chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). The patient took concomitant medications which include seasonable. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Mar2023) Negative, notes: Tested negative on Day 4 of taking Paxlovid; (14Mar2023) positive, notes: Then again tested positive 3 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient tested negative on Day 4 of taking Paxlovid, but then again tested positive 3 days after finishing Paxlovid. The patient received Paxlovid from 05Mar2023 to 10Mar2023. Patient was on other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300116349 same patient, different drug, different event;
My arm was sore and red then it was red all around the injection spot it was itchy and hot. I was dizzy and light headed felt like i was going to throw up.  Now my whole left arm just had a pain in it
FATIGUE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 vaccinated at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.  Version created to amend previously reported information on 16-Mar-2021. Upon review the following information was amended: Therapy end date was added. Product vaccine facility No information (Vaccine) re-entered in red font. DD correction done as reporter details were available.
fainting - 8:00 am after injection the day prior at 12:00 pm.  EKG results: Sinus bradycardia with sinus arrhythmia left atrial enlargement right ventricular conduction delay
Resident physician wants to register in the pregnancy form; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of PREGNANCY (Resident physician wants to register in the pregnancy form) in a 34-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.    Co-suspect product included non-company product MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    The patient's past medical history included No adverse event, Pregnancy (Live, full-term birth) on 20-Dec-2017 and Abortion (Spontaneous abortion) on 24-Apr-2020.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) (unknown route) at an unspecified dose. The patient's last menstrual period was on 07-Jul-2020 and the estimated date of delivery was 12-Apr-2021. On an unknown date, the patient experienced PREGNANCY (Resident physician wants to register in the pregnancy form). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) during pregnancy.  At the time of the report, PREGNANCY (Resident physician wants to register in the pregnancy form) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Standard tests are the lab test reported by reporter which is everything normal.   Reporter did not allow further contact
Patient states she felt pain at the injection site, nausea, fatigue, and HA. She states the symptoms began late early 21MAY14. However, she did not report until 23MAY14.
Body aches, a little light headedness, sleepy.  Began 3 hours after injection
Swelling of the lymph node; Injection site discomfort; Injection site pain; A spontaneous report, was received from a pharmacist (patient), a 29 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced injection site discomfort, swelling of the lymph node (lymphadenopathy), and injection site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, for days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 025L20A), intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient began to experience swelling of the lymph node, injection site pain and discomfort. The symptoms were still ongoing. Currently, the patient has not received any treatment for her symptoms and wants to know if she can take any medication to treat her symptoms.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event events, swelling of the lymph node, injection site pain and discomfort, were considered as not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt woke up and had difficulty walking due to poor balance. Swaying while standing and seated, falling when he tries to walk.
Pt developed pain in his shoulder joint and could not lift left shoulder up without extreme pain that radiated down his arm. He also mentioned tingling in his 4th and 5th fingers that resolved shortly after starting. When I talked with him, the pain was improving. Patient wonders if this is related to being on Evolocumab.
PT CALLED AFTER SHE LEFT HEALTH DEPARTMENT AND STATED SHE HAD ITCHING ALL OVER.   SHE STATED SHE STAYED 30MIN AFTER GETTING VACCINE, AND ITCHING STARTED 20 MIN AFTER SHE GOT THE VACCINE, BUT DID NOT TELL US.  SHE STATED SHE THOUGHT IT WOULD JUST GO AWAY.   SHE TOOK BENADRYL ORALLY AFTER SHE GOT HOME.  INSTRUCTED HER TO GO TO ER IF HAS ANY SHORTNESS OF BREATH, ITCHING THROAT, OR RASH.  PT VOICED UNDERSTANDING AND AGREEMENT.   I CALLED HER BACK AT 2PM TO CHECK ON PT AND SHE STATED ITCHING HAS IMPROVED, BUT NOT TOTALLY GONE.  DENIES ANY RASH, SHORTNESS OF BREATH, OR ITCHY THROAT.  INSTRUCTED HER TO GO TO ER IF DEVELOPS RASH, ITCHY THROAT, OR SHORTNESS OF BREATH.  PT VOICED UNDERSTANDING AND AGREEMENT.
pt recv vax & 6 days post vax pt devel an itchy rash all over body & was getting swollen;
On 12/21/2020 I developed menzies & on 12/26/2020 I was seen by my doctor.
