chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious report of medication error has been received from a nurse concerning a three-year-old male. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient had a medical history of Down's Syndrome. No concomitant medications were provided. While the FluMist was being administered, the patient was jerking and moving. As a result, the patient received only a partial dose of FluMist and some went into the patient's eye. No symptoms were reported. No outcome for the event was provided by the reporter. The patient did not experience a rechallenge while receiving the suspected product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  A non-serious report of partial dose of vaccine given and some got into eyes has been received from a nurse concerning a three-year-old male. The patient received FluMist on 11-Oct-2007. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The nurse stated that she is not even sure that the patient actually got FLUMIST into his eyes since he did not even wipe his eyes after the FLUMIST was administered. The nurse stated that she reported the incident because the patient's mother was convinced that some of the FLUMIST went into the patient's eyes. The patient was seen in the pediatricians office on a date after the incident and did not report any adverse events. The patient had not experienced any adverse event(s) as of 21-Feb-2008. The events were resolved on 11-OCT-2007. The patient did not experience a rechallenge while receiving the suspect drug. The reporter provided no causality assessment for the event. The reporting sources of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received 27-Nov-2007: No adverse events resulted after the patient received FLUMIST; information regarding the administration. Additional information received on 21-Feb-2008 and incorporated into the case: patient demographic information corrected, date of birth, date of administration of FLUMIST, and lot number.
Left arm, swelling began on 7/24 (red, warm to touch, no tenderness), swelling continued to worsen until 7/27 (size of softball, hot to touch, painful), her father traced outline with marker, all symptoms began to dissipate 7/28.
Good ad but I am allergic to it (Prevnar 20); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (174934). The reporter is the patient.  A 76-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Good ad but I am allergic to it (Prevnar 20)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started having issues with my nasal passages being very dry so much that it makes me have scabs or it is an open sore. It is painful when it occurs, and this only started about a month after my COVID-19 shot. There is this stabbing feeling in my nose, and it is really sensitive and sore so much so that I want to breath in through my mouth rather than my nose. I have started using the Flonase when this happens and that tends to help when the pain and soreness start coming on. I got a humidifier and that will help when this starts becoming a consistent problem and I can get it to calm down for a bit and go back to normal. I do have also have sinus tension headaches at times with this but not all the time. It does tend to be worse if it is colder and it will come on more often in colder weather and sometimes, I will even wear a mask to try and help avoid this happening. I am seeing my healthcare provider tomorrow and will be discussing this issue as it is still ongoing. While it is not consistent, but it does happen sporadically which is also why I am putting that I am not recovered at this point.
Sudden onset of feeling bad; Feverish (no fever); Bad joint pain; Very tired; Arm hurt a lot more with the 2nd shot; Woke up soaked in sweat, still no fever; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included autoimmune, several, graves, thyroid, eye disease and colitis. The patient did not have any allergies to medications, food or other products. Concomitant medications included thyroid (ARMOUR THYROID), sulfasalazine (SULFASALASIN) and alendronate sodium (FOSAMAX); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. After the first shot the patient had no problems at all and after second shot at 17:00, Saturday, April 10th, the patient had no problems until 21:30. On 11Apr2021, Sunday evening, the patient experienced sudden onset of feeling bad, feverish (no fever), bad joint pain, very tired. Went to bed, a lot of joint pain. Took 3 tylenol and drank gatorade, went back to bed, and slept 2 hours well. Woke up soaked in sweat, still no fever, drank more gatorade went back to sleep and slept well. The patient woke up on Monday feeling good, normal. Basically for 4 hours of feeling very bad. The patient's arm hurt a lot more with the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with 3 tylenol and the patient drank gatorade. The clinical outcome of the events feeling bad, feverish (no fever), bad joint pain, very tired, woke up soaked in sweat and the patient's arm hurt a lot more were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
A report has been received from a physician concerning patient of unknown gender. No information regarding relevant medical history, concomitant disease, or concomitant medication was provided. It was reported that after receiving FLUMIST Quadrivalent last week the patient developed flu symptoms. The outcome of the event of patient develops flu symptoms after receiving FLUMIST was unknown. The reporter assessed the event of develops flu symptoms after receiving FLUMIST to be non-serious.
