chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got the booster dose; Hair is falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FG3527) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOVASTATIN (ongoing); MEDROXYPROGESTERONE; AMITRIPTYLINE taken for fibromyalgia, depression; METFORMIN taken for diabetes mellitus (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); ESTRADIOL (ongoing); METOPROLOL SUCCINATE ER (ongoing); CYCLOBENZAPRINE taken for muscle spasms (ongoing); L-THYROXINE [LEVOTHYROXINE] taken for blood pressure measurement (ongoing); AMLODIPINE BESYLATE taken for blood pressure measurement (ongoing); SYNTHROID (ongoing). V accination history included: Bnt162b2 (Dose Number : 2, Lot- EL9266, Administered in left upper arm), administration date: 19Feb2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (Dose Number : 1, Time the Vaccination Was Given: 1:10PM, Lot- EN6199 , Administered in upper left arm), administration date: 12Mar2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "Hair is falling out". The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021, outcome "unknown", described as "She got the booster dose"; ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "Hair is falling out". The event "hair is falling out" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia.  Follow-up (06Dec2021): Follow-up attempts completed. No further information expected.
This child had red, swollen eyes, weakness, erythematous skin, questionable difficulty breathing, and a rash.
After receiving the flu shot on Saturday, Oct. 6th, woke up Sunday Oct. 7th. With body ache, headache, nausea, and slept all day. Definitely flu symptoms.
After the 2nd shot, I had flu like symptoms, my arm was sore and I felt tired.  3 weeks later,  I took my mother to get her vaccine and that was when I started having symptoms of my own.   In the holding area, even though I was not getting a vaccine, I started to have symptoms.   I started having heart palpitations, increased heart rate and increase in pulse rate.  My BP was also high.    I did follow up with my cardiologist.  My symptoms included difficulty  breathing, shortness of breath and palpitations. I was instructed to wear a heart monitor.  Results showed possible arrythmias and rapid beating.   Recently,  I have been noticing increasing pain in both my knees and my osteoarthritis has been flaring up.
Headache, Myalgia, Fever & NauseaVomiting Narrative: Fever, body ache, chills, fatigue, headache, Nausea and vomiting
still lacking normal energy; stomach pain; nausea; loss of appetite; extreme exhaustion; Dry cough; Injection site still somewhat tender; extreme pain in whole length of arm; joint pain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 16Feb2021 as single dose for COVID-19 immunisation. Medical history included covid-19 (November). Patient was not pregnant at time of vaccination. Patient had not received any other vaccines within 4 weeks. Patient had received other medications within 2 weeks. The patient previously took terfenadine (SELDANE) and experienced allergies. Prior to vaccination, patient was diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. It was reported that Day One on 16Feb2021 patient had extreme pain in whole length of arm and joint pain that woke me numerous times during the night. Day Two on 17Feb2021 extreme pain in the whole length of arm, joint pain, stomach pain, nausea, loss of appetite, extreme exhaustion often requiring returning to bed within 30 min. of getting up, infrequent dry cough that happened once--5 coughs in succession (symptoms mirrored symptoms that I had when I had Covid in November). Day 3: repeat of day 2. Day 4 on 19Feb2021 Arm pain lessened, no fever, still lacking normal energy. Was able to eat extremely small meals. Did too much, which caused arm pain to return. Day 6: Symptoms gone, except unusual fatigue. Injection site still somewhat tender on 16Feb2021 to the touch on 07Mar2021. No treatment received for events. The outcome of events extreme exhaustion, injection site pain was not recovered, while remaining events were recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
injected with an expired Tenivac 3 days after it has expired for Immunization, with no reported adverse event; Initial information received on 13-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 7 years old female patient who was injected with an expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] 3 days after it has expired for immunization, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3V (vero) (IPOL) for Prophylactic vaccination (immunization).  On 27-Jun-2023, the patient received 0.5 mL dose 1 of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (batch number: U7092AA; expiry date: 24-Jun-2023) via intramuscular route in the arm (left arm as per patient mother) for Immunization 3 days after it has expired with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event injected with an expired tenivac 3 days after it has expired for immunization, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
brain shut down; This case was reported by a pharmacist via call center representative and described the occurrence of disorientation in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received Shingrix (intramuscular) .5 ml. On 20th August 2019, 1 days after receiving Shingrix, the patient experienced disorientation. On an unknown date, the outcome of the disorientation was recovering/resolving.   It was unknown if the reporter considered the disorientation to be related to Shingrix.  Additional details were provided as follows: The patient experienced a brain shut down. She would run a stop light or walk into a room and not realize she was in that room. The pharmacist referred to it as a possible loss of time.  At the time of reporting, the patient started to get better. The pharmacist was transferred to medical information for additional assistance.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Dec2021 as dose 3 (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: "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; VITAMIN C [ASCORBIC ACID]; FARXIGA; OZEMPIC; ATORVASTATIN. Other medication in 2weeks was reported as yes. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid, treatment start date=25Apr2022, treatment stop date=29Apr2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1158 - Vaccine administered 1348 - Witnessed fall in front of OCC patient entrance on MLK. Patient had been waiting for Ride Connection scheduled at 1400 since vaccine observation complete. Stepped off curb to look for ride in pick-up area then tripped trying to step back onto sidewalk. Landed on bilateral knees and then down to right right hip. Witnessed in full by Safety Lead. Partially witnessed by Observation Lead  and RN Lead. Assessed by these staff with MD Lead present. Okay to stand. Transferred to wheelchair. Okay to go home.  1412 - Observation Lead stayed with patient until ride arrived and patient left.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018, and 04-OCT-2018) for prophylaxis (doses were unknown), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no previous temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 9-week-old patient of unknown gender. On 12-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
fine vibration, like a low level electrical buzzing, fizzing, humming in legs and trunk just under the skin.
