chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing; wheezing; shortness of breath; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 90 years, first dose on 19Jan2021 09:00 (lot number: EK4176) and second dose on 09Feb2021 (lot number EL9261); via unspecified routes of administration on the left arm at single doses for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included losartan, terazosin, melatonin, glipizide, linagliptin (TRAJENTA), clopidogrel bisulfate (PLAVIX), clopidogrel bisulfate, citalopram, zinc, famotidine, amino acids nos (PROTINEX) and colecalciferol (VITAMIN D). On 20Jan2021, the patient experienced coughing, wheezing and shortness of breath. The patient was taken to the ER and put in the hospital for five days (date of hospitalization was unknown). Treatment received by the patient was unknown. Lab data includes COVID test: Unknown results on an unspecified date. The outcome of the events was recovered with sequelae on an unspecified date.
Recvd immun @ 10AM slept til 1230-115 was pale, weak, couldn't sit up; Taken to MD stated was a rxn to pertussis was given advil & PCN; 11SEP91 mom states doing much better;
Slightly dizzy, weird feeling. BP 154/73, pulse 97, Os sat 100%. F/U BP 156/67 (pulse 92). Bit of a headache.
passed out briefly 3-5 minutes after receiving the shots.  10/31/2007 MR received for OVs 8/2/07 and 10/8/07. After receiving Menactra and Gardasil 8/2/07 pt passed out in reception area. Regained consciousness after a few seconds. Assessment: Postural Hypotension. Increased fluids advised.  After 2nd Gardasil 10/8/07 pt felt dizzy and passed out. ? Vagal effect or hypoglycemia.  Pt was seen having jerking movements when down.  3/13/09 Additional records received from PCP. OV 11/16/07 for college PE.  Parent refused diagnostic tests since pt has been fine since syncopal episodes. Playing college soccer.  8/1/08 pt was running and felt tightness in chest and SOB. In office felt faint and dizzy, color pale, skin clammy.  PE with RRR and clear lungs. Assess:  R/O EIB. Syncope. OC 9/5/08 for eczema flair.  Assess:  Atopic dermatitis. Normal exam 3/4/09
Patient passed away on 4/29/2021. A member of our staff noticed his name on the obituary section of our local news. We do not know of any other details.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unspecified dates, the patients were administered improperly stored PROQUAD (Merck) Lot number L050908 with expiration date of 14-JUN-2017 and L044055 with expiration date of 02-MAY-2017, (dose and route were not reported), which were stored at 7.9 F for 12 hours, 10.6 F for 12 hours, 6.8 F for 12 hours and 6.8 F for 12 hours, the worst case scenario was 48 hours cumulatively. The vaccines did not have previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
12/23/2020 VACCINE 12/26TH EVENING FATIGUE, ARM PAIN AT INJECTION SITE, ENDED UP WITH BIG RED SPOT BELOW RIGHT COLLARBONE AND BRUISE ON 12/29; PAINFUL.  12/28 WOKE WITH BILATERAL EXTREME SWOLLEN LYMPHNODES. SEVERE IMMUNE REACTION. ZERO FEVER. ABDOMINAL PAIN. DIARRHEA (WEEK LATER) SAW DOCTOR FOR LYMPNODES VIA TELEHEALTH. HAD IMMUNE RESPONSE TO THE VACCINE; IBUPROFREN, ICE, AND PROB 'COMPROMISED'.  SYMPTOMS WENT ON FOR 14 DAYS. SOUGHT CARE AT URGENT CARE FOR ABDOMINAL PAIN.  DR WANTED CAT SCAN, CONCERNED WITH LYMPHNODES. PAIN WENT AWAY AND I DIDN'T FEEL NEEDED TO DO.
Sinus; Shoulder pain; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old male patient received BNT162B2, dose 1 via unknown route in left arm on 24Feb2021 at 10:00 AM (at the age of 36 years old) at single dose for covid-19 immunization. The patient medical history included seizure disorder and had known allergies: penicillin. Concomitant medications were not reported. Patient had other unspecified medications in two weeks. There was no other vaccine in four weeks. The patient experienced sinus and shoulder pain on 24Feb2021 at 03:00 PM. AEs was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No Covid prior vaccination and no Covid tested post vaccination. No treatment for the AEs. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected. The information about lot number and expiration date cannot be obtained.