Patient passed out after I had left the room following the administration of GARDASIL and the flu vaccine. The patient's mom and sister witnessed the event. I heard a loud bang and heard mom yelling for help. I ran back into the room and patient was unconscious in her mom's arms. The patient responded after a few attempts of calling her name. The patient stated she hit her head when she fell back.
Third dose booster: Fever, body ache, swelling at injection site, swelling of armpit lymphs. Symptoms persisted for four days.
This spontaneous report as received from a nurse refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The nurse reported that a patient received her first dose of GARDASIL on 18-NOV-2014, her second dose of GARDASIL on 02-MAR-2015, and her third dose of GARDASIL on 18-MAY-2015 (dose, site and route of administration, lot# and expiration date were not reported for all), which was outside of the recommendations in prescribing information. There was no adverse effect reported. Additional information has been requested.
severe vomiting; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW0153; Expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 10Apr2021 16:15 (at the age of 17-years) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included none. Had no known allergies. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Other vaccines within 4 weeks prior to the COVID vaccine included none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced severe vomiting, nausea on 10Apr2021 22:00. The events were not serious. Therapeutic measures were taken as a result of the reported events. AE resulted in Emergency room/department or urgent care. AE treatment included IV fluids, nausea medication via IV. Clinical outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Expected reaction to 2nd of two inoculations; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, after expected reaction to 2nd of two inoculations and no reaction from  the 1st dose of Shingrix and asked if it was possible if the  previous version of shingles vaccine was administered. It was also reported that, was it possible to have no reaction after receiving 1st dose of Shingrix.
Stabbing head ache, chills, and body aches; Stabbing head ache, chills, and body aches; Stabbing head ache, chills, and body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on arm left on 09Jan2021 16:45 at single dose for COVID-19 immunization. The patient was diagnosed as COVID prior vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did not have COVID tested post vaccination. The patient experienced stabbing head ache, chills, and body aches on 10Jan2021 with outcome of not recovered. No treatment was received for the events.  Information on Lot/ Batch number has been requested.
Patient describes paresthesia to left arm and hand in the distribution of the ulna nerve. In addition patient's ulnar nerve is more sensitive to touch than in the contralateral arm.  This is in the same arm that she received the Covid vaccine and has worsened over the last 9 days.  Patient also complains of increased fatigue.
Extreme shoulder pain for 8 days, shoulder appears frozen and unable to rotate forward. Worse at rest. Believed it was due to improper injection site for both my husband and I. Received vaccine in room 15. RN misplaced injection, was very high and distal, almost in the shoulder joint instead of muscle.
Patient received a vac in another country, in immunization registry also received moderna in April 26, 2021.
I received my first dose of the Pfizer vaccine in my left arm via injection on Wednesday the fourth of August, 2021. On Friday, two days later on the sixth of August I started to feel pain in my left leg and noticed a vein bulging out behind my knee. The pain comes at various parts of my leg (thigh, knee, calf, shin, foot) and leaves just as fast. It is not super painful, but it is enough for me to be irritated and worried.
Pregnant female was given MMR, Varicella, DT by above name facility despite informing them that she was pregnant.
Information was received from a physician via a company representative regarding unspecified patients (demographics or details of patients not provided). The physician stated that an unspecified pediatrician sent an email with an article from an unspecified pediatric or infectious disease journal that stated that there have been deaths associated with GARDASIL. No further information is expected.
