chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe fatigue for 4 days following 2nd dose and from 5th day to present fatigue after mild to moderate excretion.
Developed Shingles 3 days after first dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The reporter Consented to follow up. The reporter did not have lot or expiration date of Shingrix at time of call.
Left supra-clavicular lymph node swelling and tenderness; Left supra-clavicular lymph node tenderness; This is a spontaneous report from a contactable physician, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 03May2021 at 15:00 (at the age of 43-year-old) as dose 2, single for COVID-19 immunization. Medical history included depression and migraine.The patient had no allergies to medications, food, or other products. Concomitant medications included fluoxetine hydrochloride (FLUOXETINE) and desipramine (MANUFACTURER UNKNOWN) both from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 43-year-old) at 09:00 as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 09:00, the patient experienced left supra-clavicular lymph node swelling and tenderness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event left supra-clavicular lymph node swelling and tenderness was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.  Follow up (02Aug2021): This follow-up report is being submitted to amend previously reported information: Products tab, events tab and narrative were amended.
injection site was itchy; injection site was hard; injection site was peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received bnt162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EL0149) at the age of 51 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "concussions", start date: 2015 (unspecified if ongoing), notes: she was in an ice storm and had concussions and contusions, this occurred in 2015; "contusion", start date: 2015 (unspecified if ongoing), notes: she was in an ice storm and had concussions and contusions, this occurred in 2015; "She had an accident" (unspecified if ongoing), notes: She had an accident and had a torn rotator cuff and she was getting different injections; "torn rotator cuff" (unspecified if ongoing), notes: She had an accident and had a torn rotator cuff and she was getting different injections. There were no concomitant medications. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "recovered", described as "injection site was itchy"; VACCINATION SITE INDURATION (non-serious), outcome "recovered", described as "injection site was hard"; VACCINATION SITE EXFOLIATION (non-serious), outcome "recovered", described as "injection site was peeling". Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site induration, vaccination site exfoliation.  Additional information: The patient is asking when the new COVID-19 vaccine will be available. She also asked about tetanus and flu vaccine and agent referred her to the manufacturer since Pfizer does not have a tetanus or flu vaccine. Reports she took all of the Pfizer covid vaccines including the booster. States that when the injection site was healing it was itchy, hard, and peeling; and she took Tylenol. Stated that it took about 3 or 4 days to recover after each dose of the COVID vaccine. The patient was told to exercise and move her arm around.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298937 same patient/product/AE, different dose number;US-PFIZER INC-202300301984 same patient/product/AE, different dose number;US-PFIZER INC-202300301987 same patient/product/AE, different dose number;US-PFIZER INC-202300301985 same patient/product/AE, different dose number;US-PFIZER INC-202300301983 same patient/product/AE, different dose number;US-PFIZER INC-202300301986 same patient/product/AE, different dose number;
0n 8/27/2018 at 10:00 pm experienced severe shivering and chattering teeth. Difficult time sleeping. On 8/28/2018 I was very fatigued and napped several times that day. On 8/29/2018 I tried to restart my usual actives but became fatigued again.
I woke up very cold, shivering, body aches, headache, chills/fever;
Initial report received on 22 December 2010 from an investigator participating an a trial. An 11-month-old male subject who at the time of vaccination had mild cold symptoms of a cough and runny nose however, upon examination the primary investigator noted "no congestion, wheezing, nor airway issue. Mild cold ok to proceed with vaccine", experienced a febrile seizure eight hours after receiving a second dose of either INFLUENZA VIRUS VACC QUAD A & B or INFLUENZA VIRUS VACC NO PRESERV. TRIVAL A&B SV-U ALT-B or FLUZONE 2010-2011 (route and site of administration not reported) on 14 December 2010. Lot number was not reported. The subject had not experienced any adverse event after the first injection of the study vaccine. The subject's parents reported he had an axillary temperature of 101.5, his eyes rolled back, his body became stiff and he was shaking. The subject was evaluated by a paramedic and received corrective treatment with TYLENOL, however he was not hospitalized. The subject was evaluated by his primary care physician the next day and per the mother the physician felt the subject had a febrile seizure, which he stated were not "uncommon" after vaccination. The subject was reported as recovered on 14 December 2010. According to the investigator seriousness was "Other: Important medical event specify Adverse Event of special interest per protocol". The subject was not discontinued from the study as a result of this adverse event. The Investigator assessed the event as related to the trial product but not related to the trial procedures. Documents held by sender: none.
