chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a program. A contactable male consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date Mar2021 as dose 1, single and second dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date 2021, patient tested positive for COVID-19 and wants to know what recommendations to follow. The patient underwent lab tests and procedures which included SARS-CoV-2 test, tested positive on an unspecified date of 2021. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Client received AstraZeneca COVID vaccine, no reaction. AstraZeneca vaccine unavailable in the US, Janssen given as an alternative on 09/15/21.
Info has been received from a surgical supply company concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641116/1160L). Subsequently the pt developed a 4 cm red spot (still red after a week), chills after the 3rd day and a fever. Unspecified medical treatment was sought. "Dr. requests a lot check". The reporter also mentioned 2 other pts (WAES #0303USA00409 and 0303USA00570). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Local reaction, Treatment-Benadryl, Keflex 500 mg BID x 10 day, cool compresses
PATIENT FELT LIGHTHEADED AFTER GETTING VACCINATED. SHE HAD STATED SHE HAS ANXIETY. ON SITE EMS RESPONDED. VITAL BELOW. SHE WAS GIVEN WATER AND RECLINED HER CAR SEAT TO LOWER HER HEAD. AFTER BEING MONITORED HER BP CAME UP TO 134/85 AND SHE WAS RELEASED TO HOME.
general body aches, fever, fatigue. Slept and took the following day off work to rest.
Received vaccination at 11:00a on 2/20.  Around 7:00p (same day) started having chills.  My whole body was shivering nonstop for about 3 hours.  Constant headache and weakness and slight temperature.  On 2/22/23, morning hours, I was dizzy and fainted but not unconscious.  Was able to get up after a few seconds.  Been in bed for 2 days.
Large, painful, itchy red area on right upper arm, 8 days after first Moderna injection
Systemic: TINGLING SENSATION ON TONGUE, SHAKINESS. PATIENT ASKED FOR BENADRYL FROM FACILITY AND WAS FINE . COUNSELED ON FALL RISK BUT SHE SAID SHE DOES FINE WITH BENADRYL AND ASKED FOR IT AND WAS COUNSELED AND
Pt. has been in with flu sx 1/5/10, but then deteriorated rapidly over coarse of 1 wk to being incapable of walking by herself with facial droop.
Initial solicited report received on 30 October 2017 from a Pharmacist. This is a prospective pregnancy registry case for Study. This case involves a 28 year-old-female subject who had vaccine exposure during pregnancy. The date of LMP was not reported. The estimated date of delivery was not reported. The mother and father's health status were not reported. The father's age was not reported. The current pregnancy history was reported as, the subject was 13 weeks pregnant and "did not have any health issues during the pregnancy". The maternal drug exposure was not reported. The subject's past obstetric information was not reported. The subject received 0.5 ml intramuscular dose of FLUZONE QIV on 30 October 2017 (batch no: UI849AC, site of administration was not reported). The pregnancy complication was not reported. It was not reported if the subject had any treatment for infertility. The subject's family history of congenital abnormality was not reported. The subject had relevant non serious adverse event of morning sickness with nausea and vomiting from an unspecified date. Corrective treatment for non-serious adverse event morning sickness with nausea and vomiting was not reported. Outcome of non-serious adverse event morning sickness with nausea and vomiting was not reported. Prenatal testing was not reported. The pregnancy was ongoing at the time report. List of documents held by sender: none. Sender's Comments: A 28-year-old female subject received a dose of study vaccine during pregancy. She had non serious event morning sickness with nausea and vomiting. The subject was followed as a part of pregnancy registry commitment. Company causality taken as associated for reporting purpose.
DOB: 3/26/1949 received her Moderna booster dose (LOT#: 035C21A) on 12/13/21 at 1124. EMT and stated that she felt her "heart racing" at 1152 and that it lasted about 5-10 minutes. , EMT took patients vital signs at 1152. O2: 96%, HR: 63. Patient stated that she no longer feels her heart racing. Patient stated that this did not happen with her first two doses of Moderna. , EMT retook patients vital signs. BP: 152/80, O2: 97%, HR: 70. , RN recommended that patient stay an extra 30 minutes for further observation. Patient agreed to stay. , EMT retook vital signs. BP: 138/80, HR: 62, O2: 97%. Patient stated that she no longer feels any symptoms and denies any new symptoms. , RN educated patient on worsening signs and symptoms of COVID vaccine and educated client on hypertension and when to seek EMS, ED, or urgent care. , RN gave patient your heart paperwork and recommended that patient make appointment with PCP. Patient verbalized understanding. Patient completed 30 minutes of observation and left vaccination site unassisted and with a steady gait at 1227.
fever 102.2; This is a spontaneous report from a contactable nurse. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07May2021 at 07:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohns and COVID-19 which was on Jul2020. Concomitant medications included ondansetron hydrochloride (ZOFRAN) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 08May2021 at 07:00, the patient reported that she missed 2. 12 hour shifts after vaccine due to fever 102'.2 (UNSPECIFIED UNIT). The patient also reported that this vaccine was not free for her it cost her $954.96. may she be reimbursed for the 2 shifts? Nursing as we know is hard enough but to miss this amount on her pay was a struggle thank you. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever 102.2 (UNSPECIFIED UNIT) was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The RN administered 1mL of the Moderna vaccine as opposed to 0.5mL. Office contacted the patient to notify and follow up on how the patient was feeling. The patient self-reported feeling great today other than arm soreness. Patient reported on Wednesday (7/28) he experienced dizziness & diarrhea. Symptoms have all subsided as of Thursday (7/29). Further instructed patient to call our office if further assistance was needed.
