chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This 39 yo ADSM received her first Pfizer covid vaccine lot# ER8727 to left deltoid on 3/19/2021. She advised she had no illness prior to vaccine. On day 2 3/21/21 her left shoulder was sore at collar bone where she has had pain on and off ever since her SPV (3/10/2010). That lymph node gets very sore whenever sick or gets flu shots. She describes site as very tender to touch, node is mobile-but hurts to move, and she notes site swelling w/o redness. She states this pain causes her shoulder to hurt and creates a "vice grip about her chest" that started on left but radiated to right upper chest. This caused SOB and difficulty inhaling due to pain. She tried relaxation techniques and maybe one TUMS for mild reflux and   This 39 yo ADSM received her first Pfizer covid vaccine lot# ER8727 to left deltoid on 3/19/2021. She advised she had no illness prior to vaccine. On day 2 or 3/21/21, her left shoulder was sore at collar bone where she has had pain on and off ever since her SPV (3/10/2010). That lymph node gets very sore whenever sick or gets flu shots. She describes site as very tender to touch, node is mobile-but hurts to move, and she notes site swelling w/o redness. She states this pain causes her shoulder to hurt and creates a "vice grip about her chest" that started on left but radiated to right upper chest. This caused SOB and difficulty inhaling due to pain. She tried relaxation techniques and maybe one TUMS for mild reflux and Excedrin for headache. This discomfort continued and on 3/19/21 she called medical and was sent to local ER. In ER she c/o sharp radiating chest pain to left upper chest radiating to neck, making it difficult to breath and episodic palpitations. She advised ER that she experienced similar discomfort on and off for last several years. Her exam was normal with following studies were all normal: EKG, CXR, labs-troponin, tsh, t4, lytes, cbc w/diff, and lipase. A CT chest w/contrast showed normal chest, heart, arteries and listed diagnosis of possible mild bronchitis and cholelithiasis. Her D-dimer was mildly elev at 0.55 (0.27-0.50). Providers gave cardiology referral and released w diagnosis of atypical chest pain and palpitation. No medication was prescribed.
Administer expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion.  Total of 102 doses/vials were given for LOT  026C21A. Date the vial was initially stored in the refrigerator was reported as unknown. The expired date for the product was 24Oct2021. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document contain non-significant information was updated.
Vial was stored in the refrigerator on 11-Jan-2022, and administered on 04-May-2022; patient received expired dose more than 30 days after 11-Jan-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose more than 30 days after 11-Jan-2022) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 11-Jan-2022, and administered on 04-May-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 001B21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose more than 30 days after 11-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 11-Jan-2022, and administered on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired dose more than 30 days after 11-Jan-2022) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 11-Jan-2022, and administered on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medications was reported.  It was reported that reporter's team had accidentally administered expired Moderna COVID-19 vaccine to 18 patients: 9 patients on 9-May-2022 and 9 patients on 11-May-2022 (vaccine expired 5-May-2022). After further investigation it was identified that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. This included 84 doses administered to 82 patients (as 2 patients received 2 doses from this lot more than 30 days after it was in the fridge) administered between 16-Feb-2022 and 11-May-2022. Vial did not undergo any temperature excursion.
I have had a "chemical" taste and smell since my second vaccine even though I had Covid in Oct2020 and did not have taste or smell alterations; This is a spontaneous report received from a contactable other Health Care Professional. A 59-years-old non pregnancy female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EK 923, Expiration date: Unknown) via an unspecified route of administration, in Arm Left on 07Jan2021 (at the age of 59-years-old) as single dose for Covid-19 immunisation. The patient medical history included Covid-19 on Oct2020. The patient had no known allergies. Patient had a historical vaccine of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EK 5730, Expiration date: Unknown), via an unspecified route of administration, in Arm right on 16Dec2020 (at the age of 59-years-old) as single dose for Covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received the medications within 2 weeks included calcium; linum usitatissimum seed oil; curcuma longa; cyanocobalamin; colecalciferol taken all for an unspecified indication, start and stop date were not reported. The patient was diagnosed for COVID, prior vaccination. The patient was not tested for COVID, post vaccination. The patient had experienced a "chemical" taste and smell since her second vaccine even though she had covid in Oct2020 and did not have taste or smell alterations on 08Jan2021. The patient did not received treatment for the events. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Abdominal pain, aches bone, aches joints, aches joints and muscles, cramps legs, cold and flu like symptoms, headaches, hearing problems, visions problem, pain legs, knee and hips, pain lower back pain eye, pain back.