3 days after receiving vaccine, developed a severe cold which was diagnosed as pneumonia which lasted 3 weeks. Then when back to the doctor for follow up and was then diagnosed with bronchitis, Consistent trouble breathing , chest pain, left arm pain for 3 months and has been prescribed multiple inhalers, steroids, antibiotics, chest xrays, ultrasounds, stress tests. Has developed allergic reaction to peanut butter and bee stings. Patient was previously a vigorous healthy man with no serious health conditions.
pt recv vax 11AM 26FEB-5PM 27FEB inconsolable crying x 4 1/2hr;T101;seen @ hosp 27FEB;
p/vax pt had little blister like a pimple area that was hard & red;had burning sensation, fingertips tingly & arm became numb;hives on body the next noc;reports hand is still swollen;MD gave ATB x 5 days, cortisone cream, & put warm heat;
Loss of balance, was unable to stand up.  Had severe nystagmus w/ unequal pupils.  Probable seizure lasted aprox 30 sec. Followed by 10-15 minutes of postictal behavior which included confusion, lack of speech.
Patient was given dose one pfizer on 4/13/21.  Patient returned to clinic today on day 21 and received dose two by accident of  Moderna vaccine lot#048B21A.
Two separate syringes from the same lot. 1) entire end piece (glass circle) separated from the barrel 2) glass finger grip shattered Narrative: PRODUCT QUALITY ISSUE AFLURIA SEQIRUE P100358553 EXP 6-22 two separate AFLURIA syringes from the same lot had quality issues 1) entire end piece (glass circle) separated from the barrel 2) glass finger grip shattered
12 month old child was inadvertently given the adult Hep A  vaccine, Havrix instead of the  pediatric dose
The day following the shot I had a lot of arm pain, a large knot, redness, and heat at the injection site. Within 24 hours of those symptoms they subsided with Tylenol/Ibuprofen. On day 8 following the shot, I began to have an itchy sensation at the injection site. Within hours the injection site began to swell to a raised lime size knot on my skin, which continued to itch, was red, warm, and the raised skin had a few bumps on it. Again I used Ibuprofen/Tylenol and the swelling, redness, and itchiness decreased within 24 hours.
Patient developed diffuse erythematous pruritic papular rash across chest, arms and hands two days after second shot.  Had a mild hand rash two days after first shot that resolved with topical steroid.  Rash is currently resolving with topical steroids.
(R) leg -> 6 x 6 cm erythematous reaction on ant/lateral aspect of leg. (L) leg -> 10 x 12 cm erythematous reaction on ant/lateral aspect of leg.
Narrative: Patient received Moderna COVID vaccine #1 on 3/26/21 and #2 on 4/23/21. There are no other notes or scanned records to indicate what happened from time of second vaccine to recorded date of death of 5/18/21. No autopsy report available. Time from second vaccine to death was 25 days.
**22 Weeks pregnant. Due date 7/1/21. 1st pregnancy** The day after the vaccine around 3pm I had cramps and light spotting. The nurse on call advised me to go to the ER. I went to ER, they ran an ultra sound and all kinds of test, they said everything looked good they thought it was a Fibroid. They discharged me, and that night at 11:30pm I had a very big and fast bleed around a cup of blood and went back to the ER. That time I went to hospital because it was closer. Again they did an ultrasound and thought it was a Fibroid. I ended up seeing my OB GYN 2/8/21, she said she didn't think it was a Fibroid and sent me to get an ultrasound on 2/12/21. At that point after the bleed I had 4 days of spotting. When I went to the ultrasound they said I had a partial placenta abruption and my cervex has shortened. Since then everything has been fine.
Red rash around injection site, hot to touch, pain and itching. Began 2 days after injection, although pain began within hours of the injection.  Had body aches, brain fog and headaches within 10 hours of injection, they lasted 24 hours.
Neuropathy; Numbness in hands and feet, increased dramatically; Tingling in hands and feet, increased dramatically; rapid heart rate, body reacting; This serious case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included small fiber neuropathy (for several years, that was diagnosed by a nerve test in February 2022).   On 20-MAR-2023 13:00, the patient received the 1st dose of Shingrix (injection, left deltoid) 50 ug. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), hypoesthesia (Verbatim: Numbness in hands and feet, increased dramatically), tingling feet/hands (Verbatim: Tingling in hands and feet, increased dramatically) and heart rate increased (Verbatim: rapid heart rate, body reacting). The outcome of the neuropathy was not reported and the outcome of the hypoesthesia and tingling feet/hands were not resolved and the outcome of the heart rate increased was unknown.   It was unknown if the reporter considered the neuropathy, hypoesthesia, tingling feet/hands and heart rate increased to be related to Shingrix.     It was unknown if the company considered the neuropathy, hypoesthesia, tingling feet/hands and heart rate increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2023 The reporter self-reported this case. The patient reported that she received the Shingrix in her upper left arm. Tuesday, 21-MAR-2023 she went to the Doctor because of rapid heart rate, which the doctor told her was her body reacting to receiving the vaccine.  On Wednesday, 22-MAR-2023, the patient reported that the intensity of numbness and tingling in her hands and feet increased dramatically after having received the Shingrix vaccine 2 days before.  The patient was not spoken with her doctor about this increase in numbness and tingling but did go to a drive in because her doctor thought she might have varicose veins, and she was told at the clinic that she had neuropathy, not varicose veins.  The patient reported that she was still having this numbness and tingling in her hands and feet on the day of reporting. The reporter did not consent to follow-up.
