chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a male patient vaccinated with improperly stored ROTATEQ (oral; lot# N000175 with expiration date 20-SEP-2018) on 22-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter (link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Headache, Myalgia, NauseaVomiting,  malaise, hot flash Narrative:
Sinus infection; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 15Mar2021 13:00 (Lot number: EL9265, Expiration Date: 31May2021) at the age of 74 years as dose 1, 0.3 ml single for COVID-19 immunisation. Relevant medical history included: "Diabetic/Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetic. Concomitant medication included: GLIPIZIDE/METFORMIN taken for diabetes mellitus (ongoing). The following information was reported: SINUSITIS (non-serious), outcome "unknown", described as "Sinus infection". The event "sinus infection" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
About 9 hours after getting my vaccine, I started noticing my temperature rising to ~99.0. About 1 hour later (12 AM), it had risen to ~103. I also noticed my heart rate was extremely high (on average 140 bpm, the highest was 225 bpm); this was also accompanied by chest pains which seemed like they were on the right side of my heart; I also had difficulty controlling my bladder and would randomly start to urinate. I had taken two Advil then slept.  The next day (~9 am) my fever went down but 3 hours later it had gone back up to ~101, I eventually kept cooling myself (removing shirt, fan on high, etc.) and took one Advil and my temperature started to get normal.  For about two days after that, I had pain in my left shoulder - but this was where the injection took place so I wasn't too worried. Currently I am feeling fine, but the initial day getting the vaccine was quite harrowing - I was quite worried I was going to have a heart attack.
Information has been received from a physician concerning a female who was vaccinated with GARDASIL (unspecified number of doses) may have 1-2 false HIV positive. The patient was seen in the office. At the time of reporting, the outcome was unknown. Additional information has been requested.
Fatigue three hours after received vaccine.  Body ache, headache, chills overnight.  Body ache, headache, nausea, fever (highest was 101.0) the following day until around 5:30pm.
This spontaneous report was received from a pharmacist and refers to a 80-year-old female patient. No information regarding the patient's concurrent conditions and pertinent medical history was reported. The patient had no allergies. On 31-OCT-2017, the patient was vaccinated with previously diluted with sterile diluent, ZOSTAVAX subcutaneously (19400 PFU; lot# N014942 with expiration date 02-FEB-2018) for prophylaxis. The patient had no concomitant medications. On 31-OCT-2017, the patient experienced local reaction at the injection site, 4 inch rash, which was red and itchy. On 03-NOV-2017, the patient sought for medical attention and returned to the pharmacy. No treatment was given for the adverse events. Laboratory test were not performed. The patient did not recover by the time of this report. Causality assessment was not provided.
Patient came in on 8/28/18 and spoke to the pharmacist. He stated that his upper left arm started swelling about 5 days after getting the vaccine and his lower left arm started swelling about 6 days ago. He told pharmacist that he was planning to go to the doctor.
Information has been received from a registered nurse concerning a 12-month old black male with a history of mild physiologic peripheral branch pulmonary stenosis who on 30-Dec-2003 was vaccinated SC in the left arm with a 0.5 ml first dose of varicella virus vaccine live (lot #647088/0853N; diluent lot #645833/0304N). There was no concomitant medication. There was no illness at the time of vaccination. On 10-Jan-2004, the patient broke out with blisters on a red base at the injection site and abdomen. The patient was afebrile and was otherwise doing well. The patient was diagnosed with varicella after vaccination. He was treated symptomatically and a prescription drug was not required. No diagnostic laboratory tests were performed. At the time of the report, the experience was still being treated and the outcome was unknown. Additional information was received from the registered nurse which indicated that on 11-Jan-2004, the patient started breaking out with several blisters on a red base at the injection site and abdomen. There was no adverse reaction. The patient was treated symptomatically and recovered without a problem. No further information is expected.
AN UNEVALUABLE EVENT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced an unevaluable event, and had to be hospitalized. It was got so bad that patient had been relocated an hour and a half away to a bigger, more adequate hospital. Number of days hospitalized and discharge information was not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of an unevaluable event was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter was linked to 20211045102.; Sender's Comments: V0:20211049317-COVID-19 VACCINE AD26.COV2.S-An unevaluable event. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
ITP SYMPTOMS STARTED IN JUNE 2013 BRUISING ALL OVER ARMS AND LEGS. PLATELETS DROPPED OVER 6 MONTHS AND TREATMENT WAS STARTED IN JAN 2014. IgG GIVEN 2 TIMES WITH NO SUCCESS. TESTS DONE FOR LUPUS AND OTHER AUTO IMMUNE DISORDERS WERE NEGATIVE, PLATELETS THEN DROPPED AGAIN AND SHE WAS TREATED WITH RUTUXIMAB IN 2014 SUMMER. PLATELETS HAVE REMAINED HIGH AFTER 4 DOSES AND INFUSIONS OF THE RUTUXMAB DRUG AT HOSPITAL. LOWEST PLATELET LEVELS WERE 4K. SHE WAS TREATED OVER 6 MONTHS WITH INFUSIONS.