Leg started swelling and started to hurt. MOC tried Tylenol at home, that did not help.
Chondrocostal junction syndrome--chest discomfort with referred left arm pain, beginning 5-7 days prior to seeking treatment (1/28/21)
Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no  drug allergies who on 27-JUL-2006 was vaccinated intramuscularly in the right deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F).  There were no concomitant medications.  At the time of vaccination the patient experienced extreme pain at the injection site and fainted.  The nurse reported that "the onset of the pain was immediate and lasted for 1 and a half to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right".  The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no post- ictal state.  Unspecified medical attention was sought.  Subsequently, the same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode.  The patient did not wish to continue the series as a result of the adverse experience.  Additional information has been requested. 01/05/2007 This is in follow-up to report(s) previously submitted on 8/10/2006. Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no drug allergies who on 27-JUL-2006 at 13:30 was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (0.5 ml) (lot # 653650/0702F). There were no concomitant medications. At the time of vaccination the patient experienced extreme pain at the injection site and fainted. The nurse reported that "the onset of the pain was immediate and lasted for 1 1/2 to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right". The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no post-ictal state. Unspecified medical attention was sought. Subsequently, that same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode. The patient did not wish to continue the series as a result of the adverse experience. Additional information has been requested.
Ill; Body aches; Extreme fatigue; Headaches; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 2nd dose of Shingrix. On 6th September 2019, 1 days after receiving Shingrix, the patient experienced unwell. In September 2019, the patient experienced general body pain, fatigue, headache and low grade fever. On an unknown date, the outcome of the unwell, general body pain, fatigue, headache and low grade fever were recovering/resolving.   It was unknown if the reporter considered the unwell, general body pain, fatigue, headache and low grade fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was ill and less than a week after vaccination experienced body aches, extreme fatigue, headaches and low grade fever. The patient asked whether is this normal for the 2nd dose. This case has been linked with case US2019AMR163561, reported by the same reporter.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient is describing pain and tingling and heaviness in the left arm starting one day after recieving 2nd covid vaccine *(pfizer). Shooting pain going up the arm as well, not improving so far
first dose 8/26/2019, second dose 9/16/2021; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st doe received on 26th August 2019).   On 16th September 2021, the patient received the 2nd dose of Shingrix. On 16th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The pharmacist stated that, the patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. No medical primary care physician information provided. Spoke per Shingrix FAQ. Gave phone number for Medical Information to be provided to consumers physician. The reporter did not consent to follow up. Theis case was linked with case US2020025200, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020025200:same reporter
Product stroage error; This spontaneous report was received from medical assistant refers to a 4 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). On 05-MAY-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: Digital data logger) (PROQUAD) lot # S021324, expiry date reported as 05-JAN- 2021 via subcutaneous route for immunisation for measles, mumps, rubella and varicella (strength and dose were not reported). The reporter stated that the administered vaccine had a temperature excursion of 12.2 Fahrenheit for a time frame of 26 minutes as recorded by a data logger (product storage error). The vaccines had no previous temperature excursion. No product quality complaint was reported. The outcome of product storage error was unknown.
Received injection on 5/4/10. Seen in office again 5/6/10 with c/o red, raised, warm area surround injection site. C/o s/s started on Wednesday 5/5/10. C/o pain, itching.
pt recv vax 3MAY99 & 9hr later 4MAY99 2:00 pt exp itching, hives, chills, dry mouth, myalgia & labored rapid breathing;pt was seen by MD who medicated pt, performed EKG (results unk) & sent to ER;dx anaphylactic rxn according to pt;
Approx 2 hrs post flu vaccine administration patient began to have throat tightening and swelling of the face & eyes - self administered 50 mg of BENADRYL repeated thru a 24 hrs.
10 days after Moderna booster went into A Fib for 4 hours. Same thing happened 2 days after 2nd Pfizer Bio N Tech vaccination.
