chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fussiness; feeds less; poor sleeping; my breastfed 7 month old daughter has not been herself since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 12:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE ALLERGY RELIEF; ZYRTEC ALLERGY.  The following information was reported: IRRITABILITY (non-serious) with onset 14Mar2021 18:00, outcome "unknown", described as "fussiness"; DECREASED APPETITE (non-serious) with onset 14Mar2021 18:00, outcome "unknown", described as "feeds less"; POOR QUALITY SLEEP (non-serious) with onset 14Mar2021 18:00, outcome "unknown", described as "poor sleeping"; EXPOSURE VIA BREAST MILK (non-serious) with onset 14Mar2021 18:00, outcome "unknown", described as "my breastfed 7 month old daughter has not been herself since". Therapeutic measures were not taken as a result of irritability, decreased appetite, poor quality sleep, exposure via breast milk. Prior to vaccination the patient was not diagnosed with covid-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021291115 Baby/mother case
Dizzy spells/When paraphrased, consumer stated that when he/she stand up, right; not feeling good; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had had the first shot and that was vaccination and she/he was due to have the second vaccination and she/he was having dizzy spells now (on an unspecified date), just last couple of days. She/he wanted to know if dizzy spells be coming on with His/her second vaccination and if it would that have any effect on the second vaccination at all. When paraphrased, consumer stated that when he/she stand up, right. Consumer further stated, you know he/she was not feeling good. She/he was just going to ask you if it is a serious thing or anything. The patient was just experiencing dizzy spells because she/he was going to be getting the second shot. That was all the patient wanted to know. If it is okay, that is all. The patient did not want to answer anything. The outcome of the events was unknown.
intense headache; intensely achey in all of my joints; unable to regulate my body temperature; chilled; This is a spontaneous report from a contactable other health professional (patient). A 67-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration in right arm on 25Jan2021 at a single dose for covid-19 immunisation. Medical history included hypothyroidism and reported as, I never was diagnosed with Covid but think I had Feb2020. Known allergies were none. Concomitant medications included thyroid NP (THYROID), st john's wort, vitamin b complex (VITAMIN B), zinc and ergocalciferol (VIT D). Historical vaccine included first dose of BNT162B2 (Batch/Lot Number: ELO140), in right arm on 04Jan2021 11:30 for COVID-19 immunisation and experienced slight headache. On 25Jan2021 12:00, the patient experienced intense headache, intensely achey in all of my joints, unable to regulate my body temperature and chilled. The report received as, the second dose I started getting a very intense headache within 2 hours of the injection. I then got intensely achey in all of my joints and was unable to regulate my body temperature. I was chilled for the duration which lasted about 2 1/2 days. I took Acetaminophen, 2 tablets every 6 hours. I also took the homeopathic remedies Ledum 30C twice daily for the injection and Thuja 200 twice daily to offset adverse reactions, as per my physician. Therapeutic measures were taken as a result of the events. Outcome of the events was recovered on an unknown date in 2021.
Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old patient with an unknown vaccination history if he has a completed his catch series for Diptheria, Pertussis and Tetanus who received vaccine ADACEL (lot number not reported) on 19-Jun-2017, via unknown route in unknown administration site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Inappropriate schedule of vaccine administered and product use in unapproved indication. The patient had a TD vaccine on 02-Oct-2017. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Constant ringing in the ears and slight feeling of pressure in the ears. Didn't have it on 7/24/21 and when I woke up on 7/25 it was pretty significant (it's bearable but always noticeable). I don't have a history of ringing in the ears or anything like concerts or loud music. Other than the ringing in the ears I feel 100% good.
This initial spontaneous report was received from a licensed practical nurse refers to an unspecified patients of unknown ages and genders. Concurrent conditions and medical histories were not provided. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ, oral (dose, strength and lot# not provided). There was no concomitant medication. No adverse events reported. This is one of two reports received from the same reporter. Additional information has been requested.
R thigh site of injection papular rash 12/3/10 started 12/1/10 also with different rash face/chest/neck - contact derm.
