chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest got tight; Shortness of breath; throat was itchy, and felt like it closed; throat was itchy, and felt like it closed; This is a spontaneous report from a contactable other health care professional (HCP) (also reported as respiratory therapist) from a Pfizer Sponsored Program.  A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 48-years-old at a single dose for COVID-19 immunization. Medical history included asthma from 2000 and ongoing (diagnosed 20 year ago).  There were no concomitant medications. On 21Dec2020, the patient experienced: chest got tight (non-serious), shortness of breath (non-serious), throat was itchy, and felt like it closed.  The clinical course was reported as follows: The caller was a respiratory therapist (also reported as health care professional (HCP)). The patient's first dose of the vaccine was on 21Dec2020 at the hospital where she works. Five hours after getting the vaccine, her chest got tight, she has shortness of breath, her throat was itchy, and she felt like it closed. The patient had asthma (diagnosed 20 years ago) and felt this reaction. It took 48 hours after the initial symptoms that she felt better.  For treatment, the patient took her salbutamol (ALBUTEROL) inhaler and diphenhydramine hydrochloride (BENADRYL). The patient was scared to have the second dose; and she was going to talk to her primary care physician (PCP) about the second dose (but she did not think she would have much knowledge on what to do). The patient had a COVID PCR test the day she received the vaccine, and it was negative. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 21Dec2020.  The clinical outcome of the events was recovered on an unspecified date.
red, swollen, hot, firm areas noted to bil. thighs the next day 7-26 that worsened 7-27-22 that caused mom to call in to clinic. patient c/o pain to the areas and significant itching. pt. came to see Dr. and started on Cetirizine daily.
went into cardiac arrest 45 minutes after receiving the flu shot; Initial information received on 09-Aug-2022 regarding an unsolicited valid  serious case received from a consumer/non-health care professional.This case is a courtesy case received from: Merck.  This case involves an unknown age female patient who went into cardiac arrest 45 minutes after receiving the flu shot ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2018, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported at an unknown dose via unknown route in unknown administration site for immunization.  In 2018, the patient went into cardiac arrest 45 minutes after receiving the flu shot (cardiac arrest) (latency: 45 minutes ) following the administration of INFLUENZA VACCINE.   Action taken :not applicable  It was not reported if the patient received a corrective treatment for the event .  Outcome: unknown; Sender's Comments: Sanofi company comment dated 12-Aug-2022: This case involves female patient of an unknown age who was vaccinated with influenza (unknown manufacturer) and experienced cardiac arrest. The time to onset is compatible (same day) with the role of the vaccine. The clinical course was not provided. Furthermore, information regarding condition at the time of vaccination, the role of medical history, concomitants, and laboratory data excluding other predisposing etiologies would be needed for a complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed. .
Headache, Myalgia, Arthralgia & Fever Narrative:   Other Relevant History:
admit from nursing home with fatigue and increased weakness. Had been COVID + for 10 days prior to admit. c/o SOB - on RA. Tests positive for GI bleed with HGB 7.1. UTI/cystitis, COVID + . Blood transfusion given. Zinc, Vit C&D, singulair and  dexamethasone given. Dexamethasone stopped due to risk for increase in bleeding.  POA declined endoscopy. having bradycardia. PT made DNR and hospice, dc back to nursing home.
This spontaneous report as received from a medical assistant refers to a 23-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-MAR-2016, the patient was vaccinated with an incorrectly stored dose of PROQUAD (therapy type: rHA, lot # L031601, an expiration date 18-FEB-2017, dose, dose number, anatomical location and route of administration were not provided). It was reported that the refrigerator was out of range. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
My watch alerted me that my resting heartrate was to high, it was over 135 per minute. I sent a message to my doctor, I went in the next day. I am now taking Metoprolol to regulate my heart rate.
Patient has darkened pigmentation on skin where bandage was applied after vaccine administration. The area is hardened.
Case number PHEH2014US017316 is an initial spontaneous report received from a health care professional on 22 Aug 2014. This report refers to a 12 years old male patient. His medical history and concomitant medications were not reported. His vaccination status was reported as up to date. He was vaccinated with initial dose of MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly in the left deltoid on 24 Jul 2014 at 11:47. It was reported that 18 to 24 hours after vaccination, on 24 Jul 2014, he experienced red and edematous area at the area of vaccination. It was reported that the patient was diagnosed with a vaccine reaction. The events outcome was reported as complete recovery on 28 Jul 2014. The seriousness and causality were not reported.
About 9 hours after receiving the vaccine (around 2am) I had a fever, chills, headache, sore arm, and muscle soreness. I fell back asleep and when I woke up the fever had broken and the chills had improved but the soreness and headache remained. I took Tylenol in the afternoon and that helped the symptoms but by the time I had gone to bed the chills had returned but not a fever. When I woke up in the middle of the night (night 2) the chills had stopped and I woke up with a moderate headache and sweating profusely. After falling asleep and awaking in the morning I felt much better with the exception of a minor headache.
