chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient was inoculated with ZOSTAVAX on or about 03-AUG-2015, at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-SEP-2015, the patient was treated at a medical center for a painful and blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles on the face. The patient was prescribed antibiotics and ointment for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Information has been requested.
PENTECEL given right thigh in am 1/15/07 - Parents came back in due to pt crying non-stop 11:30 2:00, vomiting X 2, not nursing pt calm at times, repeatedly screamed with movement right leg X 3.  No redness, swelling or ecchymosis @ site.  11/6/09 called mom stated leg still sore, little swelling, T-100-using warm & cold compresses & TYLENOL.  Notified mom we would report
Systemic: Dizziness / Light headiness-Medium, Additional Details: PThad a syncope evenet after vaccination with the J and J vaccine but after lying down recovered  but was observed for 30 minutes. Pt has a history of sycope while receiving shots
had a little lump; it was hot to the touch; arm hurt; it's itchy; has a rash/rash is 3 inches wide in the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (had a little lump), VACCINATION SITE WARMTH (it was hot to the touch), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE PRURITUS (it's itchy) and VACCINATION SITE RASH (has a rash/rash is 3 inches wide in the vaccination site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016CZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (had a little lump), VACCINATION SITE WARMTH (it was hot to the touch), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE PRURITUS (it's itchy) and VACCINATION SITE RASH (has a rash/rash is 3 inches wide in the vaccination site). At the time of the report, VACCINATION SITE MASS (had a little lump), VACCINATION SITE WARMTH (it was hot to the touch), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE PRURITUS (it's itchy) and VACCINATION SITE RASH (has a rash/rash is 3 inches wide in the vaccination site) outcome was unknown.            No Concomitant medications were provided by the reporter. Treatment given as Put Cold on affected area.   This case was linked to MOD-2021-364966.
Patient started having emesis and bloody bowel movements 5/9/22, family called EMS 5/11/22 and patient was taken to the local hospital and found to have intussusception.  She was transferred to Hospital where an attempt at air enema reduction was unsuccessful and patient required emergent surgery and bowel resection for incarceration ileocolic intussusception 5/11/2022.
Patient complained of heart racing. Patient assessed and vital signs taken. Patient sent home in stable condition. B/P 147/97, HR 64, 02 SAT 97%RA RR 20. Patient educated
Patient reported severe fatigue and being "floored" by medication. She was ill for a few weeks and is currently feeling better.
The side effect with the second dose of Pfizer-Biotech was swollen lymph nodes (lymphadenopathy) on the left armpit. The side effect began on March 27, 2021, around 2:00 am. As of March 31, 2021, there are still side effects but not as bad as March 27th.
A 26 year old female patient experienced faintness, lightheadedness, headache and nausea, one hour after receiving RabAvert. Two hours later, the patient returned to see the nurse with complaints of sweating. At that time she had no fever, shortness of breath or change in blood pressure, but was flushed. The patient was a veterinary student who was getting pre exposure prophylaxis. The patient received the second of three doses of RabAvert on 02/02/04. No further details are available at this time.
Excruciating pain from shoulder to finger tips. Had a bruise which went away but pain & ache still remain as of today (11/10/2015). Also extreme soreness in entire arm.
I received my vaccination mild soreness at injection site subsided within 2 days, no other reactions.
Patient came to the pharmacy stating she had a reaction to the flu shot last year and it happened again this year.  She stated it never happened before.  She said her arm got really sore and red all the way down to the elbow.  I asked if she had any other symptoms such as a rash, hives, itching  or difficulty breathing.  She said no.  I asked if she was allergic to eggs, she said no.  I asked to see her arm as she stated it was still red and swollen.  What I observed was a little redness near the injection site.  I explained that is a normal reaction some people have when receiving a vaccination.  I told her that should subside.  If it doesn't I instructed her to contact her physician.
On day 7 the injection site got swollen, hot, and red, and was very sore. It then got itchy so I started spraying Benadryl twice a day. The swelling went down approx four days later, but the itching remained until day 7 (14 days after injection).
PT STATES ARM SWELLED FROM ELBOW UP. STATES FEELS LIKE CELLULITIS. PT HAD A MASTECTOMY IN THE RIGHT SIDE SO WANTED BOTH IS SAME ARM
Information has been received from a physician concerning an approximately 36 year old male patient who on 23FEB1995 was vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine. Subsequently, in January 2004 , the patient had a titer that was negative for mumps. Unspecified medical attention was sought. The physician also reported that a female pt was vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine and had a recent titer that was negative for measles and an unknown number of patients were vaccinated with a dose of measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine and subsequently had negative titers. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 12 months old patient, of unknown gender. Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 20-MAR-2019, the patient was vaccinated with improperly stored dose of the following vaccine: VARIVAX lot # R018780 and expiration date 01-JUL-202 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. Non improperly stored diluent used was reported. The vaccines was exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of 6 same reporter cases. Sender's Comments: US-009507513-1903USA011480: US-009507513-1903USA011573: US-009507513-1903USA011571: US-009507513-1903USA011574: US-009507513-1903USA011570.
