chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nurse called and reported administration to patient with improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a currently 1-year old patient of unknown gender.  The patient's medical history, concurrent condition and concomitant medication were not provided.     On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose: 0.5 milliliter (ml), lot # S038178, expiration date 26-NOV-2021; strength, route was not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status of rHA (recombinant human albumin)) (M-M-R II) (dose: 0.5 ml, lot# S020962, expiration date 07-JUL-2021; strength and route were unknown) for prophylaxis (product storage error).   Temperature excursion of these vaccines was 11 Fahrenheit degrees for 3 hours and 29 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA009426:01724666, US-009507513-2009USA009631: US-009507513-2009USA009446: US-009507513-2009USA009550:
11mins post vaccination pt reported dizziness.  Pt was taken to med bay via ambulation, layed down on cot Vitals: @16:44 125/69, 96, 22, 100% -- > 17:05 120/77, 96, 22, 100% -- > 17:19 113/77, 95, 100% 16:47 Hands feel weak/cold.  Pt stated she can breath but feels shaky.  NO clamminess, no palpeness.  Pt appears to be in NAD.  Resting back in cot. 16:50 Blanket, juice, water given 17:05 pt reports improvement in symptomsw but hands still weak. 17:11 Hands warm, adverse side effects improving but hands still feel a little weak.  no dizziness.  no SOB or respiratory issues 17:19 All adverse side effects resolved except hand still feel a litttle weak but pt feels well and wants to leave 17:25 Pt ambulated independently and w/ steady gait accompanied by staff.  NAD to women's restroom and then out of facility.  Pt was educated to rest and take it easy @home tonight.  Also informed pt that for any future vaccination of this incident and stay well hydrated. Dizziness and feeling cold/shaky resolved.  Pt stable and released from the vaccination site.  NAD.
Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/"thickening"/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms.  Vital signs and symptoms improved by discharge from Emergency Department.
Pt recvd 4 doses of Engerix-B & had a borderline response;
I received the first and second vaccine early in my pregnancy, I didnt know I was pregnant at time. July 1st 2021 I first went to the ER with leg pain/cramps. As the weeks progressed I started to feel a sharp poking and tingly feeling in my legs that traveled up to my arms, breast, abdomen and fingers. During this time I also started to feel a burning sensation in my breasts and abdomen. Once all the symptoms kicked in I was about 13 weeks pregnant. I had multiple labs done and my CRP and sedimentation rate were elevated. I had multiple autoimmune and hemotological labs done and the work up was negative. I was in and out of the ER with extreme pain and numbness and tingling, but they couldnt do anything for me because I was pregnant. I was sent to a Physiatrist that placed me on Tramadol during my whole pregnancy. I was told all my symptoms were probably from pregnancy and theybwould probably go away once I had the baby. I had the baby and the symptoms came back with a worse intensity. I was placed on gabapentin and had a upper and lower bilateral EMG done that was unremarkable. I am now on waiting  list to see neurology and rheumatology. They did do another ANA test last week that came back positive. All in all this has changed my life. If I miss a fose of Gabapentin the numbness, tingling, pain and while body coldness comes on as a cascade of symptoms that always start the same way, numbness, pain and tingling starts in my feet and goes up to my legs, then arms and fingers, then the whole body coldness kicks in. The worst of all the symptoms is the coldness.. no matter what i do It will not go away, my while body starts to sweat.... but im freezing, then i take my gabapentin and sometimes tramadol for the pain and everything slightly goes away. No one can tell me whats wrong. I am desperate for an answer.
