chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left arm swelling size is pretty close to a golf ball; elbow is swollen/left elbow swelling/knot on his elbow; This is a spontaneous report from a contactable Consumer. This male consumer (patient, reported for herself)  A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 26Jan2021 10:45 as single for covid-19 immunisation.  Medical history included blood pressure high (Caller says it has been diagnosed for every bit of ten years) and two stents from Apr2020 to an unknown date. Concomitant medications included gabapentin taken for blood pressure high as 100mg once a day by mouth and a blood thinner. Patient says he has had no other vaccinations recently. He says that the Gabapentin is in a white bottle, but the LOT/EXP was covered by a pharmacy label. No further details provided about the other two medications patient mentioned that are not new medications.  Patient reported that he got his first dose of the Pfizer COVID-19 vaccine at 11:00AM on 26Jan2021. He says he has developed a swelling on his elbow, and called but no one answered. Patient says he didn't see his doctor about it yet, he woke up this morning and noticed it, today 29Jan2021. He says that it is just one elbow that is swelling, on the arm where he got the injection. Patient says he has his hand-written vaccine card, but they didn't write NDC/LOT/EXP on it. Patient clarifies that he probably got his shot injected around 10:45AM, because he had to wait until 11:00AM to leave. He says that the left arm swelling size is pretty close to a golf ball. Regarding Investigations, the patient reported that he had labs at the (Medical center name) before he got his COVID vaccine shot, which he also got there, but he hasn't got the results back yet. Investigation Assessment: Unknown. The patient reported that so far the swelling is not sore or anything, he just has a knot on his elbow. He says he would like to know if he should see a doctor if it gets worse, and find out if he should put a cold compress on the swelling. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Towards 3:00 pm I noticed I had a fever of 100.0; I started to feel body aches and fatigue around 2:00 am the next day; I started to feel body aches and fatigue around 2:00 am the next day; This is a spontaneous report from a contactable Other Health Professional (patient). A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EK9231, via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for an  COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient's historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE (lot number: EH9899) administered on 18Dec2020 12:00 PM, via intramuscular in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19 prior to vaccination. He has not been tested for COVID-19 since the vaccination. The patient did not feel anything after receiving the vaccine on 05Jan2021. He started to feel body aches and fatigue around 2:00 am the next day (06Jan2021). Towards 3:00 pm, he noticed that he had a fever of 100.0 (unspecified unit). He took some TYLENOL and slept most of the day. He woke up Thursday morning feeling great. The patient recovered from 'body aches and fatigue' and 'fever of 100.0' on an unknown date in Jan2021. The events were reported as non-serious. Therapeutic measures were taken as a result of the events.
left upper arm was warm to the touch; left upper arm has become redder; upper left arm was swollen; spotty discoloration all over her left upper arm that starts about 2" above her left elbow; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 17Feb2021 11:05 (Batch/Lot Number: EN6200) at the age of 71 years, as dose 2, single for COVID-19 immunisation. Medical history included lung cancer diagnosed about 3 years ago and has been in remission for approximately 2 years. There were no concomitant medications. The patient previously received her first dose of BNT162B2 via intramuscular route in the same arm (Arm, Left Upper) on 27Jan2021 (Lot number: EL9264). The patient had no other prior vaccinations within 4 weeksThe patient stated she seems to be having a reaction to the arm that she had received the COVID-19 Vaccine shot. On 17Feb2021, the patient experienced upper left arm was swollen and she had a spotty discoloration all over her left upper arm that starts about 2" above her left elbow. On 22Feb2021, left upper arm was warm to the touch and has become redder. The patient asked if it was common to have that type of reaction, and to have the reaction last as long as 5 days after getting the COVID-19 Vaccine. Patient declined any treatment. Events did not require emergency room or physician office visit. She clarified that her left upper arm swelling seems to have worsened. She said her left upper arm has become slightly bigger and redder. She said she noticed her left upper arm was warm to the touch. Patient had no relevant test. Reported she signed up for COVID-19 Vaccine tracker on the (smartphone based tool name). No further details were provided. Outcome of the events was not recovered. Events were reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Patient developed rash and sore muscle pain below deltoid muscle between elbow to area near armpit height. Pain exist for 6 days after vaccine administered. Not other treatment to date.
