chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt hot; nauseous; lost control of bowels; "I knew that I would pass out soon so I lower my head to the floor and tried to take deep breaths, ...never lost consciousness"; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm, on 15Feb2021 at 04:45 (at the age of 69-years-old) at a single dose for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included trazodone (MANUFACTURER UNKNOWN) and letrozole (MANUFACTURER UNKNOWN).  The patient previously took codeine (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, tetracycline (MANUFACTURER UNKNOWN) for an unspecified indication and experienced allergies, doxycycline (MANUFACTURER UNKNOWN for an unspecified indication and experienced allergies, and cyclobenzaprine hydrochloride (FLEXERIL) for an unspecified indication and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Feb2021 at 01:15, the patient felt hot, nauseous, and lost control of bowels. The events were reported as non-serious. The clinical course was reported as follows:  About 8.5 hours (as reported) after the vaccination, the patient briefly felt hot and nauseous. She knew she would pass out soon, so she lowered her head to the floor and tried to take deep breaths. The patient lost control of her bowels but never lost consciousness. The episode was reported to be over in about 20 minutes. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered on 16Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 at 15:45 as dose 1, single (Lot number: EL0140), in left arm, on 02Mar2021 at 13:30 as dose 2, single (Lot number: EN6205), in left arm, on 02Oct2021 at 14:15 as dose 3 (booster), single (Lot number: BA30135), in left arm and on 07Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing), notes: Mild hypertension; "Emphysematous lung changes due to 2nd hand smoke" (unspecified if ongoing), notes: Emphysematous lung changes due to 2nd hand smoke; "Emphysematous lung changes due to 2nd hand smoke" (unspecified if ongoing), notes: Emphysematous lung changes due to 2nd hand smoke; "Hypogonadism" (unspecified if ongoing); "Macular degeneration" (unspecified if ongoing); "Fall", start date: 12Mar2022 (unspecified if ongoing), notes: Fall 12Mar2022 resulting in hospitalization; "T7-8 fracture" (unspecified if ongoing), notes: T7-8 fracture & remains in full upper body clam shell that restricts respirations.; "T7-8 fracture" (unspecified if ongoing), notes: T7-8 fracture & remains in full upper body clam shell that restricts respirations.; "Restricts respirations" (unspecified if ongoing), notes: full upper body clam shell that restricts respirations.; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: BYSTOLIC; DEPO-TESTOSTERONE; CALCIUM; FISH OIL; VITAMIN C [ASCORBIC ACID]; PRESERVISION; TRAZODONE, stop date: 16May2022; EYLEA. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17May2022, outcome "unknown", COVID-19 (medically significant) with onset 17May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: + on antigen test on 17May; (25May2022) Negative, notes: Antigen test negative on 25May; (28May2022) Positive, notes: Tested + on 28May. Therapeutic measures were taken as a result of covid-19. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient received other medications in 2 weeks. Patient received treatment for COVID-19 as Paxlovid from 17May2022 to 22May2022. Patient was positive on antigen test on 17May2022, as symptomatic after which wife was positive on PCR several days earlier. Took 5 days Paxlovid from 17May2022 to 21May2022. Symptom free and antigen test was negative on 25May2022.  No follow up attempts are possible. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain and headache. On an unknown date, the outcome of the pain and headache were unknown. It was unknown if the reporter considered the pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but was captured adult as per vaccine indication. The healthcare professional (HCP) stated that a lot of patients were complaining of feeling sore and experiencing headaches the day after they received a dose SHINGRIX. No other details were available.
The fist symptoms were unusual bruises in my legs, then some sort of like pimple looking thing start showing on the right of my rightfoot. Then swelling and pain start showing and by today the pain is making me difficult to walk.
Blister, area looks burned. Pain at blistered site.    Appears to be lower than site of injection.  Patient denies other injury.  Treated with tylenol #3 and omnicef.  Will follow up with doctor next week.
