chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a female patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) in her hip. The patient reported that she was late to receive her second injection in the series of GARDASIL. She did not specify exactly how late she was to receive the second injection. No adverse effects were reported. Additional information has been requested.
Patient received a Hepatitis A vaccine rather than the Hepatitis B vaccine. Patient had no adverse reaction, reporting vaccine given in error. Hepatitis B vaccine administered August 2, 2011.
breakthrough infections; breakthrough infections; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), 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 "breakthrough infections". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Clinical course: The patient reported that the patient was fully vaccinated with Pfizer's Covid vaccine, including the inital series in Mar2021 (unspecified date), booster in Sep2021 (unspecified date), and updated (new variant) booster in Sep2022 (unspecified date). The patient work in clinical research and was not sure if the data of breakthrough infections would be liked, as the patient had then tested positive in three separate infections on May2022 (unspecified date), on Oct2022 (unspecified date) and on Dec2022 (unspecified date).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
EXTREME HEADACHE, TREMORS, COLD EXTREMITIES, TROUBLE BREATHING, BODY ACHES, FATIGUE.
Redness and puffiness at the vaccine site at 24 hrs worse at 48 hrs (7 x 11 cm area on R thigh).
pt had elevated fever, sz, vomiting, lethargic & turn blue was taken to ER; told there was nothing wrong; pt had double ear infection;
Red rash over 80% of body.  Rash started on right arm, vaccination was given in left deltoid.  Lot number UT423AA.
I have been having a lot of dental work. After the visit of 9/19/2022, my lips started swelling a lot and peeling, which never happened before. It continued to worsen for about 3 1/2 weeks, subsequently I have been seeing an allergist. My primary prescribed an oral steroids and antihistamines. I had to get off the steroids to have the patch test done. This morning, 11/02/2022, they applied the patch test. They are expecting the results in two days. No results yet.
Patient's mom left message: go shots yesterday, fever at 102.0F. Red, swollen on legs. Talked with mom suggesting cold compresses and Tylenol. Call us back if fever persists. A follow up report received 9/20/2002 adds: No site reaction.
Fever today in a 3 y/o previously healthy male with h/o bat exposure. He is otherwise well appearing and in no distress. Likley the fever is from a concurrent viral illness.  It is unknown if the bad made any contact with the child, there are no visible wounds/scratches but it is possible that a bat can leave no mark.  Bats are high risk for rabies transmission.  Discussed risks/benefits of rabies vaccine and HRIG.  Discussed that rabies is a potentially preventable illness which can be highly fatal.  Parents agree with vaccine and HRIG administration. Patient described as "angry" by parents starting on the day prior to the second dose of the rabies series (2nd dose given on 5/28/15) and has persisted through the visit for the 3rd vaccination on 6/1/15.
About 2 hours after she had the vaccine, she felt a thickness in her throat, phlegm inducing, and numbness. She took Benedryl, went to bed and symptoms resolved.
Severe itching, dull headache for 4 days and large, red, swelling 4 1/2" x 2" for 3+ days.
It has been a little over two weeka after my second dose of the Moderna vaccine and about a week and a half after the second dose I  began having a lot of pain in the muscles and tendons stretching from my left shoulder down to my elbow. The pain is ongoing and limits my range of motion in my left arm. Icing it helps a little  along with taking ibuprofen.
chills; Diarrhea; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIARRHOEA (Diarrhea) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), DIARRHOEA (Diarrhea) and NAUSEA (nausea). At the time of the report, CHILLS (chills), DIARRHOEA (Diarrhea) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.    No treatment information was provided.   Reporter did not allow further contact
This spontaneous report was received from a physician referring to a 14 year old female patient with none drug reactions/allergies. The patient's medical history included unspecified thyroid level abnormalities since 2013. On 02-SEP-2014 the patient was vaccinated with her first dose in the vaccine series of GARDASIL (injection, lot # K008335, expired date as 23-JUN-2016, dose and route were unspecified). No concomitant therapy was taken. On 03-SEP-2014, "1 day later", the patient developed hives all over her body. The physician reported that the hives lasted 1 day and then the patient fully recovered (date unspecified). Physician also reported that no medical treatment was sought because the patient's mother never told the physician that her daughter developed the hives until a year later when the patient's mother came in for an appointment for herself. No lab diagnostics studies was performed and no treatment was give for the event. Additional information has been requested.
Fever, chills, nausea, headache, body aches, dizziness, cognitive fog, and severe fatigue for 14 days.
swelling @ site & around arm fr elbow to armpit states sl fever; swelling noted 4 days p/inj; pt states had sprayed arm w/bug spray noc p/inj w/new military type
Patient was given the Moderna COVID19 Vaccine on his right gluteus instead of deltoid per pt. request and with the medical provider approval.
