chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hair loss/losing a lot of my hair since the vaccine/hair is falling out/losing hair five months afterward and it's coming out in clumps; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss/losing a lot of my hair since the vaccine/hair is falling out/losing hair five months afterward and it's coming out in clumps) 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 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ALOPECIA (hair loss/losing a lot of my hair since the vaccine/hair is falling out/losing hair five months afterward and it's coming out in clumps). At the time of the report, ALOPECIA (hair loss/losing a lot of my hair since the vaccine/hair is falling out/losing hair five months afterward and it's coming out in clumps) outcome was unknown.            No concomitant medication was reported. Treatment information include not provided.
2x3cm pale erythematous flat rash with central raised red mac-pap rash 1.5x1.5cm; non tender, no increase in warmth, no edema.  No meds needed, expected to improve over the next 1-2 weeks
Pain in (R) deltoid radiating up into (R) neck area with noted swelling of 5 inches in (R) upper arm.
losing hair in clumps after getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing hair in clumps after getting vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (in December 2020).    On 01-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 experienced ALOPECIA (losing hair in clumps after getting vaccine). At the time of the report, ALOPECIA (losing hair in clumps after getting vaccine) had not 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.   No relevant concomitant medications were reported. No treatment information was provided.
Pt arrived to emergency department complaining of RIGHT side facial droop that includes the right eye.   Diagnosis by physician is bells palsy second to Covid-19 vaccination that she received two weeks prior.  Pt also going to be evaluated for further neurological problem and will requiring admission to inpatient hospital.
Significant bruising at the very injection site (onset within 2-hours), which could have been the administration of the injection.  Three days post injection, there developed redness, swelling, and inflammation (hot to the touch) ~2-inches below the injection site. These symptoms have been persistent to-date, with intermittent and very slight itchiness.  Symptoms have not been alarming or persistent to the point of requiring medical attention.  Also to note (which may or may not be related), I have experienced migraine headaches daily beginning with Wednesday, September 14, inclusive of today, September 17, for which I have taken Zomig doses (2.5mg once daily).
Redness and swelling of right lateral thigh; noticed on Thursday morning (02/06/03). Mother applied alcohol compresses. Friday AM, decreased redness and swelling, but still with significant swelling.
Swelling the size of a softball at site; fever, and spreading up the arm from injection site.
pain at the injection site; swelling at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than a week after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. 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: 02-Nov-2022 Reporter's comment: The patient received dose of Fluarix vaccine and experienced pain and swelling at the injection site. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Began with an itchy neck then turned red and warm.  Spread from neck to chest (put anti-itch on which removed the redness). About an hour later spread to left side, then right side with large red area that was itchy and warm to the touch.  Took Benadryl and applied anti-itch cream. Woke up at 1AM that morning to extreme desire to itch my burning arms.   Went to the bathroom and found that both arms from shoulders to wrists were red and inflamed, along with both legs from hips to knees and splotches all over chest and ribs.  Took more Benadryl. Next morning no spots but desire to itch different areas.
Her arm became swollen, her head hurts so bad til it is making her ear hurt, nausea and feel weak.
Had a seizure after each of her doses; disease recurrence; Stomach ache; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional) from medical information team. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Nov2021 17:45 (Lot number: FK5618) at the age of 9 years as DOSE 1 (TRIS), SINGLE and administered in deltoid left, administration date 01Dec2021 17:45 (Lot number: FK5618) as DOSE 2 (TRIS), SINGLE for covid-19 immunisation. Relevant medical history included: "seizures from heterotopia diagnosed about two years ago" (unspecified if ongoing).  The patient had no vaccinations prior to BNT162B2 within 4 weeks. Concomitant medication(s) included: LEVETIRACETAM taken for seizure, two and half tablets in the morning and two tablets at night by mouth. The following information was reported: SEIZURE (medically significant) with onset 2021, outcome "unknown", described as "Had a seizure after each of her doses"; DISEASE RECURRENCE (medically significant) with onset 2021, outcome "unknown", described as "Disease recurrence", ABDOMINAL PAIN UPPER (non-serious) with onset 21, outcome "recovered" (2021), described as "Stomach ache for two days"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache for two days". The event "had a seizure after each of her doses" and "disease recurrence were evaluated at the physician office visit.  Follow up (13Dec2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (father) reported for a 10-year-old female consumer (daughter).  Updated information: Patient details updated.  Additional information: New events added. Vaccine start/stop dates and time added. Lot numbers added. Event duration for events added. Vaccination facility information was added.   No follow-up attempts are needed. No further information is expected.
