chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight swelling, warmth and redness in right thigh noticed evening of 6/13/19. Swelling continued to spread down to knee and Pt having trouble with ambulation. Seen 6/14/19 in Physician's office, exam is c/w local reaction to vaccine vs cellulitis. Suspect local reaction is more likely so will tx with ibuprofen and benadryl every 6 hrs as needed and monitor for improvement. If swelling/blotchy redness improves after ibuprofen/benadryl given in office, it is ok to continue ibuprofen and benadryl every 6 hrs as needed until reaction has resolved. If redness/swelling worsens, then go ahead and start antibiotic as directed for a possible cellulitis.
Blurry vision, difficulty focusing eyes. Also happened with the first dose of the vaccine on 4/13/2021 lot #ER8731
within 24 hours, pt broke out in papular rash to abdomen, then scattered hives over body, still having ongoing hives intermittently, along with joint pain a month out from vaccination
No additional AE; given third dose PROQUAD 09/09/2020 in error; This spontaneous report has been received from a a physician (administrator) referring to a patient of an unknown age and gender. Information concerning the patient's concurrent conditions, pertinent medical history, concomitant medications, and previous drug allergies or reactions were not provided.  On 24-AUG-2020, the patient was vaccinated with the second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen, route of administration, lot number and expiration date were not provided) as prophylaxis.   On 09-SEP-2020, a third dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) lot # T009930, expiration date 16-SEP-2021 (dosage regimen and route of administration were not reported) was given in error as prophylaxis. No additional adverse event (AE) was reported.
This is a spontaneous report from a contactable Physician via Pfizer sales representative. This Physician reported that a 16 year old patient received the first dose of TRUMENBA on an unknown date in the arm at single dose for immunization. Patient medical history and concomitant medications were not reported. It was stated that the patient experienced a swollen, sore arm from shoulder down to elbow. The information on the batch number has been requested.
This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Oct2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Feb2021 at 16:00 (at the age of 58-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 26Oct2021 at 00:00, the patient experienced extreme pain in right hip, arthritis type pain in shoulders, neck, back and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events experienced extreme pain in right hip, arthritis type pain in shoulders, neck, back and headache was resolved with sequelae on an unknown date in 2021. The lot number for BNT162b2 was not provided and will be requested during follow up.
Severe nausea with near vomiting; lightheadedness, near loss of consciousness, localized pain at injection site. Recommended NSAIDS with GI protection, Claritin QAM X 3 days+ prn; Benadryl QPM X 3 nights + prn.
Initial and follow-up information has been received from a nurse concerning a 22-year-old female patient with a medical history of menstrual migraine and dysmenorrhoea and with no drug reactions/allergies who on 23-APR-2009 was vaccinated IM with the first dose of GARDASIL (Lot # 661531/1311X). On 26-JUN-2009 the patient was vaccinated IM with the second dose of GARDASIL (Lot# 662404/0312Y). Concomitant therapy included omeprazole (MSD), butalbital and YASMIN. On 30-June-2009 the patient developed a red bump rash on her stomach, arms and chest. The patient had called the office on 30-JUN-2009. There were no labs or diagnostic studies performed. The patient's status was unknown at the time of report. The Health Care Professional contacted during telephone follow-up could not supply the following information: recovery status. Follow-up information has been received from a nurse indicated that the patient was a 22 year old admin assistant with no illness at time of vaccination. The second dose of GARDASIL was vaccinated in the left deltoid at 3:15PM on 26-JUN-2009. On 27-JUN-2009, the next day after GARDASIL, the patient noticed a rash located on trunk, back, upper arms and upper thighs which was bumpy and red rash. The patient was treated with BENADRYL 25 mg and the rash improved. There were no lab diagnostic tests performed. On 01-JUL-2009 the patient was recovered. Additional information is not expected.
allergic reaction; arm is still swollen; itched like a thousand mosquito bites; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (allergic reaction), PERIPHERAL SWELLING (arm is still swollen) and PRURITUS (itched like a thousand mosquito bites) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced ALLERGY TO VACCINE (allergic reaction), PERIPHERAL SWELLING (arm is still swollen) and PRURITUS (itched like a thousand mosquito bites). At the time of the report, ALLERGY TO VACCINE (allergic reaction), PERIPHERAL SWELLING (arm is still swollen) and PRURITUS (itched like a thousand mosquito bites) outcome was unknown.            Concomitant information were not provided by the reporter.
This spontaneous report was received from a pharmacist refers to a 65 year old female patient. The patient's concurrent condition and medical history were not reported. On 25-SEP-2014, the patient was vaccinated with PNEUMOVAX 23, (lot #, dose number and dosage were not reported). Concomitant medication was not reported. The pharmacist reported that on an unknown date in June 2015, the patient was inserted with a cochlear implant for an unspecified reason. On an unspecified date in 2015 (reported as 1 week later, since the insertion of cochlear implant), the patient developed Bell's Palsy. The pharmacist considered Bell's Palsy to be a significant disability. The patient was not recovered at the time of reporting and was still experiencing Bell's Palsy. The reporter did not provide the relatedness of the event and the suspect therapy. Additional information has been requested.
