chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Elevated heart rate and BP; Elevated heart rate and BP; Felt unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EW0158) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: Other medical history: Graves' disease, FM/CFM, osteoarthritis, IBS; "FM/CFM" (unspecified if ongoing), notes: Other medical history: Graves' disease, FM/CFM, osteoarthritis, IBS; "osteoarthritis" (unspecified if ongoing), notes: Other medical history: Graves' disease, FM/CFM, osteoarthritis, IBS; "IBS" (unspecified if ongoing), notes: Other medical history: Graves' disease, FM/CFM, osteoarthritis, IBS; "Known allergies: gluten" (unspecified if ongoing), notes: Known allergies: Salicylates, gluten, dairy; "Known allergies: dairy" (unspecified if ongoing), notes: Known allergies: Salicylates, gluten, dairy. Concomitant medication(s) included: TAPAZOLE; CETIRIZINE HCL; VITAMIN B [VITAMIN B NOS]; VIT D [VITAMIN D NOS]. Past drug history included: Salicylates, reaction(s): "Known allergies: Salicylates", notes: Known allergies: Salicylates, gluten, dairy. The following information was reported: HEART RATE INCREASED (non-serious), BLOOD PRESSURE INCREASED (non-serious) all with onset 08Apr2021, outcome "recovered" (2021) and all described as "Elevated heart rate and BP"; MALAISE (non-serious) with onset 08Apr2021, outcome "recovered" (2021), described as "Felt unwell". The events "elevated heart rate and bp", "elevated heart rate and bp" and "felt unwell" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, blood pressure increased, malaise.  Additional information: Patient did not have other vaccine in four weeks. Patient did not had COVID prior vaccination. Patient did not had COVID tested post vaccination.  Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 14 year old female with no medical history and no known drug allergies who on 27-AUG-2008 was vaccinated with a first 0.5ml dose of GARDASIL intramuscularly.  Concomitant therapy included topical clindamycin.  The patient experienced myalgia in calves, lower thigh, back and neck after the vaccination in 10-SEP-2008-17-SEP-2008.  She also is experiencing fatigue.  Medical attention was sought, the patient was seen in the office.  Laboratory tests were performed, all of following were negative: lyme panel, CPK level, antinuclear antibody, rheumatoid factor, mononucleosis, sedimentation rate 2, CBC.  The patient has not recovered at the time of report.  Additional information has been requested.
PFIZER vaccine that was stored in refrigerator given outside of 31 day expiration. Vaccine received on 11/19/2021. Expiration date on vial 02/2022. NDC# 59267100001.
Multiple 1-3 mm erythematous papules on trunk and perineum with mild ext to neck and back. Lesions blanchable.
Redness, swelling and increased warmth at site of injection. Redness - 12cm x 10cm.
Patient had H1N1 immunization on 11/20/2009. At the end of January, 2010, patient began having pain at injection site, and has become worse, spreading down right arm. Patient saw PCP late February 2010.
After 5th shot of PREVNAR given on 8/24/10 pt developed progressively larger red, tender & hot area at site of injection.
About a week after the first shot, I experienced COVID arm and had redness, swelling, lesions, and itchiness at the injection site. The itchiness and lesions lasted a couple of days as I used hydrocortisone on the area. The redness lasted for about a week.
Lightheaded, hot, cold, headache tingling reported about 2 minutes after injection. Cold pack and cold water given. V/s 96.4, 20, 110/60. No wheezing no shortness of breath and no chest pain and no syncopal episode. 911 called and client decline to go. About 10 minutes later stated felt better 98-100% left Aox4 and ambulating well. All protocols followed
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was inoculated with ZOSTAVAX for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). Following the vaccination (date not specified), the patient experienced a painful rash accompanied by persistent pain. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the Company's product. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not resolved. Causality assessment was related. The lawyer considered painful rash and persistent pain to be disabling. Additional information has been requested.
This case was reported by a consumer and described the occurrence of human papilloma virus test positive in a 49-year-old female patient who received CERVARIX. On an unknown date, the patient received CERVARIX at an unknown dose. On an unknown date, unknown after receiving CERVARIX, the patient experienced human papilloma virus test positive and inappropriate age at vaccine administration. On an unknown date, the outcome of the human papilloma virus test positive and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the human papilloma virus test positive to be related to CERVARIX. Additional information received: Patient stated when she was 44, she fought her insurance company to receive CERVARIX. After a year, they agrees to pay for it, so she went and got the vaccine, and administered it to herself (at age 45) following the dosing schedule in the Pl. She had a recent test that said she was potentially HPV positive. She feels that is impossible because she has had two sex partners in the last 4 years. She did not wish to answer template questions, because she feels it is not "yet" and adverse event. Permission to contact being denied.
