chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given at 11:15am. Pt started with HA and dizziness 5-10 min after vaccine. 1145 she informed recovery nurse of her dizziiness. 1145 B/P 122/78, HR-71, 02 sat 98% RA. Pt reports she has been taking ativan for the past 5 days every day but did not take it today. Reports did not eat today. Pt given 2 baby ruth candies and water. 1200 reports starting to feel better. 1210 reports HA and dizziness resolved. 02 sat 98% RA, HR-72, B/P 124/80. Pt instructed to f/u with MD prn states she has a appointment friday. Pt stood up walked around no dizziness reported. Pt released to go home.
Developed Chronic Hives.  Never had hives prior and has been battling them for 5 months now.  Is now receiving an extremely expensive pharmaceutical in an attempt ti settle her immune system down.  Family is under huge financial burden on account of all of this and Dr?s are telling us it is from the vaccine and we may have ti continue the extremely expensive treatment indefinitely.  I don?t know how we will or even if we can.    My wife, two oldest daughters and myself are all vaccinated?.so we aren?t anti vaccine or anything  like that.  Along with the chronic hives she also experienced very low heart rate in conjunction with dizzy spells back in August, September and October of 2021.  These have subsided but were also considered linked to vaccine by Dr?s as she hadn?t ever experienced them prior either.
Shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related injuries. On an unspecified date, the patient was treated by a healthcare professional for shingles. The outcome of the event was unknown. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.
Narrative:  Provider documentation surrounding the event is provided under the events section above. Please reach out if further details are needed. Thank you!
pt recvd 1st dose of Hep B vax w/no noted problem; pt recvd 2nd dose of vax 18AUG92 w/in an hr following vax pt exp a sore arm w/pain @ the inject site; sx resolved w/in 24 hrs;
Headache, Myalgia, NauseaVomiting, shaking chills Narrative: Reports that one hour following the vaccine she developed a migraine and had nausea/vomiting, severe arm pain, and shaking chills
Case number PHEH2014US003832 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 18 JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Headache, Myalgia, Fever, Skin sore to touch all over, migraine HA, fever, hot and cold sweats Narrative:
Enlarged lymph nodes to the neck. Laterally and posteriarly also to the left axilla.
Headache, Myalgia, Fever, INJECTION SITE PAIN Narrative:
Body ached Bad; Chills; Nauseated; Weak; Vaccine shot area sore; Arm Hurting bad within hours.; Red; swollen; Hot to touch; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Aug2021 16:00 (Batch/Lot Number: FC3182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included myalgia Other medical history: Polymyalgia. HBP. Thyroid, hypertension Other medical history: Polymyalgia. HBP. Thyroid, thyroid disorder Polymyalgia. HBP. Thyroid, drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Sulfa. 0n 26Jul2021 Historical Vaccine BNT162B2 for COVID-19 immunisation Other vaccine 4 weeks details: other vaccine 4 weeks product: Covid Pfizer Other vaccine 4 weeks vaccine date: 26Jul2021 Other vaccine 4 weeks lot number: FA7485 A7485, Other vaccine 4 weeks vaccine location Left arm. covid prior vaccination No If Covid tested post vaccination No. On 17Aug2021 15:00 the patient experienced Body ached Bad. Chills. Nauseated. Weak. Vaccine shot area sore. Arm Hurting bad within hours. Couldn't lay on it. Red, swollen. Hot to touch. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected
Rash with blisters developed immediately around injection site and appeared within 24 hours of treatment. Blisters ruptured and have scabbed over. Affected area approximately .5? in diameter. Injection site was sore/achy for three days.  Other symptoms included headache and over all fatigue.
