chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MIGRAINE HEADACHE; TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a pharmacist (PVX2019-004) on 02-Jan-2019. The report describes a 20-year-old female consumer who had migraine headache following the intake of Vivotif for typhoid prophylaxis. The consumer also "took an unrefrigerated dose".  It was reported that the consumer picked up Vivotif and left it out of the refrigerator for 26 hours before taking a dose yesterday (01-Jan-2019). She had a migraine headache this morning (02-Jan-2019). She had vomited after taking the first dose, but later clarified that she forced herself to vomit because she heard that the vaccine was unstable if it was kept unrefrigerated.  The action taken with Vivotif with respect to the event migraine headache was unknown, while with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the events migraine headache and "took an unrefrigerated dose" was unknown.  Company's Comment: In this case, it was reported that 20-year-old female consumer experienced migraine headache following the intake of Vivotif. The event occurred after the consumer forced herself to vomit the dose and there is limited information regarding the medical history in this case.  Migraine headache is unlabeled as per CCDS. Hence, the causality of the event "migraine headache" with Vivotif is assessed unlikely. The consumer also "took an unrefrigerated dose". The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: In this case, it was reported that 20-year-old female consumer experienced migraine headache following the intake of Vivotif. The event occurred after the consumer forced herself to vomit the dose and there is limited information regarding the medical history in this case.  Migraine headache is unlabeled as per CCDS. Hence, the causality of the event "migraine headache" with Vivotif is assessed unlikely. The consumer also "took an unrefrigerated dose". The causality of the event "took unrefrigerated doses" was considered as not applicable.
Hives in her hip/Hives in her chin/Hives in her mouth/Hives in her neck/Hives in her arm; Second vaccine on 19Jul2021 and Booster on the 19Nov2021; Vision got worse since the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision got worse since the booster shot), URTICARIA (Hives in her hip/Hives in her chin/Hives in her mouth/Hives in her neck/Hives in her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine on 19Jul2021 and Booster on the 19Nov2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033A21A, 030A21A and 024N20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High blood pressure). Concomitant products included PROPRANOLOL for Heart disorder, LISINOPRIL for Hypertension, APIXABAN (ELIQUIS) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced VISUAL IMPAIRMENT (Vision got worse since the booster shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine on 19Jul2021 and Booster on the 19Nov2021). In December 2021, the patient experienced URTICARIA (Hives in her hip/Hives in her chin/Hives in her mouth/Hives in her neck/Hives in her arm). At the time of the report, VISUAL IMPAIRMENT (Vision got worse since the booster shot), URTICARIA (Hives in her hip/Hives in her chin/Hives in her mouth/Hives in her neck/Hives in her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine on 19Jul2021 and Booster on the 19Nov2021) outcome was unknown.            Concomitant medication Eliquis was indicated to use as Blood Thinner and Neuro Propranolol indicated to use as heart medicine.  It was reported that, On 30-Dec-2021, hives got very bad for a couple of days. Patient did not have any allergies, was never tested positive for COVID-19. Did not have any acute or chronic illnesses.   Treatment included allergy pills and cut down foods which might caused allergy.   This case was linked to MOD-2022-513779 (Patient Link).
pain at injection site; fever; nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 8th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain, fever and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever and nausea were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 59 or 60 years. After vaccination with Shingrix, had injection site pain, nausea and fever. The reporter consented to follow up. This case has been linked with case US2019224047, reported by same reporter for same patient.
Muscle aches in chest, some difficulty breathing, progressed next day to fatigue, fever, weakness, diarrhea, loss of appetite for 48 hours.
A territory representative reported that a 15 month old child received a 2nd dose of Prevnar and subsequently developed Pneumococcal bacteremia, serotype unknown. No further info was available at the date of this report. Streptococcal septicemia is considered medically important. Follow up data received from the physician on 03/20/2001 indicated the patient received Prevnar and Engerix-B vaccines on 08/14/2000. A blood culture was positive for Streptococcus pneumoniae. The patient recovered.