This is a spontaneous report from a contactable physician via a Pfizer Company representative. This physician reported several adverse events for four patients. This is the 2nd of four reports. A 17-year-old male patient of an unspecified ethnicity received the first dose of TRUMENBA (Lot # S26985), intramuscular at single dose, TDAP IMMUN, via an unspecified route of administration, MENACTRA, via an unspecified route of administration, all on 21Aug2017 for immunisation. The patient medical history and concomitant medications were not reported. On 21Aug2017, the patient experienced fainted but never lost consciousness, fell to the ground 10 minutes after administration. After 20 minutes of laying down with an ice pack and feet elevated, he was able to leave with his parent. The patient underwent lab tests and procedures which included PPD test on unknown date. The outcome of the events was recovered. Sender's Comments: Linked Report(s): US-PFIZER INC-2017421689 Same reporter/product, different patient/event.
652 pm-scene safety, 911 call initiated by staff(ER) Vital signs and Oxygen Saturation 130/90,114,22,02 96% 654 pm- Epinephrine 0.3mg IM via auto injection administered by staff (RA) , Benadryl 25mg tablet by mouth. (RA) 655 pm- vital signs: 140/92,108,20,O2sat 96% Benadryl 25 mg tablet by mouth administered (RA) 656pm-lung assessment by staff (RA) : clear bilaterally, breath sounds present O2sat 96% . 700 pm- patient self reports throat doesn't feel scratchy and clearing throat cough is subsiding. Pt states he does not want to be transported to hospital but will accept Medic evaluation. Pt states has long history of allergy to penicillin with throat raspiness and always takes Benadryl as needed. Vital signs 148/90,104,16,O2sat 96% Pt is speaking in full sentences without cough. 705pm- Fire Department Medics arrive, course of events/treatment report given to Medics by staff (RA). Care assumed by Medics. 710 pm- Vital signs per medics are stable, pt states he is feeling better and departs vaccination observation area.
pain at injection site 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection site 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection site 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 27-Feb-2021, INJECTION SITE PAIN (pain at injection site 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-067610 (Patient Link).
Injection site soreness, swollen glands underarm, pain in glands, low-grade fever, clear fluid leaking from the injection site. Benadryl, ice, ibuprofen. Glands are still swollen and painful
Student noted 2 small itching "mosquito bite" like areas under L deltoid where received vaccine during am on 12/10/09 - about 24 hrs after vaccination student came to school clinic @ 1:30 pm with 12" long x 4" wide flat hot, red pruritic rash with some small hives. Denies difficulty breathing. Denies itching mouth or throat. No dizziness or nausea. BENADRYL 50 mg given after talking to dad. To dr office with mom @1:55 pm. Spoke to student @3:30, drowsy but rash resolved. Mom had left msg that student seen by doctor - allergic reaction but not to H1N1 vaccine, will be @ school 12/11/09. 12/11/09 - not at school due to fever/rash per office. 12:00 spoke to mom, fever 101 last pm and hives this am - No problem w breathing etc. ZYRTEC given this am - helped hives, Appt 1:30 w doctor for follow-up.
Patient called occupational medicine to report adverse reaction post 2nd dose Moderna Vaccine Admin 1/26 Chills, and body aches 1/27 with severe SOB this morning, heard over the phone. Was advised to head to ED for evaluation and 02 sat check. NP team advised. Patient did not report to ED for evaluation.
Fainted in lobby approx 5 min after GARDASIL IZ. Taken back to room to rest on exam table x 10 min. Felt fine and left the clinic.
Within 3 hrs of getting the vaccine injection, I noticed that the injection site had a red mark approximately 1 1/2 inches in diameter.  By the following morning, the injection site had a red mark, approximately 3 inches in diameter and was hot to the touch and hard.  I also woke up with joint pain as well as tender glands in my neck and my jaw joints were achy. Over the next 4 days my glands in my neck were so swollen my, neck was actually swollen and my jaw caused me so much pain that I went to the dentist as I could not touch my teeth on my lower left jaw.  I had just been to the dentist for a cleaning, exam and xrays the week before and had reported no problems nor did the dentist identify any issues either, therefore I believe that the adverse reaction to the vaccine was directly related to the pain that I had in my neck and jaws.  By Monday 9/9/13, the injection site area on my arm was the size of my hand, it was hard, hot, swollen and now had the texture of the skin of a grapefruit.  The glands in my neck were still extremely swollen and tender and I had extreme pain in my jaw and could not go to work as I was light-headed and sweating.  After the visit to the dentist on Monday, I went to my doctor on Tuesday, 9/10/13 to discuss the pain I was in and discussed the adverse reaction which I had phone in on the day I received it.  Although there was no indication of any infection, I was place on an antibiotic, cephalexin, 500 g 3 times a day for 10 days.  I then returned to my dentist on Thurs 9/12/13 and was told that since the swollen glands were bilateral, it was a medical problem.  After several days, I did not feel any type of relief from the antibiotics.  Please note that only as the swelling of my glands went down, did the pain in my neck and jaw. Pain meds from the dentist did not help. I had no infection in my jaw or mouth.  It took approximately 16 days for my arm to recover.  It took 20 days for the swelling in my glands, neck and pain in my jaw to return to normal.  I also had peeling on the injection site after the swelling went down.
