chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of the Pfizer COVID-19 vaccine. She felt fine right after her vaccination but as she drove to her destination where she was going to take a walk, she started to develop left-sided facial burning and swelling.  That prompted her to call her PCP in that office recommended she come back to the vaccination clinic to be evaluated.   I evaluated her at approximately 2 PM.. She was feeling well for the most part with the exception of left-sided facial burning and swelling and a little bit of redness over her left cheek.  She denied fevers, chills, itching, other areas of rash, difficulty speaking, difficulty swallowing, tongue swelling, lip swelling, wheezing, chest pain, or difficulty breathing.   She recalls a penicillin allergy at age 5 or 6 but cannot remember the reaction. She has never reacted to a vaccine before.   Initial vital signs included a blood pressure of 134/73, a pulse that was 70 and regular, and an oxygen saturation of 100% on room air. She had normal mental status and her lungs were clear. The left side of her face was slightly swollen over her left cheek as compared to the right with some slight increased flushing on the left side. There was no stridor, she was speaking comfortably, and her lungs were clear with good airflow. Her heart demonstrated S1 and S2 with regular rate and rhythm.   I administered 2 doses of Benadryl, 25 mg with each dose about 15 minutes apart with her last dose at approximately 2:25 PM.   I rechecked her vital signs at 2:50 PM and her blood pressure was 138/79 with a pulse of 70 and regular and an oxygen saturation of 99% on room air. Her lungs were clear and she was moving good air. I did take a relook at her face which was improved with decreased swelling.   At 3 PM, because she was doing much better, I discharged her to home with instructions to use Benadryl 50 mg when she got home and then 25 to 50 mg every 4 hours today. If she develops any respiratory symptoms such as difficulty swallowing, cough, breathing difficulty, swollen tongue or swollen lips, as well as increased facial swelling, she will call 911 to be evaluated.   She should not get the second Pfizer COVID-19 vaccine.
Developed shortness of breath, cough, throat tightness, chest pressure treated in ER. Steroids, nebulizer tx, BENADRYL.
Information has been received from a physician via a company representative referring to a child patient of unknown gender and age. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(TDAP) and MENVEO. Information about pertinent medical history and lab reaction/allergies was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. It was reported that the patient after getting vaccinated while still being at the clinic "got very dizzy" and was "close to passing out" but did not completely pass out. The patient experienced "heart rate increased" and the patient had "anxiety" as well. It was unknown if the patient was receiving their first, second or third dose in the GARDASIL 9 series at that time so frequency was unspecified. The outcome of events was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown by the reporter. There was no intervention to prevent serious criteria. The causality was not provided.
Covid19 breakthrough.  1st Vaccine received 03/19/2021.  Pt presented to ED with c/o 2 day history of worsening SOB, body aches, cough and fever.  Pt also c/o COPD exacerbation.  IV steroids and Remdesivir.
New packaging for GSK vaccines is very similar. I am specifically reporting the similarities between the hepatitis B vaccine (Engerix-B NDC 58160-8200-52) and tdap (Boostrix NDC 58160-842-52). The packaging is nearly identical with a slight variation in the shade of green used. Both medications require refrigeration. We have had to remove Tdap from the automated dispensing cabinet in out obstetric unit due the similar packaging and concern over a newborn being given tdap instead of the hepB vaccine.
TRUMENBA was given as an alternative to MENACTRA. No adverse reaction reported to this facility.
Hubbie had breathing issues for a month on the first shot along with the normal side effects; Hubbie had breathing issues for a month on the first shot along with the normal side effects; hubbie was bad/breathing for a month; but then he does have asthma which did help; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hubbie had breathing issues for a month on the first shot along with the normal side effects), VACCINATION COMPLICATION (Hubbie had breathing issues for a month on the first shot along with the normal side effects), FEELING ABNORMAL (hubbie was bad/breathing for a month) and ASTHMA (but then he does have asthma which did help) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Hubbie had breathing issues for a month on the first shot along with the normal side effects), VACCINATION COMPLICATION (Hubbie had breathing issues for a month on the first shot along with the normal side effects), FEELING ABNORMAL (hubbie was bad/breathing for a month) and ASTHMA (but then he does have asthma which did help). At the time of the report, DYSPNOEA (Hubbie had breathing issues for a month on the first shot along with the normal side effects), VACCINATION COMPLICATION (Hubbie had breathing issues for a month on the first shot along with the normal side effects), FEELING ABNORMAL (hubbie was bad/breathing for a month) and ASTHMA (but then he does have asthma which did help) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided. No Treatment Medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up received on 19 AUG 2021 included updated current condition On 18-Aug-2021: Follow-up received on 19 AUG 2021 included updated event Asthma.
According to the mother, the patient had a subjective mild fever at 2pm and was given Motrin. At 8pm the infant became unresponsive, stopped breathing, and was limp. She states that the symptoms lasted for around one minute, and that thereafter he appeared sleepy. When he arrived at the emergency department, he was afebrile and alert & oriented x3. No further symptoms have been noted.