Arm is very sore, not able to move it well, nauseated, blurred vision, fever, joints are very pain.
Pulsating tinnitus in my left ear. The tinnitus comes and goes, but it is becoming more frequent than when I first started experiencing it after the vaccine.
Patient was fine after the covid and flu shot; however, after the gardasil shot she proceeded to have a small seizure lasting less than 1 minute where she did loose consciousness. Upon regaining consciousness, she was extremely nauseous. EMS was called and she was directed to the hospital especially since she had extreme hypotension
pt presented to Er 2 days p/vax w/erythematous, pruritic swelling approx 10cm x 12cm i size surrounding the inj site on the upper rt triceps area;
Fainted / passed out.  As background to my report, I note these ordinary symptoms: starting a few hours after the shot, my arm became quite sore and I experienced a strong flareup of various chronic pains which lasted 2-4 days, just like when I previously got a Moderna booster (and to a much lesser degree with the initial two Pfizer vaccinations).  My report: The day after getting the booster I felt weak and fatigued, took a couple of naps, and went to bed early. The next morning I felt no better. In the shower, I started feeling shaky and bad in ways I don?t remember clearly. I felt I wasn?t getting enough air and stuck my head out of the shower for a breath without water vapor, but it didn?t help. Feeling increasingly ill, I rinsed off as fast as I could and stepped out of the shower, too clumsy to more than half-wrap towels around myself. Next I knew, I was three feet away sitting on the floor leaning against the wall. It must have been a slow faint because I didn?t collapse across the toilet but somehow got past it and sat, and it must not have lasted long because I hadn?t dried off to any noticeable degree. I took an hour?s lie-down and have since felt somewhat better, but it?s close to six days out from receiving the booster and I still feel a little shaky all over, sometimes barely, sometimes to the point of sitting down or lying down for a few minutes.
10/26/01 at 3:30 pm child developed rash on cheeks, by evening rash spread all over body. Child has been on Amoxicillin approximately 2 weeks. Child taken to ER. Dr said rash could be from one of the vaccinations or the medication. Child given stronger type of Benadryl and late evening rash gone. As of 10/23 child doing ok.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose, refer case US2018164471). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and fever. On an unknown date, the outcome of the influenza-like symptoms and fever were unknown. It was unknown if the reporter considered the influenza-like symptoms and fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported.
Pt developed left sided numbness and tingling 48 hours post vaccine of face/jaw, left upper extremity, left upper chest, left leg.  Recommended ER evaluation, but not sure if pt followed up.
Red circle around area of injection (left deltoid).  Measure about 2 1/2 inches long by 7cm x 6.5cm - area erythematous; tender to the touch & mildly swollen.
Client vaccinated with Moderna vaccines approx Jan 15 and Feb 15, 2021.  Symptom started 11/23 - fever 100.1 and nasal congestion.  Reported as case of breakthrough Covid in a previously vaccinated person.  Has not received booster dose.
About 38 hours after receiving the vaccine (2-20-21 - 1:00 am) I realized there was a blister located on my shoulder about 1.5? to the right of the shot area (which was bruised). I don't know exactly when the blister started.  I put 2-18-21 on this form since I didn't know. The size of the blister was approx. 1/4 x 3/8.  I realized I had taken my blood pressure using the shot arm (3 times about 3 hours after receiving the shot and again the next day) and worried the tightness of the BP cuff had affected the shot and pushed the vaccine to cause the blister.  I spoke to a couple of medical people at medical center and they didn't think so and said it was probably ok and to report it.  The blister has gone away but the skin is a reddish pink.
Pt c/o redness & swelling and pain at site of vaccination, redness spreading almost to elbow Pt called one day later after vaccine to report spreading redness down (R) arm.  He has called for F/U He came in for assessment to clinic on 6/19/2019. He was given Ibuprofen which he took for 2-3 days. Sx subsided & completely resolved within 7-10 days.