Immediate swelling at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE SWELLING (Immediate swelling at the injection site) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced INJECTION SITE SWELLING (Immediate swelling at the injection site). In April 2021, INJECTION SITE SWELLING (Immediate swelling at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that they did monitored the patient for 30min in the waiting area and it was subsided by then. No concomitant medication were given by the reporter. No treatment information were provided by the reporter.
Patient had an anaphylatic reaction post vaccination. Patients throat progressively started to close and swell up. Patient stated it was becoming harder for her to swallow, had audible wheezing, and her whole face became numb. Patient given epi 0.3 mg and taken down to ER.
Extreme swelling in arm pit lymph nodes, with small bumps around the injection site and back of my arm. The injection site was a light purple. The spots They grew red and increased in amount. They formed a solid plaque in the back of my armpit, deltoid, and back. It was extremely itchy with pins and needles pain.
Information has been received from a Certified Medical Assistant concerning an 18 year old female who on 22-AUG-2007 was vaccinated with a first dose of GARDASIL (lot #658222/0927U) intramuscularly. On 26-JUN-2008, the patient was vaccinated with a second dose of GARDASIL. The patient was started on an unspecified birth control pill sometime after receiving both doses but prior to having the stroke. On an unspecified date, the patient had stroke when attending school and then was hospitalized. The patient is currently taking COUMADIN. The patient called the reporter's office, but had not been seen yet. At the time of reporting, the patient was recovering from stroke. The patient's stroke was considered to be life-threatening. Additional information has been requested.  3/12/09 Received hospital medical records of 12/4-12/8/2008. FINAL DX: diabetes; right cerebellar infarct w/hemorrhagic conversion; right transverse sinus thrombosis; superior sagittal sinus thrombosis. Records reveal patient experienced HA, nausea, vomiting, fevers, chills & sweats x 4 days.  Saw PCP, dx w/pyelonephritis & tx w/oral antibiotics.  Symptoms persisted & developed nuchal rigidity & pain.  Admitted directly for possible meningitis.  LP done.  Developed numbness, tingling, difficulty swallowing & double vision.  Neuro, neurosurg consults done.  Developed possible heparin induced thrombocytopenia. Transferred to higher level of care.  3/18/09 Received Rehab hospital medical records of 12/17-12/24/2008. FINAL DX: RUE hemiplegia; diplopia; cranial nerve VII palsy, left side; neuropathic pain; hyperglycemia.
Patient presented to the emergency department of Hospital on 1/16/21 with severe hypoxia to 70s% on room air and was found to have COVID-19 infection with pneumonitis. Patient is a resident where  received Covid Vaccination on 1/15/21
Patient described previously that she had muscle tightening with the 1st J  & J prior to receiving her 2nd J & and J today and knew she would be experiencing the same adverse reaction.  She was lead into a quieter  room and laid on a gurney for comfort and safety.  Upon receiving her J & J dose today after about 15 seconds, she experienced muscle tightening with both her arms, legs and her head lifted from the gurney and let out a groan.  This continued  for about 10-15 seconds every 2 to 3 minutes for about 10-15 minutes all during the time she was fully conscious.  VS was stable throughout.
Fatigue, Myalgia, Fever - Began in the morning. Fever was relieved with 1000mg Acetamenophen.  By the evening, I was started to feel relief from my symptoms. By the next day, I had complete resolution of my symptoms.