Bruising under the eye / Left eye; Flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of eye contusion in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2021) for prophylaxis.   On 14th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced eye contusion and influenza-like symptoms. On an unknown date, the outcome of the eye contusion and influenza-like symptoms were unknown.   It was unknown if the reporter considered the eye contusion and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix was updated from 303PR to 3L3PR, as per sales data sheet. The patient Flu like symptoms and bruising under the left eye.  No other information about the patient of vaccine available not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226582:same reporter
Discharge Provider: MD Primary Care Provider: MD Admission Date: 10/19/2022 Discharge Date: Oct 22, 2022  PRESENTING PROBLEM: COVID-19   HOSPITAL COURSE: Patient is a 86 y.o. male with a PMH of paroxysmal atrial fibrillation on Eliquis, coronary artery disease mild per 2017 LHC, nonischemic cardiomyopathy with LBBB s/p biventricular pacer 12/2017, chronic combined systolic and diastolic heart failure LVEF 40%, orthostatic hypotension, OSA on BiPAP, CKD and history of GIB who presents today with weakness, myalgias, productive cough, orthostatic dizziness and anorexia. He recently received the COVID-19 booster and has felt unwell since. He presented with multiple concerns including myalgias, chills, nausea, productive cough, weakness, and decreased appetite. In the ER he was found to be hypoxic and required 2L nasal cannula. CXR showed low lung volumes and basilar density consistent with atelectasis vs infiltrate. He tested positive for COVID-19 and was admitted to general medicine for further evaluation.   He was evaluated by cardiology and was well compensated from his heart failure perspective and no other concerns. Attempts to wean supplemental oxygen were unsuccessful and pulmonary rehab was consulted. He will need home oxygen with 2L at rest and with activity. He developed hypertension on his midodrine and therefore this was held with some improvement. His chronic orthostatic hypotension was unchanged with holding midodrine. He worked with PT who recommended home services. He was discharged home in stable condition on 10/22.
Information has been received from a registered nurse referring to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored ROTATEQ (lot # K004921, EXP date 25-FEB-2016, dose and route not reported). No adverse effects was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Pale, shaky since 11-11:30 pm. Yesterday.  Had covid vaccination yesterday.  Reported that breathing was labored.  Heart rate was 115-130.  Fever 102.7 but now down.  Blood pressure generally low.  Some cough last night after opening gatorade mix but that stopped.
Chills; Body aches; headache; lethargy; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202), via an unspecified route of administration in left arm on 10Mar2021 at 15:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and allergic to sulfa-based drugs. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was receiving unspecified concomitant medications within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN5318) via an unspecified route of administration in the left arm on 17Feb2021 at 15:30 (at the age of 66-years-old) for COVID-19 immunisation. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Mar2021 at 1:00, the patient experienced chills, body aches, headache and lethargy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events chills, body aches, headache and lethargy. The clinical outcomes of the events chills, body aches, headache and lethargy were resolved on an unknown date in 2021.     No follow-up attempts are needed. No further information is expected.
second dose is schedualed >35 after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose is schedualed >35 after the first dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose is schedualed >35 after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose is schedualed >35 after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Contact information updated
Corona Arm. Reaction 8 days prior to injection. Injection site hot, red, slightly swollen, & very itchy.
Pt became nauseous/sweaty/dizzy 10 minutes after 1st vaccine. Passed out w/ EMS for about 20 seconds then vomited. Pt fully recovered and hydrated. Released home.
sore arm, months later; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, months later) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm, months later). At the time of the report, PAIN IN EXTREMITY (sore arm, months later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment concomitant medication reported.
Approximately 9:00 pm pm 11/5/21 I began with body aches, fever, headache and chills.  These symptoms continued to progress throughout the night.  Fever ranged from 100.00 - 102.4.  All muscles were tense and body uncontrollably would shake for about 6-9 hours once symptoms first began.  I did not take any medication during the first night.  The following morning chills and body shakes had decreased.  Fever was low grade in the morning and disappeared by mid-afternoon.  I still had a headache, feeling "unwell" and dizzy the entire day.  I started taking tylenol on Saturday afternoon (11/6).  On Sunday my left arm and left armpit began to be sore. My headache, and feeling "unwell" lasted until Monday afternoon 11/8/21.  Left arm pain at injection site stopped hurting around Tuesday 11/9/21.  There was minimal swelling in left armpit for about 1-2 weeks after vaccine, and pain and discomfort was constant for about 2 weeks.  Pain and discomfort in armpit was intermittent from about week 2-4 post vaccine, and also had spread to side of left breast.  Now 2 months later I occassionally will still get pain and discomfort in left armpit and left side of breast.
A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 13:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), amlodipine besilate (NORVASC) 5mg and magnesium 400 (MANUFACTURER UNKNOWN) (unit unspecified) for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3247) via an unspecified route of administration in the left arm on 04Mar2021 (at an age of 61-year-old) at 11:30, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 13:30 (immediately after vaccination), the patient experienced change in saliva flow. On 26Mar2021 at 06:30 (in the next morning), the patient experienced 103.1 F temperature, muscle ache and joint ache. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events changes in saliva flow, 103.1 F temperature, muscle ache and joint ache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt vaccinated with DTP/OPV became very fussy w/2 hrs of continuous crying, brief shaking of arms & legs during crying.
