chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx. 15 minutes after injection-student became lightheaded-dizzy-c/o soreness @ injection site. Reclined student on floor. Vitals-148/79, P-90, Temp 98.3. Ice to site. LOC-alert x 3. VS rechecked after 20 minutes-B/P-115/81, P-102. Call made to mother-gave report of student and condition after injection. Student reported sx decreased-"feeling better". Requested to RTC. RTC with instructions to return to nursing office if complications arise.
20 yo M with a medical hx of Congenital myopathy, anxiety, and seasonal allergies who presented for his second Pfizer vaccine. He experienced more anxiety after the dose and mentioned that his throat is littlie itchy. Denies Chest pain, SOB, Palpitations, dizziness, or rash. His Vital signs were stable O2 99% RA, HR 73, BP 124/84. Exam were unremarkable, Uvulae midline and no throat swelling, Lung clear to auscultation b/l, and no rash. Received 25 mg IM Benadryl and felt much better. Observed in tent for 30 min
some mild congestion; chills; pain at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (some mild congestion), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site.) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 20-Apr-2020.  On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Sep-2022, the patient experienced NASAL CONGESTION (some mild congestion), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site.). At the time of the report, NASAL CONGESTION (some mild congestion), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site.) outcome was unknown.     It was reported that, patient was less than 50 years old. No concomitant information provided Patient received 1st dose: 10Apr2021 with Lot: 037B21A Patient received 2nd dose: 09May2021 with Lot: 048B21A Patient received 1st booster: 21Nov2021 with Lot: 067F21A No treatment information provided   This case was linked to MOD-2022-650968, MOD-2022-651006 (Patient Link).
C/O difficulty breathing, slight dizziness. Had pt. sit down for a few minutes, gave juice. BP 132/50, HR 60, R 16. Tolerated juice well and reported that dizziness was gone and breathing eased. Lungs clear, no wheezing noted.
This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a female subject of unspecified age who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of H1N1 (unknown route, site of injection and batch number). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine at an unspecified trimester. At an unspecified time after vaccination with H1N1 and prior to 20 weeks gestation, the subject experienced spontaneous abortion. This case was assessed as medically serious by GSK. This case in linked to 27 other cases (related by publication). Summary of the article: The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remain less than optimal. Surveys have demonstrated that mothers' concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 pandemic season, when lack of safety data about the pandemic H1N1 (pH1N1) monovalent vaccine was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information on pH1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. To assess risks and relative safety of the pH1N1-containing vaccines, the author conducted a prospective cohort study of pH1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. There were 1032 subjects available for analysis; 841 women were exposed to a pH1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Patient taken to ED on 02/10/18. Vaccine given 02/09/18. From ED note: Rt. arm is red, warm and markedly swollen. Pt. given acetaminophen and diphenhydramine.
Low grade headache and nausea started shortly after the vaccine administration. On 11/12, started to have bright flashing vision and numbness in right knee with leg weakness. Also experienced twitching of eye muscles and odd sensation in right forearm. Father and sister also got flu shot at same time with no issue.
fatigue, headache, night sweats, chills, nausea intermittent since COVID vaccine 04/05/2021.
