chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose in 2019, did not receive second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The patient did not receive his second dose of Shingrix. No additional details were provided by the patient. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Joint pain, dizziness, falling due to dizziness, fatigue, headaches, worsening depression with suicidal ideation, lasting several weeks to more than 2 months.
The day after receiving the injection both arms would tingle and have a vibration feeling at intermittent times. The tingling and vibration lasted for approximately a week after the injection. Now I keep having an intermittent tingling sensation to my Left shoulder blade. This has been happening intermittently for approximately 2 months.  I do not have a primary physician, only an OBGYN, so did not follow up with a doctor regarding this issue.
A severe itchy rash began on the ears and spread to the neck, face and upper back.  Hydrocortisone helped but only temporarily. After 2nd dose, rash on hands and has continued months after the vaccine and has skin discoloration on part of hands and neck.  Skin appears to be extremely dry/scaly.
No additional AE; Patient had been given a dose of ROTATEQ six days early on 28-OCT-2021 after receiving the first dose of ROTATEQ on 06-OCT-2021; This spontaneous report was received from a nurse and refers to a 4 months old patient of unknown gender. The information about patient's concurrent condition, medical and drug history and concomitant medications were not provided.  On 06-OCT-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2ml, orally ( lot number and expiration date were not reported) for prophylaxis. On 28-OCT-2021, the patient received second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at the dose of 2 ml (lot number and expiration date not reported); six days early after receiving the first dose (Inappropriate schedule of product administration). No additional adverse event (AE) reported.
A patient received a booster dose of moderna vaccine 4 to 5 days earlier than the 5 months waiting time/A patient received booster dose early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received a booster dose of moderna vaccine 4 to 5 days earlier than the 5 months waiting time/A patient received booster dose early) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received a booster dose of moderna vaccine 4 to 5 days earlier than the 5 months waiting time/A patient received booster dose early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A patient received a booster dose of moderna vaccine 4 to 5 days earlier than the 5 months waiting time/A patient received booster dose early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  It was unknown when the patient received the first and second dose of vaccination.  No Treatment medication reported.
left shoulder where the vaccine was put in his shoulder has been sore; Patient was in bed; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: EN6200; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 21Feb2021 13:30 (at the age of 90-years-old) at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously got the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; EL9265, expiration date was 31May2021), via an unspecified route of administration, in Arm Left on 31Jan2021 at dose 1, single for covid-19 immunization. The patient probably had a little sensation on the vaccination day but left shoulder pain started the next day after the second shot and has not gotten better, has not gotten worse on 22Feb2021. Patient was in bed. Caller stated the left shoulder where the vaccine was put in patient's shoulder has been sore and tried a hot water bottle, it did not help. The most recent vaccine was administered at the Forum, it was a big round building. Patient got no other vaccines the same day. The events not resulted in Emergency Room and Physician Office visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. They do not have a primary care physician. Patient goes to a heart specialist and if they have a certain thing they go to a specialist for that. Caller asked if shoulder pain after the vaccine has been reported by other people. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
9/11/21 the patient had some hives on left arm, patient took 12.5mg benadryl, the hives went away. 9/13/21  hives  on stomach and chest daily , took benadyl 1-2 times per day
itching on the injection site; swelling on the injection site; redness on the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2021) for prophylaxis.   On 10th February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient experienced a reaction (itching, redness and swelling) on the injection site after vaccination with Shingrix. The reporter consented to follow up.
Nausea, aching, flu like symptoms, vomiting diarrhea for two days.
TOP LIP WAS SWOLLEN AS MY LOWER LIP; CHILLS; HEADACHE; RINGING IN EAR; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: not reported) dose was not reported, administered on 12-MAR-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 22:30, the subject experienced ringing in ear. On 12-MAR-2021 22:30, the subject experienced chills. On 12-MAR-2021 22:30, the subject experienced headache. On 13-MAR-2021 14:30, the subject experienced top lip was swollen as my lower lip. On 13-MAR-2021 15:30, treatment medications included: ibuprofen. On 13-MAR-2021 17:30, treatment medications included: diphenhydramine hydrochloride. On 30-MAR-2021 17:30, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in ear, chills, and headache on 13-MAR-2021, and was recovering from top lip was swollen as my lower lip. This report was non-serious.
Case number PHHY2013US117484 is an initial report received from Vaccine Adverse Event Reporting System (VAERS reference number: 482627) on 15 Oct 2013. This report refers to a 64-year-old female patient. Historical drugs of this patient include atenolol, dyazide, hydrochlorothiazide, flu vaccine, lisinopril, nifedipine and simvastatin. Current condition of this patient includes hypertension, pre diabetes, obesity, hypercholesterolemia and cardiomegaly. Concomitant medications include acetaminophen, omeprazole, irbesartan and metoprolol. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date. She developed allergic reaction to that vaccination on an unspecified date. Outcome of the event, seriousness and causality were not reported.
