chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had syncope. VS initiated, elevated both legs, and applied cold compression. Gain consciousness within 20 seconds
Initial report from the nurse received on 16 Dec 2009: The patient (3 year old) had received with FLUVIRIN on an unknown date. No further information reported at the time of the report.
This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot # reported as N019282, expiration date 09-JAN-2019 and VARIVAX lot # N021581, expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). Administered dose of PROQUAD and VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Lot number N01982 is non valid for PROQUAD. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient. On 08-FEB-2018, the patient was vaccinated with improperly stored dose of PROQUAD lot # N019828 (previously reported as N019282) expiration date 09-JAN-2019; and VARIVAX on an unknown date. This is one of six reports received from the same reporter. Albumin status for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, for lot # N019828 has been verified as recombinant human albumin (rHA).; Sender's Comments: US-009507513-1806USA007938: US-009507513-1806USA007939: US-009507513-1801USA006139: US-009507513-1806USA007936: US-009507513-1806USA007937:
Lymph nodes right arm pit swollen and painful.; Lymph nodes right arm pit swollen and painful.; This is a spontaneous report from a non contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6201) via an unspecified route of administration in the right arm on 16Mar2021 (at the age of 63 years old) as a single dose for COVID-19 vaccination. Medical history included autoimmune disease. Concomitant medications were not provided. Prior to the vaccination, the patient was diagnosed with COVID-19. On 17Mar2021, the patient experienced swollen and painful lymph nodes in right arm pit. The clinical outcome of lymph nodes in right arm pit swollen and painful was not recovered.  No follow-up attempts are needed. No further information is expected.
lightheaded; "funny feeling" in throat; systolic BP in the 80's; given famotidine and loratadine @ 12/16 (2 hrs later); pressure and heart rate improved greatly (3.5 hrs later)
This case was reported by a physician and described the occurrence of vomiting in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subjects received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced vomiting, heme-positive stool that were dark green. The 2-month-old subject was at a WCC (well child care) visit and received ROTARIX. Approximately one week later started with vomiting (intermittent, large amount one to two times per day for a week, plus dark green (heme positive) stools for two weeks. This report was received second hand from a vaccine congress meeting, so this is possibly additional information or duplicate case. At the time of the report no other information was available. At the time of reporting the vomiting, heme-positive stool that were dark green were resolved.
Patient c/o fast heart rate since receiving flu shot.  Also c/o some dizziness.  Evaluated in ER and seen by PCP.
injection site reaction Narrative: Patient had some redness and itchiness in injection site but resolved after 1 day.
Mom reports after vaccine given the pt developed a fever of 100-101 degrees. Also developed "pox" lesions on back and was nauseous for 2 weeks.
Information has been received from a physician concerning a 6 month old male who on 20-AUG-2007 was vaccinated PO with his second dose of rotavirus vaccine live (human-bovine). Subsequently, the patient experienced "black stools". The patient was scheduled for an appointment with the physician. A stool specimen lab test for the presence of decomposed blood was also scheduled. The patient's outcome status was unknown at the time of this report. There was no product quality complaint. Additional information has been requested.
Patient received the BOOSTRIX vaccine about 4:30 pm on 9/7/17. She said she started having stomach pains shortly after and started vomiting. She went to hospital and had.
nausea; dizziness; Would the second shot now do any good?; red arm; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced erythema of extremities, nausea, dizziness and incomplete course of vaccination. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the nausea, dizziness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the erythema of extremities, nausea and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient had the first Shingrix shot and had a red arm for a week, nausea and dizziness.  The patient asked would the second shot now do any good. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Patient had a blood clot (superior mesenteric vein thrombosis in the months after his Pfizer vaccine, Hematologist attributed blood clot to vaccine)
Pt reported raised circular painful rash approx 4" in diameter around injection site, starting day of injection and continuing several days later. Also had fever and malaise evening of vaccination.
Pain / at the injection site; Redness / at the injection site; Swelling at the injection site; Muscle pain; Have been shivering; My face is bright red; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2021, the patient received the 1st dose of Shingrix. On 1st March 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, shivering and red face. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and muscle pain were unknown and the outcome of the shivering and red face were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, shivering and red face to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix in afternoon. The same day the patient developed injection site redness, pain and swelling. The patient also had muscle pain and chills. The patient's face also turned red after vaccination. The patient took two X-strength Tylenol for injection site pain. The patient did not consent to follow up.
About 12 hours after vaccination, I woke up with chills and sweating with a fever and headache. Fever was at 101. Woke up next morning with my fever maintained at 101 and a pounding throbbing headache. The injection site is also hard and red, with the bump increasing in size. I took Tylenol and slept then woke again at 6pm 2/2 with a 100.7 fever and body aches. Took more Tylenol and went to bed. This morning 2/3 I feel about 90% back to normal. The bump on my arm however is growing in size and more painful.
