTHMA FOR ONE AND 1/2 MONTHS  AND EXPERIENCED FEVER , BODY ACHES , AND CHRONIC  FATIGUE.  HAD A REALLY HARD TIME BREATHING.
High fever lasting for 3 days followed by a full body rash. Also experiencing lethargy and choking cough. Have treated with Tylenol and ibuprofen.
Moderna COVID-19 Vaccine EUA. Temp at time of vaccine 97.8. Temperature at 7:20 pm 1/18/2021 99.4 degrees; highest 101.1 degrees at 8:30 pm 1/19/2021. Chills. Headache. Nausea, no appetite. Fatigue. Weakness. Legs with moderate pain, aching. Left deltoid red, swollen, hot, painful to touch, this area continued to slowly improve for four days. Still have discoloration to left deltoid 02/01/2021. All symptoms resolved EXCEPT weakness, fatigue at 2:30 am 1/20/2021. Weakness and fatigue resolved 1/21/2021 8:00 am.
Symptoms muscular cramping of abdomen no nausea no vomiting. Appetite good. Went to school Wed, Thurs, Friday (12/10-12/13). Symptoms worse today. Child unable to attend school today. Cramping whole center of abdomen. Has not seen the doctor.
Myalgia & Fever Narrative: fever, chills fatigue, unable to work on 2/3 from 1030-1530 due to symptoms
sore joints, chills, palms & arm broke out into a rash were inj was given sl swollen;ice or heat, APAP, antihistamine;
very sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 60-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: ILLNESS (non-serious), outcome "unknown", described as "very sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pericarditis; extreme chest pain; had to sleep sitting up; couldn't breath; couldn't walk or talk; couldn't walk or talk; fever; couldn't function for weeks; it was painful; She has been sick; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: Not reported) via an unspecified route of administration on 07Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for Covid-19 Immunization. On 11Mar2021, 4 days after second vaccination, the patient had extreme chest pain after walking on a flat walk that she normally does and she reports walking trail is nothing new to her. Patient also reports patient is 61-years-old, and she's going to have aches and pains and she has to get over it, and went home. It kind of passed. And then patient was diagnosed with Pericarditis. Patient states that she couldn't breath, couldn't walk or talk, and had a fever. She states she couldn't function for weeks, it was painful and she had to sleep sitting up. On an unspecified date in Mar2021, patient has been very very sick. It was reported patient used to work in clinical trials and she knows we need the information and it is important. Reporter does not wish to complete a safety report because she believes her husband might have completed one already and Reporter would like to know if are we receiving reports of women experiencing this or is it only adolescent boys. The outcome of event for Pericarditis was Not recovered, and rest of the events was taken as Unknown.   Information about lot/batch number cannot be obtained. Additional information has been requested.  Follow-up attempts are completed; information about lot/batch number cannot be obtained
Chest Tightness x 5 min Hx of irregular heart beat  x 3yrs. Normal limits: V/S BP= 132/96; HR= 77; RR= 20 No SOB
Left bicep region was red, swollen and hot 9/22/11. Cellulitis below injection site (injection site left deltoid; cellulitis site left bicep region) - This occurred one to two days post PNEUMOVAX injection in left deltoid. Treatment: KEFLEX 500mg Q6 hours x 10 days, moist head to area and elevation of extremity.
Day after injection, redness at injection site, fever. Advised pt to see doctor. Doctor prescribed Doxycycline 100mg BID & Hydroxyzine 25mg TID prn.
Severe body ache stomach pain, headache, nausea and vomiting, 103 temp severe joint pain
Redness and swelling began Wed. 16Jan08 then it became hard and warm to touch. Spreading beyond injection site per pt.
Patient was seen for his 15 mos 7/6/23, given PCV15. On 7/7/23 AM, patient was seen w/altered mental status, in vomit on his crib. Mom called EMS + was brought at the ER. He had seizures at the ER. Brain imaging showed bleed from AVM/aneurysm.  Presently intubated and on anticonvulsants.
Broke out in hives 3 days after 2nd dose. Hives started on left arm then spread to right arm, then all over including face and groin area. Treated in ER with intravenously with Decadron, Benadryl, Pepcid  and sodium chloride.  Released from ER but went back a few hours later when lips began to swell. Given same meds in pill form. I was over an hour away from home and had to wait until later in the day to fill prescription which included Prednisone.
5/25/22 Pt in office to have PPD read from placement on left forearm 5/23/22.  PPD was negative.  Pt asked nurse to look at Right upper arm.  There was a large red area above the elbow.  100cm by 100cm and smaller redder oval in center of larger red circle that measured 25cm by 50cm.  Area was warm to tough.  Pt states it is not painful.  Noticed late evening of day of vaccine, or next day.  Arm was sore where other shots were given but not this one.   Pt denied fever or pain, never had any allergies like this before.  Dr.  came and consulted with pt.  Advised pt to take 600mg-800mg of Ibuprofen 2 times per day and put ice on area.  If worsens over next couple days or develops fever or other symptoms to go to ER.  Pt agrees with plan.   Nurse will call pt to check in day or so.