Patient states she woke up from sleep after receiving the vaccines with chest pain. Per provider note: "having a tightness in her chest in the middle and to the left. She experienced the same thing after her first dose. It has been on and off since the first dose (she did not make the connection until she got the second dose). No association with foods. She is able to breathe okay and is taking it easy today. Last night she woke up at 3am and she has had it since that time. Feels like a muscle pain that seems to go away and come back."
Patient had series of HPV9 vaccine July 2017 and June 2019 Patient was only to get Meningococcal vaccine, was accidently given HPV9
arm pain , fever , chills , neck pain and headache  , whole body pain  for 3 days  and  arm pain continued on and off until now and from yesterday the pain extend in my shoulder too
At 7 days post injection, noted itching and 2-3 inch red lesion at injection site. Treated as allergic reaction, diclofenac gel topical, Zyrtec oral antihistamine. Size monitored with 'Sharpy" circle. Subsequent increase in size of lesion prompted current course of Doxycycline. Incident on going at this date.  Discussed with Doctor - sent photo.   No visit.
Recurring fever on and off since vaccine; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19Feb2021 13:30 (Batch/Lot Number: EN6200), at the age of 68 years old, as dose 1, single for covid-19 immunisation. Medical history included headache, tiredness, pancreatic condition, and hip back issues, all from unknown dates and unknown if ongoing. No COVID prior to vaccination and was not tested post vaccination. No known allergies. Concomitant medications included pancreatin (CREON), oxycodone, omeprazole (PROTONIX), metoprolol succinate (TOPROL), alprazolam (XANAX), and sertraline hydrochloride (ZOLOFT), all taken for unspecified indications, start and stop date were not reported. On 20Feb2021, the patient experienced recurring fever on and off since vaccine. Treatment not given. The patient has not recovered from the event.   No follow-up attempts are possible. No further information is expected.
Minutes after the injection the patient complained of numbness around the right ear.   The vaccine was given in the right arm.  She felt fine otherwise, denied pain in the arm, etc.   She was stable and discharged.   Follow up several hours later was that she felt better, took an oral dose of Benadryl 25 mg.   She states now the neck is just sore.   She read that this is a rare side effect of the Pfizer vaccine.
No treatment recieved, relative experiencing more same but more severe symptoms and all treatments have failed he recieved pfizer. Feels like a constant pressure in my ears and hearing loss. Almost like ears need popped constantly. Random tinnitus that comes and goes.
Mom reports she started running a fever around 11 am after receiving her vaccines. Her temp was up to 102.
Bruise with a hard lump in the center appeared on my upper/inner arm, by my elbow (a good 6+ inches down from vaccine site) about 30-45 minutes after getting the vaccine.
Within one minute of receiving injection, my heart started racing and I felt dizzy and light headed.  After waiting at the vaccination site for 30 minutes, my heart rate slowed and the dizziness lifted enough to drive myself home.  It's now been almost 3 hours and I still feel a little off but mostly just have a headache.
Information has been received from a health professional concerning a 6 month old female who was vaccinated with a dose of Haemophilus B conjugate vaccine (manufacturer unknown). Subsequently, two weeks after vaccination the patient developed febrile seizures, and was also found to have urosepsis after a sepsis workup. The patient's cerebrospinal fluid immunology and serology studies were positive for Haemophilus influenza B, with weak agglutination. The cerebrospinal fluid cultures however were negative. The reporter considered the patient's experiences to be important medical events. No further information is available.
