chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report is the first of two reports (other case related: 1209USA004977) received from a Registered Nurse (RN) concerning a female patient in her 60's. The patient pertinent medical history and drug reactions or allergies were not given. On an unspecified date, one or two years ago, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously (Lot # and Exp. date were not given). No other co-suspects were reported. No concomitant medications were reported. The RN reported that on an unknown date the patient broke out in a very mild case shingles with a year or two after receiving ZOSTAVAX. No treatment was given. The outcome was reported as recovered/resolved. Additional information has been requested.
Pain & swelling at the injection site; Pain & swelling at the injection site; low grade fever (100.3); chills; fatigue; headache; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 08Feb2021 at the age of 38-year-old as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications none. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on unspecified  date as dose 1, single for covid-19 immunisation. On 09Feb2021, patient experienced pain and swelling at the injection site, low grade fever (100.3), chills, fatigue and headache. her symptoms lasted about 2 days. she felt normal by the 3rd day. The outcome of the event was recovered on 11Feb2021.  No follow-up attempts are possible. No further information is expected.
One hour after the injection on 2/18/2022, my pulse dropped to 48 bpm & severe chills started two hours after the injection, followed by pain at the injection site & nausea.  The next day (2/19/2022), I had the normal vaccine side effects (fever up to 100.7*F, nausea, headache, injection site pain, fatigue, muscle/joint pain, abdominal pain), which were much worse than I had after dose 2, as well as intermittent left side chest pain & left arm tingling, with difficulty standing upright.  The symptoms lessened on 2/20/2022, then increased again on 2/21/2022, with fatigue that kept me from working, intermittent left side chest pain becoming more frequent, and difficulty regulating blood pressure when standing up after sitting (intense pounding pressure in head & blurry vision causing me to immediately sit back down until it would pass).  A pressure-like pain spread into my upper back, the lymph nodes in my left armpit were swollen, & it felt like fluid was sloshing at times in my chest, especially on the left side.  Since 2/22/2022, I continue to have intermittent left side chest pain, swollen lymph nodes, fatigue, & headache, as well as left leg muscle cramps that started in my calf & now span from my heel through my thigh, & a dry cough early in the morning & late at night.
Pt devel macular rash around neck, chest & shoulders; 25APR rash lasted <48 hrs; Fully recovered;
04/13/2021-after receiving your vaccine-my chronic condition Cranial palsy went away till mid July 2021. At that time the muscles that controlled the eye and I had to go back to my PT for the eye. In early September of 2021 my dr did a visual test was bout 90% under control then.
Given 12:20 pm.  Extreme fatigue, eyes swollen/heavy 7:00 pm for about 2 days. New soreness at injection spot 3 days later for appx 24 hours (bearable). Extreme itchiness, splotchiness, and increasing rash on face and neck 7 days later. Currently on day 6 of rash and day 2 of Prednisone prescription with rash slowly lessening.
received the second and final dose of the Pfizer BioNTech vaccine on 09Feb/receive the first dose of the Pfizer BioNTech vaccine on 17Jan2021; fever; body aches; chills; severe nausea; even vomited a few times; overall weakness and fatigue; overall weakness and fatigue; This is a spontaneous report from a contactable Consumer. This 29-year-old female consumer reported for herself. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EK9231) via an unspecified route of administration in arm Left on 09Feb2021 18:30 as dose 2, single (age at vaccination: 29 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EL9261) via intramuscularly in arm Left on 17Jan2021 18:30 as dose 1, single (age at vaccination: 29 years) for COVID-19 immunisation. No other vaccines given the same day and no problems with vaccines in past. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. On 10Feb2021, the patient experienced fever, other symptoms associated with after the vaccine were body aches, chills, severe nausea, even vomited a few times, overall weakness and fatigue and this was reported as worsened. The patient received vaccine doses, reported post vaccination experience with DSU. On 11Feb2021, stated that she was out of work today for fever. It was queried that will the vaccine cause a false positive on covid-19 rapid test. Her workplace is wanting her to get a rapid Covid test to rule that out and to clear her to go back to work. Wants to see if it's okay for her to that testing or if she can pretty much go back once the symptoms subside. Fever started yesterday evening around 6:30-7:00. The patient underwent lab tests and procedures which included fever resulted as 100-101.4 on 10Feb2021 hovering about 100-101.4 even this morning. It's been hovering over the 100's. The clinical outcome of the events received was not resolved and the event received the second and final dose of the Pfizer BioNTech vaccine on 09Feb/receive the first dose of the Pfizer BioNTech vaccine on 17Jan2021 was unknown.  Follow-up attempts completed. No further information expected.
