chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN 6199), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER 8732), in left arm, on 29Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: 038A22A) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). Concomitant medication(s) included: VIT D3, start date: 01Jan2022; VIT B12, start date: 01Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient had no known allergies. The patient received vaccine. The patient received Paxlovid for COVID 19 Treatment as other medication in 2weeks. The start date for paxlovid was 11Aug2022 and stop date was 16Aug2022. The patient took Multi vitamin (Vita fusion) as other medication in 2weeks; lot: YY20695090) with start date as 01Jan2022. The patient took Ibuprofen (lot: 2BE2284A) 200mg as needed as other medication in 2weeks product with start date as 01Aug2022 and stop date as 22Aug2022. The brand name for vit B12 was reported as Nature Made and brand name for Vit D3 was reported Vita fusion.
approx 3 hrs p/vax pt noted tight throat, laryngitis, cough, sl SOB; pt did not contact clinic or MD; pt reports used ASA only; states sx lasted from onset until next AM then were gone;
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/ not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and still got shingles. It had been 5 months now.  The patient was tired of the pain. The patient enquired about what could be done. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Feel horrible; Hurts all over my body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel horrible) and PAIN (Hurts all over my body) 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 22-Mar-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (Feel horrible) and PAIN (Hurts all over my body). At the time of the report, FEELING ABNORMAL (Feel horrible) and PAIN (Hurts all over my body) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Redness, sore, itchy and warm to touch at injection site on right buttocks. Was told to use Benadryl cream.
Gross hematuria 4 hours after the second shot of covid vaccine. Called pharmacy, they told me it?s not related. But I did not change my habit at all. Went to doctor, they found blood and protein in my urine. The blood was visible for the next 3 days. Urine was sent for culture. Came back clean. 3 week prior, had physical penal done, bodily functions were in great shape. Last November I ever had ultrasound on my kidneys, nothing came back. I was sent to urologist,, blood was still present then. Then sent to Prime Diagnostic for CT scan. Waiting to hear back for that result.
Severe headaches started, vomiting, one sided numbness of body, inability to speak, confusion, and altered mental status.
Admitted with altered mental status, generalized weakness, and fever. Went into cardiac arrest and required intubation. Currently with questionable seizure activity and requiring warming.
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On an unknown dates, an unspecified number of patients were vaccinated with an improperly storage doses at a temperature of 47 °F to 77 °F for 9 hours and 54 minutes of LIQUID PEDVAXHIB (lot # L014429 and expiration date 15-MAR-2018) (lot # M014925 and expiration date 16-FEB-2019) (lot # M036056 and expiration date 18-MAY-2019) for prophylaxis (dose and route of administration were not reported). The vaccine did not have a previous temperature excursion and this information was provided due to the data logger. No adverse effects were reported. There was no product quality (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004700: US-009507513-1704USA010790: US-009507513-1705USA004699:
Patient reported feeling dizziness, nausea, tachycardia and chest pain. Patient reported having a history of SVT. EMS was called, patient was found to be stable.
At her 2 month shots, she broke out in eczema from head to toe and had a bad rash all over stomach. She was fussy and threw up. Eczema was not gone by the 4 month visit.
Patient received Fluzone HD and began profusely sweating and feeling faint. Stated anxiety of needles and not eating today. She received fluids and attention from pharmacist and store management. Once calmed down and feeling better she left the store.
No adverse effects reported; 2 improperly stored doses of ROTATEQ were administered to unspecified patients on unspecified dates; This spontaneous report was received from a registered nurse refers to a 6-month-old patient.  There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 10-JUL-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R012954, expiry date: 04-DEC-2019), via oral route for prophylaxis. Lot # R033256 with expiration date: 23-JUN-2020 was also reported in previous report.        The vaccines underwent temperature excursion of the highest temperature above 47 degrees Fahrenheit (48.7 degrees Fahrenheit) for 18 minutes (product storage error). There was no previous temperature excursion. The digital data logger was involved in recording excursion details. No adverse effects were reported. The outcome of product storage error and no adverse event was unknown.     This is one of two reports received from the same reporter (1907USA010818).
10 days after vaccine, I developed random hive like rash on my arms, and back. They were circular in shape, sometimes itchy and some were flaky. They would get darker in color as time pasted. The hive like rash was the worst on my arms and my flanks. A few were on my legs but a lot less, compared to my arms. I took methylprednisolone and hydroxyzine. A month later they are present, however they are fading away but no new ones are present.
Hospitalization: 8/15/2022 admitted; 8/25/2022 discharged.  Presentation to the ED: left knee pain s/p fall 3 days ago. Patient was confused and weak and required increased O2.  COVID-19 + date: 8/15/2022 Treatment: IV antibiotics given. No COVID prophalyxis.  Discharge to: Extended Care
Left arm lymph node pain; Left arm lymph node pain and swelling; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date and unknown if ongoing. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), taken for unknown indication from an unknown date and unknown if ongoing. On 03Mar2021, the patient experienced left arm lymph node pain and swelling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm lymph node pain and swelling was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Admitted to hospital on 6/26/22-6/28/22 for pneumonia, covid, hypertension, diabetes, a-fib. Pt was treated with antibiotics and Remdesivir.
