chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a office manager refers to unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with a dose of improperly stored GARDASIL 9 lot # N012093, expiration date: 13-JAN-2020, (route unspecified) for prophylaxis. Temperature: 32 ° F to 35 ° F, time frame: 37 hours. There was no previous temperature excursion. No adverse effects reported. Call was because of a data logger. No product quality complaint was involved. No further information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA012033.
Side effects after receiving the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects after receiving the moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects after receiving the moderna vaccine). At the time of the report, ADVERSE EVENT (Side effects after receiving the moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. Treatment information not provided.
Rec'd FLUZONE vaccine 10-10-12 at 1345 - adm left deltoid IM. Tol. well & left health dept upon receipt of vaccine. Pt. called health dept at approx 1545, c/o itching & hives. She was concerned about adverse reaction to flu vaccine. Advised to seek medical attention immediately. Stated she has had allergic reaction to bee stings.
mom reports that 8AM day p/vax @ MD office pt was just rag doll like;pt limp (entire body); LOC-alert no change & no other s/s apparent;
I received the Adacel vaccine in my right deltoid feb 8th at 5pm.  While driving home my head to my right finger tips ached.  On arriving home I felt miserable and went to bed.  I awoke at midnight in full rigors, chills, and had sweat through the bed sheets.  The shaking continued all night long but the chills stopped with 1000mg of tylenol.  By morning I was weak, aching from head to toes and mildly delerious.  That night (Feb 9), my fever was 102 and the chills, aching, rigors started again.  My urine was bright orange through Feb 11th am.
pt recvd vax;had local rxns (erythema, induration, warmth at site); fever, irritability w/in 24 hrs of vax;apap given; recovered;
Patient received a flu vaccine injection on 11/13/2013. Patient states that she felt lousy for 1 week, erythema near the injection site, rash all over her body, muscle pain and soreness described as "being punched in the arm". Patient denied any fever, patient still has a nodule near the injection site. Muscle soreness, and a slight rash on the arm of the injection site.
Patient had severe myalgia which presented a week after vaccine was given. Patient is slowly improving but still has muscle pain.
Injection site red, swollen, hard to the touch, and hot starting 09/23/2023 through the present. Additionally, site became itchy 09/24/2023. Swollen area around injection site about 3" width and 1" height.
None.  Patient received 3rd dose of HPV vaccine too soon.  Will reschedule patient & readminister.
BILATERAL VISUAL SYMPTOMS; SENSORIMOTOR SYMPTOMS IN EXTREMITIES; OBJECTIVE WEAKNESS; NEUROPATHIC SYMPTOMS IN EXTREMITIES; This spontaneous report received from a physician concerned a 30 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was 7/52 postpartum. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose was not reported, administered on 15-DEC-2021 for prophylactic vaccination. The dose number in series was 1. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-DEC-2021, the patient experienced neuropathic symptoms in extremities, and objective weakness. Laboratory data included: Visual acuity tests (NR: not provided) Reduced in both eyes. On an unspecified date after vaccination, the patient experienced bilateral visual symptoms, and sensorimotor symptoms in extremities (dose number in series was 1). Laboratory data (dates unspecified) included: LP test (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bilateral visual symptoms, sensorimotor symptoms in extremities, objective weakness and neuropathic symptoms in extremities was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211257058-COVID-19 VACCINE AD26.COV2.S-neuropathic symptoms in extremities. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Bell's palsy. Facial paralysis. Numbness on one side of face. Strong headaches and pain behind ear.
sore arm, chills, and extreme urge to urinate lasted 1 hr took oxycodone/tylenol. exhausted next 24hr
4/6/21 - got bloody nose at 10:00 A.M, which would not stop.  Nose still bleeding 2 hours later, got dizzy, so lied down.  Vomited blood and could not stop the bleeding.    Went to the ER at 2:00 PM, to have them stop the bleeding 4/6/21- E.R. - Fainted n the lobby while waiting.  Taken back to room and given IV and gave multiple tests.  E.R. doctor put packing in nose to slow bleeding.  Still The Diagnosis was Epistaxis and Vasovagal syncope, and advised to follow up with my doctor and otalaryngologist. 4/8/21- Nose bleeding finally cam to stop in the evening, but had fatigue, weakness, irregular heartbeat, and shortness of breath 4/9/21- ENT and Allergy removed packing, completed nasal scope.  Nose still felt like it was stuffed with blood clots until 4/13/21
)Diarrhea and Weakness - Generalized (COVID positive 21st, symptoms started 18th with vomiting and congestion. Dialysis pt, missed today, shortened run thursday due to diarrhea. )
This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions drug reactions or allergies were not reported. On an unknown dates in 2016, the patients were vaccinated with improperly stored GARDASIL 9, lot number as reported M026306, expiration date 30-APR-2018, by intramuscular route, (frequency and anatomical location were not provided). No adverse effects were reported. The temperature and time frames were: on 24-AUG-2016, 34 Fahrenheit degrees for 14 hours, and, on 29-AUG-2106, 30 Fahrenheit degrees for 14 hours; there no were any previous excursion and digital data logger was not involved. Product quality complain was not involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 4 month old pt who was vaccinated with a dose of Comvax. Subsequently the pt experienced fever > 101. The lot number was not provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Tingling/pin prick feeling on both hands, and both sides of the face.  Progressed quickly & over weeks to sever headaches, muscle soarness, muscle weakness in hands face, jaw.  Tingling occured in both legs, more so on the left sife of the body.  Soar back, shoulders and neck.  Still experiencing symptoms 6 weeks later.  11/20 and 11/27/09:  Hospital and medical records received for date of service 10/2/09 to 10/30/09.  Dx:  Paresthesia,  facial neuralgia.  Assessment: Pregnant Gravida 2, Para 1, presents with tingling in face, arms and down leg, soreness at injection site, stiff/achy neck and back. Heaviness of right arm. Sharp pin prick sensation to right side of face, when she touches her face it doesn't feel normal.   Nares red and sore, slight swollen glands in neck and behind ear.  Normal neurological exam.