Feeding the infant; He got extremely restless; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a male patient(baby). An infant male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via trans-mammary route of administration on 06Jul2021 as Dose 2,Single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. Pharmacist said that he gave the second dose of the Pfizer Covid 19 vaccine to a patient yesterday even though she is breastfeeding. He said that the patient checked with her doctor and her doctor told her to move forward with the vaccination. Mother reported that last night after feeding the infant, he got extremely restless. The outcome of the event was unknown.  Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021855248 Maternal case
Patient did not experience an adverse outcome. Reporting a medication error.  Administered covid vaccine to patient with daughter present. Informed of reason for booster and nothing else was said. 30 minutes after administration the daughter informed me that patient had only received the second vaccine last month. MD notified and aware.  upon investigation, we did not find any record of patient's previous shots in the registry.   If the patient demographics don?t line up with what is in the immunization registry then it won?t come over, there?s been a lot of this occurring and if the pt got the vaccine outside of the State, it won?t show.
upset stomach, bad dreams, fever, chills, vomiting, diaherra, pain throughout the body, night sweats
A very faint line appeared but after the time limit (15 mins); A very faint line appeared but after the time limit (15 mins); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Lot number: FF8841) at the age of 51 years as dose 3 (booster), single, administration date 10Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 2, single and (Lot number: EP6955, Expiration Date: 30Jun2021) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Apr2022, outcome "unknown" and all described as "A very faint line appeared but after the time limit (15 mins)". The reporter was the patient's wife who stated that the patient took a rapid test for Covid on 03Apr2022 after learning his son was positive. A very faint line appeared but after the time limit (15 mins). He took another rapid test this morning and it was negative. He was awaiting results from a PCR. His daughter and his wife also fully vaccinated and boosted with the Pfizer vaccine have tested negative this morning on the rapid test. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Apr2022) positive, notes: A very faint line appeared but after the time limit (15 mins); (04Apr2022) negative.
Same day as vaccine administered:  fever of 101, felt serious chills, abdominal discomfort, headache, serious general weakness.   Next day:  temperature 99.8, general weakness.  Following day: no symptoms.  No treatment aside from bed rest.
Around 5:45 pm when I got home I started getting intense body pains. By 7 pm that same night I was literally screaming and felt like I was being electrocuted from the inside. I had taken 8 tylenol is less than 4 hours later that night because the pain was so unbearable. Every other second I was screaming from the jolts of pain. I am used to the typical sore arm body aches from shots, but this was completely different. The next day I started benadryl and that was the only thing that helped me feel a little better. It's now a week later and I'm getting another round of it starting up again. Again, it's not the typical aches and pains. It literally feels like my insides are getting electrocuted every few seconds.
About 20 hrs after vaccination, i woke up with nausea and severe cramping epigastric and abdominal pain, radiating to my back. I did not have fever, but felt ill. These symptoms lasted 10 hrs.
Chills; Headache; Fatigue; injection site soreness and redness; injection site soreness and redness; Shortness of breath; nausea; feeling unwell; This is a spontaneous report from a contactable other health professional (HCP) who reported for herself. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly in the left arm on 19Dec2020 at 08:45 (at the age of 24-years-old) as a single dose for COVID-19 vaccination. Medical history included being diagnosed with COVID-19 prior to vaccination, on an unspecified date. Otherwise, other medical history and known allergies to medications, food, or other products were all reported as "no". The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020 at 00:30, the patient experienced chills, headache, fatigue, injection site soreness and redness, shortness of breath, nausea and feeling unwell. The events were reported as non-serious and the patient did not receive any treatment for the events. The clinical outcomes of the events chills, headache, fatigue, injection site soreness and redness, shortness of breath, nausea and feeling unwell were all recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt recv vax 25NOV96 & 1 day post vax pt exp dizziness;the event resolved p/1mo;
Chills, shiver; Pt was given a blanket, water, rest; s/s resolved; BP 153/93; HR 74; RR 18
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 52-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 06-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-APR-2023 The patient who received unstable shingles vaccines after a temperature excursion. The reporter stated that all the vaccines were administered, lot numbers, administration dates and patient involved. The reporter provided the consent for a follow up via email by safety team. The patient who received unstable shingles vaccines after a temperature excursion, which led to incorrect storage of vaccine. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
30 minutes after:  numbness in extremities, dizziness; 12 hours later: nausea, shortness of breath, high bp, low HR, dizziness, fatigue, shakes, sensitivity to light; Some lasting more than a week.