Patient and father came in for his appointment on 4/14/2021 at 830 am they had made it online and the form they submitted online states that his DOB is 9/29/2004. We tried running it through his insurance and it came back non matched DOB, we called the insurance and they said they had the DOB as 9/29/2005. Parent and patient both stated that was incorrect and the real DOB is 9/29/2004. We explained to them that they should call the insurance and get it fixed because if we try to run it through with that DOB it gives us a stop because you have to be 16 to get the vaccine.  Parent stated that they would just pay for it and call insurance later to get it fixed. So we verified that DOB was 9/29/2004 and he was in fact 16 they both stated yes, so we got parent's ID and patient's ID (patient only had school ID with no verifiable DOB on it) and ran it though under no ins and gave the vaccine.   4/19/21 -- Email stating that we incorrectly gave dose to 15 year old. I explained the situation and they stated that the DOB they have cannot be incorrect because it is from the state vital records.   4/20/21 -- I called parent he had no recollection of our conversation and stated that the DOB is 9/29/2005, so he is in fact only 15 years old. I explained to him that patient should not have been given the vaccine and that we won't be able to give the 2nd dose until he is 16 years old. Put in incident report and VAERS report
About 5 minutes after getting the vaccine, patient started to have tunnel vision, loss of hearing, change in LOC unable to answer where he was,  he was pale, diaphoretic and unable to respond to signals patient stated he was going to pass out he was removed from the chair and placed on the floor with his legs in the air, his pulse via palpation was slow, he stated that he does not like needles and he had a similar reaction to the H1n1 vaccine . He was placed on a back board and lifted to a litter and taken to the medical obs, vital signs on arrival were 134/75, pulse72 and oxygen 100 in the right arm, @ 1830 , and at 1834 vital 148/88 HR 75 pulse ox 99 on room air. patients skin was now warm and dry, he reported that he was feeling better, at 6:35 bp 133/81, patient was then placed in a sitting position and blood pressure with position change was :143/92, pulse 68 and 99% on room air, standing after 1 minute patient was 145/87 and heart rate 78 and pulse ox 99%.  Patient reported feeling better.  His color had returned, he was given water and monitored for another 5 minutes.
Received vaccine, went to work next day and had fever 102.7. stayed home from work on 8/4/2021. Today 8/5/2021 feels heart racing and lightheaded while at work. Feels flushed.
Patient complained of increased left hand swelling, "turned purple" and pain in hand - thumbs and 1st finger, after receiving vaccine in left deltoid (0.5mL of meningococcal vaccine). Physical exam: no circulatory deficits, no swelling, no sensory deficits of left arm. * See attached: Patient complained of feeling pain in her left hand, swelling of left hand, and that her left hand turned "purple" soon after receiving her meningococcal vaccine, IM in her left deltoid. She also stated that she had a headache - she denied photosensitivity. Exam revealed 2+ radial pulses bilaterally, no circulatory deficits to left hand, no sensory deficits to left hand (simple touch). Patient was reluctant to strong left grip, to abduction of her left arm more than 110 degrees of elevation, because she complained of pain her left deltoid with these activities. Left deltoid (site of vaccination) had no swelling, warmth or erythema, and was somewhat tender to palpation. Patient stated she thought she would be okay during her last class, and had friends to walk her home. She stated she could not take pills, and usually takes pain medicine in liquid form. Since we had no liquid pain medicine available on site, she was instructed to take some pain medication (ibuprofen, acetaminophen) when she arrived home, and to inform her parent(s) and family doctor if she had worsening or persisting pain or discomfort.
Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Other- Patient had ate lunch before vaccine administration and had emesis after 1 minute of receiving the vaccination
Excruciating pain for 10 hours later that day and night.  I think the person who injected me hit a large nerve.  Called the pharmacy the next day.  They showed no concern.  Also, reported my scary and painful reaction to my doctor?s office!
