chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of 2 reports. This consumer reported for a male patient. A male patient, of unspecified age, received unknown dose number of of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot#unknown, expiration date: unknown), via unspecified route, administered on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date, after the vaccination, patient experienced chills, aches, pain, a little fever and etc. The events assessed non-serious, with outcome of unknown. No follow-up attempts possible. No further information expected. Follow-up (Apr 2, 2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. Sender's comments: Linked report(s): INC-2021204977; same product and events, diferent patient
about 8 hrs. after the shot I contracted a fever, vomited, bowel movement, runny nose, at same time, felt as though i had the flu vert tired, and weak. could not eat or drink afterwords, went to bed, slept ok. got up this morning feeling like a "a train ran over me" now eating and recovering like I had the flu.
Approximately 18 hours after the shot, I had a near syncope event. My arms and legs became weak and heavy. My limbs still have not recovered their strength. I cannot be left alone because of near syncope events and I cannot stand long enough to make food or shower by myself.  I have had 6 more near syncope events, two of which landed me in the ER. About a week after the shot, I developed moderate vertigo with nausea and a worsening of tinnitus in my right ear. The tinnitus has returned to normal as of today, so far. The vertigo is decreasing slowly.  I am still nauseous, especially first thing in the morning. I still have limb weakness and shaking. The intensity waxes and wains. I check my blood pressure multiple times a day, especially when feeling light headed or faint.  Most of the time it is in 100-115/ 60- 90.  The worst near syncope episodes were 102/56 and 108/60, respectively. Blood sugars within normal range. Oxygen between 97-99% and pulse between 80-95 bpm.   Currently, I am on a 30-day event monitor for my heart. My doctor has prescribed a low blood pressure medication, 2.5 mg of midodrone, but haven?t taken it out of fear.
Information has been received from a healthcare worker (certified medical assistant (C.MA)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 19-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The patient states 5 days after the vaccination the bottom half of her left arm from elbow to hand was painful and had trouble moving her hand. The next day it was her entire arm and had some reaction at the site of injection. She then went to the doctor and the doctor gave her shot that was describe to her as liquid benadryl but she is not sure it was benadryl. Then a predinsone taper.  At the time of reporting to me the patient states she has from her elbow to shoulder on upper arm.
started fever about 4PM-8PM 102; 10PM-102, 11PM -103, 4AM 104.6 & vomiting; was taken ER-treated w/APAP suppository & sent home w/directions on use of suppositories & instructed to watch;
Information has been received from a physician via Pfizer Inc. (manufacturer control # 2016275305) referring to a currently approximately 18 years old female patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unknown date (reported as "years ago"), the patient was vaccinated with varicella vaccine (manufacturer unknown) (lot #, expiration date, strength, dose and route were not provided). Other suspect therapy included FLUMIST (lot#, dose and route were not reported) on an unknown date. On an unknown date the patient experienced anaphylaxis and had to be put in an ambulance and later recovered. Later on an unspecified date, the patient went to an allergist and was determined to be allergic to gelatin. The physician stated one of the vaccines, she could not remember if it was varicella vaccine (manufacturer unknown) or FLUMIST, contained gelatin. The causality of the event was not provided. Upon internal review, anaphylaxis was considered to be medically significant. Additional information has been requested.
Initial unsolicited report received from a consumer on 07 April 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of IMOVAX (batch number, expiration, site and route of administration was not reported) on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination the patient experienced high temperature on and off, was not getting better and felt hurting. Lab data was not reported. The patient received corrective treatment with pain medications which she felt were not working. Patient was not yet recovered from the event. List of documents held by sender: none.
his lower body (lower back, hips, legs) are ach; his lower body (lower back, hips, legs) are ach; his lower body (lower back, hips, legs) are ach; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (47: Age, Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 2, single for COVID-19 immunization. The patient's medical history included Type 1 diabetes. The patient's concomitant medications were not reported. The day after getting second dose of Pfizer COVID-19 vaccine, his lower body (lower back, hips, legs) are achy. Event took place after use of product. Reporter does not wish to be contacted for follow-up. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sudden dermatographism occurring mostly on upper body. This is a condition I have never had before. Wheals present after skin is stimulated - the site(s) then become itchy for approximately 10-30 minutes before subsiding.  Currently treating with 20mg Zyrtec per day.
After about 12 hours my arm at injection site became sore but this happened on the first dose.  When I woke up the following morning my arm was still hurting.  I felt my arm and it had a  large,  red, hard, lump and was warm to the touch.  Today, three days later it is now itchy.  I looked it up on line to see what I should do so I am now taking an  antihistamine along with the Ibuprofen I was already taking.  The area affected is between 6 and 7 cm.
Shingrix vial for reconstitution did not have powder tablet within the vial. This is the second vial we have received like this.
