chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds .5 mLVIs 10 SDV, which had the lot # K008409, with expiration date 04-MAR-2016 (dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced different temperature excursions of 88, 344, 168, 152, 184 and 264 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree), 31 F (-0.555555556 Celsius degree), 33 F (0.555555556 Celsius degree), 30 F (-1.1111111111 Celsius degree) 29 F (-1.666666667), 32 F (0 Celsius degrees) respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of several reports received from the same reporter. Additional information has beenrequested.
40 Y/O M 15 mins post vaccine- A/Ox0, presented disoriented with a confused daze followed by complaint of dizziness and general feeling of "not right". v/s within normal limits. PT given emesis bag for episode of nausea. PT A/Ox3 w/in 2 minutes post-episode. W/in 10 minutes still feels "cloudy". EMS called for evaluation.
4 days /p Td booster injection in lt deltoid, developed pruritus & spreading erythematous rash @ inject site until today
On the same day in evening, there was discomfort on my arm. next day, i was tired, fatigue and chills and body ache and like flu by evening I had a fever 102. The next day the fever was gone but there was redness and swelling on the injection site. Saturday, AM I called the nurse as it felt like it was spreading and lymph nodes were swelling and was told to take Claritin and if you are worried, go see the doctor and I didn't see the doctor. I googled it and didn't worry about it. It got better and lymph nodes is gone. Still have light redness.
It was sore at the injection site, like both other shots, but this time it's been hot to the touch and a rash has developed about 3 inch; It was sore at the injection site, like both other shots, but this time it's been hot to the touch and a rash has developed about 3 inch; warm to the touch; itchy; The third dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 11Dec2021 14:45 (Lot number: 3113084) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Dupuytrens" (unspecified if ongoing); "seasonal allergies (hayfever)" (unspecified if ongoing). Concomitant medication(s) included: NATURE MADE D; PROTANDIM; PB8 PROBIOTIC. Past drug history included: Amoxicillin, reaction(s): "Allergy". Vaccination history included: bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=pfizer,, Prev dose Lot number=EN6206,, Prev dose dose number=2,, Prev dose vaccine Location=Left, arm), administration date: 16Mar2021, for COVID-19 immunization, reaction(s): "sore at the injection site like both other"; bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=pfizer,, Prev dose lot number=EN6200,, Prev dose dose number=1,, prev dose vaccine location=Left, arm), administration date: 22Feb2021, for COVID-19 Immunization, reaction(s): "sore at the injection site, like both other shots".The following information was reported: IMMUNISATION (non-serious) with onset 11Dec2021 14:45, outcome "unknown", described as "The third dose"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE RASH (non-serious) all with onset 12Dec2021, outcome "not recovered" and all described as "It was sore at the injection site, like both other shots, but this time it's been hot to the touch and a rash has developed about 3 inch"; VACCINATION SITE WARMTH (non-serious) with onset 12Dec2021, outcome "not recovered", described as "warm to the touch"; VACCINATION SITE PRURITUS (non-serious) with onset 12Dec2021, outcome "not recovered", described as "itchy". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site rash, vaccination site warmth, vaccination site pruritus.Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient had not taken any other vaccine in four weeks, had no COVID prior to vaccination and not tested COVID post vaccination. The patient stated that the third dose hurt a lot more than either, which surprised her. It was sore at the injection site, like both other shots, but this time it was hot to the touch and a rash has developed about 3 inches below the injection. The site was still very warm to the touch and itchy.No follow-up attempts are possible. No further information is expected.Sender's Comments: Linked Report(s) : US-PFIZER INC-202101803543 similar report from same reporter
DIAGNOSIS #1.  Left testicular torsion 34yr old male who presents to ED via private car with complaints of low back/flank pain.  Patient also complains of abdominal pain.  Patient states pain started suddenly around 2300.  Patient states he took tylenol at that time and has tried ice and heat packs.  Patient also states that his testicles hurt.  Patient states he has vomited from the pain.  Patient states he took a hydrocodone at home as well just prior to coming in.  Patient pacing in room.   Patient with sudden onset 2-1/2 hours ago of left testicular pain and abdominal pain, with severe nausea and vomiting.  He was enjoying the evening at the bar with friends when this came on very suddenly.  No fever or chills.  Blood pressure 129/79 and pulse rate 116.  Patient was feeling fine before this.
