chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got Gillian Barre Syndrome; pain gets worse and its horrible; partial use of my leg now, The other leg is failing too; This case was reported by a consumer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), pain and mobility decreased. On an unknown date, the outcome of the guillain barre syndrome, pain and mobility decreased were unknown.   The reporter considered the guillain barre syndrome to be related to Shingrix. It was unknown if the reporter considered the pain and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JUN-2022  Reporter's Comments: The patient got Guillain Barre syndrome from the vaccination four months  ago from reporting date and the pain just got worse and was horrible.  The patient also had partial use of his/her leg now and the other leg was failing too.  The patient was finally getting to see a neurologist tomorrow.  The patient asked what else he/she could do before this gets even more destructive to his/her body.
lost hearing in his left ear; felt like something entered into his ear; [felt like something entered into his ear] and went down his throat; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (lost hearing in his left ear) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Insulin-requiring type II diabetes mellitus (insulin -dependent). Concomitant products included DOXYCYCLINE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DEAFNESS (lost hearing in his left ear) (seriousness criterion medically significant), EAR DISCOMFORT (felt like something entered into his ear) and OROPHARYNGEAL DISCOMFORT ([felt like something entered into his ear] and went down his throat). At the time of the report, DEAFNESS (lost hearing in his left ear), EAR DISCOMFORT (felt like something entered into his ear) and OROPHARYNGEAL DISCOMFORT ([felt like something entered into his ear] and went down his throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient developed a lump at the site of injection. The lump is firm and tender. No sign of bruising.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On an unspecified date the patient was administered a dose of improperly stored GARDASIL (Lot #, expiration date, strength, dose, route of administration was not reported). The patient's physician office contacted the patient and stated that the patient would need to be revaccinated. No adverse event was reported. No product quality complaint was involved. Additional information has been requested.
Pt given TWINRIX 1ml, Tdap 0.5 ml, IPV 0.5 ml, MMR 0.5 ml and PPD 0.05 ml. Pt passed out in 1 minute and was given smelling salt and recovered.
Symptoms: Chills, full-body shakes, headache, loss of appetite, nausea, vomiting, malaise  Signs: Frank blood in urine Time frame: Lasting 72 hrs.
Pt has been on VIOXX for 1 week, received flu shot and started itching within 2 hrs on back of neck.  Raised area on back of neck, and nausea.  No reaction with previous flu shots.
When she received the MCV4 (Menactra) within 5 minutes she broke out in hives and rash. it covered her ears, face, legs, back and arms. She was immediately given Benadryl by her doctor and monitored. She then received another dose of Benadryl after about 15 minutes after receiving her first dose and it not working. After over an hour of observation we were sent home with steroid to add to her Benadryl. After returning home within a couple hours she complained of her throat tightening, tongue swelling and shortness of breath. Paramedics were called and the next morning her doctor advised us to take her to the emergency room, sent home with Epi Pen.
Had flu shot 1/12/09. Also, exposed to many children with URI symptoms 1/12. On 1/13/09, had syncope related to quick changed in position. Also nasal congestion /sneezing /rhinorrhea /chills and aches with T to 100 deg. Also headache
101.4 Temperature/fever, aching joints severe, malaise, no appetite, diarrhea, migraine, nausea, heart palpitations, breathing difficulty, dizziness, unable to move, unable to sleep regular times, severe exhaustion.
Chills, fever, shaking could not get out of my bed. My arm got a big knot on it the left arm where the shot was placed. My arm was very hot on fire, I threw up all night and had the shakes with fever. I got worse and worse until I went to the emergency room 11/05 at 2pm.
my chest is heavy like someone is sitting on me a bit. I can breathe. Just feels like pressure; stomach cramps day two; Sick to my stomach on and off; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non pregnant female patient received first dose of BNT162b2 (Pfizer BioNTech Covid19 mRNA lot number EN6207) via unspecified route of administration in the right arm on 16Mar2021 at 14.45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included post cancer, mild COPD (coronary obstructive pulmonary disease) and mildly high BP (blood pressure) on unknown dates. Other medications the patient received within 2 weeks of vaccination was reported as yes. The patient previously received codeine (MANUFACTURER UNKNOWN), Gentamycin (MANUFACTURER UNKNOWN), and ropivacaine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. The patient experienced stomach ache on17Mar2021, stomach cramps and chest heaviness in 18Mar2021. The patient was sick to her stomach on and off and stomach cramps day two. Also, day two her chest was heavy like someone was sitting on her a bit. She could breathe. Just felt like pressure. It was not known whether the patient received any treatment for the reported events. The clinical outcome for stomach pain and chest heaviness was recovering and of stomach cramps was unknown.   No follow-up attempts are needed. No further information is expected.
