chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid; tested positive for Covid; pulse ox in to high 80's-low 90's; sick; This is a spontaneous report from a contactable pharmacist (patient's wife) via the Medical Information Team. This pharmacist reported similar events for 5 patients. This is the 5th of 5 reports. A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 26Apr2021 (age at the time of vaccination was 46 years) as DOSE 1, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on 17May2021 (age at the time of vaccination was 46 years) as DOSE 2, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested positive for covid, pulse ox in to high 80's-low 90's and sick. The reporter, her husband, and her other two daughters also tested positive for Covid. She and her husband had received both doses already but her other two daughters have not. She says this was the sickest she has been in twenty years. Reportedly, the patient was also very sick with a pulse ox in to high 80's-low 90's and still has not returned to normal. He was a marathon runner and now has a pulse ox in the mid 90's. The reporter enquired what was the optimal interval post COVID infection, to administer the second dose (ex. wait until clinical symptoms resolve vs. wait 3 more weeks vs don't exceed 6w from first dose vs do not complete series vs give ASAP regardless). On an unspecified date, the patient underwent lab tests and procedures which included Pulse Ox: high 80's-low 90's, Pulse Ox: mid 90's and COVID: positive. The outcome of the event tested positive for covid was unknown. The outcome of the event pulse ox in to high 80's-low 90's and sick was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Amendment: This Amendment report is being submitted to amend previously reported information (To update narrative leadline): This is a spontaneous report from a contactable pharmacist (patient's wife) via the Medical Information Team.  This pharmacist reported similar events for 5 patients. This is the 5th of 5 reports.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event s Drug Ineffective and COVID-19 and the suspect drug bnt162b2
It was discovered that the pharmacist administering the vaccine on 10/21/22 had improperly diluted the vaccine resulting in a higher than recommended dose due to improper dilution. The patient and primary care physician were contacted. The patient's mom has said no adverse event has occurred so far to her knowledge. The patient seems like he has a cold today if anything.
Patient received 2nd dose of GARDASIL9 later than recommended in the current prescribing information; Information has been received from a pharmacist referring a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown day in October 2020, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (route of administration, lot number and expiration date were not reported) for prophylaxis. It was reported the patient received her second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) outside of the recommended prescription (Inappropriate schedule of vaccine administered).
This spontaneous report as received from a licensed nurse practitioner regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 lot # M016193 and expiry date: 24-JAN-2018 (dose and route were not reported). The vaccine was exposed to a temperature of 34 Fahrenheit for a time frame of 50 hours. There was no data logger and no previous excursions. No adverse events were reported. There was no product quality complaint involved. This is one of the several cases reported by the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. Patient's concurrent conditions and relevant medical history was unknown. On 16-MAY-2014 the patient was vaccinated with ZOSTAVAX, (0.65 ml), subcutaneously. Concomitant medications were unknown. The patient came to the pharmacy and reported that she has been experiencing arthritis type of pain in her shoulder sporadically following vaccination with ZOSTAVAX and asked if pain can be related to ZOSTAVAX. No treatment was given for adverse events. The patient sought medical attention by speaking to pharmacist. The outcome of arthritic type of pain in her shoulder sporadically was reported as not recovered/not resolved. The causality of the events with ZOSTAVAX was not reported. Product quality issue was not involved. Additional information has been requested.
Patient informed us on 12/16/2019 that she developed left ankle spasms/pain on November 3rd. Patient stated spasms started at left ankle and traveled to the ball of her left foot. Patient described pain similar to a "charley horse" Patient stated spasms would last 30 to 40 seconds. Patient stated these symptoms lasted from November 3 to November 6th. Symptoms reappeared again Thanksgiving weekend, but were not as severe.
