chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Daughter states : My mother became nauseous after receiving the flu shot. She was also lethargic and her face appeared reddened around the cheeks. She felt like that until about 7 pm. She refused to go to an emergency room. Her MD was not available . She felt better after 7 pm.
Off label use; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OFF LABEL USE (Off label use) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included CLL.   On 13-Jan-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced OFF LABEL USE (Off label use). On 08-Apr-2021, OFF LABEL USE (Off label use) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up  received on 31 may 2021 included no new information On 20-Jul-2021: Follow-up information received on 20-Jul-2021 contains no new  information.
From the patient communication: "For at least the next 2 days after the shot I experienced side effects including, mild nausea, mild muscle aches, headache (which I am just now reporting as these were listed as the most commonly possible side effects, I wasn't  urgently concerned) and within 6 days following I experienced severe numbing/tingling/loss of circulation (PAD) type symptoms in both of my big toes. The pain was severe. I am still experiencing some numbness although not quite as intense."
Pt developed optic neuritis and diffuse demyelinating disease of the brain around the time of his vaccination.
Initial report received from a consumer's grandmother to health care professional on 25 October 2013. A 5 year old female patient, medical history of Dandy-Walker syndrome and concomitant medications were not reported, had received a dose of FLUZONE (lot number, route and site of vaccination were unknown), on an unspecified date in September 2013. On an unspecified date, after receiving vaccine next day, the patient experienced hip on opposite side from vaccination was swollen. Reporter stated swelling of hip had continued to today, 25 September 2013. She did not know lot number of vaccine. Documents held by sender: none.
Patient admitted to hospital on 8/9/2021 with shortness of breath.  He was diagnosed with acute hypoxic respiratory failure with COVID-19 pneumonia.  His symptoms started on 8/8/2021.  He was on 40% on room air and then required BiPAP to follow over 630% FiO2 with baseline home oxygen of 4 L at rest and 5 L with activity.  He was started on dexamethasone, IV antibiotics,  and fluids.  He had further worsening of respiratory status on the morning of 8/10/2021 and was transferred to ICU and was intubated.  He was placed on Levophed for hypotension and was continued on full ventilator support.  He also had infectious disease consultation with continued fever and cultures and was switched antibiotics along with addition of antifungal.  He continued to stay encephalopathic with CT head showed diffuse mild to moderate atrophic changes and prominent periventricular small vessel disease change.  With not further waking up on lightening of sedation patient had a neurology consultation had a EEG x2 and suggested concern for anoxic brain injury.  Patient's family including wife and son were discussed about overall prognosis and worsening neurologic status and they did not want him to continue full aggressive measures and switched him to comfort measures and had a vent withdrawal.  He passed away in the afternoon of 8/15/2021
6 hours after receiving my flu shot developed left sided facial paralysis, mouth drooping, unable to close my eye. Diagnosed the next morning with Bells Palsy by Dr at Urgent Care.
Bell's Palsy right side of face. Right upper eyelid droop, righ cheek numbness on palpation, slight smile effected/off from left, no ringing in ear, able to raise eye brow. Mental status WNL, able to hold conversation, made proper eye contact.
Patient got light headed while waiting in the waiting room and collapsed from her chair. Another customer caught her. She was alert within a few seconds and said she was feeling light headed, chills and sweaty. Patient claimed she hadn't eaten this morning and had a fear of needles and shots. Patient blood pressure was monitored and given water while we waited for the paramedics and her father to arrive. Paramedics assessed the patient and advised her to come with them to be checked by a provider. Patient refused and went with her dad to the ER.
vaccine exposure during pregnancy with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 35 years old female patient who was exposed to vaccine Influenza quadrival A-B vaccine [Fluzone Quadrivalent] in context of vaccine exposure during pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported vaccine exposure during pregnancy with no reported adverse event occurred at 14 weeks of pregnancy and the patient was exposed to Influenza quadrival A-B vaccine at 14 weeks of pregnancy, during first pregnancy trimester for Influenza quadrival A-B vaccine.  The date of last menstrual period was reported as 25-Jun-2022. The estimated due date is 31-Mar-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had not reported previous pregnancy/ies.   On 21-Sep-2022, the patient received a  dose of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7682; dose, frequency, strength and expiry date not provided) via unknown route in the left deltoid for prophylactic vaccination.  On 21-SEP-2022 the patient had vaccine exposure during pregnancy with no reported adverse event (exposure during pregnancy).  Relevant prenatal testing after exposure was not reported.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event vaccine exposure during pregnancy with no reported adverse event.  Additionally, at time of reporting, the pregnancy is still ongoing.
swollen arm, shoulder pain, dec rom in shoulder, nausea, headache, lighteheadedness, left shoulder pain
Tiredness for several hours followed by chills, fever, arm pain, headache for 30 hours.