Got covid after vaccination; COVID-19; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got covid (COVID-19) after vaccination on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
OB Hx: G2P0100 EDD 06/04/23. Previous hx of preeclampsia w/ severe features  Pt was due for updated covid vaccine. No previous hx of concerns w/ vaccines or allergies. Pt was supposed to get the Moderna 12+ vaccine 0.5mL. However, the pediatric dose 5-11yr was given. The dosing for 5-11 yr is 0.25mL. Pt received 0.5mL of pediatric dose.
This spontaneous report was received from a physician, who referred to a 3-weeks-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was provided. On 05-OCT-2017, the patient was inadvertently administered a dose of LIQUID PEDVAXHIB (Lot# M047666 and expiration date: 24-OCT-2019; dose and route of administration were not reported) for prophylaxis at the age of 3 weeks. No adverse effects were reported. No product quality complaint was involved.
experienced no symptoms; expired dose of VAQTA administered; Information has been received from an X-ray technician and refers to a patient of unspecified age and gender.  The patient's concurrent conditions medical history or concomitant medications were not reported.  On 24-JAN-2020, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (dose number, dose, frequency and anatomical location were not reported) lot number R032910 with expiration date 18-NOV-2019.  The patient experienced no symptoms.
My son woke at 4:00AM the morning after receiving the flu vaccine with a headache and 100.7 temperature. I treated the symptoms with MOTRIN and then noticed later that morning that the arm he received the injection in was swollen twice the size of his other arm, bright red and hot to the touch. As soon as I discovered his swollen arm, I called the Pediatrician and they advised me to bring him in immediately. The Doctor examined him and said that he had a "type 4" reaction and she advised me to never give him the flu shot again. She also advised BENADRYL as needed to help with his reaction. When he woke the next day, after two doses of BENADRYL, his arm was less swollen, red and hot.
Shingles; blister like rash presented this morning on her husband's forehead; All areas are also itchy; chest has also started to look red; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th February 2020, the patient received the 1st dose of Shingrix. On 11th March 2020, 14 days after receiving Shingrix, the patient experienced shingles, blistery rash, pruritus and erythema. On an unknown date, the outcome of the shingles and erythema were unknown and the outcome of the blistery rash and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blistery rash, pruritus and erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. In the morning of the day of reporting the patient experinced a shingles blister like rash on his forehead and right cheek. The chest has also started to look red although there are no blisters there, All areas were also itchy. Consented to follow up.
x2 seizures lasting 15 minutes at home. Body shaking with starring, some apnea, duskiness, lethargic afterwards. Paramedics called both times. No treatment. (01:30 and 08:00 10/22/04).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulum" (unspecified if ongoing); "hormone replacement" (unspecified if ongoing). Concomitant medication(s) included: COMBIPATCH taken for hormone replacement therapy, start date: 15Oct2010. Past drug history included: Flagyl, reaction(s): "Known allergies: Flagyl"; Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient received PAXLOVID for treatment of Covid-19 from 09Dec2022 to 13Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt reports left upper arm swelling and pain started at night after injection in left deltoid at 11 AM. At 10 AM in clinic redness, warmth and swelling  present at left bicep. Dr. notified and pt instructed to continue icing arm and take Ibuprofen. Advised to call or proceed to urgent care if not improving.
Redness, swelling and pain at the injection site.  Not getting better after 3 days.
7-17-12 (1400) erythema (R) arm at injection site with redness measuring approximately 2 inches in diameter reassured pt., encouraged use of cold compresses to area and can use OTC BENADRYL as directed - referred to private MD if needed.
Patient came in with his mom. Mom stated that 48 hours after first dose Pfizer LOT#: FF2587 on 10/02/21 Patient developed an itchy rash all over his body. No shortness of breath or any other symptoms. Mom took him to his PCP where he was given an allergy medication (unknown name). Patient took medication and after three days he saw an improvement in his symptoms. PHN sent a medical consult to the medical consult team. PHN received the go ahead from medical consult team to proceed with second dose Pfizer with a 30 minute observation. PHN educated mom and patient on adverse effects and allergic reactions of receiving second dose Pfizer vaccine and when to seek EMS, urgent care or emergency department. PHN educated patient and mom to follow up with PCP if symptoms reoccur. Patient and mom verbalized understanding of education. Patient stayed the 30 minutes in observation. Patient did not experience any allergic reactions during observation. Patient left vaccination site at 1533 with a steady gait accompanied by his mom.
SM notes that with each anthrax received, she has had a large local reaction, each one worse than previous one. All shots given SQ. Redness, swelling, pain at injection site, burning at site, pruritis. Reaction would occur within 48 hrs of receiving the shot. Lost duty time with each shot. Per SM, would take about one month for symptoms to resolve. SM also notes HA and fatigue that lasted a few days after receiving the AVA. Symptoms: Edema at injection site 50-120mm, Erythema, Swelling, Pruritus, Pain, Fatigue, Malaise <60 Days, Headache, general.