Client stated that he was experiencing some redness and itchiness on 11/13/2018 at FLU injection site on LUA. Client denies receiving any other vaccine or injury to arm post vaccination and prior to. Client stated that the area is "dime size"  flat and with some redness and itchiness. Denies any numbness, tingling, pain and has full ROM of hand and arm. Denies any fever or illness. Client stated that he had the FLU vaccine before in previous years with no reaction but had not received the high dose. This nurse advised client to have area evaluated by his PCP or walk in facility asap. Client stated that he was going to Clinic on 11/15/2018. I spoke with the client on 11/15/2018 and he was going to have it evaluated after our phone conversation.
headache; fever; malaise; Initial information received on 21-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves Infant and unknown gender patient who experienced headache, fever and malaise after receiving vaccine DIPHTHERIA AND TETANUS TOXOIDS (DT vax).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (dose, strength, formulation, lot number and expiry date: not reported) via intramuscular route in unknown administration site for Vaccination schedule (Immunisation).  On an unknown date, the patient developed non-serious events of headache, fever (pyrexia), malaise (unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with DIPHTHERIA AND TETANUS TOXOIDS was not applicable.  It was not reported if the patient received a corrective treatment for the events (headache, fever, malaise).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event headache, was Unknown for rest of the events.
Severe Pain to entire arm.   Described as "Nerve Pain".  States Kept he awake all night and experienced tingling to hand and arm
c/o pain, swelling, aching from lt deltoid (site of inj) up neck down finger tips;site is red swollen (about 4-5" in diameter) very tender & warm to touch;states had fever 7/27/99 PM;
Patient with history of TBI obtained Moderna mRNA covid19 vaccines on 11/18/2021 and 12/16/2021 at the same pharmacy in his hometown. On 1/1/2022 (unsure if connected) the patient presented to the Hospital Emergency Department with complains of nausea and vomiting for previous 2 days, waxing and waning in intensity. The patient reported subjective fevers. At that time he was diagnosed with acute gastroenteritis and discharged home. One week later on 1/8/2022, the patient presented again to the same Emergency Department with a friend who stated that the patient awoke at 1pm that day with inability to speak normally, cannot write things normally, cannot print letters and does not follow commands well. He was somewhat aphasic. There was some right-sided weakness noted in the right hand. The patient denied headache or falls. The patient states he had a similar episode one week prior. CT Scan of the head (see below) showed potential left middle cerebral artery thrombus. Neurology was contacted at the local tertiary referral center and Code Stroke was initiated. No thrombolytics were given per Neurology consultant request. Patient's blood pressure on presentation was 160/88; HR 83; RR 18, Afebrile and O2 sat 98% on room air. Patient was transferred to Medical Center Emergency Department that evening. The outcome from this event is unknown by this staff at this time.
During night after injection, woke up with headache and  pain everywhere. During day, pain and headache continued. Along with just feeling miserable. Low grade temp. By 6pm started vomiting and diarrhea. Violent vomiting.  4/18/21 morning feeling better. Just tired and weak.
This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient had the first dose and need the 2nd one but he/she could not had it because he/she was not able to find an appointment due to the fact they were working with Covid vaccine.
Light headedness, Anxiety, stated she needs water.  B 118/82, HR 78, O2Sat 96% 10:56am Patient left site, stating that she feels ok.
I was pregnant when I received the vaccine on3/31/21 but did not know.  On 4/2/21 I had a positive pregnancy test...I miscarried on 4/3/21.  I do not know if this was because of the vaccine or not.  I have not been to the doctor yet because today was Saturday and everything is closed.  I just wanted to make sure that it was documented.  Thankyou
Symptom:  Very sharp pain at top of stomach followed by very low heart rate and brief loss of consciousness after 1 hour Diagnosis:  Partial thombus (blood clot) of celiac axis which extended into the common hepatic artery and splenic artery Treatment:  Blood thinners Timeline:  Stabilized farily quickly and then pain subsided after 2 days Course of treatment:  Monitor for any additional symptoms through additional CT scans
Patient was under-dosed and given 0.25 mL, rather than 0.5mL .
I was positive for COVID-19 on 30JAN2023, I was tired and fatigued, I had a headache, sore throat. I was also muscle aches and fever. I saw my doctor and got paxlovid, I starting feeling better about couple of days.
ADACEL given 2/14  2/17 - arm puffy, warm to touch, redness around site and trailed down arm
Arm pain in 2 hrs, resolved after 36hrs, fever 101.4 degrees and chills started after 15 hrs and resolved after 30 hrs from injection time, lethargy resolved after 36 hrs
Patient developed severe leg pain and increased shortness of breath 2 days after the vaccine.  She was seen by her PCP and diagnosed with A COPD exacerbation, thought to be caused by the vaccine.
Approximately 10-15 minutes after vaccination, patient reports he began feeling lightheaded and dizzy. After approximately an hour, he developed a mild h/a (2/10) and nausea. At 1435, when he reported these sx, BP 114/76, RR 20, SpO2 97% and T 97.9 Orally.