Side effects of lethargic; Body aches; Headache; Awful for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of lethargy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced lethargy, general body pain, headache and feels awful. On an unknown date, the outcome of the lethargy, general body pain, headache and feels awful were recovered/resolved.   It was unknown if the reporter considered the lethargy, general body pain, headache and feels awful to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced side effects of lethargic, body aches, headache and awful for 3 days.  The patient stated that after he/she was seeing people suffer from shingles it was totally worth it. Additional supportive information: The follow-up would not possible as no contact details were available.
flu; Initial information received on 30-Nov-2022 regarding an unsolicited valid social media non-serious case received from via consumer/non-hcp.  This case involves patient of unspecified demographics who experienced flu while receiving vaccine Influenza Vaccine (flu shot).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for flu vaccination.  Information regarding batch and expiry date requested.  On an unknown date, the patient developed a non-serious flu (influenza) at unknown latency following the administration of Influenza Vaccine.  It was reported that "I got flu shot and still ended up getting the flu".   Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the event flu.
Narrative:  He alerted staff to his throat feeling itchy/tight about 17 minutes post vaccination. On further evaluation, patient notes that he felt throat itchiness/tightness a/w some difficulty in swallowing almost almost immediately after the vaccination - a/w mild lightheadedness. While this started to improve during he wait time, it had not resolved prior to him leaving - which prompted him to alert staff. Prior to full evaluation, he denied known allergies and had no known  contraindications to diphenhydramine. Advised diphenhydramine 25 mg po x1, which he was able to take with water w/o difficulty. Patient w/o issues s/p initial vaccination other than general fatigue and injection sit tenderness. No prior similar response to past vaccination. He denies itchiness, urticaria, flushing,  palpitations, nausea, abdominal cramping, or feeling the need to vomit/have diarrhea. O: T 97.7F (after drinking cool water) BP 129/83 HR 65 RR 12 SpO2 99-100% on RA Gen: non-toxic, not in distress, answering questions appropriately, pleasant, well groomed, speaking in full sentences w/o increased respiratory effort HEENT: atraumatic/normocephalic, PERRL, nares patent, throat non-erythematous/no swelling Neck: no swelling, no stridor CV: regular rate and  rhythm, normal S1/S2, no murmurs Pulm: clear to auscultation bilaterally with no wheeze Ext: moves all 4 spontaneously, no edema Skin: no visible erythema,  lesions or rashes Neuro: CN III-XII grossly intact, 5/5 strength UE and LE Psych: appropriate, thoughts linear and non-tangential A/P: 28 yo pt with concerns  for throat itchiness/tightness indicating potential immediate allergic reaction post 2nd COVID vaccination. Complaints continued to improve during examination/interview post administration of diphenhydramine and he felt well enough to leave clinic to return home (no major plans for the rest of the day). He was able to consume water during examination and swallowed w/o difficulty.  Plan at this time: *ER precautions discussed at length, emphasis places on reasons to seek care for angioedema and immediate allergic reactions *Recommended referral to allergy (can be done over phone) for evaluation as he may potentially benefit from pre-/post-tx if booster is needed in the future. Reviewed that this referral is not time sensitive given that the need for a booster is still being evaluated. He is amenable to allergy referral, which will be placed *Discussed rx of steroid burst pack to have on-hand to a/w sx in case concerns do not completely resolve in the next few hours, which patient politely declines
positive COVID-19 test; positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The patient had a positive COVID-19 test on an unspecified date and started COVID-19 treatment with Paxlovid from 16Dec2022 to 20Dec2022. After four days of negative tests, the patient had a positive COVID test on 25Dec2022. Outcome of the events was not recovered.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Frequent crying, gassiness, difficulty sleeping (wakes up every 5-15 minutes, increased tone (twisting and turning). Seen by collegue 7/15, noted to be fussy but consolable, normal tone.
Approximately 15-20 minutes after vaccine administration pt described itching on his left index finger, hand, & shoulder, as well as pain in his lower left back.
Severe pain at injection site.  High fever not responding to acetaminophen and ibuprofen.  Body aches/pains.  Excessive sleepiness.  Headache.  General malaise.  Dizzy/
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Itchy peeling eyelids Itchy peeling lips, worsening to include area @mouth.  Blister-like redness and irritation on tongue.  Lips and tongue tingly.
pt recv vax10AUG98  215PM & 11AUG98 began @ 1130AM c/o goose bumps, very cold, shivering, no fever & extremely tired;c/o soreness rt arm Td site, tingling sensation in rt arm that comes & goes;no vomiting/v not having much appetite;
not able to move his arm; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (not able to move his arm) and MYALGIA (soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (not able to move his arm) and MYALGIA (soreness). At the time of the report, PAIN IN EXTREMITY (not able to move his arm) and MYALGIA (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No irrelevant concomitant medication were reported
he was looking at his immunization record and they put the same date that he got his vaccine as the date that it expires.; redness, tenderness, and soreness at the injection site; redness, tenderness, and soreness at the injection site; redness, tenderness, and soreness at the injection site; This is a spontaneous report from a a Regulatory Authority. A contactable consumer reported for a 41-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 24Jun2021 (Batch/Lot Number: EW0180; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included BNT162B2 (Dose: 01, No events reported.) for Covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced he was looking at his immunization record and they put the same date that he got his vaccine as the date that it expires. (circumstance or information capable of leading to medication error) (non-serious) on 24Jun2021, redness, tenderness, and soreness at the injection site in Jun2021 , red-ness, tenderness, and soreness at the injection site in Jun2021 , redness, tenderness, and sore-ness at the injection site in Jun2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Caller was given the following information from the PI: Across both age groups, 18 through 55 years of age and 56 years and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. Customer given expiration of lot number EW0180 as given but (Withheld) from Pfizer Customer service: 31Aug2021. The outcome of the events was unknown.Information on the lot/batch number has been requested.