The patient developed disequilibrium symptoms lasting for approximately 2 weeks that self resolved. No better explanation for symptoms.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 49 or 50 years old. The patient experienced pain, redness and swelling at injection site for 48 hours. The redness continued for 6 days. After the redness became more pronounced for 6 days, they were wondering if it was shingles, Asked to physician and he did not believe it was shingles. After speaking to the physician, wondered if it was because of a preservative. The patient would get the 2nd dose.
sore arm; Low grade fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (Low grade fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: MONOCLONAL ANTIBODIES. Past adverse reactions to the above products included No adverse event with MONOCLONAL ANTIBODIES.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (Low grade fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (Low grade fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.  Reporter stated that the patient was given the first dose of vaccine 14 days after the Monoclonal antibody infusion.
Pt recv vax on 3/8/99; on 3/9/99 pt exp erythema/ blisters/ vesicles around vax site; tx=Benadryl & Prednisone
Pt. immunized on 2/4/12 with 0.65mL dose of ZOSTAVAX. Pt was monitored for 10 minutes post dose w/o incident. Returned on 2/7/12 with redness, irritation, swelling, itching from injection site to left elbow. Also complained of fever. Pt. referred to MD.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 37-year-old male.  Neither medical history nor concomitant medications were reported.  On 02-Mar-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there was no adverse events associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 12-May-2009:  product complaint investigation results.
My left arms started hurting the same day and started swelling the following day. I had a headache and fever and my eyes were running and I got cold and I got migraines
my hand is getting swollen and red; I felt coughing; I lost completely my taste; my hand is getting swollen and red; This is a spontaneous report received from a contactable consumer. A 66-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not reported), via an unspecified route of administration on 23Mar2021 as 1st dose, single dose and then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not reported), via an unspecified route of administration on 23Apr2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, he took vaccination, the first one on 23Mar2021, the second one 23Apr2021. The hands got swollen and red but after that he felt coughing and lost taste completely. He went to emergency clinic to a family doctor and did everything but could not complain because of the vaccination. The clinical outcome of the events unknown.  Information about batch no/lot no has been requested.
Severe muscular pains. Started below my right shoulderblade. Then worked over the right pectoral muscle. Then across the whole of my back. Now also affecting my right hand. It was so bad on Sunday that I didn't think I was going to make it into work. Ibuprofen does nothing to the pain. If I cough, it really hurts. Bending my back is well nigh impossible. The discomfort severely restricts my daily activities as a school bus driver.
Swollen and very painful lymph node on the right armpit. Pain on the injection site. Feeling tired and chills and feeling warm.
diffuse itchy rash to back, chest and perineal area treated with Benadryl and patient is feeling better but rash has not yet completely resolved.
Pt developed shinges rash at site of vaccination,started the day of vaccination and got progressively worse over 12 days treated with Valtrex
PATIENT COLLAPSED/FAINTED 5-10 MINUTES AFTER RECEIVING VACCINE.  DID NOT FULLY GO UNRESPONSIVE, BUT WAS DAZED AND CONFUSION. WAS SHAKING, SWEATING, LIGHTHEADED, NAUSEOUS, FLUSH, AND WARM TO TOUCH. AFTER 10-15 MINUTES PATIENT FELT FINE.
pt developed a DVT in left leg, 2 weeks post vaccination.  first one he has ever had.
8 hours of the flu shot, felt severe fatigue, chills, fever, headaches, dizziness, fast heart beat.
Headache; Fever 100.5; Stomach; Flu like muscle ache; Tired.
Information has been received from a certified medical assistant concerning a patient who "one week ago" was vaccinated with a dose of VARIVAX (Oka/Merck). It was reported that on approximately 15-JAN-2009 the patient was given VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck). It was reported that the pharmacy sent the wrong medication to administer to the patient. No adverse reactions reported. Follow up information was received on 28-JAN-2009: the certified medical assistant stated that the mistake was made at the pharmacy. It was reported that the pharmacy gave the male patient (previous gender unspecified) the wrong medicine. It was reported that the VARIVAX (Oka/Merck) and ZOSTAVAX (Oka/Merck) (MSD) come in the same box and are packaged the same way, which causes a lot of confusion. Follow up information was received on 12-FEB-2009 from a certified medical assistant concerning a 74 years old male with acute alcoholic hepatitis, diabetes mellitus, gastritis, duodenitis, hyperlipidemia, obstructive sleep apnea, paralysis agitans patient who on 16-JAN-2009 (previously reported as approximately 15-JAN-2009) was vaccinated with a dose of VARIVAX (Oka/Merck) (Lot #) into his right deltoid at 9:00. There was no adverse event reported. Further information is not expected.
Headache, Myalgia, Arthralgia, Fever, left sided facial drop Narrative: 1/5/21 severe left ear pain and on 1/7/21 left facial drop went to ED dx with Bell's Palsy
felt fine p/shot ate oatmeal for breakfast a/that;ate apples & some grapes-lunch;upset stomach 1:45 onset of vomiting 2PM; cont until MN;did not eat any other food that day;vomited to point of dry heaves;accompanied by h/a
Extreme Dizziness on Friday the 8th of October associated with being extremely weak. Again on Monday, October 11th, 2010 @ 8:00pm had Heart Palpitations and dizziness, was taken to the Emergency Room, @ 8:39 pm was given EKG, Chest X-ray and blood work. All tests were normal except a low potassium count. Was given a potassium pill and sent home.  Was told by ER physician could be having a bad adverse affect from the Flu vaccine.
