chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; one dose of an improperly stored vaccine was administered to one patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided.    On 07-MAY-2019, the patient was vaccinated with one dose of an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, subcutaneously, lot # R034391 with expiration date on 27-NOV-2020 (frequency was not reported)  for prophylaxis. Concomitant therapies included sterile diluent (Merck Sharp & Dohme). The vaccine underwent  temperature excursion of 12.7 degrees Fahrenheit for 50 minutes. There was previous temperature excursion of 6.8 degrees Fahrenheit for 20 minutes on 01-MAY-2019. The digital data logger was involved in recording excursion details. Sterile diluent was stored in the correct temperature storage range. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA007760: US-009507513-1905USA010267:
pt recv vax 6DEC95 & 7DEC95 pt exp weakness in legs, dizziness, problems walking & was unable to lift arms easily;
pt recvd vax 9NOV93 & devel a rash on chest, abdo, inner arms, & legs; pt was treated w/ATB, oral Pred, & topical lotion; however rash persists;
Received flu shot on 9-15-2011 - took band aide off and had red area, next 2 days redness spread, painful, swelling around arm/site of injection. By time of office visit on 9-17-2011 starting to feel nausea, HA, and achy, warm and clammy.
Rash on chest and left arm. Started with a warm red painful rash on right upper arm.
This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02348 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 4-year-old male patient had received 4 previous injections of DTaP: Doses 1, 2, 3 and 4 of PEDIARIX, GlaxoSmithKline, received on 12 September 2007, 16 November 2007, 18 January 2008 and 14 November 2008 (routes and sites not reported). The patient had received a 0.5ml injection of DTaP (lot number, manufacturer, route and site not reported) on 19 August 2011. On the same date, the patient also received a 0.5ml dose 4 injection of IPV, a 0.5ml dose 2 injection of MMR and a 0.5 ml dose 2 injection of Varicella (manufacturer, lot number, route and site not reported). The patient was seen on 23 January 2012 with complaints of cough for a week, almost a whoop, vomiting after cough, fever, sore throat, runny nose, congestion and appetite decreased. Upon examination, the patient had nasal congestion, oral erythema, lungs were clear to auscultation bilaterally with no wheeze or crackles and skin-colored papules with sandpaper feel on back. The physician's assessment was cough and rash. A nasopharyngeal swab and rapid strep test was performed. The patient's nasopharyngeal swab PCR results on 26 January 2012 were "Bordetella parapertussis DNA detected. Negative for Bordetella pertussis DNA." The patient was treated with azithromycin. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of torticollis, PE tubes, frequent strep, tonsils and adenoids removed, constipation, wheeze, speech delay and possible upper extremity strength issue. The patient's father had a medical history of weight problems. The patient's mother had a medical history of migraines/headaches and weight problems. The patient's paternal grandmother had a medical history of high blood pressure, maternal grandfather had a medical history of cancer, maternal grandmother had a medical history of weight problems and paternal uncle had a medical history of migraines/headaches. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Information has been received from a female patient with a history of cervical cancer who was vaccinated with varicella virus vaccine live (Oka/Merck) at a free clinic several years ago and had a breakthrough of varicella. Concomitant vaccine included influenza virus vaccine (unspecified). The patient also developed the flu after receiving the flu vaccine. Unspecified medical attention was sought. The caller could not provide any additional information at this time. No product quality complaint was involved. No further information is available.
about a minute after injection, pt began to feel light headed and started to get pale and sweat profusely, started to lose focus and hearing, i placed an ice pack on the back of his neck and elevated his legs, as soon as I did that, he began to get some color back and started to feel better. we kept him for 30 minutes afterwards to keep an eye on him. he stabilized and felt better and back to normal.
Reported to program that this client was provided a second Pfizer COVID-19 vaccination with 16 days interval from 1st dose (3/16/2021).  Client did not provide accurate information regarding COVID-19 vaccination status on 4/1/2021 when she received the 2nd dose.  Client vaccinated 5 days earlier than Manufacture and FDA  guidance for 2nd dose in the Pfizer COVID-19 vaccination series: no adverse reactions reported during or post vaccination to program personnel.
Pt recv vax on 1/25/99; on 2/6/99 pt exp rash of red pinpoints on face, neck & chest
Maculopapular rash on chest/abd/trunk/back/arms started approximately 2 days after immunization. No fever/chills. No pruritus/hives. Given prednisone course by urgent care.
Was living happily and independently in a retirement community. After the second dose because losing his memory, focus, depression,  followed by 2 strokes, brain bleed,  blood clots, seizures, and a Dx of Parkinson's and Parkinson's dementia. He saw doctors monthly and never had any signs of any of these things.
Profuse total body rash. Hives around throat. Itchy throat. Vertigo. Still present 48 hours later.
I received the Moderna vaccine on February 20, 2021. After 7 days, my right arm started to itch at the injection site. Then it turned into a large red lump that feels warm to the touch. It is also very tender in that area.
