chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient woke up screaming at 1 am.  there was no consoling him, refused to eat.  he would scream, fall asleep for about 15 minutes, then scream again.  i took him to hospital.  they did a full work up.  the x-ray did not catch the intussuseption, but the doctors were confident that that was what had happened.  he had a 2 night stay in the hospital.  this occured 2 weeks after he received the rotavirus vaccine.  (this was not 100 percent diagnosed and was not reported for that reason by the hospital.  i thought the information should be shared however.  i am very concerned with giving the second dose.)  he received the air enema as diagnosis and treatment.  he had a upper gi with a small bowel series.  he had gi consult and surgery consult as well. 02/23/07-records received and reviewed for DOS:01/17-01/18/07 DC DX: abdomen pain  12/23/06-possible intussusception but not diagnosed, also with otitis media. Completed 10 day course of antibiotics. Presents with nasal congestion and cough, prior to admission mucous like stool and decreased feeding, grunting with loud shrieking noise.
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. Number of doses from the lot number- 048C21A were 168. No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains updated reporter details.
After receiving the immunization, patient complained of swelling and pain. The next day, rash development on right arm around injection site.
COVID 19 Treatment; COVID 19 Treatment; developed new Covid symptoms; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Syringomyelia" (unspecified if ongoing); "thyroid nodules" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "adhd" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, start date: 15Oct2019, stop date: 02Aug2022. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "developed new Covid symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: appearing positive antigen test result than previously; Negative, notes: Tested negative after completing course for 2 consecutive days. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid. Therapeutic measures were not taken as a result of disease recurrence. Clinical course included: patient tested negative after completing course for 2 consecutive days. Six days after completing course developed new Covid symptoms (different from those I had originally). Had sever sore throat then over the next couple days developed cough, congestion and sneezing. Decided to re-test for Covid after3 days and had new stronger/more immediate appearing positive antigen test result than previously.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal association, a causal relationship between all the events and BNT162b2 cannot be excluded.
sore arm; I had an antibody test which was negative; This is a spontaneous report from a contactable physician.  A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, first dose on 21Dec2020 and second dose on an unspecified date in 2021, both at single dose for COVID-19 immunisation.  The patient medical history included chicken pox, she got those in the 1990s, probably in 1994-1995. The patient had unspecified concomitant medications. The patient stated, "I had an antibody test which was negative" on 27Jan2021. She says she had no symptoms other than a sore arm on an unspecified date, and then she had her antibodies checked and it is negative. She says she has no known immune deficiencies. The outcome of the events was unknown.   Information of lot/batch number has been requested.
Information has been received from a physician concerning a 20 year old female who on 21-JUN-2010 was vaccinated with the first dose of GARDASIL (Lot # unknown). The patient was also vaccinated with a dose of hepatitis A virus vaccine inactivated (manufacturer unknown), in the same office visit. The physician reported that at the day of vaccination, on 21-JUN-2010, the patient experienced seizure-like symptoms (including arm shaking). At the time of reporting, the patient had recovered. The patient did not seek medical attention. Upon internal review, seizure-like symptoms were considered to be other important medical event. Additional information has been requested.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a four months old male patient who was vaccinated with second dose of PENTACEL (0.5 ml) (batch number, expiration date, route and site of administration was not reported) on 14-Aug-2018 in the left thigh. The patient's medical history was not reported. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization. It was an actual medication error due to inappropriate reconstitution technique as the patient received second dose of series for PENTACEL without the ACTHIB component. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
6 people got Covid; 3 were vaccinated; 6 people got Covid; 3 were vaccinated; This is a spontaneous report from a contactable consumer. This is for the 3/3 patient of 6 people got Covid, 3 were vaccinated.   A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated that at her workplace, 6 people got Covid, 3 were vaccinated (did not know if it was Pfizer) and 3 were not. The outcome of evens was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
i got my shots they hurt a little; my arm was very sore for about 3 or 4 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: i got my shots they hurt a little) and pain in arm (Verbatim: my arm was very sore for about 3 or 4 days). The outcome of the pain was not reported and the outcome of the pain in arm was resolved (duration 4 days).   It was unknown if the reporter considered the pain and pain in arm to be related to Shingrix.     It was unknown if the company considered the pain and pain in arm to be related to Shingrix.   Additional Information: Receipt date: 20-AUG-2023 This case was reported by patient via interactive digital media. The patient received first and second dose of vaccination. The patient got her shots they hurt a little but there worth, her arm was very sore for about 3 to 4 days.
Pt received vaccine at 0830 am in the right thigh area and then at about 0835 area was red and was about 10 mm red, pt had mild itching to area at about 0840 area was red and 40 mm red and still mild itching and warm to the touch. Nurse did assess trunk area and there was no other redness no soa or any other signs area was localized, nurse did call PAC assessed pt and said she was ok to go home and to give tylenol and benadryl childrens to help with the discomfort and to return  for any new or worsening symptoms. Nurse did draw a line around reddened area and pt was discharged at 0855 and redness and itching did not get any worse.
