chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received his 1st dose of Pfizer at 1500. Lot number EW0180. Approximately 9 minutes later the patient reported that he felt like his "throat was closing." Brought back to the observation unit. Lung sounds clear, stridor is not audible at this time. VS stable;   VS @ 1511   148/79 99% P=63 Resp= 18 Temp= 98.8   Dr. notified. Verbal order received to administer Cetirizine 10 mg PO now. This was done at 1514. Standing order for Epinephrine 0.3mg received as needed for anaphylaxis. Continuing to monitor.    Follow up VS 1516   130/85 P=68 O2=99 on RA Resp= 18=20   Lung sounds remain clear, no stridor indicated.    Follow up VS @ 1530   124/83 P= 67 O2 99% on RA Resp 18-20   Lung sounds remain clear, no stridor indicated. Pt stated he feels that his "eyelids feel heavy, little eye blurriness, and feels like ears are closing in". Laid patient down and ice pack was applied behind patient's head. Pt stated symptoms are improving. Continue to monitor.   Follow up VS @ 1545   128/67 P= 62 O2= 98% on RA Resp 18-20   Lung sounds remain clear, no stridor indicated. Pt stated eye blurriness and heavy eyelids symptoms are gone. Pt stated the "ear closing feeling" is improving. Continue to monitor.     Pt stated he feels a consistent non-radiating "needle point size pain" to left chest that started at 1550. Pain resolved in 2 minutes. No rash/hives indicated. Lungs are still clear.    Follow up VS @ 1600   116/76 P=60 O2=98 Resp=18-20   Pt stated previous symptoms are gone and not experiencing any new symptoms. Continue to monitor.   15:15  Contacted Dr. and updated regarding the patient's status. He requested for the patient to swallow some fluids. If he tolerates it well he is clear to go. Patient tolerated well.    Follow up vital signs  15:20 BP= 124/70 HR= 67 O2= 100% Resp = 18-20   Sister drove the patient home.
The vaccine was given in the left arm. The left arm began to tingle and get heavy as expected.  However, during the 15 minute waiting period after receiving the vaccine, the left side of my face began to feel ever so slightly thick and numb. It felt as if I had been to the dentist for a filling a hours ago.  I never lost speech or had a discernable facial deformity, but the numbing caught me off guard.   The facial feeling faded in about the same manner as the arm recovery.
arm is still swelling; it really hurts; Pain, its just real sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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), outcome "not recovered", described as "arm is still swelling"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "it really hurts; Pain, its just real sore".  Additional information: Reporter stated that Her arm was still swelling and it really hurts; Pain, its just real sore. Reporter mentioned that she got vaccinated yesterday and as of the moment her arm is still swelling and it really hurts. She wanted to know if she could take any medication to keep the swelling away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 14 years old patient. On 21-AUG-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # and dose not reported) instead of VARIVAX (Merck). No adverse event reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. On 25-JUL-2014, the patient was vaccinated with ZOSTAVAX (lot # J004266, Expiration date: 12-JUL-2014) (dose and route was unspecified). On 25-JUL-2014 (also reported as expired by one week), the patient was administered with expired ZOSTAVAX. No product quality complaint was reported. This report is linked to the MARRS#1408USA011772 (same reporter link). Additional information has been requested.
