chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000067:
I had not had my period for several years, as a consequence of taking birth control pills, but I had 2 periods in the 2 months following my covid injection.  I also had severe menstrual cramping, which I had not had for years.  I have since gone back to having no periods.
DIZZINESS; DIFFICULTY CONCENTRATING; BLURRED VISION; DIFFICULTY BREATHING; SWEATS; BLOOD PRESSURE INCREASED; HEADACHE; EXTREME WEAKNESS; NAUSEA; LIGHT SENSITIVITY; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient was previously treated with azithromycin for covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, administered on 19-MAR-2021 10:20 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced light sensitivity. Laboratory data included: Blood test (NR: not provided) Normal. On 27-MAR-2021, the patient experienced dizziness. On 27-MAR-2021, the patient experienced difficulty concentrating. On 27-MAR-2021, the patient experienced blurred vision. On 27-MAR-2021, the patient experienced difficulty breathing. On 27-MAR-2021, the patient experienced sweats. On 27-MAR-2021, the patient experienced blood pressure increased. On 27-MAR-2021, the patient experienced headache. On 27-MAR-2021, the patient experienced extreme weakness. On 27-MAR-2021, the patient experienced nausea. On 01-AUG-2021, Laboratory data included: Echocardiogram (NR: not provided) Not reported. On 20-AUG-2021, Laboratory data included: Blood pressure (NR: not provided) 105/95. Treatment medications (dates unspecified) included: cyanocobalamin, ondansetron, glyceryl trinitrate, acetylsalicylic acid, and meclozine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, was recovering from blood pressure increased, and had not recovered from dizziness, headache, difficulty concentrating, nausea, difficulty breathing, extreme weakness, sweats, and light sensitivity. This report was non-serious.
Patient reports pain/swelling at injection site (right deltoid) down right arm to elbow and wrist.  Patient states it's hard for her to move her arm.  Patient also reports swollen lymph node in neck, fatigue, muscle pain, joint pain, and fever.
Vial was initially stored in the refrigerator on 21Jun2022, vaccine administered on 17Aug2022; No adverse event; Patient received vaccine after the 30 days beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21Jun2022, vaccine administered on 17Aug2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21Jun2022, vaccine administered on 17Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21Jun2022, vaccine administered on 17Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21Jun2022, vaccine administered on 17Aug2022).    No concomitant drug was reported.  The vial size was reported as 2.5 ml.  It was reported that Lot AS1414B was moved from the freezer to the refrigerator on 21-Jun-2022.  It was reported that the vial did not undergo temperature excursions.  They had multiple doses administered after the 30 days beyond use date.  None of patients reported experiencing any symptoms after receiving those doses.  No additional doses, medications or treatments had been administered in response.   This case was linked to US-MODERNATX, INC.-MOD-2022-654157, US-MODERNATX, INC.-MOD-2022-654164, US-MODERNATX, INC.-MOD-2022-654166, US-MODERNATX, INC.-MOD-2022-654171, US-MODERNATX, INC.-MOD-2022-654167 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654157:Patient 1 (same reporter) US-MODERNATX, INC.-MOD-2022-654164:Patient 3 (same reporter) US-MODERNATX, INC.-MOD-2022-654166:Patient 4 (same reporter) US-MODERNATX, INC.-MOD-2022-654171:Patient 6 (same reporter) US-MODERNATX, INC.-MOD-2022-654167:Patient 5 (same reporter)
Full body convulsions, quick breathing, not reacting to name being called, staring off to left, arched back, lasted 20 minutes, at end of seizure body limp, poor affect, fussy, extremely tired.
Pt devel rash & fever compatible w/mild measles following a vax w/ measles vax;
tested positive for Covid after receiving the vaccine; tested positive for Covid after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose (with a syringe) on the right arm for protection of COVID 19. The patient medical history and concomitant medications were not reported. Patient stated that he had got the vaccination on 08Jan2021 and ended up testing positive for COVID/tested positive for COVID after receiving the vaccine on 14Jan2021. He was supposed to get the second dose this week. Treatment was none. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Shortness of breath, redness to injection site with warmth and tenderness. Administeration of Solumedrol 125mg IM at 5:00 PM 6/11/13.