Tested positive for Covid 24 after second dose in vaccination series; Tested positive for Covid 24 after second dose in vaccination series; This is a spontaneous report from a contactable nurse. This 41-year-old female nurse (not pregnant) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EN5318), intramuscular, administered in Arm Right on 03Feb2021 as single dose for COVID-19 immunization. Medical history included known allergies: Sulfa drugs (drug hypersensitivity) from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (ESTRADIOL) 1 mg daily taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: E3249), intramuscular, administered in Arm Right on 13Jan2021 as single dose for COVID-19 immunization. The patient reported that she tested positive for covid 24 after second dose in vaccination series on 27Feb2021. No treatment received for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Feb2021. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Heart palpitations started after full immunization. No treatment, labs and ECG done. Abnormality on ECG, stress test pending.
This spontaneous case reported by an other healthcare professional, describes the occurrence of lymphadenopathy (lymph node swelling) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced lymphadenopathy (lymph node swelling). At the time of the report, lymphadenopathy (lymph node swelling) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Information has been received from a physician concerning a 23 year old female patient with no pertinent medical history and no known drug allergies/reactions who on 8-AUG-2008 (also reported as 8-AUG-2009) was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot # 659184/0843X). There was no concomitant medication. On 8-AUG-2008 the patient experienced muscle aches near the injection site. No lab diagnostics studies were performed. On 10-AUG-2008 (also reported as 10-AUG-2009) the patient recovered. The patient sought medical attention via going to the office. The patient would be getting the second dose of GARDASIL on 30-MAR-2009 which was late. This is one of several reports from the same source. Additional information has been requested.
approximately 5 days after 2nd COVID vaccine pt had onset of headache and bilateral labyrinthitis, with symptoms of 3 hour periods of dizziness in the afternoons.  Headache improved (headache features are c/w migraine and pt did have some migraine type headaches prior to vaccination) but she is having persistent c/o dizziness which can be provoked by inner ear maneuvers and is accompanied by mild nystagmus
A SIGNIFICANT RINGING IN EARS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced a significant ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a significant ringing in ears was not reported. This report was non-serious.
Swollen, itchy, inflamed, hot, irritated skin around the injection site (shoulder), spreading out to neck/lower arm. (PENTACEL injection arm).
This case was reported by a nurse via sales rep and described the occurrence of shortness of breath in a adolescent male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced shortness of breath (serious criteria other: serious as per reporter). On an unknown date, the outcome of the shortness of breath was recovered/resolved. It was unknown if the reporter considered the shortness of breath to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The dose of BEXSERO which was received by the patient was believed to be his first dose and he was then seen at the local emergency department for shortness of breath. The specifics of the emergency request (ER) visit were unknown, but the issues were resolved at the time of reporting. This case has not been reported to VAERS. All questions were asked, but limited information was provided by sales representative. This case has been linked to case US2016122906, reported by the same reporter.
Within 30 seconds hives developed at injection site. 4 teaspoons diphenhydramine HCl liquid 12.5 mg/5 ml administered. Observed for 45 minutes. Condition improved. No respiratory signs and symptoms.
Pt received vaccine on 5/1/00. On 5/3/00, the pt has a large reddened area, very tender to touch, arm very sore. Pt states had the same reaction with previous dose.
24 hrs after the vaccine I had fatigue, sleepiness, extreme shortness of breath with any activity., Brief runs of SVT. Went to the emergency room and was admitted for cardio work up and pulmonary spirometry test. All test were negative and I was realeased 3 days later with improved symptoms
Info has been received from an RN via a company representative concerning a female pt who "just delivered a baby" and "was rubella titer negative" and on 5/6/05 was vaccinated, SC, in the hospital with an 0.5mL dose of MMRII (lot unknown). On 5/21/05, the pt developed a rash. It was reported that the pt did not have a family practitioner and she called her obstetrician's office. The office told her to go to the ER if the rash worsens. The pt reported to the ER, the next day and they told her she had a measles rash. The ER physician prescribed prednisone and told the pt they gave her something to prevent the measles from spreading but the nurse that reported this  to the company representative did not know what was given. It was unknown if the pt recovered from measles rash. There was no product quality complaint involved. Additional info has been requested.
client received first dose of pfizer covid 19 vaccine. walked over to recovery area and passed out.
