chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Congestion; This is a spontaneous report from a nurse. An 88-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: Unknown), intramuscular on 20Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Historical vaccine includes first dose of bnt162b2 on 30Dec2020 at the age of 88 years for COVID-19 immunization. The patient experienced congestion (pending clarification) on 21Jan2021 13:00. Treatment was not received for the adverse event. The vaccine was administered in a Nursing Home/Senior Living Facility. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.  Information on the Batch/Lot number has been requested.
3 inch red area around injection site.  Warm to touch.  Slight swelling, mild itchiness.  Onset Day 8
A report was received from a health professional on 11/06/2003, concerning approximately 20-30 vaccinees who developed a warm, red and sore spot at the site of injection. This occurred approximately 24-48 hours after they received Fluvirin on 11/04/03 or 11/05/03. On 11/06/03 the vaccinees developed a warm, red sore spot about the size of a silver dollar at the site of injection. The reporter described the reaction as cellulitis and attributed it to the short needle length of the prefilled syringe. There was insufficient information to determine the reporter's causality. Follow up pending.
This case was reported by a healthcare professional and described the occurrence of injection site inflammation in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; unknown given on an unspecified date; varicella virus vaccine; manufacturer unspecified; unknown given on an unspecified date. On either 28 March 2011, 29 March 2011, 2 April 2011, 8 April 2011 or 13 April 2011 the subject received unspecified dose of KINRIX (unknown route, unknown arm). Less than one month after vaccination with KINRIX, the subject experienced injection site inflammation, swelling injection site and injection site soreness. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 7 children experienced the same side effects after receiving KINRIX vaccine. The vaccine was administered on 28 March, 29 March, 2 April, 8 April, and 13 April 2011. This is case 5 of 7; see case IDs A0924034A, A0924036A-A0924038A, A0924040A, A0924041A for details of the other reports.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Sycope with twitch, fully awake and oriented within a minute.
Pt felt dizzy after administering the vaccine.  Pt did not eat or drink all day. Pt was given water
Pt had a syncopal event with associated dizziness. Vitals: 125/77, 50, 17.  Pt given juice and crackers. Pt stable and released from the vaccination site
nausea, chills, body ache, dizziness  Got shot in the afternoon, nausea, chills and aches set in that evening. Nausea and chills worsened overnight. Got dizziness overnight and passed out. The next morning, chills and aches had passed. Nausea and dizziness had worsened. I passed out in my kitchen and hit my head. Went to the ER for a broken nose, possible concussion, staples in my skull and stitches in my chin from the fall.
From chart documentation: Parents reported--had vaccines yesterday and today has new onset puffy facial rash started 6 hours after vaccine and very fussy today with crying and apparent pruritis.  Exam revealed: erythematous macular papular rash to face , dense with slight plaque to cheeks but no scale includes scalp, trunk rash is more diffuse macular papular rash with an apparance more c/w exanthem rash. No wheezing.  Cleared promptly with Benadryl with some return of symptoms as dose wore off and good response to repeat dose. At re-eval day after above rash was nearly entirely gone except faint residual macules on trunk still similar in appearance to exanthem.
This case was reported by a consumer and described the occurrence of nausea in a 48-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included asthma, dystonia and laryngospasm. In November 2006 the subject received unspecified dose of FLUARIX (unknown). Two hours after vaccination with FLUARIX, the subject experienced nausea, sweating and heart palpitation. The subject reported experiencing sweating, nausea and heart palpitations two hours after receiving the flu vaccine in November 2006. The subject experienced these symptoms intermittently for three to four days. At the time of reporting the events were resolved.
Late for second dose; missed dose; health issue   not related to COVID; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose), ILLNESS (health issue   not related to COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 26-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose) and ILLNESS (health issue   not related to COVID). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose), ILLNESS (health issue   not related to COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late for second dose) had not resolved. Not Provided          Upon in internal review on 21 May 2021, the age was corrected to unknown age.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Patient received second dose of vaccine outside of time period
Moderately severe Laryngospasm 1 hr after vaccination.  Rx with EPI in ER.