02/28/22 presents to ED for "AKI". PMHx of "atrial fib s/p PPM/ICD, 1 kidney after donating a kidney to family member ~40 years ago"
Headache, Myalgia, Fever, Chills, Fatigue, injection site pain Narrative:
Patient initially with fever and chills rigors on evening of and day after the vaccine.  On date of emergency room visit 01/28/2021 patient had awoken with right lower quadrant pain, rash on her back and palmar aspects of her forearms, swelling around her eyes.  Abdominal pain was crampy she had no diarrhea constipation.
Fatigue all the time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue all the time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue all the time). At the time of the report, FATIGUE (Fatigue all the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Client presented to receive Pfizer Vaccine  Client omitted receiving Astrazeneca prior to receiving Pfizer in Mexico. Client was given a booster four months earlier than when he was supposed to receive booster.  When client was sitting at vaccination table he was asked by Vaccinator if he had previously received a COVID vaccine. He denied. Vaccinated noticed Client?s mother had received a different vaccine in Mexico due to seeing her Mexico Vaccination card. He then preceded in asking the client a fourth time if he had received a different vaccine in a another Country. Client said he had forgotten that he had received Astrazeneca in Mexico. Client went to observation area and brought with him his vaccine documentation. Astrazeneca dose 1 6/9/21 and dose 2- 9/1/21.  RN was informed and spoke to client. Client was educated on waiting the six months to receive his booster and had received it too early. Per CDC guidelines, Client was informed by  RN ,Pfizer dose he received today will count as his booster and is considered fully vaccinated. Client verbalized understanding. Client was asked how he was feeling and client responded he was feeling fine. Client was recommended to speak to his primary care provider for any questions or non-life threatening symptoms might have. And to seek emergency care for any adverse reactions. Client verbalized understanding. Client left observation area at 1412 in a steady gait
Rt upper arm swelling after approx 24 hrs of receiving polio vaccination. After approx 32 hrs, the arm became warm, erythematous, and tender
Information has been received from a NP concerning a 35 year old female employee who on 06/23/03 & 08/06/03 was vaccinated with a dose of MMRII. Subsequently the pt had a equivocal measles titer. Medical attention was sought. The pt was not pregnant. No additional information was provided and the physician may not be contacted.  Additional information is not expected.
FEVER 102.9F (PT WAS ACCIDENTALLY GIVEN THE VACCINE INTRAVENOUSLY)
Pt recvd vax 22NOV91 & by the next morning noticed heat, redness & pain @ the site of pneumococcal vax; Pt went to clinic & recvd ATB due to recent heart bypass surgery 5APR91; BY 25NOV91 swelling & heat down;
t100.9 R, pt crying, lethargic, chilling; very limp only one dose of APAP given; seen by MD-fever cont through evening until 1130PM t104.8 R, resp 60; crying-given APAP every 3 hrs; Saturday 8AM temp back to nl;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:19 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.50 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Vial was moved to fridge on 30-Mar-2021. Product moved to clinic on 03-Apr-2021. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. Beyond use date for the vial was reported as 29-Apr-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
first dose- can feel a lump in right arm; first dose- lump goes back up in her neck; first dose- can hardly move her neck; first dose- stated that she is not eating; first dose-right arm sore/has a lot of pain in her right arm; first dose- stated that she lost so much weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Dec2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB MASS (non-serious), outcome "not recovered", described as "first dose- can feel a lump in right arm"; NEOPLASM (non-serious), outcome "not recovered", described as "first dose- lump goes back up in her neck"; PAIN IN EXTREMITY (non-serious) with onset 05Dec2021, outcome "not recovered", described as "first dose-right arm sore/has a lot of pain in her right arm"; MOVEMENT DISORDER (non-serious), outcome "not recovered", described as "first dose- can hardly move her neck"; WEIGHT DECREASED (non-serious) with onset Dec2021, outcome "unknown", described as "first dose- stated that she lost so much weight"; EATING DISORDER (non-serious), outcome "unknown", described as "first dose- stated that she is not eating". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report has been received from a medical assistant, regarding an unspecified number of patients of unknown gender and age. On unspecified dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L017138), expiration date 13-AUG-2016), dose and route were not provided. No adverse effects were reported. It was reported that the vaccines were exposed to 7F for 12 hours, and there was a past excursion at 36F for another 12 hours. This was recorded as a result of a digital data logger. This is one of the two reports from the same reporter. (see MARRS 1606USA003558). Additional information has been requested.
Fever onset 3-4 hrs after receiving vaccine, varying from 100F to 102.6F for a prolonged period of time (5 days at present); abdominal pain; nausea; fatigue; chills
No adverse event. Patient asked for 2nd booster Pfizer Monovalent vaccine and did not want to come back for the bivalent due to traveling. Pharmacist gave her the monovalent without realizing the guidelines got changed.
States on 10/03/2018 around 9 AM received a influenza vaccination. She states the next day 10/04 had body aches which have improved, also approximately two inches below injection site there was a quarter size redness and it was itchy. The next day after, 10/05 the redness was worsening and slight swelling. Denies itching. Advised to monitor and report for signs of infections. Recommend OTC ibuprofen PRN. Continue to ice area.
