chrisvoncsefalvay/vaers-outcomes huggingface dataset:
resp distress; This is a spontaneous report from a non-contactable consumer (patient). An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at 16Dec2020 12:00 pm at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The patient medical history and concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced respiratory distress on 19Dec2020, he was hospitalized for three days. Patient received treatment for the adverse event. Since the vaccination, the patient has been tested for COVID-19 with nasal swab on 19Dec2020, it was negative. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown. The event was serious, the seriousness criteria was Caused/prolonged hospitalization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within the hour from 5:00- 6:00 PM. My throat became sore and swollen making swallowing difficult (was asymptomatic up until that time). Asthma like cough developed and breathing became an effort. At 6:15PM I took one 25mg Benadryl thinking it could be an allergic reaction. By 7:00 PM I was feeling relief and breathing easy. Throat remains feeling slightly "tight" but continues to improve.
went to give pt shot and as soon as needle hit skin, arm flailed and did not adminster due to inability to calm child. child received non of the vaccine.
weakness, headache, temperatrure of 101, fever, sweating, itchy, body rash,
Immunizations given in office 5/27/14. Mom reports redness to (lt) arm began next day. (+) H.A. and low grade temp began ever of 5/27/14. Temp 102F 5/28/14. Seen in office for reaction on 5/29/14 9 cm x 1 1/2 cm area redness (lt) arm, no edema. Tx - BENADRYL; Return increased fever/redness.
rash on body/ red bumps on body; itching all over; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 17th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced generalized rash and generalized pruritus. On an unknown date, the outcome of the generalized rash and generalized pruritus were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The patient was experiencing a rash, red bumps, and itching all over the body. The reporter consented to follow up.
Rash across Left upper extremity, chest, neck, shortness of breath, tachycardia, severe itching.
After a few hours at first I was lightheaded. The next day I was feeling hot and then cold and still with the headache. My stomach was feeling messed up and I felt drained. When I went to the hospital they said I was dehydrated and I had a fever.
This literature marketed report as received from a health professional refers to a 4 month old male patient. On an unknown date the patient was vaccinated with Hib vaccine (manufacturer unknown) (dose, route and lot# not reported). Other concomitant therapies included pneumococcal vaccine (manufacturer unknown) (dose, route and lot# not reported), rotavirus vaccine (manufacturer unknown) (dose, route and lot# not reported), DTAP and IPOL on an unspecified date. It was reported that the patient developed hemolytic anemia shortly after receiving his four month immunizations including Hib vaccine (manufacturer unknown), pneumococcal vaccine (manufacturer unknown), rotavirus vaccine (manufacturer unknown), DTAP and IPOL. The authors described the method of isolating the causative vaccine, Hib vaccine (manufacturer unknown), during his 6 month immunizations. Design/Method: Case Report. Results: Following two days of irritability, vomiting, and dark stools, the patient was found to have an initial hemoglobin of 2.7 g/dL at a community hospital. He was transferred to the academic center where he had a weakly positive direct antiglobulin test with negative complement component 3 and immunoglobulin G. Further testing revealed immunoglobulin A mediated autoantibodies. Significant improvement in his hemoglobin was observed after oral corticosteroid administration. A staggered approach was utilized for administering his 6 month immunizations which included serial complete blood counts following each individual vaccine to monitor for evidence of hemolysis. IPOL and DTAP vaccines were given without incident. However after administration of the Hib vaccine, his hemoglobin dropped to 7.0 g/dL, with hemolysis, suggesting that this vaccine was responsible for the initial episode. The authors planned to give him further Hib vaccine (manufacturer unknown) vaccine doses with steroid pretreatment. The outcome of autoimmune hemolytic anemia was reported as recovering/resolving. Additional information has been requested.
Child had tonic/ clonic seizure, unresponsive x 4-5 minutes, Taken to hospital via ambulance.