Was admitted to hospital 1/31/07 with abdomenal pain, vomiting and diarrhea. An air contrast enema during the hospitalization was felt to be consistent with intussusception. This resolved after the enema. The child received IV fluids and was subsequently discharged home in good  condition. 06/14/07-records received for DOS 01/37/07-Successful reduction of ileocolic intussusception by air enema. Presented to ER with vomiting and diarrhea. Diarrhea started 4 days ago. Loose stools some with blood in stool initially but this has cleared. Nonbilious, nonbloody vomiting. Decreased PO Intake.  Vaccination record received supports data submitted. No discharge summary dictated.
Rash after MMR-face, neck trunk and extremities. Benadryl given within 5 minutes.
Employee felt nauseated, dizzy, and had a metallic taste in mouth. Vomited after approximately 17 minutes of first onset of symptoms.
Slightly swollen lymph node right side of neck; however, presents with extreme pain when swallowing--thus far has lasted over 24 hours.
Case number PHEH2014US023278, is an initial spontaneous report received from a physician on 14 Nov 2014. This report refers to a male patient of unknown age. His medical history and concomitant medications were not reported. His current condition includes psychiatric disorder. He received one dose of FLUVIRIN (batch number: 1412301) intramuscularly in Oct 2014 or in Nov 2014 (reported as within the past 30 days) in their facility but the patient has reported he received more doses of influenza vaccine from other places to make his own high dose. All the doses were not administered on the same day. The patient's story was not consistent. The reporter was unable to confirm what the patient had told. The reporter was unknown whether patient really received additional doses. No adverse events reported after the maladministration (inappropriate schedule of vaccine administered).
Low grade fever (100.6 degrees); Body aches; Headache; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 44-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EN6203), via an unspecified route of administration on 24Mar2021 at 09:45 AM (at the age of 44-year-old) administered in Arm Left as a single dose for COVID-19 immunisation at Workplace clinic. The patient had received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EN6203), via an unspecified route of administration on 01Mar2021 at 09:45 am administered in Arm Left as a single dose for COVID-19 immunisation at Workplace clinic. The patient medical history was reported as none. The patient had allergies to penicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Mar2021 at 01:00 AM, the patient experienced Low grade fever (100.6 degrees), body aches, headache, fatigue. Query included that the Drug safety unit recently received the attached report submitted by you via website. Please help to confirm the date that you became aware of the adverse events in this report as these effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any colleague learned of the adverse event. If you learned of these events from another colleague, please provide the date that the first colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a colleague became aware of the adverse events. The clinical outcome of the events was recovered.  Follow up attempts are completed. No further information is expected
pt had first round of vax on 8MAR93 & mom states pt never quit crying p/recvd shot & @ 8PM that noc had a convuls & was carried to the ER;
Woke up with 45X30 cm reddened area around injection site at back side of Left arm (not deltoid region) itchy and sore.  Came to PHN office to report, instructed to avoid itching and call if worsens.
After receiving the flu Vaccine(not sure which exact one) my shoulder was sore which was to be expected, but a week later it still had not improved. Heat and ibuprofen has helped a little, over the head movements pushing or pulling things using my upper arm muscle is very painful. To be able to sleep at night I half to sit up since laying down in any position is to painful to sleep. While sweeping and mopping I felt a crunching sensation in my shoulder similar to clicking and poping but no sound. It is now FIVE WEEKS LATER and my shoulder has not improved.suden movements of my arm or my shoulder flexing is very painful, and there is generally a constant ache. I went to an orthopedic walk in clinic and the doctor said the main pain is in my deltoid muscle but doesn't know why. He has refered me to a physical therapist to learn some at home stretches and exercises to hopefully help my arm heal.
Swollen painful lymphnodes- collarbone, armpits, neck, throat, chest  Edema in chest neck throat and face   Water, Aleve, activity to move lymph around
Started pain; my arm is hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Started pain; my arm is hurting". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had coughing, headache, sore throat, and running nose. I went to my doctor for a Covid-19 test, negative.
Information has been received from a registered nurse concerning an 8 year old hispanic child with no medical history or allergies who on 23-APR-2007 at 10:45 AM was vaccinated SC on left arm with 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 656076/1490F). At the time of vaccination the patient did not have any illness. On 24-APR-2007 the patient developed a "baseball sized" red, hot, swollen and painful area at the injection site. Unspecified medical attention was sought, no treatment was required. It was reported that the child had also received a dose of varicella virus vaccine live (Oka/Merck) at a year old without adverse symptoms. At the time of report, the patient had recovered. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated that the patient developed a painful, red swollen warm to touch arm in morning of 24-APR-2007. The patient recovered on 28-APR-2007. No further information is expected.