This spontaneous report was received from a physician and refers to a 36 year old female patient. Information regarding the patient's concurrent conditions included tobacco user. The patient had a medical history of drug allergy to PHENERGAN. The patient had no concomitant medications. On an unknown date, the patient had an accidental eye exposure with PROQUAD (dose, lot # and expiration date were not provided). On 04-OCT-2018, the patient experienced burning sensation in her eye. On the same date, the patient was seen in the medical office and the patient was given an unspecified treatment for the event. No laboratory diagnostic studies were performed. No hospitalization was required. The outcome of eye irritation was not recovered/not resolved. The causality between the event eye irritation and PROQUAD was not reported.
Reported by patient that they were diagnosed with Guillain-Barre' syndrome approximately 1 month after receiving influenza vaccination.
Patient received a COVID-19 Vaccination Pfizer BioNTech Dose 1 on 06/15/2021 at around 4:15pm in the afternoon. Patient was mistakenly processed for and administered this vaccination in error since patient originally had an appointment for a  Shingles Vaccination (Shingrix). Patient also received the completed 2 Dose Series of Moderna COVID-19 Vaccination which was completed in May of 2021. Patient was asked if he felt fine and if he would like us to call 911 for immediate medical attention, we also did call his primary care physician which was closed but we will re-call them tomorrow on 05/16/2021 to follow up with the physician and the patient. Patient is alert and aware at the current time. Follow up with patient is recommended.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. ON 22-APR-2013, the patient was vaccinated with dose 1 of VARIVAX (Merck) (lot #, expiry not reported). On 16-JUL-2013, the patient was vaccinated with dose 2 of VARIVAX (Merck) (lot #, expiry not reported). No adverse symptoms reported. Additional information has been requested.
Redness and swelling developed at injection site of MMR administration on (L) thigh. The same day became worse progressively over the next 2 days. Slight redness at site of VARIVAX and Flu vaccine. Administration. Put on OMNICEF on 10/19, did not improve. Given ROCEPHIN on 10/20. Did improve on 10/21/16.
pt recvd vax & did not develop a titer p/8wks;pt reported approx 14pts assigned WAES 95081597 & 95081815 through 95081827
After Flu shot was given, injection site became swollen, hard bump and injection site turned red. Instructed patient to take BENADRYL for the swelling.
Nine days after my first shot, I developed a red Pringle-sized rash at the injection site (upper left arm). It was warm to the touch and swollen. It also made my whole arm feel swollen and heavy. That day, I took Benedryl. The next day, I took a natural anti-histamine product called Histamine Shield Plus. Within 24 hours, both the redness and warmness decreased, but the rash was still visible. I didn't take any more medicine to treat the rash. After 5 days, the rash has subsided, but the area does look slightly bruised.
Warmth, redness and swelling at the injection site developed the next day. I was prescribed Keflex to treat cellulitis.
I had pain and swelling at the injection site. I was tired. Then after a few days, I starting having joint pain. A few days later, my joint pain was getting worst and severe pain. I had pain in my shoulder, knees, neck and arm was the worst. About a week later, I had loss of appetite and started having weight loss. I starting having chest pain. I also had some nausea as well. I went to see my doctor about this. They are going to do a CT scan. I am still having these symptoms.
Erectile dysfunction, inability to achieve tumescent nocturnal erections, in the days immediately following 2nd dose of Pfizer Covid-19 vaccine. Patient was treated with sildenafil 25 mg PRN and initially presented to my clinic in 10/2021.
Reports severe neck and trapezius pain/stiffness followed by profound fatigue. Narrative:  The profound fatigue was severe enough that the patient was bedridden for 2 days.
Patient came to pharmacy presenting with redness, swelling, lump on the left arm where vaccine was given. Patient says it started to happen a few days after the vaccine was given.
PT CALLS TO REPORT THAT HE HAD A PNEUMONIA VACCINE ON 3/15/10. HE HAD A SEVERE REACTION AFTER THE VACCINE. FELT NAUSEA, AND DIZZINESS OVER NIGHT. NEXT DAY HE WAS EXTREMELY TIRED AND HAS DEVELOPED SEVERE PAIN IN HIS LEFT SHOULDER RADIATING TO HIS ARM. THE SITE OF THE VACCINE IS RED, THE SIZE OF A "SILVER COIN", AND VERY PAINFUL. HE CANNOT USE HIS ARM TO HELP HIMSELF WITH ADL.
Patient had episode of hypotension First bp reading several minutes after vaccination  was 82/46, second reading several minutes was 88/57, several minutes later was 93/62, next reading was 112/79 and resolved.
Pt recvd vax & began serum sickness type react consisting of joint pain, weakness &/or diarrhea; workup has included numerous tests for collagen vascular diseases, & been non-diagnostic;
hives first two months over entire body then still experiencing red vascular blotchiness in arms and legs
The pt experienced a right thigh with edema and with a silver dollar sized area of redness with white area in the middle.