Urticaria rash on legs, lower trunk, very itchy, no fever.  Advised by doctor on telephone to use Benadryl 3tsp and Aveeno bath and f/up in office am.
Chills, severe shaking, insomnia, body aches for over 24 hours
Hemi-circumferencial swelling at injection site on R deltoid with redness and warmth, about 5x5 cm.
Fever or chills Cough Shortness of breath or difficulty breathing Fatigue Muscle or body aches Headache New loss of taste or smell Sore throat Congestion or runny nose Nausea or vomiting Diarrhea Migraine  Tinnitus
By the next morning I had, what was confirmed to be, an outbreak of HSV-2.  Never have I had it previously.  Treated Monday, March 15.  Prescribed a10 day dose, 2 times a day, of anti-viral medication. Partner also received Pfizer vaccine on March 24 and had HSV-2 outbreak as well.  Although he admits to having had outbreak 20 years ago.  Timing was the same.  Day after vaccine.
Patient comes today 10/27/2017 for an annual PPD and mentioned her left arm continues to be "sore" from an Influenza Vaccine administered in this Clinic on 4/10/2017. The vaccine was administered in the left deltoid according to the CDC guidelines. This is the first report on symptoms. The patient complained of soreness when moving left arm over head, behind her back, and across her chest. She did state there may be some slight weakness in the arm also. There was no redness or edema in the left upper arm. The symptoms have decreased but she still complains of soreness with movement.
I tested positive for Covid-19 4/27/2022 I was asymptomatic at time of positive test and have remained asymptomatic.
Vaccine was stored in the  freezer and thawed at room temperature. Freezer temp was 34F Vaccine was noted to be expired  after administration
Hallucinating and falling down. Told by doctor, he is allergic to vaccine, but told to complete the series.
child was given 3 doses of Rotarix (Extra Dose); This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7LX33, expiry date 14-FEB-2024) for prophylaxis.   On 02-DEC-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 02-DEC-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix (Extra Dose)).  The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142498:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142499:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142502:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter
Intermittent  blurred vision began 15 minutes post injection and continuing upon filing of this report (11.5 hrs) facial flushing, headache
Spotting between menstrual cycles which has not occurred in past 5+ years, including time following IUD placement. First menstrual cycle following first vaccine dose was 32 days instead of the 23-24 days for the past year
This case was reported by a physician via sales rep and described the occurrence of pain in a female patient who received BEXSERO for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and MENACTRA at an unknown dose. On an unknown date, less than a year after receiving BEXSERO, the patient experienced pain and tingling. BEXSERO was discontinued. On an unknown date, the outcome of the pain and tingling were recovered/resolved. It was unknown if the reporter considered the pain and tingling to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient was in her early 20's at the time of reporting. The age at vaccination was not reported. The patient experienced severe pain and tingling for several days. The patient would not get the second dose of BEXSERO because of the side effects she experienced. The reporter thought it had something to do with receiving this BEXSERO vaccine and MENACTRA previously. The reporter agreed to be followed up. It was unknown if the reporter considered the severe pain and tingling to be related to MENACTRA as well. This case has been linked to the US2018GSK140943, reported by the same reporter.
On 4/21, 4/29, and 5/5 I experienced double vision lasting a few minutes each time.
pt recv vax 9DEC97 & 10DEC97 pt exp cold sx;pt was treated w/ATB;pt was ill for 3wk;pt required a visit to MD office;15JAN98 pt exp same resp sx w/nasal congestion w/dose 2;several days later pt exp itchy rash;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unknown date, the patient experienced a case of shingles after vaccination. It was unspecified if the patient had sought medical attention. The outcome of the patient's adverse event was unknown. This is one of several reports from the same source. Additional information has been requested.