1 of 8 pts recvd flu-imune exp pain @ inject site w/in 24 hrs of vax; pain lasted 1-5 days;
achy; not feeling well, overall feeling unwell; flu symptoms; nausea; joint pain; arm is a little sore; This is a spontaneous report from a contactable consumer, the patient. This 70-year-old female patient of received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 15Mar2021 "between 12:20 - 12:30" (at the age of 70-year-old) as single dose for COVID-19 immunization. Medical history included thyroid removal due to thyroid cancer when she was 32-34 years old, shingles, broken rib on chest X-ray, and hearing problem. The patient also stated that she doesn't have a spleen, so she is very sensitive to ASPIRIN (acetylsalicylic acid). Concomitant medications included valaciclovir hydrochloride (VALTREX S) 7 days treatment for shingles, and levothyroxine (manufacturer unknown). The patient previously took the influenza vaccine on 28Nov2020, then 9 days later (Dec2020) she thought she was having a heart attack and went by EMS to the hospital where they checked her for a heart attack but it was negative and she also got an echocardiogram that was negative. She was diagnosed with costochondritis ten days after getting the Flu shot. She took ibuprofen (MOTRIN) about a month for costochondritis and it made her blood pressure go up, so she was off it. On 15Mar2021, the patient reported that she was feeling fine after her first dose of COVID vaccine. She stated even her arm is a little sore (in Mar2021). Until 14:00 on 17Mar2021, the patient reported not feeling well, experiencing overall feeling unwell, flu symptoms, nausea and joint pain. Later, she also stated feels like she is coming down with the flu now and has joint pain, though she doesn't have a fever, and she is achy. The clinical outcomes of the feeling unwell, flu symptoms, nausea, joint pain, achy and arm is a little sore were not reported.
Symptoms: Congestion, cough, sore throat, fever 101 F,  body aches, fatigue. Fever lasted three days. Other symptoms lasted several days except for congestion, cough and fatigue which lasted several weeks.  First tested positive for covid on 6/27/2022 using at-home test kit provided by government.  Tested positive for covid every few days until first negative test on 7/10/2022. Second negative test on 7/11/2022. Contacted personal physician by phone and email who prescribed Paxlovid five day course because of pre-existing condition. Also used over-the-counter medicines to treat including ibuprofen and Mucinex-D. Note: Received original Pfizer covid vaccine on 4/22/21 and 5/13/21. First Pfizer booster on 12/14/2021. Second Pfizer booster on 4/27/2022.
3 days after 2nd dose developed itchy rash on left side of upper back and very painful, saw Dermotologist and she diagnosed it as Shingles
Chest Pain, Left side. Shortness of breath.  Irregular heart beat. Chest pain increasing in level over the past several months.  It now has increased to a level that wakes me in the night.  prevents sleep.
This is a spontaneous report from a contactable consumer or other non hcp (reporting for mother). An 81-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced a serious adverse reaction that was incurable. After 5 months of suffering, she hung herself with her bathrobe belt . The patient died on unspecified date.  It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: she hung herself with her bathrobe belt
A non-serious spontaneous report of acute bronchitis has been received from a health professional concerning a 15-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 19-Aug-2011. On 22-Aug-2011, the patient experienced labored breathing, wheezing and fever of 102 degrees F, subsequently she was diagnosed with acute bronchitis. The patient saw the physician on 24-Aug-2011 and was administered a breathing treatment with albuterol. The outcome of the event was unknown.
pt recv vax 5/11/99 & 5 days later pt began vomiting & passing blood in diaper;dx of intussusception was made & pt hosp;
Rash started at injection site with in an hour of receiving vaccine, patient later experienced nausea and shortness of breath.  patient is still having issues with shortness of breath while going up stairs
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Aug2021 as dose 2, single (Lot number: EW0191) at the age of 17 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Treatment of COVID-19 with Paxlovid.  No follow-up attempts are possible. No further information is expected.