very tired; sweaty; running a 100 degree fever; no appetite; Hurt immediately and could not move left arm; This is a spontaneous report received from a contactable consumer, the patient. A 70-year-old male patient received his second dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 28Feb2021 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included generic Lipitor (MANUFACTURER UNKNOWN), FENOFIBRATE within 2 weeks of vaccination.  The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EM9809) via an unspecified route of administration in the left arm on 07Feb2021 at 09:30 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 28Feb2021 at 13:00, the patient was hurt immediately and got worse with time. On 01Mar2021 patient could not move the left arm due to pain and experienced 100degrees fever, no appetite, sweaty and very tired. On 02Mar2021, patient felt much better with the arm and had 40 percentage of mobility and on 03Mar2021 the pain was gone and was even able to work out. No therapeutic measures were taken as a result of the events. Patient recovered from vaccination site pain on 01Mar2021. The clinical outcome of the events fever, no appetite, sweaty and very tired was resolved on an unknown date.   No follow up attempts are needed. No further information is expected.
I got vertigo. Started Vomiting 60 to 70 time that day. Went to ER given medication to take care of nausea and vertigo.
Started with tooth ache. Very painful, like i needed a root canal. Couldn't get into dentist for 1 week. Felt bad all over. Just thought it was from the pain. Slept on heating pad which helped. Couldn't do normal activities due to pain making me feel bad all over. Went to dentist this morning 1/27/23. He told me it is intraoral herpes in mouth. Swelling has affected my two upper back teeth pushing one of my crowns down which he may have to address after the lesions are gone in my mouth. He thinks another week.
anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that a patient had an anaphylactic reaction following a single dose of the Pfizer BioNTech COVID-19 vaccine. Because it is contraindicated for the patient to take the second dose, she is finding the best way to protect the patient from COVID-19. She wants to know the duration of coverage of the vaccine. She said she knows that after a single dose, the vaccine is 92.6% effective. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known on available information and known drug profile, a possible causal relationship cannot be excluded between the suspect product and the event anaphylactic reaction. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Felt weak, dizzy, blurred vision and nausea Vitals normal except for several episodes of O2 stat 89-90. No wheezing . One dose of  Diphenhydramine 25 mg dose. Back to normal in 1 hr.
Mom states pt had temp 103 & rt leg was swollen & red from knee to hip; Went to MD & advised to not given DTP to give DT only;
Pt returned for 3rd dose of GARDASIL (HPV) vaccine and reported on questionnaire that she broke out in hives around injection site after 2nd dose on 4.07.08, relieved with ice pack. Denied any difficulty breathing. Indicated allergy to honey on 4.07.08. This writer decided not to give 3rd dose.
Sore arm; Bad body aches; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Bad body aches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l20a) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised. Concomitant products included RITUXIMAB (RITUXAN) for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) and SPIRONOLACTONE for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Bad body aches). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Bad body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided.   This case was linked to MOD-2021-371163, MOD-2021-371168 (Patient Link).
Headache, chills, shivering, fever of 100 degrees, myalgia lasted approximately 12 hours. Began approximately 10:00 AM and tapered off around 10:00 PM on the day following the SHINGRIX shot. Very tired, slept approximately 5 hours during the day which is not usual at all.  Arm very sore and bright red with about a 3-inch diameter red, painful area on the 2nd day. Took ADVIL the 2nd day after the shot for residual headache which helped. Did not take anything the first day after the shot for shivering, fever, just too tired and miserable and didn't want to eat and felt taking aspirin or ADVIL on an empty stomach would only make matters worse with possible stomach upset.
Delayed skin reaction on day 8. Rash, swelling, itching. Day 8 dime size, Day 9, 2/3 inch circle, Day 10, same as day 9.
