chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on her throat, her leg, her face; lost her voice completely/ Couldn't talk/She is not able to speak; allergic reaction; face is so red; bottom of the throat is little swollen; eyes are watery; she itched in blood; excessive bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Jan2022 14:15 (Lot number: FJ1611) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Alopecia effluvium" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. The following information was reported: RASH (hospitalization, medically significant) with onset 14Jan2022, outcome "not recovered", described as "rash on her throat, her leg, her face"; APHONIA (hospitalization, medically significant) with onset 13Jan2022, outcome "not recovered", described as "lost her voice completely/ Couldn't talk/She is not able to speak"; HAEMORRHAGE (medically significant) with onset Jan2022, outcome "unknown", described as "excessive bleeding"; HYPERSENSITIVITY (medically significant) with onset 14Jan2022, outcome "unknown", described as "allergic reaction"; ERYTHEMA (medically significant) with onset Jan2022, outcome "not recovered", described as "face is so red"; PHARYNGEAL SWELLING (medically significant) with onset Jan2022, outcome "unknown", described as "bottom of the throat is little swollen"; LACRIMATION INCREASED (medically significant) with onset Jan2022, outcome "unknown", described as "eyes are watery"; PRURITUS (medically significant) with onset Jan2022, outcome "unknown", described as "she itched in blood". The events "rash on her throat, her leg, her face", "lost her voice completely/ couldn't talk/she is not able to speak", "excessive bleeding", "allergic reaction", "face is so red", "bottom of the throat is little swollen", "eyes are watery" and "she itched in blood" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash, aphonia, haemorrhage, hypersensitivity, erythema, pharyngeal swelling, lacrimation increased, pruritus.  Clinical course: Patient was prescribed with dexamethasone and Benadryl for the events. Patient had no prior vaccination (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Weakness; Lightheadedness; fast heart beat/heart rate is 101; coughing a little bit; panic attack; he was not acting well and his blood pressure was 158/98; he feels silly then has nervousness; he feels silly then has nervousness; feeling tired; not feeling well; This is a spontaneous report from a Contactable consumer (patient). This 52-years-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) (lot number: AK5730), on 20Dec2020 at single dose on left arm for COVID-19 immunisation. Medical history included Blood pressure high. The patient's concomitant medications were not reported. He had one injection given in his left arm around 08:30 or 08:40 in the morning on 20Dec2020, before 9 o clock. He says that they let him rest for 15 minutes after his injection, and it is a delayed reaction that just started this morning and he tried to go to work and had to go home. The patient got the vaccine on yesterday morning then tried to come to work on this morning but he was feeling weak and having light headedness, and his heart beat is so fast. He did go home to try to relax. He said he experienced a panic attack at some other times where his heart beat fast and he was quite light headed at some other times gone from rest and get up to walk or try to do something, and that's why he had gone home after he reported to work earlier. He says just now also trying to have something to do he is feeling it. He says that he took Tylenol and some cough syrup for feeling lightheaded and weak. He clarifies that he took Tylenol yesterday and then after he took vaccine and this morning the nurse gave him Tylenol also. He says he told them he was not feeling well, he felt silly and weak. They told him to go home because he told them he was not acting well and his blood pressure was 158/98. He has been doing Lisinopril 20mg for his high blood pressure, and he has been on it for a long time. He says that the label says discard after 01Oct2021. He says he takes 20mg once a day by mouth, and he keeps refilling it every 30 days. The patient took the cough syrup because he was coughing a little bit. He says that the EXP date on the Tylenol he took that he has at home is Mar2022. He provides EA013 as LOT and dose strength as 500mg. He says he took this last night and this morning at the facility they gave him the 500mg dose too. He says that he took vitals with his nurse, and his heart rate is 101. The patient asks what can he do since he is worried about reading side effects of vaccine so now he is feeling fine, then some other times it comes like first time this morning at work he feels silly then has nervousness or something and a panic attack, so they let him go home. He says he got home, and was feeling fine again. He says he tries to go to the bathroom, or tries to do something in his garage, and feels light headed and is feeling tired. He says he would like to know if that is normal, should he take anything. Lab data on 21Dec2020 included Blood pressure was 158/98, Heart rate was 101. The outcome was unknown.