Initial report was received 04 February 2011 from a health care professional, who received the report from the patient. This report involved a cluster of three patients. The other two patients have been captured in case numbers 2010-05974 and 2010-05986. A 34-year-old female patient had received a first dose right deltoid injection of FLUZONE, lot number U3720AA (route not reported) on 14 October 2010 and that same day at 10:00 P.M. (also reported as the day after receiving the vaccine), the patient began to experience pain between her breast and underarm on the same side as vaccine administration (right arm). She also felt a knot in the area of the pain. The event did not require medical intervention and no laboratory or diagnostic testing was performed. The patient had no illness at the time of vaccination and she had not received any other vaccines within four weeks prior to receiving FLUZONE. She had no identified pre-existing physician diagnosed allergies or medical conditions. Concomitant medications were unknown. Outcome was recovered (date not reported). Follow-up information was received from a health care professional on 07 March 2011. The patient received the FLUZONE intramuscularly in the right deltoid on 14 October 2010 at an unknown time. The onset of the event was reported as 10:00 PM on 14 October 2010. The patient's pain persisted for 2-3 days. She did not see a physician and therefore, no etiology or diagnosis was made. The patient recovered on 17 October 2010. No additional information was available at this time. The reporter for this case is the same as for case numbers 2010-05974 and 2010-05986. Documents held by sender: None.
mild fever; body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on an unknown date (at the age of 24-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included anxiety and depression. Concomitant medication included escitalopram oxalate (LEXAPRO). Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination in Jan2021 and experienced body chills. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced mild fever and body aches. The outcome of the events mild fever and body aches was unknown. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021144818 same reporter/patient/vaccine, different dose/event
Generalized hives (urticaria) began within half hour after administering shots. No other symptoms, only hives.
Rash on forehead, collarbone, left arm, and left leg. Migraine headache. Vision loss in left eye. Blurry vision in right eye. Sensitivity to light from computer and phone screens. Periodic headaches.
Information has been received from registered nurse. It was reported that GARDASIL vaccine were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 23-JAN-2013 exposed to temperature of 11C (dose, route and lot number not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Vaccine Error:  2nd dose of pfizer administered on day 14 instead of 17-21. Agency contacted and advised to repeat 2nd dose at least 21 days after last dose.
started with bruising immediately after infection, baseball size, x 2 weeks, then as bruising went away, pain started in right upper arm radiating into my shoulder, described as throbbing, limited daily functioning such as making a bed, buttoning bra due to pain, pain continues daily
2 minutes loss of sight after having COVID-19 injection. Patient has no history of allergic reactions in the past no history of loss of vision in the past. Patient states that she is somewhat clammy and may have low blood sugar. No fever chills sweats no nausea vomiting diarrhea. Symptoms have completely resolved.
Extreme pain at injection site (upper left arm) about 3 hours after injection.  Pain remained overnight and into the next morning.  Could barely move my arm.
On 02/09/2023 in the early morning, I noticed a distortion in my vision in my right eye. It looked like a small half-moon on the inferior portion of my eye, near my nose. I thought I was having an ocular migraine, which I have a history of, but the distortion never went away. On 02/10/2023, I went to see an eye doctor. He looked at scans of my retina and thought he saw a bulging in my retina. He suggested I see a retina specialist as soon as possible. On 02/14/2023, I was able to see a specialist. When she examined me, she saw a detached retina in my right eye and another tear in my retina. She also noticed a lattice in both eyes. She set me up to see another specialist, who saw that I had the detachment in my right eye and two tears that needed to be treated immediately. He conducted laser treatment on the tears and lattice in my right eye. He then instilled a gas bubble in my right eye to hold the retina up. On 02/14/2022, I returned to the original specialist who lasered the detachment to seal it up to the globe of my eye and further lasered the lattice in my right eye. I went back yesterday to the second specialist who lasered most of the lattice in my left eye. I have an appointment this Friday for more laser on my left eye and to check the right eye.
Woke up at 3:30am on 3/31/2021 with an 100.7 fever. Went back to sleep. Woke up at 9:30am with an 100.5 fever. Took advil and rested until 12:30pm. Fever went down but later had a migraine. Took more Advil at 6:00pm and went to sleep. Woke up the next day feeling fine.
PERIPHERAL NEUROPATHY SYMPTOMS IN  FEET DISAPPEARED FOR 6 DAYS (UNEXPECTED THERAPEUTIC BENEFIT); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included peripheral neuropathy bilateral feet, and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced peripheral neuropathy symptoms in feet disappeared for 6 days (unexpected therapeutic benefit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of peripheral neuropathy symptoms in feet disappeared for 6 days (unexpected therapeutic benefit) was not reported. This report was non-serious.
