chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fully vaccinated and tested Covid positive; fully vaccinated and tested Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 05Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  Clinical Course: The patient was fully vaccinated. She tested negative three times in the last week (Jan2022). On 03Jan2022, she tested negative after the two minute rapid test. On 05Jan2022, she thinks that she had the PCR test and that was negative. She stated that she was not feeling good. On 06Jan2022, she took another rapid 15 minute test that was negative. She stated that over the weekend she was feeling sick and had an appointment today (10Jan2022) at 9:45 and got her results where she tested Covid positive today (10Jan2022). She inquired when is the soonest she can schedule for a booster dose of the Pfizer covid vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "fully vaccinated and tested Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) negative, notes: the 2-minute rapid test on Monday was negative; (06Jan2022) negative, notes: the 15-minute rapid test on Thursday was negative; (10Jan2022) positive, notes: Covid positive after she tested negative three times in the last week; (05Jan2022) negative, notes: PCR test on Wednesday was negative.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 20Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "A-fibrillation" (unspecified if ongoing). Concomitant medication(s) included: Eliquis; Metformin; Jardiance; Insulin; Cartia XT; Metoprolol; Omeprazole. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril"; Penicillin, reaction(s): "Known allergies: Penicillin"; Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Getting better and testing negative on home tests; Dark black test line, notes: Retested and home test was immediately dark black test line. Therapeutic measures were taken as a result of Covid-19. No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: Eh9899), in right arm, on 19Jan2021 as dose 2, single (Lot number: EL1283), in right arm and on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Valley Fever" (unspecified if ongoing). There were no concomitant medications. 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, notes: COVID 19 Treatment; (01Oct2022) Negative; (04Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient was given Paxlovid as treatment on 23Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
At 1319, COVID vaccine nurse reported self administration of epinephrine auto injector 0.15 mg on left thigh mistaken with trainer auto injector. Washed injected area with soap and water, vital signs initiated, no discomfort  noted. Offered EMS but nurse refused. She chose to go with family member. Observed until family arrived. Leftsite at 1429 with family member in stable condition.
fever; sore arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 months after receiving Shingrix, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with 1st dose of shingrix, experienced  fever and a sore arm  which lasted a few days and then resolved. For the tolarence of 2nd dose refere case US2020037860, reported by same reporter for the same patient.
Chronic and debilitating migraines 15 days (consecutive) post injection. Residual headaches post 29 days and counting. Shortness of breath 14 days post injection. Golf ball-sized lymph node in left armpit of injection arm, 12 days post injection. Hyperhidrosis 21 days (consecutive) post injection.  Fever (99-100.6) 8 days post injection. Sharp, piercing joint pain continuing 29 days and counting, post injection.
Pain in left shoulder and arm to the elbow,unable to get enough sleep hard to get dressed or Drive a Car no help from pain meds. or creames.Except i am not Dead dit not push that button on the bottom
PATIENT DESCRIBED SIGNIFICANT SWELLING BEGINNING 2 DAYS AFTER RECEIVING VACCINE.  THE SWELLING OCCURRED AT SITE OF INJECTION, WAS RED, WARM, AND PAINFUL TO THE TOUCH.  PATIENT DESCRIBED SWELLING TO BE BASEBALL SIZE IN DIAMETER.  PATIENT DID NOT TAKE ANYTHING OR USE ANYTHING TO RELIEVE ANY REACTION.  THE SWELLING LASTED ABOUT 3 DAYS AFTER IT STARTED.
Neuropathy; Tremor; I stared getting involuntary head jerks and leg jerks; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 052E21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), TREMOR (Tremor) and DYSKINESIA (I stared getting involuntary head jerks and leg jerks). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), TREMOR (Tremor) and DYSKINESIA (I stared getting involuntary head jerks and leg jerks) outcome was unknown.            No concomitant medications were reported. It was reported that patient had started developing a tremor. And then the next couple of nights the patient stared getting involuntary head jerks and leg jerks. When the neuropathy came, it spread through the whole body. The patient remember staring at the ceiling and thinking that was it  the patient was dying. No treatment medications were reported.  Company comment.  This spontaneous case concerns an adult female patient, with no medical history reported, who received two doses of mRNA  1273 original vaccine and experienced the unexpected, serious (medically significant) event of neuropathy peripheral. Latency cannot be properly assessed since exact onset date was not provided. It was reported that the patient started developing a tremor. After a "couple of nights" she experienced involuntary head and leg jerks. She also mentioned "When the neuropathy came, it spread through my whole body". No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.