Information has been received from a physician concerning a 10 year old girl who on 26-SEP-2000 was vaccinated with the first dose of MMR. On 24-JUN-2003, the patient was vaccinated with the second dose of MMR. On 23-DEC-2009, the patient experienced mumps. It was diagnosed on 05-NOV-2009 that the patient had left parotitis. The patient was afebrile. The first blood work on 09-NOV-2009 revealed IgM < 1:10, and IgG 8.11. The second blood work on 24-NOV-2009 revealed IgM <1:10, and IgG 8.2. At the time of this report, the patient's outcome was not reported. Follow-up information was received from the physician indicating that on 01-DEC-2009 the 10 (also reported as 8) year old patient developed mumps. It was diagnosed on 03-DEC-2009 that the patient had bilateral parotitis. The patient had jaw pain. It was reported that the first blood test on 03-DEC-2009 revealed IgM <1:10 and IgG 6.49. This is one of several reports from the same source. No further information is available.
Headache, Myalgia, Fever, FATIGUE, CHILLS, NAUSEA Narrative:
lightheadedness while sitting, BP 151/90 at 2:15 pm, HR at 111, sx improved at 2:30 pm BP 142/83, HR 99
Information has been received from a female with no known allergies who on approximately 04/11/2001 was vaccinated with Hep A vaccine. There was no concomitant medication. In April 2001, the pt experienced dry mouth and other symptoms which she attributed to morning sickness. At the time of this report on 04/19/2001, the pt was 8 weeks pregnant (estimated LMP 02/21/2001, estimated due date 11/28/2001). Unspecified medical attention was sought. Additional info has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 16-Oct-2018, the patient was administered FLUAD (TIV), [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805539 was crossed linked to original cases 201804863 due to same reporter.
Developed a rash around the area, recommended to take an antihistamine, use a compress, and seek doctor visit.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported   No adverse reactions were reported by any patients.   No Treatment medication reported
Moderna COVID-19 Vaccine EUA  Chills, HA, Aches
Tested Covid positive after getting the 1st dose of the Pfizer Vaccine; This is a spontaneous report from a Pfizer-sponsored program.   A male patient (reporter) of an unspecified age received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, via an unspecified route of administration from 31Jan2021 at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced tested covid positive after getting the 1st dose of the Pfizer vaccine on an unspecified date.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive, Tested Covid positive after getting the 1st dose of the Pfizer Vaccine on an unspecified date.  Outcome of tested Covid positive after getting the 1st dose of the Pfizer Vaccine was unknown.  Information on the lot/batch number has been requested.
Blurry vision; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0158), via an unspecified route of administration in the left arm on 13Apr2021 at 17:45(at the age of 40-year-old), as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0173), via an unspecified route of administration in the left arm on 05May2021 at 14:00 (at the age of 40-year-old), as dose 2, single for COVID-19 immunization. Medical history was reported as not applicable. The patient was not a pregnant at the time of vaccination. The patient was allergic to wheat and lactose. Concomitant medications included multivitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. On an unspecified date in 2021, the patient underwent nasal swab test (SARS-CoV-2 test) and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced blurry vision. On 05May2021, the patient again experienced blurry vision. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event blurry vision (started on 13Apr2021) was recovered on 14Apr2021 and that of the event blurry vision (started on 05May2021) was resolved on 06May2021.   No follow-up attempts are needed. No further information is expected.  Amendment (03Aug2021): This follow-up report is being submitted to amend previously reported information which included updated Age at Vaccination to 40 years, dose 2 Anatomical Location added, Vaccine Facility Information added, lab test time captured as 2021 since test post vaccination, per narrative "Blurry vision that started soon after and lasted until next day. It happened after each dose", merge event in one slide and event start date/stop date leave blank since it is also happened after first dose, Medical history was reported as none" updated as medical history was reported as not applicable.  No follow-up attempts are needed. No further information is expected.
Intermittent mild ache/pressure back of R thigh, calf, and back of R knee x 1 week  (started before vaccine, not worsened with vaccine administration)
Vaccine not diluted before drawn-out of vial (administered 0.2mL concentrated).
Vaccine about 2 PM - by 3 PM - weak knees, shaky. Felt "unwell"- 1/22/10 - Still weak shaky- unwell and diarrhea, watery stools- still unwell. Hot/cold event lasted 5 days - no lasting effects that I know of.
