chrisvoncsefalvay/vaers-outcomes huggingface dataset:
.This is a spontaneous report from a contactable consumer who reported for his daughter. The reporter was reporting for his two daughters. A 14-year-old female patient received TRUMENBA, via an unspecified route of administration, at single dose, on 24Apr2015. The patient medical history and concomitant medications were not reported. In Apr2015, the patient experienced chills, fever and numbness of leg. The patient received ADVIL as therapeutic measures, taken for chills and fever. The patient did not recover from chills and fever; while clinical outcome of the event, numbness of leg, was unknown
Pt reports approximately 2 hours after the injection, she began having redness and swelling as well as tenderness in her L upper arm, extending beyond her elbow. She reports she is not allowed to take BENADRYL, sought no treatment and did not self-medicate reaction. Pt presents today 10/9 with mild redness and swelling noted to L upper arm distal to injection, but proximal to the joint. Area is not hot to touch.
pt recv vax & w/in hrs of vax pt began crying;poor feeding & nightmares;pt was evaluated 6 times by MD & was eventually referred to ER;pt adm to hosp; t102, fussiness, ear infect & seborrhea;dx OM;prominent head size noted;
DTaP given in right arm on 1/8/02. On 1/10/02 pt. presented to office with redness, swelling, heat  & itching at site of vaccine. Dr. examined & put pt. on Keflex 250mg BID for 10 days.
Shivering about 4 hours, body aches, redness and swelling, tiredness weakness, no appetite, was in the bed 48 hours.
fever up to 102, body aches, cold chills & sweats could not get out of bed  or work until the next morning
Varicella like rash <42 days after vaccination with dose 2.  Suspected vaccine strain associated rash.
Beginning on 3/19 he developed a progressive ascending numbness first in his toes, then progressing to include bilateral legs up to knees and bilateral arms up to mid forearm. He also had mild leg weakness bilaterally. He has absent reflexes. His lumbar puncture showed albuminocytologic dissociation. He was diagnosed with Guillan-Barre syndrome and is being treated with IVIG.
Vaccine administered to a 17 years outside of FDA guideline. Mom was informed and aware, patient is not experiencing any side effects.
Pt saw another MD at different location with rash which was diagnosed as shingles. This was 4 wks post Immunization.
Received vaccine on 6/5/21, next morning at 7:00 am mother heard a loud noise and found PT face down lying half way in bathtub unresponsive,  attempted to lift him observing his eyes were rolled back in head, was unconscious for approximately 1 min trying to lift him out, then he blacked out a second time hitting bathtub a second time.  Lifted him out and placed on floor, he was unresponsive - called 911, he came to slightly after 3 minutes.  Ambulance took him to ER and we stayed all day receiving fluids and chest XR (clear).  We were discharged in the afternoon with the doctor saying he has a syncopy episode.  At 4:00 PM PT was going to the bathroom and he stated he didn't feel good.  I stood in front of him because he turned white and eye rolled up into his head and he blacked out and stopped breathing for approximately 2 minutes while I got him on floor and gave CPR.  Called 911 and he began breathing again .  Back in ambulance to hospital and we stayed in hospital for 2 days.
patient received COVID 19 Pfizer vaccine instead of COVID 19 Pfizer Bivalent vaccine
No AE reported; HCP called to report T/E for PROQUAD. PROQUAD outcome was Supported. HCP stated it was administered to a patient. No additional AE reported. No PQC reported.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 29-SEP-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number  X009733, expiration date 02-SEP-2024 (dose and route of administration not provided) for prophylaxis (product storage error). No adverse event was reported.
sick; body aches; sever arm pain/arm is hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "not recovered", described as "sever arm pain/arm is hurting"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "recovering", described as "body aches". Therapeutic measures were taken as a result of pain in extremity, illness, pain.  Additional information: After consumer received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine on 03Apr, she was sick and had body aches and a sore arm. Today, she woke up and it was worse, arm pain was severe and her arm was hurting. She also mentioned that she has been taking Advil, Tylenol to treat the symptoms, but said that she thought they are not working. Consumer wanted to know if this was a normal reaction to the vaccine and how long it lasts. Patient clarified she has body aches which was better and an achy arm which was now severe. Patient stated it was Pfizer for her eye surgery next week and she was an educator and needs it for work. Information regarding expiry date, other products, Investigation Assessment and patient history was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At 5:00pm. Blood pressure was elevated to 137/91, No temperature noted even though he felt hot and clammy. Gave him water, and put legs on a pillow and he lay down  At 6:30 he began to feel sweaty, clammy and included nausea. These episodes continues until about 8:30pm when he started to feel a bit better After a night of sleep that was restless and about 6hr long woke to feeling better but tired.