Pt recv vax on unknown day; post vax pt exp vax site induration, erythema & itching from shoulder to elbow; pt imp 3 wk
low rubella titer; This spontaneous report has been received from a nurse referring to a 25-years-old male patient. The patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were not reported.  On 01-DEC-1997 and 01-MAR-2002, the patient was vaccinated with the first and second doses of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) for prophylaxis (therapy type, dose, vaccination scheme, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported).   Since an unspecified date, the patient had a low rubella titer (rubella antibody negative). The patient's measles and mumps titer were within normal limits.  The outcome of rubella antibody negative was reported as not resolved. The nurse causality assessment was not provided between the measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II), and rubella antibody negative.
got sick; Initial information was received on 23-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who got sick (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient took one once and got sicker that year than ever before not saying shot caused it but it sure, as hell didn't help.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
pt recv vax 17JUL96 & pt was fussy but responded to APAP initially;day 2 following vax pt began to get irritable, crying alot & mom noticed that pt stiffened up & became unresponsive for a couple of seconds;acted clingy afterwards;
Sharp tingling/blood pooling in hands and feet, nausea, & chest tightness/pain experienced frequently the day following vaccination.
This spontaneous report as received from a certified medical assistant, refers to an unknown number of patients of unknown demographics. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2013, an unspecified number of patients received improperly stored Vaccine For Children (VFC) doses of RECOMBIVAX HB (dose and route, lot and expiration date were not reported) exposed to 20F and 30F on multiple occasions, from 22-SEP-2013 until 20-DEC-2013 (for 122 days. No adverse effects were reported (the reporter stated that the vaccines administered were RECOMBIVAX HB and VAQTA but on a second call was reported that no doses of VAQTA were involved in this excursion). Follow up information has been received from the certified medical assistant which reported that one of the patients was vaccinated with a dose of RECOMBIVAX HB (lot number reported as J0030722) on 06-SEP-2013. This is the one of several reports from the same source. J0030722 is not valid lot number for hepatitis b vaccine (recombinant). Additional information has been requested.
Background: about 2 years ago, it turns out I had a bilateral deep vein thrombosis blood clot in both lungs. It manifested by a very sharp muscle pain, to the left side of my back. I attributed it to be a muscle strain, however the next day I became very weak. I found myself to have difficulty exerting myself in any degree whatsoever. I happened to pick up an oximeter. I was playing with it that night and it read 85. That night I went to be ER. I was given a blood thinner, Eliquis, and was released the next day. I went off the blood thinners after 6 months. I was diagnosed with DPE/dual pulmonary embolism. I was put on Eliquis on 03/04/2018. The source of the blood clot was my left leg. I was taken off the Eliquis 09/2018. On 03/05/2021 about 9 hours later after the vaccine, I started to have that very sharp pain in my back. The exact same place I felt it 3 years prior of the vaccine. The oximeter was down to 90. I decided to hang tough before I went to the ER. Within 2 hours the pain had gone away the oximeter went up to 96. At 8:00PM on Friday the pain had gone away and the oxygen level was back to normal. On Monday, I called my PCP and I asked him to prescribe blood thinner and I restarted the Eliquis bd on Monday. I continued that until I got my 2nd dose on 03/26/2021. I did not have the symptoms I had after the 1st dose. I had the booster 10/01/2021. I also started Eliquis 2 weeks before the dose, and I did not have the same reaction as the 1st dose. I honestly do not know if I would have had the same reaction with the booster, but I was not going to take the chance.
