chrisvoncsefalvay/vaers-outcomes huggingface dataset:
malaise; swelling on the left side of the head (near to ear); Pain in arm; Fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling on the left side of the head (near to ear)), MALAISE (malaise), VACCINATION SITE PAIN (Pain in arm), FATIGUE (Fatigue) and HEADACHE (headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Concomitant products included THIAMAZOLE (METHIMAZOLE), METOPROLOL and IBUPROFEN for an unknown indication.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced HEADACHE (headache). On 02-Jul-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm) and FATIGUE (Fatigue). On 16-Jul-2021, the patient experienced SWELLING (swelling on the left side of the head (near to ear)). On an unknown date, the patient experienced MALAISE (malaise). On 01-Jul-2021, HEADACHE (headache) had resolved. At the time of the report, SWELLING (swelling on the left side of the head (near to ear)), MALAISE (malaise), VACCINATION SITE PAIN (Pain in arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant Follow-up :- Events added. Gender and age were not confirmed and route of administration unknown.
Patient received Pfizer vaccine on 1/5/21 and 2/5/21. Got tested for contact with COVID positive patient and had COVID positive test herself on 2/25/21, more than 2 weeks post 2nd dose of vaccine. As of 2/27/21 patient had no symptoms of any kind
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 22-MAY-2014 the patient was vaccinated with (Merck) VARIVAX (lot number: J000202 with expiry date of 09-JAN-2015) (dose, frequency and route unspecified). Concomitant medications were not reported. The reporter stated that temperatures of (Merck) VARIVAX have not been monitored since January 2014. The reporter does not known if (Merck) VARIVAX had any temperature excursions. No adverse symptoms were reported. The outcome of the events was unknown. The causality of the events with (Merck) VARIVAX was not reported. This case is linked to #1410USA011166 via same reporter link. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 22 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus, immunocompromised; "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Mar2023) Positive, notes: first tested positive on 25Mar2023; (30Mar2023) Negative, notes: I tested negative the following day (30Mar2023); (02Apr2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She had a rebound. She had symptoms starting on 24Mar2023, first tested positive on 25Mar2023, started Paxlovid that day, finished 29Mar2023. She tested negative the following day (30Mar2023). Two days later, on the night of 01Apr2023, she started feeling sick again. She woke up the next morning and tested positive again.
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient experienced numbness and tingling to the lower extermity on the right arm upto her elbow after receiving the covid19 2nd vaccine. She said the numbness went away the same day in the evening and the tingling went away in the late afternoon on 11/6/21 (saturday). she has recovered from her tingling and numbness.
Patient recieved 2nd Moderna vaccine on 4/19/2021. The following 2 days patient reported to have normal side effects (fever, headache, body aches) that lasted for 2 days. On Saturday, 4/24/21 patient said she developed a rash that formed over her entire body on arms, legs, back, and torso. She described them as hive-like. Asked patient if she sought medical treatment which she denied. She said that she has been treating with OTC products like Benadryl and Hydrocortisone cream but wanted us to know. Patient contacted pharmacy on 4/29/21 to report her symptoms.
pt recv vax 12AUG98 & 14AUG98 inj site had 6cm area of induration,e rythema, warmth, tenderness & pruritis, oral temp 100.1;duricef given;later in day 14AUG98 d/t inc pruritis @ inj site DPH given;
developed fibroadenomas in both breasts; On 30-NOV-2020, the patient received her third dosage of Gardasil; Intermittent migraine headaches accompanied by nausea, vomiting, and light sensitivity / blurry vision and sound sensitivity; Information has been received from a lawyer regarding an adolescent between 16 to 17-year-old (currently adult) female patient regarding a case in litigation. Information about concurrent condition, history condition, and concomitant medication was not reported. On 03-JUN-2019, when the patient was 16-year-old, she was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiry date, route of administration, and anatomical location were not provided). The patient's mother agreed to her daughter receiving the vaccine injections after been exposed by marketing by the company, that the vaccine was very safe and that the vaccine prevented cancer. Also, the patient's health care provider recommended that she received the vaccine, which was stated as a safe and effective vaccine for preventing cervical cancer. On an unknown date in 2019, following the first vaccination, the patient began to suffer from intermittent migraine headaches, accompanied by nausea, vomiting, and light sensitivity (Migraine). On 01-NOV-2019 and 30-NOV-2020, the patient received the second and third doses, respectively, of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiry date, route of administration, and anatomical location were not provided) (Inappropriate schedule of product administration). On an unknown date (reported as "the months progressed"), the patient's intermittent migraine headaches progressed with accompanying symptoms of nausea, vomiting, blurry vision, and light, and sound sensitivity. As a result of those symptoms, the patient had difficulty attending her college classes and completing her schoolwork when in the grips of a migraine or severe headache. On an unspecified date, the patient developed fibroadenomas in both breasts, and every six months, the patient had to check with her doctor to make sure there was no new growth. The outcome of the events was not recovered. The causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was considered as related by the reporter.  The event of migraine was considered to be disabling by the lawyer.
