chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose pneumococcal vaccine 23 polyvalent. The reporter indicated that the patient was revaccinated in less than two years time and experienced a "very significant swollen arm reaction." The reporter was unable to provide any additional specific patient information. The reporter also mentioned multiple patients who were vaccinated with a dose of pneumococcal vaccine 23 polyvalent and subsequently developed "sever reactions that were temporarily rebilitating including tingling in the arm and fingers that lasted five or more days" (WAES0302USA02407). Additional information has been requested.
Case number PHEH2016US030248, is an initial spontaneous report received from a consumer (patient's wife) on 15 Nov 2016. This report refers to a 58-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine in the past and had no problems (unspecified details). The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618701) at a dose of 0.5 ml intramuscularly, on 15 Oct 2016. On the same day after the vaccination, the patient experienced inflammation and pain at the injection site which radiated up arm to neck on 16 Oct 2016. When he moved head in certain manner he experienced pain if he lifted arm it became numb down to thumb and with no improvement. It was reported that tingling worsened. The outcome of event tingling and numbness of arm was reported as condition deteriorated and of the events inflammation and pain at the injection site and pain was reported as condition unchanged. The seriousness and causality of the events were not reported.
Patient received nasal H1N1 vaccine at a school clinic. The following day he woke up with mild nasal swelling and upper lip swelling.He was seen in the ED and no interventions were needed.
EARS TO ROAR VERY LOUDLY AND CAUSE EXTREME BAD TINNITUS; EXTREME VERTIGO; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced ears to roar very loudly and cause extreme bad tinnitus. On MAY-2021, the subject experienced extreme vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ears to roar very loudly and cause extreme bad tinnitus and extreme vertigo was not reported. This report was non-serious.
Injection was given in right arm with immediate pain after. Redness immediately and pain to move arm. Still continues to be painful to move, sleep on, lift anything. I took a picture the day after because I couldn't believe how much pain I was in.
five minutes after getting the Bexero Vaccine in clinic. Pt. c/o N/dizzyness/visual tunneling.  Vomited x2. Pt.  in char. Transferred to clinic RN observation area from the Vaccination area by RN.  moved to stretcher w head of bed at 30 degrees.  VSS checked q 10 minutes.  Face pale. c/o slight HA. After 15 minutes: Color returned; no further N/V/ or abdominal pain..  Afebrile.  Symptoms resolved.
Headache, Myalgia, Arthralgia, Fever, thirst sever thirst, body aches, muscle pain, joint pain, fever
Received Havrix and a second dose one month after that; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Concomitant products included HAV (Havrix).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix and an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details provided were as follows: The patient received 2nd dose of Havrix, 1 month after the 1st dose, which led to shortening of vaccination schedule. The reporter did not consented to follow-up. No further details provided.
The day after first COVID vaccine patient noted a red area the size of her hand and warm to the touch around injection site. This lasted approximately 10 days. No other symptoms noted. Patient received 2nd vaccination 02/26/2021.
5 MIN POST ADMINISTRATION: SOB, DIZZINESS, CHANGE IN VISION - GAVE BENADRYL 25 MG AND 1 VIAL ALBUTEROL VIA NEB 1 HOUR POST ADMINISTRATION: SWOLLEN LIPS, RASH ON CHEST AND ARMS - GAVE 1 DOSE OF EPI PEN AND IM SOLU-MEDROL, CALLED EMS, LEFT TO GO TO ER BP, HR, OXYGEN STABLE THROUGHOUT
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events were possibly related to vaccination with KINRIX.  This case corresponds to a pharmaceutical product complaint.  The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX.  At the time of reporting, no additional information was available.  This is case 3 of 15 (see case IDs A0860669A, A0860688A, A0860691A - A0860702A for the other reports).
pt has rash/hives on face, neck, arms, hands & legs;no fever;no signs of any difficulty w/breathing, no pain;pt does c/o itching;
I experience muscle pain in my upper back muscles, both sides.  When I moved my head, I felp sharp stabbing pains which made me shout. I could not sleep much on March 8 evening. The pain persisted all day Tuesday March 9, 2021.  I called my ortho doctor and made a morning appointment for March 10, 2021 at 8:15am. I did not sleep much on evening of March 9. On Wednesday March 10 I went to the doctor. On this morning, the upper back muscles were OK, and the pain and spasms wer now in the neck. I could hardly move my head up or down and left and right. Dr. perscribed Methylprednazolone (4mg, 6-5-4-3-2-1 doses) and cyclobenzaprine 5mg (3x daily).  after 1 day and 1 dose, I feel I can movemy head a little farther without the stabbing pain.