Moderna lot number 038B21A expired in facility system on 9/25/2021, and vaccine was given 9/27/21.  No expiration on Moderna box or vials
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-JUL-2015, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a community outpatient clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated by a physician at a medical office for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Severe
Information has been received from a physician concerning a 14 year old female patient with penicillin allergy (AMOXIL) and no pertinent medical history who on 13-JUL-2009 was vaccinated with her first dose of GARDASIL. On 23-SEP-2009 the patient received her second dose of GARDASIL. There was no concomitant medication. The patient complained of numbness on her left arm after receiving her second dose of GARDASIL. The numbness was from her wrist to her elbow. According to the physician, the area looked normal. At the time of the report the patient had not recovered. The patient sought medical attention. No diagnostic tests were performed. In follow up, the physician indicated that the patient's elbow pain and numbness from the elbow to the hand resolved within 6 hours. She also stated that, the patient denied any trauma to the elbow or arm. The vaccine injection site was not tender and showed no signs of inflammation or discoloration. No further information is available.
she is unable to step on her left leg due to pain in her left heel; she had to move on her tip toes,she had to move on her tip toes, her husband had to support her, she has to use a cane; sharp pains in her leg that shot into her heel; This is a spontaneous report from a contactable consumer or other non-health care practitioner (patient herself). A female patient of an unspecified age received BNT162B2 (BNT162B2 solution of injection Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 26Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. she had a reaction to her second dose of the Covid vaccine on 26Feb and asks if her reaction is a side effect to the vaccine. On the 27th everything was fine, on 28Feb the patient started having sharp pains in her leg that shot into her heel, she had to move on her tip toes, her husband had to support her, she has to use a cane. On day 3 the caller is unable to stand on her left leg at all. When the patient had received this vaccine, she was given paper-work and the paperwork said if they had any problems, she would have to call this number, she is calling today to find out what to do next. The patient wants to know if it is a vaccine reaction, just to make sure, and if it could be determined as a yes then she wants to know what to do in this case. The patients states that she understands, she mentions that she is going to see this new doctor next week. The patient wants to know if we can we get her on the phone with a doctor, she has been unable to get in with her doctor. The patient was again informed that Pfizer does not medically advice callers and we do not have a doctor service to medically advise her. The outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Recieced 1st vaccine on 9-9-21 I did not go through any worksheets of what could happen of if I had any problems . After 1 hour I was sweating profusely  had shortness of breath, dizzzyness and had spots all over my legs that were burning  with pain. I was exhausted and had no energy.
This is not a serious event but someone told me that the CDC is collecting any data.  After I got the shot, I noticed a strong pungent smell  coming from my arm pits,  it was strange because when I work out and am sweating, I don't get this smell.  When I got home I took a shower and a couple of hours later without any kind of physical activity, the smell was back.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient of an unknown demographics who received a dose of FLUZONE QUADRIVALENT lot UJ023AA expiry date: 25-Apr-2019 via unknown route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to vaccine underdose. It was reported that the vaccine seemed to leak at the bottom where the needle attaches to. Pharmacist stated that there was not issues or anything out of the ordinary that she noticed when attaching the needle to the pen and felt that she tightened it down as she always did. Pharmacist stated that she was unsure if the patient received the full dose or not. It was also a case of syringe issue. It was not reported that if any adverse reaction occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient is a pleasant 77 y.o.  male patient of Dr. who presents today from ER as a direct admit to CCU for acute respiratory failure with hypoxia secondary to bilateral pneumonia with COVID 19 positivity.     Patient tested positive for COVID 19 2 days ago and was sent home, but became increasingly confused and short of breath at home, so his wife called 911 and patient presented to ER at 2100 last night.  His presenting pulse oximetry was in the 50's.  He was titrated up to a non-rebreather mask and then placed on HFNC at 60 L/min and titrated up to 95% Fi02.  Patient's respiratory rate on transfer was in the 20's with his Sa02 in the low 90 range.     ER was requesting transfer due to their high census.     Patient was transported by ambulance to our CCU.  Patient was hemodynamically stable on presentation and transitioned back to HFNC.  He needed a NRB mask to recover after the transfer on a NRB in the ambulance.     He is an excellent historian.  His son is sick with COVID 19 pneumonia in the Hospital.  He has had CLL for several years and is under the care of Dr.  He wanted us to make sure that he received his medications.  He denies history of COPD or asthma and hasn't smoked since his son received his kidney transplant 26 years ago.   His initial symptoms were around 4 days ago when he had a stuffy nose and drainange in the back of his throat.  He had a fever.  He then developed cough and shortness of breath.  He tested positive and tried to recover at home, but became increasingly short of breath followed by confusion and came to the hospital for treatment as above.  He didn't have monoclonal antibody treatment when he tested positive and didn't require oxygen at that time.  It was likely related to his medication for leukemia.     Code status is discussed.   CXR reviewed EKG reviewed Labs from ER yesterday and labs today reviewed.   DVT risk is high so Lovenox 40 mg SQ BID ordered GI prophylaxis with Pepcid.   His wife is his emergency contact, and I will call her tonight as requested, as she is currently visiting her son in the hospital while he recovers from COVID 19 pneumonia.     Spoke with Dr. today who said to hold treatment for CLL while admitted.
