chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bell's palsey; headache returned; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient (not pregnant) received bnt162b2 (Pfizer, Batch/Lot Number: EW0173), second dose via an unspecified route of administration, administered in left arm on 22May2021 at the age of 58-year-old as dose 2, single for covid-19 immunization. Medical history included Hodgkins Lymphoma from an unknown date and unknown if ongoing. The patient previously took morphine and experienced allergies, first dose of bnt162b2 (Pfizer, Batch/Lot Number: EW0172) via an unspecified route, administered in left arm on 01May2021 at the age of 58-year-old for covid-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included: WOMEN'S ONE A DAY OVER 50. The patient experienced bell's palsey on 08Jun2021, headache returned/ headache on 23May2021. Onset of headache was 23May2021 which lasted until 27May2021 in back of head. Headache returned 03Jun2021 with no relief, so she went to the emergency department on 08Jun2021 and was diagnosed with bell's palsey. No prior history of nerological issues or disorders. Medication was provided and symptoms of bell's palsey went away by 22Jun2021. The event resulted in emergency room/department or urgent care visit. Therapeutic measures were taken as a result of events included empiric valacyclovir and prednisone, eye patching. The case was reported as non-serious. The outcome of events was resolved on 22Jun2021. Facility where the most recent COVID-19 vaccine was administered was hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 66 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-AUG-2016, the patient was administered the ZOSTAVAX by a pharmacist (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a physician for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
pt recvd vax & 1-2 days p/vax exp flu-like sx, h/a, cough, fever, aches & was exhausted;
PATIENTS LAST COVID SHOT WAS ON 7/13/22 AND PATIENT RECEIVED A BIVALENT PFIZER ON 9/12/22 WHICH IS ONE DAY EARLIER FROM THE RECOMMENDED TWO MONTHS
The morning following the immunization, I had small blemishes (like whiteheads) on both lower legs.  These increased in number for the next 4 days, then subsided.  A few also presented in the area of my clavicle, but it was mostly on my legs.  They resolved after about a week, but the spots are still visible.  I had a low grade fever and swollen lymph nodes that lasted approximately 5 days, and on the morning of the 5th day I woke up with significant left ear / jaw pain.  It felt as though there was jaw/inner ear swelling and my teeth on the left side of my mouth could no longer make good contact.  It has now been nearly a month and these ear/jaw/bite issues persist, however, they have subsided somewhat.  It is still painful to open my jaw very wide (like to yawn or bite a sandwich), but chewing is no longer as painful and my bite feels closer to normal.  I am scheduled for my next vaccine tomorrow (second Moderna shot).
light headed; nervous; really tired; made me really sleepy; i had a few skipped heart beats while laying down; weird/ didn't feel normal; get restless; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 20Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included having one thyroid and had a benign tumor removed from behind heart when she was young and birth control. Concomitant medication included benzalkonium chloride, sodium chloride (ALIVE) and desogestrel, ethinylestradiol (ISIBLOOM) for birth control. After taking the shot she got light headed as she was walking to her car on 20Jan2021 15:00. Didn't think nothing of it since she was nervous about taking the shot. Then once she got home, she got really tired. She only had one thyroid so the shot made me really sleepy and she had a few skipped heart beats while laying down. After she slept, she felt fine but weird then after being up for a few hours she would get restless again. She got light headed again the next day going to the grocery store then back restless. She didn't feel normal until this Tuesday, she was not feeling weird and she was not as tired as she had been since she took the shot. She had tried to get seen from her doctor but she was booked up. No treatment was received for the events. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovering.
Swollen, hot, red and itchy arm, 33cm x 36cm, from shoulder to mid-forearm. 24 hours lost duty time. Mild headache.
febrile reaction & malaise 2 days post vax; generalized arthralgia, but mostly in hips & knees persist to date; still has joint pain & leg muscle pain; takes Motrin everyday;
pt w/hx of asthma, stable;pt recv flu shot-over next 24hr had asthma exacerbation not relieved w/meds;required ER visit;
Redness, itching and swelling around injection site. Theses symptoms began 3/28/21 at 5am.