2-26-21 8pm bump quarter sized to injection site, numbness and tingling lasting half an hour after taking ibuprofen, today reports itching. reports area of bump is now larger at the size of a golf ball
Patient developed chest pain and L sided abdominal pain on 5/7. Was seen by telemedicine video visit on 5/10 and was initially diagnosed with acute gastritis. He was then seen again in clinic on 5/13 reporting worsening of symptoms with additional dizziness, low BP, nausea, and unable to eat. He was tachycardic at  the time and ECG performed showing arrhythmia; pt sent to hospital via EMS where he was subsequently diagnosed with Afib RVR secondary to pericarditis.
Parent noticed yesterday. Warm itchy red and swollen 3 x 1 inch (L) arm.
pt broke out in varivax rash several days after vaccine was given. Had fever on first day of rash, fever resolved, rash still present.
6yo patient received Pfizer COVID monovalent vaccine for 5-11yo on 1/20/22 (lot # FK5127) and 2/16/22 (lot # FK5127). On 12/19/22, patient was supposed to receive Pfizer COVID bivalent booster vaccine for 5-11yo but instead received Pfizer COVID monovalent vaccine for 5-11yo (lot # GD1857). Patient's mom is informed to bring the patient back after 2 months to receive the bivalent booster vaccine. This was an administration error, no adverse event.
Patient received Fluzone HD in the right arm. She received Prevnar 13 in the left arm following the first vaccine. Immediately following administration, she announced she became light headed. She held her hed between her legs at that time. Her blood pressure and pulse dropped and she was sweating. Paramedics were called to the scene.
Fever, chills, weakness, extreme exhaustion.   Took low dose aspirin about 4 hours in.  Symptoms lasted 7 hours.
Severe body aches. Pain in the injection site. Extreme body shakes. Headaches and back pains.
Warm raised itchy reaction noticed 1 week at injection site.  From moderna covid 19 vaccine
After the 1st dose vaccine, about 20 minutes, I noticed my hands were bright red with bright red streaks. Within 1 minute, it had resolved. I called Moderna to report the adverse event. About a week later, I started to develop severe headaches and muffled hearing. This was occurring 24/7. It sounded like a machine constantly running in my head. I consulted with my doctor who prescribed a Z-pak and Flonase nasal spray. This helped a little. I proceeded to get my 2nd dose vaccine (lot number 048A21A IM RA)  even though I was having muffled hearing.   I had  even more severe symptoms with the 2nd dose. I had flu like symptoms which included night sweats, severe abdominal pain, headaches, nausea and chills. The flu like symptoms lasted 24 hours and resolved. The muffled hearing started about 1 week later and was even more severe than the 1st time around. I consulted with my doctor  and was prescribed a steroid dose Pak and within 1.5 weeks all symptoms resolved.  I do suspect that my adverse event is from the vaccine. My suspicions was confirmed when I visited my dentist and described my symptoms and my dentist commented that he knew a person who contracted COVID infection and had the exact same symptoms of the muffled hearing. Unfortunately, this person did not have successful treatment and committed suicide after a year.
Itching; 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) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "not recovered", described as "Itching". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101671141 same patient/drug, different dose, similar event.
Began to sense an abnormal taste in the mouth; Smell abnormal odors; The taste and odor are like persistent bad breath.; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN0150) via an unspecified route of administration in the left arm on 08Apr2021 at 15:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient did not receive any concomitant medications. On 10Apr2021, approximately 2 days after vaccination, the patient began to sense an abnormal taste in the mouth and smelt abnormal odours. The taste and odor were like persistent bad breath. This had persisted then ever since. The patient had been experiencing that for 5 days total as on the day of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events abnormal taste in mouth, smell abnormal odours and persistent bad breath was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt had Bruise about 4 inches in diameter. She came to pharmacy oN 9/12/21  about 2 weeks  after Receiving vaccine.  Bruise  is  healing But was large in size.