Systemic: Dizziness/Lightheadedness-Medium, Systemic: Exhaustion/Lethargy-Medium, Systemic: Fainting/Unresponsive-Medium, Additional details: Patient received vaccine, several minutes later she passed out. Her mom caught her and brought her to the floor. She lied on the floor for several minutes then walked to a chair, sipped some water, ate some chips and sat in chair for approximately 5 minutes. She then felt well enough to leave store.
Small bumps  on both  hand and both ankles.  Like little pimples.  They don't itch.
Blood present in stool at 5am; pain in lower abdomen; constipation; BNT162B2 on 26Oct2021, influenza vaccine on 26Oct2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via unspecified route in right arm on 26Oct2021 14:00 (Lot Number: FF2589) single dose for covid-19 immunization at 44-year-old; influenza vaccine via unspecified route in Left Arm on 26Oct2021 unspecified dose for immunisation. Medical history included diverticulum. No known allergies, no covid prior vaccination. Concomitant medication included vilazodone hydrochloride (VIIBRYD); iron; vitamin D. No other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm for covid-19 immunisation, first dose on 28Mar2021 13:00 (lot number: ER2613) at 44-year-old, second dose on 16Apr2021 13:00 at 44-year-old; both had upset stomach and diarrhea. The patient experienced blood present in stool, pain in lower abdomen, constipation on 28Oct2021 05:00 with outcome of unknown. The third dose of vaccination was administered on 26Oct2021, patient woke up with pain in lower abdomen, constipation. Blood present in stool at 5am. The patient was keeping an eye on symptoms and would seek medical attention if it didn't improve. Outcome of the other event was unknown.  No follow-up attempts are needed. No further information is expected.
pt recvd vax; that eve pt has fever & chills; flu like sxs; got worse; v & d that last 48 hrs; v stopped but could not eat; friday almost fainted & took to hosp for severe dehydration; dec in potassium & protein level; given IV's; in hosp;
1Pm began coughing, 1:30 felt throat closing, took two Benadryl's and an inhaler. Eyes were swollen and goopy felt better by 3AM.
fever 99.6 , headache, chills, nausea (not sure these are adverse events but thought ya'll should know this anyway)
Initial misuse report received from a pharmacist on 06 November 2013. The patients had received ActHIB. It was reported that they used sterile water for reconstitution in a few cases. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Nausea, temperature, arm soreness, joint soreness,  sore top of mouth headache for 2 days.  Called ER Doctor and she told me to drink liquids, eat crackers and take Pepto Bismol.   Finally got better but injection site still hurts and still have roof of mouth pain and slight headache.
No reactions to vaccines per patient, medical assistant administered expired MMR vaccine with lot number T012806 and expiration date 04/14/2022. Physician contacted and informed family of patient and adviced family member to follow up with in 30 days to repeat the administration of the vaccine. No reactions to vaccines per patient, medical assistant administered expired MMR vaccine with lot number T012806 and expiration date 04/14/2022. Physician contacted and informed family of patient and adviced family member to follow up with in 30 days to repeat the administration of the vaccine.
Worsening of a current headache, fever, vomiting, joint pain - ER visit 6/1/13 at midnight.
no adverse event. Tdap vaccine given to an individual greater than 64 years of age.
patient has erythematic area at injection site that is swollen, and warm to touch and patient reports pain. Patient states it started the day after the injection and has progressively gotten worse. Treated for cellulitis and allergic response.
The patient received the third/booster dose of BNT162b2; Maternal Exposure During Pregnancy, third trimester (35 weeks (Months 8-9)); Major swelling and bumps on one side of labia majora; Bumps on one side of labia majora; Veins also bulging out on same side in leg area; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old 35 weeks pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration on an unknown date in Oct2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The last menstrual date of the patient was on an unspecified date in Feb2021. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within two weeks of vaccination included prenatal vitamins from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration on an unknown date in Jan2021 (at the age of 35-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration on an unknown date in Jan2021 (at the age of 35-years-old); both as single doses for COVID-19 immunisation. On an unknown date in Oct2021, within one day of receiving booster (third vaccine), the patient experienced major swelling and bumps on one side of labia majora. The veins were also bulging out on same side in leg area. There were no changes reported in diet, activity, prenatal vitamins, other than receiving vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events major swelling and bumps on one side of labia majora; veins were also bulging out on same side in leg area was not resolved at the time of this report. The reported due date was on an unspecified date in Nov2021.  No follow-up attempts are possible. No further information is expected.