phizer -10 days off and on  started wheezing, then went into cough, thru up twice; 10 days - itching  but no rash etc.   first 3 days - warm like a mild hot flash or low blood sugar.    blood sugar wasn't low that , started right after.   headache for a week or so. 1st 24 hrs felt bitchy, (not sure how to put it) for atleast week felt off, not sure how to explain it.     tired.   took naps
Started with a swelling in my throat that got much worse also swelling in lips and tongue. By 07:00 I was also experiencing severe flu systems including severe chills and shivering, body aches, 103 F temp, headache and extreamly bloodshot eyes.  The next morning fever was gone and after two days all symptoms were gone except for some lingering numbness in my tongue.
Asthma exacerbation that required hospitalization and admission.  Patient received oral steroids, inhaled steroids, magnesium, continuous nebulizer
Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient during her waiting period that she felt some tingling throughout her arm. Nothing she was concerned about. After approximately 1-2 hours, I contacted her to see how she was feeling. She stated the tingling was now throughout her left side arm and leg. She also stated she felt some head pressure, but nothing she found to be alarming. She has had prior vaccines that give similar responses, that have all resolved.
BIB mother for covid19 vaccine, patient has no significant allergy history before, no other allergy history, no significant medical history, not on medication, not sick today, eats and active. 3 minutes after pediatric covid vc when mother and me were talking also giving her a flu vc soon, she slipped to the chair and staring eye, pale and weak for 1-2 minute,  she was immediately put on the examination table, vitals: BP=110/70, P=92, she was regain conscious in 1-2 minutes, and answered all questions, jumping well in the room, no SOB, no cyanosis, no seizure, no rash.  O2sat 99%; Observed 30 minutes, no sick sign,  Recheck pulse = 88/mins, had pediasure and candy after the fainting, smiled and sent home w/ f/u instruction and apt on next Monday.
Dose administered past the 30 use by date expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30 use by date expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30 use by date expiration). In November 2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30 use by date expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that 3 doses were administered past the 30 day use by date and the number of doses/vials: 2 vials total, 3 doses administered On 04-Oct-2021 at 09.28 am, the vial was initially stored in the refrigerator and on 04-Nov-2021 and 05-Nov-2021, the 3 doses of vaccine were administered. The vaccine did not undergo any temperature excursions.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-386462, MOD-2021-378185 (Patient Link).
SORE ARM THE NEXT DAY,  SORENESS EXTENDING DOWN ARM AND UP TO SHOULDER / NECK
On 4/26/00, I received my 1st pre-exposure rabies shot. The next day, I started getting a headache that would not go away. On 4/30/00, I became very sick; headache, nausea and vomiting, dizziness and disorientation. At about 21:00, I went to the ER and they treated me for migraine headache with a shot and pills. On 5/3/00, I had my 2nd rabies shot. I still had the headache all of this time and on 5/5/00 at about 11:45, I got ver nauseated, disoriented, my glands became swollen, became either cold or hot to the touch, neck pain, tingling in hands and feet. I went to doctor and was given a prescription of promethazine 25 ml to help with nausea, but it took more than 24 hours to get out of my symptoms. I stayed out of work until 5/10/00. On 5/8/00, all of the same symptoms re-accrued. I stayed with a friend of mine who is a nurse so that she could keep an eye on me. I went back to doctor on 5/10/00, for blood testing.
Dizziness, NauseaVomiting, Tachycardia, Fatigue, Muscle spasms Narrative:
No additional AE reported; the vaccine was administered after expiration; This spontaneous report was received from a pharmacist referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.   On 28-OCT-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T017385, expiration date: 01-SEP-2021) 0.5 milliliter administered for prophylaxis. It was mentioned that the vaccine was administered after expiration. It was also mentioned that the vaccine did not have a temperature excursion.
