chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed bodyache, chills, fever after 1-2 day of shots, and also developed swelling & rash on R deltoid area over site of shot.  He had lot of HA.  Went to ER.  Had CT brain and LP both negative.
TOOK THREE UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-610) on 08-Mar-2019. It described a 71-year-old elderly female consumer who "took three unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif correctly and then left the remaining three doses out of the fridge and took them all. She would be travelling on 14-Mar-2019.  The action taken with Vivotif with respect to the event "took three unrefrigerated doses" was not applicable.  The clinical outcome of the event "took three unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three unrefrigerated doses" was considered as not applicable.
-complained of sore and chest pain 5 days after vaccination. -broke out in rash to face . Treated with antibiotics-Breathing has continually gotten worse with ICU admission. Per 60 day follow up: Remains seriously ill, finally diagnosed with CHURG STRAUSS disease-took several years to finally diagnose but sx started soon after the receipt of smallpox vaccine. Is no on cytoxan-one treatment for tis life threatening illness. He has multisystem involvement.
Pt has a history of DM2, HTN, HLD, HCV cirrhosis (sp treatment, Child Pugh A), CKD3 with baseline Cr 1.5 who presented to the ER after a syncopal episode and with headaches. She has no history of a positive COVID test. She reported receiving the J&J vaccine on 3/6 and reports headaches since then. She also had a syncopal episode that prompted her presentation to the ED. She underwent MRV of the brain looking for sinus thrombosis. The brain portion was normal but she was found to have a LIJ thrombus. She denies prior history of VTE. It is overall unclear if this thrombus is related the her symptoms, to the vaccine, or completely incidental. Pt was started on a heparin drip in the hospital...
temp elevated 4PM 2MAR96 103.9 motrin given;temp elevated 8PM 2MAR95 104.9 motrin  & APAP given;temp elevation cont to 105;sz 1030PM 3MAR96 cont APAP & Motrin;office visit 4MAR95 2PM sz temp 103.6;hospitalized 4MAR96-5MAR96;
Patient was diagnosed with bilateral pulmonary emboli on 5/24/22. He has no risk factors/provoking factors for PE other than his symptoms of dyspnea on exertion and chest pain started approximately 2-3 days after the vaccination.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer who reported similar events for two patients. This is the second of two reports. Information were collected also from a Pfizer-sponsored program. A 74-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Shortly after the first dose the patient came down with COVID, tested positive for COVID in Jan2021. On 24Jan2021 he received monoclonal antibodies as treatment. He was scheduled for the second dose on 09Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021070373 as same reporter/drug, different event/patient;US-PFIZER INC-2021070373 Same reporter/drug, different patient
RASH with itching started second day after injection then became worse on day #3 after injection pt took Benadryl and prednisone; tx in clinic on 2/5/21 and prescribed prednisone x 10 days, bendaryl and famotidine
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.  Patients were administered vaccine after the published expiration date. None of these patients have reported any known symptoms following vaccination.
Information has been received from a licensed vocational nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date between 01-SEP-2016 and 09-OCT-2016, the patient received improperly stored PROQUAD (lot # L031600, expiration date 18-FEB-2017; dose and route were unknown). No adverse effects were reported. The vaccine was stored under temperature 18.03 Fahrenheit degree for 16 hours. There was no prior temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 34-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Non-alcoholic fatty liver" (unspecified if ongoing); "pcos" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19; patient received Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Reporter documented "Patient was accidently given Dtap instead of Tdap on 1/12/21". Additional documentation from reporter "A couple months ago or so, we did not have Tdap and the long green box of Dtap appeared  on our top shelf in the fridge. It is a different brand, I looked at the ingredients were the same , so I had thought it said Dtap was because it was a different company. I didn't realize that one was the initial vaccine and the other was the booster. Someone did recently write on there for 6 weeks to 6 years.  It was still  on our shelf in the fridge until I moved it to the bottom shelf the day I discovered the mistake. I notified the midwife as this was her patient. She tried to contact patient. I also notified my supervisor.  I did share with fellow employees that there is a difference in Tdap and Dtap and to always make sure you have Tdap when giving in clinic".
Recurrent fever of up to 103.5 throughout the 48 hour period following the vaccine administration, along with lethargy and decreased appetite. One incident of vomiting (without fever) approximately 36 hours after vaccine administration. Fever was treated with acetaminophen & ibuprofen, which brought the fever down on all but one occasion.