This case was reported by a lawyer and described the occurrence of short term memory loss in a 19 year old female pt who received Lyme disease vaccine recombinant (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received Lymerix. At an unk time after receiving Lymerix, the pt experienced migraine headache, fatigue, loss of short term memory, poor concentration, balance problems, joint pain and a positive SPECT (single photon emission computerized tomography) scan. Time to onset, treatment and outcome were not reported.
Information has been received from a physician concerning a 5 year old male with no allergies or medical history who was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 22 February 2006, the patient was seen in the office for break through chickenpox. He had approximately 20 lesions. Since then itchy lesions were not relieved with diphenhydramine hydrochloride (Benadryl) at home, the physician prescribed hydroxyzine hydrochloride (Atarax). No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested.
crying constantly since vax;faint macular rash on rt chest & in diaper area;rx APAP;
Ninety-five years female with no significant past medical history presented to the ED for evaluation of difficulty breathing refer patient she was exposed to go with past week. Denied any fever, vomiting, chest pain. Denied any nausea vomiting. Tested positive for COVID-19. CT scan of the chest revealed bibasilar atelectasis and possible pneumonitis. Troponins were noted to be elevated. Oxygen saturation was 88% on room air at presentation. Was placed on 4 L oxygen by nasal cannula.
Noted left arm - red raised area approximately six hours after injection 3 by 2 1/2 inches. Ice applied to area.
woke up with horizontal diplopia that lasted 2 hours (occurred three days after the vaccine was given). work up in the ER negative for stroke
Pt's mother reported hives, progressing from the time they got home and worsening by bed time.  States the child had received Hib before but never Hep A.  No other changes in routine noted.  Advised by our MD to give benadryl.  Did relieve sx.
On 9/21/16 I started to feel pain in my lower back. As time went by I started feeling pain in my left leg. It was painful, muscle tightening and stiffness. I couldn't take a shower I had to take a wash up with a bucket. In my room sitting on my bed. It was hard for me to get in and out of the car. I also had a hard time sitting on the toilet and getting off. I went to the ER on 10-7-16 and 10-11-16 and they didn't give me anything to take. I went to doctor on 10-27-16. He gave me some gabapentin 300 mg and diclofenac 75 mg. On 11-15-16 I will seek further treatment. On 10-7-16 I went to the ER and they gave me an X-ray. An on 10-11-16 they took blood. On 10-27-16 doctor took two x-rays.
Inpatient hospitalization (2/26/21-3/3/21) and diagnosis with COVID-19 following 2nd dose of COVID vaccination.
rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.; rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.) and VACCINATION SITE RASH (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.) and VACCINATION SITE RASH (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.). At the time of the report, VACCINATION SITE PRURITUS (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.) and VACCINATION SITE RASH (rash on the side of her body. It´s just one line of rash on the same side of the body were she received the injection. It´s very itchy.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-500852.
This spontaneous report was received from a registered nurse referring to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 26-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M005714, expiration date: 03-OCT-2017 (Strength, dose, frequency and route were not reported) as prophylaxis, which experienced a temperature excursion of 9 Celsius degrees for 20 hours. Previous temperature excursions were reported as from 02-OCT-2016 to 04-OCT-2016 of 9 Celsius degrees for 43 hours 30 minutes. From 25-OCT-2016 to 26-OCT-2016 of 9 Celsius degrees for 23 hours and 30 minutes. On 28-OCT-2016 of 9 Celsius degrees for 48 hours. From 23-DEC-2016 to 24-DEC-2016 of 9 Celsius degrees for 20 hours. Data logger was not involved. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information is not expected as there was no further information to report.; Sender's Comments:  US-009507513-1704USA015304: US-009507513-1704USA001013:
Patient tested positive for COVID 19 on Jan 5th 2021 Patient was admitted to the hospital January 9th for pneumonia due to COVID
Caller stated that she is "freaking out"  and that she does not want to receive the second dose of the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: As underlying conditions she has high blood pressure; "nose bleeds" (unspecified if ongoing), notes: nose bleeds; "venous insufficiency in both her legs" (unspecified if ongoing), notes: venous insufficiency in both her legs; "an ears disease that cause her to feel vertigo" (unspecified if ongoing), notes: an ears disease that cause her to feel vertigo; "she has 13 allergies to medicines." (unspecified if ongoing), notes: she has 13 allergies to medicines.; "Vertigo" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Caller stated that she is "freaking out"  and that she does not want to receive the second dose of the vaccine.".  No follow-up attempts are possible. No further information is expected.