Back pain, joint aches, fever 102, abdominal pain, nausea, sweating, right upper quadrant tenderness, soreness and induration of left deltoid.  Human bite appears stable. Evaluated 1:30PM 10/10/10.
Arm hurts; Chills; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 13:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced arm hurts and chills. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not  been tested for COVID-19.The clinical outcomes of the events arm hurts and chills were unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
devel classical herpes zoster @ T5-6 of rt posterior-anterior hemithorax on 27DEC95-1wk following vax;
Syncopal epis after leaving facility (>85 degree temp et non-air conditioned vehicle).  -SOB, rash.  Pt had been observed x15 min after immun with no adv rxn noted.
Client stated that she started to have redness and warmth in her left arm approximately 2-3 days following the vaccine being given, she then stated that the redness and warm sensation started to spread down her left arm and then she started to notice the same reaction on her chest and neck. Client stated that she took over the counter BENADRYL x4 doses and the reaction went away.
Fever, chills, and fatigue the night of the shot. Patient most likely just reacted to the shot itself
Patient presents to office with <25 vesicles, mainly goled crusted confluent areas. The largest area was the left axilla area of 3in by 2in. No fever; however, the affected area was infected and treated accordingly.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen at single (dose 2, single) and second regimen at single (dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid Treatment start date: 17Jun2022, Treatment stop date: 21Jun2022, Lot number: 1914705A.
Patient states arm was sore the day she got the vaccine. the next 2-3 days she experienced swelling, soreness, redness, hot to the touch.  today (6 days later), she states that the soreness went away however the area is still red and warm to the touch. For treatment, pharmacist recommended to apply cold compress and take ibuprofen. Patient may also try to take benadryl as well.
Patient reports acute pain at the injection site immediately after vaccination that lasted for an hour and a half, she also had pain up and down her arm and into her neck. She reports numbing/tingling in both cheeks for half an hour after receiving the vaccine. 9 days later she continues to experience pain up and down the injected arm from wrist to shoulder and into her neck.  The pain is somewhat relieved by NSAIDs.
Patient here with a reaction left arm where she had injection for PNEUMOVAX and flu vaccine. She is widespread achiness and feels feverish. Area of erythema is enlarging slowly.
Patient presented to Immunizations clinic for Covid Vaccine (Pfizer LOT EW0175 EXP 08/2021) Dose 2.  Patient received vaccine and moved to post-vaccination observation area.  After 15 minutes, patient went to leave clinic.  Shortly after patient returned and informed lobby staff that she was not feeling well.  Nurse on staff went to escort patient back to observation area when patient complained of feeling weak.  Nurse held patient and patient had syncope episode.  NUrse was able to guide patient to floor without impact to floor.  Patient was alert and oriented when placed on floor.  Patient denies history of syncope and/or vasovagal after injections.  Patient returned to baseline and stayed for additional 20 minutes for further observation then released.
Vomiting, shortness of breath, itching, joint pain, hot, swollen, red, itchy arm from shoulder to elbow started 45 minutes after vaccine.
I experienced weakness in all of my muscles, chills, temperature was 100.4 Monday morning; dizziness; extreme fatigue. I am continuing to experience slight weakness, slight dizziness, and am still extremely tired as of Tuesday late morning, March 16th.
Pt developed a red rash on abdomen and groin area that itches. Sign and symptoms began on 8/1/01.
Narrative: 73yo female reported pruritus with influenza vaccine in the past to her new primary care provider when she moved. No other info available about the vaccine. Provider flagged pt's ADR in chart
Symptoms started 01/17/2022. Vaccine was applied on 01/14/2022, Couple days after I started feeling strong heart palpitation, throat sourness. On 01/22/2022 I started with the body itching all over the body and on 01/252022 I develop a unusual rash next to the area where the vaccine was applied. I called my Dr. and spoke with one of her staff I mentioned all  my symptoms and she took all the information and told me that she will call me back, However, she never did. Therefore, I contacted the night Nurse and she advise me to call me Dr, again first thing on the next morning, In the mean time for me to take Benadryl for the itching and the rash.