30 year old male was given Fluzone High Dose, no AE; 30 year old male was given Fluzone High Dose, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 30 years old male patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on 19-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to overdose and Inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Muscle soreness; Low fever; Abdominal pain; Tiredness; Redness on neck and face;; This non-serious case was reported by a other health professional via sales rep and described the occurrence of muscle soreness in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced muscle soreness (Verbatim: Muscle soreness), fever (Verbatim: Low fever), abdominal pain (Verbatim: Abdominal pain), tiredness (Verbatim: Tiredness) and erythema (Verbatim: Redness on neck and face;).  The outcome of the muscle soreness, fever, abdominal pain, tiredness and erythema were resolved (duration 1 day).   It was unknown if the reporter considered the muscle soreness, fever, abdominal pain, tiredness and erythema to be related to Arexvy.     It was unknown if the company considered the muscle soreness, fever, abdominal pain, tiredness and erythema to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-SEP-2023 The reporter reported that the patient received Arexvy vaccine and experienced low fever for a few hours, muscle soreness, abdominal pain, tiredness, redness on neck and face all recovered the following day of the adverse events onset. The reporter did not consent to follow up.
Low-grade fever, loss of appetite, irritability, vomiting. Two days later, raised red rash started on face and spread to trunk and back.
On the Prevnar leg on left lateral thigh raised blanching erythematous rash which localized, spreading distally to left lower leg. Benadryl.
sore throat; rash on lips; First two days-fever; chills; headache; body aches; fatigue; This is a spontaneous report from a contactable consumer (Patient). A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 18Feb2021 at 11:45 (at the age of 28-year-old), as dose 2, single in left arm for COVID-19 immunization. The patient's medical history was not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 28Jan2021 at 12:00 PM (at the age of 28-year-old), as single dose in left arm for COVID-19 immunization. The patient's past medication included amoxicillin and experienced allergies. Concomitant medications in 2 weeks included sertraline daily and birth control pills; taken for unspecified indications, start and stop dates were not reported. Patient did not receive other vaccine in four weeks after COVID vaccine. On 18Feb2021 at 22:00, 10 hours and 15 minutes after vaccination, the patient experienced fever, chills, headache, body aches, fatigue for the first two days. On 25Feb2021, 6 days, 12 hours and 15 minutes (reported as a week) after vaccination, the patient had sore throat and rash on lips. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment with viscous lidocaine for throat. The patient had no COVID prior vaccination and was tested COVID post vaccination. The patient underwent lab tests and procedures which included SARS-CoV-2 test (nasal swab): negative, post vaccination on 25Feb2021. The clinical outcome of all the events was resolving.
shot on 10/28/21, symptoms of dyspnea on exertion starting 11/19/21 that prompted ED visit 11/21/21 with normal workup. Back to ED on 11/29/21 with noted larger pericardial effusion causing tamponade and required pericardial window and drainage
Experienced shills for 1 - 2 hours beginning around 11:00pm the day of the vaccination.   Subsequently experienced severe headache throughout the night.  Took 2 Tylenol Extra Strength capsules approximately 24 hours after the vaccination.
Delayed his second dose of vaccination; Fever 102 degree; Pain in my hands"; So week; Bad headache; Body ache; can't move very fast; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Delayed his second dose of vaccination), PYREXIA (Fever 102 degree), PAIN IN EXTREMITY (Pain in my hands"), ASTHENIA (So week) and HEADACHE (Bad headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Delayed his second dose of vaccination), PYREXIA (Fever 102 degree), PAIN IN EXTREMITY (Pain in my hands"), ASTHENIA (So week), HEADACHE (Bad headache), MYALGIA (Body ache) and HYPOKINESIA (can't move very fast). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Delayed his second dose of vaccination), PYREXIA (Fever 102 degree), PAIN IN EXTREMITY (Pain in my hands"), ASTHENIA (So week), HEADACHE (Bad headache), MYALGIA (Body ache) and HYPOKINESIA (can't move very fast) outcome was unknown. Not Provided      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 was not provided. No treatment was reported   This case was linked to MOD-2021-103514 (Patient Link).