10/29/09 at 10:00 AM student received intranasal H1N1 vaccination. After 12:00 PM same day she c/o headache and dizziness. Patient was examined by Dr.
Hot, red, itchy bumps all over my body (Hives). I went to my doctor who prescribed me a steroid, but the hives did not go away. I then saw an allergist who prescribed me Xyzal to take twice a day. I still have hives even with the medication.
Patient came in 3/18/21 to inform us that she had an adverse event to the flu shot she received on 10/15/2020.  She says that when she receieved the vaccine  she felt "something weird where she was injected".  She said that she did not think too much of it until later when she had a bruise at the injection site.  She said that the bruise later extended and she had a series of bruises going up  a line on her deltoid muscle.  Her nurse friends told her that a nerve might have been hit during administration of the flu shot.  She said that ever since she has had issues with her left arm, feeling pain in that left shoulder.  They have given her steroid shots and at one point were going to do suregery on her rotator cuff but they found nothing to be wrong with it so canceled that procedure.  She says that her shoulder is still sore up to today and that she just started regaining strength in her arm.  According to the patient, she did not do anything to her arm (hit it, etc) and the only connection is the flu shot.
Swelling and itching at injection site; wheezing and coughing; mild anaphylaxis. Self treatment with rescue inhaler and BENADRYL symptoms subsided after treatment. No previous history of flu shot reactions.
Patient had severe swelling and redness in arm of injection. She had to go to the emergency room 6 days after admin and received an antibiotic. MD said she had cellulitis.
Severe headache/ back of head ached; neck ached; Nausea; fatigue; muscle pain; chills; swollen lymph nodes - left neck; generally feeling unwell; This is a spontaneous report from a contactable other health care professional, the patient. A 57-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via unspecified route of administration in the left arm on 26Mar2021 at 10:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as COVID-19 on unspecified date. The patient was allergic to aspirin and penicillin. Concomitant medications were reported as karma cleanse, hepata tox, heverts lymph detox and H, (MANUFACTURER UNKNOWN) for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 26Mar2021 at 11:30 patient experienced severe headache, back of head and neck ached, nausea, fatigue, muscle pain, chills, swollen lymph nodes of left neck and generally feeling unwell. The patient did not receive treatment for the reported events. On 21Jun2020, the patient had nasal Swab resulted positive, whereas on 03Aug2020 and 01Oct2020 it was negative, respectively. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of all the events severe headache, neck pain, nausea, fatigue, myalgia, chills, lymphadenopathy and malaise were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with LIQUID PEDVAXHIB (lot # M027884, exp 19-APR-2019; lot #M034188, exp 20-MAY-2019) for prophylaxis. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. This is one of several reports received from the same source. ; Sender's Comments:  US-009507513-1707USA011495: US-009507513-1707USA011496: US-009507513-1707USA011494:
Fever - 24 hours Headache - 16 hours Body aches - 24 hours Traveling intense sharp pains through body - 36 hours Clamminess/chills - 24 hours  Feeling of general heaviness - 24 hours Heaviness in upper chest - 6 days and counting  Cough - 6 days and counting
Patient reported " A few days after the vaccine, I developed a large red spot on my torso, a few days later I started to get pale splotches scattered on my torso. Each day I have more splotches, spread out even more, and they have gotten darker".
Janssen COVID-19 vaccine taken on 4/7/2021. Shortness of breath started on Day 10 after the vaccine. The shortness of breath continued until time of this reporting.  (1) On 4/29 afternoon, patient visited PCP for shortness of breath, the CBC, D-Dimer was ordered, reports were normal.  (2) On the same night (4/29 around 10:30 pm EDT), patient experienced severe shortness of breath and also developed lightheadedness, tingling in hands and feet, body shivering and was rushed to the Emergency Room (4/29, 11 pm EDT). ER Physicians performed chest x-ray, EKG and COVID-19 test (swab) ? reported ?negative?. ER Physician diagnosed ?shortness of breath?. Recommended ibuprofen 400mg every 8 hours.
This case was reported by a physician via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever after the 1st dose of SHINGRIX which was recorded as 100 degree F. Lab comments: Lab test was done on an unknown date.