chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right 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: "Asthma" (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 Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 13Jun2023, stop date: 17Jun2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231714 Same patient, different drug and different AE.;
adjuvant was not reconstituted iwith the lyophilized vial.; Administration of adjuvant only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: Nurse reported that a patient was administered the Shingrix adjuvant only without reconstituting it with the lyophilized vial. The vaccine administration facility was the same as primary reporter. The reporter did not have lot number or expiration date at time of call, she said she could provide if GlaxoSmithKline follow-up via email. The reporter consented to follow-up. Additional Supportive Information: The patient was administered the Shingrix adjuvant only without reconstituting it with the lyophilized vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
10/20/08 FLUVIRIN given. 11/17/08 patient complains of tingling, burning sensation on left arm. Not constant, on and off.  (vaccine in left arm).
This case was reported by a healthcare professional and described the occurrence of red bump at injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). The subject's medical history included bone marrow biopsy, "calicimia minor", lymph node biopsy, pneumonia and respiratory syncytial virus. Concurrent vaccination included MMR II vaccine (non-GSK); Merck given on 19 May 2010; VARIVAX (non-GSK); Merck given on 19 May 2010. On 19 May 2010 at 11:00 the subject received 1st dose of KINRIX (.5 ml, unknown route, left thigh). On 20 May 2010, 1 day after vaccination with KINRIX, the subject experienced red bump at injection site and hotness at injection site. The event was descried as "red, hot knot 3 centimeters at site". At the time of reporting the events were unresolved.
febrile seizure; This case was reported by a nurse via call center representative and described the occurrence of febrile seizure in a 4-year-old female patient who received DTPa (Infanrix) (batch number AC14B119CA ?, expiry date unknown) for prophylaxis.   On 18th January 2011, the patient received Infanrix. In January 2011, less than a week after receiving Infanrix, the patient experienced febrile seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the febrile seizure was unknown.   It was unknown if the reporter considered the febrile seizure to be related to Infanrix.  Additional details were provided as follows: Within seven days of receiving Infanrixin 2011, the patient had significant febrile seizures. The reporter did not consent to follow-up. The reported batch number AC14B119CA was not available in sales data base, however it was captured as AC14B119CA ?
face feel hot and flushed within 10 minutes after injection and lasted for about 2 hours
The evening immun were administered pt devel inc temp 104-105 & cried all noc; elevated temp between 102-104 continued for next 72 hrs;
mild flu after the shingles vaccine; This case was reported by a consumer via licensee and described the occurrence of influenza like illness in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included thyroidectomy (Thyroid removed from nodules and a goiter). Concomitant products included levothyroxine sodium (Synthroid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was unknown.   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingles vaccine a year ago of reporting date and experienced mild flu. This case has been linked to USCH2021AMR045885, reported by same reported.
Severe bone and joint pain started about 21 hours after the injection and lasted for approximately 36 hours. I took oxycodone (7.5mg), but  it only took the edge off of the pain. It felt like a nasty RA flare up. Since then, I have more bone and joint pain than usual. I am afraid to take the second dose.   Insomnia since receiving the injection. (ongoing) I can't be sure that this is related to the vaccine, but I work with others who are also experiencing ongoing insomnia since receiving the Moderna vaccine.
Patient had full body rash 7 days after dose was given. Chest pain sometime (unknown) after rash. Patient passed out 11 days after dose was given. Patient went to ER the day after passed out.
Information has been received from a consumer, who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown). Subsequently, the consumer developed a rash from the knee down to the ankle. No product quality complaint was involved. At the time of this report the consumer's outcome was unknown. Additional information is not expected.
24 hours after inj Bells Palsy face sag, pain behind ear, eye tear and not fully shut, cant lift brow, increase BP, no pucket mouth, drool, difficulty with suck.
Patient fainted and fell on the floor. Patient was awake and oriented on the floor. Vitals taken, BP 100/52,pulse 72, respiration 12. EMS called. Patient transported to hospital for further evaluation.
My gums started bleeding and I don't normally have bleeding gums. It continued on for about two weeks - about 10 days into it, I called the dentist. And he took a look and it didn't look like anything was infected. And it did just go away after about two weeks or so. Subjuctoval hematomas - looks like my eye is bleeding - it was my left eye - that symptom started about a week or two weeks ago. That lasted a few days and I haven't gotten anything else since then with my eyes.
