chrisvoncsefalvay/vaers-outcomes huggingface dataset:
23 female patient who was given PROQUAD by mistake; This spontaneous report was received from a registered nurse and refers to one of 23 female patients of unknown age. There was no information about her concurrent conditions, concomitant therapies or medical history provided. On 01-MAR-2021, the patient was mistakenly vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported).
I experienced lower back pain down into my legs. I went to my doctors office where they checked me from head to toe. I had an MRI, blood work, a bone scan with contrast and a sonogram of my kidneys. Everything came back normal. The pain lasted for about four months where the pain gradually subsided.
It was reported to this writer by the lead responder that soon after receiving the vaccine, the guest began feeling dizzy and nauseous. She told the lead responder that she took Zyrtec this morning but did not have any breakfast. She was given some juice and laid down on the  cot. EMS was called. Guest  stated that she had an itchy throat but that is baseline for her as she has seasonal allergies. No signs of difficulty breathing. VS were WNL. She was released by EMS about 30 minutes following the initiation of reported symptoms.  At that time she stated that she felt better and had not worsening of her itchy throat. Continued to have even, unlabored breathing.
Resident received flu vaccine left deltoid 12/5/16 at 8am. He also received BEXSERO (#1) Rt deltoid 12/5/16 at 8:10AM. On 12/6/16 at app 8am, developed severe H/A sinus pressure in maxillary region, dizziness. Vital signs normal baseline.
It was given on Oct - 15 and pt reports side effects on Dec. 21. She complains about sore arm but there is no bruise, redness or anything else. She said she had blood shot eyes they were clear today and pain on left knee and left side does not feel right.
911 - paramedics; considered ambulance to ER. Spiked high fever, uncontrollable shaking, violent vomiting 8 times. White lips. Ill for 2.5 days - terrible!!
next AM arm sore, unable to lift, hive below the site of inj-advised to call MD if desired, APAP, soaks to arm;28JUN96 4PM reports red, hot, ridge back of arm;pain, lo grade fever;MD called;3JUL96 arm sore, swelling dec doing fine;had bumps
Stomach swollen; Stomach pain; Sore arm; Chills / still present; She had vomited all night; Upset stomach / still present; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 7th August 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, chills and vomiting. On 8th August 2021, the patient experienced swollen abdomen and stomach pain. In August 2021, the patient experienced upset stomach. The patient was treated with simeticone (Gas X) and ibuprofen (Motrin). On an unknown date, the outcome of the pain in arm and vomiting were recovered/resolved and the outcome of the chills, swollen abdomen, stomach pain and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chills, vomiting, swollen abdomen, stomach pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and within 2 hour, she experienced sore arm, chills, and then she had vomited all night. One day after vaccination, the patient experienced stomach swollen and stomach pain. The patient had taken GasX and Motrin to treat the symptoms, but nothing was alleviating the symptoms. The symptoms of sore arm and vomiting have gotten better, however, chills and upset stomach was still present. The reporter did not have lot number or expiry date of the vaccine. The reporter gave a consent to follow-up with health care professional. However, she did not have the first name of health care professional, a complete address to health care professional, as well as fax number and an email address to health care professional. The reporter provided her email address.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (strength, dose, frequency and route were unknown; lot # was M008172 with expiration date 16-FEB-2018). No adverse effects were reported. This is one of several reports that received from the same reporter. Additional information has been requested.
Mar90 pt vax;  exp pain in both legs, back, neck; vision was disturbed, saw yellow spots before eyes, felt like was going to pass out, legs & back fatigued, legs weak, fell down, hypoesthesia of her left leg & occational tingling in legs.
Patient wqs reported to have a general rash 2 hours after her vaccination.  She was reported to have the rash from her mid chest area to her bottocks area.  She did not have shortness of breath or any swelling in the throat.  She was also reported to not have this reaction at the injection site on her   arm.  Nurses stated that she had also very recently had her chemotherapy infusion.   An hour later, no additional symptoms were reported and the home was awaiting further direction from her physician's office.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient has complained of redness at injection site which has enlarged over the past 2 days from inital injection.  Also swelling has occured and she also expressed a tightness in the injection site area.  She was advised to take benadryl for the redness and we will follow up with her tomorrow to see if redness has resolved or improved.