This spontaneous report as received from a pharmacist refers to an unspecifide number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated swith GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot# J006850, expired date: 31-MAR-2016) was administered to a 9 year old patient on 03-MAR-2014. This case was linked to 1405USA001165, 1405USA001161, 1405USA001163, 1405USA001162, 1405USA001166 and 1403USA007625. Additional information has been requested.
[Moderna Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): pt received moderna covid shot on 12/2/2021. presented to ED on 12/27/2021 with stroke-like symptoms. CT demonstrates LEFT temporal lobe intraparenchymal hemorrhage
At the second injection became tachicartic and short of breath. This was reported by the facility.  After that had sporadic tachycardia events that have become progressively more frequent. Now occurring several times per day.
Husband called this am ( 04/14/2021) to ask questions about pt" side effects of vaccine" Called and spoke to pt. .Pt reports receiving J&J vaccine on 04/12/2021 at 12:30 pm. She began noticing " a severe headache" about 5:30 pm. She relays between 8:00 and 10:00 pm she begin experiencing " leg weakness that made it hard to walk" " I was suddenly walking like a 95 year old woman". This continued and on 04/13/2021 she reports that she noted " the tops of both feet became numb and my left foot was swollen" Relays legs now hurt to front and back of thighs and also at times behind knees.  This am ( 04/14/2021) she reports " when I take a deep breath a pain shoots from my throat to underneath my right armpit. Advised pt to go to ED now and notify them of recent vaccine.
He was taken to hospital 2/27/2021 for respiratory problems, diagnosed with pneumonia and died in hospital.
Palpable, tender, indurated subcutaneous nodule - 3.5 cm x 4 cm
My  Arm  is swollen, angry, red and fever. I am having double, vision,  when I walk I feel  weird.
Dizziness, Arthralgia, Fever & Diarrhea Narrative:
A report was received from a health care professional on 12/16/03 concerning 42 vaccinees, both males and females under 4 years of age who inadvertently received Fluvirin on unspecified dates in December 2003. On unspecified dates in December 2003 the vaccinees inadvertently received Fluvirin. It was unknown by the reporter if the vaccinees experienced any adverse symptoms at the time of the reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Achy in joints, tired eyes and muscles, low grade fever 100 degrees tympanic, general malaise. loss of appetite
Redness, warmth, tenderness to left upper thigh began approx. 24 hours after injection. Erythema measuring 10.5 cm in diameter. Advised to apply cool compresses and give BENADRYL/liquid.
Broke out in rash. Treated with antihistamine, CLARITIN. Possible egg allergy.
Headache; drowsiness; Injection site is hot to touch and redness about 3 inches wide on top of arm (band).
I had fever and chills starting about 12 hours after my vaccine. Plus, I had an upset stomach. These symptoms lasted for about 24 hours.
mouth full of oral ulcers/lesions inside of his mouth/ irritated/looks like ulcer; they are really inflamed; sweating; fever; chills; This spontaneous case was reported by a pharmacist and describes the occurrence of MOUTH ULCERATION (mouth full of oral ulcers/lesions inside of his mouth/ irritated/looks like ulcer), STOMATITIS (they are really inflamed), HYPERHIDROSIS (sweating), PYREXIA (fever) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 014M21A and 046A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever) and CHILLS (chills). On 29-Nov-2021, the patient experienced MOUTH ULCERATION (mouth full of oral ulcers/lesions inside of his mouth/ irritated/looks like ulcer) and STOMATITIS (they are really inflamed). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MOUTH ULCERATION (mouth full of oral ulcers/lesions inside of his mouth/ irritated/looks like ulcer) and STOMATITIS (they are really inflamed) had not resolved and HYPERHIDROSIS (sweating), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
redden area, knot size of egg, & heated;no problem breathing or any other sx;
12 hours after injection, patient with low grade fever, severe shaking chills, nausea, and headache.
