chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse and described a 67 year old male subject who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). This report was initially received via manufacturer. Medical history included diabetes and hypertension. Concurrent medications include Ramipril (Altace) to treat hypertension, Metformin hydrochloride (Metformin) and insulin to treat diabetes, Calcium salt and Centrum, Esomepraxole (Nexium) for nutritional supplementation. Concurrent medications also included Hydrochlorothiazide, Thyroxine sodium (Synthroid), Ezetimibe + Simvastatin (Vytorin), Foltx, Metoprolol succinate (Toprol XL) Pioglitazone (Actos), Risedronic acid (Actonel), Carteolol, Bimatoprost (Lumigan), and Aspirin for unspecified drug indications. On 12/14/2004 the subject received the 1st dose of Engerix B (lot ENG5466A4). On 1/24/2005, the subject received the 2nd dose of Engerix B (lot AHBVA059BA) and on 6/23/2005 the subject received the 3rd dose of Engerix B (lot AHBVA059BA). On an unspecified date in 7/2005, the subject was vaccinated with Tetanus toxoid vaccine due to injury. The nurse reported that approximately one week following receipt of the tetanus toxoid vaccine, on 7/21/2005, a hepatitis B surface antibody titer shows non immune response of less than 2 mIU/ml.
On Saturday, January 14, 2023, I felt extremely tired, napped several times throughout the day, and had a brief, mild headache in my left temple.  On Sunday, January 15, 2023, I was confused around mid-morning according to my daughter, whom I had called to help me move something.  She took me to the Emergency Room in the town that I live.
1 day after shot, temp rose to 104.8.  Took to PMD for evaluation. Using motrin and tylenol
Shortly after the vaccination was given, a pea sized lump developed under the injection site. Within 48 hours the area was approximately 2 inches in diameter, raised, hard and pink. She iced and massaged the area, getting no relief. She has some discomfort in her left shoulder and neck but is able to carry out her daily ADL's and work.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-JUN-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-MAY-2015, the patient was treated at an urgent care for the onset of severe rash symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir for management of his symptoms and pain. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Additional information has been requested.
Initial reaction was extreme exhaustion.  Wake up after about 5 1/2 hours with migraine-like headache.  I took 2 Advil, when normal dose is 1, for me.  I have been taking an average of 3 Advil every day since the vaccine because of the pain from the headache.  I would guess last time I had to take Tylenol or Advil for pain was about September or October, 2019..  Depression is beginning to take hold, likely because of the headache; it has become very hard to work and concentrate.  External body temperature is measured most days and it is only running about 97.8-98 F.  Before vaccine, usual temperature was about 97.3-97.7.  (We have a body temperature scanner at work due to the pandemic.)
unk reaction 2nd report for this place where event was not knnown; 1st report logged under CO4264; this event occurred 14 days p/1st report on 14MAY92;
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-OCT-2015, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-OCT-2015, the patient was treated at a medical center for the onset of a severe vesicular  rash, which was diagnosed as shingles. The patient was prescribed valacyclovir (VALTREX) for management of her painful symptoms and chronic pain. 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. Additional information has been requested.
Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # was reported as "L022447", expiration date 26-FEB-2017; lot # L008996, expiration date 01-DEC-2016; lot # L004466, expiration date 02-AUG-2016; lot # L008578, expiration date 14-DEC-2016, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient returned to pharmacy 2 days after immunization and showed pharmacist a rash measuring 1/2 inch diameter in size that had developed around the injection site which itched occasionally. PCP aware according to patient. Patient using calamine lotion.
This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M035487, expiration date: 23-FEB-2019 and lot # M037248, expiration date: 21-FEB-2019, as prophylaxis. (Strength, dose and route were not reported), which experienced a temperature excursion between 47 and 77 Fahrenheit degrees (51.9 Fahrenheit degrees), for 2 hours and 10 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010796: US-009507513-1704USA003974:
Patient had near syncope episode and felt dizzy 2 minutes after first dose of primary series.
bells palsy symptoms  facial numbness and tinging going down LT side and down arm, headaches, affected vision
Localized erythema to R deltoid area about 5cm x 7cm. Rx: Benadryl 15/5mg, 1 tsp every 4 to 6 hours.