Vaccination given  in the joint of Left shoulder (Top of shoulder).  Not Deltoid Muscle as recorded. Although I did not see the location of the vaccination given at that time, the location of the bandage indicated site of vaccination given. Pain in Left arm  was excruciating for 3 days. Ice packs and Tylenol was taken but  did not help. Pain continues since vaccination was given. Spoke to nurses and physicians since the incident occurred, and all sources has stated that vaccination should not have been given in the joint but in the muscle. I am reporting this so nurse  can be corrected so that she does not cause unnecessary pain and trauma to other people.
pt had DTP/OPV/MMR/HIB on 16SEP92; mom states pt had sz (shaking & rolling of eyes) in the evening; states no fever; pt was taken to hosp;
Woke up sweaty; Achy head; Feeling off; Temperature was around 101/ My temp was 101.7 at the highest I took.; Felt fatigued; Felt some weakness; Achy; Felt some nausea; Hives on left lower arm; Hives on temple area; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of an unspecified age 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 15Mar2021 as single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 17:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient reported that "it was similar to the first dose, just not quite as bad". The time frame was very similar. On 06Apr2021 at 07:45, the patient woke up feeling off and then in another 6 hours she felt worse. Her temperature was around 101 (unspecified units), she felt fatigued, achy and felt some weakness. She napped for some time that afternoon. She felt some nausea. The patient went to bed at 18:30 and slept off and on all night. Her temperature was 101.7 (unspecified units) at the highest she took. On 07Apr2021, the next morning she could tell that she felt better although she had an achy head and felt off, but could continue some of the normal activities. She did not nap and went to bed at 22:00 and slept all night. On 08Apr2021, the patient woke up sweaty and changed tops. On 09Apr2021 in the morning, the patient felt better but still noticed an achiness in her head. The patient also had hives on her left lower arm "during this time" on an unspecified date in Apr2021 and during the first time on an unspecified date in 2021, they were on her temple area. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome for the events feeling off, fever, felt fatigued, achy, felt some weakness, felt some nausea, achy head, sweaty and hives on the left lower arm and hives on the temple region were recovered with sequelae.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
17OCT92 pt recvd vax & 20OCT92 devel h/a & stiff neck was seen by MD 21OCt92; ELISA study was performed which indicated borderline pos lyme diease titer; pt was treated w/amoxicillin;
Nauseous /Lightheaded/Fatigue /Headache/Dizziness at 3:00PM CST - took Ibuprofen 600mg and Metoclopromide 10mg
Nausea, Severe head & body aches, Severe chills, Weakness, Fever
Injection site , IM, LT, with swelling, pain, warmth and redness with an onset of 1 day.
Headache; Low grade fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Low grade fever) and MYALGIA (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0417018821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had COVID before her first dose).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (Headache), PYREXIA (Low grade fever) and MYALGIA (Body aches). On 15-Apr-2021, HEADACHE (Headache), PYREXIA (Low grade fever) and MYALGIA (Body aches) had resolved.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-060493 (Patient Link).
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may had been vaccinated with unspecified dose of GARDASIL (route, lot numbers and expirations dates not reported) which were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
4 days after COVID-19 booster vaccination developed pain in left shoulder. Initially had some redness  that resolved. "feels that joint is swollen".  Patient notes that vaccination was given "higher" on shoulder than prior vaccination. Some low grade temperature, tired - resolved
Moderna COVID-19 Vaccine EUA. Muscle soreness at injection site starting about 1 hour after and continued the day after that. Little muscle soreness on the third day.
Arm tenderness right away that progressed through the day until I could not lift my arm. The stiffness and pain moved into my back and by 7 p.m. I had chills and immense fatigue and all over muscle aches, like the flu. No headache. I did not take my temp, but had a hard time getting warm for about 3 hours, despite a heating pad and down comforter. Today--24 hours later-- I feel better, but still with a very sore arm, backache, and exhaustion. I'm not up to normal activities.
