chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner (NP) concerning an approximately 13 week old male with a history of loose stools and no drug allergies who on 28 Feb 2007 was vaccinated with the first dose of Rotateq (Lot# 654248/0577F). The NP reported that on approximately 07 Mar 2007, the patient developed looser stools and has a positive stool sample for rotavirus. Unspecified medical attention was sought. A stool occult blood test was also performed (results not provided). At the time of this report, the patient's rotavirus persisted. Additional information has been requested. 06/01/2007 Information has been received from a nurse practitioner (NP) concerning a 13-week-old (previously reported as approximately 13 weeks) male with reactive airway disease, a history of loose stools and no drug allergies who on 28-FEB-2007 was vaccinated PO with the first dose of ROTATEQ (Lot #654248/0577F). Concomitant vaccinations administered on that same day included the first IM dose in the right anterior thigh of PEDIARIX (Lot #AC21B084BA), the first IM dose in the right anterior thigh of PEDVAXHIB(MSD) (Lot #654397/1014F) and the first IM dose in the left anterior thigh of PREVNAR (Lot #B362583). Other concomitant drug therapy included albuterol. The NP reported that on 04-MAR-2007 (previously reported as approximately 07-MAR-2007), the patient developed looser stools up to 3x/day. Unspecified medical attention was sought. On 07-MAR-2007, the patient's stool sample was positive for rotavirus. A stool occult blood test was negative and stool cultures were normal. The patient recovered after a few days. Additional information is not expected.
pt recv vax 22AUG95 & from the time of inj, again exp a very painful rxn in the inj arm which lasted 4 hr;
After giving the first dose of Pfizer vaccine , pt  fainted  after coming out of consultation room. Patient's parent were with him and called out for help. With parent's help , rph was able to lay patient on floor immediately, monitored the blood pressure, gave him water and ice.  Rph took another  BP reading after few minutes and  it was normal. Patient went home with parents after 30 minutes of incident onset.
Assumed febrile seizure (no one witnessed it)-Pt woke from nap and was 'frozen' on the bed staring and looking stunned. Non-responsive and disoriented, extremely hot to the touch-dazed and unsteady, so called ambulance and went to ER (4 days after shots).
Night of "shot" severe pain negated sleep and the following night. The day after it was administered, could not lift that arm. Six days later, still painful with crepitus in my shoulder. 8/15 - still pain in arm/shoulder. Pain is severe at times. Husband has to help me get shirts on and off.
After HPV, pt. had fainting episode with brief jerking generalized lasted for a few seconds.  Laid down.  Diaphoretic.  Responded to voice, flat voice, but sleepy. O2 sat OK.  P 66, BP WNL, +c/o pain with light touch.  Postictal x10 min.  Then alert to date, day events.
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX, 0.5 ml, subcutaneous (lot # not reported). On an unknown date the VARIVAX was exposed to a highest temperature of 11F for 2 hours total over four different excursions. There was no adverse effect reported. This case is linked to MARRS # 1406USA003453 (same reporter link). Additional information has been requested.