razor burn; has a rash that started 2 days ago on her face; she is in pain; Developing a rash around her mouth and nose; developing a rash around her mouth and nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 10Jan2022 17:40 (Batch/Lot number: unknown) at the age of 11 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "bee sting", start date: Jul2021 (unspecified if ongoing), notes: she had a prior bee sting this summer in Jul2021. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Location: Arm right, time: 17:40), administration date: 20Dec2021, for COVID-19 Immunization, reaction(s): "Break out in a rash on her forearm". The following information was reported: ORAL MUCOSAL ERUPTION (non-serious) with onset Jan2022, outcome "unknown", described as "Developing a rash around her mouth and nose"; RASH (non-serious) with onset Jan2022, outcome "unknown", described as "developing a rash around her mouth and nose"; SKIN IRRITATION (non-serious), outcome "unknown", described as "razor burn"; RASH (non-serious) with onset Jan2022, outcome "unknown", described as "has a rash that started 2 days ago on her face"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "she is in pain". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Generalized itching, runny nose since time of injection. On day 6 develop raised warm area over site of injection, 8 cm, 4 cm x 1 mm
rt thigh @ site of inj w/hematoma, inc warmth w/ 2" x 2" area skin erythema;
Large red welt appeared 8 days after 1st dose of vaccine.  About 3 inches x 2 inches.  Slight itch, no pain.
I began feeling achy around 4:00 PM.  It progressed to chills, headache, burning eyes, fever.  My fever was 103.2 when I went to bed at midnight.  Between 9:00  PM and midnight I also had difficulty with bladder control.   I slept 12 hours and today I fell 100%.
Information has been received from a registered nurse concerning a child who on 06/23/1997 was vaccinated with a dose of varicella vaccine. Subsequently, the pt developed chicken pox. The reporter indicated that there was a chicken pox breakout at a day care in her area. It was reported on 01/04/02 that 15 children had developed chicken pox since the end of December 2001. The first onset date was 12/31/2001 and the last date was 01/04/2002. The number of lesions were reported to be unknown. The pt sought unspecified medical attention. It was also reported that 7 of the children were vaccinated with varicella virus vaccine live (WAES0201USA00351, 0201USA00755, 0201USA00756, 0201USA00757, 0201USA01038 and 0201USA01039). Additional info has been requested.
Swollen lymph node under arm closest to injection site. Node continues to swell and is painful if I have even a mild cold.
I had ear pain through the night after midnight so 11-1-2014. Couldn't sleep...went to doctor with ear pain and pain in head behind ear on Sat Nov 1st. Sunday Nov 2...I went to emergency room for right side of face paralyzed. Went back to emergency room Tuesday morning around 6 am due to symptoms worse. Couldn't see out of right ear and severe speech problems. I have been out of work since all of this. I have been to eye doctor...ent doctor...and emergency room twice. Also had an MRI at the hospital. I am on steroids...acyclovir...and eye lubrications. All doctors feel that this came from flu shot. They have called this Bells palsy.
Pt noticed left gland in neck was swelling, developed headache, which she treated with Tylenol and ibuprophen. The pt's symptoms began on Thursday 7/26/01.
The pt received the chickenpox vaccine (Varivax) on 1/11/99. She was dx'd with chickenpox rash on 12/19/01.
Immediate pain upon injection, pain worsened and has not gone away (7 months after the fact); ROM decreased and normal daily activities very painful; now experiencing sleep interruption; physical therapy ordered but not yet completed, Motrin for pain as tolerated, ice/heat not helpful.
Fever greater than or equal to 102 degrees. Inconsolable then lethargic.
Patient received her first Pfizer COVID vaccination and subsequently experienced profound fatigue coupled with LUE/LLE weakness that persisted and was ultimately diagnosed with an acute CVA.