Fever ranging from 99.4 degrees to 102 degrees. 99.4 degrees initially early on 7/23/18, increasing to 100.9 later that morning. CHILDREN'S TYLENOL given at 5mL periodically (4 times total since 7/23/18 morning to 7/24/18 evening) when temperatures reached near to or 101 degrees. First TYLENOL given late morning 7/23/18, second dose around 6pm on 7/23/18, third dose 5am 7/24/18, and fourth dose at 5:45pm on 7/24/18. Low energy and reduced appetite during peak of fever. No other symptoms of illness such as runny nose.
very itchy, red rash/small, few dots of a rash / progressively gotten worse / is systemic / including / armpits; very itchy, red rash; received dose #1 of Shingrix on 10/28/2020.; received a prescription from her rheumatologist to receive Shingrix off-label; This case was reported by a pharmacist via sales rep and described the occurrence of itchy rash in a 48-year-old female patient who received Herpes zoster (Shingrix) (batch number CE4DE, expiry date 25th September 2022) for prophylaxis.   On 28th October 2020, the patient received the 1st dose of Shingrix. On 28th October 2020, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and off label use. On 29th October 2020, the patient experienced itchy rash and red rash. On an unknown date, the outcome of the itchy rash, red rash, inappropriate age at vaccine administration and off label use were unknown.   It was unknown if the reporter considered the itchy rash and red rash to be related to Shingrix.  Additional details were reported as follows: The patient received a prescription from her rheumatologist to receive Shingrix which led to off label. The patient received vaccine outside recommended age which led to inappropriate age at vaccine administration.  The patient received dose 1 of Shingrix  and stated that she experienced a small, few dots of a rash the day after injection which were progressively gotten worse each day. On day 5, the rash was systemic, including in her armpits. The rash was a very itchy and red spread all over. At the time of patient reported the rash to the pharmacist, the patient had not used any treatment for the rash, nor sought medical attention. The pharmacist suggested that the patient contact her doctor for follow-up since the rash has not gotten better.
Information has been received from a registered nurse concerning a 16 year old male who on 09/05/2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot3634844/1869J).  In April 2004, the patient developed chickenpox with greater than 50 lesions.  He was being treated with acyclovir and hospitalization was not required.  A product quality complaint was not involved.  Follow up information indicated that the patient subsequently recovered.  No further information is expected.
Mom states baby got shots on 08/08/2001 at around 12 noon. At 9pm, baby began crying a lot and mom could not calm him down, no matter what she did to console him, it didn't help. Crying at least 3 hours, probably more. Mom brought baby to ER that night. Baby was checked and found to be healthy, no noted fever.
pt recvd vax 18JAN96 & 1 1/2 to 2 days later devel achy feeling,t100-101,loss of appetite,diarrhea stools-very smelly;mom states had same sx p/hep B #1 on 13NOV95
Headache, falling in sleep fever (up to 103), vomiting, pharyngitis, cough, body aches, decrease in appetite. Pt received shot in afternoon, sx started that evening. Rapid strep negative, Rapid flu negative, CBC within normal limits.
within half hour after injection patient contacted triage nurse.  Arm is red and warm from the injection site to her fingers.  She has a rash on arm.  She states her fingers are numb and the numbness is moving up her arm.  She denies any shortness of breath, difficulty breathing, or swelling of her airway.  Patient was advised to seek emergent medical care a an urgent care or emergency room.
Developed mild erythema multiforme, 16 days after Smallpox vaccination.
