chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tachycardia HR into 140s; numbness and tingling around lips; numbness and tingling around lips; warm flushing; This is a spontaneous report from a contactable nurse (patient). This 35-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) intramuscular, in left arm, on 22Jan2021 at 08:00, for COVID-19 immunization. No other vaccine was given on the same day or in 4 weeks. The patient received the first dose of BNT162B2 vaccine on 04Jan2021 at 03:00 PM, lot number EK9231, intramuscular, in left arm. Medical history included Crohn's disease. The patient had no COVID before vaccination. Concomitant medication included azathioprine (IMURAN) at 150 mg, daily. On 22Jan2021 the patient experienced warm flushing within 5 minutes of vaccination and at 08:15 tachycardia (HR into 140s), numbness and tingling around lips. The events required Emergency room/department or urgent care and treatment with diphenhydramine (BENADRYL) 25 mg IV. COVID was not tested after vaccination. The events were resolving.; Sender's Comments: Based on a compatible temporal association, causality between events tachycardia (HR into 140s), numbness and tingling around lips and warm flushing and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Ears plugged up (just one, according to hearing test done?) Stayed plugged for a couple weeks. Occasional right ear pain. Steroid pills for 10 days cleared it up, but plugging came right back within a day after treatment ended. MRI was normal. Only thing keeping hearing loss at bay seems to be antihistamine with decongestant taken constantly. Even so, can hear/feel ears continuing to try to plug up again. On and off tinnitus entire time other than when on steroids. This has now been going on for over a month, and only other treatment offered by dr. is steroid injected into ear drum.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age (pediatric population) and gender. The patient's concurrent conditions, past medical history, concomitant medications or drug reactions and allergies were not reported. On an unknown date in January 2019, the patient was vaccinated with an adult dose of VAQTA (exact dose, route and site of administration were not reported) lot # R009799, expiry date 02-JUN-2019 for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1903USA000213.
Day 1 arm red, hard and sore About a week later, large red, itchy rash which lasted for about a week and a half
Site: Pain at Injection Site-Medium, Systemic: Other- injection site muscle twitching which was greatly lessened with arm motion/neck massage
This spontaneous report was received from a consumer concerning her daughter patient of unknown age and race. There was no information about the patient's medical history, drug reactions, allergies, concurrent conditions or concomitant medications to be reported. It was reported that the patient received her first shot of GARDASIL 9 (strength, dose, route, lot number and expiration date not reported) for prophylaxis, sometime "probably on an unspecified date in fall 2017". At the reporting time, the patient had not received the second dose, as she was away in college. The patient did not experience any adverse event. There was no product quality complaint (PQC) reported.
Patient developed fever of 100 degrees. Inj. site was red, swollen and itchy. Mom gave MOTRIN and BENADRYL. Helped a little. Now arm is still swollen, itchy and is purplish in color at inj. site. Redness is spreading around and down right arm.
Sore arm/ leg aches; Headache; Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/ leg aches), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/ leg aches), HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 27-Feb-2021, HEADACHE (Headache) and FATIGUE (Tiredness) had resolved. On 07-Mar-2021, PAIN IN EXTREMITY (Sore arm/ leg aches) had resolved. At the time of the report, PYREXIA (Fever) outcome was unknown.            No concomitant medications were provided.   This case was linked to MOD-2021-036877 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non-significant follow up appended.; Sender's Comments:  MOD-2021-036877:Husband case
Fever; Pain in left side; Chills; Slept for 2 days; Felt very tired; Somewhat trouble breathing whilewith Fever; This is a spontaneous report from a contactable other healthcare professional, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 03:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included buprenorphine hydrochloride (BELBUCA), fluoxetine (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN); all from unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 21:00, the patient experienced fever, pain in left side, chills, slept for 2 days and felt very tired. The patient was able to eat and drink during all this time, continued to have a fever off and on and had somewhat trouble breathing while with fever. The patient also reported that she was scheduled for the second dose of the vaccine on 22Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 08Apr2021, the patient underwent lab test included body temperature and the result was 102.3 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as results of events. The clinical outcome of the events fever, pain in left side, chills, slept for 2 days, felt very tired, somewhat trouble breathing while with fever was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22May2021 as dose 2, single (Batch/Lot number: unknown), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Jan2010, stop date: Jul2022; ATORVASTATIN, start date: Jan2010, stop date: Jul2022; LOSARTAN, start date: Jan2010, stop date: Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (30Jun2022) Negative, notes: tested negative for Covid 3 days after completing treatment; (02Jul2022) Positive, notes: tested positive for Covid 5 days after completing treatment. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient had no known allergies. Patient experienced Covid rebound 5 days after completing treatment. Tested negative for Covid 3 days after completing treatment and then tested positive for Covid 5 days after completing treatment. Anti viral for COVID 19 Treatment included Paxlovid, from 23Jun2022 to 27Jun2022, lot number=GA5109. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It is unknown the exact onset of symptoms.  Patient reported pain and loss of mobility in the immunization arm, reporting she cannot lift her coffee pot.  The adverse reaction was reported as a complaint to the company hotline, not directly to the pharmacy where it was administered.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 12-SEP-2012 (dosage, lot number, and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JUN-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 21-MAR-2014 the patient was vaccinated with RECOMBIVAX HB strength reported as: 2.5mcg/0.5ml (dose, route and lot # not provided). Later on 27-MAY-2014, 07-AUG-2014 and 25-SEP-2014 the patient received doses of PEDIARIX (dose, route and lot # not provided). No adverse effects were reported. This is one of several reports received from the same patient. Additional information has been requested.