Started thinking it was either a bug bite  or scratch, then thought poison ivy rash but has progressed steadily over both legs and little on arms.  Was prescribed prednisone and cephalexin to treat has steadily worsened over 2 weeks.  Have an appt with dermatologist scheduled on 8/26/21.  Not totally sure if this is related to vaccine but was encouraged to report.
Dizziness, HYPERtension, BP 220/103 after first dose given. Hx. HTN. c/o chills, dizziness and headache. Narrative:  BP 220/103 after first dose given. Hx. HTN. c/o chills, dizziness and headache. To ED for BP. 201/99, 92, 18, 97.1 temp. Admitted for telemetry obs bed. Returned for 2nd vaccine on 1/22/2021.
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Weakness-Mild
Employee states after her first hepatitis B vaccine injection (1-2 days after the shot) she broke out in a fine rash on her arms, shoulders and back with itching. She states the bumps were like "heat bumps". She did not report until almost a year later when came in to get 2nd shot.
Adverse event onset was 8-08-09 - Client noticed a knot and soreness at injection site on (L) arm. By the next day, soreness, swelling, hardness, and vein enlargement were noted at the bend of the arm on the inner aspect. Area today is only slightly swollen, but remains sore to touch. Vein running along the inner aspects of the (L) mid arm is slighly larger and harder than vein in (R) arm. Client has been applying cold compresses and taking OTC pain/inflammatory medication with some noted improvement, but problem is better one day and then worse the next. Client is concerned.
Redness below the breast and lateral chest wall thigh proximal elbows and forearms Tx given PREDNISONE 10mg.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild
Fever, tiredness/sleepiness, shakes, headache, pain at injection site. Lasted about 40 hours.
Swelling in the injection  site   of 0.5 cm,  hardness, Redness, Muscle pain for 3 days, Headache,
EXPIRED VACCINE GIVEN. NO TEMPERATURE EXCURSIONS OCCURED.  NO PROBLEMS NOTED WILL REVACCINATE AS DETERMINED BY POLICY AND PROCEDURE.
At 9 pm I felt suddenly extremely dizzy while drinking lemonade from the jar in front of the open refrigerator door. Before I could react I blacked out completely and fell from a standing position to the kitchen floor. I think I regained consciousness immediately when I felt the pain from the back of my skull hitting the floor. I remained extremely dizzy for a couple of minutes so I remained on the floor until it had mostly subsided. I assessed my own condition. as best I could and found no blood or lacerations or broken bones. I crawled back to bed. It is three days later and I'm experiencing occasional mild dizziness from abrupt head movement. Other than that, and bruising from the fall, I think I am okay.
after receiving the shingles vaccine around 11 am, i woke up at 3 am: - fever, shivering and sweating - sore all over, not particularly where i got the shot - sharp pain behind the eyes - strange dreams and rumination   was a rough night, took 3 advil at 0930. better now
Received vaccine at 12:45pm on 02/04/04.  At the time of vaccination child was asymptomatic and afebrile.  Mom called to report symptoms of vomiting, diarrhea and fever 100.6 at 15:00.  Mom stated she had been giving the child Tylenol.  Mom stated child was stable at this time and she was also going to call the pediatrician.  Both the pediatrician and the health department nurse told mom to continue to watch for further changes and go to the hospital immediately if child becomes worse.  Child woke up the next day in the AM with a fever of 100.8.  The child had vomiting x3 and diarrhea x2.  Child had first seizure at 10:00am and mom took child immediately to the hospital.  Upon arriving at the hospital around 11:50 the child had second seizure and two more after that before discharge at 15:00 on 02/05/04.  Mom stated tests were done but they are unknown.  Child was sent home after being stabilized and dehydration was resolved.  Spoke with mom at 14:00 on 02/17/04.  Mom stated child has been fine since coming home from the hospital on 02/05/04.  The Hep B vaccine was given at birth also Hib, IPV, PVC7 and 2nd Hep B on 02/16/03 by the pediatrician with no adverse reaction.
Bloody nose for 4 days usually in the evening around 7:00 pm. After tilting head back and using a tissue in the nose, bleeding stopped after 15 - 20 minutes.
One week after injection I had a severe headache, stabbing pain all over my head, like a knife.  Dizziness, nausea, vomiting.  Sweats and chills.  I have never had anything like that before.  I have never had a severe migraine headache.
I have had a baseball sized red, hard welt develop at the injection site approximately 12 hours after vaccination. The area continues to be red, hot and swollen even 24 hours after when it started. I have also had fevers up to 100.8. I am taking tylenol, aleve, and using ice on my arm. I did not have any of this with my last two shots.
pt recv vax & p/15min pt c/o mild itch;but 2hr later noticed warmth & redness;bruise formation also noted;no tx was given;pt did not report this until next day;