"Significant episode of high-pitched crying p/1st DTP, lasting 4-5 days";
Tinnitus - severe.  2 weeks so far.  NEVER had any issues with my ears.  Bilateral, high pitched, NON-STOP ringing.
Patient presented with complaint of vomiting  for almost 12 hours and approximately 10 episodes.
Mom called from the room for help.  When we came in the pt had fallen from the bed to the floor.  She was pale.  We rolled her over and woke her back up.  Lifted her feet and gave her cold water and a sucker.  She layed on the floor for about 5-10 minutes.  Dr. looked her over and said she looked fine.
A short time after getting up in the morning (10 -15 minutes) I felt light headed and unstable on my feet. I couldn't walk or stand without holding on to something, touching the wall, a chair, or kitchen counter top, etc. It looked like everything was moving sideways. I measured my BP and O2; BP = 119/77, HR = 80; O2 = 98%, HR =77. I also felt nauseous and only had a piece bread with butter. I took a Nautamine tablet and slept for about 2 hrs, until 10:30. Things were better, I could move around and back to normal by 2 pm.
Information has been received from a physician assistant referring to a male patient of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. The patient received the first dose of unidentified Merck HPV vaccine (name and lot number not provided) on 14-JUN-2014 and the second dose on an unspecified date in Jun 2015 (dose and route unknown for both doses) (inappropriate schedule of drug administration). No adverse symptoms reported. Additional information has been requested.
Patient did feel itchy all over and ached some after first shot, but didn't say anything about that.  Morning after 2nd shot became nauseated; ran fever and ached all over.  He felt this was for 2 -3 days, and also very tired.  Still very tired on 4th day after shot, but no fever or aching. Patient did take Tylenol, didn't help so also 1 dose of Ibuprofen.  Take Prasugrel, so Ibuprofen wasn't really an option for him.
pt recv vax 5SEP96 & 5SEP96 pt exp a temp of 104 w/a sz lasting 10-15min;pt recovered;pt was seen by a MD the following day w/no problems noted;CT scan negative;
Burning and itchy eyes; Burning and itchy eyes; This is a spontaneous report from a non-contactable consumer (the patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2) vaccine,  via an unspecified route of administration on 07Jan2021 10:45 at single dose for covid-19 immunisation.  The patient medical history  and concomitant medications were not reported.  The patient  stated that starting 07Jan2021 at 17:00 it started burning and itchy eyes. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tingling/soreness inside upper and lower lip, on tongue, gums, and inside of cheeks.  Eruption of hundreds of tiny mouth sores.  Happens each year after flu shot is administered (3rd year).
Flu like symptoms mild fever and fatigue that lasted thirty six hours and the on 14OCTOBER 2022 flu like symptoms that lasted seven days and included fever of 104 degrees for two days, severe congestion, fatigue.
had no energy; overheated; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "AVM in her stomach" (unspecified if ongoing); "Smoker", stop date: Feb2023, notes: Use to smoke at least half to one pack a day for the last 50 years.; "COPD", start date: 2019 (ongoing), notes: possible Covid strands.; "Asthma", start date: 2019 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Date:  08Feb2021- Pfizer Covid 19 TRIS 12 plus Vaccine , Lot: EL9265, Exp/NDC: Unknown , Time: Unknown; about 3 in the afternoon , Anatomical : Right arm, in the deltoid, intramuscular. Then added, it could have been sub q, but she was not paying attention), administration date: 08Feb2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Second Dose: Pfizer Covid 19 TRIS 12 plus Vaccine , Date: 01Mar2021, Lot: EN6201, Time Administered : About 1 in the afternoon , Anatomical Location Left arm), administration date: 01Mar2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "had no energy"; FEELING HOT (non-serious), outcome "unknown", described as "overheated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that she went to the same clinic. She was out working and had no energy. She was overheated. Route Administered: Initially stated sub-q, but then stated the form looking at it does not say.