Pt reports "hive like rash " on neck and face 24 hours after receiving second dose.  Similar symptoms occurred about 10 days after receiving the first dose.
broke out in red areas & bumps, swollen, red, eyes, mucous in throat, itching;
Developed  chest pain over time, went to dr , had blood work done and the D- Dimer results were extremely elevated, dr requested that more tests be done
High fever, all body aches, pain, severe congestion, coughing, fatigue. Received Advil 200mg IT PO Q 4-6 hours. Ocean Spray, increased fluid intake.
Pt arrives with increasing shortness of breath and cough. She is non-insulin dependent diabetic and oxygen dependent COPD patient. She has had known COVID exposures and does test positive. She is admitted with COPD exacerbation related to COVID infection.
Information has been received from a registered nurse and a health professional concerning a 44 year old female with allergic reaction to antibiotics (+) CLAVULANTE POTASSIUM, a history of rash to AUGMENTIN and adverse reaction to TETANUS TOXOID (manufacturer and date unspecified) and slight cold symptoms at time of vaccination, which she was treated with FLAGYL 500 mg (unknown date). On 18-SEP-2008, the patient was vaccinated with PNEUMOVAX (lot # 657626/1084U (previously reported as lot # 662020/0614X)), 0.5 mL intramuscularly in the right arm. Concomitant therapy included LEXAPRO, PATANASE, NASONEX, MSD, AUGMENTIN. On 18-SEP-2008, the patient experienced nausea, chills, clammy, runny nose and some coughing. On 19-SEP-2008, at an office visit the day after the vaccination it was reported that the patient experienced very large local reaction at injection site (previously reported as the patient had no local injection site reaction), the patient had an extremely painful arm that she could not move or touch and she had a fever of 101.9 degrees F. The patient was flushed with the face, neck, chest and breast area beet red. On an unspecified date, was performed to the patient a metabolic panel which was normal and white blood cell count which showed the white blood cells slightly elevated. On 20-SEP-2008, the patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number 662020/0614X was satisfactory. The lot # 662020/0614X met the requirements of the Agency and released. Follow-up information has been received from a registered nurse who confirmed that the patient was dosed with PNEUMOVAX, lot # 657626/1084U. A standard lot check investigation was performed. All in-process quality checks for the lot number 657262/1084U were satisfactory. The lot met the requirements of the Agency and was released. Additional information is not expected.
Pt received FLUZONE vaccine at approximately 2 pm and called us at 4:45 pm. Rash, swelling, itching developed at around 4:00 pm (10/23/13).
Symptoms of Guttate psoriasis appeared about 112 days after the first shot. I've had this once before so knew what it was. It appeared mostly on my hands (near the joints especially), with some on my knees and elbows. I was able to apply Clobetasol Propionate ointment USP, 0.05%, which was able to successfully treat the psoriasis. The effects did appear after the second shot as well, though not nearly as strong.
At 11:30am  Patient received a Pfizer booster in his left deltoid. After shot was administered, the needle hub fell off  when  the nurse attempted to put the safety cap on. There were a few drops of  fluid next to the needle after it was disengaged. The patient stated he knew he got about 95% or more of the vaccine. However, he was worried about the 2 or 3% he didn't get. Patient said he wanted to request an antibody test. Site leaders were informed.
Rash by the injection site; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) in the left arm on 24Mar2021 at 08:45 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) in the left arm on 03Mar2021 at 08:45 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, few days after the second dose, the patient developed rash by the injection site which lasted about a week before going away. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event rash by the injection site was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Felt increased wooziness/dizziness/feeling off for several hours.  Progressed to  a migraine (not a person to ever have had migraines)x 24 hrs. Resulted in not going to work the next day.  Also a large, raised, redden/inflamed injection site remains on the right deltoid.