Extreme and worsening right upper hip pain, spreading to center lower back. Making it extremely difficult to take full breath. Unable to bend, sit up. Extreme pain while laying in any position and needing help to stand. Pain lvl 9.5
After about 10 minutes of observation after the injection, patient started feeling tachycardic with some chest tightness and narrowing of her vision.  No associated wheezing, shortness of breath, intraoral swelling, changes in voice quality or character.  She has had no nausea, vomiting, abdominal pain or diarrhea.  She reports rash on her chest, but no hives.  No history of allergies.  No history of vaccine reactions in the past other than feeling unwell for 24 to 48 hours after her initial and second dose of the moderna vaccine.
Pt had HIGH DOSE flu shot today at 11AM. Developed SOA, wheezing about 1:30 PM. Unresponsive to albuterol inhaler. Chest tightness worsened with, film over eyes and vision distorted prompted call to clinic. Advised to present immediately. Chest tightness, heaviness to lungs progressed in route. No oral swelling. Had been feeling well.
Chills, body aches, joint pain, fatigue, red/warm area at injection site
Tenderness and swelling of left cheek at site of cosmetic filler (Juvederm Voluma, injected October 2018) starting within 30 minutes of first Moderna COVID-19 vaccine dose. Resolved fully within 48 hours
moderate swelling of rt upper arm approx 6"x 4" warm to touch & pt c/o tx being very painful since 3NOV98 evening;pt had last pneumonia vaccine in 1992;
Got the vaccination it cost $200 that was years ago now and I still have shingles/ suspected vaccination failure; I still have shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient got the vaccination that was years ago before the reporting date and the patient still had shingles at the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
RASH ON ARMS AND LEGS (ITCHING AND HOT AND SPLOTCHY DEPENDING IN THE PART OF THE  BODY); SWELLING; REDNESS; BURNING; ITCHING; SNEEZING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced burning. On 05-APR-2021, the subject experienced itching. On 05-APR-2021, the subject experienced sneezing. On 05-APR-2021, the subject experienced swelling. On 05-APR-2021, the subject experienced redness. On 05-APR-2021 08:15, treatment medications included: hydrocortisone. On an unspecified date, the subject experienced rash on arms and legs (itching and hot and splotchy depending in the part of the body). Additional treatment medications (dates unspecified) included: loratadine, and fexofenadine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning, itching, and sneezing on 05-APR-2021, was recovering from redness, had not recovered from swelling, and the outcome of rash on arms and legs (itching and hot and splotchy depending in the part of the body) was not reported. This report was non-serious.
headache, muscle aches, armpit tenderness, arm soreness, congestion, fatigue, nausea
within 5 minutes, experienced shortness of breath, tight throat, palpitations, lightheadedness
Immunization 07/02/2003. Rash 07/15/2003- chest and back - spreading to mid legs and face. No fever. Happy
Client replied, "warm feeling and lightheadedness 2 minutes after vaccination.  EMS initiated care.  BP 160/90, P 94, O2Sat 100%.  Client states that 150/90 is her normal BP"  Monitored for 40 minutes.  Client stated that she "feels better".  Encouraged to follow up with primary care provider (PCP) and emergency services if needed.  Verbalized understanding.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 77 years old male patient who was inadvertently vaccinated with extra dose of 0.5 ml FLUZONE HIGH DOSE lot UJ036AB, exp date: 09 May 2019 via intramuscular route in the left deltoid on 15-Oct-2018. No information regarding medical history. Concomitant vaccine included PREVENAR 13 on 15-Oct-2018. It is an actual medication error due to extra dose administered. It was reported that the patient received a first dose three weeks ago and inadvertently received a second dose on 15Oct2018. It was unknown that any adverse event was occurred or not. 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 documents held by sender: none.
Mom reports started having diarrhea x 1 and vomiting several times. Had 4 Bm's x 5 days afterwards. Reports fever 104 degrees F and "red pinpoint rash" all over her body. Reports crying and was itching. 1st symptoms started day after Hep A given. No tc except "cream given and issue resolved.