SEVERE DIARRHEA WITH MUCUS AND BLOOD, CURRANT JELLY CONSISTENCY, PULLING KNEES TO CHEST WITH LOTS OF IRRITABILITY AND CRYING, CONCERN FOR INTUSSUSCEPTION,WITHIN 2 DAYS OF VACCINE, SENT TO HOSPITAL WITH 3 DAY STAY,
On 3/7/99, had Anthrax #1 with flu-like symptoms. On 3/19/99, had Anthrax #2 had blisters on arms and legs, 3 days later, which were largely resolved over 1-2 months. On 5/13/99, had Anthrax #3 and on the 2nd day, post vax, had blisters over entire body.
can't see straight; dizzy; This is a spontaneous report from a contactable consumer (patient).  A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264 and expiration date not provided), via an unspecified route of administration first dose on 29Jan2021 at single dose for Covid-19 immunization.  The patient's medical history included ongoing high blood pressure. The patient's concomitant medications included unspecified blood pressure medication. It was reported that patient had first shot on Friday 29Jan2021 and everything was fine, it was the easiest shot has ever had. On Sunday 31Jan2021, the patient started getting dizzy. The patient had to hold on to the wall to balance himself. The patient was dizzy again today. The patient doesn't know if it is a coincident or a side effect. It probably started about 40 hours after the vaccine. The patient stated that he was currently miles from home, and he was going to start driving, but he can't see straight. The outcome of the events was not recovered.
I woke up at around 4 am the very next day and my tinnitus was really bad.  The ringing was and still is at least twice as ?loud? to me (if I had to quantify) and is now a problem I need to see a therapist for.  The ringing has not subsided at all and it has been almost 2 months since my 3rd shot.  I?ve had tinnitus as long as I can remember but it was always very mild and not intrusive to my life.  The ringing is terrible and this is now a minor problem for me.
According to patient, developed overall rash on @/16, two days after vaccine.  Denies any changes in daily living habits that might cause a systemic allergy response.   The rash is "red, prickley and covers back, neck, inner thighs, and chest".    Denies SOB or difficulty breathing.  Denies swelling.    Encouraged to seek care with her MD or attend an Urgent Care for appropriate follow up.
Got a dose 19OCT2022 and another 2NOV2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 68-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 2nd November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, 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: 2-Nov-2022 Reporter's comment: The caller provided an email after transfer to second-line agent. The caller did not ask if email follow-up  was okay because the health care professional wanted to remain anonymous in their system. In accordance with their ways of working, the caller will email the health care professional's contact details. The caller consented to follow-up with a phone call, but the caller wished to stay anonymous in their system. Additional supportive information: The patient inadvertently received another dose of Fluarix (same lot) on the day of reporting, which led to extra dose administered.
extremely low heart rate; Right arm was weak; Fingers on right hand were numb; Pain in the jaw; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (extremely low heart rate) in an 88-year-old male 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 No adverse event (No medical history 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, the patient experienced BRADYCARDIA (extremely low heart rate) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Right arm was weak), HYPOAESTHESIA (Fingers on right hand were numb) and PAIN IN JAW (Pain in the jaw). At the time of the report, BRADYCARDIA (extremely low heart rate), MUSCULAR WEAKNESS (Right arm was weak), HYPOAESTHESIA (Fingers on right hand were numb) and PAIN IN JAW (Pain in the jaw) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Heart rate: low (Low) Extremely low..         No concomitant medications were reported.  On an unspecified date, the patient's spouse reported that the primary doctor advised a cardiologist consult. The cardiologist recommended that he go to the emergency room.  No treatment information was reported.  Based in current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Very little information is provided for the event of bradycardia and further information has been requested.; Sender's Comments: Based in current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Very little information is provided for the event of bradycardia and further information has been requested.
Patient has redness and redness in right lateral thigh. Skin is coming off and injection site is painful and tender; Treatment: Benadryl, and neosporin.
Dizziness, Vision got significantly worst out of nowhere, can't focus, Balance issues, Seems like vertigo, room spinning when laying down.
aching in both arms progressing to severe weakness, paresthesia in finger tips & aching in both thighs;
SEVERE HIVES; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.   Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  The patient asked, was it advisable to take 2nd dose after having had severe hives with 1st dose.
This spontaneous report as received from a physician refers to an 80 year old male patient with high cholesterol. The patient had no pertinent medical history or drug reactions/allergies. On 29-NOV-2012, the patient was vaccinated with a dose of VARIVAX (Merck), subcutaneously, lot # reported as 0834AA and expiry date on 02-JUN-2013. Concomitant therapy included unknown "statin" for high cholesterol. It was reported that ten days ago, on 28-JUN-2016, the patient developed a case of shingles on his genital area. The patient was so swollen in that area, that the patient was unable to urinate which the physician felt was causing significant disability or incapacity to the patient. The reporter also stated that patient sought medical attention by being seen at unknown urgent care and was then seen at the physician's office on 27-JUN-2016. During the doctor's visit, the patient was administered a dose of DECADRON and a dose of DEPO MEDROL intramuscularly, as treatment for the swelling and the shingles outbreak. The patient was also prescribed acyclovir cream and unknown dose of famciclovir oral as treatment for the swelling and the shingles outbreak. At the reporting time, the patient had not recovered from the events. No laboratory studies were performed. The causal relationship between the events and suspect therapy was not provided. The reporter considered the event of urinary retention to be disability/incapacity. Upon internal review, the event of urinary retention was considered to be medically significant. Additional information has been requested.