chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 4 years ago, didn´t received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix four years ago).   On an unknown date, the patient received 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 details provided were as follows: Age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The health care professional did not provide any information about vaccination date or patient. The patient was not interested in having a conversation, it only required information about revaccination. The reporter denied to follow-up.
DIZZY AT THE SAME TIME; BODY GOT HOT AND SWEATY AND GRADUALLY GOT WORSE OVERNIGHT; PROBLEM TALKING, WAS TRYING TO SAY WORDS AND COULD NOT GET THE WORDS FULLY OUT; BODY CHILLS; NAUSEOUS ALL DAY AND THREW UP A COUPLE OF TIMES LAST NIGHT; WHOLE HEAD HURT EVEN THE SLIGHTEST MOVEMENT; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included: abdominal blunt force trauma, and surgery for abdominal blunt force trauma, and concurrent conditions included: steroid allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced dizzy at the same time. On 15-SEP-2021, the patient experienced body got hot and sweaty and gradually got worse overnight. On 15-SEP-2021, the patient experienced problem talking, was trying to say words and could not get the words fully out. On 15-SEP-2021, the patient experienced body chills. On 15-SEP-2021, the patient experienced nauseous all day and threw up a couple of times last night. On 15-SEP-2021, the patient experienced whole head hurt even the slightest movement. The action taken with covid-19 vaccine was not applicable. The patient recovered from problem talking, was trying to say words and could not get the words fully out on 15-SEP-2021, and had not recovered from nauseous all day and threw up a couple of times last night, body chills, whole head hurt even the slightest movement, dizzy at the same time, and body got hot and sweaty and gradually got worse overnight. This report was non-serious.
WHILE ADMINISTERING INFLUENZA VACCINE, THERE WAS LEAKAGE FROM THE PREFILLED SYRING. PATIENT DID NOT GET THE ADEQUATE DOSE
VACCINATION SITE ERYTHEMA (SCRATCHED IT MADE RED INFLAMED MARK); This spontaneous report received from a consumer via a company representative concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccination site erythema (scratched it made red inflamed mark). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccination site erythema (scratched it made red inflamed mark). This report was non-serious.
Rash - started 2 days after injection. Papular rash w/o erythema at site of injection.
Information has been received from a health professional concerning a male pt who in 04/17/2000 was vaccinated with a dose of varicella virus vaccine. On 01/21/2002 the pt developed chickenpox with about 15 lesions that were itchy. No other symptoms were reported. Unspecified medical attention was sought. Additional info has been requested.
Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours). On 31-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the vaccine from a vial that was punctured and stored for greater than 12 hours) had resolved.        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.   Concomitant product use not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up: Event term updated. On 11-Aug-2021: Follow up received on 11-AUG-2021 contains non-significant information.
Resident found unresponsive without a pulse at approx. 0730am on 9/22/21, CPR initiated, spouse chose to discontinue CPR, resident expired.
Developed meningitic like illness while out of state. Ultimate diagnosis is Acute Disseminated Encephalomyelitis (ADEM). Had ataxic gait, stiff neck with deviation to one side and severe pain in her neck. 6/11/09 MR received for DOS 5/31/09-6/09/09 with final DX:  ADEM, suspected triggers-infection, pneumonia or immunizations..  Pt initially presented with c/o neck pain and stiffness, abdominal pain, irritability, myalgias, gait disturbance and pain in the arms, legs. Initially thought to be menigitis with photophobia. PE(+) for abdominal tenderness, lymphadenopathy, torticollis, (+) Kernig's and Brudzinski's signs and wide based gait. Tx: steroids. 09/29/09 D/C summary received for date of service 6/1/09 to 6/9/09. D/C DX: Acute demyelinating encephalomyelitis.
At time of injection and for about 30 minutes after, had light tingling to left arm to fingertips, face flushed and warm. Resolved without intervention. No other side effects except muscle soreness to this arm. ( Wouldn't report but a coworker had a similar but more severe reaction and is still having effects 3 wks out)
Patient received vaccines, 5 minutes later he was noted to be pale, complained of headache and nausea. Was laid down on exam table, BP 96/60, assessed by MD. Still pale but talkative. Fully recovered and was discharged from office approx 30 mins after vaccine administration.
Nurse manager discovered while auditing charts with nurse that she had punctured a vial of Moderna on 10/26/2021. She placed the vial in the vaccine fridge and proceeded to pull a dose from same vial on 11/03/2021.  This dose was administered outside the recommended time after puncture.  Patient remained in clinic x 20 minutes with no s/s reaction and no reports up to now.
4/4/12 - shot given. 4/8/12 - nausea/vomiting started - Pt states losing hair - weight loss noted by Pt & could not take oral DM meds.