Per report by RN who vaccinated patient:  Pt received 1st Covid vaccine, and after the vaccination was standing by her mother watching her sister get vaccinated.  Suddenly she fainted, slumped to floor; she did not hit her head. She lost consciousness for less than 10 seconds. Her father picked her up and put her on his lap.  1st Aid RN and EMT on site responded. Applied ice pack to back of her neck. Pt was pale, diaphoretic and oriented x3. At this time, the father revealed that child has history of fainting with shots (which parents did not inform clinical staff of prior to vaccination). Dad carried child to 1st aid station where she was assessed and monitored. She was placed supine on cot with feet elevated; pallid and slow to verbal response. 10:35 vital signs B/P 102/68, pulse 81 bpm, O2 99%.  Pt slowly regained color, had water and crackers. Vital signs sitting up B/P 98/68, O2 98%. Pt still slow to respond and lethargic. Paramedics called at 11:00, arrived at 11:10. Assessed child and interviewed parents, made decision to not transport. Pt became more animated, color returned and able to stand and walk safely on her own. 11:20 Family left clinic.
10:25 started itching at site, red welt. 10:30 redness spreading up neck. Continues to itch. 10:35 taken and placed in room at Occ Health. 10:45 EPI PEN 10:55 ER
Pt's mom c/o swelling on right upper deltoid area with redness the "size of an apple"- Non-painful. This developed 07/25/02. Pt received immunizations on 07/23/2002. Recommended ice and Ibuprofen. If sx persist or worsened , office would see pt. Mom couldn't bring him in on 07/25/02. Unable to reach mom by phone today.
I developed gingivitis, it started on the right bottom side the day after the vaccine and now the inflammation is on all of my gums
3/24/21 surgical removal of gallbladder, admitted for >48h iv abx d/t hydrops HPI: Lives in a group home and listed diagnoses include mental retardation, GERD, anxiety, hallucinations and hyperlipidemia. Also listed are siezure disorder, Parkinsons, thyroid enlargement (not confirmed on today's exam) and thrombocytopathy.   She is accompanied by a staff member who provided some history. The patient seems to have limited comprehension.   The patient says she had GI upset once after eating meat but can't provide any more detail. The staff says she generally eats well but "is not a complainer" so that even if she had post-prandial pain she doubts she would mention it unless it was significant and obvious to staff (which it has not been to date). No history indicative of jaundice. Vague on stools but it sounds like she may have loose stools episodically.   She has a physical every 6 months including blood work. She was most recently seen on 2-2-21. She is also seen periodically  by Dr. (hematology).    Blood work demonstrated increased WBC and mild LFT elevations. Apparently moderate increased WBC has been noted in the past w/o a clear etiology.   Note from Health Ctr on 3-2-21 mentions elevated WBC and LFTs. Elevated WBC to 14,600 Hg12.5  Plt 420K on 2-26.   LFTs on 2-26 show Alk Phos elevated mildly at 123 and AST/ALT mildly at 98/73 anomaly was a mild elevation in AST. Hepatitis screen negative.   US on 3-12 demonstrated multiple stones in a contacted GB. CBD 5.3 mm.