Pericarditis  and pleural effusions bilaterally  in May 2021   may or may not have anything with it. I am a female and 65 .  6 negative covid PCR since may  fever low grade 100.9 to 102.9 ,pain in shoulders and chest ,shortness of breath, pleural effusions and pericarditis.  the pericarditis may have started earlier and that is unclear
Nausea and vomiting, Headache, severe fatigue and malaise, sinus pain and congestion since vaccine x 4 days
WASN'T SATISFIED WITH EFFICACY RATE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient wasn't satisfied with the efficacy rate of covid-19 vaccine ad26.cov2.s , On 26-APR-2021,patient scheduled to get the first dose of Pfizer-BioNTech vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wasn't satisfied with efficacy rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210524437-Covid-19 vaccine ad26.cov2.s-Wasn't Satisfied with Efficacy rate.. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Within 2-3 weeks I developed a puritic, excoriating red rash to both underarm areas.; a puritic, excoriating red rash to both underarm areas.; a puritic, excoriating red rash to both underarm areas.; No longer sweat (minimally only) or smell. I no longer need to use deodorant; I did have a rash to my shin areas as well bilaterally which resolved on its own.; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on unknown date in Jan2021 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included lynch syndrome carrier (MSH2). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not provided. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the right arm on 21Dec2020 (at the age of 41-year-old), as a single dose. On 31Jan2021, within 2-3 weeks, the patient developed a pruritic, excoriating red rash to both underarm areas. The rash did not improve with steroid creams or antifungals. The rash continued for 4-6 weeks and required steroids to resolve. As of today (as reported), the rash had resolved but patient no longer sweat (minimally only) or smell and no longer needed to use deodorants. The patient also had a rash to shin areas as well bilaterally which resolved on its own. One week ago (as reported), the patient developed a pruritic rash to right hip area which patient found as a strange reaction. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with steroid creams or antifungals and tapered steroid prescription (not specified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pruritic, excoriating red rash to both underarm areas, rash to my shin areas as well bilaterally and pruritic rash to my right hip area was resolved with lasting effects on an unknown date in 2021. The clinical outcome of the events no longer sweat (minimally only) or smell was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Red halo immediately following vax;increasing to total redness & swelling of upper arm w/hive-like areas.This was accompanied by nausea,vomiting & diarrhea.Tx was Benadryl.
Swelling and pain  in left hand major knuckles (particularly in the ring and pinky fingers). Unable to make a  fist. Consulted virtually with Nurse at noon on 3/8/21. Prescribed Meloxicam 15 MG 1x daily for 15 days. Welling has reduced. major knuckle joints still stiff, but with less pain. Able to make a fist.
her arm got sore; tired; and 3oclock today she has a bad headache; chills; little achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 18:47 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm got sore"; FATIGUE (non-serious), outcome "unknown", described as "tired"; HEADACHE (non-serious), outcome "unknown", described as "and 3oclock today she has a bad headache"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "little achy".  Additional information: 72 hrs ago patient experienced side effects, her arm got sore, tired, and 3oclock today she had a bad headache, chills, and a little achy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 100.1, body and muscle aches, chills, fatigue, headache, beginning at ~ 4 hours after injection and continuing - now at 28 hrs after the injection. Feeling so bad that it is Interrupting my normal activities -- feels like I have the flu. My normal body temperature is 97.5 degrees F.
Pt. claimed that she never received vaccination for covid. Pt was vaccinated with moderna. After vaccination the nurse checked MIIC and found out that pt. recieved 3 doses of Moderna before. No side effects after vaccination
she had issue with migraine and that issue went away; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (she had issue with migraine and that issue went away) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (she had issue with migraine and that issue went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (she had issue with migraine and that issue went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-076401 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076401:Case for patient's friend with MI referecne number MOD21-075201 (Same reporter)
Diagnosed with Erthyema Nodosum - appearance of widespread large nodules of lower extremities followed by bruising & joint pain.
Patient reported swelling and rash after SHINGRIX first dose. She said the rash has lasted about a week.
Multiple joint pain, heat, swelling;muscle pain and cramping throughout body, "hot" sensation all over body but no fever noted; sore ant. neck, paresthesias in legs and hands, painful nodule developed on finger, TSH increased from about 1.5 to 2.64 after injection, severe fatigue lasting more than 3 weeks still some resid. symptoms.
Redness, swelling, pain, burning, and itching at injection site x 3 days.
02/09/22 presents to ED for "weakness, confusion, altered mentation"'. PMHx of "HTN, hypothyroidism, left sided hemiparesis"
Patient experienced fever with T-max of 102, chills, arthralgias, muscle spasms, and headache. No medical treatment required. Patient took a sick day from work to recover.
Received vaccine on 1/15 and developed rash c/w shingles (herpes Zoster) on 1/28.
Original symptoms were tiredness, aches and a very sore injection site.  These symptoms resolved within the next couple of days.  Since then experiencing ongoing, persistent deep ache in arm from shoulder to elbow.  Feels like the bone hurts.  Very painful even without movement.  Pain is eased with multiple doses of pain reliever such as Advil.
Thigh with erythema, firm swelling when DTaP administered crying for 45 mins tx with infant Advil 10 mg
Pt said she was experiencing right arm tightness along with palpations, headache ,chest tightness.  Pt was experiencing difficulty breathing with a rapid heart rate and high BP. Pt was then administered EPI at 9:20 am in the left lateral thigh. After epi was administered a rapid response was called and ER personnel and preformed a assessment. and was taken to the ER
PATIENT FELT DIZZY  AND SICK TO HER STOMACH .  HER WHOLE BODY WAS HURTING . SHE WANTED ME TO CALL 911.