On 7/9/09 Patient received Hep a, Menactra approx. at 3PM.  Mother reports trip to ER around 5:30 due to hives and itching.  States received Benadryl and steroids.  Phone call to health department today to report above and resports child continues with symptoms without resolution from the ER medication. (Mother contacted the Health Dept. on 7/22/09)
Reported to Rph. Reported 9/22/12 about 12 pm. Pt showed her a mild rash that itched around the injection site.
Red raised rash below injection sites, but not around sites themselves. Patient complained of arm pain and heat in the area of the rash. Rash was still evident after 24 hours, but patient stated that it was not as raised or severe as it had been previously. She had taken ibuprofen in the interim.
Within  3 minutes of first dose both eyes had streaming of black floatings. Throughout the the next weeks had severe heart Palpitations and both knees giving out/ knee pain.  Continue to have heart pain and left arm tingling and right knee severe pain. Went to the mountains (10/8-10/10) thought I was having heart attack. I?m tough and shrugged it off. Going to make a cardiologist appointment- continue to have chest pains. Also need to see a knee specialist since knee is getting worse. Did not have any of these issues before other than random PVCS that I was told are nothing to be of concern. Let primary dr know of everything after first dose and she told me to get second dose (due to Covid causes death)  - I don?t think she reported my adverse reactions.
This spontaneous report was received from a pharmacist via a company representative referring a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in 2016, reported as "both were given within the year 2016", the patient inadvertently received 2 doses of PNEUMOVAX 23 (route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported. There was not product quality complaint involved. Additional information is not expected since there was no consent to contact the reporter.
Information has been received from a health professional for pregnancy registry for GARDASIL concerning a 16 year old female with no relevant medical history who on 27-JUN-2007 and 24-APR-2008 was vaccinated with a first and second dose of GARDASIL intramuscular injection (lot number and injection site not reported). She also received her first dose of PEDVAXHIB (MSD) on 27-JUN-2007, the second dose on 27-2007, and third dose on 27-MAR-2008. There was no concomitant medication. Then it was discovered that she was pregnant. No adverse effects reported. The patient had her first prenatal care visit this week and an ultrasound was scheduled for 26-JUN-2008. Follow up information was from a registered nurse reported that the patient had no previous pregnancies history. On 26-JUN-2008 ultrasound (checks fetal development late prenatal care) was performed and result was within normal limits. The patient's LMP=14 FEB-2008 and the estimated delivery date = 20-NOV-2008. Follow up information was received from a registered nurse (R.N.) who reported that during this pregnancy, the patient was on placed on ferrous sulfate for the treatment of anemia, globulin, immune (RHOGAM) for treatment of rhesus antibodies negative and prenatal vitamins as supplementation. On 25-JUN-2008 the patient underwent ultrasound. The patient was late in receiving prenatal care (30 weeks). On 23-JUL-2008, 39 weeks from LMP, the patient delivered a normal female baby whose weight was 6 pound and 6 ounce, length 19 inches, head circumference 13.5 inches and Apgar score 9/9. There were no congenital anomalies or other complications or abnormalities. Additional information is not expected.
Immediately upon getting the vaccine it felt like someone was pouring water inside my arm. From that time on the arm was very sore, making it difficult to raise my arm above my head. I am taking ADVIL every day and also using heat and cold on the arm. The symptoms have lessened, but are still not completely gone. I did contact my primary care physician who offered to do tests to determine what damage had been done. Since I knew it is from the flu shot, I declined testing.
Severe joint pains and Gout at left leg big Toe. Started midnight and could not sleep and tolerate pain due Gout.  Visited Clinic on 09/16/2021 and got prescription COLCHICINE 0.6 MG TABLETS and PREDNISONE 10MG TABLETS  FOR FIVE DAYS.  AFTER 24 HOURS got relief from severe pain and it two weeks to become normal.
