chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of pain in arm from flu shot in a 38-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 September 2013 (in the afternoon) the subject received a dose of FLUARIX (.5 cc, unknown route, left deltoid). On 16 September 2013, immediately after vaccination with FLUARIX, the subject experienced "shooting pain from injection site down to wrist". The event was reported as a local injection site reaction. On 17 September 2013, the event was resolved. The healthcare professional considered the event was probably related to vaccination with FLUARIX. On 11 October 2013, follow-up was received from the healthcare professional. It was reported that the 'pain in arm from flu shot' resolved on 18 September 2013 (initial report indicated the event resolved on 17 September 2013). The reporter did not consider the event to be serious. It was indicated that this case was not reported to a regulatory agency. It was reported that no action was taken with the FLUARIX. The subject had received FLUARIX before. The subject had not experienced any adverse events following previous vaccinations.
Patient had requested hepatitis B vaccine and was given hepatitis A vaccine in error. He has been notified.
One week after injection the site on upper left arm became red, swollen, hot and itchy.  The area is around four inches in diameter.  Itchiness spread to my torso.  Symptoms persist to present day (January 23, 2021)  The symptoms are mild and I've used ice to treat.
Cramping behind the legs; Visual Changes/vision changed; This non-serious case was reported by a consumer via call center representative and described the occurrence of leg cramps in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced leg cramps (Verbatim: Cramping behind the legs) and visual disturbance (Verbatim: Visual Changes/vision changed). The outcome of the leg cramps and visual disturbance were not resolved.   It was unknown if the reporter considered the leg cramps and visual disturbance to be related to Shingrix.     It was unknown if the company considered the leg cramps and visual disturbance to be related to Shingrix.   Additional Information: GSK receipt date 30 Jun 2023: The patient was the reporter who desired to remain anonymous.  The patient would not release any information, except 5 days after taking her Shingrix vaccine her vision changed and her back of legs started cramping, this was ongoing. The patient asked if Shingrix caused these.
Patient received a first dose of COVID 19 vaccine Moderna on 2/26/2021,  he inadvertently received a first dose of Janssen vaccine on 3/23/2021.
This spontaneous report was received from a nurse refers to a 33 year old male patient. Past medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with (wistar ra 27-3) M-M-R II for prophylaxis. On 22-JUN-2018, the patient visited the nurse's office and inquired about receiving an (wistar ra 27-3) M-M-R II vaccination. Nurse reported that it was unknown if the patient will follow through and receive the (wistar ra 27-3) M-M-R II dose (circumstance or information capable of leading to medication error). No adverse event was reported. Nurse also reported that (wistar ra 27-3) M-M-R II and diluent were stored properly.
Dizziness, Headache, Myalgia, Arthralgia, Fever, "chills" Narrative:
Type 2 diabetes mellitus with right diabetic foot infection.  Patient was started on IV antibiotics and underwent bedside I&D. Culture was positive for MRSA. PICC line was placed as patient will need outpatient infusion of vancomycin. He is medically stable for discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a healthcare worker refers to an unspecified patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215, exp. 05-MAY-2015). No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information is not expected as the reporter did not wish further contact.
Could not move arm that night of the vaccine, really sick to my stomach, flu like symptoms, fatigue, we were tired and did not feel way, never had a fever over 100 my arm hurt for a good week, no appetite, nauseas
She is experiencing a sore arm; Headache; Low grade fever; Feels tired; This is a spontaneous report from a contactable consumer. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Apr2021 at 10:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) of 20mg from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 10:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 18Apr2021 at 10:00, the patient experienced sore arm, headache, low grade fever, and felt tired. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported event which included treatment with paracetamol (TYLENOL). The clinical outcome of events sore arm, headache, low grade fever, and feels tired were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received the Pfizer-BioNTech COVID-19 Vaccine EUA at 1006. Developed flushing tongue itching, local redness on shoulders at 1010. Patient was given Benadryl 25mg po in the clinic and remained for observation. After observation, patient cleared to leave clinic - was instructed to call 911 and go to ED if exhibiting any signs or symptoms of anaphylaxis. Patient was given an extra dose of Benadryl, 25mg to take if needed.