9/27 - Developed fever & chills at night on day of PNEUMOVAX. 9/28 Temp as high as 103 - soreness in arm - mod. 9/29 Was seen in MD office report 101 during noc CRP 186 WBC 21.37 - headache x 2days. 9/30 Was seen - temp 100 - fatigued.
product: COVID 19 Treatment; product: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: PROZAC, start date: 01Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 08Feb2023 to 12Feb2023.  Clinical course: The vaccine lot number was unknown due to it was misplaced/discarded. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report , a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Sore Arm; Fatigue for a few days; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29May2021 17:00 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. Past drug history included: None, notes: The patients past drug therapy was reported as no. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29May2021 21:00, outcome "recovered with sequelae" (2021), described as "Sore Arm"; FATIGUE (non-serious) with onset 29May2021 21:00, outcome "recovered with sequelae" (2021), described as "Fatigue for a few days"; HEADACHE (non-serious) with onset 29May2021 21:00, outcome "recovered with sequelae" (2021), described as "Headache". Therapeutic measures were not taken as a result of pain in extremity, fatigue, headache.  Additional information: The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My arm was red and swollen at the injection site.  About 10 days after the injection, my arm still has a lump at the site.  It hurts to touch.
pt recvd vax 24FEB93 & pt began feeling ill & exp aching on the lt side of head, neck & ear & soreness in lt arm down to wrist; also devel a fever of 100 & red scabby needle pots @ inject site;
Information has been received from a nurse immunization coordinator concerning a patient with sickle cell anemia who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed shingles. There was no information regarding patient history of chickenpox or varicella virus vaccine live (Oka/Merck) immunization. The patient sought unspecified medical attention. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Follow-up information was received  on 11-DEC-2007 indicating the patient did not received the second dose of varicella virus vaccine live (Oka/Merck). "Concern was raised because increase in shingles since beginning routine of second dose of varicella virus vaccine live (Oka/Merck)." this is one of several reports received from the same source. Additional information has been requested.
titer is negative for measles; This spontaneous information has been received from a male patient of unknown age, concerning himself. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unspecified date (reported as a child), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).  On an unspecified date, an unspecified test result showed his titer was negative for meales (measles antibody negative). The outcome of the measles antibody negative was not provided.  The causal relationship between the measles antibody negative and the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
1ST Vaccine:  25 minutes after: Rash and Itching rib cage, ithching  ears, headache.  Swelling of the throat. within 2 day - 2 weeks: , swelling of breasts and fingernails strength & headache    2ND Vaccine:  20 minutes:  Rash on both inner part of arms. 2days:  swelling of breasts, headache, fatique.  Please note:  I took cetirizne oral after 20 minutes  of both vaccines. Due to itching, rash and throat swelling QUESTION 23 will NOT let me fill:  Has the patient ever had an adverse event following any previous vaccine?: (If yes, describe adverse event, patient age at vaccination, vaccination dates, vaccine type, and brand name) ? Yes.  Prefinar13 - Pfizer 2017  Allergic reaction
Expired dose of Proquad was administered; No additional Adverse event reported; This spontaneous report was received from a nurse referring to a patient (age and gender unknown).  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-MAR-2022, the patient was vaccinated with dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #T032150, expiration date: 20-MAR-2022 for prophylaxis ( route and site of administration were not provided), that was expired. No temperature excursion on the vaccine was reported,  No additional adverse event reported.
Itchy, red, raised skin ,1.5cm in diameter surrounding injection site. First noticed 7 days after the injection. No other symptoms besides a three day headache/migraine that started about 48 hours after the injection. I have chronic migraines though, so that may or not be related.
While waiting in after the vaccination I experience the slightest discomfort with my breathing but thought it might be related to double masking. Upon driving home, I realized I had non-itchy and non-painful hives on the upper portion of my right cheek and the lower jaw on the left side. As time progressed, the hives disappeared from left side and moved down the right side of my face. After it passed on the right side it reappeared on the left side and followed the same pattern. My dermatographia also returned on my chest and I haven't had an episode of it for over year. The roof of my mouth was also itchy. All hives, itchy mouth, and slight breathing discomfort passed by 7 pm without the use of an antihistamine. No other signs of allergic reaction has been noted since. Breathing concerns passed the quickest (after 2 or so hours), then itchy mouth, and last the non-itchy hives. Other than that, I experienced the common side effect of body aches during the night and pain in vaccinated arm.
About 5 minutes after receiving the vaccine, the individual reported feeling light headed and stated that her "vision wasn't matching up." She was assisted to a laying position and symptoms did not resolve. She was given 50 mg of benadryl IM in her right arm. 15 minutes later, her symptoms resolved and she was able to go home.
Less than 48 hours after I suddenly noticed a raised blister on the inside of my cheek. When I showed my mom she said it looked bright red. It was a symmetrical about the size of a pencil eraser raised spot. It didn?t hurt or itch. That evening raised blister went away and looked like asymmetrical  blood rash under the skin. The next day you couldn?t see anything on inside of cheek at all.