1/28/03 mother called office, stated child had chickenpox. Spoke with mother she says "mild case" - lasted 7 days.
Bells Palsy, crooked mouth, effective speech, one eye remains open, fatigue 11 days and counting
9 hrs after vaccine were administered, patient had an episode of becoming limp and started to moan.  Episode lasted 1 min. pt febrile 100.6.
Patient states developed a low fever (about 100 F), aches all over (included shoulders, arm, and back) and sick feeling.  Lasted for about a day and resolved the next day.
Approx 3-5min post vax pt crying & became unresponsive for a 5min period; Breathless for 1 min given mouth/nasal breath; Pt unresponsive arms & legs were extended & stiff; Pt watched 30min @ clinic p/1st unresponsive period of 5 min;
Patient originally Covid + on 10/02/2021. Sent home and came back to the hospital for worsening symptoms. Tested positive again on 10/13/2021. Now hospitalized.  Per ED Note; Patient is a 95-year-old male with past medical history of hyperlipidemia, hypertension, GERD, hypothyroidism, TIA presenting to the emergency department chief complaint of generalized weakness.  Patient states he was in the emergency department approximately 1 week ago and records show that the patient was diagnosed with Covid 10/2/2021.  Patient also had a urinary tract infection at that time.  He does note that he has been at home with this illness and that he has had decreased appetite as his food tastes like rubber and cardboard.  He states he called his primary care physician who sent him in for a "full work-up "and to receive some IV fluids "so that (he) could regain his taste buds".  The patient also complains of cough and chronic intermittent episodes of diarrhea.  He otherwise denies headache, chest pain, shortness of breath, abdominal pain, nausea, vomiting, urinary symptoms, numbness, loss of coordination.
immediate tingling in right arm and hand immediate arm pain at injection site pretty immediate chest tightness/pressure ebbing and flowing but always slightly present until 9pm. Very brief sensation of tongue going numb and throat constricting (10-15 seconds)
Narrative: COVID infection following COVID vaccine series 01/15, Pfizer, dose #1 02/01, Pfizer, dose #2 09/14 COVID swab, result: detected 09/08 pt cc: cough, fatigue, nausea, loss of taste or smell, myalgias, diarrhea, cough exposure: unknown 09/22 clinically resolved 10/28 COVID swab, result: not detected
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of PROQUAD (lot#: M031567; expiration date: 24-DEC-2017; lot#: M031565; expiration date: 24-DEC-2017; lot#: M006102; expiration date: 01-AUG-2017; lot#: M043306; expiration date: 24-APR-2018; lot#: M033612; expiration date: 14-JAN-2018) (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA003300: US-009507513-1707USA002262: US-009507513-1707USA003302: US-009507513-1707USA003303: US-009507513-1707USA003298: US-009507513-1707USA003299.
4/6 Wednesday afternoon (1 day after vaccination), pt noticed redness and swelling and pain to (L) upper arm and axillary area. No fever reported. No medical care sought. Pt. states she took Ibuprofen for pain relief. Presented to health dept Thursday 4/7. Advised to elevate arm, apply warm/cold compress. 4/11/11 still reports pain although swelling decreased. To follow up with MD 4/11/11 at 1:30 pm.
pt devel gen urticaria w/in 24ht of vax as well as fever to 101;
PNEUMOVAX given (L) deltoid 10/19. Redness, warmth, tenderness. 16 x 10cm (L) deltoid. No fever.
Scattered hives occurred that pm or next am. Patient has DX of urticaria Dermatitis. HX of local reaction to latex band aids- only RX for this incidence was OTC BENADRYL.
Flu like symptoms.  Felt foggy no energy. Tingling on neck and head and face felt swollen and hot but was visibly normal.  **** I am having a screen reaction on injected arm that strain the day after injection and has continued to spread. As of 4-16-2021 at 10:30 Pm it is the size of a tangerine.  Red , warm to touch with undefined boards.