Information has been received from a pharmacist who received a telephone call from a nurse concerning a patient who was vaccinated with hepatitis b vaccine recombinant (yeast) (manufacturer unknown). Subsequently the patient reacted to recombinant hepatitis b vaccine. The pharmacist did not know any details of the reaction or the manufacturer of the vaccine. Additional information has been requested.
H1N1 administered around 3 PM 2/12/10. At 4 PM; she reports she passed out for an unknown period of time; thinks a few minutes. Arms and legs felt shaky inside; heart rate increased, pupils constricted; face felt like on fire-red all night. Weak till 7 PM 2/12/10. Awoke 2/13/10 arms and legs rubbery, vision hazy; head in a fog. Not herself till midday Saturday 2/13/10. Fell 3x on Saturday. MD was notified by client 2/12/10 at 6:30 PM by client's husband.
Experienced unilateral muscle spasms on left side. Eye twitching, bicep spasms, calf spasms
Dull headache for one week and advil would not help. After the headache was gone I have a severe stiff and extremely painful left side of my neck. Have used heating pad and no I have on pain patches.
PAIN IN LEFT SHOULDER; NUMBNESS IN RIGHT LEG UPON SITTING OR FOLDING LEGS; TINGLING IN LEG ONCE STANDING OR UNFOLDED; HEADACHE ABOVE THE EYE ON THE RIGHT SIDE; TIGHTNESS IN CHEST; This spontaneous report received from a patient concerned a 41 year male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 06-MAR-2021 on left arm for prophylactic vaccination. When he had primary vaccination, about 1-3 hours after vaccination he felt dizzy, eyes shaken and then those symptoms disappeared. Face was numb then stopped, this occurred for 5 seconds. The patient took 2 Tylenol Ex-Strength Rapid release gels 500 mg before he went to bed. This did help the pain. He also took it the next day, the pain was not that bad. The day of the vaccination when he got out of the car he felt dizzy/fainting feeling that lasted about 5 seconds. The patient also experienced chest tightness, lots of cold sweats, very cold when was going to sleep, fever, shortness of breath, sex drive went down a lot and had been very low, forget, memory loss/mind not sharper like before, mind goes into a fog (between brain mind fog), get lost, headache on the left side of head, and brain freeze, and the vivid dreams at sleep (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, 1 total, administered on 13-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-DEC-2021, the patient experienced pain in left shoulder. On an unspecified date in DEC-2021, the patient experienced tightness in chest, numbness in right leg upon sitting or folding legs, tingling in leg once standing or unfolded, and headache above the eye on the right side (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightness in chest, and pain in left shoulder on DEC-2021, was recovering from headache above the eye on the right side, and had not recovered from numbness in right leg upon sitting or folding legs, and tingling in leg once standing or unfolded. This report was non-serious. This case, involving the same patient is linked to 20210313117 (case for dose number in series 1).
Morning of April 19, awoke with severe dizziness and persistent vertigo. Symptoms increased over the next two weeks, and diagnosis of vestibular neuritis was made by Dr. , ENT, of   Institute, . As of May 22, symptoms of persistent dizziness and frequent, daily episodes of vertigo (triggered by any physical activity) continue.
Complaints left shoulder joint pain,limited range of motion noted since pneumococcal vaccine on  11-10-2009.
Malaise, mild fever 99.3, headache, fatigue, cough, really bad nasal congestion, sore throat. The nasal congestion was pretty severe, cough got pretty severe at some point, went away and lingered after I felt better; sore throat was mild to moderate; fatigue and malaise was moderate to severe. I took Tylenol, Mucinex, cough drops and saline nasal flush.
ALZHEIMERS PT PULLED AWAY DURING INJECTION AND REFUSED THE REST OF THE DOSE. PT WAS GIVEN 0.04 ML AND WASTED 0.46 ML.
Starting evening of 10/02/18, started with muscle soreness /weakness in left hand (injection site was right arm) and spread to arms and legs and back. Condition improved. (22 Weeks pregnant) Seen by OB doctor.