0855 - approximately 10 min after pfizer covid vaccine, patient had itching on her bell and face (Dr notified) VS 144/88  HR74  O2sat 100%   0902 - now nose is starting to itch   0907 - Benadryl 25mg PO per Dr   0918 -  Decrease nose itching... continued face itching VS 132/86 HR71   0929 - chest/ back and eye now itching             Benadryl 25mg PO per Dr   1006 VS 137/87  HR65   1026 - red welts on chest   1103 - Cetririzine 10m PO   1200 - slight decrease in itching / now feeling tingling   1230 - sleepy / decrease itching and tingling   1310 - home with husband driving
Abnormal, nonstop twitching on the chin since a few days after first dose of Pfizer (April 13th, 2021).  Still persisting until today May 4th, 2021
It's real hard under his skin/ it's like a rock, hard surface, it's like holding a rock instead of a soft area/  approximately 4 inches by 3.5 inches around the injection site; his left shoulder became inflamed/ put ice on it to put the inflammation; he put ice on it to put the inflammation and swelling down/ there was a bulge there; he was real tired after he came home from the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (It's real hard under his skin/ it's like a rock, hard surface, it's like holding a rock instead of a soft area/  approximately 4 inches by 3.5 inches around the injection site), VACCINATION SITE INFLAMMATION (his left shoulder became inflamed/ put ice on it to put the inflammation), VACCINATION SITE SWELLING (he put ice on it to put the inflammation and swelling down/ there was a bulge there) and FATIGUE (he was real tired after he came home from the injection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 045A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced FATIGUE (he was real tired after he came home from the injection). On an unknown date, the patient experienced VACCINATION SITE INDURATION (It's real hard under his skin/ it's like a rock, hard surface, it's like holding a rock instead of a soft area/  approximately 4 inches by 3.5 inches around the injection site), VACCINATION SITE INFLAMMATION (his left shoulder became inflamed/ put ice on it to put the inflammation) and VACCINATION SITE SWELLING (he put ice on it to put the inflammation and swelling down/ there was a bulge there). At the time of the report, VACCINATION SITE INDURATION (It's real hard under his skin/ it's like a rock, hard surface, it's like holding a rock instead of a soft area/  approximately 4 inches by 3.5 inches around the injection site), VACCINATION SITE INFLAMMATION (his left shoulder became inflamed/ put ice on it to put the inflammation) and VACCINATION SITE SWELLING (he put ice on it to put the inflammation and swelling down/ there was a bulge there) had not resolved and FATIGUE (he was real tired after he came home from the injection) outcome was unknown.            No concomitant medications were reported. Patient took the booster dose on left shoulder. Patient applied ice on left shoulder to put the inflammation and swelling down. Patient stated that he was real tired after he came home from the injection, had fatigue and took a nap. Patient reported that he was not happy about getting the shot. Patient did not left the house and is waiting to see if it goes down as it was cold outside.
pt recv vax around noon & 4PM devel hives on chest, back & neck;DPH given & hives resolved;
At 28 mins after 1st dose, her mouth got itchy; cheeks were flushed; Her BP went up about 20-30 points of her normal BP; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (At 28 mins after 1st dose, her mouth got itchy), FLUSHING (cheeks were flushed) and BLOOD PRESSURE INCREASED (Her BP went up about 20-30 points of her normal BP) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ACYCLOVIR [ACICLOVIR] and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Mar-2021, the patient experienced PRURITUS (At 28 mins after 1st dose, her mouth got itchy), FLUSHING (cheeks were flushed) and BLOOD PRESSURE INCREASED (Her BP went up about 20-30 points of her normal BP). At the time of the report, PRURITUS (At 28 mins after 1st dose, her mouth got itchy), FLUSHING (cheeks were flushed) and BLOOD PRESSURE INCREASED (Her BP went up about 20-30 points of her normal BP) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication was oral chemo therapy. Treatment medication included diphenhydramine hydrochloride and asthma inhaler.
swollen lymph nodes; under his left armpit it is super sore; sore arm on his left arm for a few days; 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 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER8732) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Apr2021, outcome "unknown", described as "sore arm on his left arm for a few days"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymphnodes"; AXILLARY PAIN (non-serious) with onset 03Apr2021, outcome "unknown", described as "under his left armpit it is super sore". Therapeutic measures were not taken as a result of axillary pain. No follow-up attempts are possible. No further information is expected.
48 hours after the second injection, I developed hives all over my forearms, chest, and back. It lasted for 48 more hours until it faded; This is a spontaneous report from a contactable Other HCP. This 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, in left arm on 26Feb2021 12:45 (at age of 72 years) as single dose for covid-19 immunization. Medical history included barretts esophogus, gastrooesophageal reflux disease (GERD). The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: 229264) via an unspecified route of administration, in left arm on 05Feb2021 12:30 as single dose for covid-19 immunization. It was reported that hours after the second injection, on 28Feb2021 patient developed hives all over my forearms, chest, and back. It lasted for 48 more hours until it faded. In general, whenever patient get sick with a virus, his body mounts an immune response and break out in hives for several days. This post vaccine outbreak was similar but only lasted 2 days. Patient assumed his body was mounting an immune response to the injection. Patient did not seek treatment as he was familiar with this reaction and just took Benadryl. No COVID prior vaccination. No COVID tested post vaccination. The clinical outcome of the event was resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Vaccine administered on 1/11/17-noticed swelling at site of TDAP-redness (L) arm where MENACTRA and HPV given-got worse 1/17/17 brought in today-area of redness.