Red painful swelling ~3CM diameter. It is now Day 7, and the swelling is still there with a hard bump. I believe this to be an Arthus rxn. I have never had a Type III reaction to a vaccine before. And certainly no painful red area with a hard bump 7 days post injection.
rash, macular entire body swelling, hands/feet Benadryl 12.5 mg QID possible allergy
fever of 103 3 hr after vaccination. 6 hrs later generalized febrile with fever of 104 6 hrs later. exam in the following day
Swelling on her feet; Redness; Rashes on both of her ankles; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on her feet), ERYTHEMA (Redness) and RASH (Rashes on both of her ankles) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included AMLODIPINE for Blood pressure management, VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling on her feet), ERYTHEMA (Redness) and RASH (Rashes on both of her ankles). The patient was treated with TRIAMCINOLONE ACETONIDE on 27-May-2021 for Rash, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling on her feet) and RASH (Rashes on both of her ankles) had not resolved and ERYTHEMA (Redness) had resolved.            Patient reported that she noticed her symptoms in March or April after the second dose. Patient stated that she would be going to be see Dermatologist and Hematologist doctor as a follow up.Patient also stated that her provider recently increase the dosage in January from amlodipine 2.5 mg to 10 mg.    This case was linked to MOD-2021-280663 (Patient Link).
patient has been exposed to COVID-19 and has been tested positive; patient has been exposed to COVID-19 and has been tested positive; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's parent) reported for a female patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via unspecified route of administration, on an unspecified date as dose1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via unspecified route of administration, on an unspecified date as dose2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter's daughter took both doses of Pfizer covid vaccine on an unspecified date. Patient may need to travel; that country doesn't have in their system that patient got vaccinated. Patient would need to get Pfizer Covid vaccine in another country. Reporter wants to know if it's safe to get 4 doses. Reporter mentioned that, patient has received Pfizer and was very happy she did, said patient had side effects, but that it's better than having COVID. Reporter said that, patient has been exposed to COVID-19 and has been tested positive. Reporter did not want information anymore with Pfizer since patient has already been exposed to COVID-19 and they already resolved their problem. The patient underwent lab tests and procedures which included SARS-CoV-2 test and result was positive on an unspecified date.  Information about batch/ lot number has been requested.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 20-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Rapid heart rate started 5 min after booster - varying between 98-107 beats per minute.  Then began vomiting 5 times 2 hours after vaccine.
No additional AE information.; a dose of PROQUAD was administered on 10/18/2022 after a temperature excursion.; This spontaneous report was received from an office manager regarding a 12-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 18-OCT-2022, the patient was vaccinated with an improper stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot #W017571, expiration date: 29-NOV-2023, (strength, dosage regimen, and route of administration were not provided) administered as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (F) (10.91 F) for 1 hour without previous excursions. No adverse events were reported.
Fever, chills, insomnia, high heart rate. Treated with acetaminophen and prescription sleeping pill at midnight. Fever broke around hour later but unable to sleep for another 6 hours
Patient came in the pharmacy on 7/26/17 stating she got a PREVNAR shot in March 2017 (4 months ago) and stated she has been having pain ever since. She stated her arm was swollen and her skin was peeling. Patient said she has not taken any pain meds or gone to the dr. Patient said she is going to see her doctor to do a MRI to see if it's caused by the vaccine. Patient has not reported any issues since getting the vaccine. Patient said it only affects her when she lie down at night, otherwise walking about and touching the area has no pain.
Pt returned to clinic 2 days after vacine administration with erythema, swelling, warmth and minimal induration below DTaP site.  Pt was diagnosed with right arm cellulitis and started on Keflex.  Pt to follow up in 24 hours.
Temp 103.5; increased somnolence; severe local rxn - red, swollen, exquistely tender. No other reason for fever found.
I developed a skin reaction that looked like petechiae on my left forearm and left inner leg about 8 days after getting the second vaccine. I redirected the vaccine in my left upper arm.  The marks are still visible. I didn't seek a doctor because it doesn't itch or hurt, is just visible.
Contacted Veteran's son.  He did mention that his father was not healthy, but also that his father did not voice any specific changes to his health as recently as Tuesday (4/13) when they last spoke after receiving his second dose of vaccine on 4/10.  He did mention that the coroner had declared his father?s death ?natural? and was not planning to do an autopsy.
The same night baby started  having body tremors and twitching. Within 48 hours was unable to tolerate formula and would projectile vomit every bottle. Baby developed an allergy to all formulas. Baby had a pink/red sandpaper like rash on cheeks that developed.
From initial information received on 11 MAY 2004 from a physician regarding an adverse event occurring in the USA, it was reported that a 43 year old female patient received a TD ADS Adult vaccination administered IM in the left deltoid on 03 MAY 2004.  The same day the patient developed pain and swelling to which she applied a gel freeze pack.  She also developed a little area of blisters with a lot of tenderness, redness and swelling over a period of a couple of days; and low grade temperature.  She was seen in a walk-in clinic on 07 MAY 2004 and was being followed for cellulitis.  The patient's recovery status was not reported.    From additional information received on 20 AUG 2004 from the responsible physician it was reported that the patient recovered with Levaquin and Erythomycin in five to six days.  She received thsi dose of TD ADS Adult as a booster and had no previous reaction in the past.  The patient's illness at the time of vaccination were reported as well as her allergies.  Additional lab information was also provided.  No further information is anticipated this case is considered closed.  The reporter of this case is the same reporter as case 200401856