Patient went home and vacuumed shortly after receiving the vaccines. During this time she felt a stiffness in the left side of her neck. Felt worse than a kink, it hurt to move until she called on 9/17/18. She had a chiropractor appt on 9/17/18 as well and stated that her neck felt better, but was still sore.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-apr-2022, post expiry date of 01-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 02-Apr-2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 02-Apr-2022, post expiry date of 01-apr-2022.) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 02-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The Pharmacist was calling to verify an expiration date for lot number 026L21B. The pharmacist said that when his Pharmacy received this vaccine on 23FEB2022 that a Pharmacy staff member looked up the expiration date and came up with an expiration date of June 2022. However, another Pharmacy Staff member looked up the expiration date of the Moderna Covid-19 vaccine in question and the expiration date is 01APR2022. Number of doses/vials: 80 doses administered. The vial did not undergo any temperature excursions. Caller mentioned 155 patients were vaccinated with expired doses from 2Apr2022 to 19Apr2022. The Pharmacist did not have any other information on the patients currently. The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that thought that the vaccine expired in Jun-2022, however it was expired in 01-Apr-2022. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up received contains non-significant information: updated reporter contact details.
pt recv vax & devel t104 & pertussis;pt still has trouble breathing @ has what sounds like whooping cough;
About 5 -10 min. patient started turning red, her blood pressure was 150/104, did not faint and no other reactions. Her skin was still red, so we administered 50mg of Diphenhydramine.
Information has been received from a certified medical assistant concerning a female pt who was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) (lot640335/1255L). The pt called to report that several hours post vaccination she developed swelling and soreness at the injection site and stated that the area was warm to the touch. The pt was advised to take OTC acetaminophen (Tylenol). No product quality compliant was involved. Additional information has been requested.
have a rash that is red and spreading 7 days after my first vaccine; This case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided a follows: The age at vaccination was not reported. The patient reported that, till the time of reporting had red rash, which was red and was spread 7 days after vaccination. The patient asked is that normal.
Starting around 1/11/2021 @ 11pm and progressing through 1/12/2021 around 6:00 pm = Fever of 102.0 F,  EXTREME body aches/head ache/chills/sore arm  1/13/2021: My lips became EXTREMELY full/swollen with slight discomfort - I had, had  juvederm injections in my lips in the in 3/2020.
2 hrs after office/shots had sore throat, swollen lymph glands in throat, 6 hrs later started running fever up to 100 range up to 102.9 took to Dr on Thursday (7/10/03). Blood tests run, white blood cell count high, went home-cont. to feel ill-vomiting-back to Dr 7/11 blood tests for West Nile and Tyyphoid. Home-that night, Friday-went to ER-not admitted "they were busy." Home-back to ER Saturday 7/12/03-admitted to hosp. sores in mouth to throat erupted. Fever broke started IV's-antibiotics started on Monday. Still in hospital 7/15/03. A 60-day follow up report received 10/09/2003 adds: The pt was followed by his MD. We are a vaccinating clinic not a care center. I spoke to his mother a number of times. His final diagnosis and long term prognosis is not known to me.
left arm pain and Malaise immediately after,  followed by sweling in both feet and purple discoloration in feet that resolved spontaenously over the next 4 days. Erythema and swelling to bilateral upper arms with associated skin tenderness, Malaise / intense fatigue both not yet resolved at time of this writing on 2/3/2021.
In the computer system that we use for patients, if the syringe next to the patient's name is a green color, that means the patient is cleared for vaccination. If it is red, I carefully review the questionnaire with the patient. Patient told me before the vaccination that she doesn't do well with vaccines. I vaccinated her. She said the vaccine hurt her and the first vaccine did not hurt her. She needed to sit on her chair where she was vaccinated for a little while after. She turned yellow, was snoring and fell off the chair. I turned her to her side and called for help. We fanned her and she was given water. She put her head down on the chair while sitting on the floor and she asked for a trash can and she threw up. She also told me that she felt disoriented after waking up. She has a previous history of this reaction to vaccines(but with no vomiting)..also I don't think she experienced these reactions to vaccines the past few years. She never vomited after a vaccine. She also said she had no problem with the first Pfizer vaccine. We brought a nurse to assist her. I checked on her after 15 minutes and she was cold and sweaty. I seated her for an additional 15 minutes. I asked her if she wanted me to call 911. I also advised her that if she still did not feel well after she left the pharmacy, that she can go to the Emergency Room. Her husband was with her.