Starting 07/19/2022, I developed the "COVID" cough and had fatigue, headache and runny nose. I was concerned that I had COVID-19. I tested myself that day and it was positive. I called my doctor on 07/20/2022 who prescribed me Paxlovid. When I tried to take it, it made me violently ill. I tried to take it one more time but, again, it made me violently sick. So, I decided not to take it. By the time I realized I would be unable to take the medicine, it was to late for the infusion so I had to tough it out. I was very sick and it would last for over a week (1.5-2 weeks). I am just starting to feel somewhat normal. I am still very fatigued and have body aches. I have slight brain fog but not to bad. I wish I would've gotten the infusion.
Date and time of vaccination: (list both if they received both shots):?  2/10/21 first / second 3/3/21 Brand and lot of vaccine: Pfizer first EL9262 / second EM9810  2/10/21 first dose sore arm later the night Caller concerned she did not watch the second vaccine go in, the nurse doing it seemed distracted. Since she has had no post vaccine symptoms concern she did not get the dose. Advised all doses are accounted for. Many have not had any symptoms after getting the vaccine.
This spontaneous report as received from the patient's daughter, reporting on her mother, a 82 year old female patient. Medical history and concurrent conditions were not reported. On 11-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency reported as one time vaccine) (route reported as injection) (lot number and expiration date were not reported) for prevent shingles. Concomitant therapies included LISINOPRIL, LEXAPRO and FOSAMAX. The daughter stated her mother got ZOSTAVAX vaccine on Monday, 11-AUG-2014 and experienced "redness, pain, itching, swelling hard lump at site of injection, headache, body aches, muscle aches, which all started same day she got vaccine". At the time of the report outcome was unknown. The patient seek medical attention and the physician suggest as treatment BENADRYL for itching, hard lump, and ibuprophen for aches pain and ice pack for swelling. No labs diagnostics studies were performed. Additional information has been requested.
Injection itself did not hurt; however, around 10 PM that night my left arm was very sore and I  couldn't lift arm without using right arm. Also experienced short, sharp headaches on right back side of head  (Not many) but the left arm was very sore which I did not have on the first injection.
Patient received vaccine and returned to home with mother called to report full body hive reaction within 1 hour of vaccine, patient given Benadryl 12.5 mg. F/u phone call 1 hour later and problems reported no shortness of breath / resp. distress.
PATIENT STARTED HAVE LITTLE BUMPS LIKE HEAT RASH THE DAY AFTER THE VACCINE. THE RASH HAS GONE DOWN AFTER DAY OR SAW BUT STILL THERE
No additional adverse events reported; dose of PROQUAD was administered to a patient on 11/18/2020 that had been involved in a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 18-NOV-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD), 0.5 milliliter, lot number T015261, expiration date 31-OCT-2021 (route of administration was not provided) for prophylaxis. Sterile diluent(STERILE DILUENT) was used to reconstitute the vaccine. No additional adverse were reported.; Sender's Comments:  US-009507513-2011USA014866:
Cold Hands; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Cold Hands) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL COLDNESS (Cold Hands). At the time of the report, PERIPHERAL COLDNESS (Cold Hands) outcome was unknown.            No relevant concomitant medications were reported.   Patient experienced a positive effect of vaccine that his legs felt 20 years younger after receiving the vaccine. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.
