chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient also reports developing a breakthrough COVID-19 infection after having been vaccinated.; I had fatigue; Felt soreness at the arm, swelling at injection site; Felt soreness at the arm, swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient also reports developing a breakthrough COVID-19 infection after having been vaccinated.), FATIGUE (I had fatigue), VACCINATION SITE SWELLING (Felt soreness at the arm, swelling at injection site) and VACCINATION SITE PAIN (Felt soreness at the arm, swelling at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and RISEDRONATE SODIUM (RISEDRONATE) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-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 COVID-19 (The patient also reports developing a breakthrough COVID-19 infection after having been vaccinated.), FATIGUE (I had fatigue), VACCINATION SITE SWELLING (Felt soreness at the arm, swelling at injection site) and VACCINATION SITE PAIN (Felt soreness at the arm, swelling at injection site). At the time of the report, COVID-19 (The patient also reports developing a breakthrough COVID-19 infection after having been vaccinated.), FATIGUE (I had fatigue), VACCINATION SITE SWELLING (Felt soreness at the arm, swelling at injection site) and VACCINATION SITE PAIN (Felt soreness at the arm, swelling at injection site) had resolved.            No treatment information was provided.  Company Comment - This case concerns a 69-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 69-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Patient presented to the ED with anxiety on 6/14/2021. Patient presented to the ED on 6/16/2021 with psychosis. Patient was hospitalized on 6/22/2021. These visits are within 6 weeks of receiving COVID vaccination.
Information has been received from a medical assistant, referring to a 2 year old female patient. The patient's medical history and concurrent conditions were not reported.  Concomitant therapies included sterile diluent (MERCK STERILE DILUENT) Lot number N013284 with expiration date on 10-OCT-2019. On 30-OCT-2017 at a private doctor's office/hospital, the patient was vaccinated with and improperly stored second dose of VARIVAX lot # N020015 with expiration date on 17-JUL-2019 in the left arm (administration route was not reported) for prophylaxis. It was reported that the vaccine was purchased with private funds. No adverse effects were reported. The reporting medical assistant stated that "per Merck vaccine's were still in a safe temperature" (unspecified temperature). The vaccine had a temperature excursion of -11.5 Celsius (C) during a time frame of 1 hour with 40 minutes and it was confirmed that no previous temperature excursions occurred.
This spontaneous report as received from a registered nurse (R.N.) from an unspecified relative of the patient, concerning to a 5 year old female patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (dose, frequency and route not reported). No concomitant medications were reported. On an unspecified date the patient experienced a high fever and abdominal distress after receiving GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
LESS ACTIVE; MORE TIRED; STOMACH ACID; MOUTH IS GETTING VERY DRY; NOT ABLE TO EAT/DID NOT FEEL LIKE EATING; FEELING VERY WEIRD; NOT ABLE TO TASTE/NO TASTE OF MY MOUTH; FEVER; CHILLS FELT VERY COLD; LOSING WEIGHT; NOT FEELING GOOD; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 100 pounds, and height was 59 inches. The patient's concurrent conditions included high blood pressure, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergies and there was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine for blood pressure, and losartan for blood pressure. On MAR-2021, the subject experienced losing weight. On MAR-2021, the subject experienced not feeling good. Laboratory data included: Coronavirus test (NR: not provided) Negative. On 08-MAR-2021, the subject experienced chills felt very cold. On 08-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 deg. On 09-MAR-2021, the subject experienced not able to eat/did not feel like eating. On 09-MAR-2021, the subject experienced feeling very weird. On 09-MAR-2021, the subject experienced not able to taste/no taste of my mouth. On 09-MAR-2021, the subject experienced stomach acid. On 09-MAR-2021, the subject experienced mouth is getting very dry. On 11-MAR-2021, Laboratory data included: CT scan (NR: not provided) Normal. On 23-MAR-2021, Laboratory data included: Endoscopy (NR: not provided) Normal. On APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Coronavirus test (NR: not provided) Negative. On 01-APR-2021, the subject experienced less active. On 01-APR-2021, the subject experienced more tired. Treatment medications (dates unspecified) included: famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not able to eat/did not feel like eating, and feeling very weird on 15-APR-2021, and chills felt very cold, and fever on 09-MAR-2021, had not recovered from not able to taste/no taste of my mouth, losing weight, stomach acid, mouth is getting very dry, less active, and more tired, and the outcome of not feeling good was not reported. This report was non-serious.
8 days after vaccine, patient presented with headache, severe body aches, fever, chills, and fatigue.  Patient had a patchy right upper lobe infiltrate, pulmonary infarction was ruled out.
COVID breakthrough. Patient presented to the hospital on 1/22/22 with shortness of breath after dialysis treatment. Tested positive on 1/23/22.
Within 2 minutes of injections, pt said she wanted to go home. Lay down on ground in exam room; mom lifted her up, noted blue-tinged lips. MD assessment at about 5 minutes: unresponsive, eyes closed, heart rate 40-48, clear breath sounds, pulse ox 100%. Given O2 and SQ epinephrine - HR to 70-80, opened eyes, still lethargic, more responsive, verbal response at 15-20 minutes. Full recovery at about 1 hour, after transport to ER.