Patient had diffuse erythematous macular rash with fever. Emesis x 1. Rash improving while on BENADRYL.
reaction to the Moderna booster injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the Moderna booster injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the Moderna booster injection). At the time of the report, VACCINATION COMPLICATION (reaction to the Moderna booster injection) outcome was unknown.            No concomitant medication  were reported. No Treatment information was provided.
Fever 103 and vomiting 24 hours later. Fever for 48 hours. Resolved
Numbness in hands. Numbness in feet spreading up through the legs. Shooting pain through the legs. Loss of strength in legs. Facial droop. Diagnosed in the hospital with Guillain-Barre' Syndrome (GBS).
body aches and nausea, used Tylenol and Benadryl, lasted 24 hours
On May 23, 1999 the pt developed chickenpox breakthrough with approximately 75-100 generalized lesions. The pt was afebrile. The child was prosented to a physician with sx on May 26, 1999.
developed shingles on right zygomatic arch near his right eye 7/20/20 and has had 2 recurrences. Has seen opthomologist, does not have keratitis
Case number PHEH2013US003647, is an initial spontaneous report received from a nurse on 08 Feb 2013. This report refers to 65-year-old male patient. He was vaccinated with MENVEO (batch number: unknown) subcutaneously on 06 Feb 2013. No adverse event was reported.
small cough; chest hurt; felt a little stuffy for about a week; 103-104 fever for 3 or 4 days; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (small cough), CHEST PAIN (chest hurt), NASAL CONGESTION (felt a little stuffy for about a week) and PYREXIA (103-104 fever for 3 or 4 days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced COUGH (small cough), CHEST PAIN (chest hurt), NASAL CONGESTION (felt a little stuffy for about a week) and PYREXIA (103-104 fever for 3 or 4 days). At the time of the report, COUGH (small cough) and CHEST PAIN (chest hurt) outcome was unknown and NASAL CONGESTION (felt a little stuffy for about a week) and PYREXIA (103-104 fever for 3 or 4 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103-104 (High) 103-104 fever.         No Concomitant product use was reported.  The patient after getting the Moderna booster dose on 18-Jan-2022, began to experience side effects as well. The patient had a 103-104 fever for 3 or 4 days and also stated that the patient had a small cough, their chest hurt, and the patient felt a little stuffy for about a week.  No treatment information was provided.
This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (route, dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
12 yo female BIB dad coming in with vasovagal reaction after IMZ update at 4:30pm. Pt was given HPV #1, MCV4, and Tdap. Pt denied any Adverse reactions to vaccinations in past. Denies allergies to food, meds, or environment, latex. Pt walked with dad down hall to exit when her knees began to buckle and she staggered backwards. Pt fell on her bottom and then her back. Denied any head, neck or back pain. Pt had lightheadedness and felt sleepy after she laid down. BP was low after vaccination and eventually went back to normal after drinking some apple juice and rest. Pt was advised to go to ER for further monitoring and workup if needed. Dad took pt to ER.
Attempted to sleep but could not focus and kept having problems all night not being able to sleep. Woke up sore and with a headache and a bit of nausea. Was shaking a little in the morning.
Fridge temp went out of range by 4 degrees overnight sunday due to storm, closed on 1/17. Vaccines were administered to patients in the morning.
SWELLING LT UPPER ARM APPROX 1/2 SIZE OF ARM, CICULAR, ITCHY.  NO FEVER OR RESPIRTOR DISTRESS.
Patient called HD 4/3/19 at 10 AM to report she had her shingles vaccine Monday April 1st around 11 am. That same day at 5:30 or 6:00 pm both of her legs from the knee down were very painful and swollen and she was not able to walk without a cane. The following day she spent the day in bed as she was not able to walk without a cane and just felt very achy all over. Today 4/3 she continues to walk with a cane, both of her legs are still swollen and painful and she is not able to bend her knees. PHN highly encouraged her to follow up with her PCP today. Patient said that she would call her doctor and try to get in. PHN asked patient to please call HD back after seeing provider.