front chest pain and back pain when had deep breath; front chest pain and back pain when had deep breath; cough; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 29Apr2021 12:00 (age at the time of vaccination 51-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. Patient do not know about any known allergies. On 29Apr2021 15:00, the patient experienced front chest pain and back pain when had deep breath, and cough. No treatment received for adverse events. The outcome for all the event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Pt recvd vax 9AUG91; Rash appeared 19AUG91; Elevated t103 R began 22AUG91; Seen by MD prescribed Septra for ear infect & DPH uneventful recovery;
Soreness on the day of the shot and a couple days following. Body aches and fatigue the following day.  Treated but not resolved by Tylenol. Itchy, firm injection site a week after the shot.   This is in the 16-17th week of my second pregnancy. Due date is 11-21-2021.
Rash/ Rash, all over, arms, legs, chest, back; Urticaria/Hives; Legs were itchy and red was reported as worsened; Legs were itchy and red was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 19-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 16:14 (Lot number: FC3181) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had gall stones" (unspecified if ongoing), notes: She had her gall bladder removed/ had the surgery, 04Feb2022; "Obesity" (unspecified if ongoing), notes: Obesity, she is  overweight, that's what the doctors say. Family history included: "Eczema" (unspecified if ongoing): Dad's side has eczema. There were no concomitant medications. The following information was reported: RASH (medically significant) with onset 20Aug2021, outcome "not recovered", described as "Rash/ Rash, all over, arms, legs, chest, back"; URTICARIA (medically significant) with onset 20Aug2021, outcome "not recovered", described as "Urticaria/Hives"; PRURITUS (medically significant), ERYTHEMA (medically significant) all with onset 20Aug2021, outcome "not recovered" and all described as "Legs were itchy and red was reported as worsened". The event "rash/ rash, all over, arms, legs, chest, back" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, urticaria, pruritus, erythema. Clinical course: it was reported that since the first dose, patient has been getting rashes, which she has not had before and wonders if she was allergic to something. She went to a dermatologist and they called it urticaria/hives, they told her to have allergy testing done, but it started after the vaccine. Patient was asking what was in the vaccine that she could be allergic to?. The event rash started the same day she got her vaccine, she went swimming and when she got out of the pool her legs were itchy and red. The rash gives her like a raised look, lately it is getting worse, itching is worse. Urticaria/Hives: rash, all over, arms, legs, chest, back, She was told to go to the ER if the rash was on her face, she has not gone to the hospital. They didn't prescribe anything they just told her to take Benadryl. She tried to use an ointment and Benadryl. The ointment was an anti-itch cream from the pharmacy. Ointment and Benadryl didn't work it didn't decrease the hives or stop the itching. She went to the dermatologist for the rash. No medical testing done, they just looked at it. It was also reported that the event took place around 4 or 5 PM. The patient has no prior vaccinations (within 4 weeks) from the administration of Covid-19 vaccine. The patient was given the second dose of vaccine on 10Sep2021 (lot: FD8448) at the age of 19 years in the right arm.  Follow-up attempts are completed. No further information is expected.
muscle twitches; This is a spontaneous report from a contactable other HCP. A 22-year-old female patient  received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  EK9231), via an unspecified route of administration in right arm on 03Jan2021 at a single dose for COVID-19 immunization. There was no relevant medical history. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) as oral contraception. She has developed muscle twitches after the first dose. Especially in the arm the vaccine was administered in. She has noticed it in other parts of her body as well. She has experienced twitching of the muscle. She noticed it a couple of days after the vaccine, Jan2021. Then she started to notice them more. She knows muscle twitches can be normal, but this was more than usual. It was especially in arm the vaccine was received in. She feels it most in her right bicep. She started taking magnesium supplements to help. Today she didn't take the magnesium, and she noticed she had muscle twitches still. The outcome of the event was not recovered.
Headache, Arthralgia, Fever, arm soreness, fatigue, diaphoresis Narrative:
pt recv vax & devel shingles;MD treating pt felt the child may have had a subclinical case of chickenpox;