DID NOT TAKE THIRD AND FOURTH DOSE ON TIME; This spontaneous case report (PVX2019-2412) was received from a consumer on 23-Sep-2019. It described a female consumer who "did not take third and fourth dose on time" (PT: Inappropriate schedule of product administration), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer did not take Vivotif doses according to the schedule. The doses were taken on 14-Sep-2019, 16-Sep-2019, 21-Sep-2019, and 23-Sep-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not take third and fourth dose on time" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take third and fourth dose on time" was considered as not applicable.
Broke out with shingles one week after receiving shingles vaccine.  Doctor prescribed Famciclovir tab 500 mg which was taken for 7 days. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a pharmacist concerning an 82 year old female, with no medical history and no known drug allergies, who on 09-NOV-2007 was vaccinated with a 0.65 ml subcutaneous dose of ZOSTAVAX (Lot# 658084/0888U). Concomitant vaccine included a dose of influenza virus vaccine (unspecified). On 15-NOV-2007 the patient had a shingles outbreak. The patient was seen by a physician and was prescribed FAMVIR. The patient's shingles persisted. No product quality complaint was involved. Additional information has been requested.
I was in bed sleeping, and heard our dog whine to go outside. I went to get out of bed, and fell right to the floor. I could not feel my legs, but they were not tingling like they were "asleep"...they just felt "dead". I could not stand up for about 5 minutes. I could move my legs, but could not really "feel" them. The closest thing I could equate it to was like having an epidural that numbed my legs from mid thigh and down. I tried several times to stand, and after a few minutes, I was able to crawl up the footboard and "get my legs under me". When I would try to walk, they would respond, but sluggishly. It took a few more minutes before I was able to walk fairly normally again. Two nights later, about 5:00 pm, I was sitting at the dining room table, and both knees felt like they were on fire, with intense aching. That lasted for about 1/2 hour, then went away. I'm not a sick person--I have an immune system that is like a tank. These two incidents were WEIRD. Not being able to walk was very startling.
got the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 04-Dec-2020.  This case involves a patient of unknown demographics who had got the flu (influenza), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, when patient was younger he/she took several flu shots and got the flu immediately each time (influenza) so the patient never got another and hadn't gotten flu since.   It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Fast heartbeat 95-126; Dizziness; weakness; Body shaking all over; Tightness across chest shoulder to shoulder; Tightness across chest shoulder to shoulder; Headache; injection site pain (could not lift my arm for 24 hrs); Tiredness; This is a spontaneous report from a contactable other health care professional (patient).   A 51-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, in Left arm on 27Mar2021 10:30 (at the age of 51-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was none (No underlying medical conditions, was in good health). Concomitant medications were not reported. The patient previously took amoxicillin, augmentin [amoxicillin;clavulanate potassium] and zyban and experienced drug hypersensitivity. 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 had not tested for COVID-19. The patient experienced fast heartbeat 95-126, dizziness, weakness, body shaking all over, tightness across chest shoulder to shoulder, headache, injection site pain, tiredness on 27Mar2021 11:30. The patient stated, could not lift my arm for 24 hrs. The patient underwent lab tests and procedures which included heart rate resulted 95-126, on an unknown date. Therapeutic measures were taken as a result of events, the patient was referred to cardiologist. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
lt thigh appears reddened & hot;hard to touch;this area is next to inj site;it measured 38x29mm;mom stated rxn started immed p/leaving;ear temp taken 97.3;
Vaccine was mislabeled with expiration date of 11/01/2021 rather than 10/03/2021 for refrigerated storage. This vaccine was used to vaccinate this patient
Subsequently post vax, the pt experienced an anaphylactic reaction, which was considered to be an other medical event, that included a rapid onset of swelling, redness, and heat at the injection site, hives all over her body, tachycardia, and shortness of breath. The pt was treated with Benadryl, epinephrine, and Solu-Medrol at a physician's office. Subsequently, the pt recovered.
Not long after receiving the vaccine, the pharmacist called me to say he had not diluted the vaccine correctly and he gave patient at least .8 mm instead of .3 mm. He then went on to say that because patient received a higher dose than he should have, the CDC advised that he would not require a second does of the COVID vaccine.  Upon researching that myself, I see that CDC guidelines instead state that if an error is made with the first dose, the second dose should still be administered 21 days later.  These are both serious errors.
tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable pharmacist.  This pharmacist reported similar events for 6 patients. This is the 5th of 6 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The pharmacist reported that 6 patients tested positive between doses 1 and 2 of the vaccine, in which the pharmacist was giving Covid vaccinations in a nursing home. It was reported that the patient was tested positive between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home. Those patients were tested every day. The pharmacist started administering the second doses. One patient was administered the second dose and then somebody said, "Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, we're under the impression you wait 90 days if they've been given antibodies after that to give the second dose. One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest who were hospitalized did not receive their second injection. Caller asked, "What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on data provided and temporal association, the event are assessed as possibly related to BNT162B2.,Linked Report(s) : US-PFIZER INC-2021222957 same drug/reporter/event, different patient;US-PFIZER INC-2021199894 same drug/reporter/event, different patient;US-PFIZER INC-2021222953 same drug/reporter/event, different patient;US-PFIZER INC-2021222955 same drug/reporter/event, different patient;US-PFIZER INC-2021222954 same drug/reporter/event, different patient
Around May 19th, 2021 my right eye became little red. Slowly in couple days the redness became prominent. Then in few days, one day I woke up and my vision in right eye was little blurry.  I went to an eye doctor and some eye drops medication was prescribed. Then in next two days my vision was almost gone as I could see only shadows. My vision kept on deteriorating every day. I had constant follow ups with the doctor, new medications eye drops were prescribed but nothing happened. I was then referred to another eye doctor who is a specialist in uveitis. The doctor increased my medication dosage of steroids and eye drops, still till that time I could only see finger shadows near my eye, as my vision was completely lost. I continued the prescribed medications for couple months and then slowly my vision started getting better probably in July timeframe. It took many many months to get better, and last my vision was tested in October, 21, and it was getting better. I am still recovering and have recovered a lot but I went through a lot of emotional and mental torture which is very hard to explain in words. I am not sure if this was the result of COVID vaccine or not, but I still wanted to report it as being a good and loyal citizen. I am still scared because I am not fully recovered and don?t want to get booster, and no one can tell me whether it was due to the vaccine or not. I hope some studies come out and help people.  Thanks
This spontaneous report as received from a pharmacist refers to a 51 year old female patient. The patient's medical history and concurrent conditions were not provided. On 04-MAR-2013 the patient was vaccinated with her first dose of MMR II, 0.5 ml, subcutaneous (lot #: 0190AA, expiry date: 08-FEB-2013). It was reported that the dose of MMR II was expired. No adverse effects reported. Additional information has been requested.
102.5 fever; can''t stay awake; throbbing headache; chills; body aches/body cramping; body aches/body cramping; arm feels very heavy; very sore at injection site; Pain in fingers; Shortness of breath; dehydrated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 16:00 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Arm Left, at 10:00 AM), administration date: 04Sep2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "102.5 fever"; SOMNOLENCE (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "can''t stay awake"; HEADACHE (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "throbbing headache"; CHILLS (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "chills"; PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 22Sep2021 19:00, outcome "not recovered" and all described as "body aches/body cramping"; LIMB DISCOMFORT (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "arm feels very heavy"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "very sore at injection site"; PAIN IN EXTREMITY (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "Pain in fingers"; DYSPNOEA (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "Shortness of breath"; DEHYDRATION (non-serious) with onset 22Sep2021 19:00, outcome "not recovered", described as "dehydrated". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, somnolence, headache, chills, pain, muscle spasms, limb discomfort, vaccination site pain, pain in extremity, dyspnoea, dehydration.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever started around 11pm, shivering fever up to 102.  Sick to stomach, weak. Continued fever on and off for about 60 hours. Diarrhea. No treatment sought. Rest/slept.
pt recvd vax 1OCT91 & that afternoon pt exp induration & pain @ inject site; several days later recovered; no further details were provided;
On day 8 of Amoxicillin. Then generalized rash starting 2 hrs after receiving vaccines. Spread over body next 24 hrs with hand and feet swelling. Seen in urgent care. Given IV Solumedrol and Benadryl with PO meds for 5 days. Temp of 100.1, improving.
Pt developed active varicella infection 16 days s/p vaccine administration. Pt had vesicular lesions over her body and was admitted to the hospital. Her hospital course was complicated by other medical conditions including the need for a renal biopsy for a pre-existing renal mass and the need to wait for resolution of lesions to perform the biopsy.
Information has been received from a patient's mother concerning a 14 month old male with no pertinent medical history and no drug reactions or allergies who was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live Wistar RA 27/3). There was no concomitant medication. Subsequently, the patient developed loss of speech, words, severe tantrums, and regression in communications. The patient was 4.5 years old at the time of the report. It was reported that symptoms are improving with speech therapy, special education, auditory and vision therapy. No further information is expected.
WENT IN TO URGENT CARE WITH THE THOUGHT OF UTI DREW BLOOD AND RESULTS WAS HYPOTHYROIDISM. SYMPTOMS WAS FATIGUE NOT INTERESTED IN DOING ANYTHING LOW DEPRESSION NOT MOTIVATED,
Evening of Day 1, shaking chills, fever (100), headache. Went to bed at 9:00, woke at 3am with severe "swelling" I felt like my brain was too big for my skull, my entire face felt swollen. Joint aches, muscle aches, nausea. Nausea has been intermittent thru day 5. Headache continues but not as severe. I still wake up with it every day (this is now day 5). Diarrhea began on Day 3 (watery, every 1/2 hour for 4 hours). fever subsided and returned on Day 3 (100). no fever since but muscle aches, headache and joint aches continue.