light area/pale spot on her arm; Burning; Itching; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (light area/pale spot on her arm), SKIN BURNING SENSATION (Burning) and PRURITUS (Itching) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (light area/pale spot on her arm), SKIN BURNING SENSATION (Burning) and PRURITUS (Itching). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (light area/pale spot on her arm), SKIN BURNING SENSATION (Burning) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Swollen lymph node in left arm pit; Fever; cough; headache; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the  second dose of BNT162B2 (Solution for injection, lot number: EL3248, Expiration date; unknown), in the left arm on 08Feb2021, 05:00 AM at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EL3248) left arm on 30Jan2021, 05:45 AM at single Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not have allergies. The patient experienced fever, cough, headache body aches and chills on 08Feb2021 at 12:00 AM. The patient was recovering from the events. On the next day, patient reported swollen lymph node in left arm pit on 09Feb2021 at 05:00 PM, the outcome of event were not recovered. Adverse event resulted in emergency room/department or urgent care. The patient performed ultrasound blood tests and received Motrin prescription for the adverse event another event fever, cough headache, body aches chills on 08Feb2021 at 12:00 AM. Patient did not receive any vaccine in four weeks. and did not have covid prior to vaccination.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a consumer refers to a 76 year old male patient with paroxysmal nocturnal hemoglobinuria (PNH). On an unknown date the patient was vaccinated with PNEUMOVAX23, lot#, dose, frequency unspecified. Other suspect therapy included intravenous SOLIRIS for paroxysmal nocturnal hemoglobinuria (PNH) (dose, frequency and therapy dates were not provided). Therapy with SOLIRIS was ongoing. On an unknown date the patient experienced cellulitis after he received PNEUMOVAX23. He was subsequently hospitalized. The patient was discharged from the hospital and the cellulitis resolved. Additional information has been requested.
Did not take her last dose; Took Vivotif on day 1,4, and 6; Spontaneous report received on 17DEC2019.  A caregiver (consumer's mother) reported that her 17-year-old daughter "took Vivotif on day 1, 4, and 6" (PT: Inappropriate schedule of product administration) and she "did not take her last dose" (PT: Product dose omission), while being on Vivotif for immunization . The consumer did not take doses according to the schedule. The three doses were taken on 09DEC2019, 12DEC2019 and 14DEC2019, respectively. Moreover, she did not take her last dose that was scheduled on 16DEC2019. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer took Vivotif doses on day 1, 4, and 6 (Inappropriate schedule of vaccine administered) and she also did not take her last dose of Vivotif (missed dose). Considering the nature of the events, the causality of both the events is assessed as not related to Vivotif.; Sender's Comments: A consumer took Vivotif doses on day 1, 4, and 6 (Inappropriate schedule of vaccine administered) and she also did not take her last dose of vivotif (missed dose). Considering the nature of the events, the causality of both the events is assessed as not related to Vivotif.
dizziness, brain fog 12/2020 - 4/2021 nauseous 2/2021 - ongoing chills/weakness at night 1/2021 - ongoing palpitations 1/2021- ongoing but better headaches/migraines 1/2021 - ongoing  Started Elavil imbalance, falling backwards, swaying side to side 1/2021 - 3/2021 loss of words 1/2021-2/2021
Day after Tdap administered noticed redness, pain, induration and warmness at site of injection.  No fever noted
3rd rabies shot after exposure to bat-brushed against her head. Pt had fever, shaking chills x 1 day . Temperature 101 F.
Fever, fatigue, aches and pains, headache, slight nausea/loss of appetite for approximately 36 hours
Information has been received from a 71 year old female who on 05 -JAN-2009 or 06 -JAN-2009 was vaccinated with a dose of ZOSTAVAX (Merck) at a pharmacy. There was no concomitant medication. On approximately 05-JAN-2009 or 06 -JAN-2009 "right after getting the vaccine" she was still experiencing pain in her arm, it seemed like she could not get any movement out of her arm, it was achy and she had trouble lifting it. The pain seemed to be going to her shoulder. The patient's pain in her arm and any movement out of her arm persisted. Unspecified medical attention was sought. Additional information has been requested.
