chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some swelling on the underside of this same arm; This is a spontaneous report from a contactable consumer(patient). A 57-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) at single dose via an unknown route in her right arm on 20Dec2020 09:50 for Covid-19 immunization. Medical history and concomitant drug were not provided. Past drug history included a reaction to an antibiotic, cefadroxil (DURICEF). Patient received her initial Covid-19 vaccine in her right arm and noted some swelling on the underside of this same arm on 21Dec2020. She wanted to know if this might be associated with the vaccine. Patient stated she had that got the vaccine on 20Dec2020 at 9:50AM in the right arm, that on Monday the next day, 21Dec2020, she got this swelling under her arm. Patient stated did not know if it had anything to do with that, wanted to know if it is a side effect. Patient stated that the swelling started on Monday the next day, 21Dec2020.  Patient stated the swelling has improved but she was going to the doctor to make sure everything was okay.  Patient stated that years ago she had a reaction to an antibiotic, cefadroxil. She asked her doctor if she should get the shot because of that and they told her she should, states this happened like 25 years ago as of 30Dec2020, no details known. Outcome of the event was resolving.
I received both the influenza and shingles vaccine around 11am on 15-Sep-2023. By 2pm, I started experiencing a headache, fatigue, fever (101 degrees F), and chills. I had aches all over my body.  My left arm was very sore.  My fever broke around 4am on 16-Sep-2023. I had a minor headache the rest of the day.   I had received these vaccinations on Menstrual Cycle Day 2. My cycles are typically 32 days long, with ovulation around Day 18. I track ovulation by taking my basal body temperature (BBT) at the same time every morning before getting out of bed, observing my cervical mucus, and using Ovulation Predictor Kits (OPK). I am on Cycle Day 55 and have not yet appeared to ovulate and have not had a menstrual period. I have taken multiple pregnancy tests (15-Oct-2023, 29-Oct-2023, 06-Nov-2023) and the results were negative. Note that I also received my COVID-19 booster on 06-Oct-2023 (Cycle Day 23); I will fill out another VAERS for the COVID-19 vaccine.
Complaining of angioedema and pruritic, urticarial rash off and on, post vax of Hep-A vaccine (which was done for travel reason).
1-16-07 _> 1st Gardasil + Hep A administered 1-29-07 Infected lymph nodes in neck w/fever Amoxicillin for 10 days. 4-4-07-2nd Gardasil shot only 5-18-07-Infected lymph nodes in neck with fever Amoxicillin-10 days-didnt work-Ceftin 1000
Stuffy and Runny Nose; Stuffy and Runny Nose; Severe Tiredness; Sore Throat that comes and goes; mild head fogginess; This is a spontaneous report from a contactable Other HCP. A 19-year-old male patient received the first dose of BNT162B2 (lot number: EJ1686), via an unspecified route of administration on 10Jan2021 11:15 at single dose in the right arm for COVID-19 immunization. Medical history included hyperhidrosis and anxiety. Concomitant medication included clonidine, gabapentin, citalopram and lorazepam. The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergies; and had influenza vaccine inact split 4v (AFLURIA QUAD) (Lot number: P100275860) on 24Dec2020 at single dose for immunization. On 11Jan2021 06:00, the patient experienced stuffy and runny nose, severe tiredness, sore throat that comes and goes and mild head fogginess. No treatment received for all the events. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included rRT-PCR Deep Nasal Swab - Both Nostrils: pending results on 09Jan2021 and pending results on 11Jan2021. The outcome of the events was not recovered.
HCP calling to report administration of VAQTA during temperature excursion on 7/14/22 (02205580). Additional AEs filed for other vaccine products and patients. No PQCs reported.; This spontaneous report has been received from a nurse, regarding a 14-months-old female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 14-JUL-2022, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 ml as prophylaxis (strength, route of administration, lot number, and expiration date were not provided) (product storage error). Temperature and period of time of the temperature excursion were not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA005196:
Patient became fatigued and uncomfortable, developed fever to 102.5 F. Treated with IVF and oral acetaminophen to good effect.
Moderna vaccine was administered outside of Facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED  J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/28/2021 PNEUMONIA
pts mom reported eve of vax a red ridge appeared around inject site & pt was sick to stomach w/fever; next day arm had more swelling; By Friday eve pts arm was swelled & hard & red from shoulder to elbow w/fever & rash;
This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M037770 / expiration date 01-JUN-2019, lot # M044717 / expiration date 19-JUL-2019, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (lot # and expiration date were unknown). The vaccine was exposed to temperature excursion between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.4 degrees Fahrenheit) and 32 degrees Fahrenheit to 35 degrees Fahrenheit (35 degrees Fahrenheit) for unknown duration. There was no previous temperature excursion and the data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA003262: US-009507513-1708USA012210: US-009507513-1708USA012211: US-009507513-1708USA012213: US-009507513-1708USA012214:
This is a spontaneous report received from a contactable consumer or other non-HCP. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had an unexpected therapeutic response (unspecified beneficial effect of the vaccine), with outcome of unknown. Follow-up attempts completed. No further information expected.