Johnson & Johnson Vaccine on Saturday, April 10, 2021 - 1 p.m. 11 p.m.: Sharp pain inside of L thigh Sweats, Chills, escalating fever All night, fever increasing to 103 High blood pressure 160/130 Sweats Lymph nodes very swollen No sleep overnight   Sunday, April 11, 2021 Aches and pains both legs Fever continued through Sunday 100F Migraine started at daybreak, lasted all day (Lots of Tylenol and Advil, alternating) Arm with shot started to hurt Few hours of sleep was interrupted again by inside thigh sharp pain in L leg  Monday, April 12, 2021 Running fever 100 Blood pressure high Arm started to show rash in the evening Woken up with sharp pain in L leg. Caused limp all day Monday. Fever broke Monday evening.  Tues., April 13, 2021 Sharp pain in L leg Leg felt hot Called physician, no return call Called pharmasist, told me to go to ER due to J&J Blood clot potential issue and my symptoms Went to the ER, long wait to get an ultrasound on L leg to make sure blood flow normal Released Didn't sleep well. Continued to have leg pain took advil to get rest  Wednesday - Thursday, April 14-15, 2021 Felt sore on leg, went about my day normally Was in Bed at 11 p.m.  Friday, April 16, 2021 Was woken by sharp pain under L armpit 1 a.m. and left arm hurt/sore Took Tylenol and Heartburn meds had trouble falling back asleep Fell asleep 4 a.m. Woke up 8:30 a.m. with sharp pain under armpit still Blood pressure 145/112, ten minutes later 145/108 Called my physician again and they told me to drop everything and goto a different ER to get an angiogram done - The first ER did almost nothing that needed to be done according to the physician.
Information has been received from the author of the literature article titled above. Human papillomavirus (HPV) was a common sexually transmitted infection and the causative agent for cervical cancer, a frequently occurring malignant disease among women in developing countries. The reporter assessed GARDASIL provision to female entertainment and sex workers (FESW). The study population consisted of a convenience sample of 220 FESW, who participated in the Study which was a prospective study conducted from August 2009 to August 2010 on the prevalence and incidence of sexually transmitted inflections (STis) and HIV, sexual behaviours, reproductive health practices, drug use, and sociocultural determinants of HIV infection amongst FESW. At baseline, only 23.65 of the study population (N=52) had heard of HPV. Of the 220 women participating in the YWHS-2 study, 192 returned at three months and 191 completed the pre-vaccination knowledge and attitude survey. On 192 participants attending the first quarterly cohort visit where vaccine was offered, 149 (78%) were eligible for vaccination (HIV negative); HIV-positive (n=32) and pregnant (n=11) women were excluded. Out of the 149 women who received the first dose of the vaccine, 138 (92.6%) returned in two months and 11 (7.4%) women were lost to follow up. Of the 138, three women had become pregnant and were ineligible to continued the vaccine series. For the third and last vaccine administered at month six, 123 (91.1%) women of the 135 who had received the second vaccine returned, and 118 received the third and final dose. Five additional women had become pregnant during the interim period and were not eligible for the final vaccine visit. The overall vaccine series completion rate among vaccine initiates was 79.2%. Women who reported use of amphetamine-type stimulants had significantly and independently lower odds at vaccine completion (adjusted odds ratio [AOR] 0.24; 95% confidence interval [C1] 0.08, 0.69). New pregnancies also had an impact on vaccine completion: 5.4% (8/149, 5.4%) who started the series had to stop due to new pregnancy. Results demonstrated the effectiveness of a simple education intervention designed to increase human papillomavirus knowledge and the feasibility of unsuccessful human papillomavirus vaccine in a population that was often difficult to engage in preventive health care. This case refers to 3 female patients of unknown age who was enrolled in the YWHS-2 study On unknown dates the patients received the first dose of GARDASIL (lot#, dose and route not reported). On unknown dates (in two months after vaccinations) the patients became pregnancy and were ineligible to continue the vaccine series. The pregnancy outcome was not reported. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Patient had seizures for 10 minutes or so roughly 10 minutes following influenza immunization.
