chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flare-ups where my eyes get completely puffy; Underneath my eyes there's splotches of red patches; Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I'm allergic to Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIORBITAL SWELLING (non-serious), outcome "unknown", described as "Flare-ups where my eyes get completely puffy"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "Underneath my eyes there's splotches of red patches"; SWELLING FACE (non-serious), outcome "unknown", described as "Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks".  Additional Information: The patient received 3 shots of the covid -19 vaccine and wanted to know the side effects because she had swelling. The patient received last Pfizer shot in Dec2021, and the past couple of months had been just getting these off and on what patient thought were allergic reactions. But they are flare-ups where eyes get completely puffy, and even underneath eyes there are splotches of red patches, so seemingly looks like an allergic reactions. The patient work on the computer all day, so not being able to see because of these puffy eyes was not good. The patient noted, got allergy tested, literally not allergic to anything. The patient had a rheumatologist check out for lupus, that's not the answer. The patient was looking for more information about possible recurring side effects, adding everything look up on the internet says the risk of not getting the vaccine outweighs the risk of getting it. No information regarding recurrence of adverse events over a period of months after administration. Caller was a consumer who reported a recurring reactions to the Pfizer Covid19 vaccine. It was reported that patient received two of boosters. The patient experienced just somewhat flare up where entire face just completely swelled up. The patient just wondering if anyone had reported any such side effects or allergic reactions post vaccine because there was no rhyme or reason to why the patient getting these flare ups and there new.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; Dose Number: 2 Moderna; Dose 3, Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 13:00 as dose 3 (booster), single (Lot number: GH9694) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Oct2021 as dose 2, single (Lot number: 011F21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 09Apr2021 as dose 1, single (Lot number: 205A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies". The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Sep2022 at 13:00, outcome "unknown", described as "Dose Number: 2 Moderna; Dose 3, Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19 and included treatment with Paxlovid.
2 weeks after receiving vaccine I developed intense itching and redness at injection site. a series of small bumps in varying sizes appeared.  The itching subsided after about an hour, but redness and inflammation continued.  The next day I showered and the site became inflammed and very hot it then morphed into one solid thick abrasion. I had no redness just soreness when first injected and no other symptoms other than an increase in sciatica issues making it difficult at times to walk, sit, or, bend.  The abrasion is approximately 3 inches in diameter.
Information has been received through the pregnancy registry from a physician concerning a 24 year old female nursing student with attention deficit disorder, seasonal allergies, and no allergies to medications, who on 07-FEB-2008 was vaccinated with a 0.5 ml subcutaneous dose of VARIVAX.  Concomitant therapy included amphetamine aspartate/amphetamineSO4/dex (ADDERALL TABLETS) and cetirizine hydrochloride (ZYRTEC).  The patient became pregnant on 14-FEB-2008.  It was reported that the patient had not experienced any difficulties at the time of the report.  The patient was seen in the office.  No product quality complaint was involved.  No other information was provided.  Follow-up information received from a registered nurse indicated that on 08-MAR-2008 or 08-MAR-2008 the patient had a spontaneous abortion.  Additional information is not expected.  Upon internal review the patient's spontaneous abortion was determined to be an other important medical event.
Son born with IUGR and agenasis of corpus collosum. Developed very slowly. He was able to imitate sounds like "gaga," "dada," "mama" and wave bye bye. THen around 14 months he stopped. Lost eye contact. Gave Tylenol. Diagnosed with autism August 2002. Hep B site was red and hard and tender for several days. Pt was more fussy than usual. The 60 day follow up received on 9/5/03 states pt is autistid and has a chromosomal abnormality sp duplication syndrome. Had an extra hep B at 9 months. Too many, too soon.
Missed period, period stopped.  Pregnancy tests all negative.  Have had 28 day cycle of 3-5 days until now.
Pt felt lightheaded, dizzy,  and nauseous approximately 5 minutes after receiving her vaccine. She was observed for a few minutes before being moved to a wheelchair and an IV line was put in through her RIGHT forearm. Pt was unable to keep her eyes open and had difficulty responding to questions. Paramedics arrived approximately 10 minutes later for transport.