On May 3, 2022 I started feeling run down, I had a little cough, and sore throat. I did a home COVID 19 test that came back negative. The next morning I still fell unwell so I took another home COVID 19 test, this one came back positive. I called my doctor, since I am on immunosuppressant drugs I am not a candidate for Paxlovid. I was referred to the hospital for the monoclonal antibody infusion, I felt better within three days of having the infusion.
stroke; This is a spontaneous report from a contactable other hcp. The other hcp reported for both the husband and wife, this is the case for husband. A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stroke on unspecified date.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021856673 Same reporter/ drug/event, different patients
Congestion, sore throat - 11/6 bronchitis - 11/13
Symptoms began on 2/5/08 with one red spot on ear and headache. Fever of 101.8 began 2/6/08 with two more itchy red spots. 2/7/08-has: many red, itchy spots in various stages of varicella. Diagnosed in office with varicella on 2/7/08 by Dr..
pallor, mottling of skin, dyspnea, choking, gagging, irritability, staring spells, arching of back;
Pt notices head falls to his left, shoulder droops to left, gait uncertain beginning 8 days post vax and continuing to present.
1:30pm Moderna COVID-19 Vaccine Vaccine Lot Number: 025B21A NKDA, No medications, no medical hx apprehension, flushing and/or skin edema, abd cramping, N/V, vasomotor collapse. pt wilted and vomited. 1:55 117/65 p98 r18 2:10 132/65 P82 r18
fever; chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On an unspecified date 14 hours after second dose the patient experienced fever and chills. It was reported that event took place after use of product. Outcome of fever and chills was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID-19 VIRUS TEST POSITIVE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-MAR-2021 for covid-19 prophylaxis. The number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 virus test positive. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient was recovering from covid-19 virus test positive. This report was non-serious. This report was associated with product quality complaint: 90000247168. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20220848259.
Within  3 minutes patient experienced Shortness of breath, mouth on fire, tingling all over body, feeling like she would pass out.  Administered 0.3mg Epinephrine via auto injector.  Within 30 seconds patient begins to recover.  Verbalizes she is feeling better.
I am 77.  I had the Pfizer vaccine, March 9th,  with a terrible reaction starting 2 days after.  I couldn't use my brain to think, to read with comprehension, to remember things I wanted to remember and had difficulty finding my words. This lasted for 3 days when the fog began to lift.  I also had some shortness of breath(SOB)  and very low energy.  The CDC has said that when giving the injection it is no longer necessary to aspirate (pull back on the syringe) which I was taught to do as a young nurse to ensure that you are not giving the injection into a vein (blood would appear in the syringe.) It is supposed to be given into the muscle which has plenty of veins so if you don't aspirate, how will you know if you are injecting into a vein? A week later, I ended up going to the local hospital ER because of the SOB and had Chest xray, EKG, brain Cat Scan and blood work which were all normal. I debated about getting the second shot but decided to get it as long as the injector gave the injection as I had been taught. Fortunately she was very experienced and agreed to inject me using the pullback method after I explained what I had gone through the 1st time. So for the second shot I had the sore arm but no other reaction. I think Dr is making a mistake about the pullback decision.  Do we even know what happens if the vaccine is injected into a vein? I am not certain if my first shot was injected into a vein because the injector never pulled back to check.  I have not heard of anyone else with my experience.
Sore upper left arm the day of vaccination. 20-26 hr after vaccination pain in left arm spread down to the elbow and unable to lift using that arm. trouble sleeping the evening of 7/21/21 due to pain in arm. Extreme fatigue beginning 3pm day after vaccination. Unable to do any physical activity for more than about 5 min. then had to rest. So tired had to go to bed for the day at 8pm when normal bed time is 10-11pm
Pt was given the wrong influenza vaccine based on age of patient. No adverse event or treatment needed.
