chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received hep B vaccine 05/07/02. Per mother pt developed Bell's palsy 05/08/02. Seen 05/24/2002 with Bell's palsy.
Case number PHEH2016US023399 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 47 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 30 Jan 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
This case was reported by a physician via sales rep and described the occurrence of rash in a adolescent female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced rash, injection site warmth and injection site erythema. The patient was treated with BENADRYL and ibuprofen. On an unknown date, the outcome of the rash, injection site warmth and injection site erythema were recovered/resolved. It was unknown if the reporter considered the rash, injection site warmth and injection site erythema to be related to BEXSERO. Additional details were provided as follows: At the time of reporting, the patient's age was 17 years. The patient received BEXSERO in an unknown arm. The patient experienced rash on an unknown site. Limited information was provided by the sales representative from the physician. This case has been linked with case US2017026063, US2017026064 and US2017026068 as reported by the same reporter.
Developed a fever; headache; Lethargic; arm soreness; and slept for 2 days took Tylenol. Recently, I have been dealing with diarrhea and severe headaches.
I had swelling in the ankle area, hurting in the right rib, back of my right lung area. Three days later the back of my knee got swollen and it was hard to walk. I went to the doctors, and they sent me to the hospital. I was extremely tired and had heavier breathing. I was in the hospital for 6 days. They found blood clots in my legs, chest after running test. The doctor advised me to take blood thinners for 6 months to a year. Blood thinners medications are ELIQUIS 5mg, prednisone 10mg, tamsulosin .4mg, and omeprazole DR 40mg.
This spontaneous report was received from a physician and refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-JUN-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot# N000236 and expiration date 24-OCT-2019 (dose and route of administration were not reported). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit for 16 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325:
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 1:07 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Sep-2022 at 1:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Concomitant medication information was not provided. Refrigeration excursions identified. The nurse reported about Moderna monovalent and bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022 that were administered to patients. The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle. The patient received 0.5 (units not specified) as fourth dose of vaccine on deltoid muscle and no adverse reactions were reported. No treatment information was provided.
a lump and pain on her left deltoid where she received the injection; a lump and pain on her left deltoid where she received the injection; This spontaneous report was received from a registered nurse via a company representative and refers to a 29-year-old female. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-FEB-2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the left deltoid for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023 (reported as few weeks after her injection), the patient experienced a lump and pain on her left deltoid where she received the vaccination. The lump was described as having no discoloration or heat. The patient described the pain as a "zing" that was worse when she leaned on her left arm. The patient felt better with acetaminophen (TYLENOL) and reached out the healthcare professional who advised the patient to take non-steroid anti-inflammatory drugs and ice the area. The patient was treated for a lump and pain on her left deltoid where she received the vaccination.  At the time of reporting, the patient had not recovered from the event of a lump and pain on her left deltoid where she received the vaccination.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
muscle "spasm" L arm injection site, then gassiness / indigestion.  Symptoms dissipated with fresh air, emotional support, sips of water.  Left parking lot after 15 mins additional wait time.
severe h/a, watery diarrhea, anorexia & 12lb weight loss began 4hr p/vax & cont until treated w/lomotil & motrin 11 days later;
Patient had high fever of 102.6 axillary a few hours after vaccines. He also developed cough and congestion.
Numbness in my hands and peripheral neuropathy -- extreme sensitivity to clothing and fabrics, particularly cotton ones.  Also: mind fog, but that lasted about three days whereas this lasted two weeks.
SHE GOT THE FLU VACCINE, ALSO NOT THE DOSE FOR 65 YEARS AND OLDER AT 2 PM ON 7/28/2022 AT CENTER. SHE MEANT TO GET COVID VACCINE BIVALENT , BUT I ACCIDENTALLY GAVE HER THE FLUCELVAX INSTEAD,  UPON RECOGNITION , I THEN GAVE HER THE CORRECT BIVALENT COVID VACCINE ON THE LEFT ARM, AND TOLD HER WHAT HAS HAPPENED, THAT WHAT I JUST GAVE HER ON HER RIGHT ARM WAS THE FLUCELVAX VACCINE
on Sunday 6-13-2021 10:45am Had a stroke and blood cot in head. Was take to emergency and is still currently there.
I got a rash all over my chest and neck within a few hours of the vaccine.  The rash went away about 24 hours later.  I also got a rash around the band-aid I had from the vaccine. I know that a sore arm is normal for shots and vaccines, but my arm was sore unlike any time before.  It was awful!
Event reported to me through nurse.  Pt reported to MD's office on 3/07/11 stating sore arm still ~ 2.5 mos after vaccine.  The pt remembers it given high on the arm, over the deltoid area.  MD recommends NSAIDs, wrapping the arm, & warm compress.  He states pain should be self-limited.  I (immunizer) do not believe that the location where the patient states she received the vaccine is accurate. I have a precedure that I follow: Explain to pt Zostavax is sub-q, that it is given in fat in back of arm, (continued in relevant diag test box)
After 24 hr. patient had itching all over body - from scalp to feet- very mild rash after 1 week on chest - was not disabling - patient was still able to function normally - just had to scratch all the time.
Patient complained of not feeling well after being administered with pfizer vaccine, she said she was cold, a little shaky, & nauseous. Checked her BP it was very low, elevated her feet, checked her BP several times after that and BP went up to 120/78. Called 911 because she was still not feeling well. EMS checked glucose level and it was low (patient did not have a meal all day). EMS said it was vasovagal syncope however patient did not pass out. Patient recovered while EMS was still on site.
A report has been received from a health professional concerning a female patient in her forties. Relevant history and concomitant medication were not provided. The patient received FLUMIST QUADRIVALENT (Intranasal). Later in the year, she contracted influenza B. The outcome of the event of influenza B was unknown. The event of influenza B was assessed as non-serious by the reporter.
product complaint; injection site pain; Vaccination site swelling; trouble driving; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 30th September 2021) for prophylaxis. This case was associated with a product complaint.  On an unknown date, the patient received the 1st dose of Shingrix. On 25th February 2019, less than a year after receiving Shingrix, the patient experienced injection site pain, injection site swelling and driving ability disturbed. On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the injection site pain, injection site swelling, driving ability disturbed and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling and driving ability disturbed to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the right deltoid and felt injection site pain as the product was being administered and she pulled away from the pharmacist.  The site became swollen and had trouble driving home.  The patient might had gotten physical therapy to deal with the pain. She did not want to get the 2nd dose. The reporter consented to follow up. The eight other patients pulled back when the vaccine was administering from the same box. The pharmacist did not administer the 10th dose and it was available for return to GlaxoSmithKline for analysis.
numbness on the side of the face and on top of the head; fever; felt like he was catching cold; sore arm; He felt like he was having a stroke; still not feeling right; This is spontaneous report from contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12May2021 16:38 (Lot Number: EW0182, at the age of 72-year-old) as single dose for covid-19 immunization. Medical history included diabetes, heart bypass from 1989. Concomitant medications included glimepiride taken for diabetes from 2020; acetylsalicylic acid (ASPIRIN 81) taken for heart bypass from 1989; metoprolol; metoprolol succinate (TOPROL XL) from 1989. Patient got the 1st dose of the vaccine on 12May2021 at 16:38 and got the reaction of a sore arm and knew that he would have that and then the next day on 13May2021 got a fever and the feeling of catching a cold or something. Stated he also had numbness of his face on 14May2021 and thought what was this and he did not have that before and the numbness feels like it was on the side of his face and the top of his head. He felt like he was having a stroke. The numbness was gone. He was still not feeling right. The sore arm began overnight and was a little better and the fever and feeling like he had a cold began the morning of 13May2021 and was now gone; stated the numbness began this morning of 14May2021 it seemed like and he woke up with it and did not notice it until this morning and it was ongoing and better but he did not know it just affected him and he did not know what was going on and it scared him. Patient had not required treatment or a visit to his healthcare professional (HCP) or the emergency room (ER) for the reported events. There was no prior vaccinations (within 4 weeks). The outcome of the events stroke and "still not feeling right" was unknown, for event "numbness on the side of the face and on top of the head" was recovering, for events "sore arm", fever and "felt like he was catching cold" was recovered on May2021.
Fever of up to 102 for five days, rashes, spots, lethargy, inconsolable crying
This spontaneous report as received from a health professional refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on an unspecified date, unspecified patients received doses of improperly stored PEDVAXHIB injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-NOV-2016, the patient was inadvertently vaccinated with the doses of PROQUAD (dose, route of administration, lot # and expiration date were not reported) and VARIVAX (subcutaneously; dose, lot # and expiration date were not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Information has been received from a health professional concerning a 6 year old male pt who on 4/29/02 was vaccinated with a dose of hep A virus vaccine inactivated. On 5/2/02 the pt presented with a mild rash on his face and an injection site rash. Unspecified medical attention was sought. Additional info  has been requested.
Headache, Myalgia, Angioedema, Diarrhea & Tachycardia
swollen; pain in arm at backside of arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), PAIN IN EXTREMITY (pain in arm at backside of arm) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 027A21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced SWELLING (swollen), PAIN IN EXTREMITY (pain in arm at backside of arm) and HEADACHE (headache). At the time of the report, SWELLING (swollen), PAIN IN EXTREMITY (pain in arm at backside of arm) and HEADACHE (headache) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR
Night of 2nd vaccine woke up with a high fever, and severe headache. Fever lasted 36 hours and peaked at 104.8 (with Tylenol).  Fever was over 103 degrees for majority of 24 hour period. Fever went away after 36 hours.  However, headaches have continued constantly (17 days and counting).    Went to the Dr. on 2/19/21.  They wanted an CT Scan of head and sinuses.  Dr. Prescribed cefuroxime 250 MG tablet in case of sinus infection and ibuprofen 800 MG tablets.  Insurance did not approve a STAT CT Scan, so Dr. told me to go to the ER if headache persisted.  Went to the ER on  2/23/21.  Dr's indicated Blood pressure was very high (180/120).  I do not have a history of high blood pressure.  They did a CT scan (normal) EKG (normal), and blood work.  They inserted an IV with migraine cocktail to alleviate headache.  Unfortunately no change.  While in the ER they gave me:  - Sodium Chloride - Tylenol - Metoclopramide (injection) - DiphenhydrAMINE (Benedryl) (injection) - Dexamethsone  - Ketorolac (Toradol)  They prescribed methylprednisolone (steroid).  Went back to primary doctor on 2/25.  Blood pressure remains high (average 158/112 throughout the day), headaches continue (constant).  They did more blood work, urine sample, and another EKG.   They also ordered a STRESS ECHOCARDIOGRAM.  The prescribed lisinopril 10 MG tablet for blood pressure.
Information has been received from a nurse practitioner concerning a 22 year old female with allergy to metals who on 30-JUL-2007 was vaccinated IM with a dose of Gardasil (lot # 657737/0522U).  Concomitant therapy included ZOLOFT and hormonal contraceptives (unspecified).  Within 12 hours of the vaccination, the patient experienced arm pain in the arm she was vaccinated in .  The nurse practitioner reported that over the next 8 days the pain was progressively worse and the arm pain and spread up to her shoulder.  She had difficulty lifting her arm and difficulty lifting her infant child.  On 07-AUG-2007 the patient was seen in the clinic.  The patient had a fever of 99 degrees, swelling and warmth around the injection site.  The patient was treated tin antimicrobial (unspecified) and ibuprofen.  On 09-AUG-2007 the patient recovered from the warmth around the injection site and all other symptoms had persisted.  Additional information has been requested.
Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
Patient tolerated vaccine well, but returned about 20 minutes after the vaccination stating he experienced some dizziness, felt shaky and anxious. He stated he didn't know if he was having an anxiety attack. He denied any other symptoms such as swelling, rash, difficulty breathing or swallowing. Called him 2 hours later. He stated he felt better and was home resting. Denied any new symptoms. Provided instructions for Benadryl and ER warnings if he experienced any allergic reaction/symptoms.
Noticed reddness, swelling and heat, slightly hard to touch at injection site while getting ready for work.  injection site appeared to be a sub Q injection not an IM injection.   came to see Health clinic on the 17th for an I/I and documentation.