21SEP 100.2 for 1 day; 20SEP reddened area approx 9cm by 5cm w/swelling; lump @ inject site; Lasted 4-5 wks; 21SEP soreness-1wk;
arm was sore; they do have a Pfizer Covid-19 vaccine that was not diluted properly and it was administered to a patient; they do have a Pfizer Covid-19 vaccine that was not diluted properly and it was administered to a patient; Product use for unapproved combination; Off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 21 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 19Jan2022 09:00 (Lot number: FJ1620) as dose 3 (booster), single for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), intramuscular, administered in deltoid right, administration date 19Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOESTRIN taken for contraception, start date: Sep2020 (ongoing). Vaccination history included: Bnt162b2 (1st), administration date: 29Mar2021, when the patient was 21 years old, for Covid-19 immunization; Bnt162b2 (2nd), administration date: 19Apr2021, when the patient was 21 years old, for Covid-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 19Jan2022, outcome "unknown" and all described as "they do have a Pfizer Covid-19 vaccine that was not diluted properly and it was administered to a patient"; PRODUCT USE ISSUE (non-serious) with onset 19Jan2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 19Jan2022, outcome "unknown", described as "Off label use"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore". Additional information: Prior vaccine in four weeks: None. For concomitant Tdap reason for use: Administered same day as 3rd Pfizer vax and the route of administration is IM RD. Patients Medical History Familial PKSD Ongoing. Medication improperly diluted Not diluted Enough.Confused w/syringe chance for diluted instead of 1.8 ml to dilute I used 0.18 ml. No pt day of a next day sand she was fine her arm was sore but started no more expected she was instanced to cast if she expected Amy adverse effect a reiterated that she was fine w/pt again today 16Feb2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (23Feb2022): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non HCP letter sent that included: Updated Information Included: New event, Reporter Information slide #2 Added, Other Relevant History, Vaccine Facility Information, concomitant medication.
Patient came to the pharmacy to get a COVID vaccine. When asked the patient for their vaccine card, they stated that it was their first shot and that they have never had one before. Patient asked about the difference between the two vaccines (moderna and pfizer) and requested to get Moderna. Before administering the 0.5 mL of the Moderna, I asked the patient again if this is their first COVID vaccine and they said "yes, I have never had one before." I gave the patient the vaccine and had them wait for 15 minutes to make sure there was no reaction. After the vaccine was administered, it was discovered that the patient has had the Pfizer vaccine 1st and 2nd dose last February and the booster in September. Patient never verbally disclosed this information upon checking in or prior to receiving the vaccine even though they were asked several times. I called the patient and let them know to not get anymore doses of the COVID vaccine until further guidelines are established by the CDC.
Pt recvd Typhoid vax & had local rxn which resolved; also devel fevers up to 103, chills, myalgia, sore throat, breathing problems, tachycardia, chest pain; pt hospitalized for URI; tx Zithromax, Rocephin, Cefazolin, & steroids;
Breakthrough case admission after two vaccines Moderna 3/1721 Lot# 002B21A; Moderna 4/14/21 Lot# 037B21A
Loss of hearing; Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Allergy to hamster" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Loss of hearing"; TINNITUS (medically significant), outcome "unknown". The events "loss of hearing" and "tinnitus" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (unspecified date) noise in her ear and loss of hearing; (2021) couldn't have been identical; (2021) no change in hearing test; (2023) sudden lost hearing, notes: The recent hearing test is identical to the other one. Clinical course: Patient was wondering if Pfizer makes Shingrix vaccine. She was trying to figure out if it was the cause or the COVID vaccine. A lot of people were getting the same thing. It could be caused by Shingrix vaccine because it was around the same time. She was having roaring in her ears, basically tinnitus and has seen 2 ENT's and they had the same answer, loss of hearing. Two years ago, she had hearing test and then this time to see what was going on with the noise in her ear and loss of hearing. The recent hearing test was identical to the other one. It was not like she all of a sudden lost hearing and was having tinnitus. It was bothersome and was getting louder. She was trying to figure out how to get rid of it and what could have caused it. Caller's friend's nephew took the COVID shot and he had the same problem, tinnitus. A lot of people are talking about it online and were demanded testing. Caller didn't had the problems two years ago and had regular hearing test. Now with tinnitus they asked for hearing test. They compared the two hearing test and they were identical. It couldn't be identical. It couldn't take 2 years to get tinnitus with no change in hearing test. It might had happened because of the Shingrix. Caller clarified COVID vaccine was the Pfizer COVID vaccine. She was unaware who makes Shingrix. After the Shingrix she got bad asthma and couldn't shake it. She went to allergist and apparently there is hamster in that vaccine and that is what she was allergic to.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300208176 same drug/reporter/AE ,different patient;