Patient reported feeling weak and shaking 24 hours after injection. Also reported symptoms of stomach flu/flu, numbness in her hands and blueness in her lips. These lasted approximately 1 week post vaccination.
Pain invloves the Left breast; Developed pain under her left arm and invloves the underarm; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain invloves the Left breast), AXILLARY PAIN (Developed pain under her left arm and invloves the underarm) and VACCINATION SITE PAIN (Pain at the injection site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 25-Apr-2021, the patient experienced AXILLARY PAIN (Developed pain under her left arm and invloves the underarm). On 26-Apr-2021, the patient experienced BREAST PAIN (Pain invloves the Left breast). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 23-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, BREAST PAIN (Pain invloves the Left breast) and AXILLARY PAIN (Developed pain under her left arm and invloves the underarm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.
Muscle pain, diagnosed with viral syndrome, inflammation on spine, weakening of muscles, groin pain on right side, injection side has tingling sensation, chest pain. platelet levels high. GF factors abnormal, blood surfaces to skin, headaches.
On 5/30/2021 and 5/31/2021:  Bedridden with chills, nausea, tachycardia, shortness of breath, fatigue, lightheadedness, sensitivity to light and sound, loss of appetite, and altered taste.    Approximately two weeks ago (around 6/27/2021):  Sudden onset of pain in the chest, then heart felt like a clenched fist, then heart started racing.  Couldn't catch a breath and felt like passing out.  I crawled to my neighbors house and told them to call an ambulance as I thought I was having a heart attack.  While waiting for ambulance, got extreme chills and sweats.  Ambulance came and did EKG which was normal.  Gave me the option to go to hospital, but felt better so I declined.  Since I have gotten the vaccine, I have consistently struggled with shortness of breath, tachycardia, and lightheadedness, to the point where I feel like I'm going to pass out, or die.
This spontaneous prospective pregnancy report was received from a currently 18 year old female consumer referring to herself. The patient's concurrent conditions and medical history was not reported. On 14-AUG-2018, the patient was vaccinated with a dose of GARDASIL 9 (Lot #, expiration date and frequency unknown), 0.05 ml via intramuscular route for prophylaxis. Concomitant medications included prenatal vitamins. On 21-AUG-2018, the patient underwent pregnancy test and found to be 5 weeks pregnant (Exposure during pregnancy). The patient's Last menstrual period (LMP) was on 17-JUL-2018 and Estimated date of delivery (EDD) would be 23-APR-2019. No adverse reactions reported.
PATIENT CAME IN THIS MORNING AND REPORTED A BIG RED SKIN AREA ON HER UPPER LEFT ARM, NEAR INJECTION SITE. IT'S WARM TO TOUCH. NO PAIN. NO FEVER.
This spontaneous report was received from a pharmacy student refers to a patient of unknown age and gender. No medical history was reported. On 03-APR-2013, the patient was inadvertently vaccinated with PNEUMOVAX 23 (lot # 670875/0631AA, expiry: 21-JAN-2013) that had expired. Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected.
No additional AE reported; an improperly stored ROT ATEQ was administered; This spontaneous report was received from a medical assistant refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 28-DEC-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1687009, expiration date: 28-JUN-2021 for prophylaxis (dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 32.1 degrees Fahrenheit for 1 hour. Digital data logger was involved. There were no previous excursions reported.
Information has been received from a RN concerning her 5 yr old daughter with an allergy to Neomycin who on 06Oct04 was vaccinated with a dose of varicella virus vaccine live. The pt's mother reports that on 13Oct04 the pt developed one sore on lip that appeared as a cold sore. At the time of this report no medical attention was sought and the pt was recovering. Additional information is not expected.
Urticaria, swollen right upper lip, hand swelling - pt treated at urgent care w/ diphenhydramine 50mg IM and famotidine 20mg po; take-home meds benadryl 25mg q6h + famotidine 20mg bid
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.   This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310559, 2020SA310759, 2020SA310708, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769, 2020SA310770 and 2020SA277871 (same reporter).  This case involved a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (Product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was reported.  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 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.
Patient's md called pharmacy to report that patient had gone to md office with diffuse papular rash with a lot of erythema on chest, back and legs with joint pain. Patient reported she had developed hot and cold flashes within 5 hours of injection.