Vaccine administered too early.  1st dose = 4.24.21;  2nd dose = 5.4.21.    Patient received 2nd dose of Pfizer vaccine too early on 5/4/21. Per MCIR, he received his first dose at Kroger on 4/24/21. This was not recognized until patient had received his vaccine already.
PATIENT CAME IN A FEW DAYS AFTER IMMUNIZATION WAS GIVEN STATING HER ARM WAS SORE. WE EXPLAINED THAT CAN BE A COMMON SIDE AFFECT. SHE CAME AGAIN 11/17/2017 AND STATED THAT HER WHOLE ARM HURT AND SHE STILL HAD A BRUISE. SHE MENTIONED THAT SHE MAY VISIT HER DOCTOR.
Warmth, erythema left upper arm that started the day after the immunization was administered in that same arm. The areas are tender to palpation. Treated with Keflex, Benadryl.
Information has been received from a physician, via a company representative concerning a 25 year old female with a history of allergies to "many products," who on 26-JAN-2007 was vaccinated with the first dose of Gardasil (yeast). On 05-FEB-2007 the patient called the physician after she developed hives. The patient believed the hives were "caused by the vaccination," though the development and timing of the onset of the hives was unclear. The patient was instructed to take BENADRYL as treatment. Additional information has been requested.
PATIENT HAS REDNESS AROUND HER ARM, SWELLING OF MUSCLE, WARM ON TOUCH
Information has been received from a 76 year old male patient who "in October of about 4 or 5 years ago" was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (dose, route and lot #unspecified), and then " the following March ("about 4 or 5 years ago" (approximately in March 2007)), he got viral pneumonia and was hospitalized for an unspecified number of days. It was reported that the patient received unspecified treatment at the hospital. It was reported that the patient's adverse event had improved after he was hospitalized. The patient recovered "some months later", but he stated he was "not sure when he felt 100% recovered". Additional information has been requested.
sore arm w/redness 1 wk p/inject near site; As of 8JUN93, is 4 1/2" in diameter;
arm began itching; splotchy-red warm to touch area on her arm 4in long 2.5 in wide; A spontaneous report was received from a Consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm began itching, splotchy-red warm to touch area on her arm 4in long 2.5 in wide.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events arm began itching. splotchy-red warm to touch area on her arm 4in long 2.5 in wide.  Treatment details included Took one Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, arm began itching, splotchy-red warm to touch area on her arm 4in long 2.5 in wide was not reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081611:
Case number PHEH2015US024762 is an initial report received from a consumer via patient oriented program on 23 Nov 2015. This report refers to a 76 years old female patient. Her family history included death of her mother and other maternal family members due to heart failure and she did not suspect that administration of influenza vaccines over the years was related to it. Her medical history was not reported. Her vaccination history included administration of influenza vaccine (manufacturer: Novartis, batch number: not reported) over the years in the past. Concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer: Novartis, batch number: not reported) on an unknown date. On 23 Nov 2015, the patient had heart problems (not further specified). She also had some swelling at the time of reporting (onset date not reported) and she had not yet informed her doctor. She was transferred in to the cardiac intensive care (CIC). The events outcome was unknown. The seriousness of the event was not reported, but the event heart problems was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported. The patient did not give permission to contact the doctor. No further information was provided.
two confirmed cases of mumps in age-appropriately vaccinated students; This spontaneous report as received from a consumer refers to a patient of unknown age.    On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis.       On an unknown date the patient experienced mumps.    The outcome of mumps is unknown.
Evening of the vaccination( 10/4/2021  malaise, soreness   (9/10 pain)  LUE @ injection site .  0300, early next morning 9/10 pain  continued through tonight  in LUE.   1100 AM Tuesday : pain/tenderness in Left axillary.  Noted a soft moveable lump upon assessment.  Malaise, ache in neck noted throughout today and into the 6th.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 02-NOV-2017, the patient was vaccinated with VARIVAX improperly stored (dosage, route of administration and frequency were not reported) lot # M033214 and expiration date: 13-JUL-2018, indicated for prophylaxis, together with an unspecified sterile diluent (manufacturer unknown) lot#: N015632, expiration date: 18-FEB-2019. The vaccines did not have any previous temperature excursions not recorded by a data logger. The vaccines were stored in a temperature of -14C for 4 hours. There was no adverse effect reported. This is one of several reports from the same source (MARRS # 1712USA013685, MARRS # 1712USA013689). Sender's Comments: US-009507513-1712USA013685: US-009507513-1712USA013689.
Febrile seizure.  Treated at ER.  Seizure started @ 6 AM 2/25/03 duration 5 - 10 minutes. Transported by ambulance.  T 103.7 F at time of arrival at hospital.