chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the area became slightly itchy; soreness; redness is the size of a baseball and it has round spots; hot to touch; it has round spots in it; swelling is slight; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes ophthalmic. Concomitant products included acyclovir.   On 26th March 2020, the patient received the 2nd dose of Shingrix. On 27th March 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth, injection site rash and injection site swelling. On 28th March 2020, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site rash, injection site swelling and injection site itching were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site rash, injection site swelling and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient had the vaccination in the afternoon of Thursday. The injection site reactions did not present until Friday night.  The soreness increased over the weekend and the area became slightly itchy.  All reactions have improved but are not resolved.   The swelling was slight and she started to ice it yesterday (day of reporting).   The area of redness was the size of a baseball and it had round spots in it. Consented to follow up.
COVID 19 Treatment; COVID 19 Treatment; 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 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: medical contrast" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: Yes. Paxlovid Treatment for COVID 19 from 25Jan2023 to 29Jan2023.
Information has been received from a nurse practitioner concerning a 17 year old female who was vaccinated, intramuscularly with HPV vaccine.  The nurse reported that the patient was having "neurological problems" after receiving the vaccine. The reporter stated that the patient explained she was having "pain and numbness" in her extremities.  The reporter stated the patient was going to see a neurologist. At the time eof the report, it was unknown, if the patient recovered.  Additional information has been requested.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient is experincing stiffness and swelling at injection site
This spontaneous case, initially received from other health professional (Pharmacist) on 13-Dec-2017, concerning a 27-year-old, adult female patient. The patient's medical history and concomitant medication was not reported. This case was associated with the product technical complaint (PTC) and the corresponding reference number was 1026624. On 13-Dec-2017, the patient was administered with FLUCELVAX Quadrivalent (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195222 and expiry date: 30-Apr-2018). On the same day, while administering the vaccine by the pharmacist, it looked like the needle was coming off the syringe and syringe leaked between the hub and syringe during administration (explicitly coded as needle issue). It was reported that the syringe leaked onto patient's arm (explicitly coded as exposure via skin contact and syringe leak). Another dose of vaccine was administered with another PFS. It was reported that patient received total dose (0.5ml) after readministration and no adverse events were occurred after vaccine readministration. Based on the product technical complaint (PTC) report it was concluded that the defect identified in the complaint was either the result of the manufacturing process or was present in the syringes or stoppers provided by an approved outside vendor. This investigation determined that it was unlikely that the defect identified in the complaint was the result of the manufacturing process. However, it cannot be confirmed whether a defect existed in the needle or whether the user inadvertently applied pressure to the retractable needle color-coded tab during administration. Therefore, the most likely root cause found that no internal root cause was confirmed, and no external/user root cause was determined. Narrative amended accordingly. The reporter assessed the events as non-serious. Follow-up from pharmacist received (follow-up 2 received on 26-Jan-2018 and combinedly processed) on 12-Jan-2018: The pharmacist confirmed that patient received a total dose (0.5ml) after readministration and no adverse events were occurred after vaccine readministration. From the PTC report it was concluded that the defect identified in the complaint was either the result of the manufacturing process or was present in the syringes or stoppers provided by an approved outside vendor. This investigation determined that it was unlikely that the defect identified in the complaint was the result of the manufacturing process. However, it cannot be confirmed whether a defect existed in the needle or whether the user inadvertently applied pressure to the retractable needle color-coded tab during administration. Therefore, the most likely root cause found that no internal root cause was confirmed, and no external/user root cause was determined. Narrative amended accordingly.
developed shortness and a cough; developed shortness and a cough; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 15Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), COUGH (non-serious), outcome "not recovered" and all described as "developed shortness and a cough"; ASTHENIA (non-serious), outcome "not recovered", described as "weakness". The events "developed shortness and a cough" and "weakness" required physician office visit.  Additional information: After my last Covid vaccine on 15Apr2022 I started having some problems that, at first, I didn't connect to the vaccine. I've seen several doctors since then but to no avail. I started having sudden bouts of weakness which became a permanent condition, and eventually developed shortness and a cough. This has worsened to the point that I have had problems coughing because it makes me short of breath and I can't get the cough out. Is there a way to reverse the effects of the vaccine?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
RASH APPEARED ON PATIENTS NECK AND TORSO.  BENEDRYL 50MG PO ADMINISTERED.
Broke out in hives all over chest, neck, and scalp approximately 4 hours after the injection.  This happened with 2nd vaccine.  Has my PCP go ahead and give me steroids prior to 3rd vaccine.  Began taking them that night.  Hives lasted 3 days.
pt. vax'd w/1st & 2nd dose of hepatitis B vac on 7MAR90 & 2APR90 & on 6APR90 developed erythema nodosum subsequent CXR revealed sarcoidosis;
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium
Chest pain and "vice like" pressure in the area of the heart, shortness of breath which lasted for three days.  During the period of pain there was limited activity on the part of the individual. After three days the symptoms had subsided completely.
