chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had a vaso/vagal reaction with a 10 second loss of consciousness.  Placed the patient on his back.  He regained consciousness, I had the patient drink some orange juice after he was feelinig better.
Narrative:  Covid infection following COVID vaccine series 01/28, Pfizer, dose #1 02/19, Pfizer, dose #2 09/12 pt cc: chills, cough, fatigue, fever, nausea, exposure: unknown 09/13 COVID swab, result: detected 09/13 SARS-COV-2 Variant Sequencing result: pending 09/23 clinically resolved
Noon-ish 01/15/2021 (4 days post shot), severe arthralgia, worse than her worst ever from Rheumatoid arthritis, continues approx  24 hours later. Nearly incapacitated. Needs help to get up off couch to go to bathroom for example  Evening of 01/15/2021, off and on chills, severe shaking Night 01/15/2021, fever up to 39.4 (103). Stayed above 101 for hours. Normal temp runs about 97.3.  Fever running 37.3 on 01/16/2021 thru current (10:54a.m.)  01/16/2021, Arthralgia still present. Almost totally incapacitated.
red raised bumps on her chest and arms / bumps with blood in them\ rash; red raised bumps on her chest and arms / bumps with blood in them; Can leave scars; This case was reported by a consumer via call center representative and described the occurrence of papular rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced papular rash, blood blister and scar. On an unknown date, the outcome of the papular rash and blood blister were not recovered/not resolved and the outcome of the scar was unknown.   It was unknown if the reporter considered the papular rash, blood blister and scar to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix shots in February and April 2019. Since then occasionally develop small red bumps with blood and could leave scars. The patient began having red raised bumps on her chest and arms. They did not itch. The adverse event was not resolved. The physician did not know anything about, what was causing this? was immunity compromised? Did need to see a specialist who can determine what it was? Also, was Shingrix one a lifetime coverage, or was a new shot required every year? The reporter did not want to provide health care professional information.  The reporter did not consent to follow up.
12/28 8am- Pfizer vaccine (lot#EL0140) received in L arm at Hospital 12:45pm- out on a walk. Lightheaded, fatigue, chills, mild nausea, stomach cramping, and muscle weakness all hit pretty hard at once. Notice slight arm soreness as well. Went back inside and essentially collapsed on the couch 5:30pm- Arm soreness is worse. Chills and lightheadedness only mild now. Fatigue has gone down to where I can resume daily activity  12/29 Wake up with moderate sore throat Stabbing arm soreness at injection site Moderate fatigue  and nausea persist. Mild chills. Tried to go for a walk outside and found a 30 minute very slow walk extremely tough  12/30-1/2 Moderate sore throat continues. Other symptoms gone 1/1-2 Arm/ injection site soreness slowly fades  1/2: exercise for the day= 70 min yoga and 7.5 miles of walking. Had a couple glasses of wine at dinner (possibly relevant if issues with vaccine are related to high histamine food issues)  1/3  Moderate headache, fatigue, and muscle aches. Skin feels hot. Sore throat worse than the previous days. Mild runny nose. Severe nausea. Go to Urgent care for COVID test and Zofran Rx. COVID rapid test and PCR test both negative. No fever, higher than usual blood pressure  1/4-5 (current) Nausea lower but still moderate, requiring Zofran. Sore throat persists. Mild fatigue and muscle aches. Skin still feels warm. Mild vertigo during exercise
Child requires several catch up doses of vaccines by Recommendations.  Trying to spare the child even more shots I administered a dose of Pediarix.  While doing  inventory 11/21/23 it was discovered the Pediarix Vaccine actually expired on 11/17/23.
RTC at most reactive area 33 cm. LTC at most reactive area 29 cm. 11 X 3 cm
Pt developed redness & soreness at inject site condition resolved. 2nd dose pt c/o itchy & widespread redness down lt arm. Condition resolved
This initial spontaneous case, was received on 16-Nov-2017 from Other Non-Health Professional, concerns a 43-year-old adult female patient. On an unspecified date, the patient was administered with FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On unspecified date, (reported as) several days after vaccination, the patient had fever and body aches. It was reported that, the patient could not move head or neck and she was too weak to stand in shower. On unspecified date, the patient got resolved from events. The reporter assessed this case as non-serious.
The patient had a localized area of paresthesia at shot location site, with surrendering area of hypersensitivity since late 08/00.
Information has been received from a pharmacist, for ZOSTAVAX, a Pregnancy Registry product, concerning herself a 45 years old 16 weeks pregnant female patient with no medical history and concurrent conditions. The patient's history of previous pregnancies and live births is not known. On 06-JUL-2012 the pharmacist was preparing a ZOSTAVAX injection (lot# 672606/1655AA, expired date 21-JAN-2013) for an anonymous consumer. The reconstituted ZOSTAVAX was in the syringe and ready to give to the consumer. The needle was not tight onto the syringe and fell off. The ZOSTAVAX splashed into the 16 wks pregnant pharmacist's face, eyes and mouth. The pharmacist's mouth had become numb and had not recovered. The ZOSTAVAX did not get on the consumer. The consumer did not receive any of the ZOSTAVAX dose either. No other co-suspects were reported. Concomitant medications included: vitamins (unspecified) (vitamins (unspecified)). The patient became pregnant with an LMP of approximately 16-MAR-2012 and an EDD of approximately 21-DEC-2012. Initial exposure to ZOSTAVAX was at 16 week (s). The patient was exposed to ZOSTAVAX during trimester 2. No treatment information was reported. Additional information has been requested.
Patient had received a flu shot about 2:30 pm. Had returned to the flu clinic at 4:00 to get child vaccinated. Patient began to feel lightheaded and complained of not feeling well when she was getting ready to leave with child. BP stable, HR 96. Client pale in color. A few hives noted on right side of neck. No nausea/vomiting. Gave juice to drink and 2 Benadryl (50 mg).
lethargic, weak, then cognition issues,  memory loss (later hallucinations began)  went to the hospital a few days later when this didn't seem to get better
In late February, I noticed I was feeling heavy in my chest. I began coughing and coughed really hard. It was not a dry cough, and it did cough up a bit of mucus that was green in color. It created floaters that were like spider webs in my eyes and light flashes behind my eyes. I went to the emergency department on February 26, 2023. They gave me some pills that were cough suppressant pearls, benzonatate (TESSALON PERLES). They made an appointment with my eye doctor regarding the issues with my eyes. I visited with the eye doctor on March 30, 2023. There was not a true diagnosis. I am no longer having the flashes of lights and the floaters are much less frequent.
Varicella vax given on 12/8/99. On same day, pt dvlped T104; became listless, pasty, & unresponsive. Pt was taken to ER were his temp was 103; given Tylenol syrup & sent home.
itchy arms, back, head, chest and legs and light headed  Sat for 1 hour, itching and dizziness resolved
Weakness, chills, headache, fatigue, injection site pain for about 12-16 hours the day after receiving the vaccine
Information has been received from a registered nurse concerning an 8 year old female who was vaccinated on 08/23/2002 with a dose of varicella virus vaccine live (Oka/Merck).  On 07/02/2003, the patient developed "breakthrough" with lesions on her groin and trunk.  The child was noted to have chickenpox breakthrough.  Unspecified medical attention was sought.  There was no product quality complaint.  The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed chickenpox breakthrough/shingles.
moderate to severe headache, fever, nausea, severe pain in left arm around injection site, body aches, chills
I was vaccinated in March and April of 2021 and was positive covid in Dec21 for 4 or 5 days. I had a cough,chills and sore throat
Sometime around March 11th (11 days after shot)my left arm became sore and very itchy around the injection site.  When scratching the itch, I noticed that an area about the diameter of a tennis ball was also swollen surrounding the injection site.   Today ( March 15) the area is still itchy, and now a red rash about the diameter of a softball has spread out from the injection site.  There is also now a small scab where the injection was given, probably from scratching too much.
Patient stated that the evening of her vaccination, the upper arm under the injection point started to swell, causing a lump the size of an orange. the swelling continued down her arm towards her elbow. The arm was red and warm to the touch. She called her primary care provider and was directed to go to an urgent care. Patient started to take Allegra in the morning, Benadryl at night, and Advil as needed along with icing the arm.  The patient came back to the pharmacy on 9/7/21 to inform of interaction. Stated that the swelling seems to be going down.
Patient reported arm pain since vaccination. She reported feeling "the whole needle go in and it felt wrong immediately, and it's been sore deep in the muscle (not the injection site) ever since." Reported no difficulty with previous vaccines, has not tried anything to treat pain.
Patient not the appropriate age for this vaccine at the time of administration. We do not know at this time if any adverse events are associated with this error.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 20-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date of refrigeration of vaccine was reported as 07-May-2021.   This case was linked to MOD-2021-363750 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 at 10:00 as dose 7 (booster), single (Lot number: 028k21a) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "kidney disease" (unspecified if ongoing); "sleep apnia" (unspecified if ongoing); "bladder and prostate" (unspecified if ongoing); "bladder and prostate" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 10Jul2022; ATORVASTATIN, start date: 03Jul2022; LOSARTAN, start date: 13Sep2022; METOPROLOL, start date: 20Jul2022; AMLODIPINE, start date: 01Sep2022; TAMSULIN, start date: 05Jul2022; VITAMIN C & COLLAGEN, start date: 03Jul2022; ASPIRIN (E.C.), start date: 04Jul2022; OMEGA 3 [FISH OIL], start date: 12Jun2022; CENTRUM SILVER +50, start date: 03Jan2021; ZINC, start date: 14Aug2022; SUPER B COMPL, start date: 05Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: product=COVID 19 Treatment, Brand=Pfizer, from 29Sep2022 to 02Oct2022, lot number=Ndc0069108506, Indication=Treatment of COVID-19.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 05Jan2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 treatment brand was PAXLOVID,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
flu from the shot; sick; chills; Very high fever; body aches; could hardly stand; could hardly stand to walk back in drs office; congestion; runny nose; cough; couldn't breathe; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294144, 2020SA294145, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294173, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294125, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves an unknown demographic patient who had flu from the shot (influenza) characterized by sick (illness), chills, very high fever (pyrexia), body aches (pain), could hardly stand (dysstasia) to walk to doctor's office (gait disturbance), congestiion (nasal congestion), runny nose, cough and could not breathe (dyspnoea), while the patient received INFLUENZA VACCINE.  Medical history and family history were unknown.   The patient had received flu vaccine (reported 9 to 10 years ago).  Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient had flu from the shot (influenza) which was characterized by sick (illness), chills, very high fever (pyrexia), body aches (pain), could hardly stand (dysstasia) to walk to doctor's office (gait disturbance), congestiion (nasal congestion), runny nose, cough and could not breathe (dyspnoea), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
I had arm pain. Then four days later, I wake up with leg pain. I also could not generally function correctly. I had headaches. These lasted for about 4 days.
Rash all over body and itching 24 hrs after. Tingling of both hands 72 hrs after.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # N00233 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT).  On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD.
It's been 6 days my left hurt still hurts and is hard where the shot was given.
About 2 weeks after my second shot I noticed that my arm was hurting real bad in the muscle that the shot was given in and it ran all the way down my side. When would rub it, it would start to feel better. I checked my arm with a thermometer and it was colder than my other chest. As long as I had heat on it, it would feel better. I also had a weird feeling in the back of my throat. It felt like something was squeezing my throat. I'm still dealing with this at this time.
12/22/2021 VACCINE @ 0630 12/22/2021 12:00 RED, SWOLLEN ARM.  ROUND, 4 CM CIRCUMFERENTIAL. FIRM EDEMA. PERSISTED THROUGHOUT WEEK. LOOKED LIKE 'SECOND DELTOID'  1/4/2021 STILL MILD REDNESS, ITCHINESS. VERY MILD SWELLING.  CONFERRED WITH DR. VIA EMAIL. 'KEEP EYE ON IT'.  IMPROVING BUT STILL VISIBLE.
I received the vaccine on 2/23 and was fine until 2/26.  I developed chills, body aches, fever and it lasted for about 24 hours.  Now on 3/3 I am having issues with arm at injection site.  My arm is swollen, red, itching  and fingers are little tingly.
Headache, right sided arm and leg numbness, pain in both calves, pain in arm pit which is worse on right side, some center chest pain and extreme tiredness.  I have been to ER 3 times as well has PCP once and have follow up with a Neuro.
70 Y/O female, visiting her daughter here states was SOB from 12/20 and developed fever, chills, panic attacks, nausea, vomiting and diarrhea. Home Covid test was +. Symptoms improved for a few days and then started getting worse. She came to ER last night due to severe SOB and felt panicky. She was tested + by PCR and was in severe hypoxic resp failure. CXR showed Multifocal Lung infiltrates due to COVID Viral Pneumonia. She also has Hx of chronic colitis. PMHX 1) T2D 2)Chronic Colitis PSHX 1) cholecystectomy 2) BIL THA Soc Hx Divorced, Smokes 3-4 cig/daily ETOH social . Received 1 dose of J&J vaccine end of November. 12/30/2021 tested positive
Patient complained of being unable to breathe and began vomiting 15 minutes after receiving her COVID vaccine. Vital signs were normal.  911 was called and patient was taken to ER by ambulance.
Case number PHEH2014US003873 is an initial spontaneous report received from a pharmacist on 21 Feb 2014: This report refers to a 13-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly on 14 Oct 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 21 Feb 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
pt rcvd vax; 1cm erythema wheal @ inject site; 6 days later pt had 6cm erythema lesion after inject site @ ctr; tx pt was already on tavist;
The child received 1st Hep-A and Hep-B shots and felt faint and then had blood drawn. After blood was drawn the pt fainted and had a seizure. The seizure lasted 5-10 seconds and pt woke up disoriented. The child was sent to ER for further evaluation.
This spontaneous report as received from a nurse refers to a 13 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 01-MAY-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. 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 is not expected, no contact details were provided.
Awakened morning after injection with swelling, induration, redness, pain, tenderness, and increased warmth in 6cm x 7cm area right deltoid. Wa seen in office 9/23/08 and diagnosed with an Arthus reaction t otetanus toxoid.
Rash-looking area with redness, warmness, and inflammation at subcutaneous injection site.
Severe Nausea Vomiting  2 hrs after. Forceful vomiting from car door no time to get anywhere. Chills Vulvar pressure- this is strange and I almost don?t mention it except for it came on  suddenly same time as vomiting and was severe !  Site soreness up thru neck Cold sweats Loss of apetite Tired Immediately 3-4 hrs after severe fatigue and drowsiness  Slowed pulse Foggy brained Hot skin Red skin allover
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. On 27-OCT-2015 the patient was vaccinated with dose of improperly stored PNEUMOVAX23 (lot # K010465 with expiration date: 23-MAR-2016, 0.5 ml, intramuscularly). No adverse effects reported. Additional information has been requested.
Information has been received from a consumer concerning a his father, a 72 year old male patient who "one month ago" (approximately 28-JUL-2009), was vaccinated with one dose of ZOSTAVAX (Merck) (dose, route and lot number not provided). The consumer reported that "2 weeks ago" (on approximately on 14-AUG-2009), his father was believed to have meningitis and the patient was suffering from paralysis in his upper and lower body. Spinal fluid analysis and blood cultures were performed (date and results not reported). The patient was hospitalized on an unspecified date. At the time of the report the patient was not recovered. Meningitis and paralysis in his upper and lower body were considered to be disabling and immediately life-threatening. No further information is expected.
October 15, 2018 patient received SHINGRIX vaccination-upper left arm. That afternoon, pt began experiencing pain/swelling from site of injection to fingertips. Slept in recliner Monday night due to pain. Red streaks appeared in arm from inj. site. Patient came to pharmacy on October 17, streaks has disappeared but still had round red swelling at inj. site and said it was still itching. Pt had been taking Diphenhydramine and using BIOFREEZE on arm for relief. (Was improving on 10/17/19 planning to visit doctor).