Janssen COVID-19 Vaccine  Chills, muscle aches, mild headache, a sudden reduced ability to hear and see, cold sweat, lightheadedness, disorientation  Starting at approximately 1:00 am on 4/08/21 I woke up with a throbbing left arm, muscle aches, a very mild headache, and chills accompanied by bouts of uncontrollable shivering.  I experienced these cold like symptoms throughout the night.  At around 6:00 am, I woke up with a very mild headache and muscle aches.   I took my temperature, and had a 101 degree Fahrenheit fever. I rested, and took my temperature multiple times that morning-- which had been gradually decreasing. At around 11:30/12:00 I experienced a sudden onset of extreme fatigue followed closely by a greatly reduced ability to hear and see, along with extreme lightheadedness and the feeling like I was going to pass out. I suddenly became cold, and my body was drenched in sweat in a matter of seconds.  I think the whole experience lasted around 10 minutes, before it eventually began to pass. I could see clearly again  and began to regain my hearing, however I still experienced some lingering auditory complications for an additional three- five minutes ( it sounded like a throbbing white noise). After that, I felt a little disoriented and tired. My aunt had taken me to Urgent Care, but they turned me away, saying I needed to go to the ER. However, by that time my symptoms had passed and I was feeling ok. So I went home and rested. By the next morning, I felt I had completely recovered
Patient presented to clinic for 4 month well child check and received his Rotavirus Immunization on 5/21/2018. On 5/31/2018 the mother of the child called the Pediatrics Clinic and spoke to the Triage RN with concerns of bloody stools. Patient was scheduled for an appointment with Dr. on 5/31/2018, PCP not available. Dr. suspected Intussusception upon assessment of child at appointment. Dr. spoke to another Dr. at hospital ED. Patient was air transported to ED for further evaluation and workup. Confirmed Intussusception upon arrival to hospital.
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 10-JUL-2014 the patient was vaccinated with M-M-R II (HSA, lot# J015503, Exp 05-DEC-2015 dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
This case was reported by a nurse via sales rep and described the occurrence of headache in a 17-year-old female patient who received BEXSERO. Co-suspect products included FLUARIX QUADRIVALENT.  On an unknown date, the patient received the 1st dose of BEXSERO .5 ml and the 1st dose of FLUARIX QUADRIVALENT. On an unknown date, 14 hrs after receiving BEXSERO and FLUARIX QUADRIVALENT, the patient experienced headache, tremor, body temperature increased, chills and flushing. The patient was treated with ibuprofen. On an unknown date, the outcome of the headache, tremor, body temperature increased, chills and flushing were recovered/resolved. The reporter considered the headache, tremor, body temperature increased and chills to be probably related to BEXSERO and FLUARIX QUADRIVALENT. The reporter considered the flushing to be possibly related to BEXSERO and FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received the BEXSERO vaccine in the right deltoid and the FLUARIX QUADRIVALENT vaccine in the left deltoid at the same time. The nurse reported after receiving the vaccines, the patient reported a mild headache, chills, flushing, 100 or 101 degree F temperature and shakes. The patient required emergency room visit. The patient was treated with ibuprofen and released. The field representative did not have any date of occurrence and lot or expiration information of the vaccine.
Three days after receiving the first dose of the Pfizer vaccination, I woke up with swollen, painful and inflamed hand and feet joints. Along with the above symptoms, I am also experiencing  a 'pins and needles feeling' in my hands and feet, constant swelling, along with difficulty and pain bending my fingers/making a fist.  All of these symptoms have been continually chronic since they first began.  I did not receive the second dose of the vaccine that was scheduled for 8/30/2021 at 9am due to the persistent manifestations I am suffering, which are affecting everyday routines and activities.  I have never had any previous joint or inflammation issues of any kind, prior to the first covid vaccination shot, nor any other health issues until now.  I have an appointment with my primary care physician today to further determine the matter.
myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". The event "myocarditis" required physician office visit. Therapeutic measures were taken as a result of myocarditis.  Clinical course: Reporter stated that after the second dose of the vaccine last year, as a mandatory requirement to come, his wife developed all the symptoms that were related to myocarditis yet all the doctors that we had been to investigate her situation said that was nothing wrong, but an inflammatory issue and recommended all sort of drugs like steroids and so on trouble was that none of them worked and it feels like there was no real support on how to handle this issue post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Standing up created close to black out conditions; had a fever that broke that night; extremely lightheaded; fatigued; Arm had typical site soreness and swelling.; Arm had typical site soreness and swelling.; Dose number=3; Dose number=3; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (COVID 19, Pfizer), dose 3 via an unspecified route of administration, administered in left arm on 01Oct2021 13:15 (Lot Number: EW0217) as dose 3 (booster), single at the age of 30 years old for COVID-19 immunization. Medical history was not reported. Concomitant medication included sertraline in two weeks. Historic vaccine was bnt162b2 received on 27Jan2021 (lot EN5318) as dose 1, single; on 17Feb2021 (lot EN5318) as dose 2, single, both at the age of 29-year-old for COVID-19 immunization. The patient previously took pancrelipase and experienced allergy. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Starting about 24 hours after injection on 02Oct2021, he was extremely lightheaded and fatigued. It came back at random intervals until 04Oct2021. Standing up created close to black out conditions. Arm had typical site soreness and swelling. On the first day on 02Oct2021, he had a fever that broke that night. He was unable to take his temperature due to misplacing his thermometer. No treatment received. The outcome of fever, extremely lightheaded, fatigued was recovered on 04Oct2021. The outcome of arm had typical site soreness and swelling, standing up created close to black out conditions was recovered.  No follow-up attempts are needed. No further information is expected.