headache; This is a spontaneous report from a contactable consumer reporting for herself.  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 23Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. The patient informed she received second dose of vaccine on 23Feb2021 and woke up with a headache. She was wondering if she can take Tylenol or Aleve. AT the time of the reporting event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Information has been received from a Registered Nurse (RN), for VARIVAX (Merck), a Pregnancy Registry product, concerning a 29 year old female patient with no pertinent medical history or known drug reactions/allergies who in "late August 2011" was vaccinated with a dose of VARIVAX (Merck) (lot #, dose, route and site of administration not reported). Concomitant therapy included prenatal vitamins (unspecified). The Registered Nurse reported that the patient became pregnant at unspecified time following vaccination with VARIVAX (Merck). The patient's last menstrual period was on 01-AUG-2011 and her estimated delivery date was on 07-MAY-2012. Pregnancy test, routine lab work and CBC were performed (results not provided). No adverse effect was reported. The patient sought medical attention (office visit). No treatment was given to the patient due to the vaccine exposure during pregnancy. Follow up information has been received from the Registered Nurse. She reported that the patient delivered a full term healthy baby boy on 04-May-2012 without any congenital anomalies. The uncomplicated delivery of the infant was by a scheduled repeat C-section. The nurse did not have the infant's birth weight or height but was positive the infant was not of low birth weight and was a healthy thriving baby on 20-MAY-2013 "today". She did not know what dose of VARIVAX (Merck) was given since their office did not administer the vaccine. Additional information is not expected.
Gave a monkeypox vaccine that was expired; Case reference number US-BN-2023-000188 is a spontaneous case report initially received from a nurse via Communications (reference number: USBAV23-0200) on 03-Feb-2023 and concerns an elderly male patient.  The patient's medical history and concomitant medication details were not provided.  On 30-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; expiration date: 27-Jan-2023), at a dose of 0.5 mL, administered subcutaneously, at an unknown site of administration, for monkeypox prophylaxis (explicitly coded as 'expired vaccine used').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 03-Feb-2023 included the local case ID.; Reporter's Comments: An elderly male patient was vaccinated with the first dose of expired Jynneos vaccine (expiration date: 27-Jan-2023), at a dose of 0.5 mL, administered subcutaneously, at an unknown site of administration, for monkeypox prophylaxis, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An elderly male patient was vaccinated with the first dose of expired Jynneos vaccine (expiration date: 27-Jan-2023), at a dose of 0.5 mL, administered subcutaneously, at an unknown site of administration, for monkeypox prophylaxis, which is considered as expired vaccine used. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Chills, low grade fever, body aches  12 hours  Tx: Tylenol 500mg +ibuprofen 400mg at onset of symptoms
COVID-19 infection started on 02/20/2023 in the morning. I had a severe headaches. I started getting congested. I tested positive that day. I took Tylenol but after 1 hour it came back so it wasn't helping much. On 04/01/2023 I went to the doctor's office because I still had the headache and I was congested from COVID-19 infection. He diagnosed me as having Sinusitis. He prescribe me with Z-pack (5 days), Antibiotics (1 week), Steroid (1 week) Allergy medication for congestions and Fluticasone (2 day).
Pt is 35 weeks pregnant and accidentally received the Arexvy rsv vaccine instead of Abrysvo.
Felt fatigue one week after the injection and developed mild shingles around upper left arm (the injection area) with rash and blisters appearing in day 13 and day 15, respectively.    Saw urgent care doctor in day 17 and confirmed they are shingles instead of coivd arm. Get antiviral medicine for treatment.
Information has been received from a male pharmacist of unknown age referring to himself. The patient's medical history, concurrent condition and concomitant medication were not reported. On 04-AUG-2016, the pharmacist inadvertently squirted ZOSTAVAX (which was in the syringe, strength, lot#, expiration date and route were not reported) on his skin and into his eye, while he was preparing a dose of ZOSTAVAX. It was reported that he immediately washed his skin and flushed his eye with water. Additional information has been requested.
Information has been received from a pharmacist referring to an over 60 year old female patient. On an unknown date a dose of VARIVAX was inadvertently administered on the patient who was indicated for a dose of ZOSTAVAX. No adverse effects reported. It was unspecified if the patient sought for medical attention. Additional information has been requested.
pt recvd vax; t >104 8 hrs after vax; apap given every 4 hrs; t cont to spike w/in 48 hrs after vax; sxs resolved w/ no sequelae according to par;
a 62 year old male patient was administered a dose of Fluzone High Dose/No AE; a 62 year old male patient was administered a dose of Fluzone High Dose/No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 62 years old male patient who a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot 6j281a, expiry date: 16-May-2020 via intramuscular route in the left deltoid on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Doctor visit on 04-Oct-2019.  It was an actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report no adverse event was reported.  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.