This is a serious observational study case initially received on 21-May-2019, concerning a 23-year-old adult, pregnant female subject of body weight 104 lbs, height 59 inches and body mass index (BMI) 21, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject's pregnancy history included one full term live birth. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal/paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was 04-Nov-2018 and the type of pregnancy was singleton. On an unspecified date, prior to vaccination, the pregnancy status of the subject was collected, and no pregnancy complications were noted. On 08-Jan-2019, the subject started Prenatal vitamins [minerals nos, vitamins nos, dose: one tablet, once daily (qd) via oral route, stop date: ongoing] for healthy pregnancy. On 24-Jan-2019, at gestational age of 11 weeks, the pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252675, dose, route of administration, expiry date and anatomical location: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On the same day, after vaccination, the subject was diagnosed with thrombocytopenic disorder. The outcome of the event thrombocytopenic disorder was not recovered (reported as ongoing). The subject's estimated date of delivery was reported as 11-Aug-2019.; Reporter's Comments: A 23-year-old pregnant subject experienced thrombocytopenic disorder, on the same day after administration of study vaccine at 11 weeks of gestation (coded to Exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event and no evidence for a biological mechanism that could cause the event, the event was assessed as not related to the study vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Patient had a positive COVID test on 2/2/2022 and passed away on 2/12/2022.
Received 0.3ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received 0.3ml) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Received 0.3ml). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received 0.3ml) 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.
This spontaneous report was received from a pharmacist referring to a 66 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
severe headache, neck pain, numbness and tingliness on right side , foggybrain, tremors
Pt experienced an 100 x 200 mm area of erythema, edema and warmth to left upper arm to 8cm below elbow.  Pt was treated with Keflex.
Chills, fever (101), muscle aches, fatigue, headache x36 hours. Passed out x1, without warning- lost consciousness >1min. Hit head, went to ED.
vaccine was stored in fridge past the allowed 30 days, administered to pt, contacted pt and advised to repeat vaccination. pt repeated on 10/3/21
Red Rash on arm appeared 3 inches below injection site 3 days after injection.
I have had very increased blood  sugar readings since a couple days after vaccine. I am fine because I have been controlling with  rapid acting insulin.  My mother is also diabetic and experiencing the same glucose rises. She is managing well also.
fatigue; diarrhea; little of fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIARRHOEA (diarrhea) and PYREXIA (little of fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.  Concurrent medical conditions included Kidney stone and Blood pressure increased.  On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced FATIGUE (fatigue), DIARRHOEA (diarrhea) and PYREXIA (little of fever). At the time of the report, FATIGUE (fatigue), DIARRHOEA (diarrhea) and PYREXIA (little of fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2022, Heart rate: 96 (normal) 96. On 18-Apr-2022, Oxygen saturation: 96 (normal) 96. No concomitant medication were provided. Patient reported no allergy. No treatment medication were provided.
I developed a sore throat, cough and chest congestion a day after. On 1/17/21, my left arm developed red lumpy spotting around the injection site that is hot to touch. I feel tingling sensation shooting down my left arm and some loss of feeling in my left pinky. I've been taking benadryl that that has helped decrease the red lumpiness and swelling.
lt thigh @ upper outer aspect injected @ site of birth mark; non-eryt 2cm x 3cm induration & tenderness;
18APR97 @ 7PM mom took pt to ER;dx w/URI-had fever of 100;20APR97 @ 04:00 mom brought pt into ER-DOA-coroner says SIDS-no autopsy;
Left arm pan, nausea, body aches. Sx started 12/11/2020 and are still present with intermittent improvemtn. Patient has taken Prednisone with some relief.
Titre drawn 9-25-12 to check immunity was "equivical" for Rubella.
Redness and swelling at injection site 8 cm x 6 cm. Vaccine appears to be given about 8 cm up from pt's elbow in possibly subcutaneous.
Vaccinating nurse, instructed mother on how to hold client while she administers vaccine. Mother was  holding  client in a "bear hug" position and when nurse went to vaccinate client he jumped. The vaccine rolled down clients arm.  Nurse is confident that client received less than 25% of dose. Client was revaccinated per guidelines.  Nurse advised mother to wait for 30 minutes after vaccine was administered- mother verbalized understanding.
received the MenA lyophilized component diluted with sterile water; received the MenA lyophilized component diluted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adult male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-March-2022 Additional Supportive Information: The nurse reported that the patient received dose of Menveo component diluted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further information reported. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022054955:Same reporter - duplicate - FU1
Lt arm red swollen. Looks like a 4 inch x 3 inch blistered area. (Pics taken by school nurse).