Information was received on 17-JUL-2017 from a nurse who was reporting on multiple unspecified patients (demographic were unknown). No medical history or concomitant medications were reported. The nurse reported that on unspecified dates, an unspecified number of patients were administered doses of improperly stored MMRII (lot N010426, expires 01-MAR-2018). The lot number and expiration of the sterile diluent is unknown. The nurse also reported that on unspecified dates, an unspecified number of unspecified patients were administered separate doses of improperly stored doses for the following vaccines: PEDVAXHIB (Lot L033690, expires 14-JUN-2018), GARDASIL 9 (lot N00326, expires 14-OCT-2019) and PNEUMOVAX 23 (lot N01867, expires 08-NOV-2018) (dose, injection sites and route not reported). No adverse effects were reported. No additional information was provided. The temperature excursion involved temperature range from 9 degrees C. to 25 degrees C. for 72 hours. There was no previous temperature excursion and a data logger was not involved. The nurse called back and reported that a male patient of unknown age received an improperly stored dose of GARDASIL 9 (lot N000326, expires 14-OCT-2019) for prophylaxis. No medical history or concomitant medications were reported. A second male patient also received a dose of GARDASIL 9 (lot N000326, expires 14-OCT-2019) (MARRS# 1708USA004622). A female patient of unknown age received a dose of improperly stored PNEUMOVAX 23 (lot N011867, expires 08-NOV-2018) vaccine on 14-JUL-2017 (MARRS 1707USA004862). No further information was provided. Follow-up information was received on 17-JUL-2017 from the nurse who reported that the actual time frame of the temperature excursion was 96 hours. The nurse also stated that the improperly stored PEDVAXHIB and MMRII were not administered. No further adverse event information was provided. Additional information has been requested. This is one of several reports by the same reporter.
Baseball sized localized reaction, developed "cold-like" symptoms, lethargy. Treated in Emergency Dept 8/9/14.
Febrile seizure 5 days later, 7 hours in ER, IV, CAT scat, chest x-ray, blood and urine samples
headache starting 3 days after vaccination that was not like her typical migraine, more intense and patient says lasted about 2 weeks
Bad headaches, dizziness, chills, fatigue, muscle soreness and nauseous, but all after being physically active later that night after getting shot. Got the shot at 9 AM and side-effects started roughly at 7 PM that night
Pt received FLUZONE HD on 11/26/16 and PREVNAR 13 on 12/1/16. Both vaccines given by same person. Pt felt ill and had fever starting 12/3/16 and presented with cellulitis on 12/5/16. Sent to urgent care and received KEFLEX on 12/5/16.
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium
Generalized urticaria and angioedema, periorbital one hour after immunizations.  Treated with epinephrine and atarax.
This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD, (strength, dose and frequency were not provided) lot # N020617, expiration date 22-JAN-2019, for prophylaxis. The doses of PROQUAD were exposed to a temperature excursion of -14°Celsius (°C) to -10°C, during a time frame of 2 hours; -9°C to 8°C (4.48 °C) during a time frame of 4 hours, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Left arm pain , with radiating pain into left arm, lt shoulder pain, left side lower neck pain, I have not mentioned too much to my provider as I thought it was just temporary muscular pain. I did see an orthopedic provider because I had some lt writs pain and numbness in my 4th and 5th finer w/trigger finger in my left thumb. I had a steroid injection in lt wrist which helped a couple of weeks or so and had a nerve conduction test still have trigger finer of lt. Thumb; biggest issue is pain in lt upper arm, lt. shoulder pain. I take Extra Strength Tylenol Arthritis, OTC Voltaren topical gel and use heating pad frequently. Pain keeps me up at night.
Lower right eye, where I received facial filler in November 2020, is grossly swollen and partially obstructing my field of vision. It?s painful, swollen and looks bruised.  I also received expected side effects: fever, painful swollen joints, full body aches, migraine.
The patient received the Pfizer dosage for 5 to 11-year-old instead of the 12 years and above upon date of vaccination.
A report has been received from a Health Professional concerning a 52 year old, female subject. who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 23-Sep-2014. The patient experienced 52 year old female has been administered FLUMIST QUADRIVALENT which started on 23-Sep-2014. The outcome of event of 52 year old female has been administered FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Shot Date/Time: Thursday, 5/6/2020 4:15p.m.  Jansssen   That evening I started having minor stomach cramping initially. Overnight I was unable to sleep. About 5a.m.  I was incredibly nauseous. I was incredibly weak. I didn't have the strength to stand or sit upright.  I sat on the bathroom floor & had to have someone prop me up in front of the commode to vomit into it I was so weak. I repeatedly vomited forcefully for about an hour with accompanying repeated bowel movements. I had a fever.I broke out in a sweat repeatedly - clammy. The most painful part as SEVERE, SHARP NON-STOP ABDOMINAL CRAMPING. I was in the fetal position on the floor writhing in pain after the vomiting & bowel movements slowed. After hours of this... my clamminess turned into chills with my entire body shaking strongly & continuously as I lay on the floor unable to do anything but shiver. I considered going to the emergency room but was able to move in my current state. Who & where should I report this severe adverse event?  Note:  I'm a 45-year old VERY physically fit athletic female.   My only health condition:  I take Enbrel for Rheumatoid Arthritis.
PATIENT WAS GIVEN A VACCINE THAT WAS OUTSIDE OF THE ALLOWABLE TIMEFRAME OF A RECONSTIUTED VACCINES. WHICH MAY HAVE AFFECTED THE EFFICACY. PATIETN WAS INFORMED , INCEDNT REPORTS WERE SUBMITTED. PATIENT VOICED UNDERSTANDING. WILL RETURN ON 6/18/2021 TO REPEATED DOSE 2 VACCINE.
pt recv vax;ate hamburger & layed down & said did not feel good & had said stomach & body ached;to MD; T 101; apap & kept at ofc x 2 hr; fell asleep at 2; dx as viral;
p/vax pt started to notice abn neurologic events: simultaneously drop/flex head and extend arms;was occurring 5-10 x/day for few wk; spontaneous resolving
fainted; fever; dizzy; stomach hurting; little tinglies; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002931.  A female patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose number unknown, single (Lot number: FC3180) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "fainted"; PYREXIA (non-serious), outcome "unknown", described as "fever"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach hurting"; PARAESTHESIA (non-serious), outcome "unknown", described as "little tinglies"; URTICARIA (non-serious), outcome "unknown", described as "hives". The events "fainted", "fever", "dizzy", "stomach hurting", "little tinglies" and "hives" required emergency room visit.  Clinical course: On 09Aug2022, it was reported that a patient started treatment on 16Aug2022 with Pfizer COVID-19 vaccine an unknown number of doses around 4:00PM CST for unknown indication. It was reported the patient had fever, dizzy, stomach hurting, fainted, little tingles, hives and went to ER. No further follow-up is anticipated.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered pharmacist concerning an unknown number of patients who on unspecified dates were vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). The pharmacist reported that an unknown number of doses of ZOSTAVAX that were transported between their facilities on dry ice, "possibly" below -58 degrees F (exact temperatures unknown) had been administered to an unknown number of patients. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
8/22/02 mom states child woke up from nap with swollen cheeks and fever and irritable. Had DTaP, HIB and IPV on 8/21/02. Ref to MD 8/23/02 mom states MD ref to ER on 8/22/02. ER states normal reaction-fever got 103 deg. Mom states child doing well today.
I had flu-like symptoms at the beginning and when I woke up from a little rest my chest felt like very intense pain and tightness like someone was sitting on it. Very quickly it turned from a concerning feeling to me screaming out in pain. Terrible chest and heart area pain. I screamed for help and went to the ER. They saw that it looked like a person going into cardiac arrest and they prescribed morphine immediately. They quickly ordered an EKG, chest X-rays, blood work, and CT scan. Throughout this period of time I had extreme excruciating pain. The pain was correlated to the heart rate. The morphine wasn't really making a difference on the heart rate. Over time, the pain started to subside probably over the course of 5 hours and they were able to see that there wasn't anything else wrong after getting the tests back. They said that is was probably an inflammatory reaction to the vaccine. They watched the baby for a while. They sent me home and gave me Benadryl. They said that if it was related to the vaccine the symptoms should subside in about 24 hours. The pain was the most excruciating pain I have had I even thought I was gonna die in the way to the hospital. I had to stay for the day at the hospital but I did not stay over time. My pregnancy history was perfect until that time. This is my second pregnancy. No complications with either. Estimated date of delivery is 08/18/2021.
vomited 30 mins p/vax & later that PM; t103.6, cried hysterically all noc, spacey p/shot few hrs; leg tender, swollen; PE nl; sl swollen, tender @ inject site;
On 9/5/01, 2 days ago, pt had URI symptoms, sore throat, clear nasal drainage. Also, had a spot on left lateral leg. Client continues to improve.
Initial report received on 11 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a three-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL, lot number C3434AA received on 18 August 2009, lot number C3498AA received on 23 October 2009 and again on 08 January 2010; and 1 dose of DAPTACEL, lot number C3449BA received on 21 December 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 10 September 2012, approximately 21 months after the last dose, and a paroxysmal cough without a whoop on 23 September 2012. The subject also developed posttussive vomiting, apnea, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 08 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
ache in upper arm, lost of feeling in lower arm, feeling of swelling in underarm area, arm & shoulder seem to bind when reaching out or up;all sxs are intermittent, & are still recurring
This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0153, Expiry date: not reported), via an unspecified route of administration in right arm on 13Apr2021 (at age of 54-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EP6955, Expiry date: not reported), via an unspecified route of administration in left arm on 23Mar2021 (at age of 54-years-old) as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced ears ringing bothering me, hay fever, allergy. Since about 17th patient suppose, started with headaches and then Monday woke up with headache and ringing in my ears. "When probed for any (treatment) medication, consumer stated that he took Ibuprofen, Zyrtec and Tylenol. Ibuprofen and Tylenol for the headache and Zyrtec for having some allergy Hay fever but stopped Zyrtec when he had ringing in his ears which was on Monday (unspecified date), so he had been taking the Tylenol since then before that (ringing in ears) he was taking Ibuprofen and Zyrtec. Those the only medicines that he had taken. The consumer stated that ears ringing was really bothering him, Tylenol helped to relief his headache. Consumer stated, was there any other thing he could do to treat those conditions. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Fever, chills, nausea, tremors, stomach pain, headache, tachycardia (130 bpm resting) and  dizziness; starting approximately, 10:00 pm, November 19, 2021, 9 hours post vaccination, and continuing through the night into November 20, 2021. Symptoms currently ongoing, less severe.
Before shingles vaccine, outbreak only about once a year; 2 small spots. After vaccine, outbreaks constant and continual, on many different areas of the body, lasting sometimes 2 months at a time. Was never told anything could be done.
Patient died approx. 5 hours after shot was administered. Cause of death reported is Atherosclerotic Cardiovascular Disease. The death certificate was signed by the county coroner without autopsy, based on the report by the onsite deputy coroner. No doctors or hospitals were involved. This report is FYI only; there has been no direct connection made between my mother's death and the  vaccine other than one followed shorty after the other.
Extreme chills, fever, and difficulty breathing from 11:30 pm to 4:00 pm this morning. Considered hospitalization but can't afford it.
woke up and had lost voice (very hoarse) for a week after; Body aches night of vaccine; This is a spontaneous report from a contactable other hcp reported for herself. A 41-years-old female patient received First dose of BNT162B2 (Pfizer-Biontech Covid-19 Mrna Vaccine, Formulation: Solution for injection) via an unspecified route of administration, in right arm on 12Jan2021 at 10:00 (Batch/Lot Number: Eh9899) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); dexamethasone (ZINE [DEXAMETHASONE]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Patient was not allergic to medications, food, or other products. On 12Jan2021 at 03:00, The patient experienced body aches night Went away next morning of vaccine and but woke up and had lost voice (very hoarse) for a week after. No treatment was received for the adverse event. On 13Jan2021, the outcome of the event pain was resolved and on an unspecified date the event Hoarseness of voice was resolved.