Information has been received from a 23 year old female medical assistant (who was also the patient) who on an unknown date was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (dose and lot # were not reported). The medical assistant reported that on an unspecified date she experienced swelling around the injection site and the area was painful for about a week and a half. The patient saw a nurse practitioner. The self therapy with MOTRIN and ice and movement exercises were given for the adverse events. At the time of reporting, the patient had recovered. The patient did not seek medical attention. No further information is available.
A report has been received from a Health Professional concerning a 57 year old, male subject, who had been receiving FLUMIST. The patient's concurrent disease(s) included egg allergy. FLUMIST started on 05-Nov-2013. It was reported that patient was administered FLUMIST to a 57 year old which started on 05-Nov-2013. The outcome of the event of administered FLUMIST to a 57 year old is unknown. The report was considered to be non-serious.
Narrative: COVID infection following COVID vaccine series 03/05, Pfizer, dose # 1 03/26, Pfizer, dose #2 08/25 COVID swab, result: detected 08/26 pt cc: NONE exposure; unknown
Shingles shot... pain left arm, level 7...... severe headache, already into 2nd day........joint aches (gone by second day..........very tired throughout the day.
Information has been received from a RN concerning an 8 yr old female who in 1996 was vaccinated with a dose of varicella virus vaccine live (lot 622684/0343E). The RN reported that in May 2005, the pt developed mild chickenpox characterized by 40 to 60 lesions. Unspecified medical attention was sought. At the time of this report, the outcome was unk. Additional information has been requested.
pt recv vax;devel raised rash w/ white ctr approximately 4cm around inject site w/ itching,swelling and redness at inject site; tx w/ dph & observed for 30 min;reporter felt that exp related to vax;
Injection site arm got really red, swollen, and hot. Also had a red stripe horizontally 4 inches below injection site. Injection site was painful.
Reports warm to touch, hard area under area with slight redness, runny nose and malaise.
I contracted COVID after my 3rd dose. I had high fever severe muscle aches, sore throat. I could not swallow. The fever went as high as 102, for about three days. I felt sick for two weeks. I had a very painful and awful cough.
Child was injected with .5mL of influenza vaccine instead of 0.25mL.  The child appeared well subsequently and no symptoms were thought to occur.
was having internal bleeding and trouble breathing; was having internal bleeding and trouble breathing; This is a spontaneous report from a non-Pfizer sponsored program, received from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-082808). This case was split from master case AER# 202101109480 for a patient taking COVID-19 vaccine and experienced internal bleeding and trouble breathing.  A 48-year-old male patient was involved in a patient support program described as "PSP-Eliquis-Lash-CW2891702" (Protocol: PSP-Eliquis-Lash-USA). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. Patients past medical included latex allergy from an unspecified date an unknown if ongoing. Concomitant medications was not reported. It was reported that, on an unspecified date, after vaccination, patient experienced internal bleeding and trouble breathing which continued at this time. The outcome of event was not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Woke up the following morning with severe headache and vomiting. Recommended follow-up immediately with MD.
My arm was sore for three days.  I had headaches off and on.  I started to develop a papulopustular rash on the forehead.
Information has been received from a registered pharmacist concerning a 66 year old male patient. The patient had no pertinent medical history and no known drug reactions or allergies. On 01-OCT-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX vial, 1 vial (lot #: H012575; Expiration date: 28-SEP-2013). Concomitant vaccination included a dose of FLUZONE. On 02-OCT-2012, the patient developed 2 inch in diameter of redness and soreness at the site of ZOSTAVAX. The patient's wife called the pharmacist to seek medical attention. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient was recovering from the events. The relatedness for 2 inch in diameter of redness and soreness at the site of ZOSTAVAX vaccination and 2 inch in diameter of redness and soreness at the site of ZOSTAVAX vaccination was unknown for ZOSTAVAX. Additional information has been requested.
On 4-5-16 ZOSTAVAX (shingles) vaccine was administered to patient. On 4-8-16 patient reports redness and swelling at site of injection. I advised her to go ER today and patient diagnosed w/shingles and cellulitis. Antibiotics, anti-virals, and pain medications was prescribed to her as a result.