headache; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EK9231) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Therapeutic measures were taken as a result of headache.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152033 same patient and reporter, different dose and event;
Headache, Myalgia, Fever,  First body ache, then fever and headache
Menstrual period stopped for 90 days Now with booster shot, period has not started back up
Patient presented to the pharmacy to get her first COVID 19 vaccine. After pharmacy technician administered the vaccine the patient waited for 15 minutes outside the pharmacy. After the 15 minutes we asked her how she was feeling and she said that she felt her tongue was a little numb and she felt a little itchy. Pharmacist asked her to sit down for observation for another 15 minutes to make sure symptoms did not progress and the patient waited another 15 minutes, the pharmacy provided patient with a bottle of water. Patient said she was feeling better after the 30 minutes she seemed physically fine. No signs of hives or difficulty breathing or anything related to anaphylaxis. Patient went home after feeling better.
Inflammation in right arm and right shoulder. Could not lift arm above shoulder and head for several days. Severe pain in upper right back muscles. Triggered return of seizures, which previously were absent 6 years. Severe memory loss, cognitive damage.
Patient had fever of 102.2 for 16 hours, crying non-stop for 12 hours, was exhibiting signs of encephalitis such as stiff neck, bulging fontanel, crying when picked up, etc.  Was very lethargic, somewhat decreased appetite.
Around 8:30 am approximately 18 Hours after the injection is when I started running a temperature of 100 along with some body aches and chills. I also had a very sore left arm from the injection sight.
Received Pfizer vaccines on  2/5/21, 2/26/21, 8/31/21; lot # for Dose 3 not documented in chart. COVID positive on 4/24/22. Admitted to hospital on 4/24/22 d/t generalized weakness, COVID infection, hypoxemia. Started on remdesivir.
Case number PHEH2013US013362, is an initial spontaneous report received from a nurse on 19 Jun 2013: This case refers to a 09-month-old female patient. She was vaccinated with MENVEO, batch number: M12188 and expiry date: Aug 2014, batch number: M12023 and expiry date: Dec 2014) at dose of 0.5 ml, intramuscularly on 18 Jun 2013. No adverse reaction was reported following this administration error.
Baby had fever 101, excessive crying pulse Ox monitor showings 80-85% O2 Sat at the time Baby received within hours, but remained fussy.
The pt developed warm, hard to touch, diffusely erythema area of 9 cm in diameter. Pt complained of pain at site, swollen left upper thigh and bruising noted around area of redness. No lymph node swelling noted.
Chills, arm pain, and soreness at injection site.  Patient was encouraged to take Tylenol/Motrin for pain and fever, instructed to use ice compresses to injection site.  Also instructed to use Benadryl as needed.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unspecified date in November 2014, the patient was vaccinated with the first dose of ZOSTAVAX 0.65 ml, subcutaneous (lot number, expiration date, and anatomical location were not reported). There was no concomitant medication reported. No adverse experience was reported. Additional information has been requested.
Muscle jerks in face. Pain in the ear. Muscle spasms. Tight jaw and difficulty swallowing.  The medical records state panic disorder, shoulder pain, flushing, and muscle twitching. The follow up received on 8/27/03 states sight of shot swollen/hurt-eye began to twitch, dizziness, blurred vision, night jerk, disorientation, bulding eye, loss of sight.