Pt recv vax on 8/3/98; on 8/4/98 pt exp fever (102) w/ headache for 1 day.
Bell's Palsy   Faxed on: 3/1/21 by: CMS
Dry chapped lips which then progressed to swelling, itching, redness and pain. Patient describes it like when your lips are sunburned.
Red size of a salonpas,  very itchy, warm to touch, bit swollen.  Itch started Monday 18Jan. getting bigger.
received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
About 4-5 days after the shot I woke up with pain on my right breast and a rash, over the next 2 days it was burning and around my right side. I went to the doctor and was diagnosed with shingles, the NP thinks the vaccine brought down my immune system just enough for the shingles to come out. This led to me having to spend $90 on bandages to keep it covered so my 6 month old son did not get chicken pox. I had to be on an antiviral medicine that caused me to lose the hearing in my left ear for 10 days as well as on norco and ibuprofen for the pain. I missed multiple days of work and was in bed a few days due to the pain. lot # may be 211A217
feverpatient received an expired dose of Havrix today (August 25, 2022).; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 25th August 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:25-AUG-2022 Reporters comment: Physician Assistant (HCP)stated that a patient received an expired dose of Havrix on 25th Aug 2022 HCP opted out of providing additional patient information. The reporter did not give consent to follow-up. Additional Supportive information: The patient received an expired dose of Havrix , which led to expired vaccine used.
potassium deficiency; shaking; nervousness; rapid heart beat; anxiety; no appetite; felt hot; Sore arm at the injection site; muscle pain; sore muscles; bad fatigue; pulse went down; blood pressure went up; didn't feel well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKALAEMIA (potassium deficiency) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergy to: tetracyclines). Concomitant products included VERAPAMIL, LOSARTAN, CHLOROTHIAZIDE, DIAZEPAM and DOXAZOSIN for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced HEART RATE DECREASED (pulse went down), BLOOD PRESSURE INCREASED (blood pressure went up) and MALAISE (didn't feel well). On an unknown date, the patient experienced HYPOKALAEMIA (potassium deficiency) (seriousness criterion medically significant), TREMOR (shaking), NERVOUSNESS (nervousness), TACHYCARDIA (rapid heart beat), ANXIETY (anxiety), DECREASED APPETITE (no appetite), FEELING HOT (felt hot), VACCINATION SITE PAIN (Sore arm at the injection site), MYALGIA (muscle pain; sore muscles) and FATIGUE (bad fatigue). At the time of the report, HYPOKALAEMIA (potassium deficiency), TACHYCARDIA (rapid heart beat), HEART RATE DECREASED (pulse went down), BLOOD PRESSURE INCREASED (blood pressure went up), MALAISE (didn't feel well), DECREASED APPETITE (no appetite), FEELING HOT (felt hot), VACCINATION SITE PAIN (Sore arm at the injection site), MYALGIA (muscle pain; sore muscles) and FATIGUE (bad fatigue) outcome was unknown and TREMOR (shaking), NERVOUSNESS (nervousness) and ANXIETY (anxiety) had not resolved.            The patient received escitalopram 10mg daily, but stopped taking after 4 days as he was feeling depressed. Reporter stated that the patient went to the emergency room  on 26APR2021 due to changes in blood pressure and pulse. "It wasn't because of the vaccine. He had a potassium deficiency."  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for  the event of hypokalemia which is unlikely.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 27apr2021: updated event and possible causality. Reporter does not think the blood pressure and pulse issues related to vaccine; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for  the event of hypokalemia which is unlikely.