Patient called saying he had been experiencing a lot of swelling, redness and pain.  Patient said he did ice for a week on and off. He spoke to his dr office and they are sending him for an ultrasound
Extreme muscle soreness on Right arm w/in min of rec. Pain spread to shoulder, neck, chest, back by mid-afternoon. Resolved after 9 days.
AM of 2/6/05 right arm became swollen, red, and warm to touch
Constant, loud ringing in ears, especially on the left side.  Frequent headaches, sometimes accompanied by sharp, sudden pain in the left side of head.
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. On an unknown date these unspecified amount of patients were vaccinated with M-M-R II (lot#, dose, route not provided) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Discoloration of skin at injection site similar to vitiligo approx 4-5 mm circular present 2 weeks after injection, no signs of infection. no treatment. notified today.
Pt exp a systemic rxn, chest pain, inc ESR, A CNS lesion, fever, flu-like illness, myalgia, depression & chronic arthralgia following vax w/rubella vax 11NOV83;
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: EP6955, Expiration Date: Jun2021) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "type A blood" (unspecified if ongoing), notes: Verbatim: type A blood; "microscopic colitis" (unspecified if ongoing), notes: Verbatim: microscopic colitis; "Pre-diabetic" (unspecified if ongoing), notes: Verbatim: Pre-diabetic; "to help with her anxiety to get to sleep" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN taken for insomnia; ATIVAN taken for insomnia; ASHWAGANDHA [WITHANIA SOMNIFERA ROOT] taken for insomnia; TRINTELLIX taken for anxiety. Vaccination history included: Bnt162b2 (First dose: Received 26Feb2021, lot EN6201, unknown expiration date.), administration date: 26Feb2021, when the patient was 70 years old, for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovering", described as "sore arm".  Additional Information: Other concomitants were reported as, Rotazipem with unknown indication and unspecified if ongoing. sleep support, every night for Insomnia. Additional Information for Concomitant Products Trintellix was reported as, started about 1.5 weeks prior to receiving the first dose of the vaccine, to help with her anxiety to get to sleep. Reporter said she received her 1st dose and her 2nd dose schedule appointment is 5 weeks not for 3 weeks. Escalating this because the 2nd dose schedule was given more than 3 weeks. Additional Information: Other concomitants were reported as, Rotazipem with unknown indication and unspecified if ongoing. sleep support, every night for Insomnia. Additional Information for Concomitant Products Trintellix was reported as, started about 1.5 weeks prior to receiving the first dose of the vaccine, to help with her anxiety to get to sleep. Reporter said she received her 1st dose and her 2nd dose schedule appointment is 5 weeks not for 3 weeks. Escalating this because the 2nd dose schedule was given more than 3 weeks.  No follow-up attempts are possible. No further information is expected.
Per patient: two days after the shot she woke up with phlegm in her throat, had a hard time swallowing, had a hoarse throat and her right ear felt "blocked inside". She went to her primary care clinic wondering if this was a reaction from the Zostavax vaccine she had received 2 days earlier. They told her it likely was not. Patient reported the phlegm cleared after a couple of days but the blocked feeling in her ear did not clear. She then went to her nephrologist who "ran labs" and confirmed that she had a flare of her Wegeners disease. She was started on Prednisone, Valtrex and omeprazole on the day of reporting.
not feeling well; she was very ill; Diarrhea; Vomiting; Chills; Headache; extremely tired, wiped out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 17May2021, outcome "recovered" (May2021), described as "she was very ill"; DIARRHOEA (non-serious) with onset 17May2021, outcome "recovered" (May2021), described as "Diarrhea"; VOMITING (non-serious) with onset 17May2021, outcome "recovered" (May2021), described as "Vomiting"; CHILLS (non-serious) with onset 17May2021, outcome "recovered" (May2021), described as "Chills"; HEADACHE (non-serious) with onset 17May2021, outcome "recovered" (May2021), described as "Headache"; FATIGUE (non-serious) with onset 17May2021, outcome "recovered" (May2021), described as "extremely tired, wiped out"; MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Additional Information: The patient received COVID-19 vaccine on 05May2021 and 12 days later she was very ill. She says she is better now. She says she was experiencing diarrhea, vomiting, chills, a headache, and she was extremely tired, wiped out.the report at this time. She says you could have a reaction 10 to 14 days later. She says her main concern is should she get the second shot. The patient asks how much longer this will be and that she has to go to the bathroom. She apologizes and says she is not feeling well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4 month old came in for well visit and immunizations. 2 mo immunizations given just 3 weeks prior. The vaccines cannot be counted and will be repeated within the next 4 weeks.