saw reports of Cerebral Palsy and feels she is heading in that direction; Face not completely drooping yet, but feels heavy/since the vaccine she has developed drooping of the face; Face is heavy on right side; severe migraine; Shoulder pain; Difficulty keeping right eye open; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on Jun2021 at 16:00 as dose 1, single for COVID-19 immunization at a pharmacy. The patient has no medical history, family history relevant to the events, and concomitant medications. No other vaccines taken 4 weeks prior to vaccination and on the same day with bnt162b2 vaccine. On an unspecified date, the patient reported that since the vaccine she has developed drooping of the face and severe migraines. The patient added that her face is not completely drooping yet, but has felt heavy on the right side of about the last 4 days, feels a lot of shoulder pain where she got the injection, and finding it hard to keep her right eye open in the evenings. She states that these symptoms have worsened, it is getting worse as it was also happening in the evenings and it now happening earlier in the day. The patient had a telehealth appointment with a physician but the doctor is not able to help her and wants to know if Pfizer is responsible. The patient added that she may go to the emergency room once she finishes talking to call handler. She saw reports of Cerebral Palsy and feels she is heading in that direction and states the doctor mentioned she might need steroids in her face if it is cerebral palsy. She would like some assurance that she is not going to end up with like a 3000 dollar bill for doing what she was supposed to do. States she has read articles about side effects and assumes that they would not be left high and dry. The outcome of the events was not recovered at the time of reporting.   Information on the lot/batch number has been requested.
Status post flu vaccine, approx. 6-7 hrs. post, experienced upper respiratory constriction. She was able to take breaths. These symptoms lasted approximately 7 hrs. Patient used albuterol inhaler, took Benadryl PO, and Benadryl cream, topically.
Pt had "welts" over the torso and arms, they weren't apparent at bedtime the day of vaccination, but were present when she woke up. She said they weren't terribly itchy, just looked bad.
BODY ACHE; FEVER (103 F); This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no pertinent medical history. The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, intramuscular, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced body ache. On 05-MAR-2021, the subject experienced fever (103 F). Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache, and fever (103 F) on 07-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210557887.
Expected side effects of fever, joint pain, chills, and severe headache.  Out of work for 48 hours. The issue is that the individual received 2nd dose only 14 days after 1st dose. 1st dose given 12/28/2020 @ 10:40 AM
Sore vaccine site, body aches, mostly behind neck and headache, fever of 101.3
Near syncopal episode after COVID-19 vaccine 1st dose.  Patient became dizzy and lightheaded.  Patient reports similar responses to injections in the past. Hypotensive early on but returned to WNL.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from office staff. This case involves 20 month old female patient who received FLUZONE QUADRIVALENT (batch number UI982AC, expiry date, not reported) intramuscularly in right deltoid on 08 Oct 2018. Concomitant vaccine included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE. It was a case of actual medication error due to vaccine overdose as 1 year 8 month old female child was given a FLUZONE QUADRIVALENT 0.5ml injection on 08Oct2018. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
sweaty; flushing; Hardly move; Passing out; Chills; shakes; My arm started hurting; This is a spontaneous case received from a contactable consumer (patient reported for herself). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EN6198, expiry date not reported), via an unspecified route of administration on 01Mar2021 at a single dose for Covid-19 Immunization. Medical history included Covid and been in the hospital because of that, from Nov2020 to an unknown date. The patient's concomitant medications were not reported. Patient just had a question here about the shot, first shot on 01Mar2021 and arm started hurting, no big deal, 7 o' clock at night, patient got shot in the morning, and took Tylenol then about 9:30 at night, patient got chills and the shakes and at 3:30, the next morning (02Mar2021), patient got all sweaty and flushing everything. On 02Mar32021, patient was passing out, and son was trying to give patient the stuff.  Patient did have Covid back in Nov2020 and had "rubbed out swab and the passing out stuff". Patient actually had been in the hospital because of that. It was exactly the same symptoms that patient had when patient got the shot. Patient did not know if patient should get the second shot and asked if those were going to happen again. Patient said that it was so scary when passing out like that. Patient just did not know what to do and then called the next day cannot, "hardly move" (02Mar2021). Patient asked if it was alright if patient just talk to the physician and will just call doctor. Patient asked if patient should get the second shot or if it was going to happen again. Therapeutic measure were taken as a result of the events arm started hurting and passing out. The outcome of the events reported was unknown.
fever; chills; myalgias; some sensory changes to the left arm; This is a spontaneous report from a contactable pharmacist. An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Dec2020, at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if patient was pregnant or not at the time of vaccination. Patient denies any history of vaccine associated reactions. Patient previously took Vancomycin and experienced allergy. Patient did not have other vaccine in four weeks. It was reported that after her first dose of the COVID vaccine she had fever, chills and myalgias as well as some sensory changes to the left arm on an unspecified date. Patient visited physician office for chills and sensory changes to the left arm, visited emergency room for myalgias. These symptoms lasted for around a day before resolving. It was unknown if patient had COVID prior vaccination or if patient tested COVID post vaccination. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
Injection site ached a little bit; This is a spontaneous report from a contactable consumer. The consumer reported similar events for 2 patients (himself and wife). This is second of two reports. This consumer reported for a 83 year old female patient (wife). An 83-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Feb2021 (at the age of 83 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past vaccination history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date. On an unspecified date in Feb2021, the patient experienced  injection site ached a little bit (duration about 12 hours). The clinical outcome of injection site ached a little bit  was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194850 same reporter/drug/AE, different patient