Fever or Chills  Cough  Fatigue  Muscle or body aches  Sore throat
Patient states that she developed hand and wrist pain on Saturday--both hands and wrists.  She also had a headache at that time.  Sunday she continued to have joint pain as well as a scratchy throat.  She also had a rash on both of her arms.  Patient went to patient first for her symptoms.  She had negative rapid Covid test and rapid strep test at patient first.   Got J and J vaccine 4/7.   Got menses 3/9 after taking med that GYN prescribed.  Got menses last week (Friday) also without medication.  Had a migraine also--went away with imitrex.  Saturday had another migraine--went away with imitrex.  Had mild dizziness Sat afternoon while in the kitchen.   Had been scrubbing the shower on Saturday prior to joint pain.  Works out 3x per week.   Saturday night her ankles were also sore.  Yesterday her throat was scratchy.  Hands, wrists, and arms were more sore.  Then notice all of her joints were sore.  "Even my collarbone hurt."   Rash on her arms yesterday--went away by the time she went to Pt First.  Send out COVID test was sent out.   Ankles were swollen last night also.  Hands and feet were red last night.  Knees hurt her to walk.  Patient states that her joint pain was severe last night.  Her husband had to help her transfer.  Took an aspirin last night.
pt recv vax; unable to give blood now; antilymphocyte virus on screening test;
p/ recv vax 3/98 approx 11 days later pt exp irritation around inject site & devel a vesicular lesion in the left ear
pt had inconsolable screaming for about 6 hrs following 1st DTP vax; also had fever, leg stiffening & local swelling; all sx resolved p/12 hrs;
Severe headache with nausea for 36 hours, happened 48 hours post vaccination.
FIRST HIVES HEAVY ITCHING SECOND DIZZINESS AND WEAKNESS THIRD NAUSEA FOURTH DIFFICULTY BREATHING FIFTH FEVER SIXTH COLD SHAKES OR SHIVERING SEVENTH PALE SKIN LOSS OF BLOOD IN THE FACE EIGHTH FEELING OF FAINTING NINTH EXTREME EXHAUSTION
felt dizzy; a fuzzy feeling; This is a spontaneous report from a contactable consumer.   A 65-years-old female patient received first dose of BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200) on 01Mar2021 at 14:00 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included high blood pressure. On 04Feb2021 the patient received pneumococcal vaccine in right arm. Concomitant medications included metroprolol, losartan, VITAMIN D3, psyllium hydrophilic mucilloid (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID). The patient informed that on 01Mar2011 after taking Vitamin D3-2000IU approximately 5 hours after vaccination felt dizzy and a fuzzy feeling for about 10 minutes, drank 2 glasses of water and the feeling stopped. The patient reported she had not taken the vitamin D3 since. The patient recovered from the event on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Excruciating stomach pain caused by consistent nausea and vomiting. Was admitted to hospital on 4/2/2021, was given fluids and anti nausea meds. Sent home. It continued, and we had to call to have a sepository prescribed. This seemed to take the pain away for about 3 hours. I was unable to sleep for two nights due to pain, nausea and chills. I?ve been throwing up so much I threw up a little blood. I had to go back to hospital on 4/4/2021 because I couldn?t keep anything down. I was given 2 liters of fluids, multiple rounds of different anti nausea meds, a medication that lowered my stomach acid, since my throat is on fire due to throwing up, and sent home. It?s now 10:05 pm on 4/4/2021, I?m still a little nauseous, and exhausted because lack of sleep.
On 29APR2023 I developed fever, chills, body aches, nausea. diarrhea, joint pain, headache. I had all the CDC symptoms of COVID-19 ecxept I did not loose taste or smell. My fever was one hundred and two point four (102.4) for eight hours.
On 3/1/21 at 11:00 AM I received my second dose of the vaccine Moderna. I was fine all throughout the rest of the day. Upon awakening early on the morning of the second, I had moderate aching in all joints, headache, weakness and fatigue. I stayed quiet for day. Upon getting ready to shower on the morning of the 3rd I found I was covered with an angry bright red rash from my neck down to my knees both front and back. Because I did not shower on the 2nd of March I have no idea when it began. On Thursday my head still felt pressure but felt a little stronger and that evening I again showered and the rash looked less angry and bright. Waking this morning on Friday the 5th the rash is gone and I am feeling much better except for soreness in the armpit of the right arm that received the injection.
While sitting in the observation area, patient was sitting in chair then fell forward and hit the right side of his head on the floor. Patient was turned onto his side. BP 100/58 P68 SpO2 99% on room air. Pt did not lose consciousness. Alert and oriented x3. Patient stated before he fell onto the ground, he felt "warm and zoned out." EMS activated. BP 130/90 P72 SpO2 99% room air.  water given. Sister who is legal guardian stated to cancel EMS and she would take patient to the hospital. Left facility at 1:23pm. No s/sx of distress noted.