chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling under the skin at injection site; noticed approximately 30 minutes after injection; swelling persists today (03.19.21). Pain at injection site but only discernable when I lean against that arm, or lie on that side (03.15.21 through today, 03.19.21). Awoke after midnight, 03.16.21 with severe headache; it persisted for about 36 hours. Slight nausea the next day (03.16.21). Slightly elevated temperature two days later (03.17.21).
LEFT UPPER ARM PAIN STARTED AFTER RECIVING 2ND COVID VAX WITH RADIATION DOWN ARM, WORSE AT NIGHT WHEN LAYING ON AFFECTED SIDE. HAS TRIED ICE/HEAT WITH LITLE IMPROVMENT. SYMPTOMS LASTING 2 WEEKS.
This spontaneous report was received from a medical assistant and refers to a 56 year old female patient. The patient's concomitant therapies included aspirin (manufacturer unknown), vitamin B-Complex, calcium plus vitamin D, FLEXERIL, gabapentin, SYNTHROID, meloxicam, PAXIL and CRESTOR. The patient had no pertinent medical history, drug reactions and allergies. On 13-DEC-2017, the patient was vaccinated with PNEUMOVAX 23, lot # N023650, expiration date: 20-MAY-2019, in the left deltoid for prophylaxis (dose and exact route of administration were not reported). On the same day, the patient was also vaccinated with TETANUS AND DIPHTHERIA TOXOIDS ADSORBED. On 14-DEC-2017, the patient called physician's office and reported skin reactions on the injection site, as there was redness and swelling at the injection site which was "size of the golf ball". There was no fever, dyspnea, rash or facial swelling. The patient was advised to put an ice on the injection site. Also, the patient was prescribed with tramadol to use per needed. There was no laboratory diagnostic studies performed. On 18-DEC-2017, the patient was seen by the physician and the injection site was still swollen, however the event resolved in a few more days on an unknown date in December 2017. The relatedness between the events and PNEUMOVAX 23 was not reported.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: has not resolved.  being refered to allergist
Patient came to report to the pharmacy to report some adverse effects he had starting on Friday through Sunday after he got the shot on Wednesday. He exercises and reported feeling SOB with any type of physical exercise that he had not had before. He also reported disorientation. But it has gotten a lot better. He did contact his Dr and the Dr is monitoring him.
Injection-No symptoms for two (2) minutes, then-severe lower back pain and minor pain to left leg, for 10 minutes. Pain:-numerous needles to back: then pain subsided.
product=COVID 19 Treatment; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster) single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: Yes, reaction(s): "Allergy", notes: Known allergies: Yes.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "product=COVID 19 Treatment"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of covid-19.The patient received Paxlovid as other medication in 2weeks for treatment of COVID-19, the treatment start date was reported as 12May2022, treatment stop date was 16May2022 with lot number Ga3567. The patient received Levothyroxine as other medication in 2 weeks products. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE reported; patient received his first dose of GARDASIL 9 in February 2020. He has not received his second dose yet; This spontaneous report was received from a physician referring to a 41 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     In February 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, for prophylaxis (strength, route of administration, anatomical location, lot # and expiration date were unknown).         In December 2020, the patient had not received his second dose yet which had to be received approximately in April 2020. Patient had been placed on hold due to the pandemic. No additional adverse event was reported.
15-20min s/p vax pt devel flushing of face & swelling of eyelids bilat & face;no resp sx;rxn localized only to face;no rxn site of inj;pt given epi @ ER:
20 patients who were vaccinated w/varicella vaccine & post vax testing revealed a 57% efficiency rate;WAES96010443-96010451 were assigned
Transient global amnesia; This is a spontaneous report from a contactable physician.  A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142, expiration date not reported), intramuscular on the left arm, from 07Jan2021 at 09:00 at a single dose for Covid-19 immunization.  Medical history included low back pain, benign prostatic hyperplasia, impaired fasting glucose.  Concomitant medications included hydrochlorothiazide (HCTZ), lisinopril, and tamsulosin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Jan2021, the patient experienced transient global amnesia. Started about 4-5 hours after vaccination and lasted 12 hours. There was no treatment received for the event. Outcome of the event was recovered on 07Jan2021. The reporter assessed the event as non-serious.
This spontaneous report as received from a registered nurse refers to a 73 year old female patient. No concurrent conditions or medical history were provided. On 31-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot # K004930 with expiry date: 16-MAR-2015, reported as "05-MAR-2014") 0.5 ml administered intramuscularly in the right arm as a single does, post supported temperature excursion of 10C for 15 hours. No concomitant medications were reported. No adverse effect were noted by patient. The patient did not seek medical attention. Additional information has been requested.