The first shot was sick and down for 4 days but that went away.   The 2nd Pfizer shot I went to the urgent care thinking I had a UTI.  Everything came back normal and was told to take Ibuprofen which I thought was strange they said I might have inflammation in my bladder with a couple of weeks everything was back to normal.   Then I got the Booster Pfizer shot on 9/13/2021 about 2 weeks I started having horrible bladder pain and was having to pee all the time.   I went back to the doctor he did a UTI test and it came back negative.  I am now going to a urologist and having to do bladder treatments.   I do not have a history of bladder issues and was going up to 40 times per day and it's been a living pain for me.
pt recvd immun lt area & went to car, father noticed pt in seat stiff & rigid, eyes glazed & fixed for approx 45 secs; became responsive but was unaware of what happen; BP 90/54, P 82 irregular alert & answering questions;
101.3 fever by 6 pm, 101.1 fever the next morning (6 am) intense shivering and aches in afternoon of 4-06 and intense heat evening of 4-06 and morning of 4-07. I took Tylenol and ibuprofen throughout it which definitely helped and my fever would break but then once the medicine wore off the fever would come back. Symptoms ended around noon today (4/07).
A report rec'd on 8/30/02, reported: medical technician called to report AE of child. The pt rec'd her 5th and final dose of Infanrix (Tripedia) the day before at approx 3pm. Beginning today at approx 1pm EST, she began to experience swelling a the injection site and swelling of her L eye. Parent's took her back to Dr's office, where she was given a shot of epinephrine. Pt has never had any previous reactions with vaccine, and she is not taking any medicines. Medical info has no letters concerning eye swelling.
right arm at the site of injection was pink; right arm at the site of injection was  puffy and hard; right arm at the site of injection was itchy; nausea; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA, PRURITUS, ABSCESS, and NAUSEA in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Abscess (Itching of the skin at the injection site) on 09-Feb-2021.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ERYTHEMA, PRURITUS, ABSCESS, and NAUSEA. At the time of the report, ERYTHEMA, PRURITUS, ABSCESS, and NAUSEA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Development of fever within a week of the MMR, then exanthem (looking like German measles) with lymphadenopathy around 2 days later.
This case was reported by a physician via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's husband. The physician did not know lot number or expiration dates. The patient received SHINGRIX in her non dominant left arm and experienced significant swelling and pain in her left arm for about a week. The symptoms were most severe for the first 2 days and dissipated over a week's time.