arm hurt; chills; muscle aches throughout his body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's family history included: "Glaucoma" (ongoing). Concomitant medication(s) included: LATANOPROST taken for glaucoma (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6202), administration date: 26Feb2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "his arm bothered him", "chills", "fever"; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8727, Site: Thinks it was the right arm by injection), administration date: 19Mar2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "his arm bothered him", "chills", "fever"; Flu shot, for Influenza Immunization, reaction(s): "bad reaction", "very achy", "run a 102 fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm hurt"; CHILLS (non-serious), outcome "recovered"; MYALGIA (non-serious), outcome "recovered", described as "muscle aches throughout his body".  Additional information: On the first shot his arm bothered him and had chills and a fever. The second shot was the same, but a little more severe. The first booster everything started getting worse. His arm hurt, he had chills and muscle aches throughout his body and that lasted for a day and a half. He only takes one medication for glaucoma for his eyes. Been on it for about 25 years. Usually gets a bad reaction from the flu shot and has not had it in years. He would run a 102 fever and was very achy and does not take it anymore. No further details provided. He does not think he will take another booster. A lot of other people his age had reactions, but they were not as severe as his. No other information provided. Looked at statistics and over a million people died.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201277494 same patient/reporter, different event/dose;
Developed rash which looks to be chicken pox.  Few lesions present 2/7/13 approx 5-7 mm in dia, some with serous pustule in center.
Information has been received from a consumer concerning her female employee who on an unspecified date was vaccinated with a dose of ZOSTAVAX (manufacturer not specified).  On an unknown date it was reported the patient developed a case of shingles even though she was vaccinated against it.  At the time of the report the patient's status was unknown.  This is one of several reports received from the same source.  Additional information has been requested. 02/17/2010 Information has been received from a Phyiscia Assistant concerning a female cleaning lady with unknown vaccination history. The patient cleans the house of a woman who was vaccinated with a dose of ZOSTAVAX on 13-DEC-2008 and subsequently developed a rash. To this woman's knowledge the patient was not vaccinated with ZOSTAVAX. Subsequently, the patient developed shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
8/31/22 ---Emergency Authorization for Pfizer monovalent had been rescinded and as of 9/1/22 only the bivalent was approved for BOOSTER doses.  Patient came first thing in the morning before communication had been received by pharmacist from company and the pharmacy did not email until 9:08am on 9/1/22 and the pharmacist had not received that communication either.  Patient received vaccination at 9:28am.
I had shingles. Starting next date I had a poking feeling in my forehead, and head heck for couple days guess 3rd day started seeing pimples in forehead and it started developing on my left forehead and until my left eye.
the day p/vax pt devel flu sx consisting of nausea, vomit, fever & chills; 2 days later pt was seen because of a 5cm red area w/a 2cm hardened, painful area devel @ inj site;
There were no adverse effects noted. Inmate was brought to medical for notification and vital signs. F/U on 3/6/23 with no adverse effects reported.
convuls-sz-catatonic-fixed rolled back-pale-blue lips; lasted 10 to 15 seconds; pt fine p/episode; MD said that pt panic; not caused by vax;
pt recvd vax 4MAY93 & started w/t101 @ 330 given APAP temp kept going up @ 530PM; mom took to MD had jerked x 2 on way; saw some reddness of ears poss vax; on way home pt had sz & stopped breathing; mom gave CPR to ER; admitted overnoc;
Approx. 5 hrs. after flu shot, I couldn't lift my arm. Started feeling pain at shot location.
Headache, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative: dose 1 - day 1-2- redness; pain at inj site; day 1- ha dose 2- day 1-2 redness; pain at inj site; day 1-5- fever;chills;bodyache;fatigue;nausea; up to 14 d- ha
pt recv vax 4NOV92 & exp episode of nausea & vomiting;
staff administer an  expired Moderna covid19 vaccine on the  2apr2022 that was expired on the 1apr2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the  2apr2022 that was expired on the 1apr2022) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026l21b) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the  2apr2022 that was expired on the 1apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (staff administer an  expired Moderna covid19 vaccine on the  2apr2022 that was expired on the 1apr2022) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-533297 (Patient Link).
itches like crazy (rash); red(rash); rash all over body after 1st dose, on her chest, face, back and arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches like crazy (rash)), RASH ERYTHEMATOUS (red(rash)) and RASH (rash all over body after 1st dose, on her chest, face, back and arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination.     No medical history reported.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itches like crazy (rash)), RASH ERYTHEMATOUS (red(rash)) and RASH (rash all over body after 1st dose, on her chest, face, back and arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itches like crazy (rash)) had not resolved and RASH ERYTHEMATOUS (red(rash)) and RASH (rash all over body after 1st dose, on her chest, face, back and arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non significant follow up received on 24-may-2021, event was ongoing.