Fever as high as 102.4; cough; spitting of phlegm to clear lungs; Runny nose; Grogginess; aching knees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever as high as 102.4"; COUGH (non-serious), outcome "unknown", described as "cough"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "spitting of phlegm to clear lungs"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; SOMNOLENCE (non-serious), outcome "unknown", described as "Grogginess"; ARTHRALGIA (non-serious), outcome "unknown", described as "aching knees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient had cough, spitting of phlegm to clear lungs, runny nose & grogginess. Patient had a fever lasting 62 hours (uses Tylenol sporadically to break fever) fever got as high as 102.4 & aching knees. Phlegm that drains into lungs while sleeping. Must sleep sitting up partially.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient began having abdominal pain in lower right quadrant 5 minutes after receiving vaccine.  pain scale 6, constant, and lasted for 40 minutes while patient was in the store.  Patient walked around but standing and walking did not relieve the pain.  Patient's primary care doctor office was contacted and patient was directed that if the pain continues for 1 hour total, if patient could not stand up straight or urinated blood or symptoms worsened to go directly to ER.  Patient  left store shortly thereafter.
A report has been received from a Health Professional concerning a female patient, Height: 118.1 Centimeter; Weight: 43.0 Pounds, who had been receiving Nasal FLUMIST Quadrivalent, 0.2 milliliters, once/single administration. FLUMIST Quadrivalent started on 16-NOV-2015. The patient received FLUMIST Quadrivalent on 16NOV2015 after temperature excursion of 34.7 Fahrenheit for 20 hours. FLUMIST Quadrivalent was discontinued on 16-NOV-2015. The outcome of the event of consumer received FLUMIST Quadrivalent on 16NOV2015 after temperature excursion of 34.7 degrees Fahrenheit for 20 hours was unknown. The report was considered to be non-serious.
Chills; A spontaneous report was received from a Consumer concerning a 81-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot batch: 041LZ019) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 3 Feb, the outcome of events, chills, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Redness and swelling at site. Pt c/o itching. Right site -> approx 5.5 cm round left site -> approx 2 cm round.
Information has been received from a female healthcare worker, who on 5/6/2005 was vaccinated with varicella virus vaccine live. On 5/18/2005 she developed a 3 area of hives at the injection site. No other symptoms were noted. At the time of this report, the patients present status was recovering. There was no product quality complaint reported. Unspecified medical attention was sought by the patient. Additional information has been requested.
VOMITING (VOMITED TWICE); NAUSEA; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to cipro, fibromyalgia, and trigeminal neuralgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-AUG-2021, the patient experienced vomiting (vomited twice). On 10-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and vomiting (vomited twice). This report was non-serious.
Patient appeared to "pass out" after 2nd GARDASIL vaccine. Mother reports her "eyes rolled back, hands and arms were clinched and arms stiffened". Episode last 2 minutes. Pt. observed and vitals obtained for 10-15 minutes. Walked out of clinic and "passed out" again. No seizure activity 2nd time.
Dizziness, Myalgia, Arthralgia, NauseaVomiting, Reports passed out hitting head on counter causing laceration Narrative:   Other Relevant History:
"Pfizer-BioNTech COVID-19 Vaccine EUA"        Exagerrated numness on the left side of my face from ear to mouth
Nauseous; upset stomach; little tired; little lightheaded; Runny nose; little hyper; my heart rate was raising; Not my arm even hurt that much; I feel like cold; got sick; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 73-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6203), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at age of 73-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure, blood cholesterol and thyroid disorder. Concomitant medication(s) included nadolol (NADOLOL) taken for blood pressure, pitavastatin calcium (LIVALO) taken for blood cholesterol, levothyroxine (LEVOTHYROXINE) taken for thyroid disorder and amlodipine (AMLODIPINE) taken for blood pressure. The patient experienced nauseous, upset stomach, little tired, little lightheaded, runny nose, got sick and little hyper on an unspecified date. The patient reported that "When I got the vaccine I just felt a little tired, a little lightheaded, that was all I experienced". After vaccination: The arm did not bother her much, she felt just a little tired and had a runny nose "could be allergies". "On Saturday I felt the same way". On Sunday night: "I felt a little nauseous and felt a little hyper and my heart rate was raising but all went away and my stomach has been bothering me it felt like a virus (infection) but I feel better today". The patient stated, "I got my Covid shot on Wednesday and I don't, I don't "tired" (not clarified) whatever but I did not feel a bit, not my arm even hurt that much but yesterday I have a runny nose, I feel like cold and I felt the cold coming on and then last night it was very nauseous and I had both so it was very nauseous last night this was I had it Wednesday, so that was last night was Sunday night I felt a little nauseous I was wondering if that's the effect of the vaccine or maybe I got the cold.". The patient also stated "I am not experiencing the problem anymore. I just wanted to call up to see if that was a side effect, I had it last night and it went away, I just was curious if that was a side effects that was the reason of phone call." The patient didn't receive any treatment medication for the events. The events outcome was reported as recovered on an unspecified date of 2021.  No follow up attempts are possible. No further information is expected.
