chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in on Saturday (11/6) stating on Friday night her arm at the injection site had started to itch her. She also has a rash at the site I gave her some BENADRYL and HC 1% creams to apply to the area. I called her Sunday, the itching had stopped but rash still present.
patient had a Daptacel instead of a Adacel today in her left Deltoid IM, Standard, Immunization/ No AE; patient had a Daptacel instead of a Adacel today in her left Deltoid IM, Standard, Immunization/ No AE; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 81 years old female patient who had DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] ] (lot C5281AA, expiry date: 05-Oct-2019) via intramuscular route in the left deltoid, instead of a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], On 11-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included- PNEUMOVAX 23  It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  There were no side effects.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  List of document held by sender: none.
I experienced the expected soreness at the injection site along with headache the evening of the 27th. I awoke the following morning with pain in all my joints including my hands neck and feet. I experienced slight fever and extreme fatigue lasting 3 days and nights. At this time my headaches are on and off with lasting fatigue and continual joint stiffness and pain.  Energy level is low. Easily fatigued.  Although my condition is slightly improved from 2 weeks ago I am still not well.
Postural orthostatic tachycardia syndrome, 1 week after receiving the first dose of Moderna vaccine.; This literature-non-study case was reported in a literature article and describes the occurrence of POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Postural orthostatic tachycardia syndrome, 1 week after receiving the first dose of Moderna vaccine.) in a 37-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:    No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Postural orthostatic tachycardia syndrome, 1 week after receiving the first dose of Moderna vaccine.) (seriousness criterion medically significant). At the time of the report, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Postural orthostatic tachycardia syndrome, 1 week after receiving the first dose of Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Postural orthostatic tachycardia syndrome, 1 week after receiving the first dose of Moderna vaccine.) to be related.    No concomitant and treatment medications were reported. Company comment: This literature-non-study case concerns a 37-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) AESI of Postural orthostatic tachycardia syndrome, a week after receiving the first dose of mRNA-1273 vaccine. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 37-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) AESI of Postural orthostatic tachycardia syndrome, a week after receiving the first dose of mRNA-1273 vaccine. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
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 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; SPIRONOLACTONE. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2022) Positive, notes: tested positive for COVID on Saturday 17Dec; (22Dec2022) Negative, notes: a rapid COVID test was negative; (26Dec2022) positive, notes: on monday 26Dec a rapid COVID test came back positive; (27Dec2022) unknown results, notes: did a follow up test on Tuesday 27Dec. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical Course: Paxlovid taken that evening. Took all of the doses concluding in the morning of Thursday 22Dec, by which time my symptoms had resolved and a rapid COVID test was negative. On Sunday 25Dec my symptoms had returned (congestion, sore throat, cough - no fever) and in the evening on Monday 26Dec a rapid COVID test came back positive, as did a follow up test on Tuesday 27Dec.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
body rash, but the reason I'm letting you know is b/c it came about 5 days after my shot. It was not bad at all, like mild poison ivy, and was gone after 24 hours and 6 Benadryl pills (the max over 24 hours the pill recommends).
Patient reported feeling tired and having photophobia (sun brighter than usual/hurt to look outside without sunglasses)
This case was reported by a consumer via call center representative and described the occurrence of unwell in a female patient who received SHINGRIX for prophylaxis. 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 unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional details were provided as follows: The caller stated that she was the second person to receive the SHINGRIX injection from her local heath department and they asked her to call them back if she experienced any side effects because the first person (female) who got the SHINGRIX shot got ill. No further details were remembered by the patient. This case has been linked with cases US2018GSK153695 and US2018151874, reported by same reporter.
1 of 3 pts who exp a localized react which included swelling & tenderness; pt recovered;
Severe fatigue, muscle and joint pain, cold and chills x 3 days, could not get out of bed or work. After sx subsided was in fibro flare with joint pain and swelling, pain in all trigger points. Had to go on prednisone to function. Still on prednisone a year later--sx return every time trial a reduction or stopping steroids.