Pt. c/o feeling dizzy once 15 min waiting period was completed.  Vital signs were checked and were stable.  Pt stated after VS were checked that he no longer feels dizzy.  Will continue to monitor for another 15 min.  Offered snacks and fluids, patient refused. VS @ 1144 AM: BP 116/74, RR 16, OxSat 97%, HR 63 .   VS @ 1159 AM BP 108/70, RR14, Ox Sat 98%, HR 83 Pt left after30 min monitoring.
2 days after the shot I got a vascular rash. I also experienced an irregular and extremely fast heart rate which lasted about 2 hours. In the original covid shot and other booster I also got a vascular rash and heart problems. I had no heart problems prior to any vaccinations. I have also reported these adverse reactions previously to vares.
leg hurting; Leg was completely clotted; 10 days was blowing blood clots out of his nose; blowing blood clots out of his nose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg hurting), DEVICE OCCLUSION (Leg was completely clotted) and DEVICE OCCLUSION (10 days was blowing blood clots out of his nose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery disease since an unknown date, Blood pressure (controlled blood pressure) since an unknown date, Diabetes (controlled diabetes) since an unknown date, Cholesterol (controlled cholesterol) since an unknown date and Stent placement (history of 7 stents in heart) since an unknown date. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), METOPROLOL, LOSARTAN, ATORVASTATIN and EMPAGLIFLOZIN, LINAGLIPTIN (GLYXAMBI) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg hurting) (seriousness criterion hospitalization), DEVICE OCCLUSION (Leg was completely clotted) (seriousness criteria hospitalization and disability), DEVICE OCCLUSION (10 days was blowing blood clots out of his nose) (seriousness criterion hospitalization) and EPISTAXIS (blowing blood clots out of his nose). At the time of the report, PAIN IN EXTREMITY (leg hurting), DEVICE OCCLUSION (Leg was completely clotted), DEVICE OCCLUSION (10 days was blowing blood clots out of his nose) and EPISTAXIS (blowing blood clots out of his nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Ultrasound scan: (abnormal) 85% plaque Plaque build up in main artery of leg.     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.   Patient have allergy to denies and  had a history of PAD Patient given Xarelto as treatment.  Please update the narrative by replacing Thrombus with Device Occlusion. Please delete the wording Occult Blood and add Epistaxis.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Case number PHEH2015US025669 is an initial spontaneous report received from a health care professional on 30 Nov 2015. This report refers to a patient of age under 4 years old and unknown gender. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. No adverse event was reported following this medication error.
Head ache, back pain, shortness of breath, chills and fatigue. Patient given Tylenol at ER.
Behind collarbone, on back, neck, down arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of radiating pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd January 2023, the patient received Shingles vaccine. On 23rd January 2023, less than a day after receiving Shingles vaccine, the patient experienced radiating pain. On an unknown date, the outcome of the radiating pain was unknown.   It was unknown if the reporter considered the radiating pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got his/her Shingles shot today on the day of reporting and reported that behind his/her collarbone on back and it was going up his/her neck and down his/her arm pain. The patient asked was that normal. Additional Supportive Information: Vaccination date and event onset date captured as per narrative. Follow-up would not possible as no contact details were available.
I got shingles after the second dose.  I went to the walk-in clinic; I had a side ache which was burning and itching and numb.  They prescribed a 7-day treatment for the symptoms I was having.  They medication did help the symptoms.  But I did get a rash about 3 days into the treatment.  The rash was raised and elevated, then it went away.
Headache, Fever fatigue In 12 hours, fever, fatigue, headache; resolved in 48 hours
Almost passed out at work around 12 pm on Sunday. After that I had a persistent headache for 12 hours, I was fatigued, nauseous and had a persistent fever.
pt recv vax 15NOV95 & lab eval on 7MAY96 revealed pt varicella zoster virus IgG antibody level was 0.44; pt tested negative for varicella zoster virus IgM antibodies;
Shingles; 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 HERPES ZOSTER (Shingles) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            No concomitant medication reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The SD attached is unable to be read.
Swelling and numbness in the right calf as well as purple spots around it. The numbness does not diminish and the purple spots have not faded. I need not to have movement so that it doesn't bother me.
This spontaneous report as received from a consumer refers to a 60 years old patient, who previously had an allergic reaction when she "broke out from" DEPAKOTE (date unspecified). The patient's medical history included chickenpox in childhood. On 26-APR-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided), 0.65 ml (one shot), subcutaneous for shingles prevention. Concomitant therapies included EFFEXOR, ABILFY, TEGRETOL, AMLODIPINE, fish oil (unspecified), lutein, calcium (unspecified), CALCIUM (UNSPECIFIED) (+) VITAMIN D (UNSPECIFIED), unspecified multivitamins and COLACE. On 15-MAY-2013, the patient developed chickenpox. The rash was reported to be itchy, and the blisters had not yet crusted over. Patient received valacyclovir hydrochloride as treatment for chickenpox. None labs diagnostics studies were performed. The outcome of chickenpox was reported as not recovered/not resolved. The patient saw the physician. Additional information has been requested.