Severe Head ache on the day after, nausea, fever of 100 degrees, felt a lot better on March 13th. Woke up on the 14th with head ache and muscle pain all over especially in my chest area. Treated with Tylenol. During the night on the 15th I had a fever of 102.5 with severe headache and vomited. Tylenol has not worked. Call my PC and let him know my symptoms. It is now late in afternoon on the 15th, still have weakness and headaches and muscle aches. Fever is down to 100.0
Numbness in toes in the beginning after first vaccination. By after second vaccination a few months later began experiencing arthritis in hands/wrists and raynauds in hands/feet. Was diagnosed with SLE Lupus by a rheumatologist in September, 2012.
61 y.o. right handed male who the Program  is consulted for possible stroke. Patient reports that he got his COVID vaccination (Johnson & Johnson) today (3/11/2021) at about 10:30 AM. While waiting after the vaccination, at about 11 AM he became dizzy and felt like he was "loaded" ("stoned from smoking weed") and the started shaking "as though he has a fever but without a fever." and left side sensory loss which is non-disabling. He was taking to a CT scan which was negative for stroke and was discharged home.
Low grade fever of 99.9 being the highest; Fatigue; Muscle Soreness at injection site
This spontaneous report was received from a consumer, a male patient of unknown age reporting for himself. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 14-OCT-2015, the patient was either vaccinated with GARDASIL 9 or GARDASIL, dose 1, intramuscular (dose unknown). The patient could not confirm which vaccine he had received. Approximately in December 2015, the patient had received second dose of vaccination which was after two and half months of receiving first dose (inappropriate schedule of vaccine administered) and the patient had received final dose (dose 3) of vaccination on 14-APR-2016. No adverse experience was reported. Additional information has been requested.
Dizziness, bad headache, arm pain at injection site, swollen and hot to the touch. Feeling pain and swelling on the right side of neck. She sought treatment with NP at work, going to prescribe her an antibiotic.
Rather pronounced ear ringing - noticed after breakfast 8am approx.  I did take an ADVIL at that time because i was feeling badly. Its only been 2 1/2 hours so possibly it is premature.
Hoarsness, weakness, dizziness, nausea, immediate headache onset, cotton mouth.
T=99.7 swelling, induration + erythema at injection site - induration 4X5cm; erythema 12 X 8 1/2 cm with some bruising onset at approximately 3hrs after injection these findings 3days after injection -> Rx w/ Benadryl, application ice + Tylenol.
No adverse event reported to facility, however patient given Engerix-B indicated for 20 years old and older but patient 17 years old at time of vaccination
Mouth sores, 2-3 days post injection. Currently still experiencing mouth sores, swelling of lips.
Pt reports redness at the injection site w/ pruritis and heat 1 week post vaccination. Pt reports heat at the injection site that has now spread down lateral length of right arm. Pt advised to take Benadryl to relieve symptoms and take Benadryl before the next admin on 2/6/21. Adverse reactions still present. Pt sought no medical attention.
Pfizer 12/30/20, 1/20/21, 9/8/21, 7/15/22. Positive on 2/1/23
Immunizations, PPD, & bloodwork were done for 4yo well child check. Pt <5 min broke out in hives body, decreased BP, vomiting, & lethargic.  IM/PO BENADRYL given.  O2 via blowby.  Sent to DCH via ambulance.  Rx for anaphylaxis-observed & sent home.
within 10 min of receiving vaccine, patient complains with itching and rash to left inner forearm.  No sob/dyspnea. Benadryl 50mg given IM. Kept patient an additional 30 minutes, no problems upon dismissal. Advised going to ER  for any emergent s/s or call PCP if rash/itching continues or worsens. Patient verbalized good understanding.
pt recv vax & devel pain,tenderness & swelling @ inj site;noted that pt's  were squalling p/vax;nurse stated that there was extra diluent p/vax felt that may have been related to the sx;no further details were provided;
Pain. Swelling (hard area, size of lemon), redness, fatigue, headache, muscle pain joint pain , 4 hours of chills on and off,) nausea.  loss of appetite, fever of low grade, duration, some lasted 1 week small vesicles on R face above R lip and R shoulder sutured area.  Took tylenol and Benadryl which decreased pain and curbed itching.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VAQTA (lot # N008823, expiry date: 26-MAY-2018; lot # N005274, expiry date: 13-APR-2018) (dosing regimen and frequency unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. No adverse effects were reported. The temperature excursion was 9 degree C to 25 degree C for 1 hour 35 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000706: US-009507513-1709USA000707: US-009507513-1709USA000708: US-009507513-1709USA000709: US-009507513-1709USA000667.