CC; patient experienced vasovagal and syncope upon vaccine administration. Treatment: no medical treatment was given. rest and food resolve the symptoms. Outcome: Patient was discharged to POV/Home
Developed "Covid Arm" 10 days after the initial shot. It started with a raised red rash.  On day 11, a ring started to form around the rash. The rash did not itch much. It faded away about 4 days later.  Other than that, the arm had been very sore Day 1 and Day 2 after the shot.  No other side effects.
Within 3 hrs. cold feet, chills, fever 101, arm very sore, could hardly lift for 3 days without lots of pain. Had to have daughter undress me. In bed 3 days with body aching. Fever went down after taking 2 TYLENOL every 3 hrs. Flu like symptoms.
Pt recvd Hep B on 27SEP91; prior vax included PPD  & tetanus toxoid on 23SEP91 & 24SEP91; approx 1 hr following vax nausea, dry heaves, t99.6 & hot & cold feelings; pt hospiitalized x 1 day & recovered;
This spontaneous report has been received from a register nurse referring to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 18-DEC-2015 the patient was vaccinated with an expired dose of VARIVAX (lot number reporter as 0494AE, expiration date 7-MAR-2014) (strength and frequency were not provided). Concomitant therapies were not provided. In additional to this, the registered nurse stated that she did not know if the product had any previous temperature excursions. No adverse symptoms reported. PQC was not involved. Additional information has been requested.
Chills then fever. Persisting headache. Fatigue. Nausea.
felt a lot of aching; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. Patient received the first vaccine at 1oclock and did not feel anything, however after an hour she felt a lot of aching and wanted to know if she could take paracetamol (TYLENOL). Patient was experiencing some reactions that they think were normal after taking the vaccine. They just wanted to know if she could take TYLENOL after taking the vaccine. Outcome of the event was unknown.  Information about Lot/Batch has been requested.
Developed 1 d hx of fussiness and vomiting and found to have intussusception and reduced by barium enema.  01/23/2008 Vax record received and Rotateq Lot # updated.  It appears that the reported lot # was for the 9/18/07 dose not the 11/13/07 dose. 5/30/2008 MR received for DOS 1/2-3/2008 with DX:  Intussusception.  Infant presented to local hospital with belly pain, vomiting and bloody diarrhea. Pt had been feeding poorly and had fewer wet diapers. Reduced by Barium enema and admitted for o/n obs.
fevers, body aches headaches  first 24 hours  sob and chest pain - two weeks later.
Mx: 68 degree F, Min: 76 degree F: Duration of excursion: Approx 24 hrs; Mx: 68 degree F, Min: 76 degree F: Duration of excursion: Approx 24 hrs; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ6738, Expiration Date: 31Jul2023) 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: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "Mx: 68 degree F, Min: 76 degree F: Duration of excursion: Approx 24 hrs".  Additional information: The date of shipment arrived at customer at 28Oct2022 and the number of product unit impacted was 1. The fridge was stored at 2-8 degree C. Maximum temperature was reported as 68 degree F and minimum temperature was 78 degree F. The temperature excursion occurred for approximately 24 hours.
Swelling; Hot area; Discomfort; Arm soreness; Redness; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th December 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and erythema. On an unknown date, the patient experienced extensive swelling of vaccinated limb, skin warm and discomfort. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm, erythema, skin warm and discomfort were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm, erythema, skin warm and discomfort to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced arm soreness and redness about a size of a quarter the day of vaccination.  The area was swollen, painful and hot to touch. The area was getting bigger and bigger, it was 5 inches long and 4 inches wide.  Her pain was on a level of 8 on scale of 1 to 10 with 10 being the most painful. The patient was in discomfort.  Reporter consented to follow up. This case has been linked with US2020000941, reported by same reporter.