Patient experienced swelling and burning sensation a couple hours later after vaccination. Patient also described having a headache along with a slight fever. She stated that she didn't have this reaction with the first dose.
The sneezing started one hour after injection, then my left arm started to itch but no rash, then my tongue lips, and throat began to swell
my arm was sore and swollen; my vision is really blurry; Itchy; feel like that I got the flu; Headache; my arm was sore and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 21Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 22Jan2022, outcome "unknown" and all described as "my arm was sore and swollen"; VISION BLURRED (non-serious) with onset 22Jan2022, outcome "unknown", described as "my vision is really blurry"; PRURITUS (non-serious) with onset 22Jan2022, outcome "unknown", described as "Itchy"; FEELING ABNORMAL (non-serious) with onset 22Jan2022, outcome "unknown", described as "feel like that I got the flu"; HEADACHE (non-serious) with onset 22Jan2022, outcome "unknown", described as "Headache".  Additional information: report was not related to study programme, Consumer stated that well patient do not want to give all the information, just ant to see if the patient do not know if calling to right number, patient want to know some thing about side effects because on Friday got the shot in the evening and then when patient woke up arm was sore and swollen and king of felt, feel itchy all over, it kind of feel like that got the flu and have a bad headache and vision was really blurry. so the patient know if should go to get check or wait and see if kind of stop or what. Consumer was informed about Pfizer Medical information department, As, consumer hung up the call abruptly. Further probing could not be done. Hence, limited information available over the call.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I experienced normal pain at the injection site, however overnight I had swelling in my bottom lip. There was no pain, I took 1 dose of Allegra since I did not have any other reactions at the time and felt fine. However, almost a full week later I have rashes on both arms in the shoulder area. They are just itchy as of right now.  There is no redness only bumps.
injection site bled but no band aid was offered.  following day a large knot appeared in my arm at the injection site, approximately the size of a golf ball. other reaction was feeling cold and tired, but not until the day after the knot appeared in my arm
Rash at injection site, generalized hives, breath holding spell. Dusky episode.
Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm; Fever/ High fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm) and PYREXIA (Fever/ High fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Recovered from COVID).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm) and PYREXIA (Fever/ High fever). At the time of the report, LYMPHADENOPATHY (Giant lump pumped out from underneath arm, it was a lymph node/ Had a giant lymph node pop out under arm) and PYREXIA (Fever/ High fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. No treatment medication was provided.  The patient had fever and was close to be put in hospital and it got recovered.   This case was linked to MOD-2021-052537, MOD-2021-325988 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up received: Patient demographic details (age and gender) and suspect start date was updated.
Narrative:  Patient received J&J vaccine on 08/31/2021 at 11am per documentation. Patient reports headache and body aches after administration. Patient then reports that evening at 930pm he "got the tremors and froze up", denied loss of consciousness or fall. Patient reported "having no control of his body for 45 seconds to a minute" referred to episode as "mini seizure" with no PMH of seizures. Patient reported to urgent care on 09/02/2021 for evaluation of "seizure". At that time also reported "increased pressure in his ears, like they were going to explode", chest pain mid sternal, and fatigue. Provider concluded that episode did not align with a seizure despite patient's belief of having a seizure despite no PMH of seizures. Patient discharged to follow up with PCP who later entered allergy as "seizure" in chart. Of note, patient has multiple MH diagnosis and history of hyperbolic narrative.
9/26-Swelling and redness at site for 7 days which began day after injection. Chills also noted. Treatment: 2 wks of Cipro and Aleve, prn for swelling and fever. 10/3-c/o tingling occass in fingers and small nodule present at base of neck. Also lower back pain, deep muscle. Went back to physician-Lt arm swollen almost double in size from shoulder to wrist. 10/9-Lt arm much better, almost back to normal.
12/23 to 12/25/06 had golf ball size swelling at injection site, redness, let deltoid x 72 hours, low grade fever x 24 hrs. Mom reported to nurse on 12/26/06.
Narrative: Dyspnea reported w/ 3rd vaccine dose no adr recorded for prior doses.