Anaphylaxis - Throat closing, hoarseness, arm redness Went to ED was given IV Benadryl, IV steroid and IV pepcid. Given prescription for EPI PEN
Secound shot was not as severe; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Secound shot was not as severe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030b21a and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema (from childhood, reported as worsening cuts on fingers), Degenerative bone disease (Started in 2015. Undergoing physiotherapy for pain), Drug allergy (codeine), Drug allergy (Bacitracin), Blood pressure high and Hypothyroidism. Concomitant products included LOSARTAN for Blood pressure high, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for Hypothyroidism.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Secound shot was not as severe). On 20-Apr-2021, VACCINATION COMPLICATION (Secound shot was not as severe) had resolved.            Treatment of the events were not reported.   This case was linked to MOD-2021-054508, MOD-2021-135260 (Patient Link).
Chills, headache, arm soreness. My arm was extremely sore the day of my vaccination. Has slowly gotten better but still hurts(48+ hours later) I had a headache through the night and into the next morning (12 hours). My chills started around 12 hours after the vaccine and continued into the night for a few hours. I felt fine again the next morning(around 24 hours after my vaccine)  I did take Tylenol twice. Once before bed, and once when I woke up.
This spontaneous report was received from a healthcare worker refers to a 6 unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored PROQUAD (Merck), lot number reported as L011080, expiration date 01-OCT-2016, (dose and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reprots from the same source. Additional information has been requested.
Felt sick to stomach, diarrhea I became bedridden for two days feeling light headed fever at that time I became aware arm had swollen and injection sight was red ring and itching. it was then I realized it was from vaccination.
Approximately 1 hour after receipt of vaccine, patient described feeling flushed, throat itchy and tight.  Self treated with diphenhydramine 25 mg.  Patient reports not feeling worse but not feeling better. Subsequently developed generalized itching.  Presented to Emergency Dept for follow-up.  No hives, chest pain, SOB, swelling of lips/tongue, lightheadedness or dizziness.  Treated with prednisone, diphenhydramine and famotidine.  Monitored with improvement.  Discharged to home .
Extreme digestive upset; constant diarrhea, lethargy, lack of energy and focus, disrupted sleep, brain fog, muscle weakness
Diplopia in one eye/ double vision in one eye.; High blood pressure; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Diplopia in one eye/ double vision in one eye.), HYPERTENSION (High blood pressure) and HEADACHE (Headache) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIPLOPIA (Diplopia in one eye/ double vision in one eye.), HYPERTENSION (High blood pressure) and HEADACHE (Headache). At the time of the report, DIPLOPIA (Diplopia in one eye/ double vision in one eye.) and HEADACHE (Headache) had not resolved and HYPERTENSION (High blood pressure) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided
Pain, edema, and erythema began the evening of the vaccination on the inside of right arm, from the bottom of the deltoid to the elbow.
Information has been received from a healthcare worker referring to a 59 years old patient of unknown gender. On 16-MAY-2016 the patient was accidentally received a dose of VARIVAX (dose, frequency and route were not reported) instead of ZOSTAVAX (wrong vaccine administered). No adverse effect was reported. Additional information has been requested.
High and long lasting fever and chills, extensive body aches. Symptoms have lasted since 10:30 night of shot.
3hr p/vax pt heart started to race & go into AV fibrillation;hosp for tx in ICU;
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (bump that itched - at injection site), VACCINATION SITE SWELLING (raised bump - at injection site), VACCINATION SITE ERYTHEMA (red bump- at injection site) and VACCINATION SITE PAIN (painful bump- at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (bump that itched - at injection site), VACCINATION SITE SWELLING (raised bump - at injection site), VACCINATION SITE ERYTHEMA (red bump- at injection site) and VACCINATION SITE PAIN (painful bump- at injection site). At the time of the report, VACCINATION SITE PRURITUS (bump that itched - at injection site), VACCINATION SITE SWELLING (raised bump - at injection site), VACCINATION SITE ERYTHEMA (red bump- at injection site) and VACCINATION SITE PAIN (painful bump- at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given.   This case was linked to MOD-2021-089618 (Patient Link).
Pt recvd 3 doses of Engerix-B 19FEB91, 19MAr91 & 5SEP91 & it was determined that pts titer was neg p/vax series;
This spontaneous report was received from a Registered Nurse refers to a 13 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 18-JAN-2018, the patient was vaccinated with improperly stored GARDASIL 9 lot # N013276 (expiry date: 21-JAN-2020) for prophylaxis (dose not reported). The vaccine was concomitantly reconstituted with properly stored sterile diluent (MERCK). The vaccine underwent a temperature excursion of 35.80 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002918: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002922: US-009507513-1809USA002923.