Severe pain in armpit. Swelling and redness about 4 inches around injection site. Headache, 30 points rise in blood pressure, tired, achy in all joints.  Mild stomach upset.
that is causing her daughter issues with her college; had trouble with the second vaccine/ second vaccine hit her daughter pretty hard; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 18-year-old female patient received BNT162b2 (BNT162B2), on 17Jul2021 as dose 2, single (Lot number: EW175) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot Number: EW175), administration date: 22Jun2021, when the patient was 17-year-old, for Covid-19 immunization.  The following information was reported: VACCINATION SITE INJURY (non-serious) with onset 17Jul2021, outcome "unknown", described as "had trouble with the second vaccine/ second vaccine hit her daughter pretty hard"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "that is causing her daughter issues with her college".  Additional Information: After reporting on her own events with the vaccine the caller provides information about her daughter. Caller states that her and her girls had their vaccines at the same time. States that her second daughter had trouble with the second vaccine and also does not want to get the booster. Caller states that is causing her daughter issues with her college. Caller states that the second vaccine hit her daughter pretty hard. Caller states that her daughter received her first dose of the vaccine on 22Jun2021; lot number reported and verified with the caller as being EW175. Caller states that her daughter's second dose of the vaccine was 17Jul2021 and states that it had the same lot number as her daughter's first dose; EW175.  No follow-up attempts are possible; No further information is expected.
PT received smallpox vax 2/11/03. Noted temp of 99.9 deg F on 2/15/03 x 3 hrs only. Felt unwell on 2/20 - took BP (186/110) Vision "a little off" RI(?) Clarity. MD visit. No TX. Rev with MD 2/24/03. MD Happy with PT. No treatment.
At approx 10 hours post vaccine: High fever (104.5 at height); intense pain in spine Lingering after 12 hour mark through 30 hour mark: General aches; gastrointestinal issues
Moderna COVID-19 Vaccine EUA. Received shot on 1-14-2021.  Several days after shot--Shot area developed a round red place on arm, about 1 1/2" inches across/down. It was tender. After a week or so I started taking Benadryl. Today is day 2 of tasking Benadryl and it is starting to fade just a little. Will continue Benadryl a couple of more days and report again if red spot is not gone.
Swelling in her arm; Inappropriate schedule of product administration; A spontaneous report was received on 03AUG2021 from another pharmaceutical company.   On 30JUL2021, a 55 year-old female patient reported experiencing swelling in her arm (PT: Injection site swelling) after receiving the "Anthrax shot". The patient received BioThrax (anthrax vaccine) 0.5cc on 03MAY2004, 17MAY2004 and 01JUN2004 (Inappropriate schedule of product administration). After each dose, she developed swelling in her arm. She described that after receiving the first dose she had swelling slightly, after receiving the second dose, she had a little more swelling, and after the third dose she had really bad swelling in her right arm and it was a lot. Expiry date and Lot Number were unknown. The patient attributes the swelling in her arm as related to the anthrax vaccine. The outcome of the events were resolved.  Medical history includes Methicillin-resistant Staphylococcus aureus (MRSA) infection in 2012. Concomitant medications were not reported.  No further information is available.  Company comment:  Injection site reaction is one of the most common adverse events associated to BioThrax vaccination. As the patient developed the same reaction with the three vaccination (rechallenge), the causality has been assessed as "Definite" related. Because it is assumed that the reported schedule was for pre-exposure, medication error was added and because medication errors are not AE per se, cannot be associated to the vaccination.; Sender's Comments: Injection site reaction is one of the most common adverse events associated to BioThrax vaccination. As the patient developed the same reaction with the three vaccination (rechallenge), the causality has been assessed as "Definite" related. Because it is assumed that the reported schedule was for pre-exposure, medication error was added and because medication errors are not AE per se, cannot be associated to the vaccination.
18 month old male patient received expired dose of ACT-HIB vaccine, no AE; Initial information received on 02-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 month old male patient who was vaccinated with an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  On 29-Jun-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ327AAB and expiry date: 28-Jun-2021) (Frequency: once) via an intramuscular route at an unknown administration site (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was also reported that the caller reported giving an ACT-HIB vaccine to a patient. That was within 24 hours after expiration date. No email was provided by caller. Patient Information Patient age greater 1 year enter as 2 month, 4 month etc. Many pediatric vaccines need month for age. Dosage Information: Frequency -once o Therapy Date: From Date of immunization To - leave blank-given 29Jun2021 by caller Route - route  and site- intramuscularly 0.5ml Dose - 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ml Strength = standard except for Fluzone HD- standard o Indications -Immunization or TB skin test-immunization. Pregnancy- not applicable Last menstrual period, Due date, AE (adverse event) symptoms or no AE. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry.  At the time of reporting, no adverse event was reported.  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 the Directive 2001/83/EC 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.