Patient was administered the initial COVID-19 vaccine instead of the booster dose. No adverse events reported.
Headache, arthralgia, myalgia, fatigue, chills. Low grade fever.
chills; feeling very lethargic; her arm is sore; Achy; lost of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-AUG-2023, the patient received the 2nd dose of Shingrix (left arm). On 03-AUG-2023, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: chills). In AUG-2023, the patient experienced lethargy (Verbatim: feeling very lethargic), pain in arm (Verbatim: her arm is sore), pain (Verbatim: Achy) and appetite lost (Verbatim: lost of appetite). The outcome of the chills, lethargy, pain in arm, pain and appetite lost were unknown.   It was unknown if the reporter considered the chills, lethargy, pain in arm, pain and appetite lost to be related to Shingrix.     It was unknown if the company considered the chills, lethargy, pain in arm, pain and appetite lost to be related to Shingrix.   Additional Information: GSK receipt date: 04-AUG-2023 The reporter was the patient who stated she received her second Shingrix dose one day before reporting and developed chills all night long and also feeling very lethargic, her arm was sore, achy and also had lost of appetite.  Education provided to caller on median duration of side effects.  The patient was referred to health care professional (HCP). The reporter consented to follow up.
Dose # 3 of primary Pfizer COVID-19 vaccine administered.  No signs or symptoms reported.
Information has been received from a nurse practitioner concerning a 16 year old female who on 19-NOV-2007 was vaccinated with her first dose of GARDASIL.  On 28-JAN-2008 the patient received her second dose of 0.5 ml of GARDASIL (Lot #659653/1448U).  Concomitant therapy included ethinyl estradiol (+) levonorgestrel (ALESSE).  On 02-FEB-2008 the patient developed hives.  The patient's outcome was not reported.  Additional information has been requested.
Fever; feeling unwell; muscle pain; chills; injection site pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient (not pregnant) received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) via an unspecified route of administration in right arm on 05Feb2021 17:15 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bacitracin and experienced allergies, nalidixic acid and experienced allergies. The patient experienced fever, feeling unwell, muscle pain, chills, injection site pain, all in Feb2021. No treatment received. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered.
Break out of a severe Oral Herpes within 3 days of taking COVID Vaccine.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Nov2021 12:00 (Lot number: FF 2593) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I have had 1 or 2 oral blisters before" (unspecified if ongoing), notes: not on a frequent basis. Can't even remember the last time I had one. The patient took concomitant medications. Past drug history included: Hydrocodone, reaction(s): "Drug Allergy", notes: known allergies: Yes Hydrocodone. The following information was reported: ORAL HERPES (non-serious) with onset 16Nov2021 06:00, outcome "not recovered", described as "Break out of a severe Oral Herpes within 3 days of taking COVID Vaccine.". The event "break out of a severe oral herpes within 3 days of taking covid vaccine." was evaluated at the physician office visit. Therapeutic measures were taken as a result of oral herpes.  Additional information: Unspecified medication given as treatment for the event. The patient did not have Covid-19 prior to vaccination. Patient was not test for Covid-19 post vaccination.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. 3 unspecified patients were vaccinated with PROQUAD (Merck) 0.5ml subcutaneously, lot # J006569, expiration date 30-NOV-2014. 2 patients received doses on 02-DEC-2013 and 1 patient received a dose on 08-AUG-2014. The patients received doses of PROQUAD (Merck) but were supposed to receive M-M-R II. The doses of PROQUAD (Merck) that were administered were exposed to temperature outside of the proper storage range. No adverse effects were reported. Follow up information has been received from a nurse. It was reported that on an unspecified date 5 doses of improperly stored PROQUAD (Merck) were administered to unknown number of patients on an unknown dates. Additional information is not expected.