This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single, and received second dose via an unspecified route of administration on an unspecified date as dose 2, single both for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that, patient have received full vaccination and then had an exposure to COVID on an un-specified date, but didn't contract the COVID 19 infection. Mentioned the incubation was 10 to 14 days, and they were on day 12, taking care of a COVID kid. The patient and patient's wife, both exposed to COVID and did not get sick at that time. Also reported that, on an unspecified date, patient's arm was  being sore. The patient underwent lab tests and procedures which included SARS-COV-2 test was negative (Direct exposure to COVID 19 and did not get COVID). The outcome of events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up. Follow-up (17Aug2021): New information received from the same contactable consumer (patient's wife) includes: event details (new event: arm being sore).
Pt's had back pain, joint pain in elbows, hands, wrists and hips when taking medication. I have a reaction in hands and feet (they get red and sore) and also have depression.
vivid dreams; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (vivid dreams) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABNORMAL DREAMS (vivid dreams). At the time of the report, ABNORMAL DREAMS (vivid dreams) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      This case was linked to US-MODERNATX, INC.-MOD-2021-093473 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. US-MODERNATX, INC.-MOD-2021-093473:
pt recv vax & had a violent rxn of n/v,d, etc that lasted approx 1 wk;
About 5 minutes after receiving the Gardasil vaccine, I passed out. I was given water and I stayed seated for about 15 minutes afterwards.
her leg was swollen; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the leg on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient's leg was swollen. The patient who was so little and skinny was administered with the vaccine in her leg rather than her arm since it was so little. The physician thought that because the patient was so skinny, it was not a good idea to give it in the arm as there was not enough fat. It was reported that the patient was fine at the time of the report. It was also reported that the physician was planning to administer the second dose into her leg again because the patient was so skinny and little. The outcome of the event was unknown.
no additional AE; the patient received the first Rotateq dose at 16 weeks of age; This spontaneous report was received from a nurse and refers to a 16-week-old female patient. She had no past medical history and she was not taking any medications. Information concerning drug reactions or allergies was not provided. On 08-MAR-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 2 milliliter via oral route, lot # 1691300, expiry date: 24-NOV-2021, for prophylaxis (product administered to patient of inappropriate age). On the same day, the patient was vaccinated with hepatitis b vaccine, diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine 13v. At the time of vaccination, the patient had no illness. No additional adverse event was reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004634: US-009507513-1802USA002182: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692:
Rifle shooting 11/6/99 with strap for rifle secured around left arm. On 11/7/99, in pm, L/upper arm sore. On 11/8/99 pm, slight fever & generalized discomfort. On 11/9/99,"every bone in my body hurt". Used Advil & heating pad. 11/10/99 RTW.
R deltoid/upper arm swelling started 10/19/2018; hospitalized and treated for cellulitis. Follow up in office 10/23/2018 with improvement.
Redness and swelling about the size of a quarter at injection site; Redness and swelling about the size of a quarter at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 16:45 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 30Nov2021, outcome "recovered" (2021) and all described as "Redness and swelling about the size of a quarter at injection site". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  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 completed. No further information is expected.
Redness at injection site.; Itching at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route in left arm on 23Mar2021 at 00:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included psychological disorders. It was reported that the patient had some allergies to medications, food, or other products (unspecified). Concomitant medication within two weeks of vaccination was not specified. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198), via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Since the vaccination, the patient had not been tested positive for COVID-19.  On 24Mar2021, at 00:00, the patient experienced redness and itching at injection site. No treatment was received for the events. The clinical outcome of redness and itching at injection site were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sharp pain behind ear, followed by an immediate drooping of left eye lid, and left side of mouth. Tongue was also numb.  Visited emergency room due to symptoms being similar to stroke.  Diagnosis - Bells Palsy/Cranial Palsy. Treatment - Steroids.
This medically confirmed literature report (initial receipt 18-Jun-2014) concerns a 73 year old elderly male patient who had not seen a physician for the past 15 years and had never had any regular screenings performed but received annual flu shots. He had no specific trauma or other history of recent injections to his shoulder. He had no preceding infectious illness, recent travels or contact with sick people. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not specified) via the intramuscular route received at a drive-through clinic. On an unspecified date, directly after the injection and for weeks afterwards, he experienced severe local pain at the injection site and felt like he had a 'knot' in his shoulder. He never developed a rash at the injection site but about five weeks after the injection, he was not able to abduct his left arm. His other extremities were unaffected and he had no neck or radicular pain or other symptoms. On physical examination, the patient pointed to the area of pain at the midpoint of his left deltoid insertion which was slightly tender on palpitation. There was notable atrophy of the left deltoid muscle, sensory loss on the lower half of the deltoid muscle and he was unable to abduct his left arm. The patient had active range of motion of the first 1- degrees of shoulder abduction, but could not abduct beyond that. He scored a two on the Manual Muscle Test (MMT) of the deltoid, indicating poor function (25%). Passive flexion of the shoulder was normal. Flexion and extension of the forearm and rotatory movement of the shoulder were normal. Deep tendon reflexes for his bilateral biceps brachii, brachioradialis and triceps were all normal and symmetrical (2+ grade). Other than elevated blood pressure, there were no other abnormal findings. The patient reported shoulder pain and abduction weakness for eight weeks following intramuscular flu shot. The patient was diagnosed with injection-induced traumatic axillary nerve injury. He declined to undergo further diagnostic testing. He was treated with analgesics and occupational therapy, including passive and active range of motion exercises. At one month follow up, his deltoid muscle showed slight improvement in contraction, sensation, atrophy and pain. At six weeks after initiation of occupational therapy, the therapist reported greatly improved flexion - he was able to achieve 120 degrees of active left shoulder flexion in a seated position with a MMT score of 4 which indicated good function (75%). Outcome was recovering. Reporter comments: The reporter stated that the finding suggested that the patient experienced axillary nerve injury by direct needle trauma. The authors hypothesised that the likely site of injury in the patient was the anterior branch of the axillary nerve.
Allergic to Hep vax, appears like rheumatoid arthritis, conjunctivitis, dehydrated, emotional trauma encephalitis like sx, enlarged joints, enlarged lymph glands, face eczema, flat irregular red rash, GI upset, hypoxemia; Detailed see WORM
Small rash on back of arm where Covid-19 vaccine was injected that progressed to hives all over body; Small rash on back of arm where Covid-19 vaccine was injected that progressed to hives all over body; it is sometimes itchy; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6198; Expiration Date: Jun2021), via an unspecified route of administration, administered in Arm Left on 22Feb2021 between 12:30 or 12:45 (at the age of 37-year-old) as DOSE 2, SINGLE for covid-19 immunisation (Work in education). Medical history and concomitant medications were reported as no. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 01Feb2021 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation and had no issues with it. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations received within 4 weeks. No AE(s) following prior vaccinations. On an unspecified date in Feb2021 (24Feb2021 or 25Feb2021, 2-3 days after receiving her second dose), the patient experienced small rash on back of arm where covid-19 vaccine was injected that progressed to hives all over body, it is sometimes itchy. It was reported that patient had covered in hives for the last 2 months. Reported that the rash was a kind of migratory and sometimes itchy in her legs, then her back, then her stomach, and then her arms. Patient visit physician office for events. The patient underwent lab tests and procedures which included blood test resulted as negative for a fungal infection or contact dermatitis, laboratory test which result was pending to check for autoimmune conditions, an allergy to the RNA pattern of the Covid-19 vaccine, and if the caller's natural histamine blockers have been shut down. The outcomes of events were not recovered.  Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.
Shortly after 3rd  HPV vaccine developed extreme fatigue, weakness, headache  2/26/09 Received hospital medical records of 8/6-8/7/08. FINAL DX: generalized weakness, intermittent spisodes of dyspnea & HA s/p vaccination Records revea patient experienced weakness, fatigue x 3 weeks.  Had been eval at outlying ER & PCP referred to higher level of care for concerns of GBS.  Neuro consult WNL & referred to PCP on d/c to home.  2/27/09 Received ER records of 8/5/08. FINAL DX: HA, malaise, fatigue Records reveal patient experienced weakness, anxiety, dyspnea, possible medication reaction x 2 wks.  Currently on meds for UTI & PUD.  9/23/08 Reviewed PCP medical records of 1/2/08-8/8/08. FINAL DX: Records reveal patient experienced good health day of first HPV vaccine.  Developed UTI & low back pain, tx w/antibiotics.  On 7/2 vs, c/o stomach pain & burning, nausea.  RTC 8/8/08 w/extreme fatigue, HA w/photophobia, weight loss, jaw pain.  Tx for H. pylori infection.