Developed a "migrating" intensily itchy, bumpy rash starting about a week to 10 days following second injection.   The rash began over upper back/shoulder blades and within 2-3 weeks migrated to upper arms and  around chest; within a few more weeks went to abdominal area, then around back to upper buttocks. By end of July the rash is predominantly on thighs with less intense itching on shoulders and chest.
This spontaneous case, initially received on 02-Jan-2018 from other health professional (nurse), concerning a 55-year-old adult male patient. This report linked to case 201800029. It was reported that, vaccine reached temperature of 58-degree F for 5 hours (explicitly coded as incorrect product storage). On 02-Jan-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 195236 and expiry date: 30-May-2018), which underwent temperature excursion of 58-degree F for 5 hours (explicitly coded drug administration error). It was stated that, no adverse event effects were noted after the vaccination. The reporter assessed the case as non-serious.
lot leg and arm weakness; very very shaking not like shaking chills but shaking like muscle weakness; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCULAR WEAKNESS (lot leg and arm weakness) and TREMOR (very very shaking not like shaking chills but shaking like muscle weakness) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced MUSCULAR WEAKNESS (lot leg and arm weakness) and TREMOR (very very shaking not like shaking chills but shaking like muscle weakness). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form. At the time of the report, MUSCULAR WEAKNESS (lot leg and arm weakness) and TREMOR (very very shaking not like shaking chills but shaking like muscle weakness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter
Information has been received from a physician concerning a 68 year old female who on 06-AUG-2007 was vaccinated SC with a dose of Zostavax. On 17-SEP-2007 the patient was seen at the physician's office. The patient developed a rash with two lesions at a non-injection site which the physician suspected to be varicella. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
1st shot 3/25/21 2nd shot 4/15/21 Within a couple minutes of shot, sharp pain in center chest to the left. A strange confusion and unknown stress/anxiety within 15 minutes, couldn't find the door easy to exit the convention center. Within 1-7 days, a internal trembling or pulsating of inner tissue, muscles and organs.  Within 2 months, twitching of muscles when put under strain or exercise Within 2-3 months, visible shaking when fingers extended for instance onto a cell phone  Within 3-4 months, symptoms seem to be getting worse or evolving into other related inner and very subtly outer shaking or trembling Within 4-5 months, overall feeling of body shaking getting worse. Please contact so that I can get help.
Bladder incontinence; Increased thirst; Dry mouth; Decreased appetite; Fatigue; Fever; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 27May2021 at 15:15 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included thalassemia minor and congenital pilonidal cyst. The patient did not have any allergies to medications, food or other products. Concomitant medication included ZYRTEC from an unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 06May2021 at 14:45 (at the age of 40-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. On 28May2021 at 02:30, the patient experienced bladder incontinence beginning 12 hours after injection and subsiding after approximately 12 hours, fatigue for more than 48 hours, dry mouth for more than 48 hours, increased thirst for approximately 36 hours, decreased appetite for more than 48 hours and fever beginning approximately 24 hours after injection and subsiding within 12 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event increased thirst was resolved on an unknown date in May2021. The clinical outcome of the events bladder incontinence, fatigue, dry mouth, decreased appetite,  and fever were resolving at the time of reporting.   Information on lot/batch number has been requested.
Had headache and eyes felt strained the day after the vaccine. Took Advil and it subsided. Had headache and eye strain every day after. By Thursday afternoon, Advil wasn't working anymore & headache had gotten worse and was throbbing. Headache and intensity was still there on Friday. Stayed home from work. Headache was debilitating, & I couldn't get out of bed. Accompanied by alternating chills and hot flashes and body aches. Next day I could get out of bed. Was back to work on Monday.
Over 48 hours after administration, tachycardic at rest 110s; fatigue; fever with max of 101.2F; body aches; and localized soreness, warmth, redness, and swelling at the injection site.
5 hrs post-  Left eye flashing lights to lateral area throughout night, leading to "floaters" in early AM, leading to linear "blur" along field of vision.  Primary eye exam suggested PVD.  Follow up w. retinal specialist 1 wk later confirmed. 22 hr post- sudden onset chills, fever.  Symptoms abated after 3-4 hr, after Motrin 800mg
I am not sure if the transient global amnesia (TGA) I experienced on May 8th is affiliated with the COVID vaccine but three other people had TGA around the same time that I had it at the healthcare facility so I was encouraged to report this (although a month had passed since I had the J&J vaccine).
SMOKING CIGARETTE SMELL ONLY; This spontaneous report received from a consumer concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced smoking cigarette smell only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from smoking cigarette smell only on APR-2021. This report was non-serious.
w/in seconds p/vax had pre syncope w/lightheaded, eye rolled back, brief time movement lasting <5 sec;no rx required;vital signs w/o change;
11 days p/vax 24AUG98 pt had onset of h/a, then fever up to 104, followed by 3 days by anerythematous maculopapular rahs w/target lesions & bullae that began lt forearm & then chest;mucus membranes of oropharynx, conjunctivae, glans penis