A report was received from a health care professional on 10 November 2003 concerning a male vaccinee less than 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date the vaccinee inadvertently received 0.25 ml Fluvirin. The vaccine had not experienced any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update report: 13 January 2004. Follow up information received from a health care professional indicated that a 14 month old male vaccinee inadvertently received Fluvirin on 27 October 2003 and had not experienced any adverse reaction. Follow up pending. Cross reference with PJP200301042.
red, very itchy, intense itch over all of trunk & on legs;tx DPH & DPH;
pt lives in a nursing home; had a positive COVID test on 4/17/21; per death certificate, pt died in the nursing home with the causes being:  Cardiac Arrest, Respiratory Failure, COVID 19; death certificate and med records emailed to info@vaers.org per VAERS request
Patient received two vaccinations (Pneumovax and Fluzone) in same arm. After vaccine administration, her arm was swollen and painful.  This gradually progressed to neck stiffness/pain and general body aches. The patient contacted her physician who advised her to take Aleve and Benadryl, and her symptoms resolved after a few days.
Blood clots in Lungs discovered June 29, 2021 after being admitted to hospital June 28th.  In the weeks leading up to diagnoses patient was feeling extreme lethargy, nauseous, lack of appetite and general extreme discomfort.
"A few days after getting nasal spray, ears felt funny. Saw doctor, no infection. 1 week later hearing loss, saw doctor who dx'd sinus infection gave 10 days of ABT. Saw ENT now total hearing loss with bilateral aids".
Patient came in describes soreness in hip, and sweating. Pat was using TYLENOL, I suggested change to ibuprofen and pt will follow up with Dr. Pt injected on 7/30, came to counter in pharmacy 8/3.
Headache and neck pain beginning on 11/12/22, followed by droopiness of left eye on 11/15/22 and dry eye burning sensation.  Progressive droopiness of left eyelid and paralysis on left side of face; droopy mouth on the left side. When I called the Healthcare for an appointment, the nurse recommended going to the emergency room and said that the symptoms could be related to a stroke.  The subsequent diagnosis is Bell's Palsy.  In researching, the onset coincides with getting the Covid booster.
48 hours after vaccine developed Left axillary lymph node swelling and pain. Currently taking alleve for pain.
Vaccine was given 1/12/21 at 10am, 3pm having chills and slight sore on L arm,  6pm chills continues and head pressure ( took Tylenol ) 8pm body aches, stiffness back of my neck, soreness on L arm worsen.  Next morning 1/13/21 L side arm, back and neck stiff, soreness and backaches, and also chills, hands are clammy and headache.
This is a spontaneous report from a contactable physician. A 19-year-old female patient received the first dose of TRUMENBA (Lot# M77282, Expiry date 30Jun2017, NDC# 0005-0100-01), intramuscular at 0.5 ml, single in the left deltoid on 08Aug2016 10:15 AM. Medical history included mood disorder, asthma on 2013, rhinitis allergic on 2013, anxiety depression on 2013. Concomitant medication included LOESTRIN 1/20 for contraception, SEROQUEL for mood disorder, LAMICTAL for mood disorder, FLOVENT for asthma, all on 2013. The patient experienced patient developed local reactions around the injection site "patches" and a "hive"/three different patches of redness which appeared to be hives on 09Aug2016 with outcome of recovering. Follow-up (29Aug2016): New information obtained from a contactable physician includes: anatomical location and date/time of vaccine administered, additional medical history and concomitant, outcome, onset date of the event updated. Follow-up attempts completed. No further information expected.