Patient received both Fluad quad 9/13/21  and Fluzone HD 10/25/21. did not disclose any adverse effects or outcomes
This non-serious medically confirmed spontaneous report (initial receipt 06-Nov-2014) concerns an approximately 1 year old infant. On 08-Oct-2014, the infant patient received an unspecified influenza vaccine (manufacturer and batch number not provided) and VARIVAX (batch number not provided), both in the left leg. On the same day, the infant patient also receive MMR II injection (batch number not provided) in the right leg as a routine administration. On 08-Oct-2014, the infant patient developed a "pretty impressive rash" where the MMR II injection was given in the right leg. Outcome was unknown.
The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022; The patient received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022 at 5:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (The patient received vaccine that had went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received Booster dose.  No concomitant medication was provided.  No treatment medication was provided.
Rash outline still faint on upper left arm (round circle-larger than bandaid used.  Removed bandaid due to thought it may be latex reaction; however, it is still there 3 weeks later.  Have photo if need.
Patient stated that he was feeling light headed, he was assessed, and initial vitals done - BP - 181/99 P-118, OX 99%, Patient reassessed after 10 minutes BP - 153/76, P -92, O2 sat 99%. Patient stated he was feeling better. Electrolyte fluid given, patient discharged in medically stable condition.
Eleven days after vaccination, having headache, fever, myalgias, swollen lymph nodes in left axilla and neck, bandage reaction and body rash.  Rash is consistent with generalized pustulosis on arms, neck and trunk.  Also with worsening facial acne.
On 01/07/2023, I started to experience a sore throat. I tested negative for Covid-19 on this day, but tested positive for Covid on 01/08/2023. On 01/08/2023, I started to have a fever, headache, developed a cough and started sneezing a lot. I contacted my doctor and they prescribed PAXLOVID to me.
nausea; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on 15Feb2021 around noon (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if nausea was one of the common side effects of the vaccine, and how long it was expected to last? The patient received her second dose of the COVID vaccine yesterday around noon (15Feb2021) and was now experiencing nausea (16Feb2021). The clinical outcome of nausea was not recovered.  Information on the lot/batch number has been requested.
Mom states fever since 07/10/01, but no temp was taken. Client fussy and crying alot. Denies redness at the sites and no knots felt under the skin. Cold compress applied and temperature medicine given. But couldn't tell us the name of the temp medicine. Asked the mother to call back with a temp by 2 pm today 07/16/01 and the name of the temp medicine. At 2 pm no response from the mother. On 07/17/01, by interpreter, the client was having a fever especially at night and since 07/10/01. Told to take the client to the doctor the dad stated he will when the mother gets home from work today at 5 pm. Tried several times to reach the client, unable; messages left on a recorder dates 07/18/01 and 07/20/01.
DISCHARGE DIAGNOSIS: 1. Suicidal ideation with history of anxiety, depression.  2. Bipolar disorder.  3. Hypothyroidism.  4. Asymptomatic COVID.  5. Atypical chest pain.  6. Nondisplaced fracture, ulnar aspect of the base of the 5th digit distal phalanx.
Child's mother states that child had rash all over her body (front and back) that was itchy. Mother states that she spoke with child's doctor and child was given BENADRYL and is currently clearing the rash.
Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.
This spontaneous report as received form a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/029AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 26-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines tha that been stored incorrectly. Additional information is not expected.
Pt reports chills, temp 101 degrees F, headache earlier but feeling better now except HA (approx 7:20 pm). Called pt 10/22/15 9:50 am - still feels bad but better, did not seek any medical attn.
Arm noted with redness 2" around injection site with swelling and increased warmth at 48 hours post injection,. recommended Advil alternate with Tylenol as per instruction of DRs nurse and instruct mom to call DR in am if swelling, redness increased.
Severe chills, fever, whole body muscle pain, headache acute lasting through night.  Ongoing severe  injection site pain, lasting for several days, fatigue ongoing, myalgia ongoing,  and arthralgia .
Fever to 101.9 R, Fussy, Mild site reactions to all imm. sites.
pain in her arm; migraine headache; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer sponsored program. A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 16May2021 as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed pain in her arm and has a migraine headache. The reporter was asking if the patient can take parectamol (TYLENOL). Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
MUSCLE ACHES, FATIGUE, POSSIBLE FEVER FOLLOWED BY 1 VESICULAR SPOT ON 4/3 AND FEW MACULO PAPULAR SPOTS ON FACE, TRUNK AND ARMS ON 4/5.
Pt recvd  2nd dose of vax on 7FEB92 & since that time, has had worsening of sx of paresthesia of hands & feet, also had insomnia;