3 months overdue formy second moderna vaccinatioon; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (3 months overdue formy second moderna vaccinatioon) in a  patient of an unknown age and gender 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. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (3 months overdue formy second moderna vaccinatioon). At the time of the report, PRODUCT DOSE OMISSION ISSUE (3 months overdue formy second moderna vaccinatioon) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included steroids.   No treatment medication were reported.
Patient had headache, fatigue, muscle pain that started at site of injection in left arm and gradually spread down to thigh muscle in left leg and then moved to muscles in right arm and right thigh. Patient says they are now having a hard time lifting their left arm above their head and not able to exercise like they previously were able to without having pain. This pain has gradually gotten worse and spread over the past month since the date of vaccination. Patient tried taking naproxen, tylenol, and aspirin over the counter and it has not helped with the pain. Patient is going to contact their primary physician for follow-up.
Patient reports waking up at 8AM with red, swollen arm hot to touch and painful lasting three days. Patient took Benadryl and acetaminophen and hot/cold compress
mom reports pt became lethargic & had dec feeding (2-3 bottles/day) on 14FEB98;15FEB98 the above sx inc & pt had fever 102 R w/o relief from APAP;16FEB98 pt seen by MD;17FEB98 sx improving;devel cough & cold;19FEB98 devel ear infect;
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 49-year-old, adult, male patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case: 201804674 was cross-linked to the case: 201804657 reported by the same reporter.
no adverse event; exposure during pregnancy; This spontaneous prospective pregnancy report was received from a nurse, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 02-APR-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (ml) once as prophylaxis (vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported), while being 28 weeks pregnant (exposure during pregnancy). No additional adverse events were reported in the patient. The date of last menstrual period (LMP) was 21-SEP-2020, and the estimated date of delivery (EDD) would be 28-JUN-2021. Neither the pregnancy outcome nor the fetal outcome were known at the time of the report. No prenatal tests or results were reported.
mild bronchial cough two weeks after injection for the 2nd and 3rd dose.
Never had AFib until recieve the 2 shots and booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, unknown lot), for Covid-19 immunization; Bnt162b2 (Dose: 2, unknown lot), for Covid-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Never had AFib until recieve the 2 shots and booster". Therapeutic measures were taken as a result of atrial fibrillation included abalition surgery. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Large area of redness, warmth, bruising, and centralized blistering, pain to area, which is worsening.  Treated with cephalexin for cellulitis.
Swollen injection site, red itchy, hard, painful.  Whole arm pain. Tylenol and also Benadryl at night.
hives entire Body, Hives up to ten inches in size. Benadryl up to  every 6 hours.
Pt admitted on 07/23 w/ hx of headache for 5 days and GTC on day of admission, found to have L vein of Labbe thrombosis complicated by L temporal lobe infarct extending into the left inferior parietal lobe w/ minor hemorrhage in infarct. Pt started on heparin gtt but still developed midline shift and bradycardia, so was send for decompressive L. hemicrani w/ subglaeal hemovac placement on 07/24. After sx, patient had persistent R hemiparesis w/ R tongue deviation and profound expressive aphasia w/ some evidence of apraxia. Pt then managed w/ lovenox for AC, keppra for seizure ppx as well as PT/OT/ST for improving strength and language. Pt expected discharge to acute rehab on 08/11.
muscle aches; joint aches; chills; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: tn6205, expiry date not reported), via an unspecified route of administration, administered in the left arm on 25Feb2021 13:00 (at the age of 69 years old) as dose 1, single for covid-19 immunisation. Medical history included adenocarcinoma and atrial fibrillation, both from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. The patient was not pregnant at the time of vaccination and of the report. Concomitantly patient had medications in two weeks (unspecified). The patient had no other vaccine in four weeks. The patient previously took wool fat (LANOLIN) and cinnamomum verum (CINNAMON), and had known allergies on both. On 26Feb2021, the patient experienced muscle aches, joint aches, chills. The patient was not tested for covid post vaccination. No treatments were received in response to the events. The patient recovered on an unspecified date in 2021 from the events reported.   No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of injection site warmth in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of BOOSTRIX (unknown, right arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site warmth, injection site redness and injection site reaction. At the time of reporting the injection site warmth, injection site redness and injection site reaction were resolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. A total of four subjects were report to have had an injection site reaction for the other three cases see A0911826A - A0911828A.
multiple red papules @ buttocks from pinpoint to 2-3mm;few blistered pustules;
Right anterior thigh swelling, redness, warmth, itching about 5 cm in diameter