Information has been received from a physician concerning a pt who on an unknown date was vaccinated with MMRII (Lot # not reported). Subsequently the pt developed redness (location unspecified).  The pt sought unspecified medical attention. At the time of this report the outcome was unknown.  Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 62-year-old male patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. Co-suspect products included SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis and FLUZONE (INACTIVATED INFLUENZA VACCINE)) (batch number U1986AB, expiry date 30th June 2019) for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX. On 28th August 2018, the patient received the 2nd dose of SHINGRIX and the 1st dose of FLUZONE (INACTIVATED INFLUENZA VACCINE) (intramuscular). On 9th October 2018, 103 days after receiving SHINGRIX and 42 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on an unknown arm. The patient received FLUZONE shot on the other arm. On 9th October2018, the patient was diagnosed with shingles. This case was considered as suspected vaccination as confirmatory laboratory test for shingle was not provided. It was unknown if the reporter considered the shingles to be related to FLUZONE.
PT PRESENTED SWOLLEN INJECTION SITE, ABOUT 5 INCHES IN DIAMETER. IT WAS ALSO RED AND WARM.
hearing loss in high frequencies; developed tinnitus; She was very depressed; This is a spontaneous report from a contactable consumer (patient) via Medical information team reported for herself. A 76-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Right on 10Mar2021 09:22 (at the age of 76-years-old) (Batch/Lot Number: EN6206) as SINGLE DOSE for covid-19 immunization. Medical history included immunodeficiency, respiratory disorder, cytogenetic abnormality, endocrine disorder, diabetes mellitus, obesity from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had first shot of vaccine on 10Mar2021 and was due for her second on 01Apr2021. Within 2 days of receiving it, she got Tinnitus and was still experiencing ear ringing. She had already spoke to HCP. She was very depressed that she may have this side effect forever. She asked if anyone else had reported this side effect. She doesn't know if it was a side effect. She was wondering if she should get second shot or will anything worse happen. There was no prescriber. It was either 12Mar2021 or 13Mar2021, that she noticed it. For tinnitus she did not pay a lot of attention until Sunday, so she knew she got it on Saturday, or Friday, unknown time. No ER or physician's office required. She did make an appointment with an ENT and audiologist on 24Mar2021. Patient did not know if it had anything to do with the vaccine. No infection. Somewhat of hearing loss in high frequencies, but she did not need a hearing aid. There were no prior Vaccinations (within 4 weeks) and no lab tests reported. Outcome of event tinnitus was reported as not recovered and outcome of event deafness and depressed mood was unknown.
Information was received from a non-pregnant female patient of unknown age referring to herself. The patient was taking medication for heart condition, diabetes, and acid reflux and was allergic to sulfa. In May 2015 the patient was vaccinated with ZOSTAVAX vial (strength, dose and route unknown) in the right arm at a pharmacy. Concomitant therapies included LIPITOR, NEXIUM and TOPROL XL tablets. On 22-AUG-2015 the patient developed a burning rash on her right shin and was diagnosed on 24-AUG-2015 by her physician as having shingles. The patient visited the physician's office and got prednisone (manufacturer unknown) and TERRASIL (an over the counter ointment) for treatment. No lab test was performed. The outcome of the event was reported as recovering. Additional information has been requested.