chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vasovagal reaction; diarrhea; she started feeling tingly; her entire body was on fire,she was hot; palms were blood red; hot and sweating; A spontaneous report was received from a consumer who was a 59-year-old, female patient who experienced a vasovagal reaction, feeling tingly, feeling like her entire body was on fire, palms were red, hot and sweating, and diarrhea.   The patient's medical history included malignant hyperthermia and Bell's Palsy following the flu vaccine. Concomitant product use was not provided/unknown by the reporter.   On 08 Jan 2021, approximately 40-50 mins prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 0126201A) intramuscularly for prophylaxis of COVID-19 infection.   The patient stated that she received her first dose of the Moderna Covid-19 vaccine and about 40-50 minutes after she received the vaccine, she started feeling tingly, her entire body as on fire, he palms were blood red, she was hot and was sweating. The symptoms would come and go in 10 minute cycles. As her husband drove her home, she decided to return to a medical facility where she was diagnosed to be vasovagal. Per the patient, the treatment given weakened the symptoms, but also made he tired and sleepy. She reported that she had diarrhea once she got home. Treatment for the event included hydroxyzine 25mg.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, vasovagal reaction, feeling tingly, feeling like her entire body was on fire, palms were red, hot and sweating, and diarrhea were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
RECEIVED SHINGLES VACCINE, NEXT PM DEVELOPED TINGLING & DISCOMFORT OVER RIGHT BREAST AND UNDER RIGHT ARM. DEVELOPED ITCHY RED BUMPS. TX WITH STEROIDS AND ANTIVIRAL.
This spontaneous case, initially received on 20-Oct-2016, was reported by a health professional and concerns a 27-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA from 20-OCT-2016 to 20-OCT-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT52406. No additional suspect drugs. Adverse event description: On 20-Oct-2016, the patient received an AFLURIA dose after a temperature excursion (Outcome: unknown, special circumstances: drug administration error without adverse event). The PFS (pre-filled syringe) was stored at 72 degrees Fahrenheit (22.22 degrees C) for 4 hours before being administered. The reporter is not aware of any adverse events that were experienced. Reporter comments: The healthcare professional considered the event non-serious and classified the report as misuse.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
12noon on 11MAY95 pt was given vax t100.1; 330PM pt was in car seat in parents vehicle when mom saw pt eyes roll back in head, lips were purple; sz w/fever & resp arrest; pt adm to hosp comatose & on a ventilator; obtunded, pale, rhinitis
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-JUN-2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-AUG-2015, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Patient's spouse called on 9/15/11 to state he was experiencing chills, fever and muscle aches. Suggested to spouse to treat fever with TYLENOL, bed rest and drink plenty of fluids. Call physician if symptoms do not resolve and please contact Walgreens too.
Batch of Vaccines drawn up may of had expired doses outside of the 6 hour window. This patient may have received a dose that was outside of that window but within 24 hours of been drawn up.   no adverse events reported.   Patient made aware
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 17-year-old male patient of unspecified ethnicity received the second dose of TRUMENBA  via an unspecified route of administration, on unknown date, at single dose. The patient was allergic to antibiotics. Concomitant medications were not reported. The next day after receiving the vaccine, the patient experienced arm red, painful, and swollen. The patient received ice and ibuprofen and the effects lasted 24 hours. The outcome of the events was unknown. The patient was not sure if he should have the d 3ose of the vaccine.
her arm was sore and was sore into her head and neck; it was swollen. It is tolerable; her arm was sore and was sore into her head and neck/it is traveling from there up her neck; her arm was sore and was sore into her head and neck/it is traveling from there up her neck; her arm was sore and was sore into her head and neck/it is traveling from there up her neck; huge lump under her arm is about the size of a golf ball, but it is not firm. It is swollen.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 17:40 (Lot number: 30130BA) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "spinal issues" (unspecified if ongoing), notes: lot of spinal issues. Family history included: "Lupus" (unspecified if ongoing), notes: Mom had Lupus. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: E11042, Caller said that it could be EL1042, Expiration: Unknown), administration date: 11Jan2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Received: 27Jan2021, Lot: EL3802, Expiry: Unknown), administration date: 27Jan2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: AXILLARY MASS (non-serious) with onset 17Nov2021 10:30, outcome "not recovered", described as "huge lump under her arm is about the size of a golf ball, but it is not firm. It is swollen."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was sore and was sore into her head and neck"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "it was swollen. It is tolerable"; PAIN (non-serious), HEADACHE (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "her arm was sore and was sore into her head and neck/it is traveling from there up her neck".  Additional information: Expiry Date of Covid-19 Vaccine was unknown. Investigation Assessment: No. Family Medical History Relevant to AE(s): Mom has Lupus and they are testing the caller for Lupus and osteoarthritis in her neck. History: She has a lot of spinal issues and did not know if it was from her neck, but said that she thinks it is from her lymph node because it is traveling from there up her neck. Patient thinks she received her first 2 doses in the right arm. Patient woke up with a huge lump under her armpit and it was sore and sore to touch, but not excruciating. She was more concerned about how big it was. Additional Vaccines Administered on Same Date of the Pfizer Suspect None. Adverse events did not require visit to Emergency Room/ Physician Office. Vaccinations (within 4 weeks), other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. Relevant Tests: None  No follow-up attempts are possible. No further information is expected.