Patient was ambulating to waiting area chair and became weak. Patient was assisted to floor with nurses help. Eyes closed and was responsive with sternal rub to upper chest wall. Respiratory rate even, unlabored. Patient opened eyes and started talking. Alert and oriented x 3. Skin color grayish white with lips white. Water was given. Vitals obtained with BP 92/58, HR 64, 100% O2 on RA. Placed in wheelchair and pushed to private area. Patient refused for EMS to assist. Denies pain. No acute distress noted. Patient left vaccine site with no further incident.
received the first covid vaccine prior to testing positive for covid; received the first covid vaccine prior to testing positive for covid; This is a spontaneous report from a non-contactable consumer (patient) from the Pfizer-sponsored program. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first COVID vaccine prior to testing positive for COVID on an unknown date. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included malignant melanoma, diverticulitis, high blood pressure and sulfonamide allergy. 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. The patient received other medicines (unspecified) and medicines for high blood pressure (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6205) via an unspecified route of administration in the right arm on 17Mar2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 09:00, three weeks after the second dose of the vaccine the patient's tongue started to hurt/burn and there were little red bumps on it and a yellowish/whitish coating. It was very painful and sore; the patient was not able to brush it off or remove the coating. It was bad for 2 days and then started to slowly resolve. On the day of reporting, it was day 6 and the coating had finally gone but it still felt as if the patient had burned the tongue on hot food. It was noted that, the patient had recently been to the dentist for a full check-up so aware that oral health was totally fine. The patient had not eaten or drank anything that would have contributed to this. Hence, the patient, was convinced it was reaction to the vaccination. 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 not been tested for COVID-19. The clinical outcome of the events tongue started to hurt/burn, was very painful and sore, there were little red bumps on it and a yellowish/whitish coating were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Felt nauseous when trying to urinate, then was sweaty, fainted and fell.
Having issues with joint pain.  On 2/20/21 noticed swelling on R hand joint between index finger and 2nd finger.  Worsening over a few days.  Physician sent in prednisone on 2/23/21.  Continue to have issues with R hand joint and now L hip and knees.   Getting xray on hand and testing ANA and other possible inflammatory or rheumatology labs.
I had seasonal flu and Shingrix 1 at the same time. Next day headache, muscle ache, hot eyes, and lethargy. About 24 hours later I had bilateral bright red rash covering my ribs from underarm region to waist. I assume this was a reaction to Shingrix, but I thought I should report it since it doesn't appear as a common side effect.
Patient decided to get a flu shot but he had not had one in many years. He came back to the pharmacy the following Wednesday and said about 2 hours after getting the vaccine he experienced irregular heartbeat with PVC and atrial fibrulation. It lasted about 2 days. He had heart problems years ago but nothing currently. The symptoms resolved themselves after about 2 days.
Body rash/hives.  Extremely itchy.  Treated with lotions(Cortizone, Caladryl) and took antihistamine(Benadryl, Claritin).  Started to go away after about a week.
Patient felt dizzy after vaccine had been administered. Patient laid down and waited 15 post injection and felt better before being let go from clinic.
Two days after injection I started getting numbness in my left toe. I went to a chiropractor thinking I had a pinched nerve. Treatment did not fix the problem.
PATIENT STARTED HAVING RASHES AND BUMPS ON ALL OVER THE ARMS. ALSO ON TORSO, AS PER PATIENT.
Information has been received from a medical assistant concerning a 48 year old female patient with insomnia, anxiety, hyperlipidaemia and hypertension and no drug reactions or allergies who on 03-NOV-2010 was vaccinated intramuscular with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z, expiration date: 18-JUL-2011). Concomitant therapy included AMBIEN, XANAX, simvastatin (manufacturer unknown), estrogens, PREMARIN, NORVASC and aspirin. The medical assistant reported that the night of 03-NOV-2010, the patient began to develop soreness at the injection site. On 05-NOV-2010, she developed redness, swelling and heat at the injection site. She also had a fever. She was diagnosed with cellulitis. She received LEVAQUIN. No lab diagnostics studies were performed. At the time of the report the patient was recovering. The office requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Research Center and was released. Follow up information was received from a medical assistant who indicated that the patient on 03-NOV-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 in his left arm. Eight to ten hours later, the patient noticed redness, heat, pain and swelling in the area of injection. The patient returned to the physician's office on 05-NOV-2010 and was treated with LEVAQUIN 750 mg for seven days. At the time of the report, the condition had resolved. The medical assistant considered cellulitis to be an other important medical event. This is one of several reports received from the same source. Additional information is not expected.