Had low grade temperature of 99.5-99.7 for 24-48 hours; a little cranky. Given Motrin. Saturday, noticed right leg swollen, no redness or warmth; just larger from groin to just below the knee on right leg. Mom talked with doctor; told to put ice pack on leg and give Benadryl. Today 1/22/03, swelling down. No complains of pain or discomfort.
Fatigue; This is a spontaneous report from a contactable consumer or other non hcp. An adult male patient of unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation patient received other vaccines within 4 weeks prior to vaccination was unknown. The patient medical history and concomitant medications were not reported. The patient experienced fatigue on an unspecified date, patient diagnosed with COVID-19 prior to vaccination was unknown patient was tested for COVID-19 to post vaccination. No treatment received for the events. The outcome of the event fatigue was recovered.  No follow-up attempts are needed; information about the lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unchecked for reporter. Initial Supplier to Safety corrected as measurable supplier in general tab and keywords corrected as Received from Pfizer colleague in additional information tab as initial report is for a Pfizer colleague. Patient's initials updated to UNKNOWN, and patient's country was added. Vaccination Facility Country was added. Treatment Received checked as No.
Patient c/o pain immediately after injection, became diaphoretic, loss of consciousness, seizure, incontinent.  Managed by EMT on site.  B/P 142/74, pulse 74, R 16, temp 97.2.  recovered quickly.  Picked up by her husband, a physician,
Not adverse affects... Pt received beyond use date Pfizer bivalent. Reported NO adverse affects.
Later on that day of vaccination around 7:00pm my head started to hurt. The next day I had a headache, nausea, chills & muscle ache. The headache lasted about 5 days & the nausea & chills lasted for 1 day & the muscle aches lasted about a day or 2. I did a consult over the phone but I didn't had to go in.
30-45 min. after injection child developed watery diarrhea followed by fine raised red rash on trunk that spread to buttocks and thighs. Saw PMD - dx as adv. reaction. Treated with prednisone 15 mg/5 ml (4 ml) and BENADRYL q 4 hrs.
urticaria on the chest and leg; This is a spontaneous report from a contactable physician (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 16Dec2020 21:00 at a single dose for COVID-19 immunization at the workplace clinic. Medical history included sulfa allergies. Concomitant medication included ibuprofen. The patient had not received other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced urticaria on the chest and leg on 24Dec2020 20:00. Outcome of the event was not recovered; no treatment was given for the event. The patient was not diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination.  Information on the lot/batch number has been requested.
Lightheaded/dizzy, toes tingling. Resolved with monitoring within 30 min.
I82.4Z1 ACUTE DVT OF RIGHT CALF, UNSPECIFIED VEIN 3/30/2023 HTN (HYPERTENSION) T78.40XA ALLERGIC REACTION, INIT 4/17/2023 HTN (HYPERTENSION)
Dizziness, Headache, Fever, chills, left arm and lower back were sore Narrative: employee states: first vaccine=5/19/21 at 2:15pm,Pfizer EW0158, left arm experienced on 5/20/2021 fever of 100.3, cold chills, diziiness which persisted even when trying to sleep. pain in the right leg making it difficult to walk, and pain in left arm and lower back. unable to work 5/20/21 and 5/21/21. after second vaccine, had fever of 100.1, cold chills, dizziness, bad headache, difficult to walk due to headache, left arm and lower back were extremely sore. States took Tylenol 3000mg over 24 hours with plenty of water. stayed home from work 6/9/21
Child given Varivax on 13 June 01 Developed variecella lesions 10-14-01 later
within 12 hours started experiencing muscle and joint pain and loud rising in the ears, within 16 hours degraded eyesight, chills and uncontrollable shivering. the next 2 days experienced increased ringing of the ears, fever (103 degrees highest monitored), profuse sweating alternating with severe chills. Muscular and joint pain from hands to feet. By Day 3 the fever and chills subsided but the muscle and joint pain migrated to the shoulder and neck concentrating in the left arm / shoulder joint. Heavy muscle fatigue, ringing of the ears and degraded eyesight for 12 days after injection.