Feeling tired and fatigued in the evening after receiving 1st dose; Fever; Headache; Reporting joint pain in her whole body that is unusual and started next day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling tired and fatigued in the evening after receiving 1st dose), PYREXIA (Fever), HEADACHE (Headache) and ARTHRALGIA (Reporting joint pain in her whole body that is unusual and started next day) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pre-diabetes.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (Feeling tired and fatigued in the evening after receiving 1st dose), PYREXIA (Fever), HEADACHE (Headache) and ARTHRALGIA (Reporting joint pain in her whole body that is unusual and started next day). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FATIGUE (Feeling tired and fatigued in the evening after receiving 1st dose), PYREXIA (Fever), HEADACHE (Headache) and ARTHRALGIA (Reporting joint pain in her whole body that is unusual and started next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include pre-diabetes medications.
Pt states that the next morning after vaccine (9/11), she woke up with a slight fever of 101. Pt took Tylenol and the fever went away the same day. 9/13 pt states her Left arm was itchy and the vaccine site was red.
Redness and swelling to left deltoid following injection 24hrs prior. Reported to Urgent Care, was seen by a provider and medication rx given.
increased frequency and severity of asthma attacks with 3 emergency room visits from May 20, 2021 to June 23, 2021.  Asthma attacks were different from the past with stomachache and defecation preceding asthma attack.  Died in June 23, 2021.  Autopsy examination found previously undiagnosed eosinophilic granulomatosis with polyangiitis/Churg-Strauss syndrome, including eosinophilic pneumonia.
serious side effects like breathing problems and rashes; serious side effects like breathing problems and rashes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as a single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after first dose patient experianced serious side effects like breathing problems and rashes. She was due to take her second dose after a week. She wanted to talk to someone about the side effects that she had. The outcome for the events was Unknown.  Information about lot/batch number has been requested.
OVERALL REDNESS, SWELLING, HEAT TO TOUCH ON UPPER ARM - FRONT AND PARTIALLY AROUND - SHOULDER TO ELBOW
Pregnant; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jan-2021 and was forwarded to Moderna on 11-Jan-2021.    This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 01-May-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) 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.   Concomitant products were not provided by the reporter.  Treatment information was not provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow up information included reporter contact details; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 24th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and swelling arm. On an unknown date, the outcome of the injection site pain and swelling arm were unknown. It was unknown if the reporter considered the injection site pain and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on left deltoid at the health department. The patient stated that after the first shot she did not call them because she stated that she "had no side effects after the first shot". She did say that her arm was barely sore (not enough to complain) at the injection site and not red at all (after the first shot) and this was no different than after getting a flu shot, in fact she bumped her arm the second day after the shot and then remembered that she had received the shot. The patient was asked for lot number for SHINGRIX shot but she was not near the paperwork to look. This case has been linked with US2018GSK153694 (2nd dose of SHINGRIX) and US2018GSK153695 (Influenza vaccine Quadrivalent unspecified season) for same patient and US2018GSK152142 for different patient, reported by same reporter.
This spontaneous report as received from a registered nurse via field employee refers to unspecified male patients older than 15 years of age. The nurse reported that GARDASIL 9 has been adminsitered to boys older than 15 years (lot number, dosing details unknown). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Fever 3 days after administration rash 1 wk, whole body after vaccines.
I noticed after my 1st vaccine my iron count dropped slightly from 14 g/dl to 13.3 after and then to below 12 after second vaccine. The low iron count has continued even though I've tried to increase my intake of iron rich foods.  I exercise frequently and noticed I am now short of breath much sooner than pre-vaccination.  My mile time has also increase significantly from ~9 min mile to close to 12 now. I also saw that post vaccination iron deficiency was also being reported on the Clinic chat site.  Seems odd that the vaccine would cause a decrease in red blood cells needed to carry oxygen throughout our body.
Offender given 2nd shot 7 days after 1st dose.   Offender denies adverse outcome.
Blood Pressure readings were taken prior to me taking the shot at the actual Vaccination Site.  BP reading was 136/87 prior to taking the shot and 138/88 fifteen minutes later.    I experienced a headache within a few hours.  By the next evening, my headache grew worse.  By early Sunday morning (2 or 3am) , I was in the ER with BP reading of 194/102.  I am concerned that 3 or 4 components containing sodium in the first vaccine dose may have contributed to elevated BP reading .  For some individuals with Hypertension it may lead to worsening conditions such as stroke.