pt exp many colds this winter & mom felt may have been a result of the flu shot; dad felt flu shot may be causing Guillain barre; has had numbness & tingling has been ill alot this winter; fevers, colds several dasy, muscle aches then fine
My cycle came back and was very short. I had one 12 day cycle where I bled for 5 days beginning March 22, a 13 day cycle starting April 3 bleeding for 3 days, a 16 day cycle starting April 16 bleeding for 4 days, and my current cycle starting May 2.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 5121), via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 22-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9267), via an unspecified route of administration in the right arm on 26Mar2021 (at the age of 23-years-old), as a single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, the patient experienced the cycle came back and was very short. She had one 12-day cycle where she bled for 5 days beginning 22Mar2021, a 13-day cycle starting 03Apr2021 bleeding for 3 days, a 16-day cycle starting 16Apr2021 bleeding for 4 days and the current cycle starting 02May2021 bleeding for 4 days. In the 6 years prior to receiving the vaccine the patient did not have a menstrual cycle. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event the cycle came back and was very short, she had one 12-day cycle where she bled for 5 days beginning 22Mar2021, a 13-day cycle starting 03Apr2021 bleeding for 3 days, a 16-day cycle starting 16Apr2021 bleeding for 4 days and the current cycle starting 02May2021 bleeding for 4 days were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Starting on 9/11: crushing fatigue, severe headache that lasted for 7 days, persistent GI distress (cramping, diarrhea), irregular heartbeat Still ongoing: GI distress, irregular heartbeat
Patient is a 79-year-old male, who was admitted to this hospital initially on 03/06, with history of ataxia and multiple falls, which apparently started following a pneumonia that he (and flu shot) supposedly had in January. He was extensively evaluated during his hospitalization between 03/06 and 03/14, including Neurology, Neurosurgery, physical therapist, and eventually was felt to have some possible form of Guillain-Barre syndrome. He was then transferred to rehabilitation where he is progressing slowly. He still has problems with his balance but states that he has improved. On his examination today, Dr. found a bradycardia in the 40s, reason why he cut down his LOPRESSOR and asked for a cardiology consultation.
Nausea, dizziness, diarrhea for 3 days constantly throughout the entire 3 days.
her husband is in atrial fibrillation right now/a fib after first dose of vaccine; heart problems; he developed arrythmia; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sponsored program. A male patient received bnt162b2 dose 1 via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included a fib. The patient's concomitant medications were not reported. The patient had heart problems and went into atrial fibrillation after the first dose of Pfizer COVID vaccine, and he is due for his second dose on 05Apr2021. The reporter stated his doctor had advised that he still should receive the second dose despite being in atrial fibrillation. No information in USPI regarding atrial fibrillation after second dose and safety of receiving second dose. The reporter asked if this is okay. The patient developed arrythmia and was seeking medical care. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Client noticed tenderness under (L) arm by armpit. Approx quarter size lump upon palpation. Client called Dr - Mon. - appt. Tues 4/27/10. Client to have diagnostic mammogram Fri - 4/30/10. Also was started on AUGMENTIN 875 mg BID x 10 days.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # L040053, expiration date: 10-MAY-2017) for prophylaxis (dose and route of administration were not informed). No adverse effects were reported.  No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions, medical histories and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # M010485, expiration date 01-MAR-2018) dose, route, anatomical location and frequency were unknown. Temperature excursions and times were reported as follows: -9.6C for 2 hours and 11 minutes, 6.6C for 5 hours and 33 minutes and -4.3C for 8 hours and 30 minutes. Data logger was reported as yes. No adverse effects were reported. Additional information has been requested.
Pre syncope symptoms - 5-10 minutes after injection:  Warmth Turning pale Getting sweaty palms Feeling dizzy or lightheaded Blurred vision  Lasted 10 minutes; was observed for 30 minutes, given a snack and drink and slowly began to subside.
Patient do not intend to spend another 2 weeks in the hospital; Initial information received on 27-Oct-2021 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media.  This case involves adult patient who had not intend to spend another 2 weeks in the hospital (hospitalisation) after receiving INFLUENZA VACCINE.  It was unknown if the patient had concomitant disease or risk factor.   The patient medical history, medical treatment(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious who had not intended to spend another 2 weeks in the hospital (hospitalisation) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves an adult patient (unknown gender) who presented with hospitalisation after the vaccination with INFLUENZA VACCINE (unknown manufacturer).Time of onset is unknown. Further information regarding medical condition during vaccination, previous vaccination and tolerance, other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
immediate numbness & tingling down arm; erythema 24hr 5x6 (3x3 on jul6, 99); soreness in legs & ankles; malaise; gastritis; burning sensation
10/22 -MMR vaccine  10/29 full body rash  later comes high fever  10/30 projectile vomiting high fever over 103  10/31 projectile vomiting high fever 104 11/1 104.2 fever lethargic vomiting -goes to ER - swabbed for everything all negative  11/2 pediatrician follow up 104.7 in office.  Re swabbed for flu and strep. All negative.  Wouldn?t eat or drink  11/3 body aches and pain  moaning in his sleep irritable restless doesn?t want to walk without fretting like in pain
Mother requested patient have Pfizer Booster. Monovalent booster was given when bivalent booster should have been given. No adverse reaction.
Nausea and vomiting within 2 hours of injection, vomited x3 , treated effectively with zofran, no further symptoms or treatment.