Initial report received on 03 March 2008 from a health care professional. A 21 year old female patient received on 11 February 2008 a dose of ADACEL (lot# C2888AA), dosage, route, and site not reported. It was determined that the patient was 11.4 weeks pregnant at the time of vaccination. Her last menstrual period (LMP) was not reported. The subject's prenatal testing included an ultrasound done on 23 January 2008 to determine size and dates. The Estimated Date of Confinement (EDC) is 26 August 2008. Past obstetric history was not reported. The patient had no allergies and had a history of depression. No adverse event was reported. Follow-up information received on 18 June 2008 via telephone contact from the original reporter who is a nurse. Per the reporter, the patient experienced a spontaneous abortion approximately two weeks after receiving the ADACEL vaccine. Per this new information, the case was upgraded to serious.
sensorineural hearing loss 1st noted p/vax;(missing data:progression of hearing loss-audiogram;defitit ranging from 30dB @low to 50dB @ high-rt ear; & 60-70dBin lt ear; speech reception thresholds 30-35dB rt ear/100dB lt ear), keh
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with vaccination. The patient was vaccinated with VARIVAX (Merck) on 1995 (17 years ago). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced varicella, 6 itchy chickenpox lesions on her face 17 years ago after receiving a dose of VARIVAX. The lesions were gone in couple of days. No treatment information was reported. The relatedness for varicella in unknown for VARIVAX (Merck). Additional information has been requested.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:19 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 1:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that on an unknown date the facility had a temperature excursion for the Moderna COVID-19 vaccine and the excursion duration was 1 month. And also, the vaccine was stored in an ultra cold freezer at -82 degrees Fahrenheit. On 19-Nov-2021 the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. 70 vials were in the ultra cold freezer, 8 vials were in the refrigerator. The vaccine was never refrozen. Number of vials impacted were 78 and none of the vials were punctured and there were no previous temperature excursions.   This case was linked to MOD-2021-402935 (Patient Link).
I had Lymph Node swelling under left armpit and (r-side) of neck.
Information has been received from a health professional concerning a 19 year old female who on 22-FEB-2007 was vaccinated, in the deltoid, with Gardasil. On 22-FEB-2007 the patient experienced mild rash all over her body. On 23-APR-2007 the patient was vaccinated with her second dose, IM injection in the right deltoid and developed a severe rash all over body. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. It was reported that the physician "did not administer the vaccine and does not have any follow up information to provide". Additional information is not available.
The patient received ZOSTAVAX immunization in his left upper arm on 2/18/08. He did satisfactorily until 2/25/08 when he felt a deep aching pain in his left shoulder that cleared about three weeks later. On 3/6/08 he noticed tingling in his left hand and forearm, which lasted until about 4/20/08. On 4/17/08 mild chest tightness started. On 4/26/08 he noticed worsening headache, malaise, aching in shoulders, neck, knees and elsewhere starting. Elevated sedimentation rates and C-reactive protein suggested an inflammation. Headache cleared on its own 7 days later, but rheumatic symptoms required low-dose prednisone for suppression. Polymyalgia rheumatica was diagnosed. The patient felt better by 5/6/08 while taking prednisone.  6/13/08 Received rheumatology office note of 5/23/08. FINAL DX: polymyalgia rheumatica Record reveals patient was pain free & feeling well at that time.  Had previously had pleuritic chest pain, now resolved.  Continued on slow steroid taper. 6/20/08 Reviewed PCP medical records of 4/29-5/6/2008. Records reveal patient experienced arthralgia/myalgia worst in morning w/stiffness in multiple joints, generalized HA 6/13/08 Received additional medical records from patient via email which consisted of labs & healthcare providers contact info.  Treated w/tapering steroids starting 5/23/08.   Follow-up: After 5/23/08 prednisone was tapered and stopped on 1/2/09. Rheumatic symptoms remain absent through 5/21/09.
After administration of vaccine the patient stood up quickly and passed out.  The patient fell down and came to rather quickly.  After she came to we helped her to a chair and sat her down, advised her to put her head between her knees, and got her some water that she requested.  After a few minutes she appeared rather pale and went to ask her if she was ok and she asked for a trash can because she felt like she was going to be sick.  We gave her a garbage bag and she did get sick in the garbage bag.  We kept an eye on her for another 15-20 minutes and she stated that she felt better and that she thought she was ok to leave.   We offered her help to her car but she denied it saying she would be ok with she walked slowly.  Her father was with her the entire time.  While talking with them the father did state that she had incidents like that in the past where she stood up too fast and got light headed and passed out.
No additional AE infomation; expired dose of VARIVAX was inadvertently administered to patient.; This spontaneous report was received from a nurse, regarding an identifiable patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAR-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 milliliter, route of administration was unknown; lot #T010313, expiration date: 24-MAR-2022). There was no additional adverse event information.