Case number PHEH2012US015336, is an initial spontaneous report received from a nurse on 30 Jul 2012, and with a follow up received on 16 Aug 2012: This report refers to multiple patients. They were vaccinated with MENVEO (batch number: unknown) intramuscularly on undetermined dates. These vaccines were stored at 25 degree Fahrenheit temperature. The temperature excursions was occurring for almost 18 months now and this was discovered at the end in May 2012. For each occurrence the temperature was at 25 degree F for up to five minutes each time. The vaccine was not frozen. The reporter stated that their refrigerator was malfunctioning and temperature as falling below the recommended for a very short time, but that was happening frequently. The reporter did not known the patient information who received MENVEO that was stored in the refrigerator at the time when it was not working properly. No adverse event was reported following this administration error. Follow up report received from a nurse on 16 Aug 2012. The reporter stated that their refrigerator was malfunctioning and patient details were not available.
Pt was vaccinated with varicella on 5/7/01. On 5/12/01, per mom, pt has skin lesion on face and left hand and finger. Questionable skin lesion. Looks like chickenpox reaction. Lesions appear healing. No other symptoms. Denied fever. No meds given.
WITHIN 5 MINUTES FOLLOWING RECEIPT OF PFIZER BIVALENT BOOSTER DOSE, CLIENT COMPLAINED OF SENSATION OF HER THROAT CLOSING, TINGLING OF HER LIPS, AND FEELING LIGHTHEADED.  CLIENT DENIED DIFFICULTY BREATHING OR HEADACHE; RASH/HIVES, CLAMMY SKIN, OR LOCAL SITE REACTION WERE NOT OBSERVED BY NURSES PRESENT, NOR DID CLIENT LOSE CONSCIOUSNESS.  CLIENT WAS GIVEN 50mg PO BENADRYL (2 TABLETS) AND PLACED IN A RECUMBENT POSITION WITH FEET ELEVATED.  A COLD COMPRESS WAS APPLIED TO HER FOREHEAD.  ABOVE SYMPTOMS IMPROVED AND APPEARED TO SUBSIDE WITHIN 20 MINUTES.  VITALS OBTAINED (BP 102/70, PULSE 70).  CLIENT REPORTED SHE FELT GOOD AND WISHED TO GO HOME.  CLIENT PROVIDED FURTHER INSTRUCTIONS AND RELEASED TO HOME.
Really bad headache/Headache comes back every often and last for 3days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Really bad headache/Headache comes back every often and last for 3days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Really bad headache/Headache comes back every often and last for 3days). At the time of the report, HEADACHE (Really bad headache/Headache comes back every often and last for 3days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
This is a spontaneous report from a non-contactable nurse reporting on herself. An 81-year-old female patient started to receive PREVNAR 13 IM (assumed by reporter) at single dose at left arm on 04May2017 between 11:00 and 11:30 for immunization, at the doctor's office. Medical history included allergy in the spring, she gets the seasonal king on sinus allergies, but that is it and she doesn't take any medications for it, sensitive skin. Concomitant medication included vitamins and maybe a ADVIL here and there. She has had 2 previous Pneumococcal vaccines (not PREVNAR 13) in 2003 and 2011, and she did not have any reaction to them. No additional vaccines were administered on same date of the suspect. The patient experienced left arm sore on 04May2017 with outcome of recovered, and injection site became very itchy, was a little red, and had some swelling that looked almost like a mosquito bite on 11May2017 with outcome of recovered. No event required a visit to Emergency Room or Physician Office. She asked the doctor if she would have any side effects from the vaccine. He said that her arm would be sore, but that was it. She also received a paper that listed all the possible side effects, which she read through before receiving the vaccine. Her arm was sore after receiving the vaccine for the first day, but she got along fine. The soreness has resolved completely, but she is unable to provide a date. About a week later, in the evening, the injection site became very itchy, was a little red, and had some swelling that looked almost like a mosquito bite. The site was itchy for about 1.5 days, resolving on 13May2017. The swelling, which started on the evening of 11May2017, worsened on 12May2017, and resolved on 13May2017. On Saturday, 13May2017, there was still a little soreness, but the site was now more red. The area of redness was round and between 1-2 inches. States that the site isn't bothering her much now, but the redness is still there. The initial itching and the swelling was the big thing that she wanted to report. She did have sensitive skin, so she didn't know if that would be a factor. She had not spoken with her physician yet regarding the reaction. This occurred over the weekend. If it had gotten worse, she would have gone to the urgent care center, but it has been improving so she is just keeping an eye on it. A product complaint was filed. The reporter considered there was a reasonable possibility that the events left arm sore and a little swelling were related to the suspect medication.