Experienced the shortness of breath.; Pain modest site in gut bowled was so painful in a side of gut and the Liver.; Tired and not feeling well; Headache; not feeling well; This is a spontaneous report from a contactable consumer (patient). A patient female of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8736 and expiry date: 31Jul2021), via an unspecified route of administration, in Arm Left on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included rheumatoid arthritis, fibromyalgia, asthma, high blood pressure, high cholesterol and morbid obesity from an unknown date and unknown if ongoing. Concomitant medications included oxycodone for rheumatoid arthritis and fbromyalgia, duloxetine hydrochloride (CYMBALTA), fexofenadine hydrochloride (ALLEGRA), gabapentin enacarbil (HORIZANT) 1200 mg, losartan , magnesium, amoxicillin, cyanocobalamin (VITAMIN B12), curcuma longa rhizome, piper nigrum fruit (TURMERIC), amlodipine besilate, famotidine, certolizumab pegol (CIMZIA), metoprolol, trazodone, cinnamomum verum (CINNAMON) 100mg, colecalciferol (VITAMINS D3) 5000 units/day; salbutamol sulfate (VENTOLIN INHALER), Albertan, Singular Montelukast, Bebuca 300 mg for an unspecified indication, start and stop date were not reported. The patient received second dose of BNT162B2 on 24May2021 for COVID-19 immunisation. The patient reported that, on an unspecified date, she experienced shortness of breath, pain modest site in gut bowled was so painful in the side of gut and the liver, headache almost in after the modest was 15 minutes. She got the vaccine that day and the whole week she was felt like tired and not feeling well after that everything was normal. The patient had visited to emergency room for the events. Outcome of the events, shortness of breath, pain modest site in gut bowled was so painful in the side of gut and the liver, headache and felt tired was recovering and outcome of the event not feeling well was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
got sick; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (Pfizer-BioNTech COVID-19), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick". Additional information: The reporter want to know what makes the Moderna COVID-19 vaccine unique and different from other COVID-19 vaccines? Reporter said that "I had moderna and had no issues, my spouse had pfizer and got sick for 2/3 days each time"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a health care professional refers to an unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L044056; expiry: 02-MAY-2017) (dose and route unspecified). No medical history, concurrent conditions or concomitant therapies were reported. Healthcare worker states that these unspecified vaccinations occurred between 30-DEC-2015 and 03-FEB-2016. Temperature: -11.8C. Time frame: 1903 minutes (or 31 hours, 43 minutes). There was previous temperature excursion and the time frame was cumulative since 30-DEC-2015. The call was because of a data logger. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Mother stated started with fever on Saturday, then Sunday fever up to 101.7, sore throat and tummy ache.
Myalgia very fatigued Narrative:  Received vaccine 1/25/21 felt very tired about 2 hours after vaccine, went home and slept all day and next day had a low grade fever, arm pain at  injection site. Still feel tired on 1/27/21. Advised that should resolve within the  next day as s&s of vaccine
This is a spontaneous case, initially received from a pharmacist on 21-Feb-2018, concerning a 34-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 20-Feb-2018, the 34-year-old (under 65 years of age) patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 179002 and expiry date: 31-May-2018). It was reported no adverse events were occurred after the vaccination. The reporter assessed the event as non-serious.
client reported to EMT feeling a headache within 10 minutes in observation. EMT notified PHN . Upon arrival at 1409, client sitting up on anti-gravity chair, alert and oriented x4. Client here today with Father who stated client had breakfast 4hrs ago. Vitals at 1410: blood pressure 159/79, pulse 98, oxygen sat 99%. Client described headache as "needles" on right side of head and pain 4/10. Client denied dizziness, blurry vision, or nausea. RN gave client Goldfish and water at 1412. Client was instructed to eat and drink slowly. PHN spoke with Father who stated client has no relevant medical history, no medications, and no allergies. Per Father, first covid vaccine went well. At 1412 client reported headache was beginning to improve. Vitals at 1414: blood pressure 150/76, pulse 104, oxygen sat 98%. Per client headache was returning and no other symptoms. Vitals at 1420: blood pressure 137/82, pulse 102, oxygen sat 98%. Client stated he felt "a lot better." PHN spoke with Father and client of when to seek medical help, ER precautions, and following up with primary provider. At 1426 client stated "almost nothing left of headache." Vitals at 1428: blood pressure 139/80, pulse 93, oxygen sat 98%. Client stood up from chair and walked a few steps with steady gait. Per client he "felt better." PHN discussed with Father client's blood pressure and importance of following up with medical provider.
Syncopal episode followed by death. Unable to be revived. Coroner's case.
dizziness reaction, shortness of breath, itchy throat and tongue. I received a dose of corticosteroids and antihestamines and all the symptoms went away. Favorable evolution.
Tiredness and sleep with the first dose. Tiredness, sleepiness, tremor on the second dose. Approximately by September 2021 body aches, headache, palpitations, shortness of breath. At the end diagnosis of cardiovascular disease in October 2021