Right wrist inflamation/pain that does not go away after a fall on the ice in early March about 1 week before dr visit. At doctor visit an xray was done-- no break but beginning of arthritis. I've been using ibuprofen 800mg/day to stem inflammation -- minimal help in pain relief. Just started Turmeric 2000mg/day which seems to actually be improving my pain relief. Reason why I am am filing this -- my husband oddly enough is having wrist pain in both wrists -- left wrist is currently locked up; right wrist seems to be starting in same progressions as left. He went to the doctor who didn't find anything -- thought maybe tendonitis and prescribed a wrist brace. He's been taking ibuprofen and will start on Turmeric since problem is getting worse. The only thing in common is our both having had full set of COVID shots along with a flu shot in the Fall along with the strange wrist inflammation/pain ailments. I have worked from home via computer during entire pandemic; my husband had a desk job with a mostly empty office --. He retired in September so has been getting into some projects around our house including adjusting some landscaping blocks 50-75lbs. each last fall. He has an entirely locked up (can't bend up or down) left wrist; his right wrist now seems to be starting on the same progression as the left. He went to the doctor in Feb. who didn't find anything -- thought it was perhaps tendonitis. Neither of us had a suspicion of or diagnosis of having had COVID. These ongoing never-ending wrist ailments are very odd/strange that they are common to both of us and are getting worse rather than better.
Narrative: PT is a 54 yr old MALE with complaints of: headache and expressive aphasia. HISTORY OF PRESENT ILLNESS: 54 y/o male who presented to the ED today for "the worst headache I have ever had and I wasn't able to get my words out correctly." He reports that this event occurred in a store at approximately 1400. He states that he has had a headache "off and on since Monday, I would take Motrin and Tylenol and the pain would go away, but it always came back." He stated that the pain occurred "mainly in my forehead." He admits to nausea this afternoon with the headache and reports photophobia. He reports he vomited x 1 today "with the headache." He denies vertigo or LOC with this event and denies loss of bowel or bladder function. He was resting quietly in on the bed in his room and appears in no acute distress. +photophobia upon exam. He reports that he has a rash on his flank that is "mostly on the left side and it it is very itchy and hurts when I touch it." He denies fever, chills, sob and chest pain. His speech is clear and non-garbled, able to speak in complete sentences without difficulty. Telestroke consult completed in ED with following recommendations: - 54 yo RH M presenting with transient episodic aphasia in setting of severe headache and zoster rash. Currently speech is close to normal. Periods of aphasia correlate with headache severity. Given history, transient aphasia likely related to migraine vs mild VZV encephalitis/vasculitis as opposed to transient cerebral ischemia. Furthermore his symptoms are improving and non disabling. Recommend evaluation by local neurology for further work up as indicated. Consider MRI brain w/wo. He will be admitted for CVA r/o, Covid 19,shingles and headache. HOSPITAL COURSE: Pt admitted to the floor. admitting dx r/o cva ; aphasia. mri of brain ordered. neurology consult. CTA of neck: No occlusion or high grade stenosis noted. CTA of head: No acute intracranial abnormality. CT of Head: no acute abnormality. prn pain med for headache. pt w/o hypoxia or fever associated with covid. resp isolation. no medications indicated. shingles - started on acyclovir. corrected electrolytes. neurology consult: Transit secondary migraine with aura vs TIA, likely due to Covid There is no evidence of vasculitis on CT angiogram, no evidence of encephalitis on MRI. recommended echo to complete work up. pt reports no headaches 6/4/22. no further aphasia. pt preference for outpt echo . pt stable for d/c to home. to cont tx for shingles for 7 days total. to self isolate for 5 days due to covid.
Left shoulder pain - She's had redness swelling and tenderness in that area starting ever since. It is incredibly painful to the touch. In fact when she took off pressure at this morning she screamed with pain. She has spreading redness in the area as well. Cellulitis this is quite possibly infection brought on by her immunization. It does not look like standard inflammation from an immunization. Plus its 2 weeks out from the immunization. Giving her Keflex and Bactrim. 1 tablet twice a day for 10 days for both medications. She will follow-up if this is not working. If this antibiotic does not work we may need to get imaging.