Severe chills. Teeth chattering. Vomiting. Extreme discomfort and flu like symptoms for 2 days. Teeth chattering
11/3/12 730 Headache, flushed, queasy, shaky, lightheaded. 11/4/12 Temp 99 degrees F. Flushed.
pt vax w/1st dose hepta B 24JUL90. 48 hrs later pt developed hypersensitivity response, w/urticaria, joint pain, muscular chest pain, cough, fatigue, & dyspnea. @ time of report pt seeing MD because of persistance of sx.
pulling sensation on left arm to neck. took ibuprofen for discomfort. 1/4/21 began to get painful. feels a lump in neck area that has movement. sharp pain in neck, hurts to turn head.   Rotating hot/cold presses to site. Using a topical cream Voltaren for pain on neck/arm.
In my early 20s I contracted HPV and for the last 20 years ,every year, my PAP smear results have been NEGATIVE. Then after the vaccine when I went to get my PAP a few months later my PAP  test was POSITIVE for HPV.  In my opinion the covid  vaccine  awoke the HPV  in my body .
1st dose 11feb2022, 2nd 14mar2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 2NT5L, expiry date 12th May 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 14th March 2022, the patient received the 2nd dose of Shingrix. On 14th March 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's comment: The registered pharmacist reported that the patient received second dose of Shingrix 31 days later the first dose of Shingrix. The pharmacist inquired should they revaccinate the patient. The doses not two months apart. Registered pharmacist confirmed the second dose was administered at their facility but not the first dose.  The reporter did not consent to follow up. Additional Supportive Information: The patient received second dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccination schedule.
pt recv vax 22MAR96 & APR96 pt exp swelling of the rt jaw & salivary gland, t102-103 & tenderness & redness of the rt mandibular region;
Patient came in for 2nd Pfizer Covid19 booster vaccination (4th total in series). Pharmacist mistakenly administered 0.3 mL of Janssen Covid19 vaccine instead of Pfizer Covid19 booster at approximately 12:16 PM on 6/29/2022.
Vaccine expired on 07/12/2022, 3 days earlier.  Pfizer was notified.  They have stability data up to 2 days after expiration date and form was submitted so that they can contact suppliers for additional stability date.  Doctor does not think revaccination is necessary.  Parent was informed.
Itchy red rash on my face with no other known irritants lasting 3 weeks with no improvement. After 3 weeks of no improvement I finally went to the dr and she said it could be an immune response to the vaccine. She gave me triamcinolone acetonide 0.1% cream to use sparingly twice a day along with an antihistamine. After one week using the cream and the antihistamine the rash is almost all the way gone
Radiating pain down arm into hand. Throbbing nerve pain. Been going on for 1 1/2 weeks now. Severe pain.
This spontaneous report as received from a healthcare worker refers to a 58 year old patient of unknown gender. Concomitant medication and pertinent medical history were not provided. On 19-MAY-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot #, dose, route and frequency were not provided) instead of ZOSTAVAX in error. The error was not a result of medication confusion, but an error of the staff in the practice in which the patient was vaccinated. The patient had not reported or demonstrated any adverse effects.  Additional information has been requested.
Information has been received from a physician concerning a 52 year old female who on 31Jan05 was vaccinated (unk route) with pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). Shortly after the vaccination on 31Jan05 the pt developed redness, swelling and local arm pain at injection site. The report indicated that the pt sought unspecified medical attention. The pt's outcome was reported as recovering. Additional information has been requested.
Improperly stored vaccine administration in reference to temperature excursion; This spontaneous report has been received from a reporter concerning to a currently 1-year-old patient of unknown gender and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route of administration not reported), lot #S038702, expiration date 01-DEC-2021, administered as prophylaxis. The improperly stored dose experienced a temperature of -9.5 degree Celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes, without previous temperature excursions. The call was due to digital data logger.