SEP97 onset of cont nausea & thoracic neuralgia-no lesions noted;neurologist can find no other explanation or reason;
Narrative: Patient called to report itching of head, neck, arm on 5/18/2021 after  2nd dose of vaccine 5/11/2021. Onset not stated. Difficulty calling patient back--  on 5/20/21 the patient reported the itching was improved. Diphenhydramine or  cetirizine OTC was offered to the patient.
High Fever: Patient began running 102 fever 2 hours after vaccine. Fever spiked to 104.3 called Dr and they said to treat with MOTRIN and TYLENOL every 4 hrs. Fever would not come lower than 102. Irritability. Refused to eat baby food/table food. Stomach felt hard like it hurt him. Screaming/crying fits like he was in pain. These would last 15-30 minutes nothing to console him. He had NEVER done this before.
Client tested positive for COVID-19 by rapid test on 1/8/21.  On 1/9/21 at 1405 his oxygen saturation dropped to 86% and oxygen was initiated at 2L per nasal cannula.  A non-productive cough was noted on 1/10/21 and oxygen was increased to 3L.  On 1/12/21 Client became non-responsive with 30 second periods of apnea.  Dexamethasone was initiated on 1/13/21.  Lung sounds were noted with crackles on 1/15/21 at 1158 and at 2120 Client was unresponsive and without vital signs.  Orders were for DNR and CPR was not initiated.
Fatigue, General Malaise, Brain Fog, Post Exertional Malaise, POTS
I didn?t see her because she is away under medical leave. After the flu shot, she complaint of a lot of pain on her left arm and went to see her doctor (she has fibromyalgia)
Sore and itchiness around the injection site. Blotches of red spots from the injections site spreading down town elbow. Arm sore and painful. Arm at injection site  was colder than rest of arm (93.5 degrees vs 97 degrees).
This is a spontaneous report from a contactable consumer who reported for himself. A 73-year-old male patient received PREVNAR 13, via an unspecified route of administration in the left arm on 17Mar2016 10:00 at 0.5 ml, single. Medical history included blood pressure abnormal, ongoing atrial fibrillation, he had to go to hospital to have an ablation. Concomitant medications were not reported. The patient received pneumonia shot and a couple days after he developed an inner ear infection and ringing and buzzing in his ear. The patient was admitted to hospital for this last event. The patient received AUGMENTIN for 10 days. He was wandering if the shot has caused this. The outcome of the events was not resolved. Follow up (03May2016): additional information received from the contactable consumer includes ringing and buzzing in his ear added as adverse event. Hospitalization added as criteria of seriousness. Case upgraded to serious. Follow-up attempts completed. No further information expected.
Headache, body aches, fever, chills, nausea began day of vaccination. 4 days later still nauseous and diarrhea and mild abdominal pain began.
Initially dramatic lymphadenopathy supraclavicular then secondary lymphadenitis with staph aureus.
Patient complained of dizziness after receiving the Pfizer COVID vaccine. He sat in the chair for 5 minutes (according to the vaccinating pharmacist) and proceeded to leave. A couple minutes later, he was laying on the ground. I was informed that he just received a shot. I checked his pulse and he had a pulse. I elevated his legs and put an ice pack on his forehead. He proceeded to open his eyes after about 1 minute. He stated he felt dizzy and sat down. He then laid down because he was afraid he was going to fall. We called 911 and they provided care for him.
Mom states she gave 2 routine doses of APAP p/vax; Pt woke @ 2AM w/104.4 temp, cool sponges, pt had to be consoled otherwise cried;
PATIENT LIED ABOUT GETTING JANSENN VACCINE PREVIOUSLY AND PRETENDED TO BE GETTING HIS FIRST COVID-19 VACCINE ON 7-24-21. FOUND OUT LATER AFTER PROCESSING THE FORM THAT THE PATIENT HAD ALREADY RECEIVED THE J&J VACCINE.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), exposed to -11.8C for seven hours. No adverse effects were reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This morning her eyes were full of mucous and right was filled and it was shut. Mother got her ready for daycare and noticed a big red bump (3) swollen in left leg upper thigh area. Mom called Dr and took her into school. They called back after message was left. Over the phone they told mom to give her Tylenol if she runs a fever, give Benadryl if she scratches it and put Calamine lotion on spots and keep her home until it crusts over. Then mom picked her up immediately. She didn't give her daughter anything