Felt lousy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: Felt lousy). The outcome of the feeling bad was resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR052758   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and felt lousy. The patient stated that he or she did not have issue, he or she may never gotten but was proactive. The patient stated that anything that gave you an edge is worth doing. This case had been linked with US2023AMR052758 by same reporter for same patient.  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR052758:Same reporter, 2nd dose
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about an unknown date in 2014, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about later in 2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 at 12:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Oct2021 at 12:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 00:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details Treatment start date 28Sep2022 and stop date 30Sep2022, Lot number 1923793A, Indication for Treatment of COVID-19. Other medication details: Other medication in 2 weeks product Amoxicillin start date: 14Sep2022 and stop date: 20Sep2022. Adverse event Severe abdominal area discomfort Rapid weight loss, without change in diet. Oily stool. Seemed like food not being absorbed. Stopped taking paxlovid due to suspected adverse effects on liver. Waking up at night with weird bad taste in mouth. Adverse event start date 29Sep2022, If patient Recovering, no Known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
01/10/21 - exacerbated trigeminal neuralgia and polymyalgia bilateral shoulder pain, had to take prednisone taper for 10 days 02/02/21 -  migraine like headache started and shoulder pain continued,  on 02/04/21 seen by neurologist ARNP  telehealth and prescribed Cymbalta 20mg,  on  02/09/21  seen in ER, Covid test negative, given migraine medicine Fioricet on 02/11 /21 seen by neurologist  ARNP to restart prednisone taper and take migraine med Fioricet Migraine symptoms  lessened but still present
Soreness in arm about 8 hours later; December 26 I started to have congestion, and headache and little bit of a cough. Some body aches, loss of taste and smell, as well. 27th - Covid test - Pos-tive (notified on 28th). Symptoms lasted for about 7 days except loss of taste and smell was only 5 days and it resolved. Took Tylenol and Mucinex D. Went to Urgent Care. Still having lingering congestion and fatigue.
Fever of 101, grunting respiration, mild retractions associated with a distant look, not focusing well with increased drooling and inability to nurse. Lasted around 45 minutes to 1 hour, then completely resolved. Possibility of seizure based on Mom's description.
This spontaneous report was received from registered nurse referring to a 34 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-SEP-2017, the patient was vaccinated with PROQUAD rHA lot number M033215 and expiration date of 09-JAN-2018 for prophylaxis (dose, route of administration, lot number and expiration date were not reported), reconstituted with water sterile diluent (lot number and expiration date were not reported). No adverse effects were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1711USA006282.
BODY ACHES; SWEATING; PAIN IN RIGHT SIDE OF LOWER ABDOMEN THAT STARTED AROUND 11PM LAST NIGHT; CHILLS; HEADACHES; VOMITING; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker, and other pre-existing medical conditions included: Patient was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 30-OCT-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 30-OCT-2021, the patient experienced body aches. On 30-OCT-2021, the patient experienced sweating. On 30-OCT-2021, the patient experienced pain in right side of lower abdomen that started around 11pm last night. On 30-OCT-2021, the patient experienced chills. On 30-OCT-2021, the patient experienced headaches. On 30-OCT-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headaches, vomiting, body aches, sweating, and pain in right side of lower abdomen that started around 11pm last night. This report was non-serious. This case, from the same reporter is linked to 20211100672.
The patient received a flu shot in her left arm and a Prevnar 13 shot in her right arm on the same day. Both shots caused expected soreness soon after. In the following days the pain in the left arm went away and the pain in the right arm worsened with limited range of motion of the right arm. She saw an orthopedic surgeon and had an MRI. It indicated an inflamed bursa which was subsequently removed. She has since been doing physical therapy. Her main purpose for reporting this incident was to ensure that our personnel are properly trained in order to prevent any future incidents.
After my second COVID vaccine injection I noticed that I had developed tinnitus. What I hear is a high-pitched tone, apparently in both ears.  It is constant, and seems to be worse at night before I go to bed.   Note: I did suffer from tinnitus about 15 to 20 years ago, until I realized the cause was my occasional use of a table saw when I was not using ear plugs.  That instance of tinnitus went away once I began using earplugs, and did not return until two days ago, after I received my second COVID vaccine. I have a regular checkup with my regular physician today, and plan to tell him about the tinnitus.