No other adverse events reported; Caller reports that an 18 month old patient received GARDASIL 9 today due to human error. Caller reports that Hep A vaccine was intended and there were no other contributing factors due to the error that was made, specifically this was not a case of; 18 month old patient received GARDASIL 9; This spontaneous report was received from a registered nurse concerning an 18-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-SEP-2022 (also reported as "today"), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, lot #W010663, expiration date: 11-MAR-2024, administered as prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age), due to a human error since the vaccine intended to be administered was hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular injection, as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (wrong product administered).   It was reported that there were no other contributing factors due to the error that was made, specifically this was not a case of product confusion. The healthcare professional that administered the vaccine did not complete the double check prior to administration. There were no other adverse events reported.
Initial report received from a nurse on 30 Dec 2009: This patient, with an unknown medical history, was inadvertently administered FLUVIRIN, intramuscularly into the thigh on an unspecified date. No adverse event was reported. No further information was provided.
Between 7-8 days later my mouth started feeling like there were cuts inside, then the following morning I woke up with a larger than ping pong sized hard ball in arm about 4" lower than injection site, hot, red, slightly itchy at times, very tender. Later on that day mouth hurts again, sore building inside bottom lip.
On 2/2/21 at approximately 10:00 am, I began experience a sharp pain in my left breast.  Over then next 24 hours, this pain developed into a burning sensation under my left arm and across the left side of my my left breast .  In addition to the burning sensation, I have been having very sharp pains.  The pain is so intense, I cannot even touch it.  There is also a numbing sensation to a section of my breast.  Approximately 24 hours after the breast pain started, I noticed the same pain in my back directly behind my breast on the left side.  It is very sore as well and hurts to touch.  On Friday, 2/5, I made an appointment with my gynocologist to help rule out breast cancer.  My doctor was not able to physically detect anything that seemed irregular but scheduled me for a mamogram just to be safe.
pain at injection site; swelling at injection site; whole body swollen; my legs and arms were swollen; ankles, elbows, wrists, shoulders had less mobility.; numbness at hands; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 24Mar2021 at 10.15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV and COVID-19 on May2020. Concomitant medications included abacavir sulfate, lamivudine, dolutegravir sodium, (TRIUMEQ), naproxen (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), hydroxyzine (MANUFACTURER UNKNOWN); all from unknown for unspecified indications. The patient previously took bioflavonoids on unknown date and experienced an food allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On the day of vaccination (24Mar2021), the patient experienced bit fatigued. Nothing bothersome. On 25Mar2021, the next morning, the patient woke up with a good deal of pain and swelling at the injection site. In addition, whole body was swollen, in particular the legs and arms were swollen, to the point that was much harder than usual to be ambulatory. The ankles, elbows, wrists, shoulders had less mobility and also had numbness at hands.  Thankfully, by mid-afternoon of the 25th, felt much better and much of the swelling had subsided. The patient did not receive any treatment for the reported events. 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. The clinical outcome of the fatigue, pain at injection site, swelling at injection site, swelling at whole body, legs and arms, decreased mobility of ankles, elbows, wrists, shoulders and numbness at hands were resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 08/25/2000 the patient developed herpes zoster. She was seen in the physician's office on 08/28/2000. It was noted that the herpes zoster was a "serious case". The clustered red bumps spanned from the patient's neck to the patient's thumb on the left arm. It was noted the patient did not have a fever. It was noted that the patient did not develop a rash at the site of injection or elsewhere within 42 day of vaccination. Follow up information from a physician's assistant reported that on an unspecified date the patient recovered.
June 27--received shot and developed rash on trunk of body and red lump at injection site. (Husband saw rash). June 28--Saw rash before giving baby (Mother saw rash). June 29--took child to hospital. Doctor mentioned rash but gave no treatment and doctor did not look rash or injection site. SIDS.
Patient was given his 2nd Pfizer vaccine 7 days before the recommended time between the 1st and 2nd dose.  Patient's mom has been notified of vaccine administration error.
pt recvd vax & exp metallic taste, dizziness, tingling & numbness, weakness in arms, paresthesia, tonic-clonic spasms, burning & yawning, neurologic response, passed out, flushing, white ring around mouth, vaso/vagal response, felt washed
diagnosed with guillain barre syndrome; This case was reported by a physician via other manufacturer and described the occurrence of guillain barre syndrome in a 15-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with Guillain barre syndrome after receiving the flu vaccine. No further information was provided.  No additional adverse effects reported and no product quality complaint.
pt recv 1 dose of varivax 7/96 & 4/98 pt devel a mild case of chickenpox
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a 35-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 06-JFeb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 11-Apr-2012: The reporter confirmed that there were no late occurring adverse events.