Patient saw this reporter at a church function on 10/10/2018 and reported she could not lift her arm 4-5 hours after receiving the flu shot. This reported ask that she call the health department the next day to make a report. The patient did not notify this reporter again until 10-29-18 and this was a phone call after hours to my cell phone. Client was asked to call the health department the next day so a proper report can be taken. Pt. did call the next day and reported she saw her doctor on 10-29-18 because the pain in her arm was getting worse- she reported the pain was going up into her neck and shoulder.  She reports the doctor gave her an injection of Toradol and a steroid shot. She was also given a Medrol pack. Patient reported that the pain had improved on the morning of 10-30-18.
Severe swelling of the left eyeball and eyelid starting at 2:30 am on 4/19/21. No pain, fever or itchiness. But there was flow of tears and couldn?t open that eye. The swelling in the eye got worse in the morning and it was completely shut.
Expired Menveo administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In DEC-2022, the patient received Menveo. In DEC-2022, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired Menveo administered).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 07-Mar-2023  The pharmacist reported that on December 2022, the patient received an expired dose of Menveo in another facility. The pharmacist did not have information about the exact date of vaccination or expiration date. The reporter consented to follow up. The patient was administered an expired dose of Menveo, which led to expired vaccine used.
she said her arm is red and itchy at the site, she had a fever, a headache, and diarrhea
Red raised bumps on arms, chest, back, buttox, and thighs.  Itchy, burning feeling on bumps.
The first two days I had a horrible headache. By Wednesday night I had cold symptoms like coughing and running nose. I tested positive for COVID-19 at home. I messaged my doctor, and he prescribed me PAXLOVID. Since COVID-19 I haven't got back to my normal lung function. Also, when I stopped taking ALLEGRA, I started getting rashes on my Moderna boosters shots.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L011846 with expiration date of 16-JUN-2016, lot # L018351 with expiration date of 11-AUG-2017, dose, strength and route unknown. This is one of several cases reported from the same reporter. Additional information has been requested.
ANAPHYLACTIC REACTION, NAUSEA, VOMITING, DIARRHEA, PAIN, DISTRESS AND HEADACHE.; BLOOD PRESSURE ESCALATED; TINNITUS AND RINGING; NUMBNESS; TINGLING OF THE EARS; HYPERSENSITIVE TO SOUNDS; This spontaneous report received from a physician and concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On an unspecified date, the patient experienced anaphylactic reaction, tingling of the ears, numbness and tingling of ears, blood pressure escalated, hypersensitive to sounds, pain/distress, diarrhea, vomiting, tinnitus, headache, and nausea. Treatment medications (dates unspecified) included: epinephrine, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling of the ears, numbness and tingling of ears, and vomiting, had not recovered from headache, nausea, diarrhea, and tinnitus, and the outcome of anaphylactic reaction, blood pressure escalated, hypersensitive to sounds and pain/distress was not reported. Initial information was processed along with the additional information received on 27-mar-2021. additional event of tinnitus was added. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350839-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.  V0: 20210350839-Covid-19 vaccine ad26.cov2.s-Blood pressure escalated, tingling of ear, numbness, hypersensitive to sound, tinnitus. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Nerve damage to left shoulder/arm, ultimately resulting in multiple torn/ruptured tendons, muscles, and labrum; loss of motor control, loss of strength, and severe persistent pain in left shoulder and arm. Symptoms began presentation on 24-Mar-2021. Attempted multiple therapeutic remedies, with no effect. Attempted pain management epidural on 23-Jul-2021, with no effect. Had surgical intervention on 15-Oct-2021 to repair damage, still undergoing (at the time of the submission) physical therapy for rehab, currently have 10% function of arm.
I developed Bell?s palsy about 24 hours after the vaccine was administered. I ended up in the emergency room and they confirmed it was Bell?s palsy. I am on steroids for one week and should see results within a few days. I went to the ER on 3/20/21 and have been on steroids since.
Pt had fainting spell after receiving HPV #1. Fell injury to wrist and Fx.