1/20/22 16 yr/o female with a very complex medical history presented with URI symptoms and persistent fever in the setting of COVID was admitted for increasing oxygen requirements on the day of admission, close monitoring for possibility of decline given her complex medical history. 16 yr/o female who is a resident of (Privacy) with PMH of Extreme prematurity, Spastic quadriplegic CP, VP shunted hydrocephalus, dysphagia with GT, global developmental delay, chronic lung disease, epilepsy, hypothyroidism, hypercalcemia, optic atrophy presented with upper respiratory congestion and persistent fever in the setting of COVID infection (tested positive on 1/18/22) and unable to wean oxygen AM of the day of admission. She was admitted for increased oxygen requirement the same day morning of admission and close monitoring for possible decline given her complex history. The patients baseline is RA when awake and 2L or less when sleeping.Inflammatory marker CRP was high and CXR revealed developing right lower lobe/atelectasis. She required 2L NC admission morning at (Privacy), came to ED on 1L with oxygen saturation 99%, and saturating well on room air soon after while in ED. She was also tachycardic and appeared dry. Antibiotics (ampicillin) and IVF started. Closely monitored her vitals and pulse ox given her complex medical history and possibility of decline. Stable throughout hospitalization with no increased oxygen requirements. The patient was on room air during the day and used oxygen 2L NC only when asleep which is her baseline. She has been HDS, afebrile, at her baseline throughout. Contact and droplet precautions with eye protection   2. RLL Pneumonia CXR was suggestive of RLL Pneumonia/atelectasis done in the ED. Started ampicillin and switched to amoxicillin through G-tube after two days of clinical and laboratory improvement. The white counts and inflammatory markers downtrended throughout admission. Today is day 5 of antibiotics. Continue antibiotics for 2 more days through g-tube at (Privacy). (6 more doses). 1/24/2022 13:26
Three days of extreme diarrhea; Right foot was tingling, numb and hurt for three days
Temperature of 102 for two consecutive days. Soreness and swelling in throat.  Body aches including muscles and head.
Got another full shot and Moderna  was giving half a shot/ Got a double dosage and not a half a dosage; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (Got another full shot and Moderna  was giving half a shot/ Got a double dosage and not a half a dosage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Got another full shot and Moderna  was giving half a shot/ Got a double dosage and not a half a dosage). At the time of the report, ACCIDENTAL OVERDOSE (Got another full shot and Moderna  was giving half a shot/ Got a double dosage and not a half a dosage) outcome was unknown.            No concomitant medications information was reported.  Reporter informed that doctors recommended to get the booster that was not approved at that time and patient and her husband both got the booster and had no reactions at all and that they got another full shot but Moderna was giving half a shot.  No treatment medications were provided.   This case was linked to MOD-2022-526032 (Patient Link).   Reporter did not allow further contact
Headache, nausea, vomiting. Observed for approx 1 hr.  Symptoms improved.
Pt got the injection and about 7 hours later developed nausea and vomiting.  Also developed a fever 6 hours after injection. He also had an injection site reaction, his arm was swollen, red and warm to the touch.
pt reported diarrhea all day tuesday 12/21.  had raised blister area on arm 12/22 that is going down now.  day 3 warm to the touch but seems to be improving.  redness will worsen in shower.  rph shared redness in shower w hot water not surprising.  might try cold pack.  diarrhea since resolved, no  treatment needed. watch and wait.  if red area/warmness persists or gets worse would need to be seen by dr.
about 1wk p/vax pt had morbid regression-unable to walk, sit, talk; was walking @ 1yr;had 7words, waved bye, clapped hands;
Af episode 10 days after the second dose Abnormal ecg, rise in septal to 20 mm in echocardiogram  Anterior and inferior infract 30 days after second dose Chest pain, shortness of breath, rise in troponin enzyme Af episodes cleaned after 8 months and the pain is gone We are going to check the echocardiogram again The patient was af free at 48 holter monitoring
Vaccines were administered Thursday morning. By Thursday evening I had 102 degree fever, which lasted through Sunday. Friday evening arm where Pneumococcal vaccine was administered, was red and swollen. Progressively worse until Sunday evening when it started to get better. Treated with BENADRYL.
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
She presented to the ED on 01/16/2022 with altered mental status and possible seizures.  Unremarkable CT scan of the head without contrast. Per Neurology physician, "Needs to be aggressively supported for the COVID infection".  No treatment as of 1/17/21 at 1930 for her COVID symptoms
Low Grade Fever, Muscle Aches, and Join Paint from 2/10/2021 in the afternoon to 2/11/2021 in the morning. Fatigue that lasted until 2/11/2021 in the afternoon.
Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. It was reported that the patient took second dose of mRNA-1273 on the 15th of an unknown month.
Patient was administered with a vaccine that had experienced a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion). At the time of the report, PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion) outcome was unknown.        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.
Received 2 doses of Pfizer covid vaccine - patient unsure of date of 1st dose. Received 2nd dose on 3/14/2021. Subsequently tested positive for covid infection on 7/26/2021.
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/18/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS