chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported; PROQUAD was inadvertently administered to an 18 year old patient; This spontaneous report was received from a certified medical assistant and refers to an 18-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 13-AUG-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, lot # U002538, expiration date: 24-JUL-2022, 1 dose (injection site and route of administration were not provided) for prophylaxis (Product administered to patient of inappropriate age). The reporter stated that the patient was due for measles, mumps and rubella (reported as MMR) and varicella so she thought it would be easier to give one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) not thinking about the labeled age range. No additional adverse events were reported.
So called ?covid arm?, swelling and hardness at injection site. It began about an hour after I received the injection, and has only grown in size and pain since then. I have not sought treatment as of now.
Nausea, feeling faint, onset of migraine symptoms  Vitals: 1013: 109/60, P: 71, RR: 22 1018: 111/64, P: 64, RR: 20 1028: 106/66, P: 68, RR: 22 1039: 110/71, P: 71, RR: 18
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-SEP-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose and frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 3 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and type of excursion (R/F) for each time were 200, 32, 0 and R; 24, 33,  0.555555556 and R; 132, 34, 1.111111111 and R. This is one of several reports received from the same source. Additional information has been requested.
Site: Itching at Injection Site-Medium, Additional Details: PATIENT HAD UPPER SKIN REACTION (REDNESS OF BOTH ARMS BUT LEFT ARM WAS MORE, ITCHIING AND LATER USED THE RESTROOM. SHE REPORTED OK IN UNDER 30 MINUTES AND LEFT THE FACILITY. i CALLED AFTER WORKING HOURS AT 8 P.M TO FOLLOW UP AND NO ONE PICKED UP THE PHONE, I LEFT A MESSAGE
swollen shoulder/ left arm swollen; Arm was tender with red patch; Arm was tender; nauseous; dizzy; Left sholder became swollen and she can't lift it; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen shoulder/ left arm swollen), NAUSEA (nauseous), DIZZINESS (dizzy), INJECTED LIMB MOBILITY DECREASED (Left sholder became swollen and she can't lift it) and ERYTHEMA (Arm was tender with red patch) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 02-Feb-2021, the patient experienced NAUSEA (nauseous), DIZZINESS (dizzy) and INJECTED LIMB MOBILITY DECREASED (Left sholder became swollen and she can't lift it). On 04-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen shoulder/ left arm swollen), ERYTHEMA (Arm was tender with red patch) and TENDERNESS (Arm was tender). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Swollen arm, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen shoulder/ left arm swollen) was resolving, NAUSEA (nauseous), INJECTED LIMB MOBILITY DECREASED (Left sholder became swollen and she can't lift it), ERYTHEMA (Arm was tender with red patch) and TENDERNESS (Arm was tender) outcome was unknown and DIZZINESS (dizzy) had resolved.            No concomitant medication was taken.   This case was linked to US-MODERNATX, INC.-MOD-2021-016520 (E2B Linked Report). This case was linked to MOD-2021-016520 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20-APR-2021. The patient age changes to 84. In initial report date for second dose was mentioned as 02-Feb-2021 and in follow-up it is mentioned as 04-Feb-2021. The patient took Advil as treatment medication. The patient reported that after taking Advil for her swollen arm, it worked. The patient also reported a new event that her arm was tender.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016520:Same patient, 2nd dose
36 hours after flu shot started with HA, stiff neck, tired and achy. Next day trouble swallowing. On 9/20 noticed mouth drooping, went to ER and dx wtih Bell's Palsy. Left eye twitches and dry because she can't shut eye, mouth drools left side. CT ruled out stroke. Given Deltasone 20mg x3/day for 7 days and valacylovir 1gm x 3/day fir 7 days. Told to follow up with PCP.
Reports 102 degree temp, abd pain, N/D, arm swollen size of softball from shoulder to elbow with redness, body aches, itching at injection site; reports taking BENADRYL, applying ice, rest; improved after 24 hours.
Redness/swelling/tenderness/warmth/itching at site and extending around circumference of arm and to axillary region--continuing to spread at 48 hrs post injection.
About 45 minutes after the shot, I felt a very hot face and neck with millions of needles.  It was like a niacin flush without the red skin.  My throat tightened down slightly.  It eased back and then about 1 1/4 hour to 1 1/2 hour it happened again.  It went from my face, through my neck, both arms and midway down my chest.  It was stronger.  My throat again tightened down.  Both times the sensation lasted for about 15 minutes.  The throat tightening was less than I have experienced with hives attacks.
States on "the following evening started having shaking all over & all of her limbs were shaking" - saw Dr. on Sat. & was told it was a reaction to the vaccines but did not required treatment because it was a nervous response - recommended not to continue series of GARDASIL.
This spontaneous report was received from a medical assistant referring to a patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 21-SEP-2017, an improperly stored dose of RECOMBIVAX HB 2 ml, once, lot number N009802, expiration date 19-DEC-2019 (route of administration and anatomical location were not reported) was administered to the patient. The dose was stored in temperature 33.8 degrees Fahrenheit for 20 minutes and in temperature 35.8 degrees Fahrenheit for 2 minutes. No previous temperature excursions were reported. No adverse effects have been reported. Data logger was involved. Product quality complaint was not involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA011805: US-009507513-1709USA012898: US-009507513-1709USA012896: US-009507513-1709USA012897.
Day after immunizations, at site of injections have red, subsequently warm area. left thigh measures 5cm by 5cm. Prescribed Augmentin
Developed urticaria approximately 24 hours after receiving vaccines PCV-13, Hep A and Flu.
A few minutes after vaccination, patient lost consciousness. She was gently lowered to floor, patient did not hit head or get injured. Skin was pale. Patient had not eaten or had anything to drink that day.  9:45 am BP= 86/50, P= 68, R=16, Patient was unconscious for approx 45 seconds then started to come around and open eyes. 9:48 am eyes open and more alert. Skin color improved. Alert and oriented x3, She knew her name, place, parents names etc. Transported to nurses office via wheelchair. Was given juice and crackers and instructed to lie down, 10:00 am BP= 94/68, P= 68, R=16. Patient continued to rest sitting up and was feeling better.
In the last 3 days, I feel body weakness or fatigue especially on both upper and lower extremities (muscle tightness or spasm), episodes of labored or difficulty of breathing or tightness of the chest. I have become anxious about this condition.  FYI, I also received Flu vaccine (FLUZONE QUAD PF 2021-2022 INJ 0.5ML) along with the COVID-19 booster
patients received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y to 11Y) instead of Bivalent booster vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y to 11Y) instead of Bivalent booster vial) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patients received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y to 11Y) instead of Bivalent booster vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y to 11Y) instead of Bivalent booster vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients received Booster dose of Moderna COVID-19 vaccine from a Pediatric vial (6Y to 11Y) instead of Bivalent booster vial).    This case pertains to the adult patient number 3.  No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow up received. IRD of initial version updated to 17-OCT-2022. On 17-Oct-2022: Live follow up received. No new information.
Information has been received from a MA concerning a 46 year old female with NKDA who on 7/19/01, was vaccinated with pneumococcal vaccine 23 polyvalent (lot 0945X) into the left deltoid. Concomitant therapy included ibuprofen (Motrin) and acetaminophen (-) and codeine phosphate (Tylenol with codeine #3). The MA indicated that there was no immediate site reaction noted The MA reported that on 7/21/01, the day after the vaccination, she started with fever, chills, swelling and erythema. the symptoms progressed until 07/22/2001 when she went  to her local ER complaining of a sore left arm with redness that was warm to the touch. she was treated for possible cellulitis while in the Er, the patient was given intravenous(IV) cephalexin (Keflex) and released on oral cephalexin (Keflex) At a follow-up visit, the pt had recovered from the possible cellulitis. The MA indicated that the treating ER physician felt the pt's event was related to the pneumococcal vaccine 23 polyvalent vaccine. It was noted that the vaccine multidose vial was tested and it "cultured no growth. Upon internal review, possible cellulitis was determined to be an "Other Important Medical Event". Additional information has been requested.
Itching, rash, and redness at injection site on 3/7/21 around 7pm before I noticed it.  Applied Benadryl cream to site on 3/8/21 around 9am.
Extremely sore, red, arm and fever that started afternoon of vaccination. Pain also felt in armpit and left breast. Patient still feels very sore in left arm 5 days after immunization.
sore swollen arm, neck, headache, chills & fever (one & two degrees), whole body muscle aches
Itching on the left foot; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching on the left foot/pruritus.  The patient's medical history was not provided. Concomitant medications reported were Multivitamin, Vitamin B12, Vitamin D, paracetamol, fish oil for drug use for unknown indication.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 022m20A) via unknown route for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced the event itching on the left foot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, itching on the left foot was unknown.
This case was reported by a consumer via call center representative and described the occurrence of chills in a adult female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced chills, fever and injection site pain. On an unknown date, the outcome of the chills and fever were recovered/resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the chills, fever and injection site pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. She also noted a history of fever, chills and soreness at the injection site with flu vaccine from unknown manufacturer. She noted her last flu vaccine was a couple of years ago when they combined with the swine flu. That was the worst of her reactions and she had not gotten one since. This case has been linked with US2018107202, reported for the same patient.
I had the first vaccine on January 21, 2021. I developed a rash on February 16, 2021 that started with just a few bumps under my armpits and gradually went down both sides of my torso to my groin.  It appeared to get much worse after the second vaccine injection.  They are tiny red bumps.
Patient  was administered vaccine on left thigh on Monday, November 21st. The condition of the patient at the time was normal, did not have any illnesses nor medical conditions (i.e. no cough, fever, no rashes, nor any ailments). The following day (November 22nd), in the morning when the patient woke up, while I (parent) was changing him, I noticed the injection site to be enlarged, swollen, and red (roughly around 3 inches in diameter). That evening, patient felt warm. The following morning (November 23rd), the injection site was even larger, more red, and swollen (roughy around 4 inches in diameter) and was accompanied by a fever of 102.4. Fever was reduced to 100.2 using Motrin and Tylenol throughout the day and night. Patient vomited violently at 11:20 pm.  Fever and vomiting continued until Friday morning, Friday November 25th (fever ranging from 100.3-103.2 F). Patient was taken to urgent care on Friday and was checked for covid 19, RSV, and the flu all which rendered negative, no sign of ear infection, and lungs as well as oxygen levels were normal. Patient continued with a fever all day Friday and Saturday afternoon (November 25-26). Fever subsided by Saturday night and was gone Sunday (November 27th), but patient has now developed a rash behind his ears and on his face.
Breakthrough case admission after 2 vaccines 2/2/21 Moderna Lot# 012L20A;  Moderna 10/25/21 Lot# 041C21A
This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient got sick and went to the hospital on an unspecified date with outcome of unknown. Patient's mother thought it was the vaccine.
After my fourth dose, I did a training run and had a sore throat when I finished. I assumed it was just due to the colder weather at the time but I woke up with a sore throat still the next morning so I went ahead and took a COVID-19 test which was positive. My symptoms have been flu like. Fever, cough, headache, sore throat, weakness, and fatigue. In general though, it has been a mild case of COVID-19. I have been in contact with my PCP and Gastroenterologist who agree that it has been a mild case overall so far.
8 CM BY 11 CAM ERYTHEMATOUS AREA WITH CENTRAL 2 CM DARKER RED AREA (MORE RAISED)  NOT TENDER TO THE TOUCH
Very fussy then had several episodes of emesis that evening. By afternoon of next day was doing better. Treated with frequent small feeds of Pedialyte until was able to hold things down.
This is a spontaneous report from a contactable healthcare professional, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 07Apr2021 at 09:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included fexofenadine hydrochloride (manufacturer-ALLEGRA), mometasone furoate (manufacturer-NASONEX) and ketotifen fumarate (manufacturer- ZADITOR eye drops) all from unknown dates for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EL3247) via an unspecified route of administration in the left arm on 17Mar2021 at 09:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 the patient experienced achy back (woke up in the morning with achy back). Therapeutic measures were not taken as a result of the adverse events. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event achy back (woke up in the morning with achy back) was resolving.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician, via company representative refers to a currently 26 years old female. The patient's medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, lot# and expiry date were not reported), intramuscularly. The physician were reporting that the second shot of GARDASIL 9 was given "not even a month" after the first shot was given. Additional information has been requested.
On the date of admission the patient experienced a fall and he states that he was too weak to stand. He managed to get himself to his bed and remained in bed until family sent ems to check on him since he did not make an agreed upon diner. Ems found him in bed. He was transported to  ED. In ed he was found to be covid + with what could be atelectasis vs pneumonia infiltrate. .
CHILLS; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache, chills and muscle aches was not reported. This report was non-serious.
Developed redness around injection sites day after getting injections, but not sure that he had it around this more medial L leg sites. In past 1-2 days, has had different rash develop without fever, pain and itch. On exam, was more dusky/pale right around injection site and then 3-4cm out had pink, urticarial not completely circumgemnal ring around it.
15 month old came in for his 15 month shots. He was given an expired Dtap it expired on 6/10/23 and pt visit was 6/14/23
mistakenly administering the Pfizer COVID-19 Vaccine Orange Cap to a 7 years old male as a second dose; The administration was of 0.2 mL but of an undiluted vial; mistakenly administering the Pfizer COVID-19 Vaccine Orange Cap to a 7 years old male as a second dose; Mild fever 99 degree F; headaches; Pain at pt of injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 7-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 03Mar2022 13:00 (Lot number: FL0007) as dose 2, 0.2 ml, (tris) single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prior Vaccinations: (Within 4 weeks), Manufacturer: Pfizer, Batch/ Lot#: FL0007, Route: In, Anatomical site of injection: LD, No. of previous doses: 0, Date: 03Feb2022), administration date: 03Feb2022, for covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid 19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "mistakenly administering the Pfizer COVID-19 Vaccine Orange Cap to a 7 years old male as a second dose"; PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown", described as "The administration was of 0.2 mL but of an undiluted vial"; INJECTION SITE PAIN (non-serious) with onset 03Mar2022 21:00, outcome "recovered" (04Mar2022), described as "Pain at pt of injection"; PYREXIA (non-serious) with onset 04Mar2022 13:00, outcome "recovered" (05Mar2022), described as "Mild fever 99 degree F"; HEADACHE (non-serious) with onset 04Mar2022 13:00, outcome "recovered" (05Mar2022), described as "headaches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site pain, pyrexia, headache.  Additional information: Received call from nurse practitioner regarding the Pfizer Pediatric 5-11 COVID 19 vaccine. A nurse injected 0.2ml of the vaccine without diluent to a 07-year-old patient. Nurse would like to know what next steps are needed for patient. No further details provided.  Follow-up (18Mar2022): This is a spontaneous follow-up report from a contactable Nurse. This Nurse reported for a patient in response to HCP letter sent that included:  Updated information included: Reporter information, Patient name, Dosage regimen slider #1, recoded, Anatomical Location, Vaccine Facility Information, Historical Vaccine, Concomitant Therapy captured as None, Lab data, New AE [Injection site pain, Fever, Headache]  Follow-Up (23Mar2022): Follow-up attempts are completed. No further information is expected.