Chills, Headache, Lethargy, Nausea,  Lip Swelling progressing from bottom left lip ... all of these symptoms 15 hours after vaccine.  Then right bottom lip 34 hours after , top lip fully swollen by 40 hours after injection. All symptoms subsided at 48hours EXCEPT top and lower lips still very swollen despite Zyrtec daily and Benedry one dose before bed on 2/9.  Past history of this injections.  Aug 4, 2020 I had Juvaderm Volbella injections around my lips.   I called my Dr Office and got a Medrol Dose pak
This spontaneous report was received from a licensed practical nurse, referring to a 17 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 06-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. There was no relevant medical history or drug reactions/allergies reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were specified). On 28-JUL-2015 the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (second dose, lot number was J007682 and expiration date was 13-JUN-2015, dose and route were unspecified). No adverse experience reported. Additional information has been requested.
Patient complained of feeling tingly/itchy after 20 minutes in waiting/observation area. Patient stated itchiness was widespread, especially over arms, also on nose. Patient while waiting stated her lips and ears started to itch. Patient given IM Benadryl by EMT on site.  Patient states that her discomfort level had increased from a 1 to a 5. Patient continued to deny any itchiness/tightness of throat or difficulty swallowing. About an hour later, patient states she feels much better but getting tired. Advised patient to have sister drive her home. Patient states itchiness was very mild at this point. Patient instructed on when to take next benadryl if needed and to call 911 or go to hospital if condition worsens.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown), in right arm and on 10Jun2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 05May2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: Hashimoto; "rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Jun2018, stop date: 23Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (21Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Anti viral details: product=COVID 19 Treatment, brand=Paxlovid, Treatment start date=05Jul2022, Treatment stop date=09Jul2022, Lot number=GA8849, Indication=Treatment of COVID-19. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: Yes. Reported Event: Covid test became negative after taking paxlovid. Then I received my orencia treatment. Then I began to feel sick the next day and tested positive for Covid. My symptoms were WORSE than the first time I had Covid for which the paxlovid was prescribed. Adverse event start date: 20Jul2022. Adverse event start time: 04:00 PM. If patient recovered: Not recovered. If treatment ae: No. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
she received a flu vaccine in the past and got sick in her stomach which caused her to miss a week of work; caused her to miss a week of work.; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 74-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced upset stomach (Verbatim: she received a flu vaccine in the past and got sick in her stomach which caused her to miss a week of work) and inability to work (Verbatim: caused her to miss a week of work.). The outcome of the upset stomach was unknown and the outcome of the inability to work was resolved (duration 1 week).   It was unknown if the reporter considered the upset stomach and inability to work to be related to Flu vaccine.     It was unknown if the company considered the upset stomach and inability to work to be related to Flu vaccine.   Additional Information: GSK receipt date: 16-MAY-2023 The reporter was the patient, who stated that she received a flu vaccine in the past and got sick in her stomach which caused her to miss a week of work.  She did not know the name of the vaccine or the manufacturer.  The reporter was consented to follow up
Patient received Moderna booster,  Patient is not 18 and not eligible to  receive Moderna and should have received 12+ Pfizer.
patient received moderna bivalent booster from the previous day (it was at room temp>12 hours)
At 18 months, stopped making eye contact, completely withdrawn, speech stopped, bizarre behavior exhibited, unusual bowel movements, much screaming for no apparent reason and hand flapping.Doc 211313 states the followings: cognitive development compromised, stopped, interrupted. Diagnosed with PDD Annual follow up states, prior to administering of vaccinations our child was prone to have weakened immune system. Upon receiving vaccines (with mercury) or the virus itself was too much for her system to handle therefore interrupting her normal developmental process. She displays many symptoms of a mercury intoxicated subject. Please re-examine your aggressive style of vaccinationg infants and children obviously they are not safe for everyone. We would apprciated any information for obtaining funds to help feed and maintain our daughter to improve her quality of life.
Patient reports a non-painful, red rash that appeared on upper arm around vaccination site that appeared 7 days after vaccination. She states it lasted about 24 to 48 hours before resolving on it's own.
Pt woke up at 3AM today with nausea and headache. Fever this morning. Vom and dry heaves several times. (+) sore throat after vom.
I been having chills and broke out with a rash all over my body that is still ongoing. I have been diagnosed with a fatty liver now. I had to go to the ER for the rash from my head to my toes. I was admitted into the hospital for 6 days. They did blood work and biopsy. They are unsure what is causing this.
About one too two weeks post second shot, I started developing soreness under my arms. I had initially thought that is was possibly pre menopausal. then a week or so later I developed  lumps in my armpits.  I thought this was from my deodorant.  A few days ago I was told that this has been a post vaccine symptom.
Back pain; Fever of 99.2; Aches all over; Fatigue; This is a spontaneous report received from a contactable consumer, the patient.  A 20-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER1741) via an unspecified route of administration in the left arm on 17Mar2021 at 18:15 hours (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypertension, chronic migraines, depression anxiety disorder and allergy to penicillin and lisinopril. Concomitant medications included norgestimate (MANUFACTURER UNKNOWN) and TRI-SPRINTEC, NORVASC and EFFEEXOR for unknown indication from an unknown date. On 17Mar2021, the patient had blood temperature test results given as 99.2 (units unspecified). On 17Mar2021 at 19:00 hours, the patient experienced back pain, fever of 99.2 (unit and reference range was not provided), aches all over and fatigue. The patient did not receive treatment for the events. The clinical outcome of the events back pain, fever of 99.2, aches all over and fatigue was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Red itchy patch about two inches across at the site of the injection. Appeared two days after the injection. I don?t recall a similar reaction after the first dose.
This spontaneous report as received from a Certified Medical Assistant refers to 3 patients of unknown age and gender. On 14-AUG-2014, GARDASIL vials were improperly exposed to 34F for 24 hours. During the time frame of 19-AUG-2014 to 27-AUG-2014, each of 3 patients was vaccinated with one dose of this improperly stored GARDASIL (lot # J010668, expiration date 29-APR-2016, dose was unknown) intramuscular. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 08-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L016428, expiration date 30-JUL-2017 (strength, dose and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
Breakthrough case admission after 3 vaccines Pfizer 4/28/21 Lot# Ew0150;  Pfizer 5/19/21 Lot# EW0158;  Pfizer 12/21/21 Lot# FH8027
On 02/08/23 I started feeling unwell, I had a sore throat, I had a cough with a lot of mucus that I was coughing up. It felt like a cold and stayed in. I was taking TYLENOL cold and flu that was helping to control the mucus. By Friday I still had a sore throat but only on one side and hurt when I swallowed. The mucus just would not go away. I decided to go to the local urgent care over the weekend and was tested for COVID-19, that came back positive. I was given a prescription for PAXLOVID. I started taking it immediately and by the time I finished it in the five days I was better.
pt recv vax & woke w/hives & facial edema below lids & upper lip;resolved w/DPh p/24hr;
Myalgia fatigue pain at injection site Narrative:  x4 d after dose #1 pain at site, swelling at site muscle aches; X4 days fatigue muscle pain after #2 dose
Second shot >36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot >36 days) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 091B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot >36 days). On 02-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot >36 days) had resolved.            Treatment information was not reported
Extreme fatigue, hacking productive cough, rhinorrhea. Symptoms resolved within 24 hours with lingering fatigue
Employee recieved Flu and vzv in Right arm and Hep B, MMR and PPD on left arm. On evening of injection date 10/24/17 ee began to feel sore, injection site on right arm was red, warm and swollen to touch. Employee also experienced pain into her right axialla and right breast. I spoke with employee Friday 10/26/17 who reported sx's mostly subsided. No more pain into axilla or breast, injection site still was slightly red and swollen.
Patient experienced a slight increase in body temp (99 F.) the day following the vaccinations. He also felt weakness come on. He has recovered since then.
Woke up early the day after receiving the 2nd shot and was extremely Dizzy & very Fatigued.  This fatigue was similar to what I experienced when I was infected with COVID.  I did not have dizziness when down with COVID. This dizziness following then2nd dose was so severe I was unable to walk without holding on to something or being helped by another person.  Spent 90% of the day in bed getting up to eat a little and use the restroom.
After the 2nd vaccine, Around 2 PM 02/09/2021 I felt really bad. I started getting a fever, had the chills, a bad headache all at the same time. I just felt awful. All of my energy was drained out. My fever kept getting higher. The next morning I decided to take a Motrin and that got my fever down within an hour or so. By 3:00 PM 02/10/2021 everything just went away all at once. It only lasted 24 hours. My period started after I got the 2nd dose vaccine. That month everything was fine but it was the beginning of March that my period started being weird and liquid-y. I know this because I used a menstrual cup, and it was just all over the place and a bright red. It was a week late which is very strange. It lasted the same amount of days it usually lasts. In April it was still liquid-y and weird. In May it got better but it was only four days long. I'm getting off my period right now (06/17/2021)  but this month (June) it's the same consistency but it only lasted 3 days and my period usually lasts 5-7 days. In May I had strep throat and went to urgent care, I tested positive for strep on May 16, 2021.