Moderna COVID-19 Vaccine EUA Itching,  circular rash around the injection site
Started developing a rash on Thursday 1/7/21. No hives, it did not itch. Started on Left arm, spread to Right arm, thighs and a bit on my abdomen. Not passing my umbilical area. It resolved by Saturday
Pyelonephritis, severe Hydronephrosis mild and slight  Blood in urine Protein in Urine Altered urine pH
Initial report received from a consumer (patient) on 20 October 2014. A 45-year-old female patient had received an intradermal dose of FLUZONE ID (lot number, dose number was not reported) in left upper arm on 17 October 2014. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as seasonal allergies, reaction to bug bites. On 17 October 2014 i.e. same day after vaccination feeling feverish and having the chills, the injection site was itchy and on next day patient felt better, but the injection site became swollen to the size of a lemon, red, and itchy. Patient also had pain from her shoulder to her breast on the left side. It was reported that patient seen by physician who stated that pain was a muscle strain and not related to vaccination. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was not recovered; however the swelling has gone down some, redness was lighter in color, and it was not as itchy. Documents held by sender: None. Follow-up information received from consumer on 23 March 2015: The batch number of FLUZONE HD was UT4993BA.
Severe fever (103.4) that tapered off for 4 days/ Severe body aches Severe Nausea Labored respiratory rate Productive cough
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-OCT-2007, the patient was inoculated with the ZOSTAVAX vaccine at county health department as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2008, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pfizer-BioNTech COVID- 19 Vaccine EUA Nausea, Diarrhea, and Headache which started at about 36 hours post vaccine, and was gone within 6 hours.
Right after given the covid vaccine. When I stood up to go to another desk, I sat down and my throat started to feel funny, and my tougue started to swell and I had a hard time swallowing. I informed the nurses that I have a problem. I was taken to the emergency room right away. I was treated with an epi injection and it did not relieve my reaction. They then gave me another injection, then later my throat started to swell again, and I was given another dose of an epi injection. I was release at 7pm after observation. Last night, I had another delayed reaction, I took a benadryl, and a zertec, and prednisone and the symptoms went away. This morning, I am fine. Today, it feels a little tight, but it's not bad.
High fever, (103). Had febrile seizure. Exam in ER showed no other pathology.
Healthy 82 yo male well at physical exam 10/31/06. Received flu vaccine mass immunization 11/04*06, Ill on Mon-Tues 11/6-7, Admitted to hospital 11/07/06. Steven Johnson Syndrome, Renal and respiratory failure and death on 11/9/06.  11/20/06 Received medical records from hospital which reveal patient admitted 11/7/06-11/9/06 for hypoxia then quickly developed a macular, then petechial associated with circumoral desquamation, very concerning for Stevens Johnson syndrome.  Patient had fever (103-104)/chills, myalgias, DOE w/dry cough, 5# weight loss over 1 week & weakness for approx 1 week prior to admit.  Also had tooth abscess approx 5 days prior to admit for which he did not receive antibiotics.  ID & resp consults done.  No death certificate included. PMH: hyperlipidemia & pre diabetes. LABS: CXR revealed bilat infiltrates w/effusion.  WBC 12.2, plts 40.  Rapid influenza test was neg.  Blood, urine & sputum cultures neg. Final DX: respiratory failure; sepsis, pneumonia, hypotension, renal failure, liver failure. 11/27/06 Received death certificate from funeral home which states COD as sepsis & pneumonia with acute renal failure as contributing factor.
temperature excursion to be 0.0 degrees Celsius human error and occurred for 7 hours with no adverse event; poor quality product administered; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and  gender patient who reported temperature excursion to be 0.0 degrees celsius human error and occurred for 7 hours with no adverse event and poor quality product administered while receiving vaccines IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number: UJ673AAA EXP: 27-04-2023) via unknown route in unknown administration site, HIB (PRP/T) VACCINE (lot number: UJ665AAA ; expiry date: 11-Mar-2023)  and  IPV (VERO) (lot number: C1AO21M; EXP: 17-02-2024) (strength, dose, formulation, route,lot number not reported) in unknown administration site all for prophylactic vaccination.  On an unknown date the patient reported a non-serious temperature excursion to be 0.0 degrees celsius human error and occurred for 7 hours with no adverse event (product storage error)and poor quality product administered  (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, HIB (PRP/T) VACCINE and IPV (VERO).    Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event product storage error and poor quality product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Redness and warmth left arm is main symptom along with SOB, light headedness, fatigue, sinus pressure and sore throat
Information has been received from a physician concerning a 6-year-old female with no pertinent medical history and no allergies who on 20-APR-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot# 654835/0823F). On 02-JUN-2008, the patient was seen in the office  for a breakthrough rash. The patient had about 15 raised lesions with no fever, no other conditions, and no treatment was provided. There were no laboratory or diagnostic studies performed. No product quality complaint was involved. The outcome was unknown. It was reported that the patient had a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and varicella virus vaccine live (Oka/Merck) as the initial vaccinations. Additional information has been requested.
Moderna vaccine x 3. Tested positive for COVID on 03/27/2022. Admitted to Hospital on 03/27/2022. Expired on 4/2/2022 while still hospitalized.
Patient has been reporting bilateral severe calf pain since the above date.  Biopsy has (reportedly) demonstrated neurogenic atrophy, w/u is in progress.
Patient reports a baseball sized raised area at injection site 3 days after vaccine administration. Rash and itching present at site.