Suspected vaccination failure; shingles; burning  left side of back; stinging pain on the left side of back; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In January 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and back pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation and back pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and back pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles, 2 weeks ago from the date of reporting. The patient never got the rash but experienced the burning, stinging pain on the left side of back. The patient was told this was internal shingles.  The patient enquired, if there was anything to help with the pain, had anyone else had shingles with no rash and anything they took to reduce the pain. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Mom called 10-12-22 said her daughter the patient was sick for few days after ,10-4-22 janseen vaccine ; malaise , fever but then felt better , then 5 days later got sick again , headache wont go away , fever and heavy period bleeding with clots . Covid test negative . Advised her to take her to PCP or urgent care to be seen
After receiving my COVID booster, I developed shingles under my eye.  My eye lost normal vision, things were blurry.  The skin under my eye blistered and was very red and raw and it hurt.  After going to the Urgent Care on 10/7/2021, the ER doctor diagnosed the shingles and gave me both an antibiotic (in case it was an infection)  and an anti-viral course of meds to be taken at the same time.  She also instructed me to follow-up with my primary care physician.
Extreme Pain in shoulder. Today is 06/04/2016 time is 6:25. I woke with same amount of pain as yesterday plus I feel Nauseated. Temp. is 97.1.
Moderate redness. Pt wanted us to report this although it's consistent with standard adverse effects for the vaccine.
About 10 minutes after receiving the vaccines the patient passed out. She came to fairly quickly but hit her head on the floor during the fall. She had a knot on her head. After checking her out and applying an icepack, her father was advised to carry her to the ER for an evaluation. When she left the clinic she was alert, oriented and her pupils were even and reactive. We have since called to check on her. They said that they took her to the ER and the MD said she was ok and she is not having any problems.
muscle aches, body fatigue, fatigue, headache began around 18 hours after shot, subsided the following day treated with Tylenol and Advil
Sensation started at the base of my neck and moved upward with rapid swelling of the neck glands and slight difficulty swallowing. Feeling rapidly moved up my head with onset strong frontal lobe headache.  I used my Pulse oximeter and PO2 remained in mid 90s, was able to swallow and drink water, No further swelling of neck. @200 am that  night woke from severe pain of injection site and swelling. Onset body aches especially legs , knees and soles of feet were the worst. By morning had to hold left arm upward too painful to hold down.  Knee pain and soles of feet painful to stand an walk, had to put shoes on to tolerate feet on floor. Nausea, fatigue, headache persisted
HYPOTENSION ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/17/2022,  6/28/2022,  8/8/2022,  8/9/2022,  8/10/2022,  8/22/2022,  9/20/2022,  10/14/2022,  10/24/2022,  12/28/2022, 11/1/1/2022,  12/30/2022,  3/9/2023,  2/1/2023,  1/17/2023  -- RECURRENCE OF SAME SYMPTOMS
no other AE occurred.; The caller said they inadvertently administered an expired dose of VAQTA today, 7/12/2022, to a patient.; This spontaneous report was received from the Medical Assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-JUL-2022, the patient was inadvertently vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dosage form, lot #t040581, expiration date: 28-MAR-2022, administered for prophylaxis (dose number, strength, an anatomical location and route of administration were not provided) (expired product administered). No further information provided.
injection was administered too low in the arm. Patient had a localized red aura around the injection site. It did not looked infected or inflamed.
This spontaneous report as received from a consumer refers to herself: a 72 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. Concomitant therapies included unspecified blood pressure medication, unspecified stomach medication and unspecified sulfa medication. On an unknown date in the fall of 2012, the patient was vaccinated with ZOSTAVAX, 1 unspecified dose (lot number, route of administration and expiration date were not reported). On an unspecified date in 2015, the patient got shingles, but they never appeared as a rash, and she described it as pain and burning on unspecified areas of the body. The patient reported that she saw her physician at that time and was treated, but the treatment was unknown. The patient recovered from shingles on an unknown date (reported as "shingles lasted for about 6 weeks"). On 12-FEB-2018, the patient got shingles again, which was not showing as a rash again, but just severe burning and pain. The patient went to her physician on 16-FEB-2018, and was treated with valacyclovir hydrochloride, acetaminophen, and acyclovir. On an unknown date in February 2018, the patient felt sick to the stomach, which lasted for an unspecified amount of time. The patient reported that she still had the shingles but they were improving. The outcome of abdominal discomfort was not reported. The reporter considered the abdominal discomfort to be related to treatment with valacyclovir hydrochloride and acetaminophen. The causality between the ZOSTAVAX and herpes zoster was not reported.
Dizziness, nausea and vomiting. Only reporting for what it?s worth to cdc. All manageable  but def not psychosomatic byproduct of anxiety.