Severe tinnitus, starting a few hours after vaccination. Has lasted for three weeks so far.
Pt received Moderna Boost 12/27/2021. He did not report any flu/viral like symptoms previous to or after vaccination. On 01/08/2022 he noticed lacrimation of his right eye and on 01/11/2022 noticed right sided facial droop and presented to the ED. Initially a stroke was suspected but an MRI was negative for any acute stroke or infarction and was ruled out. Pt was diagnosed to have bell's palsy with persistent lacrimation of right eye and right sided facial droop, no other symptoms.  Upon history the only inciting factor was the moderna booster shot 1.5 weeks before onset of symptoms.
Immediately post vaccination developed hives.  No difficulty breathing or swelling noted.  Vital signs normal.  Benadryl given and rash resolved in a few minutes.
hTis initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this male (age unknown) were reported to be  1) 30-OCT-2015  and 2)  15-MAY-2016 (The date for this vaccination was also reported as 16-MAY-2015.)  Further clarification needed. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269.
Night after received shots (PEDIARIX, Hib, PCV13, flu, Rota), developed rhythmic jerking spells for 3-5 min happened 2-3 times first night, then once during nap and next night again. Would jolt a few times then stop, then start again for 3-5 min. stopped after 5 or so episodes. Jerk awoke pt from sleep. No video made but progressively worse through episode. Whole body jerking while asleep, then maybe an arm or leg when awoke. No fever documented but higher than nml per mother. No vomiting. No FH sz disorder or developmental delays.
Pt recvd 1 dose of Engerix-B 30APR92 & therapy discontinued p/1st dose due to pregnancy; last menstrual period 27APR92;
BlurredVision, purple vision, fstigue, feet felt hot and heavy, chills, swets, and chest pressure Narrative:
Severe Vertigo, dizziness and spinning.  Lasted for 2 days, day 3 lessened to instability and milder dizziness lasting for 2 weeks.  Still occurring.
2 minutes of seizure with eyes rolled back and to the side, body stiff then limp, not breathing right and turning blue, not responding to eye contact or his name.
Woke up the next day with chills, fever, headache, extreme fatigue, mild wheezing (took Zyrtec), moderate arm pain. Felt somewhat better in the afternoon. This repeated for the next two days, with the morning symptoms getting milder each day. Felt fine on the fourth day.
Menstrual Cycle began, a week early, two hours post dose.  Menstrual Cycle number 2 following this one was delayed by 10 days.
8cm diameter erythema. Pain at injection site & swelling, warmth at site. Temp-reported by pt. Ibuprofen 600mg TID. Ice for comfort prn. Excuse from work x3 days.
I got my last booster in December of last year. I experienced rapid heart rate right after the vaccine that spontaneously went away. It came back again in April. I went to the emergency room on March 09, 2022, where they did an ECG and Blood work. They sent me home indicating they could not find anything. I went to a cardiologist. They did a 15-day heart monitor. I completed that and it indicated my minimum heart rate was 56 bpm and max heart was 168. Predominately underlying rhythm was sinus. Isolated SVE's were rare as well as isolated VE. I got Edema in my feet and ankles which has been treated with Hydrochlorothiazide in July. This medication did help but I am still under the care of a cardiologist for other things that resulted from the Edema.  Currently I am experiencing heart related issues with shortness of breath. I also COVID-19 in August as well and they suspect these may be long COVID symptoms.
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 17:00 as dose 4 (booster), single (Lot number: 649694) at the age of 40 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Apr2021 at 11:30 as dose 1, single (Lot number: EW0161), in left arm, on 11May2021 at 11:30 as dose 2, single (Lot number: EW0183), in left arm and on 11Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Allergy to sulfa" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE, start date: Feb2022; LISINOPRIL, start date: Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: ; Positive, notes: ; Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300152156 Same patient, different product, different event;
pt recv vax & 2 the time of vax inform MD that was not pregnant, but following vax informed MD was 3 wk pregnant;1 to 2 wk following vax pt terminated pregnancy;no further info was provided;
It began with itching on 2/13 at and around the injection site.   2/14-17 some hardness developed, then it turned into a rash and became quite tender.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information provided. Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date. Before use date reported was 12-May-2022. No treatment information provided.       This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up received: Patient information and vaccination details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case