The patient began experiencing numbness on the right side of her face about 10 minutes after her vaccine was administered into her right arm. She reported that the right side of her face felt like it was red and swollen. She endorsed some drooping of her right eye. She was able to communicate fully, denied shortness of breath, difficulty breathing, and difficulty swallowing. She denied irritation at the vaccine site or any new rashes. Her only known allergy is to shellfish and iodine, which cause nausea and vomiting. The patient waited for about 25 minutes following the administration of the vaccine. Her symptoms did not begin to improve and it was recommended to contact EMS. The patient refused to call EMS and instead contacted her physician and left the facility.
Began aching all over around 10:30pm the day of vaccine.  The following day (January 6), I experienced 102 fever and violent chills, headache, blurry vision and eye pain off and on throughout the day (alternated acetaminophen and ibuprofen).  The following day (today, Jan 7), I have a low grade fever and fatigue with some lung pain, labored breathing.    I had COVID the end of Oct into Nov.  and lab tests the end of Nov showed antibodies but I continued with the vaccine since it was recommended.
2 hrs following flu iz, felt flush, turned white, took a bath & needed assistance out of bathtub - then started "feeling sick". Is fine now 12/16/10.
Breakthrough case of COVID-19: I was exposure to COVID from a co-worker. I went to the urgent care and I tested positive on 04/27/2022, I stayed in a hotel to quarantine. I had a headache, fever, and cold like symptoms. It was mild flu like symptoms the first day then the remaining days were cold like symptoms.
Pt received vaccination at pharmacy at approx 9:25am.  Waited 15 minutes at pharmacy without incident.  At about 1:00pm same day pt reports began itching on arms, neck and face.  Eyes and mouth soon began to itch and hives developed over arms, neck, face and chest.  Eyes also swelled.  When throat began swelling pt went to the ER at approx 3:00pm.  Pt was treated with Solu-Medrol and given prescriptions for Prednisone and Famotidine to take upon discharge.
Employee states, "On 02/07/2013, I received a MMR vaccination from Employee Health. I did not have any side effects that I noticed from then to before Friday. But on 03/01/2013, when I came home and tried to lay down on the bed and rest, I noticed a golf ball-size lump at the site of injection at my right upper arm. It was hot and painful and it has not gone away. I tried ice, heat, and Benadryl and Motrin. The size became a little smaller and there is just little heat."
Extreme body aches and chills. Fever that is not going down when taking medicine.  Started around 7 pm same night and got worse. It's currently 9:30 pm.
Patient had a distant history of hypertension 5 years ago but his cardiologist had cleared him then. He has not had high blood pressure until about a week ago. He came in since the headache has become quite unbearable and his blood pressure is worrisome.
4/25: MD exam on clinic, 2 days after vaccine (Varivax administration, notes: large well demarcated warm red, tender area, left deltoid - about 3x3 in. 4/24: Pt noted Sl swelling and redness 4/25: inc redness and swelling with fever 100.9 F. 4/25 treatment plan: ice to area 10 min 3x day. Motrin 400 mg 3x day for 2-4 days. return Dr 24-36 hrs if not better.
I was diagnosed with Bell's Palsy; treatment: I was prescribed to take prednisone for 6 days.
Information has been received from a physician concerning a male who on an unspecified date was vaccinated with ZOSTAVAX . Per physician, the patient received ZOSTAVAX and developed a bad case of shingles. Lot # was not available. At the time of reporting the patient's shingles persisted. Additional information has been requested.
headache/back of head, body aches, pain in right arm from elbow to shoulder and into neck, stiff neck, fever 101, nausea
Moderna COVID-19 Vaccine EUA Symptoms on 1/7/21 Fever of 101.3 Chills Symptoms on 1/8/21 Fever of 99.9 Headache Nausea Symptoms on 1/9/21 Headache
Left arm injection site pain more intense over 3 days.  within 3 hours of injection return of severe body aches like before.  Within 12 hours developed rigors, a-febrile, still ongoing shortness of breadth, chest pain, diapheresis, sinus congestion, excessive mucus production,  harsh cough, non-productive cough, nausea, periodic vomiting, brain fog, vision distortion, headache, inflamed sore throat, swallowing difficulty, gastro-intestinal disturbances including diarrhea, abdominal aches/cramping, right hip pain, right knee pain, general joint pains, malaise/fatigue. Lack of libido.
pt recvd vax 13JUL94 during the day & 10-11PM pt exp a generalized sz lasting 30 sec; pt appeared febrile prior to sz; no signs of illness were apparent;