About 2 days after the shot patient started having trouble breathing. He is an elite runner, running 50 plus miles a week. In the past he had asthma, but hasn?t had any flare ups in over 2 years.  He mentioned before his race yesterday that he had been having trouble breathing while running . He  took Flovent the day before (2x/day)  and used albuterol (3 puffs pre race and 2 after).  For the first time ever he was unable to run his fastest because he felt he couldn?t breathe. . He said his chest hurt more than it ever has and during the race and continued after. Several hours later he said his chest was still hurting. He is not wheezing, coughing or showing any of the signs of asthma that would cause a visit to immediate care or ER, his chest is just feeling very tight and hurts.  A little later he tells me he has been having this ?breathing problem? for over a week.
heart racing; feeling a little uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 05Mar2021 (Lot number and Expiry date was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced Heart racing on, Feeling a little uncomfortable on Mar2021. The patient underwent lab tests and procedures which included heart rate: heart racing on Mar2021. He reports that afterwards he woke up in the middle of the night with his heart racing, heart rate: subsided on Mar2021, he mentioned that he hadn't taken his blood pressure medication yet, so he took it then, a few hours later his heart rate had subsided. Therapeutic measures were taken as a result of heart racing. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
9/9/16 Rxn started. Sat morning swelling itchy, hard, sore, swollen.
started cough & wheezing immed rt eyelid edematous;rx w/prelone;
I landed up with flu like symptoms and shortness of breath. After about 4 days the flu symptoms went away but the shortness of breath did not. Then my legs started to swell. My doctor sent me to the ER and they did testing. They found blood clots in my right calf. They kept me overnight for monitoring and they put me on ELIQUIS. I saw a pulmonologist and she thinks I might have a blot clot in my lungs so I am getting further tests.
High fever 102-104 very weak couldn't eat, still doesn't want to. Real bad cough and vomiting. Got shot on Tues got sick Sunday stayed sick 12 days. Nurse said she had a reaction bu told me to take her to private Dr. No ins. No money.
Fatigue, soreness at injection site, loss of smell and taste. All symptoms gone within 3 days with the exception of taste and smell. Those are still have not returned
November 16 at 20:30: Deeply uncomfortable pain in right arm from shoulder to elbow. Noticed rash on right side of cheek and chin. November 16 at 22:00: went upstairs (first physical exercise), had hot flashes/throbbing hot body, deep arm pain, noticed right cheek and chin rash was almost gone. Put hydrocortisone cream on cheek and chin. November 16 at 23:00: laid down due to fever feeling and lethargic, immense arm pain continued (couldn?t move without pain), body felt feverish because of cold fingers/toes and hot legs. Took temperature (97.2) November 17 at 08:30: fever was broken during the night. Arm didn?t hurt as badly, noticed an uncomfortable itch on left chin and cheek there was a rash present.November 17 at 09:30: looked at chest in mirror, red and agitated and one large skin-colored bump. Decided to put medication on after class (by 11:00). November 17 at 12:00, there was not a rash or redness on cheeks, chin, or chest at that point despite not having any medication on it. November 17 at 13:45: right shoulder felt uncomfortable under a loose fitting cotton t-shirt, bright red agitation and raised skin-colored bumps. Photos were documented. Chest was slightly itchy at that point. November 17 at 14:15: despite most of the bump disappearing without doing anything, I put Benadryl and hydrocortisone cream on both cheeks, chin, and chest.
w/in 1 1/2 to 2hr p/vax pt started getting hives & later on had chest discomfort & went to ER & recv DPH;
Very hard induration at site of injection. Site also had redness, heat, and itching for 3 days following injection. Systemically experienced chills, muscle aches/soreness, and fatigue. Of note, the vaccine administrator said they were going to hold the injection in place for 10 seconds following the injection per instructions to do this this way, which I had never had occur before. I have also never had a vaccine reaction before. Unsure if the local site reaction could have been worse due to this practice.
24 hours after-headache- sinus type 48-hours -after- headache and body aches particularly left buttock 72- hours after- all of above  plus 100.2 fever, extreme body aches, chills and could barely walk 96 hours after- symptoms going away,  120 hours after- only headache remained and red spot on left arm developed One week later all symptoms gone
Pt's mom stated had previous reaction to multiple vaccines at once including dizziness. I had the patient sit for 10 minute and after 10 minutes the patient began sweating, losing color in his face, had chills, and vomited. Patient reported tingling in his arm and blurry vision. Patient remained conscious and was given fluids and cold compresses. Monitored patient for an additional 30 minutes and condition improved.
loss of taste; This is a spontaneous report from a non-contactable consumer via medical information team. A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter mentioned that his "significant other" received the Pfizer-BioNTech COVID-19 Vaccine first dose but s/he is currently experiencing some side effects (loss of taste) on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected.