chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; extreme fatigue; body aches; low grade fever around 99-100 Fahrenheit; This is a spontaneous report from a contactable Nurse. This 40-year-old female Nurse reported for herself: A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3246), via intramuscular, administered in Arm Left on 20Jan2021 (at the age of 40-year-old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from 2009 and ongoing. Patient's family history reported as none and no relevant test was performed. The patient's concomitant medications were not reported. Patient was not received any vaccine on same day of Covid-19 vaccine. Patient was not received any other vaccine four weeks prior vaccination. Patient said that she had a little bit of effects after the first dose and even her flu vaccine. Patient clarified that with the first dose she had a sore arm, extreme fatigue, body aches, and a low-grade on 21Jan2021, fever around 99-100 Fahrenheit for about 6-8 hours the next day. Adverse events not required visit to Emergency room or Physician Office. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL0142), via Subcutaneous, administered in Arm Left on 10Feb2021as single dose for covid-19 immunisation and experienced the adverse event almost sure it was administered Subcutaneous on 10Feb2021. The patient underwent lab tests and procedures which included body temperature: around 99-100 Fahrenheit on an unspecified date. The outcome of the event low grade fever around 99-100 Fahrenheit was reported recovered on unspecified date in Jan2021 and all others were unknown.  Follow-up attempts completed. No further information expected.
Light headedness, dizziness, heavy feeling and throbbing in affected arm. Treated with Benadryl 50 mg PO.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were unknown. It was unknown if the reporter considered the fever and vomiting to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Monday at 17:00 pm (no exact date provided), the patient received SHINGRIX. On Tuesday (no exact date provided), the patient experienced intractable vomiting wished described as she could not stop vomiting. The patient went to an emergency care facility for treatment. The patient did not provide any additional information outside of what has been documented in this report. The patient had denied permission to contact their physician. The reporter did not wish to complete adverse report, she felt that GlaxoSmithKline would be getting more from her, than she would be getting from them. No lot or expiry date of SHINGRIX was provided. The patient did not wish to provide a street address.
Will started having a fever and cough 5 days following vaccination. Cough prolonged into croup the following day. By 4th day, he was floppy, blue, lethargic, unresponsive. Trouble breathing, wouldn't eat or drink. Fever of 102.3
Headache  left arm pain radiated to neck and shoulder, left armpit radiated to inner arm to elbow  Narrative:
3x4 inch red area on left deltoid, warm to touch,, no lesions, no fever
Pt reported a prior reaction with first dose of Moderna received on 07 APR 2021.   Following 1st dose she experienced dizziness, blurred vision, nausea and MS changes of slow speech and decreased responsiveness.  She was transported from vaccine clinic site to ED. No epinephrine was given, she was treated and released to home.  Reported sx continued 3-4 hours after and then improved. Pt verbalized consent for vaccine, educated on what to expect .  Directed to back room for closer clinical observation post vaccination.   1035: c/o dizziness, feeling warm, tired, feel very heavy, like I want to go to sleep." Denied SOB, difficulty breathign, no wheezing, dyspnea, urticaria, erythema.  B/P: 1127/75, HR 70, 99% SPO2 RA. Vital signs monitored for next 20 min.  1040: 115/78, 99% RA, 70, 0/10 pain 1045: 114/74, 100% RA, HR 63, 0/10 pain 1050: 111/80, 100% RA, HR 59. Pt drowsy, less alert than baseline. Oriented to person, place and time. Delayed in responding to questions, appeared to have to focus to find answer. Stated "feel like I am waking up from anesthesia", speech slower than baseline. She denied SOB, urticaria, no erythema/rash noted.  Discussed disposition and options for further evaluation by EMS. Pt responded she slower to respond to questions.  Pt reported a prior reaction with first dose of Moderna received on 07 APR 2021.   Following 1st dose she experienced dizziness, blurred vision, nausea and MS changes of slow speech and decreased responsiveness.  She was transported from vaccine clinic site to ED. No epinephrine was given, she was treated and released to home.  Reported sx continued 3-4 hours after and then improved. Pt verbalized consent for vaccine, educated on what to expect .  Directed to back room for closer clinical observation post vaccination.   1035: c/o dizziness, feeling warm, tired, feel very heavy, like I want to go to sleep." Denied SOB, difficulty breathign, no wheezing, dyspnea, urticaria, erythema.  B/P: 1127/75, HR 70, 99% SPO2 RA. Vital signs monitored for next 20 min.  1040: 115/78, 99% RA, 70, 0/10 pain 1045: 114/74, 100% RA, HR 63, 0/10 pain 1050: 111/80, 100% RA, HR 59. Pt drowsy, less alert than baseline. Oriented to person, place and time. Delayed in responding to questions, appeared to have to focus to find answer. Stated "feel like I am waking up from anesthesia", speech slower than baseline. She denied SOB, urticaria, no erythema/rash noted.  Discussed disposition and options for further evaluation by EMS. Pt responded she slower to respond to questions.  EMS to be called. Pt stated stated difficult to breath, HOB
I had ringing in my right ear starting the night of getting the shot (has not stop, but is not as bad now as first day). I had muscle pain in my left leg initial (night of shot, but was gone by next day) However, it does reappear occasionally. I had stomach pain the first night as well. This pain seemed to disappear for awhile only to return and it come with nausea now. My heart rate from time to time is elevated without doing any strenuous activities. Today is one of those days where it seems if I can hear my heart beating.
Caller states that 3 days or 48-36 hours after the dose he broke out into whelps on his back; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that that 3 days or 48-36 hours after the dose the patient broke out into whelps on his back on an unspecified date in Jul2021. The patient was seeking information about if he should get the second dose or not? His family doctor advised him against it. The outcome of event was unknown.      The lot number for BNT162b2 was not provided and will be requested during follow up.
Post vax, the patient presented with chicken pox on 11/24/2000. The patient had "postulates/lesions, and a modified case of chicken pox, and her temperature ran 99-100F. The patient was cleared to return to school. No further information is available.
head trauma; phobia of needles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient 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: HEAD INJURY (medically significant), outcome "unknown", described as "head trauma"; FEAR OF INJECTION (non-serious), outcome "unknown", described as "phobia of needles".  clinical course:Caller states she is calling regarding the pill that they had advertised on TV. She states that she works in (Hospital Name withheld) and she had asked them about if they have a pill out for taking the vaccine, a pill for the booster. She states that she wants to find out because she has a phobia of needles. She has a phobia that she will start flailing and screaming and running. She took the 2 shots and had to have Xanax to try and calm down, it was still not enough. She wants to know if she could probably take the pill so that she can do her third shot. Was unable to clarify the name of the pill the caller was referring to. Caller states she did not know the name of the pill. She states there is a pill for the Pfizer that she wanted to take for the booster shot. Clarified that the booster shot the caller was referring to was the Pfizer booster shot for Covid. She is really wanting to know because she would rather take pill then the shot. She states that she has had head trauma. She would rather take the pill than go to a public place and go to the store. They are telling them they have to go to (Facility name withheld) to take the shot. Caller states she does not really have anybody there or somebody to hold her down.  She wanted to know where she could go to take the pill. Caller was advised to check with her state or local health department regarding vaccine locations and to consult with her primary care provider. Caller states she will try to see her primary care doctor. She states she is really anxious to take the shot and she just wants to get this over with.  The lot number for bnt162b2 was not provided and will be requested during follow up.
1st on 17-Feb-2022, another on 24-Feb-22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Concomitant products included HAV (Havrix).   On 24th April 2022, the patient received Havrix. On 24th February 2022, unknown 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 Information: GSK Receipt date: 28-APR-2022 Reporters comment: The patient received first dose of Havrix on 17th February 2022 and another dose on 24th February 2022.  Healthcare professional did not want to provide neither personal or the patients information or demographic. The reporter consented to follow up. Additional supportive information: The patient received booster dose of Havrix earlier than the recommended schedule which led to shortening of vaccination schedule.
Lost use of both my arms and hunching over when upright:  began in left arm, travelled across my back to my right arm; CPK numbers at 5000 when I went to hospital; right arm swelled up.  I believe the ensuing colon resection is related.  However, treatment for arms was IV fluids and occupational and physical therapy in-patient and out-patient.  I do not have 100% use, but close.
redness that is kind of blistering to one foot; he had GI problems the week of getting the shot; had diarrhea for a couple days that went away; joint pain; his skin is all deformed; covid toes; redness that is kind of blistering to one foot; This is a spontaneous report received from a contactable consumer or other non hcp. A 62-years-old male patient received 1st dose of bnt162b2 (Pfizer COVID 19 vaccine,Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Right on 28Feb2021,at the age of 62 years old, as Dose 1,single for covid-19 immunization.Medical history included lower limb fracture from Sep2020 to an unknown date Verbatim: Broken leg , diabetes mellitus from Aug2020 to an unknown date Verbatim: Diabetic and diabetic neuropathy from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient experienced covid toes on an unspecified date, redness that is kind of blistering to one foot  on Mar2021, redness that is kind of blistering to one foot, he had gi problems the week of getting the shot, had diarrhea for a couple days that went away, joint pain and his skin is all deformed on an unspecified date.Therapeutic measures were taken as a result of redness that is kind of blistering to one foot ,had diarrhea for a couple days that went away.The outcome of the events was unknown.Caller reports covid toes since he got his 1st shot 3 weeks ago on his broken leg, for which he had surgery. He also reported that he is a diabetic.The patient received treatment with Kaopectate for the diarrhea and Gold Bond Diabetic Lotion on the blistering, no further details provided about his lotion. Follow up(18Mar2021) This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported about the treatment received for diarrohea and blister.  No follow-up attempts are possible. No further information is expected.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter. No treatment information provided by the reporter. It was reported that the Moderna vaccine pulled from the freezer on 13-OCT-2021 with a use by date of 12-NOV-2021 (30 days storage viability in the fridge).   This case was linked to MOD-2021-364614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up document received on 28-OCT-2021 contains no new information.
1st dose 13May2021 2nd doce 25May2021; T cell reaction; RUE Sever Redness; pain; This is a spontaneous report from a contactable Nurse (Patient). This nurse reported for herself in response to HCP letter sent in cross reference case which included that a 43-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Right Upper Arm on 25May2021 at 07:30 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing GERD, ongoing thyroid, Hypo, ongoing Mild HTN, ongoing seasonal allergies, EGD from Jan2021 to an unknown date. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0162), via Intramuscular route of administration, administered in Upper Right Arm on 13May2021 at 09:30 (at the age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced lip and right cheek got very tingly/tingling in cheeks and lips, numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips went numb/numbness was all over her face bilaterally/numbness tongue down her throat, concerned about signs of Bell's palsy, pounding headache, lightheadedness and dizziness, severe left ear pain which was Important medical event as seriousness criteria which required to visit physician office and emergency room and received treatment with prednisone taper dose x days with outcome recovered on 25May2021. On 25May2021 at 07:30, the patient experienced 1st dose 13may2021 2nd dose 25may2021, t cell reaction, rue sever redness, pain. Events required to visit physician office. On 13May2021 the patient underwent lab tests and procedures which included non-fasting glucose resulted as 117, magnesium, TSH, BMP all resulted as normal, CBC: Lymphocytes absolute 3.30 H. Therapeutic measures were taken for events with Clobetasol. The outcomes of events were recovering.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Pt mother called 8/23/03 and states right leg swollen, red, size of hand. Dr was not in office. Sent to hospital.
28JUN95 2nd immun mom reports on prev immun pt had constant crying for 4-6hrs;unconsolable;
Patient noted left sided facial numbness, tingling, left sided facial droop.  Diagnosed with Bell's palsy
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site swelling were recovered/resolved and the outcome of the injection site erythema and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness, swelling and pain at the administration site. Symptoms began the day of vaccination. The patient experienced flu-like symptoms for a few days following the vaccine. Actually the patient had to leave work and go home to bed. At the time of this report, the swelling went down but redness and pain persisted. The reporter agreed to be followed up. This case has been linked with US2018GSK152346, reported by same reporter.
Burning and itching hands and feet,  hives on face and neck, still have symptoms  Taking Ceterizine 10 mg daily
Extensive dural venous sinus thrombosis, SAH, acute ischemic thalamic infarct. Headache, lethargy, diplopia, right arm weakness
Patient had generalized urticaria with several itchy raised blotches present on arm and torso.
After about 4 hours patient's throat began to swell, eyes were swollen, lips swelled.  She took oral BENADRYL and went to her home town ETC where she wa given IV BENADRYL.  Swelling subsided completely after 3 days.
Urticarial rash. Prednisone, Zyrtec, Zantac. Follow-up with primary physician if continues. Follow-up sooner for any worsening. Patient understands to stop prednisone if fever develops.
Pt devel inc temp 31JAN91 & 1FEB91 t104.8 & 2FEB91 temp back to 104.8; Taken to MD office fever would not go down; Had sz in MD office; Admitted to Hosp 2FEB91 stayed overnight; MD stated due to ear infect;
Patient received DTaP (Lot U1029DA) in the right anterior thigh IM on 4/6/04.  Patient presented in office on 4/7/04 with redness and swelling of entire right thigh.
Pt given FLUZONE flu shot. Approx. 20 minutes later felt faint, became pale, diaphoretic. Feet elevated, ice packs used. Symptoms lessened. 10 minutes later symptoms returned x 2. BP 70/40 P 64. Decreased alertness pt laid down BP increased to 90/60. Pt returned home felt fatigued began fever 104, vomiting, nausea saw physician 11/2/11.
I felt great and had no left home the week prior to vaccine as I work from home and my husband was off. My son was home with us as well. None of us had a cold/virus. I went to the vaccine clinic, received first pfizer and 6 hours later the dizziness, nausea, severe headaches started. After 5 days I had to go to ER because I was still so sick. They did blood work and gave me fluids. Thursday, 9 days after vaccine, I went to PCP as I was still so sick. I could barely work part-time at work 4 hours a day due to severe dizziness and headaches. Today is Saturday, day 10 and I still have dizziness, nausea and severe headaches.
giving the wrong dosage of the Pfizer Covid 19 vaccine 4 to 11 years old/Covid vaccine it was the 5 to 11-year-old dose; This case has been considered invalid as Unspecified AE.  This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID: (004756; 159558).  A young patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (orange cap), 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: INCORRECT DOSE ADMINISTERED (non-serious), described as "giving the wrong dosage of the Pfizer Covid 19 vaccine 4 to 11 years old/Covid vaccine it was the 5 to 11-year-old dose". Additional information: The verbatim of the caller was, it was the Covid vaccine it was the 5 to 11-year-old dose.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.  Follow-up (03Feb2023): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included:  Updated information included: dose description updated. The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.
Received the vaccine Saturday am 3/20/2021.  Saturday pm had numbness in right foot that lasted a few minutes.  Headache off and on started Sunday 3/21/2021.  No medication taken for headache.  On Tuesday evening 3/23/2021, driving home from work had a sensation of something being wrong.  After arriving home at 7 pm had a short term memory loss.  Could not remember details of the day, for instance, or that he'd already had the Moderna shot three days prior.  Was driven to the emergency room at about 9:30 pm.  Memory gradually improved over the hours following the spell.  They kept him in hospital until 3/25/2021, doing tests to rule out stroke, seizure, brain tumor etc.  All tests came back negative.  Was diagnosed with Transient Global Amnesia.
Began as a dull ache within 24 hours. Within days, pain became worse. Consistently a dull ache with intermitted sharp pain depending on movement of arm. After a month, the pain is still consistent as previously stated. Went to local Urgent Care on 10/30/19 for consult and was advised to seek Physical Therapy.  Physical Therapy on 11/13/19 for short term plan with exercises to perform at home. Following visits are pre-scheduled for 11/18/19, 12/4/19 and 12/11/19. Acetaminophen (650 mg) without any relief.   This effect has limited my ability to complete simple daily functions as self dressing and grooming. Difficulty sleeping too because of too much discomfort.
Injection site induration, "Swelling in the Deltoid Area where shot was given 2.5"x2.75"; Redness, itching, hot and hard to the touch. The redness and hardness spreading.
Patient had swelling at injection site (golf ball size or larger) for one week. Swelling then resolved without treatment.
pt recv vax & 3 to 4 days following vax testing revealed GGT 47 & RPR in the rang of 1 through 8;