Patient was asked to remain in store after injection and was walked over to the seating area. Within minutes, patient complained of nausea, and faintness. eyes rolled back and head lolled. Momentary loss of consciousness occurred, without a fall from the chair. Quick recovery and was oriented to person place and time.  Patient was observed for about 10 minutes, and then was escorted to restroom with his mother. Orange Juice was given, and Patient was taken home by mother. Call to home around 6:30pm revealed patient has fully recovered.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 44 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: Ep7533), on 27Apr2021 as dose 2, single (Lot number: EW0171), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 300308D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Uterine fibroids" (unspecified if ongoing); "Migraines with aura but no headache..aura but no headache." (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 03Oct2023 to 08Oct2023. Patient felt better days after taking paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329598 same patient, different drug and different event.;
Pt. visited to HD 9/2/15 concerned about her condition since Imm administered on 6/26/15. Fever (3 days) and generalized rashes subsided but she still has (R) upper inner arm with small area reddened and slightly swollen and said painful. She c/o prickling pain on both (R) arm and leg and swelling, (+) edema noted on both legs. No treatment provided. Refer to PCP for further evaluation. BP 184/84, P-91, T-98.3.
inflammation, erythema and calor over the upper arm surrounding and distal to injection site, Initially had pain but that has resolved after 7 days.
was sick for weeks; Initial information received  on 17-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was sick for weeks after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was sick for weeks (illness) after receiving an unknown dose of suspect Influenza vaccine produced by unknown manufacturer, lot number not reported in unknown administration site for immunization with unknown form, strength, frequency, route, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (was sick for weeks).  Outcome: Unknown.
nausea; lightheadedness; ill-appearing; Hot; vomiting; dry mouth; chills; This is a spontaneous report from a contactable Healthcare professional. A 30-Year-old Male patient received BNT162B2 (BNT162B2) 1 single dose via Unknown route of administration in unspecified anatomical location on 20210315 (Lot number: EN6206) for COVID-19 immunisation. On 15Mar2021, during his 15-minute waiting period after the injection, the patient experienced chills, dry mouth, Hot, ill-appearing, light-headedness, nausea and vomiting. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The patient had complained of chills and vomiting (scantly, x 3 times) and was ill-appearing. He was not diaphoretic. Zofran. The therapeutic measures taken as a result of the adverse events were not reported and follow up response to treatment had no change. The patient was transported to ED (emergency department) by POV (privately owned vehicle). The patient had not recovered from the events at the time of this report. No follow-up attempts are possible. No further information is expected.
Within 2 days of vaccination in left deltoid, patient developed tingling in the left arm and paraesthesias in hands with generalized arthralgias. The joint pains lasted for several weeks.
This case was reported by a physician via sales rep and described the occurrence of injection site burning in a 56-year-old female patient who received BOOSTRIX. Concomitant products included Pneumococcal vaccine. On 16th December 2016, the patient received BOOSTRIX .5 ml. On 17th December 2016, 1 days after receiving BOOSTRIX, the patient experienced injection site burning. On 18th December 2016, the patient experienced injection site induration and back pain. On 19th December 2016, the patient experienced injection site inflammation, injection site erythema, inflammation localized and erythema. On an unknown date, the outcome of the injection site burning, injection site inflammation, injection site erythema, injection site induration, back pain, inflammation localized and erythema were unknown. It was unknown if the reporter considered the injection site burning, injection site inflammation, injection site erythema, injection site induration, back pain, inflammation localized and erythema to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received BOOSTRIX in his left deltoid. One month before the reporting date ago, the patient received Pneumococcal vaccination. The patient experienced burning and pain at injection site. Two days after vaccination, the patient experienced back and injection site pain with induration at injection site. Three days after vaccination, the patient experienced injection site and back inflammation and redness. Field representative reports doctor had previously contacted GSK regarding this event. Field representative was unable to provide doctor's complete address.
Patient reports pain and redness at site. Redness is raised, hot to touch and measures 3in by 3in.