This spontaneous report as received from a pharmacist refers to a 10 patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 24-JUN-2015, 10 plastic syringes were pre-filled with GARDASIL and then were refrigerated. On 25-JUN-2015, the 10 patients was vaccinated with GARDASIL intramuscular (dose, lot # and expiration date were not reported). The patient received a doses of GARDASIL that was stored improperly. No known adverse effects. Additional information has been requested.
Bell's Palsy, left side began drooping/complete drooping of left side, unable to close eye; taste as being off; numbness; soreness, achiness; bad headache; A spontaneous report was received from a Health Care  Professional, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed bell's palsy, bad headache, taste as being off, soreness, achiness, numbness.  The patient had no history of bell's palsy. Concomitant product use was not provided by the reporter.     On 10 Mar 2021, patient received her  second of two planned doses of mRNA-1273 vaccine. (Batch number:027A21A) intramuscularly for prophylaxis of COVID-19 infection.   On Saturday 13 Mar 2021, patient had  bad headache and on 16 Mar 2021, patient reported taste being off, soreness, achiness, numbness and left side began drooping.  On 17 Mar 2021, patient went to emergency room  due to complete drooping of left side and unable to close eye.   Treatment for the event included IV methylprednisolone sodium succinate and patient was sent home with prednisone pack and valacyclovir (1g/5 days).  The patient received both scheduled doses of mRNA-1273 prior to the events; the action taken with respect to the drug in response to the events is not applicable.    The outcome of the events, bell's palsy, bad headache, taste as being off, soreness, achiness/pain, left side began drooping/complete drooping of left side, numbness and unable to close eye were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient had a really bad headache first and thought she was going to pass out several times for a few days after the dose. It also made patient wheeze for 3-4 days, and then starting the second week until now her blood pressure is continuing to be out of control even after her doctor doubled her dose of bp meds.
Sore arm Fever of up to 102 for three days Fatigue  Took Ibuprofen to manage
Terrible pain in both the forearm after 13 days post first dose of vaccine; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021 at 17:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as not applicable. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 12Apr2021, the patient experienced pain in both the forearms after 13 days post first dose of vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event terrible pain in both the forearms was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a elderly female patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. In December 2018, 20 years after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient completed a series of Hepatitis B vaccines 20 years before the time of reporting. The healthcare professional was unsure if the patient completed Hepatitis B series with Engerix-B or a different manufacturer. The patient tested for Hepatitis B antibody, which was found to be Positive 20 years before the time of reporting. In December 2018, the antibody against Hepatitis B showed non-reactive, which led the patient to be a therapy non-responder. The reporter gave consent to follow up. Lab Comments: on an unknown date, 20 years before the time of reporting the Hepatitis B antibody tested positive for immunity.
Patient reported a 5" area of pinkness that became itchy with slight tingling, slight pain.  This developed 3-4 days after vaccination.  Reports the area seems to be getting better but wanted to make us aware of the situation.  Patient is not treating with anything.
Administered 8/12/02 AM. Mom called 8/14 5PM child developed H/A 8/13 progresses worsened, stiff neck, unable to close fists, "worst H/A of life," no fever.
