chrisvoncsefalvay/vaers-outcomes huggingface dataset:
haven't been feeling well; I feel so tired all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 89-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "haven't been feeling well"; FATIGUE (non-serious), outcome "unknown", described as "I feel so tired all the time".  Additional information: She hadn't been feeling well that past 10 days. She felt so tired all the time she did not feel that way. She asked what is happening to her and what they suggest. She also asked if she should take the pneumonia vaccine now or wait.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Tested Positive for Covid19 after receiving first dose of the Covid Vaccine; Tested Positive for Covid19 after receiving first dose of the Covid Vaccine; This is a spontaneous report from a contactable physician (primary care doctor) and other healthcare professional. This physician reported similar events for two patients. This is 1st of 2 reports.  A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, NDC number: 59267-1000-1, Expiry Date: 30Jun2021, Batch/lot number: EN6203) intramuscular in left arm on 28Feb2021 at 0.3mL single for COVID-19 immunisation. Medical history included ongoing diabetic years ago. Concomitant medication included ongoing allopurinol tablet at 300mg once a day. She takes tons of medications but nothing that interferes. She doesn't want to provide them all because she will be here all day. Reporter stated that a couple in their 70s received the Covid vaccine on 28Feb2021 and this past week, they came in here after a Covid exposure and they both tested positive for Covid19 after receiving first dose of the Covid Vaccine on 16Mar2021. They may have cold symptoms. Reporter asked if the couple could still get their second dose of the vaccination next week. The outcome of events was unknown.  Relatedness of drug to reaction(s)/event(s): Reaction assessed: Tested Positive for Covid19 after receiving first dose of the Covid Vaccine; Source of assessment: Primary Source Reporter; Method of assessment : Global Introspection; Drug result: Unrelated.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event COVID-19 and the suspect vaccine BNT162B2.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date (reported as Friday or Saturday), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and dose were not reported). On an unknown date, the patient developed flu-like symptoms, headache, redness and swelling at the injection site. The outcome of flu-like symptoms, headache and redness and swelling at the injection site was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
(L) leg pain - sens. to touch, could not walk on it. No redness, no swelling. Pt. was given MOTRIN -> to hosp. for X-ray in case injury -> pt. was better by the time he returned from X-ray.
Patient complained of redness and muscle aching in area where shot was given and down forearm, right arm.
Moderna booster COVID 19 Vaccine (0.25ml) was administered to patient one month early. Patient received the first Booster dose on 2/17/22. Second Booster dose  was administered on 5/20/2022.  Patient was oriented and alert after vaccine administration. Patient denied any side effects or any adverse reaction. Patient was monitored for an additional 15 minutes
Pt reported  metromenorrhagia starting 3 days post vaccination, prior to regular onset of menses, lasting 3 weeks .  No hx of irregular or heavy menses reported.
A 15 yrs old female patient complained she could not see anything 10 minutes after receiving Pfizer vaccine. She seemed sleepy,and her face looked pale.She was responsive and conscious, She denied difficulty of breathing, She was hot to touch and asked for water. After approximately 5 minutes, her vision was back to normal,and her face color changed to its normal complexion. the patient has not received anything during this period. She was encouraged to be calm and breathe in and out slowly.Vitals not recorded. EMS arrived and patient went to the ER for further follow-up. Patient's mom confirmed patient remains stable an hour after the incident.
Immediately afterwards developed tingling to the corner of her left eye. Patient states over the course of the day she developed numbness to the left corner of her lip and ear fullness. Patient states once in a while she will experience tingling to thenar eminence of her left hand.  Symptoms have improved over the course of 24 hours.  Patient is in stable condition and offers no additional complaints at this time. Informed patient that tingling has been a reported side effect of the vaccine, but it's unclear whether her symptoms are due to the vaccination. Patient wishes to go home.  Discussed with patient diagnostic results and differential diagnosis. Patient advised to return to the ED for new or worsening symptoms. Patient is agreeable with plan for discharge.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on concurrent conditions, medical history and drug allergies of the patient were not reported. On 10-FEB-2016 the patient started therapy with properly stored expired dose of sterile diluent, lot-1004012, expiry date -08-FEB-2016 with ZOSTAVAX (lot, expiry date, dose, units, route and anatomical location were not reported (expired product administered) (wrong technique in product usage process). Concomitant medication were not reported. On an unknown date the patient experienced no adverse event. Additional information has been requested.
pain; cool to touch; redness moved down to the wrist; it was hot; red and hard; site swelled to like a golf ball size; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of   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) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: The follow up received contain email address of the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt is an autistic child who when he received the booster DTaP vaccine shot had a very adverse reaction that has lasted over a month. The reaction was apparent within 2 days of the shot
10/20/09 - Mild erythema + swelling - Reaction occurred morning after vaccine was administered per pt. 10/21/09 - Treatment: Ice, BENADRYL ointment, RTC if symptoms persist.
The pt experienced a rash, the pt sought unspecified medical treatment. Additional information has been requested.
unable to move lt shoulder @ 90 degree angle;no redness, edema or drainage;
Itching along length of arm that was injected shortly after receiving shot. Lasted few hrs. w/o treatment. No other reactions.
Patient given the 2nd Pfizer vaccine 6 days before recommended time between the 1st and 2nd dose.
Fluid retention in my legs, migraine headaches started about 3 weeks after my shot. blisters and skin rashes that were painful.  Excedrin for migraines compression socks to get the swelling to subside'
Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; Fever; sore throat; head congestion; body aches; cough (less severe); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown, Expiry date: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown, Expiry date: unknown), in left arm and on 23Sep2021 at 08:00 as dose 3 (booster), single (Batch/Lot number: unknown, Expiry date: unknown) at the age of 62 years, in left leg for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro"; Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19"; PYREXIA (non-serious), outcome "not recovered", described as "Fever"; OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "sore throat"; UPPER RESPIRATORY TRACT CONGESTION (non-serious), outcome "not recovered", described as "head congestion"; PAIN (non-serious), outcome "not recovered", described as "body aches"; COUGH (non-serious), outcome "not recovered", described as "cough (less severe)". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of pyrexia, oropharyngeal pain, upper respiratory tract congestion, pain, cough.  Clinical course: The patient received Paxlovid as COVID 19 Treatment from Apr2022 to 30Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a 70 year old consumer (height: 5'1 inch, weight: 128lbs) refers to himself. In November 2009 (4 years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route not reported) for prevention of shingles. The patient reported that in November 2013 "now", he thought he had gotten the shingles. The patient had not seen his doctor yet and he was almost sure it was. The outcome of the event was unknown. Additional information has been requested.
Information has been received from a physician concerning a 73 year old female who on an unspecified date was injected with ZOSTAVAX (Merck) (lot number and specific route not reported). A couple of days after receiving the vaccine, the patient developed a rash around the crease of her elbow and the base of her neck, not around the injection site. The patient went to the doctor's office for medical attention. She was given a steroid cream and an antihistamine. Outcome of the event was not reported. Additional information has been requested.
Fever 101.4, increased fussiness, lethargic <24 hours after shot HepB #3.  Tylenol for fever.
Intense itching mostly in torso and upper body.   Has not stopped as of today"s date
I gave the patient their 2nd booster of moderna because they asked specifically for it not the bivalent. No adverse event or symptoms.
Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) 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 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness). At the time of the report, ASTHENIA (Weakness) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA is not applicable.
Pain in arm where the injection was given. Tx=Ibuprofen - one time  400mg. Hurt for 3 days.
After being administered the second covid vaccine, my arm became sore (quicker than it had for the first covid vaccine). 14 hours after the vaccine, I had a temp of 99.8, aches and chills. Later, I had a headache and nausea.
8 x 5 1/2 cm. Red area mildly warm to touch, no fever
The autoimmune diseases I have battled for 35 years had been in remission for over 3 years. Within 18 hours of my first vaccine, I developed mouth ulcers, skin rashes, shortness of breath, and joint pain -- all symptoms I experience with disease flares. Also bruising in several locations. Recovery took 2 weeks and later experienced cold stores and shooting nerve pain on one side of my face.
Flu vaccine given 11.18.2005; bell's palsy noted 11.28.2005. Terms added from Discharge summary rec'd 01/08/2006: Blurred vision, myopathy, facial asymmetry/sr
Patient received HPV vaccine in exam room at 1427. He and family were advised to wait 15 minutes for observation before leaving. Family failed to follow instructions and began to leave once nurse left the exam room. Once in the clinic lobby for check out at 1428, patient reportedly passed out, hitting his knee on the ground.  Doctors immediately present to find patient laying on a bench with eyes closed. Patient is responsive, alert, and orientedx3 with a neurological exam normal, BP 116/70, HR 80, O2 97%. He was supplied with a cold, wet rag to be placed on his head. By 1440, patient is sitting upright in exam room drinking water and eating crackers with no complaints of dizziness, weakness, or nausea. Patient and family successfully left the clinic after the appropriate 15-minute observation period. Patient and family successfully left the clinic after the appropriate 15-minute observation period. On 4/4/23, the mother called the clinic patinet has been expereincing intermittent nausea and dizziness ever since the date of vaccination. She was encouraged to call back later in the day after pateint got home from school to give an update., but she failed to do so. She was also counsled to take him to urgen care if he was still feeling ill after school. Unknown if this was ever done.
Mild soreness and swelling at injection site. Woken in the middle of the night with throbbing arm pain. In the morning patient was cold with the chills no fever and his hand felt funny. He was very itchy. The rash started a little before noon. The doctor on call recommended BENADRYL 50mg every 6 hours. In the afternoon the bottom lip swelled patient's wife called the Dr back and the Dr on call recommended an ice pack. If worse go to the ER. Pt went to ER and received two Epinephrine shots and was observed for 6 hours. He is still on the BENADRYL and will take for a few more days. He is still a little itchy. The majority of the itchiness is gone.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 7/29/2022,  3/9/2023,  3/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Menveo + Reconstitution of powder portion with sterile saline water; Menveo + Reconstitution of powder portion with sterile saline water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMZA9838, expiry date 30-SEP-2024) for prophylaxis.   On 23-OCT-2023, the patient received Menveo. On 23-OCT-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo + Reconstitution of powder portion with sterile saline water) and inappropriate dose of vaccine administered (Verbatim: Menveo + Reconstitution of powder portion with sterile saline water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 The reporter stated patient received a dose of Menveo powder reconstituted with saline water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow-up.
Myalgia, Angioedema, arm pain, face numbness Narrative:  facial numbness for 45 min. Started 30 min after the  vaccine was given. Arm pain on side of vaccine admin. Pain goes into  neck and chest wall.   Other Relevant History:
12 hours after receiving the first Shingrex shot, next to the vaccination site in my upper left arm, I developed redness the size of a golf ball, the next day, it grew to the size of a tennis ball, slightly swollen and itchy. There was barely any soreness in the needle site, only tenderness upon touch. The accompanying post instructions indicated that any redness would be subside in 2-3 days; however, the redness did not dissipate until two weeks later. I returned to the Pharmacy to show them and was told this was normal. My reason for submitting this report is to suggest that future accompanying instructions for Shingrex indicated that the redness could last longer than 2-3 days to prevent any anxiety.
dizziness and could not stand up; dizziness and could not stand up; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness and could not stand up), DYSSTASIA (dizziness and could not stand up), CHILLS (Chills) and NAUSEA (Nausea) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 6:00 AM, the patient experienced DIZZINESS (dizziness and could not stand up), DYSSTASIA (dizziness and could not stand up), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DIZZINESS (dizziness and could not stand up), DYSSTASIA (dizziness and could not stand up), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment was taken by the patient.
s/s= vertigo 12 hrs p/vax lasting 24 hrs; no tx rendered;
Swelling of left arm, down  to the wrist Swelling of the front and upper back, I couldn?t see my clavicle bones Stiff  neck, left side only Skin felt tight, 10 minutes after receiving the immunization, like a bad sunburn  Felt like there was something in my throat  Body ache  Headache  Tiredness  Nauseous
Discoloration of all toes of both feet, dark discoloration across knuckles of both hands.  Unexplained bruising up upper thighs and b/l anterior shins
four hours after receiving vaccine, I experienced diarrhea, then fever.  Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless.  The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor.  Each time I fell it too approximately 20 minutes for me to get either in bed or a chair.  Still had fever of a 100-101 through out  the day, took ibuprofen to help, which it did for a short time but then fever was back.  About 7pm I took some Benadryl  and was finally able to fall asleep.  The next morning, no fever but very weak.  Went to health club to help with my legs.  This day was ok, weak but improved.  No falls
passed out in his car; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out in his car) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out in his car) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2021 to 08-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out in his car) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.  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.   This case was linked to MOD-2021-085853 (Patient Link).; Sender'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.
Arm was swollen and red and warm to touch.  The size of the arm doubled in size.
pt recv vax 27OCT97 & 3NOV97 exp soreness, devel a red mark on lt leg & went back to crawling;
This spontaneous report as received from a other health professional refers to unspecified number of patient of unknown age and gender. Licensed nurse reported that since 17-JUL-2014, improperly stored (Merck) VARIVAX (dose, strength, route and lot number were not reported) was dispensed to patients. No adverse effects were noted. Follow up information has been received from Licensed Practical Nurse. Nurse did not have the information (patient identifiers, lot number, expiration date or dates of vaccine administration) available. Follow up information has been received from Licensed Practical Nurse referring to a 5 year old patient of unknown gender. On 18-AUG-2014 the patient was vaccinated with improperly stored (Merck) VARIVAX lot # J013905, expiration date 30-OCT-2015. This is one of several reports received from the same reporter. Additional information is not expected because all follow ups requested to complete the case were received.
Information has been received from a licensed practical nurse concerning an 11 year old female with acne who on 17-NOV-2006 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot# 654741/0013U). On 02-FEB-2007 the patient received a second dose of GARDASIL. Concomitant therapy included adaplalene (DIFFERIN). Two weeks after receiving the second dose, the patient developed wart-like lesions on her hands. It was reported that the physician arranged a dermatologist consult for the patient. No diagnostic laboratory studies were involved. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/13/2007.  Information has been received from an advanced practice registered nurse concerning an 11 year old female with acne on 17-NOV-2006 was vaccinated IM with a first dose 0.5 ml of GARDASIL vaccine (lo#654741/0013U). On 02-FEB-2007 the patient was vaccinated IM, in the left arm with a second dose of 0.5 ml of GARDASIL vaccine (lot #653978/0955F0. Concomitant threrapy included DIFFERIN. Two weeks after receiving the second dose, the patient developed 12-13 warts on her hands. It was reported that the physician arranged a dermatologist consult for the patient. No diagnostic laboratory studies were involved. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Facial flushing radiating to neck. VS:  11:45am  145/95  97  02 -96%;  12:00PM  140/92  88 02-96%  12:15PM 134/94  92  02-94%.  Disposition: 12:20pm  Pt. feeling well.