1st dose on 31 may 2021, 2nd dose on 30 Jun 2021 and 3rd dose on 31 Aug 2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 31-AUG-2021, the patient received the 3rd dose of Twinrix. On 31-AUG-2021, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose on 31 may 2021, 2nd dose on 30 Jun 2021 and 3rd dose on 31 Aug 2021). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Aug-2023 A pharmacist called in to report that a patient measured their tithers to check for immunity after received the complete series for Hepatitis B and wished to know how to proceed.  Partial information was given.  No consent was given. Did not consent to follow-up. The patient received the 3rd dose of Twinrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Pt got Flu shot & PNEUMOVAX & next day got ST, HA & cough 2 d after vaccine had T=107, fever resolved in 1 wk & cough in 3 weeks.
Patient's left eye and cheek were extremely swollen. He was irritable and crying with a fever.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It hurt little bit when they put needle in) and EXPIRED PRODUCT ADMINISTERED (got medicine that was expired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was reported). Concomitant products included OMEPRAZOLE, CITALOPRAM, AMLODIPINE, LISINOPRIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ACETYLSALICYLIC ACID (BABY ASPIRIN), ZINC, DOCUSATE SODIUM, TEMAZEPAM and ROSUVASTATIN for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (got medicine that was expired). On an unknown date, the patient experienced PAIN (It hurt little bit when they put needle in). On 11-Jan-2021, EXPIRED PRODUCT ADMINISTERED (got medicine that was expired) had resolved. At the time of the report, PAIN (It hurt little bit when they put needle in) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: no antibodies OTHER. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included Centrum silver, Omega3 fish oil, CoQ10
Mother called PCP office 1/5/2018 indicating child had immunizations at his WCC on 1/4. Later that evening about 4 hours after receiving he started with a temp by 7:30 pm his temp was 102.3- Gave ADVIL and it did come down but at 3:30 am temp back at 102.3. She said he did c/o left leg shot really hurt but no redness or swelling. He c/o that his hands don't want to work when he tries to pull up his pants, he did throw up a bit in the morning of 1/5 but mom attributed to ADVIL. She indicated he is not happy, cranky. No resp sx, was in good general health prior to shots. Mother called today 1/8/2018 to report all symptoms completely resolved in 24 hour period. The highest his temp reached was 103 during that 24 hour period.
Pfizer / BioNTech: Mar2021, Apr2021, Moderna Dec2021; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Mar2021, Apr2021, Moderna Dec2021; Paxlovid: Treatment of COVID-19; The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ALKA SELTZER PLUS [ACETYLSALICYLIC ACID], start date: 04May2022, stop date: 07May2022; THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE], start date: 08May2022, stop date: 09May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech: Mar2021, Apr2021, Moderna Dec2021; Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date= 06May2022, Treatment stop date= 10May2022. Indication=Treatment of COVID-19, Adverse event: Rebound Covid after taking Paxlovid, Adverse event start date: 14May2022, Ae resulted in: Not recovered, If patient recovered: Not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I contracted COVID-19 on 07/04/2022 with symptoms of headache, congestion, runny nose, sore throat, clogged, ears, and cough. I was prescribed doxycycline 07/05/2022. I was ill for 7 to 8 days before my symptoms began to resolve. I had a lingering cough for an additional week that resolved. I am fully recovered now with no lingering symptoms.
On the 26th I started experiencing dizziness, confusion, and brain fog. At the time I associated it with anxiety I was experiencing. Since that time I have started Lexapro and trazodone to help with those symptoms, and the anxiety is now controlled. I am still experiencing the dizziness and brain fog daily throughout the day. It interferes with my life. I never had COVID that I am aware of. I certainly never had dizziness prior to the 26th. It has been  10 weeks. Next week my dr has me scheduled for an EKG and blood work. I often struggle with putting thoughts together and am fatigued. My mind feels off kilter.