Sore arm and head first 6-8 hours  Myalgia major muscles, headache - head and through eyes, chills, tired
19MAR92 pt recvd Engerix-B  2-3 days later flu-like sx (achy, h/a, coughing); 19APR92 pt recvd Engerix-B & 4-5 days later reported throat closing off & high fever; tx ACTH; Reporter states events exp by pt were questionably immed life thre;
This spontaneous report was received from a pharmacist regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored PEDVAXHIB lot # K007258, expiration date- 04-MAR-2017. No concomitant medication was reported. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Possible Bells Palsy; This is a spontaneous report from contactable other healthcare professional (HCP). A 66-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), intramuscular on 13Jan2021 at a single dose for COVID-19 Immunization. Medical history included hyperlipidemia, chronic kidney disease, essential hypertension, obesity, hyperuricemia, iron deficiency anemia, type 2 DM and obstructive sleep apnea. The patient has no known allergies. Concomitant medications included amlodipine besylate (AMLODIPINE BESYLATE), glimepiride (AMARYL [GLIMEPIRIDE]), levothyroxine sodium (LEVOTHYROXINE SODIUM), metformin (METFORMIN), losartan potassium (LOSARTAN POTASSIUM), ascorbic acid, calcium, minerals NOS, retinol, tocopheryl acetate, vitamin B NOS, vitamins NOS, zinc (CENTRUM SILVER [ASCORBIC ACID; CALCIUM; MINERALS NOS; RETINOL; TOCOPHERYL ACETATE; VITAMIN B NOS; VITAMINS NOS; ZINC]), sucralfate (SUCRALFATE), glimepiride (GLIMEPIRIDE), furosemide (FUROSEMIDE), atorvastatin (LIPITOR [ATORVASTATIN]), pantoprazole sodium (PANTOPRAZOLE SODIUM), cyclobenzaprine (CYCLOBENZAPRINE), cholestyramine (CHOLESTYRAMINE). Other vaccine in four weeks included the first dose of influenza vaccine, intramuscular on the left deltoid, on 22Dec2020, lot number: UJ475AA. The patient has no COVID prior vaccination and had not tested post vaccination. The patient experienced possible Bell's palsy on 14Jan2021. Treatment for the event was unknown. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not recovered from the event.     Information on the batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Red welts and boils appeared on the patients face around the lips and nose area that appeared the day after the vaccination. The red raised bumps have the appearance of aggressive HSV eruption. The red bumps have not disappeared yet and have been around for 1 week.
Fever starting 1-2 days after no other side affect at time treated with baby ADVIL, few days later single ear infection treated with amoxicillin for 5 days-gone, few days later double ear infection treated amoxicillin and baby ADVIL gone, pulls on ears still months later, falls over hard while sitting had severe crying for no apparent reason from the day after for a few weeks.
Tetanus Diphtheria Decavac - left deltoid - sore arm. Flu injection right deltoid - unsettled stomach, lethargic, pain everywhere, inability to focus.
Swelling at injection site with "redness and feels hot" along with itching. Area involved is the size of a "fist".
Pt recvd 3 doses of Engerix-B & following dose 3 esp inc BP w/tachycardia, vertigo & weakness; The inc BP & weakess cont 3 wks & pt was off work during that period; returned to work 1JUL92;
Even a week later my arm is swollen and warm, I was in bed for a week with all kinds of symptoms, diareaha, swollen right lymphnode, sore throat, lost voice, congestion in lungs, and ended up being treated for a sinus infection
Im a pfizer vaccinated person who contracted covid 19 are there in study trails for me; Im a pfizer vaccinated person who contracted covid 19 are there in study trails for me; 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) (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Im a pfizer vaccinated person who contracted covid 19 are there in study trails for me". The lot number for bnt162b2 was not provided and will be requested during follow up.
Inadvertent administration via intramuscular route vs. subcutaneous route; No adverse effect; This spontaneous report as received from a nurse refers to a child patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (DILUENT MRK INJ).  On an unknown date, the patient was inadvertently vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R028623, expiry date: 04-OCT-2020) (dose and frequency were not reported) intramuscularly versus subcutaneous route for prophylaxis (incorrect route of product administration). No adverse effects were reported. No product quality complaint was involved.
known atopic individual who was given DTP/OPV @ 18mo & exp swelling of eyes w/in 1/2 hrs of shot;