Pain of the right bicep muscle that has worsened with time. Seemed to be getting better but flared recently again.  Note that the pain never fully went away, it just seemed to be intermittent. As of last week, pain started to increase again, especially when raising arm while extended, with weakness and slight numbness of hand.  Responsive (but not fully anymore) to NSAIDs. Didn?t seem to be the shoulder/bursa related issue but now unsure. Painful to extend arm and lift objects is bad enough that I am finally reporting it. I mentioned this problem to my PT when it occurred and he can corroborate that I have complained of it again at my last visits. I?m already in pain from my leg and find this additional complication most unfortunate. It seems to me that the national guardsman injected my muscle too deeply. I actually thought I heard him say ?oops? at the time, but I?m not sure. I didn?t think much of it because muscle soreness for a period is normal, but when it hadn?t gone away by my second vaccine I actually asked them to go easy on me because my arm was still sore from the first vaccine. They took note of that and were quite gentle. They also had to give me a new vaccine card, because the guy who stabbed me spelled my name wrong etc. on the first card.
Pt recv vax on 8/28/98; on 8/29/98 pt exp swelling/ red /pain at vax site, fever (103F), myalgia
Patient had just recieved her first dose of her COVID 19 Pfizer vaccine and was waiting 15 minutes in the pharmacy waiting area where she experienced syncope and fell down from the chair she was sitting and got a cut on her forehead from the fall onto the floor.  Patient was unconscious for about 30 seconds.  As the pharmacist on duty I quickly responded to the patient's side as she regained consciousness. EMS was called and quickly responded and took the patient with them under their care.  Patient had filled out vaccine consent form prior to getting vaccine, counseled on possible side effects and how to manage those side effects, as well as counseled to remain in the pharmacy waiting are for 15 minutes after receiving the vaccine.
Pt vaccinated with Engerix-B receive first & 2nd dose a month apart.reported having joint pains since the second injection. Pains similar to those she experienced after the first injection. Admitted through the ER w/severe swelling knee.
pt recv vax 23SEP98 & 7OCT98 pt exp a small pruritic rash on abd (RLQ, approx 1/4inch in diameter), a dime size pruritic rash on rt lower calf (approx 1/4inch diameter), 1/4 inch diameter on rt anterior & other spotty rashes measuring 2-3mm
Pt was playing at 5-6 PM. C/O knee and legs ached to the point tears. Temp of 102 degrees; became cold and chilled and nauseated all noc. 1 AM c/o of pain behind eyes; crying still - fever and pain behind eyes and legs.
I tested positive for Covid -19 on 12/18/2022, began feeling febrile on 12/17/2022
Few days of low grade fever by patient self report (no temperature was taken), +4 weeks of recurring muscle and joint aches and pains, which gradually decreased in frequency until gone.  None reported in last week.
severe redness and cellulitis from the shoulder down to mid bicep and going around the whole arm area. It is very hard to the touch with fever and very itchy.
Other people in house tested positive for COVID-19. Started having a scratchy throat and tested positive as well. Had a Telehealth appointment and was prescribed PAXLOVID. Started feeling better on the 3rd day of taking PAXLOVID.
Palpatations, increased heart rate (double normal resting heart rate), elevated blood pressure, dizziness,  shaky, throat became increasingly sore, voice hoarse.  Treated with 50 mg benedryl and saline IV drip after sitting in the ER waiting room for an hour+   Heart rate returned to 80-90 beats per within 90 minutes, dizziness subsided, throat returned to normal
Generalized abdominal pain that started 2 days following the booster shot (11/18/2021). Over the course of 5 days, pain localized to the right lower quadrant with rebound tenderness. Diagnosed with acute appendicitis per abdominal/pelvic CT scan (11/23/2021).
Initial misuse report received from a pharmacist on 03-October-2013. The patient had received FLUZONE 0.5 ml via subcutaneous route. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
sore arm; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The patient was reporter's mother in law. The age at vaccination was not reported. The patient had a sore arm for a week after receiving Shingrix.
Information has been received from a physician assistant concerning several female patients (ages unknown), who, on unspecified dates were vaccinated with doses of GARDASIL. Subsequently, the patient experienced fainted. The patient sought unspecified medical attention. At the time of the report, the outcomes of the patients were unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.