This spontaneous report as received from a consumer via Clinic refers to a currently 83 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-APR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Numbness, tingling and weakness in calves, ankles and feet which progressed to diagnosis of GUILLAIN BARRE syndrome. Neuropathy Calves. Sensation, increase Calves and feet. Paresthesia Feet. 03/30/07-records received with report. Numbness, tingling and weakness in calves, ankles and feet which progressed to DC of Guillain Barre Syndrome. Developed parethesia of lower extremities vaccines included meningococcal and flu. One month after vaccines he received yellow fever 7/13/06. He had an URI in the preceding month. Felt clinically well and had no illness during preceding month of training. On 7/14/06 felt sick with fever, congestion, rhinitis and headache. 7/16/06 awakened with numbness in both feet. Admitted to ICU for 5 days with DX peripheral neuropathy. Systemic symptoms did not improve and on 8/6/06 seen by neuromuscular specialist at UCSD and DX with GBS. TX with IVIG for 3 days. No improvement with treatment. Left Marine Corp 9/8/06 and continued to have numbness and tingling in feet, feet extremely sensitive to touch, cannot flex or wiggle his toes, pressure on calf muscles causes pain. 1/4/10 Patient had not regained function completely in his legs. His doctor state he never will, he will be permanently disabled.
I received Moderna shots as follows: o March 18, 2021 - Dose #1 o April 15, 2021 - Dose #2 o COVID-19, Moderna dose #1 (lot 045A21A) was administered as in injection in my Right arm on 03/18/21 at. o The next morning (3/19/21), I experienced tremor/pulling type sensation in my right lower lip / jaw area that lasted a few seconds, then subsided. o COVID-19, Moderna dose #2 (lot 022B21A) administered as in injection in my Right arm on 04/15/21 at. o The next morning (4/16/21), I woke up to Left side jaw pain that lasted several hours, then subsided. Mid-morning of that same day, I experienced a strong spasm type pain in my Left leg (inner groin area to knee area), lasting a few seconds, then subsided. That same day I felt tired and experienced a loss of appetite. o Over the next few weeks, I felt an unusual lack of energy and little appetite, resulting in weight loss.
Pt informed the nurse that she was having some numbness in her lips and some weird feeling in her tongue. Pt was given Zyrtec and by the 35 minutes later the symptoms had resolved
five minutes after administration child began to stare became dizzy with severe HA and eye felt funny with lights floating. Lights continued to float with severe HA and pallor. Pupils equal and pearla. Stable. Continued to have H/A 30 minutes after.
Myalgias, Fatigue, Weakness, Tremulousness of 4-6 hours duration
My arm started to really hurt on Saturday (20th) and I noticed a red bulls-eye rash on my arm around the injection site today (22nd).
This spontaneous report has been received from a nurse practitioner referring to a 4 month old male patient. The patient did not have pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 07-APR-2018, the patient was vaccinated with the second dose of ROTATEQ by oral route (strength, dose, lot number and expiration date were not provided) for vaccination. Approximately on 09-APR-2018 (reported as "within two days of receiving the vaccine"), the patient developed a "bloody streak in his stool, which was very mucous-like". Although medical attention was sought, none laboratory studies were performed and no treatment was given. The outcome of haematochezia was reported as not resolved. The causality assessment between therapy with ROTATEQ and the event was not reported. Upon internal review, haematochezia was determined to be medically significant. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1805USA000914.
Ache at vaccine site; slight vertigo; diarrhea [one day 2/13/21]
Small lesion appeared under right shoulder blade on back, thought it was a bite and put triple antibiotic cream on it, radiating pain through right breast - took 200mg Advil every 6 hours for 3-4 days. Made dr appt after a photo taken looked to me like shingles. Dr diagnosed herpes/varcella zoster. No further treatment.
red, hard, sore, hot to the touch, irritation applied warm compresses, tylenol 325 mg as needed for pain
crying/screaming unable to stop;t102.6;red area, tender to touch-rt thigh;tx APAP;
Information has been received from a registered nurse referring to an unknown number of patients. On unspecified dates the patients were vaccinated with doses of VAQTA (dose, route and lot number not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Racing and irregular heartbeat: In a 9-minute span of time, heart rate went from 81 to 95 to 102 to 97, all while sitting still. This is just one example. Watch  heart measurements were confirmed in primary physician?s office. Shortness of breath doing just regular things. Sitting up from the kitchen table, walking to my desk. I am very healthy and have a healthy weight. I never experienced these symptoms before the second dose. They lasted about 2-3 months.
Severe fever, muscle pain, headache, and chills. From time is started as mentioned and until now still.
Injection site reaction, red, warm, swelling, tenderness; Injection site reaction, red, warm, swelling, tenderness; Injection site reaction, red, warm, swelling, tenderness; Injection site reaction, red, warm, swelling, tenderness; Injection site reaction, red, warm, swelling, tenderness; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 27Feb2021 at 16:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included amitriptyline hydrochloride (ELAVIL) and meloxicam (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown dates and unknown if ongoing. On 28Feb2021 at 08:30, the patient experienced injection site reaction, red, warm, swelling, tenderness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events injection site reaction, red, warm, swelling, tenderness was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Complaining of tingling and weakness in right arm and right leg X 1 week. Equal strength assessed bilaterally in all extremities. Has been taking Rabana BID (4 tsp in last week). This is a wine derivative from radishes in a foreign country.