Loss of sense of smell; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received the first dose of BNT162B2 (lot EL1284) via an unspecified route of administration on 23Dec2020 07:00 (07:00 AM) at a single dose on the left arm as COVID-19 vaccine. Medical history included seasonal allergies. There were no concomitant medications. The patient had an adverse event of loss of sense of smell on 24Dec2020 assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. There was no treatment for the event. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He had no other vaccine within four weeks, no other medications within two weeks prior to the COVID vaccine, and no Covid prior to vaccination. He did not have the Covid tested post vaccination. The outcome of the event was not recovered.
DOB: 3/21/1991. Received her second dose Pfizer (LOT#: EW0185 EXP: 8/2021) at 1441 on 5/18/21. Patient alerted EMT. Patient stated that she felt dizzy and had a severe headache. Patient stated it was an 8/10 on the pain scale. Patient stated she had lunch around 1200. EMT took patients vital signs at 1500. BP: 108/72 pulse: 86, O2: 99%. Patient was given water. Patient was asked to stay an extra 30 minutes for further observation. EMT reassessed and re-took vital signs at 1510. BP: 122/72, pulse: 82, O2: 97%. Patient stated she was feeling slightly better. Patient stated the pain from headache went down to 7/10. EMT reassessed and re-took vital signs at 1530. BP: 124/78, pulse: 74, O2: 96%. Patient stated she was feeling a lot better. Patient stated the pain from headache went down to 5/10. Patient was educated on worsening signs and symptoms of vaccine and when to seek EMS or urgent care. Patient verbalized understanding of education. Patient completed observation time. Patient left vaccination site at 1535. Patient left vaccination site unassisted and with a steady gait.
Patient received both vaccines on 7/23/20, patient came in on 7/27/20 with complaint of redness and hot to touch in the areas of injection site. I confirmed with patient she does not have any other symptoms besides these listed. Due to the time frame and patient still having reaction to injection I advised she seek further medical care and to be examined by her provider.
Rash on face 6:30 pm, diminished by 8:00 PM  Inspite of hydrating all day, awoke very dry 1:20 am, 3 18 21.  Drank, went back to sleep.  'Awoke' around 2 am hallucinating I was out of body with my limbs as  cards as in solitaire ( I play a lot) that I was unable to rematch in correct order.  Altho aware of 'dreaming', I was not able to stop this from continuing until sunrise, around 7 am. I had minor aches and sore arm for three days after.  Reported this to clinic.
I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood blister; I had loss of balance; I could not walk; I was short of breath/Trouble breathing; I had blotting stomach; I had pain in my head; I had trouble sleeping; I was very weak; I have a problem with my memory; I was so ill; I feared I would die I was so sick; This is a spontaneous report from a contactable consumer or other non hcp. A 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8733) via an unspecified route of administration on 06Apr2021 at the age of (89-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced that she had loss of balance, could not walk, short of breath, blotting stomach and trouble breathing, pains in my head and trouble sleeping and she got a blood blisters on her mouth and it was after 6 week she still had a spot on her lips where blood blister was it was not painful, but she was very weak. She had a problem with her memory. She took Benadryl first and it did not really help after 3 or 4 weeks and then did not help she visited the emergency room for two times and later she went to doctor cabin for several times. This was how ill she was and eventually she had problems with Prednisone (Not clear and not clarified). She informed that she was so ill and did not take the second shot. The patient stated that she was very very ill, and she and her husband went to cemetery, a place where she could be buried because she feared she would die she was so sick, and her husband had a shot, and he was absolutely fine. The patient reported that there were people like who did not help and actually made her very ill maybe it was her age maybe it was her chemistry but it was definitely not for every single person. The patient finished taking drugs as she took them for a period of time (completed the course). She was not taking any drug and she was recovered, and she was doing better and her health was better. The patient took treatment for all the events. The outcome of the event the problem with her memory was not resolved whereas other events were resolved on an unknown date.  Follow-up attempts are completed. No further information is expected.