This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 23-month-old male patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (1st dose received) and BEXSERO (2nd dose received). On an unknown date, the patient received the 3rd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient missed the booster dose of BEXSERO (which should have it at 12-15 months), which led to incomplete course of vaccination. The patient was arranged to get the booster dose of BEXSERO soon. The reporter just read that the patient cannot have it at aged over 24 months. The reporter asked to let know why this was. He would hopefully be having it a week or two before 24 months but the reporter was worried as it is so close the 24 months stipulated in the leaflet. The reporter would like to know what the implications are of having the 3rd injection this late.
contracted Covid; contracted Covid; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was due for his second dose but was in the middle of the period where he contacted COVID on an unspecified date. The outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
positive human papillomavims test; This spontaneous report was received from 39 years old female patient, referring to herself. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.   On 23-FEB-2021 and 24-MAR-2021, the patient was vaccinated with the first dose and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot# and expiry date were not reported) respectively for prophylaxis.   On an unknown date in 2021, following the second dose, the patient was positive for the human papillomavims test. The outcome of positive for the human papillomavims test was unknown. The patient had not yet received a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and expected to receive a third dose 24-AUG-2021.   Causality assessment was not provided.
PT DESCRIBED REACTION TO VACCINE AS ITCHY BREAKOUTS ALL OVER HER BODY WHICH LASTED FOR 3 WEEKS.
Blisters on head, in mouth, tongue.  Rash on legs , arms, back, stomach. Started on head, then moved to mouth and tongue, then down the extremities.
This morning, 11/18/09, mother noticed that patient had a yellowish green substance at the nape of her neck that was oozing out of skin.  Patient received injectable H1N1 shot in her right arm at her school on Monday morning 11/16 as part of the Health Department vaccination campaign for H1N1. When mother wiped the neck area with a wash cloth this morning, the yellowish substance continues to come out of the skin surface.  School Health Nurse reported this occurrence first and Investigator contacted mother for more specifics. School Health Nurse had examined the child in clinic today and looked at child's neck.  She took a sterile gauze pad and wiped the neck area that was reported as yellowish.  The gauze showed a yellowish substance that looked like a fluorescent marker fluid oozing out of skin.  She allowed a few seconds to go by and wiped again and found that the same thing occurred.  The child's 22 month old brother DOB 02/08/2008 has also showed the exact same thing on the nape of his neck.  He received vaccine yesterday, 11/17/09.  Injection site for both children shows no rash, warmth or oozing of any substance. A separate VAERS report will be done on brother. Time above is approximate. Mother said that child complained of a headache and throat hurting on the evening of the 16th.  Child has had chronic problems with tonsils and allergies. Nurse contacted mother 11/18 and discussed at length any new cleaning products, shampoos, clothing, bedding etc that may have caused this.  We also discussed food eaten.  Mother bathes both children with "Johnson's Head to Toe" wash and has used this product for years with no effect. She uses "Mean Green" cleaning solution and sprayed the bathtub about a week ago and also used comet in tub. She has done this also for several years with no effect.  No pesticide spraying in the last several months. No change in detergents or soaps. Mother gave Tylenol at proper dosage for sore throat symptoms yesterday.  Child takes Flintstone vitamin every day along with Singulair for allergies. There is no wound at the site of substance oozing.  Otherwise, child seems to be okay according to school health nurse.
Her hands, feet became swollen; Her ankles became swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 Immunization.  The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Her hands, feet became swollen"; JOINT SWELLING (non-serious), outcome "unknown", described as "Her ankles became swollen". Additional Information: Patient wants to know if these side effects have been reported with the vaccine, and if she needs to see her doctor. Responded from the attached SRD, "CONS-what are the risks of the vaccine" also referred the patient to HCP for more guidance.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Started to feel itching and hives on left wrist within a few minutes after vaccine administration. Chest area became red and mottled. Contacted workers and received around 25 mg of liquid Benadryl. Allergic reaction subsided shortly after. Monitored in the hospital Emergency Room for around 2 hours.