Information had been received from a physician concerning a 14 year old female who was vaccianted with a dose of varicella virus vaccine live. it was reported that a few years later the patient developed herpes zoster. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Starting 11/30/2022, I developed a runny nose and some nasal congestion. I waited a few days because I thought it was a cold. It progressed into chills and more severe nasal congestion. I developed a cough and some wheezing, and also felt very fatigued. After waiting a few weeks thinking, again, it was just a cold, I decided to see my doctor. I saw my doctor via telehealth about 3 weeks into December and she prescribed some antibiotics and a cough medicine to take at night time. She had me do a COVID-19 PCR test which came back negative. I was taking MUCINEX before I saw her but had no relief from it. I took the antibiotics for about 5 days (Z-PAK) and I felt better after a few days. I felt the congestion and post nasal drip come back about 2 days after finishing the course of antibiotics. I tried to wait it out to let the medicine do its job and I took a cough drop to help the cough when it came back. On 12/28/2022, I had sneezing and sinus congestion but worse than last time and a cough. I called my doctor on 01/02/2023 and I scheduled it for 01/04/2023 because I had to wait for a COVID-19 PCR test and Flu A/B to come back before I could go into the office. All of the tests ended up coming back negative. In the office, they did a strep test due to my post nasal drip and the hoarseness of my voice, and that came back negative. She said I was wheezing and coughing, the same way as before. She prescribed me a stronger dose of antibiotics (AUGMENTIN) and prescribed an inhaler (albuterol). I am still taking those to this day. I still have congestion and wheezing but not as much as before. Also, I am still getting some intermittent fatigue.
Pt presented in clinic with approximately 30 rectal pustules all in the same stage of ulceration. He had experienced itching, pain, feverishness, and diarrhea. He was cultured and started on Acyclovir and Keflex at the direction of MD. Nasal lesions in the right nares with yellow crust appeared 2-3 days later, but were not cultured- presumed Herpes0 although he had no history of this and no recent oral or other intercourse. The culture of the rectal lesions returned as Vaccinia.
I have had severe chills, headaches and body aches. I am having a temperature that spikes and breaks. I have a runny nose and am exhausted
Initial report received from a health care professional on 06 May 2011. A 5-year-old male patient, with a history of asthma, received on 03 May 2011 a right thigh intramuscular injection (dose 5) of DAPTACEL, sanofi pasteur lot number C3358AA, a left thigh intramuscular injection of IPOL, sanofi pasteur invalid lot number D0674, and a left thigh subcutaneous injection of PROQUAD, Merck lot number 02837. He had no illness at the time of vaccination, no other vaccines within 4 weeks and took no medications. The patient did not have any adverse event following prior vaccinations. On 04 May 2011, the patient developed an 8 x 5.5 centimeter (cm) red, blistered area on the left thigh. He was seen in the office on 04 May 2011. Later that evening and into the next day, the patient developed red, swollen, painful area on the right thigh where the DAPTACEL was given. The patient was treated with steroids. The outcome was reported as not recovered. Follow-up information was received on 09 June 2011 from a health care professional. The lot number for IPOL was reported as D0674-1, which is a valid sanofi pasteur lot number. No information regarding the patient's recovery status was provided. Documents held by sender: None.
Patient called around 1pm on 1/5/11 and complained that her both arms still feel painful since 1/2 vaccinated. Especially the right arm. She feels dull pain & hard to lift even she took tramadol. We suggested to check with Dr.
Patient developed low grade fever 99.8 degrees F for 3 days following the vaccine. About 48 hrs after vaccination he had a seizure. The 3rd day following vaccine administration developed rash c/w rubella.
Since administration 2 weeks ago, pain in my shoulder at the site of injection is intense. Unable to lift my arm or move it in certain ways. I have gotten the flu shot for years, and I noticed the position it was placed was awkward, it was really high and toward the back of my shoulder, almost under my bicep. When the actual fluid was injected (not the needle) it was very painful.
pt recvd vax 12SEP93 & 14SEP93 devel pain & stiffness in neck; stiffness went to back, shoulder & upper thigh; 19SEP93 recovered; No further details were provided
Generalized Redness more distinct on the face and arms Feeling hot High BP  Rapid pulse ( >110) ( No treatment, monitored by fire dept who administered the shot.  got better after 1:5 hour ) After 3 days developed Shingles !!
Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.
Fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4326469.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Fatigue" (ongoing). Concomitant medication(s) included: OCREVUS; RITUXAN. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  Additional information: On unknown date, patient started therapy with Pfizer covid 19 vaccine. On unknown date, it was reported that patient experienced: Fatigue.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna vaccine administered to a 16 year old but the minimum age is 18 years old.
Information has been received concerning a 9 month old white non-Hispanic female who on 10/5/96, 1/3/97 and 4/21/97 was vaccinated with a 1st, 2nd and 3rd dose of haemophilus b conjugate vaccine. Subsequently, the pt experienced "other" related to vaccine failure and an "other" specimen indicated haemophilus influenza type b. Upon medical review, the pt's experience was considered to be an "other medical event". The reporter indicated that the pt's outcome was "yes".