Developed bursitis in right elbow less than 24 hours of receiving vaccine. Doctor recommended compression band. After 6 weeks of wearing band swelling  went down. Gritty bursa sac and soreness remained after 4 months of wearing band. Stopped wearing it after 4 months.
Ct reports onset of symptoms started 9/18/18 around 11pm with back and neck pain. On 9/19/18 woke up with nausea and "flu like" symptoms. Then on 9/20/18 had SOB and felt like having a heart attack. Ct went to ER and was admitted. Stress test and blood work done. Stress test shows inconclusive. Ct was discharged on 9/21/18 and was advised to f/u with PMD. Ct saw PMD on 9/22/18. KENALOG shot, EKG and addition blood work was done. Ct reports she is now having fever, confusion, stomach pain, weakness and lethargic. Instructed client to go to ER or urgent care to follow on symptoms. Ct states that she will call her PMD today.
Per hospital reporting system " Student doctor was administering immunization to right thigh area when infant jumped and jerked leg back which causes the student to pull the needle out and she had to stick again. So patient had 2 sticks to right thigh for one immunization."
Shortened period length by 7 to 10 days every period after the vaccine. Average cycle length changed from 33 days to 23 and is still occurring
Vomiting, fevers up to 102, dizziness, weakness, body aches.
fully vaccinated (Pfizer, 2/24/21, 3/17/21); symptom onset 8/3/21
Shot given on 26th.  Fever around 100F (max 100.4F) lasted about 18 hours, waking me at night about 12 hours after injection.  The following day, (28th) no fever but fairly severe vertigo, so that if I moved my head quickly the world spun badly, persisted through the whole day.   No treatment, but all symptoms gone on the 29th.
Erythema, swelling, bumps at 1cm x 1.5 diameter at both thighs.
No adverse effects; A patient was administered VAQTA that expired on 09/05/2019; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 28-SEP-2019, the patient was vaccinated with an expired hepatitis a vaccine, inactivated(VAQTA) lot # R021233 with expiration date of 05-SEP-2019, (strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 Immunization, reaction(s): "Site of vaccine has no pain, unlike previos 3 Pfizer"; Bnt162b2 (Dose 2, single), for Covid-19 Immunization, reaction(s): "vaccine has no pain, unlike previos 3 Pfizer"; Bnt162b2 (Dose number unknown (booster), single), for Covid-19 Immunization, reaction(s): "vaccine has no pain, unlike previos 3 Pfizer"; Moderna vaccine (Dose number unknown (booster), single), for Covid-19 Immunization. The following information was reported: UNDERDOSE (non-serious) with onset 21Sep2022, outcome "unknown", described as "It leaked, 2 drops on my hand, one or so on the arm of the chair, and some on the floor"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 21Sep2022, outcome "unknown", described as "Patient was given the Pfizer bivalent booster"; GINGIVAL DISORDER (non-serious), outcome "unknown", described as "light raised bump". Additional information: Patient was given the Pfizer bivalent booster yesterday (as reported) at a (Pharmacy name). The vaccine was delivered at an angle, as she was asked to be seated and the pharmacist was not. It leaked, 2 drops on her hand, one or so on the arm of the chair, and some on the floor (didn't see, just saw her wipe it, maybe a drop or two). Effective dose or not. she weigh about 125 pounds, when she was 68 years old. Site of vaccine had no pain, unlike previous 3 Pfizer and one Moderna vaccine or booster. Patient stated, she had a light raised bump, but no soreness. The person at pharmacy said she got enough. She had a reaction every single time before, but not this time. Patient asking if the fact she had no side effects after the vaccine means the vaccine was not working. 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.; Sender's Comments: Linked Report(s) : PFIZER INC-202201182347 similar report from same reporter; PFIZER INC-202201182346 similar report from same reporter;
GIVEN MODERNA VACCINATION AS SECOND DOSE, PFIZER GIVEN AS FIRST DOSE.