Case number PHEH2012US013368 is an initial spontaneous report received from a pharmacist on 02 Jul 2012 with a follow-up received on 01 Aug 2012: This report refers to an adult female patient. She was given only with MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X11402) intramuscularly and did not receive MenA lyophilized conjugate on 21 Jun 2012. No adverse event was reported following the maladministration. She was re-vaccinated with a full dose of MENVEO (batch number: not reported) on 01 Jul 2012. Follow-up received from the pharmacist on 01 Aug 2012: Updated patient's demographics, vaccination date and batch number of MENVEO.
cellulitis started early am on 11/3/19. raised red area not directly near the injection site. seen by physician and antibiotics given.
Papules and pustules on bilateral thighs, posterior neck, and bilateral lower eyelids starting 9 days after vaccination.  Patient started on viroptic eye drops until cleared by Opthamology.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and fever. On an unknown date, the outcome of the injection site pain and fever were unknown. It was unknown if the reporter considered the injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The pharmacist reported that multiple physicians have reported that patients complain of pain at injection and fever and do not want to get the 2nd dose. The pharmacist reported that some of the physicians said they reported it and others said they did not. The pharmacist consented to follow up. No patient identifiers were reported. This was all the information provided. This case has been linked with the case US2018GSK217223, reported by same reporter.
the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.; since then the injection site hurts; it hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (since then the injection site hurts; it hurts) and MYALGIA (the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (on late September-early October). Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOL [OMEPRAZOLE] for Acid reflux (esophageal).    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced VACCINATION SITE PAIN (since then the injection site hurts; it hurts). On an unknown date, the patient experienced MYALGIA (the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (since then the injection site hurts; it hurts) and MYALGIA (the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient thought it was normal for the first day or so, but now it's been 3 weeks. He has the second dose scheduled for 16-Dec-2021. Patient stated he does a lot of physical work and used to some aches to his age, but this is bothering him the most. Patient took Tylenol because if not the pain wakes him up.
Oral ulcer inside bottom lip 3 days after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Jul2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included adenoids removed as child and C-section 9 years ago. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ascorbic acid; herbal nos; levoglutamide; lysine; magnesium; manganese; retinol; riboflavin; selenium; tocopherol; zinc (AIRBORNE), clonazepam (ZICAM),  colecalciferol (VIT D3), one a day womens vitamin (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. On 27Jul2021 at 12:00, 3 days after vaccine, the patient experienced oral ulcer inside bottom lip. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event oral ulcer inside bottom lip was not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Local reaction - 2 inch diameter, chills, sore throat, body aches. Symptoms began 12 hours after injection. Home care instructions given.
I took the shot yesterday morning at 930 am. This evening 08/18/21, my left arm started a dull ache and felt like dead weight, tightening in my chest and pain in my chest. I immediately took a nitrate pill, the didn't subside after 15 minutes I took a second one at that point the pain and my have started to subside. I was having the beginning of a heart attack. I haven't had one of these in over 10 years, since they placed 4 stints in. I will notify and follow up with my doctor in the morning.
Information has been received from a physician concerning a 4 week old patient who on 25-JUL-2007 was vaccinated with the first 2.0ml oral dose of ROTATEQ. On 25-JUL-2007 the patient developed profuse diarrhea with up to 6 to 8 stools daily for a period of time and lost 3 ounces. Unspecified medical attention was sought. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
About 2-3 mins after receiving vaccine pt stated that he felt dizzy & had blurry vision.  He was placed in supine position with feet elevated v/s HR 100/mt, RR 21/nt, BP 90/60.  Pt reports same reactions after immunizations in Oct 2008.
Pt. states that after receiving the 1st dose of Moderna 04/22/2021, started experienced symptoms 30mins later after standing was dizzy, weakness, Heartrate of 40, transported by Ambulance to nearest hospital, and observed for 24hrs.
p/vax pt exp an inj site rxn characterized by redness, swelling & warmth;
vaccine 6/2/2021, next evening  on lying down, aggressive lower legs vibrating. Vibrating has gone on every night since 2nd dose, minus 1st night. No treatments available for unknown conditions rising from vaccines. Scary.
pt recv vax; large red swollen mass lt thigh w/ 1mm puncture tender site; tender to touch; refuses to move hip, irritable;
Arm hot to the touch. It was itchy and swollen. Patient went to clinic to seek treatment. She received Steroid shot and dose pack and a antibiotic.