chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was due for second dose of adult Hepatitis A (Havrix) vaccine.  Patient was inadvertently given a Twinrix dose. Patient was then given a pediatric dose of Hepatitis A (Havrix) on the same day, to equal a full adult dose of Hepatitis A vaccine. Patient was informed that if she wants to complete her three-dose Hepatitis B series, she would need two additional doses of Engerix-B or Heplisav-B.  Patient denied any symptoms, complications, or adverse effects from the vaccine.
pain in head and neck; pain in head and neck; glands in neck swollen; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain in head and neck, with glands in neck swollen. She received the shot on 23Dec2020 and is wondering if there have been any reports on a delayed reaction to the vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.
Lightheadedness, brain fog, exhaustion.  The main issue is lightheadedness, they come in waves, they are worse when I am tired, there is no movement or anything that I am doing to cause them.  They are worse when I lay down in bed and get up in bed. Balance issues and eye twitching have also become an issue.  However, again the feeling like my brain is floating in my head is the main issue
fever/100.9 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient).  An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on 14Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  It was reported that patient had the covid vaccine on Thursday (14Jan2021) and on Saturday (16Jan2021) night, she started running temperature and had fever. She took  paracetamol (TYLENOL) every 4 hours and on Sunday (17Jan2021) she was still running a fever. Today (18Jan2021), it's about 100.9 degrees Fahrenheit. Wants to know if that is normal for this vaccine. Yesterday, she laid in bed all day and does not know if she can continue to use paracetamol (TYLENOL) and quite concerned about still running a fever. She states it didn't start right away and wanted to know how long the fever will last.  The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to 5 year old female patient. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 11-JUL-2018 the patient was vaccinated with improperly stored Oka-Merck PROQUAD dose 1, subcutaneous in the left arm from lot R003292 expiry date 31-JUL-2019 for prophylaxis (Product storage error). On the same day, the patient was also vaccinated with VAQTA dose 1 intramuscular in the right deltoid from lot R002086 expiry date 22-APR-2019 and KINRIX from lot 95FR9, dose 1, intramuscular in the left deltoid; both for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The reporter was not sure which sterile diluent (manufacturer unknown) lot numbers were used. The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
Pt. stated that vaccination site was warm to the touch, red and itchy. Was wondering if it was an allergic reaction. Told pt. to follow up with MD.
Two days following the first COVID vaccination he developed  epigastric pain and was evaluated in the ER and was admitted for gallbladder surgery. He has a 6 year history of gallbladder disease but was not experiencing symptoms until after the COVID vaccination.
Arm soreness and fever from vaccine - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration
ED visit on 10/19/2021.  Tested + for COVID. The last few days she's been complaining of fatigue, fever, chills. At the onset she had some nasal congestion and runny nose. No real cough or shortness of breath. Denies chest pain. Denies nausea, vomiting, diarrhea, dysuria. She has some body aches. Denies rash. Denies syncope. She has been vaccinated for Covid in the past. Stable vital signs. At this time recommended supportive care and discharge. To return to the ER if symptoms worsen.
I received the injection mid-day. During the night I had nausea and hot and cold episodes. I got up around 5:30 a.m. extremely nauseated, went to the bathroom, and waited until the nausea passed. Walked into the kitchen, became extremely nauseated again, and then blacked-out. When I came to I was on the floor and bleeding. I believe when I fell I hit the kitchen island, counter top and then the floor. Contusions to the head (4), trauma to the left eye, and 2 rib fractures (#4 and5).    Because of my history of Meniere's I want to clarify that I was NOT experiencing vertigo.
Presented 3/30/15 with 2 day Hx of diffuse rash/generalized. 4 days prior had low grade fever, cough, runny nose. Had MMR on 3/18/15.
A rash on the arm of injection that showed up on 02/05/2021 was told by physician to take antihistamines and use a steroid cream. Rash cleared up mostly in 2 days before steroid cream was even used. Circles were drawn around rash splotches to check if spreading. Rash did spread outside of one of the circles, but has since cleared up.
ERROR: Age- UNAUTHORIZED AGE GROUP (15 years old, Pfizer EUA approved only for children 16 years and older. Parent signed consent form with incorrect DOB indicating age greater than 16yo). Event discovered and forwarded for VAERS reporting. Signs and symptoms: None known Diagnosis and treatment: None known Outcome: No adverse reaction reported
side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a female 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 at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the physician received flu shot herself and experienced side effects from the flu shot. The reporter stated that the physician found out there was something bad in the formulation that she was administering, something like formaldehyde. The reporter stated that the physician ordered the flu shots that were made in specific countries and this formulation did not contain any of the other ingredients (just the flu strains).   The reporter stated that at the time of reporting this formulation was administered none of the flu shot patient got any side effects any from the flu shot any more. The reporter herself has never received a flu shot. This case has been linked to US2019AMR222423, reported by the same reporter.
Patient immediately felt pain after receiving the vaccination. She describes having symptoms of bursitis. She has yet to see a doctor about this. I advised her to go at once.