04/10: 7:30pm - dizziness, chills, and nausea begin 8pm - fatigue and vertigo, slight fever 8:18pm - loss of 90% sense of smell (can faintly smell smoke after blowing out a candle in front of own face) 9:22pm - fever of 101.2, extreme vertigo, pounding head, chills, and nausea get worse; feeling of dehydration; shallow breathing and increased heart rate begin 11pm - fever of 103.4, continued increase in all symptoms except chills, which have been replaced with excessive heat; vertigo is so intense that movement is nearly impossible and symptoms are preventing sleep  4/11: 12:32am - fever of 102.1, heart rate stabilizing, other symptoms persist but patient was able to sleep 9:56am - fever down to 101.2, vertigo has subsided enough to allow movement and sense of smell has returned  main symptoms are now headache, fatigue, and slight nausea for 24 more hours  some fatigue and nausea persists until 4/15
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox at 3 years of age) and shingles (had shingles at 50 years of age). Previously administered products included Shingrix (received 1st dose in September 2021, refer case US2021248411). Concurrent medical conditions included reaction to drug preservatives. On 1st December 2021, the patient received the 2nd dose of Shingrix. On 1st December 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, general body pain, chills, heart rate increased, headache, weakness, tiredness, dizziness and vaccine administered at inappropriate site. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, general body pain and dizziness were not recovered/not resolved and the outcome of the chills, heart rate increased, headache, weakness, tiredness and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the pain in arm, general body pain, chills, heart rate increased, headache, weakness, tiredness and dizziness to be related to Shingrix. Additional details were provided are as follows: The patient received 2nd dose of Shingrix in left upper arm and she felt pain after the injection was administered and then in 3 to 4 hours she experienced the pain spread throughout her body and had body pain, chills, weak and tired. Three hours after receiving the vaccine, the patient had racing heart and headache. The patient received 2nd dose of Shingrix too high on the arm near the shoulder, which led to vaccine administered at inappropriate site. The reporter called to inquire how long was Shingrix effective in patients 50 years and older, regarding approval date of Shingrix, placement of Shingrix in arm and ingredients of Shingrix. The reporter reported that she had many allergies including allergy to preservatives and would like to know the ingredients in the vaccine. The reporter was given medical disclaimer and referred to health care professional. The reporter consented to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021248411:Same reporter.
feeling achy; tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.     Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 07-NOV-2023, the patient received the 2nd dose of Shingrix (left arm) and INFLUENZA VACCINE (left deltoid). On 08-NOV-2023, 1 days after receiving Shingrix, the patient experienced pain (Verbatim: feeling achy) and tiredness (Verbatim: tired). The outcome of the pain was not resolved and the outcome of the tiredness was not reported.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  It was unknown if the company considered the pain and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 8-NOV-2023 and 15-NOV-2023 The patient stated that he received Shingrix dose 2 and Flu shot (not sure which brand) in same (left) arm and woke up (next day) feeling achy and tired. On 08-NOV-2023, 1 days after receiving influenza vaccine, the patient experienced pain and tiredness.  It was unknown if the reporter considered the pain and tiredness to be related to influenza vaccine. The reporter did not consent to follow up.
Affect blood results; This case was reported by a contact via interactive digital media and described the occurrence of blood test abnormal in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced blood test abnormal. On an unknown date, the outcome of the blood test abnormal was unknown.   It was unknown if the reporter considered the blood test abnormal to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments:  This case was received from Patient via interactive digital media. The patient reported that affect blood test result The follow-up would not possible as no contact details were available.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 29-JUL-2013, lot # H011350 expiration date: 21-FEB-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Moderna COVID-19 Vaccine EUA:     I had fatigue and body aches within the first 24 hours.  Around 48 hours after, I had about 16 hours of dizziness with certain movements. All has passed and I am fine. No treatments needed, just rest.
This spontaneous report was received from a physician via a company representative and refers to two elderly (their ages were reported to be between 65 and 70) patients of unknown gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with ZOSTAVAX injection (dose, route of administration, lot number and expiration date were not reported) to prevent shingles. On unknown dates, a couple of years after vaccination, the patients developed shingles. There was no product quality complaint involved. The outcome of the shingles and the relatedness between shingles and ZOSTAVAX were not reported. Additional information is not expected as no consent to contact the physician was granted.
Mild fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient wanted to know did the vaccine cause a mild fever.