Approximately 8 hours after injection I began experiencing extreme fatigue. This was soon followed by uncontrollable shaking and chills. As this progressed I began to experience extreme aching pains all over my body, a headache, and dizziness. I fell asleep somewhere around 11pm or 2 hours after on set of symptoms. I awoke multiple times in the night to body aches and a head splitting migraine. During the night the chills and shaking turned into a fever and sweating. At 6am the next day I forced myself to take some painkillers and hydrate. The body aches had started to recede at that point but the migraine was extremely painful and It was nearly impossible to open my eyes with a hypersensitivity to light. I slept on-and-off through the next morning and nearly all symptoms stopped by 1pm on May 8 or 24 hours after the injection.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 28-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (route and site of administration, dose, lot number and expiration date were not reported) and on 21-DEC-2015, received second dose of GARDASIL dose: 0.5 ml, intramuscular, lot # K006960, expiration date: 19-FEB-2017 (coded as inappropriate schedule of vaccine administered). There was no adverse effects reported. No product quality issue was involved. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. An 87-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF3592) at the age of 87 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism. Vaccination history included: BNT162b2 (Vaccine Name: 1st dose Pfizer COVID-19 Vaccine, Lot Number / Expiry Date: EL9262 or GL9265/ unknown, Route, Anatomical Location: left arm), administration date: 25Jan2021, when the patient was 86-year-old, for COVID-19 Immunization, reaction(s): "received all 4 COVID-19 Vaccines in her left arm and has 4 tiny scar spots"; BNT162b2 (Vaccine Name: 2nd dose Pfizer COVID-19 Vaccine, Lot Number / Expiry Date: EN5318 or GN5318/ unknown, Route, Anatomical Location: left arm), administration date: 16Feb2021, when the patient was 86-year-old, for COVID-19 Immunization, reaction(s): "received all 4 COVID-19 Vaccines in her left arm and has 4 tiny scar spots", "thought this was a rash like her second one". The following information was reported: SCAR (non-serious), outcome "unknown", described as "She states she received all 4 COVID-19 Vaccines in her left arm and has 4 tiny scar spots.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: She has been taking Synthroid for years and thinks 10 years. Sender's Comments: Linked Report(s) : PFIZER INC-202200789445 same patient and drug, different dose and events;
sore jaw; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN JAW (non-serious), outcome "unknown", described as "sore jaw". Therapeutic measures were taken as a result of pain in jaw.  Additional information: Patient mentioned he was taking Amoxicillin 500 mg and wants to get a booster shot of the vaccine but is afraid the medication might interact with booster shot. Patient was taking Amoxicillin for a sore jaw after his dentist recommended he take it. He said it was time for his booster so he was wondering if this could conflict with taking Amoxicillin. He said he the sore jaw was probably because he had a root canal years ago that needs to be revisited, and he was not going to be able see him for that for a couple weeks. He said the dentist is having him take Amoxicillin because of infection, so he was wondering if he can get the booster dose now or if he needs to wait.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-MAR-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-MAR-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-MAR-2022) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2022 at 9:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Mar-2022 at 9:49 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Ethnicity of patient was reported.It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day or within one month prior to any dose of Moderna COVID-19 Vaccine to the patient.  Patient received the booster dose.  No treatment medications were provided.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 12-NOV-2015 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II (rHA (recombinant human albumin), lot #L003856, expiration date 05-FEB-2017, strength, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 192 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
LEFT UPPER ARM AFTER 8 DAYS BECAME RED, HOT TO THE TOUCH, PAIN ON MOVEMENT, ITCHING. STILL RED, ITCHING ON DAY 10.
Came into Public health travel clinic and received travel vaccines in preparation of going in April x 2 weeks on a humanitarian mission to build wells and help with local school children.  Got IM vaccines and Cholera during appt 3/18/19 and then took Vivotif home and started them at home that evening.  Experienced severe nausea for a couple days after starting vivotif and that resolved. Then developed Diarrhea about 2 days after completion of Vivotif.  No fever; felt fine; no cramping; occasional "queasiness"; Diarrheal episodes occurred 1-2/day average. She took Imodium daily to control it. Has experienced Diarrhea since. Started 2 days after completing Vivotif, continued on through trip and continued on. On 5/7/19 we received the report from her provider. They did a stool culture which didn't show growth so she states they will continue to do some tests to help determine cause of diarrhea.