This case was reported by a physician via sales rep and described the occurrence of erythema in a 12-year-old patient who received MENVEO (batch number M15079, expiry date 30th April 2017). On an unknown date, the patient received MENVEO. On an unknown date, an unknown time after receiving MENVEO, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The sales representative called to report the adverse event on behalf of physician. This case has been linked with US2016109244, reported by same reporter.
Fifteen minutes post vax, mother asked that MMR injection site be checked. Redness, heat and swelling 1.5
Arm pain with redness and swelling at injection site,  headache, severe shaking/chills, fever of 102.7 for 2 days, numbness on left side of face including tongue and gums with a slight facial droop lasting for 3 days, night time hallucinations lasting 6 days.
pt recv vax & exp local rxn, which consisted of redness & irritation @ the inj site; pt recovered;
Headache.  Also numbness in jaw area and cold sensation inside the mouth and around the jaw as well as dry mouth.
Extreme fatigue--flu like, in bed 36 hrs, no temp. or fluids etc.
had headache for a few days, then starting on 8/24 had rash all over body from head to toe
genital herpes; Nerve pain/Nerve pain inside of my head/Nerve pain in my feet; Lip tingling with no outbreaks; awakening of the herpes virus; Tingling in affected area of outbreaks; Burning of my right hand; This non-serious case was reported by a other health professional and described the occurrence of genital herpes in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection.   On 07-JUN-2022, the patient received Shingrix .5 ml. On an unknown date, 1 week after receiving Shingrix, the patient experienced genital herpes (Verbatim: genital herpes), nerve pain (Verbatim: Nerve pain/Nerve pain inside of my head/Nerve pain in my feet), tingling lips (Verbatim: Lip tingling with no outbreaks), herpes virus infection (Verbatim: awakening of the herpes virus), tingling (Verbatim: Tingling in affected area of outbreaks) and extremities burning sensation of (Verbatim: Burning of my right hand).  The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the genital herpes, nerve pain, tingling lips, herpes virus infection, tingling and extremities burning sensation of were not resolved.   It was unknown if the reporter considered the genital herpes, nerve pain, tingling lips, herpes virus infection, tingling and extremities burning sensation of to be related to Shingrix.     It was unknown if the company considered the genital herpes, nerve pain, tingling lips, herpes virus infection, tingling and extremities burning sensation of to be related to Shingrix.   Additional Information: GSK Receipt date: 26-SEP-2023 The patient's description was that she was misdiagnosed by her dermatologist who said she had shingles and not the actual Herpes Simplex, her Primary care physician agreed, he suggested that she get the Shingles vaccine, which she did. The vaccine caused her symptoms to flare up and it's been 16 months with constant outbreaks and nerve pain.  The patient only received one shot and one week after vaccine shot, awakening of the herpes virus. Symptoms are still current.  Non-stop nerve pain outbreaks every 3 to 7 days and nerve pain inside of her head.  Tingling in affected area of outbreaks and lip tingling with no outbreaks.  Burning of her right hand, outbreaks on her right hand and nerve pain in her feet, antivirals did not stop the outbreaks. The symptoms were treated. The reporter consented to follow up.
she developed anemia; loss of weight; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (she developed anemia  ) and WEIGHT DECREASED (loss of weight) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included COPD and Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (she developed anemia  ) and WEIGHT DECREASED (loss of weight). At the time of the report, ANAEMIA (she developed anemia  ) and WEIGHT DECREASED (loss of weight) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Reported that already received all of their Moderna doses and boosters, but after receiving the shots she developed anemia and loss of weight, and every time she gets another booster she gets worse.   This case was linked to US-MODERNATX, INC.-MOD-2023-747881 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747881:Same reporter (SPIKVAX NOS)
12 hours after vaccination developed chills, severe muscle pain, shivering, headache, nausea without vomiting. Symptoms persisted for 24 hours.
Vaccine was administered beyond use date after the thaw process; second dose received was 0.25; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) and UNDERDOSE (second dose received was 0.25 ) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) and UNDERDOSE (second dose received was 0.25 ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) and UNDERDOSE (second dose received was 0.25 ) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19. It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had any chronic or long standing health conditions. The patient had no adverse reactions and no reports of any reactions after the administration of the vaccines. No treatment information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
5/26/17 Redness, swelling (R) thigh, also very tenderness. Pt. is bearing weight and otherwise active. Pt. also seen at ED - altogether monitored and Tx'd. Has appt. 6/2/17 and U/S and spclst. notes given to pt. parents 5/26/17.
Headache; sharp ear pain in both ears; fever (102); night sweats; muscle cramps; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Vaccine location: Left Arm), administration date: 30Jul2021, when the patient was 33 years old, for COVID-19 Immunization, reaction(s): "muscle cramps", "arm pain". The following information was reported: HEADACHE (non-serious) with onset 21Aug2021, outcome "recovering", described as "Headache"; EAR PAIN (non-serious) with onset 21Aug2021, outcome "recovering", described as "sharp ear pain in both ears"; PYREXIA (non-serious) with onset 21Aug2021, outcome "recovering", described as "fever (102)"; NIGHT SWEATS (non-serious) with onset 21Aug2021, outcome "recovering", described as "night sweats"; MUSCLE SPASMS (non-serious) with onset 21Aug2021, outcome "recovering", described as "muscle cramps"; PAIN IN EXTREMITY (non-serious) with onset 21Aug2021, outcome "recovering", described as "arm pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, ear pain, pyrexia, night sweats, muscle spasms, pain in extremity.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine, other medications the patient received within 2 weeks of vaccination are Blood Pressure Meds. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received varivax on 03/14/2000. Pt diagnosed with varicella on 03/11/2002.
10/15/21:  Awoken from sleep with severe tinnitus, 911 call, ambulance to nearest hospital due to tachycardia, hypertension, concern for stroke.   Severe tinnitus resolved within an hour?  Discharged following morning with recommendation  to see Neurologist.  Milder tinnitus on 10/16/ 21 pm managed at home.
This spontaneous report as received from a medical assistant refers to a 6 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 16-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
NUMBNESS AND TINGLING TO FACE, HEAD, BILATERAL HANDS AND FEET.
I've developed a hard, itchy lump at the injection site. I guess this is being referred to as Covid Arm.
The first symptom was blurred vision. Around 2:00 I had difficulty breathing, hoarseness and a dry cough. An hour later I had swelling of the face and lips, headache and a racing pulse.
Information has been received from a licensed practical nurse (LPN) concerning a 66 year old white female who on 01/10/2003 at 14:00 hours was vaccinated in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 644217/1026M). Concomitant therapy included acetaminophen (+) dextromethorphan hydrobromide (+) doxylamine succinate (+) pseudoepherine HCl (NYQUIL), aspring (A.S.A.), lansoprazole (PREVACID) and atorvastatin calcium (LIPITOR).  Illness at the time of vaccination included an upper respiratory infection (URI).  The LPN reported that on the evening of 01/11/2003, the patient developed erythema at the injection area.  The LPN also reported that the 17cm x 9 cm injection area was raised and hot to the touch.  Unspecified medical attention was sought.  On 01/20/2003, the patient's events resolved.  It was also reported that another patient developed injection site swelling, erythema, and warmth after being vaccinated with pneumococcal vaccine 23 polyvalent.  (WAES # 0303USA00340).  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information is not expected.
On the day of the shot slight itching /soreness. On day 2 sore arm slight itching. Day 3-22 Jan slight itching. 23 Jan swelling,  rash,  and redness around injection site. 24 Jan treated w/ topical Benadryl.