Focal seizure - head turning to left and face twitching. No post-ictal. 4 episodes on 8/24. Chem panel normal. Head CT, MRI normal. Pt s/p loading dose phenobarbital 15 mg/kg IV. Discharged on 30mg qhs. Will follow up w/ neurology.
No adverse event; inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day ; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day ) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day ).    No concomitant product was reported. It was confirmed by medical assistant that her office utilized a primary vaccine vial that expired 10 days ago wherein only 1 dose from 1 of the 10 vials of lot 015B22A was administered to the patient. HCP stated that they inadvertently administered the monovalent Moderna vaccine which was beyond the 30 day use by date to a patient on 07-Feb-2023, at their facility. Lot number 015B22A, manufacturer expiration date 12-Feb-2023, date when the vaccine was initially stored in the refrigerator was 28-Dec-2022. No treatment information was reported.
Pt described feeling sick and "flu like symptoms" for 48 hours after receiving both the prevnar and flu shots. She also presented with a large rash/red/welted area extending the entire of the right shoulder.
This 31 year old male report receipt of first AVA on 11/10/2008 to left upper arm subcutaneously. He advised approximately 2 min after leaving facility he began to feel dizzy "as if drunk". He returned to medical (estimates about 10-15 min since given vaccination) and placed flat. He recalled while speaking to medical staff he felt strange, had chest tightness, difficulty breathing with sensation of a rapid heart rate, and was crying for no reason. He advised tensing of hand-knees muscles then tensing and jerking of legs. His vision would fade in and out. This cycle came and went. He stated when his vision would fade in and out he would awaken with medical officer rubbing his chest or pinching arms. His medical  records note heart rate of 98 to 59 (vital signs: 10:06 am 168/95, heart rate 98 bpm; 10:09 am 167/92, HR 61 bpm; 10:12 am 140/91 HR 59 bpm; and 10:23 am 163/92, HR 87 bpm, 1027-1049 am BP 144-157/82-90, HR 69-90 bpm; Temperature 99 degree F, and respiratory rate not recorded, O2 sats 100% room air). His pulse was steady. His provider's exam documented "fluctuating consciousness being responsive to voice alternating with tactile stimuli only"; otherwise his exam was unremarkable. He was transported by EMS to ER where he reported being observed for a few hours and released. An ER discharge summary lists diagnosis of "reaction to immunization-resolved". Attempts to locate actual ER records at medical center have been unsuccessful by two providers. Patient  reported full recovery without relapse as of 11/21/2008. Pt recalls he ate a donut that morning and did not exercise. He denied any use of energy drinks that day but did use "stacker 2" supplements in workouts. Patient denied any use of other supplemental vitamins or medications. He denied any head injury, illness or health issues prior to vaccination (preparing for 2009 trip). He does not wear glasses. He did go go in Jan 2009 for 10 months without problems. Patient is concerned this syncopal event was an adverse reaction from the AVA vaccine. A review of limited medical records documented receipt of AVA vaccinations on 11/10/2008 (FAV168), 11/28/2008 (FAV196), 12/20/2008 (FAV196) and 3/27/2011 (unknown); however he denied receiving AVA 2, 3 or 4. Other vaccines given included FLUMIST on 11/24/2008 and SPV on 12/28/2008. He remembers no unexpected reactions from these two vaccinations or any since.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II (lot # L027434, expiration date:22-JUL-2017, lot # L035674, expiration date: 17-AUG-2017, lot# L039613, expiration date: 08-OCT-2017) (strength, dose, route of administration and frequency were not reported). Administered doses of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 1 hour; 34 degrees Fahrenheit for 5 hours and 33 degrees Fahrenheit for 17 hours. No adverse effects reported. Additional information has been requested.
On 9/30, I began have upper back pain, mild nausea and frequent bowel movements. After about 20 minutes of this, I began to run a fever and was chilled with body aches. During the night, I experienced fluctuations in my heart rate ranging from 52 to lower 80s. In the morning when I stood up, I had pain on the backs of both thighs which intensified over a 15 -30 second period and then radiated down my legs. I only had the pain while standing. If I sat or walked, it lessened. This lasted for 4 days. I also experienced exhaustion upon any exertion such as walking to the mailbox. The heart rate fluctuation lasted about 2 weeks, long with the mild nausea and frequent bowel movements.  Sleep was also interrupted during this period with frequent awakenings when my heart rate was higher. After 2.5 weeks, I began to be less winded.