Myself and my two sons are having similar heart symptoms after receiving the COVID vaccination.  For myself: Several days (maybe weeks) after the second dose of the vaccine, I began having a racing heart beat.  I became constantly aware of my heart beat as though it was beating harder than before the shot.  Occasonally, it would feel like there was also a breif arrhythmia (several seconds) before resetting to a normal beat.  There was no pain, only discomfort.  I didn't immediatly connect the issue to the vaccine, but I spoke to my doctor about it.  Only after my two sons started having the same issues, did I connect the timeline to the vaccine.  My Oldest son (18 years old) recently received his second dose of the Pfizer vaccine (Aug 8th, 2021).  After 2 or 3 days he began feeling the same symptoms; strong heart beat.  However, he has had additional, more sever, symptoms.  Within 5 days, he stopped eating and we complaining of strong tightness in his chest.  We took him to emergency care where he received a EKG and chest x-rays.  The EKG was high, but not severly high and his resting heart rate was 112, way above normal.  He is lathargic, has diarea and is not eating.  We are taking him back to the hospital today.   I've run out of time, so I can't report on my middle sons symptoms.  They were similar to mine.  ALso requiring a dr visit.
830PM flushed, t104 R, cranky;APAP given per rectum (suppository) (calmed down) exam AF flat, lt drum erythematous;neck supple;lungs clear;heart RSR;neuro exam nl;
Fever, chills, stomach pain, body aches and pain. Almost like the flu. All night and still feel the same the next day.
10 minutes post flu vaccination, patient presented to nurse with a small hive behind his ear.  Nurse provided 1 25 mg tablet of benadryl and advised patient to remain in the room where shots were being administered.  After 15 minutes patient returned to his desk to work.  When flu clinic ended for the day (5:30pm) nurse returned to patient to check in on him.  He said he was fine.  This writer contacted patient by phone the next day to follow-up.  He said he was fine.  Symptoms did not worsen.
Swollen right thigh from hip to knee-red, warm, tender to touch-per parents and nurse, swelled to "size of softball".
Cried for 3 hrs p/DTP & fussy 2 days after; Seen in office on 20APR92 for fussiness, dec appetite, dec activity;
Fever 1 day following vaccine administration.  Rash/hives at site 2 days following administration of vaccine.
This spontaneous report was received from a registered nurse refers to 9 unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates since 29-JUN-2015, patients were vaccinated with doses of improperly stored VARIVAX (Merck) injection, lot K007979, expiry date 03-JUN-2016; lot K021485, expiry date 03-NOV-2016; or lot L001330, expiry date 13-JAN-2017, (dose, route and frequency not reported). No adverse effect reported for these patients. The outcome of the events was unknown. No product quality complaint (PQC) was reported. No further information provided regarding these patients. This is one of three reports received from the same reporter. Additional information has been requested.
Fever, NauseaVomiting, Chills, injection site soreness and swelling Narrative:
I received the first dose on October 5, 2021 and had my monthly menstrual cycle from October 13-21.  The length of my cycle was normal, but it was unusually heavy.  I'm 45 and sometimes that happens, so I didn't think much of it.  On October 26, I received the second dose of the vaccine.  On the evening of October 29th, I had some breakthrough spotting.  By the morning of October 30th, I was bleeding heavy.  Since then, the bleeding has been so bad that I have considered going to the emergency room on more than 1 occasion.  I'm hoping my GYN provider can see me tomorrow.
pt recvd vax; 2 days after vax pt noticed arm numbness at inject site, about size of 50 cents piece; also w/ movement there was sharp shooting pain at inject site; tx alternating ice & heat, advil PRN & passive ROM;