temporary partial paralysis.; During my hospitalization my creatinine levels elevated and I was diagnosed with Kidney Failure.; During my hospitalization my creatinine levels elevated and I was diagnosed with Kidney Failure.; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:30 PM (at the age of 60 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Diabetes, High Blood Pressure, Asthma, Lupus, Fibromyalgia, Bipolar, PTSD from an unknown date and unknown if ongoing. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), lisinopril (LISINOPRIL), gabapentin (GABAPENTIN), tizanidine (TIZANIDINE) taken for an unspecified indication, start and stop date were not reported. The patient has allergy to Sulfa, Ibuprofen, Heaprin, Lisinipril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 14Apr2021 at 01:00AM the consumer stated that she had the Pfizer first vaccine 02Apr after which I was hospitalized for back surgery. During my hospitalization my creatinine levels elevated, and I was diagnosed with Kidney Failure. Which doctors attributed to an allergy to my blood pressure medication Lisinipril. I also experienced temporary partial paralysis. I have taken Lisinipril for 5 years with no side effects. I had previous blood test with normal findings. The adverse event resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering.  Information on Lot/Batch number has been requested.
Information has been received from a physician concerning a male pt who in May 2000 was vaccinated with varicella virus vaccine live. On 03/15/04 the pt was seen in the office with five lesions. It was reported that the pt had a breakthrough case of chickenpox. The pt sought unspecified medical attention. There was no product quality complaint involved.  It was also reported that four other pt's developed chickenpox after being vaccinated with varicella virus vaccine live (WAES # 0403USA01611, 0403USA01644, 0403USA01646 & 0403USA01647).  Additional information has been requested.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported.  It was reported that 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.   No treatment medications were reported.  This case contains information for the 8 of twenty adult patients as described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-662871, MODERNATX, INC.-MOD-2022-662860, MODERNATX, INC.-MOD-2022-662881, MODERNATX, INC.-MOD-2022-663016, MODERNATX, INC.-MOD-2022-663014, MODERNATX, INC.-MOD-2022-662866, MODERNATX, INC.-MOD-2022-662861, MODERNATX, INC.-MOD-2022-662875, MODERNATX, INC.-MOD-2022-662995 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-662871:Patient 9 MODERNATX, INC.-MOD-2022-662860:Patient 3 MODERNATX, INC.-MOD-2022-662866:Patient 7 MODERNATX, INC.-MOD-2022-663014:Patient 19 MODERNATX, INC.-MOD-2022-662861:Patient 4 MODERNATX, INC.-MOD-2022-662875:Patient 11 MODERNATX, INC.-MOD-2022-663016:Patient 20 MODERNATX, INC.-MOD-2022-662881:Patient 14 MODERNATX, INC.-MOD-2022-662995:patient 16
I don?t know the exact manufacturer or vax but it was for meningitis and the lot number is U6543AA Symptoms include fever pain chills hot and cold cough headache
Narrative: Report of med error (not ADE)- patient reported potential underdosing. Patient reports getting covid vaccine dose #1 in covid vaccine clinic on 2/10/2021. Pt states he had fluid that ran down his arm. He thinks this was the  vaccine. He states it was wiped up with a piece of gauze.
This spontaneous report as received from a nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored M-M-R II lot # K024825, expiration date- 20-DEC-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Additional information has been requested.