At 4AM on 10/3/17, pt felt sick to her stomach, passed out, went to Emergency Room, stated iron was low. Next day 10/4/17, went to another ER, feeling hot and increased HR. That day received IVF. Pt was started on iron tablets.
administration of expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. Reporter stated that 14 patients were given vaccine which was expired. Number of doses/vials: 10-dose vial Date the vial was initially stored in the refrigerator: 02-SEP-2021   This case was linked to MOD-2021-345833, MOD-2021-345448, MOD-2021-345457, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021:  follow up appended  : Reporter added , Lot no added , Expiration Date updated .
Same evening immunization felt hives and wheezing (4/15) which lasted through 4/17. Then on  4/18 started to notice pain and swelling in volar surface of the ipsilateral forearm - unclear at time if it was related Was then evaluated in the office, noted to have palpable mass in volar aspect of ipsilateral forearm. duplex ultrasound showed possible mass but no clot.  Follow-up ultarsound showed possbile AVM and finally MRI showed no etiology to explain the mass. repeat ultrasound described it as vascular) HIT antibody was weak positive (at 0.4) In the interim, multiple d-dimer tests were normal, but one drawn simultaneously was elevated (possible specimen issue), and there was also an transient thrombocytopenia which we understand has completely resolved. Currently, hematology + allergist referrals are pending.
Sick on and off; Missed 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Sick on and off) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick on and off) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, ILLNESS (Sick on and off) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was  sick on and off after first dose of vaccination and she did not received call to get her 2nd dose of MODERNA vaccine so she missed it.   No concomitant medication was reported  No treatment medication was reported
Cold; Shaking; Chills; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Jun2021 (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: NASOPHARYNGITIS (non-serious) with onset Jun2021, outcome "unknown", described as "Cold"; TREMOR (non-serious) with onset Jun2021, outcome "unknown", described as "Shaking"; CHILLS (non-serious) with onset Jun2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Jun2021, outcome "unknown", described as "Headache".  Additional information: I have a concern for my friend that got the shot yesterday so do you understand like why I am calling? Because somebody had an adverse reaction. Would you be able to give us the (incomplete sentence)? What's the guidelines? So her reaction was (incomplete sentence) and she's young, she's like 17 maybe, 110 pounds or something and she got cold last night she's shaking and then she's said like chills and then today her head is hurting really bad, really bad headache." Reporter stated, "No right now. I just want to know what's going on. Is that like a severe symptom, is that symptom that she really needs to go because she's saying that she's okay because she's having a headache and I'm telling her it's really up to you, you should probably go, you still have a headache anyway you have any kind of reaction that's not cool, just go to the doctor so, what's going down the grave, you got people turning purple and biting people and stuff (Further clarification was unknown), I mean what's coming down the pipe? What's weird for a typical young female to have a bad reaction, Is this serious? Is this bad, shaking because that freak me out? Shaking like that's like a seizure kind a thing like that's so bad (Reporter was unsure, hence not captured as event), you got to go, she's like Nah, nobody want to go to the doctor, I don't want to go and like I am fine and I'm like, you are not because your body just 'weirded' out. She probably go get it checked out because even though you feel better later something might happen, something might be going on and you are ignoring it and it's going to pick up again later and you won't even know what happened. So, right here right now somebody took the Pfizer shot young female, had headaches the next day, female, 120 pounds, shakes, and headaches the next day, what we are supposed to do?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received expired vaccine beyond 12 hour expiration limit of the punctured vial/the vial first punctured on Aug 19, 2021) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026C21A) for COVID-19 immunization. No medical history reported. On Aug 26, 2021, patient received the 2nd dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 26, 2021, patient experienced administered expired product (received expired vaccine beyond 12 hour expiration limit of the punctured vial/the vial first punctured on Aug 19, 2021). At the time of the report, administered expired product (received expired vaccine beyond 12 hour expiration limit of the punctured vial/the vial first punctured on Aug 19, 2021) outcome: unknown. Lot number: "026C21A" Number of doses/vials: "1 dose /1 vial." Date the vial was initially stored in the refrigerator: "Unknown." Date of administration of vaccine: "Aug 26, 2021." Did the vial undergo any previous temperature excursions? "No." Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77° F): "Unknown." The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessment, concomitant medication or treatment information.
Nausea, dizziness, lightheaded, drowsy. Symptoms lasted a couple of days. Patient stated he also drove off the road on 10-14-09.
4 month old AF received DTaP, Hib, IPV and Prevnar. About 5 min after injection. Pt developed redness most part of face- esp B cheek and forehead, also patches of redness on top of head and swelling or induration
Fatigue, confusion, memory lapse, anorexia, off balance. Unable to recall conversations, activities from the day after vaccine. Was acting unusual all day after vaccine but no weakness of body parts, no slurred speech, no fever or syncope. Red and painful arm which has persisted