Child had shots at 10:00-10:05 and at 10:12, he became diaphoretic and pale and vomited a large amount X 2. At 10:15, his BP-80/40, P-70 and R-32, eyes open but not responsive to verbal stimuli. At 10:20, BP-90/50, P-70 and R-30 and shallow, color sallow, eyes open and starting to respond to verbal stimuli. Paramedics were called immediately and arrived at 10:20 and transported father and child to ER for evaluation X 2 hours. Telephone call to parents and they report child is well.
became positive for covid 19; became positive for covid 19; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration on 22Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient she received covid vaccine on 22Dec2020 and on 30Dec2020 became positive for covid 19. The patient wanted to know when she can schedule her 2nd dose. Outcome of the event was unknown.  Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
My first Moderna dose was 2/26. I had a low-grade temp and body aches on the 9th day for 24 hours. The second dose was on 3/26. That afternoon my eyes were burning with eye strain. On Saturday into Sunday had low grade temp escalating to 101.5 p.o. with severe body aches, fatigue, and loose stools. My blood pressure dropped to BPS of 80's on Monday morning. On Thursday following had leg discomfort ? sciatica and episode of SOB. On Friday, another episode of SOB. On Sunday (April 4th), noted left ankle/leg swelling which persisted on and off for next two months. Swelling went down with leg elevation. Early June, had developed severe sciatica on left. Appointment with primary provider June 18th. Left leg remained swollen and sciatica was severe enough to cause difficulty with ambulation. Doppler studies completed 6/21/2021. Results below in #19.
This spontaneous report as received from a physician via a company representative refers to a 50 year old female patient with Diabetes. No information regarding the patient's medical history was provided. On 03-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX23 injection in her arm (lot# K016294; dose, route of administration and expiry date were not reported) and with a dose of an unspecified Flu vaccine (in the same arm; dose and route of administration were not reported). There were no concomitant therapies reported. On 04-NOV-2015, the patient experienced redness and swelling in an unspecified arm. On 06-NOV-2015, reported as today, the patient experienced fever of 101.4 degrees (units not further specified). There was no product quality complaint involved. The patient sought medical attention- she had an appointment scheduled for the day of this report. The outcome of the events was not reported. The relatedness between the suspect therapies and the events was not provided. Additional information has been requested.
Patient felt lightheaded about 20 minutes after her dose. Improved over 15 minutes while drinking water and sitting in air conditioning.
Case was hospitalized for Covid 6 months after completing the primary Pfizer series. At Hospital.   Discharging physician: MD.  Acute respiratory failure with hypoxia   Assessment & Plan In respiratory distress with hypoxia in ED at rest needing 2 L.  He had complained of shortness of breath in ER in Polson 6/21 and was started and Advair inhaler PFT from 6/28/21 noted FEV1 3.27 ( 101% of predicted) with normal DLCO and CXR at that time was normal so unlikely that he has underlying lung disease  It appears that his sats in MD office on 6-17-21 were 97% on RA Today on the day of discharge sats are 94% on RA   COVID-19 virus infection Assessment & Plan Tested + 9/24/21 Sxs present for ~ 7 days prior to admission Got 3 days of and 2 days of remdesivir which was stopped because sats were 94% on RA Vaccinated on 1/21
really bad headache that has lasted almost 3 WEEKS  .  Also chest pains. Tested positive for covid after vaccine
Patient was to office with mom 9/24/2018, received FLULAVAL vaccine at that time, signed consent. 9/26/2018, patient returned to office for recheck with grandmother, she asked for flu vaccine and signed consent. Flu vaccine give two days apart. No side effects reported by mom at this time. GSK company made aware, information reviewed with mom.
Intermittent rash to begin with - gradually got worse - dry/scaly at both arms, or both sides of neck, rash similar to heat rash under breasts - rash appeared/disappeared...  Also rash in groin area - inner upper thigh both sides of vagina - dark reddish/purple.  Again, intensity varies.  Rash pattern seems to follow lymphatic nodes -i.e. both sides at once.  Can appear on different areas.  Biopsy result (3/21/22 report - from 'Doctor' 14 above states: (see 19, which also states 'The features are not classic for an execematous/atopic dermatitus'.)
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 26-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Lack of coordination, forgetfulness, disorientation, felt feverish/sweating. Didn't experience any of these for 1st 4 vaccinations. Stayed away from family and work to rest and avoid having conflicts, this started about 12 hours after vaccination. Severe pain at injection site; started within 6 hours of vaccination. Used pain relievers. Did experience this for 1st 4 shots, but after a few days, not so immediately.
PT CLAIMED AFTER A WEEK OF 1 DOSE OF MODERNA COVID 19 PT START GOT ACNE ON BOTH OF HIS TEMPO FOREHEAD
has tingling in 3 fingers in his right hand/his fingers are still tingling; This is a spontaneous report from a contactable consumer (patient himself) via medical information team. An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in right arm on 22Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that he received the vaccine in his right arm and he has tingling in 3 fingers in his right hand on an unknown date in 2021. It began mildly after the vaccination and has progressively gotten worse. His fingers are still tingling. The outcome of the event was not recovered.