Clt fell, experienced light-headedness, brief loss of consciousness, ringing in ears, nausea, right hand shaking and mild headache. BP taken by clinic PHN 102/64. Later BP was 118/72. Per client, all symptoms resolved before leaving clinic. This PHNC advised mother to have clt evaluated by medical provider today after leaving clinic.
After both doses and after the booster for COVID-19, my left arm swelled from shoulder to elbow, and it stayed that way for many days--more than a week each time.  I also had an itchy red rash down my left arm with doses one and two that started midway down my arm and went to my elbow.  My shoulder swelling caused an impinged shoulder, which I've never had before.  Months later, I'm still in physical therapy (and my arm still looks a bit swollen) to get full movement without pain back.  It started immediately after each dose of the vaccine, so it's not conincidence, or related to anything else.  Has never happened before, and I've never had an issue with this shoulder.
NO REATION  ME AND MY WIFE RECEIVED THE MODERNAVACCINE AS THE BOOSTER
I received the Moderna COVID-19 booster and a flu shot on 9/21/2022. On 12/13/2022, I was on a plane returning from a 21-day trip abroad when I developed a stabbing headache, a minor dry cough, clear nasal drainage, general malaise, and sudden body aches. I also had plugged ears, but that may have been due to flying. I took some TYLENOL for the headache, which helped some, but it did not get rid of it completely. I took a home antigen test on 12/14/2022 and quickly got a positive result. My PCP prescribed me PAXLOVID. I ran a minor temperature for a few days. My temperature is normally 97, but it was about 98 for a few days. I began to feel a lot better on 12/16/2022, since the headache and body aches were gone. I have not tested again since 12/14/2022, so I don't know whether I'm still COVID-positive. Although I feel much better now, I still deal with residual fatigue, nasal congestion, and occasional runny nose. I can feel pretty tired after doing something as simple as dusting. I also had a dry cough at one time, but it is now gone.
24JUL92 fever of 102 for 2 1/2 days; 25JUL92 flat red rash on chest, back & under arm pits, also itchy; 28JUL92 taken to MD 4AUG92 rash disappeared over weekend;
Spent a day in bed; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles for many years). Concurrent medical conditions included nerve pain.   In July 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient had shingles many years and still had the nerve pain. The reporter stated that the patient received Shingle vaccine in July 2022. The reporter reported that after received Shingles vaccine the patient spent a day in bed. The patient needs to receive second dose in September, patient asked should he gave the second vaccination. Additional supportive information: Follow-up would not possible as no contact details were available.
Fever, chills for 2 days, headache, cough, sore throat through 4 days. At day 3 I received a monoclonal antibody infusion and felt much better after that.
Information has been received from a nurse referring to a patient of unknown age and gender. On 30-JAN-2015, the patient was inadvertently administered a dose of improperly stored PROQUAD 0.5 ml, (lot number and expiry date were not reported), subcutaneously. No adverse effects reported. This is one of two reports received from the same reporter (linked to 1502USA000768). Additional information has been requested.
Pt had been SOB for about an hour at the nursing home before being sent to ED. Pt became increasingly hypoxic and required BiPAP and was hypotensive. She was found to be COVID positive and was in lactic acidosis. Pt also had an NSTEMI.
Chest pain, palpitatations, shortness of breath.  Resolved with Advil.
Breakthrough COVID-19 infection. Patient tested positive on FEB 23 2021. Patient was fully vaccinated on FEB 16  2021.
Patient developed a red rash on left arm starting at injection site and moving down arm towards wrist/hand. Patient stated her palms felt clammy and numb. Patient expressed feelings of anxiety.
Rash around her trunk area of the; Chills; This case was reported by a other health professional via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced rash and chills. On an unknown date, the outcome of the rash and chills were unknown.   It was unknown if the reporter considered the rash and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix injection to a local pharmacy and did not know if it was 1st or 2nd dose 3 to 4 months ago and reported a rash with chills around her trunk area of the body.  The Doctor had just left the office but took her laptop with her that had more information such as date of birth, patient initials and maybe if other Vaccinations were recommended that day.