About 5 minutes after both vaccines were administered, the potential new Volunteer started to look pale in his face and stated he felt "a little lightheaded", also started sweating on his forehead. Monitored for over 20 minutes for his safety with another Employee at the time and also gave him some water. Potential new volunteer refused to lie down or be taken to Emergency dept. upstairs. After 20 min, he stated he felt fine. Possible vasovagal episode.
This spontaneous report was received from a pharmacist refers to a 79 year old male patient with aspirin allergy who had been hospitalized from unknown date and reason. On 17-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and route of administration were not reported). There was not concomitant reaction. In August 204 the patient experienced redness, swelling, pain and hardness at the injection site. Some warm compresses were used as treatment for these reactions. There were not laboratory diagnostics studies performed. The reporter stated that the patient had been hospitalized prior to receiving PNEUMOVAX 23 therefore the hospitalization was not related to the adverse events. The outcome of redness, swelling, pain and hardness at the injection site was reported as not recovered/not resolved. Additional information has been requested.
patient received an expired dose of Rotateq; no adverse effect; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. Information on pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (strength, dose, lot # and expiry date unknown) for prophylaxis (expired product administered). The re was no known adverse effects (no adverse event).
Took her down; This case was reported by a consumer via call center representative and described the occurrence of malaise in a female 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 malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided are as follows: The case was reported for reporter's husband aunt. The age at vaccination was not reported. The reporter stated that the patient said that the Shingrix vaccine took her down. The reporter could not clarified what the statement meant. The reporter had limited information. The reporter did not consent to follow-up. The case has been linked with case US2021225705 and US2021225710, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021225705:same reporter US-GLAXOSMITHKLINE-US2021225710:same reporter
Day after: Fatigue, headache, malaise/muscle pain.  Day 2: Night sweats & excessive sweating
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 16-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805461 was crossed linked to the original cases 201804863 due to same reporter.
Patient is a 75 yrs female who presents with a skin infection vs reaction to Prevnar (PCV-13). She got the vaccine on Thurs. 1-23-15.   She first noticed symptoms on 1-24-15. The infection is located on the medial to the anterior side of the R upper arm. (vaccine given on lateral side).  She has not had fever.   She has not had chills, rigors and/or sweats.  She has not noticed red streaks moving proximally from the main area of infection.  There is a history of trauma.  She had the vaccine in the lateral portion of the arm. Symptoms are burning and itching.  No previous reaction to any vaccines. Plan: Cephalexin (KEFLEX) 500 mg Oral Cap.
Vaccine entered my body, ate up all my platelets in blood. Unknown bruising, blood spots all over body, mouth blistering  and light headed; dizziness. Diagnosed with ITP on 12/19/2022.
Directly after I had bivalent booster, I had chills and fatigue for about three days afterwards. That resolved around the time I would normally start my period. I had pain in my abdomen area like a dull ache that was persistent, not stabbing. It felt like a fullness without touching as if there was something there. This pain was coming from my gall bladder area. I then began running a fever on the night of October 13th. I have continued to run a low-grade fever, the abdominal pain, my neck feels stiff and fatigue. I went to an urgent care. They drew blood. I will follow up with my doctor. My period cycle was over one week late. I took a home pregnancy test that was negative and this was confirmed at the urgent care.
Reporting this because it was unexpected, not because it was 'harmful'.    I had the shot on Thursday evening, then returned home, watched tv for a few hours before bed.   My sleep was interrupted as usual (chronic insomniac), but I got approx 6-6.5 hours of sleep before getting up on Friday.   My normal 'sleep' schedule is from 1/2am to around 9-9:30am.    I woke up at 8am feeling *fantastic* - clear-headed, full of energy, in a great mood.   This is the best I've felt in MONTHS, possibly over a year.    Around 3-4pm in the afternoon, my energy came to a complete halt.  Fortunately I work from home and was able to take a 2 hour nap.  When I woke up again, the 'great' feeling had returned.   This continued throughout the weekend until Monday night.    Today, I feel like I expected to feel 'post-booster' - tired, a little run down, like I'm fighting a cold.    I hadn't heard anyone mention a reaction like mine, so I figured I would report it even though it's not your typical 'adverse' reaction.