This spontaneous report as received from a healthcare worker refers to a 11 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 02-JUL-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. On 03-SEP-2015, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (strength, dose and route were not provided) lot # L000610 expiration date 31-JAN-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
After the three vaccines were administered, she began screaming, and felt warm to her grandmother. She became flushed with small urticarial lesions on her cheeks. There was no stridor, or hypotension; no drooling. Lungs were clear. Benadryl was administered and the child was observed for thirty minutes.
Woke up 3 am with injection site/arm very swollen. Very warm .Site muscle sore.
Administered 5th dose of Prevnar13 instead of Infarix (Dtap) to pt. No adverse effects noted at time of vaccination. Notified provider, supervisor, and mother of patient. Mother of patient denied any adverse effects at that time.
Information has been received from a consumer who was also an author of an article on a newspaper, referring to her granddaughter, a female patient of unknown age. The information of concurrent conditions, medical history and concomitant medications was not provided. On an unknown date, the patient was vaccinated with GARDASIL (lot#, dose, frequency and route were not provided). On the same date, the patient had a severe and frightening reaction within 30 seconds of receiving the GARDASIL in the doctor's office. The patient survived but had lived through a post-vaccination period that had negatively affected her health and included several emergency room visits. The outcome of the events was unknown. The reporter considered the event severe and frightening reaction within 30 seconds of receiving the vaccine to be life-threatening. Additional information has been requested.
Left Deltoid. Arm was very sore and hard to move. Area where vaccine administered was "size of a grapefruit" according to home nurse.  Area was bruised and remained bruised at the 10 day mark.  Pt was seen by her PCP who stated it was fine and no treatment needed.  Area resolved itself.  Pt stated was not on coumadin.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-DEC-2015, the patient was vaccinated with an improperly stored doses of GARDASIL 9 lot # L017407, expiration date: 15-AUG-2017 or lot # L016428, expiration date: 30-JUL-2017 (it was not specified by the reporter which lost was administered)(dose, route of administration and location were not reported0. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Received Shingrix on 2020 Jan 30th Never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Received Shingrix on 2020 Jan 30th Never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-JUL-2023 The reporter did consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
pt recvd vax & had welts on head & lower leg; no fever; advised to see PMD who felt rash not related to vax;
2-3 inches purple pink rash, patient reported feeling warm (no temperature taken) then feeling cold. Feels occasional burning itching pain.
1 of 3 pts vaxed from the same vial who exp inj site rxn;pt recvd vax 6MAY94 & several hrs later,arm very painful;had erythema,swelling,hot to touch from elbow to shoulder;8MAY red streaks appeared;MD visits 9MAY;rxn had subsided;bruised
Lost eye sight with headache for one day,  Muscle weakness in all limbs. Fatigue. Unable to walk or move . High level anxiety  Unexplained rashes
COUGH; THROAT PAIN; cough...sore throat...diagnosed with bronchitis; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (cough...sore throat...diagnosed with bronchitis), COUGH (COUGH) and OROPHARYNGEAL PAIN (THROAT PAIN) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Aspartame). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced BRONCHITIS (cough...sore throat...diagnosed with bronchitis). On an unknown date, the patient experienced COUGH (COUGH) and OROPHARYNGEAL PAIN (THROAT PAIN). At the time of the report, BRONCHITIS (cough..sore throat..diagnosed with bronchitis) had not resolved and COUGH (COUGH) and OROPHARYNGEAL PAIN (THROAT PAIN) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. On 11-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     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.   No treatment information was provided for cough.   This case was linked to MOD-2021-058662 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow-up received and addition of two new event COUGH (COUGH) and OROPHARYNGEAL PAIN (THROAT PAIN)
Information has been received from a registered nurse concerning her approximately 20 year old cousin with no pertinent medical history or drug reactions/allergies who was vaccinated with a first dose (in February 2009), second, and third dose (two months ago, in approximately October 2009) of GARDASIL, IM (Lot # not provided). Concomitant therapy included ALLEGRA, XANAX, and ORTHO EVRA. Patient did not remember when the 2nd dose of GARDASIL was given but remembered to have had swelling and redness at the injection site for 2 weeks. The patient prior to vaccination tested negative for HPV. The nurse mentioned that her cousin received all 3 doses of GARDASIL and tested positive for HPV. Patient mentioned that she found out her HPV test was positive when she called the office trying to get medication for a yeast infection. The patient has sought unspecific medical attention by phone call. At the time of this report, the patient status was unknown. Additional information has been requested.
Arm  sore; Began throwing up for hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  sore) and VOMITING (Began throwing up for hours) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm  sore) and VOMITING (Began throwing up for hours). At the time of the report, VOMITING (Began throwing up for hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Pt complained of shortness of breath that improved when nurse arrived. Pt was feeling much better. BP  158/90 History of HTN with no meds taken that AM . Pt monitored for 30 minutes with no return of shortness of breath.
11:10am- nasal congestion with drainage. Denies SOB or tightness of throat. 11:20am - reports throat closing in. Constant throat clearing. Face  and neck red. 911 called. 11:24 - epinephrine 0.3 mL given left arm subq. pulse =80, R=34. 11:28 ambulance to ER.
Case number PHEH2014US020793 is an initial spontaneous report received from a health care professional on 13 Oct 2014. This report refers to a 2 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1411501) intramuscularly at a dose of 0.5 ml on 10 Oct 2014. No adverse events reported after the maladministration.
On the Initial injection day the 15th there was soreness and fatigue. The 16th, there was muscular pain and soreness and extreme fatigue. The 17th there was still muscular pain and fatigue. The 18th-21 there was no symptoms. On the 22nd, the injection site began to itch, was warm to the touch, there was firmness  and there was redness. On the 23rd, the injection site is now sore again  along with the whole arm. There is now a red patch where the injection was given.
I had a large preexisting sebaceous cyst in my left armpit that had never caused any problem before, but suddenly it became extremely inflamed, infected, and painful. I also had body aches. I went to Urgent Care on May 19 and was given Keflex, which didn't help, and again on May 24, and was given doxycycline. On May 28, I was able to pull part of the cyst out of the wound--it was right at the surface, poking through. Over the next few days, more pieces of the cyst came out--all shaped like pieces of a sack or a shell. After that, the pain went away and the wound began to heal. Today, I still have a very small part of the cyst remaining, which I plan to have surgically removed.
Td administered 04/08/04 called parent 7/13/04. Mother stated no adverse reaction other than initial soreness at injection site. Mother denied hardness, fever or other problems. Mother stated client didn't even take Tylenol for discomfort. No unusual findings occurred, only expected soreness at site.
The vaccines that were administer moderna booster (NDC 80777-275-05) and it suppose to be toddler
Trouble speaking, hoarse voice, chest clear, no rash.  No throat swelling.  Temp 98.8, BP 130/90, Pulse 92.  Speech cleared 10 minutes after treatment with Epinephrine.
Patient reported "not feeling well" after vaccine administration. Vitals were checked - patient in SVT at 177 with BP of 129/78. Valsalva maneuver abated SVT and patient returned to Sinus Tach. Patient a few minutes later began having tachycardia into the 170's and with use of Valsalva maneuver and metoprolol returned to a normal sinus rate in the 70's.
got very loud tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (got very loud tinnitus) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus. Concomitant products included LISINOPRIL for an unknown indication.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (got very loud tinnitus). At the time of the report, TINNITUS (got very loud tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Pt recvd 1st dose of Hep B vax & 5 to 10 days following vax pt exp weird-looking rash on trunk;
Vaccine was given "Beyond Use Date" of 6/19/23.  Not expired.  Healthcare provider informed. Moderna contacted and assessed vaccine to be viable.  No complications reported by patient.
bad back pain under his right rib; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his COVID vaccine on Wednesday morning (03Feb2021) and he was having a really bad back pain under his right rib on Feb2021. The consumer was calling to find out if this was a side effect, and how and what was it that the patient needs to do because the consumer read that they were not supposed to take ibuprofen or any kind of pain medications. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Tachycardia Tingling tongue Tight throat/swelling Shaking Shortness of breath
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist.  The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot#J016188, expiration date: 02-OCT-2016 and lot #J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.   Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 9 weeks old infant patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot#J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter.  Additional information is not expected.
VIS WAS GIVEN TO MOM. VERIFIED BY ANOTHER PERSON. NO REACTION
Extreme pain in hip joint/leg, not related to obvious accident or impact. ER visit to address pain and seek cause, approx 65 hours after injection. Subsequent treatment so far has included acupuncture and steroid injection into hip. Pain and very limited mobility still present 17 days after vaccination, 16 days after onset of symptoms, 14 days after ER visit.
pt.recd 3rd. dose of Hep B vac. & developed nausea, vomiting,aching,migraine,diarrhea,& sore arm.
Achy body Extreme tachycardia (HR in the 180s). Unable to get below 90.  Uncontrollable shaking  Migraine
Pin and needles feeling in all joints, excessive swelling of body, difficulty swallowing, nausea, motion sickness, dizzy. Saw Primary Doctor, given Epi and Prednisone.
Headache, Diarrhea, DAY 2 AND 3 AFTER INJECTION, PT EXPERIENCED SORE ARM, DIARRHEA, AND HEADACHE  Narrative:
Diagnosed with Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Jan-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). At the time of the report, COVID-19 (Diagnosed with Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Patient was diagnosed with COVID-19.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Meningoencephalitis with ADEM and optic neuritis. Headaches, nausea, vomiting. Tx: Methylprednisone.
"Redness, Swelling, Soreness x 3 days, no further problems".
I had very bad diarrhea that lasted for a whole day. I also had a headache and was very tired that lasted for a day as well.