This spontaneous report as received from a health care professional refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. An unspecified number of patients received unspecified dose of LIQUID PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (strength and dose unspecified) series between 25-AUG-2015 and 28-SEP-2015 that were improperly stored. No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an elementary school aged child who on 21-JUL-1999 was vaccinated with a dose of varicella virus vaccine live. On 21-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Pt presents back to clinic 2 hrs p/2nd vax w/hives progressed from thighs to trunk & face; DPH & Epi given; angioedema; lungs CTA, RRR, Abd soft; given pred; 24 hrs later rash & itching resolved;
Pt recvd 1st dose of vax on 26JUN92 & approx 7 days later devel optic neuritis;
tested positive for covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). The patient was treated with BAMLANIVIMAB for Adverse event, at a dose of UNK dosage form. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
suffered bronchitis 2 weeks after 1st covid vaccine and developed progressive weakness and paresthesia in BUE/BLE, now diagnosed with AIDP
Tonic-clonic sz 17DEC93; temp 103.6; URI; had spinal tap, CXR, blood cultures; rocephin in hosp; ceclor at home;
The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 16:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced product administered to subject of inappropriate age. On 08-APR-2021, the subject experienced off label use. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age, fever, headache and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420704.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Narrative: COVID fully vaccinated, COVID positive on admission and treated with remdesivir x 3 days
Report 20010077051 describes a 47 year old female who did not seroconvert following receipt of an injection of hepatitis B vaccine (Engerix-B). Concurrent medical conditions were not specified. Concurrent medications included fluoxetine (Prozac), conjugated estrogens (Premarin), and phenylephrine/phenylpropanolamine/guaifenesin (Entex). The vaccinee received hepatitis B vaccine (lot 1382J) on 04/14/2000 and a second injection lot 0510J on 05/16/2000. On 10/17/2000, she received 1.0ml of Engerix B pediatric, rather than 0.5ml of engerix B adult. On 11/22/2000, 36 days following receipt of Engerix-B, antibodies against hepatitis B surface antigen were < 2 (positive, >10).
Fever for 10 hours at 101.9 Fahrenheit, bodyaches, chills, fatigue, weakness, nausea, dizziness.
pt recv vax 3/17/98 & w/in 12hr of vax pt exp an allergic rxn to vax;pt devel 2 little urticarial welts;face became swollen & ears, eyes, nose & insides cheeks became puffy & swollen;
pain and soreness in back behind heart and in left shoulder; pain and soreness in back behind heart and in left shoulder; pricking and burning all over body; pricking and burning all over body; congestion; tightness in neck; feeling like heart is being squeezed from back; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 12:30 (Lot number: FD0809) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 3203080, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM), administration date: 04Nov2021, when the patient was 32 years old, for COVID-19 Immunization, reaction(s): "Diagnosed with Covid after first dose", "Diagnosed with Covid after first dose", "numbness in face", "pricking sensation all over body including face", "headache", "chest discomfort", "feeling like heart is being squeezed". The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 11Dec2021 08:00, outcome "not recovered" and all described as "pain and soreness in back behind heart and in left shoulder"; PARAESTHESIA (non-serious), SKIN BURNING SENSATION (non-serious) all with onset 11Dec2021 08:00, outcome "not recovered" and all described as "pricking and burning all over body"; NASAL CONGESTION (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "congestion"; MUSCLE TIGHTNESS (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "tightness in neck"; CARDIAC DISCOMFORT (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "feeling like heart is being squeezed from back"; HEADACHE (non-serious) with onset 11Dec2021 08:00, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of arthralgia, back pain, paraesthesia, skin burning sensation, nasal congestion, muscle tightness, cardiac discomfort, headache.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient did not test for COVID-19. Second dose- pricking and burning all over body, feeling like heart is being squeezed from back (has happened once so far after second dose on 10Dec), pain and soreness in back behind heart and in left shoulder, congestion, headache, tightness in neck. Patient did not received treatment for events. Device Date: 11Dec2021  No follow-up attempts are possible. No further information is expected.
Two days ago DTAP+ IPV IM given in left thigh, MMR+ Varicella subcutaneously given in right thigh. Findings today consistent with localized, inflammation delayed reaction to vaccines. Sites marked. Cool compresses and motrin encouraged. Sites' symptoms should not worsen. Monitor for increasing redness, pain, drainage, and swelling- if these occur he needs to be reevaluated, office open weekends and evenings.  Should not be scratching as it can make worse.
I experienced heart palpitations (heat rate was 170) and went to Urgent Care on 10/27/2021  where they diagnosed me with A-Fib and sent me to the hospital. EKG and blood work was performed by Urgent Care and then again at the hospital. The Doctors prescribed Eliquis and Cardizem.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).  This case involves an adult patient of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  Outcome:  Unknown for both the reported events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.