Fever; Chills; swelling on injection site; body aches; This spontaneous case was reported by an other and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE SWELLING (swelling on injection site) and MYALGIA (body aches) in a male patient of an unknown age 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 reported).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE SWELLING (swelling on injection site) and MYALGIA (body aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE SWELLING (swelling on injection site) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Administration error: Patient came into the pharmacy reporting no prior vaccination for Covid, and requested Janssen vaccine.  The patient also indicated on the pre-vaccination checklist that they had not previously been vaccinated for Covid-19.  When attempting to bill insurance for administration, we noticed an unusual error. We called the insurance to resolve the error, but instead were informed that the patient had already received the Pfizer vaccine (doses on 3/18/2021 and 4/7/2021).  Since this is not currently recommended by FDA/CDC/ACIP, I decided to report the instance as an administration error.  I have attempted to call the patient to discuss any adverse events, but no answer and no returned call.
9/28, took 2 Tylenol,  9/29, 16 hrs after injection, severe aches, joint pain, fever headaches,  nausea, left arm pain, fatigue, no strength. Lasted until 9/30 8:00 am, except the nausea lasted until bedtime at 11pm. and aches in right leg lasted till around 12 pm, when I laid in the recliner where it stopped hurting.
Kinrix to 4 month old baby / this was / 2nd dose for IPC and DTAP; Kinrix to 4 month old baby on 05/03/2021; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (Pediarix administered in February 2021).   On 3rd May 2021, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Kinrix dose was given to the patient at 4 month old, which led to inappropriate age at vaccine administration. Reporter stated that this was patient's 2nd dose for IPC and DTAP, which led to inappropriate schedule of vaccine administered.  No side effects reported from parent.
Wrong expiration written on outside by employee-Wrote 10 weeks out, after short dated drug received; Arm Sore; Initial information received on 14-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 5 years old male patient who experienced arm sore and wrong expiration written on outside by employee-wrote 10 weeks out, after short dated drug received while receiving vaccine INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED [FLUZONE UNSP].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Oct-2022, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED lot GT774YJA via intramuscular route in unknown administration site for immunization.  On 21-OCT-2022 the patient developed a non-serious arm sore (pain in extremity) 1 day following the administration of INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED. On an unknown date the patient developed a non-serious wrong expiration written on outside by employee-wrote 10 weeks out, after short dated drug received (expired product administered) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B VACCINE - UNSPECIFIED.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event arm sore and was Unknown for the event wrong expiration written on outside by employee-wrote 10 weeks out, after short dated drug received.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the Regulatory 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.
I got the [Pfizer] vaccine and then I got Covid; I got the [Pfizer] vaccine and then I got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got the [Pfizer] vaccine and then I got Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
18DEC92 on 16DEC 8 days p/vax receiving vax pt began w/fever 101 to 103 ax; loss of appetite, testicular tenderness & swollen lymph nodes; 22DEC ear infect;
Pt is reporting  very large bruising (3.5-4 inch bruise) across arm, it is hot to the touch and feels like there is a scab (hard spot) beneath the skin. Pt has an appointment scheduled wit h the doctor on Monday 10/16/2023
Information has been received from a pharmacist concerning to her husband (unknown age). The patient concurrent conditions included "tends to be easily injured, muscle twitches, spasms and dry eye". The patient's pertinent medical history was not reported. On an unspecified date in 2012, reported as "four years ago", the patient was administered a dose of ZOSTAVAX (lot #, expiration date, concentration, dosage and therapy route were not provided). Concomitant therapies included simvastatin (manufacturer unknown) tablets administered per oral route (lot #, expiration date, concentration, dose and indication were not provided); ranitidine (lot #, expiration date, concentration, dose, therapy route and indication were not provided); RESTASIS (lot #, expiration date, concentration, dose, therapy route and indication were not provided); and "over the counter eye" vitamins (unspecified) (lot #, expiration date, concentration, dose, therapy route and indication were not provided). The pharmacist reported that on an unknown date her husband has had three mild outbreaks of shingles starting "2 1/2 years, approximately in 2016, after" receiving ZOSTAVAX and at the time of the report, her husband had another outbreak. The pharmacist stated that the outbreaks of shingles were "incredibly uncomfortable and affecting his quality of life". The patient sought medical attention by visiting the physician and he received unspecified treatment for the events. There were no diagnostic laboratory tests performed. The outcome of the three outbreaks of shingles was recovered and for the current outbreak of shingles was not recovered at the time of the report. No product quality complaint (PQC) was involved. Additional information has been requested.
Information has been received from a physician concerning a 77 year old male who on approximately 15-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 16-JUN-2007, one day after vaccination the patient developed shingles.  It was reported that it was not at the injection site, but the patient had a T10 distribution of shingles.  The physician reported the case as mild, not painful and slightly itchy.  The patient was treated with 500 IPD of FAMVIR for 7 days.  A product quality complaint was not involved.  Additional information has been requested.