COVID-19 confirmed by positive COVID-19 test/Got infected with covid 19 and was symptomatic; COVID-19 confirmed by positive COVID-19 test Got infected with covid 19 and was symptomatic; This is a spontaneous report from a contactable nurse (patient)    A 27-years-old non pregnant  female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 04Feb2021 08:00 (Batch/Lot Number: El9262) as SINGLE DOSE, dose 1 intramuscular, administered in Arm Left on 06Jan2021 12:00 (Batch/Lot Number: El0142) as single dose for covid-19 immunization.  Medical history included peanut allergy. The facility in which the vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  There were no concomitant medications.  On 18Apr2021, at 23:00, The patient experienced covid-19 confirmed by positive covid-19 test/got infected with covid 19 and was symptomatic .The patient underwent  Lab tests include SARS-CoV-2 test (PCR test Nasal Swab) on 18Apr2021 results positive, SARS-CoV-2 test (Nasal swab) on 19Apr2021 results positive. Treatment was given for the events.  The clinical outcome of the events was recovering
Feel that she is having hives. asthma.  Patient stated that she is feeling better.  155/102, Renew 140/90, HR 77, O2Sat 98%.
No additional AE reported.; GARDASIL 9 was stored improperly and administered; This spontaneous report was received from a licensed practical nurse and refers a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, concomitant medications and drug reactions or allergies.  On 29-JUL-2020, the patient was vaccinated with an improperly stored dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# 1637651 and expiration date 09-JUN-2022 for prophylaxis (exact dose, route and site of administration were not reported). Administered dose of vaccine was exposed to the temperature of 50 degrees Fahrenheit (F) for 1 hour and 46 minutes. There was no previous temperature excursion. The call was because of a digital data logger. There were no additional adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA000326: US-009507513-2008USA000372: US-009507513-2008USA000367: US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2007USA012124: US-009507513-2007USA012061: US-009507513-2007USA012060: US-009507513-2007USA012054: US-009507513-2007USA012014: US-009507513-2008USA000266: US-009507513-2008USA000307: US-009507513-2008USA000370:
Next day post vax, the child developed fever up to 102. He then developed wide-spread erythematous rash on trunk with possible areas of urticaria.
fever went up to 102.7, body chills, aches,  headache, legs felt weak, little back pain
The primary reporter is the field representative. The representative reported this AE as he heard it from an HCP. The HCP had a patient who developed hives "all over her body" after receiving her second dose of GARDASIL. She also received a flu shot concomitantly; however, it was not AFLURIA. This AE refers only to the GARDASIL AE. No further AE information was provided. Treatment given: oral prednisone and referred to allergist.
pt c/o mosquito bite on rt arm on 8/26 AM;by PM entire upper arm  red & hot to touch, swollen;child c/o minor pain but not enough to interfere w/activities;as of report date 8/27 s/s had not worsened or improved;
Nausea, Dizziness, Abdominal discomfort, Muscular weakness, Vomiting, Fatigue, Paraesthesia, Feeling abnormal  This case was reported by a nurse and described the occurrence of nausea in an adult male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  There was concurrent medications. On 13 February 2006 the subject received 1st dose of Energix-B (lot AHBVB229AA).  Approximately 2 weeks after vaccination with Engerix-B, on an unspecified date after 13 February 2006 and before 14 March 2006, the subject experienced nausea, muscle weakness, "felt weird," and had "abnormal skin sensations like pins and needles while having unprotected sex." The subject "did go to a sexually transmitted disease clinic to be tested for any possible sexually transmitted diseases." The results of these test were not provided.  The events resolved on an unspecified date before 14 March 2006, the subject received the 2nd dose of Engerix-B (lot AHBVB256AA).  "Immediately" following the receipt of the 2nd dose of Engerix-B, on 14 March 2006, the subject again experienced nausea and dizziness.  The events resolved after "a few minutes." On 15 March 2006, the subject again experienced nausea, gastrointestinal distress, and dizziness.  on 16 March 2006, the subject experienced muscle weakness, vomiting and fatigue.  The subject was unable to "work out in the gym due to these side effects." On 17 March 2006, the events improved, but the subject experienced a "pins and needles sensation" on his skin.  The events resolved on 20 March 2006.  The nurse considered the events to possibly be related to vaccination with Engerix-B and also possibly due to sexual disease exposure.