VARICELLA VACCINE WAS ADMINISTERED 5/22/07 IN THE AFTERNOON TO THE PATIENTS RIGHT ARM.  THAT EVENING THE PATIENT DEVELOPED REDNESS, SWELLING, AND TENDERNESS TO THE AREA.  MOM OF PATIENT REPORTS THAT "PATIENT FELT WARM".  MOM ADMINISTERED MOTRIN AND APPLIED AN ICE PACK TO THE AREA.  ON 5/24/07, PATIENT RETURNED TO THE CLINIC FOR THE PPD READING AND SHOWED DR. (THE CHILD'S PCP) THE INJECTION SITE.  AN ICE PACK WAS APPLIED TO THE AREA.  MOM REPORTED THE AREA WAS IMPROVING SINCE THE DATE OF INJECTION.  INSTRUCTIONS WERE GIVEN TO THE PARENT FOR FOLLOW-UP CARE INCLUDING RETURNING TO THE CLINIC FOR WORSENING SYMPTOMS, APPLICATION OF AN ICE PACK, AND ADMINISTERING ANTI-INFLAMMATORY MEDICATIONS.  PT. WAS INSTRUCTED TO AVOID GYM CLASS FOR THE NEXT WEEK.
No further adverse effect reported; patient received a dose of improperly stored ROTATEQ; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.  On 21-FEB-2020, the patient received a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (orally; lot number S014947, expiration date 10-DEC-2020; strength and frequency unknown) for prophylaxis (incorrect product storage).   The storage temperature of the vaccine was below 36 degrees Fahrenheit (34 degrees Fahrenheit) for a time frame of 27 minutes. There was no previous temperature excursion. The call was because of a data logger. No further adverse effect was reported. No product quality complaint (PQC) was reported.
Unilateral left sided tinnitus. Constant. High pitched. No associated hearing loss or vertigo. Persistent since vaccination 2 days after vaccination.
Complete numbness of the right side of the face and the right arm. Ears filled with fluid and vertigo persisted for weeks after.  Numbness in the right hand still is present today. All symptoms began within 24 hours.
This spontaneous report was received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. The medical assistant reported that on an unknown date in 2015, after second temperature excursion, the patients were administered an unspecified number of improperly stored doses of GARDASIL 9 (lot number reported as L004741, expiration date: 08-MAR-2017) (dose, route and frequency were not reported). No adverse effects were reported. Concomitant medications were not reported. The reporter was unable to provide any patient identifiers during a phone call. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162B2, BNT162B2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 10:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (28Nov2022) Positive, notes: Positive test. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162B2, BNT162B2 OMI BA.4-5 has been requested and will be submitted if and when received.
Patient came into my store for second covid vaccination his first shot was done at another pharmacy and the pharmacy had called first because they did not have the moderna and wanted to make sure we had it before sending patient to us.  When patient came her it was noted that he was only 16 years old.  We checked with our corporate immunization leader and it was determined that even though the patient should not have received the moderna vaccine we needed to complete the series with the same vaccine he received first.
improperly stored administered PROQUAD AE; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drugs reactions or allergies were not provided.  On 21-SEP-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella virus vaccine live(PROQUAD) (lot # T013540, expiration date: 17-OCT-2020)(dose, route of administration were not provided) for prophylaxis.  The vaccine was stored from  6 Fahrenheit degrees (F) to 14 Fahrenheit degrees (11.7 Fahrenheit degrees) for a time frame of 25 min. There was no previous temperature excursions. Digital data logger was involved.  The outcome of product storage error was unknown.
Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not provided. Approximately in August 2016 (reported as: August-September 2016 time range), the patient was vaccinated with the first dose of combined vaccine with hepatitis A and hepatitis B, possibly a TWINRIX. Approximately in September 2016 (reported as: some unspecified time in September 2016, "about 5 weeks from first dose"), the patient inadvertently received a dose of VAQTA (dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis (interchange of vaccine products; wrong vaccine administered). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Mother states that pt. had fever the night of vaccination.  Called health center on 3/19/10 and was told that fever following vaccines was to be expected, but if continued, to go to the ER.  Was seen in Emergency Room on 3/20/10 with Temp = 39.5 rectally, a runny nose and bit of a cough per ER report.
Pt reported to the pharmacy approximately 48 hours after injection with warmth, redness, tenderness, pain, and hard lump at injection site. Instructed her to take BENADRYL, TYLENOL, and use cold compress.
This is a spontaneous report from a contactable consumer (patient). A 12-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 12, via an unspecified route of administration, on Oct 17, 2021, at 11:45, in the left arm, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. No medical history or allergies reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other concomitant medications within two weeks prior to the vaccination. On Oct 19, 2021, at 22:30, patient experienced rashes on the whole arm. No therapeutic measures taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The outcome of rashes on the whole arm: unknown (at the time of this report). The lot number for  BNT162B2 not provided and will be requested during follow-up.
pt developed sx consistent with, and then was tested positive for, Covid-19 when presented to hospital/ER
Swelling in face, jaw and lips & hands (worse on left hand), itchy rash welts on torso, front & back. Nausea and slight head discomfort.
swollen injection site; red injection site; swollen area underneath armpit area feels like someone is pulling on a stitch type of pain; swollen area underneath armpit area feels like someone is pulling on a stitch type of pain; This is a spontaneous report from a contactable healthcare professional (patient). A 21-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the right arm on 15Jan2021 15:45 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE). The patient received first dose of BNT162B2 on 28Dec2020 03:15 for covid-19 immunization. On 15Jan2021 08:15, the patient experienced swollen injection site and red injection site. The patient added that swollen area underneath armpit area feels like someone is pulling on a stitch type of pain. The patient has taken Benadryl and Tylenol Friday, Saturday, and Sunday as treatment for the events. The patient is not pregnant. The patient has not tested positive for covid post vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Cellulitis (tender, hot, red injection site 50 x 36 mm erythema, with fever 100.8 degrees). Treated with Zithromax 250/5 1 tsp daily for 3 days.
Information has been received from an office manager concerning a 10 year old white female pt who on 11/02/1998 was vaccinated with a first dose of varicella virus vaccine live. Subsequently, the pt experienced full blown chicken pox with well over 50 lesions. The pt sought unspecified medical Tx in an ER and is now recovered. No product quality complaint was involved. Follow up information indicated that on 06/17/04 the pt had a fever, was lethargic and had a rash all over the body including the mouth and the vagina. The child was given meds to limit the duration "due to her twin sisters earlier illness" It was reported that the event lasted for 4 days and the pt recovered on 06/30/2004. The pt's twin sister (WAES 0408USA002071)also experienced a full blown case of chickenpox after vacciantion with varicella virus vaccine live. Additional information is not expected.
First in 2/19. Does she need to start over?; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked that the patient need to start over. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a Medical assistant refers to a female patient of unknown age. Medical assistant reported that a patient received Dose 1 of GARDASIL (lot# was not reported) sometime in August 2012 and then received Dose 2 sometime in July 2013. Patient had not received Dose 3 yet. No symptoms reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker (reported also as a Certified Medical Assistant) refers to a female patient of unknown age. On 06-FEB-2013 the patient was vaccinated with a first dose of GARDASIL injection (lot # and expiration date not provided) (dose: 0.5ml), intramuscular (IM). On 08-APR-2013 the patient was vaccinated with a second dose of GARDASIL (lot # and expiration date not provided) (dose: 0.5ml), intramuscularly (IM) and on 21-JUL-2014, reported as today, the patient would received the third dose of GARDASIL (lot # and expiration date not provided) (dose: 0.5ml), intramuscularly (IM). No adverse effect reported. Additional information has been requested.
SPREADING RASH ON BELLY AND ARM; COLD EXTREMITIES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced spreading rash on belly and arm. On 07-MAR-2021, the subject experienced cold extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spreading rash on belly and arm, and cold extremities. This report was non-serious.
24 hours after receiving her second Moderna vaccine, the patient experienced a rash and swelling in both arms.  The reaction in the right arm resolved in a few days, but her left arm has remained swollen and painful for the pas 2 months.  The patient has weakness, pain, tingling, numbness in her left hand that waxes and wanes.  She also has pain in her deltoid muscle.  The patient has continued to have a 6 cm x 2 cm rectangle of rash on the radial side of her left arm.  The patient has tried hydrocortisone creams and ibuprofen to no avail.
Fever 102.5- Pain, swelling, Erythema at site, Myalgia, fatigue.
patient received extra dose for flu vaccine. patient already received the dose on 11/3/22.
recvd vax series x 3,anti HBS low x 3 (1981-1992);In 92,devel loss of balance,n,extreme lethargy,aches & pains,no stamina;MRI showed changes in deep white matter of CNS,consistent w/ mult sclerosis;sxs cont;
Information has been received from an unknown age male physician via a company representative referring to himself. There was no pertinent medical history or concomitant therapy. The patient was allergic to penicillin and sulfa. On an unknown date in 1990, the patient was vaccinated with one dose of M-M-R II (dose, route, lot number and expiration date were not provided) for prophylaxis. Other suspect drug included sterile diluent (MERCK STERILE DILUENT) (strength, dose, route, lot number, expiration date and indication were not provided). The reason why the patient received the M-M-R II was because all of the residents were required to receive a dose of M-M-R II regardless of whether or not the residents had M-M-R II in the past. The physician was not sure but he thought he may have received one or two previous doses of M-M-R II in the past (prior to 1990) when he was a child. On an unknown date, after receiving the dose of M-M-R II in 1990, the patient began to experience arthralgia and myalgia. His symptoms lasted for 4 to 6 weeks and then he recovered (pervious reported "myalgia that lasted for 6 weeks''). No lab diagnostics studies were performed. There was no treatment given for the event and not seek medical attention. The causality between the events and M-M-R II and sterile diluent (MERCK STERILE DILUENT) was unknown.
Five weeks after the second dose on 05/08/2021 I woke up in the morning with a lump on my left leg near my shin that was the size of a golf ball. I had a Telehealth visit and I monitored it. I went to the Urgent Care on 06/08/2021 because it was getting worse. I had started to have some swelling, pain and discomfort in my legs and ankles. It was confirmed that I had Deep Vein Thrombosis in my left leg. They did not check the other leg because the medication would take care of any DVT in that leg. I also had heart palpitations at that time. I was prescribed injections of Lovonox and now I take Pradaxa. I still have pain and discomfort but no swelling in my left leg.  I went to my doctor and a Hematologist with a Cardiology appointment scheduled.
I experienced fatigue, sore throat, cough, respiratory stress, diarrhea. no appetite, upset stomach and no taste.