chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a female patient who received FLUARIX QUADRIVALENT (batch number 2F5P4, expiry date 30th June 2016). Concurrent medical conditions included iodine allergy and shellfish allergy. On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced allergic reaction (serious criteria disability, life threatening and other: as per reporter), optic nerve damage (serious criteria disability, GSK medically significant, life threatening and other: as per reporter), stroke (serious criteria disability, GSK medically significant, life threatening and other: as per reporter), headache (serious criteria disability, life threatening and other: as per reporter), throat constriction (serious criteria disability, life threatening and other: as per reporter) and eye pain (serious criteria disability, life threatening and other: as per reporter). The patient was treated with BENADRYL (nos) and steroids nos (unspecified). On an unknown date, the outcome of the allergic reaction, optic nerve damage, stroke, headache, throat constriction and eye pain were unknown. It was unknown if the reporter considered the allergic reaction, optic nerve damage, stroke, headache, throat constriction and eye pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The health care professional stated that right after receiving FLUARIX QIV, the patient's throat started closing on her. The patient also experienced optic nerve damage (severe eye pain, headaches). The patient was allergic to iodine/shrimp and knew right away that she was having an allergic reaction because her throat started closing. She was wheeled over to the emergency room in a wheel chair. She was given BENADRYL and steroids. She was discharged that day on steroids and followed up with an ophthalmologist. The ophthalmologist stopped the steroids and her pain came right back. She then went to another eye specialist who started her back on the high-dose steroids.
As soon as the shot went in,  I had a warm feeling that went down my arm to my fingers. Then I had a radiating soreness then went across my entire upper back.  Then a feeling like a liquid in the back of my throat with strange taste in my mouth. And  then simultaneously my heart started racing.  For several months the a feeling like a liquid in the back of my throat happened every time my heart would race. The a feeling like a liquid in the back of my throat went away after a few months but the racing heart beat has continued periodically since the vaccination.
deviation from dosage (less than 0.5mL); A spontaneous report was received from a healthcare professional concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced deviation from dosage (less than 0.5mL) (Incorrect dose administered).  The patient's medical history was not provided. Concomitant medications were not provided by the reporter.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, 3 or 4 drops of the vaccine fell on the patient's arm during injection. There were 0.5mL in the syringe during the administration, and the patient received almost all of the vaccine except for those three or four drops. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was unknown.  The event deviation from dosage (less than 0.5mL) (Incorrect dose administered) was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Yellow/green discoloration over injection site, 12/20/2021 Red splotch formed below injection site, 12/23/2021
I woke up because of a fever very early in the morning. At that time it was low grade - about 99.9. As the day progressed my fever went up to 101, and it was 103 by 9:00 PM. 1000 mg of Tylenol helped control the fever early in the day, but by 9:00 PM it had no effect. Fever continued to by high throughout the night, but had fallen back down to 100.00 by morning.
started day as shot and has lasted last 6 days. vomiting, diarrhea, complete loss of appetite, extreme fatigue, violent headaches at the back of head
PATIENT EXPERIENCED TIGHTNESS IN THE THROAT AND WAS HAVING PROBLEMS BREATHING WHEN AT HOME. HE USED HIS EPIPEN AND IT ALLEVIATED THE SYMPTOMS. THE PATIENT NEVER WENT TO THE ER OR TOLD ANYONE UNTIL I CALLED HIM TO TELL HIM HE WAS DUE FOR HIS 2ND DOSE ON 12/2/18.
complete loss of hearing in the left ear, woke up with it 2 days after vaccination, has not recovered at all.
Pt received Anthrax IZ. The next day began having pain and swelling in area. Has received Anthrax shots in the past. Dx is localized reaction.
This spontaneous case reported by a consumer, describes the occurrence of chills in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 027A21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 8, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 10, 2021, patient experienced chills. On Mar 11, 2021, chills resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment information provided.
24 hours after vaccine: feverish but afebrile, chills,  headache, nasal congestion, change in taste and smell, malaise lasting for 5 to 6 hours. 48 hours after vaccine: chills, intense headache, nasal congestion, change in taste ans smell, malaise lasting over 8 hours. 96 hours after vaccine: feverish but afebrile, chills, intense headache, nasal congestion, change in taste and smell, occasional cough, malaise lasting over the next 24 to 48 hours.
A spontaneous report  has been received from a Health Professional concerning a female patient. The patient's medical history, concurrent diseases and concomitant medications were not provided. The patient was receiving nasal FLUMIST (intranasal) started on an unknown date for influenza vaccine. It was reported that the patient received 2 doses of FLUMIST 4 days apart. Doctor explained she thought the first dose was expired, then later found out it was not expired-after administering the second dose. Action taken on FLUMIST was unknown. The outcome of the event of overdose was unknown. The reporter assessed the event of overdose to be non-serious.
sore arm; Red arm; injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm), VACCINATION SITE ERYTHEMA (Red arm) and INJECTION SITE PRURITUS (injection site itching) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Implantation complication (Patient had an artificial shoulder in left arm due to infection, some years ago.) since an unknown date. Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Joint ache.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 14-Feb-2021, the patient experienced AXILLARY PAIN (sore arm), VACCINATION SITE ERYTHEMA (Red arm) and INJECTION SITE PRURITUS (injection site itching).   The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency.   At the time of the report, AXILLARY PAIN (sore arm), VACCINATION SITE ERYTHEMA (Red arm) and INJECTION SITE PRURITUS (injection site itching) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt reports swelling in left arm where vaccine administered which just appeared this morning (2 days after vaccine administration). Pt reports not bothersome/itchy. Has not tried any treatment other than occasional ice.
Patient requested to her provider to receive her booster dose during a medical visit on 3/23/2022. She received booster dose of Pfizer on 3/23/22. Provider and MA checked medical system which showed she was due for her booster. However, shortly after Patient received her vaccine, staff discovered she had already received a booster dose of Moderna (Lot # 025L20A) on 1/12/2021 in her Left deltoid. After finding this out, the provider spoke with Patient and let her know that she was actually not due for a booster dose being that she had already received a booster dose on 1/12/2021.
HEADACHE FROM 9:00 AM 12/15/18 UNTIL 12:00 PM 12/17/18. ACHES AND LOW GRADE FEVER FROM 9:00 AM 12/15/18 UNTIL 10:00 PM 12/16/18. SORE ARM AT INJECTION SITE, DON'T REMEMBER WHEN BEGAN, UNTIL APPROXIMATELY 1:00 PM 12/18/2018. RASH AT INJECTION SITE, 8 INCHES X 2 INCHES. 8:00 AM 9/16/18, STILL PRESENT APPROXIMATELY 1:00 PM 12/18/2018 BUT LESSENING.
Admit 2/20/22-2/25/22 for COVID who presented 2/28/22 with dyspnea. She was found to have acute CHF and CoNS bacteremia. Course complicated by pancytopenia.  Continued steroids for post Covid lung injury, wean down slowly
Seizure activity < 1 min: stiffening, shaking, drooling.
Patient falsified date of birth and age on vaccine consent form. Patient was actually 15 years old at time vaccine was received, but gave a DOB and age that indicated he was 16 years old. Vaccine was administered and patient reported no adverse effects. True DOB was discovered when processing consent form through insurance.
Developed aggravation of Grave's/Thydroid Disease with New Proptosis of Eye
2nd dose administered after 24 hours at proper room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered after 24 hours at proper room temperature) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021 at 1:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered after 24 hours at proper room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose administered after 24 hours at proper room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter states that a vial was removed from the proper refrigerated temperature and punctured at 11:54 am  05-AUG-2021. After puncture, the vial was removed from the refrigerator and kept at 65F to 66F until a dose was given to a patient at 1:30 pm  06-AUG-2021.  On 30th of July,2021 vial was moved from freezer to refrigerator.  No concomitant medication was provided.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received on 13 AUG 2021 and Pharmacy address was updated. Vials details was added.
01/16/2005 Pt noticed rash on back and c/o itching soon developed rash all over. 01/19/05 TC to PHN. Mom said had called PMD's office was told to use Benadryl but still has rash (welt like). Advised to call PMD again. Child was seen by doctor and given Allegra and Cimetidine TC to mom. 1/26/05 still has rash (worse when he gets hot).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 68-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 27Apr2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 68 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single, as dose 3 (booster), single and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia"; "osteoarthritis"; "known allergies: sulfa". The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "allergy". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective: Paxlovid from 08Sep2023 to 12Sep2023.
Information has been received from a nurse practitioner concerning an 18 year old female with chlamydial infection who on approximately 16-JUN-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast). Concomitant therapy included doxycycline. The patient had experienced vomiting and nausea for the last three weeks (from approximately 20-JUN-2008). The patient's vomiting and nausea persisted. No further information is provided. Additional information has been requested.
Information has been received from a pharmacist concerning a 74 year old male patient with hypertension and no known allergies who on 30-SEP-2009 was vaccinated IM in the right arm with a dose of PNEUMOVAX 23 (lot number 663889/0632Y). Concomitant therapy on the same day included a dose of influenza virus vaccine (unspecified) (manufacturer unspecified) in the left arm. On 30-SEP-2009 the patient experienced shivering, swelling at injection site on right arm and low grade fever. The patient saw the pharmacist in the pharmacy. There were no lab studies performed. The patient was treated with TYLENOL and BENADRYL which seemed to help with the symptoms. At the time of the report, the patient was recovering. Additional information has been requested.
pt recvd vax & exp malaise, fatigue, joint pain & slept for 10 to 12 hrs per day; NOV93 was dx w/polymyalgia rheumatica; lab tests showed inc serum albumin, serum alkaline phosphatase & LDH; pt felt sx may have been related to viral infect
supraclavicular lymphnode swelling/mobile; lymph node is not as painful, but is still tender and is mobile.; This is a spontaneous report from a contactable physician (patient).  A 28-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested) in the hospital via intramuscular route of administration on 04Jan2021 at 10:00 AM at a single dose on the right deltoid for COVID-19 prophylaxis.  The patient medical history was not reported and there were no concomitant medications. The patient was previously administered a flu vaccine on an unspecified date for immunization and experienced sore arm. The patient had no prior vaccinations within 4 weeks. It was reported that the patient developed supraclavicular lymphnode swelling on 11Jan2021 and was calling to see if this is normal or if it was something others have experienced. She noticed that last week or about 5 days (also reported as 11Jan2021) after receiving the vaccine her supraclavicular lymph node was swollen.  She stated that it was just that one lymph node on the same side that she received the injection. She added that the lymph node is not as painful, but is still tender and is mobile. She said that it is tender if she pushes on it. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Patient developed COVID.  Symptoms of  loss of smell, bodyaches, cough, fatigue and congestion started on 4/30/21.  She denies covid exposure, but reports that her child was exposed to covid positive person.  She tested negative for covid on 5/1, symptoms worsened, she was retested on 5/3 and found to be positive for COVID.
Swelling; Cellulitis; Pyrexia, Erythema.  Information has been received from a physician concerning a female patient over the age of 65 who on 10/24/05 was vaccinated with a 0.5ml second dose of pneumococcal 32v polysaccharide vaccine (lot 650302/1039P). Subsequently, the patient presented to the office with complaints of "cellulitis type reaction", swelling, redness and fever. The onset of the symptoms was within 2 to 3 days post vaccination. The patient was treated with acetaminophen (Tylenol), ibuprofen (Advil, or cold packs as needed. The patient also received unspecified oral antibiotics and symptoms improved. At the time of this report, the patient was recovering. The physician expressed concern for lot 650302/1039P and requested a lot check be performed on lot 650302/1039P.  The physician felt that cellulitis type reaction, swelling, redness and fever were disabling. Additional informational has been requested.
Rash on back; swollen arm and armpit; vomiting; nausea; chills muscular pain and migraines.
diagnosed with covid; diagnosed with covid; head feels like it is in a cloud and he is very disoriented; head feels like it is in a cloud and he is very disoriented; This is a spontaneous report from a contactable consumer reporting for her friend. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose for COVID-19 immunization, dose 1 on an unspecified date, dose 2 on 28Mar2021 (Lot number was not reported). There was no medical history or family medical history relevant to AE. Prior Vaccinations (within 4 weeks) was none. The patient's concomitant medications were not reported. The patient was diagnosed with COVID in Jul2021 3 or 4 days before 15Jul2021. His symptoms were loss of taste for short period of time, no fever, very very light sore throat, head felt like it was in a cloud and he was very disoriented. On 14Jul2021 he could taste his food and was hoping yesterday was the worst of it. The patient declined any treatment. No Emergency Room or Physician Office was required. No relevant rest. The outcome of events was unknown.  Information on the batch number has been requested.
Information has been received from a physician concerning an 18 year old female with no known drug allergies and no pertinent medical history who on unspecified dates was vaccinated with the first and second doses of GARDASIL.  On 23-JUL-2008, after receiving her third dose of GARDASIL the patient passed out and exhibited seizure like activity.  The patient sought unspecified medical attention.  No lab/diagnostic studies were performed.  Fifteen minutes after the event, the patient improved.  She recovered the same day.  Upon internal review, seizure like activity was considered to be an other important medical event.  Additional information has been requested.
7 days out  from first vaccine I had extreme pain in my neck, shoulders and upper back. Could not turn my head left or right because the 6 Scalene Muscles in the neck were so tight. The pain also went up the right side of my face & skull affecting my TMJ and eating. The Scalene Muscles are on the side and front of a person's neck so I looked on the web as to how to release them. I gently used my knuckles, fingers and a tennis ball for 4 days on these 6 muscles while someone used a large 2 ball massager on my spine from my bra line and up my neck, and I laid on a heating pad but the stiffness and pain remained.  Pain last 2 weeks, first week the worst. Extreme fatigue for a week . I believe I might have some arthritis in my neck and I frequently have minor aches and pain in my upper back, shoulders, & neck. So this area is venerable so maybe that's why it happened.  I hope my 2nd shot won't be worse.
Shivers, cold sweats, and body ache. Treatment: none. Outcome: mild improvement
If she touches the injection site is a little tender but not painful; Stomach sick; Chills; Vomiting; Extremely sick; Diarrhoea; Felt hot but had no fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Extremely sick), DIARRHOEA (Diarrhoea), FEELING HOT (Felt hot but had no fever), ABDOMINAL DISCOMFORT (Stomach sick) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Blood pressure and Thyroid atrophy (.).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced MALAISE (Extremely sick), DIARRHOEA (Diarrhoea), FEELING HOT (Felt hot but had no fever), CHILLS (Chills) and VOMITING (Vomiting). On 22-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach sick). On an unknown date, the patient experienced VACCINATION SITE PAIN (If she touches the injection site is a little tender but not painful). At the time of the report, MALAISE (Extremely sick), DIARRHOEA (Diarrhoea), FEELING HOT (Felt hot but had no fever), ABDOMINAL DISCOMFORT (Stomach sick), CHILLS (Chills), VOMITING (Vomiting) and VACCINATION SITE PAIN (If she touches the injection site is a little tender but not painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
the patient was inadvertently administered a dose of PEDVAXHIB by the subcutaneous route instead of the intramuscular route; there is still a knot present in the area of administration of the right thigh; This spontaneous report as received from a pharmacist refers to a 2-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-APR-2019, the patient was inadvertently vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R027329, expiration date: 12-JUL-2021, in the right tigh via subcutaneous route instead of the intramuscular route. On an unspecified date in 2019, the patient experienced knot present in the area of administration of the right thigh. At the time of the report, the knot was still present.  The causality assessment was not provided.
she is still having effects in her left shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0168), as dose 2, single (Lot number: FJ1620) and as dose 3 (booster), single (Lot number: EW0169) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB INJURY (non-serious), outcome "unknown", described as "she is still having effects in her left shoulder".  Additional Information: Caller is a 60 year old patient who states that she got her everything done last year in Dec", and she is still having effects in her left shoulder, which is where she got both doses of the primary series of the Pfizer BioNTech Covid 19 vaccine, as well as her booster dose. She does not have a medical inquiry, she simply wants to report that it is ongoing.
On the morning of day eight after my first dose of covid 19 vaccine I developed a red, itchy and hot circle about the size of a quarter at the injection site.  That spot continued to increase throughout the day and by noon time it had spread to most of my upper arm. I did NOT take any medication or use any topical treatments. The next morning ( day 9 ) the area was just as large but the center was returning to normal color with just a ring of red. It was no longer hot or itchy. On day ten it had completely resolved and i have had no further issues or reactions.