Patient presented to ER on 5/22/21 complaining of left eye swelling and vision being blurred.  Physician diagnosed as a corneal abrasion and left periorbital cellulitis.  Patient came back to the ER on 5/24/21 complaining of left side of face drooping.  Patient stated he noticed this the day prior.  Patient was having difficulty closing his left eye.  Today 5/24 he is drooping on the left side of his face and difficulty drinking water without running out of his mouth.  No chest pain.  According to physician, exam was most consistent with Bell's palsy but given patient's HTN, age and bounce back status, a CT was done.  Everything was negative.  Physician treated patient for Bell's Palsy with Valtrex and prednisone.  This all happened within two weeks of receiving the 2nd dose of the Moderna Vaccine.
2nd dose until 6 months later; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included TWINRIX (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29 Apr 2022 Reporter's comment: The pharmacist reported that the patient received her first dose of Twinrix and did not come back for a 2nd dose until 6 months later. The reporter consented to follow up via email, he had no details at time of reporting due to being at home and not at work. The details provided for 1st dose. Additional supportive information: It was unknown if the patient received 2nd dose till the time of reporting which led to incomplete course of vaccination.
severe numbness; tingling; pain in hands, feet, arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (severe numbness), PARAESTHESIA (tingling) and PAIN IN EXTREMITY (pain in hands, feet, arms and legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (severe numbness), PARAESTHESIA (tingling) and PAIN IN EXTREMITY (pain in hands, feet, arms and legs). At the time of the report, HYPOAESTHESIA (severe numbness), PARAESTHESIA (tingling) and PAIN IN EXTREMITY (pain in hands, feet, arms and legs) outcome was unknown.            No concomitant medication was provided. No treatment medication information was reported.
Right sided facial swelling involving right cheek and lower jaw. No eye involvement. No breathing or swallowing difficulty. Symptoms were noted around 21 hours after the injection
My son received the first dose on Sunday and he is being sick ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 22Aug2021 (Lot number: FC3184) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MOTRIN. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "My son received the first dose on Sunday and he is being sick ever since".  Additional information:  Other medications and medical conditions: Reporter stated, "A cough syrup. I don't know it is generic a pharmacy generic. I don't even know if he is really taking it." (Further not clarified hence, not captured in tab and however yes was checked in tab). Reporter stated, "Can I ask how long should we expect side effect for last" Reporter was informed about Pfizer Medical Information and asked to provide the number. Reporter stated, "You know what, I will call back tomorrow."  No follow-up attempts are possible. No further information is expected.
Apparent SIDS 8 hours post immunizations.  2/5/07 Received autopsy report which states COD as SIDS (category II).  Findings at autopsy: unclear if found in bassinet or in infant seat; 36 wks gestation, complicated by preeclampsia; s/p overnight hospitlization 12/3/06 for RSV negative bronchiolitis; s/p multivax on 12/7/06. 03/06/07-received immunization records and family history along with PCP note of adverse event .
Severe allergic reaction;anaphylaxis; Dizzy; Shortness of breath; Numbness; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness, severe allergic reaction, shortness of breath, numbness, anaphylaxis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received a dose of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Dec-2020 the patient felt dizzy, had severe allergic reaction, shortness of breath, numbness, and anaphylaxis. Treatment details included diphenhydramine and immune medications.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, dizzy, severe allergic reaction, shortness of breath, numbness, anaphylaxis, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fatigue; Nausea; Vertigo; Indigestion; Severe heartburn; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 16Apr2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease since an unknown date and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 09:00, the patient experienced fatigue, nausea, vertigo, indigestion and severe heart burn. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events nausea, indigestion and severe heart burn which included treatment with unspecified medication (Medication for Gi issues). The clinical outcome of the events fatigue, nausea, vertigo, indigestion and severe heart burn was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Had first part of Zoster Vaccine, SHINGRIX 50 mcg/0.5ml Inj Glax. Awoke with burning pain on my right hand 12 hours later, the next day I had needle like puncture pain in my back about 10 minutes apart, later on the frequency was longer and longer. Now at days is infrequent. However, in the last week I have rash feelings in my back, shoulder and legs.
Pt to ED 9/25 for c/o abd pain x 4 hours. Pt COVID+ 9/25, denies SOB. 9/26 Pt is in no apparent distress,  confused but noncombative, respirations regular and unlabored. 9/27 pt discharged.
pain and pulling sensation under my arm. uncomfortable sensation in chest, back. moderate pain and swelling in arm, chest and back that lasted 4 days. severe headache lethargy, fogging /hangover sensation
Injection site soreness (x4 days), moderate headache, fatigue. Headache has been moderate and intermittent daily since vaccination #2 on 01/19/2021.
Injection site was red and the size of a quarter. The redness continues to enlarge from the size of a quarter to the size of a plum, the size of an apple and now the size of a grapefruit. Site is puffy and warm.