Initially, soreness at site awakened patient from sleep. On 9/18/15 she came in to clinic.  Site was red, warm with localized reaction approximately golf-ball sized, with hardness in center.  On 9/24/15 she returned to clinic.  Redness has spread across width of upper arm and has a tag moving toward axilla.  Warm to touch and itching.  Central area of hardness is much smaller.
Patient received a dose of the Fluzone HD which is for patients 65 and older and they were only 62 at the time of the dose.
Area has swollen with redness, sore around two inches on next day (after 24 hours). Injection area extra bright red. Nurse report this has been common effect.
sore throat, dry cough, body aches, sinus congestion, nasal congestion, worn out.        Patient denies fever, headache, shortness of breath, loss of taste, loss of smell, diarrhea, , chest congestion, chest tightness, chest pain.  starting 1/3/22
Treatment of COVID-19/first tested 06Jun and was positive.; Treatment of COVID-19/first tested 06Jun and was positive.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 at 17:00 as dose 3 (booster), single (Lot number: Ew0183) at the age of 40 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunzation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19/first tested 06Jun and was positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Positive; (12Jun2022) Negative, notes: All 5 were negative; (13Jun2022) Negative, notes: All 5 were negative; (14Jun2022) Negative, notes: All 5 were negative; (15Jun2022) Negative, notes: All 5 were negative; (16Jun2022) Negative, notes: All 5 were negative; (02Jul2022) Positive, notes: tested. It was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Other medication were given in 2 weeks: Ibuprophen and tylenol. Patient received paxlovid for treatment of Covid-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Patient came in today and had a rash on her right arm.  She said her arm is a little sore, but she is not having any trouble moving it.  I told her that if the effects continue to call her prescriber.
Hives occurred 20 minutes after 1/2 dose (0.25 mL) vaccine given (done due to h/o RAST + for egg).  Child's urticaria worsened for 30 min after given diphenhydramine and prednisone than resolved.  No respiratory symptoms or facial swelling.
administered 0.25mL due to incorrect reconstitution technique; administered 0.25mL due to incorrect reconstitution technique; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 61-year-old patient who received Herpes zoster (Shingrix) (batch number H7AT2, expiry date 28th August 2023) for prophylaxis.   On 27th July 2022, the patient received Shingrix (intramuscular) .25 ml. On 27th July 2022, unknown after receiving Shingrix, the patient experienced underdose and inappropriate reconstitution technique. On an unknown date, the outcome of the underdose and inappropriate reconstitution technique were unknown.   Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The health care professional (HCP) reports that 2 patients were administered 0.25mL of Shingrix by the pharmacist due to incorrect reconstitution technique. The reporter consented to follow up. Additional Supportive Information: The patient was administered 0.25mL of Shingrix by the pharmacist due to incorrect reconstitution technique, which led to under dose and inappropriate reconstitution technique. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022111775:Same reporter
Patient received the wrong dosage of the moderna vaccine back in 10/05/21. Patient received 0.50ml instead of 0.25ml. No adverse effects were noted at the time of observation 04/28/2022. Clinic personnel reported the incident.
Possibly injected to bursa or joint. Inability to move arm with abduction. Cannot take off shirt or use backpack.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that her office had improperly stored ROTATEQ. It was possible that on an unspecified date, an unspecified number of patients might have been administered with this improperly stored ROTATEQ (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. No symptoms reported. No symptoms reported. This is one of the several reports received from the same reporter (MARRS# 1211USA012711, 1211USA012715, 1211USA012716 and 1211USA012717). Additional information has been requested.