Received vaccine 10/6/11 approx 6 hr late had very bad headache next morning noticed flashing light out of corner of (R) eye. Headache and flashes continued so I called eye dr after 3 eye appt in 3 day determined optic nerve was inflamed and optic migraines prescribed NSAID follow up 6 mth. Headache 15 day still have eye pain.
pretty bad excruciating, constant headache /constant brain fog headache; pretty bad excruciating, constant headache and fogginess; feeling hung over; This is a spontaneous report from a contactable other health care professional. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. Medical history included History of migraines. No medication she takes is helping. The patient's concomitant medications were not reported. On Jan2021, the patient has a pretty bad excruciating, constant headache and fogginess, feeling hung over, constant brain fog headache. The outcome of the event was unknown.   Information about batch/lot number has been requested.
Sore arm for 24 hours after initial vaccination. I am breastfeeding and starting on day 7 after vaccination my breastfed infant had diarrhea and fevers for a few days, and continues to have diarrhea without fevers despite not making any other changes in diet, etc.
Starting 4 days after receiving the first Covid vaccine, my daughter stopped wanting to breastfeed. She said that the milk tasted like plastic and that it didn't taste right. She said the same thing for several days in a row, at which point she stopped wanting to nurse. Within a month of the first vaccine, and ongoing ever since, my menstrual cycles have been irregular. The start date of my cycle varies up to a two week difference, which had been very regular before I received the vaccine. The bleeding is inconsistent, may be very heavy one month and light the next. I have frequent night sweats. The night sweats started in January, a week before my period started. This has changed over time, and I now have night sweats any time during the month. I also have frequent problems with constipation, a problem that I have never had before I received the vaccine. I now have frequent headaches, at least 3-4 per week. This was not an issue before the vaccine.
Red, inflamed at site of administration. Entire upper arm is red and swollen. Doctor prescribed steroid cream and antibiotics for arm.
Patient never told us she got the Bivalent Pfizer vaccine in September, she doesn't speak well. Didn't have her vaccine card at the beginning. It was when her husband came to get his shot we noticed that they are both already vaccinated by a bivalent covid vaccine. The husband speaks better. Patient doing well, and insisting the doctor told them to get both bivalent forms.
Information has been received from a Registered Nurse, for GARDASIL, a Pregnancy Registered product, concerning a 25 year old female that was 26 weeks pregnant, and with no allergies who on 07-JUL-2010 was vaccinated subcutaneously with 1.0 ml GARDASIL (lot# not reported) in place of tuberculin purified protein derivative ("PPD") due to human error, not product confusion. Concomitant therapy included vitamins (unspecified). Office stated that 1 ml GARDASIL was given subcutaneous, not standard PPD dose of 0.1 ml. Unspecified medical attention was sought. The patient's last menstrual period was approximately 07-JAN-2010 and estimated delivery date will be 14-OCT-2010. Follow-up information has been received from the Registered Nurse. She reported that the prenatal patient was given 0.1 ml of GARDASIL subcutaneously. She stated that even though the dose of GARDASIL was much less than the normal dose they were still given GARDASIL. The patient was given GARDASIL in place of PPD due to human error. This is one of several reports received from the same source. Follow-up information has been received from the Registered Nurse who reported that the patient on 24-OCT-2010 at the 41 weeks from LMP delivered a normal male infant, weight 3730 grams and Apgar score 9/9. There were neither congenital anomalies nor other complications/abnormalities regarding the baby. For obstetric information, the mother also was no complication during pregnancy, during labor/delivery and no infections or illnesses during pregnancy. No further information is available.
Hospitalization for shortness of breath with COVID-19 on dates 7/24/2023- 8/2/2023.  Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 at 16:00 as dose 1, single (Lot number: EN6203), in left arm, on 21Mar2021 at 16:00 as dose 2, single (Lot number: ER8730), in left arm, on 02Nov2021 at 16:00 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 01May2022 at 16:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer- total thyroidectomy" (unspecified if ongoing); "Thyroid cancer- total thyroidectomy" (unspecified if ongoing); "Breast cancer lumpectomy and radiation" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Feb2002; BUPROPION HCL XL, start date: 01Mar2021; PRAVASTATIN SODIUM, start date: 01Jan2015, stop date: 15Aug2022; ANASTROZOLE, start date: 01Jun2019; VITAMIN D3, start date: 01Oct2016; CALCIUM, start date: 01May2011; VITAMIN C [ASCORBIC ACID], start date: 01Feb2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (24Aug2022) Negative; (25Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course information: Patient received other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.