On March 8, 2021 I went to pharmacy and got the J&J covid vaccine. There were no apparent adverse effects. On March 30, I work up with a rash on my right leg. After about 2 days the rash appeared on both legs. As of April 9, 2021 the rash has not cleared completely! I have photos which I will try to attach to this report.
Patient experienced chills, numbness of lips, itching around haw area, elevated heartrate 103 bpm, and lump in throat. Blood pressure slightly elevated at 121/90. Oxygen levels and breathing remained normal. Administered 25mg diphenhydramine orally. No improvement after 15 minutes. EMS called. EMS evaluated patient and took her to the hospital.
Fever Moderate amount of edema noted from under left axillary to the deltoid area (with two pools of edema). Injection site, raised and very red with purplish discoloration (not like a bruise). Shingles rash started < 48 hrs (under left breast and down left ar Narrative: Seen MD a couple of days after the injection (72 hours) after injection
Adverse event: Woke up 2 days later feeling dizzy and shaky. She noticed potential infection and rash localized to shot administration. Pain radiating to lymph nodes, tingly fingers and nausea. Treatment: Benadryl for rash; went to urgent care Sunday morning. She was prescribed cephalexin and Zofran. She is considering a doppler if not feeling better by Tuesday.
pt recvd vax & on 26AUG92 devel cough which was productive of a yellow brown mucous & then became nonproductive; sx persisted for 5 wks; No further details were provided;
10/12/2005 - left arm red area about 4cm diameter, hot and painful to touch, monitored and treated with Motrin.  10/12 vomiting, went to ER, diagnosed with virus and Cellulitis.  Treated with IV Rocephin and Augmentin.
3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NECK; SHE CALLED HER PCP WHO HAD HER SUE HER EPI PEN - THE SWELLING RESOLVED. ON 3-20-21 SHE ALSO HAD A EARACHE, HEADACHE AND BLOODY NOSE. HAS TAKEN TYLENOL.'
tingly arm; suspect that only about half the dose was given; This case was reported by a pharmacist and described the occurrence of tingling of extremity in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 53X42, expiry date unknown) for prophylaxis.   On 27th December 2020, the patient received the 1st dose of Shingrix. On 27th December 2020, less than a day after receiving Shingrix, the patient experienced tingling of extremity and accidental underdose. On an unknown date, the outcome of the tingling of extremity and accidental underdose were unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The reporter was giving the Shingrix vaccine to the patient, and quite a lot of liquid squirted out the sides of the plastic part of the needle, which led to accidental underdose. The reporter suspected that only about half the dose was given. The patient's arm felt tingly. The reporter asked for recommendation to give another dose or to give half dose or to wait until the next dose was due or other. On 28th December 2020, the reporter called for information regarding the administration of less than the recommended dose of Shingrix to a patient. The patient received around half a dose of Shingrix due to a needle leakage. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020256888:FU1 deleted
This spontaneous report was received from the mother of a 6 month old male patient, referring to the child. No information was provided regarding the patient's medical history, concurrent conditions, drug reaction/allergies or concomitant medications. It was reported that in approximately August and October 2018 (reported as "at two months and at four months"), the patient was administered first and second doses of LIQUID PEDVAXHIB, for routine vaccination (dose, route and site of administration, lot number and expiration date were not reported). The mother reported that on 10-DEC-2018, the patient, now six months old, was administered another dose of a "generic" form of the hib conj vaccine (unspecified carrier) (manufacturer unspecified) at a new pediatric office. The mother reported that on the same date her child experienced fever. At the time of the report, the event of pyrexia was reported as "ongoing" (not recovered). The patient did not seek medical attention. The reporter did not assess the causal relationship between therapy with LIQUID PEDVAXHIB and the event. There was no PQC reported.
1 day post vaccination reported feeling faint, dizziness, headache, and fatigue.  Took two Tylenol in am.
Beginning around 12 hours after 2nd booster shot, I had to urinate around once an hour for 8 hours (throughout the evening after going to bed). I was not taking in any liquids. Also had pounding headache, swollen and painful sinuses, body aches, fatigue, chills and fever-this lasted for around 36 hours.
Rash on back of hands, painful and tender sores on inside of hands at joints, similar spots on feet.
This case was reported by a physician via Merck and described the occurrence of HIB Meningitis in a 5-month-old subject of unspecified gender who was vaccinated with (non-GSK) PENTACEL, (Sanofi Pasteur MSD), HIB. The subject's medical history included intraventricular hemorrhage and premature birth. The subject was one of twins born prematurely at 29 weeks gestation. Concurrent medical conditions included gastroesophageal reflux disease. Concurrent medications included ZANTAC. In 2013 the subject received 1st dose of PENTACEL (unknown details), 2nd dose of HIB vaccine (unknown details). In 2013, within months of vaccination with HIB vaccine and PENTACEL, the subject experienced HIB Meningitis and possible vaccination failure. It is unknown whether this case meets GSK criteria of vaccination failure. The subject was hospitalised. Relevant test results included a CSF culture that was HIB positive by latex agglutination in 2013. At the time of reporting the events were improved.