Left vastus lateralis red and swollen, child inconsolable. Dr. instructed mother to administer Tylenol every 4 hours around the clock for the next 24 hours as needed. Apply ice to site for 20 minutes at the time as needed.
5 minutes after the injection I got hot and my heart started racing. My throat felt tight. This feeling dissipated after 5 minutes.
Primary side effect that I experienced is swelling and tenderness in my left armpit and collarbone, which onset 24 hours after the vaccine injection. After about three days, the swelling and tenderness had expanded to both armpits, the entire collarbone area, neck and throat (difficulty swallowing). It's been four days now and still experiencing side effect, which hasn't subsided.  I also experienced muscle pain, joint stiffness (especially in neck and shoulder), fever/chills and fatigue for the first 24 hours.
Patient was very whiney, kept complaining his leg hurt, and then stopped walking on it. Just laid around all weekend and only would be active if he had Tylenol.
This spontaneous report was received from a registered nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 02-NOV-2015, the patients were vaccinated with oral ROTATEQ, Lot number L008054, expiration date 30-NOV-2016, Lot # L008996, expiration date 01-DEC-2016. No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
Streaks up her arm 1 day after vaccine, felt weak on (L) side & numb; no fever or viral symptoms & lasted 3 days. Her left leg was not moving right x3 days.
Initial report received from a nurse via clinical medical officer on 18 NOV 2009.  A 2 year old female patient was vaccinated i.m. for the first time with Influenza Virus Vaccine-pandemic INN (influenza virus vaccine, batch unknown) on an unknown date. On 17 NOV 2009, she experienced a 'staring spell' after receiving her vaccination. These events were reported as staring. A neurological work-up was so far negative. An MRI brain scan is scheduled. The outcome of the patient was not provided.
Neutropenia/neutrophil absolute count was down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: NEUTROPENIA (hospitalization, medically significant), outcome "unknown", described as "Neutropenia/neutrophil absolute count was down". The patient was hospitalized for neutropenia (hospitalization duration: 4 day(s)). The event "neutropenia/neutrophil absolute count was down" required emergency room visit. The patient underwent the following laboratory tests and procedures: Neutrophil count: down to 0.1, notes: My neutrophil absolute count was down to 0.1 and normal  range started at 1.7.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Soreness in arm at injection, 24 hrs; Day after debilitating lower back pain; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day.; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration on 18Jan2021 09:30 AM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included psoriasis, hypothyroidism and insomnia. Patient has no known allergies. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included levothyroxine, trazodone (reported as "Trazadone"), phentermine and ergocalciferol (VIT D). No other vaccines in four weeks. Facility type vaccine was Workplace clinic. The patient experienced  "soreness in arm at injection, 24 hrs. Day after debilitating lower back pain which moved down towards buttocks & legs by 3rd day. Pain in walking, sitting & movement", all on 19Jan2021 11:00 AM which resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received for the events, also reported a s "Call into pcp but was not helpful". Outcome of the events was not recovered. Patient was not tested for COVID since the vaccination.
Injection hurt, which I expected until others said they did not feel it at all.  Then within 48 hours of getting it I had severe throbbing pain at the injection site high up on my arm.  I assumed it was normal since they said you could experience pain at the injection site.  However, the pain did not go away and I started to lose range of motion in my arm and started getting extreme sharp pain along with the almost constant throbbing pain if I moved my arm certain ways.
Mom reports that pt devel inc fever day p/vax; went to hosp ER t104.5 R & had a lot of crying that couldn't be consoled; ER gave meds to bring temp down & could not find anything else wrong;
Pt received Engerix-B and experienced diarrhea, dizziness, fatigue, diminished exercise tolerance, insomnia, muscle aches, nausea, neck stiffness, loss of apppetite, palpitations, tachycardia, vomiting, lost 5 lbs, flu like symptoms, restl
redness & swelling lt arm;onset 12hr p/vax;not much pain;no other sx