Information has been received from a physician concerning a 12 month old female twin who on 6/13/03, two weeks ago, was exposed to her mother who had herpes zoster. On 6/17/03, the patient was vaccinated IM with a dose of varicella virus vaccine live. On 6/26/03 the patient started to develop generalized vesicles all over her body with at least 50 lesions. The physician was going to speak to the parents to see if they wished to pursue a lab culture of the vesicle. No additional information was available. Unspecified medical attention was sought and no treatment was required. No product quality complaint was involved. It was also reported that the patient's twin sister was vaccinated with a dose of varicella vaccine live and also developed the same reaction. Additional information has been requested.
I started having Diarrhea and have to pee a lot more. It started yesterday evening and I noticed all day today that I had to pee more often than normal. I had diarrhea 3 times.  (My wife got the same vaccine at the same time and has similar symptoms)
Patient administered KINRIX with exp. 10-19-15 on 10-29-15. Parent notified and will plan to revaccinate in 1 month at next check-up. Child underage for vaccine. CDC contacted.
The day after the immunization the mother noted a red, warm, swollen patch at the site of the immunization.  This worsened the following day, so the mother brought the child in for examination.  There was an indurated, erythematous patch about 10 cm in diameter present at the site of the injection
Shingles; This is a spontaneous report from a contactable healthcare professional (patient). A 71-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm in 2021 (Lot Number: EN6200) as 2nd dose, single for covid-19 immunization, administered at the hospital. Medical history included high blood pressure, hypothyroid, and hypercholesterolemia. Historical vaccine included first dose of bnt162b2 on 05Feb2021 at 14:30 in the right arm (lot number EL9263) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medications included hctz; levothyroxine; and rosuvastatin. The patient experienced shingles on 10May2021 at 13:00. The event resulted in emergency room/department or urgent care. The patient received treatment for the event which included valacyclovir 3 times a day, 1 gram per dose. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
HEAVY MENSTRUAL BLEEDING; EARLY MENSTRUAL BLEEDING; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 119 pounds, and height was 65 inches. The patient's past medical history included miscarriage, and concurrent conditions included pollen allergy, mold allergy, cedar allergy, mollusk muscles and clams allergy, alcohol user, non-smoker, endometriosis, fertility difficulties, and cyst on ovaries, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced heavy menstrual bleeding. On 11-JUN-2021, the subject experienced early menstrual bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy menstrual bleeding, and early menstrual bleeding on JUN-2021. This report was non-serious.
Missed periods for March, April and May. Had a period for June and July then started missing again in August. My periods have always been regular and I never miss.
11-17-22-extensive Rash, itching (on upper body               - oral, topical injections steroid(s) 60 day tx (no response)               - head, lower body, upper bidy, 70-120 day tx (no response)               - stratum corneum compromised (extensive)                  - extreme dehydration of skin                - hands and feet, skin has extreme exfoliation               - hypergrowth of moles, warts, and other derm growths
stomach bothering him; suddenly collapsed when he was going to the bathroom; blood pressure was low; The day after the booster, her husband woke up with a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, The previous vaccines and booster shots they had were from Pfizer too.), for Covid-19 immunization; Bnt162b2 (Dose 2 , The previous vaccines and booster shots they had were from Pfizer too.), for Covid-19 immunization; Bnt162b2 (Dose 3 (Booster), He had no reaction with other boosters., The previous vaccines and booster shots they had were from Pfizer too.), for Covid-19 immunization. The following information was reported: PYREXIA (hospitalization) with onset Dec2022, outcome "unknown", described as "The day after the booster, her husband woke up with a fever"; HYPOTENSION (hospitalization) with onset Dec2022, outcome "unknown", described as "blood pressure was low"; ABDOMINAL DISCOMFORT (hospitalization) with onset Dec2022, outcome "unknown", described as "stomach bothering him"; FALL (hospitalization) with onset Dec2022, outcome "unknown", described as "suddenly collapsed when he was going to the bathroom". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: low; all kinds of tests: Unknown results, notes: they came up with nothing out of the ordinary. Clinical course: Caller called in regards to Pfizer Covid-19 Vaccine. She stated that her husband got hospitalized after getting the shot. Caller and her husband got their second booster, fourth shot, last Sunday. Her husband is hospitalized. The day after the booster, her husband woke up with a fever, stomach bothering him. He had no reaction with other boosters. Confirmed that this booster shot is Pfizer adult bivalent. The previous vaccines and booster shots they had were from Pfizer too. He slept and then "suddenly collapsed when he was going to the bathroom, called an ambulance, blood pressure was low. They kept him overnight for observation, running all kinds of tests to see if there was an infection. they came up with nothing out of the ordinary."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Report 2001028667-1 describes headache in a 47-year-old female who received hepatitis B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the pt received her 1st injection of Engerix-B. Subsequently, she experienced injection site pain, headache, fever, nausea, and malaise. As of 12/03/2001, the outcomes of the events were unknown.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-JAN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX subcutaneously, once, lot # K023622, expiration date: 20-FEB-2016 (dose was not reported). There was no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 70 days (reported as 70 days +) since 22-SEP-2015. This is one of several reports received from the same reporter. Additional information has been requested.
very weird and annoying bumps at the back of her tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (very weird and annoying bumps at the back of her tongue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) 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) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced TONGUE DISORDER (very weird and annoying bumps at the back of her tongue). At the time of the report, TONGUE DISORDER (very weird and annoying bumps at the back of her tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information provided.  Caller advised she went to an urgent care, but was not seen.
A pharmacist reported VARlVAX was improperly stored and administered; This spontaneous report has been received from a pharmacist, referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 26-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) 0.5 milliliter (mL) once (lot number T028306 and expiration date 20-AUG-2022 were verified as valid) (route of administration, vaccination scheme and anatomical site of vaccination were not provided) as prophylaxis.  The vaccine was improperly stored at 41 Fahrenheit degrees for 24 hours (product storage error). The temperature excursions were not detected by a data logger. There was no previous temperature excursion; Sender's Comments:  US-009507513-2107USA000237: US-009507513-2107USA000111:
Pain in underarm lymph node that started two days after second dose and persisted for 4 days; Also had nausea the night of the second dose; This is a spontaneous report from a non-contactable consumer, the patient. A patient of an unknown gender and age 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 14Apr2021 at 17:00 as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included oral birth control (MANUFACTURER UNKNOWN) from an unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 at 15:00 as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced pain in underarm lymph node that started two days after second dose and persisted for four days. It was reported that the patient did not experience this pain during the first dose, also had nausea the night of the second dose. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in underarm lymph node, nausea was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Patient states symtoms started 2 days after receiving vaccination. This caused him to be unable to eat. At this time, he then started to have pain on one side of his neck. He noticed over the next couple of days that he had increased swelling and pain. It has stayed the same size/pain level. He does not have a PCP and is going to wait until the following week to seek care, if needed.
pt recv vax OCT97 & 1wk p p/vax pt exp joint ache w/a fever & fatigue;
Patient arrived on 1/7/2023 with his father to receive the pediatric Pfizer bivalent vaccine. Everything was managed correctly. Today, 1/9/2023, one of the pharmacy technicians realized that the "beyond use day" for pediatric vaccines was 12/26/2022, therefore they could not be used. Pharmacy manager, called the manufacturer Pfizer to obtain information on the stability of the vaccines in question and they asked her for information on the vaccines and temperatures, which she sent by email. We are waiting for responses from them via email in order to establish a protocol, if any.
Severe stomach cramps and diarrhea in the middle of the night.  Shingles outbreak.
rt arm (deltoid inj site was red, warm, splotchy that appeared yesterday 9OCT95 administered inj on 4OCT95 w/no apparent problems until yesterday;referred to MD; local superficial rxn per MD